What a difference a decade makes. In 1995, Newt Gingrich claimed the Food and Drug Administration was endangering Americans’ health by taking too long to approve drugs for public use. The solution, Gingrich and others said, was to allow drug companies to conduct the trials that determine if a new drug is safe. The proposal was soon enacted into law under the guise of “reforming” the FDA.
Now it is 2004, and the FDA has been charged with endangering the health of Americans by allowing drugs to be placed on the market before adequate trials are conducted. The result: Vioxx, which was recently shown to double the risk of heart attacks and strokes among people who used the painkiller.
Once again, the invisible hand of the marketplace is giving the American public the finger. Vioxx was more than a new painkiller. It was also the response of Merck, the maker of Vioxx, to Pfizer’s Celebrex. There was no need to prove Vioxx was safe; the burden of proof was on those who questioned Vioxx.
Vioxx was indeed questioned, as far back as 2000. At that time, Merck was warned about the possibility that Vioxx might increase the risk of death from heart attack, stroke or blood clots for 7.5 to 15 people out of 1,000. Merck executives decided not to conduct clinical trials to specifically investigate the safety of Vioxx. Instead, they would monitor other clinical trials to see if there was any increased risk. To do otherwise might have sent a signal that Merck lacked confidence in the drug.
For years after being warned of the risks, Merck continued to market Vioxx directly to consumers as a wonder drug. Dr. David Graham, associate director for science in the FDA’s Office of Drug Safety, estimates Vioxx was responsible for anywhere between 88,000 and 139,000 cases of heart attack and stroke.
How was this allowed to happen? Is this a simple case of government regulators failing to do their jobs, or is it a case of corporate profits coming first? It would be easy to blame either culprit, but the fault seems to lie with the nature of clinical trials themselves.
Back in the 1980s, the demand for a drug, any drug, which could combat AIDS, put pressure on the FDA to allow drugs to reach consumers without waiting for trials to finish. AZT was a drug that initially showed great promise in halting the development of AIDS, and was made available without the lenghty trials that once were obligatory, essentially because AIDS activists demanded it.
It is not hard to see why. AIDS was once considered a death sentence, and a grim one at that. Activists demanded access to a drug that everyone knew would work.
Later, investigators questioned AZT’s effectiveness and even claimed that the rapid approval of AZT hurt the fight to find a cure for AIDS. They reasoned that by placing so many untested drugs on the market it becomes difficult to determine how successful any one of them is in fighting a disease.
Often, drugs that appear to be a success are later found to be nothing but trouble. When initial success matches a great need, there is an impulse to charge ahead instead of making a slower, careful examination of the situation. People suffering from conditions like chronic pain are eager to get some relief, and may not want to wait for trials to finish before getting it.
Since it has become acceptable for drug companies to market their products directly to consumers, the public’s awareness of new drugs has dramatically increased in recent years. It is indeed market forces that pushed a drug like Vioxx into the hands of consumers before it was fully evaluated.
I understand the suffering of people with chronic pain. It is not a fun way to live. However, employing full clinical trials are necessary to safeguard drugs.
The invisible hand of the marketplace has allowed us access to unsafe and damaging medicine. It might be time to see what that hand is up to, and insist that it behave.
William Lodge can be reached at email@example.com.