New Birth Control Warnings

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birth control warning
The FDA just received a Citizen’s Petition submitted by a group of physicians, scientists, and women’s health advocates regarding side effects caused by hormonal birth control. After a comprehensive review of literature, the petitioners believe there is enough compelling evidence to warrant new and more forceful warnings for all hormonal birth control products. I am humbled to have been invited to collaborate during the final stages of this project.

If approved, new black box warnings would specifically advise women of increased risks associated with breast cancer, cervical cancer, inflammatory bowel disease, systemic lupus erythematosus, venous thrombosis, cardiovascular events, depression, and suicide. The petition also requests that additional information be provided to patients regarding birth control’s link to multiple sclerosis, interstitial cystitis, bone fractures, as well as its effect on body mass. Finally, the petitioners request that Depo Provera be removed from the market “based on conclusive evidence that it facilitates the transmission of HIV from men to women.”

The Consequences of Birth Control

Adjunct Professor of Medicine at the University of Pennsylvania, Deacon William V. Williams M.D. began reviewing contraceptive studies for an article he was going to write for the 50th anniversary of the papal encyclical letter titled, Humanae Vitae. The letter came out in 1968 at a time when the Catholic Church was under enormous pressure to change its teachings on contraceptives. The rest of the world, including other Christian denominations, had embraced birth control. Many anticipated the letter would be Pope Paul VI’s official capitulation. Instead, he boldly explained why the Church would never accept contraception and offered numerous warnings that have proven to be quite prophetic.

As the editor of the Linacre Quarterly, the official, peer-reviewed academic journal of the Catholic Medical Association, Dr. Williams felt a golden-anniversary nod was fitting for this important papal document. Along with some of his colleagues, he began to review scientific literature related to some of the effects of hormonal contraceptives. As the overwhelming evidence began to mount, the group cross-referenced prescribing information for several birth control products and realized many of these side effects weren’t listed – even though there was a pretty large set of peer-reviewed data available.

That’s when the group realized that this called for action beyond the originally planned article. The shocking amount of empirical data being withheld from hormonal contraceptive users represented a serious women’s health issue. They invited others to collaborate and decided a petition to the FDA was in order.

Double Standards

Kathleen Raviele, M.D., an Atlanta-area Ob/Gyn was on the team that assembled the petition. She points out that drugs with fewer risks, such as Vioxx, have been removed from the market because they affected both men and women. She says, “Women deserve respect and certainly deserve to know the risks they are exposed to with going on any hormonal contraceptive. An article in Vanity Fair in February 2014 detailed three women who lost their lives or nearly so using the NuvaRing and this should have prompted a recall of the product, but instead the company continues to tout it as: ‘The birth control ring (AKA NuvaRing) is a safe, simple, and affordable birth control method that you wear inside your vagina.’”

However, she adds that the blame doesn’t just lie at the feet of the drug companies. She explains, “Providing contraception represents one-third of an Ob-Gyn’s practice, and in the back of their minds they think this will hurt the number of patients coming to see them. However, even for medical problems often treated with hormonal contraceptives, there is always a better, safer way to manage the problem that gets to the cause rather than acting as a cover-up.”

Mrs. Information

Aside from asking the FDA to include new warnings, the petition also requests that current warnings be modified for clarity. For example, there is significant evidence dating back to the late 1960s that suggests hormonal birth control contributes to a higher risk of stroke and heart attack for any woman taking it. That already elevated risk rises even higher for women who are over 35 and smoke.

The warning on some formulations currently reads, “WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS.” In fact, the warnings in many formulations are worded in a way that renders them completely ineffective. An argument is made in the petition that, “This is misleading and has shown to be misinterpreted by many women who infer that the increased risk only occurs with cigarette smoking and/or with being over 35 years of age.”

The petition also contends that it should be required that these warnings be included in all direct-to-consumer advertising.

Was It Really Consensual?

Despite the misleading and missing information withheld from the current patient information pamphlets, there are still a lot of unsavory side effects that are listed. However, with the complicated text printed in an unreadable, tiny font, it isn’t surprising that so few women know what they’re getting into when they start taking birth control. What is surprising is how few doctors seem to recognize the dangers. Many still proclaim that the benefits outweigh the risks.

Speaking to this apparent disconnect, Dr. Williams said, “Doctors who say the benefits of hormonal birth control still outweigh the risks are victims of the groupthink mentality in the medical profession right now. It goes something like this – people are going to have sex, and because they are going to have sex, we need to make sure they don’t suffer the consequences. Therefore, we need to prescribe The Pill to prevent pregnancy. That’s just the way doctors are trained to think. They’re not trained to think that in front of me is an individual who can make their own choices for better or for worse, who has a free will, and who, rightly informed, can make the right choices.”

The mentality Dr. Williams describes in today’s medical industry sounds eerily similar to Plato’s description of doctors of slaves versus the doctor of free people. The slave’s doctor visits the patient in a hurry with a lack of compassion. He “neither gives a servant any rational account of his complaint, nor asks him for any; he gives an order based on empirical belief with the air of exact knowledge, in the insolent manner of a tyrant, then jumps off to the next ailing servant.”

Ultimately, the goal of this petition is to pave the way to a better conversation – one more akin to what should be expected as free people. Plato described this approach as the doctor entering into a discourse with the patient. Through this discourse, the doctor is at once gathering information and instructing the patient to make the best choices for his/her health.

Putting the goal of the petition in its simplest terms, Dr. Williams explained, “We’re trying to make sure that when patients give informed consent to use this stuff that it’s actually informed. It’s not just consent.”

Weighing Outcomes

For her part, Dr. Raviele doesn’t have much faith that this scholarly petition will be taken seriously by the FDA. However, she does see another way it could ultimately serve its purpose. She described what she sees as the more practical possibility, “What this petition may do is give lawyers more ammunition for suing the drug companies over the harmful effects of these hormones on women and girls. These companies will not take them off the market voluntarily. It will only be through multiple lawsuits.”

To read the petition, click here.

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