Double Dip: Doctors Paid to Advise, Promote Drug Companies That Fund Their Research

This story was co-published with The Boston Globe.

Pharmaceutical
companies pay for the clinical trials that Dr. Yoav
Golan conducts on antibiotics at Tufts Medical Center.

They also
pay him tens of thousands of dollars a year to give speeches and advice on
behalf of their drugs.

If Golan
worked at some teaching hospitals, he would be barred or severely restricted
from accepting both research funding and personal payments for promotional
speaking or consulting from drug makers. These hospitals fear the money could
influence clinical findings, or at least create the appearance of a conflict of
interest.

Yet Tufts
and many other academic medical centers allow doctors to accept overlapping
payments — and some doctors still take them.

A ProPublica analysis shows that more than 1,300
practitioners nationwide received both research money and speaking or
consulting fees from the same drug maker in 2012. All told, they received more
than $90 million in research grants — plus nearly $13 million for speaking
engagements and another $4 million for consulting.

Critics say
doctors who conduct a clinical trial while accepting personal payments from the
company sponsoring the study can feel beholden to the drug maker.

“The
pharmaceutical company has a paramount stake in a favorable outcome. The
[research] grant recipient has a stake in a favorable outcome and the
honorarium recipient or consultant has yet another stake in the outcome,” said
David Rothman, director of the Center for Medicine as a Profession at Columbia
University. “It’s not only my lab. It’s my mortgage.”

ProPublica
used its Dollars for Docs database, which tracks payments to
practitioners by 15 drug companies, to conduct the review. Not every company
discloses all types of payments — research, speaking and
consulting — or distinguishes between the types. The analysis covered the
nine companies that disclosed payments in this form.

Golan, an
infectious disease specialist, was the only doctor who received speaking,
consulting, and research payments from three companies in 2012, the most recent
year for which data has been compiled. Pfizer, Merck, and Forest Labs gave
Tufts $51,000 for his research that year, in addition to paying him $125,000 to
speak about their drugs and $13,000 for consulting. His speaking fees ranked
second nationally among all the researchers examined, and his total personal
payments ranked fourth.

Golan
referred questions to the public relations department at Tufts Medical Center,
which said in a statement that Golan complies with its research
conflict-of-interest policy and that officials keep a close watch over his
work.

“Dr. Golan’s
work has contributed to the development of two important antibiotics, including
the first antibiotic developed in the past 25 years to treat the growing threat
of deadly C. difficile,” the statement said.

Pharmaceutical
companies’ payments for promotional speaking and consulting appear to have decreased in recent years, as blockbuster
drugs have lost patent protection and the push for transparency has advanced.
Beginning this fall, all drug companies will have to publicly disclose
payments they made
to doctors, under the Physician Payment Sunshine Act, part of the 2010
Affordable Care Act.

But
industry-backed clinical studies, which can lead to advances in care, have
largely been seen as a separate matter.

ProPublica’s
is the first large-scale analysis of how frequently researchers receive
additional payments from companies that fund their clinical trials. About 10
percent of researchers for the nine companies examined for this story also
received money for speaking or consulting, or both.

Pfizer had
the lowest rate of dual relationships among its researchers, about 7 percent;
Novartis and ViiV Healthcare had the highest, at more
than 15 percent.

ViiV
spokesman Marc Meachem said his company focuses
exclusively on HIV medications, so “the number of people with the expertise to
do both the research and be expert speakers is a lot smaller.”

In a
statement, Novartis said it abides by the policies of different academic
institutions, and requires doctors it works with to receive permission, if
needed, from their employers.

The Mayo
Clinic and University of California San
Francisco prohibit
employees from receiving personal compensation from companies that concurrently
fund their research. Harvard allows doctors to take no more than
$10,000 annually in personal income from companies funding their research.

“It’s such
an enormous conflict of interest to have personal financial gain from the
company that’s sponsoring a clinical trial on human subjects that you’re the
principal investigator on,” said Lisa Bero, a professor of pharmacy at UC San
Francisco who chaired its conflict of interest committee from 1999 to 2010.

Tufts
University School of Medicine does not bar overlapping payments, but has a
policy banning faculty members from speaking for a pharmaceutical company if “the
company controls the content of the presentation, which may include creating or
having final approval over the slides or presentation materials or setting
limits on the scope of discussion.”

The
companies that employ Golan as a speaker say they do create and have final
approval of any materials used, but because he is an unpaid “volunteer faculty
member” at the medical school by virtue of his hospital job, its rules don’t
apply to him, a spokeswoman said. Tufts Medical Center requires only that
doctors agree that the slides provided by companies for their lectures are
scientifically accurate; Golan’s slides are reviewed by his department chairman
as well.

Beyond his
work for Pfizer, Merck, and Forest, Golan has reported receiving research,
consulting, and speaking payments from Cubist Pharmaceuticals of Lexington. He
co-wrote a 2011 research study, published in the New England
Journal of Medicine, about the antibiotic Dificid
with employees of its maker, Optimer Pharmaceuticals —
a company purchased by Cubist last fall.

According to
the most recent disclosure statement Golan submitted to Tufts Medical Center,
covering the 12 months before March 4, 2014, Golan said he received a total of
$260,000 to $359,995 in salary, speaking, consulting (and some travel) fees
from Forest, Merck, Pfizer, Optimer, and Cubist. That
does not include grants for research and is on top of what he earns for treating
patients, according to Tufts which provided the data to ProPublica.

Tufts
Medical Center said it has a committee with the authority to bar doctors from
accepting additional payments from companies that fund their research if panel
members conclude there’s no other way to mitigate the conflict of interest.

Instead,
hospital officials have put Golan under a “rigorous management plan to ensure
the research is done in a transparent and ethical manner, including meetings
between Dr. Golan and a committee of research and physician leaders every six
months to review his research and any changes in his relationship with
industry,” the center said in a statement.

Ethicists
and experts on conflicts of interest say overlapping payments can give researchers
an incentive to bend or break the rules, sometimes in ways they aren’t even
aware of. They note that published research supported by pharmaceutical
companies tends to be more favorable to the drugs being studied than research
funded by other sources.

Some
questioned whether it was possible to balance a commitment to research with
outside work for pharmaceutical companies.

“I would
argue that any academic that has the time to be a part-time drug salesman needs
to have a talk with their department chair right away about how they’re
spending their time,” said Eric Campbell, a professor of medicine at Harvard
Medical School who studies the topic. “If doctors want to be drug salespersons,
they should go to be drug salespersons.”

Not every
doctor who accepts research and promotional money is an academic. Some work for
hospitals not tied to universities; others run their own clinical trial
centers, and others are solo practitioners.

Dr. Andrew Wachtel is co-director of a research group called the Southern
California Institute for Respiratory Diseases. He practices at Cedars-Sinai
Medical Center in Los Angeles, but said he is not employed by the hospital.
While conducting research for Merck, GlaxoSmithKline and Forest Labs, he
received nearly $110,000 in 2012 for speaking on behalf of their products (the
vast majority was from Forest).

“If I was
doing research and speaking exclusively for one company, that might be
construed as a conflict, and it is potentially a conflict,” he said. Working
with multiple companies, he added, shows “I don’t have a personal gain by
promoting one over the other.”

Still, Wachtel said that if he were given the choice between
research and speaking, he would choose research. “I would just stop lecturing.
It’s not a huge part of what I do or that big a deal.”

Dual
relationships have come under scrutiny from lawmakers and regulators in the
past. In 2009, Sen. Charles Grassley (R-Iowa) asked the National Institutes of
Health to
investigate university physicians who were paid by Merck to work on a campaign
for the cholesterol drug Vytorin even though an
internal study had showed it was no more effective than cheaper drugs. The
relationships were first reported by the Chronicle of
Higher Education.

Grassley
raised particular concerns about Baylor College of Medicine, which didn’t tell
the NIH that one of its researchers, Dr. Christie M. Ballantyne,
had accepted $34,000 from Merck to consult about Vytorin
while also receiving money from the NIH to study cholesterol-lowering
therapies.

NIH director
Francis Collins told Grassley in a
letter that while Ballantyne had followed the rules and notified Baylor, the
institution had not shared the information with NIH as it should have.

Even after
Baylor said it tightened its practices, Ballantyne’s
work with Merck continued. In 2012, ProPublica data
shows, Ballantyne received speaking and consulting
money from Merck while conducting research on the company’s behalf. Merck data shows he received $11,000
as a speaker and $7,175 as a consultant in 2013 as well.

Ballantyne
said in an email that he is no longer participating in speakers’ programs
because companies insist on having the final say on the slides used. “The position of the companies is
clearly not consistent with the position taken by our medical
school, and most other medical schools, so academic physicians almost
never participate in speakers bureaus,” he wrote.

Baylor spokeswoman
Lori Williams said Ballantyne spoke internationally
on behalf of Merck in 2012 and 2013 and used his own slides, which did not
violate Baylor’s rules.

Ballantyne wrote that he does not see a conflict in continuing to work as a
consultant for companies that support his research. “I consult for
companies because I have expertise that I hope may help in the search for
new therapies. Research saves lives. I participated in a clinical trial
when I was treated with lymphoma. If I had been diagnosed 50 years
ago I would have lived less than 6 months.”

Ballantyne was one of several Baylor faculty members who received speaking
or consulting payments in 2012 from companies that fund their research.

Baylor’s senior vice
president of research, Dr. Adam Kuspa, said the
school stepped up its review of research conflicts after the NIH findings. He
said faculty are not permitted to serve as company speakers if a drug maker
retains final approval of slides, but can spend up to 20 percent of their time
on consulting.

Kuspa cautioned against going too far to regulate payments to doctors.
“You certainly wouldn’t want people who didn’t know anything about the drugs
consulting about what Pfizer’s doing in that area,” he said.

The
Pharmaceutical Research and Manufacturers of America, the industry trade group,
said it sees benefits in doctors working with companies in multiple roles. A
company could hire a researcher overseeing a clinical trial, for example, to
consult with other trial sites about patient recruitment or to speak about new
uses for drugs being studied, officials said.

Kendra
Martello, PhRMA’s deputy vice president of strategic
operations, said research integrity is protected by institutional review
boards, which are appointed by hospitals to approve the design of studies and
patient consent forms, as well as by the U.S. Food and Drug Administration, as
part of the drug approval process.

Massachusetts
has taken a harder line than most states on doctors’ conflicts of interest. For
a time, it banned meals to physicians. The state requires all pharmaceutical
companies to disclose payments to Massachusetts doctors, though not for
research, and posts the information online.

Policies at
academic medical centers in Massachusetts differ. While Harvard caps the
outside income of researchers, UMass Memorial Medical Center, Tufts Medical
Center, and Boston University do not. They require researchers to disclose dual
relationships internally but do not limit them as a rule.

Even so,
John Randolph, vice president and chief compliance officer of UMass Memorial
Health Care, said his conflict-of-interest committee rarely allows researchers
much leeway.

“We are very
conservative about it,” he said. “I don’t think we’ve allowed any faculty
member to have a relationship like this where we’ve approved greater than
$5,000 of activity from the same company — and that was only in the situation
where the research and the consulting were in completely different areas of the
company.”

ProPublica news applications fellow Eric Sagara contributed to this report.