Analysis

‘No adverse outcomes’ of hormonal contraception use? Not so fast, says expert panel

birth control

A recent article published in JAMA Network Open, a monthly open-access journal of the American Medical Association, claimed that based on a review of 58 meta-analyses, hormonal contraceptive use was found to have “no adverse outcomes” for women. According to the Key Points tab on the first page (emphasis added), “In this umbrella review of 58 meta-analyses of randomized clinical trials and cohort studies describing 156 associations between hormonal contraceptive use and adverse health outcomes among women, no associations with adverse outcomes, including cardiovascular and cancer risk, were supported by high-quality evidence.”

But most women, at a minimum, already know that use of hormonal contraception leads to increased risk for potentially fatal blood clots and depression, just to name two among a myriad of established side effects.

On February 25, mindful that as host Grace Stark commented, “these studies have a very significant impact on how people view these very powerful drugs,” Natural Womanhood hosted a live roundtable discussion with three women’s health experts to explore the truth behind the “no adverse outcomes” claim.

The experts were researcher Dr. Joel Brind, Ph.D, researcher Dr. Bill Williams, MD, and Dr. Kathleen Raviele, a retired board-certified OB/GYN with 30 years of experience. They outlined problems such as use of misleading language plus creation of a brand-new classification system for what research counts as “statistically significant” that invalidate the study’s “no adverse outcomes” conclusion.

Misleading language from the start

Dr. Brind first addressed the misleading title, “Association of Hormonal Contraceptive Use With Adverse Health Outcomes: An Umbrella Review of Meta-analyses of Randomized Clinical Trials and Cohort Studies.” The title would appear to suggest that all forms of hormonal contraception were studied, including oral contraceptives (the Pill), the patch, the vaginal ring, progestin-only pills, and progestin-only implants.

Dr. Brind pointed out as well that the article’s own words reveal the hypocrisy of the title. The article stated, “When drawing conclusions about clinical practice from the findings of this umbrella review, it is necessary to be mindful that progestin-only methods i.e. progesterone only tablets, Depo-hydroxy, DMPA injections, progesterone implants, and levonorgestrel-releasing intrauterine systems are not represented in a clinically meaningful way.

Brind said that in contrast, the title should have specified that the umbrella analysis only applied to research on combined estrogen-progestin oral contraceptives (the Pill).

A Brand-New Definition of “Statistically Significant”

An umbrella analysis is actually a study of studies of studies. A research study examines, say, a particular group of women and whether they experienced side effects from a particular type of hormonal birth control (such as the vaginal ring) over a certain period of time. A meta-analysis looks at multiple studies on this topic, and then an umbrella analysis looks at all relevant meta-analyses that have been done on the topic or series of topics.

The JAMA umbrella analysis redefined the terms of what counts as statistically significant. Previously, a side effect would be considered “statistically significant” if researchers in the study were 95% or more certain that that side effect’s occurrence was real, not just random or due to chance. But the JAMA study didn’t examine study results in terms of being statistically significant or, conversely, not statistically significant.

READ: New study finds hormonal contraceptives affect ‘brain structure and function’

Instead, the study authors arbitrarily created a whole new five-tier classification system to achieve their result of “no adverse outcomes.” The new tiers are Convincing, Highly Suggestive, Suggestive, Weak, and Non-significant, which Dr. Brind compared to an A,B,C,D,F grading scale like students receive on homework. Results recognized as “statistically significant” (representing a confidence level of 95%) in any other area of medical research would only get a “Weak” designation, equivalent to a D grade. In order to receive even a Highly Suggestive (B grade), results would have to have a confidence level of 99.999%.

Since none of the evidence for hormonal contraceptive side effects reviewed by the JAMA study authors achieved 99.999% certainty, they concluded that there were “no adverse outcomes.”

Study Ignores Known Risks of Hormonal Birth Control

Dr. Bill Williams, lead author of a Natural Womanhood petition (summarized simply here) requesting the FDA update hormonal contraceptive packaging to reflect all of the known associated risks, pointed out that far from being given to sick people to make them well, hormonal birth control is given to healthy women and can potentially cause harm.

He stated, “with hormonal contraception, you’re taking normal women and giving them potent steroid hormones… and so, their safety profile has to be as clean as a whistle… for it to even be ethical to prescribe them.” Instead, he said, hormonal contraceptive use leads to increased risk of “breast cancer, cervical cancer, Crohn’s disease, ulcerative colitis, systemic Lupus… and depression.” Further, “the progestin-only [contraceptives] cause osteoporosis risk and they admit that in the prescribing information. But the evidence is now clear that it’s not just softening the bone as in osteoporosis, but actual fractures increase.”

The labeling for hormonal contraceptives already acknowledges the increased risk for heart attacks and strokes. Still, the JAMA study downplayed even these known, widely acknowledged risks.

Even when you subtract out the slight protective effects from hypothyroidism, uterine cancer, ovarian cancer observed in hormonal contraceptive users, Dr. Williams said, “You still end up with a million excess cases in the population of all these different diseases out there [connected to hormonal contraceptive use].”

Downplaying Risks Hurts Real Women 

After 17 years of prescribing hormonal contraception, Dr. Kathleen Raviele stopped after observing the negative effects on patient after patient. She observed that methodologically flawed studies like the JAMA study have real world negative impacts because, she believes, “the purpose of this study is really just to keep doctors in lock-step and believing that it’s okay to keep prescribing birth control pills for younger women and older women, and to ignore what they’re seeing actually in real life in their patients.”

This disconnect between what doctors see and what they read in the literature can lead them to downplay or dismiss the adverse reactions their patients are experiencing.

Dr. Raviele estimated that fully one-third of an OB/GYN or family practice doctor’s day is spent managing common adverse reactions to the Pill like abnormal bleeding, migraines, and abnormal mammograms. She shared, “What many people don’t realize is that almost 45% of women stop taking birth control pills in a year. They have a lot of adverse reactions that cause them to stop taking the Pill.”

She further said that the JAMA study is in conflict with the World Health Organization’s classification of combined oral contraceptives like the Pill as a class 1 carcinogen, in the same category as asbestos.

Unfortunately, Dr. Raviele added, much of the research on adverse reactions, particularly life-threatening ones, doesn’t make it into the hands of OB/GYNs because it’s not in the OB/GYN literature they’re reading and familiar with. Instead, increased blood clot risk (March is Deep Vein Thrombosis Awareness Month), for instance, shows up in the literature for other medical specialties like Hematology, Pulmonary, or Cardiology.

Hormonal contraceptives have real adverse outcomes. Fortunately, women have other, safe, reliable options for family planning as well as treatment of reproductive issues that don’t compromise or further compromise their health.

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