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New – Dark Alley – Report on Drug Studies
Staff Reporters
A report in Bloomberg News, January 13, says that drug regulators haven’t done enough to force disclosure of financial conflicts among the researchers who conduct clinical trials of medications and medical devices.
Quid-pro-Quo
Financial connections between companies that make drugs and devices, and the doctors and other researchers who test them on humans, may compromise the safety of patients in studies and the integrity of the results.
According to the report, lawmakers led by Senator Charles Grassley [Republican from Iowa] have raised concern that conflicts of interest among doctors and manufacturers may influence prescribing decisions.
Assessment
Furthermore, the report said the “FDA should ensure that sponsors submit complete financial information for all clinical investigators.” Is this a new or novel idea?
Conclusion
And so, your thoughts and comments on this Medical Executive-Post are appreciated. Is this entire “pay-2-play” or “quid-pro-quo” idea another dark-alley of drug research and development; or not?
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Filed under: Drugs and Pharma, Ethics, Health Law & Policy, Quality Initiatives | Tagged: big-pharma, drug trials, Drugs, Grassley |
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Medtronic Pays … Very Well !
Did you know that according to the Wall Street Journal, January 16, 2009, a prominent spine surgeon and researcher at the University of Wisconsin received $19 million in payment over five years from Medtronic Inc., one of the country’s largest makers of spinal devices?
The alleged, Thomas Zdeblick, allegedly received the payments while helping Medtronic develop and promote a number of spinal products. Medtronic’s $19 million in payments to Dr. Zdeblick from 2003 to 2007 went “greatly” beyond what was evident in disclosures he made to the university.
The University of Wisconsin, like other academic centers that conduct federal research, is required by the government to monitor its researchers’ financial conflicts. In each of the five years cited in the letter, Dr. Zdeblick told the university that he received $20,000 or more from Medtronic, and in one year, he reported getting $40,000 or more. The disclosures conform to school policies, which currently don’t require researchers to specify amounts received above $20,000.
Talk about DME healthcare 2.0 transparencies; NOT!
Benjamin
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Pot for Pain,
Well, if drug studie are lacking in big-pharma, supporters of programs to provide legal marijuana for patients with painful medical conditions should be celebrating.
Attorney General Eric Holder’s statement this week that the Drug Enforcement Administration will end its raids on state-approved marijuana dispensaries, should be music to their ears.
Ann
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More on the Big-Pharma Disclosure Wars
The institutional war on conflicts of interest continues.
The Council of Medical Specialty Societies has just come out with a new code of conduct that will lock industry out of developing medical guidelines and force society leaders–and editors of associated journals–to cut financial ties with drug makers.
http://www.fiercepharma.com/story/doctors-sign-tough-conflicts-interest-rules/2010-04-22?utm_medium=nl&utm_source=internal
Ben
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