The insanity that is evident from examining the role (or lack thereof) of the FDA in regulating alternative remedies may be finally coming to a head. It s about time.
Earlier this week, in what must have resembled Wrestlemania X, proponents and critics of homeopathy went at it during a two-day listening session that was held by the FDA to discuss whether homeopathic products should go through the same approval process that conventional drugs do. New drugs must be judged to be safe and effective in order to gain FDA approval. It is a very long, arduous, and expensive process.
These terms are not cut and dried. Both safe and effective have different meanings depending on the drug in question and the disease it is designed to treat. The severe side effects of cancer chemotherapy drugs would, of course, never be acceptable for a drug to treat male pattern baldness. But when life-threatening diseases are the target, the risk-benefit ratio changes dramatically, and more toxicity (less safety) is permissible.
Conversely, a drug that has no side effects, and even marginal therapeutic value of any kind would stand a good chance of being approved.
The latter case is quite relevant to the the FDA hearings. which were superbly discussed by Rob Stein, a correspondent and senior editor on NPR's science desk.
The FDA has been allowing homeopathic remedies to be sold without clinical trials since 1988. But, they are now reconsidering this policy, much to the chagrin of homeopathic retailers, as well as individuals who swear by it.
ACSH s Dr. Josh Bloom says, On the surface, it would seem that these quack treatments are at the very least safe, since they are nothing but water. But there are two problems with this statement: 1) they have never been shown to be effective, and 2) they become indirectly unsafe when they are used in place of legitimate medicines for diseases that could otherwise be treated.
The still-relevant adage, the dose makes the poison was coined by Paracelsus (aka Philippus Aureolus Theophrastus Bombastus von Hohenheim) in the early 16th century, and it is still the basis of modern pharmacology. It is really quite simple: one tablespoon of sodium cyanide will kill you, but a tiny grain will have no effect whatsoever. Intuitively obvious.
When it comes to critics of homeopathy, the rock star is the incomparable Dr. Joe Schwarz, a professor at McGill University in Montreal, Quebec. Dr. Schwarz (also known as Dr. Joe) is an author, a regular guest on television and also the host of his own radio show. He is also the director of McGill's Office for Science & Society, an organization dedicated to give the general public a clearer idea of science. Dr. Schwarz is currently spearheading a movement to stop the University of Toronto from conducting yet another study about homeopathy.
His recent letter to Dr. Heather Boon, the Dean of the Leslie Dan Faculty of Pharmacy at the University of Toronto, was signed by more than 50 scientists (including Dr. Bloom). He asked, [We] are curious about why, given the need to investigate natural therapies that may actually have a potential for benefit, and faced with a scarcity in funding, a Department of Pharmacy is interested in investigating a subject that has been addressed extensively in the literature and has been found wanting both in evidence and plausibility.
Another critic, Steven Novella, a neurologist at Yale University, who also runs the Science-Based Medicine website thinks likewise: "Homeopathy is an excellent example of the purest form of pseudoscience. These are principles that are not based upon science."
Dr. Bloom says, In the end, this is not really about the merits of homeopathy. It is really about whether products that are designed to treat a wide variety of human conditions one component of the FDA s definition of what a drug is should be judged by different standards than other products, e.g. prescription drugs. If these products really work, then they will demonstrate efficacy in clinical trials. If not, you might as well sell them in the bottled water aisle at CVS.