Tuesday, December 1, 2009

FDA - an ingrained culture of corruption and greed


FDA - an ingrained culture of corruption and greed

If you have any doubts about how corrupt the FDA really is; you can read the many articles I have placed in this post as some reasonable verification.

Or you just have to listen to what the FDA's own scientist are saying.

The FDA is a corrupted politicized body that is doing the Pharmaceutical Industries bidding at the behest of those wonderful Washington DC congressional representatives that are pocketing dirty lobby money in return for political favors. How does 30 million plus dollars a year in direct lobbying to our elected representatives sound (pharmaceuticalmoney ).

Why should you care that Huge Multinational Corporations are lobbying and influencing your elected representatives? How about that they are not looking out for the best interest of our Country and it's Citizen for starters. These corporations are lobbying to make money, control legislation, influence oversight, and to change laws that protect the safety & rights of American Citizens.

How Bad is it? Please read, listen, and learn America. Every American's health, and even are economic existence as leading nation in this world are at stake.

If you happen to think a change of administration or major political party will save us; you may be dead wrong unfortunately.

I have thrown a whole bunch of information and articles together in this post so you the reader can draw your own conclusions. I hope many will take the time to investigate and demand that Government listen now, before the clock has ran out for all of us.

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Capitalism Gone Mad - The Newt Gingrich doctrine:

SOURCE: MOTHER JONES, September/October 1995, “agency under attack;” Author: Leslie Weiss

SYNOPSIS: The Food and Drug Administration (FDA), sometimes criticized in the past for being too cozy with corporations, is now under attack for exactly the opposite reason. A powerful bloc of critics in the drug industry has joined hands with the Republican Congress and together they are pushing to overhaul the FDA. These critics claim the FDA is too tough on drug companies, unnecessarily inhibits innovation, and delays approval of new drugs and medical devices.

Leading the charge in Congress is Speaker of the House Newt Gingrich, who has labeled the FDA the “number one job killer” in the country, and called its head, David Kessler, “a bully and a thug.” Gingrich’s Progress & Freedom Foundation has a radical plan to privatize much of the FDA supervision of drugs and medical devices.

If enacted the Progress & Freedom Foundation’s plan will place responsibility for drug development, testing, and review in the hands of private firms hired by the drug companies themselves, while retaining a weakened FDA to rubber-stamp their recommendations. Additionally, the plan limits the liability of drug companies that sell dangerous drugs to the public.

Under the plan, government-licensed firms called DCBs (drug or device certifying bodies) would be retained by drug companies to develop, test, and review new products. According to the proposal, “competition between firms would inevitably produce a lower-cost, faster, and higher-quality development and approval process.”

FDA spokesperson Jim O’Hara charged, “What this report proposes is dismantling many of the safeguards that protect the public from drugs and devices that are unsafe or just don’t work. This is basically a proposal that says public health and safety are commodities for the marketplace.”

Though drug testing and review would be privatized under the plan, the FDA would still exist and would theoretically have the final say on new products. However, the report states there would be “a strong presumption that private certification decisions would not be overturned without substantial cause.” Further, the FDA would not be authorized to request additional testing or data, and it would “have to exercise its veto within a fixed time period (e.g. 90 days) after which the drug or device would automatically receive FDA approval.”

The Progress & Freedom Foundation plan also limits the drug company’s liability should a patient be injured or killed by a dangerous drug or medical device. According to the plan, a victim could not sue for punitive damages if the manufacturer of the product could show it met regulatory standards (no matter how weakened they were) during development and testing.

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Some recent news article examples from naturalnews.com:

From Pharmalot Dec. 2, 2009 journalists-to-fda-take-off-those-muzzles

http://www.naturalnews.com/FDA_corruption.html

FDA refuses to pull dangerous diabetes drug Avandia, even knowing it will kill thousands

8/1/2007 - The Food and Drug Administration voted overwhelmingly to keep the diabetes drug Avandia on the market, despite its known deadly effects. Two FDA committees met yesterday in Gaithersburg, Maryland, to consider whether the drug -- which has led to the...

Why health freedom will ultimately overcome Big Pharma mischief and FDA corruption (opinion)

5/10/2007 - Do you find yourself frustrated with the lack of progress in the fight for consumer rights against Big Pharma and the FDA? Take comfort, my friends, in knowing that even though we did not achieve the victory we wanted in this latest legislative effort...

Americans fed up with drug industry influence, FDA corruption, reveals remarkable Consumer Reports survey

4/16/2007 - (NaturalNews) More than four out of five Americans think drug companies have too much influence over the Food and Drug Administration, and 84 percent believe that advertisements for prescription drugs with safety concerns should be outlawed, reveals a...

Conflicts of interest at the FDA are rampant and largely ignored

1/5/2007 - Last year, Public Citizen, a national non-profit public interest organization, exposed that while conflicts of interest at the FDA's drug advisory committees are common and often have serious dollars at stake, advisory committee members and voting consultants...

FDA may face serious reforms in 2007 under Democratic majority

11/21/2006 - (NaturalNews) Senator Edward M. Kennedy stands to criticize the Food and Drug Administration (FDA) during a Senate hearing this week for allowing what he is calling "prevailing political winds" to take a higher priority than science. "Science has, too...

While scientists clash over the dangers of ADHD drugs, the U.S. government does nothing to protect children

9/6/2006 - Since the Vioxx scandal broke in late 2004, most Americans are all too familiar with the idea that prescription drugs can be dangerous and even deadly. But how would America react if it were to discover that a class of drugs being primarily prescribed...

With COX-2 decision, no longer any doubt about FDA corruption and U.S. drug racket

2/18/2005 - Following the death of as many as 60,000 Americans from COX-2 inhibitors (source: British Medical Journal, author Dr. David Graham, FDA drug safety researcher), an FDA advisory panel has now voted to allow the drugs to return to the market with full...

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The ugly story continues:



WSJ Exposes Corruption at the FDA


By Ryan Chittum - http://www.cjr.org/the_audit/wsj_exposes_corruption_at_the.php

FDA Scientists Complain to Obama of 'Corruption'

The Journal on page one today shines a bright light on some shady doings at the FDA, finding that Democratic politicians, doing a corporation’s bidding, put pressure on administrators to approve a medical device, causing corners to be cut, lies to be told, and the product to be approved on a fast track.

This is the kind of work we love to see, even though, as a commenter on the Journal’s site says about the headline “Political Lobbying Drove FDA Process”:

“This headline is akin to “Sun Rises in East”.

Granted (I discuss WSJ heds down below, for all you copy editors out there), but it’s essential to get a look inside the sausage factory every once in a while.

The Journal describes a process in this case that’s, well, corrupt. I don’t know what else you’d call it. It even has a smoking gun:

In November, agency officials drafted a letter to ReGen saying the FDA had taken into account the company’s “criteria” for the “structure and composition” of the panel, according to emails reviewed by the Journal.

The FDA’s acting chief counsel warned against that language, saying it would “document special treatment for ReGen.” Another FDA lawyer said the wording would “cause significant problems for the agency” because other companies don’t have the same “opportunity.”

The director of the FDA’s integrity office replied, “I’ll excise the language.”

The final letter didn’t include the language.

There you go. It’s so obvious that reporter Alicia Mundy even pulled a mea culpa out of somebody responsible:

“There’s something wrong with how that decision [to go the fast-track route] was made,” said Andrew von Eschenbach, who was head of the FDA in December, when Menaflex got the go-ahead. “We fumbled that process.”

Hey, you’ve got to give the guy some credit for owning up to it. How many other Washington (or Wall Street) creatures have done that?

Here’s some background on what happened. The FDA, apparently correctly, declined to let ReGen’s knee-implant product go in for fast-track approval. After the second time, a bunch of Democrats in Congress from New Jersey, where ReGen is based, went to see the FDA chief. Two days later, the FDA chief handed the request to an underling, who took a shortcut through the normal approval process, let ReGen influence who got on the approval panel, distorted what the panel said, and approved it.

The FDA’s regular committee process was circumvented, says Dr. Mabrey, the Baylor surgeon and committee chair, because members were given only six days to review hundreds of pages of documents instead of the usual several weeks.

When Dr. Schultz summed up the meeting in a letter afterward, he said the committee “clearly and unanimously” found Menaflex to be at least as effective as other surgical meshes on the market.

A majority of the eight committee members, including Dr. Mabrey, said in interviews that Dr. Schultz was wrong in saying the members were unanimous. “I made a point of noting that we were not unanimous,” Dr. Mabrey says. “The important thing is that we didn’t say the device was substantially equivalent to other devices.” In addition to Dr. Mabrey, at least two committee members expressed reservations. Dr. Mabrey says if he had known Dr. Schultz was going to approve the device citing the panel, he would have strongly spoken out against it.

Good work by the Journal.

Although as a side note: It’s sad to see that the paper’s signature leders, like this piece, are relegated to below-the-fold status under the Murdoch regime. This seems to pretty much be a permanent change.

And you’re not going to sell papers with giant fonts that result in five-word headlines like this one. The old Journal triparte headlines drew readers in. These push them away.

Fortunately, the “aheds” still have them, like this one from a couple of weeks ago:

A Florida Court’s ‘Rocket Docket’ Blasts Through Foreclosure Cases

2 Questions, 15 Seconds, 45 Days to Get Out; ‘What’s to Talk About?’ Says a Judge

Sure sounds a lot more interesting than “Political Lobbying Drove FDA Process.” Zzzz.

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Are you suffering from corruption overload yet?




By Susie Madrak Friday Jan 09, 2009 10:00am - http://crooksandliars.com/susie-madrak/fda-scientists-complain-obama-corrupt

I used to work for an consulting firm that specialized in FDA compliance for pharma and medical device companies, and I can tell you the consultants had no faith whatsoever in the FDA approval process during this administration. Looks like their concerns were warranted:

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.

[...] The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the scientists wrote.

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Hopefully; WE THE PEOPLE CAN STOP THIS


Americans Are Sick of FDA Corruption

April 16, 2007 by Astra Yaddira - http://www.associatedcontent.com/article/217163/americans_are_sick_of_fda_corruption.html

A new survey done from Consumer Reports was released on April 16, 2007 showing that Americans are getting fed up with the FDA. The survey telephoned and spoke to 1,026 American adults and found some interesting responses.

Apparently, 96% of the people surveyed agreed the government should have the power to require warning labels on drugs with known safety problems. As Consumer Reports explains, "Right now, the Food and Drug Administration must negotiate safety warning labels with a drug maker.Americans Are Sick of FDA Corruption currently being done because the FDA is getting paid a lot of money from the drug companies in order to not include such information.

Americans are also becoming more aware of the serious conflict of interest that the FDA has in drug regulation because 84% of the respondents agreed that drug companies have "too much influence over the government officials who regulate them." Also, over two-thirds of the people are concerned that drug companies actually pay the FDA to review and approve their drugs. The consumers are not the customers of the FDA, the drug companies are. What business wants to make their customers unhappy?

Pharmaceutical companies like to pick and choose their clinical findings to make their drugs look better than they really are. Apparently, we have caught on to this fact because 92% agreed that pharmaceutical companies should disclose the results of all of their clinical trials, not just the ones the end up producing positive results.

There is danger in the fact that the FDA cannot require any follow-up studies to be done on the drugs they approve for use. 93% of the respondents also think that the FDA should have the power to demand follow-up safety studies from drug companies so that this danger can be minimized.
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"An appeaser is one who feeds a crocodile—hoping it will eat him last" - Sir Winston Leonard Spencer Churchill

"All that is required for evil to prevail is for good men to do nothing." -- Edmund Burke

Make Your Voice Heard - The "White House" link is on my sidebar, and your senate/congressional representative is just a phone call, letter, or email away.

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