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Hilary's Desk

FDA to be made "more" pure and clean

Hilary Butler - Saturday, May 01, 2010

FDA has introduced changes designed “to return to science” with policies to “make things more pure and clean.”  You mean, FDA wasn't talking science before? Shock horror.  Don't the Ministry of Health, IMAC and others say that the opinion of FDA and CDC, is already the paragon of purity and cleanliness? What's that washing powder slogan?, ...   "Whiter than white"

There's a big disadvantage in shouting new changes from the roof top.  People see that everything they've been told before, wasn't true. 

These changes are necessary, so FDA says, because the current FDA committees rubberstamp products for approval almost every time they meet. Supposedly, committee members voice serious doubts about the safety and effectiveness of a products, promptly recommend it, then cover their backsides by saying that voting yes, doesn't mean they don't have grave concerns.

How could grave concerns translate into a yes vote? Apparently, members of these panels are too wimpy to be true to themselves. Voting is undertaken by a show of hands, which supposedly results in members following the leader in what they call "lockstep voting". Or as the article more politely says, 'following like sheep" ..."Bbaaaaaaaa......"

Then there’s the practice of "steering" by FDA backroom boys who go around making “presentations” on a drugs ‘approvability’ to try to create voting blocks.  Sounds like the New Zealand politicians and the Super city to me....

Business as usual, the world over. 

The new changes in FDA involve secret electronic voting in order to avoid committee members being intimidated-by other committee members, particularly those with pharma ties, or being too weak willed to be seen to be their own person. FDA will be “allowed” to present minority reports in order to “avoid the appearance that upper management is squelching dissident points of view”.  Finished laughing yet?  Supposedly, this all means that FDA is “correcting it’s course”. Sorry.  Becoming purer than pure.

Question is, changing from what course, to what course?

What does FDA intend to do about all the drugs and devices approved under the previous unsavoury, coercive, illegal, wimpy anti-consumer "course" they ran, before these new "course" changes?

Anyone who has followed the FDA’s evolution knows all about their track record of rubberstampage.

FDA was once called the Division of Biological Services (DBS).  It's decades of corruption was first exposed to the American public during a Senate hearing in 1972, which looked at layers of corruption, harrassment of honest scientists, dismissal of more, and scientific, ethical and financial fraud. 

This extended from the deliberate silencing of Bernice Eddy and Anthony J Morris, to the approval of useless influenza vaccines, as well as the release of at least 32 ineffective and dangerous vaccines into the market over two decades.  The latter action absolutely stunned the Senate. 

Page 435 of the 1972 S3419 congress hearing states:

The failures cited in the report I am releasing today, are major failures in consumer protection. It would be misleading however to focus only on these incidents and ignore the larger problems of bureaucratic regulation.  These problems are symptoms of a general disorder.

The real problems lie in a regulatory bureaucracy in which authority is apportioned according to irrational distinctions; in which different federal agencies frustrate each other's policies by pursuing conflicting goals; in which questions are decided not on their merits, but in order to preserve or extend an agency's jurisdiction; in which important regulatory authority is buried between layers of bureaucracy, and decision-makers lose their visibility and public accountability; in which the only day-to-day influence on regulators from outside the government comes from representatives of the regulated industry; in which agencies with regulatory responsibilities also view themselves as advocates for a particular interest group; in which regulators move back and forth between jobs in government, and executive positions in regulated industries; in which important decisions are made without input from a variety of affected interests.

Senate disbanded the DBS, and set up the FDA.  Which.... was staffed with the same people sitting at different places at the table, in a different building.

In 2010, what exactly has CHANGED in modus operandi, since 1972? Nothing.
  
How do you the public feel, when the very agency which NZ medical authorities take advice from, is filled with people who lockstep vote; and who don't vote on the basis of evidence based medicine?

In 2004, when the BMJ wrote with a slight tinge of incredulity, “Something is rotten at the heart of the FDA.” the rest of us just laughed.

In 2005, the then Head of Health and Human services asked the FDA to set up a Sentinal drug monitoring system which would allow FDA to monitor immediately how drugs affect health. The Sentinel Initiative finally grew legs in 2008.  While supposedly a “quantum leap forward in F.D.A.’s capacity to monitor the use of medical products that are currently on the market” – experts then said that this immediate monitoring would not bear fruit for many years. The point being????  Yet another gravy train to feather someone’s nest.

An example of FDA’s wimpy corruptness was an event in 2009 when Lilly/Daiichi Sankyo rang FDA four days before a meeting about it’s drug Prasugrel, to question the inclusion in the panel, of Dr Sanjey Kaul who is an expert in Cascular physiology and an outspoke critic of Prasugrel. Dr Kaul was dropped from the committee, and the panel unanimously approved Prasugrel.

“Same old.”

Again, in 2009, four New Jersey congressmen, and a former FDA commissioner “steered” an FDA committee into approving a patch for injured knees. This patch was highly dangerous and often resulted in subsequent operations ...  Money money.

Wall Street journal was none too impressed at the FDA’s new policy of easing the way for drug cocktails

Mind you, this is a war for drug companies too, who have been known to hire private detective agencies to track members of the FDA in order to work out whether they are favouring other competitor’s products. Which is a bit of a joke when you know that you can pretty much catagorise the whole lot of them as an unholy alliance with money and promises under the table in all directions. 

How else could it be that FDA directors resign from FDA’s offices, and step right into the plush BOD suites of vaccine and drug manufacturers? Anyone keen on looking at the revolving door policy, can see that’s been going on since the days of DBS.  The same pretty much applies for those working for Centres for Disease Contol (CDC) as well.  Like CDC's Dr Julie Gerberding walking out of CDC into her office as Chief of Merck's vaccine section. 

Underneath the new wallpaper, the rot and borer is exactly the same as it ever was in the DBS or the FDA, and nothing will change except, they hope, the public's perception.

Quite simply, these organisations are run by the industry, for the industry, while at the same time creating a mirage of altruism, to fool all but those whose eyes are wide open.

So here for those interested, is the full text of today's article. I'd hate to be accused of taking something out of context. 

http://www.medscape.com/viewarticle/720923?src=rss

New Procedures for FDA Advisory Panels Benefit Public Health, Says Watchdog Group
Robert Lowes


April 28, 2010 — New procedures for expert panels that advise the US Food and Drug Administration (FDA) on medical device approvals will benefit the public by focusing panel members on matters of science, rather than regulation, and reducing the possibility of undue influence by FDA staff, the head of a consumer watchdog group told Medscape Medical News.

"The changes will allow the FDA to get the information it wants most from the panels — what are the benefits and risks of a product," said Diana Zuckerman, PhD, president of the nonpartisan National Research Center for Women and Families, which specializes in health issues. "Then the FDA can decide what to do about approval."

The FDA has 49 advisory committees and panels. All 18 panels are subsets of the Medical Devices Advisory Committee, covering fields that range from radiology to immunology.

In 2006, Dr. Zuckerman's group released a report stating that many of the FDA's advisory committees for devices and drugs function as "rubberstamps for approval almost every time they meet." Too often, the report states, committee members voice serious doubts about the safety and effectiveness of a product only to recommend that the FDA okay it for marketing. The report quotes a committee member as saying, after casting a "yes" vote, "Don't take that to mean that I don't have grave concerns about the safety of this drug."

The new procedures, announced April 26, address some of the issues raised by the report. Beginning May 1, 2010, device advisory panels will no longer vote on whether to recommend product approval or conditions of approval. Instead, they will take a vote on a product's safety and effectiveness, as well as how its benefits stack up against its risks. An FDA spokesperson told Medscape Medical News that panels would vote on 3 different questions, which would follow along these lines:

• Do the data included in the product submission provide substantial evidence of safety for the requested indication?
• Do the data included in the product submission provide substantial evidence of effectiveness for the requested indication?
• Do the available data indicate that the benefits outweigh the risks of the device when used for the requested indication?

This method of voting represents the most important change, said Dr. Zuckerman, because up until now, panel members who have had reservations about a device frequently would attempt to compromise by supporting it only under certain conditions, such as postmarketing studies or label warnings. However, the FDA usually does not impose conditions recommended by advisory panels nor enforce them if they are adopted, said Dr. Zuckerman, noting that many of these conditions are unenforceable or vaguely worded.

The new format "will allow panel members to address issues related to their expertise instead of regulatory issues that may be unfamiliar to them," Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a press release.

Another change will discourage lockstep voting by advisory panels. Instead of voting by a show of hands, panel members will do so electronically. Their decisions will still be public, but members can make them "without immediate influence by other votes," according to Dr. Shuren.

One panel member can unduly sway colleagues with his or her vote, said Dr. Zuckerman. "People follow the leader like sheep." That kind of influence is alarming, she said, if the pivotal panel member has financial ties to the product manufacturer.

Advisory Panels Will Now Hear FDA Minority Reports

The new rules for advisory panels also extend to the FDA staff members who brief panels on their clinical and statistical review of a medical device under consideration. In a departure from past practice, these scientists will no longer include comments about a product's "approvability." Dr. Zuckerman said that FDA staffers do not baldly recommend that a product be okayed, but that their presentations nevertheless can steer panels in one direction or another.

Steering is also less likely to occur with a provision that calls for more nuanced staff presentations. FDA reviewers have traditionally "presented a unified, consensus analysis of supporting data," the FDA press release states. "Now reviewers will present together with data and analysis the range of scientific opinion in the group."

This approach will allow FDA staff to offer minority reports about a medical device, said Dr. Zuckerman, and avoid the appearance that upper management is squelching dissident points of views. A number of FDA physicians and scientists have complained to Congress and President Barack Obama that "corrupt" managers have suppressed scientific evidence showing that some products coming to the agency for approval are unsafe.

To the head of the FDA's Orthopedic and Rehabilitation Devices Panel, the changes for advisory panels signal that the agency is correcting its course.

"The movement is to return to science," said John Kelly IV, MD, an associate professor of clinical orthopedic surgery at the University of Pennsylvania School of Medicine, Philadelphia. "We are here as scientists. That makes things more pure and clean.

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