Which Drugs are Best and Safest For You? Don’t Ask Your Doctor

April 9, 2010

By Terry Smiljanich:

When your doctor prescribes a drug for you, it seems safe to assume that he or she has clinical information demonstrating that the drug is the best and most cost-effective therapy for you, right? Think again.

As it turns out, most drug studies are not only financed by the drug companies themselves, but are really only studies indicating that the particular medicine under review is more effective in treating the condition than simply doing nothing at all! Relatively few clinical studies address whether other existing drugs, or other health alternatives (diet and exercise, for example) might be better for you, safer or more cost effective than the new drug.

Comparative Effectiveness Studies of New Drugs

Recent articles in the Journal of the American Medical Association (JAMA) have pointed out that FDA standards for approving new drugs do not take into consideration whether they are in fact less effective or safer than existing alternatives. Taking that new drug, whose advertisements urged you to “ask your doctor,” might actually do you more harm than existing alternatives with a track record of efficacy and safety. Your doctor doesn’t know because there may be no studies comparing the new drug to existing alternatives.

A new study published in JAMA this month surveyed a broad range of published drug studies and found that most studies were financed by the pharmaceutical company seeking approval of the drug, and in addition were studies comparing the new medicine to placebos (i.e., doing nothing). “Comparative effectiveness” research studies (that is, actually comparing the new medicine to existing alternatives) were in the minority, and those studies were almost always done by non-commercial funding sources such as the FDA.

Here’s how the 328 studies that were surveyed shaped up:

  • only 14% of the studies compared two or more medications with each other;
  • just 3% of the total studies looked at comparing the medications with non-drug interventions (e.g., simply exercising more);
  • 6% of the total studies examined the comparative safety of the new drug with other existing alternatives;
  • less than 1% of the studies included any cost-effectiveness analysis whatsoever.

Of the studies funded by the drug companies themselves, only two in the survey of 328 looked at comparative safety issues, and only one looked at potential non-drug alternatives.

Pharmaceutical Industry Spin

What is the excuse given by the pharmaceutical giants? A spokesperson for the “Center for Medicine in the Public Interest” (despite its title, a front for the pharmaceutical industry) argues that losers in a comparative effectiveness study might still work for some people.

It is certainly more arguable, and understandable, that drug companies simply don’t want to fund studies comparing their products to their competition, or to doing something else besides taking their new product. What if they lose?

Solutions to the Problem

Most non-commercial drug studies are done by the FDA, but the FDA does not have sufficient funding to conduct many such studies. To remedy the situation, a part of the stimulus legislation from last year was earmarked to provide one billion dollars in new funding to support comparative effectiveness studies. Hopefully, when such studies are completed doctors will have some more information to use in deciding whether to prescribe a drug and, if so, which one.

A one time funding boost is, however, no long term answer. Current FDA standards only require that drug companies simply demonstrate that their proposed new drug is better than doing nothing. A Commentary in JAMA has argued that the FDA drug approval process should include a requirement that drug companies demonstrate comparative efficacy and safety in order to establish that their new drug should be allowed to enter the market.

Such a change would require new legislation. Any wonder what the pharmaceutical lobbyists will try to do to such a proposed change to improve the public welfare? Let’s just ask the “Center for Medicine in the Public Interest,” shall we?