Congress Criticizes FDA Over HRT Ingredient
7 CommentsBy Ed Silverman // May 8th, 2008 // 12:36 pm
A bi-partisan group of Congressional reps have introduced a resolution* criticizing the FDA for its recent move to warn compounders about their use of estriol in their bioidentical versions of hormone replacement treatments.
Last January, the agency questioned the safety and effectiveness of BHRT products, citing unsupported medical evidence, and false and misleading claims. The agency accused seven compounders of claiming their products are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat such diseases as Alzheimer’s, stroke, and various forms of cancer, according to the FDA.
And last month, US Senator Tom Coburn, a Republican from Oklahoma, wrote a letter to FDA commish Andy von Eschenbach seeking agency data on actual adverse events and and to demand the agency reconsider its decision, because some insurers are supposedly no longer covering the products.
The issue has pitted compounding pharmacies, among others, against Wyeth, which in 2005 filed a citizen’s petition with the FDA in an effort to stop compounders from making bioidentical versions of Prempro, its controversial hormone replacement therapy. In lawsuits, some women claim Prempro has caused them to develop breast cancer.
* To view the resolution, go to Thomas.gov, click the little button that instructs you to search for bill number and type in H. Con. Res. 342.
Dan
Congress is not the only critic:
The Conversion of Our Protector
The Food and Drug Administration was created several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed in forming a pathological alliance with the pharmaceutical industry through the money the industry gives the FDA for various reasons, yet so large amounts of funds are issued to the FDA by the industry that it has resulted in half of the FDA’s annual income. Results of this relationship, one could posit, have been the approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform, and have failed to do so as much as they should for our benefit.
And the intimacy between the two organizations seems to continue to progress, as illustrated with the new proposal by the FDA to allow the industry to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and have been penalized for this behavior in the past.
This FDA protocol, called, “Good Reprint Practices”, would require reps to use what does not truly exist, which is truthful and authentic clinical trials if they do speak off-label. This in itself lacks etiology for such discussions by reps, as most clinical trials are flawed due to the trials being manufactured by the pharmaceutical companies of the meds involved in such trials. Additional trial deception involves ghostwriting and invalid authors of such trials. These facts can be validated and have been discovered by others.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability to analyze data regarding this issue. This complicates the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to manipulate statements to prescribers for their own benefit. So, our previous safety association, the FDA, appears to be evolving into our harmful association by suggesting such practices with deliberate intent and reckless disregard for public health, so it seems. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, in my opinion. Further, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med.
However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds. Regardless, awareness needs to happen by the citizens involving tactics that are deceptive such as this and many more activities by the pharmaceutical industry that are overall covert and tacit, to insist on the focus of the interest of others besides themselves.
Dan Abshear
Justice in Michigan
Just a couple of partics re: Dan’s post - PDUFA does not fund half of the FDA, but rather half of CDER (about 1/3 of the FDA overall).
Its impact continues to be much debated. Personally, I have been more convinced by arguments concerning its impact on CDER’s resources (which have been downsized in the interest of paying the other half) then the “coziness” argument.
Re: this particular case, I have no knowledge. The link above didn’t get me to the resolution. So - allowing for later correction - it has the “feel” of Orrin Hatch and Company protecting the supplement biz.
Off-base?
Anyway, nice to see at least one conservative Senator (Coburn) arguing against the omniscience of FDA. I hope he will bring the same wisdom to consideration of preemption.
But I doubt he will.
Dan
Justice,
Thanks for the correction, but I read the FDA is funded by 46 percent by the industry, but that may include other industries besides pharma.
Appreciate the info,
Dan
Justice in Michigan
Maybe someone can clarify for us. PDUFA is, of course, Prescription Drug User Fees - so that’s the drug arena, and half of the CDER budget.
I am not sure whether devices and biologics also entail user fees (probably so). And then there’s food, pesticides, etc..
Someone in the know will probably chime in.
harpy
Yes, JIM, there are medical device user fees too.
compound pharmacy
Ingredient i guess are not much harmful but the way compound mix must required stricknes.I like your blog.Its very informative.A “compounding pharmacy” is a pharmacy that will take one type of medication and put it with another medicine or another type of vehicle in which to give the medicine. For instance, say that you had a cat that wouldn’t take it’s medicine - I would call up this compounding pharmacy and ask them to grind up the pills and put it into a specially flavored medicine (triple fish works well). Or - they could put it into a gel that we could put on the cat’s ear - and it would go through the skin. Or you could mix two medicines together, etc. They also sell medicines like a regualar pharmacies. Hoope that helps!
jeffrey dach md
The Safety Of Bio-Identical Hormones by Jeffrey Dach MD
Are Bio-Identical Hormones Safe? When used properly, my opinion is that they are safe. What about the issues of Breast Cancer and Heart Disease?
Let’s take a closer look at the data and come to some conclusions…To read more…
http://jeffreydach.com/2008/06/27/the-safety-of-bioidentical-hormones-by-jeffrey-dach-md.aspx
Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
http://www.drdach.com