How the FDA Prolongs Pain and Suffering

Posted by Enrique on 08.24.2008

Your government at work



Last week, an op-ed appeared in the Wall Street Journal that highlighted some of the unintended consequences of government over-regulation. The article was written by Greg Conko of the Competitive Enterprise Institute, a libertarian think tank. Conko recounted two recent cases that demonstrate how the Food and Drug Administration's tiresome approval process prevents cancer-stricken Americans from voluntarily using experimental drugs.

A few years ago, an Indiana woman named Kianna Karnes wanted to use pharmaceuticals developed by Bayer and Pfizer to help combat her terminal kidney cancer. Although the drugs wouldn't have cured the disease, they might have improved Ms. Karnes' quality of life in the time she had left. However, the FDA requires that experimental cancer drugs go through unnecessary clinical trials before they can be distributed on a limited, "compassionate use" basis. Even if a person like Ms. Karnes wants to use such a drug, and understands that the drug hasn't been approved, that person is prohibited from volunteering until the FDA gives its blessing. Ms. Karnes died in March 2005.

13-year-old Anna Tomalis had been battling liver cancer for three years, when her parents found out about a drug called Deforolimus being developed by ARIAD and Merck. Anna was too young to be included in the clinical trials, and like Ms. Karnes, the Tomalises discovered that obtaining "compassionate use" approval from the FDA is an unrewarding process. After months of being tied up in a government regulatory scheme (cooked up with the best of intentions, of course), Anna finally got approval to use the drug in July. She died less than one month later.

In both cases, we can't know for sure whether or not those unapproved drugs would have helped. But imagine that at some point in the future Deforolimus is proven to ease the suffering of cancer patients. How many people like Anna Tomalis will have had to suffer needlessly while the FDA dragged its feet? If we ever do come up with a cure for cancer, it will be tied up by the FDA for years before anyone is able to use it. As Conko notes, this predicament will get worse before it gets better:

The problem has been magnified in recent years as the number of new drug approvals has fallen dramatically. The FDA approved just 16 new drugs last year, and is on pace to approve only 18 this year. That's down from a high of 53 in 1996 and 39 in 1997.

After a few high-profile drug scares, such as the 2004 withdrawal of Vioxx from the market, FDA officials have become gun-shy about approving new products. After all, the agency receives scathing criticism from Congress and the press when an approved drug turns out to be more risky than expected -- but rarely for keeping beneficial ones off the market.

It typically takes several years and hundreds of millions of dollars for a pharmaceutical company to get FDA approval, which in turn drives up the price of the drugs when they finally come to market. As the Vioxx example demonstrates, even rigorous clinical trials aren't a guarantee that some drugs won't have tragic complications. But that's no defense for a convoluted and expensive government-mandated regulatory process.

Private drug companies would conduct their own clinical trials even if they weren't required to by the government, because profit-driven corporations wouldn't sell a drug unless they knew it was safe. After all, a company that sells drugs with dangerous side effects won't be in business for very long. It's in a drug company's best interest to conduct meticulous clinical trials, which would no doubt take less time and be less costly than the ones created by government bureaucrats. There's no sense in FDA regulations that do little more than drive up drug prices and prevent "compassion use" of experimental treatments. It makes you wonder why we have an FDA at all.