Trust No One? Hollywood Tagline Threatens Future of Biomedical Research
There is a trust crisis today. Government is trusted a great deal by 16 percent of the populace, business by 17 percent, and media by 17 percent. As dismal as those numbers are, should we at least find some solace in the fact that the 2013 numbers are all higher than 2012?
These figures come from Edelman's Trust Barometer for 2013, based on 31,000 respondents from around the world. A Forbes headline emphasized that 82 percent of people do not trust their boss to tell the truth.
Pretty much all businesses today get hammered by public mistrust, but in an editorial in JAMA, the authors underscore that "lack of trust in the pharmaceutical industry threatens the future of biomedical research." The comments are from JAMA Editor-in-Chief Howard Bauchner, MD, and JAMA Executive Editor Phil B. Fontanarosa, MD, MBA, who certainly are familiar with the complicated issues related to industry-supported and -analyzed studies.
They cite reports of:
- Manipulation and misrepresentation of data,
- Important discrepancies between new drug applications and the published pivotal trial data, and
- Substantial fines for unethical and illegal marketing practices.
As a result, recent data suggest that clinicians devalue the credibility of industry-funded trials, even when they are well-designed and executed.
Then there are those rare adverse events that can pummel a company's reputation in today's risk averse society. Add in the fact that 2013 will see more than 40 brand-name products losing patent protection, with an estimated value of $35 billion in annual sales, and it's easy to imagine that biomedical research could be affected.
Bauchner and Fontanarosa offer several suggestions to "help restore credibility and trust" in pharma-sponsored research. They make the following suggestions:
- Data analysis performed by academic investigators not employed by the company funding the research;
- Especially with respect to initial drafts, which establish the frame and tone of papers presenting study results, manuscripts should be written by the academic investigators;
- Clinical trial data could be made publicly available to qualified investigators for analyses; and
- Pharmaceutical companies could voluntarily limit direct-to-consumer advertising until post-marketing studies are completed.
Given that three of these suggestions are already being implemented by some pharmaceutical companies, the editorial authors think there could be a reversal in the erosion of trust seen in the last decade or so.
Steven Nissen, MD, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, told CSWN, "I strongly agree with the JAMA editors. The essential ingredients in restoring trust include academic oversight of clinical trials, independent statistical analyses, and placing datasets into the public domain."
He added his own personal thoughts. "Physicians involved in leading clinical trials should not participate in marketing activities for sponsors, such as speaker's bureaus," said Dr. Nissen. "I would also take a tougher stand on use of medical writers. In my opinion, writers paid by industry should have no role in preparation of manuscripts reporting clinical trial outcomes."
< Back to Listings