Wednesday, April 16, 2008

Scientific Fraud for Fun and Profit!

Let's say you're a giant drug company that's developed a very effective new drug which eliminates some of the serious side effects that plague similar medicines. A drug that has the potential to be fantastically profitable. Only there's a bit of a problem. People who use your new drug tend to have heart attacks. Lots of heart attacks.

What do you do?

Well, if you're Merck & Co. you fudge the data, forget to tell the FDA about all the bodies piling up during your studies, and hire consultants to write favorable review articles which you then pay well-known and respected researchers (everyone has a price) to publish as their own original work.

Unethical? Sure. Illegal? Maybe. Standard operating procedure for Big Pharma? Probably. This is the sorry tale of Vioxx (rofecoxib), a revolutionary drug that helped millions of people lead better lives, yet also killed far more Americans than the attacks on 9/11.

JAMA, the Journal of the American Medical Association, just published a paper showing how Merck gamed the medical, scientific, and regulatory communities for years in order to protect its Vioxx profits, and a second paper detailing how Merck hid mortality data that showed significantly increased death rates for patients using Vioxx. Wednesday's Washington Post has a great story on the JAMA articles.

Vioxx is sort of a super aspirin. Like aspirin and similar nonsteroidal anti-inflammatory drugs (NSAIDs), it reduces pain and inflammation, but it does so without causing stomach upset, bleeding, or ulcers. Vioxx is a COX-2 inhibitor, which means that it mitigates the effects of prostaglandins, chemicals in your body that cause pain and inflammation.

Unfortunately, all COX-2 inhibitors also suppress an anti-clotting chemical called prostacyclin, and increased clotting activity causes heart attacks. This effect was well known even before Vioxx hit the market, and should have set off regulatory warning bells. It appears that Merck decided to play down the drawbacks in order to maximize market share and profits. Vioxx's biggest potential market was senior citizens, a group already at significant risk for heart attacks, and acknowledging that Vioxx increased that risk even further would have had a big impact on sales.

The problem here isn't Vioxx, or for that matter any of the related COX-2 inhibitors such as Arcoxia, Celebrex, and Bextra. They're all great drugs for treating chronic pain, and are probably at least as safe as older drugs when used properly. But Vioxx wasn't used properly because Merck hid the risks. Doctors simply didn't know when Vioxx was appropriate, and when it wasn't, and a hell of a lot of people died as a result.

My interest in this issue has several roots. As a good-government liberal I'm deeply concerned about the influence of money on politics, and Merck's apparently successful manipulation of the FDA is a perfect example. Not that Merck is unique, just last month the FDA admitted that it had ignored hundreds of scientific studies questioning the safety of BPA, a common ingredient in many plastics, and instead used just two studies funded by the chemical industry to conclude that BPA is perfectly safe.

As an engineer with a strong scientific background, I'm also worried about the potential of corporate money to corrupt the scientific process. Science is the search for objective truth, and we have to be able to trust what science tells us in order to make wise policy decisions.

I also have personal connection to this issue. My wife is a pharmacologist, a scientist who studies drugs. She's had to deal with the complexities of maintaining her professional and scientific integrity while accepting grants from pharmaceutical companies. In both science and politics, money almost always comes with an agenda. Anybody who tells you otherwise is lying. Sometimes you just have to say no when they wave that big fat check in front of you.

Vioxx shows what can happen when large corporations place short-term profits ahead of human safety, and more broadly it illustrates the conflict between uncontrolled capitalism and the public good. Merck was able to buy off our political, scientific, and regulatory systems. Not surprising perhaps, but it's a serious problem that needs to be fixed. As one of my friends says, corporations don't have hearts, they have bottom lines.

(Phil Witte, 2007 Union of Concerned Scientists Editorial Cartoon Contest)