Study Lashes Medical Schools For Drug-Research Conflicts
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[Karl Note: Here we have a criticism of research that is too much under the control of the drug companies. But, consider that research into the use of chelation therapy for preventing and curing cancer? Such research would NEVER be started or paid for by any drug company. Obviously. There is no reason in the world, except helping people, for a drug company to pay for research on anything where a drug will not be the solution -- none!]
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Study Lashes Medical Schools For Drug-Research Conflicts
By RACHEL ZIMMERMAN
Staff Reporter of THE WALL STREET
JOURNAL
Medical schools conducting experiments paid for by the drug industry are putting researchers and participants at risk by failing to follow guidelines meant to keep such studies independent and free of bias, according to a study published Thursday in the New England Journal of Medicine.
The study found that in many cases, research contracts between academic institutions and companies fail to adhere to minimal standards of accountability that were established last year. For instance, the study also found that academic institutions rarely ensure that researchers participate in the design of the clinical trial and control editorial and publication decisions.
Marcia Angell, former editor in chief of the New England Journal and now a senior lecturer at Harvard Medical School, said she isn't surprised by the findings. "The academic community is still trying to have it both ways -- to maintain their very close and lucrative contacts with private industry while trying to respond to public concern about conflicts of interest."
A total of 108 research institutions participated in the study. Respondents said only 2% of their contracts established an independent executive committee to oversee the design and conduct of industry-sponsored trials. And only 1% required a data and safety monitoring board overseeing design and conduct.
Medical centers surveyed in the study also reported that only 1% of their contracts require that researchers, who typically work at a single medical site, have access to the clinical data at other sites in the trials.
"There are dangers here," said Kevin Schulman, a professor of medicine at Duke University Medical Center, Durham, N.C., and the lead author of the study. "Our findings suggest that a re-evaluation of the process of contracting for clinical research is urgently needed."
The study, conducted from November 2001 through January 2002, measured actual clinical-trial contracts against guidelines issued by the International Committee of Medical Journal Editors to address growing concern over bias and conflicts of interest in published research. It concluded that the guidelines, established in September 2001, have largely been ignored.
Responding to the study, the Pharmaceutical Research and Manufacturers of America, the pharmaceuticals industry trade group known as PhRMA, said that three weeks ago it issued new principles for the conduct of clinical trials and communication of trial results. "These principles reaffirm our commitment to the safety of research participants and the timely communication of research data," said spokesman Jeff Trewhitt. "One of the provisions of the new PhRMA policy says the independence of clinical investigators should be respected so they can exercise their own decision-making authority to protect research participants."
Dr. Schulman's study didn't determine whether specific patients were hurt because of the failure to follow guidelines; nor did it document particular cases of academic investigators blocked from viewing important data or from publishing negative findings. Instead, the study suggests a general trend of academic independence compromised by business interests.
To underscore the point, the New England Journal published another article on how collaborations between industry and academia can be more transparent and independent. In a third piece, it examined the case of Canadian researcher Nancy Olivieri, who was sued by generic-drug maker Apotex Inc. after publishing negative findings about one of the company's medications.
Michael Spino, senior vice president of scientific affairs at Apotex, based in Toronto, said the company stopped funding Dr. Olivieri in May 1996 for a host of reasons. He said the only reason the company sued Dr. Olivieri was because she sued them first. Moreover, he said that the New England Journal article is "inaccurate, there are major errors, it is an irresponsible piece and we will be asking for a retraction."
The value of the Apotex drug remains unclear. But "the point is that the investigator had an obligation to come to a conclusion and act on it," said David Nathan, president emeritus of the Dana-Farber Cancer Institute and the lead author of the article. "The drug company didn't like the news, and the drug company may be right. But she still has a total obligation to tell the truth as she sees it."
Write to Rachel Zimmerman at rachel.zimmerman@wsj.com 2
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URL for this article: http://online.wsj.com/article/0,,SB1035400555170438791.djm,00.html |
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Hyperlinks in this Article: (1) http://wsj.com/health (2) mailto:rachel.zimmerman@wsj.com |
Updated October 24, 2002
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Copyright 2002 Dow Jones &
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