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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (14890)12/22/2004 5:40:08 PM
From: NOW  Respond to of 52153
 
FDA Scientist Survey Summary

In late 2002, the Department of Health & Human Services Office of Inspector General asked FDA scientists a battery of 52 questions yielding the following results:

I. Safety of Drugs on the Market

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Two-thirds (66%) of respondents lacked confidence the agency “adequately monitors the safety of prescription drugs once they are on the market;”
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Only 12% of scientists were completely confident that FDA “labeling decisions adequately address key safety concerns” while 30% were not at all or only somewhat confident; and
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Only 13% of scientists were completely confident that FDA “final decisions adequately assess the safety of a drug” while nearly a third (31%) were only somewhat confident and 5% lacked any confidence in those decisions.

II. Scientific Quality in FDA

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With drugs classified as a priority (allocated only a 6-month review period), well more than half (58%) of scientists did not believe FDA has enough time “to conduct an in-depth, science-based review” of a new drug; and
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Nearly half (48%) reported that FDA does not do enough “to monitor and improve” its drug assessment process.

III. Scientific Dissent Within FDA

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Nearly one in five scientists (18%) said that they “have been pressured to approve or recommend approval” for a drug “despite reservations about the safety, efficacy or quality of the drug;”
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Less than one third of scientists (29%) felt that the “work environment” at FDA allowed wide leeway for “expressions of differing scientific opinions related to” new drug application decisions, while 21% said the work environment offered little or no room for dissent, with fully half (50%) answering that scientific dissent was allowed only “to some extent”; and
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Less than one in five (17%) felt the agency had “adequate procedures in place to address scientific disagreements” to a “great extent,” while 45% felt adequate procedures existed only to “some extent” and more than a third (38%) said procedures for resolving dissent existed only to a “small extent” or “not at all.”

The HHS/OIG surveyed 846 FDA scientists with a 47% rate of return.

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To: Biomaven who wrote (14890)12/22/2004 5:48:14 PM
From: Sam Citron  Respond to of 52153
 
The movie will probably have the Time cover story stock effect.

Sam



To: Biomaven who wrote (14890)12/23/2004 4:46:57 AM
From: Doc Bones  Respond to of 52153
 
MICHAEL MOORE: LOOK IN THE MIRROR, SICKO

Battle of the 'eminems.' A little Christmas cheer out of right field - bet she'd say the same about Santa. Happy Holidays everyone.

Doc


By Michelle Malkin
December 22, 2004 11:01 AM

The Los Angeles Times has details on Michael Moore's latest piece of propaganda theater--a hit on the health care/pharmaceutical industry titled "Sicko:"

<snip>

Quick aside: My hubby worked in the health care field (both government and pharma) for several years, and I'm well aware of a lot of the crap--kickbacks, marketing violations, pricing shenanigans, etc.--that goes on.

That said, unhinged pharma-bashers like Moore put all the blame for America's health care crisis on greedy drug companies--and none on Americans themselves. One of the biggest factors driving up health care costs and fueling pharma is obesity.

Nearly 130 million adults are overweight in the US alone, and 60 million of them are considered clinically obese. RTI concluded last year that the health care costs associated with obesity now rival those attributable to smoking. Obesity costs in the U.S. totaled up to $92.6 billion last year, and government-funded public insurers Medicare and Medicaid financed about half the bill.

Instead of whingeing (it's my word of the day) about the high cost of cholesterol drugs and diabetes treatments and gastric bypass surgeries, and instead of demonizing the pharma innovators who are rescuing Americans from their destructive vices, Michael Moore could actually do some good for the country by taking personal responsibility and turning the camera on himself.

The demon is in the mirror, dude.

michellemalkin.com