Healthy Skepticism Library item: 11733

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E.
Boning Up: Journal Tightens Disclosure Policy
Pharmalot 2007 Oct 12
http://www.pharmalot.com/2007/10/boning-up-medical-journal-bolsters-disclosure-policy/

Notes:

Numerous interesting links not included here. Please see Pharmalot site.

Full text:

Over the past three years, a controversy raged concerning a study about Procter & Gamble’s Actonel osteoporosis med in the Journal of Bone and Mineral Research. Although the tale was complicated and sordid, at its heart was the issue of corporate influence over study data and the responsibilities of a journal to act as a credible gatekeeper of information. For these reasons, the astonishing spat between the journal, P&G and a UK researcher, Aubrey Blumsohn, gained considerable media attention. Now, though, the journal promises to behave, well, differently.

What caused this ruckus? To keep it simple, an Actonel study was conducted by Blumsohn and Richard Eastell, a Sheffield University colleague, and the results were favorable. However, they had divided the work. Blumsohn subsequently learned that P&G never allowed Eastell to perform his own analysis of Actonel data. Blumsohn, who suspected P&G was mostly concerned with how Actonel would fare with Merck’s Fosamax, went back to analyze samples and asked P&G for the raw data, but was refused.

Meanwhile, P&G analyzed the data and wrote up the final results for him to present at the American Society of Bone and Mineral Research, which publishes the journal. And a P&G ghostwriter was assigned to ready the work for publication, listing both men as authors. Eastell’s previous Actonel research indicated “all authors had full access to the data and analyses,” which alarmed Blumsohn, who worried about being accused of scientific fraud. The study was eventually published in 2004, with data that Blumsohn argued was massaged by P&G. (For a complete rundown, read this trail of e-mails, or a 2005 story in Slate).

For three years, Blumsohn fought with P&G to release the data, and with the journal to correct the mistaken info. The journal balked and delayed, prompting Blumsohn to question its integrity.

For their part, the journal editors claim they were “hamstrung” by a lack of necessary info needed to act. Eventually, P&G acquiesced and, last year, the journal published a Statement of Concern, and began requiring disclosure of potential conflicts of interest by all authors and that all authors attest that they had full access to underlying study data. And clinical trials must be registered before subjects are enrolled.

In its latest issue, however, the journal published an editorial in which researchers must now confirm that they’re “not aware of any disagreement about the content, analyses, or conclusions of their manuscript by anyone who has made a contribution to the work contained.” And there was a separate article noting that the an as ASBMR task force voted to adopt Association of American Medical Colleges principles for reporting clinical trials.

The journal never explicity acknowledges any mistakes, but by virtue of adopting new procedures, this can be interpreted as a mea culpa, of sorts. In the end, the editors write that there are lessons to be learned, starting with this one: “The ultimate protection to science is open discussion.” Indeed.