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The Avandia debacle is still ravaging the employee ranks at GlaxoSmithKline especially at its Research Triangle Park, North Carolina and in Philadelphia locations. According to a post at Pharmalot, the UK-based drug manufacturer is cutting as many as 350 jobs (2.0% of its workforce) at both locations. This represents an almost 40% reduction in drug discovery and development activities that take place at both sites.

These cuts come after GSK closed a factory and drastically cut its sales force late last year. To make matters worse (particularly for those folks who lost their jobs) GSK purchased an early-stage drug discovery company called Sirtris Pharmaceuticals for about $720 million earlier this year. Clearly, company executives have more faith in external rather than internal drug discovery at GSK.

The saga continues……

Until next time

Good Luck and Good Job Hunting (forget North Carolina)!!!!!

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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

So what do Merck and Schering Plough have to say about the results of the unpublished safety trials? According to the New York Times, Dr. Robert J. Spiegel, Schering Plough’s Chief Medical Officer said “The companies had not considered the studies scientifically significant enough to publish their findings. Some may eventually be published.” Similar statements were made by Merck executives about Vioxx’s safety after they pulled it from the market! Not surprisingly, most of the safety studies that were published by Merck and Schering Plough generally played down the liver problems associated with Zetia and statin combination therapy.

Although many physicians still think that Zetia is safe, I believe that the failure of Merck and Schering Plough to promptly and openly disclose all research about the drug may be leaving the American public with a misleadingly favorable view of Zetia’s safety and efficacy (sort of like Vioxx). For the past 8 years or so, FDA has been slow in issuing safety warnings and demanding label changes for many widely used drugs like Merck’s pain killer Vioxx, GSK’s diabetes medication Avandia and Lilly’s anti psychotic drug Zyprexa that have turned out to carry serious safety risks. I think that it is time for FDA to “step up to the plate” and do its job—provide Americans with SAFE and efficacious medicines. Also, I hope that pharmaceutical companies are beginning to realize that they must be more forthcoming about the safety of their products if they want Americans to use them. Finally, and perhaps most importantly, drug company profits should never come at the expense of patient safety—NEVER!

Until next time….

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

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The New York Times reported today that an independent study that analyzed thousands of older people with diabetes found that those treated with the widely used drug Avandia had significantly elevated risks of heart attack and death.

According to the Times article, the finding, published on Tuesday, in this month’s Journal of the American Medical Association (JAMA), could rekindle the debate about whether Avandia, a controversial treatment for Type 2 Diabetes, should remain on the market. Earlier studies drew similar links between Avandia and cardiac risks.

The new study concludes that Avandia users had a 60 percent increased risk of heart failure, a 40 percent increased risk of heart attacks and a 30 percent increased risk of death compared with patients taking other oral diabetes medicines.

Sales of the drug, formerly a $3.4 billion product globally, have declined sharply since June 2007 when an article appears in the  questioning the drug's safety.

Not good news for GSK. The big question now is whether the company ought to cut its losses and take Avandia off the market or continue to squeeze as much money out of the product until lawsuits begin to accumulate.

Until next time…

Good Luck and Good Job Hunting (not at GSK)!!!!!!!!!!!

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The FDA ruled today that GlaxoSmithKline’s blockbuster diabetes drug Avandia will now carry as part of its label a warning advising that its use might raise the risk of suffering a heart attack.

A black box warning is the sternest warning a drug can carry and still remain on the market in the U.S. Avandia already carries a black box warning advising it could cause or exacerbate congestive heart failure in some patients.

With 2006 sales of almost $3 billion, Avandia has been a major revenue driver for Glaxo.

Look for continued corporate right sizing at GSK through 2008.

Until next time….

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

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A sharp drop in sales of its blockbuster diabetes medication Avandia has forced GlaxoSmithKline (GSK) to embark on a major cost cutting campaign that includes job cuts. It is not clear where the cuts will take place or how many jobs will be lost. The company said it would close some of its manufacturing plants, including a plant in Puerto Rico which employs around 900 workers and has been a target of regulatory scrutiny because of ongoing quality control issues.

Although this is the first official public announcement of layoffs at GSK, my inside sources tell me that several hundred employees have already lost their jobs at GSK’s Collegeville, PA facility.

GSK’s announcement coupled with a sharp drop in Amgen’s third quarter profits and Lilly’s problems with clinical development of prasugrel (its highly anticipated anti-clotting drug) indicate that the road will be rather bumpy for the biopharmaceutical sector in the near future.

Until next time…

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

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First, there was the torcetrapib catastrophe and now the Exubera debacle. Pfizer announced late yesterday that it would stop selling Exubera, the first approved inhaled insulin product, less than two years after its approval. Despite heavy promotion by Pfizer, Exubera sales were tiny, with prescriptions amounting to less than 1% of the multi-billion dollar insulin market.

Once heralded as a potential blockbuster drug by industry analysts, Exubera was plagued with questions about its safety, efficacy, convenience and cost. The bottom line is that it worked no better than injected insulin and, results from clinical trials showed that Exubera could decrease patients’ breathing ability. This coupled with the appearance of the delivery device, which resembled a bong (not that there is anything wrong with that), contributed to the inability of Exubera to gain acceptance among patients and physicians.

Exubera was originally developed by Nektar, a small publicly traded California-based biotechnology company that specializes in inhalation technology and protein delivery systems that include PEGylation. Pfizer bought the marketing rights from Nektar and assumed responsibility for clinical development of Exubera.

Nobody knows how much Pfizer spent on developing and promoting Exubera, but the company took a $2.8 million charge yesterday to cover costs associated with the drug–making it one of the most expensive failures in the history of the pharmaceutical industry.

Despite its status as the world’s largest pharmaceutical company, things are not going well for Pfizer. The company has already consolidated operations and laid off thousands of workers a result of the torcetrapib mess. Further, the ripple effect that the Exubera debacle may have on Nektar and other companies like Eli Lilly that are developing similar inhalable insulin products is unknown at present. 

I do not think that the pharmaceutical and biotechnology industries can withstand much more bad news. Pfizer’s  ongoing bad news, coupled with the GlaxoSmithKline’s Avandia mess and Amgen’s epoetin woes suggest that it may be a good time to load up  your portfolio with already “cheap” pharmaceutical and biotechnology stocks—there is only one way for these stocks to go—and that is up!

Until next time….

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

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