The Life and Death Struggle between the FDA and GlaxoSmithKline

“Medicine is for the patients…the profits follow.”

So said George Merck II, then CEO of pharmaceutical giant Merck & Company, sometime during the first half of the 1900s. Merck, in those days, hoarded cash for investment in research and development and followed a corporate philosophy that focused first on improving the human condition. Merck believed a selfless approach would be in the company’s self interest.

What a contrast is revealed in the headlines these days. Merck’s travails with its arthritis drug, Vioxx are well documented. But this week’s Time Magazine report documenting GlaxoSmithKline’s efforts to thwart the Food and Drug Administration’s investigation into its diabetes drug, Avandia, should outrage consumers.

In summary, GSK and the FDA have been aware of an increased risk of cardiovascular issues with Avandia since 1999. In 2007, GSK’s own internal study showed a 46% increased risk of heart attack for diabetics taking Avandia. Time reports that GSK’ s U.S. sales of Avandia reached $1.5 billion by 2004, six years after receiving FDA approval.

The Time article (click here) documents GSK’s corporate efforts to deceive regulators at the FDA to keep Avandia on the market. While GSK was very effective in doing so, the focus of the article is the failure of the FDA to protect citizens from corporate malfeasance. In this case, the corporation may have been knowingly causing the death of its customers! Remember, an internal study showed that you are 43% more likely to have a heart attack if you are diabetic and taking Avandia when compared to other alternatives including taking a placebo.

It is indeed an outrageous story, illustrative of today’s corporate philosophy…increase profits and shareholder value at all costs. But it also points to a more nuanced issue that pulsates through the American political landscape today. Just how much government do we need? Those describing themselves as tea partiers would suggest a small federal government with self-regulation of corporate America a very desirable thing.

While that argument appeals to business-people on many levels (myself included), Time points out that the FDA, which is largely funded by user fees paid by Big Pharma and whose officials are heavily lobbied by the industry, has become ineffective in its role as it relates to drug development and approval. In this case, we aren’t talking about upside down mortgages and bankruptcies, we are literally talking life and death.

But, let’s return to Avandia. If you, a friend or a family member is taking Avandia, you should read the Time article. I’ll bet you will be talking with your physician about alternatives therapies very soon.

Time to take my Lipitor.