Patients Are Not Statistics: The Case for Personal Stories in Medical Research

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Lucine Health Sciences and Hormones Matter have begun an important new research project to investigate the relationship between hormonal birth control and blood clots. They are surveying and interviewing women and the families of women who have suffered blood clots while using hormonal contraceptives. A big part of this study includes publishing the personal health stories of these women. (You can read my story here.) Hormones Matter has always been a place to question the status quo in healthcare and believes that one of the most powerful ways we can do that is by allowing patients to have a voice.

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?

Case Studies Drive Research

A doctor that testified after Dr. Goldzieher completely refuted Goldzieher’s stance on case studies and the British Medical Journal.

Dr. Philip A. Corfman said (in Nelson Pill Hearings, page 6400.):

“I believe the thromboembolism story provides a good example of what kinds of studies are needed. The story started with clinical observations, letters to the British Medical Journal, and case reports in Sweden and American literature. These observations brought this problem to the attention of medical science, but it was not for several years, five or six at least, until well-designed, carefully controlled studies were undertaken to show that there is indeed a positive relationship between the use of pills and [blood clots].”

 

“We are still in the early stage with the other problems that have been discussed, such as cancer, hypertension, and diabetes.”

Clearly, it takes patient stories to help detect these problems. We cannot afford to wait for an observable statistical jump in the mortality of young women or any group of people before we start investigating whether these medications are really safe. We really cannot trust the drug manufacturers to make this decision for us.

Pharmaceutical Companies Against Case Studies

Perhaps it is no surprise that when Senator McIntyre asks Dr. Goldzieher if he had ever worked for the drug companies, his response was, “I am a consultant at various times to various drug companies.”

So maybe it boils down to Dr. Clark’s testimony upon being asked if he would give his daughter the pill.

“There are two sensible answers to that. The first is, my daughters are both college age now and they would not do anything I told them to anyway. The second answer, I think, is that in a survey such as this, one is dealing with statistics. These have to be looked at in the light of a group of other statistics. When you come down to a question of the patient, that patient is no longer a statistic.” -Nelson Pill Hearings, page 6152.

Patients are Not Statistics

Patients are NOT simple statistics. This is why sharing personal stories is so vital and why we make that a priority at Hormones Matter. The manufacturers and many astute doctors and researchers knew over 40 years ago that hormonal contraceptives needed much more research. In 2016 we still don’t fully understand the risks for deadly blood clots and other serious side effects. Had women not been silenced then, perhaps we’d know more today; perhaps fewer women and their families would suffer the consequences of hormonal birth control related blood clots.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

 

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