Wednesday, September 09, 2009

Ghostwriters in the sky and kickbacks: Through a glass darkly?

This month's blog is a takeoff on a classic 1950's song, Riders in the Sky (aka Ghost Riders in the Sky), recorded by Vaughn Monroe and more than 50 others. (Note: I recommend that you right click on all links and choose Open in new tab.)
The blog is a protest of sorts. Do you ever feel like protesting? Or are we all so cynical in the 21st century that we accept shady practice as standard practice?
The focus will be on these items in TraQ's September newsletter:
  • Ghostwriting of scientific papers in industry-initiated papers
  • Pfizer, the world's largest drug company, fined for illegal marketing and kickbacks to physicians
In its simplest form, ghostwriting occurs when someone has significantly contributed to writing a paper but is not mentioned in the paper. In universities this is know as plagiarism and can result in serious consequences, including student expulsion. In the world of medical research it seems to be business as usual.
Earlier this year Merck was accused of ghostwriting and even producing its own "medical journal".
Apparently, it is not uncommon* for drug companies to have favorable papers about their products ghostwritten internally or contracted out, then published under the names of willing physicians who receive 'honoraria': (* not uncommon, an example of a litotes, a new word I learned this year, courtesy of my pal, RMC)
The Glaxo news article is instructive. The reporter writes:
  • An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.
  • Direct quote from the memo: “Physicians will be eager to participate ... regardless of their professional stature.’’

And as the TV infomercial hucksters shout, "Wait, there's more...."
In a nutshell, according to news reports, Pfizer
  • Pleaded guilty to promoting the painkiller Bextra (withdrawn in 2004) for uses that were not approved by regulators
  • Settled civil allegations regarding kickbacks to doctors who prescribed other drugs, although Pfizer denies these charges
News Items
  1. Pfizer receives biggest criminal fine in US history for mispromoting drugs & paying kickbacks
  • $2.3 billion is 4th fine of Pfizer or a subsidiary since 2002 over illegal marketing
  • Pfizer Fact Sheet (US govt)

  • Yes, they paid a $2.3 billion fine (that's a B for BILLION). Speculation is that the fine was so large because the practices had occurred over time with no change in behavior despite earlier fines.
    THROUGH A GLASS DARKLY?The unseen players in all of this are the physicians who lend their names to papers they never wrote and who accept kickbacks, as in this March 2009 report in the NY Times:

    All these stories made me speculate that we may be viewing our world 'through a glass darkly' (Bible, New Testament, 1 Corinthians 13:12). Are we looking into a dark mirror that poorly reflects the true situation?

    Us versus Them?
    I wonder if transfusion medicine professionals have ever tried their hand at ghostwriting for so-called 'honoria' or taken kickbacks for prescribing or promoting products such as IVIG and erythropoietin?
    If not blatant kickbacks, how about
    • sponsorship of research?
    • support for blood conservation programs?
    • a consulting position?
    • funds to travel to conferences, whether speaking favorably about the product or not?
    • or who knows what else?
    Of course, research sponsorship and other program funding are not in themselves wrong, indeed they are welcome. It's only if the support influences outcomes, which is why medical journals have moved to more transparent forms of disclosing conflicts of interest and competing interests. Readers are left to judge whether or not funding has influenced a study.
    The news items above describe clear cases of unethical physician behavior that could result in a doctor losing a license to practice. But ethical lines can become very fuzzy once we accept even simple perks that slowly lead to more and more entanglement with commercial interests, no matter how seemingly benevolent at first.
    Moreover, is it only 'them' or does it include 'us', members of the transfusion medicine community? Are we looking through a glass darkly?
    These current news items remind me of Sackett and Oxman's spoof on how doctors can grow rich pimping for drug companies:

    In that vein, here's a fun ditty and a feel-good song that expresses a wish for all of us:
    As always, the views expressed are mine alone.Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

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