Playing God at the FDA

[Guest guest]

re - Playing God at the FDA

Very informative article.

Scary this FDA.

Even more scary to me the AMA and AVMA.

All are puppets of drug companies in my expereince.

.......Irene

--

Irene de Villiers, B.Sc AASCA MCSSA D.I.Hom. Box 4703 Spokane WA 99220.

www.angelfire.com/fl/furryboots/clickhere.html (Veterinary Homeopath.)

Proverb:Man who say it cannot be done should not interrupt one doing it.

[Guest guest]

Playing God at the FDA

By Dale Steinreich

Posted on 5/2/2005

In about every presidential administration for the last three decades the vile underbelly of an Executive-Branch organization spills out into the open. Right now an implosion is in progress at the U.S. Food and Drug Administration (FDA) that could fully expose not only its phony pretense as a protector of the public's health but the agency as a dangerous and dictatorial handmaiden of a federally protected drug industry.

The most recent cracks in the FDA edifice began to show earlier this month on April 12 when the General and Plastic Surgery Devices Panel, an advisory body of the FDA, voted 5-4 against recommending that silicone-gel breast implants made by Inamed Corporation be sold since an effective ban was imposed on such devices in 1992. The decisive point with some panelists was that Inamed didn't provide data about the probability of its implants lasting ten years.

Where events started to get strange was the very next day, when the same panel voted 7-2 to recommend that the silicone breast implants made by another company (Mentor Corporation) be allowed on the market under certain conditions.[1]

Despite the pretense of meticulous deliberation, the two disparate votes were completely arbitrary. "They're two different devices," said FDA adviser Li, hardly clarifying anything. Mentor, like Inamed, had studied rupture rates for the devices for a three-year period. Yet Inamed's sample size was more than double that of Mentor's. The advisory panel made a show of being impressed by Mentor's presentation of evidence from a British study showing that 5% of Mentor's implants had ruptured within nine years. However, the FDA's own staff attacked this study, alleging that its sample was skewed toward volunteer subjects and excluded certain high-risk women.

The popular TV and print-news coverage of the disparate panel votes was typical. It implied that there was some sort of plausible significance to what was in reality a two-day charade by a body of capricious, pompous, and self-serving clowns. Glib answers by panel members to reporters' questions about the inconsistency of the two votes were accepted without much question. Not a single report raised the possibility of favoritism toward one company over another.[2] The same panel (with some of the same advisers) in October 2003 voted in favor of Inamed when it had less data then it does today.[3] In particular Li, the panel member who now grandstands as a meticulous champion for women's health in 2005, voted in favor of Inamed in October 2003.

The panel's actions might be justified for devices that had been proven to be a significant threat to public health. The problem is that they weren't.

The Anti-silicone Legend

The campaign against silicone implants began in 1978 when a woman received two of them after a double mastectomy.[4] The following year she sued the manufacturer, Dow Corning Corporation, asserting that the implants were the source of health problems she had contracted. In 1984 she won almost $2 million. Buoyed by her victory, a deluge of suits began such that in 1992 the number of lawsuits against Dow Corning went from around 200 to about 10,000.

That same year the FDA banned the devices claiming that they had not yet been proven safe. Maybe, but plaintiffs' attorneys and their "experts" had not scientifically proven that the devices were dangerous or that they were the cause of the connective-tissue diseases[5] mentioned in the lawsuits. Despite this lack of evidence, plaintiffs went on to win as much as $20 million from their suits. In one memorable case, despite the fact that a woman's doctor conceded in court that her connective-tissue disease began before her implant surgery, the woman was still awarded more than $7 million by a jury.[6] Studies [7] debunking the alleged link between implants and connective-tissue diseases began to appear, but they didn't save Dow Corning from bankruptcy.

With the specter of connective-tissue disease now gone, the FDA's newest contrived danger became ruptures. Meanwhile in Europe, silicone-gel implants are not only available but much more popular than their saline counterparts because both patients and physicians agree that they look and feel more natural.

What chain of events led to so many of our medical options getting usurped by a capricious government body?

Playing God at the FDA - Mises Institute for the rest of the storySee what's new at AOL.com and Make AOL Your Homepage.