A judge in Texas announced that mifepristone, a drug approved by the Food and Drug Administration (FDA) twenty-three years ago, must be taken off the market. The FDA was established nearly a century ago to protect the national food supply and to evaluate drugs for safety and efficacy. The process for evaluating drugs is lengthy, expensive and exhaustive. Pharmaceutical companies routinely spend tens or hundreds of millions of dollars for research and development over the course of several years to gather the information required by the FDA before it can request approval from the agency to sell a drug. With his ruling this Texas judge made all of the time and expense of drug development irrelevant. Every drug that enrages, frightens, or merely confuses the litiginous public may have its availability cancelled and its prescribers punished if this ruling is upheld.
Mifepristone is a hormone antagonist. It blocks the action of progesterone, a hormone produced in abundance during pregnancy. Blocking the effects of progesterone will usually terminate a pregnancy. The judge argued in his ruling that the FDA failed to take into consideration the longterm psychological effects of the medication when it approved it as a safe and effective medication for the termination of pregnancies. It is unlikely that he expected any adult with more than a third grade education to believe this was the actual reason for his ruling. Simply put, he was intent on outlawing abortion in the United States, and this ruling helped advance that objective.
We are outraged when we see women in the streets of Tehran being assaulted by the morality police for not wearing clothing that conforms to the dress code dictated by the ‘religious’ autocrats ruling the country. We are horrified by reports that unmarried women in Afghanistan who have been impregnated by rapists are stoned to death for not providing the two credible witnesses to their rapes as required by law as a defense against charges that they have had illicit sex. But we are comfortable compelling 14 year old girls who have been date-raped to bear the child of their rapist. We are comfortable with a woman who is in the 20th week of her pregnancy and the doctors caring for her facing criminal charges if they decide it is best to end the pregnancy when that woman develops complications that may kill or cripple her.
The people outside the United States making these laws to dictate what women can or must do are invariably men. What is peculiar to the American experience is that many women have voluntarily pushed for the restriction of their rights. Although most photo opps at the signing of bills restricting women’s reproductive rights are cluttered with widely grinning men, rather than women, one cannot deny that there are many women in the ranks of those pushing legislators to sign bills that require their daughters to accept the fruits of incest and that make them provide a nurturing womb for a fetus so encumbered by genetic defects that it is unlikely to survive to term.
For those of us old enough to remember the introduction of safe and effective birth control pills, this is a somewhat familiar scenario. Articulate young women would routinely denounce birth control pills on national programs as somber-faced men serving as moderators would nod in agreement. These women argued that the pills were often lethal and unnecessary if women led more chaste lives. With a solid moral compass, they insisted, women had no need for these hormonal poisons. Gynecologists fearing malpractice suits from patients (or more probably from the husbands of patients) if that patient had an adverse event while on a birth control pill routinely suggested hysterectomies to women who were otherwise healthy but still fertile after having four or five children.
America struggled through the resistance to female autonomy that birth control pills offered and ended up accepting these hormones as a woman’s right. What is different now is that a woman’s right to choose when, with whom, and how often she has a child is being violently opposed. The Roe v. Wade decision is history and, given the youth of the Supreme Court members who voted to kill it, it will not be resurrected this decade or the next. Although a majority of Americans indicate their support for a woman’s right to terminate an unwanted pregnancy, state and federal legislators insist on eliminating safe and effective options available to women. What is even more worrisome than this counterintuitive legislative trend is the change in the social position of women in America that is evolving.
Once again we are labelling the woman who has an unwanted pregnancy as an incompetent or immoral actor, unworthy of society’s trust. This Taliban-type logic concludes that she cannot be trusted to make a wise or moral choice with regards her sexuality or reproduction; therefore, she needs the protective custody of a man to ensure she does not deviate from righteousness. This is nonsense, just as is the Texas judge’s decision to outlaw a drug that expands a woman’s autonomy is nonsense.
There were numerous drugs and poisons used to terminate pregnancies prior to the approval of mifepristone. None was safe and many were not effective, but our friends and neighbors and children will resort to these hazardous chemicals and compounds as safe and effective drugs and procedures for terminating pregnancies become unavailable. Our self-righteous legislators have embraced the notion that the fusion of an egg and a sperm is the dawn of a fully vested human being. This means that fertility clinics which inevitably discard embryos, the natural products of those egg/sperm fusions, must be outlawed and closed in all fifty states. Those who lose frozen embryos because of a power failure will necessarily be charged with negligent homicide. The tens of thousands of embryos ‘on ice’ already must be rescued and implanted in women. ‘Morning after’ pills and intrauterine devices must be banned because they both interfere with the implantation of fertilized eggs (aka, human beings) in the uterus and thereby kill innocent embryos.
If the judgment against mifepristone stands and it is outlawed anywhere in the United States, our system for assessing and approving medications and medical devices will collapse. Any party objecting to an unpopular or controversial pharmacologic agent or medical device can appeal to the Judiciary after the drug or device has been approved by the FDA. Drugs interfering with the transmission of sexually transmitted diseases (STDs) are obvious targets for the ‘morally superior’ minions. Narcan obviously frustrates the judgment of nature in her harvesting of drug abusers. The list of targets for the outraged is endless. The damage to our society’s health and health options is incalculable.
Dr. Lechtenberg is an Easton resident who graduated from Tufts University and Tufts Medical School in Massachusetts and subsequently trained at The Mount Sinai Hospital and Columbia-Presbyterian Medical Center in Manhattan. He worked as a neurologist at several New York Hospitals, including Kings County and The Long Island College Hospital, while maintaining a private practice, teaching at SUNY Downstate Medical School, and publishing 15 books on a variety of medical topics. He worked in drug development in the USA, as well as in England, Germany, and France.
