Limiting Testosterone
Testosterone and libido studies:
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Testosterone and muscle mass:
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Testosterone and fatigue:
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Hi guys. I think the issue is not well understood how FDA regulate drugs.
There are two main problems that worry the regulators on the issue of the enormous up use of testosterone and some data claiming bad outcome on patient.
Making claims by the pharma industry which were not backed by data submitted reviewed and approved by FDA.
The other basic issue in medicine and drugs is that a medical treatment should be for a defined medical state, illness and “make no harm” to patients. Aging and antiaging are not defined as medical condition or illness. It is defined as natural course of life. Industry never proved
by clinical studies that giving male testosterone made any man younger or elongated male life.
3. The existence of scientific doubt, though may be bad science, raise the issue of “may harm” to patients and drug adulteration and is enough to make the regulator, FDA , worry and try to block illegal use, abuse of drug and request industry to perform clinical studies and submit data on the issue raised e.g. cradiological issue.
You can read for instance what is the regulatory state of Depo-Testosterone T-Cyp and understand what kind of data submitted to FDA on that product and for which indications industry submitted data on efficacy and safety for the product. You will see that FDA have not been requested to review data on benefit of aging male.
http://www.drugs.com/pro/depo-testosterone.html
You can read for instance what is the regulatory state of AndroGel at
http://www.drugs.com/pro/androgel.html
For instance the state of data submitted by abbvie in support of Geriatric Use is :
“There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing AndroGel 1% to determine whether efficacy in those over 65 years of age differs from younger subjects. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH”.
So by advertising AndroGel, abbvie was violating drug laws claiming or suggesting adulteration and false claims and cheating consumer according to the law. FDA forced abbvie to stop those false advertisement.
It does not mean that there are no scientific data that Testosterone is involved in libido, muscle mass or fatigue. It just means that AndroGel or any other T product cannot be sold as drug for those unproved and unapproved indications as law require. And as T products are defined by law as drug, FDA by law has to control sale.
It is another issue of the insurance, if the drug is not authorised for an illness of course the insurance will refuse financing, except for the approved indications .
It may be now a challenge for industry to decide whether they wish to finance and back the claims with clinical trials that cost so and so in order to have the ability to add these claims to the label . Not us the patients nor FDA can put the money and effort to generate the data . It is going to be an interesting game to follow what FDA -industry-and medical bodies will act in the mater. May be we the patients are going to lose an important treatment .
. Actually double checked my facts.
