On the Latest and Greatest

When I was a resident in Latrobe I rotated with a surgeon who was very conservative in his approach to medicine. He once handed me a surgery textbook and said, “I only do surgeries that are in that book.” I looked at the book and remarked that it was 5 years old. “Yes, and at least 10 years out of date. I have seen too many procedures come and go that have been hailed as the latest and greatest, and then are abandoned.” At the time I did not fully appreciate the wisdom of his words, but the comment stuck with me.

Since I entered medical school in 1992 the Federal Drug Administration (FDA) has withdrawn from the market more than 20 previously approved medications. This happens for 4 reasons. First is the structural bias in the research process. An experimental drug is given to doctors’ offices around the country who participate in research for a fee. These doctors have their own practice but also invest money in hiring a certified research assistant and in remodeling the office to make the process secure. If a doctor reports a lot of side effects then the drug companies will stop using that office and the research investment goes down the drain.
Second, the FDA does not require independent verification of drug company research to get a new drug approved. Third, approval is based on testing small numbers of patients to establish efficacy; safety, on the other hand, cannot really be established until the drug is on the market and is used by hundreds of thousands of patients – and this takes years. Fourth, the drug is used in actual practice on patients very different from those in the approval studies.

In actual practice patients are on multiple medications. We pretty much know how any 2 drugs interact with one another, but when you add a third we do not know how the mix affects efficacy or safety. The average 65-year-old patient is on 8 medications. We are creating chemical soups with unknown consequences; so the addition of every medication to the patient’s regiment is in reality an experiment.

Drug company representatives regularly visit doctors’ offices to give samples of medications, all of which are on patent and expensive. The doctor then gives the samples to patients who thereby become dependent on costly and unproven medications. We do not allow drug company detailers to visit our practice, but most doctors do. If a specialist gives you a sample medication, then you should ask for a generic equivalent instead. If you do not feel comfortable doing that then review the situation with your family practice provider before becoming dependent on a drug that is the latest and greatest.

– Gary Gallo, MD