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Conflicts of Interest:
    Research and Clinical Ethics
SWINY-CUNY-Hastings Center Bioethics Bootcamp
              March 30, 2012



             Ivan Oransky, MD
        Executive Editor, Reuters Health
         Co-Founder, Retraction Watch
Does Funding Influence Results?
Does Funding Influence Results?
Do Journals Have COIs?
Do Journals Have COIs?


Publishers know that pharmaceutical companies will
often purchase thousands of dollars' worth of reprints,
and the profit margin on reprints is likely to be 70%
An editor may thus face a frighteningly stark conflict of
interest: publish a trial that will bring US$100 000 of
profit or meet the end-of-year budget by firing an editor.

                       -- former BMJ editor Richard Smith
Are Journal Policies Consistent?
COI Reporting Tips
COI Reporting Tips
COI Reporting Tips
COI Reporting Tips

1. Find out just what “no conflicts” means. I have definitely been guilty of
taking at face value statements by authors that they “have no conflicts of
interest,” especially when other authors on the same paper disclose
voluminous conflicts. Joelving actually followed up to see what was hiding
behind that phrase:

…of the 50 most recent BJD reports from scientists at L'Oreal, Shiseido, Novartis
and similar companies, 13 declared no conflict of interest. And that's not
counting one study that promoted a L'Oreal-Nestle product on shaky grounds
without disclosing that most of the authors were employed by the manufacturer
or had been paid by it. The BJD only corrected the problem (reut.rs/eTnMOq)
after a Reuters Health story (reut.rs/jujOYb) pointed it out in July.
COI Reporting Tips

2. Ask the author. Too few health writers do this. Joelving showed that it’s
simple and that it works. He wrote about an author, Dr. Fernand Labrie, who
holds patents for a hormone called DHEA and “owns companies dedicated to
marketing it for certain medical problems.” Has Labrie disclosed this? No.

But when Reuters Health contacted him, he acknowledged that he owns the
company that funded the research, EndoRecherche, and holds patents for
DHEA, including one for anti-aging skin treatment. EndoCeutics, a daughter
company of EndoRecherche, is currently involved in late-stage development and
marketing of DHEA for female sexual problems. According to a 2010 press
release, the company has signed a contract with pharmaceutical giant Bayer,
which may net EndoCeutics up to $330 million (CAD) in addition to royalties
from sales. Of three recent DHEA skin studies published by Labrie and his
colleagues, none mentions this relationship.
COI Reporting Tips

3. Give the science a stress test. Don’t just take a study’s word for it. Show the
study to other experts and see what they think. Probe the study’s limitations
and weaknesses, especially when scientists with conflicts are involved.

But the findings only looked at skin changes at a microscopic level, and
whatever visible effects the hormone might have -- and potential side effects
with long-term use -- are uncertain. In fact, one dermatologist who reviewed the
study for Reuters Health said it shows DHEA also boosts skin molecules that may
slow wound healing. "I would ask if giving DHEA actually has a pro-aging effect
and not an anti-aging effect," said Dr. Christos C. Zouboulis of Dessau Medical
Center in Germany.
COI Reporting Tips

4. Find the rebels. It’s easy to see the widespread funding of medical journals
of drug makers and device makers as a fact of life, but there are journals that
refuse industry funding. Joelving provided examples throughout.

Earlier this year, an Australian medical journal decided to pull the plug on drug
ads. "Essentially, our subscribers had to pay more for the journal," Dr. George
Jelinek, past editor of Emergency Medicine Australasia, told Reuters Health in
an e-mail. "We believe that is perfectly reasonable," he added, "and far
preferable to having a dependence on drug company revenue, a dependence
which ultimately requires some repayment."
COI Reporting Tips

5. Cite when it’s right. Reporters are often discouraged by editors from citing
other people’s work. We particularly liked the way the story gave due credit to
the Milwaukee Journal-Sentinel.

One of the most egregious examples of financial double-dipping in the journal
community is Dr. Thomas Zdeblick, editor-in-chief of the Journal of Spinal
Disorders & Techniques. Since taking the helm at the journal in 2002, Zdeblick
has made more than $20 million in patent royalties for spinal implants sold by
Medtronic, according to a 2009 report in the Milwaukee Journal Sentinel. At the
same time, Zdeblick's journal published dozens of studies on Medtronic
products, and they often were positive, the Journal Sentinel found.
It’s Not All About Money
Acknowledgements/Contact Info


Thanks to Nancy Lapid, Reuters Health

 ivan.oransky@thomsonreuters.com
       @ivanoransky (better)

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Tips for covering conflicts of interest

  • 1. Conflicts of Interest: Research and Clinical Ethics SWINY-CUNY-Hastings Center Bioethics Bootcamp March 30, 2012 Ivan Oransky, MD Executive Editor, Reuters Health Co-Founder, Retraction Watch
  • 5. Do Journals Have COIs? Publishers know that pharmaceutical companies will often purchase thousands of dollars' worth of reprints, and the profit margin on reprints is likely to be 70% An editor may thus face a frighteningly stark conflict of interest: publish a trial that will bring US$100 000 of profit or meet the end-of-year budget by firing an editor. -- former BMJ editor Richard Smith
  • 6. Are Journal Policies Consistent?
  • 10. COI Reporting Tips 1. Find out just what “no conflicts” means. I have definitely been guilty of taking at face value statements by authors that they “have no conflicts of interest,” especially when other authors on the same paper disclose voluminous conflicts. Joelving actually followed up to see what was hiding behind that phrase: …of the 50 most recent BJD reports from scientists at L'Oreal, Shiseido, Novartis and similar companies, 13 declared no conflict of interest. And that's not counting one study that promoted a L'Oreal-Nestle product on shaky grounds without disclosing that most of the authors were employed by the manufacturer or had been paid by it. The BJD only corrected the problem (reut.rs/eTnMOq) after a Reuters Health story (reut.rs/jujOYb) pointed it out in July.
  • 11. COI Reporting Tips 2. Ask the author. Too few health writers do this. Joelving showed that it’s simple and that it works. He wrote about an author, Dr. Fernand Labrie, who holds patents for a hormone called DHEA and “owns companies dedicated to marketing it for certain medical problems.” Has Labrie disclosed this? No. But when Reuters Health contacted him, he acknowledged that he owns the company that funded the research, EndoRecherche, and holds patents for DHEA, including one for anti-aging skin treatment. EndoCeutics, a daughter company of EndoRecherche, is currently involved in late-stage development and marketing of DHEA for female sexual problems. According to a 2010 press release, the company has signed a contract with pharmaceutical giant Bayer, which may net EndoCeutics up to $330 million (CAD) in addition to royalties from sales. Of three recent DHEA skin studies published by Labrie and his colleagues, none mentions this relationship.
  • 12. COI Reporting Tips 3. Give the science a stress test. Don’t just take a study’s word for it. Show the study to other experts and see what they think. Probe the study’s limitations and weaknesses, especially when scientists with conflicts are involved. But the findings only looked at skin changes at a microscopic level, and whatever visible effects the hormone might have -- and potential side effects with long-term use -- are uncertain. In fact, one dermatologist who reviewed the study for Reuters Health said it shows DHEA also boosts skin molecules that may slow wound healing. "I would ask if giving DHEA actually has a pro-aging effect and not an anti-aging effect," said Dr. Christos C. Zouboulis of Dessau Medical Center in Germany.
  • 13. COI Reporting Tips 4. Find the rebels. It’s easy to see the widespread funding of medical journals of drug makers and device makers as a fact of life, but there are journals that refuse industry funding. Joelving provided examples throughout. Earlier this year, an Australian medical journal decided to pull the plug on drug ads. "Essentially, our subscribers had to pay more for the journal," Dr. George Jelinek, past editor of Emergency Medicine Australasia, told Reuters Health in an e-mail. "We believe that is perfectly reasonable," he added, "and far preferable to having a dependence on drug company revenue, a dependence which ultimately requires some repayment."
  • 14. COI Reporting Tips 5. Cite when it’s right. Reporters are often discouraged by editors from citing other people’s work. We particularly liked the way the story gave due credit to the Milwaukee Journal-Sentinel. One of the most egregious examples of financial double-dipping in the journal community is Dr. Thomas Zdeblick, editor-in-chief of the Journal of Spinal Disorders & Techniques. Since taking the helm at the journal in 2002, Zdeblick has made more than $20 million in patent royalties for spinal implants sold by Medtronic, according to a 2009 report in the Milwaukee Journal Sentinel. At the same time, Zdeblick's journal published dozens of studies on Medtronic products, and they often were positive, the Journal Sentinel found.
  • 15. It’s Not All About Money
  • 16. Acknowledgements/Contact Info Thanks to Nancy Lapid, Reuters Health ivan.oransky@thomsonreuters.com @ivanoransky (better)