Legal Issues Affecting Academic Medical Centers Conference
American Health Lawyers Association
The Industry: Health law
The Attendees: 175 attorneys laboring to reduce teaching hospitals’ exposure to stem-cell snafus, bioethics breaches, bioterror threats, and Big Pharma
• Eggsploitation? Regulations that forbid payment for certain human embryonic stem cell sources are “out of touch,” said panelists. For in vitro fertilization, egg donors are commonly paid $15,000 to $20,000, said one doctor, Pearl O’Rourke. That can jump to $60,000 for the eggs of a blond, 5-foot-11, varsity-sports-playing, high SAT scorer. However, she added, there’s still demand for “the regular, old, short, not-that-smart donor.”
• Quid Pro Status Quo: Doctors may claim that pens, pizza, parties, and trips from drug and equipment companies don’t influence them, but Stanford University doesn’t believe them. Ann James presented the school’s new policy tightly regulating vendor relationships. She told of a doctor who objected to the new policy because a drug company would cancel her deal to appear in an infomercial if she couldn’t tout her Stanford credentials. Another frustrated physician asked how could she learn about a new drug if she had to skip the pharma-sponsored junket. James’ suggestion: “Read the journals.”
• LifeTM: Should biomedical breakthroughs be eligible for patent protection? While laws of nature, physical phenomena, and abstract ideas have not been patentable, non-naturally occurring and nonhuman organisms are. Business-minded medical researchers should “prepare for war,” advised intellectual property lawyer Maximilian Grant. “Defensively and offensively patent.”
• Researchers Behaving Badly: The Havasupai Tribe filed a $25 million suit claiming that Arizona State University researchers improperly used blood samples, originally provided by tribe members for diabetes research, to study inbreeding, schizophrenia, and ancestral migration patterns.
• Spare Parts: Moore v. Regents of University of California has sparked debate over human biological materials ownership. During treatment for hairy-cell leukemia, the plaintiff’s physician collected large amounts of blood, bone marrow, and other tissue, then advised Moore to have his spleen removed. The doctor arranged to give part of the organ to a research facility. A patent was even granted for a cell line established from Moore’s lymphocytes, with royalties and profits shared between the doctor and the university. The California Supreme Court ruled that the defendants “failed to disclose the extent of research and economic interests in Moore’s cells” before obtaining consent.
• Tissue Issues: Among recent stories of raiding the genetic cookie jar: While chief of geriatric psychiatry at the National Institute of Mental Health, Trey Sunderland received $285,000 after shipping spinal fluid and plasma taken from 538 Alzheimer’s disease research subjects to Pfizer. A congressional report deemed this a “breach of trust.” The doctor was sentenced to two years probation and ordered to forfeit his drug company “consulting” fee.
• Money Talks: National Institutes of Health clinical bioethics chief Ezekiel Emanuel asked if attendees would interpret data differently if a drug company offered them $5,000 to present a lecture. Grants, speaker’s honoraria, stock ownership, and consulting fees can pose conflicts of interest, Emanuel said. Then there’s the finding that industry-funded clinical research that produces positive results is more likely to be published than is government-funded clinical research.
• Control Group: Prisoners are considered a vulnerable population requiring extra safeguards when participating in human subject research. For example, researchers must not offer any incentives to participate in research, except for “soft drinks and snacks to be consumed at the test setting.” Researchers must also provide prisoner-subjects with a statement of exceptions to any guarantee of confidentialityófor example, when the subject indicates an intent to break out.
• New Kind of Property Rights: New DNA databases are enabling researchers to drill down to deadly genetic conditions that contribute to cancer and sudden infant death syndrome. But it has spawned a tug of war between rules governing informed consent, notification of genetic disease risk, de-identifying genetic material, and use of excess tissue from medical procedures in research.
• Contamination Nation: In a bioterror attack, can you legally compel health-care personnel to come to work? Probably not, unless they’re designated first responders, said panelists. But can government authorities close, destroy, or commandeer private property for public use? Yes, if that’s deemed reasonable and necessary to respond to a public-health emergency.
• The Road to Hell: Just as a precisely written sonnet can still be woefully bad, Syracuse philosophy professor Samuel Gorovitz warned that medical decisions made in compliance with regulations and protocol are not necessarily wise decisions. It’s easy to get caught in traps like ignoring the qualitative for the quantitative and choosing solutions merely because they are simple to apply and possess a thin veneer of credibility.
• California Schemin’: A Golden State proposal calls for lowering in vitro fertilization fees for clients willing to donate their excess eggs for human stem cell research. Opponents view this inducement as coercion for lower-income women.