Hot Flash? Wyeth And A Vexing HRT Ingredient
3 CommentsBy Ed Silverman // February 14th, 2008 // 4:03 pm
In October 2005, Wyeth filed a citizen’s petition with the FDA in an effort to stop compounding pharmacies from making bioidentical versions of Prempro, its controversial hormone replacement therapy, which some women claim in lawsuits has caused them to develop breast cancer. Last month, the FDA responded by sending warning letters to seven compounders that their claims about the safety and effectiveness of their BHRT products are unsupported by medical evidence, and are considered false and misleading.
The FDA explained that the drugs made by the compounding pharmacies contain hormones such as estrogen, progesterone and estriol, which the agency made a point of noting isn’t a component of any approved drug and hasn’t been proven safe and effective for any use. And this makes for a little bit of irony. In its petition, Wyeth harps on the presence of estriol in these BHRTs as a prime reason the FDA ought to yank the compounded drugs from the market.
The “FDA should…initiate enforcement action against compounded BHRT products containing Estriol and the pharmacies manufacturing them on the grounds that the products are adulterated and misbranded, and that their sale without prior FDA approval of an NDA (new drug application) violates the
new drug provisions of the (Food Drug & Cosmetic) Act and poses a serious threat to public health.” (See pages 18 and 19 of the petition).
At the same time the petition was filed, however, Wyeth was selling Cyclo-Menorette, a menopausal drug in four European countries - Estonia, Germany, Latvia and Poland - that contained, yes, estriol. (This is the package insert from Germany). The drug was since discontinued due to “limited sales,” according to a Wyeth spokesman. So how does the drugmaker reconcile what appears to have been a contradiction?
“Our issue is NOT that estriol is unsafe, but that it has not been reviewed/approved by appropriate authorities (FDA) in the US and does not carry the appropriate patient information as required,” he wrote us in a note. “The fact that estriol is used in a Wyeth product lawfully marketed in a foreign country, after review and approval from that country’s health authorities, has absolutely no bearing on this issue.”
A spokeman for the International Association of Compounding Pharmacies, which has been battling the drugmaker over BHRT for the past few years, says that Wyeth is trying to have it both ways. He concedes the FDA views estriol as an unapproved product, but argues that compounding pharmacists typically use estriol as one of a few components to make treatments and oversight is provided by state boards of pharmacy.
“They’re tyring to tie their legal argument to a public health issue, but it’s not valid,” says Josh Wenderoff for the IACP. “They’re trying to make a safety issue out of estriol when the FDA isn’t pressuing compounding pharmacies to take it off the market over actual safety reports. Wyeth is trying to talk out of both sides of its mouth. It’s disingenuous to say the ingredient poses a public health risk in the US, when it was okay to use it in Europe, where they discontinued it because of poor sales, not safety.”
Jack2
While Wyeth’s arguements may appear hypocritical to some (they don’t appear hypocritical to me), unnecessary pharmacy compounding:
-costs insurers more money
-delivers a product to a patient that is manufactuered less stringently
The only winner is the compounding pharmacist.
Would you rather have a car manufactured by GM, or a car manufactured by some guy in his shop trying to duplicate the GM car - who then charges you more money for that car?
Thanks for bringing some light to this. Also compounding pharmacists address many needs that would not get served in any other way, but they don’t do the public any good in this case.
Jack2 (not Jack)
a pharmacist
Laurie
Sounds like Wyeth is looking for a way to make their marketing of Effexor for hot flashes the only game in town. Scary!
Randy Ice P.T., C.C.S.
Obviously Jack2 has never had a menopausal wife who seeks
to relieve her symptoms and prevent degenerative disease via individually prescribed and compounded hormone creams that Wyeth and Big Pharma do not make. If he had, he would see how safe and effective compouned estriol and/or estriol/estradiol preparations are and not make a ridiculous statement that compounders “don’t do the public any good in this case.” The prescriptions come from the patient’s physician…….the compounders only make what he/she orders to be made.
Bi-Est and Tri-Est, two compounded estriol/estradiol hormone creams have been in use since 1983 having been developed by Jonathon Wright MD. Hundreds of studies have demonstrated their safety and effectiveness and many have shown bio-identical estriol has anti-cancer effects. Balancing compounded estriol creams with bio-identical progesterone provides additional long-term protection against cancer, osteoporosis, dementia, diabetes,
autoimmune disease etc. Thousands of women in the USA have used this over the last 25 years……not one study has shown any risk from using them. We have used them in our clinic for the last 8 years and they are incredibly efffective. No woman using them has had any problem whatsoever.
All Wyeth has to offer these woman is Premarin, a product
made from pregnant horses urine that contains several estrogens that are unique to horses and are foreign
chemicals in the human body. Their synthetic, non-bio-identical “progestin” product Provera has so many intolerable side effects since it too is
a chemicalized, foreign-to-the-body drug (not hormone), that
it cannot be tolerated by half the women who take it and causes increases in cancer, heart attack, stroke and pulmonary embolus when combined with Premarin (PremPro). Yet the FDA did NOT take these dangerous drugs off the market despite their proven disease-inducing effects when the WHI study proved that in 2003. Further proof is the fall in breast cancer rates over the last 5 years that is attributed to thousands of women discontinuing these dangerous drugs.
I would suggest to Jack2 he do more research on the benefits and safety Estriol before he makes erroneous conclusions that attempts to deny physicians and their patients the right to prescribe compounded bio-identical hormone creams.
Randy Ice P.T.,C.C.S.
Vintage Medical Group
Temecula, Calif.