The Daily Beast says an over-the-counter-pill isn’t safe. Science says they’re wrong.

The Daily Beast has published what I can only describe as a hack job on the quest of the oral contraceptive pill (OCP) to go over-the-counter OTC). The piece opines that it isn’t safe for women to take OCPs without a prescription from a doctor and intimates that a lot of women are at risk for blood clots.

The reporter, Sarah Watts, doesn’t quote any published research on OCPs going OTC although there is plenty, after all the idea has been kicking around for 20-25 years and has stalled due to politics not medicine. Instead, the article rests heavily on the opinion of Dr. Poppy Daniels, an OB/GYN in Springfield, MO (who hasn’t published any work on the birth control pill that I can find in PubMed), and the views of Holly Grigg-Spall, a woman who tried four or five different pills and then wrote a book about how the pill is really a tool of the patriarchy, addictive, and we should all just be able to work when our cycle says we are most productive. I think. I found her arguments poorly constructed and difficult to follow and felt the medical information, such as it was, was grossly mishandled. If you want to know more about her book read this review from Slate that calls it, “poorly researched, shoddily argued, and fundamentally incoherent.” 

However, unlike the reporter for the Daily Beast I know how to contact published experts in the field, search PubMed, and read articles and consensus opinions so let’s take down the piece point by point.

Problem #1: The assertion that blood clotting disorders are extremely common, thus the pill is very dangerous for many women

According to Dr. Daniels, “blood-clotting disorders are extremely common, and are typically related to a gene mutation that affects an estimated forty percent of the population.”

The link goes to a Daily Beast piece on the MTHFR mutation. The geneticist I spoke with (so an expert in the area) says an MTHFR mutation affects 25% of the population not 40% and is almost never associated with clotting issues.

There actually isn’t one mutation, but many and you have to inherit the specific mutations that cause homocystinuria to be at increased risk for clots. Homocystinuria affects 1/200,000 people in the United States (a far cry from 40%) and is included in the newborn screening tests (the heel stick).

According to the genetics home reference library the link between clotting disorders or high blood pressure and MTHFR is controversial and it remains “unclear what role changes in the MTHFR gene play in these disorders.” 

According to Dr. Daniel Grossman MD, one of the leading experts in the field, if 100,000 women use the pill (one of the older pills or what we call 2nd generation pills) for a year 12.5 will have a clot. So if 40% of women were truly at high risk for clotting on the pill, considering how many women actually take the pill we would have known years ago – basically that number would be a lot higher than 12.5.

Problem #2 – The idea that women need special screening for the pill, screening that only a doctor can do

Dr. Daniels only prescribes “hormonal contraception—including the pill, the patch, or the NuvaRing—after she has carefully evaluated the risks for each patient, including a rundown of the patient’s family history for blood clots, strokes, and heart attacks.”

Science tells us that she is wrong and if the Daily Beast wanted to be accurate they would have told their readers that flipping a coin is about as good as asking about risk based on family history.  A meta-analysis from 2012 looked that this very question.  I read the article when it came out, but here’s a tidy summary from the abstract:

Obtaining a family history of venous thromboembolism before starting combined oral contraceptives is not a valid means to detect a woman’s risk of thrombophilia. Even in high-prevalence populations, in which the positive predictive value is increased, a positive family history of venous thromboembolism was no better than flipping a coin in predicting thrombophilia.

I even spoke with the lead author personally, Dr. David Grimes, to confirm this. He has written 42 articles on the oral contraceptive pill so he’s got this covered.

Dr. Grossman agreed that the only screening needed is “measuring blood pressure and asking about personal medical history.” Grossman also wrote to me that “having a family history of someone having a deep venous thrombosis is not a contraindication.”

Problem #3 The idea OTC medications are much safer than the pill

According to Dr. Daniels “To put [hormonal contraception] on the same aisle as Tylenol and Zantac is absurd.”

Acetaminophen and many OTC medications can be quite toxic if used incorrectly. In the UK the amount of acetaminophen one can buy in a pack is severely  limited for one reason –safety. It kills people and causes liver failure much more often than you think.  If women can be trusted to take Tylenol or Advil or Aspirin in the United States they can be trusted to take the pill.

The safety of over the counter OCPs have been well-researched, which is why the American Congress of OB/GYN supports a OTC move. The cause has been championed by organizations aiming to improve reproductive health through research. This isn’t a decision taken lightly, but rather a well-researched one.

Problem #4: Quoting a non expert on screening for clotting and the pill

The Daily Beast quotes Ms. Grigg-Spall thusly, “In a perfect world, women would be screened for blood-clotting disorders. They would know their medical history.” 

Science disagrees. Researchers have looked at this very thing and screening women for clotting disorders is not currently recommended. Factor V Leiden mutation, which affects 3-8% of the population, is the clotting disorder most people are talking about when it comes to potential risk and the pill, but it’s not as simple as the Daily Beast or Grigg-Spall would have you believe. Just because you have the mutation doesn’t mean you’ll get a blood clot. This is what the American College of Medical Genetics has to say:

Routine screening for factor V Leiden in asymptomatic women contemplating or using oral contraceptives is not recommended, except for those with a personal history of thromboembolism or other medical risk factors.

(The American College of Medical Genetics being the experts).

Hey Daily Beast, why the fear mongering?

Confirmation bias? Slow day in the news room? A press release from Ricky Lake’s new movie burning a hole in your in box?

There is no medical controversy about OCPs going OTC. At all. All you need is a blood pressure check and a check list for some specific medical contraindications (like you find on many medications you can buy over the counter).

Want to know if you can safely take the pill? Download this free app from the CDC and you can search by condition and method of contraception. If you are over 35 and smoke, you can’t take the pill with estrogen. When it comes to the birth control pill without estrogen (the progestin only pill) there is essentially no contraindication at all.

The Daily Beast should retract this piece. It is devoid of science and it is the very definition of patriarchy to suggest that a woman can’t read a package insert and get her blood pressure checked at a pharmacy before picking up her pills.

   

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Due to the high number of personal attacks I would like to restate my commenting policy.  Don’t make personal attacks. Really. If you want to counter the science with links to research, please do so. If you want to express your opinion, please do so. If you want to comment on what I wrote, fine. But personal attacks will not be approved.