Marcia Angell, former editor in chief of the New England Journal
of Medicine, wrote in an editorial this spring titled “Is
Academic
Medicine For Sale?” This article seems to confirm these
suspicions. Hearings are scheduled next Tuesday in
Washington, D.C. on this issue. Mark
———-
Questioning Research
Hearings on Keeping Conflict of
Interest Out of Clinical Research
Subjects of clinical trials are typically required to sign informed
consent papers that explain every detail about the experiment’s
risks and benefits. But these papers often fail to say whether the
investigators will be profiting from the results. (Art Today)
By Melissa Schorr
B O S T O N, Aug. 14 — An 18-year-old young man dies in a
gene therapy trial led by an investigator at University of
Pennsylvania.Soon after, it is revealed that the investigator and
the school both had a stake in the biotech company planning to
commercialize the study’s findings.
Rezulin, a diabetes drug that was put on the fast track for
Food and Drug Adminstration approval, is yanked when it is
found to have led to the deaths of 63 patients and caused liver
damage in thousands of others. It is later revealed that
members of the review board and trial investigators had received
compensation from the drug’s manufacturer.
In response to cases like these from the past year, and a
rising concern that financial conflicts of interest could be
harming the safety of patients in clinical trials — not to
mention
the integrity of research itself — the Department of Health and
Human Services will kick off a two-day public meeting on the
issue Tuesday in Washington, D.C.
Patients, Not Pocketbooks
The conference, called “Human Subject Protection and Financial
Conflicts of Interest,” will bring together patient advocates,
university academics, clinical researchers, hospital staff,
entrepreneurs and government officials to help the agency firm
up its policy requirements.
The key issue will be ensuring that medical researchers are
always looking out for the best interests of their patients, not
their
pocketbooks.
Of concern: Might some researchers bend the results to get
the answer that will give them the million-dollar payoff? Would
they cover up any adverse effects when signing on new patients?
And should patients always be told of possible investigator
bias?
“Today, we’re living in a world where the primary
investigator
may own the company [conducting the study] or have stock in it,”
says Abbey Meyers, president of the National Organization for
Rare Diseases, a patient advocacy group. “It’s in his best
interest that if the trial isn’t successful, maybe he won’t
release
all that information to the public.”
Gelsinger Case Highlighted
The case of Jesse Gelsinger, the 18-year-old Tuscon, Ariz.,-man
who died in a gene therapy trial last September, has put this
issue in the spotlight.
After Gelsinger’s death, an FDA investigation revealed he
may
not have been properly informed of all the risks of the study and
that he may not have been a suitable candidate for the study, but
was admitted anyway.
“We’re left wondering: Was the scientist’s
financial benefit
linked to the fact that this young man was not told the whole
truth?” says Meyers, who will be voicing such concerns at the
conference. “There should never be that doubt.”
Of course, experts point out, other motivations have always
been at play in the research world: ego, reputation, social
agendas, pressure to “publish or perish.”
Money Conflicts Potentially Enormous
But financial conflicts of interest are of immense interest now
because academic researchers today are more likely to also be
stakeholders or CEOs of companies than ever before.
Marcia Angell, former editor in chief of the New England
Journal of Medicine, wrote in an editorial this spring titled “Is
Academic Medicine For Sale?” that the ties between industry and
academia have gotten out of hand.
“So much clinical work today is co-mingled with
commercialization,” agrees Sheldon Krimsky, a science policy
expert at Tufts University in Medford, Mass.
And that may affect decision-making. “Any time you’ve
invested money into something, it’s going to reinforce any
enthusiasm you have,” Krimsky says. “You wonder, `Are
they
holding on to this trial because their kid’s education is in the
balance?’ It’s a real issue.”
Lapses Exception, Not Rule
But many researchers say that these high-profile cases of
alleged ethical lapses reflect the exception and not the rule.
Adequate protections are already in place and just need to be
better enforced, they say.
“If I invent a new drug and build a start-up company and
begin
to test my invention, I must follow a dizzying set of regulations to
assure a valid and honest test of the drug,” says Dr. Patrick
Lyden, chief of clinical neurology at the University of California at
San Diego. “I believe that further legislation or administrative
rule-making is unnecessary.”
Current policy requires researchers to disclose possible
financial conflicts of interest when applying to the Public Health
Services, including the National Institutes of Health, for a grant,
and when applying for FDA approval. Researchers must then
inform their patients of financial conflicts, as well.
Money Interests Not Disclosed
But no one is ensuring that patients are being told.
At individual hospitals, institutional review boards are
given
the responsibility of evaluating proposed clinical trials and
making sure patients will be protected.
Subjects of clinical trials are typically required to sign
informed consent papers that explain every detail about the
experiment’s risks and benefits — but often omit whether the
investigator will be profiting from the results.
At schools like the University of California at Los Angeles
and
at Johns Hopkins School of Medicine in Baltimore, Md., policy
requires that researchers tell patients when they have a financial
interest in the product being tested.
“We are obligated to fully disclose any information that
a
reasonable person would want to know,” says Steven Peckman,
associate director of human subjects research at UCLA. “A
potential research subject can make a considered decision
whether they want to embark on the project.”
Public’s Right to Know
But Mark Brenner, associate vice president of research at
University of Indiana, who will speak at the conference on behalf
of the American Association of Universities, says the AAU’s
policy will be that researchers disclose possible conflicts of
interest to their review boards, who then make the call as to
whether the information gets passed along to the research
subjects.
“Whenever it’s appropriate, you should inform
patients,” he
says. “But there are times where you may well overdo it. There
are examples of where it is more benign.”
Some worry the public will stop volunteering for trials if
the
suspicion of impropriety is planted in patients’ minds. “This
could have a downside effect, it might turn people away from
entering clinical trials,” says Krimsky. “It produces a kind
of
skepticism that is not really going to be helpful to science.”
But Meyers advocates that patients have a right to know.
“Leave it up to the judgment of the patients,” she says.
“It’s
wrong to hide it.”
Link to at:
http://www.abcnews.go.com/sections/living/DailyNews/fdahearin
gs000814.html
