I’m not God and I’m not the FBI
“I’m not God and I’m not the FBI.” So stated Dr. Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, as she responded to questions regarding publication of study results by researchers who did not disclose their drug company ties.
JAMA has published a clarifying letter from the study researchers and a related statement from JAMA that states, in part:
In this case, financial interests and relationships with manufacturers of products that are used in the management of migraine or cardiovascular disease certainly are relevant and should be disclosed, as the authors have now reported.
This is bad timing for JAMA, because it comes days after JAMA announced a crackdown on researchers who do not disclose drug company ties. Lindsey Tanner, the Associated Press medical writer who wrote the news story, quoted Dr. Jerome Kassirer, a former New England Journal editor as saying that JAMA editors “appear not to have done their homework. It sounds like they’re being sloppy.”
DeAngelis said JAMA lacks the staff to check every researcher’s background. “I’m not God and I’m not the FBI,” she is quoted as saying.
Contrast that with a blogger, who typically works alone, with no support staff. Neville Hobson points to results of a study by the Pew Internet and American Life Project on Americans’ activities with blogs. Among the findings:
While more attention is being placed on what journalists think about the professionalism of bloggers, I want to remind us that we shouldn’t place journalists (and I’m including editors of professional publications) on a pedestal. No one who publishes news and information is a “god,” and we all need to be watchful of the basics.
July 19th, 2006 at 2:56 pm
Isn’t it up to the PR people at the drug companies to make sure proper disclosure is made in relation to grants from the drug companies?
BAK
July 20th, 2006 at 12:14 pm
Hi Brian,
To address your question, I’d think that the drug company’s legal or compliance departments would be involved with a disclosure statement if asked. However, in the situation covered by this post, the drug companies would not be involved.
The researchers submitted study results to an industry publication without noting that some of them received compensation from drug companies. The researchers submitting the study results would be responsible for notifying the publication.
A drug company would not automatically know that the study results were being sumitted to the publication. The drug companies would learn about the submission when the results were published, just like most everyone else–unless the researchers or someone else notificed the drug companies in advance.
July 21st, 2006 at 8:56 am
I’ve heard from someone who is closer to the pharma industry than I am, and who provided some insights that I could not. This person wishes to remain anonymous, so I will include the thoughts, without attribution.
This person described an “incestuous” relationship between drug companies and many researchers. A large portion of research by universities and other groups is funded by the drug companies, and it’s indefensible for the JAMA editors to say that it’s not their responsibility to check into the affiliations and/or funding of any authors’ work, my colleague says. They need simply ask whether, for example, any of the authors “is an employee, consultant or has received funding from the drug companies.” It would take very little time and be a major step toward ensuring honesty and ethical behavior all around.
Drug companies are aware of the results of these studies before they’re published (although, contrary to Brian’s post, their PR firms may not be aware), my colleague says. “You can be sure that those researchers who have any connection with the company (i.e., employee, consultant or receives funding) would have given their sponsors complete results/findings/conclusions right away… and even when the researchers/authors have “clean hands” (i.e., no relationship), there’s no benefit to publishing results without sharing with the drug company at the same time (if not before), if for no other reason than out of a sense of fairness. (Remember, we’re not talking tabloid journalism here, we’re talking about a professional journal.)”
No reputable, ethical researcher/author is out to “get” a drug company, the colleague continued. They’re out to provide valuable data that provides greater insight into the safety and effectiveness of a particular drug and/or treatment. That may or may not be to the drug company’s benefit (as we’ve seen with recently published studies on Ketek, Polyheme and Vioxx), but if the research is going to be in the public’s interest, the editors have just as much responsibility as the authors to provide the fullest disclosure right away. Anything less is an ethical sham.