Practice Guidelines: Can We Trustthe Evidence in Evidence-Based Medicine?

Practice Guidelines: Can We Trustthe Evidence in Evidence-Based Medicine?

Sun, 25 Sep 2005

“Research and Clinical Practice Guidelines: Can We Trust the Evidence in Evidence-Based Medicine?” is an article by Dr. John Abramson* (Harvard) and Dr. Barbara Starfeld (Distinguished Professor, Johns Hopkins), published in the Journal of the American Board of Family Practice.

While other critics have mostly addressed industry’s corrupt practices in the testing, marketing, and advertising of drugs, few have pointed a finger at the pivotal contribution the scientific journals have made toward the current credibility crisis in medicine.

Medical journals, as much as academic scientists have helped make a mockery of “evidence-based medicine” by publishing false claims about the safety and value of new drugs whose lethal side effects were concealed from journal readers–i.e., physicians, health care policy officials, thye judiciary, and the public at large. Eliott Spitzer called such practices fraud.

In 1980, the enactment of the Bayh-Dole Act opened the gates of academia, encouraging academicbased scientists to collaborate with industry (See today’s earlier Infomail). Within a decade, the pharmaceutical kindustry increased its research expenditures 6-fold–most was spent in academia. Everyone involved got rich, but the integrity of medical practice and medical research took an uninteded but predictable hit, and the American public in particular has suffered from being prescribed bad medicines.

In 2005, a UK Parliament report found that 75% of clinical trial reports published in the world’s major medical journals–such as, The Lancet, the New England Journal ofr Medicine, the Journal of the American Medical Association–are funded by the drug industry. [1] Even research of the highest quality–such as meets the Cochrane standards–is tainted by bias when funded by industry. This is demonstrated by a 5.3 times greater likelihood of a favorable published report. That funding controls the trial design, the patient selection criteria, the data, the analysis of the data, the findings that are reported, and the adverse events not reported. In short, industry funding controls what’s published in journals and what information is then passed off as authoritative “evidence” which is used to influence physician prescribing practices. Dr. Abramson and Dr. Starfeld point out that “the process by which raw data becomes medical “knowledge” – [is] through publication in respected medical journals and incorporation into clinical practice guidelines.”

The authors cite the false published reports about the COX 2 inhibitors, Vioxx and Celebrex: VIGOR report about Merck’s Vioxx (NEJM, 2000) and the CLASS report about Pfizer’s Celebrex (JAMA, 2000) whose authors all (but one) had financial ties to the manufacturers. The Celebrex report was based on partial data (only 6 months from a 12 month trial) which misrepresented the trial results . When JAMA editor was confronted by The Washington Post with the evidence, she feigned dismay, much as the chief of police in Cassablanca was “shocked” that there is gambling: Catherine deAngelis said: “I am disheartened to hear that they had those data at the time that they submitted [the manuscript] to us. . . We are functioning on a level of trust that was, perhaps, broken.” But she did not retract this or any other published article that misrepresented the data.

Not only have the editors of prestigious journals lent the appearance of legitimacy to fraudulent research reports–but they have contributed toward the perpetuation of those false claims by subsequent authors who cite these reports, and contributed toward the incorporation of harmful treatments into practice guidelines, resulting in harm to patients. Journals like academicians have sold their integrity for cash: journals have been making lots of money by selling tens of thousands of reprints to corporate sponsors who widely disseminate these fraudulent reports bearing the seal of a NEJM or JAMA stamp of authenticity.

So what are dedicated clinicians to do?

Dr. Abramson and Dr. Starfeld : “The first step is to give up the illusion that the primary purpose of modern medical research is to improve Americans’ health most effectively and efficiently. In our opinion, the primary purpose of commercially funded clinical research is to maximize financial return on investment, not health.”

“Although one can make a case that the purpose of an industry is to make a profit and not necessarily to serve the public good, it is difficult to accept this as a justification for the behavior of medical scientists and regulatory agencies.”

“Medical journals are ill equipped to withstand the drug companies’ financial pressure, research and statistical capacity, commercial ties with most recognized experts, and lack of transparency in the research they fund.”

But, medical journals so have an option which they have resisted exercising; namely, medical journals have option–one would argue, the obligation to readers and to medicine–to retract the erroneous, if not fraudulent, published reports that misrepresented the actual data from the trials.

Second, medical journals are free to set publication standards for clinical trial reports. They can require authors of clinical trials to submit their manuscripts accompanied by the raw data sets upon which their analysis is based–so that reviewers CAN determine the legitimacy of the authors’ claimed findings.

Unless and until, the medical profession–including journal editors–conduct their activities in accordance with professional standards they will not regain public respect, much less public trust.

*Dr. John Abramson is the author of Overdosed America: The Broken Promis of American Medicine, whyich has just been released in paperback.

The article with citations appears in JABFP September­October 2005 Vol. 18 No. 5 http://www.jabfp.org

1. The House of Commons Health Committee, The Influence of the Pharmaceutical Industry, Volume 1. April 5, 2005, p. 55. Available from:

http://www.parliament.the-stationery-office.co.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf

Contact: Vera Hassner Sharav
212-595-8974
veracare ahrp org