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The Biotechnology Industry Organization (BIO) kicked off its annual meeting in Atlanta, Georgia today and shortly thereafter, issued a press release detailing an education study (that it commissioned) which suggests that American high school students are continuing to fall behind in life sciences education and competitiveness. The timing of the BIO education report is curious, given that over 100,000 life sciences employees have lost their jobs over the past several years and more job cuts at pharmaceutical and biotechnology companies are expected in the next six months or so.

The report concluded that “middle and high school students across the country are generally falling behind in life sciences, and the nation is at risk of producing a dearth of qualified workers for the life sciences industry. Students are showing less interest in taking life sciences and science courses, and high schools are doing a poor job of preparing students for college-level science, The deficiencies will hurt the country's competitiveness with the rest of the world in the knowledge-based economy.”

Some of the report's finding include:

• 52 percent of 12th graders are at or above a basic level of achievement in the sciences as measured by the NAEP science test
• Average scores on the NAEP for 12th graders in the sciences and life sciences declined from 1996 to 2005
• Only 28 percent of high school students taking the ACT reached a score indicating college readiness for biology.

The report also found a deficiency in the number of well-qualified biology teachers available in high school, with one-in-eight biology teachers not certified to teach biology. To improve U.S. competitiveness in the biosciences industry, the report recommends that states incorporate biotechnology into their science standards, make sure students are ready to take college biosciences courses and focus more on professional development for teachers.

While BIO ought to be commended for the study, the results and the conclusions of the report are nothing new and have been known for over a decade by industry thought leaders and life sciences industry executives. The crux of the problem is that neither academia nor industry is willing to provide funds or invests in ways to find a solution to this vexing, ongoing issue. Also,while high school science curriculum experts and teachers are typically cited as the cause of the problem, most of the blame more aptly lies with life science educators at the undergraduate and graduate school levels.

Today, many US high schools and community colleges already offer life sciences and biotechnology training to their students. In fact, biotechnology curriculum development and outreach has been ongoing in US for well over a decade. For example, Bio-Link, an NSF-funded consortium of community colleges that began in the late 1990s, has diligently worked to create a network of community colleges and high schools that offer biotechnology education and training ranging from biomanufacturing to bioinformatics to forensic DNA sciences. Further, a quick perusal of many high schools and science academies in biotechnology-rich locales like the Northeast, California, New Jersey, Maryland, North Carolina and others reveals that life sciences education and training are readily available to many students interested in biology and bioscience.

In my opinion, the system doesn't break down at the high school level but at the undergraduate and graduate school levels. This is because for the past 15 years, many undergraduate life sciences courses have jettisoned their hands on laboratory components in favor of more lecture driven and e-based learning experiences. This is because these laboratories are costly to run and extremely labor intensive. Further, many undergraduate students may choose not pursue science careers because of the mistaken perception that life sciences jobs require a PhD. Ironically, there are many more jobs in the life sciences industry for students with undergraduate or masters' degrees than for those with PhD. This is because there is a glut of PhDs in today's market and the number of jobs in academia and the life sciences industry are growing smaller. I believe that academia and industry are responsible for the rapidly declining job market for PhD-life sciences.

First, let's look at academia. Most academicians who are charged with training PhDs and postdoctoral fellows have little appreciation or understanding of the technical and regulatory skill sets required in the life sciences industry. Second, many academics don't feel that it is their responsibility to prepare students and postdoctoral fellows for jobs in industry because that is tantamount to job training—a big no-no in academic circles. Finally,and perhaps most important, graduate programs are reluctant to provide career counseling or job-specific training for their students because it might interfere with their productivity, which in turn may reduce the amount of data principal investigators have to write papers and win grants to fund their laboratories. In other words, there is little or no incentive for education and training to change at the graduate level because there is no benefit or upside to principal investigators and tenured faculty members.

While the American life sciences industry has loudly and repeatedly complained about a lack of qualified job candidates to work at its companies, they have done little to support and fund efforts to reform US life science education and training. This is likely because many life sciences executives contend that they are in business not education and the responsibility to prepare students for careers in science should not fall on them. Rather, it rightfully belongs in the purview of secondary and post secondary educational institutions. And, rather than train new employees without previous industrial experience (to inject new talent and ideas into their organizations), companies typically only hire job candidates with previous industrial experience. As many newly minted PhD and postdoctoral students frequently ask: “How are we suppose to get industrial experience if nobody will hire us without previous industrial experience?” Good question! 

The BIO report warns that the US is falling behind in bioscience education and American life science companies may experience workforce shortages in the future. The fact that about 100,000    (many of whom were scientists) pharmaceutical employees have lost their jobs over the past several years, suggests otherwise. Nevertheless, American science education and training needs to be improved and reformed if the US wants to maintain its dominance in the life sciences. The piecemeal approach that has been pursued for past decade or so hasn't worked. And why should it? Neither academia nor industry, the two main players in the story, don't really have any “skin in the game.” In other words, they have nothing to lose right now!

I believe that its time for academia, industry and government to come together to craft a cohesive, national life science curriculum that meets the needs of all stakeholders. We have a President in the White House who believes in science, the ingenuity of the American people and change. The time is now!

Until next time...

Good Luck and Good Job Hunting!!!!! 

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As we all know, the H1NI pandemic has been raging on for close too 10 ten days now. Curiously, “Fear & The Flu: The New Age of Pandemics” is the title this week’s cover story in Newsweek magazine. From an informational standpoint point, “this may be too little, too late”—as the old saying goes. While the Internet has been around for over twenty years now, government agencies, most notably the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to rely almost exclusively on old media to communicate with the American public during infectious disease outbreaks. Apparently, the administrators who run these government agencies haven’t been listening closely enough to President Obama’s assertion that “we live in the digital age.”

Communications between the public and government health officials is vital when trying to manage and control infectious disease outbreaks. “Every single government agency as well as companies and non-profits need to be digitally literate and competent in a time of pandemic” asserts Eye on FDA blogger Mark Senak. For their performances in recent infectious disease outbreaks, Mark gives CDC an “A” for effort—although there is substantial room for improvement. FDA on the other hand didn’t fair as well. “The FDA is not nearly as sophisticated in terms of digital. Their only Twitter account is for food recalls.  And their YouTube channels are all confusing and unorganized. They have a long way to go.”

The Internet was originally designed as a digital tool to transmit and move large amounts of information from one place to another. That said, it is also a powerful communication vehicle that can be used to broadcast valuable, scientifically-accurate information during infectious disease outbreaks by leveraging social media tools like Twitter, Facebook and instant messaging. To that end, it’s time for public health agencies to recognize the power of digital media and craft communication plans that can be implemented in the next infectious disease outbreak.

Until next time...

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

 

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Over the past several years, I have publicly called for fundamental changes in graduate education and training for life scientists. To that end, I was delighted to read an OP-ED piece in today’s New York Times entitled “End Universities as We Know It” written by Professor Mark C. Taylor, Chairperson of the religion department at Columbia University. 

In his post, Professor Taylor recommended several fundamental and systemic changes that ought to improve the likelihood that graduate students and postdoctoral fellows find jobs at the end of their graduate education. While some of Dr. Taylor’s ideas are novel and innovative, two in particular; 1) expanding the range of career opportunities for graduate students and postdocs and 2) abolishing tenure and mandatory retirement; are ones that I have suggested many times in the past few years. Rather than paraphrase, I decided to repost what Dr Taylor said about these two very important, seminal issues.

Expand the range of professional options for graduate students

Most graduate students will never hold the kind of job for which they are being trained. It is, therefore, necessary to help them prepare for work in fields other than higher education. The exposure to new approaches and different cultures and the consideration of real-life issues will prepare students for jobs at businesses and nonprofit organizations. Moreover, the knowledge and skills they will cultivate in the new universities will enable them to adapt to a constantly changing world.

Impose mandatory retirement and abolish tenure

Initially intended to protect academic freedom, tenure has resulted in institutions with little turnover and professors impervious to change. After all, once tenure has been granted, there is no leverage to encourage a professor to continue to develop professionally or to require him or her to assume responsibilities like administration and student advising. Tenure should be replaced with seven-year contracts, which, like the programs in which faculty teach, can be terminated or renewed. This policy would enable colleges and universities to reward researchers, scholars and teachers who continue to evolve and remain productive while also making room for young people with new ideas and skills.

For many years now, I have been struggling with the moral and ethical obligations of graduate education. Recently, I came to the conclusion that it is our role as educators to selflessly impart knowledge and training to graduate students and postdoctoral fellows so that they can pursue the careers (and lives) that many have trained for a decade or more. I think Professor Taylor’s view of the role of an educator says it best: “Do not do what I do; rather, take whatever I have to offer and do with it what I could never imagine doing and then come back and tell me about it.” This is the attitude that must be by academicians if America wants to remain competitive in the life sciences.

Until next time....

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

 

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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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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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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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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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For the past year or so, I have been dealing with Donna Roberts, a so-called dog breeder who recently was convicted in New Jersey on three counts of animal cruelty. Ms Roberts recently contacted me because I chose not to post several of her most recent vitriolic and abusive rants against people who maintain that she is less than scrupulous.

In case you are interested, I didn’t post her most recent comments (like I have in the past) because I am frankly bored with them. That said, when Ms. Roberts has something honest to say, I will gladly publish her comments. I suspect that it will be a cold day in hell before I do that!

If you would like to contact Ms. Roberts directly --to hear what she has to say--please contact her a shadyoakhavs@yahoo.com  I am sure that she would love to  hear from you!

 

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My oldest son is a high school sophomore and is currently taking “honors” biology. While he is generally an “A” student, it is obvious that he is neither interested in biology nor motivated to perform to his ability in the class. Many of his “A-student friends” are also not doing well in biology class. This gave me pause for concern as a life-long science educator (and certified high school biology teacher). With this as a backdrop, I decided to meet with his teacher to determine why so many good students are underperforming in her class. After meeting with his teacher on two separate occasions, it was readily apparent why so many talented students were performing poorly in her class—she lacks the requisite educational and scientific skills to be an effective biology teacher.  This was confirmed by the head of curriculum development in my school district who told me that the last time that the district had an opening for a high school biology teacher he had two applicants (neither of which had strong biology credentials)—this in the state of New Jersey which is touted to have one of the best public school systems in America.

It is no secret that there is a nationwide dearth of qualified science and math teachers. US officials have been angsting over this problem for about 20 years and have been unable or unwilling to come up with solutions. To that end, I propose the following: induce some of the many currently unemployed life sciences PhDs to consider teaching at the middle and high school levels. While this may sound unorthodox and unappealing to most card-carrying PhDs, there are many benefits to becoming a middle or high school teacher.

1. Starting salaries for public school teachers with PhDs are very competitive
2. The school year is only 10 months long and your summers are free
3. The healthcare and 401 K/pension benefits are better than those in academia and industry (and contributions are usually paid by the school district)
4. There are guaranteed, negotiated yearly raises and longevity pay
5. Tenure is awarded after only three years
6. Curricula requirements and guidelines exists but teachers can run their classes any way that they like
7. Motivated and innovative teachers are encouraged to create new courses, apply   for grants for curriculum development and sometimes—depending upon facilities—offer students an opportunity to conduct independent research projects
8. School districts like to hire PhDs because it implies scientific excellence

While there are many benefits to being a teacher, it is not for everybody who holds a PhD degree.  I don’t recommend taking a teaching job (out of desperation) if you don’t like to teach—you, your supervisor and your students will be miserable And, you likely will have frustrated and unhappy parents— like me—visiting your regularly.

We PhDs are enormously invested in the ways that we are perceived by our peers. And, I suspect that the mere mention of teaching high school to your friends, colleagues and supervisors will likely result in surprised looks and lot’s of head shaking. Unfortunately, it is this parochial thinking that has caused America to lose it competitive edge and scientists who chose to teach rather than do research are generally perceived as being less intelligent or competent than their peers. Ironically, it is this close-mindedness and pejorative thinking that has contributed to America’s two-decade long slide in science and technology. Perhaps it is time for PhDs to be part of the solution rather than part of the problem!

Until next time…

Good Luck and Good Job Hunting

P.S. Please contact me if you are interested in teaching biology in the East Windsor Regional School District in New Jersey.

 

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I believe in free enterprise and that publicly-traded companies ought to be able to buy one another if a deal makes sense. In any other financial market, Pfizer’s impending acquisition of Wyeth would be a noteworthy event but not extraordinary. However, we are living in unprecedented and uncertain financial times and Pfizer’s possible purchase of Wyeth has serious implications for American taxpayers.

As you may recall, the US government has pumped hundreds of billions of dollars into American banks so that they remain “solvent.” This was done to unfreeze credit markets and to purportedly provide relief, albeit indirectly, to American taxpayers many of whom are in financial trouble. However, the government’s infusion of TARP money didn’t unfreeze the credit markets and banks are still reluctant to lend to one another or to small business owners and consumers who need financing to keep their business and homes.

The Pfizer-Wyeth deal began about a year ago when Pfizer’s CEO floated the idea of a merger or acquisition. Negotiations between the two companies were on and off over the past year mostly because Pfizer and Wyeth couldn’t agree on an acceptable purchase price. The financial meltdown of last October changed all that and it became economically feasible for Pfizer to purchase Wyeth at a sharply discounted price.  However, one of the missing variables in the equation (that might kill the deal) was the availability of credit to complete the transaction. Because US banks are currently flush with TARP cash (because they stopped lending) and the Pfizer-Wyeth deal represents a safe deal with a substantial financial upside, it was not surprising that four of the largest US banks were willing to finance the deal.

According to the NY Times, “Pfizer’s bid is being financed by four banks that received bailout money: Goldman Sachs, JP Morgan Chase, Citigroup and Bank of America.” Ironically, last week the US government agreed to give Citigroup and Bank of America an additional TARP infusion to prevent them from “failing.” Amazingly, these very same banks (that have been teetering on the brink of insolvency for the past several months) can find the cash (taxpayer money) to finance Pfizer’s purchase of Wyeth. And, what can the American taxpayers expect to receive in return for investing in the deal—massive job layoffs— if Pfizer’s past purchases of Warner Lambert and Pharmacia are used as harbingers of things to come.

In better financial times, these layoffs would be noteworthy but not insurmountable jobs—there were always jobs at rival pharmaceutical companies and smaller biotechnology companies. However, over the past three years, the pharmaceutical industry has shed over 160,000 jobs and the biotechnology industry, the usual refuge for former pharma employees, has also layed off tens of thousands employees. Put simply, there is no longer a place for these highly skilled and experienced pharmaceutical employees to go to seek employment.

Wyeth shareholders and the banks will undoubtedly benefit financially from the impending deal. On the other hand, while Pfizer may garner some short term benefits from the Wyeth purchase, I think the ROI from the deal will be nominal over the long haul. Ironically, the people who stand to lose the most from the deal are the very same people who made the deal possible—the American taxpayers!  Imagine how you might feel if a deal made on your behalf using your hard-earned money resulted in your eventual unemployment!

Until next time…

Good Luck and Good Job Hunting!!!!!

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The Bush administration spent the last eight years trying to weaken and dismantle the US Food and Drug Administration (FDA).  I thought the carnage at the agency would end in the waning days of one of America’s worst leaders. Sadly, I was mistaken.

As many of you may know, FDA regulations forbid drug companies from promoting off label use of previously approved drugs. Not surprisingly, drug companies were able to find loop holes in the regulations and off-label drug promotion reached unprecedented levels in the early 2000s. In response, the agency embarked on an aggressive, unrelenting campaign to combat off label drug promotion by drug manufacturers. This effectively changed the way in which pharmaceutical sales representatives interacted with physicians in the past few years. No longer would there be unsolicited gifts, lavish pizza lunches for office personnel or tickets to local sporting events. Neither the drug makers nor physicians were happy about the rule changes but the revised guidelines helped to lessen off label promotion of previously approved drugs. That said, it came as something of shock late last year, when FDA officials proposed a new set of guidelines that would ease the restrictions on off label drug promotion.

The new rules would allow drug makers to supply physicians with copies of published research reports describing off label uses of drugs that were previously approved for other therapeutic indication. As you might have guessed, the drug companies are ecstatic with the new guidelines. Who needs pens, mugs or pizza when you can simply hand a physician a reprint of article that show that off label use of an approved drug can treat potentially life threatening medical conditions.  What an ingenious way to boost sales of extant drugs for new indications without having to spend larges of money trying to win regulatory approval for them. While this would be a financial boon to the pharmaceutical industry, I don’t think it would be in the best interest of patients who may be prescribed a drug that hasn’t undergone the rigorous scrutiny of controlled, human clinical trials.

Many congressional democrats and drug industry critics opposed the guidelines when they were first proposed last year. But, like many other times over the past eight years, the Bush administration prevailed. Today, the agency announced (with little fanfare) that the new off label drug use guidelines would go into effect—one week before Barack Obama is inaugurated as President. 

Until next time…

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

 

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News Day reported today that Wegmans Food Markets, a grocer with 72 locations in New York, Pennsylvania, New Jersey, Virginia and Maryland is giving away “free generic antibiotics” for customers (with a prescription). Wegmans joins a growing list of supermarkets pharmacies including Giant Food and Publix that are giving free generic antibiotics to its customers.

I first learned about the “free generic antibiotic give away offers” several weeks ago after reading a post on the Wall Street Journal (WSJ) Health Blog. I took the WSJ health blog to task for posting the story without editorial comment on the potentially dangerous practice of “hawking free antibiotics” to drive business at regional and nationwide grocery store pharmacies. Luckily, in today’s WSJ Health Blog post about the Wegmans program, the author (Sarah Rubenstein) did suggest that the practice may lead to unnecessary promotional  use of antibiotics.

As you all should know by now, we are in the midst of bacterial antibiotic-resistance epidemic. People are beginning to regularly die from bacterial infections that were easily treatable a decade ago. Ironically, we are slowly approaching the morbidity and mortality rates for bacterial infections that previously existed in the pre-penicillin era. Moreover, there are no new, orally bioavailable, broad spectrum antibiotics on the horizon. A lack of new antibiotics coupled with rapidly emerging resistance to extant ones is wreaking havoc on the healthcare system in both community and hospital settings.

The “free generic antibiotics” advertising and marketing programs concocted by Giant, Publix and Wegman’s are egregious examples of how a lack of or unwillingness to understand science poses a serious public health threat to all Americans. I have no doubt that the marketers who devised the give away programs have nary a clue about the relationship between antibiotic use and the emergence of antibiotic resistance strains of bacteria. Further, while physicians may be aware of increasing rates of antibiotic resistance, many are reluctant to not prescribe antibiotics to patients who request them. After all, these physicians are running a business and if they don’t write the script, the patient will take his/her business elsewhere. The potential public health implication of these free antibiotic programs begs the question: Why not give away generic ace inhibitors, generic statins or other generic medications whose profits margins are also negligible but don’t carry any public health risks?

Put simply, the promise of free generic antibiotics is a marketing strategy that is in my opinion, reckless, dangerous and may have serious public health implications in the future. Make no mistake about it, I am a capitalist but not when profits are placed before human lives.

Hat tip to the WSJ Health Blog

Until next time…

Good Luck and Good Job Hunting (try antibiotic drug discovery—we need new ones)

 

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Today is a sad day in the pharmaceutical and biotechnology blogging world. Pharmalot, a two year old, pioneering blog created by the intrepid Ed Silverman and the Star Ledger News has decided to call it quits. Unfortunately, the Star Ledger is in dire financial straits and it could no longer provide Ed with the support he needed to continue to run the Pharmalot blog. Please read Ed’s last blog post for the full story.

Pharmalot was a well crafted and informative blog. I frequently (more times then I care to admit) used Pharmalot as source material for many of my posts at BioJobBlog. I am not sure how I will fill the void left by Pharmalot’s untimely  demise!

I first met Ed about 8 years ago when he did a story about a biopharmaceutical company that I founded (along with Abe Abuchowski) called Prolong Pharmaceuticals.  His coverage was outstanding and I am pleased to report that Prolong is still in business today. Ed and I reconnected a little over a year ago at a panel discussion about scientific integrity and journalism. Ed shared the podium with the WSJ Health Blog, the New York Times, Advanstar Publications and several well known authors who write about pharma and biotech. I was truly impressed with his understanding of the pharmaceutical industry (he is a journalist not a scientist) and his commitment to telling people the truth regardless of the consequences. I took his message to heart and have attempted to apply the same philosophy to my posts at BioJobBlog.

I want to personally thank Ed for his unwavering commitment to journalistic integrity and his help in ferreting out the truth. I wish him the best for whatever the future may hold for him—he will be sorely missed.

Until next time…

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

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BioCrowd, a new social networking site for bioprofessionals was officially launched today.  We are still making last minute fixes and cosmetic changes so please bear with us over the next few weeks.

BioCrowd's main goal is to provide a venue for career development and business interactions for students, scientists and other bioprofessionals.  We plan on adding new applications and functionality as the network evolves.  That said, please let us know what you think, what you like and don't like and how we can improve BioCrowd to meet your needs.

Thanks and I hope that you become a member of the BioCrowd!

Until next time...

Good Luck and Good Job Hunting!!!!

 

 

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Glassdoor.com a site that allows people to rate CEO and company performance selected Arthur Levinson, one of the original founders and current CEO of Genentech as the “nicest CEO” of the year. Dr. Levinson received a 93 percent approval rating and he is the only biotech CEO on the list. A strategic planner at Genentech wrote “He leads the Silicon Valley biotech company with a “decision-making structure that intrinsically forces authority downward to the lowest possible level providing many opportunities to exercise and test one’s judgment.”  I have worked with Genentech on education and training initiatives in the past and as far as I am concerned it is “second to none” in the biotech industry. 

It is evident from Genentech’s continued success, that Dr. Levinson is truly one of the unsung heroes (and pioneers) of the biotechnology industry. I am glad that he is finally getting the recognition that he deserves.

Until next time…

Good Luck and Good Job Hunting (try Genentech, they are hiring!)

 

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Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it will lay off 85 of its 115 employees or almost 75% of its workforce. The news follows the FDA’s rejection of its application for oritavancin, an antibiotic it is developing to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic resistant bacteria. The agency wants Targanta to conduct another Phase III clinical trial to further assess of oritavancin’s safety and efficacy.

The company estimates that the new clinical trial will cost about $20 million. Targanta CEO Mark Leuchtenberger said “We are no longer a pre-commercial company. We are back to being a Phase three company, and that requires us to right-size and to streamline our operations.”

Things are not going well for companies in the antibacterial drug discovery and development space. Late last month, FDA rejected Swiss-based Arpida’s NDA for iclaprim an antibiotic it was developing to treat complicated skin and soft infections caused by MRSA. Shortly after receiving the news, Arpida layed off roughly 72% of its employees and is down to about 30 employees like Targanta.

It is unfortunate that big pharma decided to abandon antibacterial discovery and development research about eight years ago. Consequently, development of  new, much-needed antibiotics has been relegated to financially-strapped, small biopharmaceutical companies whose likelihood of success is questionable.

Until next time…

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

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I received a phone call late Thursday afternoon from the general counsel from the Biotechnology Industry Organization (BIO).  At first I thought he was calling to invite me to give a talk at this year's annual meeting, but after he mentioned something about a blog post circa Feb. '08, I quickly realized that it wasn't going to be a fun call.  It turns out that I inadvertently and mistakenly uploaded  BIO's logo to the post. Because I was not authorized to use the logo, I had violated BIO trademarking rights.  After I hung up, I quickly removed the logo.  And, I am happy to report that the post is alive and well (albeit photo-less).

What strikes me as curious is that the post in question had been on the blog for almost a year. Interestingly, the call asking me to remove the logo came about 24 hours after posting a piece that was unkind to a proposed biotechnology industry bailout package. I think the call was BIO's way of telling me that from this day forward they will be carefully monitoring BioJobBlog.   So it goes....the more the merrier!

Until next time....

 

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

 

 

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It seems that every day a new American industry asks the US government for a bailout because of impending financial exigency. That said, I was somewhat surprised to learn today that the biotechnology industry is planning to ask Congress for a bailout. The plan calls for Congress to temporarily changes tax laws to allow unprofitable biotech companies to get cash now, in exchange for tax credits that they would pledge not to take if they eventually become profitable. The companies that receive the cash would pledge that the money would be used ONLY for research and development activities. The reasoning behind the proposed government bailout is that the infused capital would allow struggling biotech companies to keep their current employees, stay in business and help to stimulate the US economy. It is not clear whether or not all biotechnology companies—publicly traded or privately held—would be eligible for the bailout package.

Currently, there are 327 publicly traded and roughly 1,000 privately held biotechnology companies in the US. A majority of these companies are not profitable and operate almost exclusively on institutional and private venture capital funds. According to the Biotechnology Industry Organization (BIO), 125 of 327 public companies currently have less than 6 months of cash on hand—nearly double the total last year. It is not surprising that the biotechnology industry like most other US industries is struggling and feeling the impact of recent financial meltdown—there simply isn’t enough liquidity in the system to keep all companies afloat. While I am not opposed in principle to government bailouts, there are several reasons why the proposed rescue plan for the biotechnology industry doesn’t sense to me.

First, unlike the automobile industry which employs millions of workers, the biotechnology industry only employs about 200,000 workers, many of whom have advanced degrees and possess specialized technical skills. And, studies show that during recessionary periods workers with specialized skills are more likely to find employment after losing a job than their unskilled counterparts. This suggest that it may be better for the American economy in the long run if the government bails out the auto industry before it even considers a bailout for biotech. Nevertheless, BIO is actively lobbying for a government bailout because it believes that a bailout will not only stimulate the American economy but also help to “preserve American innovation and competitiveness.” Of interest, the pharmaceutical industry which shed over 123,000 jobs in the last year or so is not asking for government assistance. As one Washington lobbyist aptly quipped after hearing about the proposed biotech bailout: saving “research-based companies that employ 30 people won’t necessarily stimulate the economy.”

Second, the biotechnology business is inherently a very risky one. The failure rate among biotech companies is roughly 90%. And, as many of you know, biotechnology companies are always started with venture capital from investors who are willing to invest in risky projects because of possible financially-lucrative returns. Because of this, biotechnology executives are generally beholden to their investors rather than their shareholders, stakeholders or employees. Unfortunately, important business decisions are frequently made at venture-backed biotech companies for financial reasons rather than scientific or medical ones. Further, many financially-challenged, biotechnology companies that would benefit from the bail out started up almost a decade ago when venture capital was abundant and IPOs were daily events. In retrospect, many of these companies shouldn’t have been started in the first place because their technology platforms were either inadequately vetted or their business models were fundamentally flawed. I believe that these financially troubled companies ought to be allowed to fail just like the technology companies that had to close down in the early 2000s after the Internet bubble finally burst.

Third, why should unprofitable companies without products or revenues be bailed out and rewarded for failure? As I posited in a previous post, a company really isn’t a business until it has a product, generates revenues and turns a profit (or at least break even). If a company cannot create a viable business after 5-10 years of capital investments then it wasn’t a good value proposition at the outset. Perhaps a better use of the proposed bailout money would be for the US government to create public funding vehicles for companies that have developed promising new drugs that already have proof of concept in humans and are ready for clinical testing.

Finally, over the past decade, the biotechnology industry has spent hundreds of millions of dollars lobbying against the reimportation of drugs from foreign companies and the development of so-called follow-on biologics (potentially cheaper versions of blockbuster biotechnology drugs that have lost patent protection). This decade-long lobbying effort was undertaken to preserve America’s biotechnology monopoly and to insure that biotech drug prices remain high. Maybe BIO and its member companies should have considered using some of those monies to help struggling biotechnology companies rather than using it to influence politicians for tax breaks and pork barrel legislative initiatives.

Lastly and perhaps most importantly, why should taxpayer dollars be used to bailout an industry that has actively opposed and steadfastly refused to provide ALL Americans with access to reasonably priced, potentially life-saving biotech drugs? Because the biotechnology industry isn’t fundamentally different than any other American industry, I believe that the Darwinian principle of “survival of the fittest ought” to be applied to it. Unless, of course, you work on Wall Street or in Detroit—but don’t get me started!

Until next time…

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

 

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We in America have grown accustomed to the constant barrage of direct-to-consumer (DTC) advertising of prescription drugs provided to us daily by pharmaceutical and biotechnology companies. That said, some of you may be surprised to learn that DTC advertising of prescription drugs is only permitted in two countries in the world: New Zealand and the US.

According to William Burns, an executive at Roche Pharmaceuticals, “Direct-to-consumer promotion was the single worst decision for the industry." He added, "When industry says we're spending all the money on R&D but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility." It may not provide much credibility to the industry but is sure does help sales.  reported that a total of $4.2 billion was spent on DTC drug ads in the U.S. in 2005, up 330 percent from 1996.

Apparently Mr. Burns is not alone in his opinion. Angus Russell, chief executive of Britain's Shire Pharmaceuticals also condemned DTC.  As many of you know, I ‘m not a big fan of DTC nor am I flag-waving American but I find it rather curious that after almost 12 years of DTC advertising that European pharma executives are suddenly speaking out against the practice. Could this be little more than a ploy to get the European Commission to re-examine and possibly loosen it restrictions on the way prescription drugs are promoted in the EU? Quite coincidentally, the European Commission is in the process of drawing up legislation that would allow a degree of information to be disseminated about medicines by their makers, although advertising pharmaceuticals would remain banned. The legislation was initially expected to be unveiled by the European Union's executive arm last week but has been delayed.

Drug makers have long campaigned against rules that prevent them from talking directly to consumers in Europe, despite a wealth of often unreliable information being available on the Internet. I think this statement by Mr. Burns sums up the situation "You've got the two extremes on the planet, where we (drug makers) are given access to the public in America, which is too much, and in Europe we're not given access to information" (sounds like sour grapes to me).

Maybe a compromise between the two extremes would be a solution acceptable to both American and European regulators? 

Until next time…

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

 

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I heard today from another one of Grace Abrams’ grifting victims. Apparently, this individual purchased a sick puppy from Ms. Abrams several months ago which at one year old developed some problems that likely resulted from congenital defects due to inbreeding. This person told me that a friend of hers also purchased a ‘Havanese” from Ms. Abrams which they suspect really isn’t a Havanese (despite ‘papers’ that indicate that it is). As you may recall, we also received suspect pedigree papers for the dogs that we purchased from Ms. Abrams (which prompted us to get both dogs tested). I sent Grace’s most recent victims information on the Wisdom Panel DNA tests that we used to perform genetic testing on our dogs, the results of which confirmed that Moose, our so-called Havanese, was really a mixed breed dog!

I wonder how long it will take Donna Roberts to send me one of her threatening, vitriolic notes  (read the comments) after I post this story?  I will keep you posted….

Until next time…

Good Luck with finding a new puppy!!!!!!!

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The Pharmalot blog reported today that this coming Friday, the US Federal Trade Commission (FTC) will conduct a workshop on the issue of follow-on biologics. The roundtable will apparently be organized into five panels to discuss: 1) the price and market share effect of entry by both biosimilar and biogeneric drugs, 2) the likely competitive effects of reference product regulatory exclusivity, 3) biotechnology patent issues, 4) the likely competitive effects of follow-on biologic regulatory incentives, and 5) the patent resolution process.

The first thing that comes to mind is “beating a dead horse” (euphemistically of course). Call me crazy but these very issues have been bandied about and discussed ad nauseum and  for the past decade or so. I am not sure what new revelations will come to light at this Friday’s FTC roundtable meeting. 

Here’s a thought. Maybe industry representatives, FDA regulators and the insurance companies ought to ask the European Union how they were able to craft their version of a regulatory pathway for approval of these products way back in 2004. Nah…let’s let the lobbyist duke it out and see which side wins!

Until next time…

Good Luck and Good Job Hunting

 

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As you all know by now, American pharmaceutical companies have been intermittently laying off thousands of employees for the past two years or so. Many of the employees who have lost their jobs are R& D scientists, marketing personnel and sales representatives. This seemingly makes sense—because fewer drugs are being discovered and brought to market, fewer people are required to market and sell them. That said, isn’t discovering new drugs the currency and lifeblood of the pharmaceutical industry? How do these companies plan to stay in business if they continue to layoff employees who are seemingly responsible for developing new sources of revenue for them? Taking their cues from the IT and software industries, many US drug makers are beginning to either transfer R&D operations to foreign, company-owned research facilities or outsourcing some or all R&D activities to foreign contract research organizations (CROs).

For those of you who may not know, US pharmaceutical companies have been routinely outsourcing various aspects of R&D and drug manufacturing for many years. For example, a majority of the active pharmaceutical ingredients (APIs) and excipients found in many drug sold in the US are routinely manufactured in places like China, India and elsewhere. Until recently, many pharmaceutical companies were reluctant to outsource many critical R&D activities, e.g., screening, medicinal chemistry, pre-clinical testing, etc. for fear of inferior quality. However, the increasing costs of conducting US-based R&D coupled with a worldwide glut of American-trained, foreign scientists (who were unable or not permitted to find jobs in the US) has made the practice of outsourcing R&D operations less risky and more economically feasible. After all, many of the scientists who work in company-owned foreign research facilities or foreign-owned CROs were trained by American scientists who work at some of America’s pre-eminent academic and government research institutions.

From a business perspective, it makes complete sense that pharmaceutical companies might opt to transfer or outsource R&D operations to foreign countries—the quality is good and it is much cheaper! That said, don’t expect the price of pharmaceutical drugs to plummet anytime soon as more drug makers outsource or expand their R&D operations in foreign countries. Put simply, pharmaceutical companies are outsourcing R&D to cut costs, drive up stock share prices and insure financial growth by preserving the staggering product profit margins that they currently enjoy. Take Bristol-Myers Squibb (BMS) for example. Late last Wednesday, its CFO told a group of financial analysts and investors that the company plans on trimming $2.5 billion by 2012 from its operating budget through US job cuts and revamping operations. Shortly after the announcement, I read with amazement that BMS is expanding its R&D operations in Bangalore, India and that they are looking to hire no fewer than five new Department heads—America’s loss is India’s gain!

While outsourcing or expanding R&D operations in foreign countries at the expense of American workers may help the bottom line of many US drug makers, it will do precious little to reverse the decade-long, decline of America’s global competitiveness in science and technology.

Until next time…

 

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

 

 

 

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The election of Barack Obama last night signals the beginning of the end of the dark ages that have plagued American science for the past 8 years. I hope that one of the first things that Mr. Obama does after he is sworn in as President is to lift the ban on embryonic stem cell research in this country. This unprecedented ban has done more to harm to American science than most lay people realize. Because of it, we are light years behind other countries which have been able to conducted unfettered research in this area.

The second thing that President Obama must do is to restore the funding levels to the National Institutes of Health and the National Science Foundation so that American scientists will have sufficient funds to innovate once again. For the past 5 years or so, many of my friends in academia were more focused on trying to keep their jobs than concentrating on divining cutting-edge research. 

Finally, and perhaps most importantly, Mr. Obama must overall the United States Food and Drug Administration (FDA) so that the American public can once again believe that prescription drugs that are marketed and sold in the US are safe and efficacious.

On a personal note, the last 8 years have felt like an eternity to me—both a scientist and a citizen. Whether or not Barack Obama lives up to his campaign promises, our next President is a man of intellect, vision and a sense of social justice. That said, this is the first time in many years, that I can truly say that I am proud to be an American!!!

The change is coming…!!!!!!!!!!!!

Until next time…

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

 

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A European friend of mine sent me a link to a video of Sarah Palin espousing her understanding of the relationship between basic research and it application to solving human disease. Along with the video (see below) she sent the message "Please ,please don't tell me they (McCain and Palin) are going to win..."  I hope for science's sake they don't....

Until next time...

 

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

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There was an article in today’s NY Times biz section which suggests that the recent financial crisis is starting to have an effect on the growth of the biotechnology industry, once thought to be a recession-proof sector. The article contends that the lack of available institutional cash and venture money is causing extant biotechnology companies to “tighten their belts.” And, if the trend continues, this lack of capital will stifle innovation, which in turn, will threaten and undermine the stability and future of the entire biotechnology sector. While times are certainly tough, the biotechnology industry, in my opinion, is alive and well and will continue to expand well into the 21^st century.

It is important to note that many biotechnology companies that are struggling today are publicly-traded companies not privately held ones. Unlike publicly-traded companies, privately-held ones don’t have to answer to millions of shareholders or worry about their price per share on a daily basis.  Further, the expectations for privately held companies are much less than those for publicly traded entities. Based on recent discussions with venture capitalist friends and institutional investment bankers (those that still have jobs) there is still substantial funding out there for start-ups and companies that are trying to advance their products from development into clinical testing. Many of the financially-troubled public companies mentioned in the Times article were struggling (and on the verge of failing) before the recent financial meltdown. The recent financial crisis is simply hastening their demise. The reason why many of these companies are on the brink is that they went public in the late 1990s—a time when writing a business plan on the back of a napkin was sufficient for investment bankers to underwrite a company’s IPO. Unfortunately, many of these companies were little more than research or tool box driven companies whose founders failed to understand that products not technology would make their companies successful. Put simply, these companies should have never gone public in the first place!

Not surprisingly, almost all of the companies cited in the Times article fit the ‘product-less biotechnology company’ profile. For example, Maxygen, a company originally founded as a “molecular evolution” company (that went public in 1999) didn’t identify a lead product until a couple of years ago. Unfortunately, after spending millions of dollars on preclinical development, the company no longer has sufficient funds to move the product into human clinical testing. Late last week, Maxygen announced that it would layoff 30% of its workforce and consider selling itself.

Another example cited in the article is Iceland’s DeCode Genetics, once a high flying genomics and bioinformatics company that regularly made headlines for discovering new genes for cancer, cardiovascular and hereditary diseases. While DeCode has a great genomic and bioinformatics platform (and “did outstanding science”—largely because of the genetic purity of the Icelandic population) it was never able to use its technology to identify a lead therapeutic product. DeCode’s stock price has fallen more than 90% in the last year to 29 cents per share and will likely fail given the horrendous state of Iceland’s banking industry and economy.

The impending failure of many financially-strapped biotechnology companies in the current financial environment should come as no surprise to biologists—is very consistent with Darwin’s theory of natural selection which says “only the strongest and the fittest will survive. To survive in the biotechnology industry, companies must be single-mindedly product-driven. Companies that lack a product focus, in this or future economies will be able to survive for a short while but ultimately they are doomed to fail. That said, while there may be fewer companies as the biotechnology industry continues to evolve, the companies that do survive will undoubtedly be extremely robust and fiercely competitive.

Until next time….

 

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

 

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My recent post about Donna Roberts appears to be a very popular one. No fewer than 50 people have read the post and I am now starting to receive comments from people who have had similar experiences to mine after purchasing puppies from Ms. Roberts and her daughter Grace aka Dawn Abrams. Check out this story and another that I found on the Ripoffreport.com after being alerted about them by one of my readers.

It appears that I am not the only person who received threatening comments from Ms. Roberts. Check out this bogus diatribe against a former customer who dared to question Ms. Roberts’ integrity and veracity after she purchased a very sick puppy from her.

Donna, in case you are wondering (I know you will read this), veracity means “truthfulness”—something that you know nothing about.

Stay tuned for the next installment of the Donna Roberts and Grace Abrams story.

 

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 I invite those of you who have been following this story to take a few minutes to read the comments that Donna Roberts continues to leave on my blog. Ms Roberts, who was convicted of several counts of animal cruelty in New Jersey last summer, is the mother of Grace aka “Dawn” Abrams who fraudulently sold me my dog Moose several months ago. Although, Ms. Roberts was not involved in the transaction between Grace and me, she continues to send me threatening and bullying e-mail messages proclaiming her daughter’s (and her own) innocence.

I continue to post Ms. Robert’s comments because I want people who read my blog to understand the type of person that I am dealing with! Unfortunately, she reminds me a lot of Sarah Palin—another woman of questionable ethics and integrity. And, I am sad to say that Ms Roberts is about as bright as Ms. Palin too!

Until next time….

Good Luck and Vote for Obama

 

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 As you may recall, I purchased two dogs, a 10 week old Havanese puppy and a supposed 9- month old male Havanese “rescue puppy” named Marcus (now called Moose, see pic) from a New Jersey dog breeder named Dawn aka Grace Abrams. From the outset, we had suspicions about Moose’s age and true heritage. Our suspicions were heightened after our veterinarian announced that Moose was much older than 9 months and that he was suffering from ear and urinary tract infections, two types of intestinal worms and had 4 loose teeth because of periodontal disease. Also, Moose didn’t look anything like Sandy.  Based on photos we found online, Moose looked more like a Maltese than a Havanese—something that was verified by casual conversations with Maltese owners and many veterinary professionals. 

Because of my molecular biology training, I wondered whether a genetic test, similar to those used for human genetic testing, was commercially available for dogs. Much to my delight, I discovered that Mars Veterinary had developed a test called the Wisdom Panel that can be use to analyze and verify or refute the lineage of over 135 breeds of dogs. Because of our growing suspicions, my wife and I decided to have both of our dogs tested to verify their breed designations. We received the Wisdom Panel results for Sandy and Moose last week. Like other things in life there is some good news and some bad news. First, let me give you the good news.

The Wisdom Panel results revealed that Sandy is truly a Havanese (there were negligible traces of other breeds but they were consistent with the Havanese breed as a whole). Now, the bad news (which is actually good news for us). Moose the supposed 9-month old Havanese is in reality a mixed breed dog whose lineage consists of equal amounts of Havanese, Miniature Poodle, Shih Tzu and Maltese. This result coupled with the bogus Havanese pedigree papers that Ms. Abrams gave us when we purchased Moose, suggests that Ms. Abrams, who claims to be an experienced Havanese breeder, likely committed fraud when she sold him to us. After all, how could an experienced Havanese breeder like Dawn, who has been selling “Havanese” puppies for the past few years, mistake a 2 year old mixed breed dog for a 9-month old Havanese puppy?  

Despite mounting evidence against Dawn and her mother, Donna Roberts, they continue to sell dogs to unsuspecting would-be pet owners. With this in mind, I recently came across several new ads likely posted by Dawn and Donna using old and sometimes new aliases to sell their dogs!

http://www.breeders.net/detail.php?id=210048 

http://www.breeders.net/detail.php?id=143532

http://www.breeders.net/detail.php?id=210055

http://www.breeders.net/detail.php?id=21004

Until next time….

Good Luck and Good Job Hunting!!!!!

 

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Beginning in 2009, Eli Lilly and Merck will post in online databases all payments made to doctors for speaking and consulting services. According to an article in today’s New York Times, the postings will “likely include” the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments.

The lack of disclosure by physicians about their relationships with drug and medical devices companies have  plagued medical journals and continuing medical education programs for many years. For those of you who may not know commercial and business relationships (including consulting and speaker fees) are common between leading medical thought leaders and drug companies. In the last two decades alone, drug and device makers have made payments to tens of thousands of doctors and researchers in all medical specialties and areas of research. Critics of these practices (including the US Congress) are worried that this money could taint doctors’ research plans or clinical judgment when it comes to new drug/device approval. These concerns have prompted government agencies, medical journals and universities to look more closely at the deals. Many medical journals and granting agencies now require that physicians disclose all of their relationships to drug and device companies before their manuscripts and grants are reviewed.

Lilly and Merck’s decision to publicly disclose which physicians are on their payrolls is a step in the right direction. Full disclose and more transparency about the relationships between physicians and drug/devices makers is an important first step to limit subjectivity and conflict of interest issues when it comes to new drug/device approvals.

Until next time….

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

 

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 On the surface, you wouldn’t think that the Human Papilloma Virus (HPV, the causative agent of venereal warts and cervical cancer) and US Homeland Security have much in common. However, they have more in common than you think as reported in yesterday's Pharmalot blog.

According to a report by the TheStreet.com , Homeland Security’s US Citizenship and Immigration Services (USCIS) is the first government agency to mandate that all female immigrants’ ages 11 to 26 years old be vaccinated against HPV. Because Gardasil is the only cervical cancer (HPV) vaccine that is approved for use in the US it will the vaccine used for the mandatory immunizations. Surprisingly, there is no HPV vaccination requirement for US visa holders or American citizens.

Since the policy was begun, an estimated 233,000 females aged 11 to 26 who entered the US as prospective citizens paid a combined $52 million or so for the vaccinations according to the Street.com article. Curiously, the USCIS is requiring only a single injection for females who receive the vaccine—the Gardasil label indicates that three injections are required for full anti-HPV effectiveness.

As you may recall, more than 20 states rejected plans backed by Merck to make Gardasil vaccination mandatory. Merck abandoned its campaign after parents and medical experts expressed concern about safety and effectiveness. While Gardasil vaccination is optional for American citizens, there is apparently no opt-out provision for females who simply want to immigrate to the US. The confusion may like lie in a document issued by the US State Department called form DS-3025, or “vaccination documentation worksheet which says vaccination against “Human Papillomavirus is required for US immigrant visa applicants.” Here is the form.

John Abramson, the former chairman of the CDC’s Advisory Committee for Immunization Practices when the HPV requirement began in April 2007, and an opponent of mandatory vaccination said “This is not a disease that is communicable like SARS or pandemic flu or even measles.” “I am stunned. It was not the intention of the policy to mandate vaccination of immigrants,”

Ironically, Merck which has been pushing as hard as it can to promote Gardasil use isn’t aware of the Homeland Security policy, according to a Merck spokeswoman. It just goes to show how effective unregulated pharmaceutical lobbying can be!!!

Until next time…

Good Luck and Good Job Hunting

 

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 Previously, on the Bristol-Myers Squibb/ImClone Let’s Make a Deal Show. BMS offered $60 per share for the outstanding shares of ImClone that it doesn’t already own. As expected, Carl Icahn, ImClones’s Chairman and former corporate raider, summarily rejected BMS’ offer as insulting and an attempt by BMS to undervalue ImClone’s stock. Then, after a month of silence between the two parties, Mr Icahn announced that an undisclosed pharmaceutical suitor had made a better offer to buy ImClone. Today, about three weeks after Mr Icahn disclosed the information about his mysterious stranger, BMS (as expected) grudgingly raised its offer from $60 to $62 per share. The mysterious stranger seems to be out of the mix now.

Conventional wisdom (and word on the street) suggests that ImClone’s stock is worth about $70-$75 per share and that Carl (and the ImClone board of directors) will not sell the company for anything less. Today’s exchange between BMS and ImClone prompted a Wall Street analyst who has been closely following the twists and turns of the deal to write “we view Bristol’s increased bid and attempt to remove the company’s board as futile. The premium over the prior $60 offer is insufficient, in our view, to woo the larger ImClone stock holders to join it in revolt against Mr. Icahn and his allies on the board. The net result of Bristol’s efforts will amount to little more than yet another exchange of testy letters between the two parties.” And, in fact, Jim Cornelius, BMS’s CEO took the opportunity to do just 

It seems to me that whether or not a deal is reached depends more on who wins the pissing match between Mr Cornelius and Mr. Icahn rather than what is in the best interest of the shareholders of both companies. C’mon guys, we are currently in the midst of the worst economic meltdown in the history of the US —do the right thing and consummate the deal already!

Tune in next time for latest installment of the BMS/ImClone Let’s Make a Deal Show.

Until next time….

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

 

 

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 Because I am trying to become a social network maven (and I wanted to be cool), joining Twitter was a no- brainer.  I have used Twitter for over two months now and I still haven’t figured out why people use it. I frequently post Twits or Tweets (whatever they are called) and I rarely get any responses, even when I direct the questions to some of my followers. Would somebody out there be so kind as to tell me what I am doing wrong or how to use Twitter correctly?

BTW, my new Twitter nick is: BioJobBlog—please follow me and make a social networking neophyte very happy!

Until next time….

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

 

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I read today in the New York Times that healthcare costs are expect to ease slightly in 2009 for employers. According to Mercer, a healthcare consulting firm, healthcare benefit costs are expected to rise only 5.7% in 2009. Since 2005, annual increases in healthcare spending have hovered around 6.1%.

At first glance, this ought to be good news for the millions of workers employed by American companies. But, like most other reports and survey conducted during the disastrous Bush Administration, the numbers don’t tell the real story. In reality, employers are aggressively shifting the healthcare burden to employees by raising premiums and pushing deductibles and co-payments to all time record highs. For example, I learned the other day that my good friend Pete, who works as recruiter in the hospitality business, has to pay $50 each time he or any member of his family (he has 5 children) goes to the doctor. Unlike other people who have less onerous co-pays, Pete has to pick and choose which family aliments really require medical attention. These decisions must be extremely difficult and stressful for Pete, who had prostate cancer surgery less than a year ago.

Regardless of your political persuasions, it is obvious to me that healthcare reform is long overdue in the US. I hope that Barack Obama begins to address this ongoing, serious problem shortly after he is elected President in November, 2009.

Until next time….

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

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Since the original post about bogus dog breeding in New Jersey, I received several comments from the alleged breeder(s)" who sold us our dogs Moose and Sandy.  I invite you to read them---they are very interesting to say to least. 

A person who became involved with our little doggy drama sent me a link to a company that does genetic testing verify or refute canine breed or pedigree claims.  We are going to have both of our dogs tested.  We suspect that Moose is not a havanese as billed but a maltese/bichon or maybe a maltese/havanese mix . As luck would have it, we met both a maltese and bichon during our trip to Moosehead Lake in Maine and learned alot about both breeds. Moose looks alot like a maltese but unlike pure malteses who are all white, he has quite a bit of cream coloring in his coat.

The jury is still out on Sandy (who we bought as a 10 week old puppy) is suppose to be a full-blooded havanese female.  She looks like havanese that we have seen in photos, but given the circumstances we are not certain that she is really what she is supposed to be!

If either or both of the dogs are not what they were claimed to be in the pedigree papers that we received, it is our belief that we have a good case of fraud or at the very least misrepresentation on our hands.  As most of us know, DNA doesn't lie!  Who says that Cary Mullis didn't deserve to win the Nobel Prize for developing PCR!!!!!!!!!

Please read the back story (see below) about our journey into the underbelly of bogus dog breeding in the Garden State!!!

Original Post

Several months ago, my wife and daughter saw a “really adorable” dog at a school fundraising event.  My wife asked the owner what type of dog it was and she was told “it is a Havanese.” Neither my wife nor I had heard of the breed before but, after doing some Internet research we learned that it is related to the Bichon and is called Havanese because the breed originated in Cuba. As former residents of Miami (we met there) and familiar with all things Cuban my wife and I decided to buy a Havanese puppy for our daughter and two sons (they had been vigorously campaigning for a dog for the past few years).

The first step in our search was to Google the breed and see whether there were any Havanese breeders in New Jersey. Much to our delight, we found five Havanese breeders in New Jersey and no fewer than three were in driving distance from our home. To make a long story short, we purchased a wonderful 10-week old Havanese puppy called Sandy from a private breeder named Grace Abrams who runs Havanese 4Ever in Vincentown, NJ. A couple of days after we brought Sandy home, my wife took her to her first veterinary appointment and disappointed to learn that Sandy had serious case of ear mites and a round worm infestation. While we concerned, we didn’t think much of this (although Grace had certified that the puppy was healthy and disease free) and went on with our newly-minted Havanese existence.

After living with Sandy for several months (and spending way too much money to build a fence for one dog), my wife and I decided that Sandy needed a companion to play with. Imagine our delight, when we saw that Grace was looking for a home for a young, Havanese male that she had recently acquired “from a couple relocating from North Carolina to New York City.”  After seeing the ad on Grace’s website, my wife, Sandy and I drove back to Vincentown examine the “9 month old healthy Havanese male” that was dumped on Grace’s door step. Grace informed us that she had been caring for the dog for two weeks and that he was filthy and in very bad condition when she first got him. Without any hesitation, we adopted the dog (Moose) for $400 (after Grace knocked off $150 because of the ear mites and worms with Sandy) and thought all was right with the world. We also received some nominal paperwork including Moose’s veterinary records, his pedigree papers and a receipt.

A couple of days after we brought Moose home, my wife took him to the vet for a physical examination. Much to her dismay, the veterinarian told my wife that Moose was not 9 months old but closer to 3 years, had a bad case of gingivitis (and 4 loose teeth that needed to be pulled) and an ear and urinary tract infections. After receiving three frantic phone calls from my wife who was in tears, I contacted Grace and informed her that things were not right with Moose and that we wanted our money back. Again, to make a long story short, Grace refused to give us a refund unless we brought Moose back to her. Of course, we didn’t comply and Moose (who is a wonderful, loyal and sweet dog) is now an official member of the family. That said, with the help of a pet advocacy organization, NJCAPSA which has been investigating puppy mill fraud in NJ, we learned that Grace Abrams is a member of a notorious ring of South Jersey dog grifters run by her mother Donna Roberts who in 2007 was found guilty under NJ Statute 4:22-26L on three of five counts of animal cruelty.

Grace aka Dawn Abrams and her mother Donna Roberts purportedly purchases puppies from Pennsylvania Amish and Mennonite puppy mills (allegedly run by a nefarious character named David Zimmerman) and sell them from Boston to Washington DC as well as locally in New Jersey. Although never convicted of fraud, numerous complaints have been filed against Donna and Grace claiming that they supplied customers with falsified veterinary certificates and bogus AKC or other registration papers. Sometimes, Robert Cohen, an odious licensed New Jersey veterinarian, issues “health certificates” for Donna/Dawn’s puppies and so-called “rescue animals”. Not surprisingly, Cohen’s name appeared in court documents in several cases of fraud brought against Donna Roberts.

Because of her convictions, Donna Roberts keeps a low profile. Grace/Dawn Abrams is the front person but her mother Donna Roberts actually calls all the shots. Over the years, Donna and Grace/Dawn have sold dogs under the following kennel names: 1) Dark Moon Havanese, Shamong, NJ,  2) Shady Oaks Havanese, Howell NJ, 3) Kissy Face Havanese, Lakewood NJ, 4) Havanese Breeze, Medford NJ, 4) Havanese 4U, Indian Mills, NJ and 5) Havanese 4ever, Vincentown, NJ. Be warned that they also advertise Havanese and other breeds on PetFinder, Craig’s List, Breeders.net, Doggie.com and others pet sites where there are no ad listing charges.

Also, be aware that they are alleged to sell dogs under the following names or aliases:

Dee Woods

Dee Roberts

Gloria Anderson

Donna Anderson

Rachel Anderson

Donna Marie Dueben

Donna Truex

Robin Lewis

Robin Anderson (Donna Robert’s sister)

Marci Jean - advertises under the same phone number as Shady Oak

Carol Lang

Grace Abrams - Havanese4ever

Paul - Shady Oak Havanese

Marci Dueben - Havana Breeze Havanese

After we learned about Donna and her co-conspirators, my wife and I (who is an attorney) thoroughly examined the papers that we received for Sandy and Moose from Grace Abrams. Sure enough, no fewer than five of their aliases appeared in various capacities (e.g., owner, seller, breeder etc) throughout our documents. Further, Robert Cohen was the veterinarian of record who signed all of Sandy’s veterinary certificates. Although Moose was billed as a 9 month Havanese we now believe that he is a 2 year old Bichon, Shih Tzu or a mix. We think that he was probably a former breeder dog in a PA puppy mill (since he was not neutered). Sandy is likely a true Havanese but I wouldn’t be surprised that turns out not to be the case.  

I wrote this piece because the emotional and gut-wrenching experience that my family and I have gone through has had a profound effect on me. To that end, I am going to do everything possibly to shut down the operations run by Donna Roberts, Grace/Dawn Abrams and their co-conspirators.  Any suggestions, ideas, help (especially Internet/technology-wise) on how to put these people and their ilk out of business would be greatly appreciated.  Please feel free to repost this piece on any appropriate pet and dog breeder sites or blogs.

Until next time….

Good Luck and Good Puppy Hunting!!!!

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A post at the Pharmalot blog said that the US FDA and the Centers for Disease Control issued a statement today indicating, that after reviewing side effect reports, Merck’s anti-HPV (cervical cancer) vaccine Gardasil is safe and effective, and its benefits continue to outweigh its risks.

According to the statement, the joint agency review determined that 94 percent of  all side effects reported after Gardasil vaccination were not serious. The most commonly reported adverse events fainting, pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted.

Although there have been 20 reported deaths following vaccination, there was no common pattern or tend that would suggest they were caused by the vaccine itself. The statement went on to say that in cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.

The statement was likely issued in response to highly publicized and widely circulated adverse events reports issued by the ultraconservative Judicial Watch which is morally opposed to HPV vaccination. It is extremely unfortunate that a small but vocal group of conservative Christians are willing to risk the health of their daughters because they are morally opposed to premarital sex and birth control. 

Until next time….

Good Luck and Good Job Hunting!!!

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Like my kids frequently say when I mutter something obvious…”Like..DUH.! According to an article in today’s New York Times, “American medical care may be the most expensive in the world, but that does not mean it is worth every penny. A study to be released Thursday highlights the stark contrast between what the United States spends on its health system and the quality of care it delivers, especially when compared with many other industrialized nations.” No surprises here—the US spends more per capital on healthcare than all other industrialized nations but a greater percentage of the US population is without adequate healthcare.

One of the things that irritate me the most is that many Americans still believe that US healthcare is second to none. True, Americans have greater access to experimental and new cutting-edge treatments than others in the world, but when it comes to preventing or prophylatically delaying the onset of chronic diseases like diabetes, high blood pressure, obesity etc, the American healthcare system is grossly deficient.  

Healthcare insiders and third party payors have known that the system has been failing for past 20 years. Unfortunately, the healthcare and drug maker company lobbies have effectively blocked and prevented any changes to correct the glaring deficiencies of the American healthcare system. Anytime, anybody utters the phrase “nationalized healthcare” a collective shudder is exhibited by most Americans. The truth is that Medicare, a government-run healthcare insurer, is responsible for covering almost 60% of all medicals claims that are filed annually in the US. This means that healthcare benefits supplied to a majority of Americans are under the auspices of a nationalized healthcare program. Why not go all the way and cover the medical costs of all Americans?????

Politicians can no longer deny that it’s time for a change—the health of America depends on it!

Until next time…

Good Luck and Good Job Hunting

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In an attempt to assuage the jitters and financial concerns of investors who own stock in pharmaceutical, biotechnology and medical device companies, the US Food and Drug Administration announced yesterday that it will be change the format of the letter received by companies whose products are not ready for approval.

In the old days (at least until yesterday), when the agency determined that drugs were not suitable for sale, it would send companies a so-called non-approval letter. This letter was designed to inform drug and device makers that their products had issues that needed to be resolved before the agency will approve them. Apparently, (at least according to drug and device manufacturers), receipt of non-approval letters by companies signaled to investors that the product in question would never, under any circumstances, be approved by FDA. This urban legend was born because most companies that receive non-approvable letters decide against investing more time and money into products that FDA has deemed “unapprovable” i.e. there isn’t enough of a financial inducement or upside to continue further development.

Now, when new products are not up to snuff, companies will receive something called a “complete response letter.” According to the agency, the new letters will describe what is missing from a new drug or device application and, when, appropriate, offer advice on how to fix or address the problem(s). However, because contents of FDA letters are not released to the public, investors may now be less informed about the prospects of a new drug than in the past when the agency was able to send “approvable” or “non-approval” letters to companies.  “While this new plan may provide more detailed information to a company regarding issues that need to be addressed, investors will likely be kept in the dark on the true status of a drug’s approvability” said a pharmaceutical analyst after learning about the format changes. He went on to say “Investors will no longer know whether a drug is truly dead in the eyes of FDA.”

In my opinion, this is another example of FDA cow towing to the whims and wishes of industry. Whether you call it, a “non-approvable” or “complete response letter”, it still means the same thing—the drug or device is not ready for prime time! I don’t think that the change in semantics will do anything to assuage concerns of jittery investors. What it WILL do is force investors to rely solely on the honesty of the management teams that receives these letters—Oy!

I think that FDA ought to stick to the business of evaluating the safety and efficacy of drugs and be less concerned with the political and economic needs of the drug and device industries. Finally, it would be prudent for FDA to allow appropriately trained professionals to provide psychotherapy to all of the frightened and jittery investors out there!!

Until next time…

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

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Just when you thought the obvious couldn’t be anymore obvious to US lawmakers, the Congressional Budget Office (CBO) today released a long-awaited assessment of the cost of a biogenerics bill and found that the legislation, if enacted, would reduce total expenditures on biologics in the US by $25 billion over the next decade—duh!!!  

According to a post over at Pharmalot, “The report comes as a growing group of drugmakers, insurers and employers agitate over the high cost of biologics, which may only be rectified if Congress passes legislation that would give the FDA guidance on creating a so-called pathway to approve biogenerics, or follow-on biologics. Two House bills have been proposed that are similar to the Senate bill reviewed by the CBO, although the looming summer recess and election-year politics suggest passage may not occur this year.”

Unfortunately, as I suggested in a previous post, the bills currently under consideration are flawed and would give unwarranted patent exclusivity to innovator companies if enacted. Nevertheless, as Kathleen Jaeger, head of the GPHA (a generic manufacturing trade group) aptly stated “We are still reviewing the analysis, but we are pleased that CBO agrees that significant savings will be achieved by bringing biogeneric medicines to consumers and that even greater savings will result from removing harmful barriers to access, including brand evergreening and unprecedented market exclusivity provisions. With Americans growing increasingly concerned about health care costs, we should be increasing access to affordable medicines while fostering competition in the pharmaceutical marketplace. “

By the time that a US approval pathway for biogenerics is divined, European and Asian biogeneric manufacturers will already control the market and the “new” (what took you so long) American legislation will provide little financial incentive for US companies to enter the biogenerics market space.

Until next time…

Good Luck and Good Job Hunting!!!!

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Last year was a banner year for the pharmaceutical lobby (the largest in Washington DC). It spent over $168 million to inform Congress about issues that its members thought were in the best interest of the pharmaceutical and biotechnology industries. So what were the main issues that occupied a majority of the lobby’s time?

• blocking the importation of inexpensive drugs from other countries
• protecting pharmaceutical patents both within the United States and abroad
• ensuring greater market access for pharmaceutical companies in international free trade agreements

You are probably wondering which company was the top spender—it was Amgen! As you may recall, Amgen’s EPO franchise was under intense medical, regulatory and congressional scrutiny because of safety issue that resulted from over prescription. In my limited understanding of how things work in Washington, I have been told by lobbyist friends of mine that there is no better way to solve nagging problems than by paying influence peddlers to make them go away.  That said, Amgen’s lobbying costs paled in comparison with the $23 million spent by Pharmaceutical Research and Manufacturers of America a pharmaceutical industry trade group.  You Go PhRMA!!!!

A quick perusal of the top lobbying list reveals that all major US pharmaceutical companies invested heavily to influence members of Congress to allow them to preserve their stranglehold on the American healthcare system. Not surprisingly, all of the major foreign pharmaceutical manufacturers were also on list.  Much to my surprise, Teva, the Israeli generic manufacturing giant made the list this year—so it goes!

I guess altruism is out and avarice is still in! Hat tip to Pharmalot.

Until next time….

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No doubt that many of you already know that DTC advertising is an effective way for pharmaceutical companies to “push” their drugs. However, when I saw the amount of money that was spent on DTC in 2007 I was shocked! In 2007 alone, drug companies spent $5,375,117,382 on advertising. Yes, that's $5.375 billion dollars (think of how many research grants could have been funded or how much money could have been spent on universal healthcare!).  The aggregate ROI for 25 pharma companies examined was impressive–totaling about $32 billion or roughly 7-fold!

A table published by Consumer Reports AdWatch highlights 25 of the biggest spenders along with their sales, giving an indication of how much their ad spending has paid off —or not! The drugs that received the biggest bang for the buck are bolded. Despite the conflict of interest and false advertising DTC flap over Lipitor, it still managed to have the third best return among the 25 products analyzed.

Drug	Approved for1	DTC advertising 20072	Retail sales 20073	Sales per ad dollar spent
Lunesta	Insomnia	$294,180,616	$712,740,000	$2.42
Ambien CR	Insomnia	$204,065,972	$876,028,000	$4.29
Cymbalta	Anxiety, depression, diabetic neuropathy pain	$183,336,687	$1,732,827,000	$9.45
Lipitor	High cholesterol	$180,866,960	$6,165,531,000	$34.09
Plavix	Stroke risk reduction	$174,942,656	$3,082,712,000	$17.62
Rozerem	Insomnia	$171,466,210	$116,658,000	$0.68
Cialis	Erectile dysfunction	$151,649,663	$453,233,000	$2.99
Vytorin	High cholesterol	$140,715,035	$1,938,882,000	$13.78
Nasonex	Seasonal allergies	$131,220,183	$892,534,000	$6.80
Advair Diskus	Asthma	$121,197,100	$3,390,766,000	$27.98
Boniva	Osteoporosis	$112,958,755	$404,109,000	$3.58
Zetia	High cholesterol	$110,357,144	$1,405,066,000	$12.73
Requip	Restless Legs Syndrome, Parkinson's disease	$106,271,994	$407,665,000	$3.84
Abilify	Bipolar disorder and schizophrenia	$105,768,412	$1,781,562,000	$16.84
Flomax	Enlarged prostate	$100,969,013	$1,002,163,000	$9.93
Nexium	Heartburn and GERD	$96,960,417	$4,355,901,000	$44.92
Valtrex	Herpes and shingles	$88,409,332	$1,395,313,000	$15.78
Spiriva	Chronic obstructive pulmonary disease	$84,002,514	$868,226,000	$10.34
Yaz	Contraceptive pill	$83,566,746	$254,592,000	$3.05
Viagra	Erectile dysfunction	$83,064,378	$824,946,000	$9.93
Lyrica	Fibromyalgia and neuropathic pain	$70,663,685	$1,000,069,000	$14.15
Chantix	Smoking cessation	$63,979,755	$764,723,000	$11.95
Singulair	Asthma and seasonal allergies	$63,289,786	$2,863,326,000	$45.24
Celebrex	Pain from conditions like osteoarthritis	$55,230,236	$1,416,084,000	$25.64
Zyrtec	Seasonal allergies	$38,476,595	$1,302,807,000	$33.86

¹Consumer Reports Consumer Drug Reference, 2008.
²Data compiled by Nielsen Media research, March 2008.
³Data provided by Drug Topics and Verispan, March 2008.


No wonder why everybody wants to work for a pharmaceutical company–despite the downsizing there is still substantial money to be made!

Until next time….

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

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As many of you may recall, Merck tried unsuccessfully last year to lobby state and federal officials to pass legislation that would require mandatory vaccination of girls aged 9-26 with Gardasil, its anti-HPV, cervical cancer vaccine. Merck came under fire for its efforts (which seemed ethically disingenuous to many). Consequently, the company’s image took a hit and its stock price started to tumble. Although Merck stopped its lobbying campaign (mostly because of bad press and a flagging stock price), Gardasil ads continued to run and went largely unnoticed.

Because GlaxoSmithKline may be close to launching Cervarix^Tm—its cervical cancer vaccine—  the company recently decided that it was time to ramp up its Gardasil advertising efforts. Starting this past Saturday and continuing through June 26, Gardasil ads will be gracing the screens of a theater  near you. The ads will be shown with films like “Sex and the City” (hmmm, clever wouldn’t you say?), “Get Smart” (who doesn’t remember Barbara Feldon), “The Happening” (what woman doesn’t love a scary movie), “You Don’t Mess with the Zohan” (Adam Sandler is hot) and several others. I want to thank Ed Silverman over at Pharmalot for the heads up on this story!  I don't know about you, but I think that showing commercials at the movies, especially those hawking pharmaceutical products, is just plain wrong!!!!!!!!

This isn’t the first appearance of Gardasil ads at the cinema—I recall seeing an ad for Gardasil the last time I went to the movies (I don’t remember the movie but I clearly can recall the ad!). According to a Merck spokeswoman (aren’t pharmaceutical companies clever?), “We purchased advertised space that is relevant for our older female target audiences; specifically for the summer movies that are relevant to those aged 19 through 26.” 

As Ed so eloquently stated in his Pharmalot post: “Of course, plenty of teenagers will be seeing some of these flicks, too. Zohan and Get Smart are rated PG-13. And Sex and The Happening are rated R, but the restrictions only apply for kids under 17– some of whom will, no doubt, see them anyway.  In any event, Gardasil is unlikely to be available as a value pack that includes soda and popcorn. But we (Pharmalot) are curious to know whether the Gardasil beach towel is about to make a comeback.”

 Until next time….

Good Luck and Good Movie Watching!!!!!!!!!!

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The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a cardiac stent called Cypher that is manufactured by the company. The television ad is the first ever to market a medical device. Nevertheless, according to an article published in this week’s New England Journal of Medicine, the ad overstates the benefits of the stent without mentioning possible adverse effects that can include heart attack and stroke.

The current brouhaha is nothing new in the ongoing battle between drug manufacturer (and now, medical device companies) and regulators over DTC advertising. As some of you may know, the US is one of a few industrialized countries in the world that allows DTC advertising.  Further, DTC ads don’t require FDA review or approval before they are aired or printed–although in some instances, companies do request FDA review. 

Because of growing problems with DTC ads (especially television spots), there is mounting pressure on FDA to limit consumer medical advertising or, at the very least, increase regulatory oversight of it. To that end, on Friday, an FDA advisory panel will convene to discuss whether television ads for prescription medications ought to include a statement encouraging consumers to report any adverse side effects via a toll free number to the agency. At present, this type of disclaimer is only required for DTC print ads.

For those of you who don’t know, FDA has (by law) a post marketing surveillance network in place to allow consumers to report any side effects (big or small) that they may experience after taking prescription or over the counter medications. Further, companies are required by FDA regulations to immediately report any and all side effects associated with their products.

Of interest, in a hearing last week on drug advertising (being conducted by the House Energy and Commerce Committee), several drug company representatives in attendance were asked whether or not they would support a toll free number on television ads to encourage viewers to report adverse side effects. Surprisingly (perhaps not) they could or would not directly answer the question. According to John D. Dingell, chair of the committee and advocate of greater regulatory oversight of DTC advertising, “Some ads appear to be misleading and others appear to be downright deceptive.” Imagine that!

What is particularly disturbing about the DTC controversy is that government officials and legislators are frequently incredulous when they learn about DTC advertising abuses. As I have stated time and time again, there are larges sums of money at stake here. This coupled, with little or no regulation, and mounting pressures to keep company stock price shares high, is a sure recipe for disaster (as we have begun to witness over the past 5 years or more). In my opinion, there is only a single solution to the problem–craft more stringent regulations and greater FDA oversight for DTC advertising. Asking drug and medical devices companies to regulate themselves in any area is tantamount to allowing a fox to live in a hen house—the pickings are easy and only the fox gets fat!

Until next time….

Good Luck and Good Job Hunting!!!!!

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I learned late last evening that Ron Mardigian, founder and manager of Bio-Rad’s Biotechnology Explorer Program, died suddenly and unexpectedly in his sleep last December. Not surprisingly, I learned of his passing in a publication from Bio-Link, an NSF-funded organization committed to biotechnology training at the high school and community college levels.

Ron and I first met (via the telephone) in1996 when he was putting the finishing touches on the first of a series of education kits that would ultimately become Bio-Rad’s Biotechnology Explorer Program. At the time, I was working at Rutgers to create variants of the Green Fluorescent Protein (GFP) that could be used for educational purposes. Like me, Ron immediately realized that GFP could be used as a powerful education tool to showcase the principles of molecular biology and biotechnology. After talking on the phone for hours at a time, Ron and I finally met in 1997 at an International GFP meeting in New Jersey at which he was conducting a series of teacher training workshops. Imagine my surprise when I saw, for the first time, this striking, long-haired, cool-looking dude of indeterminate age who purportedly worked for the Bio-Rad Corporation! I knew that this was the beginning of a long and enduring friendship. 

Ron was one of those special people who have an amazing energy about them. His unrelenting drive, passion and commitment to education (and life for that matter) were always palpable. When Ron was “in the house”, nothing was impossible and no problem was insurmountable. At work, Ron was a consummate professional who was available 24/7. I can’t remember an instance when Ron failed to quickly return a phone call or e-mail query. But, when Ron was on vacation, everybody who knew him understood that it was “his time” and that they shouldn’t bother him. He was an avid windsurfer, cyclist and intrepid explorer who could not resist an adventure. Ron’s annual three week sojourns to Hawaii, Northern California and places unknown are now legendary.

Ron once told me how he convinced the President of Bio-Rad to allow him to start the Biotechnology Explorer Program. As the story goes, Ron, who had worked at Bio-Rad for several years in a technical capacity, was at a crossroad in his career. As he put it, “he needed to clear his head” and the best way for Ron to do that was a road trip. After a three week jaunt to the Baja and Mexico, Ron came up with an idea to leverage his knowledge of molecular biology into a series of self-contained kits to teach biotechnology to high school teachers and students. The fact that he was able to convince a multinational, laboratory reagent and equipment manufacturer to take a risk on education is a testimonial to Ron’s charisma, passion and skills as an inveterate salesperson. Nobody I know was ever able to say no to Ron–including me! 

Unfortunately, the last time I spoke with Ron was about a year ago. He told me that things were going well and that life was full and rich. I regret the fact that I didn’t have an opportunity to speak to him before he passed away.

Bio-Rad’s Biotechnology Explorer Program has been wildly successful during its first 10 years of existence. I’m sure that nobody but Ron expected this. Like any parent, I suspect that he experienced nothing but pleasure and joy watching his baby mature into adolescence. Unfortunately, he will not be here to shepherd his child into adulthood. I hope Bio-Rad will keep Ron’s memory alive by continuing to support and promote the Biotechnology Explorer program.

Farewell “bro”–thank you for allowing me to accompany you on a part of your journey!

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I was reading the paper this morning and I happened upon an article about the uproar over Miley Cyrus aka Hannah Montana posing in a topless photo for Vanity Fair magazine (as it turns out she is not topless, but wrapped in a silk sheet in a very, alluring, adult-like pose). For those of you who care, the photo was taken by Annie Liebowitz, photographer extraordinaire. According to 15 year old Miley, it was a cool, artsy photo that she didn’t have a problem with– although she is now publicly stating that she is “embarrassed” by it!  So, why are parents everywhere in America going ballistic over the photo?

As you may know, Hannah Montana is a Disney creation. And, for some reason, Disney has come to represent “good, clean American family values and fun”.  If this is true, it begs the question: Why would Hannah Montana, who has been canonized as a wholesome, innocent, and drug-free All American teenage girl, pose in a sexually alluring photograph? I think the answer to the question is obvious—money! Miley’s handlers; agents (and parents?) probably understand that she likely has made as many million as she can playing Hannah Montana, the all American girl.  They must have decided that it was time for Miley to grow up, become a sex icon and continue to sell as much merchandise and movie tickets as possible. After all, this tactic has worked for many other young female stars (and has also helped to sell tens of millions of dollars of inappropriate attire to girls aged 8-16), so why should Hannah Montana not be allowed to cash in on the opportunity? Isn’t becoming rich what the American dream is all about?

What I find disingenuous about the whole incident is that Disney is publicly outraged over the photo! I guess they have a right to be; Miley recently signed a new, multimillion, seven year deal with the company.  If, contrary to popular opinion, her image is actually tarnished by the photograph, she may be worth less than less Disney expected and the company may not be able to recover its ROI on the Hannah Montana franchise. What I find even more astonishing is that many Americans truly believe that Disney represents (and is synonymous with) American family values.  I hesitate to tell these folks that Disney is like any other multinational, publicly-traded company —primary goal is to make as much money as possible to provide profits to its stakeholders. Morals and ethics have little to with what actually makes Disney or any other corporation tick! In my opinion, American values ought to be taught to children by their parents, relatives and friends; not publicly traded corporations.

After seeing the photograph, my wife and I had very mixed feelings about the entire Miley Cyrus incident.  So, we asked our nine (9) year old daughter, who is a big fan of Hannah Montana, what she thought about the photo. After viewing the photo, she said that “she thought that it was wrong for Miley Cyrus to have her picture taken that way because she is only 15”. My wife then asked: “How old she thought that someone should be before posing in a picture like that”, my daughter shrugged and said, “I don’t know, 25”?  I must admit, that I was very surprised and pleased with her answer! For the record, my wife and I have never taken our daughter or two sons (ages, 14 and 12) to Disney—so I say “Rock on Hannah Montana”.

Until next time….

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

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The Boston Globe reported the other day that regulators at the US Food and Drug Administration (FDA) rejected a request by Framingham, MA-based Genzyme to continue to market and sell its Pompe Disease drug, Myozyme, which is being manufactured at a newly built production facility in Allston, MA. Myozyme is a recombinant version of alglucosidase alfa that is used to treat Pompe Disease, a rare enzyme storage disease. Genzyme is seeking to transfer Myozyme manufacturing operations from its Framingham production site to the larger Allston facility to meet increased market demand for the drug. Pompe Disease affects an estimated 5,000 to 10,000 patients worldwide.

According to Genzyme, FDA rejected the manufacturing transfer request because of slight differences that were detected in the carbohydrate array of Myozyme manufactured at the Allston site as compared with similar material produced in Framingham. Because of these slight but detectable carbohydrate variations, FDA is insisting that Genzyme conduct new clinical studies (safety and efficacy) with Allston-manufactured material before it will allow the company to sell it in the US. Company officials claim that they have data from approximately 900 patients who are currently taking the new version of the drug and will share this information with the agency. Interestingly, over 40 countries have already approved the new version of Myozyme manufactured at the Allston facility.

Personally, I think it is perfectly reasonable for FDA to request additional clinical studies to insure that the Allston version of Myozyme is as safe as the original. For those of you who don’t know, Myozyme was originally approved as an orphan drug. Typically, this means that only a small number of human safety and efficacy trials were conducted to gain initial approval for a product. Therefore, I think that Genzyme should only be required to conduct safety trials (not efficacy studies) before the Allston material is allowed to be sold in the US.  That said, the safety data that Genzyme has already collected from the 900 patients using the Allston-manufactured drug may obviate the need for any safety studies at all!

If FDA forces Genzyme to conduct new efficacy and safety studies, then it wouldn’t be unreasonable for Genzyme to ask the agency to issue a second license for the “new” Myozyme. After all, it appears that FDA is treating the Myozyme manufactured at the two Genzyme –run production facilities as distinct and unrelated drug products. And, according to the provisions of the Orphan Drug Act, newly approved orphan products are entitled to receive seven years of market exclusivity from the their date of approval. Therefore, if FDA issues a new license for the Allston material, Genzyme ought to receive an additional seven years of market exclusivity for Myozyme!

As one Genzyme official noted, FDA’s decision regarding Myozyme sends “a very loud and clear message and sets a very high bar.” It suggests that FDA regulators will be reluctant to approve any generic versions of biologics or biotechnology drugs without clinical studies that prove that the new drugs are as safe and efficacious as the originals Continue Reading...

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I just returned from my career development sojourn at this year’s FASEB meeting in San Diego, CA. Not surprisingly, all of my sessions were well attended. In fact, attendance at many of the presentations was standing room only. Again, this was not terribly surprising because the job market for graduate students and postdoctoral fellows for the last 5 years has been dismal. However, in contrast with past years, there was a noticeable and palpable difference in the attitudes of many of the students and postdocs who attended the sessions. In previous years, many career development participants seemed resigned to the possibility of a “jobless future”. However, this year there was a small but vocal group of participants who openly expressed their anger and resentment at the possibility of not finding a job after completing their training. I think that many graduate students and postdoctoral fellows have begun to realize that they are being exploited by a fundamentally flawed academic system and that they are “not going to take it anymore.”

 

Academia has always resembled a medieval, feudal system. Principal Investigators (PIs) are the kings because they hold all the power, money and authority and rule with impunity. Postdoctoral fellows are the lords or vassals who behave somewhat autonomously but have sworn oaths of allegiance and fealty to their kings. Research associates (technicians) are the indentured servants who rely on the king and his vassals for sustenance and protection. Finally, graduate students are the slaves whose lives and well being solely depend upon unquestioned obedience to their Kings. As we all know, feudal systems broke down when kings could no longer maintain control over their slaves and indentured servants. This culminated in rebellions and revolutions, the eventual demise of monarchies and ultimately gave rise to modern republics and democracies.

Although I am not necessarily advocating revolution (okay, so maybe I am), it is time that drastic and systemic changes be made to academia as we know it.  First, there needs to be a limit or moratorium on the number of students that are annually accepted into graduate programs. There are simply not enough academic, industrial or government jobs to justify the number of PhDs and postdoctoral fellows that are trained each year. Second, tenure should be abolished at all research universities and medical schools and be replaced with 5 year renewable contracts. This will force PIs, whose primary job is to do research (not teach), to remain competitive and productive. Further, it will reduce the likelihood that ego-centric PIs will be able to accumulate enough wealth and power to establish the “fiefdoms” that are prevalent in academia today. Third, PIs must increase their reliance on technicians (rather than postdoctoral fellows) to achieve their research objectives and goals. Allowing postdocs to work 5 or more years in the same laboratory because it is cheaper to hire them than technicians is, in my opinion, ethically and morally bankrupt. Finally, and perhaps most importantly, it is vital that PIs actually become mentors and play active roles in advising and shaping the careers of their students and postdoctoral fellows. Given the paucity and competitiveness of academic positions, it is disingenuous for PIs to promote academic careers for every person who passes through or works in their laboratories. As a former medical school tenure track Assistant Professor, I didn’t find it too difficult to identify which students and postdocs were “cut out” for academic careers. Further, it is incumbent upon PIs to take the time to

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Metals like copper and silver have long been known to possess antibacterial properties. I learned this as an undergraduate microbiology major circa 1972. That said, I didn’t know whether to laugh or cry when I read an article in today’s NY Times entitled "Regulators Stamp Copper as a Germ Killer". According to the article, the Copper Development Association (CDA), a NY-based trade group for copper companies, announced that federal regulators at the US Environmental Protection Agency (EPA) approved its application to market copper, bronze and brass-containing products as antibacterials that are effective enough to protect against bacterial infection. Apparently, what made this newsworthy is that this is the first time that EPA has allowed health claims to be attached to a solid antimicrobial material (rather than an aerosol or liquid disinfectant). For those of you who may not know, EPA (not FDA) regulates antimicrobial agents like disinfectants and air fresheners that are not directly applied to the human body.

Not surprisingly, there are many consumer products already on the market which are impregnated with silver and some other antimicrobial substances that claim to reduce the risk of infection.  Some of the more creative and pricey ones include silver-coated computer keyboards and mice manufactured by Iogear. However, none of the companies that manufacture these products can legally claim that the impregnated metals in them kill bacteria or provide a health benefit because they never thought to submit data to  EPA regulators to substantiate these claims. This is marked contrast with the CDA which smartly and painstakingly performed “clinical studies” for the past 4 years with copper and its alloys (mostly door knobs) to gain regulatory approval to claim that these metals have bona fide antibacterial properties. According to a CDA spokesperson, additional “clinical trials are underway to test how copper bed rails, arm rests and other hospital fixtures can reduce the numbers of bacteria in hospitals.”

Don’t get me wrong–you gotta love the creativity of the CDA for developing an innovative business strategy to help maintain the price of copper and bolster the sales of copper-based products. As you may know, the advent of fiber optics and silicon chips has been steadily pushing the price of copper down for the past few years–something that the CDA is keenly aware of.  Unfortunately, in contrast with CDA’s new vision, I believe that the only way to effectively reduce the high bacterial loads in our hospitals is through vigorous enforcement of hospital sanitation and hygiene programs, regular screening of hospital personnel and routine environmental monitoring.  Based on over 30 of experience with food borne and nosocomial bacterial diseases, I firmly believe that improperly sterilized equipment and instruments and people who are either unsuspecting carriers or fail to maintain good sanitation and hygiene practices are the main causes of bacterial contamination and transmission in hospital settings. I don’t think that inanimate metal objects (which have long been known to have inherent antimicrobial properties) contribute to the high levels of bacteria that are commonly found in today’s hospitals. Nor do I think that replacing existing hospital fixtures with copper, brass or bronze ones will do much to reduce bacteria levels in most hospitals.  Nice try CDA–but no cigar this time (at least not from me)!

Until next time….

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

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There was an alarming article in today’s New Times which reported that greater numbers of parents are rejecting vaccination for their children. You may ask, “How is this possible. Aren’t childhood vaccinations mandatory?  Well, yes and no. As it turns out, 20 states including California, Texas and Ohio allow some kind of personal belief exemption from otherwise mandatory childhood vaccinations. And, more and more parents are opting out every year. In 1991, less than 1% of children in states with personal belief exemptions went without vaccinations. By 2004, the most recent year for which data are available, the percentages swelled to over 2.5 %. Frighteningly, according to a 2006 article in the Journal of the American Medical Association, exemption rates of 15% to 18% has been found in certain areas of Oregon, Washington and California.

So, what is responsible for this startling increase? Unfortunately, misinformation on the Internet promulgated by American news media outlets has caused some parents to question the safety of many childhood vaccines including those for measles, mumps, rubella, and diphtheria and whooping cough. Although parents who opt to not vaccinate their children believe that they are protecting them from serious vaccine-induced side effects, they are, in reality, increasing the risk that their children and others may contract these diseases. Surprisingly, many parents who choose not to vaccinate their children are aware hat they may be placing other children at risk. For instance, in the NY Times article, one mother chose not to vaccinate her child said, “I cannot deny that my child can put someone else at risk” 

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After an exhaustive nationwide search, FDA Commissioner Andrew von Eschenbach decided yesterday that Janet Woodcock, a career FDA staffer, was the best choice to lead the agency’s struggling Center for Drug Evaluation (CDER). For Dr. Woodcock who has been the acting head of CDER since September, this will be the second time that she was tapped to lead the center. She was previously appointed to the top CDER job in 1994 by then FDA Commissioner David Kessler (the last time FDA had any real leadership).

The inside skinny on the appointment is that she beat out Jesse Goodman for the position, another career FDA employee  who is currently the head of the agency’s Center For Biologics Evaluation and Research (CBER).  What surprises me the most about Woodcock's appointment is that after a nationwide search to find a new leader for CDER, von Eschenbach’s final choice was between two career FDA bureaucrats!  Why bring in an outsider with fresh new ideas when the best available talent in the land already works for you?

Don’t expect anything to change at the agency.  Dr. Woodcock tows the party line and is loyal to von Eschenbach (who by the way is a personal friend of the Bush family). It is no secret that FDA is broken and desperately needs to be fixed. Choosing a person to lead CDER (for the second time) who has been at FDA for almost her entire career, signals  that Commissioner von Eschenbach is neither ready nor willing to implement the systemic changes that are so drastically needed at the agency.  Maybe something will change at FDA when someone other than George W. Bush is in the White House?

Until next time….

Good Luck and Good Job Hunting!!!!!

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We all know (or should know) that eating dirty or yellow snow is a big “no-no”. Those of us who are parents (and live in regions where there are regular snowfalls) teach our children this lesson as quickly as possible. That said, should parents worry when their children eat new or freshly falling snow because it contains air-borne bacteria? 

Last week, a group of scientists at Louisiana State University reported in Science magazine that there may be a relationship between ice-nucleating, air-borne bacteria and global rainfall patterns. For those of you who don’t know, the formation of ice in clouds is required for snow and most rainfall. Although dust and soot particles serve as ice nucleation particles, bacterial ice nuclei are capable of catalyzing freezing more quickly at much warmer temperatures and their presence in the atmosphere may affect the processes that trigger precipitation. Results from the Science study suggested that bacteria like Pseudomonas syringae, which have long been know to serve as nucleators and induce ice formation, are widely distributed in the atmosphere and likely play critical roles in influencing the amount of rain that falls at various locations in the world–pretty cool new stuff for those of us interested in global warming and climate change in general. Therefore, it surprised me when I saw that lay newspaper reporters chose to “cherry pick” data from the paper to suggest to Americans that even freshly fallen snow contains large numbers of bacteria and that, perhaps, parents should be careful when they allow their children to eat snow!

As a card-carrying microbiologist and seasoned science educator, I want to assure all of you that eating freshly fallen snow will not cause disease in you or your children. The types of bacteria found in the atmosphere, and ultimately in snow, are not human pathogens and don’t cause disease. Thankfully, in a story entitled “Study: Driven snow isn’t all that Pure” that appeared in my local paper (The Trenton Times)– a member of the American Academy of Pediatrics Committee on Environmental Health was quoted as saying ; “We eat stuff that’s covered with bacteria all the time, and for the most part, it is killed in the stomach.” Another pediatrician, who is a member of the academy’s committee on infectious diseases, reinforced the claim that snow munching was not harmful and said “Children practically bathe in bacterial when they go to the playground and they won’t get anything from snow that they would not get from dirt.”  

Although most of the stories about bacteria and snow munching that appeared in the lay media were “fluff pieces”, they did alarm some parents! As one mother said in the Trenton Times article: “When I heard bacteria, at first, I went “eeeewwww”. But as long as the kids eat snow as it’s falling, I think it is okay. I tell them not to eat it if it’s on the ground.” What was particularly troubling about her remark was her initial negative reaction to the mere mention of the word bacteria. Unfortunately, most Americans have little understanding about bacteria and the negative impressions that they have formed are based on the sensationalistic and often scientifically inaccurate pieces about “dangerous” bacteria and fungi (mold) that often appear in print media and on television.

In my opinion, America’s negative attitude and poor understanding of science is a consequence of ongoing, misguided science reporting that has plagued this country for years. Although the American lay news media is mostly responsible for this, scientists are also complicit because of their unwillingness or inability to publicly speak out on important scientific issues and problems.

I believe that scientists are obliged to do everything in their powers to ensure that lay science reporting is fair and balanced and that the correct scientific messages reach the American public. Our failure to act will surely jeopardize the future of American science–something that we Americans can ill afford. Enough said–have a plate of snow on me!

Until next time….

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

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For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to Baxter’s heparin which has been associated with illnesses and deaths in this country.  

I suspect that this recent spate of China bashing has more to do with political and future economic issues than the safety and well being of the American public. Nevertheless, according to US Food and Drug Administration Current Good Manufacturing Practices (CGMP) regulations, companies that hold the licenses to manufacture pharmaceutical and biotechnology products assume full responsibility for the quality and safety of their products. To accomplish this, companies are required to test all raw materials, excipients and APIs (regardless of their source) before they are assembled to make a finish pharmaceutical or biotechnology product. The results of these tests must be carefully analyzed and compared with the product quality specifications established by the company and approved by FDA. If the test results for product ingredients are outside of the normal range of established specifications, then the company is obliged to reject the materials and not used them to manufacture product. To that end, there was clearly, something was wrong with quality testing at the Baxter heparin manufacturing facility because the adulterated heparin API should have been detected long, before it was used to manufacture the final product. Although the Chinese heparin may have adulterated, the onus was on Baxter (the company that holds the product license) and not the Chinese government to insure its final product met quality standards and was safe for public use.

Outsourcing is a fact of life in almost every sector of the American economy. Pharmaceutical and biotechnology companies import the materials they use in their products from all over the world. It is FDA’s job to insure that American companies remain CGMP compliant so that they produce safe and effective medications. To blame America’s regulatory shortcomings on foreign manufacturers and their governments is dangerous and naïve-not to mention chauvinistic.

Until next time…

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

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I am old enough to remember when the artificial heart was invented and used to extend the life of Barney Clark, a dentist in Seattle, WA. It was a phenomenal accomplishment back in the day. So, it seemed appropriate to me that Robert Jarvik, the guy who invented the artificial heart, appeared in Pfizer’s Lipitor ads as a spokesperson to promote heart health. However, a Congressional committee examining consumer drug advertising has questioned whether the Lipitor ads may have misrepresented Dr. Jarvik and his credentials to promote the drug.

Although Dr. Jarvik has a medical degree, he is not a cardiologist nor is he licensed to practice medicine! Further, one television ads depicts Dr. Jarvik as an accomplished rower but the ad used a body double for him and, as it turns out, he does not even row! To make matters worse, a former colleague of Jarvik contends that he is not the actual inventor of the artificial heart. He suggested that the distinction belongs to Jarvik’s mentor Willem J. Kolff and his associate Tetsuzo Akutsu at the University of Utah. Go figure! Despite the firestorm, Pfizer continues to air the television ad ( I saw it just a few days ago).

Pfizer has spent more than $258 million advertising Lipitor (a cholesterol-lowering statin) since January 2006, most of it on the Jarvik campaign in an attempt to protect Lipitor from generic competition. Lipitor is the world’s best selling drug and generated $12.7 billion in revenues in 2007. While Lipitor has patent protection until 2010, some patients have already switched to a generic version of a competing cholesterol drug Zocor. According to published reports Pfizer agreed to pay Jarvik about $1.35 million under a two-year contract that expires next month. I think it is safe to assume that Jarvik will not appear in any future Lipitor ads.

As many of you may know, drug companies FDA is not required to review direct-to-consumer ads before they are aired to the American public. While some companies request FDA review of their promotional materials before they are used in advertising campaigns, the vast majority of companies do not. Unfortunately, because of this regulatory loophole, direct-to-consumer advertising has turned into something of a cat and mouse game–there are only consequences and penalties if you get caught misrepresenting or not fully disclosing information about your products.

In my opinion, Pfizer’s misrepresentation of Jarvik’s credentials (and Jarvik’s complicity) is unethical and unconscionable. More importantly, it demonstrates how easily and willing companies are to “bend the truth” to preserve blockbuster drug franchises that generate billions of dollars in annual revenues. I think that what Pfizer did was wrong and shameful. The company should be fined and sanctioned for the Lipitor campaign. That said, it is likely that the size of the fine levied by FDA will pale in comparison to Lipitor revenues generated by the Jarvik campaign. I believe that it is time for Congress and FDA close the loopholes in current direct-to-consumer advertising regulations–the safety and health of the American public depends on it!

Until next time….

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

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 A report on the state of the Massachusetts biotechnology industry suggests that global competition and shortages of trained workers might cause the state to loss its reputation as one of the world’s top life sciences cluster. The report points out that there simply aren’t enough trained workers to meet the growing demand from Massachusetts-based biotechnology companies-both because of a lack of adequate training programs and lack of interest from students.  

To help to remedy the situation, the study recommended that more job training programs ought to be created at two- and four-year state colleges and that Massachusetts should do more to encourage students to pursue careers in the life sciences. As usual, the report recommended that math and science education should be improved at the K-12 levels. Other suggestions included setting up a “summer bio camp” and launching an unpaid bioscience internship program.

Unfortunately, this report, which was prepared by Boston-based Mass Insight Corp and McKinsey & Co and was likely very expensive, is almost identical to other studies published over the past decade about ongoing workforce shortages in the life sciences industry. Like its predecessors, it contains the same tired and unimaginative recommendations that others have proposed to solve bioscience labor shortages. To learn more about some creative solutions to avert life sciences workforce shortages click here.

Despite what the experts and pundits would have you believe, the etiology of the workforce shortages in the life sciences industry is easy to decipher. Put simply, most universities and colleges don’t believe that job training or career development should be part of their academic initiatives or educational missions. Likewise, companies don’t feel that education or training should fall within their purview–according to industry executives, college and professional school graduates ought to be sufficiently prepared to enter the workforce after they complete their education.

Because neither academia nor industry wants to assume responsibility (financial or otherwise) to prepare or train students for careers in the life sciences, it should come as no surprise that there are workforce shortages in this industry. Although a number of federally-funded biotraining programs were initiated in the late 1990s, these programs were poorly promoted and are incapable of sustaining themselves without government support. Paradoxically, there are many more innovative, industry-focused biotechnology and bioscience training programs at the high school level as compared with the undergraduate and graduate levels. I suspect that many professors in undergraduate and graduate life sciences departments are more concerned about their own research programs than about the careers of their students. Go figure………!!!!!

There will continue to be workforce shortages in the biotechnology, pharmaceutical and medical devices industry until either academia, industry or both claims ownership of bioscience training and career development.  I think that it time for academicians and industry professionals alike to put their heads together to solve this serious and ongoing problem. Failure to do so will result in the loss of America’s global dominance in the life sciences industry.

Until next time…

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

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Despite what the American public has been led to believe, the scientific, regulatory and safety issues related to biogenerics aka follow-on biologics, biosimilars, or subsequent entry biologics have been clearly are no longer controversial issues. They have been identified, analyzed and carefully vetted. This allowed EMEA, the European Medicines Agency in 2006 to craft a comprehensive regulatory approval pathway for biosimilars. For those of you who may not know, several biosimilar products are currently are the market and sold in all European Union member states. This begs the question–what is taking the US so long?

From the beginning, big pharma and big biotech have unequivocally and steadfastly opposed any legislation that would allow biogenerics to be approved and sold in the US. The trade groups BIO and PhRMA have literally spent millions of dollars lobbying members of Congress to oppose any legislation that would allow approval of biogenerics in the US. Now, in a sudden and unprecedented about face, big biotech and pharma have thrown their collective weight behind proposed biogenerics legislation that will be introduced in the near future by Representative Anna Eshoo (D-CA).

As far as I can tell, the primary reason for this sea change is the market exclusivity that may be afforded to innovator companies by the legislation. A quick perusal of the bill reveals that innovator companies will be granted 12-year market exclusivity for a product after its initial licensure. Further, under certain circumstances, this period of market exclusivity for an innovator product may be extended to 14.5 years. Also, reference product sponsors (innovator companies), as well as interested third parties (most notably universities) that own patents on the reference product may sue a biogeneric applicant for patent infringement. Under certain circumstances, such litigation could delay or prevent approval of the biogeneric product.

So what does the proposed legislation mean for biogeneric manufacturers seeking regulatory approval for their products in the US?  Unfortunately, it means that a biogeneric product application may not be approved or made effective until 12 to14 years after the original date of licensure of the innovator (reference) product. It also opens the door for patent litigation against biogeneric manufacturers to hinder or delay approval of their products. In my opinion, the proposed legislation is extremely one-sided and biased toward innovator companies. More importantly, it seems to me that the real intent of the legislation is to discourage (rather than encourage) biogeneric manufacturers from seeking US approval for their products, i.e. there are no real financial incentives or inducements for these manufacturers to seek approval because of the excessively-long market exclusivity period for innovator products.

On the surface, the proposed legislation would appear to be a long sought victory for biogeneric advocates and the American public which would benefit from less costly versions of potentially life-saving biotechnology drugs. That said, it seems to me that the proposed legislation is nothing more than a disingenuous attempt by big biotech and pharma to placate biogeneric advocates and the American public. In reality, the legislation provides innovators companies with a legally-binding regulatory approval pathway that will allow them to maintain or extend their monopolistic stranglehold on blockbuster biotechnology products. I think that the US Congress can do better when it comes to biogeneric legislation–the American public not only deserves it but demands it!

Until next time…

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

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Unlike many other countries with national healthcare systems, US healthcare and prescription drug costs are primarily shouldered by employers. As healthcare costs continue to rise, many American employers are calling for the US government to assume more of the costs through nationalized healthcare. The opposite situation is unfolding in the rest of the world, where overburdened nationalized healthcare systems are forcing employers to pay for workers supplemental health care costs.

A recent survey conducted by Watson Wyatt found that in countries like India, China and Russia healthcare is the number 1 benefit desired by a majority of workers. Globally, companies are projecting large year-to-year increases in medical and healthcare costs. In many places, medical and healthcare costs are rising faster than inflation.

Contrary, to popular belief, it appears that the US is not the only country struggling with skyrocketing healthcare and prescription drug costs. The graph below shows the expected increases in national healthcare costs from 2007 to 2008 (source Watson Wyatt).

  

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The US Food and Drug Administration announced late last week that it intends to post inspectors in embassies and consulates throughout the developing world to improve the quality of the food and medicines that flow into the US. FDA Commissioner Andrew C. von Eschenbach (Bush’s latest appointee to head the agency), said that he wants to have “boots-on-the-ground in developing nations like India and China and regions like Central and South America and the Middle East.” At present, less than 1% of the food imported into the US is inspected each year

As many of you know, FDA inspectors are required to visit both domestic and foreign manufacturing facilities that produce food, cosmetics and medicines that are sold in the US. By law, these inspections must take place every 3 years. Unfortunately, due to budget shortfalls and inspector shortages, routine inspections at domestic facilities are now taking place every 4 to 5 years– it is unclear how frequently inspections occur at foreign manufacturing facilities.  Based on von Eschenbach’s call for more foreign-based inspectors, the answer is likely “not frequently enough.”

The obvious solution to this problem is to increase the agency’s budget to hire and train new inspectors. However, despite repeated attempts by lawmakers, the Bush administration has steadfastly refused to endorse or consider budget increases for the agency. Instead, White House officials have urged the agency to uses any means possible to “bolster the aggressiveness and effectiveness of foreign health regulators” to prevent unsafe or tainted products from reaching the US market. I do not want to sound overly cynical but good will can go only so far with financial inducements or incentives.

Despite the obvious need for more inspectors, von Eschenbach admitted that his plan to post inspectors in foreign countries is “only in its infancy”. Also, he hasn’t decided whether he will ask Congress for additional funding for the agency or find money in the current budget for the foreign inspectors. I suspect that “finding money” in the current budget would translate into curbing other regulatory activities at FDA –something that would not bode well for the already-embattled agency. The inability of von Eschenbach to secure funding to train and deploy new inspectors is another reason why I believe that the FDA Commissioner ought not to be a political appointee!

Until next time…

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

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The New York Time reported today that the American Heart Association (AHA) publicly advised patients who are taking Vytorin “not to abruptly stop taking the medication without consulting their physicians.” On the surface, this would appear to be sage advice from physicians who have their patient’s' health and best interest at heart (so to speak). However, it  could be interpreted differently when you learn that the AHA receives nearly $2.0 million form Merck Schering/Plough Pharmaceuticals, the joint venture that markets and sells Vytorin! Call me crazy-but no matter which way you slice, dice or spin it-there is an inherent conflict of interest here. How can you expect a professional organization (that subsists largely on member dues and advertising revenue) to be objective about a product that is manufactured by a company that underwrites part of its operating budget? As one of the democratic candidates asserted the other night in the South Carolina debate –whether you accept campaign contributions yourself or the contributions are accepted on your behalf, you know in the back of your mind that you owe that individual/corporation something in return. As the old adage goes “Never bite the hand that feeds you”.

Don’t get me wrong, I don’t care where or how the AHA gets its money. That said, if AHA had disclosed that it receives money from Merck /Schering Plough Pharmaceuticals, the public recommendation about Vytorin use might have been viewed in a different light. The failure of AHA to disclose its financial relationship with Merck/Schering Plough Pharmaceuticals has, in my opinion, hurt its image and weakened its credibility with the American public. 

Until next time….

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

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As the cost of prescription drugs continues to spiral upward, the affordability and accessibility to prescription drugs and healthcare will likely be fiercely debated and may influence the outcome of the presidential election next November. Despite growing public concern over the cost of prescription drugs in the US, Eli Lilly has vowed to fight federal legislation that will allow Americans to import lower-priced prescription drugs from Canada, Japan, Australia and many European nations. Lilly spokespeople and their lobbyists in Washington DC argue that the policy would put consumers at huge risk of consuming dangerous and unsafe counterfeit drugs. Big pharma has been using the drug safety argument for the past decade or so to stifle drug importation legislation. That said, blocking prescription drug importation legislation has very little to do with drug safety and everything to do with profit margins and corporate stock prices.

The stakes of prescription drug importation are high for drug makers. In contrast with the US, most other countries keep drug prices low through government distribution programs and strict price controls. Because the US government does not control prescription drug prices, American typically pay two-thirds more than Canadians, 80% more than Germans and 100 per cent more than French residents for identical prescription drugs. Lilly and other big pharma companies contend that price controls for prescription drugs stifle innovation and competition (tell that to the European and Japanese drug companies). Currently, according to government and industry surveillance data only a tiny fraction of counterfeit drugs (about 5 per cent) actually enter the US market. But Lilly and other pharmaceutical companies argue that there could be enormous increases in the number of counterfeit drugs that enter the US annually if Congress relaxes the federal ban on imported prescription drugs.

Pharma’s counterfeit drug argument is a convenient scare tactic that it has been using to lobby against relaxing current drug importation legislation. What the drug makers don’t tell you is that they routinely import and sell drugs in America that are manufactured in foreign production facilities. Further, many of drugs that are sold in Canada, Europe, Japan and Australia are manufactured in the same production facilities that supply drugs that are sold in the US. This begs the question —if drugs are manufactured in the same foreign production facilities and one lot is sold in the US and the other in Canada, would American consumers really be at a greater risk if they bought a Company’s drug in Canada or the US? The answer to the question is a resounding NO–unless you believe that the Canadian Regulatory Agency is less competent at monitoring and approving drugs than the US FDA The real story is this–.counterfeiters stand to make much more money selling bogus prescription drugs in the US than in other countries because there are no price controls in the US (which means much larger profit margins for the counterfeiters–duh!)

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I want to thank for his intrepid reporting on the Vytorin scandal and keeping BioJobBlog abreast of all late-breaking news and rumors that are flying about. 

In today’s post Ed reports that  “…..the House Energy and Commerce Committee wants to know more about the so-called independent panel formed to review the Vytorin trial data, the study’s Data Safety Monitoring Board, stock sales by Schering-Plough execs and the amount of money spent on Vytorin by the Centers for Medicare and Medicaid Services (CMS), given the Enhance trial results showed the drug wasn’t more effective than cheap generic versions of Zocor, which is part of the Vytorin combo therapy.

The congressmen leading the probe - John Dingell and Bart Stupak, both Democrats from Michigan - sent separate letters today seeking all sorts of info from CMS and Schering-Plough. Already, they’re looking at whether Merck and Schering-Plough concealed or manipulated clinical trial data, given that the release of the Vytorin data was delayed nearly two years and the primary endpoint was briefly changed without the consent of the lead investigator. The probe is also focusing on the heavy advertising for Vytorin.

The Vytorin scandal coupled with the Vioxx debacle has done little to instill any consumer confidence in the pharmaceutical industry or the US Food and Drug Administration. Industry’s growing involvement in the drug regulatory approval process coupled with the Bush Administration’s intentional destabilization of FDA has resulted in the recent approval of drugs with dubious therapeutic efficacy and questionable safety profiles. 

Pharma has made it abundantly clear that profits are more important than patients’ health or safety. It is time for the Congress and the American people to stuff the corporate genie and its unbridled avarice back in the bottle!

Until next time….

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

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Fred Hassan joined Schering Plough as its CEO five years ago. At that time, Mr. Hassan inherited a company that was being investigated by FDA for regulatory compliance violations and the SEC was investigating it former CEO for investing and accounting irregularities. Since his arrival at the company, Mr. Hassan increased sales of key products, filled an empty product pipeline and returned profitability to a company that posted losses in 2003 and 2004.  

Much of his success can be attributed to Zetia and Vytorin, cholesterol-lowering drugs Schering Plough sells jointly with Merck & Co. Zetia lowers blood cholesterol levels by preventing absorption of dietary cholesterol from the gut. Vytorin is a combination product that contains Zetia and Merck’s statin drug called Zocor. Statins help to reduce blood cholesterol by inhibiting its production in the liver. Sales of both drugs have doubled to $5 billion a year since 2005. But that rich revenue stream is at risk following this week's disclosure that results from a large scale clinical trial called ENHANCE (which was initiated in 2002) showed that Vytorin did not reduce the incidence of atherosclerosis or lower the risk of heart attacks or strokes.

Schering and Merck said Monday that results of the now-controversial ENHANCE study showed that Vytorin failed to slow progression of heart disease more effectively than simvastatin generic form of Zocor that is sold at a far lower price. After learning about the results of the study, Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic  quipped "Here we are, six years after this drug was marketed and promoted with a massive marketing campaign and has become a $5 billion drug" without evidence that it works as well as a statin. Now, "the first trial we have, is reported much too late and doesn't show really any evidence of benefit."

As reported in the Wall Street Journal “The impact of the finding was amplified by a long delay in releasing the results, and the revelation in November that the researchers considered altering the study's primary goals -- widely considered a violation of scientific protocol. The developments exposed the companies to suspicions -- which they have denied -- that they had postponed announcing the results because they were unfavorable. Also, the results of the Enhance trial were announced at a press conference rather than published in a peer reviewed scientific journal.”

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There are currently two injectable products on the market that are used to treat chronic Hepatitis C infections. Both products, PEG-INTRON (Schering Plough) and Pegasys (Roche) are PEGylated versions of the cytokine interferon-alpha that are used in combination with ribavarin (an orally-delivered small molecule drug) to treat patients infected with Hepatitis C virus.  

PEG-INTRON (peginterferon alpha-2b) was co-developed by Schering Plough and Enzon in the early 1990s and brought to market in 2000. Pegasys (peginterferon alpha-2a) , which use a different chemistry to attach PEG to interferon-alpha, was approved in early 2002 and quickly supplanted PEG-INTRON as a treatment of choice for Hepatitis C infections. Pegasys also gained approval in 2005 to treat chronic Hepatitis B infections.

The knock on PEG-INTRON was that it appeared to lose potency in liquid form (a claim that has always been denied by Schering and Enzon). Nevertheless, PEG-INTRON was supplied to patients as a sterile powder which had to be reconstituted prior to injection. In contrast, Pegasys was supplied in liquid form in pre-filled self injection pens to infected patients. This was possible because the PEG chemistry used to create Pegasys was found to be extremely stable (as compared with PEG-Intron?) in liquid form. Although there appeared to be no real differences in efficacy between PEG-INTRON and Pegasys to treat Hepatitis C infections, patients tended to prefer Pegasys over PEG-INTRON because it was easier and more convenient to use.

Schering Plough has been struggling for the past 5 years or so to recapture the market share that it lost following Pegasys’ introduction in late 2002. To that end, in 2003 the company received FDA approval for a pre-filled injection pen to administer PEG-INTRON. Further, to dispel any rumors regarding PEG-Intron’s efficacy relative to Pegasys, Schering decided to conduct two large head-to-head clinical studies that compared PEG-Intron or Pegasys in combination with ribavarin as treatments for Hepatitis C patients. Today, Schering-Plough announced the results of the first of these two large scale clinical studies called IDEAL. The results from the IDEAL study showed that PEG-Intron was just as effective as Pegasys for treating patients with Hepatitis C. Further, it appeared that fewer patients taking PEG-INTRON relapsed after treatment.

It is not clear whether Schering will win the war but the company certainly appears to have won this most recent skirmish!

Until next time…

Good Luck and Good Job Hunting (try Schering Plough)!!!!!!!!!

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Health care spending in the United States grew 6.7 percent in 2006 to $2.1 trillion, or $7,026 per person. This represents a slight increase over the 6.5 percent rate in 2005 (which was the slowest growth since 1999). Health spending accounted for 16 percent of US gross domestic product in 2006, outpacing overall nominal GDP growth by 0.6 percent. However, total health care spending in the US is not the real story here.

The federal government reported that the new Medicare drug benefit called Part D, which was implemented in early 2006, contributed to an 18.7 percent increase in Medicare spending that year, the fastest rate of growth since 1981 and double the rise in 2005.  In 2006, Medicare spending rose to $401.3 billion, up from $338.0 billion a year earlier, according to the government’s annual health spending report.

The impact on funding sources that paid for prescription drug benefits varied. The public share of spending (federal and state)  increased from 28 percent in 2005 to 34 percent in 2006, while funding from private sources (insurers) fell from 72 percent to 66 percent.  The shift in funding was most dramatic for Medicare and Medicaid. Medicare’s share of total retail prescription drug spending surged from just 2 percent in 2005 to 18 percent in 2006, following Part D implementation. Meanwhile, Medicaid’s share fell from 19 percent to 9 percent.

At present, the US government cannot negotiate prescription drug pricing with drug companies that produce the medications–only drug distributors and third party insurers can do that! As the baby boomer retirement continues, the amount of government spending on prescriptions drugs will increase exponentially and ultimately cause healthcare costs in this country to explode. In my opinion there are two options: impose price controls on prescription drugs or provide all US citizens with a national healthcare system that allows the government to negotiate drug pricing directly with drug manufacturers. And for those of you who think national healthcare is a fantasy–over 60% of all healthcare claims in the US are currently handled and paid by Medicare–a federally finaced and run government healthcare system!  We are closer to a national health insurance program than you think!

Until next time...

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

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The New York times reported today that Britain’s Serious Fraud Office has demanded documents from GlaxoSmithKline, Astra Zeneca and a British affiliate of Eli Lilly & Company in connections with allegations that the companies paid bribes to secure lucrative drug contracts in Iraq while Saddam Hussein was in power. The 3 companies are accused of violating the United Nations’ oil-for-food program that was instituted in post war Iraq in the 1990s.

A report from the fraud office in 2005 accused some 2,200 companies from 40 countries of colluding with the Hussein regime to cheat the UN program out of about $1.8 billion. As I have stated time and time again, drug companies are no different than other companies–profits and stock prices always come before ethics, morality and sometimes the law!

Until next time….

Good Luck and Good Job Hunting!!!!

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"Quite simply, life-saving drugs are irrelevant if they are not affordable"

–Christopher Begley, chairman and chief executive of Hospira Inc., the Lake Forest-based maker of hospital products and specialized medication-delivery devices commenting on the intransigence of FDA to craft legislation that would allow the approval of follow-on biologics aka biogeneric drugs.

For those of you who may have missed it, The Senate Health, Education, Labor and Pensions Committee approved in June the Biologics Price Competition and Innovation Act of 2007, which would allow for biogenerics. The House is expected to take up similar legislation in early 2008 in hearings before the House Energy and Commerce Subcommittee on Health.

Don’t be surprised if this legislation does not see the light of day until well after the 2008 presidential election and only if a democrat is elected.

Until next time….

Good Luck and Good Job Hunting!!!!!

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There is a storm brewing around Zetia, Merck and Schering Plough’s blockbuster cholesterol-lowering drug. However, let me preface this post by reminding everyone that all drugs have side effects and if a drug’s benefits outweigh its risks then it will likely be prescribed to patients. That said, new evidence has been uncovered which shows that Merck, and  Schering Plough, conducted  at least 8 clinical trials from 2000 to 2003– to evaluate Zetia’s risk to the liver when taken with other cholesterol-lowering drugs (statins) – but chose to not publish the results of those studies. This is what we know about Zetia:

• Zetia has annual sales of over $ 5 billion
• Despite no evidence that Zetia’s cholesterol-lowering ability actually reduces the incidence of heart attack or stroke in patients who take the medication, it was approved by the US FDA in 2002. A 10,000 patient Zetia clinical study called ENHANCE is currently underway to determine whether the drug’s ability to lower cholesterol really translates into a reduction in heart attacks and strokes
• Millions of people who take Zetia also take statins such as Zocor, Lipitor, Pavachol, Crestor and Mevacor to lower cholesterol (Vytorin, Merck’ new cholesterol-lowering drug contains Zetia and Zocor in a single pill)
• From 2000 to 2003 Merck and Schering Plough conducted 8 long-term safety studies of Zetia in combination with a variety of statins but only published the results from 3 of the 8 studies. Also, the unpublished studies were not listed on industry websites where companies are supposed to register by law the results of all ongoing clinical trials after 2002 (because some of these trials were initiated before 2002 the law does not apply to them)
• FDA supposedly reviewed the results of the unpublished studies and approved Zetia use with statins anyway
• Prior to its approval in 2002, at least one internal FDA reviewer recommended that Zetia not be approved for use with statins because the combination caused liver disease in animals. Also, since 2006 a number of case reports have been published in medical journals that suggest the combination of Zetia and statins has caused severe liver damage in some patients
• In the US, Zetia’s product label only contains mild warnings about the drug’s potential to cause liver damage. However, since 2005, product labels in Canada and Australia have carried strong warnings about Zetia’s potential to cause hepatitis, pancreatitis and depression—warnings that have seemingly been ignored in the US

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The US Food and Drug Administration (FDA), like other federal agencies during the Bush administration, has been hobbled by a lack of leadership and an agency-wide feeling of ennui. What do you expect from a federal agency that didn't did not have a Director for 5 out of 8 years since 2001? At present, the agency is in disarray, grossly ineffective and under siege.

Over the past 5 years or so, numerous product recalls and safety issues with newly-approved drugs have caused many medical professionals and the American public to lose faith in FDA. This is clearly evident by a willingness of the US Congress to step in and assume many of the regulatory activities and legal responsibilities granted to the agency in the Food, Drug and Cosmetic Act of 1938. For example, the New York Times reported today  that a Congressional committee is investigating Merck and Schering-Plough for their handling of a critical clinical trial of Zetia, their blockbuster cholesterol-lowering drug. The House Committee on Energy and Commerce demanded more information about delays in the trial, which was completed in April 2006 but whose results have not yet been released. Independent scientists have viewed the results of this study as crucial because it is the first trial that would answer whether Zetia’s ability to lower cholesterol has real biological benefits for patients. The results might also help answer nagging questions about Zetia’s safety.  I ask: "Why are their still nagging safety questions about a blockbuster drug that has been on the market since 2002? "

FDA’s mission is to insure that all approved drugs and medical devices are safe and effective for Americans. Overall, from a historical perspective, I think that the agency has accomplished its mission and done an outstanding job. It is only recently that things have begun to become undone and spin out of control. I believe that the time has come for FDA to “step up to the plate”  to right itself and get back on track. Personally, I would rather have medical and regulatory experts rather than politicians reviewing medical and scientific data to determine whether a drug is safe and efficacious. FDA may be broken but the damage is not irreversible. With a little determination, hard work and competent leadership the agency ought to be able to regain its former reputation as a preeminent regulatory agency.

Until next time….

Good Luck and Good Job Hunting (they are looking for a few good men and women)

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I was reading a post about the Exubera deal that Pfizer cut with Nektar the other day and I stumbled upon this tidbit–“The two companies will continue to jointly develop an inhaled formulation of PEGylated recombinant human growth hormone (rHGH) to treat growth problems”.

For those of you who may not know, protein PEGylation–developed about 30 years ago by Frank Davis and Abe Abuchowski at Rutgers University– involves chemically attaching polyethylene glycol (PEG) to proteins. PEGylated proteins are less immunogenic and circulate longer in the bloodstream than native, unPEGylated proteins. Protein PEGylation has revolutionized the biopharmaceutical industry because it reduces immunological side effects, improves clinical efficacy and enhances patient compliance (by reducing the number of injections that are required) for many protein-based drugs. Several companies including Schering Plough, Roche and Amgen have used protein PEGylation to create multibillion blockbuster a year biotechnology products like PEG-Intron, Pegasys and Neulasta.

Like most protein-based products, rHGH needs to be injected daily to achieve its desired clinical effects. At present, there are no fewer than 8 rHGH products on the market that are used to treat pediatric and adult growth hormone deficiencies. The holy grail of the growth hormone market is to develop a sustained-release version of rHGH so that daily injections are no longer necessary. To that end, several companies, including Nektar, have developed PEGylated versions of rHGH which are in various stages of clinical development. These products should hit the markets in Europe and the US within the next few years.

Although Pfizer is in the rHGH biz, it is puzzling (to me) why any company would consider developing an inhaled form of PEGylated rHGH –given all of the regulatory hurdles and exhorbitant development costs-when an injectable form of PEGylated rHGH would be far superior and offer greater patient benefits than any of the currently marketed rHGH products? Maybe I am missing something here. That said, the larger question is: Why hasn’t Pfizer learned that the inhaled protein market is a dicey one at best?  Maybe that's why Pfizer is still Pfizer!

Until next time….

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

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Finally, three years after withdrawing its pain medication Vioxx from the market, Merck announced today that it will pay $4.85 billion to settle 27,000 lawsuits by people who believe they or their family members suffered injury or died after taking the drug. The settlement, one of the largest ever in civil litigation, comes after nearly 20 Vioxx civil trials over the last two years from New Jersey to California.

In 2005, most Wall Street analysts estimated that Merck’s ultimate liability in Vioxx would be between $10 billion and $25 billion after plaintiffs announced that they would file lawsuits against Merck. Merck stunned just about everyone in the industry by not settling and announcing that it would fight each Vioxx lawsuit one-by-one. In hindsight, this was a brilliant legal strategy. As you may recall, Merck’s stock price plummeted to the mid $20s shortly after the Vioxx scandal broke. After Merck implemented its legal strategy–and won a few lawsuits after a crushing initial defeat–its stock price began to steadily rise. Merck's stock closed yesterday at almost $55 per share–it is up about 5% today in early trading.

Although one of the largest ever, the settlement payment represents less than one year’s profits for the company. The agreement is far smaller than Wall Street analysts and lawyers predicted when Merck withdrew Vioxx, and especially after the verdict in the first case. By agreeing to settle, Merck will be able to get past the Vioxx debacle and also sharply reduce its Vioxx-related legal defense fees, which are now running at more than $600 million annually.

I must admit that I was one of the many who thought that Merck was making a big mistake by not settling all of the Vioxx lawsuits. It just goes to show you that some of these well paid pharmaceutical executives actually know what they are doing.

Maybe that's why Merck is still hiring and its competitors’ are not?????

Until next time….

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

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There has recently been an inordinate amount of press coverage about methicillin-resistant Staphylococcus aureus (MRSA) or “MERSA” as it is called on my local nightly news. As a card-carrying microbiologist, I think that it is great that the American public is finally learning about multidrug resistant bacteria and the serious public health threat that these bacteria pose. For those of you who don’t know, the incidence of MRSA (and other multidrug resistant bacteria) has been steadily rising since the early 1990s –mostly in healthcare and hospital settings (not in the general population). Not surprisingly, the recent media focus on MRSA has resulted in a lot of misinformation about MRSA strains. For example, every MRSA news clip that I have seen in past week has a school janitor in a mask, gloves and laboratory coat feverishly washing walls, desks (and even toilets) at the schools where MRSA-infected students and staff have identified. I can’t help but chuckle (after I get righteously indignant) when I see these clips because S. aureus (whether it is methicillin resistant or not) is an opportunistic pathogen that is transiently carried in the nasal passages of over 50% of all Americans! Contrary to popular belief, S. aureus does not survive for long periods outside of the human body. That said, school janitors can scrub as much as they want but they will not eliminate the natural reservoir of the organism which is the students and staff who work at the schools! Further, the organism, although infectious, is not easily transmitted from person to person–it requires direct and intimate personal contact in order for that to occur. Also, just because the organism is resistant to methicillin it doesn’t mean that there are no other antibiotics that can be used to treat MRSA infections. In fact, if diagnosed early and correctly, MRSA infections are easily treated. So, why is the news media making such a big deal about MRSA? Continue Reading...

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Biotech giant Genentech is moving towards restricting the use of its cancer drug Avastin to treat wet age-related macular degeneration (WMD), the most common cause of blindness in the elderly. Currently, many ophthalmologists use Avastin to treat WARMD even though it was not approved by the US Food and Drug Administration (FDA) for that indication. For those of you who may not know, physicians who are licensed to practice medicine in the United States are permitted to use approved medications to treat any disease or condition if they believe that the medication is in the best interests of a patient.

Genentech said it is restricting Avastin use because it recently won approval for a new drug called Lucentis to treat WARMD. Many ophthalmologists started using Avastin (which has the same mechanism as action as Lucentis) before Lucentis won approval from FDA in June 2006. The New York Times reports that Lucentis is being used to treat 55 percent of new patients with WMD and Avastin accounted for most of the rest of the patients — or nearly half the market.

From a medical and regulatory standpoint, Genentech is justified in restricting the use of Avastin to treat WMD because it was not approved for that indication. Further, promoting or encouraging off-label use medications is a big regulatory no-no! Nevertheless, many ophthalmologists suspect that business rather than medical reasons are what is driving Genentech’s decision to restrict the use of Avastin—Lucentis costs about $2,000 per dose whereas Avastin only costs $50 per dose.
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The US Congress is poised this week to pass a new healthcare bill that gives the Food and Drug Administration (FDA) more authority to scrutinize drugs after they reach the market, including power to mandate label changes that warn of new risks. This is good news!

The bad news is that follow-on biologics advocates were unable to add legislation to the bill that would allow the FDA to approve follow-on biologics for sale in the US. As many of you may know, there is no legally sanctioned pathway for approval of generic versions of protein-based biotechnology drugs in the US. In stark contrast, the European Medicines Agency (EMEA) crafted legislation in 2006 to allow these products to be approved and sold in Europe. Since that time, several biosimilar drugs (the European name for follow-on biologics) have received marketing authorization by European regulators and are currently marketed in many countries in Europe and elsewhere.

Biotechnology drugs are typically very expensive and out of reach for many people who lack adequate healthcare insurance. Follow-on biologics advocates argue that their products can be sold at lower prices –anywhere from 25%-30% less – than their branded drug counterparts. The lower prices of biosimilar products that are currently sold in the EU tend to support this assertion.

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In an attempt to dispel the notion that it is “dysfunctional” and "lax in policing drugs once they are on the market", the US Food and Drug Administration (FDA) earlier this week launched MedWatch - The FDA Safety Information and Adverse Event Reporting Program. An integral part of the new program is The Drug Safety Newsletter a quarterly publication that provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research.

The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals. The first issue of the newsletter contains reviews of the following products (information in the brackets are the most serious side effects)

• Rituximab (marketed as Rituxan): [Progressive Multifocal Leukoencephalopathy (PML)]
• Modafinil (marketed as Provigil): [Serious Skin Reactions]
• Temozolamide (marketed as Temodar): [Aplastic Anemia]
• Deferasirox (marketed as Exjade) -recently approved new molecular entity
  

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The Motley Fool published a synopsis today on the surprising strength of ImClone’s anti-cancer pipeline. According to the article, the company is conducting Phase 2 clinical trials on two new cancer treatments; an anti-insulin-like growth factor-1 receptor monoclonal antibody as a treatment for late stage metastatic prostate cancer and vascular endothelial growth factor receptor (VEGFR) inhibitor as a treatment for metastatic kidney cancer in patients who have failed with other VEGF inhibitors. Both drug candidates are highly touted and stock analysts are anxiously awaiting the results of these trials. Speaking of stocks, ImClone is trading around $35 per share, a stock price that is higher than Pfizer or Schering Plough.

For those of you who don’t remember the ImClone scandal, it resulted in Sam Waksal (ImClone’s CEO and founder) and Martha Stewart (Sam’s friend) going to prison and is partly responsible for the resignation of Bristol Myers Squibb’s previous CEO. Despite all of ImClone’s critics, Erbitux® has turned out to be a pretty good treatment for advanced colon cancer and the company is making money as a result. This has provided ImClone with the largesse to build a new manufacturing facility and add jobs in New Jersey (as I reported in a previous post).

Everyone (Stan Yakatan and I) thought that ImClone was finished a mere five years ago.  What a difference a few years can make in this business!

Until next time…..

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

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This morning, Jacob Goldstein at the Wall Street Journal's healthblog, suggested that Wyeth may be an attractive buying opportunity for beleaguered pharmaceutical giant Pfizer.  He based this possibility on a note that he received from Credit Suisse analyst Catherine Arnold, in which she posited that Wyeth's strong pipeline and plummeting stock price (due to recent regulatory setbacks) may  make it attractive as a buyout opportunity for pipeline-challenged Pfizer. 

Call me crazy but I think the assertion is ridiculous and simply an overt attempt by Mr. Goldstein to boost readership for the WSJ's healthblog.  In my opinion, Pfizer has been mired in a downward financial spiral ever since it acquired Warner Lambert (for Lipitor) in the late 1990s.  I think by now that Pfizer executives have learned the lesson that bringing companies with contrasting corporate cultures under a single roof  (regardless of monetary inducements and a financial upside), is more costly and challenging than it appears to be "on paper"

Although Mr. Goldstein's assertion is speculative, I do not  think it is appropriate to start fresh rumors about  possible corporate buyouts that could affect an already erratic and destabilized stock market. That said, I think that bloggers have an ethical responsibility  to consider the impact that their posts have on everyday folks before they begin to speculate on possible corporate mergers or buyouts. Imagine the effects that these rumors could have on the daily lives of already demoralized Wyeth and Pfizer employees! 

Until next time....

Good Luck and Good Job Hunting!!!!!

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The NY Times reported today that the New Jersey-based, health care giant, Johnson & Johnson has sued the American Red Cross for trademark infringement. According to the article, J & J actually owns the American Red Cross symbol–a fact that is not disputed by either party. Back in 1895, J & J and the American Red Cross agreed that the American Red Cross could use the J & J symbol for not-for-profit activities. Over the years since the agreement was struck, the American Red Cross symbol has become synonymous with disaster relief and humanitarian aid. However, over the past few years, the American Red Cross has entered into licensing agreements with several for-profit companies who use the Red Cross symbol to sell their products. Licensing fees from the sale of these goods has been reported to net the American Red Cross about $10.0 million per year (the American Red Cross purportedly uses the licensing revenues for disaster aid and other humanitarian activities). Nevertheless, it seems likely to me that the American Red Cross violated the original trademark agreement that it entered into with J & J over 100 years ago. Consequently, I believe that the American Red Cross ought to stop licensing its symbol (actually J & J’s symbol) for for-profit activities. After all, the American Red Cross is registered as a not-for-profit entity! Continue Reading...

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I read this fascinating Op-Ed piece in the New York Times today by Tyler Cowen, a Professor of Economics at George Mason University. The article focused on the unbridled entrepreneurial drive exhibited by many young Americans. Dr. Cowen attributed this drive and the growing abundance of young American entrepreneurs to: 1) The willingness of Americans to help/mentor strangers (as compared with friends), 2) A less disciplined and more flexible education system and 3) America’s pervasive culture of marketing.

In my opinion, people who grow up in America are inherently more entrepreneurial than those who grow up in other countries. Unfortunately, many Americans do not recognize that they possess this talent and, consequently, tend to minimize or take their entrepreneurial spirit for granted. To that end, I was once hired by an Australian biotechnology company to help them find American business partners so that they could  expand their Australia-based company into the US. I was a bit surprised that they hired

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Maybe I can’t remember things as well as I used to, but I cannot recall a time when the safety of so many FDA-approved blockbuster pharmaceutical products has been questioned. The latest casualty is Avandia, GlaxoSmithKline’s blockbuster diabetes medication. The New York Times reported today that FDA knew about the potential cardiovascular risks associated with Avandia almost 7 years ago. Why did is take a newly published article in the New England Journal of Medicine to bring these safety issues to light? And, how did this drug, like the Cox-2 inhibitors, get approved without a label that mentioned these potential risks? Maybe the agency thinks that Americans are willing to take more risks than in the past when it comes to the medications that they take? I do not have answers to these questions. That said, the US public’s confidence in FDA must be at an all time low or close to rock bottom!

The recent commotion over Avandia, Vioxx and other drugs made me to think about a comment that a friend of mine (who has worked in the pharmaceutical industry for over 25 years) said to me about 10 years ago; “I never take a new drug until it has been on the market for at least 5 years”!

Maybe she knows something that I don’t?

Until next time….

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

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Sales are up, Eli Lilly’s share price closed at $59.28 yesterday and its blockbuster anti-psychotic drug Zyprexa® had worldwide sales in excess of $4.0 billion in 2006. So, what is wrong with this picture? Apparently, there are new questions about the accuracy of the safety data that were submitted by Eli Lilly to FDA as part of the Zyprexa new drug application (NDA) in 1996.

The FDA has questions about a Lilly document from February 2000 that suggests that patients taking Zyprexa in clinical trials were three and half times as likely to develop high blood sugar (hyperglycemia) than patients who were not taking the drugs. According to FDA, this bit of information was not submitted as part of the Zyprexa NDA. Instead, the company submitted data to the agency that indicated that patients treated with Zyprexa developed high blood sugar at a rate of 3.1% whereas those taking placebo developed hyperglycemia at a rate of 2.5%. Further, there are other documents from Feb. 2000 that indicated that Lilly scientists discussed whether Zyprexa’s label should changed to alert doctors of the risk of hyperglycemia associated with the drug. These documents along with internal e-mail messages contradict public statements that were made by Lilly about Zyprexa’s risks and overall safety.
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Amgen announced yesterday that Aranesp®, its longer-acting version of EPO®, did not increase the death rate among patients with small-cell lung cancer. This news, based on preliminary results from the Company’s so-called 145 clinical trial, was SO GOOD that Amgen’s stock price jumped $2.31, or 4 percent, to close at $62.32 on Thursday. I find it troubling that the news that a drug (used to treat cancer patients with non-chemotherapy- induced anemia) does not kill more people than placebo is noteworthy considering the drug is not being used to treat the cancer itself. That said, I guess any news to assuage safety concerns dogging a $12 billion drug franchise is good news to investors (maybe not to cancer patients).

On another note, the New York Times reported today that a study published in JAMA this week showed that profit-making dialysis centers used significantly more EPO-like drugs than non-profit centers did. This is largely because Amgen and J & J and others Continue Reading...

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Pfizer, the world’s largest pharmaceutical company, is on the ropes and in serious danger of imploding. After a decade long buying spree, gobbling up pharmaceutical companies that included Warner Lambert (Lipitor®) and Pharmacia (Celebrex®) and a host of smaller biotechnology companies including Agouron (antivirals) and Vicuron (antibiotics), the company has an extremely small drug pipeline. This is not surprising because Pfizer’s business model was to acquire rather than develop its own blockbuster drugs. As always, hindsight is 20/20 but it is patently obvious that Pfizer should have re-invested the billions the company made through sale of its blockbuster drugs (Celebrex®, Viagra®, Zoloft® and Lipitor®) into its own internal R & D programs to remain competitive in the long term.

So, with all of these blockbuster products; why is Pfizer in such deep doo-doo? Unfortunately, all of its blockbusters have either lost or are soon to lose patent protection making these multi-billion drug franchises susceptible to competition by generic drugs. Further, the recent failure of torcetrapib, (Pfizer’s new anti-cholesterol replacement for Lipitor®) in Phase III clinical trials coupled with sluggish sales of its new inhaled insulin product Exubera® due to safety, cost, and convenience issues Continue Reading...

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The official debate over the future of follow-on biologics in the U.S. began in earnest today in Washington D.C. during hearings held by the House Oversight Committee. One of the first people to tesify before the Committee was Dr. Janet Woodcock, Deputy Director of FDA.  She told committee members and representatives from the biotechnology and pharmaceutical industries that “while FDA can currently establish the safety between versions of simple protein-based drugs, it will likely "be a stepwise progression over a decade or so," before the agency can scientifically verify that a knockoff version of a complex biotech drug is similar to the original “.  Nothing new here...Janet has been saying the same thing about follow-on biologics ever since the debate began back in 1999.  But, her statements today led me to wonder where Dr. Woodcock has been over the past few years? Because, in 2006, EMEA  (the European regulatory agency) crafted an approval pathway for follow-on biologics or biosimilars as they are called in Europe.

It took EMEA over five years to develop the regulatory process but at least the EU, (unlike the US) has one for these new products!  Several biosimilars including Omnitrope and Valtropin are already being sold with much success in EU countries. And, much to the surprise (I am sure) of BIO, PhARMA, and other lobbying groups who have mounted expensive and aggressive lobbing campaigns against approval of follow-on biologics, Europeans are not dying in droves after using biosimilar products. All kidding aside, the bottom line is that any regulatory approval process for follow-on products in the US will require  human clinical trials. That said, the number and type(s) of human clinical trials that will be required for regulatory approval will be determined on a case by case basis. This, in turn, will determine whether follow-on products can really be sold at  lower prices. Based on current scientific and technological capabilities, I believe that even the most complex follow-on biologics can be brought to market with good safety profiles  coupled with a 15%-20% price discount over existing branded products

I think it is time for FDA to get back to the business of approving safe, efficacious and cost- effective medicines rather than supporting lobbying efforts and engaging in politics to allow the American biotechnology industry to maintain its global dominance in biopharmaceuticals.

Until next time.....

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

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I just finished teaching in the SUNY-Stonybrook Fundamentals of Biotechnology Certificate Program and the Georgetown Masters of Biotechnology Program for the year. Each year, I ask my students how much they think it costs to develop biotechnology drugs and they invariably give me the $800-$1.2 million figure that is bandied about by the Tufts Center for Drug Development. I contend that this number is grossly over-inflated when one realizes that the lion's share of development costs is used for advertising, promotion and sales. Because the pharmaceutical and biotechnology industries complain about the extremely high costs of drug development, they feel that it is their "god-given' right to charge exorbitant prices for their products.  A recent article listed the price per patient costs for some commonly-used biotechnology-based cancers drugs. The important thing to understand about mthese drugs is that most of them do not "cure" cancer but simply extend patent's lives (by months not years).  Some examples are listed below.

Avastin
Genentech (NYSE:DNA)
colorectal: $46,000
lung: $56,000

Vectibix
Amgen (NasdaqGS: AMGN)
colorectal: $36,000

Revlimid
Celgene (NasdaqGS: CELG)
multiple Myeloma: $67,000

Sutent
Pfizer (NYSE: PFE - News)
kidney: $46,500

The product price that I find most curious is Revlimid which was developed by NJ-based Celgene. For those of you who don't know , Revlimid is a modified version of thalidomide, which is an off patent small molecule drug (not a biotech product) that was used incorrectly in the 1950s to treat morning sickness in pregnant women.  I guess Celegene charges biotechnology-like prices for its small molecule product simply because there is a vibrant market for the product.

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The New York Times reported today that a Congressional committee has begun an inquiry into the marketing and regulation of widely used anemia drugs that have recently raised safety concerns. The House Committee on Energy and Commerce has sent letters to Amgen and Johnson & Johnson, the drugs’ marketers, requesting information about when they knew of possible risks and about how they have promoted the products.

The letters also asked them to suspend any consumer advertising of the drugs and any incentive programs for doctors who prescribe them until after the Food and Drug Administration has time to determine whether further safety precautions are necessary.

The products — Epogen and Aranesp from Amgen and Procrit from Johnson & Johnson — are all forms of erythropoietin, or Epo, a protein made by the human kidney to spur production of red blood cells. The drugs are mainly used to treat the anemia caused by kidney failure or cancer chemotherapy and have combined worldwide sales of roughly $10 billion a year.

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