2005P-0411

Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

FDA Comment Number :

EC6970

Submitter :

Ms. Eve Salczynski

Date & Time:

03/06/2006 09:03:12

Organization :

Ms. Eve Salczynski

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

It is ludicrous to even think of banning naturally occurring hormones because their operating mechanism is similar to or even identical to a patented formula. If anything, it should be the other way around!!

Several factors need to be kept in mind:

1. Naturally occurring hormones/medications existed first and, as such, cannot be patented. And because they can't be patented, they can't generate any significant income for pharmaceuticals.

2. The natural versions, however, were the 'templates' for the laboratory-concocted formulas. These formulas can indeed be patented and thus be the source of a huge income. Bottom line: it's all about money and nothing more.

3. Both the naturally occurring hormones and the lab formulas can be obtained only by prescription from certified medical professionals. These professionals, who actually know the patients and their particular conditions, are best suited to decide what therapies to prescribe.

4. Wyeth Pharmaceutical's argument that patients will suffer adverse effects from natural hormones is both spurious and even ludicrous since it is a lame attempt to deny both physicians and patients the right of informed choice.

5. If informed choice determines that the natural hormone is more beneficial, then it's the patients' right to receive it and the physicians' duty to presecribe it. Since this essential axiom isn't part of Wyeth's reasoning, then their arguments, no matter how seemingly rational or even benevolent they seem to appear, clearly demonstrate that what's best for the patient is not their priority. Their priority is what's best for Wyeth. Bottom line: it's all about the money and nothing more.

There's nothing wrong with making money, even a lot of it. But money should not be made at the expense of what's best for patients. Concoctions were once referred to as snake oil and there were a lot of people that swore by their efficacy. So there's a place for snake oil in the marketplace and it's the option of choice for some people and physicians. Just don't let it be the only option.