| Editorial: The Wyeth Petition, Part I: Is it Profits or Patients?
It is quite apparent that the recent actions of Wyeth involving petitions to the FDA do not involve the best interests of patients. This has been quite evident for many years, as Wyeth has been producing and heavily promoting conjugated estrogens for postmenopausal hormone replacement therapy (HRT) despite the many problems associated with their continued use, especially brought to the public's attention through the Women's Health Initiative.
Also, in the last decade, Wyeth was successful in preventing "generic" versions of the product from coming to market because of lack of detailed, consistent, and documented information on what the conjugated estrogens product actually contained. Wyeth's position is that there cannot be a generic copy of Premarin because the precise characteristics of the drug have not or cannot be characterized. You cannot produce or manufacture an approved generic of a drug for which the composition is still unknown. Wyeth has been successful in preventing competition and lower costs under the guise of "patient safety," when in reality their primary goal has been economic in nature.
Pharmacists that compound bioidentical hormone replacement therapy (BHRT) have been accused by Wyeth of copying Wyeth's drugs. This is absolutely ridiculous and demonstrates either a lack of knowledge about what compounding for BHRT really is, or it is their desire to misrepresent what compounding for BHRT really is. Pharmacists that compound for BHRT are simply using the same identical hormones that are already in the body for supplementation. For example, estriol, estradiol, estrone, progesterone, and testosterone are a normal component of the human body. As one ages, these levels tend to decrease. Even though Wyeth's product (Premarin) uses different components that are not the same as what is in the human body, they have sold it for many years for HRT. In a way, it is similar to the issue with insulin. For years, we sold insulin that was isolated and purified from pigs or cows. Today, however, the "human insulin" we provide to patients is identical to human insulin. Which is better? Obviously, the insulin that is identical to that in the body is best. The same applied to BHRT, the hormones that are identical to those in the body are best, not those derived from the urine of pregnant mares. Our patients deserve the constituents that are the same as what are already in the body, whether it involves insulin or HRT.
It should be quite evident to any objective person that compounded hormones are not copies of Wyeth's commercially available Premarin, because according to Wyeth's own arguments, there can be no copies of Wyeth's pregnant mare urine-based drugs since they are not even sure of their exact contents. Given that Wyeth has repeatedly maintained to FDA that no drugs can be the same as its products, and that the hormones compounded by pharmacists are tailored to individual patients using individual hormones meeting USP standards that are identical to those already in the body, compounded hormones are absolutely not the same as Wyeth's product.
More next week.
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief |
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This week 29 citations and abstracts were added to the CompoundingToday.com literature search database. Eight of these articles discuss saliva testing. In addition, 27 articles were added on the topic of asthma and another 11 on miscellaneous topics discussed from the Compounders' Network List. Here is a sampling of the articles now included on CompoundingToday.com's literature search:
- ACOG Committee on Gynecologic Practice. ACOG Committee Opinion #322: Compounded bioidentical hormones. Obstet Gynecol 2005; 106(5 Pt 1): 1139-1140.
- Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: A review. Menopause 2004; 11(3): 356-367.
- Curcio JJ, Smolinski D, Dye J. A review of bioidentical hormones. Menopause 2005; 12(6): 774-775.
- McKee J, Warber SL. Integrative therapies for menopause. South Med J 2005; 98(3): 319-326.
- Stefanick ML. Estrogens and progestins: Background and history, trends in use, and guidelines and regimens approved by the US Food and Drug Administration. Am J Med 2005; 118(12 Suppl 2): 64-73.
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