medical research

No Medication is Perfectly Safe

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A few weeks ago, I was accused of being biased and unscientific for acknowledging that all medications carry risks; that no medication was, in contrast to this commenter’s perception, ‘perfectly safe’. In her view, some medications were perfectly safe, even during pregnancy.

I went on to suggest that while no medication was perfectly safe, certainly some medications were safer than others and some medications were quite necessary for either maternal or fetal health, despite their potential risk for side effects. Sometimes those risks are minimal, and other times, they are not so minimal but necessary nevertheless. Medication use, whether during pregnancy or not, is never without risk. This commenter would have nothing of it. Certain medications were perfectly safe and I was biased and unscientific for suggesting otherwise.

The accusation was in response to the suggestion that meds should not be taken during pregnancy, posted alongside a press report about a recent study delineating the newly recognized side effects to male fetal development when mom takes of paracetamol, (acetaminophen – Tylenol in the US), during pregnancy. Up until recently, the safety of this over-the-counter drug was not contended (aside from the liver damage) and so generations of women took this medication believing it was perfectly safe. It wasn’t until researchers began investigating a broader range of outcome variables than is traditionally considered that these issues with fetal development became apparent. In other words, it wasn’t until we asked the right questions, until we knew what to look for, that we found the right answers.

When one studies maternal health long enough, a common pattern emerges. Drugs once considered perfectly safe are seemingly overnight recognized as not so safe. In reality, this recognition took years, sometimes decades before bubbling to the surface. Across the entirety of pharmacology we see this happen with great frequency, but in maternal health, the presumption of safety has always been spurious at best. More often than not, the research to determine safety is never conducted, and when it is, the studies suffer from serious methodological flaws, including small sample size and overly narrow range of outcome variables.

This happens across maternal health research. For example, a recent, very well-funded and highly touted study of blood pressure medications during pregnancy didn’t even ask whether or which medications to lower blood pressure during pregnancy were safe or safer. It simply asked whether high dose or low dose, aggressive or not so aggressive treatment of high blood pressure during pregnancy was more effective. Since all of the women studied were taking medications, the complications were similar. Since the women in the study were on multiple medications during pregnancy, tying any one complication to a specific medication was impossible. This allowed the researchers to avoid the side-effect/complication discussion altogether and avoid it they did. Beyond simply carrying the pregnancy to term, how did these medications affect overall maternal health, fetal health and infant development? We don’t know, these questions were not asked.

Conventional outcome measures for most maternal/fetal health research include only the most easily observable signs of maternal complications and fetal distress and development, generally within a short time frame of birth. Since those variables often show no apparent connection to the medication (because of design flaws in the research as in the blood pressure study above), the medication is deemed safe. But is it?

This brings us back to the absurd notion that any medication can be perfectly safe. When evaluating research on any topic we have to realize that how we frame the questions and what questions are asked determine what we can know about a given subject. With medical research this is not well understood, except perhaps by those who benefit from an incomplete knowledge set. In women’s health we see this pattern all the time, poorly designed studies fail to ask the right questions or, more often than not, there is no research at all. In both cases, the absence of evidence about a medication’s ill-effects is then transformed into evidence of an absence of any ill-effects e.g. that the medication is perfectly safe. And once the label of perfectly safe becomes entrenched, it is very difficult to disprove.

In the case of the paracetamol research, it wasn’t until the notion of endocrine disruption became more commonplace that researchers expanded their scope of side-effects. Kudos to the researchers for connecting paracetamol to male genital development, but if we’re honest with ourselves, not many of us, even if we are researchers, would have thought to ask that question. We couldn’t have considered questions connecting male or female genital development (notice, they did not concern themselves with female genital aberrations) to acetaminophen until recently, until the notion of endocrine disruption became more firmly established in medical research. When we don’t know what questions to ask (or tacitly ignore certain questions as in the blood pressure research) the answers returned are inadequate.

Returning to my biases about perfectly safe medications: I do have biases. Everyone does. I begin from the standpoint that nothing in life, but especially in medicine, is perfectly safe. This presumption is then colored by the understanding that most research is necessarily flawed, sometimes by economic interests, sometimes by poor design and sometimes just by the limitations of the knowledge base within which the investigators were operating. An absence of evidence is never evidence of absence. The lack of evidence means only that we have yet to ask the right questions. Does that mean medications are never warranted? Certainly not. It just means that I accept that all medications carry risks, many of which we have yet to understand. Those are my biases.

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Image credit: PickPik.

This article was published on Hormones Matter originally on July 1, 2015. 

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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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Crowdfund Hormones Matter – Buy an Unsubscription Now

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Hormones Matter is a labor of love, but an unfunded labor of love that needs your help. Hi, I am Chandler Marrs, PhD, founder, editor and chief trouble-maker at Hormones Matter. I want to continue our offerings and provide our community with as many resources as possible. This takes financial and human resources that I simply do not have. So I am offering you, our readers, community members, supporters, friends, family, and fellow health advocates, the opportunity to help crowdfund Hormones Matter.

Crowdfunding with a Twist – The Unsubscription

As with everything we do here at Hormones Matter, this crowdfunding campaign is a little bit different than others. Technically it’s not a crowdfunding campaign at all, because I am not going to offer you any kitschy certificates, t-shirts or other products you don’t need or want. Nope, I will not offer you any of the standard fair associated with traditional crowdfunding campaigns.

What I will offer is the continued health advocacy, science and medical reporting, and the research that you have come to trust, plus the much needed additions to the website that our community desperately needs. I will offer the opportunity to change healthcare dramatically, by giving voice to those with the invisible, difficult to diagnose and seemingly impossible to treat, diseases. And finally, I will offer the opportunity to contribute to a deeper understanding about medication safety and efficacy. If you believe in what we are doing here at Hormones Matter and want to be part of the healthcare solution, help us stay online and help me fund the next steps in our development.

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Yes, you read that correctly, an unsubscription. Why an unsubscription?  Well, I want our reporting, our research, everything we do, to be open to all. The unsubscription model, also called the pay-what-you-can model, allows those who can pay, to pay, and those who can’t afford to pay to still have access to all of the great health and science information we provide. I believe very strongly that one’s ability to access the latest health research should not be contingent on income, and hence, the unsubscription model.

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Well, yes and no. Hormones Matter was formerly an arm of a  B-Corp (for benefit corporation), that I ran for many years as a service to the community. Without the resources to run this type of business endeavor any longer, and in an effort to keep Hormones Matter alive, I have closed the corporation and moved Hormones Matter over to a single entity LLC. What this means is that any money you contribute is not tax deductible, for that I would have to be a not-for-profit enterprise. So while the donation is a contribution to our on-going operations, it is not a donation to a non-profit.  Your financial contribution will help keep Hormones Matter online.

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