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Beware: Natural Substance Knock-Offs in FDA Pipeline are Dangerous

September 25, 2008 | 38,776 views

supplementsSome of the natural substances taken through the FDA approval process don't appear to be dangerous. Omacor, the FDA approved fish oil, is only a problem because it is so expensive compared to regular fish oil -- although taxpayers bear the brunt of this price difference, because Medicare won't reimburse any other fish oil.

However, there are other natural substances coming through the FDA approval process that are even more troubling. Pipex Therapeutics is seeking approval for Trimesta, a knock-off of natural estriol -- a substance that the FDA has just effectively banned.

But Trimesta may not be a safe version of natural estriol. Trimesta is a taken by mouth, which is known to be a greater risk factor for endometrial cancer than taking the hormones transdermally (through the skin).

And the FDA has already approved Prestara, another drug company version of a natural hormone, in this case DHEA. Prestara is taken at an oral dose of 200 mg daily, which is much too high for women; even doses of 50 mg in women may cause facial hair and other undesirable side effects.

Meanwhile, there are now bills in Congress calling for a ban of DHEA. Supposedly the concern is about athletes’ use of synthetic steroids. But contrary to false claims, no one can make synthetic steroids out of DHEA. The real reason to ban natural DHEA is to knock out the competition for expensive knock-off drugs.

Dr. Mercola's Comments:

At first glance FDA-approved versions of natural substances like omega-3 fats (Omacor) and the bioidentical hormone estriol (Trimesta) would seem like a step forward. The FDA, it would appear, is listening to public demand and providing some natural alternatives to prescription drugs, yet with their FDA seal of approval, making you, the patient, feel safe and secure. The illusion is that the FDA-approved omega-3 or estriol is somehow safer and more effective than the over-the-counter varieties or those coming from compounding pharmacies.

This, of course, is what the FDA (and the makers of Trimesta and Omacor (now Lovaza)) want you to believe, and it is incredibly far from the truth.

In reality, you can get very high quality, animal-based omega-3 fats without a prescription, and for a fraction of the cost of Lovaza. Why would the FDA want you to think otherwise? Because the FDA and 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.

Naturally, the FDA tends to protect the hand that feeds it, and a perfect example of that is what happened with estriol.

The FDA “Banned” Estriol, Now May Approve an Unsafe Prescription For It

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 Boards (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.

Aside from the obvious bias, this is even more troubling because Trimesta may not be a safe version of natural estriol.

According to Dr. Jonathan Wright, the problem with Trimesta is that it’s taken by mouth. Taking this hormone orally is known to be a greater risk factor for endometrial cancer than taking the hormone transdermally (through your skin).

As Dr. Wright said:

 "...When the inevitable findings of excessive endometrial cancer are ultimately disclosed, you can bet the blame will fall on the bio-identical hormone itself -- and not on the oral route of administration, which is known to be more risky."

And all the while, innocent people will be taking this “FDA-approved” version and assuming it’s safer than the one they used to get from their compounding pharmacist.

Calling All Physicians …

If you are a physician who prescribes bioidentical hormones, and would like to continue to prescribe them freely to patients whom you believe would benefit from them, please see the Health Freedom Foundation’s website. They have created an alert that will be faxed directly to the FDA Commissioner, and also be emailed to your Congressional representatives. You can personalize your letter if you wish.

If you are someone who is simply seeking the truth about where to find reliable health information, and safe natural substances to support your health, do not look to the FDA. As history has shown, they are not looking out for your safety. Sad as this may seem, the sooner you realize it the wiser, and the safer, you’ll be.

[+] Sources and References

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