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There is a growing worldwide shortage of nurses and other typically female-dominated medical professionals. The acute shortage of nurses in Europe has induced at least one Czechoslovakian clinic to develop a novel—albeit somewhat controversial— approach to retain and recruit hospital personnel. According to an article in today’s New York Times (which was also reported on NPR several weeks ago) “When Petra Kalivodova, a 31-year-old Czechoslovakian nurse, was considering whether to renew her contract at a private health clinic special perks helped clinch the deal: free German lessons, five weeks of vacation, and a range of plastic-surgery options, including complimentary silicone-enhanced breasts.” She opted for cosmetic breast surgery (which normally cost about $3,500) and also had liposuction on her thighs and stomach citing that she her appearance is important to her and her patients.  Perhaps, more importantly, she could never have afforded to have the procedures done on her current salary which is lower than most bus drivers. Of the 50 nurses working at the clinic, 10 opted for plastic surgery, while several more were considering it. And, at least one male employee is seriously considering liposuction.

While offering plastic surgery as an inducement to recruit and retain hospital employees is somewhat controversial, it highlights the need to improve the salaries and benefits of nursing and other medical care professionals. In many places in Europe, nurses and other hospital employees make considerably less than bus, truck drivers and other non-technical workers. The same is true in the US which has also been experiencing ongoing nursing shortages. But, hospitals and clinics here have yet to offer plastic surgery options to recruit or retain medical and support staff personnel. Unlike Europe, where cosmetic surgery is booming, plastic surgery procedures have dropped about 9 per cent this year as compared with years past.

Like it or not, cosmetic surgery is an option in today’s world and, accordingly, people ought to have the right to choose whether or not it is right for them. However, it is important to remember that cosmetic surgery is invasive and potentially serious medical complications including infection, disfiguration and death can occur. The fact that 20 per cent of the Czech nurses chose cosmetic surgery over more vacation time or free German lessons may be indicative of the growing pressure placed on both women and men to look young, vibrant and remain sexy. Further, there are marketing and employment studies which suggest that younger more attractive people get hired more easily and advance their careers more rapidly than average, older-looking ones.

When Petra Kalivodova, the 31-year-old Czechoslovakian nurse who opted for breast augmentation and liposuction was asked about her choice she said “People of my mother’s generation look down on me for getting the surgery—“I see it in their eyes. But I don’t care. I did this because I wanted to and I didn’t ask anyone’s permission, including my boyfriend.” I think her comments reflect a changing and growing attitude among women 35 and under who believe that personal choice, feminine beauty and pursuing professional careers are no longer mutually exclusive.

Until next time.

Good Luck and Good Job Hunting!!!!

 

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A much-anticipated Federal Trade Commission (FTC) report was released on Wednesday that will likely help House Energy and Commerce Chairman Henry Waxman bolster support for his fledgling follow-on biologics (FOB) bill. For those of you who haven’t been closely following the debate over proposed legislation to create a regulatory framework for approval of FOBs in the US, I provide a brief synopsis.

The Promoting Innovation and Access to Life-Saving Medicines Act (H.R.1427) introduced by US Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ) and Nathan Deal (R-GA) calls for an abbreviated development pathway (at the discretion of the agency), the possibility of substitution or interchangeability (if the follow-on biologics manufacturer can prove a high degree of structurally similarity and an identical mode of action) and five years of data exclusivity. In contrast, The Pathways for Biosimilar Act (H.R. 1548) introduced by US Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton(R-TX) requires clinical data, rigorous immunogenicity testing and limits on interchangeability and substitution provisions for follow-on biologics. Further, it calls for a minimum of 12 or up to 14 years of data exclusivity for innovator companies—a period during which FDA can’t rely on innovator data to approve follow-on biologics. For example, if a biotechnology drug was approved in 2009, the earliest that FDA could consider and approve an application for a competing follow-on product is 2021.

The FTC report concluded that a 12- to 14-year wait is unnecessary because follow-on biologics will not be offered at the same steep discounts as traditional generic drugs. It also pointed out that no evidence exists that biologic patents will not hold up. The agency estimates follow-on biologics would be sold at discounts ranging from 10 percent to 30 percent. Not surprisingly, the FTC did not recommend a specific number of exclusivity years. This allows legislators to continue to squabble and debate the point ad nauseum, until concessions are made by both innovator and follow-on biologics proponents.

The measure by Eshoo and Barton has garnered 88 co-sponsors, while Waxman and Deal's bill has 11. In the Senate, the Health, Education, Labor and Pensions Committee reached a bipartisan compromise on follow-on biologics in 2007 that allowed for 12 years of exclusivity, but that deal seems unlikely. Democrats are trying to address generic firms' concerns that brand companies could make slight changes to their products and start the exclusivity period over again. Some senators introduced a more generic-friendly bill like Waxman's earlier this year.

Conventional wisdom suggests that the data exclusivity provisions in the final legislation will be five years—a period identical to that provided stipulated in the 1984 Hatch Waxman Act, which created the US generic pharmaceutical industry. 

Stay tuned for new updates on this unfolding drama!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!! 

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Pfizer, the world’s largest drug maker, announced on Thursday that it is unveiling a new program that will let people who have lost their jobs and health insurance to keep taking Pfizer medications — for free, and for up to a year. The company will provide more than 70 of its prescription drugs ranging from Viagra to Lipitor at no costs to unemployed and uninsured Americans who lost their jobs since Jan. 1 and have been taking Pfizer drugs for me than three months. It is not clear how much Pfizer will spend on the program and whether or not costs will be capped.

The announcement comes amid massive job losses caused by the recession and a campaign in Washington to rein in health care costs and extend coverage. The move could earn Pfizer some goodwill in that debate after long being a target of critics of drug industry prices and sales practices. The program also likely will help keep those patients loyal to Pfizer brands. Don't be surprised if other pharmaceutical companies announce similar program over the next few weeks.

Pfizer and the rest of the drug industry wants is trying to have a voice in the debate over how to overhaul the U.S. health care system, partly by joining in a pledge this week to help hold down inflation of health costs. In the mean time, drug companies have been raising prices on their drugs, partly to offset declines in revenue as the global recession reduces the number of prescriptions people can afford to fill.

Pfizer ought to be commended on the program and its concern for the health and well being of unemployed and uninsured Americans. However, it is important to point out that this is little more than a high profile, marketing campaign designed to improve the image of drug makers. More important, it is the first public acknowledgement that drug makers are willing to engage legislators in discussions about how to reform healthcare to reduce costs and cut expenditures. 

What really is at stake here is whether or not the US government will begin regulating drug prices as part of a comprehensive healthcare reform package. As many of you may know, the US government, unlike most other governments in the world, cannot negotiate or set prescription drugs prices. Not surprisingly, the US prescription drug market is the largest and most profitable in the world. It will be interesting to see how the US healthcare reform discussion unfolds—clearly a lot is at stake for the American prescription drug industry.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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A team of scientists from the UK report in this week’s edition of Nature that they were able to induce the formation of ribonucleotides using ribose, phosphate and the bases adenine, uracil, guanine and cytosine and environmental conditions that may have been present in the early history of the Earth. This had been a fundamental but elusive step in the early evolution of life on Earth.

The results of the study entitled “Synthesis of activated pyrimidine ribonucleotides in prebiotically plausible conditions” provide evidence that self-assembling RNA molecules were likely the first to be formed and were likely the first step in the evolution of life on Earth. According to John Sutherland of the University of Manchester a co-author of the study, “Ribonucleotides are simply an expression of the fundamental principles of organic chemistry,” said Sutherland. “They’re doing it unwittingly. The instructions for them to do it are inherent in the structure of the precursor materials. And if they can self-assemble so easily, perhaps they shouldn’t be viewed as complicated. It’s like molecular choreography, where the molecules choreograph their own behavior. In other words, the origins of life may be much simpler than previously imagined—so much for intelligent design! 

Evolution rocks! Hat tip to Steve Munro.

Until next time....

Good Luck and Good Experimenting!!!!

 

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A quick perusal of the media coverage of the swine flu outbreak of 2009 would lead many to conclude that this outbreak has the potential to rival or surpass the 1918 flu pandemic—widely regarded as the worst influenza outbreak in history. While the emergence of a new H1N1 swine flu variant is significant note worthy— and has possible public health implications— the unrelenting, often scientifically-inaccurate media coverage did little to quell the fear and anxiety of many Americans.  Once again, the media—rather than physicians, public health officials and influenza experts—“got out in front of the story” and managed to create enough panic, fear and anxiety, the likes of which haven't been seen since the 2003 SARS pandemic. It wasn't until last Friday, when the Wall Street Journal published an interview with Dr. Peter Palese—a leading scientific expert on influenza A infections— did a clearer picture emerge about the severity and public health implications of the current swine flu pandemic.

According to Dr. Palese, there are several reasons why people and public health officials ought to be optimistic about the current pandemic:

• In 1976 there was a an outbreak of an H1N1 swine virus in Fort Dix, New Jersey, which showed human to human transmission but did not go on to become a highly virulent pandemic strain
• The presently circulating swine virus is most likely not more virulent than the other seasonal strains we have experienced over the last several years
• The current swine virus lacks an important molecular signature (the protein PB1-F2) which was present in the 1918 virus and in the highly lethal H5N1 chicken viruses.  If this virulence marker is necessary for an influenza virus to become highly pathogenic in humans or in chickens, then the current swine virus doesn’t have what it takes to become a major killer
• Since people have been exposed to H1N1 viruses over many decades, we likely have some cross-reactive immunity against the swine H1N1 virus. While it may not be sufficient to prevent becoming ill, it may very well dampen the impact of the virus on mortality.  I would postulate that by virtue of this “herd immunity” even a 1918-like H1N1 virus could never have the horrific effect it had in the past.  The most likely outcome is that the current swine virus will become another (fourth) strain of regular seasonal influenza

The landscape of vaccines and anti-influenza drugs has dramatically improved over what it was just a few years ago. Based on what we know of the structure and sequence of the swine virus, these FDA-approved drugs and FDA-licensed vaccines (modified to include the swine strain) would be highly effective against this new virus.  Also, present technologies as well as manufacturing capacities will allow us to make sufficient quantities of a swine virus vaccine for the winter 2009-10 influenza season in the US.

In other words, there is reason for concern but no need to panic beyond typical public health precautions that are taken during “normal” influenza outbreaks.

Dr. Vincent Racaniello, a viral disease expert who writes the Virology Blog, reported that as of Monday there have been laboratory confirmed cases of H1N1 infections in 30 US states with a total of 226 cases and one death in Texas. Globally, 20 countries had reported 985 cases of infection. The highest numbers are in Mexico, with 590 cases and 25 deaths. While there have been 26 deaths to date, the severity of the infection appears to be waning and person-to-person transmission appears to be low.

Unfortunately, there has been some fallout from the news media’s oft times “over the top” coverage of the pandemic. Many US hospital emergency rooms (most notably in Texas and California) have been overwhelmed and overburdened by visits from people who think they may have swine flu. Also, while some schools and daycare center closures were warranted, others may not have been. Finally, and perhaps most important, it is becoming increasingly apparent that the lay public's understanding of infectious agents and the outbreaks that they cause is grossly deficient and must be improved. 

We live in a world where viral pandemics, food poisoning outbreaks and infections caused by multiple-antibiotic resistant bacteria are becoming commonplace. While vaccines, antivirals and antibiotics can afford some protection against many viral and bacterial disease, the best way to fight infectious diseases is to understand what causes them, how they are spread and what public health measures can be implemented to prevent or control their transmission. Until the world becomes better educated about infectious diseases, we will continue to be overly-dependent on the news media during future outbreaks and epidemics.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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Do you lie awake a night overwhelmed by the possibility of another infectious disease outbreak? Well, if you want to get a good night’s sleep, I highly recommend that you take a look at a brief history of American epidemics that was published in this past Sunday’s New York Times. According to the article, history shows that the number of American epidemics has been relatively small. In fact, the author suggests that there were only nine major epidemics in the US since 1892. 

While there were several major outbreaks in the early to mid 1900s (Spanish flu, 1918; smallpox, 1947 and polio, 1952), the US has been relatively unscathed in recent years—with the possible exception of the HIV/AIDS epidemic and possibly the herpes and HPV epidemics. This is because of America’s outstanding infectious diseases surveillance networks, its comprehensive vaccination programs and modern medical and hospital infrastructures.

However, no matter how vigilant we are, there is no way to prevent infectious disease outbreaks unless the pathogens that cause the diseases are eradicated from the planet as was the case for the smallpox virus. That said, the best way to manage infectious disease epidemics is to be prepared for all contingencies.  In my opinion, the recent swine flu outbreak—this was its second appearance, the first taking place in 1976—was a practice run. And I think the world did “pretty, pretty good” as Larry David, my former NYC softball teammate and co-creator of Seinfeld would say!

Until next time...

 

Good Luck and Good Job Hunting

 

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When Rupert Murdoch, the owner of New Corporation (Fox News), bought MySpace for $580 million in 2005 it was viewed by many as one of his savviest acquisitions ever. At that time, MySpace was arguably the most successful social networking site on the Web and its financial future was extremely bright. Shortly after the acquisition, a young, upstart college social networking site called Facebook began operations without much fanfare. Back in 2005, MySpace had 14 million monthly users and Facebook was still raising capital. Now, MySpace has 126 million users whereas Facebook’s user base has grown to over 200 million. Facebook continues to expand while MySpace’s growth appears to be stagnant. This led to the dismissal last week of one of MySpace’s co-founders and the appointment of a former Facebook executive as CEO.

Since 2005, MySpace has generated about $1.6 billion in revenues and earned 200 million last year alone. However, it is important to note that a major portion of its operating capital comes from $900 million that Google guarantees every year. That agreement comes up for renewal next year and the likelihood of Google agreeing to the original terms is questionable. This is probably why Murdoch is shaking things up at MySpace. While it is likely that Google will attempt to renegotiate the terms of the original agreement, I seriously doubt that it will severe all financial ties with MySpace. That would be a bad business decision and Google doesn’t make many of those!

While many social networking pundits attribute Facebook’s ongoing success to its connectivity rather than its content, I still contend that “content is king” and social networking sites built around user-generated content are great investment opportunities. After all, status updates, pithy wall comments and photo tagging tend to “get old” quickly after a few months.

While the possible loss of Google’s annual cash infusion will hurt MySpace, I don’t think that MySpace is on its “deathbed” yet and rumors of its demise are premature. The social networking universe is vast and niche networks—not large unfocused ones—will ultimately prosper because of targeted advertising and other business opportunities. That said, I believe there will always be a place for MySpace in the social networking world.

Until next time...

Good Luck and Good Networking!!!!!!!!!! 

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National DNA Day is a unique day when students, teachers and the public can learn more about genetics and genomics! The day commemorates the completion of the Human Genome Project in April 2003, and the discovery of DNA's double helix by Watson, Crick and Rosalind Franklin.

National DNA Day is usually observed on April 25 (it was created by the US Congress seven years ago), but this year the National Human Genome Research Institute (NHGRI) will hold most of its activities on Friday, April 24 to accommodate classroom schedules. Building upon the popularity of the online chatroom and ambassador programs, NHGRI and its DNA Day partners this year have expanded their outreach efforts even further by creating National DNA Day social networking pages on Facebook and Twitter.

National DNA Day is much more than a time to honor historical achievements. It's a day filled with opportunities for students, teachers and the public to learn how the exciting field of genome research affects our lives. NHGRI researchers, called DNA Day Ambassadors, are visiting dozens of high schools throughout the nation during April to give presentations and field questions from students. This year, NHGRI is particularly focusing on the southwest region of the United States, sending DNA Day ambassadors to high schools in Utah, Colorado, Arizona, New Mexico and Texas.

No matter where they live, students and teachers can participate in National DNA Day through a live, moderated online chat with NHGRI researchers, which will be open for questions Friday, April 24, from 8 a.m. to 6 p.m. Eastern. NHGRI experts will be available to answer questions on a wide range of topics, including basic science, clinical research, genomics careers and the ethical, legal and social implications of genome research. For those unable to participate in the live event, a transcript of the chat will be available on the DNA Day Web site at National DNA Day Online Chatroom.

You can also participate online on Facebook and @dnaday on Twitter

Happy Birthday DNA!

 

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Emily Rachel Silverstein, a sophomore anthropology major and peace activist at Gettysburg College, was brutally murdered early last Thursday morning, allegedly by her ex-boyfriend, a fellow student and senior at the school. She went to visit him around 3:00 AM to console him because he called her and “he was not acting right” a family friend told me. While I didn’t know Emily well, I knew of her, and by all accounts, her response to her ex-boyfriend’s cry for help was consistent with who she was—a bright, compassionate, peace-loving, social activist who believed that the world could be a better place.   

I attended Emily’s memorial yesterday that was held in Roosevelt, NJ, a town founded by artists and social activists in the late 1940s. My wife, 15 year old son and I were there because Zach is good friends with Jaime, Emily’s younger brother and we know his parents Linda and Bob. Also, one of our best friends’ son dated Emily when she was a senior at Hightstown High School, our local high school. Everybody in the tightly-knit, surrounding communities of East Windsor and Hightstown, NJ has been grieving and affected in some way by Emily’s death.

There were hundreds of people at the memorial, many of whom who spoke and shared their stories about this beautiful and extraordinary young woman. At Gettysburg College she lived at the “Peace House,” founded a new chapter of the resurgent Students for a Democratic Society (SDS for those you who can remember) and was studying Arabic to spend a year abroad in Morocco helping battered women. As one of Emily’s best friends said “she was a vegan, but unlike some vegetarians, she didn’t chide her meat-eating friends because she believed that vegetarianism is a personal choice. That was Emily!” 

Many of the men and boys who spoke sported pony tails and beards and the women and girls who shared childhood and college stories about Emily had flowers in their hair. All of them, regardless of age, race, religion or ethnicity, spoke of Emily’s dreams and plans for peace and social change—the things that mattered most to this vibrant, smart, compassionate young woman who truly believed that she could help change the world by one act of kindness at a time.  

I hadn’t thought much about social activism since the early 1970s and found myself fondly thinking about those days and what they meant to me as young man trying to find his way in the world. And, as more people shared their stories about Emily, I remembered what it felt like to be 19 again and I began to recall my own dreams and plans to make the world a better place. Despite my profound grief and sadness, I began to experience feelings of joy and hope—because unlike some of us who have lost sight of the importance of social activism—many GenYers and Millenials have embraced it, believe in its power and plan to use it to change the world into a safer and more peaceful place.

Emily’s senseless murder was tragic, but the tragedy would be if we don’t try to keep her principles and ideals alive even though she is no longer with us. Please visit a Better World dot net a fund dedicated to the memory of Emily Rachel Silverstein. 

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Earlier this week, the US Food and Drug Administration (FDA) sent warning letters to 14 different pharmaceutical and biotechnology companies to advise them that their approach to Internet advertising is violating federal pharmaceutical advertising and marketing guidelines and regulations. While the agency’s attempt to regulate Internet-based drug advertising is laudable, the fact that warning letters were sent to 14 different life sciences companies means that there is a poor understanding of the regulations regarding use of Internet—and more recently, social media—to market and advertise drugs, medical devices and diagnostics. This isn’t surprising because FDA has yet to issue any meaningful guidance on the use of the Internet and social media to market life sciences industry products. The reluctance of the agency to issue guidance is very puzzling—the use of web based-advertising and social media by life sciences companies has exploded in the past few years.

In a post today on the EyeOnFDA blog, Mark Sendak pointed out that Twitter is fast becoming the medium of choice for life sciences messaging, branding and product promotion. Despite FDA’s lack of guidance on the use of social media, an increasing number of life sciences companies and organizations are using it to stay in touch with their stakeholders and constituents. For example, the Juvenile Diabetes Research Foundation, the Lancet, the New Scientist, Roche, Novartis, AstraZeneca, Boehringer, Cell Therapeutics and Novartis and others have Twitter accounts. Many of these companies also have fan pages or accounts on Facebook. 

It is becoming increasingly evident that the agency will have to issue guidance on social media sooner rather than later. The wide reach, immediacy and highly interactive nature of social media suggest that the current wait-and-see attitude of FDA is no longer feasible. To jump start the discussion, Social Pharmer, a group of life sciences social media enthusiasts are holding an “unconference” in Boston on April 21, 2009. I hope that FDA sends representatives to this grassroots meeting!!!

Until next time....

Good Luck and Good Job Hunting!!!!!!!

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Tainted pistachio nuts are the culprit for this week’s Salmonella outbreak.  Fortunately, Kraft Foods’ quality unit was doing its job and was able to alert consumers about the problem before the outbreak reached epidemic proportions. At present, there are only two suspected cases of Salmonella gastroenteritis that may be linked to tainted pistachios. The contamination has been traced back to a California company which, according to reports, is the second leading producer of pistachios in the US.

As I have mentioned several times before, Salmonella outbreaks are nothing new and not out of the ordinary in the food industry. However, what is new is the growing lack of regulatory compliance that seems to be pervasive at American food manufactures. Many blame declining food safety on the US FDA’s lack of trained inspectors. While this may play a role, I believe that the real problem lies with the failure of many food industry executives to make a commitment to quality outlined in FDA’s Current Good Manufacturing Practices (cGMPs). 

I have been teaching cGMP to biotechnology students for the past six years or so.  I always tell them that the regulations are meaningless unless management makes a commitment to quality. And, the only way to accomplish this is by insisting that all manufacturing taking place at a company stringently adheres to all GMP regulations and guidelines. For those you who may not be familiar with cGMPs, they are the minimum regulatory standards that must be met to insure US product (food, drugs and cosmetics) quality and safety.

Over the past decade or so, Americans have grown accustomed to a wide variety of choices when it comes to raw and processed foods. To meet demand, US food manufacturers must source and import fruits, vegetables, spices and other foodstuffs from all over the world. Regardless of the origin of a food source, cGMPs clearly state the onus is on the manufacturer (not the supplier) to perform the necessary tests to insure food safety and quality. The recent spate of Salmonella outbreaks suggests that some food manufacturers are either cutting corners or don’t fully understand what testing is necessary to guarantee food safety. Unless something changes, Americans confidence in the safety of US food supply will continue to wane.

Until next time...

Good Luck and Good Easting (avoid pistachios)

 

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It has been a long standing practice of mine to avoid co-mingling science and religious issues in any of the materials that I post online. I have refrained from doing this because I believe that enough tension already exists between religious advocates and scientists.   However, I was unable to control myself today after my wife pointed out two interesting articles in Wednesday’s New York Times.

The first article dealt with Pope Benedict XVI’s views on condom use and HIV transmission in Africa. Yesterday in Cameroon, he publicly said, for the first time, that condoms are not the answer to Africa’s fight against AIDS. Not only did this statement send a collective shiver down the spines of many HIV health workers, clergy working with AIDS patients are divided on the issue. The pope told reporters that “You can’t resolve it with the distribution of condoms. On the contrary, it increases the problem.” Apparently, church dogma suggests that fidelity in marriage and abstinence from premarital sex are crucial weapons in the fight against AIDS. There are currently 22 million people in sub-Saharan Africa infected with HIV and three-quarters of all HIV/AIDS deaths occur in the region. Apparently, attempting to be faithful and just saying no doesn’t seem to work in Africa—or anywhere else! The pope’s statement prompted a representative from the Treatment Action Campaign in South Africa to say “Instead, his opposition to condoms conveys that religious dogma is more important to him than the lives of Africans.” Ironically, Africa is the fastest-growing region for the Roman Catholic Church.

The second article reported the results of a study which showed that terminally ill cancer patients who drew comfort from religion were almost three-times as likely to seek aggressive, life-prolonging treatments as compared with less religious patents. Also, the most religious patients were much more likely to ask doctors to do ‘everything possible to keep them alive.’  Study results showed that patients who were devout were three times as likely as less religious patients to be put on a mechanical ventilator to maintain breathing during the last week of life, and they were less likely to do any advance care planning, like signing a do-not-resuscitate order or preparing a living will. The findings prompted one of the study’s authors—it will appear in Wednesday’s Journal of the American Medical Association (JAMA)—to say “People think that spiritual patients are more likely to say their lives are in God’s hands — ’Let what happens happen’ — but in fact we know they want more aggressive care.” To explain this apparent paradox, the author speculated “To religious people, life is sacred and sanctified and there’s a sense they feel it’s their duty and obligation to stay alive as long as possible.” Alternately, in my opinion it may be that religious people haven’t adequately dealt with the possibility of their demise and are hoping for miracles—medical or religious— to keep them alive because they are deathly (pun intended) afraid of dying? Regardless, aggressive life-prolonging care is expensive, Medicare spends about one-third of its budget on people who are in their last year of life and much of that is spent on patients at the very end of their lives. Moreover, researchers have found that aggressive end-of-live care for terminal patients frequently can lead to a more painful process of dying and greater shock and grief for family members.

One of the few places in the world where the nexus of religion and science is difficult to fathom is the US—one of the most scientifically advanced and religious nations in the world. Several years ago, I met a scientist at a FASBEB Career meeting who, for the first time, was able to successfully articulate to me how science and religion can co-exist in American society (she taught in the South). While I can’t recall her exact words, she said something like “Both science and religion have their purpose and place in society. However, they are belief systems that are not interchangeable. That is why I can believe in God and still fully endorse and embrace evolution. They serve different purposes for me and help me to live my life.” With this in mind, I don’t think that religious dogma should be invoked when it comes to treating patients or inhibiting advances in public health, science and medicine.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!!

 

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As many of you know, the life sciences industry, one of the most highly regulated industries of the economy has been hesitant and reluctant to embrace social media to reach out to patients, physicians and the lay public. This is because the US Food and Drug Administration, specifically Division for Drug Marketing, Advertising and Communications (DDMAC), has been mute on the subject and hasn’t issue one iota of guidance on the use of social media in the pharmaceutical, biotechnology or medical devices/diagnostic industries.

Mark Senak, a regulatory affairs lawyer and owner of the blog eyeonfda.com, invited Dr. Jean Ah Kang, Special Assistant at DDMAC in charge of Web 2.0 policy development to talk about FDA’s views and ideas about social media and its use in the life sciences industry. Listening to the 15 min podcast would be, according to Mark, “time well spent” for social media advocates in the pharmaceutical, biotechnology and medical devices/diagnostics sectors.

Hat tip and much “love” to Mark who wrote “BTW, I absolutely expect waves of love for this (the podcast)."

Until next time....

Good Luck and Good Listening!!!!!!!!!! 

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Some of you may have been wondering why the$41.1 billion Merck-Schering Plough merger announced yesterday was designed as a reverse merger. For those of you who are not familiar with the reverse merger strategy, this is how it works. Generally speaking, a failing or failed publicly traded company that is listed on one stock exchange or another merges with a privately held company. The privately held company takes over the public stock listing and manages the day-to-day operations of the new business. Private companies that engage in reverse mergers are usually looking for cash infusions for product development or a stock listing (without going through an initial public offering) which offers it shareholders immediate cash value.  Investors who previously held stock in the public company are either compensated for their shares in cash or given shares (at a negotiated price) in the new entity. Any cash (or assets) left in the public company can be used to develop the formerly private company’s product(s) and if successful, shareholders in the old public company can eventually benefit. 

If reverse mergers are designed to bolster the prospects of private companies in need of cash why was the Merck-Schering Plough deal structured as a reverse merger? As I mentioned in a post yesterday, Schering-Plough markets Remicade outside of the US under an agreement with Johnson and Johnson which sells the drug in America. A termination clause in the original marketing agreement stipulates that the ex-US rights to Remicade (and another drug being developed) would revert to Johnson and Johnson if control or ownership of Schering Plough changes. Remicade, a treatment for rheumatoid arthritis, developed by Johnson and Johnson’s subsidiary Centocor, represented $2.1 billion in sales for Schering in 2008. Further, about 70% of Schering Plough’s revenue comes from outside the US. That said, the success or failure of the deal really hinges on whether or not Johnson and Johnson will challenge the change-in-control clause for Remicade. To obviate that possibility, Merck devised an unusual reverse merger strategy in which ownership of Schering Plough will not change hands—at least on paper anyway. Instead, even though Merck is putting up the money to purchase Schering, and Richard Clark, Merck’s Chairman and CEO, will run the newly combined company, Merck would technically become a subsidiary of Schering Plough and consequently there would be no change in Schering Plough management! Recall that Fred Hassan, Schering Plough’s CEO will remain with the newly formed entity during the transition. After the deal closes, Fred would step down as CEO, Merck’s current CEO—Richard Clark—would assume leadership and quietly change the name of the company from Schering Plough to Merck.

Of course, Johnson and Johnson could challenge the deal anyway, and if Merck was to lose in arbitration, it could possibly jeopardize the entire financial upside of the deal. Merck contends that even if it loses the rights to Remicade, the deal still makes sense.  Not so, said one Wall St analyst, “I think that is a lot of malarkey. You don’t take out 20 percent of a company’s revenue and their core international growth driver and say it is not worth anything,” he said. Other analysts think that the uncertainty over Remicade puts Schering Plough shareholders at a disadvantage and one response may be for Johnson and Johnson to make a higher bid for the company.  Still others believe that, while sale of Schering Plough makes sense, the $41.4 billion price offered by Merck is too low. Johnson and Johnson didn’t comment on the deal.

Schering Plough employees who I talked with yesterday after the deal was announced are not pleased with it either. They feel that Johnson and Johnson would be a more suitable partner and that Fred Hassan, who was under enormous shareholder pressure, had no choice but to sell the company as quickly as possible. It is not surprising that many Schering Plough employees would rather have the company sold to Johnson and Johnson rather than Merck. Unlike most pharmaceutical companies, Johnson and Johnson tends to leave the companies it purchases alone and runs them as wholly-owned after it purchases them.  Another reason why a merger with Johnson and Johnson makes more sense than one with Merck is that Johnson and Johnson has a very profitable consumer products division. This would be a better fit for Schering which has several highly visible and profitable consumer products like Coppertone and Dr. Scholl’s. In contrast, Merck sold its consumer products division years ago and will almost certainly divest itself of Schering’s consumer products division after the deal closes.

Now that Schering Plough is no longer in play, all eyes are on Bristol-Myers Squibb (BMS). BMS is about the same size as Schering Plough, has plenty of cash on hand and is thought to have a robust biotechnology pipeline. And, like Schering Plough,  it has been rumored to be a takeover target for the past 20 years!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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A panel of eight judges at the Wharton School of Business at the University of Pennsylvania was asked to identify the top 20 life-altering technologies that were developed over the last 30 years. The survey was sponsored by Knowledge@ Wharton, U Penn’s business publication and the PBS’s “Nightly Business Report.” 

Not surprisingly, the Internet was voted the top innovation followed by computers, mobile phones and e-mail. Interestingly, DNA sequencing and testing was listed as number 5—one of five technologies from the life sciences and medical sectors—the others being MRI, laparoscopy, genetically-modified plants, biofuels and anti-retroviral (HIV) drugs. Finally, Internet social networking, a recent innovation, made a surprise appearance on the list at number 20!. The entire list is as follows:

1. Internet, broadband, WWW (browser and html)
2. PC/laptop computers
3. Mobile phones
4. E-mail
5. DNA testing and sequencing/Human genome mapping
6. Magnetic Resonance Imaging (MRI)
7. Microprocessors
8. Fiber optics
9. Office software (spreadsheets, word processors)
10. Non-invasive laser/robotic surgery (laparoscopy)
11. Open source software and services (e.g., Linux, Wikipedia)
12. Light emitting diodes
13. Liquid crystal display (LCD)
14. GPS systems
15. Online shopping/ecommerce/auctions (e.g., eBay)
16. Media file compression (jpeg, mpeg, mp3)
17. Microfinance
18. Photovoltaic Solar Energy
19. Large scale wind turbines
20. Social networking via the Internet
21. Graphic user interface (GUI)
22. Digital photography/videography
23. RFID and applications (e.g., EZ Pass)
24. Genetically modified plants
25. Bio fuels
26. Bar codes and scanners
27. ATMs
28. Stents
29. SRAM flash memory
30. Anti retroviral treatment for AIDS

If your favorite technology wasn’t listed in the Top 30, please let me know and we can add it to the list!

Until next time...

Good Luck and Good Job Hunting (try social networks)!!!!!!!

  

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If you are not convinced that vaccines are safe, please listen to a conversation between Dr. Ginger Campbell of the Brain Science Podcast and Dr. Paul Offit.

Dr. Offit is a pediatrician who is also Chief of Infectious Diseases and Director of Vaccine Education at the University of Pennsylvania School of Medicine. He is co-developer of the rotavirus vaccine and author of the book Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure. This book should be read to obtain a complete appreciation of the vaccine-autism controversy. However, I found the podcast also highly compelling, because Dr. Offit is extremely knowledgeable and an excellent speaker.

The furor surrounding childhood vaccines began when Wakefield, a British gastroenterologist, published a Lancet article in 1998 claiming to show a link between the measles-mumps-rubella vaccine (MMR) and development of autism in children. Although the study was flawed, it established a clear question: does MMR cause autism? This question has been addressed in 12 different epidemiological studies involving millions of children who either did or did not receive the vaccine. The answer is quite clear: that vaccine never caused autism. Here are Dr. Offit’s thoughts on this:

…science is enormously self-correcting. Andrew Wakefield stands up in 1998 and says, ‘I believe MMR causes autism.’ Well, he raises a hypothesis. It’s a testable hypothesis. It’s been tested. He was wrong. And that’s what I love about science. It’s just enormously self-correcting, and I just think people don’t see it that way¹

The original Wakefield paper has been retracted by 10 of the 13 authors. However, the damage has been done: immunization rates with MMR have dropped in the UK, Europe, and the US. The incidence of measles is increasing and there have been deaths of children from the disease. Deaths that could have been prevented had parents chosen to have their children immunized with MMR. The controversy over MMR has lead the public to distrust all viral and bacterial vaccines, and consequently the incidence of other preventable diseases is rising.

The notion that MMR causes autism was accompanied by safety concerns about thimerosal - a mercury-containing preservative used in some vaccines to prevent microbial contamination. The results of several large epidemiological studies found no connection between autism and thimerosal. Nevertheless, the preservative was removed from most childhood vaccines - probably an error, according to Dr. Offit, which simply made parents more suspicious. Autism rates have not dropped since the use of thimerosal was discontinued.

Many parents still do not believe the conclusion that vaccines do not cause autism. Part of the problem is that the etiology of autism is not understood. To a parent, the temporal association of immunization with onset of autism is difficult to ignore. Dr. Offit recalls a story which addresses this issue:

…it’s hard to make a statistical argument, or an epidemiological argument, to a parent who’s seen something that’s very emotional. There’s a story that I tell, because I think it’s a powerful one. My wife is a privately practicing pediatrician in the suburbs. And she was in the office one day and there was a four-month-old sitting on her mother’s lap. And my wife was drawing a vaccine into a syringe that she was about to give this child. Well, while she was drawing the vaccine into a syringe the child had a seizure, and actually went on to have a permanent seizure disorder—epilepsy. And there had been a family history of epilepsy, so she was certainly at risk for that. If my wife had given that vaccine five minutes earlier, I think there’s no amount of statistical data in the world that would have convinced that mother that anything other than the vaccine caused the seizure, because I think those sort of emotional events are very hard to argue against.

Some have accused Dr. Offit of pandering to the pharmaceutical establishment and enriching himself by publishing Autism’s False Prophets. I don’t think these arguments contain a shred of truth. Dr. Offit is donating all the royalties from the boook to autism research. More compelling are his words from the interview:

I worked on that (rotavirus) vaccine because I thought that it could do a tremendous amount of good for children. It’s the same reason that I stand up for the science of vaccines and the science of vaccine safety. I care about children. That’s my motivation.

¹Quotations by Dr. Offit are taken from a transcript of his conversation with Dr. Ginger Campbell.

 

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How many of you read the printed ingredients and nutrition fact boxes found on packaged foods to help you decide which of two similar products you ought to buy? What if the same concept was applied to direct-to-consumer (DTC) prescription drug ads? Do you think that it would be easier to determine which of two similar medications may be best for you? Well, researchers at Dartmouth Medical School think so! And, they are urging the US Food and Drug administration to adopt a similar concept for all DTC advertising.

Based on results from two randomized, clinical studies, the Dartmouth team proposed that numerical tables that quantify the benefits of a drug (compared with placebo) and also the odds of developing certain side effects should be included on DTC advertisements including television, print and web-based ads. In those studies, patients were shown drug ads that did and did not include a fact box. Participants looked at ads (with and without fact boxes) for two similar prescription heartburn medications and two widely prescribed cardiovascular drugs. The trial using the heartburn medications was designed to evaluate consumer decision-making about drugs that are used to treat symptoms whereas the cardiovascular medications trial was used to evaluate decision-making about the use of preventative medications that reduce the risk of future events, e.g., heartache or stroke.

Overall, the researchers said, the addition of facts boxes to prescription drug ads allowed consumers to make better decisions about the choices of drugs for their symptoms and were better informed about the benefits of drugs that could be used for prevention. For example, when asked which drug they would choose for heartburn 68 percent of those who had seen ads with facts boxes picked what the researchers referred to as "the superior drug," as compared with 31 percent of those who had seen ads without facts boxes. Also, about 80 percent of the facts-box group, as compared with 38 percent from the non-fact-box group, knew that both drugs had similar side effects. After looking at cardiovascular drug ads with or without fact-boxes, 72 percent of those who saw ads with facts boxes correctly described the risk reduction associated with both drugs whereas only 9% of non-fact-box participants were able to do this.

DTC advertising is big business—last year the pharmaceutical industry spent approximately $4.8 billion on television and print ads alone. While DTC advertising is known to influence prescription drug sales, it is also somewhat controversial suggested Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine "Direct-to-consumer drug advertising is controversial in medical circles, largely out of concern that drug companies will talk patients into preferences not in their best interest, "But I often encounter the opposite problem in my patients. After hearing the litany of potential side effects of a drug, they absolutely refuse to take it," Katz said. Nevertheless, he and the Dartmouth researchers agree that better-informed patients make better drug choices.

Drs. Woloshin and Schwartz, leaders of the Dartmouth team, are scheduled to present their findings tomorrow to an FDA advisory panel on “risk communication.” The panel is tasked with examining how best to provide consumers with data about prescription drugs using printed matter. 

Adding fact-boxes to print, television or web-based ads won’t substantially increase the cost of creating and producing them. Also, rather than hurt prescription drug sales—what most pharmaceutical companies are worried about—the new approach may be good for the industry. According to Robert Ehrlich, who heads DTC Perspectives, a company that specializes in pharmaceutical marketing, “If there is high benefit and low risk, doctors will prescribe more of the drugs. If there is low benefit and high risks than the drug should probably not be on the market,” said Ehrlich.

Stay tuned for updates.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

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Over the past ten years or so, pundits have been warning that the US is losing its competitive edge and that it is no longer the world’s leading nation when it comes to innovation in science and technology. Measuring national competitiveness and innovation is very tricky business and until now, most of evidence to support these claims has been anecdotal. According to an article in today’s New York Times, a report by the Information Technology and Innovation Foundation suggests that the US ranked sixth among 40 countries and regions based on 16 indicators that measure innovation and competitiveness including venture capital investment, numbers of per capita researchers, research spending and educational achievement. 

While the results of Foundation study may be troubling (if you are a US citizen), another recent study conducted by the World Economic Forum found that America ranked first in innovation and global competition. However the forum’s report was based entirely on opinion survey data.  Like the forum report, a study conducted by the Rand Corporation last year, also found that “the US was not in any imminent danger of losing its competitive advantage in science and technology.” The use of the word “imminent” is perhaps the most telling aspect of the Rand Corporation’s conclusion about American competitiveness.

The US lost ground to much smaller countries like Sweden, Finland, Taiwan, Singapore and also to one of it's main competitors, China.  Unlike the US, all of these countries are pursuing government-sponsored initiatives designed to promote innovation and global competitiveness. Some of the elements of these initiatives include education, workforce development training, intellectual property protection and immigration. Surprisingly, results from the foundation report (adjusted for population and size of each economy) showed that the US ranked sixth in venture capital investment (Sweden was first); fifth in corporate research and development spending (Japan was number one) and fourth in the number of science and technology researchers (again Sweden was first). Over all, Singapore ranked first in innovation and competitiveness. As some of you may know, Singapore--for the past 10 years--has heavily invested in the life sciences and has managed to induce some of world’s leading bioscientists to immigrate.

One of the main recommendations of the report suggests that the federal government ought to follow the lead of the individual states, many of which developed state government-sponsored programs designed to attract investment, talent and improve the work force skills of  local would be employees. Further, the report specifically recommends that the federal government offers tax breaks and incentives to induce American companies to innovate at home rather than outsource R&D activities abroad. Some of these incentives could include tax research tax credits  and increased federal funding or corporate tax breaks for workforce development programs.

Finally, one of the most shocking statistics that I heard in President Obama’s speech to Congress last evening was that 50% of American students drop out of high school and over 50% of college students never complete their education. This begs the question: How can America expect to remain competitive when a majority of its population is less educated than the rest of the developed world? 

A past commitment to education is what propelled the US to become a world leader in innovation and competitiveness.  To regain its past status as an innovator, the US must overhaul and vastly improve is primary, secondary and post secondary education system. This is something that cannot wait—the future of American depends on it!

Until next time...

 

Good Luck and Good Job Hunting ( give teaching a shot)

 

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The sequence of all known rhinovirus genomes reported in Science last week is an important advance for the field. Analyses of the sequences have revealed new relationships among the viruses, evidence for recombination, a new viral species, and conserved regions of the genome. These findings will be extremely valuable for those studying the biology, pathogenesis, and epidemiology of the common cold. But the press has over reacted to this work -  it was reported on the front page of the New York Times with the headline “Cure for the Common Cold? Not Yet, but Possible“.  Does the work deserve such fanfare?

The Times quoted Stephen Liggett, an asthma expert, as saying “We are now quite certain that we see the Achilles’ heel, and that a very effective treatment for the common cold is at hand.” He was apparently referring to the observation that a sequence within the 5′-noncoding region of the viral genome is highly conserved among the 99 rhinovirus sequences, in comparison with other regions of the viral RNA. He suggested that all 99 rhinovirus serotypes would therefore be susceptible to the same drug. But what kind of drug, and what function would it inhibit? The very 5′-end of the genome of enteroviruses and rhinoviruses binds viral and cellular proteins, and these interactions are essential for viral replication. So it might be possible to identify small molecules that block these protein-RNA interactions. But such drugs are very difficult to identify. Furthermore, if such a drug were identified, its efficacy would have to be tested against all rhinovirus serotypes. Therefore it is not clear that knowing that this sequence of the genome is conserved helps to identify drug targets and more readily than did the observations made years ago about the importance of RNA-protein interactions in this region. Clearly, many years of research are needed before such drugs are developed - not consistent with Dr. Liggett’s a treatment is ‘at hand’.

An even more crucial aspect of the problem was omitted from the Times article. Even if an antiviral drug could be identified that blocks essential RNA-protein interactions, it probably would not be useful in treating the common cold. As we discussed last week, rhinoviruses cause acute infections - characterized by rapid onset of disease, a relatively brief period of symptoms, and resolution within days. Most are complete by the time the patient feels ill, and the virus has already spread to another host. Antiviral therapy  must be given early in infection to be effective. There is little hope of treating most acute viral infections with antiviral drugs until rapid diagnostic tests are become available.

 

 

Continue Reading...

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In the February issue of Genetic Engineering and Biotechnology News, J. Leslie Glick a former CEO of Genex and veteran of the biotechnology industry put forward a novel solution to financial crisis that is currently gripping the life sciences industry and the rest of the US economy. Dr. Glick proposed that the US government ought to consider injecting taxpayer monies into venture capital firms (VC) which, he believes, would foster creation of new companies, create more jobs, stimulate the ailing economy and also provide the government with an outstanding return on its investment.

According to Dr. Glick, “historical results reported by the National Venture Capital Association for the 20 year period ending December 31, 2007, show an annualized return of 16.7% to investors in some 1,860 U.S. venture capital and private equity partnerships. If the U.S. government had made annual investments of $10 billion in VC firms throughout the U.S. during that 20year period, the $200 billion total investment would have yielded a total return of almost $1.5 trillion.” Further, he asserts that according to the  International Trade Administration of the Department of Commerce, from 1970 to 2000, U.S. VC firms invested over $270 billion in more than 16,000 companies. In 2000, the surviving VC-backed companies employed 7.6 million people, representing 5.9% of all U.S. jobs, and generated sales of $1.3 trillion, accounting for 13.1% of the U.S. GDP.

This financial upside sound enticing but who is going to keep track of the money and keep an eye on how and what the VCs are investing in? Dr. Glick proposes creation of a non-partisan funding mechanism, possibly overseen by an independent panel of business people that would disburse $10 to $25 billion annually of taxpayer’s dollars to vetted and certified VC firms. Because of its investment, the US government would become a limited partner in these firms and could direct them to invest in technologies that would help to reduce health care costs, develop energy alternatives or improve food production capacity. While this proposal is unprecedented and controversial, we are living in extremely uncertain financial times that may necessitate innovative and out-of-the-box solutions to restore normalcy to the US economy. That said, all proposals—no mater how unconventional or outrageous—ought to be carefully evaluated and vetted to determine whether or not they have merit to help overcome our deepening recession.

Kudos to Dr. Glick!

Until next time,

Good Luck and Good Investing!!!!!!

 

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While I have never been layed off, I understand how awful and painful it must be. After all, unlike people who were fired for cause or otherwise, most people who are layed off are performing well but they simply became too expensive or expendable to remain with a company facing financial exigency.

Most of us feel for employees who have been layed off—anyone who has experienced a layoff will tell you that it can be a life altering or changing event. But, what about the people who are charged with delivering the bad news to the employees who will be layed off? How do you think they feel and what impact does it have on their lives? 

There was a poignant and heartfelt piece in this past Sunday’s New York Times that was written by a company executive who made the decision to layoff workers and then delivered the news to them himself. While his plight doesn’t compare with that of the employees who lost their jobs, it shows how difficult and disruptive layoffs can for companies that are forced to downsize.

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

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Convincing students and adults that science can be fun and even cool at times can be a very challenging proposition. This is mostly because science is perceived as “being hard” and in many cases, the people who teach science are not appropriately trained. Consequently sciences classes are frequently boring and unimaginative. Nevertheless, creative scientists can sometimes figure out ways to overcome these negative perceptions of science. One of the best examples of this is the use of the Green Fluorescent Protein (GFP) in some so-called consumer products.  While this application of GFP may pose ethical dilemmas for some, I haven’t met many children or adults who don’t think that transgenic mice, fish or flowers that glow green, red, blue or yellow (or a combination of these colors) in dark aren’t cool! While this wasn’t GFP’s intended use—the scientists who first demonstrated GFP’s utility as a genetic engineering application won a Noble prize last year—it certainly exposed the lay public to wonders and powers of modern day scientists.

With this in mind, researchers at the University of Tokyo’s Institute of Industrial Science (IIS) announced that they had created a 5-millimeter tall doll composed of living cells to demonstrate a new method for fabricating three-dimensional living biological structures. The researchers created the tiny figurine by cultivating 100,000 cell capsules — 0.1-millimeter balls of collagen, each coated with dozens of skin cells — together inside a doll-shaped mold for one day. After the cells had fused to form the doll-shaped structure, it was placed in a culture solution and survived for more than 24 hours. The researchers hope to use the method to create tissues and organs with complex cellular structures, which may prove useful in the fields of regenerative medicine and drug development.

While this new technology may never rival GFP and its multitude of applications, it shows that scientists like to have fun from time-to-time and can introduce complex scientific ideas to the lay public.  In my opinion, many kids get turned off to science at an early age because we scientists take ourselves too seriously and rarely explore ways to inject fun into sometimes tedious and boring material. After all, nobody made it fun for us and we became scientists anyway! We live in a different world now and I can see from watching my own children grow, that today’s  kids today are inquisitive, creative, comfortable with sophisticated technologies and open to new ideas—requisite traits for all scientists!

Unlike the past eight years, a new window of opportunity exists to challenge and convince young people that science is fun and can be very cool at times. To accomplish this, we science educators must step outside of our comfort zones and begin to inject some fun and wonderment into science. The kids will love it and I suspect so will we!

Until next time…

Good Luck and Good Teaching!!!!!!!!!!

 

 

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About a year ago, I was eating lunch and bunch of pharma executives were at the table next to me. I inadvertently overhead bits of their conversation and I heard the words, Facebook, MySpace and YouTube mentioned. This suggested to me that pharma was more aware of social media (and its business implications) than pharma publicly cared to admit. Pharma has been reluctant to embrace social media because of possible legal and regulatory ramifications. Nevertheless, a few companies have decided to boldly go where no pharma company has gone before—to YouTube.

The Eye on FDA blog, which is very bullish on social media, has been keeping aof pharma companies that have created channels on YouTube, the video site owned by Google. To date, Sanofi Pasteur, GSK, Abbot and JNJ have taken the YouTube plunge (see SanofiPasteurTV , GSKVision, AbbottChannel, andJNJHealth).  I suspect that pharma companies are willing to take a risk on YouTube, because unlike other social media platforms, they can disable the functionality that allows viewer to leave comments, kudos or kvetches after viewing videos. This shields the companies from unwarranted claims, misinformation about its products and negative publicity.

At present, the US Food and Drug Administration, has issued little or no guidance on the use of social media by drug makers. This means that drug makers are in uncharted territory and can experiment with social media without fear of much regulatory oversight or scrutiny.  Now that pharma has broken the social media barrier, I wonder whether MySpace, Facebook and Twitter (the hottest new social media tool at the moment) will be next. Interestingly, I learned yesterday that Novartis uses twitter and can be followed @Novartis.

Off the record conversations with MySpace representatives suggest that a number of pharmaceuticals have quietly created branded product pages on MySpace for years.  As the MySpace rep put it, how can you ignore an audience of 60 million people?  Further, Facebook’s fan pages are growing in popularity and don’t be surprise to see pharma pages begin to appear there. It will be interesting to see how pharma will incorporate social media into its business and marketing models in the future.

Until next time…

Good Luck and Good Video Watching!!!!!!!!

 

 

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Vincent Racaniello, a pioneer in RNA virology and world class researcher on the pathogenesis of polio, believes that social media can be used to enhance scientific research and improve science education. Vincent recently blogged about this on his virology blog and graciously allowed me to repost it to BioJobBlog. It is an interesting perspective from an innovative and creative scientist.

 

Science and the Social Web

In a previous post about why I blog and podcast, I discussed how these activities allow me to think more about virology and to teach far more people than I ever could in a laboratory or classroom. Is there even more value in the web for scientists?

There are three different web activities, besides blogging and podcasting that enhance science in new ways. The first is the ability to post comments on blogs and podcasts. In so doing, people can interact in ways that were not previously possible. Scientists who have never met, or students hoping to learn, all can connect and create an instructive and creative dialog. Don’t understand something in a post? Just ask. Have something different to contribute? Post it. Science can only benefit from interactions not limited by geography or time.

The second powerful web tool for science is the social networks. We know how MySpace and Facebook made it easy to meet and interact with new people. These networks also allow scientists to connect and talk about their profession. There are various groups on Facebook that enable focused, productive discussions among scientists. Even more useful are the social networks that have been developed specifically for scientists - well over 20 according to this  blog post. These networks exist to foster interactions - meeting other scientists, looking for jobs, troubleshooting experiments, finding answers to thorny questions. The value of scientific social networks is that they enable dialogue far beyond what you could achieve on your floor, in your building, by telephone or email. The result is scientific interactions at unprecedented levels.

The third web tool for scientists is Twitter. This microblogging platform restricts users to posts of 140 characters or less - the end result is concentrated information. For scientists, Twitter can be either a distraction or a gold mine. If you choose to follow individuals who are interested in science, you will, in the course of a day, find tweets with links to interesting science - news or journal articles; comments on science; questions about science or science methods - in brief, the kind of exchange originally facilitated by email but far more immediate and pithy. Follow the right people on Twitter, and receive useful information. I keep an eye on Twitter to find tips on how scientists use the web, the latest science news, and comments on science in general. In turn, when I learn of an interesting science news event or article, I tweet it. Mr. Tweet’s discussion of  the evolution of a twitter user crystallizes this concept.

There is also great value for scientists at FriendFeed. No, it’s not a fourth category - it’s an aggregator of the three activities described above, one-stop for all your blogging, podcasting, social networking, and twittering.

These three aspects of the social web are revolutionizing science. By using them, I am learning more about my field than I ever have before. Those who choose not to take advantage of the social web will miss the opportunity to become more creative and productive scientists.

 

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Salmonella enteriditis, an organism dear to my heart (luckily not my posterior small intestine) is a common cause of food poisoning. As some of you may know, I did my PhD thesis work on Salmonella gastroenteritis (aka food poisoning) and I like to think that I am something of an expert on the topic. 

Typically, Salmonella food poisoning outbreaks are localized and rarely reach epidemic proportions. However, there have recently been two major nationwide Salmonella outbreaks in the US —one in 2007 and now in early 2009.

The current outbreak has afflicted 388 people in 42 states and may be caused by the same strain (Saint Paul) that was responsible for the 2007 outbreak. Ultimately, the 2007 outbreak was linked to contaminated tomatoes. The jury is still out on the cause of the most recent outbreak. Needless to say, CDC scientists are scurrying to quickly identify the source of the current outbreak because it took the agency over 5 months to conclusively identify the culprit in the 2007 epidemic. Not surprisingly, many grocery stores and restaurants suffered financially because of the outbreak.

Many of you may be wondering why Salmonella food poisoning is becoming such a problem in the US. I don’t believe that the strains responsible for the most recent outbreaks are more virulent than the ones that have traditionally caused more localized outbreaks. Instead, the reliance of food manufacturers and grocery store chains on one or two major food distributors (rather than multiple suppliers) is likely responsible for the severity and breadth of these nationwide outbreaks. This suggests that regulatory agencies ought to more closely scrutinize the microbiological quality of the operations of the major distributors. I believe that those efforts would greatly reduce the likelihood of future major outbreaks of food poisoning.

Until next time.

Good Luck and Good Job Hunting (avoid raw vegetables, undercooked poultry and raw eggs)
 

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For those of you virology junkies out there, This Week in Virology (TWiV) has just released a podcast on the top 10 virology stories of 2008. BioCrowd founder, Vincent Racaniello and Alan Dove, a professional science writer (and one of Vincent's former students), discuss their top picks for 2008 and make some predictions for 2009.

For those of you with no plans for this evening’s festivities, open a bottle of champagne, kick back and have a listen—it's good stuff!

Until next time…

Good Luck and Good Job Hunting!!!!!

 

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Like it or not, the best way to land a new job whether or not there is a recession is to network. While career counselors and recruiters trumpet the virtues of networking to job seekers, many people really don't understand what it is or how to do it correctly. I found an outstanding article that demystifies networking and offers tips on how to excel at it. 

For many scientists, online networking is ideal because they frequently lack the requisite skills to effectively network in real life situations. Until recently, face-to-face networking at conferences or "professional social events" was the only way to effectively network. However, the advent of web-based social networks allows job seekers to eschew the awkwardness and time requirements for  one-on-one networking in favor of a more convenient and less-threatening online experience. BioCrowd, a new online social network for scientists and other bioprofessionals, was created to help scientists advance their careers and find new jobs. While BioCrowd and similar online networking sites can help scientists make connections, it is still the face-to-face networking experience that will ultimately  help them land new jobs!

Because networking is not taught or emphasized in graduate school, it is not surprising that many graduate students and postdoctoral fellows are notoriously poor “networkers.” That said, for those of you who recognize the importance of networking and want hone your networking skills, Contacts Count a Maryland-based network training company may be worth a visit. I have no doubt that there other organizations and companies out there that specialize in network training. If you find any, let me know and I will gladly post them!

Until next time…

 

Good Luck and Good Job Hunting

 

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I had little to do last night, so I decided to download Stumble Upon for Firefox.  While I was stumbling, I came across an outstanding video that teaches and reinforces the underlying principles of chemical reactions. If I had this type of tutorial when I was an undergraduate, I might very well have become a chemist rather than a biologist!

 

Until next time….

Good Luck and Good Reactions!!!!!!!

 

 

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For the past five years, I have been giving career development seminars that offer graduate students and postdoctoral fellows alternate careers choices (instead of research) for life scientists. The intent of these seminars is to get students who may not be enamored with a possible life long career at the bench (I know that there a lot of you out there) to think about what they really want to do after they complete their graduate or postdoctoral training.

I recently met Jane Chin (on Twitter) who, like me, has had an unorthodox career trajectory for a life scientist. After exchanging several tweets, I learned that we both are microbiologists, Cornell University graduates, entrepreneurs and social media enthusiasts. But, the main reason I am telling you about Jane is that she crafted a fascinating PowerPoint presentation entitled “3 Lessons About Career Life From a Career Nomad” that provides insights into the decisions and choices that she made to shape her current career path. I highly recommend that you take a peek at the presentation—it may help to reduce some future career stress and angst!

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

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Vincent Racaniello, my partner at BioCrowd, and I were chatting the other day about how cool it would be to develop a web-based map that was able to track infectious diseases outbreaks in real time. After a spirited chat, we both thought that we were on to something REALLY big. And, as is frequently the case, somebody else also had the very same idea.

For those infectious disease aficionados out there, you must check out the Health Map: A Global Disease Alert Map. The map was developed by Clark Freifeld and John Brownstein and is based on an algorithm that is beyond my comprehension. It is not as robust as the map that Vincent and I envisioned, but it is pretty cool and it works very nicely.

Until next time…

Good Luck and Good Disease Hunting!!!!!!!

 

 

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Recently, I have come across posts on blogs and websites reporting on lay offs and cost-cutting measures that are taking place at some biotechnology companies. A good example of this is a post that appeared yesterday on the Fierce Biotech Web Site. The headline read: “New round of layoffs, cost-cutting at biotechs.”  I thought “OMG this can’t be happening—not the biotechnology industry too!”

However, I am happy to report that many  of my concerns were assuaged after I read the post and realized that the reported downsizing was taking place at small companies, most of which were on shaky ground before the recession even began. Some of the companies that were mentioned included: Titan Pharmaceuticals, Pressure BioSciences, Insite Vision, WuXi PharmaTech Cayman and Targeted Genetics—not exactly titans (pardon the wordplay) of the biotechnology industry. 

There is no question that the current economic downturn will hurt some biotechnology companies (mostly because debt financing is so difficult to secure these days). That said, I think that the biotech industry may struggle a bit over the next couple of years but it will survive because it is in much better financial shape than most other American industries. 

It is important to note that the downsizing and cost-cutting taking place at many pharmaceutical companies is based almost exclusively on projected lost revenues that may occur 2-5 years two years from now—when many blockbusters drugs begin to lose patent protection— not on immediate cash concerns (most pharma companies have plenty of cash on hand). Pharma companies began downsizing in earnest about two years ago because they realized that they had gotten too big and their empty pipelines could no longer justify employing large numbers of unproductive employees. In my opinion, the current economic downturn provided pharmaceutical companies with a good excuse to continue to lay off employees, slash costs and maintain their stock prices. 

Many of the companies mentioned in the Fierce Biotech post have been around for 5-10 years and haven’t been profitable since their inception. As a former business partner once said to me “You don’t really have a business unless you have a product to sell and are profitable.” I suspect that many of these so-called biotechnology “companies” will go out of business—not because of the recession—but because they were unable to develop financially-viable products or services.

 Until next time…  

 

 Good Luck and Good Job Hunting!!!!!

 

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This post was originally written by Vincent Racaniello, a long time friend and colleague, who runs the Virology Blog. 

Here is what Vincent had to say:

My colleagues (generally the older ones) often ask me why I blog or podcast. They believe that I am wasting my time. After all, I am a scientist, and it is my job to carry out research. In order to do this I must publish papers and obtain grants. The grant funds are used to pay salaries (mine and those in my laboratory) and purchase the supplies needed for research. In my institution, nothing matters except raising money for research. Teaching, mentoring, and other community services mean very little. Blogging and podcasting do nothing to help fund my laboratory.

Here are my answers. Why did I go into science? Because my parents (physician and teacher) and my teachers inspired me. But for many other children, the only inspiration they have is their teachers. They need input from other sources. I believe I can help provide that input over the internet.

Most people - kids, teens, adults - don’t understand science. Their teachers can provide only a very rudimentary, often flawed view of some of the fundamental concepts. While I cannot cover all of science, I can do a good job of teaching what I know. I have been studying and thinking about viruses for over 30 years, so I understand them quite well. I am also able to talk and write about them clearly and concisely, a gift I probably received in part from my teacher parent. These qualities put me in a unique position to educate the public about viruses. 

Early in my career, I didn’t think much about teaching. I focused on research. Later I realized I had a reasonable ability to communicate what I knew, which turned into a love of teaching. My blogging and podcasting about viruses represent part of the effort to impart some of my knowledge to the public. 

As I have read and heard many times on the web, if you want to blog or podcast, do it about something you are passionate about. And that is what I am doing.

 

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Bruce Charlton, a professor of theoretical medicine at the University of Buckingham and Editor in Chief of the journal Medical Hypotheses recently published in Oxford magazine and his blog a provocative and controversial article entitled “Why Scientists Are So Dull”

The article, which caused a firestorm in the UK was crafted to get the scientific establishment to rethink its parochial approach to scientific training and career development for young scientists. Because of the blunt nature and in-your-face tone of the article, Dr. Charlton may have alienated some would-be supporters who unfortunately failed to see the intended humor and call-to-action of the article. Unfortunately, in my experience, the public perception of scientists is consistent with Dr. Charlton’s claim—that, we as a group, are dull.

Throughout my career, I have routinely been asked by non-scientists (after meeting them in social situations) “You’re not really a scientist—are you?” Invariably, they say something like “You are too funny and too much of a character to really be a scientist.”

I know that stereotyping is inherently dangerous and wrong, but stereotypes usually originate from commonly observed, shared characteristics (traits) exhibited by members of a particular group of people. That said, maybe it is time for us to let the lay public know that not all scientists are dull, “eggheads” types and that many of us are very insightful, creative people. In my opinion, the only way for us to lose the ‘dull’ moniker is to publicly promote the importance and creative aspects of science whenever we can. To that end, it is time for us to log off of our computers, leave our laboratories and let the world know that—contrary to public opinion—we aren’t DULL people!!!!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

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For those of you who want an answer to this age old question, check out this post at the What’s New In Science Research blog.

Personally, I only feel tired after eating turkey on Thanksgiving….maybe my sleepiness has more to do with overeating and excessive drinking rather than anything to do with turkeys?

Happy Thanksgiving!!!!!

 Until next time.....

Good Eating and Good Napping!!!!!!!

 

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The other day I was chatting with Tony Stubblebine of CrowdVine (the social networking company building BioCrowd for us) and I was lamenting the possible burst of the social networking bubble before BioCrowd is launched. Tony reassured me and said that “Everyone thinks that after the dot-com bubble burst that almost all Internet-based businesses failed. However, when you look more closely, you will find that this simply isn’t true—there were many survivors who were able to build robust business as the Internet matured.”  While I felt a bit better after hearing that (Tony generally knows what he is talking about) I wasn’t totally convinced that he was right. After all, I am one of his customers who are building a new social network. That said, the very next day after my chat with Tony, I found an unusually. insightful article in the New York Times entitled “Lessons of Survival, From the Dot-Com Attic.”

The authors of the article suggest that based on their analysis of existing data that 48% of dot-com companies founded in 1996 were still in business in 2004 (more than four years after the Nasdaq’s peak in March 2000 and the so called dot-com bubble burst). According to the authors, “most people are stunned by this figure: they tend to guess that about 90% of the companies failed.” Further they suggest that “the dot-com survival rate is as good as or better than that for technologies like automobiles, tires and televisions during their formative years.”

How did the dot-com survivors do it? Instead of trying to a make a big splash in high profile market sectors, they identified niche markets that didn’t offer ROIs of hundreds of millions of dollars returns but represented viable Internet-based, business opportunities that could flourish if nurtured correctly. This largely assuaged most of my concerns about a possible impending social network bubble bust and proved to me that Tony knows his stuff! So, whether or not the social network bubble is going to burst, BioCrowd will be launched and we hope that like any new member of a species that it will be strong and fit enough to survive! 

Until next time.

Good Luck and Good Job Hunting!!!!!!!

 

 

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I never truly understood the power and reach of Twitter until I caved in and started using it about a month ago. Over the past couple of weeks, I realized that Twitter is an ideal tool for networking and job hunting. Apparently, I am not alone. Miriam Salpeter from Keppie Careers has graciously agreed to shares some tips on using Twitter to help you search for a Job. Follow Miriam on Twitter @Keppie_careers. 

Tweeting Your Way to a Job

Would you believe that you can tweet yourself to a job opportunity 140 characters at a time? It’s been done! Statistics show that job search networking is much more effective when you make “loose” connections - touching base with people beyond your immediate circle whose networks and contacts are much different from your own. With over 3 million users, Twitter offers an unparalleled opportunity to create an extended network.

Not convinced that Twitter is actually a high-powered job search tool? Read on to learn how Twitter can uniquely position you for job-hunting success!

What Can Twitter Do For You?

1. Afford access to other professionals in your field. When you follow industry leaders, you’ll know who spends time with them, what conferences they attend (and what they think of the speakers!), what they’re reading and what is on their minds. This is great information to leverage for your search.
2. Provide exposure and credibility as well as personal and professional relationships when you connect to others in your industry.
3. Offer you a venue to demonstrate your expertise and share information in quick, pithy bursts of wisdom. This is perfect if you don’t have the time or energy to create a blog.

Unique Aspects of Twitter

1. It is casual and immediate and a great place to “meet” informally.
2. You’ll find an array of people on Twitter, including CEOs, top-level executives, hiring managers, recruiters and everyone in-between! It’s one-stop shopping for your networking needs. You’ll be surprised to find that stars in your field (mentors) may follow you if you reach out to them!
3. Unlike Facebook, where it is kind of creepy if you start trying to “friend” people who are connected to your contacts, it is acceptable (and expected) to follow people on Twitter because another friend or colleague does.
4. It forces you to be brief. Coming up with your “Twit-Pitch” - what you have to offer in 140 characters or less - will help you clarify your value proposition. Remember: less is more!

 

Continue Reading...

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I had many discussions with undergraduate students at the ABRCMS in Orlando last week who were interested in pursuing PhD degrees in the biomedical sciences. I felt that I had an ethical and moral responsibility as a former academic and career development professional to tell them that the job market for PhDs is not good and that it is likely to get worse over the next few years. These discussions prompted me to revisit the role and contributions of tenure to the lack of academic jobs in the US today.

As I stated in a previous post, systemic changes must be made to the current academic paradigm to increase the likelihood that PhDs will be able to find jobs at the end of their training. In that post, I suggested that abolishing tenure and replacing it with renewable, performance-based five year contracts may help to reduce the glut of jobless PhDs by freeing up a small percentage of new faculty positions every five years. While this approach has been tried at several academic institutions, it has been largely been deemed unsuccessful. That said, I came across a provocative article in today’s New York Times about a bold new tenure proposal put forth by Michelle Rhee, the new, 38-year old Chancellor of the Washington, DC school system.

Ms Rhee’s revolutionary proposal offers tenured teachers salaries raises of up to $40,000 per year to give up tenure. It is important to note she has not proposed to completely abolish tenure. Under her proposal, teachers would choose between two compensation options—the green or red plans. Salaries for teachers in the green plan would rise meteorically, nearly doubling by 2010, but they would have to give up tenure for one year, after which they would need a principal’s recommendation to keep their job or face dismissal. Teachers who choose the red plan would also get big pay raises but would lose seniority rights that allow them to bump more junior teachers if their school closes or is overhauled. Red plan teachers who are not hired by other schools would either have to take early retirement, a buyout or face eventual dismissal. I like her plan because poorly- or under performing teachers can opt to take the cash and then either drastically improve to keep their higher paying jobs or do nothing, get paid well for a year or two and then get fired.

While Ms. Rhee’s proposal may work at the primary and secondary school levels, it likely would not be effective at the college and postgraduate levels, where salaries vary widely and are largely grant driven. Instead, I propose that tenure-for-life should remain intact at these institutions but be replaced with a “for cause” tenure review system. This system is tried and true and similar models have been successfully used for over 100 years by employers and labor unions. In this model, management and its unions agree upon the job responsibilities and performance metrics for individual that must be met each year, e.g. an annual performance review.  If a person is under performing or fails to meet his/her performance metrics, an employer can attempt to dismiss the employee “for cause” reasons.  However, before a dismissal for cause can occur, the employer must convince a judge or arbitrator in a hearing that the employee in question has violated the “dismissal for cause” provisions.  Because an employer must prove that an employee has violated the provisions that constitute for cause dismissal, the “for cause” claims against individual employees must be fastidiously documented and vigorously substantiated. This prevents employers from arbitrarily firing employees who are either outspoken troublesome or disruptive. According to my wife, who has been a union-side labor lawyer and union representative for 20 year, this system works well because the players (management and unions) all understand, abide by and play according to the rules of the game.

So what are some of the performance-based “for cause” metrics that I think ought to be considered for yearly evaluations of tenured professors? They are not much different than those currently used to adjudicate tenure decisions. That said, I propose the following five categories: 1) teaching, 2) publication record, 3) grant support, 4) institutional service and 5) commitment to innovation. In my opinion, adoption of the “for cause” tenure review model would help to do two things: improve the overall performance of tenured faculty members and provide newly minted PhDs and postdoctoral fellows with regularly occurring new job opportunities.

Until next time…

 

Good Luck and Good Job Hunting!!!!!!!!

 

 

 

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No matter what you may think of Google, you gotta love the brilliance and innovative moxy of the guys who run that company. In today’s New York Times, there was a story about a new web tool called Google Flu Trends. This tool is being evaluated as a new early warning system for fast-spreading flu outbreaks in the US.

Tests of Google Flu Trends, suggest that it may be able to detect regional outbreaks of the flu a week to 10 days before they are reported by the Centers for Disease Control and Prevention (CDC). It works by tracking and quantifying number of Americans who enter search phrases like “flu symptoms” into Google and other search engines. By analyzing these searches as they come in, Google Flu Trends creates graphs and maps of the country that show where the flu is spreading.  For example, in early February the CDC reported that the flu cases had recently spiked in the Mid-Atlantic States. But Google says its search data showed a spike in queries about flu symptoms two weeks before the CDC report was released.

According to public health experts “The CDC reports are slower because they rely on data collected and compiled from thousands of health care providers, labs and other sources. The Google data could help accelerate the response of doctors, hospitals and public health officials to a nasty flu season, reducing the spread of the disease and, potentially, saving lives.” Researchers have long contended that information published on the Web amounts to a form of “collective intelligence” that can be used to spot trends and make predictions.

Google Flu Trends appears to be the first public project that uses the powerful database of a search engine to track a disease. This could be the beginning of a new trend in epidemiology. Google hopes to publish the results of its study in Nature.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

 

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A friend sent me a link to the video shown below.  It is called the Sarah Palin Song and it rocks!!!

 

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The Centers for Disease Control and Prevention said about 25% of teenage girls received at least one dose of Merck & Co.'s Gardasil vaccine in 2007, providing the first national estimate of usage of the company’s controversial anti- HPV (cervical cancer) vaccine.

A 25% usage rate for a a new vaccine during its first year on the market is outstanding. That said, Merck’s Gardasil is the only approved anti-HPV vaccine in the US. Approval of GlaxoSmithKline’s competing product, Cervarix, by FDA has been delayed for so-called “regulatory issues.” Also, Merck has been heavily promoting Gardasil use via well-crafted DTC ads and a variety of clever promotional campaigns aimed at adolescent girls and their mothers.

Despite all the negative press and Merck’s questionable marketing practices, Gardasil appears to be doing very well—something that Merck desperately needs.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

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Just when the medical device industry is gaining steam and poised to challenge pharma and biotech companies for market share and profits, some lawmakers have begun to question the medical devices industry’s direct-to-consumer (DTC) advertising practices. Last year, the medical device industry spent about $193 million for DTC advertising on television and the Internet—a mere fraction of what was spent on DTC consumer advertising for prescription drugs sold by pharmaceutical and biotechnology companies.

One reason given by lawmakers to justify its current scrutiny of medical devices DTC advertising practices is that “medical devices can have more of an impact on a patient’s well-being than a drug because devices often require surgery to implant and may remain inside the body for years.” However, in response, a representative from the Advanced Medical Technology Association, a medical devices trade group said, “While an advertisement may stimulate a patient to ask a doctor about device, the process of receiving one involves a discussion of its benefits and risks.” He went on to say “You may take a pill because it doesn’t involve very much. But you don’t undergo surgery unless you think you have a serious need for it.” 

Another reason cited by Herb Kohl, a Democrat from Wisconsin is “The medical device industry is just beginning to get into the game.” Yes, Mr Kohl’s assertion is absolutely correct. Unlike most pharma and biotechnology companies, which have engaged in unregulated DTC advertising for the past 10 years or so—and literally made billions— the medical devices industry was slow to recognize that DTC advertising could be used to effectively hawk its products. I guess the thought here is: “to head ‘em off at the pass!”

The current call for an investigation into the DTC practices of some medical devices companies raises several interesting questions. First, is the investigation simply a red herring to distract FDA from crafting new regulations to rein in and more tightly control DTC advertising by pharmaceutical and biotechnology companies? (While FDA has recently revised some of its DTC advertising guidelines, the changes are still not rigorous enough). Second, could the call for increased scrutiny of the medical devices industry simply be an attempt (by pharma and biotech lobbyists) to stifle the recent, explosive growth of the medical devices industry?  Finally, why are lawmakers rather than the agency (which oversees the device industry) investigating the DTC advertising practices of medical devices companies?

On a personal note, I support tighter regulations and increased scrutiny of the DTC advertising practices for all  life sciences companies. Although DTC ads are directly aimed at consumers, their real purpose is to influence prescribing practices of physicians by inducing patients to ask questions about whether or not the drugs or devices that they “saw on TV” are appropriate for them. That said, I believe that it is up to FDA to insure that all DTC ads are fairly balanced (risks vs. benefits) and medically accurate before they are viewed by the American public.

Until next time…

 

Good Luck and Good Job Hunting!!!!!!!!!!!

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The Pharmalot blog reported today that Merck received approval from the US Food and Drug Administration to use Gardasil to prevent vaginal and vulval cancer in addition to cervical cancer.

Of late, Gardasil has been a lightening rod for controversy—mostly because of Merck’s unrelenting marketing campaigns (and the behind-the-scenes lobbying for the vaccine to be placed on the US mandatory vaccination list)  coupled with the Christian right’s moral machinations about premarital sex and sexually transmitted diseases in general. Also, let’s not forget the brouhaha surrounding FDA’s decision to delay approval of GlaxoSmithKline’s competing cervical cancer vaccine called Cervarix. Finally, about a month ago, there was study published in the New England Journal of Medicine questioning the cost effectiveness of Gardasil vaccination of women after the age of 18.

Regardless of your moral, ethical or business concerns about Gardasil, the bottom line is this: girls/women vaccinated with Gardasil are much less likely to develop cervical cancer as compared with those who are not vaccinated.

As I have mentioned before, all approved and marketed drugs have side effects and possible safety/tolerability issues. More importantly, the decision to approve a particular drug is always based on a careful risks/benefits assessment by government healthcare regulators. Whether or not a person uses a drug or vaccine is ultimately a personal choice. With the exception of mandatory childhood vaccines (children can be exempted for moral or religious reasons), every American has the right to decide whether or not to use a medication or undergo a treatment recommend by a healthcare professional. Based on everything that I have read about Gardasil, it appears to be a safe and effective vaccine to prevent cervical cancer. When FDA finally approves Cervarix (probably sometime in late 2009), it will offer women who may have concerns about Gardasil with an alternate vaccine to protect them against developing cervical cancer.

The funny thing about the Gardasil firestorm is that cervical cancer isn’t a major healthcare problem in the US. This is because a majority of American women undergo annual routine gynecological examinations (that include pap smears, the current gold standard for cervical cancer detection). In contrast, cervical cancer is a major healthcare problem and economic concern in Asia, most notably in China and India. This begs the question—why are Merck and GSK so intent on selling their cervical cancer vaccines in the US? Put simply, there is still much more money to be made in the US than in Asia. Look for approval of Gardasil and Cervarix in China and India when the middle class of both countries reach a critical mass.

Until next time…

Good Luck and Good Job Hunting!!!!!!

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I previously posted a piece on BioJobBlog about direct-to-consumer advertising that is used by many pharma and biotech companies to induce people who see the ads to ask their physicians about a “ drug that they heard about on TV.” John Heubusch who runs Writing Frontier.com, read the post and pointed me in the direction of a piece that he wrote on the same topic. His slant on the topic is different than mine but we both reach similar conclusions—DTC advertising needs to be better regulated by FDA.

Until next time… 

Good Luck and Good Job Hunting!!!!

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Just when I thought the absurdities surrounding the American follow-on biologics debate couldn’t get any sillier, the US Federal Trade Commission (FTC) announced today that it would sponsor public workshops and round table discussion to learn more about the impact of follow-on biologics on American competitiveness, regulatory policies and healthcare costs.

I am not certain what role the FTC has in the follow-on biologics debate (as far as I am concerned, it shouldn’t have much of one) but what new information does the FTC think that it is going to get that other more relevant government agencies like FDA or the US Congress don’t already have about follow-on biologics? After all, the debate to formulate an approval pathway for follow-on biologics in the US has gone on for almost 10 years now. How ineffectual and ineffective can the US government and its agencies be (rhetorical question)?

 

As far as I can ascertain, the main reason why follow-on biologics are not already being sold in the US are the never-ending efforts of power, well-funded lobby organizations like BIO and PhRMA. The data are incontrovertible: 1) the cost of branded drugs is out of reach for many Americans, 2) access to potentially life-saving drugs and treatments is hindered by restrictive drug formularies and onerous insurance co-pays and 3) many local and state governments and large, multi-national corporations can no longer provide adequate healthcare coverage for their employees because of out-of-control medical costs and expenditures.

 

In my opinion, the irony of the US follow-on biologics brouhaha is that it is putting American companies at a competitive disadvantage in the biosimilar/follow-on biologics space. Selling profitable, cheaper generic versions of blockbuster drugs is no longer a dream but a reality in countries like China and India whose middle class has finally come of age. True, the American pharmaceutical/biotech market is still the largest in the world—but will it still be the largest 10 years from now? Only time (and Asia) will tell.

 

Until next time….

 

Good Luck and Good Job Hunting!!!!!!!!

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 I previously wrote a piece which suggested that being perceived as smart is typically what separates the great scientists from the mediocre ones. To that end, whenever a former postdoctoral mentor (who I think is really smart) wanted to “motivate me” he would invariably say “C’mon Cliff, you’re a smart guy…..” Of course, the implication was that I wasn’t being smart enough or —as I heard it — “if you want to be as smart as me you better think harder and better”. According to a post by Karen Ventii at the Science to Life Blog, I wasn’t the only fledging scientist who was treated this way.

Does making a graduate student or postdoctoral fellow feel stupid motivate or hurt them? To learn more, read this provocative article by Martin Schwartz, PhD a professor at the University of Virginia that appeared in the April 28, 2008 issue of the Journal of Cell Science.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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Earlier this week, Roche announced that it wanted to buy the remaining portion of Genentech that it doesn’t already own. On Friday, one of Europe’s largest pharmaceutical companies, Sanofi-Aventis, announced that it was buying the UK-based vaccine manufacturer Acambis for $547 billion.

Like Roche and Genentech, Sanofi-Aventis was already partnered with Acambis and by purchasing Acambis, Sanofi gains a smallpox vaccine that was contracted by the US government for $425 million. Sanofi is the world’s largest manufacturer of influenza vaccines and last month announced plans to open a $157 million manufacturing facility in France, citing projections that demand for vaccines will double by 2016. In case you didn’t know, vaccines, once the scourge of the pharmaceutical industry, are now the hottest”pharmaceutical” products on the market!

Because of growing demand and lucrative margins for biologics and biotechnology products, many big pharma companies are attempting (through acquisitions and mergers) to quickly enter the biologics and biotechnology markets. These days, small molecules are passé and biotech is the next big thing (where have all the pharma execs been for the past 20 years).  

Europe has long wanted to dominate the biotechnology market. This has not been possible because of the US’s large lead in the space. However, all this can change because of a weak dollar and a surging Euro! Rather than attempt to create their own biotechnology companies, large cash-rich, European pharma companies can simply buy profitable US biotechnology companies with strong product pipelines.

I suspect that the weak dollar and failing US economy contributed to Roche’s decision to buy Genentech and Teva to buy Barr Pharmaceuticals last week. I would not be surprised if there are more acquisitions of American biotechnology and pharma companies in the very near future. I think that it may be time for Amgen and Bristol-Myers Squibb employees to begin to brush up on their French or German.

Until next time….

Good Luck and Good Job Hunting (in Europe)!!!!!!!!

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At lunch the other day, I was telling a bunch of people about how brilliant Roche’s biotechnology strategy has been for the past 20 years or so. All of this changed for me on Monday, when Roche announced that it wanted to buy the remaining shares of Genentech that it already doesn’t own for $ 43.7 billion —Roche currently owns 56% of Genentech’s stock. More importantly, Roche doesn’t have control of Genentech’s board of directors nor does it influence corporate strategy or product development.

Unlike many other pharma companies who have historically purchased  biotechnology companies and then integrated them into existing corporate structures, Roche previously opted to buy controlling interests in companies and then allowed them to continue to operate independently with little corporate input or guidance. Unlike pharma culture, which is very structured and inherently conservative, the most successful biotechnology companies have been built on cultures that promote creativity and “thinking outside the box”.   If Roche buys Genentech and attempts to integrate it into the existing Roche family of companies, I suspect that all of this will change dramatically.

For the past 30 years or so, Genentech has been one of the brightest stars in the biotechnology universe.  Genentech’s management team worked long and hard to implement and maintain a vision that was formulated way back in the late 1970s when the company was first formed. Even though it is the world’s largest and most financially successful biotechnology company, Genentech has steadfastly resisted the temptation to go “corporate” and has worked diligently to maintain its “biotechnology identity” —symbolized by innovation, creativity and employee-centric policies.

I have no doubt that if the Roche-Genentech deal is approved, there will be a mass exodus of talent from the company. Based on my experience, a publicly-treaded biotechnology employee’s greatest fear is the dreaded corporate takeover! I have yet to meet a biotechnology company employee who is willing to sacrifice freedom and creativity (despite a possible financial upside) for more structure, discipline and an endless plethora of rules! 

In my opinion, the deal makes sense for Roche—competition in the cancer space is intense and they want to hedge their future success on Genentech’s oncology franchise. In the best case scenario, Roche will buy Genentech but allow it to operate as a wholly owned subsidiary with an independent management team that spends as little time in Basel as possible. I think the old adage “If it ain’t broke, don’t fix it” is particularly apt here!

Until next time….

Good Luck and Good Job Hunting!!!!!!

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Richmond Va-based INSMED, a US-based follow-on biologics manufacturer, posted a press release on its website entitled: “Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company” that reports on the results from a Phase I clinical trial that demonstrated that it lead product INS-19 was bioequivalent to Amgen’s Neupogen^(R) (recombinant G-CSF) in stimulating human white blood cell production. 

, Dr. Geoffrey Allan, President and CEO of Insmed said  "These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. “ The company has requested a meeting with FDA to discuss the design of a Phase III human clinical trial for INS-19.

I am not sure why INSMED is so excited about its results. Sandoz essentially accomplished the same feat with Omnitrope, its biosimilar version of recombinant human growth hormone (HGH)and it took a law suit and a loophole in the approval process for growth hormones for FDA to allow it to be sold in the US. In my opinion, until legislation is passed that provides a clearly defined legal pathway for approval of follow-on biologics I suspect that INS-19 will suffer the same fate (or perhaps worse) than Omnitrope. Bioequivalence is only legal defined for and relevant for approval of small molecule NOT BIOLOGICS when seeking expedited approval for generic versions of branded products. That said, I want to tip my hat to INSMED for its willingness to take a lead role in the fight to get follow-on biologics approved in the US. Finally, there is nothing like an edgy press release and a few bloggers to bring an issue that is rapidly losing momentum back to the forefront.

Kudos to INSMED!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!

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The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

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Monoclonal antibodies (MAbs) directed against vascular endothelial growth factor (VEGF) receptors on cancer cells, have been found to slow the growth of a variety of cancers including colorectal, breast and lung.  While a number of blockbuster biotechnology products( based on these MAbs (Avastin by Genentech/Roche and Eribitux by Bristol-Myers Squibb/ImClone/Merck KGA) have been approved to treat a variety of different cancers their effectiveness as cancer treatments has been the subject of intense debate since their approvals.

Although numerous human clinical trials have shown that VEGF inhibitors slow the growth and development of tumors, they, as a class, don’t seem to significantly increase the survival time for most cancer patients. Further, Avastin and Erbitux are generally not used as stand alone treatments but are used in combination with more tradition anti-cancer chemotherapies. The high costs of these drugs, (Avastin’s worldwide sales hit $ 3.5 billion last year) and their variable effectiveness have caused many to question the usefulness of this class of drugs to treat cancer patients.

The well-publicized use of these drugs as cancer treatments coupled with anecdotal evidence about their effectiveness has put practicing oncologists between a rock and a hard place when it comes to treating patietns with cancer. In an article in Sunday’s New York Times one prominent oncologist said that depsite the controversy,  “I still use Avastin routinely. It’s not a slam dunk and, in fact, the incremental benefit may be more modest than we want to admit.” Others are more sanguine about VEGF inhibitors as cancer treatments “Even when these drugs ‘work,’ what kind of impact are you talking about?” said Fran Visco, president of the National Breast Cancer Coalition. But we market them and give them to everybody.”  

Nevertheless, most oncologists find it difficult to withhold Avastin or Erbitux from cancer patients seeking hope. As one oncologist put it “ When I am not sitting in front of a patient, I think about whether drugs like Avastin are worth it to society. But when facing a seriously ill patient, who, based on clinical trial results, might benefit — even if only a little — from Avastin, I think about the patient’s needs.” 

Regardless of their therapeutic value, the main issue with this class of anti-cancer drugs is cost. Avastin treatment costs patients about $4000-$9000 per month— Eribitux treatment is even more costly! While Medicare and most private insurers cover 80% of the cost, patients can be responsible for 20% or more of treatmetn costs.  As posited in the Times article “If Avastin were inexpensive or if it cured cancer or even held it at bay, as the drug Gleevec does for blood cancer, few might care.”

Are anti-VEGF drugs real cancer treatments or expensive red herrings? Clearly, the jury is still out on that one. That said, I think that only cancer patients can truly provide an accurate response to that question!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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According to a survey of 1,800 American professors in the life sciences conducted by economists at the University of Wisconsin-Madison, 90% of life sicentiest hold only one or no patents.  This means that  remaining 10% hold more than one (and are probably weathier than the other guys). 

The results of the study led its authors to surmise that despite the recent explosion in patenting in the life sciences, a majority of academics still do research the "old-fashioned way"--by winning federal research grants, publishing in scientific journals and training PhD and postdoctoral students.  Yeah right--I bet many of the old-fashioned folks wish they had patents and were able to start biotechnology companies!!!!

Until next time....

Good Luck and Good Patenting!!!!!!!

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A friend of mine accidentally gashed his leg on an open dishwasher door and thought nothing of it for several weeks until he noticed that the wound wasn’t healing and it hurt really badly. He eventually went to the emergency room at a local, where the ER docs cultured the wound and sent him home with a prescription for oral antibiotics. The antibiotics stopped working several days later and he wound up in another local hospital–this time he was admitted and the spent the next 5 days on a variety of intravenous antibiotics. Despite the treatment (they could not find the right antibiotic combination at first because  they never recultured the wound) his leg turned black from his ankle to his knee and they almost had to amputate. He is back at home now and will be treated with a regimen of iv antibiotics for the next 6 weeks or so. I talked with him last week and I learned that his leg wound is still not completely healed and the infectious disease docs are worried!

My friend almost lost his leg because of a lack of understanding about bacterial infections and antibiotic resistant bacteria and— unfortunately— because of substandard wound care treatment. With this in mind, I am posting what I think are useful tips (from the June issue of the Mayo Clinic Women’s Health Source) about how to prevent, manage and treat wound infections to minimize the emergence and spread of multiple, antibiotic- resistant bacteria.

• Wash your hands: This simple procedure, done properly, remains the best defense. Carry alcohol-based hand sanitizers for times when hand washing isn’t possible.
• Keep personal items personal: Don’t share towels, soap, sheets, razors, clothing or athletic equipment.
• Sanitize linens: If you have a cut or abrasion, wash towels and sheets with hot water and added bleach. Wash gym and athletic clothes after each use.
• Get infections tested: If an infection requires treatment, ask your care provider to take a culture to confirm what bacteria are present before you are given an antibiotic. (Editor’s note: Unfortunately, this is no longer standard practice—most infections are treated empirically which is partly responsible for the increasing frequency of antibiotic resistant bacteria.) If you test positive for a Staphylococcus (Staph) infection, ask that a culture be tested specifically for MRSA in case you need a special antibiotic.
• Use antibiotics appropriately: When you take antibiotics, take all doses even when you start feeling better. Don’t demand antibiotics for viral illnesses; antibiotics don’t work with viruses. Taking too many antibiotics over time could become a detriment because the medication’s effectiveness can be compromised by overuse.
• Use antibacterial products sparingly: Antibacterial soaps and cleaning products probably don’t prevent infections at home and may make these products less effective in hospitals.
• Take precautions in the hospital: Ask all hospital staff and visitors to wash their hands or use an alcohol-based hand sanitizer before touching you. Ask care providers to wipe stethoscopes and other equipment with alcohol. Don’t set food or utensils directly on tables or beds. Make sure that intravenous tubes and catheters are inserted under sterile conditions.

I hope that these tips will help to keep you out of the hospital with potentially life-threatening, antibiotic resistant bacterial wound infections!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

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After a failed attempt at getting elected to the East Windsor Town Council last Fall, I thought my days in politics were over.  But, then I received an e-mail from a friend that is causing me to reconsider a life as a politician.

Please look at this video and tell me whether you think I ought  to resurrect my political career.

 I want to thank Jack Goldenberg for his political advice and support!

until next time....

Good Luck and Good Job Hunting!!!!!!!!

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As many of you may know, Ranbaxy was involved in a bitter patent dispute with Pfizer over Lipitor, Pfizer’s blockbuster multibillion, dollar anti LDL-cholesterol drug. Ranbaxy was challenging the validity of Pfizer’s intellectual property estate for Lipitor which would have extended patent protection for the drug until 2013 or longer. The patent dispute began after Ranbaxy filled an ANDA with the US Food and Drug Administration to sell generic Lipitor after uncontested Lipitor patents expire in early 2010.

Conventional wisdom suggested that Pfizer would ultimately lose the patent dispute and that Ranbaxy would be able to immediately flood the market with a much cheaper generic version of Lipitor. This would have an enormous negative impact on Pfizer’s financial stability and its future (Lipitor had $12.8 billion in sales in 2007). Nevertheless, untilDaiicho-Sankyo announced its intention to acquire Ranbaxy last week, Pfizer was willing to gamble and run the risk of losing the lawsuit. Apparently, Ranbaxy impending sale was enough of an impetus for Pfizer to settle the patent dispute which has grown increasingly acrimonious over the past year or so.

According to agreement (which needs to be approved by the US Federal Trade Commission), Pfizer was able to get Ranbaxy  to agree to delay the release of generic Lipitor until November 2011 — up to 20 months later than many analysts had been expecting (some insiders believed that generic Lipitor could reach the market as early as March 2010). Further, as part of the agreement, Pfizer will allow Ranbaxy to sell its version of Lipitor in Australia, Canada, Belgium, Germany, Italy, the Netherlands and Sweden two to four months before Liptor’s patents expire. This is likely the sweet part of the deal for Ranbaxy because all of the above mentioned markets are top sellers for anti-cholesterol drugs. Finally, because Ranbaxy was the first to file an ANDA for generic Lipitor with the FDA, it will get 6 months of market exclusivity guaranteed (in the Hatch Waxman Act) to a generic manufacturer that is first to file for generic production of a brand name drug nearing patent expiry.   However, after quickly perusing the terms of the deal, I think that it more closely resembles an authorized generics deal rather than a “true” competitive generics launch.

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Just when you thought things couldn’t get any stranger, a new pharmaceutical assessment tool called the Access to Medicine Index (ATMI) was unveiled earlier this week. The ATMI is the brainchild of Wim Leereveld, a former pharmaceutical marketing entrepreneur who is CEO of the  based in the Netherlands. 

According to Leereveld, the ATMI can be used to evaluate, rate and rank a pharmaceutical company’s commitment and ability to deliver, drugs, vaccines and other medicines to patients in poor countries. In other words, the ATMI helps analysts and interested parties determine whether or not a company is doing its share to be a good corporate citizen.

The rankings are based on eight, sometimes difficult-to- interpret variables that include; 1) management; 2) influence (huh?); 3) patents (access to?) 4) R& D, 5) pricing, 6) drug donations, 7) philanthropy (isn’t this what the index is really measuring?) and 8) capacity (for what?). At present, GSK has the highest ranking and Schering Plough is dead last.

Whether or not you believe the analysis or think that the ATMI has any socially-redeeming value (remember it was developed by a former marketing executive), it is still a pretty fun tool to monkey around with. Check it out….

Until next time…

Good Luck and Good Job Hunting (try non-profits) !!!!!!!

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Does the smell of a fresh pot of coffee brewing get you going in the morning? Do you experience a rush of energy simply by getting a whiff of freshly-brewed joe? If you do, there may be a genetic explanation for it.

A group of scientists at Seoul National University in Korea exposed sleep-deprived rats to coffee bean aroma and then assessed the effects by performing genetic and protein analysis on their brain tissue. These results were compared with those obtained from sleep-deprived rats that were not exposed to coffee. Unstressed, non-coffee exposed and unstressed - coffee exposed rats served as controls in these experiments.

According to results published in The Journal of Agriculture and Food Science, the Korean scientists found that mRNA levels of 11 of 13 genes were elevated in the coffee-exposed rats: the levels of 2 others were decreased. They also found differential expression of proteins (using mass spectroscopy) in the two groups of rats. For example, a protein known to have an antioxidant effect was expressed at higher levels in the coffee-treated group.

So what does this all mean? According to the authors “the roasted coffee bean aroma changes the mRNA and protein expression levels of the rat brain, providing for the first time clues to the potential antioxidant or stress relaxation activities of the coffee bean aroma.” Will these observations hold true for humans? Only time will tell. That said, remember that the best laid plans of mice (rats?) and men often go astray.

Until next time…

Good Luck and Good Job Hunting (try Starbucks) !!!!!

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I returned from my trip to China on Monday evening and I think that I am finally functioning on US time again (actually it took me less time to adjust than I expected).

China is an amazing country filled with its fair share of contrasts, paradoxes and breathtaking scenery.  From the donkey-drawn carts and traditional hutongs of Beijing to the modern skyline and hustle and bustle of Shanghai, my travel companions and I never had a dull moment in China.

The thing that struck me the most was that the Chinese people appear to be very happy and comfortable with their lives. This was shocking to me because I came of age when the People’s Republic of China was referred to as “Red China”! I expected everybody to be downtrodden and depressed. Don’t get me wrong, it is very clear that the Chinese government has complete control over its people. That said, you can basically do what you like in China as long as you understand and abide by the “rules”.  Put simply, you are free to do whatever you like in China as long as you don’t hurt anybody or openly criticize the central government. Not surprisingly, most Chinese people understand the “game” and have learned how to live their lives to the fullest despite the obvious limitations on their individual liberties. However, it is important to note that although you can visit MySpace, Facebook and other websites in China, you cannot upload blog posts (I learned that the hard way) or visit certain “sensitive” sites–they are blocked!

One of the most curious China paradoxes is the unbridled entrepreneurial and capitalistic behavior of the Chinese people that you meet on the streets or in the shops. Haggling and price negotiations are required before buying anything in China (nobody pays retail in China!). We learned very quickly that “Nothing in China is for free. But, everything is for sale!” Is China really a communist country?  That is something to ponder.

Despite its natural beauty and interesting culture, China is an environmentally-challenged country. During our 10 day visit, we saw blue skies only once. Most of the time, the air is heavy and thick and the sky is filled with dust and smog. My Chinese friends assured me that there are blue skies but mostly in winter.  

Because I am a businessman at heart, I did do a little business in China. There are still enormous opportunities in the pharmaceutical and biotechnology industries. However, the window of opportunity is beginning to close (China is beginning to outsource some of its manufacturing to Vietnam and Malaysia).  So, if you are considering starting or doing business in China, now is the time to do it!  One industry that has enormous growth potential is refrigeration and air conditioning. If you want cold anything in China, you have to ask for it—we quickly learned this after repeatedly drinking warm beers!  I don’t think this opportunity has gone unnoticed—Haier, the Chinese air conditioning and refrigeration company ( previously called it a German company until a reader corrected me)— is one of the main sponsors of the 2008 China Olympic Games!

All in all, I had a great time during my trip to China.  I loved the food, the people and the enormity of the place.  I hope that I get a chance to visit again!

Until next time….

Good Luck and Good Job Hunting (try China)!!!!!!!!!!

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Well, I am off to China for a 10 day visit. Turns out that I will be visiting a Chinese pharmaceutical manufacturing facility in Shanghi.  Should be very interesting....If I am lucky I may be able to blog from China!

I hope too much doesn't change while I am away. 

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!

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In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). The remaining three are “knock off” versions of erythropoietin alpha–Binocrit (Sandoz), Epoetin alpha Hexal (Hexal) and Abseamed (Medice Arneimittel Putter).

There is no doubt, at this point, that Europe is leading the way in the biosimilar space. However, it is important to point out that a variety of biosimilars, developed by Indian generic manufacturers and others, are already being sold in less- regulated Asian markets (see Table 1). Unfortunately, political issues and the fierce struggle between innovator

Table 1. Biosimilar Manufacturers and Their Products

Company	Launched Biosimilars	In the Pipeline
Barr                                                          (www.barr.com)	EPO scheduled for launch in Eastern Europe	G-CSF (Filgastrim), Insulin, and HGH
Biocon                                          (www.bioconinc.com)	Insugen (Insulin in India and China), Erypro (EPO) G-CSF, Nimotruzmab, BIOMAb EGFR (cancer)	Insulin, glargine and HGH
Biopartners                             (www.biopartners.ch)	Valtropin (rHGH)	Alpheon (INF-α) and EPO
Cipla                                                   (www.cipla.com)	None	Autoimmune, cancer and cardiovascular
Dr. Reddy’s Labs                       (www.drreddys.com)	G-CSF (Filgastrim)	Nine (9) development programs
Glenmark                  (www.glenmarkpharma.com)	None	GBR 500 (mAb for MS), GBR600 (antithrombotic) and mAbs for adhesion molecular inhibitors
Intas Biopharma (www.intasbiopharma.com)	Neukine (G-CSF), Erykine (EPO) and Intalfa (INF-alpha2b)	Six (6) development programs
Prolong Pharmaceuticals (www.prolongpharmaceuticals.com)	None	PEG-EPO and other PEGylated proteins
Ranbaxy (www.ranbaxy.com)	Nugraf (Filgrastim), Macrogen (Molgramostim from Zenotech)	mAbs in oncology and neurology
Sandoz (www.sandoz.com)	Omnitrope (HGH), Binocrit (EPO)	Six (6) development programs including G-CSF (Filgrastim)
Shanta Biotechnics                              (www.shantabio.com)	Shaferon (INF-alpha2b, Shankinase (streptokinase) and Shanpoietin (EPO)	mAbs and PEGylated therapeutic proteins
Stada                                               (www.stada.de)	EPO-Zeta (approved)	Filgrastim
Teva                                           (www.tevapharma.com)	G-CSF (Filagstrim),Teva-Tropin (HGH), INF-alpha2b	Insulin, EPO and interleukins
Wockhardt                             (www.wockhardt.com)	Wepo (EPO), Wosulin (insulin) INF-alpha2b, G-CSF	Insulin Glargine

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I just finished reading a  wonderful article entitled "My Son the Number" that was written by Dulcie Leimbach in  last Sunday's Education section  of the New York Times.  in it, she describes how high school students are now defined by the scores that they receive on standardized tests like the SAT and ACT and by their grade point averages and class rank.  Thankfully, by the end of the article, she posits that numbers are simply numbers and that they are not predicative of how students will perform in college or in life, for that matter.  What is most important, she says, is a student's sense of purpose and his/her ability to get along with others and finish a task at hand. Numbers, she asserts, don't measure creativity and wit and they certainly don't predict the future (something that I have learned along the way too!)

I think that if we want to improve our competitiveness in science than we ought to focus less on the numbers and more on developing a sense of purpose in student who have an interest in science. This means drastically changing the way we teach and promote science at both the primary and secondary school levels. 

I still believe that there is wonder in science and that there is also wonder in being a kid.  So, let's forget about the numbers and allow our kids be kids again! And, we just might be able to regain our edge in science!

Until next time.....

 

Good Luck and Good Job Hunting!!!!!!!!!!

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As I mentioned in a post about a month or so ago, the US Food and Drug Administration (FDA) floated a proposal to ease the rules regarding promotion of off-label use of previously approved drugs. According to the newly proposed rules, FDA would allow drug makers to provide physicians with reprints of journal articles that conspicuously promote off-label uses for previously approved products. At present, drug companies are strictly forbidden to promote off-label use of their products.  A major proviso of the proposed rule changes is that the articles/reprints must be published in peer reviewed medical journals before they can be disseminated to physicians and other healthcare professionals. Apparently, FDA officials believe that peer review can take the place of the rigorous regulations and requirements that are currently in place for US approval of drugs, biologics and medical devices!

For those of you who don’t know, an editorial appeared in last week’sJournal of the American Medical Association (JAMA) that took drug maker Merck to task for using alleged ghostwriters and ghost authors on clinical studies that were published about it painkiller Vioxx. As you all know, Merck voluntarily took Vioxx off the market in 2004 after it was revealed that the drug could lead to increased risk of heart attack and stroke.

The incendiary firestorm that has ensued since the appearance of the  Although I believe that the practices of ghostwriting and ghost authoring are not as widespread as the JAMA authors would like you to believe, I think that it is a good thing that FDA may scuttle its proposed new off-label drug promotion rules.

In my opinion (humble or otherwise), drug makers MUST be required to prove that off-label uses of previously approved products  don’t pose any serious safety or health risks before companies are allowed to promote them for new indications. As we have seen time and again in recent years, safety issues and serious health risks can arise for drugs even though they received FDA approval. With this in mind I ask: “Why would FDA allow drug makers to provide less rigorous proof for an off-label indication than that required for approval of the intended use of the original product?”  It makes little sense to me. However, looking more closely at the proposed rule changes,  it would obviate the need for companies to spend additional monies (possibly hundreds of millions) to garner FDA approval for a new product indication.  Hmmm….maybe I am beginning to see a pattern here!!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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People who become scientists spend many years learning how to design, conduct, collect and analyze data from the experiments that they conduct. The ultimate goal of this seemingly endless exercise is to craft peer-reviewed publications that either support or refute the underlying hypotheses used to initiate the experiments in the first place. As part of our training, we are repeatedly reminded that it is our obligation to fastidiously and accurately report the results of our experiments and to assume “full ownership of the manuscripts and publications" that we author. The idea of allowing a person who didn’t participate in the design or execution of the research, to craft a manuscript for peer review is something that is virtually unheard of in the scientific community and, in the minds of some scientists, tantamount to scientific misconduct or fraud.

Physicians, on the other hand, who don’t learn how to conduct research or write scientific papers during their medical training, are frequently poor writers and have a little or no time to spend on writing scientific or medical manuscripts. Because of this, it is not uncommon for physicians who conduct medical research on behalf of pharmaceutical, biotechnology and medical devices companies to hire medical writers to write manuscripts for them. In fact, many physicians who work with pharmaceutical and biotechnology companies prefer and expect this arrangement. So, why the recent commotion over medical “ghostwriting”?

Drug companies typically hire medical communication agencies to develop and craft manuscripts that showcase the results of clinical or research studies that they have conducted. These companies will usually provide an agency with background information about a study, a research summary, clinical study reports, ideas or titles for proposed manuscript and a list of prospective authors (usually physicians who performed the studies on behalf of the company).  Medical writers, who are either employed by the agency or work as freelancers use these materials to craft a detailed outline for the proposed manuscript. After the outline is completed, the agency usually shares the outline with physicians who were named on the list to determine who may be interested in authoring the publication. After an author is identified, the medical writer works closely with the author to develop a first draft of the manuscript. After the draft is reviewed by the author, changes are made to the draft, a revised version is circulated and the process is repeated until all stakeholders are satisfied with the manuscript. Once the publication has been copyedited and undergone legal and regulatory review it is submitted for peer review.

For the record, in my five years as a medical writer, I have never encountered a situation where the primary author doesn’t have final say over what will and won’t appear in a manuscript. When scientific, medical or business disagreements do arise, the author(s), medical writer and company representatives usually negotiate mutually-agreed upon solutions. Rarely, have I seen a company remove an author from a publication because his/her views or interpretations of the data were not consistent with those of the company that sponsored the research. The reason why drug companies and medical communication agencies have recently come under fire for their “ghostwriting” practices is because they have repeatedly failed to disclose that many of their publications were written by medical writers —whose names didn’t appear anywhere on the publications. Although this practice still exists, it is no longer as widespread or commonplace as it once was. These days, the names of medical writers who author manuscripts routinely appear in the acknowledgement sections of many scientific and medical publications. Moreover, in some instances, a medical writer may be able to garner co-author status on a publication —depending upon his/her level of involvement in the project. 

In my opinion, there is little difference between graduate students, postdoctoral fellows and medical writers when it comes to preparing manuscripts for publication. It is not uncommon for the names of PIs, supervisors and others to appear as authors on publications even though their contribution to a project (or preparation of a manuscript) has been limited or nominal at best. Consequently, I fail to see any credible legal or ethical arguments against hiring a medical writer to write manuscript on behalf of an “author” as long as the “author” can demonstrate that he/she actively participated or was intimately associated with study design, conduct or analysis. Finally, to maintain the integrity and transparency of the medical writing process, it is imperative that medical writers who prepare manuscripts on behalf of study authors should be acknowledged or credited with “authorship” somewhere in a publication.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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There is mounting evidence that RNAi, once hailed as a panacea for the pharmaceutical and biotechnology industries, may not be all that it was claimed to be. Yes, there are several new RNAi drug candidates in late stage clinical development but it isn’t clear, at this point, whether any of these products will ever make it to market. Companies like Allergan, Alnylam, Opko Health and Merck, which recently bought the RNAi company Sirna Therapeutics for $1.1 billion, have invested hundreds of millions of dollars and literally “bet the farm” on RNAi therapeutics.

The use of DNA and RNA as therapeutics is not a new or novel idea. Isis Pharmaceuticals, a pioneer and champion of oligonucleotide therapeutics, has only be able to bring a single, oligonucleotide-based product to market in the past 20 years. Ask any Isis executive and they will tell you that turning DNA or RNA into drugs is a challenging process that is fraught with many difficulties. Most notably, there are bioavailability, delivery and target specificity hurdles that most be over come before the utility of these drugs as therapeutic agents can be realized. That said the attractiveness of these molecules as therapeutics (and perhaps their real danger) is the simplicity and elegance of their mechanism(s) of action. Most scientists tend to “fall in love” with elegant and parsimonious solutions to complex processes—why would we not, they are type of discoveries that we all train and live for! And, as many of us know, when people “fall in love”, there is a tendency to overlook or not notice warning signs that things may not be as they seem.

The scientific community fell quickly and deeply in love with RNAi soon after the first papers appeared touting its benefits and possible therapeutic applications. Scientists were so convinced and confident about RNAi that they induced the financial community to invest billions of dollars into the emerging technology. The love and affection for RNAi reached its pinnacle in 2006 when two scientists, who played a crucial role in discovering its mechanism of action, won the Nobel Prize. Since then, the harsh realities of RNAi drug development have begun to be realized by companies that invested in the technology.

I have been around long enough to understand that there are fads in science. In the mid 1990s it was combinatorial chemistry, in the late 1990s it was genomics, proteomics and computational chemistry and in the 2000s it is RNAi. Don’t get me wrong–all of these technologies have helped to advance science and  provide researchers with sophisticated tools that have helped to expedite the drug discovery and development process. That said, none of these technologies, by themselves, yielded the plethora of new medications or therapeutics that their advocates promised. Industry veterans know that there are no easy solutions or panaceas in drug discovery and development. The process is inherently time-intensive, painstaking and tedious. And, despite what we scientists want to believe in our “heart of hearts,” there are no guarantees that simplicity and elegance will translate into safe and effective medications.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!

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After weathering the Vioxx storm for the past three years, Merck again finds itself in choppy and unchartered waters. Still reeling from the Vytorin flap that erupted two months ago, there are new allegations that its blockbuster allergy and asthma medicine, Singulair, may be linked to suicide. The US Food and Drug administration (FDA) was quick (this time) to announce that it is launching an investigation into reports that suggest that Singulair may cause patients taking the medication to commit suicide. Merck received approval for Singulair in 1998 and it had sales of $4.3 billion in 2007.

There are several reasons why FDA quickly alerted the American public to its investigation into Singulair. First, FDA has been relentlessly chastised in recent months by Congress for not notifying Americans early enough in drug safety investigations. Historically, FDA has waited until the end of an investigation (rather than the beginning) before alerting the public about possible drug safety issues. Second, the agency was well aware of emerging and ongoing safety issues with Singulair. For example, over the last year, FDA regulators asked Merck to update Singulair’s label four times. These changes included information on side effects such as tremors, anxiousness, depression and suicidal ideation.

As part of its current investigation, FDA requested that  Merck “dig deeper into its clinical data on Singulair for any evidence of possible links to suicide.” Merck quickly responded and noted that none of the 11,000 patients enrolled in 40 Singular clinical trials had committed suicide. Of course this doesn’t mean that people taking Singulair didn’t think about committing suicide. In Merck’s defense, the company may not have thought to include a question about suicidal thoughts as part of Singulair’s clinical development program. Nevertheless, it is important to note that the safety profiles for many approved drugs are not fully realized until the drug has been on the market for several years. This is because the small numbers of patient used in the clinical trials for approval of a new medication are usually not sufficient to identify all  potential safety problems. Unforeseen  or unanticipated side effects typically begin to emerge only after a drug is used by larger numbers of people in the general population.  

For this reason, the Food Drug and Cosmetic Act requires that all companies that win approval for new medications are required to set up post marketing surveillance programs. The purpose of these programs is to report any and all side effects of approved drugs to the agency. The post marketing surveillance regulation stipulates that physicians, patients and drug manufacturers must report any side effects or adverse events to the agency. Based on the number of adverse events reports that it receives, FDA can launch an investigation to determine what regulatory actions, if any, should be taken by the drug’s manufacturer to deal with the safety problems. Possible regulatory actions include label changes, black box warnings, physician notification letters, Phase IV clinical trials and possible suspension or revocation of a drug license.

Luckily for Merck, the jury is still out (no pun intended) on Singulair. That said, the good news is that the drug safety and post marketing surveillance programs outlined in the FD&C act are working exactly the way they were designed to!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station NJ)!!!!!!!!

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I spent the entire morning reading various articles, blog posts and comments about what is wrong with the US Food and Drug Administration (FDA). Not surprisingly, phrases like “drug lag”, the large size and costs of clinical trials, political and corporate influence, reduced numbers of NME approvals etc appeared ad nauseum. These are the same old, tired complaints with the agency that have been bandied about for the past 10 years or so. 

In my opinion, the bottom line is this: the agency is egregiously under staffed and under funded despite the fact that companies pay steep user fees for regulatory reviews. I can understand why corporate America is dissatisfied with the service that it receives from FDA. It is natural to expect good customer service after paying large sums of money to a service provider.  However, it is important to note, that the words “customer service” don’t appear any where in the Food, Drug and Cosmetic Act of 1938 (although it can possibly be implied fromPDUFA in 1992 and FDAMA in 1997).  Nevertheless, what is mentioned in the FD&C is SAFE and EFFICACIOUS pharmaceuticals, biologics and medical devices. Put simply, safe and efficacious products, not customer service, is REAL the mission of FDA.  With this in mind, the agency is legally required to do everything in its power to provide Americans with carefully scrutinized and safe medical devices, pharmaceutical and biotechnology products.

If we Americans want FDA to accomplish its REAL mission, then the agency must be sufficiently funded, adequately staffed and have strong, non-partisan leadership. Unless this occurs, FDA will continue to struggle and remain dysfunctional well into the 21^st century.

Until next time…

Good Luck and Good Job Hunting!!!!!

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Oh, what a difference a couple of years or results from a pivotal clinical trial can have on a company’s financial outlook. As you may recall in 2005, Merck was in a shambles after the Vioxx scandal broke. Its CEO was ousted, its stock was trading at less than $35 per share and employee morale was at an all time low. After two short years, Richard Clark, a life-long Merck employee, was able to turn the company around. Merck’s stock reached a high of almost $61 last December and many of its employees were dancing in the streets of Rahway because their stock options were now worth more than the paper that they were printed on. But, like many things in life, all good things must come to an end.

Since December Merck’s stock price has plummeted to $40 and appears to be headed downward. What sparked the retreat was the release of results from the now infamous ENHANCE clinical trial which showed that Vytorin, which is co-marketed by Merck and Schering Plough, offered no greater benefit than a cheaper, generic version of Zocor (one of the two active ingredients of Vytorin) to reduce the risk of heart attack and stroke. The fallout from this revelation has been intense and dramatic. Both Merck and Schering Plough are being investigated by Congress for marketing violations and the financial maneuvers’ of several senior executives from both companies are under intense scrutiny. 

Many industry analysts believe that Merck may be on the ropes again and are afraid that the company may slip back into the morass it found itself in after the Vioxx debacle.

I have always held Merck in high regard–no fewer than 15 people who I went to graduate school have worked at Merck at one time or another. Further, the Merck name used to be synonymous with “second to none” science and outstanding pharmaceutical products. Sadly, over the past decade Merck’s leadership has consistently placed profits before good science causing the American public to lose confidence in one of its flagship pharmaceutical companies. Maybe Dick Clark, who was around during Merck’s glory days, can restore Merck’s reputation by insisting that from now on, good science will always come before corporate profits. Time will tell….

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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I have been following the trials and tribulations of New Jersey-based Enzon Pharmaceuticals for the past decade. My interest in Enzon was kindled because of a friendship with Abe Abuchowski, Enzon’s former Chairman, CEO and Founder.  For those of you who may not know, Abe is sometimes called the “father of protein PEGylation” because he was first to harness the commercial power of the technology (he played a pivotal role in creating the technology as a graduate student in Frank Davis’ lab at Rutgers University).

Abe left Enzon in the early 1990s (after shepherding the US regulatory approval for Adagen®, Oncospar®, and PEG-Intron®) and in 2004, he (along with my help) founded Prolong Pharmaceuticals, a biopharmaceutical company that specializes in PEGylation of biogenerics. Prolong is also using protein PEGylation to create new antimicrobial and blood replacement products.

Over the years, Enzon has had its share of “ups” and “downs.” Although profitable through much of the 1990s, Enzon is now a company riddled with huge debt– mostly because of bad decisions made company executives in the post-Abuchowski era.  Since 2004, Enzon’s Chairman and CEO, Jeffrey Buchalter, has worked diligently to “right” the company. He realigned and focused the company’s strategic objectives and, through some creative financing, reduced some of Enzon/s more onerous debt obligations. To that end, he was able to restore shareholder confidence and stabilize Enzon’s stock price. Unfortunately, Jeff’s efforts may not be enough to save the company from acquisition or merger.

Many industry insiders believe that Buchalter was hired four years ago to prepare the company for sale. Yesterday, Enzon disclosed in a SEC filing, that the self-proclaimed biotech maven, Carl C. Icahn, increased his Enzon stock position from 1,760,001 to 3,072,103 shares. After the purchase, Icahn owns about 6.93% of the company’s outstanding shares and is one of its largest, single shareholders. Not surprisingly, Icahn now wants the company to consider putting itself up for sale. Maybe the insiders were correct in their thinking?

Stay tuned for more details.

Until next time….

Good Luck and Good Job Hunting (forget New Jersey)!!!!!!!

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FDA approvals of biopharmaceutical products have decreased in recent years. This includes recombinant proteins and monoclonal antibodies and cancer therapeutics. In the decade from 1996-2005, an average of 16.6 new drugs were approved each year. In marked contrast, there were only 11 and 12 new medications approved in 2006 and 2007, respectively.

Last year was an unusually unproductive year for the pharmaceutical and biotechnology industry. The combined sales for products approved in 2007 are projected to be less than $1.0 billion dollars–the benchmark for drugs that receives blockbuster status. Further, most or the approved drugs were similar to ones that were previously approved (so called “me too” drugs) and none will significantly improve healthcare for large numbers of patients.  Finally, only two recombinant protein drugs were approved in 2007–a level more representative of the 1980s.

Most analysts agree that it is unclear why FDA approval of new drugs has decreased over the past few years and who, if anybody (FDA and/or industry), deserves the blame for the approval drop-off. Regulatory filings for a number of new products are either expected or currently pending. To that end, it is likely that there will be more new approvals in 2008 and 2009 as compared with previous years. To learn more about the drug approval conundrum please read this article recently written by Ronald A Radar.

The rate of new approvals must increase in order for the biopharmaceutical and pharmaceutical industries to remain economically healthy and viable. Industry and the FDA must work more closely with one another to continue to insure that the American public has ready access to innovative, safe and efficacious, new biopharmaceutical and pharmaceutical products. 

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Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

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I happened upon a Sunday morning talk show yesterday where one of the guests was discussing strategies that employees ought to adopt to keep their jobs in a recessionary economy. For those of you who haven’t been paying attention, the US economy lost 63,000 jobs last month; another bit of evidence that we are sliding into an unavoidable recession. 

The talk show guest posited that only those employees who were able to quickly adapt to rapidly changing corporate/business environments would keep their jobs; the other less adaptable employees would find themselves jobless. Call me crazy, but his analysis sounded eerily similar to Darwin’s principle of natural selection or “survival of the fittest”–only those members of a population who were able to adapt (through mutations in Darwin’s case)  to changing environmental conditions will survive; the other less adaptable members will perish. Imagine that, using a recessionary economy to illustrate one of the fundamental principles of Darwin’s theory of evolution–how cool is that?

Here are some insights into how to keep your job during a recession when many companies are unstable and in flux. First, employees who work at financially-troubled companies must embrace the changes frequently instituted by management whether or not they agree with them. Invariably, there will be a cadre of employees who openly and publicly criticize the “new corporate policies”–these will likely be the employees who are demoted or “right-sized” out of the company.  In Darwinian terms, these employees are unable to adapt to change and they will either be eliminated or their standing in the population (company) will be diminished.  On the other hand, the employees who are able to embrace change will not lose their jobs and will likely be able to maintain or improve their standing in the population (company).  In other words, adaptable employees have a selective, competitive advantage over unadaptable ones which will allow them to survive and flourish in their new environment. Second, it is probably not wise during periods of corporate upheaval, for mid-level managers or employees to tout their past accomplishments or remind management about their worth to the company. In times of change, management embraces individuals with forward-looking ideas (to facilitate change) not those who are rooted in the past and are invested in antiquated corporate policies and practices. Again, only those employees who adapt will be able to survive and compete in their new corporate environment.  Finally, as a science educator, it is always exhilarating and exciting to find new ways to teach Darwin’s Theory (sic) of Evolution so that it makes sense to lay audiences. Maybe watching Sunday morning talk shows isn’t a waste of time after all!!!!

Until next time… 

Good Luck and Good Job Hunting (adapt)!!!!!!!!!

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According to Terry Leap, a Professor of Management at Clemson University, CEOs that exhibit some or all of the following traits or behaviors are likely to be problems.

• An obsession with acquiring prestige, power and wealth
• A reputation for unwarranted and shameless self promotion
• A tendency to propose “grandiose strategies” and failing to include a detailed plan to carry them out.
• A superb ability to compartmentalize and rationalize things.
• A history of emphasizing activity, like hours worked or meetings attended, over accomplishment.
• A reputation for implementing major strategic changes unilaterally or for forcing programs down the throats of reluctant managers.
• An impulsive, flippant decision–making style.
• A love of monologues coupled with poor listening skills.
• A tendency to display contempt for the ideas of others.
• A penchant for inconsiderate acts

The thing that worries me is that many academicians and most CEOs that I know exhibit five or more of these traits. Oy! 

Until next time…

Good Luck and Good Job Hunting

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By law, drug makers are prohibited from marketing or promoting (in any way) their medicines for uses that have not been approved by FDA. But, somewhat paradoxically, physicians who are licensed to practice in the US can prescribe drugs for uses beyond FDA-approved indications, a practice known as off-label use. The agency is no stranger to the issue of off-label drug use and has vigilantly policed the industry over the last decade to prevent the practice. Drug makers including Pfizer, Astra Zeneca, Eli Lilly, Amgen and others have been targeted by federal prosecutors for off-label marketing practices. Click here to see which types of drug are commonly prescribed for off-label use.

However, in something of a policy reversal, FDA officials proposed last Friday new guidelines that would allow pharmaceutical companies to use peer-reviewed medical journal articles to promote drugs for unapproved uses. The proposed guidelines will replace a law that expired in 2006 law. Under the expired law, companies had to submit copies of the articles to FDA for review before sending them to physicians. Under the new proposal, drug companies don’t have to submit articles to the FDA before distributing them to physicians. The agency says it will not punish companies for distributing literature on off-label use if they adhere to certain practices. Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by a company. The proposal also says companies should attach a disclaimer to the materials indicating FDA has not reviewed them.

I, along with Congressional Democrats, most notably Henry Waxman (D-CA), am totally baffled by the proposed new guidelines.According to Mr. Waxman, the new guidelines would create a “large loophole” in laws against off-label promotion. “It’s a conflict of interest for the company to be promoting sales when they haven’t been able to establish that a drug is safe and effective through the rigorous FDA process,” he said. Not to mention that a company could save hundreds of millions of dollars by not conducting clinical trials to gain approval for an off-label indication. Risperdal, a Johnson and Johnson medication that is approved to treat serious mental disorders like schizophrenia, bipolar disorder and irritability associated with autism was used off label 66% of the time and brought in $4.2 billion in 2006. If you were the CEO of J & J would you spend any additional monies to win approval for new indications for Risperdal?

I would think that by now the agency would have figured out that drug manufacturer are incapable of policing themselves; there is simply too much money at stake. And, unfortunately, profits will always come before patient safety.  In my opinion, the proposed guidelines are another egregious example of just how much influence the pharmaceutical and biotechnology industries have at FDA. The Bush administration has done everything in its power to destabilize and emasculate the agency. The American public no longer has confidence in FDA and the products that it approves. Something has got to change to restore a sense of wellness in America!

Until next time…

Good Luck and Good Job Hunting!!!!!

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I learned on Wednesday that my dear friend and colleague, Carleen Collins, died suddenly and unexpectedly from cancer. I first met Carleen in 1987 in the Department of Microbiology and Immunology at the University Of Miami School Of Medicine. We had both joined the faculty as Assistant Professors. As fate would have it, we were the only microbiologists in a department of immunologists. Needless to say, both Carleen and I learned more immunology than either of us would care to admit (we both subsequently published immunology-esque papers as Carleen would say).

Carleen was a quintessential Californian. She was easy going, extroverted and never had a negative thing to say about anyone. I, in contrast, was a brash, sarcastic New Yorker who couldn’t stop complaining about everything. Despite our seemingly opposite personalities, Carleen and I became fast friends (later I met Ira, her future husband and quickly understood why she and I hit it off so easily). Because Carleen and I were single back then, we used to hang out together after long hours in the lab. Whenever one or more of her sisters came to Miami, we would go to the Clevelander Bar on South Beach to watch the locals. It was always fun to watch the Collins girls “torture” the “boys” at the Clevelander bar.  

Carleen was one of my closest friends in Miami. Whenever things weren’t going well for me either scientifically or personally I would stop by her office or lab and chat (okay so I complained). Not surprisingly, the world always seemed like a brighter place after talking with her. If it wasn’t for Carleen and her smile, I don’t think I would have survived my first three years in the department.

One of my favorite Carleen stories involves Hurricane Andrew. Carleen, who was living on Miami Beach at the time, was forced to evacuate and decided to stay with my wife Alice and me in Kendall (which is inland). As it turned out, Andrew never made it to Miami Beach but Kendall, which was on the northern rim of the hurricane’s eye, was almost completely destroyed. I will never forget the four hours that Carleen, Alice, our dog AJ and I spent together in our tiny, dark, air condition-less bathroom listening to the sounds of Andrew’s devastation. I guess if you go through a natural disaster with someone, you can’t help but become lifelong friends!

I left Miami in 1994 and moved to New Jersey where I still reside. Carleen married Ira, had two children and left Miami for the University of Washington several years later. We would see each other from time to time at meetings but with kids and hectic careers it became harder to stay in touch. Nevertheless, I heard through the science grapevine that things were great and life was good in Seattle.

When Martin Flajnik, a mutual Miami friend and colleague, called me the other day with the bad news, he told me that he spent an evening Carleen and Ira a couple of years ago. He said that during dinner, Carleen told him how wonderful her life was and how much she loved being a mother and scientist. I was happy that she was able to experience that joy and satisfaction with her life before she passed away.

Carleen touched and enriched many lives. She will be sorely missed.

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In my post yesterday about Insmed's advocacy role in the Follow-on Biologics fracas, I inadvertantly mentioned that the results of the economic analysis that they commissioned had yet to be published.  One of my intrepid readers (they do exist!), pointed out that the study was recently finished and available at the Insmed website or here.

Mea Culpa!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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Insmed a small, Richmond Va-based biotechnology and manufacturing company has upped the ante in the fight to bring follow-on biologics to America.  After spending some time on Capitol Hill, company executives  found that “people in Washington, as well as payors and patients don’t have an understanding at a reasonable level of the debate that is going on and the issues” surrounding that follow-on biologics debate. To reach as wide an audience as possible and frame the debate on the issues” the company decided to use the Internet to take the initiative to the next level–the Internet.

A key to Insmed’s initiative is an economic study on the potential savings follow-on biologics could provide to patients, payors and healthcare providers. The study is still being conducted and its results will be published on the net when available. The campaign also includes advocacy components that like user-generated content (blogs) and social networking sites. Recently, Insmed posted a video clip on YouTube that feature one of its scientists extolling the virtues and cost-saving advantages of follow-on biologics.

As many of you may know, I have long been an advocate of legislation to allow the approval and sale of follow-on biologics in the US.  Unfortunately, until now, only one side of the debate–from big biotech and BIO–has been heard by the American public. This has largely been due to marketing muscle and deep pockets of big biotech coupled with a lack of unity among follow-on biologics advocates. Web 2.0 with its social networks, blogs and video sites allows people with the smallest voices to be heard. And, sometimes those small voices can turn into  roars!

Kudos to Insmed for having the courage to boldly go where no generics manufacturer has gone before–on YouTube! Yeah baby!!!

Until next time….

Good Luck and Good Job Hunting (see you on Web 2.0)!!!!!!!!

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Unraveling the Cholesterol Conundrum

By now, I am sure that everyone is sick of hearing about Zetia, Vytorin, cholesterol levels and heart disease. Whether you like it or not, results from the now infamous Enhance study have certainly caused many scientists and physicians to rethink the relationship between cholesterol levels and heart disease and stroke. Conventional wisdom (and current medical dogma) holds that low LDL cholesterol levels reduce the risk and incidence of heart disease and stroke. This belief is now so widespread and entrenched in that the medical community that FDA now approves drugs to prevent heart disease, as it did with Zetia and Vytorin, solely on the evidence that they lower LDL cholesterol levels. Unfortunately, Enhance study results indicate that lowering LDL cholesterol levels alone are not sufficient to reduce the incidence of heart disease or stroke. 

Zetia, one of the active ingredients of Vytorin, lowers blood LDL cholesterol levels by reducing absorption of cholesterol in the gut (from foods that we eat). In contrast, the other ingredient in Vytorin, Zocor, is a statin that acts to lower LDL cholesterol by interfering with its production in the body. The results of the Enhance study, which showed that Vytorin doesn’t reduce the risk of heart disease or stroke any better than Zocor itself, suggest that the only way to prevent heart disease and stroke (by lowering LDL cholesterol) is through statin use. This assertion is supported by results from clinical trials involving Lipitor and Zocor (both statins), which showed that lowering LDL cholesterol also resulted in a lower incidence of heart disease and stroke. This suggests that statins may act to reduce heart disease and stroke by mechanisms other than their LDL cholesterol-lowering properties. Indeed, statins have also been found to reduce inflammation, keep artery walls flexible and healthy and help to maintain LDL and HDL cholesterol balance in the blood.

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As many of you know, the pharmaceutical industry has been trending downward for the past year or so. Weak pipelines, uncontrolled corporate expansion and soaring drug prices have been offered to explain the recent down turn. However, the real back story to the downturn is the loss of  future revenues that is expected to occur starting in 2010 when many current blockbuster pharmaceutical products, e.g., Lipitor (Pfizer), Plavix (Sanofi Aventis), Avandia (GlaxoSmithKline), Zyprexa (Lilly), and others lose patent protection.

The loss of patent protection of branded blockbuster products is almost always accompanied by the development and subsequent, regulatory approval of lower cost, generic versions of the drugs. The Hatch Waxman Act permits generic manufacturers to begin to develop generic versions of branded products five years prior to patent expiry. This allows generic manufacturers to develop and gain regulatory approval of their products well in advance of a patent expiry date. Further, generic manufacturers usually launch their products (and flood the market) with generic versions of a branded product on the same day that its patent lapses. To induce and hasten generic development, Hatch Waxman grants market exclusivity for 180-days (6 month) to the first company that gains US regulatory approval for a generic version of a branded product that has lost patent protection.

Revenue generation and a company’s market share of branded drug products generally fall precipitously following introduction of less costly, generic versions of the drugs. From a financial standpoint, this is not surprising—why would anybody chose to pay more for a branded product when there is a cheaper and therapeutically efficacious generic alternative available?  In the past, most pharmaceutical companies chose to neglect (and ultimately abandon) blockbuster products after generic versions were introduced.  Many companies chose this strategy because, in the past, there was always another blockbuster in the pipeline that would replace the lost revenues caused by generic competition.

Unfortunately, as we all know, the days of the billon-dollar-a year blockbuster drug are long gone! This realization has caused many pharmaceutical companies to rethink their business strategies when a blockbuster drugs lose patent expiry. Many pharmaceutical companies are experimenting with a relatively new kind of product called an authorized generic–a copycat version of a company’s branded drug that is sold through a licensing agreement between the innovator company and a generic-drug manufacturer. This type of arrangement allows the innovator company to hold on to a larger share of a revenue stream from the drug once it loses patent protection and it falls prey to generic manufacturers.

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C’mon admit it–deep down inside I know that many of you have wondered how those wily monarch butterflies migrate from the US to the same place in Mexico each year. Why, just the other morning, when I was trying to figure out why a flock of turkey vultures seem to return to the same tree on my property every winter, I began to think about how monarch butterflies know when and how to migrate to the same place each year (hey, I took several entomology courses as an undergrad at Cornell).

And much to my surprise, after firing up my computer that very morning, I read a headline on Science Daily–“Molecular Basis of Monarch Butterfly Migration Discovered”. At long last, somebody had figured it out! Of course, I am still trying to understand the molecular mechanism responsible for the monarch’s migratory behavior (circadian rhythm stuff has always been hard for me)! Nevertheless, I tip my hat to the researchers who did the work! Now maybe they can help me out with my turkey vulture problem?

Until next time…

Good Luck and Good Flying…oops I mean ….Job Hunting!!!!

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Over the past 30 years or so, the vast majority of chief executives in the drug business have made their way to the top via the sales and marketing departments. Few senior executives have toiled in a research laboratory or for that matter, know the difference between NMR and protein purification. However, things may be changing in the industry. A quick perusal of the CEOs of the top 20 pharmaceutical and biotechnology companies (see below) reveals that 11 of 20 have degrees in engineering (4), medicine (2) and science (5). The remaining 9 have degrees in business and finance (3), sales and marketing (4) or law (2). Several of the scientists (2), engineers (3) and one physician also earned MBA degrees.

 

Conventional wisdom suggests that scientists usually do not make good CEOs (they are not formally trained in business). However, doesn’t the lack of scientific sensibility put non-scientist CEOs at a disadvantage when it comes to making strategic and operational decisions about R &D?  One would think so….!!!!

 

A careful examination of my top 20 list suggests that some of the most successful companies are run by scientist CEOs, e.g. Genentech, Gilead, Novartis and Lilly. Expect to see more scientist CEOs at large biotechnology and pharmaceutical companies in the future–R&D have become way too complex for non-scientist to truly understand its nuances and potential pitfalls. Plus, we scientists know that obtaining a MBA degree is a “piece of cake” as compared with the PhD degree! Hmmm, I wonder what business people think about PhDs?

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On Tuesday, ScienceDebate2008, an amalgamation of politically-minded scientists, challenged Democratic and Republican candidates to hold at least one debate focusing on the environment, medicine and health and science policy.

Despite my advancing age, I am still a “revolutionary” at heart….I kinda miss the marches, energy and vision of the “60s!  Maybe if we come together as a lobbying group we scientists can use politics to effectuate changes in science and healthcare policies—stranger things have happened!

Until Next Time….

Good Luck and Good Job Hunting!!!!!

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Forget about the medicine….just take the honey. A study published in the December issue of Archives and Pediatrics and Adolescent Medicine found that a teaspoon of honey before bed seems to calm children’s cough and makes them sleep better.

For the study, researchers recruited 105 children with upper respiratory infections from a clinic in Pennsylvania. Parents were given a paper bag with a dosing device inside. Some were empty. Some contained an age-appropriate dose of honey-flavored cough medicine containing the cough suppressant dextromethorphan. And some contained a similar dose of honey.

The parents were asked about their children's sleep and cough symptoms, once before the bedtime treatment and once after. They rated the symptoms on a seven-point scale.
All of the children got better, but honey consistently scored best in parents' rating of their children's cough symptoms. “Honey may work by coating and soothing an irritated throat” the study authors said. For those of you who don’t know, honey is an amazing substance that is very nutritious and possesses anti-bacterial properties (I took a bee keeping course as an undergraduate at Cornell—bees are way cool).

This is good news for parents because federal health advisers have recently warned that over-the-counter cough and cold medicines should not be used in children under 6 and several pharmaceutical companies are taking some products for young children off the market. However, honey SHOULD NOT be given to children under age 1 because of a rare but serious risk of infant botulism.

So grandma was right after all…

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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The buzz and promise of biotechnology is the likely cause of the buying frenzy that big pharma has been on lately. Word on the street is that biotechnology products are innovative, have a higher return on investment (ROI) and are generally perceived to be “better” than conventional small molecule drugs. I agree that biotechnology products are certainly innovative and the gargantuan ROIs are titillating. But, are biotechnology products always safer and more efficacious than extant small molecule drugs? According to a recent study–maybe not!

A study conducted at the Agency for Healthcare Research and Quality in the UK evaluated the effectiveness of 11 different drugs to treat rheumatoid arthritis (RA). They analyzed the results of clinical trials that enrolled at least 100 subjects that were conducted between 1980 and 2007. After analyzing 101 studies (50% of which were conducted by or on behalf of drug companies) they were unable to detect a significant difference in efficacy or safety of small molecule and biotechnology medications that are used to treat RA. The drugs that were analyzed included conventional corticosteroids, synthetic disease modifying anti-rheumatic drugs (DMARDS) such as hydroxychloroquine, leflunomide, methotrexate and sulfasalazine and a variety of biotechnology products including Orencia® (abatacept, Bristol Myers Squibb) Humira® (adalimumab, Abbott Laboratories) Kineret® (anakinra, Amgen), Enbrel® (etanercept), Remicade® (infliximab, Johnson & Johnson) and Rituxan® (rituximab, Genentech).

As is the case with all medications, there are substantial patient-to-patient variations in efficacy and side effect profiles and one drug may work better for patient than another– whether it is a protein-based biotechnology product or a small molecule drug. Generally speaking, biotechnology drugs focus on novel targets and may have unique mechanisms of action. That said it is not prudent to assume that new biotechnology drugs are inherently better than pre-existing small molecule treatments. The jury should remain out on any drug, biotechnology or otherwise, Phase IV clinical trials and exhaustive post marketing data are collected, analyzed and evaluated.

Until next time….

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New Jersey is an interesting place to live. For the past month or so, there have been daily local newspaper reports (recently elevated to national status by the Associated Press) about a dog named Congo who was sentenced to be euthanized by a NJ judge. The story goes something like this: Gardeners (who happen to be Hispanic) show up an hour early for a landscaping job that they were slated to perform at a Princeton, NJ home. The homeowner decides that the workers arrived too early for the job (go figure) and tells them by phone to wait until he is ready for them and to not step onto his property because the dog was “still outside”. Well, as you may have guessed, after about an hour of waiting, the gardeners decide to get out of their truck anyway and one of them is attacked and seriously maimed by the family dog named Congo. The attack culminates in Congo’s arrest, having his day in court, losing his case and then being sentenced to death. Now here is where it gets interesting. The dog’s owner, who happens to be wealthy, decides to mount a campaign to prevent Congo’s pending death. The “Free Congo” movement gains enough public support and momentum to get Congo released from doggy jail pending an appeal (sort of the like the “Free the Chicago 7” movement for those of you who remember 1968).

Yesterday, there was a Congo update story in my local paper. Congo is alive and well, living with his family and wearing a muzzle when he goes outside. Nobody really knows what is going on with the guy who was mauled but that is beyond the scope of this post.  Yesterday's article was basically a rehash of the Congo epic with a spin related to immigration and immigrant rights. But, what got me thinking was this statement in the article; “ The governor’s office has received more telephone calls, e-mails, letters and faxes about Congo than any other issue since the Governor took office” (two years ago). This is in a state where its citizens recently rejected a referendum to publicly fund stem cell research and where many people (in its largest cities) do not have adequate access to healthcare or health insurance.

Personally, like NJ Governor Corzine, I do not want Congo to be euthanized (I am philosophically opposed to the death penalty). But the larger issue that ought to be addressed is:” Why can people quickly mobilize and get emotionally involved when a pet’s life is in danger and seemingly not care about the well-being of other people whose lives may also be in danger?  What about the rights of guy who was mauled and the people who suffer daily because of inadequate or no access to health care?"

Think about it and let me know.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!

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Fellow blogger, Jacob Goldstein, over at the WSJ Health Blog posted a story today about a prominent hypertension researcher who was approached by a medical communications agency about  putting her name on an abstract (she did not participate in the research) that was being prepared by the agency for a pharmaceutical client. According to the Health Blog, the researcher was so outraged by the offer that she decided to go public about the alleged “ghost writing” incident. I have no doubt that the story is accurate.  That said,  I think that a comment posted to WSJ’s blog about the story sums it all up nicely:

 “So, this is some new revelation for the WSJ? There are plenty of studies in the medical literature which have been ghost written by an industry-sponsored medical writer, that was then submitted under the name of a highly-recognizable leader in the field–always at a steep price”.

As much as I hate to admit it, the person who posted the comment is right--sort of. Although ghost writing was commonplace in the medical communications industry as recently as a few years ago, the practice is no longer tolerated at most medcom agencies, and, perhaps more importantly, by the would-be authors whose names ultimately appear on the publications. That said, medcom agencies and their clients must remain vigilant in their attempts to eradicate ghost writing entirely so that all medical communications are written (and published) in the most scientifically-sound and ethical manner.

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Every major pharmaceutical company on the planet declares that it “invests billions of dollars into R &D to develop novel medicines to address unmet medical needs”. Further, pharmaceutical company advocates and lobbyists frequently justify the high costs of medicines by suggesting that they are necessary because companies must reinvest a portion of their profits into R & D to discover new drugs. After receiving several comments posted to BioJobBlog informing me that high drug prices are necessary in order for pharma companies to continue to meet unmet medical needs, I decided to delve a little deeper into what “addressing unmet medical needs” really means in the pharmaceutical industry.

My personal favorite that seems to fit pharma’s interpretation of “addressing unmet medical needs” is the development of no fewer than 3 medications (Viagra®, Levitra® and Cialis®, with several more in clinical trials) to treat erectile dysfunction (ED). For those of you who don’t know, all three drugs have almost identical mechanisms of action. Who knew that so many men had this serious, potentially life-threatening medical condition? Don’t get me wrong–there are men that must take these drugs to …well…rise to the occasion. That said, pharmaceutical marketers realized early on, that this class of drugs could yield billions of dollars–not necessarily as ED treatments (the number of men who actually suffer from ED is relatively small) – but as recreational drugs to enhance male sexual performance. The booming sales figures for these drugs indicate that the pharmaceutical marketers were absolutely spot on in their thinking. Thanks to these pioneering medical marketers men all over the world no longer have to fret about dying or succumbing to the perils of ED.



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Genentech announced yesterday that it is delaying a plan that would have limited the use of its cancer drug Avastin to treat wet macular degeneration. Earlier this month, Genentech unveiled plans to ban purchases of Avastin by independent compounding pharmacies to prevent them from creating smaller doses of the drug that can be used by ophthalmologists to treat wet macular degeneration.  By banning sales of Avastin to these pharmacies, Genentech sought to force ophthalmologists to use Lucentis($2,000 per dose) in lieu of Avastin –which is (40 to 50 times lower than a comparable dose of Lucentis–to treat eye disease. Lucentis, which was recently approved to treat wet macular degeneration, and Avastin®, have very similar mechanisms of action.

 

The company acted to reinstate it supply of Avastin to compounding pharmacies after senior Genentech officials met with the American Academy of Ophthalmology and American Society of Retina Specialists. I guess doctors still have some clout over the disingenuous practices of some drug companies.

 

The FDA also weighed in on the dispute and reiterated in a statement that the agency did not previously ask Genentech to stop distributing Avastin to compounding pharmacies and that it has not taken any action to limit the off-label use of Avastin to treat wet macular degeneration.

Don’t you just love it when drug companies try to blame FDA for their failed avaricious plans to increase corporate profits and bolster their stock prices?

 

Until next time…

 

Good Luck and Good Job Hunting  

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Biogen IDEC hired Goldman Sachs & Co and Merrill Lynch & Co as their investment bankers late last week to find a buyer for the company after it put itself up for sale. Once this story broke, the names of the usual suspects–Pfizer, Sanofi-Aventis and Johnson and Johnson– were bandied about as potential buyers. Although Pfizer and Sanofi-Aventis desperately need to expand their biotechnology portfolios to remain competitive, the acquisition of Biogen IDEC makes little sense for either of the two companies. Pfizer is just too big and has spent the last five years trying to figure out how to reorganize its pipeline and what to do with all of the employees it inherited from its acquisition of Warner Lambert and Pharmacia in the 1990s. Sanofi-Aventis has little experience in biotechnology and has no real expertise in neuroscience. J & J which already has a big biotechnology presence in Ortho Biotech (Procrit) and Centocor (Remicade) may be looking to expand into the neuroscience realm.

Although Biogen IDEC may be a better fit for J & J than Pfizer or Sanofi-Aventis, the rights to Biogen IDEC’s two best selling products, Rituxan and Tysbari, are co-owned by Genentech and Elan respectively. To complicate matters, Genentech and Elan both have the right to buy Biogen’s rights to the drugs if ownership of the company changes. To that end, Genentech has both the resources and the motivation to gain complete control of Rituxan, one of its leading anti-cancer drugs. The outlook for Tysabri, a treatment for multiple sclerosis which has been plagued by safety problems is still unclear and Avonex, another treatment for MS, has been steadily losing market share for the past few years. Because sales of Rituxan are what are driving Biogen IDEC’s current growth, the loss of the rights to this product would severely diminish the company’s value to prospective buyers.
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I recently participated in a career development recruiting event where I had the opportunity to chat with folks involved with career development for PhDs and postdoctoral fellows at a major NYC university. Not surprisingly, they confirmed my observation that the job market for PhD-level scientists is not a good one. After several spirited discussions, we all agreed that systemic changes must occur at the graduate school and federal granting agency levels to reduce the number of PhDs that are minted each year to insure that extant PhDs may actually find employment after they complete their training. That said, somewhat to my surprise, I learned that there is a growing demand for Masters level students in the private sector. Apparently, hiring managers at biotech and pharma companies are finally realizing that undergraduates with basic science training and a smattering of postgraduate work either in business or biotechnology (or both) can bring real value to their companies. Continue Reading...

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Blogging is a very personal and often times, a subjective exercise. That said, there are many bloggers who blog for personal reasons and then there are some bloggers who blog for commercial, advertising or even sensationalistic purposes. I think that Jacob Goldstein who writes the Wall Street Journal Health Blog fits into the latter category.

First, he floats the idea that Pfizer may acquire Wyeth. Although I believe that anything can happen (like pigs flying) this hypothetical was nothing more than a sensationalistic attempt to bolster the number of folks who visit and read his blog. Today, he blogged about a Seattle-based, so called “biotech superstar”, named Christopher Henney. Apparently, Mr Henney is a superstar because he was co-founder of several successful biotechnology companies that he sold for billions of dollars to the likes of Amgen and Eli Lilly. Interestingly, Mr Henney has started a new company and is seeking to garner sufficient Series A financing to get it off the ground! Is there a better way to get the word out on the street that Mr. Henney is looking for money than by posting it on the Wall Street Journal Health Blog?

The biotech superstardom label ought not to be awarded to individuals solely on the basis of the return on investment that they provided to venture capitalists and stockholders. Continue Reading...

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I have to tip my hat to Merck. I thought it was silly that company executives decided not to settle all of the litigation surrounding the Vioxx debacle. Instead, the company decided to challenge all of the individual Vioxx lawsuits filed against it. That said, the New York Times reported today that the New Jersey Supreme Court rejected a bid by Vioxx plaintiff lawyers to bring a Vioxx class action suit against Merc which is based in Whitehouse, NJ. The state's highest court reversed two lower court rulings and decided that a nationwide Vioxx class action suit was not appropriate. The suit had been brought by a union health plan on behalf of all insurance plans that paid for Vioxx prescriptions, or about 80 percent of all Vioxx sold.

This was huge victory for Merck because New Jersey consumer fraud law allows for triple damages and the class action suit could have cost the company $15 to $18 billion. Further, the company’s strategy of fighting Vioxx lawsuit individually has also paid off. Of the cases that have reached verdicts, Merck has won 9 and lost 5. A new trial was ordered in one case and two ended in mistrials. To the objective observer, Merck is winning–possibly paving the way for the company to reintroduce Vioxx to the market with new restrictions for use.

After the ruling was made public, shares of Merck rose more than 2 percent to $50.47 on Thursday. For those of you who do not follow the stock market, Merck’s share price plummeted to the mid-twenties after the Vioxx situation developed close to two years ago. I guess that is why Mr. Clark and not I is the CEO of Merck.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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After I posted my piece on August 20, 2007 on why it would not be a good idea for Pfizer to purchase Wyeth , I came across this post today at CNNMoney.com "Why a Pfizer-Wyeth merger is a bad idea"  by John Simon at Fortune magazine.  He essentially says the same things that I did in my posts, but since he is journalist who works at Fortune magazine,he will probably get credit for the insight even though I debunked the Pfizer-Wyeth rumor thing 4 days before he did.  I tell you life is just not fair!

Hmmmmmmmmmm....maybe I am smarter than I think I am.  Alternatively, maybe people are slower than I thought.  So it goes.........

Shoudd I re-evaluate my career options and apply for a job as a journalist for Fortune magazine? Whadda think?

Until Next Time....

Good Luck and Good Job Hunting!!!!!!!!!!!

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It has been nearly three years since Merck pulled Vioxx off the market for safety reasons. However, there is a movement afoot, by former users of the medication, urging Merck to bring the drug back onto the market. Folks who swear by Vioxx have been sending letters and e-mail messages to Merck executives pleading with them to reconsider the decision to remove the drug for sale.
Not surprisingly, there is a growing number of people who have tried other COX-2 inhibitors related to Vioxx to treat chronic pain (caused by inflammation) but without success. Many of these individuals cannot find any relief from chronic pain unless they use Vioxx. I learned about the benefits of Vioxx from a friend of mine who suffers from an autoimmune disease. She recently told me over a cup of coffer that no other pain medication or treatment other than Vioxx provides her with the pain relief necessary to function on a daily basis. To that end, she confided in me that she had squirreled away her remaining doses of Vioxx and only uses them when her pain is unbearable. Further, she also told me that she knows of alternate ways, e.g., the black market, to obtain Vioxx -something that shocked me since she is one of those people who is typically law abiding and lives her life according to strict moral standards. My friend’s experiences along with those of countless others, beg the question–Should Vioxx be available for sale in the U.S?

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An article in today’s NY Times entitled “Setback for Novartis in India Over Patent Ruling” started me thinking about big pharma and its relationship to the generics industry. On the surface, the differences between pharma companies and generic manufacturers would appear to be somewhat stark. For example, pharma companies are perceived to be highly innovative, do good science and provide the world with potentially life-saving medicines. In contrast, generics manufacturers are typically viewed as distributors of lower-priced, copycat versions of highly successful innovator products whose science may be dubious at best. However, when you get right down to it, both types of companies share a common goal– to sell as many drugs as possible to make as much money as they can! This makes perfect sense–a company is only truly in business when it turns a profit!
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I finally decided to redesign the BioInsights website to bring it into the 21st century.  Although I received many kudos for the old site, it was beginning to look old and dated (not unlike me). So, in the spirit of re-invention, I decided to take the plunge and rebuild the site from scratch.  The new site will be more interactive, slicker and a bit more edgy...I like edgy these days.... and will still contain a lot of the old content plus some new stuff!

I hope that you all stop by and take a look at the new site after Labor Day!!!!

Until next time,

Good Luck and Good Job Hunting!!!!!!!!!!!

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About 30 years ago the group,The Bee Gees, gave us "Jive Talking"; a catchy tune that was popularized in the movie Saturday Night Fever. Now, a group of  well intentioned and entreprenuerial scientists are offering us some "Sci Talking" via their new website called SciTalks.  The concept is novel;  view and listen to your favorite scientist(s) expatiate on the wonders of nature, science and the universe.  For all you video junkies out there, It is the YouTube for science "nerds"---not that there is anything wrong with that! 

All kidding aside, I think it is a great idea and I wish them great success.  Check them out.....a little sci-talking never hurt anybody!

Until Next Time.......

Good Luck and Good Job Hunting!!!!!!!!!!!

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I was reading Yahoo news and came upon an article that mentioned a blog called "Question Authority with Peter Rost".  For those of you who do not know Dr. Rost, he is a former pharmaceutical marketing executive who had the courage and conviction to speak out against some of the more odious marketing practices of his former employer.  Before he was fired, Dr. Rost condemned the off label marketing practices used to increase the sales of certain pharmaceutical and biotechnology products. He appeared on the CBS news program "60 Minutes" and gave many candid interviews with various news publications regarding the dark side of pharmaceutical and biotechnology marketing practices.

I had the opportunity to talk with Dr Rost at length several years ago when I was organizing a conference on  drug counterfeiting and re importation . I was very impressed with his forthrightness and kind manner. He is the author of two books entitled "The WolfPack" and "The Whistleblower: Confessions of a Healthcare Hitman".  Check em' out!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!!!!

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As you know, I recently started a new job at a medical communications firm.  Well, I resigned on Monday after only 3 weeks on the job.  The odd thing about medical communications companies is  that they communicate on behalf of their pharmaceutical and biotechnology clients but have problems with internal communications.  Go figure....

Luckily, my colleagues at my previous company graciously invited me back to work for them as a copy writer again.  They are a great bunch of folks and the corporate cafeteria is one of the best in the industry.  That said, I will have much more time to blog and to do my bioscience training and career development gigs.

I will keep you posted.

Until next time....

Good luck and Good Job Hunting.....

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Despite Merck's recent decision to abandon its lobbying campaign to promote the use of its HPV vaccine, the Colorado state legislature is still considering making cervical cancer vaccination mandatory for all girls who are in the sixth grade.  Girls would have to show proof of vaccination before they could attend Colorado middles schools (although provisions in the legislation would make proof of vaccination confidential ).  In another twist, Colorado state legislators also put forth a bill that would require all Colorado health insurers to pay for the vaccinations.  

The efforts by the Colorado state legislature and other state governments to help to reduce the incidence of cervical cancer among American women are laudable. However, the morbidity and mortality associated with cervical cancer in the US are extremely low . This is due to an excellent  cervical cancer survelliance and screenining system that was put into place in the US in the1960s.  In marked contrast with the US., the incidence of cervical cancer is reaching epidemic proportions in countries like China and India.  If Merck is truly intent on  reducing the global incidence of cervical

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