As technology magnifies the power of individuals, it is more critical than
ever before in history that individuals exercise their power ethically. Yet in
health policy circles in Washington at least, that message either has not been
heard, or it has been ignored, judging by a series of scandals being revealed to
“shocked” legislators.

It is ethically unavoidable for a responsible scientist not to speak out when
government shows every sign of being anti-science, as the present one does again
in the case of an emergency contraceptive drug.

The ethical decay appears to have infected some hospitals too, in the form of
offers of free services to pro sports
teams. Thankfully, there are some voices raised against the
practice.

The head of the US National Institutes of Health (NIH) is sending confusing
signals about whether the White House will relax its policy limiting federal
funding of embryonic stem-cell research. On the one hand: “Not,” he wrote in a
letter to 206 members of the House of Representatives including some
anti-abortionists who had asked Bush to modify his policy, “any time soon;” and
he asserted that “much of the basic research that needs to be done can be and is
being supported with federal funds under the president’s policy.” But on the
other hand: “From a purely scientific perspective, more cell lines may well
speed some areas of hESC [human embryonic stem cell] research.”

In restating the administration’s position that “taxpayer funds should not
‘sanction or encourage further destruction of human embryos that have at least
the potential for life,'” he seemed to optimists to be perhaps opening the door
to federal funding for research using some 400,000 surplus frozen embryos
produced during in vitro fertilization attempts. But pessimists
interpreted his words as “No change in policy.”

The NIH spent $24.8 million on human embryonic stem cell research in fiscal
year 2003, described by some as a pittance and prompting New Jersey and
California to provide state funding. Some see signs of growing public support
for embryonic stem cell research and say pressure is mounting on President Bush
to change his policy. In May, former first lady Nancy Reagan added to the
pressure by publicly calling for a change in the policy.

Reference: Unknown (2004). “Gov’t Just Says No
to Stem Cells.” Reuters via Wired News, May 16.

Reference: Harding, Anne (2004). “US stem cell rules
loosening? Advocates read good, bad news between the lines of Zerhouni
statement.” The Scientist, May 20.

Ethics and HHS

Over-ruling their subordinates, senior legal and ethics officials in the US
Department of Health and Human Services have repeatedly allowed government
scientists to engage in lucrative — and ethically suspect — consulting deals
with pharmaceutical and biotechnology companies, a House subcommittee has been
told. Some prestigious names are being bandied about, including that of National
Cancer Institute director Richard D. Klausner, who accepted a $40,000 award from
a major NCI grant recipient. Other examples cited during a “tense five-hour
hearing” served to “significantly widen a congressional investigation into
possible conflicts of interest in the federal biomedical enterprise,” reports
Rick Weiss in the Washington Post.

That enterprise includes the FDA, where ethics officers approved a request by
agency scientist Emanuel Petricoin to accept payments, free travel, and an
honorarium to speak at a beach resort conference from companies developing
products that would plausibly be regulated by the agency. The somewhat anemic
response from acting FDA Commissioner Lester M. Crawford is a new policy
requiring that center directors — not lower-ranking officials — review
employee requests for outside work, and “an internal review.”

It also includes the Center for Medicare and Medicaid Services (CMS), whose
former administrator Thomas A. Scully negotiated a job with an Atlanta law firm
that represents drug makers, hospitals, and other healthcare businesses, while
he was still in his government position.

“It is clear from the cases we have reviewed that some NIH scientists are
either very close to the line or have crossed the line” of ethical conduct, said
subcommittee chair Rep. James C. Greenwood (R-Pa.). “If we are serious about
upholding the highest ethical standards at the NIH, then NIH scientists should
not even be close to the line.”

Incidentally, while Greenwood is one of few House members to voluntarily
refuse contributions from political action committees, “contributions from
individuals employed by pharmaceutical and health product companies have kept
him among the top 20 recipients of donations related to health care companies
for three of the last four election cycles,” says Weiss, citing data compiled by
the Center for Responsive Politics.

Reference: Weiss, Rick (2004). “Probe
Targets Government Scientists’ Consulting.” Washington Post, May 19.

Reference: Weiss, Rick (2004). “House
Panel Scolds NIH Chief, HHS Members Threaten To Pursue New Ethics
Legislation.” Washington Post, May 13.

More Anti-Science

A dozen members of Congress have called for the resignation of Steven Galson,
acting director of the US Food and Drug Administration (FDA)’s Center for Drug
Evaluation and Research, and Lester M. Crawford, acting FDA commissioner, for
their decision to reject a request for over-the-counter status for the emergency
contraceptive Plan B — a decision the outraged legislators said amounted
to politics trumping science. A coalition of women’s health and pro-choice
religious groups joined the members of Congress in calling for a review and
reversal of the decision. In addition, 41 members of Congress wrote a letter to
Crawford asking that the decision be reviewed and overturned.

“The rejection came,” writes Marc Kaufman in the Washington Post,
“despite a 23 to 4 vote in favor of approval by an FDA expert advisory panel,”
and despite an FDA staff recommendation that it be approved. “When a scientific
panel votes 23-4 in favor of over-the-counter status but the FDA goes the other
way, there has to be something at work other than science,” said one legislator.

Reference: Kaufman, Marc (2004). “2 FDA
Officials Urged to Resign Over Plan B: Lawmakers Call Decision Political.”
Washington Post, May 13.

Ethics and Sports Medicine

Hospitals and medical practices have begun bidding to pay professional sports
teams “as much as $1.5 million annually for the right to treat their
high-salaried players” and provide physician services at little-to-no charge,
writes Bill Pennington in the New York Times. The payoff to the provider
is the exclusive right to market themselves as the team’s official hospital,
HMO, orthopedic group, etc. While not a bad deal in strictly business terms, as
Pennington describes, it doesn’t necessarily do any favor for the consumer who
is “sold” on an official but possibly inferior provider, along with the official
pop, beer, and pickup truck.

The president of the American College of Sports Medicine told Pennington that
“about half the teams in the four major North American professional sports are
now tied contractually to a medical institution,” and the number is expected to
grow significantly. The director of sports medicine at Duke University Medical
Center and a former NFL team doctor said “I guess it is a sign of the times.”
But other doctors are less inclined to resigned acceptance and more inclined to
deep concern about the propriety of these arrangements, says Pennington, quoting
the director of Harvard Medical School’s Division of Medical Ethics as saying
“It doesn’t sound quite right, and there is a clear conflict of interest.” The
editor in chief of The Physician and Sports Medicine, who is also
Stanford University’s team doctor, said: “It hurts us all,” and the Atlanta
Falcons’ team doctor said he would resign if the team wanted to enter into a
sponsorship deal with a hospital group.

And it’s not just the doctors who are unhappy. A top executive of the Major
League Baseball Players Association told Pennington “Our players do not like
this trend in medical-care agreements one bit.” The president of the NFL Players
Association said “It destroys trust and credibility on all sides” and is “bad
for the sport and bad for the community it serves.

In an attempt to alleviate such concerns, some teams have renegotiated the
agreements so they still get paid between $500,000 and $1.5 million by the
medical providers, but “instead of accepting physicians’ care without charge,
the teams began to pay the doctors, though at a significantly discounted rate,”
writes Pennington. The director of marketing for the Jewett Orthopaedic Group,
which has such a contract with the Orlando Magic basketball team, defended it as
“creatively circumventing” a “negative connotation.”

It seems to us it makes no difference whether ethics are circumvented
creatively or crassly.

Reference: Pennington, Bill (2004). “A Sports
Turnaround: the Team Doctors Now Pay the Team.” New York Times, May 18.