What's in the News

At it Again-be Warned

by Tammera J. Karr, PhD, BCHN, BCIH

I look forward to the holidays, my efforts to provide you with warm uplifting holiday cheer however is on hold this week as our illustrious congressmen are at it again – hoping we are all having dreams of health freedom dancing in our heads while we sleep.

Senator Dick Durbin and Congressman Henry Waxman are trying a new tactic in their attack on supplements after previous legislative failures. They have asked the Government Accountability Office (GAO) to review adverse event report data—but only for supplements. The GAO operates at the call of Congress, so some action on this request is inevitable.

In a statement, Sen. Durbin said, “The FDA has the tools necessary to determine which supplements can cause and have caused severe health problems—they should use them effectively.”

There is no evidence that legitimate supplements, that comply with existing law, have caused severe health problems. What the FDA needs to do is enforce existing law, not muddy the waters with continued bad policy, bureaucracy and ineptness.

The Alliance for Natural Health editorial posted on November 22, 2011- “Durbin’s idea that the FDA has the expertise to evaluate all supplements is pure fantasy. They aren’t set up for it and would fail even if they were. The agency is biased against supplements, it wants them to go through the drug approval process and thereby contribute to the agency’s budget. The end result of this mindset will simply be to clear the shelves of supplements.”

Just look at the number of adverse events reported (AER) for vaccines and drugs for 2008 alone:

• Supplements: 1,080 adverse events, of which 672 were considered serious;
• Vaccines: 26,517 adverse events, of which 3,923 were considered serious;
• Prescription drugs and “therapeutic biologics”: 526,527 adverse events, of which 275,421 “had serious outcomes.”

What may be considered an adverse event for one category may not be for another. If an FDA-approved drug has listed in the product labeling that it can cause fainting or nausea, chest pains or seizures, then it is considered to be within the range of expected outcomes.

USA Today noted, when it comes to supplements, what the FDA considers an adverse event can be “anything from a concern that a supplement isn’t working to a serious illness that follows consumption.”

What is clear is there are over 487 times more AERs for FDA-approved prescription drugs than for supplements, and 409 times more serious events for drugs than supplements. And Durbin thinks it’s supplements that are endangering the public?

The lack of attention to vaccine AERs is criminal, Alliance for Natural Health (http://www.anh-usa.org) reported the cover-up of HPV vaccine adverse events in the fall of 2011. The Institute of Medicine says it will only look at peer-reviewed research on vaccine AERs, but won’t sponsor any. They then conclude that vaccines like the dangerous HPV shots are “safe” because there is no “evidence” otherwise. “Huh, really are you serious?”

FDA positioning to incorporate European Union dietary regulations

In many areas of health practice and education, the European model is greatly restricted when compared to the US model. This means we can look to what has already happened in Europe to understand the consequences of the laws and regulations proposed here in the United States, as the laws and regulations often mimic those already in place in in the European Union.

KEY POINTS

1. Natural healthcare, most especially herbal medicine, is under fire in Europe at the moment. The losers in this process are the smaller players who have long been at the forefront of providing the most therapeutically relevant natural products.
   1. The FDA has been getting closer to the European authorities, they have worked together as the two most powerful entities in the Codex Alimentarius for many years. On July 2, 2007, the FDA signed a key agreement for scientific cooperation with the controversial European Food Safety Authority (EFSA).
   2. The Novel Foods Regulation in Europe requires pre-market approval for foods or food ingredients not used ‘significantly’ in the EU before 15th May 1997; and the Food Supplements Directive limits choice in food supplements and aims to reduce the maximum dosage of those remaining to levels that do nothing except prevent gross deficiency.
   3. In the USA– Dietary supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994. DSHEA has yet to be fully implemented, came about following the largest popular mobilisation against Congress ever seen in the USA. A pre-market authorization system, like the THMPD, would create an impossible obstacle for smaller companies.
2. The Trilateral Cooperation Charter
   1. The Charter was established in 2004 and signaled the intent of the USA, Canada and Mexico to combine their efforts in a trade protection bloc, focused primarily not on facilitating trade, but cracking down on “drugs, biologics, medical devices, food safety, and nutrition.”

After some 700 products were forced off the market, and the public and campaign groups started objecting, the FDA has withdrawn the Charter’s website.

The FDA constructed an incredibly broad definition of health fraud. Obvious targets are products that compete with pharmaceuticals because they are effective.

Health Fraud Definition [from the Trilateral Cooperation Charter]

The false, deceptive, or misleading promotion, advertisement, distribution, sale, possession for sale, or offering for sale of products or provision of services, intended for human use, that are represented as being safe and/or effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), to rehabilitate patients or to provide a beneficial effect on health.    Source: FDA, 2006

Regulators worldwide are working increasingly together, it’s no surprise we can expect increasing convergence in regulatory systems. This is what globalisation is, and it’s all about making the environment as cosy as possible for the biggest corporate players. Big Pharma, Big Food and Big Biotech are among the masterminds of this system.

Even though it is the holiday season, don’t let yourself be lulled into fantasia – the most valuable gift you ever receive is your health, it is your responsibility to protect it. Write your representatives before the end of 2011 voicing your opinion on what is happening to your health rights.