Maine Liberty Journal

Via Union of Concerned Scientists:

The U.S. Food and Drug Administration (FDA) is responsible for protecting and advancing public health through the regulation of drugs, food, medical devices, cosmetics, and the blood supply—including products that, according to the FDA, account for 25 cents of every American consumer dollar spent.

In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed a 38-question survey to 5,918 FDA scientists to examine the state of science at the FDA. The results paint a picture of a troubled agency: hundreds of scientists reported significant interference with the FDA’s scientific work, compromising the agency’s ability to fulfill its mission of protecting public health and safety.

The National Academies Weigh In

In September 2006, the National Academies Institute of Medicine released a report critical of the FDA and its ability to protect the public from unsafe drugs. In a section discussing the poor handling of scientific disagreement, the report mentioned the UCS survey result indicating that hundreds of agency scientists had been pressured to approve a drug despite reservations about safety.

The report describes the acknowledgment of these concerns by acting FDA commissioner Andrew von Eschenbach when questioned about the UCS survey at his Senate confirmation hearing and in a separate meeting with UCS about scientific integrity at the FDA.

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Via WMTW (10/26/2009):

The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn’t extend patients’ lives, say congressional investigators.

A report due out Monday from the Government Accountability Office also shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits — even when such information is more than a decade overdue.

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Via WMTW:

The Campaign for Safe Cosmetics had baby shampoos, bubble baths and lotions tested for a chemical called 1,4-dioxane and formaldehyde.

Researchers found many products contained the substances, which the FDA does not require on product labels.

People get lulled into complacency because the assumption is made that the FDA is looking out for them and that if the FDA fails to declare something to be unsafe it must be safe for consumption.

On the other hand, if competition were allowed in the market place, the producers and sellers of these products would go to great lengths to demonstrate to the consumer how safe their product is.

In other words, there would be an incentive to go above and beyond the minimum standards set by the politicized alphabet-soup agencies under control by politicians and the wealthy lobbyists/corparations who pull their strings.

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Via Ms. Magazine (August 2, 2006):

Scientists found that scientists at the Food and Drug Administration (FDA) feel that their work is subject to outside pressures, both political and commercial, and that these pressures influence agency conclusions for the public. The anonymous survey was sent to close to 6,000 FDA scientists and 997 responded, 62 percent of whom are senior scientists.

The survey found that 18 percent of the scientists had been asked “for non-scientific reasons, to inappropriately exclude or alter technical information” for FDA documents. Sixty-one percent had knowledge of instances where political appointees had “inappropriately injected themselves into FDA determinations or actions.” Seventeen percent, or 169 scientists, responded that they had been asked to “provide incomplete, inaccurate or misleading information to the public, regulated industry, media or elected/senior government officials.”

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Via Washington Post (December 16, 2004):

Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality.

The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency’s ability to assess the safety of a drug.

The results of the survey, conducted by the Department of Health and Human Services’ inspector general, appear to support some portions of the controversial Senate testimony last month by FDA safety officer David J. Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated.

Graham’s testimony, at a hearing into the sudden withdrawal from the market of the arthritis drug Vioxx, put a spotlight on the FDA’s safety and management record. Top FDA officials later criticized Graham’s testimony as inaccurate and unscientific, but the survey results indicate that some other agency scientists share similar views.

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Union of Concerned Scientists (December 16, 2004):

A previously unpublished internal survey of Food and Drug Administration (FDA) scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released today by the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER). The FDA survey results, obtained under the Freedom of Information Act, closely track the safety concerns raised by the agency’s own associate science director of the Office of Drug Safety, Dr. David Graham, in testimony before the U.S. Senate last month.

The Health and Human Services Office of Inspector General (OIG) conducted the survey in late 2002 as part of a management review of how the agency was meeting stringent deadlines for approving new drugs. OIG polled 846 FDA scientists, with nearly half (47%) completing the survey. Survey findings included:

• Two-thirds (66%) of respondents lacked confidence that the agency “adequately monitors the safety of prescription drugs once they are on the market”
• 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
• More than one-third (36%) of scientists were not at all or only somewhat confident that “final decisions adequately assess the safety of a drug”
• 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”
• Despite the disquieting survey results, when the OIG published its report in March 2003, a lead conclusion was that FDA scientific reviewers “have high confidence in decisions FDA makes.”

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Via CBS News (July 12, 2001):

Dr. Robert Misbin is a sort of scientific detective at the FDA, hunting for early warning signs in the newest drugs seeking FDA approval.

As reported in a CBS News investigation last year, Misbin wanted the diabetes drug Rezulin taken off the market for safety reasons. But he locked horns with his FDA superiors and even publicly accused his own agency of putting the drug maker’s interests ahead of the public.

These types of news “stories” serve a valuable purpose on many fronts. The casual observer probably comes away from a story like this with heightened confidence in the FDA and corporate news outlets, since it appears as if corporate media is really investigating the government, and it appears as if the government is really working to protect the public from reckless pharmaceutical corporations.

On the other hand, I trust none of the above.

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