#51

DECEIT BEHIND THE US FDA`S FAST-TRACKING OF RU 486

One of the dark deeds of the Clinton/Gore years - perhaps their most sinister from a woman`s health standpoint - was the devious fast-tracking of RU 486, the experimental drug designed to flush a woman`s womb of its developing baby. With the toppling of America`s first abortion president, a man fiercely dedicated to enshrining the procedure in all its most barbaric forms, ugly details are now surfacing concerning the Clinton administration`s politicizing and corruption of the federal Food and Drug Administration - a body created to ensure the health protection of trusting U.S. citizens. And these details make for pretty ugly revelations on the part of a government whose policies on women were dictated by the fiercely pro-abortion National Abortion Rights League, National Organization of Women, and Planned Parenthood of America - the world`s largest private provider of abortion.

On February 6, 2001, Congress introduced the "RU-486 Patient Health and Safety Act" - legislation meant to codify and strengthen the FDA's patient protections for women who take RU-486. Under the proposed law, prescribing physicians must, among other things, be "qualified to handle complications of an incomplete abortion, be legally empowered to perform an abortion and trained to do so, and be properly trained in the administration of this drug. This should really come as a great surprise to most Americans who must all be asking themselves why women are presently being offered a fast-tracked drug without the benefits of the above obviously important directives.

Why are some experimental drugs fast-tracked, that is, put under an accelerated drug-approval process? Until the advent of RU 486, it was solely to provide new, safe and effective treatments for serious or life-threatening illnesses such as HIV, AIDS and cancer. Even the most hardened pro-abortion champions should find it difficult to argue that a drug with inherent serious side effects, mainly meant to give women more "choices," should fall under the fast-track rule.

RU 486 was approved for marketing under a special section of the FDA`s accelerated drug-approval process, referred to as the "Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses." Note the exclusive ‘life-threatening’ requirement which precludes any other rationalization for short-circuiting the licensing of important drugs. The FDA condition for fast-tracking approval hinges solely on whether a drug is safe and effective "in treating serious or life-threatening illnesses" and, in addition, whether it will "provide meaningful therapeutic benefits to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy)."

How could anyone, but masters in the art of bafflegab, invoke justification for the special treatment received by pushers of RU 486? It takes a heavily politicized and morally inert body to do so. Unsurprisingly, the Clinton-nominated cadres of the FDA met this criterion to perfection. In a memo to the company seeking registration of the abortive drug, the FDA makes the outlandish claim that RU 486 should qualify under the requirements of treating a life-threatening illness and providing meaningful therapeutic benefits over existing treatments because "the termination of an unwanted pregnancy is a serious condition," adding that "the meaningful therapeutic benefit over existing surgical abortion is the avoidance of surgical procedure."

This bizarre explanation should be kept in proper perspective. First, only a very small group of drugs, numbering 30 at most, had ever been fast-tracked before RU 486 was submitted to the process. Of these, half were for the emergency treatment of AIDS and HIV. The others were for cancer, tuberculosis, leprosy and other similar appalling chronic diseases. It takes an unimaginable leap of imagination to classify a healthy pregnancy as a disease or chronic illness. But who knows what words really mean nowadays? In the hands of the pro-abortion Clintonites, they certainly took on a life of their own as the actions of the FDA showed in granting RU 486 exceptional treatment.

Resorting to the wildest of rhetoric one can imagine, the FDA unabashedly defined the "meaningful therapeutic benefit" of RU-486 as "the avoidance of a surgical procedure." However, this was in direct contradiction of its own previous medical findings published in late 1999. Trials in Cuba, India and China, had shown that abortions from RU 486 caused "more adverse events, particularly bleeding, than did surgical abortion." In addition, the abortion pill was responsible for a much higher incidence of severe cramping, nausea and vomiting. Similar results were also replicated in a 1999 US study.

Unfazed by these glaring contradictions, the FDA shamelessly ignored its own research indicating that the use of RU 486 may lead to possibly disastrous, even deadly effects. Against all reason, it maintained having met its own strict standards in demonstrating that this human pesticide has therapeutic benefits that vastly exceed those under current surgical abortions.

A second and final consideration with respect to RU 486 is the off-label use of one of its two ingredients, Cytotec. This drug is produced by Searle, a company recognized as a world-leading producer of pharmaceuticals. It is labeled solely for ulcer treatment and strongly contraindicated for pregnant women. Any women aware of the possible devastating effects of Cytotec during pregnancy - including maternal or fetal mortality, prolonged vaginal bleeding, pelvic pain, rupture of the uterus, etc. - would certainly think twice after balancing the perceived advantages of an RU 486 abortion over the surgical kind. From where I sit, just one of these complications seems like a terribly high price to pay in order to obtain what proponents of this week-long appalling procedure deceptively promote as a less invasive form of abortion.

Let`s hope for a quick passage of Congress` "RU-486 Patient Health and Safety Act." The exacting requirements it proposes could have the ultimate effect of making further prescription of the drug by abortionists a thing of the past. The fallout from this would likely reverberate throughout the world and probably make Canada and other RU 486 promoters scrap its unethically based promotion.

Thaddée Renault

New Brunswick Canada


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