The Ethical Nag

I’ve often said to my hockey-mad son Ben that we could end on-ice fighting in hockey (not, incidentally, our national sport, but arguably our Canadian obsession) if only the National Hockey League would put me in charge for just one week.

But the folks who do run the NHL clearly have no appetite for banning hockey fighting, or they would have acted to end it by now. Despite their feeble protests about the unacceptability of fighting, team owners tolerate beefy goons who drop their gloves and fight. The League accepts it, the owners accept it, the players accept it, and the fans just love it.

There is, alas, no organizational will to ban violence on the ice.

And much like hockey goons, medical journal editors could end the appallingly unethical and dangerous practice of medical ghostwriting in one week, but these editors clearly have no appetite for banning ghostwriting in their journals, or they would have acted to end it by now. 

There is, alas, no organizational will to ban medical ghostwriting. Read more…

Let’s not pop the champagne corks just yet to celebrate the recent announcement of new guidelines for Big Pharma from the trade group Pharmaceutical Research & Manufacturers of America (PhRMA).  The wordy guidelines are called Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. They went into effect last week, and are a response to mounting scandals and scrutiny about how clinical research trials are conducted and reported. These new principles also cover issues like authorship contributions and medical ghostwriting; disclosure of financial conflicts of interest; public registration of clinical trials; and publicly accessible summaries of all clinical trial results. These last two are apparently a stab at addressing the current reality that negative clinical trial results either never see the light of day or are only selectively reported to favour the drugs being tested. The principles have been hailed by some as a step in the right direction, although many point out that they may have more bark than bite in addressing, for example, the chronic problem of medical ghostwriting.

Commenting on these relatively toothless new principles in a Heartwire interview, cardiologist Dr. Steven Nissen of Cleveland Clinic highlighted the niggling issue of compliance and enforcement.

“The new PhRMA guidelines are useful, but will have little impact in solving this chronic problem. The guidelines are voluntary, and history has taught us that such efforts rarely succeed. There is no penalty for violation of these recommendations.”   Read more…

Participants at this month’s 2009 International Congress on Peer Review and Biomedical Publication in Vancouver heard an interesting medical journal survey report on ghostwriting vs. ‘guest authorship’ that has me scratching my head in confusion. Presented by the Journal of the American Medical Association, the report confirmed that the prevalence of both ‘honorary’ and ‘ghost authors’ in medical journal articles is “still a concern”. 

Here’s a dose of reality for JAMA editors: it’s not just a “concern”.  It’s global fraud being perpetrated upon the innocent patients of the world thanks in part to the lax (some more cynical than I might say ‘non-existent’) controls in place in many medical journal editors’ offices. For example:

• only four of the journals surveyed ask and then publish information on who the actual article authors are (Annals of Internal Medicine, JAMA, Lancet, and PLoS Medicine)
• New England Journal of Medicine claims that the journal “asks about author contributions but doesn’t publish them.” (Earth to NEJM: this is the same as not asking).
• Nature Medicine has “no instructions to authors about disclosing author contributions.”

This sounds like a de facto stamp of approval for the common practice of ghostwriting and ‘guest writing’. But by now, you may be asking the question: “Carolyn, what is the difference between ‘guest writing’ and ‘ghostwriting’ in research published in medical journals”?  The answer, my fellow Nags, is:  not much.  But here’s JAMA’s official definition:  Read more…

Just when we thought things couldn’t get any more slimy in the wonderful world of Big Pharma-funded medical journal articles, along comes last week’s editorial in the Canadian Medical Assocation Journal.  According to the September 9th editorial: “Somewhere between 50% and 100% of articles on drugs that appear in journals are ghostwritten,” says Dr. David Healy, a psychiatrist at the University of Cardiff in Wales, and a critic of the drug industry’s influence on physicians’ drug prescribing habits.

“Dr. Healy claims that ghostwriting “crept up on” the medical profession and became so common by the mid-90s that even senior researchers came to accept it as an ethical practice. Other critics of the practice agree, claiming that many researchers will put their name on a document as primary author even if they just edited it — or only read it and made no changes.

“If you have people like me who say they can’t do this, the pharmaceutical industry can easily go elsewhere and find a person who will,” says Dr. Healy.  Read more…