Senator Tom Coburn, MD

(Who We're Hoping Will Introduce the Emord Amendment to Protect DSHEA)

IAHF List: Please See Byron Richard's latest update on the S.1082 below. Thanks for your ongoing assistance- please keep making calls and sending faxes and emails today. The Senate is out of session today, but staff are still there for you to communicate with. 

An IAHF ally on Capital Hill is making a concerted effort to try to persuade Senator Tom Coburn of Oklahoma to introduce the Emord amendment (our amendment to remove the terms "Foods and Food Ingredients") to the bill. Senator Coburn is an MD and he is in the dietary supplement caucus. He values alternative medicine and dietary supplements and has expressed the view that the high cost of health care could be reduced if more people were to utilize dietary supplements for preventive purposes.

I am going to need to travel to DC at some point when this legislation gets into the House, but its too soon to tell when that will be. Please keep in mind that the Senate and House language ends up being cojoined via whats called a "Conference Report" and that COMBINED PACKAGE is what gets sent to the President's desk for his signature. (All kinds of mischief often happens when the combine the House and Senate language into one package.) The price of freedom is eternal vigilance. Donations for airfare and 10 days lodging on the Hill to insure that we don't get burned in the House and in the Conference Committee Markup would be very helpful at this time.

 IAHF 556 Boundary Bay Rd. Point Roberts WA 98281 USA

Paypal http://www.iahf.com/index1.html  

May 5, 2007

By Byron Richards, CCN

NewsWithViews.com

permission to reprint

Bill S1082 is a bill that helps fund the FDA with Big Pharma money.  It is known all over Capital Hill as Big Pharma-designed legislation.  It is running into all sorts of credibility problems.  A vote is likely on Monday – delayed due to all the opposition flooding the Senate by “we the people.”

Realizing that meaningful FDA reform legislation is not likely again for ten years numerous Senators are backing the Dorgan amendment to S1082.  The amendment enables U.S. citizens to buy drugs from Canada and other industrialized nations.  This will save us at least 50 billion dollars over the next ten years and cut the price of many drugs in half.  Those opposing the amendment, which includes most of the major proponents of S1082 and the Bush administration, are the ones clearly on the payroll of Big Pharma.   Their excuse for not supporting it is flimsy – that it will cause safety problems.  The majority of Senators are not buying this transparent cover-up.  Dorgan won Round 1 of the voting on his amendment yesterday (63-28), showing that he has the power to hit Big Pharma where it hurts – in the pocketbook.  A final vote on the Dorgan amendment is expected Monday (keep up support for the Dorgan amendment).

Last year’s Institute of Medicine report labeled FDA management as dysfunctional causing FDA reform to pick up momentum.  To deflect public outrage S1082 was created by Kennedy and Enzi, in close consultation with the FDA and Big Pharma.  As you might expect from such a meeting of the minds, the bill is really a Big Pharma-sponsored con job and it actually increases the power of dysfunctional FDA management. 

Unfortunately for Big Pharma and the FDA, Charles Grassley (R-IA), a man concerned with true and meaningful safety reform, has gone through S1082 with a fine tooth comb.  He has proposed 11 amendments to close the Big Pharma loopholes that Kennedy, Enzi, the FDA, and Big Pharma built into this legislation.  Big Pharma and the FDA hate all 11 Grassley amendments and Big Pharma has its legion of lobbyists trying to defeat them as you read this.  Support the Grassley amendments for true and meaningful safety reform.

As I have been reporting for the last week, language relating to the Reagan-Udall Foundation for the FDA creates a new regulatory category and broadens FDA power in a way that can be used to attack dietary supplements.  In response to this devious threat, Jonathan Emord, our nations leading health freedom attorney, prepared amendment language to nullify the threat – an amendment we now call The People’s Amendment.  Many of you flooded the Senate with your objections – AND YOUR VOICE IS BEING HEARD.

I have obtained an e-mail message from David Taylor, the president of the Natural Products Association, which went out to various heads of nutrition companies – in an effort to get companies not to protest S1082 (dietary supplement trade groups are not the friends of health freedom).  It contained an attachment with a transcribed conversation between Hatch, Harkin, Kennedy, and Enzi about all the phone calls you’ve been making.  It shows that Hatch and Harkin don’t really understand what the Reagan-Udall foundation is, that Kennedy and Enzi are lying about what it will do, AND THAT WE ARE GETTING THROUGH.   Here is the text:

SEN. HATCH:  My office has been inundated by calls from people throughout the country who believe that this legislation, specifically the provision establishing a Reagan-Udall Institute, will overturn the Dietary Supplement Health and Education Act of 1994.  That has not been my reading of the bill, but I wonder if other Senators have heard similar concerns?

SEN. HARKIN:  Yes, I have received a good many calls as well.  And, I have to say that I would be very concerned, as I know the Senator from Utah is, if anything in the bill we are considering, S. 1082, would overturn DSHEA, a law we fought side-by-side to see enacted.

SEN. ENZI:  It might be helpful if I explained the provision you are discussing, as my office has received many calls as well and I believe the callers are not informed about this matter.  Subtitle B of Title II of S. 1028, establishes the Reagan-Udall Foundation for the Food and Drug Administration.  That simple purpose of that non-profit Foundation is to lead collaborations among the FDA, academic research institutions and industry designed to bolster research and development productivity, provide new tools for improving safety in regulated product evaluation, and in the long-term make the development of those products more predictable and manageable.

SEN. KENNEDY:  That is exactly the purpose of the Foundation, which was included in the drug safety legislation Senator Enzi and I introduced last year.  The Foundation will be financially supported by industry and philanthropic donated funds.  A Chief Scientist at FDA will promote intramural research and coordinate it with efforts at the Foundation.

SEN. HATCH.:  That explanation is very helpful.  What, specifically, would the role of the Foundation be with respect to dietary supplements?

SEN. KENNEDY:  Let me make absolutely clear that the Reagan-Udall Foundation will in no way override, overturn or conflict with the Dietary Supplement Health and Education Act.  Nothing in this bill would have that effect.

SEN. ENZI:  Yes, we took great pains to make certain there would be no conflict with DSHEA.  Regarding foods, and dietary supplements are generally regulated as foods, the general directive of the Foundation is to identify holes in the evaluation of food safety and identify ways to address those deficiencies through collaborative research with industry.

SEN. HARKIN:  So, to make this absolutely clear, what you are saying is that the bill we are debating would in no way interfere with consumers’ access to dietary supplements?

SEN. HATCH:  To add to that point, it seems that the language could, in fact, help dietary supplement consumers, because it would allow collaboration between government and industry to conduct research on issues that might be helpful to supplement consumers?

SEN. KENNEDY:  Yes, that is the case.

SEN. ENZI:  I agree with Chairman Kennedy’s assessment.

SEN. HATCH:  I thank you for those assurances and that clarification.

SEN. HARKIN:  This has been a very helpful discussion, because Senator Hatch and I could never support legislation that would interfere with DSHEA and we are glad to receive the assurances of the Chairman and the Ranking Republican on the Committee.

This is a major breakthrough – Kennedy and Enzi are now on record stating this will in no way affect our dietary supplements.  And Hatch and Harkin are on record as being concerned.  There are still two problems.  1)  Kennedy and Enzi are hard to trust, based on all the Big Pharma loopholes built into their bill.  2)  The FDA and its lawyers get to interpret what S1082 means once it becomes law.  The FDA could care less what Hatch, Kennedy or Enzi intended to say.  Until the language is fixed it is a problem of magnitude. 

As you can see from the Kennedy and Enzi comments above, they are portraying the Reagan-Udall Foundation for the FDA as a benevolent and friendly group that will facilitate collaboration between the FDA, academia, and private industry – receiving funding from industry and philanthropic donations – and oh yes, let’s not forget the foundation may even help with safety.  Do you really think the FDA needs to create a whole organization to do that?  And why wouldn’t such duties just be the function of a few people or a department within the FDA?   

It is my opinion that the primary reason for bill S1082 is to create FDA, Inc. by using the Reagan-Udall Foundation for the FDA.  The FDA wants to be in the drug development and marketing business and is looking for a way to do it.  Most of the issues in S1082 are a smokescreen, keeping Senators like Grassley busy fighting all the Big Pharma loopholes.  So far Kennedy and Enzi have skillfully created so much diversion that nobody is paying attention to the FDA becoming a drug company.

In a nutshell, Andrew von Eschenbach, M.D, head of the FDA, has a long history of involvement with the cancer-for-profit industry.  His resume includes being head of the National Cancer Institute, where he routinely diverted funding from solid cancer science into the pockets of his friends in Big Bio Tech.  He was also a lead player in an old boy network called C-Change, a group of the most powerful vested interests in biotechnology and cancer research – which is headed by George Bush Sr. and his wife, Barbara.  It is not surprising that the current president backs Big Pharma and Big Biotech as he does – his family wealth depends on it.  Drug research and development performed at the Reagan-Udall Foundation will undoubtedly be paid for, in large part, by companies who have grants from the National Cancer Institute (taxpayer funds). 

Von Eschenbach took over the helm of the FDA to create his dream of a cancer sickness industry wherein nobody actually gets well – they just live indefinitely in a sick condition on really expensive biotech drugs.  This project is called the Critical Path Initiative.  The FDA has created highly sophisticated software that can identify protein-molecule changes at the cellular level.  The FDA wants to use this computer software to design the entire next generation of powerful biological medicines – making all of private industry use its software technology.  The Reagan-Udall foundation is the tool that FDA plans to use for patent protection and licensing arrangements of its technology with private industry – and thus the creation of FDA, Inc.  Von Eschenbach is on record as stating that the Critical Path Initiative is the FDA’s top priority (not drug safety or food safety).

The Critical Path Initiative has been repeatedly attacked because it would expose patients to drugs with far less testing for safety and effectiveness compared to drugs already on the market.  Furthermore, these biologic drugs will be far more powerful because they throw gene switches in cells – meaning the risk for adverse events skyrockets.  Initially, just patients with no other medical hope will be the guinea pigs.  The FDA wants to run this technology in all doctor’s offices around the country – which will require your DNA in an FDA-owned government database.  This is not science fiction – this is what the FDA is on public record as wanting to do.

Anti S.1082 Food and Drug Revitalization Act

May 5, 2007

The Honorable (Senator First and Last Name)

Address
Address

Dear Senator Last Name;

The issue of drug safety and access to drugs at a fair price is of the utmost importance to myself and all Americans. In general, I am opposed to Senate bill S1082: Food and Drug Administration Revitalization Act, as it does not go far enough to protect myself and my family from the dangers of drugs. If it is to be passed I want all 11 Grassley amendments which are true safety reform added to the bill.  I am also in favor of the Dorgan amendment that enables Americans to get a fair price on prescription medication.

As one of the 150 million Americans that rely on dietary supplements to keep myself and my family well, I am especially concerned that this legislation broadens FDA regulatory power to harass functional foods and dietary supplements – which has nothing whatsoever to do with drug safety.   While Senator’s Kennedy and Enzi are telling us not to be concerned – we simply don’t trust the FDA and want language that protects dietary supplements in this legislation.

It is vital that the terms “food” and “food ingredients” be removed from this legislation. There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. This bill authorizes the creation of a new regulatory category that enables the FDA and the Reagan-Udall Foundation for the FDA to attack dietary supplements and functional foods. This problem in the wording can be corrected with this simple amendment – so as to be sure this legislation is about drugs and drug safety only.

Purpose of the amendment:
The bill, S1082: The Food and Drug Administration Revitalization Act, is hereby amended to eliminate any reference to the terms food or food ingredients, such that food and food ingredients will not be subject to any jurisdiction or control by the Reagan-Udall Foundation for the Food and Drug Administration.

Intent of amendment:
To eliminate from the bill any possibility that food or food ingredients would be treated like drugs either for safety review purposes or for assessment of their efficacy. It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.

Sincerely,

Related articles:

Senators Bribed by Big Pharma vs. Senators not Bought Off 5-2-07

Dietary Supplements Threatened, Freedom in Danger 4-30-07

U.S. Health Freedom on Verge of Collapse 4-25-07

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