FDA Declares War on Bioidentical Hormone - Part 2

How to Stop Wyeth? It’s David and Goliath

In the last issue of the Health Watch (Will Wyeth Bully You out of Your Estriol?), I wrote about the drug company Wyeth using the FDA to attack pharmacies that offer natural hormones. I promised I’d let you know if any group called for a specific petition to elected representatives asking the FDA to leave our natural hormones—and specifically estriol—alone. Once again P2C2, an action group for compounding pharmacies, has provided an easy-to-use online petition: Oppose Wyeth & FDA Actions to Limit BHRT Access!

I’m not wild about the copy on their petition, so if you have your own point of view about it, please express it! If you have a personal experience you’d like to share, all the better. If you have a political bent, express your opinion politically. Assure your elected representative that this issue really matters to you.

How to Get Goliath’s Attention

I’ve been contemplating what it will take to get Wyeth to back off. While it’s important to let your elected representatives know your opinion, the amount of money this mega-corporation hands out to politicians may outrank citizen protest. Because didn’t we just do this last spring? They’re back at it again.

What corporations care about most is profits and stock prices. How about a boycott of Wyeth products? They have almost 80 products, and many of us are probably using at least one. What if we examine their list of Wyeth Products (http://www.wyeth.com/products), and then next time we’re shopping for a pain reliever (e.g. Advil) or a cold medicine (e.g. Robitussin), or anything else pharmaceutical, choose another brand. They also make a lot of pet medication products.

Now I have a quite a few readers, but it’s not a drop in the bucket compared to the millions of products Wyeth sells every month. This is a David and Goliath thing. But what if you forward this e-mail to three friends, and they forward it to three friends and so forth? I believe strongly in the power of grass roots movements, and with the power of e-mail, we might hit their bottom line enough to at least make them go “ow!” Oh, and consider calling the Wyeth Consumer Information line—800-322-3129—and let them know that you’re boycotting their products because they’re going after natural hormones. That way they’ll know what hit them.

Keep it natural,
Virginia Hopkins

Editor, Virginia Hopkins Health Watch

http://www.virginiahopkinshealthwatch.com

Patients: Oppose Wyeth & FDA Actions to Limit BHRT Access!

Two weeks ago we informed you via our newsletter that on January 9, 2008 the FDA agreed to support Wyeth in their campaign to end access to compounded hormone medicines and announced that it will “halt” compounding of hormone treatments that contain estriol. Estriol is a common and critical component of many bio-identical hormone therapies (including Bi-Est and Tri-Est). It has a monograph form the U.S. Pharmacopeia and meets standards that were established for compounded medicines in Congress’s 1997 FDA Modernization Act.

“If I were Janet Woodcock, FDA’s Chief Medical Officer, I would be embarrassed,” says Dr. Randolph. “Not only does the FDA not have official jurisdiction here as compounding medications are regulated by state boards of pharmacy, but more importantly, the FDA’s position paper about estriol includes several egregious errors.”

“I’ll address two flaming misstatements here. 1.) According to the FDA ‘no drug containing estriol has been approved by the FDA and 2.) The safety and effectiveness of estriol is unknown. Actually, in the 1970s there was an FDA approved drug on the market called Hormonin that contained the active ingredients estradiol, estriol and estrone. I know about this drug because I was a licensed pharmacist before I returned to medical school. The company manufactured Hormonin here in the U.S. was acquired and today that drug continues to be manufactured in Great Britain.”

“As for the question of estriol’s safety,” Dr. Randolph continues, “I would have thought that Dr. Woodcock would have done her homework. There are over 300 published medical (Pubmed) references indexed ‘estriol/therapeutic use’ going back more than 30 years and yet there are no reports of any adverse effects associated with estriol usage. Most of the references refer to the favorable effects estriol has been shown to have on health parameters such as blood lipids and beneficial effects on menopausal symptoms. In fact, results of recent research at both the Medical College of Georgia in Augusta and the University of Nebraska Medical Center in Omaha actually show that estriol can have anti-cancer effects.”

“I am deeply concerned that access to safe and efficacious bio-identical hormone replacement therapies (BHRT) could be at risk,” says Genie James, Executive Director and Dr. Randolph’s co-founder of The Natural Hormone Institute of America. “Even more, I am horrified that Wyeth would once again so brazenly attempt to use its corporate wealth and power to twist the facts, manipulate the research and, ultimately, push their mercenary agenda through a federal governing body.”

“In light of Wyeth’s most recent petition, I am forced to ask several seminal questions: First, does the pharmaceutical industry regard women’s health as a sacred arena of medicine or does it simply see women - particularly baby boomer women - as a burgeoning target market to be exploited via product sales? Is it any coincidence that Wyeth’s own Premarin is the brand leader in the synthetic estrogen product market? Can physicians and patients trust the FDA to be fair and unbiased in addressing this issue if the agency’s drug evaluation center receives over $300,000 per year (approximately half of its operation budget) from pharmaceutical companies, including Wyeth? Finally, is the power of pharmaceutical profit so great that even the FDA can be manipulated to turn a blind eye to the fact that the rate of female cancers continues decline in lockstep with the decline in the sales of synthetic estrogen products?”

“I can’t speak for the conscience of the FDA but I can speak for physicians like myself who have for years relied on BHRT to successfully and safely treat patients suffering from hormonal imbalances,” says Dr. Randolph. “I can also presume to speak for the tens of thousands of patients who have found that BHRT gave them not only relief from symptoms but a feeling of having “their life back”. In speaking, I hold out these truths:

• BHRT is a safe and effective option for treating hormonal imbalances. Side effects are minimal, if any. Unlike synthetic hormone therapies, there has been no evidence linking BHRT to any carcinogenic effect or increased
  risk for heart attack, stroke, blood clotting or Alzheimer’s disease.
• Clinical studies have linked prescriptions of Wyeth’s Premarin with an increased risk of breast and uterine cancers, heart attack, stroke, blood clotting and Alzheimer’s disease.
• The FDA often regulatory decisions based on industry-sponsored studies and research. In presenting their research, pharmaceutical companies often only publish selective results, even presenting the same selective findings in several different journals. The FDA had no control over this selective publishing. This practice is not unbiased research and evaluation of pharmaceutical products; it is plain and simple spin marketing.
• There is a need for more research on BHRT. While there are many credible and clinically significant published studies evidencing the efficacy and safety of BHRT, there is not enough data to once and for all squash the promotion of synthetic hormone therapies. Why not? Think about it. Who funds most clinical research? You got it: the
  pharmaceutical companies like Wyeth.”

“This is not the first time the FDA has attempted to prohibit doctors from prescribing compounding medications to their patients,” says Ms. James. “A similar attempt was made by Wyeth Pharmaceutical and the FDA in 2005 but over 70,000 persons (physicians, pharmacists and lay people) contacted the FDA and voiced their strong disfavor of such a move. Now we face that same challenge to raise our voices and insure that one-size-fits-all manufactured synthetic hormone therapies do not replace the much more safe and individualized option of prescribe bio-identical hormone replacement.”

“We are raising our voices to battle for the truth about BHRT and the dangers of synthetic hormone therapies. You can too. I urge you to voice your opposition to the Wyeth Complaint by going to IACP and telling the FDA your story.”

Best wishes,
C.W. Randolph, Jr., M.D., R.Ph., Medical Director, and Genie James, M.M.Sc., Executive Director of The Natural Hormone Institute of America.

Australian Implication of the recent FDA decision to cease the advertising and compounding of the Oestrogen, Oestriol (Estriol)

The U.S Food and Drug Administration’s (FDA) decision to stop compounding pharmacies from marketing the oestrogen, Estriol, on the grounds that “the safety and effectiveness of Estriol is unknown” was pre-empted by Wyeth’s petition of October, 2005 which asked the FDA to crack down on the hormone replacement products marketed by compounding pharmacies. Since 1942 Wyeth Pharmaceuticals, the maker of Premarin is the world’s largest manufacturer of prescription menopausal hormones. The sales of these products fell by more than 57% in just three years, from $2.07 billion in 2001 to $880 million in 2004 as a result of the increase in strokes, breast cancer, heart attacks and blood clots, as outlined in the massive 2002 Women’s Health Initiative (WHI) study.

Putting aside the political aspect of the FDA’s sudden attack on compounding pharmacies, the reasoning on a pharmacological basis is inherently flawed. Firstly, Oestriol has a monograph in the U.S. Pharmacopeia (as Estriol ) and as a result is legally able to be compounded by Compounding Pharmacists as a peer reviewed reference does exists to guide compounders as to the therapeutic limitations of Oestriol in the form of the “drug bible” namely the Pharmacopeia. Secondly, the FDA states that “Estriol is not FDA approved and has never been subject to safety studies by the FDA”.

Since the FDA is not the world authority on Estriol, it would be prudent for such an influential organisation to move beyond corporate pressure and look at the global safety and usage of Oestriol on a more humane level as Oestriol has been well studied in Europe and Asia for more than 60 years, where it’s commonly prescribed by physicians and Wyeth actually sells two types of Estriol in Europe.

Doctors Zava and Lemon has dedicated over 30 years of study to the safety and efficacy and to the clinical use of Estriol in breast cancer patients. Dr.Lauritzen has spent nearly five decades researching the effects of Estriol in women. In his pioneering paper of 1961, Dr.Lauritzen showed that an oral form of estriol is quite effective for relieving menopausal symptoms without causing the typical stimulation of the uterus as seen with estradiol. In the 1980s, Dr.Robert Greenblatt, one of the foremost researches in hormone therapy at the time, commented that “the ability of estriol to relieve vasomotor symptoms [hot flushes] and to improve vaginal maturation [prevent vaginal dryness] without inducing notable side effects, is sufficient reason for it to be included in the management of the post menopausal syndrome”. Dr.Wulf Utian, editor of the North American Menopause Society’s journal Menopause has stated that, “Estriol, it would appear, has the potential for reduced risk but similar benefit to alternative estrogen or estrogen-progestin combinations” Another quote by Dr. Utian says: “The potential to minimise risks yet maximise most benefits places estriol in a unique category amongst the estrogens”

As far as the correlation of the above with respect to the equivalent body to the FDA in Australia, albeit, the Therapeutic Goods Administration (TGA), I believe common sense will be the TGA’s modus operandi with respect to compounding pharmacists and patient safety. Believe it or not, the TGA is actually a more powerful body than the FDA in the aspect of its powers to act rapidly in the case of consumer safety. A recent example would be the TGA’s closure of Pan Pharmaceuticals. The FDA has a somewhat more cumbersome legal process to follow before it can do what the TGA did in the case of Pan Pharma. Having said that, the TGA at the current moment has taken the sensible and logical stance of organising various focus meetings with key stakeholders to see what can be done to understand what compounding pharmacists actually do and how best to put standards in place that will make sure that the pharmacy profession not only adheres to a good code of compounding practice, but also, that the public has access to a standard of compounding that meets certain professional standards that are accepted by all relevant parties and stakeholders. I have received feedback by people attending these meetings that the TGA is somewhat gobsmacked by the level of competency and variety of dispensing undertaken by these creative compounders who have raised the level of pharmacy practice in Australia.

As far as Oestriol is concerned in Australia, the TGA has already approved a product by Organon called “Ovestin” on the Pharmaceutical Benefits Scheme (PBS), thus I believe that the TGA will take a more measured stance than the FDA in the sense that if no studies show that Oestriol is harmful to patient care then it will see no reason to use the same illogical approach as undertaken by the FDA. Common sense would argue that to achieve the greatest benefit from oestrogen replacement therapy, we should try to mimic the body’s own production of Oestrogen. In other words, we should use the same proportions of oestriol, oestradiol and oestrone normally produced in the human body not that of a pregnant mare as in the manufacture of Premarin®. On this basis alone, I believe that the TGA will not be as unrealistic as the FDA and will allow compounders to be involved in the individualisation of patient hormonal care. When you have influential organisations like the American Medical Association saying: “ Estriol may not only be non carcinogenic but indeed anti-carcinogenic” one will fully realise that the FDA was somewhat “trigger happy” in its stance to target compounding pharmacists and at the request of lobby groups with vested fiscal interests. [ Follingstad, Alvin. Estriol, the forgotten Estrogen? JAMA 1/2/78 Vol.239, No.1, 29-30]

In summary, it is my opinion that the use of Oestriol (Estriol) should not be removed from the compounding pharmacopoeias of either the United States of America or Australia on the grounds of its unknown safety and effectiveness. The very person who first discovered the therapeutic effects of the combination of the three Oestrogens as Tri-Est, Dr. Jonathan Wright, who still practises today, has had extensive experience with the prescribing of this oestrogen combination for almost 30 years with no reported ill-effects. [Tri-Est usually contains: Oestriol 80%: Oestradiol 10%: Oestrone 10%]

The decision as to which type of Oestrogen best suits the patient should be entirely up to the patient and the doctor with the appropriate regulatory bodies (FDA or TGA) making sure that ALL the available data are used in the decision making process as to the safety thereof rather than just perusing the literature that is funded by the pharmaceutical companies. And if “natural hormones” or “bio-identical hormone replacement therapy (BHRT) “ does not cut the mustard with the FDA then let’s all go back to school and confuse all parties once again by giving them the correct scientific name, albeit : Iso-Molecular Hormone Replacement Therapy” or “IMHRT”.

Written by Bert Frigo, Consultant Pharmacist, Compoundia: Australia
Feb10, 2008

References:

• What your Doctor May NOT tell you about Breast Cancer: How Hormone Balance Can Help Save Your Life. Drs: John R. Lee/David Zava/Virginia Hopkins. (2002).
• The Miracle of Natural Hormones: Dr. David Brownstein. (1999)
• Textbook of Bio-identical Hormones: Dr. Edward Lichten. (2007).