Editorial: FDA Losing Credibility

The FDA is losing credibility in its crusade to deprive patients in the U.S. of compounded estriol preparations. It's difficult to understand why they have "driven a stake in the ground" over this issue. Let's look at some facts.

1. Estriol is a natural component of the body.
2. Women's bodies have been producing estriol throughout the history of man.
3. Estriol has been marketed commercially in the U.S. in the past.
4. Estriol has a USP monograph.
5. Estriol is marketed in numerous countries throughout the world.
6. Estriol has been marketed in other countries for many, many years.
7. Estriol has not been proven to be unsafe; indeed, quite the contrary.
8. Estriol has not been proven to be ineffective; indeed, quite the contrary.

In their effort to dry up the supply of estriol, the FDA has warned pharmacies not to compound estriol preparations as it is an "unapproved" drug. (But, in fact, the FDA considers ALL compounded preparations as "unapproved drugs"). The FDA has warned suppliers they are selling an "unapproved" drug (How about the numerous other unapproved drugs, including acetaminophen, codeine, morphine?). The FDA is monitoring the importation of estriol through customs. It seems that estriol is now "outlawed". It also appears they have influenced insurance companies to decline reimbursement for compounded HRT preparations containing estriol.

What's next? Having women from puberty to postmenopausal age line up once a month for a dialysis treatment to remove the estriol from their bodies? Ridiculous sounding isn't it! However, it simply points out that estriol is a part of the hormonal complex upon which women depend. As the postmenopausal years approach, there is a decline in some hormones resulting in symptoms that can be effectively managed by hormone replacement therapy (HRT), including estradiol, estrone, estriol and progesterone.

As previously presented in this column, there are many, many commercial estriol products on the market throughout the world. In fact, the following news is available on the Internet today:

Trimesta� is being developed as an oral, immunomodulatory and anti-inflammatory agent for the North American market. Estriol has been approved and marketed throughout Europe and Asia as a mild estrogenic agent for over 40 years for the treatment of post-menopausal hot flashes.

In addition, other companies have estriol in clinical trials. So, why the big push?

In summary, IF estriol is dangerous and IF estriol is ineffective, THEN I don't think anyone would have a problem with discontinuing its use. However, that is NOT the case. This is a situation of a government agency making flawed decisions and losing its credibility. IF the FDA has valid data that estriol is unsafe or ineffective, THEN make it public!

One last word:

"FDA, we need you�but we need you to evaluate, approve and monitor commercially manufactured drugs�those that impact millions of patients and continue to kill large numbers of patients. We need you to regain credibility by doing what the agency was designed to do in the first place! Don't be influenced by the manufacturers you were designed to establish and enforce standards for and monitor. Let physicians prescribe and pharmacists compound individual prescriptions for patients, including those hundreds of thousands of women who are being satisfactorily treated using compounded hormone replacement therapy, including estriol."

I am reminded of a scripture verse, "� you strain at a gnat and swallow a camel". Let's hope the agency get's its priorities straight�too many people are being adversely affected and dying from FDA approved drugs. The numbers just don't add up for the agency to be spending so many resources when the numbers are so small in compounding. It's not good stewardship of our tax dollars.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Blood Levels, Bioavailability and Effectiveness!

Have we extended the concept of therapeutic blood levels and bioavailability too far into areas where they are not applicable? Are these concepts applicable to topical and transdermal therapy? In 2004, we published a paper on the relative bioavailabililty of ketoprofen in a PLO. The relative bioavailability was low (low blood levels) even though this formulation is very commonly prescribed and compounded with a great deal of success in pain management in patients.

Now, FlectorPatch (diclofenac), an approved new drug, is commercially available with "�improved pain relief at a variety of sites, including back, knee, ankle, shoulder, upper and lower leg, and hip". The promotional material goes on to say and even emphasize, "Minimal steady-state plasma concentrations. Range: 1.3 ng/mL to 8.8 ng/mL).

Perhaps we need to re-think our criteria for therapeutic blood levels and bioavailability in light of demonstrated effectiveness with minimal blood levels in an FDA approved product and other published studies.

Pharmacists as Government Professional Pharmaceutical Service Representatives-A Good Idea?

From the New York Times, March 20, 2008
A potentially useful antidote to drug company influence over the prescribing practices of doctors is under consideration in Congress. The idea is to have government-funded health professionals visit doctors to give unbiased guidance on the safety and effectiveness of drugs to counter the one-sided sales pitches they get from pharmaceutical company representatives. The end result should be better care, quite often at lower cost.

(With the example of the FDA and estriol and misinformation, I'm not so sure that the above will be an improvement. The FDA is certainly not without bias!-Editor)

IJPC supplies this list of providers of USP Chapter <797> products as a service to our readers. We strongly urge you to support the current advertisers and supporters (listed in bold) of IJPC.

The National Community Pharmacists Association has a new Pharmacy Compounding Committee that hit the ground running last week at its strategic planning meeting. Tony Welder chairs the committee and we look forward to the committee addressing a lot of compounding pharmacy issues.

Over-the-Counter Highlights
Each month, emphasize a different "OTC" group of drugs with decorations and informational leaflets you can put together and print out. For example, hay fever and allergies as spring approaches; sunscreens in the summer, etc. Use your imagination and you will educate your patients and even increase sales. Simple decorations using streamers, lighting, balloons, etc. can highlight the product section.