Principles in Practice: The Blog of the Objective Standard

Saturday, August 11, 2007

The Deadly FDA

Posted by ARI Media at 9:28 AM

Irvine, CA—The Court of Appeals for the District of Columbia Circuit recently ruled that terminally ill patients do not have a right to take medicines that have not been approved by the FDA.

"Barring individuals from choosing what medicines to take is immoral and destructive," said Dr. Yaron Brook, executive director of the Ayn Rand Institute.

"The decision about what drugs to put in one's body rightfully belongs to each individual, not to FDA bureaucrats. To deny individuals this right is to impose a death sentence on those who, in the face of certain death, would rationally choose to accept the risks of an experimental treatment, but are barred from doing so until the urgently needed drug completes the FDA's onerous, years-long approval process. Indeed, this case was initiated by a group founded by the father of a girl who died after she was denied access to an experimental anti-cancer drug the FDA later approved.

"Individuals, in consultation with their doctors, should be free to assess the evidence of a drug's effectiveness and safety, taking into account their own personal context (such as their unique risk factors, or the fact that they are certain to die without the treatment). Some people may take ineffective or harmful drugs, but FDA approval does not eliminate such risks. The individual always assumes some level of risk when deciding on a course of treatment, and it is capricious—and too often deadly—for the FDA to usurp the individual's right to decide which risks it is in his interest to accept.

"Some claim that, freed from the necessity of gaining FDA approval for new medicines, 'greedy' drug companies will sell ineffective and dangerous drugs. But a company that sells such drugs is only ensuring its own financial destruction. And if a company knowingly misleads the public about a drug's safety or reliability, or is negligent in putting a dangerous drug on the market, it should properly be prosecuted. The solution is not to give FDA bureaucrats the power to condemn sick people to certain death.

"Some claim that allowing individuals to take unapproved drugs will make effective clinical testing impossible, since, as they say, no rational person would willingly submit to the double-blind, randomized tests that are currently used in clinical trials required by the FDA. In such tests, some of the participants are unknowingly given a placebo, which, it's said, no one would chance if he could ensure that he received the drug by paying for it. But, contrary to those who make this argument, individuals are not lab rats who may be blackmailed by the government into becoming test subjects. It is chilling that defenders of the FDA's current trial system are, in effect, advocating as an incentive to take part in such trials: 'join or die.'

"Moreover, such twisted ultimatums are not necessary in order to make effective drug research possible. Were individuals free to take untested medicines, new incentives to take part in clinical trials would surely arise, such as, for instance, an offer of free treatment to those who choose to take part—an inestimable value to people unable to afford the drugs.

"Anyone who values human life, and the freedom of judgment required to maintain it, should oppose this disgraceful ruling—and demand an end to the unnecessary deaths caused by FDA drug regulations."

Labels: Business and Economics, Individual Rights and Law