How Do Drugs Get Tested?

The recent news about over-the-counter (OTC) Zicam causing a loss of sense of smell in over 300 people raises a few eyebrows. Frankly, Bextra being withdrawn in 2005 for being linked to causing an increase in heart attack risk raised quite a few eyebrows, too.

It's important to make a distinction between pharmaceuticals and supplements.

Pharmaceuticals are regulated and approved by the Food and Drug Administration (FDA) and must be proved to be safe as well as effective in treating the condition for which approval is being sought.

Supplements, herbs and vitamins are marketed as nutritional or dietary supplements and therefore are not required to meet any such standards. Let the buyer beware!

By the time a pharmaceutical has received FDA approval to be sold, it has been researched and extensively tested in labs and then in humans for both safety and effectiveness. The testing in humans usually involves several thousands of folks, half of whom receive the tested drug and the other half a placebo.

This is done in such a way that the doctor giving the drug doesn't know whether the person will receive an active drug or a placebo. This is called randomized, double-blind placebo/control study, and is intended to keep people from reporting or not reporting side-effects because they know beforehand whether they got drug or placebo. Also, it is done this way so the doctor cannot reveal whether they are getting drug or placebo, either.

Granted, this assumes that the drug manufacturer is conducting the research in accordance with standards, and isn't "massaging the data". It also assumes that the directorship of the FDA is aggressively pursuing its mandate on behalf of the public.

In the case of Bextra, the drug company reported 11 months of heart attack data as a full year, thereby under-reporting the incidence of heart attacks related to the drug to the FDA.

Also note that the burden of proof of effectiveness and safety is on the company, and not the FDA. This is as it should be from the point of view that the costs of such proof should be on the company which stands to profit from FDA approval, and should not be upon the consumers and taxpayers.

Also, it is important to realize that if a drug as a rare side-effect and perhaps only occurs in one out of 10,000 or 50,000 people who take it, this is not going to become evident until several million people have taken it. This is neither a failure of the drug company, nor the FDA. This is simply a fact of life, which is why there are processes for reporting potential rare but serious side-effects with medicines. An example of this is the current investigation of psychiatric side-effects with the new smoking cessation drug Chantix.

Bottom Line:

Supplements and herbs differ from pharmaceutical drugs significantly in that they are not required to be proven to be safe or effective, nor to be tested for interactions with medicines or foods, nor for truth in labelling.

This does not mean that they do not work or should never be taken, but it does mean that a reasonable degree of skepticism in the literal sense should be exercised.