Marketing often mars work done in big pharma labs

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.

more via montrealgazette.com

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