Well, the battle lines have been drawn. On one side, the FDA, Wyeth, and the organizations that rely on pharmaceutical manufacturers, and on the other, compounding pharmacy, independent physicians, and hundreds of thousands of patients. Obviously you know what side I am on in David vs. Goliath struggle.
There is not enough space here to go into all of the details, and that is what the FDA et. al. is counting on. The idea is that the issues are too complex and involved for the average folk to understand.
The FDA recently wrote letter to 7 pharmacies and told them to stop making false claims about Bio-Identical hormones, to stop calling them Bio-Identical hormones, and to stop using Estriol in their preparations, because they don’t have any data on the safety and effectiveness of Estriol. The FDA did not even visit these places, they just looked at their web sites.
Counterpoints to the FDA’s claims are several, and more compelling than the original arguements. Let me first say that it is not appropriate to make false claims and to mislead the public about safety and effectiveness. On that much everyone agrees.
The source of the data is where the fight is. There are volumes of data that show the “claims” that are made about bio-identicals can be justified. The FDA may not like that data, so they can use terms that marginalize the data.
As for the term Bio-Identical, what else should we call the hormones….Iso-molecular?, Same as endogenous?. They all mean the same thing. Even manufacturers use the descriptive term Bio-Identical. So what is the real harm is using this term?
The data on the safety of Estriol is also voluminous. This item is used all over the world. Estriol has an official United States Pharmacopeia monograph (which means it is recognized by the authority over drug manufacturing as well as compounding). Estriol is even in the final stages of study for FDA approval for safety and effectiveness for a commercial drug manufacturer.
The idea that an item needs to have the FDA seal of approval brings up several points. There are several medications that are available that have not had FDA approval. There are less than in the past, but they are still there. A couple that come to mind are aspirin, and phenobarbital. I believe that digoxin is on that list as well. Each of these items plays an important roll in our society without the FDA 'ok'.
Having the FDA approve a medicine as safe and effective, is no guarantee of either. Many drugs have been removed from the market because they are not safe, or are not effective. Just this past week, a study on a heavily advertised cholesterol drug was released that showed there was no benefit to taking the medicine, and there might even be a problem if taken with another popular drug.
The bottom line is that you need to make informed choices about your medicine, and you’re health care in general. The FDA and drug manufacturers can be a part of that equation, just as compounding pharmacies like ours can be, but they should absolutely not control your care and your choices. This is something that we must all fight for!
Take care,
Rich
