THE BLOG
11/05/2010 08:27 am ET Updated May 25, 2011

Prescription Drugs: Why It's So Hard to Find Legit Psychiatric Medications

Although the concept may seem simple, that of a psychiatrist prescribing medications that supposedly work, cause little or no harm, and are scientifically proven to meet at least these aforementioned three criteria, couldn't be further from simple. Many well-intentioned, very well-educated, highly experienced and dedicated psychiatrists face medication dilemmas in many ways and many times each day. Where is the properly researched, scientifically based drug information?

There are many elements that combine to make this search dauntingly difficult. Not necessarily in order or complete, the following are some:

1) Lack of reliable research. Reliable, high quality, properly done, easily accessible, double-blind placebo controlled research, should it exist (which it usually doesn't), is nearly impossible to find. Evidence-Based Medicine, perhaps the sine qua non of drug research information, is in its infancy and very hard to find.

2) Advertisements in medical journals are usually useless and often misleading. There are ugly and pretty pictures, the ugly to illustrate pre-drug nightmarish visage and the latter to illustrate beautiful butterflies, flowers and birds, ostensibly showing a drug's "success." These dueling pictures usually present only vapid information about the medications advertised.

In-article, relevant and reliable information as to how to find the research to support claims made in the advertisements are virtually always absent. For example, criteria for accepting advertisements by the New England Journal of Medicine (NEJM) -- one of, if not the most, prestigious medical journals in America -- can be read on it's website. Basically, the ads that are published are what drug makers want to sell. The rules of NEJM governing the publication of ads are virtually all designed to keep the NEJM from getting sued/held liable with very little if any attention paid to the need, quality, appropriateness, research support and safety of the drugs that are advertised. If you can't prove it, don't print it, would be a good start for medical journal advertising.

3) Separating properly done research from it's improperly done brethren, is nearly impossible.
Journals do not publish but rarely the findings of failures. 'Researchers' seeking FDA approval of a drug usually follow the same pathway. Their bias is to find positives, not negatives. Car company ads will never point out their particular car's defects, but their wondrous features. If their car has 'real' wood ashtrays, we'll all know. Information on serious defects will be buried.

4) The FDA. A useful and reliable FDA would, of course, be very helpful. It should be a veritable Fountain of Eden of information about both new and past-approved drugs. It is neither. Previously FDA approved drugs form the vast amount of drugs that are frequently used. For every new drug approved, there are many that have long since been approved. Review of past FDA approved drugs is minimal or nonexistent.

The FDA has a set of steps that a new drug must pass to be approved. There were, until 1996, three steps to approval. Since 1996, the number has gone up to a whopping four. The FDA initiated Step 4 in its drug evaluating procedure in 1996, a required re-testing and reevaluation of new and recently approved drugs by the manufacturer, not the FDA. Presently, only 14 percent of drug companies follow this rule on at least one drug. There are no penalties for not following this procedure.

The parameters of this reevaluation are not clear, but are not followed anyway. Sixteen years since Step 4 and virtually no adherence. (Not to worry, the FDA is thinking of pulling from the market a drug whose Step 4 has been asked for by the FDA for 14 years without response. Haste must make waste.)

The FDA does no research of its own, but only receives information from the manufacturers of the drugs seeking approval. Obviously, that procedure is fraught with opportunities to manipulate test results. Clinical trials, Step 3, leading to FDA approval are usually woefully short, ordinarily lasting between 6-12 weeks. I sometimes think, cynically, that 6-12 weeks of 'trial,' usually compared against a placebo, is about enough time to see if someone drops dead or not. Nothing more.

For example, a newly FDA approved drug, "Intuniv" in an ad in September's "Clinical Psychiatry News," states, apparently proudly, that two clinical tests were run on this drug prior to FDA approval, one lasting six weeks, the other nine. Any information as to how these trials were done is absent. This drug is to be used by our children, diagnosed with ADHD/ADD. I think our children deserve a vastly more thorough evaluation by the FDA prior to approval of this or any drug. How one determines the actual usefulness and safety of a new drug in six to twelve weeks of clinical trials completely escapes me.

Marcia Angell, M.D. the first woman to serve as editor-in-chief of the New England Journal of Medicine and currently a Senior Lecturer in the Department of Social Medicine at Harvard University School of Medicine, has been a stern critic of U.S. health care in general and the pharmaceutical industry in particular. She is scathing on the topic of how clinical trials are conducted and advertised in America. She also comments on medical scientific papers.

5) Direct, personal, sales promotions to psychiatrists are usually professionally empty -- yet a social delight. Usually, psychiatrists are visited by pleasant, smart, attractive drug reps, extolling the virtues of their products. Their presentations usually include charts and graphs showing the superiority of their drugs over placebo. There is never a comparison of their Drug A and Drug B, which are similar drugs, but made by different drug companies. Pleasant visit, no useful information.

Meetings, usually dinners, as of this year, have taken on a new and ominous quality. They used to be more fun. Psychiatrists can be suckers for meals, particularly dinners. Build a dinner at a nice restaurant and we will come. The format used to be that an expert, unfortunately paid by the drug company, would come and participate in the dinner, answering questions, offering information, etc. These meetings, depending on the speaker, were often very informative to the psychiatrists in attendance. The rules for these meetings have changed radically as of January 1 of this year. The speaker is only allowed to talk about the drug of the sponsoring drug company, unless, and only unless a question is brought up by attendees about other topics. The pall that envelops the audience with these restrictions and reluctance to ask 'other' questions, such as information abut other drug manufactures' similar drugs, is stultifying.

So, we have one more sales meeting and one less source of information and at least one less attendee -- myself.