CASAA Call to Action: My goal is to document the systemic corruption in the FDA. Their culture is corrupted. The corruption is systemic. They are corrupt and so are many of their leaders which I will cover in another post. They lie. They falsify records. They hide stuff. They spin and twist issues to suit their own deplorable goals. They are controlled and beholding to the Pharmacetical Industry. They are not primarily concerned with public health. I see absolutly no significant purpose or real world justification in attempting to negotiate or modify the FDA regulations with either Zeller, Hamburg, or anyone else at the FDA. Why bother when the culture/burocracy which they represent has continually and consistently exibited these disgusting traits. Congress has the power to eliminate the FDA from the picture and my hope is that we educate members of Congress about the FDA actions so Congress and only Congress can remove the FDA from the regulatory equation. None of my thoughts should be construed as not wanting you to send comments to the FDA during the current period and undertaking grass roots actavisim via yourself or any organization you wish. I passionately want you to do this. For me and I hope you, it’s all a prelude to the big battle with Congress and hopefully we can use some of the articles listed below in our talking points with Congress.
We start our examination of the FDA in 2008 under the Bush 2 Administration and continue to today under Obama. Just incase one of the missguided and specious bloviaters in the peanut gallery want to try and pin this debacle on one political party or the other.
From the WSJ Feb. 6, 2008
This article talks about the inefficiency of the FDA and documents a number of blunders and mistakes it has made. The following quote hits the nail on the head:
“The real scandal is that these policies are the product of the FDA’s institutional culture, which puts political incentives and bureaucratic procedure above patient results. Congress and the press could do some good if they investigated that problem, but it’s so much easier to say, “spend more money.”
From the Washington Monthly – October 2, 2008
The article begins with “CULTURE OF CORRUPTION AT THE FDA…” It then documents a “sweetheart” deal with Alaska Newspapers Inc.
From Tobacco Analysis – July 30, 2009
Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones
Scare tactics by the FDA using half truths and omissions of facts. Deplorable! “The FDA last week condemned electronic cigarettes on the basis that an FDA laboratory detected carcinogens (tobacco-specific nitrosamines) in the cartridges of several electronic cigarette manufacturers. The FDA held a press conference in which it attempted to scare electronic cigarette users into discontinuing e-cigarette use (and therefore a return to conventional cigarette smoking).”
“As these data show, the level of tobacco-specific nitrosamines present in electronic cigarettes is at the trace level. It is measurable in parts per trillion (nanograms per gram). It is comparable to the nitrosamine levels in nicotine replacement products which are approved by the FDA.”
From Judicial Watch – October 14, 2009
FDA’s $7 Million Cover Up
“The famously unscrupulous government agency responsible for protecting public health and safety will waste millions of tax dollars to further examine a common household chemical that’s already been deemed unsafe in hundreds of scientific studies and banned in several states.
To appease the chemical’s manufacturer the Food and Drug Administration (FDA) is delaying issuing a negative report by essentially disregarding the results of nearly 1,000 reputable scientific studies that have collectively concluded it presents a public health risk. Used to make hard, clear plastic Bisphenol A, or BPA, has recently been banned in cities and states across the nation based on the research.
Study after study has determined that BPA causes cell changes that lead to breast and prostate cancer yet the FDA has conveniently utilized a pair of studies—paid for by BPA manufacturers—to rule that the chemical is safe. Bombarded with the more dependable research contradicting BPA’s safety, the agency is further stalling on banning it by investing $7 million to conduct its own probe.
A group of insulted scientific experts who have thoroughly examined BPA have written a letter to FDA Commissioner Margaret Hamburg accusing the agency of stalling at the risk of public health. Spending significant time and money on a very well researched chemical is disturbing, the scientists write, pointing out that there are significant flaws in the government’s plans.
From Masters in Health Care – April 5th, 2011
15 Disturbing Facts About the FDA
You might want to take your blood pressure meds when you read this article.
7. They were partly behind the Vioxx deaths: Along with drug company Merck, the FDA was blamed for promoting and refusing to recall the drug Vioxx, which “caused an untold number of fatalities among the American population,” according to NaturalNews.com. Apparently, the FDA was pressed to run additional clinical trials after Vioxx caused heart attacks, but the FDA approved the drug anyway, without extra research or recalls.
9. FDA leaders have chosen to side with drug companies, and ignore science: Two years ago, a group of FDA scientists wrote a letter to President Obama asking for wholesale change of the organization, as they believed leaders were corrupt and consistently ignoring their research, and instead choosing to promote drug companies. At first, some believed the letter was a fake, but when it was validated, a closer look of the letter revealed that the scientists also accused the FDA of actually breaking their own laws, “altering scientific findings,” removing Black Box warnings, made false statements in FDA documents, and the approval of a mammogram device after FDA experts voted unanimously against it.
10. They re-approved a drug that killed 80,000 people: Many health and patient advocates felt that the diabetes drug Avandia should be taken off the market after it was suspected of killing around 80,000 people, but after a special meeting was called, the FDA disagreed. Although the FDA proved through a vote that they believed the drug was dangerous, they decided stronger warning labels would be a sufficient solution.
From The New York Times – July 30,2012
Caustic Crusader at Center of F.D.A. Scandal
As he often did, Dr. Robert C. Smith was hammering away at his bosses at the Food and Drug Administration in the most caustic of terms at a meeting to address his concerns about the approval of medical devices. With seven fellow scientists seated behind him in support, Dr. Smith charged that managers “are not following the law, not following the science, not following F.D.A. core values,” according to notes of the 2008 session. He glared at a supervisor, who sat fuming in front of him.
From Drug Discovery & Development – 10/10/2013
Senator Calls For Investigation of FDA “Pay To Play” Scandal
U.S. Sen. Joe Manchin (D-W.Va.) sent a letter to Margaret Hamburg, the commissioner of the U.S. Food and Drug Administration (FDA), informing her that he will be calling for a full investigation after news reports of “pay to play” allegations between the pharmaceutical industry and FDA officials overseeing safety regulations of painkiller medicine.
Earlier this week, The Washington Post reported that private companies paid as much as $25,000 to participate in FDA advisory panel discussions on federal regulations for prescription painkillers. If these allegations are accurate, this could be a direct conflict of interest, allowing pharmaceutical companies to have influence over the FDA’s decision-making process, particularly in regards to rescheduling hydrocodone combination drugs, a highly addictive painkiller.