Isn't it nice to know that government is not looking out for you or your health. But be assured they are definitely looking out for those that hand them piles of cash for election campaigns. The FDA is a horrible symptom of a deadly disease we have in our government. It's called "for sale to the highest bidder".
from Fierce Pharma - http://www.fiercebiotech.com/story/fda-reform-advocates-want-more-clinical-data-transparency/2009-06-25
and the Wall Street Journal - http://online.wsj.com/article/SB124588492308150255.html
FDA Pressed for TransparencyBy JARED A. FAVOLE
WASHINGTON -- Consumers, doctors and scientists told the Food and Drug Administration Wednesday the public deserves to know more about how the agency makes complex scientific decisions about the medicine and food Americans consume.
Consumers said the FDA needs to more rigorously oversee clinical trials to ensure patients get treated fairly; doctors urged the FDA to flag safety concerns with drugs and devices as quickly as possible; and scientists recommended the agency air dissenting opinions by FDA scientists.
These thoughts were balanced, in part, by industry representatives who said that, while they agree the FDA should explain decisions more thoroughly, confidential commercial information shouldn't reach public eyes.
The meeting is part of an FDA effort to counter accusations that it makes decisions without explaining them. The FDA has long faced criticism, some of which was repeated at the meeting, that it sits on safety information that should be public and works too closely with industry.
For instance, the FDA faced criticism that it was too slow to remove the painkiller Vioxx from the market after the drug was linked to an increased risk of heart attacks. The drug was removed from the market in 2004. The agency has been under fire in the last several years for not quickly releasing information showing that the diabetes drug Avandia, made by GlaxoSmithKline, may increase a patients' risk for heart attacks.
It's too early to tell what recommendations, if any, the agency will implement. But FDA officials, including Deputy Commissioner Joshua Sharfstein, and the heads of nearly every division within the agency, eagerly questioned consumers and scientists about their recommendations and said over and again they looked forward to reading more details in written testimony.
Steve Findlay, a senior health-policy analyst at the Consumers Union, said the FDA should tell the public, through its Web site, whenever agency officials have meetings with industry representatives. Such disclosure, Mr. Findlay said, would help restore the FDA's credibility. FDA officials appeared open to the idea, but questioned what meetings would warrant telling the public about.
Mr. Findlay said "important" meetings, but acknowledged the FDA will have to decide what that means.
This highlights a broader challenge the FDA will wrestle with as it decides to make decisions more transparent: What should it release? What can it release? And is there such a thing as "too much information'?
For instance, Francesca T. Grifo, of the non-profit Union of Concerned Scientists, said the agency should allow FDA scientists to publicly air opinions about a drug or medical product when they disagree with a final agency decision.
Mr. Sharfstein questioned such a move, saying scientists often "disagree sharply," and airing those differences might erode the public's trust in FDA decisions. In the last several years, veteran FDA scientists have complained to Congress and the White House that they have been silenced when they disagree with agency managers. Some have also said they've been forced to manipulate scientific data.
"I don't think that the idea that we might confuse someone is powerful enough to actually silence an opinion that might in fact save a life," Ms. Grifo said.
How did we get to this dark place in our history you might ask? Because our government has been bought and over influenced by huge lobbying efforts that don't have your interest as an American Citizen in mind.
A great read and important information at -