Let's get the conversation started about the dangers of hormonal contraceptives.
Ever since the debate began over the Affordable Care Act’s contraceptive mandate, public commentaries have focused on how badly women “need” free contraceptives on one hand and how the mandate violates the religious freedom of objecting organizations on the other.
It’s time we discussed the miserable, dangerous and even lethal side effects of popular contraceptives. Rather than bringing “freedom” to women by disabling their healthy, normal-functioning reproductive systems, too often they result in disabling far more than reproductive systems.
People naturally assume that any drug or vaccine approved by the federal Food and Drug Administration (FDA) has been found safe, or at least that its benefits in preventing or curing a disease or condition vastly outweigh any health risks to the patient. Of course, we know that some drugs are later pulled from the market after cases of life-threatening and fatal side effects have accumulated.
Former FDA Commissioner David Kessler, MD suggested several factors that could explain why dangerous drugs and devices get approved and remain on market while patients are dying from side effects.
First, he noted, even large-scale clinical trials can fail to detect serious adverse events that may occur at a rate of 1 in 5,000 or 1 in 10,000.
Second, physicians often fail to attribute a patient’s health problems to the drug they are taking because they have little exposure to pharmacology in medical school.
Third, there is no “culture” in U.S. medical practice of reporting drug side effects to the FDA or to the manufacturer. As a result, only about one percent of drug- or device-related adverse events are reported to the FDA, according to a study Dr. Kessler cites. For these reasons, the magnitude of the dangers are not recognized early enough to prevent fatalities and near-fatalities.
Some commentators have also suggested that in recent decades, top FDA employees may be particularly “friendly” to pharmaceutical interests, and employees who raise safety concerns are pressured to approve a drug anyway. Some of those involved in approvals had recently joined the FDA, coming from the very manufacturers of the drugs/vaccines under review. Others, like Dr. Julie Gerberding, for example, who headed the Centers for Disease Control and Prevention (CDC) from 2002-2009 when Gardasil was fast-tracked and approved and when she later was in charge of adverse event oversight, became President of Merck Vaccines (including the cash cow Gardasil) in 2010.
To open the conversation on contraceptive drug safety, I’d like to mention just four of the highly touted contraceptive drug/device innovations approved since 2000 that have turned out to be miserable, dangerous and/or lethal for the girls and women who have used them.
Yaz/Yasmin, two of Bayer Pharmaceutical’s combined oral contraceptives, were introduced in 2006. The type of progestin used in Yaz and Yasmin, drospirenone, has been found in five large studies to significantly increase the risks of venous thromboembolism (VTE) or blood clots, that can lead to stroke, heart attack or pulmonary embolism.
A 2009 study by A. Vlieg et al. in the “British Medical Journal” (BMJ) reported that (1) combined oral contraceptives with 3rd generation progestins increased the risk of VTE fivefold compared to the risk for non-users of COCs, and (2) drospirenone increased such risk by 6.3 times compared to that of non-users.
In the United States alone, there have been about 100 known deaths, almost 12,000 lawsuits on behalf of U.S. patients, now consolidated in Multidistrict litigation in the federal district court (SD-IL).
Ortho Evra Patch
In 2008 “The New York Times” reported that Johnson & Johnson concealed evidence that its Ortho Evra birth control patch delivers a level of estrogen far higher than allowed by the FDA. Introduced in 2002, the patch delivered 60% more estrogen than COCs, increasing the risk of VTE by three times. There have been over 40 known deaths (50 were then reported to FDA) and over 3,000 lawsuits have been filed. Some lawsuits, as of 2008, were settled for $68 million. A 2012 product information site now offers a fair picture of its dangers.
It is alleged that “the company knew that users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than Pill takers. Further, NBC revealed, a vice president of research at J&J, Dr. Patrick Caubel, had quit over frustration that the company ignored his data showing elevated levels of complications and mortality associated with the patch.”
A 2001-2010 study in BMJ by O. Lidegaard et al., published in BMJ in 2012, reported that the relative risk of confirmed venous thrombosis in users of Ortho Evra is 7.9 compared to non-users of hormonal contraception and 2.3 compared to users of 2nd generation COCs.
The same Lidegaard study found that users of Merck’s NuvaRing were at a 6.5 greater relative risk for VTE compared to non-users of hormonal contraception and twice that of women using a 2nd generation COCs.
NuvaRing was introduced in 2001 and since then enjoyed global sales of $3 billion. Merck settled some 1,700 U.S. lawsuits for $100 million in early 2014.
Mirena is a progestin-only intrauterine device (IUD). Since 2000, more than 70,000 adverse events have been filed with the FDA involving Mirena IUD problems, including at least 5,000 cases involving women who complained that Mirena moved out of place since 2008, and 1,322 reports where the Mirena IUD punctured the uterus. Over 2,000 lawsuits have been filed nationwide, of which 600 were consolidated in federal Multidistrict litigation in the Southern District of New York. The trial is scheduled for March 2016.
Even if these risks may be called "relatively rare" given the total number of users, every stroke, every heart attack, every death was completely unnecessary. The excess hormones provided no benefit to users beyond what they could have safely enjoyed through the use of the modern methods of natural family planning.
Susan E. Wills is spirituality editor of Aleteia’s English-language edition.