By Tim Millea, MD
Catholic Health Care Today
The Food and Drug Administration (FDA) was established 116 years ago. Since then, it has grown to 18,000 employees and a $6.5 billion dollar budget. Its mission is the protection of “public health by ensuring the safety, efficacy, and security” of medications, medical devices, food and other products. The FDA is the final arbiter to determine whether a drug should require a prescription or can be purchased over the counter (OTC). The agency’s actions and decisions have historically been deliberate and thorough, which has helped ensure safety for Americans. Unfortunately, that reputation is endangered.
On May 10, an FDA advisory panel recommended the approval of a contraceptive that can be obtained without a prescription. The drug, known as Opill, is classified as a progestin-only contraceptive, in contrast to the more common combination drugs that contain both progesterone and estrogen. The advisory panel reviewed data provided by the manufacturer, leading to the opinion that the benefits of OTC availability outweighed the risks.
However, independent studies done over the past two decades make this decision questionable at best. The most significant risk with two-drug combination contraceptives is blood clots. Fortunately, that risk is not as significant with progestin-only medications like Opill. Unfortunately, other worrisome adverse effects have been identified. In March of this year, a study from Oxford (U.K.) and Adelaide, Australia, reported a 20-30% increase in breast cancer in women using progestin-only contraceptives. Even the federal government’s own National Cancer Institute confirms a 24% increase in breast cancer risk, as well as an increased risk of cervical cancer as high as 60% with more than five years of use. These reports support the World Health Organization’s designation of hormonal contraceptives as “Class 1 carcinogens,” among the highest level of cancer risk.
Studies from Denmark are very concerning for non-gynecologic problems as well. In 2017, Danish researchers reported a decade-long study of nearly a half-million women with no history of mental health problems. With contraceptive use, the incidence of suicide attempts nearly doubled and the rate of completed suicide more than tripled. It is tragic to note that the highest risk was seen in adolescent females. Further caution relates to a 2014 Danish study that identified a two- to four-fold increase in gliomas, a malignant brain tumor, in women using progestin-only contraceptives.
There is also a recognized increased risk of HIV transmission with hormonal contraceptives. A study published in the highly regarded British journal, Lancet, in 2011, reported that the risk of contracting HIV doubled in previously HIV-negative women taking these drugs. The effects of the contraceptive medication appear to lessen the ability of the woman’s immune system to protect her from infection.
If the FDA ultimately approves Opill over the counter this summer, the negative societal effects will become evident quickly. Adolescents will be able to purchase it without either a prescription or parental knowledge. In addition, without a prescription, medical evaluation will not be required. This eliminates the important and potentially life-saving screenings for women, leading to delayed and missed diagnoses of gynecologic cancers and sexually transmitted infections. Ironically, even the American College of Obstetricians and Gynecologists (ACOG) website recommends that “adolescents need special attention at every visit for contraceptive services.” It is quite justifiable to question why the ACOG publicly supports OTC Opill access, a direct contradiction to its statement.
Of great concern is the exploitation of this OTC availability by sex traffickers. The women who are under the control of traffickers often have an opportunity to escape from their situation when they seek medical care. Clinics and emergency departments are trained to identify victims of human trafficking. Tragically, if no medical evaluation is needed to obtain contraceptives, those opportunities will be lost and more women will remain victims.
The final decision by the FDA on this potential OTC availability is expected sometime this summer. In light of the scientific evidence of multiple associated harms, approval would significantly jeopardize the agency’s credibility. The FDA is already under scrutiny for recent announcements that allow chemical abortion pills to be dispensed in retail pharmacies and is also being sued by multiple medical organizations charging that the approval process for these drugs has been inadequate and misguided.
If OTC contraceptives become available, it will not be a victory for women’s health nor for our society. There will be an increase in many dangerous medical conditions that afflict women and lives will be lost. Such a decision would be one of convenience and not one of reason supported by science. America’s women deserve a decision by the FDA that is committed to their best interests.
(Dr. Tim Millea is president of the St. Thomas Aquinas Medical Guild and a member of St. Paul the Apostle Parish in Davenport.)
Excellent summary of the issue. My only issue is that I believe we, if we want to make headway in pro-life arguments, need to be more specific in our language. Most current birth control options are not technically “contra+ceptive” – they don’t prevent conception, they prevent uterine implantation of a fertilized egg.