Binders of Women? Reflections on ASRM Annual Meeting Round 2

by Katie Kraschel

Mitt Romney’s anecdote about the binders of women he relied upon in selecting members of his cabinet when he was Governor has fueled criticism from feminist groups and filled my Facebook feed with a plethora of Halloween pictures featuring costumes depicting his unfortunate choice of words.  People generally have an instinctive aversion to being summarized into a page in a loosely bound, plastic-covered book.  However, this level of summary and (arguably) downright objectification happens every day when individuals peruse  IVF clinic and cryobank catalogs shopping for sperm or eggs.  And while many of us worry that a Romney win next week would result in four years of presidential leadership that is clueless and insensitive to the plight of women in the workforce, the ASRM decision to remove the experimental label from oocyte cryopreservation is likely to literally increase the number of “women in binders,” which presents a different set of concerns.

Oocyte retrieval — the process of harvesting eggs that allows a woman to place her age, weight, height, eye color, S.A.T. score, college major, baby picture and perhaps even celebrity look-a-like into a gamete catalog — has long been a topic of bioethical debate and criticism due to the risks associated with the high level of hormones involved in the process and the accompanying high level of compensation frequently offered for women’s eggs.  The likely increases in demand and number of oocytes produced presents a unique opportunity to revisit these issues and reconsider what regulations may be necessary to keep all parties involved respected and protected.

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Pharmacy Compounding: Federal Law in Brief

by Jonathan J. Darrow

Until recently, most ordinary people had never heard of “pharmacy compounding.”  Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).

Compounding is the practice of preparing a drug for an individual patient’s needs, and is used when those needs cannot be met by a mass-produced drug.  See Thompson v. Western States Medical Center, 535 U.S. 357, 360 (2002).  For example, if a patient is allergic to a particular excipient (inactive ingredient) in an FDA-approved medicine, a doctor may order a special compounding pharmacy to prepare the medicine without that excipient. Because of the very small scale of compounding, Congress in 1997 attempted to exempt (via 21 U.S.C. § 353a) the industry from a number of provisions of the Food Drug and Cosmetic Act, including the requirement to submit a new drug application prior to interstate sale (21 U.S.C. § 355), the requirement that the drug labeling bear “adequate directions for use” (21 U.S.C. § 352(f)(1)), and the need to strictly follow good manufacturing practices, or GMP (see 21 U.S.C. § 351(a)(2)(B)).  A number of controls on compounding were included, however, such as the requirement that there be a valid prescription from a licensed practitioner (21 U.S.C. § 353a(a)(1)), that the drug be compounded by a licensed pharmacist (or physician) (21 U.S.C. § 353a(a)(1)), and that the drug be compounded from ingredients that meet certain quality standards (21 U.S.C. § 353a(b)(1)(A)–(B)).

However, § 353a—and with it, all of the provisions and exemptions just mentioned—was held unconstitutional in its entirety in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), aff’d 535 U.S. 357 (2002), on the basis of certain restrictions on free speech that were also contained within the statute and which, according to the Ninth Circuit, could not be severed from the remaining provisions because “Congress intended to exempt compounding from the FDCA’s requirements only in return for a prohibition on promotion of specific compounded drugs.” See 535 U.S. at 366. Thereafter, the FDA promulgated a policy by which it would primarily “defer to state authorities regarding less significant violations” but would enforce a number of provisions relating to ingredient standards, unapproved substances, commercial scale production, adulteration, and promotion.  The FDA made clear that its enforcement activities “need not be limited to” these or any particular areas, however, thus negating any expectations that Congress’ now-invalidated exemptions might nevertheless provide a safe harbor through the weight of influence, if not law. Since then, the FDA has in fact exercised oversight of compounding pharmacies, as is evident from the handfuls of warning letters that it sends to non-compliant facilities each year.  These letters have addressed, for example, promotion that made unsubstantiated efficacy claims, contamination, and the large-scale manufacture of what were essentially copies of FDA-approved drugs.

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Occupy Public Health? A Social Determinants Tea Party?

By Scott Burris

Kathy Ward is a veteran public health worker in Nebraska. She has a neat idea, which I summarize here in mostly her words:

Public health policy needs more proponents who are knowledgeable and able to express their positions freely. The shortage of advocates presents a danger for public health in a time of anti-government attitudes, uninformed public health policies, deficit reduction efforts, and looming budget cuts to the public health programs that protect our country.
A 2008 study by the Association of Schools of Public Health indicated that 23% of the current public health work force–almost 110,000 workers–will be eligible to retire by 2012. This generation of baby boomer public health workers has a high level of expertise in public health; passion for improving the public’s health; and strong partnerships with nonprofit, government, and private health organizations. They have the credibility to be effective spokespersons for public health and to influence its partners.
Why not use these assets to build a movement of public health advocates?

• Enlist national public health organizations such as ASTHO, the Chronic Disease Directors Association, and the Association of Maternal and Child Health Programs in finding and enlisting public health advocates.
• Find advocates through similar organizations at state and local levels, such as state public health associations and nonprofits such as the American Cancer Society and the American Heart Association.
• Build linkages with other national associations such as AARP. Consider public health in the broader sense, including in this effort retired Medicaid professionals who can knowledgeably describe the losses that will occur to the public from cutting Medicaid programs.
• Provide training in advocacy through webinars conducted with public interest lobbyists and health associations that employ advocacy staff

Sounds like a sensible idea to me. Mobilizing a lot of effective volunteers at a low cost. What do you think?

Reminder: Tomorrow, Institutional Financial Conflicts of Interest in Research Universities

Friday, November 2, 2012
8:30am – 6:30pm (reception to follow)
Milstein Conference Rooms, 2nd Floor
Wasserstein Hall
1585 Massachusetts Avenue
Cambridge, MA

The Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Derek Bok and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!