If you're looking for some of the brightest and best minds, you'll find them in the research labs of pharmaceutical companies.
Unfortunately, though, it takes an appropriate background to truly appreciate the ingenuity involved in isolating vancomycin, the "antibiotic of last resort," from a soil sample collected in the jungles of Borneo, or to be awed by the cleverness of synthesizing complex molecules, like the cholesterol-lowering agent atorvastatin (Lipitor), from simple substances. Designing the right sequence of chemical reactions that culminate in the specific three-dimensional structure needed for biological activity is nothing less than brilliant - and potentially life saving.
While the work of the researchers is admirable, that of the marketing division is often suspect. These are the people responsible for staining the image of the industry, and for hiding skeletons in closets. And yes, there certainly are skeletons in Big Pharma's closets. Just for a start, there are issues about holding back negative clinical trial data, about promoting drugs for unapproved uses and about manufacturing diseases as well as drugs.
Pharmaceutical companies fund clinical trials and, of course, there is nothing wrong with that. There is, however, plenty wrong with not being forthright about the results of the studies if they are not to a company's liking.
Take, for example, the case of Vytorin, a medication developed to reduce the buildup of arterial plaque, and thereby reduce the risk of a heart attack. The idea was a clever one. Vytorin was a combination of simvastatin, a drug with an established record of lowering blood cholesterol by interfering with a liver enzyme involved in cholesterol synthesis, and ezetimibe, a drug that prevents the absorption of dietary cholesterol.
The double action should have resulted in less arterial plaque buildup, but, as demonstrated by a large clinical study known as ENHANCE, it did not.
The combination of simvastatin and ezetimibe was no better than simvastatin alone in preventing the buildup of arterial plaque. This was already clear when the trial was completed in 2006, but the information was not brought to the attention of physicians at that time, and the results were not published in the New England Journal of Medicine until 2008.
Why the delay? Was it due to problems with analysis of the data, as the producers of Vytorin claim, or was it an attempt to gain time to promote Vytorin to doctors and get them to switch their patients to the drug? We can only make an educated guess about that, but it is a fact that in 2007 sales of Vytorin and Zetia (ezetimibe alone) amounted to $5.2 billion, an amount that plummeted in 2008 after publication of the ENHANCE study.
Neurontin, an epilepsy medication developed by Warner-Lambert and approved in 1993, has been mired in an even more complex controversy. Soon after its introduction, the company, purchased by Pfizer in 2003, began to promote it to physicians not only for epilepsy but for pain relief, bipolar disease and depression.
Once a drug is approved, physicians can prescribe it for any condition, but companies cannot promote it for such off-label use. Yet that is exactly what happened, and that is why in 2004 Pfizer pleaded guilty to marketing a drug for unapproved uses and paid $430 million in criminal fines and civil penalties.
Even more disturbing is the fact that there was scant evidence that Neurontin was effective for any of the off-
label conditions.
Pfizer had commissioned a number of studies to investigate the use of the drug for these conditions, but failed to publish the mostly negative results. In one of the neuropathic pain studies that was published, later independent analysis revealed that many of the subjects given high doses of Neurontin experienced sleepiness and dizziness as side effects and, therefore, were able to guess whether they were taking the drug or a placebo. Once these subjects were eliminated from the study, Neurontin did not show a significant effect.
With the 2004 settlement, Pfizer promised to desist from off-label promotion, yet last year charges were again brought against the company for the same offence. This time the drug in question was Bextra, approved for arthritis and menstrual problems, but promoted for the treatment of acute pain to all kinds to physicians who had been enticed to presentations at resorts with cash payments. Pfizer ended up paying a $1.19-billion fine, the largest in U.S. history, for illegal promotion of Bextra, a drug taken off the market in 2005 because of possible cardiac complications.
Since 2004, Pfizer paid a total of $2.75 billion for off-label promotion, a drop in the bucket compared with sales of $245 billion between 2004 and 2008.
Since 2004, seven major pharmaceutical companies have paid a total of $7 billion in fines for promoting unapproved drug use. They all promised to never do it again. Sure.
Another way to increase sales is through manufacturing diseases:
- Want to sell testosterone gel to men, well, come up with "aging male syndrome."
- Categorize restless children as having "attention deficit disorder," and promote a pharmaceutical solution.
- Work to lower the guidelines for blood cholesterol levels and sell more cholesterol-lowering drugs.
- Buy ads on U.S. television that insinuate depression is caused by low levels of serotonin, and sell more serotonin-reuptake inhibitors.
As I said, there are skeletons in Big Pharma's closets, although not nearly as many as in the closets of the "alternative" health product industry.
But it is unfair to blame the scientists toiling away in pharmaceutical research labs, seeking to develop life-saving drugs, for the inappropriate marketing decisions that are sometimes made.
Joe Schwarcz is director of McGill University's Office for Science and Society (www.OSS.McGill.ca). He can be heard every Sunday from 3-4 p.m. on CJAD. joe.schwarcz@mcgill.ca
1 comment:
A bit like the scientists Phil and Lem in the Sitcom Better Off Ted
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