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

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Dr. Mercola
September 25 2008

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

Some 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.

Sources:

Health Freedom Foundation

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.

Related Links:

FDA Announces Plan to Eliminate Vitamin Companies

The Codex Conundrum and How it Affects Supplements in America

Secrets of the FDA Revealed by Top Insider Doctor

Community Comments (14)

Posted On Sep 05, 2008

Omacor is a completely ineffective and rancid oil that is highly refined. There is absolutely no healing qualities in this oil whatsoever and it is a complete scam and waste of our tax dollars. I have tested this synthetic 'so called oil' on tons of my patients and it will never work in their body the way quality fish oils are supposed to. They will never get any benefits from this oil which unfortunately is like so many other over the counter refined rancid oils that are available today. Buyer Beware!

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NutritionalHealingCenters

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Posted On Sep 25, 2008

At a meeting w/the PA at a cardioligist's office, I was explaining that I was taking fish oil (I now take Neptune Krill Oil) instead of statins and that I would never take statins. The PA said " I have some samples of a fish oil".(Omacor) As he handed me the little bottles, he made the mistake of saying "And the good news is your insurance will pay for them b/c they are prescription." RED LIGHT!!! When I got home I "did my due diligence". Omacor maybe was, at one time, fish oil. But "they" have tinkered w/it much as Splenda was once sugar. So I never took any. AND I took my samples AND my research to the cardioligist at my next visit. Sadly, I have no doubt it was immediately filed in "File 13"!!!!!

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Hopegiver

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Reverend Alan

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Posted On Sep 25, 2008

Those free samples of "fish oil" that "your insurance will pay for" are probably in just about every doctor's office by now. My NP handed me a few free samples since he knew I was into "health". NO THANKS!

I really liked how you put it, "much as Splenda was once sugar." LOL! That was great.

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A Storm

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Posted On Sep 25, 2008

Hey Reverend,

Great response to the doc. Maybe if everyone would say 'no thanks', the docs would complain and get things changed. They are so busy that it takes a knock on the head before they take the time research one single subject.

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KelleyEidem

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Posted On Sep 25, 2008

In order for the drug company to obtain a patent, they have to turn the compound into a different physical shape than what is natural.

It's like a key with the notch in the wrong place...useless. Only when it comes to swallowing things with bad notches the outcome is usually worse than useless.

Dr. Emanuel Revici, M.D. (The Doctor Who Cures Cancer) found that rotating one hydrogen atom on a fatty acid (fish oils are rich in fatty acids) a mere 90 degrees would turn that fatty acid into a killer. It literally produced rancidity in the body.

If a single 90 degree shift can do that, imagine what more would do. It is critically important make sure the fatty acids we consume are natural.

The best to you.

Kelley Eidem

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Posted On Sep 25, 2008

nature/intelligent design always wins and no side effects -_-

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sobber

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Posted On Sep 25, 2008

My husband has been prescribed Lovaza (Omacor) by his personal physician After he filled the prescription, I reviewed the ingredients in the capsule and was shocked to discover it contained partially hydrogenated vegetable oils including soybean oil. I sent an email to GlaxoSmithKline regarding this concern and referenced a New England Journal of Medicine report, which stated that "on a per-calorie basis, trans fats appear to increase the risk of CHD more than any other macronutrient." I did receive a reply from GSK, which appeared to be an automatic response telling me basically that "a physician can best discuss concerns and answer any questions about symptoms, conditions, and treatment." Why in the world would they include partially hydrogenated oil in a product like this. Unbelievable!

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swdickens

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MiaLucia7

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Posted On Mar 03, 2009

On a related note, the free samples of prescription prenatal vitamins my OB gave me at my first pregnancy visit contained...you guessed it, hydrogenated oils! In prenatals?! Yikes!! I threw them all away and used Dr. Mercola's multi and Carlson's cod liver oil throughout the pregnancy. I ate very well, exercised 5-6 times a week, and had a fabulous pregnancy and a healthy baby boy!

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Posted On Sep 26, 2008

No thank you the Fool's Drug Advactor has not approved any of this. What a joke that we have a Government agency that only looks at one side of everything. It is a dream, but would it not be sensible to look at all presentations rather than just the one that is very expensive, and then berate those that did not have the involvement of BIG PHARMA'S Alchemists involved.

I will stick with my vegetarian 3-6-9. According to my health professional, I doing fine.

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curious7

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