Today we had a large discussion about what medical researchers would be required to disclose when publishing an article in the New England Journal of Medicine. This has been a subject of discussion at Politico today, a source few of us would ever consider reputable.
Another diarist made the Rec list with an attack on Dr. Gruber for not disclosing information that he had received grants from HHS to conduct research unrelated to an article he published in June 2009. The implication is that Dr Gruber's support for the excise tax is suspect because he is an unethical SOB who lied about his belief that the excise tax makes sense because he does not disclose his true financial relationships.
This may bother some of you, but the fact is, he's not required to. Let's take a look.
NEJM uses a disclosure form provided by the International Committee of Medical Journal Editors, referred to as "ICMJE Uniform Disclosure Form for Potential Conflicts of Interest."
http://authors.nejm.org/...
I am not sure if everyone can access that or just people who subscribe to NEJM (like me).
We'll start with something found at the end of the form, Item 3:
For grants you have received for work outside the submitted work, you should disclose support ONLY from entities that could be perceived to benefit financially from the published work, such as drug companies, or foundations supported by entities that could be perceived to have a financial stake in the outcome. Public funding sources, such as the NIH or the MRC, need not be disclosed. For example, if the NIH sponsored a piece of work you have been involved in but drugs were provided by a pharmaceutical company, you need only list the pharmaceutical company.
I think everyone would acknowledge that a grant from HHS would be considered public funding. Additionally, the HHS--at least according to NEJM--would not be considered to benefit from the relationship.
Let's pretend, however, that the ICMJE (and, by extension, NEJM) do require you to report grant money from publicly funded institutions. Dr. Gruber still would not have been required to report his funding from HHS for the June article.
From Item 2:
The time frame for this reporting is that of the work itself, from the initial conception and planning to the present. The idea is to provide for the reader information about resources that you received, either directly or indirectly (via your institution), to enable you to complete the work.
From Item 3:
Please report all sources of revenue relevant to the submitted work that accrued either directly to you or were paid to your institution on your behalf over the 36 months prior to submission of the work. This should include all monies from sources with relevance to the submitted work, not just monies from the entity that sponsored the research.
In addition, please disclose relationships that fall outside the 36-month window [ie, before] that readers may want to know about and could reasonably criticize you for not disclosing (for example, long-term financial relationships that are now ended).
According to Slinkerwink's timeline, Gruber received a grant in March 2009 that lasted until July 2009 and a new grant on June 17, 2009. Slinkerwink says the article was published online (e-published ahead of print) on June 10, 2009, and published in print form on July 2, 2009.
Some journals tell you when an article was submitted. NEJM does not. Journal of Clinical Oncology does.
This is from an article published online on November 17, 2009, and in print in December 2009 (sorry, no link, but you can't see it unless you have a subscription to JCO, which I do):
Submitted April 13, 2009; accepted September 25, 2009.
That's right. It took 5 months from submission to acceptance. It took 2 months from final acceptance for the article to appear online. If we apply this timeline to Gruber's June article, it would have been submitted 7 months before publication--back in October 2008. That is typical for large journals. It would have been accepted around March 2009--the same month he received the grant.
Obviously Gruber would not have had the grant at the time the research was conducted or the article submitted for publication.
But let's say he "fast tracked" the article through NEJM's fast track policy, which takes 2 to 3 weeks from submission for acceptance. Based on this timeline, it would have taken at least 2 months to publish the article, which means it would have been submitted in early March 2009. Clearly, the grant was not available at the time the research was conducted and the manuscript written, which means Gruber was not required to disclose it.
Now let's address the Washington Post and New York Times opinion pieces. According to Politico (yeah, I trust Politico), Gruber was asked the following on disclosure:
Washington Post op-ed editor Autumn Brewington emails that the Post, as a practice, asks writers to disclose any "conflicts of interest that might be relevant to this op-ed, including but not limited to financial or family relationships with any of the subjects of the article" and that Gruber, when asked whether he "received any funding, for research or otherwise, from organizations or persons identified in the column," answered "no."
And rightly so. HHS was not mentioned in the article, and HHS is an independent department that is not run by the Obama administration; it does not, as a rule, endorse legislation. But wait! Brewington clarifies:
She also defended the column. "The subject of the op-ed was not related to Gruber's work for the administration, and we accepted the column based on the body of his work and knowledge in this field," Brewington said in an email. "Generally we think more disclosure is better than less. But in this case he was writing about a Senate proposal and an idea that he has been promoting for years, so in the end we might well have decided his work for the administration was not relevant."
So, even though the editor of NEJM and the editor of the Washington Post would not have felt Gruber needed to disclose these HHS research grants, according to Gruber's would-be discreditors, Gruber was supposed to feel the need to disclose the relationships.
Why would he? He is an academic, and his nondiscosure of the HHS grant to the Washington Post and New York Times were in line with the very strict disclosure policies practiced in academic publishing.
This is nothing more than an attempt by opponents of the excise tax and the Senate healthcare bill to discredit Gruber's valid points in support of the excise tax by discrediting Gruber himself. It is a poorly researched accusation, with no factual basis.
There was, quite simply, no ethical violation here by Gruber, by NEJM, or by the newspaper publications. One is not required to disclose a financial arrangement that is unrelated to what one is writing about.
This is nothing more than a case of people trying to discredit the integrity of an ethical good person just because they disagree with his professional conclusions. Now that is unethical.
UPDATE:
mem from somerville made a good point below, pointing out that Gruber didn't accept money from big pharma or health insurers.
He accepted government funding for a research project. Is the argument the anti-Gruberites are making that accepting money from the government (because it is headed by President Obama, who supports the healthcare bill) is now just as bad as accepting money from Big Pharma and the healthcare industry?
That argument is beyond absurd. Since when is HHS or NIH money considered "tainted"?