Forty years ago, on September 4, 1969, the Food and Drug Administration (FDA) declared the new birth control pill to be “safe” for use by women to regulate births.
Forty years later, the true safety of oral contraception is still in question.
In 1951, steroid biologist Dr. Gregory Goodwin Pincus of the Worcester Foundation for Experimental Biology in Shrewsbury, Massachusetts, and Dr. John Rock, a clinical professor of gynecology at Harvard Medical School, took on the assignment of developing an oral contraceptive pill with a $40,000 grant from Planned Parenthood.
Because it was already known that fertility could be controlled led by hormones, it took Pincus only a year to determine that progesterone did indeed work as an anti-ovulent in rabbits and rats. By 1956, drug maker G.D. Searle and Company, developed Enovid, the first birth control pill. But in order for the new drug to be approved by the FDA, it had to be tested on humans.
Serious health problems arose almost immediately during the testing phase. While the pill successfully prevented ovulation, it also caused blood clots and strokes. Eleven deaths were reported but Searle maintained that there was no conclusive evidence that the Pill caused those deaths.
In spite of evidence to the contrary, Searle managed to convince the FDA that the drug was safe. In a May 11, 1960 memo, the FDA agreed, saying it based its conclusion on tests of 897 women who had used the Pill. However, the memo also admits that only 132 of those women were actually tested, some after only a year of use.
On the basis of 132 of 897 women who used the Pill for a relatively short period of time, a powerful oral steroid unique in the history of medicine was pronounced safe and beneficial for all women of childbearing age.
Reports of serious medical complications such as thromboembolism (TE) began to come from England, including a number of fatal cases. In December of 1961, it was discovered that the FDA had investigated the deaths of two Los Angeles women, and was investigating six other deaths.
The company continued to claim that “there is no evidence to suggest this causal relationship . . . between Enovid therapy and the development of thromboembolism.”
During that same year, the FDA was actively investigating 350 cases of TE and deaths associated with Enovid and concluded that death from TE did indeed increase for Enovid users over the age of 35.
Public anxiety rose, and the FDA decided to handle it by endorsing a new study. But instead of assigning it to disinterested scientists, it was given to Searle and Planned Parenthood – the two principal promoters of the pill. Naturally, they concluded that their pill was safe. Their study omitted any deaths occurring in women before 24 months of use even though the vast majority of deaths were known to occur within the first six months of use.
In 1966, the FDA formed an Advisory Committee on Obstetrics and Gynecology which also declared the pill to be safe. Of the thirteen committee members and consultants that formed the group, four were directly associated with Planned Parenthood, which was, by now enjoying tremendous profits from the sale of the pill.
The situation reached a peak in the 1970’s when congressional hearings chaired by Senator Gaylord Nelson (D-WI) were convened to address safety concerns. During these hearings, Sen. Nelson said that the literature being supplied to women on the pill “is inaccurate. It is misleading 8,500,000 women in this country and it has been doing it for ten years.”
The Couple to Couple League reports that as of the early 1990’s, there were 13.8 million women in the U.S. on the pill and 60 million worldwide (conservative numbers). There are 7.9 pill-related deaths per 100,000 women ages 15-44, which results in more than 1,000 deaths a year in the U.S. alone.
A recent study by researchers at the Leiden University Medical Center in the Netherlands and published in the August 13, 2009 issue of the British Medical Journal, found that some of the original safety concerns about the pill remain to this day.
In this study, researchers analyzed 26 different oral contraceptives in use by 3,000 women and determined that the pill can increase the risk of suffering a clot known as a deep vein thrombosis (DVT) in the leg or lungs up to fivefold.
The study found that “second generation” pills first used in the 1970s, which contained low levels of estrogen combined with a second hormone levonorgestrel, were the safest.
Newer “third generation” pills, which have been available since the 1980s, which contained a hormone called desogestrel, carried twice the risk of DVT than the second generation medication.
Norplant, an injectable contraceptive that remains in the body for five years, was pulled off the market in 2002 for causing many problems such as ovarian cysts, hair loss and dangerous blood clots. Tens of thousands of lawsuits were filed against American Home Products, the manufacturer, but the company insists they did nothing wrong.
Studies released in 2004 regarding Depo Privera, another injectable version of the pill, found that many women who used this form of birth control suffer a serious loss of bone density which leads to osteoporosis. This loss of bone density appears to be permanent and does not return to normal after discontinued use.
Pills such as Mircette and Orth Tri-Cyclen, which contain a compound called desogestrel, are also the target of class action lawsuits from women who suffered blood clots with girls as young as 16 having died from their use
The Ortho Evra patch, which delivers the same hormones as the pill through a patch worn on the skin, has also proven deadly. Introduced in 2002, it caused 17 deaths and dozens of adverse reactions in women in just the first two years after its introduction. It remains on the market.
Yasmin or “Yaz”, designed for women who have trouble with pill side effects, contains a synthetic progestin known as drospirenone. According to a lawsuit recently filed against Bayer, the manufacturer, more than 50 women died after taking the drug in the four years since it was introduced, some as young as 17 years old.
The FDA also approved emergency contraception, known as Plan B, which contains unusually high doses of the same stroke and blood-clotting hormone found in lower doses of the pill which require a prescription. Not only was it approved, but it is now available over-the-counter without a doctor’s prescription to women age 17 or older.
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.
The Dr. Shezad Malik Law Firm is currently evaluating and accepting Yaz, Yasmin and Ocella Side Effect cases.