Recently the FDA approved over-the-counter use of the Plan B pill for women of all ages. Secretary Sibelius disagreed and limited it to women over 18. (More)
This issue has become highly politicized as an element of women’s reproductive rights. And while the FDA says the drug is safe for women 14-16, it is relevant to consider that the only reported study had a sample set of just 50 girls age 14-18, a very small sample set by any statistical measure. Nor can the study reveal long term-effects on the developing female body.
All of us have certainly seen the rising number of lawsuits over drugs that were released to market and within a few years have been proven to cause death and disability among those who take them. I, for example, was on Byetta for about 18 months before I could no longer afford it. Two years later lawsuits began because the drug was shown to cause liver failure in long-term users.
Fifty-four years ago my mother was given Diethylstilbestrol (DES) to stop premature labor. This had been a common practice since the late 1930s. Twenty-five years later she had to advise my sister that since she had been given DES, my sister was now facing an inflated risk of cancer, something not realized until the drug had been used for over 50 years.
Some of us are still old enough to remember when we were advised not to give OTC cold medicines to children under two. For decades before that we were led to believe such remedies were safe, as dosing for children was right there on the label. Uh-oh, not so.
Sample sets of youngsters are always small, even when they are tested, and risks are insufficiently evaluated until trouble occurs. It took generations to discover that treating a child’s fever with aspirin could result in Reye’s Syndrome.
It’s important to note that the FDA no longer has enough scientists to adequately review drug company clinical trials for errors and discrepancies. Many drugs are making it to market based solely on a drug company’s clinical trials without adequate review by independent scientists. A study in 2006 highlighted the problems at that time:
In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed a 38-question survey to 5,918 FDA scientists to examine the state of science at the FDA. The results paint a picture of a troubled agency: hundreds of scientists reported significant interference with the FDA’s scientific work, compromising the agency’s ability to fulfill its mission of protecting public health and safety.
The National Academies Weigh In
In September 2006, the National Academies Institute of Medicine released a report critical of the FDA and its ability to protect the public from unsafe drugs. In a section discussing the poor handling of scientific disagreement, the report mentioned the UCS survey result indicating that hundreds of agency scientists had been pressured to approve a drug despite reservations about safety.
Additionally, the same article notes:
“Scientific discourse is strongly discouraged when it may jeopardize an approval…. Whenever safety or efficacy concerns are raised on scientific grounds … these concerns are not taken seriously.”
“First class scientists are leaving the FDA, and recruiting new ones will be very difficult.”
— selected FDA survey essay responses
Returning to its Scientific Mission
The FDA mission statement calls for “helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” Unfortunately, scientists at the agency are concerned that science no longer plays this crucial role in the FDA’s regulatory decisions.
I am not arguing against contraception for young women. But I do think we need to take a step back from the politics and ask ourselves just how much risk we want to take with the youngest of our women.
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