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AMA Tangles With 'Gene Doping' Guidelines

<ѻý class="mpt-content-deck">— Also: emergency room evidence; impact of corporate investors in healthcare
MedpageToday

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CHICAGO -- Some of the most interesting resolutions debated at the American Medical Association (AMA) House of Delegates meeting are those that aren't easily resolved.

On Monday delegates wrestled with one such resolution from the Committee on Science and Technology, which proposed a statement that the AMA "encourages the development of safety guidelines and regulation regarding performance enhancing non-therapeutic gene therapies."

The use of gene therapies for non-therapeutic purposes has for athletes and other types of enhancements, which may come with unexpected health risks.

Speaking from the House floor, Adam Roussas, a regional medical student delegate from Arizona, urged support for the resolution and said the AMA was in a "unique position" to get out in front of this problem and prevent unnecessary harms associated with inappropriate gene therapy use.

However, Andrew Rudawsky, MD, an alternate delegate from Ohio, objected to the resolution on the grounds that it contradicts the AMA's Code of Medical Ethics policy 7.3.6, which puts the AMA firmly against non-therapeutic genetic tinkering.

The code -- -- states that "genetic manipulation should be reserved for therapeutic purposes. Efforts to enhance 'desirable' characteristics or to 'improve' complex human traits are contrary to the ethical tradition of medicine."

"If the AMA says we ought not to do something, then we shouldn't create guidelines about how to do this in a more ethical way," Rudawsky said.

The AMA initially passed the committee's amended version of the in a vote of 274-243, amended to scratch original language calling for collaboration with other "relevant institutions" and "permissible uses" of performance-enhancing non-therapeutic gene therapies.

Just after voting, Charles Hickey, MD, an Ohio delegate, expressed concern that the House had adopted a resolution that directly conflicted with the AMA's own code of ethics. "Are we allowed to do that?" he asked.

Different delegates then pushed for different actions: holding another vote, referring the resolution back to the AMA's board for decision, postponing the vote until more information was gleaned (an unpopular idea).

Sometimes "hard-stop policies" from the Council on Ethical and Judicial Affairs (CEJA) are revised as medicine learns to approach them differently, said Mark Bair, MD, a delegate from Utah who supported referral for decision.

Allaying some confusion, although not the philosophical disagreements, a representative for CEJA stepped up to clarify that the Council's opinions and House policy are separate entities, and may differ. The House ultimately voted to refer the resolution back to the Board.

Burnout, Emergency Room Evidence

A report on physician burnout and wellness challenges that called on hospitals to conduct a confidential survey of physicians to help identify factors that might lead to burnout or "demoralization" (the preferred term) was also referred to the Board for further study, at the recommendation of the Committee on Medical Practice, due to "the depth and breadth of numerous amendments offered in testimony."

In testimony on Sunday several delegates raised concerns that hospitals were not the right entities to conduct such surveys, and a few criticized the report for not incorporating more tangible solutions to the issue of burnout and getting at its root causes.

The Committee on Science and Technology also recommended against adopting a resolution that suggested the AMA study drug testing for date rape drugs at the point of care.

Despite the "well-intended wishes" of the resolution's authors, "the technology's not there" said Mike Miller, MD, of the Wisconsin Medical Society. Others pointed out that there are also "chain of custody" challenges -- a legal concern related to the custody control and transfer of evidence -- in emergency department settings.

A motion to refer the resolution for further study was voted down.

Resolutions Adopted on Monday

A resolution from the Committee on Medical Services opposing "lock-out" provisions that exclude Medicaid-eligible patients for "lengthy periods" of time and supporting provisions allowing such individuals to "reapply immediately for redetermination" was adopted.

As was a policy requiring the AMA to study corporate investors' impact on the healthcare marketplace when they gain a "majority or controlling interest" over groups that manage physician practices.

Initially the focus of the study was to target private equity firms. But speaking on the floor of the House, anesthesiologist Sherif Zaafran, MD, an alternate delegate from Texas, recommended the more expansive term "corporate investors." He suggested possible players might include public companies, venture capital private equity firms, insurance companies, and hospital systems. His amendments to expand the scope of the study were approved, despite concerns from some delegates that they could weaken or dilute its focus and impact.

The House also adopted a report calling for the AMA to work with the Centers for Medicare and Medicaid Services to "redefine" the requirement for an updated history and physical within 24 hours of a surgery or procedure. The requirement would instead be that a physician or "non-physician provider" has reviewed the "pertinent data" and the initial history and physical, and has sufficient information to determine that it is safe to carry out the procedure. This was also submitted to the board by the Committee on Medical Practice.

In testimony on Sunday, several delegates, including some ob/gyns, suggested there are times when a physical isn't feasible, such as when a patient is in a room with several other patients.

The report was adopted with some minor amendments, including the addition of the term 'provider,' a trend that has not been universally supported.