IACP Finds Numerous Flaws With Wyeth Citizen Petition Regarding Bioidentical Hormone Replacement Therapy

Oct 27, 2005, 01:00 ET from International Academy of Compounding Pharmacists

    SUGAR LAND, Texas, Oct. 27 /PRNewswire/ -- Today the International Academy
 of Compounding Pharmacists (IACP) sharply criticized pharmaceutical
 manufacturer Wyeth for manipulating the law and facts in an attempt to
 restrict patients' access to customized bioidentical hormone replacement
 therapy (BHRT).  On October 6, 2005, Wyeth petitioned the Food and Drug
 Administration (FDA) to impose far-reaching restrictions on physicians'
 ability to prescribe and pharmacists' ability to prepare and dispense
 bioidentical hormones.
     "Wyeth's aims are clear: to restrict the ability of physicians to
 prescribe and patients to use customized BHRT following studies that have
 raised serious health concerns with the company's own products," said L.D.
 King, executive director of IACP.  "When Johnson and Johnson discovered that
 Tylenol had been contaminated, it didn't file a petition to limit access to
 ibuprofen; it acted responsibly and fixed the problem.  Wyeth would be wise to
 follow this responsible course."
     IACP said that one example of Wyeth's contorted logic in the petition is
 that the company is trying to have it both ways: arguing that bioidentical
 hormones are illegal because they are copies of off-the-shelf pharmaceuticals
 on the one hand, and claiming that compounding pharmacists are fabricating
 new, untested drugs on the other.  The truth is that compounding pharmacists
 are preparing bioidentical hormone replacement therapies, which doctors design
 and prescribe to meet their patients' individual needs.
     The organization also said the Wyeth petition is trying to mislead FDA by
 suggesting that compounding pharmacists are "simply trying to dupe an
 unsuspecting patient population."  Wyeth knows full well that physicians must
 prescribe BHRT for each patient before a pharmacist can provide her with this
 medicine, just as they would order Wyeth's own medications.  Yet Wyeth
 completely ignores the role physicians play, never mentioning them in the
 petition.  To suggest that pharmacists who prepare customized medicines based
 on doctors' orders are duping patients is an insult to all physicians,
 patients and pharmacists, the organization said.
     IACP said it will formally oppose the Citizen Petition in its own response
 to FDA in the weeks ahead.  The organization cited a number of other
 substantive flaws with the Wyeth petition.
       * Wyeth wrongly presumes that FDA's authority extends completely across
         every facet of the practice of compounding.  This is incorrect;
         pharmacy compounding is a wholly distinct practice and is not subject
         to the same requirements as manufacturing.  Since the Food, Drug, and
         Cosmetic Act of 1938 passed, compounding has been regulated by state
         boards of pharmacy, not the FDA.  In fact, because compounded
         bioidentical hormone replacement therapies are prepared to meet
         patients' individual needs, they are inherently incompatible with the
         FDA's years-long new drug approval process required of manufactured
       * Wyeth mischaracterizes the First Amendment protections to commercial
         speech and misconstrues the U.S. Supreme Court's Western States
         ruling.  Wyeth is trying to undermine the Supreme Court's decision,
         which found that "prohibitions on soliciting prescriptions for, and
         advertising, compounded drugs amount to unconstitutional restrictions
         on commercial speech."   While the court also affirmed that
         "misleading" advertisements are not protected by free speech -- a
         ruling IACP supports and its policy reflects -- Wyeth's condemnation
         of virtually any communication regarding BHRT is excessively broad,
         contrary to Western States, and would violate the First Amendment if
         enforced by the FDA.
       * Wyeth relies on bad science to support many of its claims.  The only
         study Wyeth uses to support its contention that compounding is unsafe
         has been criticized in the U.S. Senate and is not supported even by
         the FDA.  When pressed on the scientific value of the data during an
         October 2003 Senate hearing on pharmacy compounding, FDA's then acting
         director of the Center for Drug Evaluation and Research, Dr. Steven
         Galson, explained, "I wasn't trying to present these as scientific
         data.  Most notably, I wasn't trying to use them to urge or call for a
         new Federal regulation."
       * In its filing, Wyeth itself blurs the line between synthetic and
         bioidentical hormones.  Most notably, Wyeth suggests that the National
         Institutes of Health Women's Health Initiative (WHI) studied
         bioidentical hormone therapies.  It did not.  Rather, WHI studied
         Wyeth's products exclusively and the study was cut short in 2002 after
         the data demonstrated that Premarin(R) (synthetic estrogen) increased
         the risk of stroke and the components of Prempro(R), Premarin plus
         progestin (synthetic progesterone), increased the risk of strokes,
         breast cancer, heart attacks and blood clots.  According to Wyeth's
         latest annual report, sales of Premarin-related products suffered
         since the study ended, having declined about 32 percent to $880
         million in 2004 from $1.3 billion in 2003.  The physical components of
         BHRT are different from the components of Wyeth's synthetic hormones
         that were studied by WHI.
       * Furthermore, Wyeth has had its own problems with FDA rules governing
         advertising.  In a letter from FDA dated January 11, 1999, the FDA
         said that promotional materials for Premarin were "false or
         misleading, and promote Premarin for unapproved uses."  One year
         earlier, the company had received a letter saying that a television
         advertisement for Premarin was "false or misleading."
     As the Cincinnati Enquirer reported this month, "For some women, hormone
 replacement therapy is the only thing that eases symptoms.  More women are
 turning to bioidentical hormones -- custom-compounded mixes of estrogens and
 progesterone that are identical to hormones produced by the body."
     Continued Mr. King, "Pharmacy compounding is performed by responsible,
 trained professionals who have strong relationships with their patients and
 their patients' physicians.  The successful practice of pharmacy compounding
 is predicated on full, open and honest communication between these three
 groups of people.  However, by attacking these communications and the ability
 to treat patients, Wyeth's petition would do far more harm than good.  As a
 result, IACP will request that the FDA deny Wyeth's petition."
     About IACP
     The International Academy of Compounding Pharmacists (IACP) is a non-
 profit association founded in 1991 to protect and promote the art and skill of
 the compounding pharmacy profession.  We represent more than 1,800
 pharmacists, physicians, technicians and patients who are committed to the
 safe practice of pharmacy compounding.  We are committed to ensuring the
 rights of physicians to prescribe, of pharmacists to prepare and of patients
 to take customized medications that meet their unique, individual needs.

SOURCE International Academy of Compounding Pharmacists