FDA Collaboration with big Pharma Raises Eyebrows

By Byron J. Richards, CCN

June 7, 2007

NewsWithViews.com

The Andrew von Eschenbach FDA era is upon is. The Avandia scandal is the tip of the iceberg. Is anyone ready? The words “illicit financial collusion” have been replaced by the politically correct term, “collaboration.” On May 30, in defense of his cozy relationship with Big Pharma and Big Biotech von Eschenbach told reporters, “This is a collaboration, but it's not just a collaboration with drug companies, it's a collaboration with academia and with other agencies." And he forgot to include that it is also a collaboration with various Senators, such as Senator Bennett (R-UT) and Senator Hatch (R-UT), as can be seen by the highly lucrative Critical Path Initiative program for cardiovascular disease research at the University of Utah.

Plainly stated, the FDA is set on becoming a drug company involved in every aspect of drug development for the next century. This pipe dream involves using sophisticated FDA software and related technologies to set the standards for the future of medicine, which will soon require your DNA in an FDA-owned supercomputer if you would like medical care. The FDA will help design all drugs from the ground up. The FDA, through the Reagan-Udall Foundation for the FDA, will control all patents and licensing arrangements regarding the drugs that are developed.

Under this plan the fox will not only be in charge of the henhouse, the fox will eat hens at will. Privacy issues, genetic discrimination, and required implantable RFID chips will be the order of the day. Billions of dollars are at stake. Wall Street can’t wait. Drug safety and the health options of all Americans hang somewhere in the balance, including access to safe and effective dietary supplements (the only true competition).

What will the FDA do when safety problems surface in the drugs it develops? Will the FDA put consumer safety ahead of its own financial interests? What legal liability will the FDA face when their drugs injure or kill? The FDA has already thought this through and is doing what it can to make sure citizens have no rights to sue when injured by FDA-approved medications.

Senators have already approved this FDA plan as part of the recently passed S.1082 – without asking a single question about it! The battle now moves to the House (HR.1561). A hurdle has been placed in front of the FDA, the unfortunately timed Avandia scandal is prying open the door to FDA and industry financial collusion, wherein tens of thousands of people die based on FDA management decisions while Big Pharma makes billions. It is time for Americans to wake up, as your health options are about to seriously diminish.

The Avandia Scandal

On June 6, 2007 von Eschenbach and various FDA employees testified before Henry Waxman’s (D-CA) Committee on Oversight and Reform. Waxman set the tone by reviewing the FDA history of Avandia approval and post marketing activities, outlining what he called “a number of missed opportunities.” Von Eschenbach skirted all issues by saying the FDA is still reviewing data and will hold an advisory committee hearing on July 30, thus attempting to delay the spotlight on this scandal so that HR.1561 can come to the floor of the House without the Avandia scandal hanging over its head.

The Avandia scandal is becoming quite a dog and pony show. On June 6, 2007 the New York Times revealed a stunning event that occurred in March of 2006 wherein FDA safety supervisor Dr. Rosemary Johann-Liang approved a black box warning on Avandia to warn about the risk for congestive heart failure. The von Eschenbach team ordered her to retract her approval of the warning. She was then stripped of her power to make such warnings and removed from supervision of the safety of Avandia. In other words, FDA management actively blocked a needed public warning regarding the dangers of this drug, consistent with eight years of FDA failures to ensure proper post-marketing studies of Avandia regarding heart attack risk.

Of particular interest is the FDA’s technical defense of its position regarding the approval of the drug in the first place. The drug was approved based on a “biomarker” or surrogate endpoint – meaning that approval of the drug was based on its ability to change blood sugar levels, not whether it improved the health of a diabetic. Avandia works by throwing a gene switch known as PPAR that is involved with multiple chemistry reactions at the cellular level, a fundamentally unpredictable and powerful drug target. By focusing on the biomarker called blood sugar the FDA was able to ignore the key safety question which was, “At what expense to health is blood sugar being lowered?”

It now turns out that Avandia has a whopping 43% increased risk for heart attacks as well as an increased risk of death from using the drug. This information is only coming to light after eight years of use. The FDA sat on the heart attack risk data and failed to warn the public, enabling the drug to become a blockbuster and rake in 3.2 billion in annual sales. GlaxoSmithKline made no proper effort to determine the heart attack risk of Avandia in proper post-marketing studies, which the FDA condoned. And as stated in the testimony of Bruce Psaty, MD, “FDA failed to warn or inform in timely manner.”

It is important to understand that the future of all drug development under the Critical Path Initiative and the Reagan-Udall Foundation for the FDA will rely on this type of biomarker evaluation (surrogate endpoints) to rush drugs to the market faster with virtually no proof of desired clinical outcomes. The American public will then be subject to a safety experiment. This approach to new drug development will sentence unsuspecting citizens in our country to a never-ending stream of Avandia-like scandals.

I’ll Stroke Your Back, You Stroke Mine

It is not an accident that Andrew von Eschenbach’s permanent appointment to head the FDA was slipped through at the end of last year during the Lame Duck session, with most Senators asleep at the wheel. About the only Senator not sleeping was Charles Grassley (R-IA), who stated during von Eschenbach’s confirmation hearing:

“People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the position he is currently occupying [acting head of the FDA].…That is an insult….In my interactions with the Department of Health and Human Services and the FDA these last 8 months, I have seen a complete and utter disrespect for congressional authority and hence the law.… This body [the Senate] should not walk hand in hand with the executive branch and sit idly by as instances of abuse and fraud continue to endanger the health and safety of American people.”

As Grassley’s warning fell on deaf ears Orrin Hatch (R-UT) rose in defense of von Eschenbach:

“To me it is simply unconscionable that the Food and Drug Administration, one of the best little agencies in Government, has gone leaderless for such a period of time…I know Dr. von Eschenbach well. He is a man of integrity….I urge my colleagues--no, I implore my colleagues--to do what is right and vote [for] this nomination….it is what the American people deserve.”

Apparently we got what we deserve. Why was Hatch so adamant about placing a bio-tech sales rep at the top of the FDA? Hatch is a large recipient of Big Pharma money. He holds a key position on the HELP committee that created Senate bill S.1082. He is currently designing legislation to protect Big Pharma and Big Biotech from generic competition in the next generation of biological drugs – a windfall worth billions for the industry. Hatch wants to place this legislation into S.1082/HR.1561 as an amendment when the bill goes to conference committee.

It is obvious that Hatch has his hand in the Big Pharma cookie jar. Von Eschenbach is certainly playing his role in rewarding Hatch for his support, helping us to gain a clear picture of what von Eschenbach means by “collaboration.” On June 1, 2007, von Eschenbach was in Utah promoting a new Critical Path Initiative project with the University of Utah. It is called the Cardiovascular Drug Safety and Biomarker Research Program. This project could be worth hundreds of millions, even billions of dollars to the state of Utah. I wonder why the FDA chose Utah for this no-bid contract known as a collaboration?

Hatch Walks an Interesting Fence

A key problem with S.1082 is that it contains a sneak attack on dietary supplements that will enable the FDA to remove helpful dietary supplements from the market at its whim in order to protect drugs from competition. This is being done through trick language the FDA has installed in bill S.1082, specifically relating to the Critical Path Initiative and the Reagan-Udall Foundation for the FDA.

Because there are many dietary supplement companies in Utah, Hatch has also been a major supporter of the dietary supplement industry and is responsible, along with Tom Harkin (D-IA) for the law known as DSHEA which provides access to dietary supplements in this country.

In the past month Hatch and Harkin were flooded with objections and concerns regarding this sneak attack on dietary supplements. This led to a conversation between Hatch, Harkin, Kennedy, and Enzi wherein they state that S.1082 will not affect dietary supplements. HOWEVER, UNTIL THE LANGUAGE IS CHANGED IN THE BILL ITSELF THE THREAT TO DIETARY SUPPLEMENTS IS VERY REAL AND IS A HUGE PROBLEM. This is fully explained by Jonathan Emord, our nation’s leading health freedom attorney, in an interview he recently had with me that can be heard by clicking here.

The Senator’s conversation, called a colloquy, has been used by the Natural Products Association (NPA) to neutralize concerns of its health food stores regarding this issue. It is obvious that NPA takes its marching orders from Hatch. Why are Hatch and the NPA trying to convince consumers that they are protected when nothing could be further from the truth? I’ve asked this question to David Seckman, head of NPA, and received no answer. It is quite a disservice to the dietary supplement industry when leaders pretend real problems do not exist.

Hatch takes in more money from Big Pharma than he does from dietary supplement companies – and as a veteran politician he walks both sides of the fence with considerable skill. It is vital that Hatch and Harkin help change the language within Senate bill S.1082 to actually protect dietary supplements.

This will require a major public demand, in both the House and to these Senators, to make this happen. You can take action now by clicking here.

Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, and educator. He is the author of Mastering Leptin, The Leptin Diet, and Fight for Your Health: Exposing the FDA's Betrayal of America.

Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. As founder of Wellness Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary supplement company since 1985, he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com