Patient stories, or case studies, are vital to the conversation about the safety of medications and they help drive research about health issues. I believe they are the proverbial canary in the coal mine. How else will doctors and researchers know what’s going on? Should they rely solely on the drug companies to share information that may be detrimental to their bottom line? I don’t think so, but over the years many doctors and scientists have dismissed patient stories as anecdotal and therefore not pertinent to the research conversation. They claim that the only valid forms of medical research are the double-blind placebo controlled trial or the large epidemiological investigations and nowhere is there room for the patient experience of his or her symptoms. But these studies are often cost-prohibitive or take many years (sometimes decades) to complete. What about the patients suffering now?
Case Studies Dismissed in Hormonal Birth Control Research
In my research involving birth control safety and the politics and policies surrounding hormonal birth control, the disregard for patient experience, let me rephrase that, human experience, is striking and entrenched. Even back in 1970 at the Nelson Pill Hearings, Dr. Joseph W. Goldzieher, one of the physicians testifying, was so adamant that case stories had no value that he impugned the entire British Medical Journal, the official publication of the British Medical Society and counterpart to the Journal of the American Medical Association. His claim was based on their willingness to publish an article about cervical cancer and the birth control pill when he felt that other journals “would turn it down as proving nothing.” Perhaps it is no coincidence that the British Medical Journal was the first to call attention to the problem of blood clots and the birth control pill. Dr. Goldzieher’s testimony is as follows (from page 6375 of the Nelson Pill Hearings).
Senator McIntyre: Does this statement, the statement that this journal—I am now referring to the British Medical Journal—this journal is noted for its lack of editorial discrimination, represent simply your own opinion, or is it based on some evidence?
Dr. Goldzieher: No, sir. It is my opinion exclusively, and it is based on the fact that this particular journal publishes large numbers of letters of an anecdotal nature, which are perhaps amusing, but are of dubious scientific merit, but which are then used for purposes which are not admissible. Having crept into the scientific literature as information—any statistician would call it anecdotal information—it then gets quoted and re-quoted. This is of questionable value to the medical community.
Senator McIntyre: Doctor, is it not true that letters to medical journals might very well be a manner and a way of detecting problems that may be occurring?
Dr. Goldzieher: I think there are better ways, Senator… This raw information should not, in my opinion, appear in a journal of this type… It should go to somebody which knows what to do with this information. Printing it in the British Medical Journal is no way to handle this kind of information.
Of course statistics are important. And of course we cannot make claims for all women based on the experience of one, or even a few, but in the case of hormonal birth control and blood clots (or really any of the side effects from hormonal contraception or other drugs), we are not talking about a few exceptional cases. Hundreds of thousands of people are harmed every year from medication adverse events. In fact, prescription pharmaceuticals are the fourth leading cause of death in the United States. How hormonal birth control contributes to that risk is unknown. We see from the testimony of doctors, scientists, and researchers that even in 1970 the drug manufacturers knew there were far more side effects with synthetic hormones than had been studied prior to their approval. Imagine what might have happened if more case studies were published instead of dismissed as anecdotal. Would that have driven more research and more awareness of risks?