Tuesday, December 09, 2008

Important Update about Reforming the FDA

The FDA is a broken agency that censors medical science, obstructs innovation, and protects the medical monopolies that pay for much of its budget. The FDA needs reform, and we need your help to do it. Elected officials and government agencies know that numbers matter. When the public is aroused and demands action, Congressional action usually follows.

Even while the FDA is approving faulty and dangerous drugs and medical devices by the thousands, it continues what can only be described as a harassment campaign against those who want to rely on wholesome foods, dietary supplements, and lifestyle changes to achieve natural good health.

Here are just a few recent examples:

□ FDA employees recently protested in a letter to Congress that they have been forced to approve medical devices against their better judgment. The letter stated that FDA managers “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.” The devices that FDA regulates impact more than 500 million adult and pediatric procedures performed every year in the U.S.

□ The FDA’s current efforts to reinterpret and thus amend the Federal Food, Drug, and Cosmetic Act threaten continued access to dietary supplements. If the FDA got its way, a food constituent studied for medical use (and published) could thereafter not be used as a new supplement. To illustrate how this might work, one company's fish oil is now an approved drug, and by this definition any new supplement with fish oil added might be prohibited. AAHF provided formal comments in response to the FDA’s deliberation process and explained why current law prohibits the FDA from adopting these anti-supplement regulations.

The FDA approves toxic chemicals for use in baby formula, baby bottles, and prescription drugs.

□ The FDA stated that no amount of melamine was safe in infant formula. Then melamine was found in formula at levels below 1 ppm. Suddenly the agency reversed itself and stated that melamine was safe provided that (coincidentally) there was no more than 1ppm. Was there a new study or other science to justify this claim? No. It appears to have been made up out of thin air in order to protect commercial interests. Melamine is a toxic chemical that has been linked to kidney damage and children are especially vulnerable.

□ The FDA recently declared Bisphenol – a (BPA) exposure to be safe for infants, even though Canada has banned the chemical from baby bottles. Thirty-six scientific advisers on an independent government panel concluded that the draft decision of the FDA on BPA used “unacceptable criteria for selecting data and depend(ed) heavily upon a key paper that is fatally flawed.” These experts concluded that the FDA chose industry-funded research studies and appeared to ignore hundreds of studies that have been funded by NIH (National Institute for Health) and its counterpart in other countries. BPA is linked to cardiovascular disease, type 2 diabetes, and liver enzyme abnormalities. In addition to being used in baby bottles, it is also used in water bottles, canned goods, dental fillings, children’s teeth sealants, and orthodontic sealants.

□ The FDA has approved the use of phthalates in prescription drugs and over-the-counter medications despite the fact that Congress banned phthalates in toys and other children’s products. Widely used as plasticizers, phthalates have been linked to abnormal reproductive organs, sperm damage, and reduced testosterone in animal tests as well as some human studies.

The epidemics currently plaguing this country-- cancer, obesity, diabetes, asthma and allergies, and many other debilitating disorders-- are linked to manmade products and processes that the FDA has approved and promoted. These failures have resulted in the sickest generation in the history of this country. The agency seems to have lost sight of its mandate to protect the public and has instead come to see itself as the guardian of corporate interests. It is time to end the many conflicts of interest linking the FDA to the pharmaceutical and chemical industries, conflicts of interest that betray the public and harm so many American consumers. It is time to reform the FDA!

Spread the word. Together, we can make a difference. We can turn the FDA around and help restore our national health. Please sign AAHF’s petition to reform the FDA at www.reformFDA.org.

1 comment:

  1. Anonymous1:45 AM GMT-5

    Thank you for keeping us informed on these issues.

    Duane Sherry, M.S., CRC