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Monday, December 3, 2012

When Profit Seeking Trumps Patient Safety

Kim Bailey

Health System Improvement Program Director

When Avandia entered the market, it was touted as one of the best medicines available to help people with type 2 diabetes. The great potential of this new diabetes wonder drug was proclaimed in an article in the prestigious New England Journal of Medicine, and Avandia was quickly adopted as the standard of care. Sadly, an important piece of information came out much later. Avandia has an unfortunate and dangerous side effect: It increases the risk of heart attack. A lot. And, what’s worse, both GlaxoSmithKline, the drug’s manufacturer, and the academics and scientists who wrote the glowing journal article likely knew this at the time.

Why would brilliant academics publish research that fails to note such an important risk? As discussed in a recent Washington Post article, it turns out that each of the 11 authors of that widely cited journal article were on GlaxoSmithKline’s payroll. Because the authors were either employees of GlaxoSmithKline or received money from the company to support their work, they had a powerful incentive to keep the company’s bottom line in mind. Developing a drug and getting it to market is expensive and Avandia had the potential to be a blockbuster.  Blowing the whistle on the drug’s heart attack risk would have been a serious setback to the company. So, the article was published, Avandia was prescribed to hundreds of thousands of Americans, and an estimated 83,000 heart attacks and deaths occurred as a result.

This isn’t the first time something like this has happened. A growing list of drugs—such as Vioxx and Celebrex—have been pulled from the market in the aftermath of a safety scandal. The growing number of such cases is likely driven by the increasing influence that the industry has over research. Prior to the 1980s, this serious conflict of interest was avoided because the government or other entities conducted the majority of pharmaceutical research. Now, drug companies finance the lion’s share. As a result, they have the opportunity to obscure the research that is done by releasing only the data that they choose to. And when that happens, as the case of Avandia shows, people get hurt. It’s time to require drug manufacturers to be transparent and release ALL of the data that their studies produce—even when the findings aren’t quite so rosy. The health and welfare of Americans is at stake.