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Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

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

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It’s official!  Roche has secured more than 96 percent of shares in Genentech Inc, completing its $46.8 billion buyout of the U.S. biotech group. It now holds some 93 percent of outstanding Genentech shares, a further 3 percent are guaranteed to be delivered within the next three business days and it will integrate the U.S. biotech group as soon as possible.

Soon after Roche completed the transaction on Thursday, the company announced that Genentech's common stock would no longer be traded on the New York Stock Exchange.

Genentech, founded in 1976, was one of the first and most successful biotechnology companies in the US. After lagging behind rival Amgen for most of the 1990s, Genentech eclipsed Amgen in the early 2000s on the strength of its oncology franchise (Herceptin and Avastin) and its deep drug development pipeline.

Its acquisition by Roche truly signals the end of an era in history of the American biotechnology industry.

Until next time...

Good Luck and Good Cloning! 

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I just returned from a weekend of teaching regulatory affairs to biotechnology students at Georgetown University where I tried to convince them that the US Food and Drug Administration (FDA) is fundamentally sound despite its near demise during the Bush administration. Even before the Bush-induced wreckage, the agency was chronically understaffed, under funded and had serious leadership and morale problems. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies—one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. For those of you who may not know, FDA became responsible for oversight and regulation of the food and drug industries, in addition to the drugs, after passage of the Food, Drug and Cosmetic Act in 1938.

Drug industry advocates and longtime FDA critics contend that the agency as it exists today can no longer effectively oversee and insure the safety of American food and drug supplies. Critics argue that the history of FDA suggests that the agency focuses on medical products and only focuses on food safety when a crisis comes up. And when they occur, FDA is so distracted that it interferes with the drug review/approval process. While this is what FDA critics want you to believe, it is simply not the case. Despite its recent problems, the FDA has historically done an outstanding job when it comes to drug and food safety—when it is funded and staffed to appropriate levels.

Unbeknownst to the American public, food borne illnesses are very common and Americans are only alerted when the outbreaks reach a certain size. While the recent Salmonella outbreaks were larger in scope and breadth than past outbreaks, they were not extraordinary. However, they were extremely media worthy at the time that they were reported on. You may recall that at the time of the outbreaks, the American economy was beginning to fail and there was an inordinate amount of China, Mexico and free trade bashing going on in the US. Unfortunately, the news media decided to exploit the outbreaks to make a case that Americans ought to reduce their reliance on imported foods—a practice that was beginning to cut into the revenues of the US agriculture and food industries. Ironically, the Salmonella outbreaks might have been prevented if the production facilities (owned by American companies) were compliant with FDA mandated quality control and assurance regulations which were designed to insure food safety.

Drug industry advocates who argue that FDA ought to be split into two separate agencies have financial interests rather than safety concerns in mind.  As an investment banker or VC will tell you, slow, new drug approval rates can have serious financial consequences for the companies that are developing them—it can literally cost a company millions of dollars a day for every day the drug is kept off the market.  Interestingly, when FDA increased its drug approval rates in the late 1990s and early 2000s, there weren’t many industry insiders advocating a break up of the agency. Only recently, as FDA has become more risk adverse which in turn, has caused the new drug approval rates to slow again have critics begun to call for massive organizational changes at FDA.

Like I told my biotech students over the weekend, the only mechanism by which FDA can insure food and drug safety is by conducting regular inspections of drug and food manufacturing facilities. Unfortunately, FDA hasn’t been able to keep up with its mandatory inspections schedule because the agency has been under funded and poorly staffed for over a decade. Several FDA inspectors, who I talked with suggested that routine inspections of manufacturing facilities takes place every three to five years rather than every two years as required by FDA regulations. While in theory this shouldn’t affect a company’s ability to remain compliant with FDA regulations, in reality it does. Put simply, pharmaceutical and food companies, like most other for profit industries are incapable of policing themselves in the absence of regulatory oversight.

I ‘m not certain that the agency needs to be split into two separate agencies to continue to insure the safety of the American drug and food supplies. What I know is the agency needs more funding and much larger numbers of trained inspectors to be successful. In my opinion, the safety of the American food and drug supplies can only be guaranteed if the companies regulated by FDA make a commitment to quality manufacturing and play by the rules.

Until next time...

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

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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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The old baseball adage which says that  “you can’t tell the players apart without a program” is particularly apt when it comes to tracing the M &A activity that led to the creation of some today's largest pharmaceutical companies.

I used to be able to keep track of all of the moving parts  of most of these mergers but advancing age and unprecedented M&A activity in the pharma industry prevents me from successfully doing this any longer. To that end, about a week ago, the New York Times published a pretty cool and informative chart that historically traces the corporate mergers that lead to creation of Pfizer, Novartis, GlaxoSmithKline, Sanofi-Aventis and others.

Check it out!!!!!

Until next time...

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

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Mention the word “scientist” to most people and they will likely conjure up an image of a socially-inept, nerdy individual who cannot talk to “normal everyday folks” because they are either “too smart” or out of touch with the “real world.” I have been fighting that stereotype for as long as I can remember. I believe that, along the way, I have convinced a few people otherwise and hope that they have learned that “one size does not fit for all scientists”—or any other professional group for that matter. The public perception of scientists was improving until George W Bush, an inveterate anti-science and anti-intellectual advocate became President in 2001. I hope that America’s attitude toward science (and scientists) will change over the next four years as President Obama tries to “restore science to its rightful place.” Nevertheless, I felt compelled to write this post after reading a New York Times review of a television drama called “Breaking Bad” (AMC, Sundays, 10 EDT) which, in my opinion, reinforces the negative stereotypes of scientists held by many members of the lay public.

Breaking Bad centers on a former Caltech chemistry genius named Walt, who failed to live up to the legend of his graduate school days. At 50, he is teaching high school chemistry in Albuquerque, NM. Although he contributed to work of a Nobel-winning team, the teaching job in New Mexico is inexplicably the best that he can get. To make matters worse, his best friend at Cal Tech has amassed a fortune (based largely on Walt’s graduate school work) and is married to Walt’s beautiful ex-wife. Walt learns  after attending a lavish party thrown by his friend, that most of his graduate school classmates (unlike him) are famous world class scientists who live in big homes and make enough money to purchase guitars that previously belonged to Eric Clapton. On top of his devastating psychic and emotional pain, Walt is also suffering from stage 3A lung cancer—even though he never smoked! To save his life, Walt partners with one of his former high school students in the crystal methamphetamine business. Walt’s chemical genius allows him to synthesize the meth from scratch—unlike his scientifically-challenged competitors who must extract the starting materials from over the counter cold remedies—earning him the reputation as one of the best meth ‘cookers” in the US. Walt uses the drug money to pay for his chemotherapy to stay alive and care for 15 year old son with cerebral palsy.  

While the show sounds intriguing, and by all accounts is well acted and provides a glimpse into the lives of people struggling with chronic illness and unrealized career aspirations, it sends the wrong messages to the American public about scientists, their motivations and their lives. First, it portrays Walt’s classmates as wealthy, elitist dilettantes who live lavish lives and don’t think twice about flaunting their status and power as world class scientists. Aside from Craig Venter and several other high profile scientists who are sometimes featured on 60 Minutes, I don’t think that there are many scientists who enjoy the luxurious and opulent lifestyles depicted in Breaking Bad. To the contrary, I suspect that the vast majority of us are struggling, like others, to make ends meet to put food on the table. And, perhaps more importantly, I don’t think that money, fame and fortune induced most of us to become scientists in the first place. Portraying scientists as ego-maniacal, thoughtless, self-absorbed dilettantes sends the wrong message to an American public that is already suspicious and distrustful of science.

Second, Walt’ colleagues view him as a “failed scientist” who, despite his brilliance, has been humiliated and reduced to teaching chemistry (at a low wage) to high school students. Listen to an exchange between Walt and his oncologist “I am an extremely overqualified high school chemistry teacher. When I can work I make $43,700 per year. I have watched all of my colleagues and friends surpass me in every way imaginable....” Unfortunately, Walt’s view of himself—as a lowly, underpaid high school chemistry teacher —is consistent with the attitudes of many academicians who feel that teaching is far less important or valuable than laboratory research. In my previous life as a medical school faculty member, it wasn’t uncommon to see a prominent researcher cringe or shake his/her head in disbelief at the mere mention of a teaching career by a graduate student or postdoctoral fellow. I contend that we ought to encourage (and not dissuade) some of our best and brightest students to pursue teaching instead of research careers. Further, academic researchers must begin to recognize that PhDs who choose to pursue careers in teaching are not less competent or failed scientists—they are simply individuals who want to teach! Given the 20-year long decline in American science and technology preparedness, the scientific community can no longer afford to continue to exclusively promote research over careers in teaching and education.

Finally, the American public has long been suspicious and distrustful of science. In support of this, scientists are often portrayed in literature, movies and in the news as dark, and sometimes mad people who, when left unchecked, will unleash scientific “horrors” on the world.  I am old enough to remember the public fears about the secret bio-warfare programs in the Soviet Union and US during the cold war and more recently, the rumor that was circulating after the HIV/AIDS epidemic was disclosed, that the virus was created by the US government. The brouhaha that erupted over genetic engineering in the 1980s and continued suspicions surrounded genetically modified foods and human cloning are other examples of the public’s distrust of science. Sadly, the decision of the Breaking Bad’s creators to turn Walt, whose chemistry brilliance is unrivaled, into a crystal meth cooker perpetuates the myth about “evil misguided scientists” who are willing to jeopardize the safety of others for their own motives or self gain. The creators of Breaking Bad want us to believe that Walt is justified in turning to the dark side because his power hungry, egomaniacal, scientific colleagues have derailed his career and forced him to become an overqualified, underpaid chemistry teacher. In other words, he had no choice but to use his scientific talents to survive, and perhaps, more importantly, prove to his colleagues (and himself) that he truly is a gifted chemist and not a failed scientist.

Admittedly, while the plot line of Breaking Bad is a little over the top, it tends to reinforce the public’s negative perceptions of scientists and does little to assuage suspicions about the dark underside of modern science.  Like most other people, we scientists are human and have made our share of mistakes. Nevertheless, I think that we  must challenge ourselves to make an effort to educate the American public about who we are and what scientists do on a day to day basis.  If we fail to meet this challenge, I think that President Obama will continue to struggle to “restore science to its rightful place in America.”

Until next time...

Good Luck and Good Job Hunting (try public education-schools are hiring!)

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As you all know by now, Merck announced on Monday that it will purchase Schering Plough for $41.1billion in a deal constructed as a reverse merger. The reverse merger strategy was concocted to prevent the new company from losing the international sale rights to Remicade, Johnson and Johnson’s lucrative, blockbuster rheumatoid arthritis drug. According to the original deal inked by Johnson and Johnson and Schering Plough, Schering would have to surrender its rights to Remicade— which generated $2.1 billion in sales outside of the US last year —and golimumab (which is pending approval in Europe) if current ownership of Schering changes. Golimumab (CNTO 148) is Johnson and Johnson’s Centocor division next-generation human anti-TNF-alpha monoclonal antibody be developed as monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.  Since the merger was announced on Monday, Johnson and Johnson hasn’t issued any public statements about the deal—prompting some analysts to speculate that Johnson and Johnson may well make a counteroffer to acquire Schering Plough. Others believe that Johnson and Johnson will challenge the new company’s international rights to Remicade and golimumab despite the great lengths that Merck and Schering Plough management went to structure the acquisition as a reverse merger. Stay tuned for updates.

In other merger news, US-based Gilead announced that it will acquire CV Therapeutics for about $1.4 billion. The deal tops the hostile takeover offer from Astellas Pharma of Japan. Gilead, an HIV drug manufacturer is purchasing CV Therapeutics—which sells the cardiovascular drugs Ranexa (chronic angina) and Lexican (reduces stress during cardiovascular surgical procedures)—to expand its therapeutic repertoire beyond virology. The stock prices of shares of Gilead and CV Therapeutics jumped after the announcement signaling Wall Street’s approval of the deal.   Nevertheless, it may be premature for Gilead and CV Therapeutics to begin celebrating—Astellas may very well tender a counteroffer!

Until next time...

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

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Late Thursday, after 8 months of difficult and often acrimonious negotiations, Genentech’s board finally caved and agreed to allow Roche to purchase the remaining 44% of the outstanding Genentech shares that it doesn’t already own. The price: $95 per share—less than the $112 per share that Genentech’s board and management team wanted —but better than the $86.50 per share that was tendered last fall.

While Roche contends that it will continue to run Genentech as an autonomously operating business unit, many Genentech employees are dubious. I suspect that many DNA (Genentech’s stock symbol) employees will embrace a “wait and see” attitude before any decisions are made about whether or not to stay at the “new company.” Roche’s greatest challenge will be integrating the two companies without ruining Genentech’s innovative culture and immediately sending its best scientists and management team out the door. Pharma and biotech corporate cultures are very different from one another and many biotech employees find it difficult to adapt to big pharma’s slow-moving and anachronistic approach to drug development. As previously reported, US business operations of both companies will be based at Genentech’s headquarters in South San Francisco, CA rather than in Nutley, NJ, where Roche’s American business is currently based. This is not good news for many of Roche’s Nutley employees. Roche has been trying unsuccessfully for years to jettison the Nutley site and it seems likely now. Don’t be surprised if you see a mass exodus at the Nutley site. All of Roche’s US products will be sold under the Genentech brand.

Roche’s purchase of Genentech, America’s oldest biotechnology company (started in 1976) and considered by many to be the crown jewel of the industry, truly signals the end of an era. Let’s hope that another “Genentech” (and others like it) emerge as the US biotechnology industry continues to evolve in the 21^st century.

Until next time...

Good Luck and Good Job Hunting!!!!!

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That methicillin resistant Staphylococcus aureus (MRSA) is in the news again is not surprising. However, to my knowledge, Nicholas Kristof‘s article in today’s New York Times may be the first Op-Ed piece written by a non-scientist about the growing threat and seriousness of MRSA infections. Mr. Kristof apparently became aware of MRSA when he was contacted by Tom Anderson, MD, a Camden, Indiana physician who was experiencing “phenomenal levels of MRSA infections" in his community.

Beginning in the early 1990s, Dr Anderson noticed a rapidly rising incidence in the number of community acquired skin infections caused by MRSA among his patients. Most of Dr Anderson’s patients were swine farmers—the predominant industry in Camden. At first puzzled by the growing incidences of MRSA outbreaks, Dr. Anderson began to suspect that his patient’s pigs may be the source of growing number of cases of MRSA skin infections. He was reluctant to alert public health officials about his suspicions because any hint livestock-related health issues might jeopardize the livelihood of many of his neighbors and friends. By last fall, however, Camden’s MRSA epidemic had grown so large that Dr. Anderson could no longer remain silent. Rather than alert the authorities himself, he decided to invite Mr. Kristof, an investigative reporter, to visit him in Camden and break the story. Unfortunately, before Mr. Kristof could visit, Dr. Anderson died abruptly at age 54. There was no autopsy, but a blood test suggested he may have died from a heart attack or aneurysm. And—this is where the story gets interesting—a recent Dutch study has linked porcine MRSA isolates to a case of human endocarditis. Dr. Anderson had himself suffered at least three bouts of MRSA infections.

In another Dutch study conducted in 2004, MRSA strain ST398 (which caused the endocarditis in the more recent study) was isolated from three family members, three farm workers and 8 of 10 pigs from a single farm. Since then, strain ST398 has spread rapidly through the Netherlands — especially in swine-producing areas— and pig farmers there are 760 times more likely than the general population to carry MRSA. More recently, a study conducted by public health officials in Ontario, Canada showed that 20% of pig farmers were colonized by strains of MRSA genetically identical to those isolated from European pigs. Finally, a 2008 study conducted in Iowa, reported that strain ST398 was isolated from 45 percent of pig farmers and 49 percent of hogs that were tested. Together, these studies suggest that colonization of swine by MRSA and pig farmers is very common and that swine (and possibly other agricultural animals) could become an important reservoir for strains of MRSA.

While not conclusive, most infectious diseases experts believe that the emergence of MRSA and antibiotic resistant bacteria can be directly linked to the widespread and rampant use of antibiotics as growth enhancers in livestock feed. Despite the alarming emergence of multiple antibiotic resistance bacteria, livestock producers in the US and elsewhere continue to add antibiotics to livestock feeds. This led Mr. Kristof to lament that “we as a nation have moved to a model of agriculture that produces cheap bacon but risks the health of all of us.” Not surprisingly, as is frequently the case, big business has chosen to place profits before the health and safety of society.

Until next time...

Good Luck and Good Reading (look for Mr. Kristof’s Sunday column on the emergence of antibiotic resistant "superbugs")

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According to a report on NPR’s All Things Considered program, the Obama Administration has nominated Margaret Hamburg, MD to head the US Food and Drug Administration. Dr. Hamburg is a former health commissioner in New York City who has worked on issues surrounding infectious diseases and bioterrorism. In New York, she instituted a needle-exchange program to help prevent the spread of HIV. She also set up a program, in which health workers went to tuberculosis patients’ homes to help them manage their drug regimens.

A Harvard Med School graduate, Dr. Hamburg was an assistant secretary of health and human services during the Clinton administration and now works at the Nuclear Threat Initiative, which tries to cut the threat from nuclear, chemical, and biological weapons. She opposes abstinence-based sex education in public schools and has been a critic of the marketing practices of the pharmaceutical industry. Further, Dr. Hamburg is a leading advocate for changes in the nation’s public health policies and infrastructure, from local health departments to the highest levels of government. Finally, after eight years of mismanagement and poor leadership, the agency has somebody at the helm with intelligence, experience and is an advocate for change. 

Kudos to Team Obama!

Until next time...

Good Luck and Good Job Hunting (FDA is hiring)!!!!!

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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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Late last week, Roche raised the price of its hostile offer to buy out Genentech to $93 a share, from $86.50. While the Genentech board advised its shareholders that the company is worth $112 per share, many financial analysts believe that the $93 per share offer may entice institutional investors to “pull the trigger” on the deal. Roche also extended its offer to shareholders by a week, until March 20. Roche already owns over 65 percent of Genentech’s outstanding shares.

Roche has indicated that if fewer than half the minority shares were tendered, it would not buy any of the shares tendered by Genentech shareholders. The new offer is likely to bring in more than half the minority shares, which would raise Roche’s ownership to at least 78 percent. About 71 percent of 131 Genentech stockholders who responded to a survey by Deutsche Bank on Friday said they would tender at least some of their shares at $93, and of those, half said they would tender virtually all. It is not clear what will happen if Roche is unable to purchase 100% of Genentech's shares.

Roche is motivated to close the deal as quickly as possible before results are released next month from a clinical trial of Avastin, one of Genentech’s top-selling cancer drugs. That trial, testing Avastin as a treatment for colon cancer after surgical removal of the tumore, could open a huge new market for the drug, which is now approved to treat cancer only at a later stage. Positive results from the trial may push Genentech’s stock price to over $100 per share—something that Roche desperately doesn’t want to happen.

If Roche is successful in its takeover bid, it  will likely to result in massive layoffs at Roche’s Nutley, NJ headquarters. Previously, Roche announced that it would move its US headquarters from Nutley to the Bay area if it acquires Genentech. Not good news for the state of New Jersey which is still reeling from the Pfizer-Wyeth takeover announced six weeks ago and the Merck-Schering Plough merger mentioned earlier today.

Until next time...

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

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Merck announced today that it was buying Schering Plough, the Kenilworth-New Jersey based drug maker, for $41.1 billion. The deal comes only six weeks after Pfizer said that it would purchase NJ-based Wyeth Pharmaceuticals. Superficially, the deal may make sense for the two struggling drug makers—they co-market the cholesterol-lowering drug Vytorin and also have collaborations in the respiratory diseases area. Also, Schering Plough has the European rights to the anti-arthritis drug Remicade and its 2007 purchase of the Dutch biopharmaceutical company Organon Biosciences NV provides access to several potential biotechnology drugs. Nevertheless, the impending merger will ultimately result in job losses and higher unemployment in the state of New Jersey.

Merck currently employs 55,200 workers and Schering-Plough—which grew significantly with its purchase of Organon—also has about 55,000 employees. While no immediate job cuts are planned, a company spokesperson acknowledged that the size of the combined workforce will be reduced by approximately 15%-20% over the next year or so. This means that as many as 20,000 pharmaceutical employees may lose their jobs—a time when unemployment in NJ is approaching 10 percent! My sources tell me that Merck employees are already on edge because of surprise layoffs that occurred in early September, 2008. I suspect that employee anxiety will be extremely high at both companies for the foreseeable future—never a good thing from a productivity point of view.

According to press releases, Schering-Plough's shareholders will get $10.50 in cash and 0.5767 Merck shares for each Schering-Plough share they own. That's a 34 percent premium to Schering-Plough's closing stock price on Friday. Merck's top executive, Chairman and CEO Richard Clark, will lead the combined company, which will attempt to remain a dominant player in treatment areas including cholesterol, respiratory, infectious disease and women's drugs, as well as vaccines. Schering-Plough's CEO, Fred Hassan, will participate in planning integration of the two companies until the close of the deal, which is expected in the fourth quarter. The transaction is to be structured as a reverse merger. Schering-Plough will be the surviving corporation but will take the name Merck. The new company will remain at Merck's headquarters in Whitehouse Station, N.J. and a company spokesperson indicated that a "substantial majority" of employees of Schering-Plough will remain with the newly-formed company. The combined revenue of both companies in 2008 was $47 billion.

Mr. Hassan, a talented, “turn-around” pharmaceutical executive, took over Schering-Plough six years ago as chairman and CEO—a time when the company was struggling with a $500 million fine (the largest ever at the time) imposed by the US Food and Drug Administration because of chronic manufacturing problems. While Schering-Plough is now in much better financial shape than when Mr. Hassan first arrived at the company, its stock price is currently almost identical to the price when he took over (it lost 50% of its value in the past 18 months). Let’s see whether or not Richard Clark, Merck’s current Chairman and CEO, has the mettle to run the combined company. While Schering-Plough has long been rumored to be a takeover target, I don’t think that the Merck-Schering Plough deal is a particularly good or strategic one. Both companies have been struggling of late because of near empty drug pipelines and the ongoing brouhaha over Zetia, Vytorin and Merck’s Vioxx. Further, both companies face price reductions and slumping sales in the next year or so because several blockbuster drugs will lose patent protection and face stiff competition from generic drug manufacturers.

Like the Pfizer-Wyeth deal, the Merck-Schering Plough merger may little more than a red herring. I still fail to see how merging two oversized, struggling pharmaceutical companies can possibly result in the creation of a single successful one. The only upside of the deal is that it allows the newly-formed company to restructure operations, eliminate tens of thousands of jobs and cut costs to bolster its stock share price. That said, I don’t think that an artificially-inflated stock share price necessarily translates into the innovation that historically has been required to create new drugs to treat unmet medical needs!

Until next time...

Good Luck and Good Job Hunting (avoid NJ at all costs)!!!!!!!

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Facebook contends that it has over 175 million members, making it the largest social network in the world! Interestingly, according to an article in today’s New York Times, most US members are “still relatively young.” “Facebook offers advertisers a target of 54.4 million members of all ages. But if an advertiser wants to narrow its target audience to those 25 or older, the number drops to 28.8 million. Narrow it to those 30 or older, and Facebook has 20.3 million to offer.” However, this is not surprisingly because people 30 and over weren’t allowed to join Facebook until 2006. In fact, many over-30 individuals have yet to sign up! In support of this, I am increasingly getting friend requests from my contemporaries—most of whom are in their 40s and 50s.

Each week, a million new members are added in the United States and five million globally—the 30-and-older group is its fastest-growing demographic (and the one with the most money to spend).  Further, Facebook members are becoming increasingly social and gregarious. In December the average number of “friends” per member was 100. Since then, it has grown to 120 per member according to a Facebook spokesperson. If Facebook continues to grow at its current rate, it will likely experience unprecedented and astonishing growth in the next few years. And, when it comes to monetizing social networks, bigger is always better!

Until next time...

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

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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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A team of researchers at the University of Wisconsin-Madison (my alma mater) genetically engineered a strain of Streptomyces platensis to overproduce the antibiotics platensimycin and platencin. They accomplished this by deleting a regulatory gene (ptmR1, whichencodes a putative GntR-like transcriptional regulator) in the antibiotic synthetic pathway that controls production. The newly engineered strain has been reported to overproduce platensimycin and platencin with yieldsof 323 ± 29 mg/L and 255 ± 30 mg/L, respectively. This represents a 100-fold increase in the yields observed with corresponding S. platensis wild type strains.

Platensimycin is the first of a new class of natural product antibiotics (with a novel mode of action) to be discovered in the past 40 years.  It exhibits strong, broad-spectrum Gram-positive antibacterial activity by selectively inhibiting cellular lipid biosynthesis. Treatment with platensimycin eradicates Staphylococcus aureus infection in mice. Because of its unique mode of action, platensimycin shows no cross-resistance to other key antibiotic-resistant strains tested, including methicillin-resistant S. aureus, vancomycin-intermediate S. aureus and vancomycin-resistant enterococci.

Platencin, also a natural product, is chemically and biologically related but different from platensimycin. Like platensimycin, it exhibits a broad-spectrum Gram-positive antibacterial activity through inhibition of fatty acid biosynthesis. And, it doesn’t exhibit cross-resistance to methicillin-resistant Staphylococcus aureus, vancomycin-intermediate S. aureus, and vancomycin-resistant Enterococci. Moreover, platencin shows potent in vivo efficacy without any observed toxicity.

Both antibiotics show promise for commercialization. While we need new antibiotics, both platensimycin and platencin target only Gram positive bacteria. Infections caused by multiple drug resistant Gram negative bacteria are threatening to overtake those caused by Gram positive in the very near future. At present, to the best of my knowledge, there are no new antibiotics in the pipeline directed against multiple drug resistant Gram negative strains.

Until next time...

Good Luck and Good Antibiotic Hunting!!!!!!!!

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Social media is the rage these days and, by all accounts, the things that are driving it popularity are making business connections, job hunting and the opportunity to meet/connect with others on a personal/romantic level. While scientists are generally perceived as being less social than others, I believe that we, like most people, primarily join social networks for two reasons—job hunting and career development or dating and sex.

With this in mind, a quick perusal of social media sites reveals that there is no shortage of social networks specifically designed for scientists for job hunting and career development. Surprisingly, there is a dearth of sites that enable scientists to connect with one another on personal or romantic levels. This doesn’t make sense to me as someone who spent 12 years as a graduate student and postdoc. Let’s face it, we scientists generally work long hours, don’t get out of the laboratory much and generally find it hard to meet prospective mates. That is, outside of the people who we work with daily. And as I learned the hard way, workplace romances can be very tricky and uncomfortable to manage at times. But, not to worry! Yesterday, I discovered an interesting website called Science Connection—maintained and run by the Scientist.com—which was specifically designed as a “the meeting place for single science professionals and others with an interest in science or nature.” I guess you can call it match.com for scientists!

From what I could glean from its website, Science Connection was started way back in the early 1990s by “erstwhile biologist Anne Lambert, with help and advice from friends who were also biologists, birders, or science types, and with the essential involvement of her friend Roy Smith, who did the original programming.” The site boasts about 15,533 members and provides some cool stats on the number of matches, relationships, marriages and even children that resulted from members who joined the network. Most of SciCon’s members are from the United States and Canada, with small numbers from other countries and regions of the world. The scientific disciplines of its members run the gamut from physical, natural, medical and social/behavioral sciences to computers and information technology. And, some of SciCon’s members aren’t scientists but lawyers, teachers, business people, musicians and artists (science fetish?).

But, before you take the SciCon plunge, you ought to know that the average age of male members is about 49 years and for women almost 46 years. However, those averages are misleading because they were calculated from the roughly 500 members who listed their ages on their profiles. There are roughly equal numbers of men and women and the age of its members ranges from 20 to 89 years. Many members are into natural history (birding, etc.) and participate in outdoor activities.  Finally, SciCon is not a free site and annual membership is $65 (~ 18 cents/day). “The $65 annual fee buys you a list of all members of the opposite sex (what about same sex individuals?) and a monthly newsletter, which has mini-profiles, discussion forums and a place where members can announce get-togethers in their area. Member Polylogue includes in-depth analyses of cyber romance, the perils of over-50 dating and friendships that bud into romance. If the $65 annual fee is too steep a price to pay for love, then you might want to consider a three month membership which costs only $30 (~33 cents/day). However, as stated on the website, the $65 annual membership represents the “the best value.”

While I had never heard of the Science Connection before, the network has been reviewed many times in the past by a variety of media outlets that include: NPR, Newsweek (2006), Discover (2007), Forbes Magazine and others. In general, the site gets favorable reviews. That said, if I wasn’t married (my wife is lawyer) I might consider joining Science Connection. After all, it certainly beats sitting around the lab on Friday and Saturday nights analyzing sequence data—not that there is anything wrong with that!

Until next time...

Good Luck—and well, err—Good Luck

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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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This morning, while doing my usual Twitter review, I came across a tweet from the Scientist.com about John McCain’s recent anti-science Twitter rants.  Based on his tweets (and snarky comments) he considers the following projects blatant examples of pork barrel spending:

"$209,000 to improve blueberry production and efficiency in GA"

"$819, 000 for catfish genetics research in Alabama"

"$900,000 for fish management - how does one manage a fish"

Older McCain tweets include:

"$1,427,250 for genetic improvements of switchgrass - I thought switchgrass genes were pretty good already, guess I was wrong."

"$250,000 to enhance research on Ice Seal populations"

"$2.1 million for the Center for Grape Genetics in New York - quick peel me a grape."

"$650,000 for beaver management in North Carolina and Mississippi"

McCain’s tweets underscore how little politicians—especially republicans(what do you expect from a party that endorses intelligent design over evolution) —understand about how science works. That said, some of the proposed projects cited by McCain may require additional scrutiny (by science experts not him) and may turn out to be projects that don't warrant funding.  Nevertheless,I believe that McCain's tweets are part of a well crafted Republican-led initiative intended to publicly discredit  these earmarked projects so that he and other Republican's can redirect public monies to their own pork barrel initiatives. Shame on McCain and his cronies for attempting to hijack Twitter to discredit worthy scientific, environmental,agricultural and conservation projects. 

Let’s try to disrupt McCain’s plan by tweeting that he is anti-science! 

Tweet away peeps!

Hat tip to the The Scientist!

Until next time...

Good Luck and Good Twittering!

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For the past decade or so, I have worked as a career counselor at national scientific meetings where I present seminars about resume writing, interviewing techniques and other career related issues. About two years ago, I started to hear about the fierce competition for H-1 and J-1 visas that foreign students must obtain to remain in the US to continue their studies and research. Many of the foreign students that I talked with sounded more like immigration lawyers than graduate students or postdocs—I was amazed at how well informed they were about visa availability and the changes and loopholes in US immigration law that can be exploited to obtain visas.

Since that time, it has become increasingly apparent that the visa problems experienced by most foreign students are beginning to wreak havoc on US science and engineering. Curiously, nobody at the US State Department seems to know why these visa problems exist. According to an article in today’s NY Times, a State Department official claims that visa delays can be attributed to “unfortunate staffing shortages.” Many of the students (and some immigration lawyers) that I talked with believe that it is annual visa limits and quotas not staffing issues that make it so difficult to obtain them.

It is no secret that American middle and high school students are no longer interested in pursuing careers in science and engineering. Because of this, American universities have come to rely on foreign students to fill open slots in graduate and postdoctoral sciences and engineering programs. With this in mind, it should come as no surprise that, over the past decade or more, foreign talent has been largely responsible for much of the technical and scientific innovation in the US.  Finally, and perhaps most importantly, American universities can no longer assume that the US is the first choice or destination for many foreign undergraduate, graduate and postdoctoral students—teaching and research at many foreign universities have vastly improved in recent years and can now compete with the best research institutions in the US.  In the past, it was largely assumed that when given a choice foreign student would choice a US university over all others. Together these findings beg the question: “If foreign students and postdocs are largely responsible for maintaining America’s competitive edge in science and technology, why would the US government make it so difficult to recruit the world’s best and brightest?”

There is no doubt that the US government, in a post-September 11^th world ought to carefully scrutinize foreign students before they are issued visas to study or work in the US. But, why has it become increasingly difficult for foreign students to renew their visas to continue to study or work in the US? Interestingly, visa availability and renewal problems are not only restricted to foreign nationals from likely places like China, India, the Middle East or Russia.  Many students and postdocs from Australia, Europe and elsewhere are also experiencing major delays and difficulty obtaining student or work visas.

While the visa issues facing foreign students may not seem like a big one to most Americans (most of who are not involved in science and engineering), its effects on American science and engineering are beginning to become apparent. For example, conference organizers are reluctant to hold international meetings in the US because they fear that many students and scientists will not be able to attend because of limited visa availability. Further, many talented foreign nationals, who want to remain and work in the US, are frequently forced to return to their home countries (to find employment) because they are unable to renew or extend their US visas. There is no question that America has grown increasingly dependent upon foreign students to conduct research in science and engineering.  I contend, that without these students, America’s competitiveness in science and engineering will continue to wane as it has over the past 20 years.  I believe that America has two choices to prevent this from happening. First, we can somehow convince larger numbers of American high school students to pursue careers in science and engineering. Second, the US government can improve and simply the visa process so that talented foreign students can continue to study and do research in the US. Nevertheless, something must be done soon—the future competitiveness of American science and engineering depends on it!

Until next time...

Good Luck and Good Visa Hunting!!!!!!

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An intrepid reader of BioJobBlog alerted me to a new venture started by Donna Roberts and Dawn Abrams. They allegedly run an operation called Groomers United (based in Shamong, NJ) and advertise on AdoptAPet.com under the same name. The reader cautions “beware of their sob stories and how they are performing a service to the community—they are actually selling older puppy mill breeders at elevated prices claiming that they are “rescuing” these dogs.”  And, for all you cat lovers out there, you can also adopt rescue cats at AdoptAPet. 

I wonder if Groomers United is a registered not-for-profit animal rescue organization. Maybe the State of New Jersey ought to look into it?

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