Big Pharma and the FDA: Suppress the Science and Ban the Natural

In 2005, the pharmaceutical company Biostratum, Inc. made a mistake -- they invested millions of dollars into developing a drug, only to discover that the active ingredient, pyridoxamine, was a common, naturally occurring substance that has been sold for decades at low cost.

Biostratum responded by asking the U.S. FDA to declare supplements containing pyridoxamine “adulterated,” and effectively ban anyone but Biostratum from selling pyridoxamine. Earlier this year the FDA agreed to ban companies from selling pyridoxamine as a dietary supplement.

The FDA’s comment on the decision specifically says, “To allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.”

Apparently, they were not as concerned about fairness to consumers.

This is hardly the first time the FDA has attacked naturally occurring substances. The FDA has banned information about scientifically proven health benefits of cherries from appearing on Web sites. And for years, the FDA barred health claims about the benefits of omega-3 fats for heart, cancer, depression, body pain, and various other conditions until a drug company paid a great deal of money to go through the approval process.

In the case of pyridoxamine, the FDA did not act out of concern for public safety. This is about a profit-seeking corporation taking advantage of corruption in what is supposed to be a public health organization.

Pyridoxamine is one form of the vitamin B6. It is an important nutrient for helping your body process carbohydrates, support your nervous system activity and prevent homocysteine, which has been linked to increased risk of heart disease, from building up in your blood.

This substance has long been sold over-the-counter as a dietary supplement, but the FDA abruptly put a stop to that in January 2009. Their reasoning has nothing to do with safety, but rather is firmly based on protecting a drug company’s investment.

As stated above, the FDA actually said:

“To allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.”

What is happening here is a blatant example of the FDA protecting the hand that feeds it. It is now essentially banning vitamin B6 in the form of pyridoxamine, and reserving it to be exclusively distributed by the drugmaker Biostratum, Inc.

If the FDA really wants to speak about being fair, why are they not worried about being fair to the supplement makers who already distribute this product … or the people who will have their inexpensive supply of this vitamin taken away?

Why?

Because the FDA and U.S. government are loaded with people trying to eliminate all competition for the drug companies, who financially support the FDA in the form of user fees for drug approval.

This Type of Injustice Has Happened Many Times Before

To get a feeling of who the FDA is really looking out for, you need look no further than the recent estriol debacle.

Estriol is a bioidentical hormone that is sometimes used in hormone replacement therapy drugs, available through compounding pharmacies. However, estriol is not an FDA-approved drug, and according to the FDA estriol “has not been shown to be safe and effective for the uses for which it is being prescribed.”

Therefore, the FDA has proposed to allow estriol-containing prescriptions to be filled only if accompanied by an Investigational New Drug (IND) application, stating that the use of INDs is “routine,” and therefore shouldn’t cause any major inconvenience or limitation on estriol’s use, if and when a physician believes it’s in his patient’s best interest.

However, the IND places a significant financial burden on physicians, most notably by requiring them to submit applications to an Institutional Review Board (IRB). Submitting necessary documentation and contracting for a private IRB can easily cost between $10,000 and $25,000 and can take months.

So the process will effectively ban most physicians from prescribing estriol, which is a much safer, natural alternative to synthetic hormones.

This news is frustrating in and of itself, and certainly highlights the need for less government involvement in health care. But what happened next is nothing short of infuriating.

Pipex Therapeutics is now seeking approval for Trimesta, a knock-off of natural estriol, and the FDA is in the process of considering the approval!

Clearly, the FDA was never concerned with estriol being used in an unsafe manner -- they were concerned that their drug-company buddies were not getting their fair share of the profits.

Is The FDA Your Protector -- or a Threat to Your Health Freedom?

Examples like this one and the latest pyridoxamine scandal are red flags that the U.S. FDA is not there to protect you, or your health freedom.

You may not be aware, but in June 2007 the FDA announced new standards for dietary supplements that were intended to improve consumer safety.

In reality, the 800-page rule surrounds the dietary supplement industry with regulations and requirements in excess of those imposed on the drug industry, and up to 50 percent of small companies will simply not be able to afford to comply.

Even before this ruling, supplement makers were (and still are) limited from making health claims (this is reserved only for drugs).

Sounds reasonable, doesn’t it?

But consider that it’s still illegal even in cases where the claims have been clearly proven -- so cherry growers cannot legally say that tart cherries may do more good than aspirin or other anti-inflammatory drugs when it comes to pain relief, even though studies back them up.

This is why the American Association for Health Freedom (AAHF) states that the FDA “ignores first amendment protections and censors the communication of valid scientific information.” They continue:

“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.”

The FDA is clearly censoring your right to know about, and purchase, foods and supplements that can help you stay healthy and prevent disease. At the same time, they are allowing dangerous drugs and consumer products to remain on the market and be sold and aggressively advertised as safe.

Even the FDA has admitted to its shortcomings and in a report said:

• “The FDA cannot fulfill its mission because its scientific base... is weak...."
• "The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability."
• "FDA does not have the capacity to ensure the safety of food for the nation."
• “The development of medical products based on 'new science' cannot adequately be regulated by the FDA.”

You Can Sign a Petition to Help

The AAHF is leading a campaign to reform the FDA, and your help is urgently needed, as a large number of signatures are required to compel Congressional Action.

So if you believe reforming the FDA is a worthy cause, please sign the petition now, and encourage your friends and family to do so also.

Congress already knows the FDA represents a serious problem. This petition will help move them to take the urgent action required to invoke much-needed positive change.