Freedom from the FDA
By Richard E. Ralston
November 28, 2008
It took the Food and Drug Administration more than a century to grow into a massive, expensive, wasteful, inflexible, ineffective, distant and indifferent bureaucracy. It now violates a founding principle of the practice of medicine: "First, do no harm."
The FDA does a lot of harm, every day. Why do we allow that?
The FDA has kept some unsafe or ineffective drugs off the market (although a consortium of independent research organizations could have done the same thing). But at what cost? We can summarize in ten ways how the FDA threatens or does real harm to our health:
1. The FDA adds billions to the development cost and price of new drugs.
2. The FDA delays the availability of new drugs for years.
3. The FDA prohibits the use of new drugs that treat conditions for which other drugs are available, regardless of how much better they might work for some patients.
4. The FDA withholds new drugs—even those that passed initial safety tests—from terminally ill patients, in the name of preserving safety. When one of these patients wins access to the drugs by going to court, the FDA, apparently in a relentless effort to protect the health of the dead, appeals the ruling until the patient dies, at which time the appeal is of course dismissed.
5. The FDA and Congress allow the drug approval process to be politicized to protect the interests of firms with political pull or to serve the anti-corporate political agenda of those who would rather see Americans die than allow any investors or businesses to make money developing new medications.
6. The FDA suppresses off-label use of drugs with proven ability to treat other conditions and restricts the circulation of information about such successful off-label use of drugs that have already been approved as safe.
7. The FDA actively seeks to extend the authority it so ineptly applies to drugs—and for which it asserts to have insufficient staff—to controlling all vitamins and food supplements. Whenever the reach of the FDA exceeds its grasp, it always tries to extend its reach.
8. The FDA constitutes a roadblock to new developments in anti-aging drugs by refusing to consider any science that would extend healthy lifespans—because "aging is not a disease."
9. The FDA states that it lacks the resources to ensure human drug safety but requests more resources to review veterinary medicine.
10. The FDA now publishes lists of drugs it approved but the safety of which it questions—leaving physicians in the lurch and creating a potential jackpot for litigation.
The FDA adds billions of dollars to the cost of developing new drugs and delays their use for years. Yet it is so obsessed with predicting exactly how each drug will perform for any patient—with any condition, in any dosage, for any length of time and in any combination with any other drug or combination of drugs in any dosage—that it often loses sight of safety. So a few years ago the FDA proposed the creation of a new "Drug Safety Board" to provide for drug safety. One would have thought that was the purpose of the whole agency.
That hypocrisy is consistent with the history of the agency. Every failure to fulfill its purpose is met with a review or a study by another government-related organization hired by the FDA to make recommendations. The recommendations are always the same: more staff, more budget, more authority, more buildings, more office furniture and more regulations.
If we want the tremendous progress in the development of medications in recent years to continue, we must act to eliminate the awesome ability of the FDA to destroy that progress. The first steps in reform should be to direct the FDA to focus entirely on safety and allow physicians and their patients to determine efficacy. Research must be encouraged, not restricted, and information on that research must be open to all.
Richard E. Ralston is Executive Director of Americans for Free Choice in Medicine.
Wednesday, December 3, 2008
Ralston on the FDA
Richard Ralston, executive director of Americans for Free Choice in Medicine, has written an OpEd sharply critical of the Food and Drug Administration (FDA):