Sponsored Research and Disclosure of Funding Sources – The Conversation Moves to the Higher L
Lives can hang in the balance when reports are written to summarize the results of medical studies. Sadly, some scientists do commit fraud, and others allow their conclusions to be skewed.
A prime example of scientific fraud became public in 2000. Sadly, the fraud arose in the scientific literature on breast cancer treatments. In an editorial letter by Dr. George W. Sledge, Jr., he explained the facts, and why "big lies" do indeed matter. He said:
"The facts of the case are straightforward. Werner Bezwoda is a South African clinical investigator who has in recent years presented 2 randomized trials comparing high-dose chemotherapy and autologous stem cell transplantation with standard-dose chemotherapy for patients with breast cancer. Both trials suggested a striking benefit of high-dose chemotherapy for both lymph node-positive and metastatic breast disease. One of these trials was considered sufficiently important to earn Dr. Bezwoda a plenary session lecture at the annual meeting of the American Society of Clinical Oncology. Because of the importance of these results, their striking positivity, and because of differences in the way in which transplant therapy was delivered, American investigators wished to examine Dr. Bezwoda’s work before launching a confirmatory trial. Dr. Bezwoda’s work was (after some delay) audited by a group of American physicians. The audit team discovered significant failings in Dr. Bezwoda’s records, sufficient to raise the question of academic fraud. Dr. Bezwoda, in a letter, has admitted committing this fraud."
See Sledge GW. Why Big Lies Matter: Lessons From the Bezwoda Affair. MedGenMed 2(1), 2000. [formerly published in Medscape Women’s Health eJournal 5(1), 2000]. Available at: http://www.medscape.com/viewarticle/408908.
In view of past fraud, scholars continue to worry about disclosures of financial interest information when scientific research projects and papers are sponsored by private usiness. A new article, reported in ScienceDaily, and published in the AMA Journal, focuses the discussion on meta-analyses. Meta studies are in esssence massive studies created by combining data from individual studies. The researchers found that financial linterest disclosures from the individual are not being reported in many meta-analyses.
In this age of cheap information creation and storage, it seems unfortunate that disclosure are not routinely made and tracked. One hopes the funding source has no impact on the research outcome or the form of the report. But it seems unwise to depend only on hope, and better to provide the disclosures as matter of routine. In the past, the AMA has been out in front in terms if requiring dislcosure for articles it publishes in JAMA, as is illustrated by this 2001 statement of its policy. Perhaps this new article will have a further, positive impact on disclosures.
Set out below are key excerpts from the disheartening story in the ScienceDaily summary:
" More and more, policy decisions and what medications doctors prescribe for their patients are being driven by large "studies of studies," called meta-analyses, which statistically combine results from many individual drug trials.
Led by Dr. Brett Thombs and McGill graduate student Michelle Roseman, the team found that important declarations of financial conflicts-of-interest in individual drug trials disappeared when those studies were combined in meta-analyses. Their results will be published in the March 9 issue of the Journal of the American Medical Association (JAMA).
Roseman, the study’s first author, and the rest of the team reviewed 29 recent meta-analyses on a range of drug treatments published in high-impact medical journals. Those 29 meta-analyses, or "studies of studies," included results from 509 drug trials. The team documented the funding sources and author-industry financial ties of all 509 trials and whether or not the meta-analyses noted who had funded the trials.
"Only 2 of the 29 meta-analyses even mentioned the issue of who funded the original drug trials, and even those 2 did it in very obscure places in the published articles," said Thombs, a psychologist and assistant professor in the Department of Psychiatry at McGill University. "Not one of the meta-analyses mentioned whether researchers who conducted the trials were employed by industry or personally received money from industry."