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candystripper -> 60 Minutes Report on Plan B (11/27/2005 5:10:13 PM)
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i wish to preface this Op post with the following caveat, which i hope members will adhere to: i wish to report on and foment discussion of a very narrow issue, and not to open to debate the most divisive issue in the US: abortion.
A pill exists which, when taken within 72 hours of intercourse, inhibits ovulation and in a very small percent of cases where ovulation has occured, prevents implantation. The pill is known as "Plan B" and under the law of New York, every hospital must offer it to rape victims.
At least one Catholic hospital in New York is under investigation for its refusal to offer the drug to rape victims. As many would expect, the Catholic Church opposes the use of Plan B on the grounds that it is birth control, and in RARE cases, it prevents a fertilized egg from implanting, which the Church regards as an abortion.
(The Church is heavily aligned with the most extreme of anti-abortion advocates, and prohibits amniocentitus as well, on the grounds that if a couple is informed the baby is defective, they may choose to end the preganancy.)
According to 60 Minutes, the activity of Plan B is distinguishable from that of RU487, which acts to cause the uterus to expell a zxygote. Plan B overwhelming acts to prevent ovulation, so no pregnancy can occur. However, the small percent of cases in which Plan B prevents implantation has given rise to what appears to be unprecedented religious interference in a scientific decision.
According to 60 Minutes, over 40 studies have been conducted on Plan B, each showing the pill is both medically safe and has no "disinhibiting effect" on the use of condomns, teen sex, or the spread of std's. The manufacturer asked the FDA for permission to sell Plan B over the counter, and a panel was installed to review the decision. The committee members voted 24 to 4 to allow Plan B to become OTC. The FDA Director or someone on his staff requested a "minority report" and based upon opinion in that report-- not borne out by facts or studies -- he decided to refuse Plan B OTC status.
The 60 Minutes report stated the manufacturer withdrew its originial request to make Plan B completely OTC and offered one in which a purchaser would need to show proof of age 16 or older, and the FDA Director has responded by requesting more studies which effectively sets the decision-point back years.
By contrast, under both Cklinton and Bush, the FDA has permitted pharmacuetical companies to advertise in what most consider a detriment to the population. Patients now go to the MD seeking specific drugs about which they are ill-informed as to side effects -- adverse effects -- comparative costs -- and other matters which in the past were considered the perview of the MD. MD's, under pressure/profit motives, prescribe these drugs.
When i represented the state of Florida, the Director of its Medicaid Drug Program told me studies have demonstrated that family physicians are generally familiar with about 25 drugs and the new drugs being so heavily marketed are not well-known to MD's as to drug interactions, etc. i was also told that most American MD's have no formal training in pharmacology during medical school.
In addition to allowing advertising of Rx drugs, the FDA, under this administration, and to be fair, under Clinton, has rapidly approved drugs based on data which in the past has been considered preliminary. It has been estimated that the time from submission to the FDA to release to the MD population for scripting has shortened as much as from 10 years to 2 years. As patients in the general population themselves become the actual "drug trial" (under a voluntary reporting system) and begin dying or suffering other serious adverse effects, tort lawyers are having a field day inasmuch as it is generally easy to prove liability.
So on the one hand, the FDA will allow you to take a drug that may kill you or give you a heart attack, but refuses to grant OTC status to a SAFE drug which, taken timely, averts the need for an abortion for a woman or girl traumatised already by a rape, as well as couples whose condomns have torn or others in need.
i am a devote Catholic and will never leave my Church, but on birth control and abortion they are wrong IMO. However, i'm not surprised at the stance taken by my Church; i am dismayed at the fact that a religious institution can evidentially make scientific decisions at the FDA.
i am adding the FDA to the list of the SEC, HUD, and other federal agencies which need a complete overhaul. This incident makes abundantely clear some action must be taken to insulate the FDA from the pressures of the religious right, as well as the profit motives of pharamcetical companies.
Yes, i'm angry and spoke frankly, and yes, i know some people cannot discuss these issues rationally. i am hoping as i said that debate can be limited to granting Plan B OTC status.
candystripper
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