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https://www.propublica.org/article/prominent-doctors-industry-ties-disclosures-medical-journal-studies
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*The Sarah Cannon Research Institute, based in Nashville, received nearly
$8 million in payments from drug companies on behalf of its president for
clinical operations, Dr. Howard Burris, largely for research work. Dozens
of his articles published in prestigious medical journals did not include
the required disclosures of those payments and relationships. (William
DeShazer for The New York Times)* Prominent Doctors Aren’t Disclosing Their
Industry Ties in Medical Journal Studies. And Journals Are Doing Little to
Enforce Their Rules*The dean of Yale’s medical school, the incoming
president of a prominent cancer group and the head of a Texas cancer center
are among leading medical figures who have not accurately disclosed their
relationships with drug companies.*

by Charles Ornstein <https://www.propublica.org/people/charles-ornstein>,
ProPublica, and Katie Thomas, The New York Times <https://www.nytimes.com/>
Dec. 8, 10 a.m. EST

*This story was co-published with The New York Times.*

One is dean of Yale’s medical school. Another is the director of a cancer
center in Texas. A third is the next president of the most prominent
society of cancer doctors.

These leading medical figures are among dozens of doctors who have failed
in recent years to report their financial relationships with pharmaceutical
and health care companies when their studies are published in medical
journals, according to a review by ProPublica and The New York Times and data
from other
<https://jamanetwork.com/journals/jamaoncology/fullarticle/2698041> recent
research
<https://jamanetwork.com/journals/jamasurgery/article-abstract/2696610>.

Dr. Howard A. “Skip” Burris III, the president-elect of the American
Society of Clinical Oncology
<https://www.asco.org/about-asco/asco-overview/leadership/board-of-directors>,
for instance, declared that he had no conflicts of interest in more than 50
journal articles in recent years, including in the prestigious New England
Journal of Medicine.

However, drug companies have paid his employer nearly $114,000 for
consulting and speaking, and nearly $8 million for his research during the
period for which disclosure was required. His omissions extended to the Journal
of Clinical Oncology <http://ascopubs.org/doi/pdf/10.1200/JCO.2016.70.1508>,
which is published by the group he will lead.

In addition to the widespread lapses by doctors, the review by ProPublica
and The Times found that journals themselves often gave confusing advice
and did not routinely vet disclosures by researchers, although many
relationships could have been easily detected on a federal database
<https://openpaymentsdata.cms.gov/>.

Medical journals, which are the main conduit for communicating the latest
scientific discoveries to the public, often have an interdependent
relationship with the researchers who publish in their pages. Reporting a
study in a leading journal can heighten their profile — not to mention that
of the drug or other product being tested. And journals enhance their
cachet by publishing exclusive, breakthrough studies by acclaimed
researchers.

In all, the reporting system still appears to have many of the same flaws
that the Institute of Medicine identified nearly a decade ago when it
recommended fundamental changes
<https://www.nap.edu/catalog/12598/conflict-of-interest-in-medical-research-education-and-practice>
in how conflicts of interest are reported. Those have yet to happen.

“The system is broken,” said Dr. Mehraneh Dorna Jafari, an assistant
professor of surgery at the University of California, Irvine, School of
Medicine. She and her colleagues published a study in August
<https://jamanetwork.com/journals/jamasurgery/article-abstract/2696610>
that found that, of the 100 doctors who received the most compensation from
device makers in 2015, conflicts were disclosed in only 37 percent of the
articles published in the next year. “The journals aren’t checking and the
rules are different for every single thing.”

Calls for transparency stem from concerns that researchers’ ties to the
health and drug industries increase the odds they will, consciously or not,
skew results to favor the companies with whom they do business. Studies
have found that industry-sponsored research tends to be more positive than
research financed by other sources. And that in turn can sway which
treatments become available to patients. There is no indication that the
research done by Burris and the other doctors with incomplete disclosures
was manipulated or falsified.

Journal editors say they are introducing changes that will better
standardize disclosures and reduce errors. But some have also argued that
since most researchers follow the rules, stringent new requirements would
be costly and unnecessary.

The issue has gained traction since September, when Dr. José Baselga, the
chief medical officer of Memorial Sloan Kettering Cancer Center in New
York, resigned
<https://www.propublica.org/article/memorial-sloan-kettering-official-jose-baselga-resigns-after-failing-to-disclose-industry-ties>
after The Times and ProPublica reported
<https://www.propublica.org/article/doctor-jose-baselga-cancer-researcher-corporate-financial-ties>
that he had not revealed his industry ties in dozens of journal articles.

Burris, president of clinical operations and chief medical officer at the Sarah
Cannon Research Institute <https://sarahcannon.com/> in Nashville, referred
questions to his employer. It defended him, saying the payments were made
to the institution, although the New England Journal of Medicine requires
disclosure
<https://www.nejm.org/doi/suppl/10.1056/NEJMoa1609709/suppl_file/nejmoa1609709_disclosures.pdf>
of all such payments.

Other prominent researchers who have submitted erroneous disclosures
include Dr. Robert J. Alpern, the dean of the Yale School of Medicine, who
failed to disclose in a 2017 journal article
<https://cjasn.asnjournals.org/content/13/1/26.long> about an experimental
treatment developed by Tricida that he served on that company’s board of
directors <https://www.tricida.com/company/> and owned its stock. Tricida,
which is developing therapies for chronic kidney disease, had financed the
clinical trial that was the subject of the article.

Alpern said in an email that he initially believed that his disclosure —
that he had been a consultant for Tricida — was adequate. However, “because
of concerns recently raised about disclosures,” he said he notified the
publication, the Clinical Journal of the American Society of Nephrology, in
October that he also served on Tricida’s board and had stock holdings in
the company.

The journal initially told Alpern that his disclosure was sufficient. But
after ProPublica and The Times contacted the publication in November, it
said it would correct the article.

“The failure to disclose this information at the time of peer review is a
violation of our policy,” Dr. Rajnish Mehrotra, the journal’s
editor-in-chief, said in an email.

He later said that an additional inquiry had revealed that all 12 of the
article’s authors had been incomplete in their disclosures, and that the
journal planned to refer the matter to the ethics committee of the American
Society of Nephrology. Mehrotra also said that the journal had decided to
conduct an audit of some recent articles to evaluate the broader issue.

Dr. Carlos L. Arteaga, the director of the Harold C. Simmons Comprehensive
Cancer Center in Dallas, said he had “nothing to disclose” as an author of
a 2016 study <https://www.nejm.org/doi/full/10.1056/NEJMoa1609709>
published in The New England Journal of Medicine of the breast cancer drug
Kisqali, made by Novartis. But Arteaga had received more than $50,000 from
drug companies in the three-year disclosure period, including more than
$14,000 from Novartis.

In an email, Arteaga described the omission as an “inexcusable oversight
and error on my part,” and subsequently submitted a correction.

Dr. Jeffrey R. Botkin, associate vice president for research integrity at
the University of Utah, recently argued in JAMA, a leading medical journal,
that researchers should face
<https://jamanetwork.com/journals/jama/fullarticle/2712193> misconduct
charges when they do not disclose their relationships with interested
companies. “They really are falsifying the information that others rely on
to assess that research,” he said. “Money is a very powerful influencer,
and people’s opinions become subtly biased by that financial relationship.”

But Dr. Howard C. Bauchner, the editor-in-chief of JAMA, said that
<https://jamanetwork.com/journals/jama/fullarticle/2712191> verifying each
author’s disclosures would not be worth the time or effort. “The vast
majority of authors are honest and do want to fulfill their obligations to
tell readers and editors what their conflicts of interest could be,” he
said in an interview.

As the debate continues, an influential group, the International Committee
of Medical Journal Editors, is considering a policy that would refer
researchers who commit major disclosure errors to their institutions for
possible charges of research misconduct.

Concerns about the influence of drug companies on medical research have
persisted for decades. Senator Estes Kefauver held hearings on the issue in
1959, and there was another surge of concern in the 2000s after a series of
scandals in which prominent doctors
<https://www.nytimes.com/2008/10/04/health/policy/04drug.html> failed to
reveal their industry relationships.

Medical journals and professional societies strengthened their
requirements. The drug industry restricted how it compensates doctors,
prohibiting gifts like tickets to sporting events or luxury trips —
although evidence of kickbacks and corruption continues to surface in
criminal prosecutions. And a 2010 federal law required pharmaceutical and
device makers to publicly report their payments to physicians.

Despite these changes, the system for disclosing conflicts remains
fragmented and weakly enforced. Medical journals and professional societies
have a variety of guidelines about what types of relationships must be
reported, often leaving it up to the researcher to decide what is relevant.
There are few repercussions — beyond a correction — for those who fail to
follow the rules.

For example, the American Association for Cancer Research has warned authors
<http://clincancerres.aacrjournals.org/content/clincanres/suppl/2017/06/21/1078-0432.CCR-16-2267.DC1/171525_1_data_set_3728065_qg0v3w.pdf>
that they face a three-year ban if they are found to have omitted a
potential conflict. But the group’s conflict-of-interest policy contains no
mention of such a penalty
<http://aacrjournals.org/content/authors/editorial-policies>, and it said
no author had ever been barred. Baselga’s failure to disclose his industry
relationships extended to the association’s journal, Cancer Discovery, for
which he serves as one of two editors-in-chief. The association said it is
investigating Baselga’s actions.

Most authors do seem to disclose their ties to corporate interests. About
two-thirds of the authors on the Kisqali study, for example, reported
relationships with companies, including Novartis. But the researchers who
did not included Arteaga, Burris and Denise A. Yardley, a senior
investigator who works with Burris at Sarah Cannon.

The Tennessee-based research center received more than $105,000 in fees for
consulting, speaking and other services on Yardley’s behalf in the
three-year period in which she declared no conflicts.

The Sarah Cannon institute said it switched over a year ago to a “universal
disclosure” practice promoted by ASCO, the cancer group that Burris will
lead. That requires doctors to disclose all payments, including those made
to their institutions.

“We believe we adhere to the highest ethical standards in the industry by
not allowing personal compensation to be paid to our leadership
physicians,” the center said.

ASCO said it would post corrections to Burris’ disclosures in the Journal
of Clinical Oncology for the past four years. The group said that in the
fall of 2017 — as Burris was seeking a leadership role in the organization
— it began working with him to disclose all his company relationships,
including indirect payments. Burris will become president in June 2019.

“Disclosure systems and processes in medicine are not perfect yet, and
neither are ASCO’s,” the group said in an email.

Burris, Yardley and Arteaga submitted updated disclosures to the New
England Journal of Medicine, which posted them on Thursday
<https://www.nejm.org/doi/suppl/10.1056/NEJMoa1609709/suppl_file/nejmoa1609709_disclosures.pdf>
.

Burris’ updated disclosure listed relationships with 30 companies,
including that he provided expert testimony for Novartis.

Other studies recently published by the New England Journal of Medicine
also omitted disclosures, including one on a 2018 study
<https://www.nejm.org/doi/10.1056/NEJMoa1715971> on a treatment for sickle
cell disease and another on the recently approved cancer drug Vitravki
<https://www.nejm.org/doi/full/10.1056/NEJMoa1714448>, to be sold by Bayer
and Loxo Oncology.

Jennifer Zeis, a spokeswoman for the journal, said it was contacting those
studies’ authors, and that it now asked researchers to certify that they
had checked their disclosures against the federal database.

Some institutions have pushed back, arguing that the journals’ inconsistent
rules make it difficult for even well-meaning researchers to do the right
thing.

In a letter last month to the New England Journal of Medicine, Memorial
Sloan Kettering objected to the treatment of one of its top researchers,
Dr. Jedd Wolchok. When he tried to correct his disclosures, the journal
shifted its position, from saying its editors were satisfied with his
disclosures to saying he had failed to comply with the rules, the center
said in citing communications with the journal.

Wolchok, a pioneer in cancer immunotherapy, ultimately corrected 13
articles and letters <https://www.nejm.org/doi/full/10.1056/NEJMx180040> to
the editor.

To clarify reporting requirements, several publications are attempting only
now to do what the Institute of Medicine recommended in 2009. The New
England Journal is testing a new system in partnership
<https://www.nytimes.com/2018/09/30/opinion/letters/disclosure-medicine.html>
with the Association of American Medical Colleges that would act as a
central repository for reporting financial relationships.

This year, JAMA began requiring authors to confirm multiple times that they
had nothing to disclose. ASCO has a centralized system for reporting
conflicts to all of its journals and speaker presentations.

Dr. Bernard Lo, the chairman of the 2009 Institute of Medicine panel, said
journals have only begun to confront some of the systemic flaws. “They’re
certainly not out in front trying to be trailblazers, let me just say it
that way,” he said. “The fact that it hasn’t been done means that nobody
has it on their priority list.”