Adventures in Ethics and Science

Revere already flagged this story, but I’m going to try to move beyond the forehead slapping to some analysis of why a journal’s confidentiality rules might matter. (I’ll leave it to Bill, Bora, Jean-Claude, and their posse to explain how a thoroughgoing shift to “open science” might make such situations go away.)

The story, as reported in The Chronicle of Higher Education, is that a peer reviewer for the New England Journal of Medicine, reviewing a manuscript that reported negative findings about the safety of a diabetes drug, broke confidentiality rules and sent a copy of that soon-to-be-published manuscript to the drug’s manufacturer:

The reviewer, Steven M. Haffner, a professor of internal medicine at the University of Texas Health Science Center at San Antonio, broke the journal’s confidentiality rules by faxing a copy of a review of studies on the diabetes drug Avandia to a colleague at GlaxoSmithKline, the pharmaceutical company. Dr. Haffner has received consulting fees and speaker’s honoraria from the company…

Dr. Haffner told Nature, “Why I sent it is a mystery. I don’t really understand it. I wasn’t feeling well. It was bad judgment.”

A spokeswoman for Glaxo said that the company had already planned to publish interim results of another study of the drug that it had sponsored, but that knowledge that the review would be appearing soon “added an additional sense of urgency.” Glaxo’s study appeared online in the same journal just two weeks after the review paper did.

“It was bad judgment” seems like an understatement. And I’m not terribly moved by the “wasn’t feeling well” excuse. If I were a meaner person than I try to be, I might compare that excuse to the classic “Gosh, after a few pitchers of beer in the airport bar, I think I maybe hit my head on the barstool and the next thing I remember I’m in the cockpit piloting the plane.”

Some free advice: on days when you’re not feeling well enough to make good judgments, set your work aside and take some time to recover.

You will notice that professor Haffner was not just a reviewer for the New England Journal of Medicine, but also a paid consultant for Glaxo. I wonder whether that wouldn’t already create a conflict of interest (or, at the very least, the appearance of one) for Haffner in evaluating a manuscript reviewing the safety and efficacy of a Glaxo product.

But let’s assume Haffner somehow has the ability to make objective reviews of manuscripts concerning the products of a pharmaceutical company for which he’s a paid consultant. Let’s assume that he didn’t tell the NEJM editors that they ought to get another reviewer for this manuscript because he was confident that he could set aside his financial interests while reviewing the goodness of the science.

Why, then, fax the manuscript to Glaxo before it was published rather than, say, emailing them a link to the article once it was published online?

Surely not so Glaxo executives could sell off their stock before the article was published. I’m pretty sure that’s insider information of the sort the Securities and Exchange Commission takes a dim view.

Was it to give Glaxo “an additional sense of urgency” in rushing their new studies to publication? Is this the kind of thing that can be expected to result in better results from a scientific point of view — results that are derived from enough data, thoroughly analyzed, checked for error? Or would these hurried results mostly be “better” from the point of view of Glaxo’s bottom-line?

Why not leak the manuscript to all the researchers studying the drug in question? The selective sharing of the pre-publication manuscript seems to reflect a bias toward Glaxo. In turn, this suggests that Haffner wasn’t entirely unbiased.

Indeed, maybe one reason for the confidentiality rule is to prevent peer reviewers from making judgments on the basis of their biases, whether those biases come from financial relationships or professional loyalties or rivalries. The rule against sharing the manuscript you’re reviewing with others is supposed to remind you that, in your capacity as a peer reviewer dealing with a manuscript, you are supposed to set those other interests aside. Feeling like you want to share the information with someone else and then remembering that the rules prevent you from doing so might also help you notice some of the biases you bring to the table, and to work extra hard to pull against them in evaluating the science. Or, it might make you recognize that, in particular instances, you can’t overcome your biases, and thus you need to recuse yourself from the peer reviewing duty and let someone more objective than you (at least in those instances) do it.

(Hat-tip to Zuska, who brought the story to my attention.)

Comments

  1. #1 steppen wolf
    February 1, 2008

    Nasty. But not unheard of. Thanks for reporting this story on your blog.

  2. #2 PhysioProf
    February 1, 2008

    Dr. Haffner told Nature, “Why I sent it is a mystery. I don’t really understand it. I wasn’t feeling well. It was bad judgment.”

    What a fucking liar. He sent it because he perceived his financial interests as a “consultant” as being aligned with those of Glaxo.

  3. #3 andy
    February 1, 2008

    He sent it because he perceived his financial interests as a “consultant” as being aligned with those of Glaxo.

    Is this typical in pharma? If so, that’s scary. How much ca we trust what’s in the literature? I won’t even mention the possibility of unethical people selling shares short. Surely nobody would do that.

  4. #4 PhysioProf
    February 1, 2008

    Is this typical in pharma? If so, that’s scary.

    Pharmaceutical companies have tens-of-thousands of physicians and scientists on retainer as consultants. This influences what drugs physicians prescribe, what studies scientists perform, and–as you can see from what Janet wrote in her post–whether and how scientists conform with their ethical duties.

    How much can we trust what’s in the literature?

    Dunno.

    I won’t even mention the possibility of unethical people selling shares short. Surely nobody would do that.

    Scientists have a vastly greater chance of getting busted by the Feds for insider trading on that kind of information, than they do having any ethical standards imposed upon them.

  5. #5 ponderingfool
    February 1, 2008

    What Haffner did was just plain wrong.

    There is another question to ask, why in the world did the editor handling the article send this to Dr. Haffner? If the editor knew enough about Haffner to select him then he should have known of the connection, a quick google finds his relationship with companies.

    “Speaker Disclosure
    Dr. Haffner reports having received research support from Astra-Zeneca, GlaxoSmithKline and Novartis.”
    http://www.crphealth.com/conf/hcp/5,9/prof.steven.m.haffner.crp.the.metabolic.syndrome.and.cardiovascular.diseases.html

    http://www.controlhypertension.org/about/bios/item.php?bio_id=130
    “Steven M. Haffner, MD, has indicated relevant financial relationships as noted: he is a member of the speakers bureau for AstraZeneca, GlaxoSmithKline, Merck Sharp & Dohme, and Pfizer.”

  6. #6 S. Rivlin
    February 3, 2008

    Of course it is all about greed, fame and power. But as we have already discussed the plague of scientific misconduct in the past, in today’s atmosphere of SCIENCE=BUSINESS, where institutions of higher education hire and fire scientists based upon their “richness” and “poorness” in grant money, it is not surprising that there are those who will resort to shortcuts and misdeeds to stay atop. Here’s another recent case of misbehavior. It will be interesting to see whether the Harvard Medical School’s investigation will resort for a cover-up or an exposure of the full truth. Any bets?

    http://www.thecrimson.com/article.aspx?ref=521653

    HMS Professor Caught Plagiarizing

    Published On Friday, February 01, 2008 1:08 AM
    By JUNE Q. WU
    Crimson Staff Writer

    Harvard Medical School has launched an inquiry into allegations of plagiarism after a British medical journal retracted one of its professor’s articles this week.

    Medical School professor Lee S. Simon’s review of treatments for rheumatoid arthritis was retracted on Tuesday from the biomedical journal “Best Practices & Research: Clinical Rheumatology” after the journal found similarities between his article and another author’s work.

    The 2004 article reproduced several sections of text and portions of the reference list from a paper by Roy M. Fleischmann, according to a statement by Elsevier, the journal’s publisher. Fleischmann’s article was published in 2003 in “Expert Opinion on Drug Safety.”

    The duplicated sections of Simon’s article were first discovered by eTBLAST, a text similarity search engine developed by Harold “Skip” R. Garner, Jr, a professor at the University of Texas Southwestern.

    In response to the allegations, the Medical School has formed a fact gathering ad-hoc committee concerning Simon’s case, according to spokesman David J. Cameron. After reviewing the two articles, the committee will then determine whether to proceed under the school’s policies for faculty misconduct.

    “This entire situation is all very preliminary,” Cameron said. “Right now, this is not an investigation–it is a review.”

    Fleischmann–whose work in rheumatology has brought him into contact with Simon in the past–was first notified of the duplication of his 2003 article in early December.

    “I was in shock,” Fleischmann said. “I didn’t know whether it was true at the time.”

    Fleischmann, a professor at University of Texas Southwestern, said he was surprised to see the extent of the duplication by Simon, whom he had always viewed as a “well-respected rheumatologist.”

    “This is truly an unethical breach,” Fleischmann said. “As the author who was violated, all I can ask for is a retraction.”

    Fleischmann added that Simon has yet to contact him or apologize since the allegations surfaced.

    To prevent future instances of plagiarism, Elsevier will require all of its editors to join the Committee on Publication Ethics, a forum that advises editors on issues of integrity. The initiative will be formally announced next week, according to the publisher’s director of relations Shira D. Tabachnikoff.

    After detecting nearly 7,000 instances of unverified duplications in medical articles in the five years since he created the program, Garner said he has come to realize eTBLAST’s value in uncovering possible cases of plagiarism.

    “Overall 99 percent of medical literature is fantastic and in great shape,” said Garner. “However, it is important to find those occurrences that may be questionable.”

    Simon did not return requests for comment.

    –Staff writer June Q. Wu can be reached at junewu@fas.harvard.edu.