1 June 26, 2006 " The recommendation also broadens the definition of conflict of interest beyond just those with financial relationships with commercial interests to include subspecialists, who derive a substantial portion of their income from certain types of care. Greenfield acknowledged that this expansion may cause consternation among some organizations." JAMA 2011 Conflict of interest ‘a set of conditions in which professional judgment concerning a primary interest (such as patient’s welfare or validity of research) tends to be unduly influenced by a secondary interest.’ Statin Sales and Cholesterol Guidelines • National Cholesterol Eduction Program (run by the NIH) lowered recommended LDL level from 130 to 100 mg/dl • Add 7 million people to the 36 million already encouraged • $26 billion drug group • Guidelines written by nine experts Statin Sales and Cholesterol Guidelines • 8 out of 9 had financial conflicts of interest • Each of the 8 experts had on average ties to seven companies • Justified? – 1000 Women on Lipitor had an increased CHD risk – No evidence that statins protect women without heart disease
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conflict of interest-summer - University of Washington...Epub 2007 Nov 1 When controlling for other characteristics of meta-analyses in multiple logistic regression analyses, meta-analyses
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1
June 26, 2006
" The recommendation also broadens the definition of conflict of interest beyond just those with financial relationships with commercial interests to include subspecialists, who derive a substantial portion of their income from certain types of care. Greenfield acknowledged that thisexpansion may cause consternation among some organizations."
JAMA 2011
Conflict of interest
‘a set of conditions in which professional judgment concerning a primary interest (such as patient’s welfare or validity of research) tends to be unduly influenced by a secondary interest.’
Statin Sales and Cholesterol Guidelines
• National Cholesterol Eduction Program (run by the NIH) lowered recommended LDL level from 130 to 100 mg/dl
• Add 7 million people to the 36 million already encouraged
• $26 billion drug group• Guidelines written by nine experts
Statin Sales and Cholesterol Guidelines
• 8 out of 9 had financial conflicts of interest• Each of the 8 experts had on average ties to
seven companies• Justified?
– 1000 Women on Lipitor had an increased CHD risk
– No evidence that statins protect women without heart disease
• Authors were contacted and questioned regarding financial relationships with calcium channel manufacturers.– 96% of the supportive authors had financial relationships– 60% of the neutral authors had financial relationships– 37% of the critical authors had financial relationships
• Industry sponsorship and pro-industry conclusions are significantly associated (OR=3.6, 95% confidence interval: 2.63-4.91)
N-Engl-J-Med: 1998: 338:101-6 BMJ. 2007 Dec 8;335(7631):1202-5. Epub 2007 Nov 1
When controlling for other characteristics of meta-analyses in multiple logistic regression analyses, meta-analyses that had financial ties to one drug company remained more likely to report favourable conclusions (5.11, 1.54 to 16.92).
GTR
• Company funded trials: 55.8% complete root coverage
“If we put horse manure in a capsule, we could sell it to 95% of these doctors”
Harry Loynd, Past President of Parke Davis and Company
From the book “Hooked” by Howard Brody
I am excited to also share that at J&J we are launching a new program for faculty called JETPack (Johnson & Johnson Educational Tools Package) which was designed to provide evidence-based content using a multimedia surround sound approach.
Colgate, Forsyth enter research partnership…
“To advance research in oral health and its effects on overall systemic health by creating the Colgate-Forsyth Center for the Advancement of Global Oral Health”
“UBC Gains $5 Million for Hi-tech Oral Health Centre”
• “A $5-million gift from a world leader in esthetic dental products to the University of British Columbia's Faculty of Dentistry will be recognized with the naming of a new oral health facility.1
• November 14, 2005• Nobel Biocare, a leader in innovative esthetic
dental solutions, and New York University College of Dentistry, the largest dental school in the U.S., will cooperate to integrate a dental implant therapy and esthetic dentistry curriculum into all four years of the NYU predoctoral dental education program.
• In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03)
• 10 of millions of prescriptions• Physician who prescribed relied on single
dimension of glycemic control
Volume 356:2457-2471 June 14, 2007Psaty and Furberg, NEJM 2007
• Data peek; no good results; may upset plans for selling company
Danish Saga II; Threats
• The company -this was poor research (they had the protocol in advance)
• Company threatens authors including legal action
• The rector patronizes the authors; drop ‘this small project’ publishing
• Dental School Dean tells rector that he can make the authors retract abstract (IADR Vancouver 1998)
Danish Saga III:
• Authors agree to retract abstract if provided with letter from rector saying that this retraction is done in the interest of the university and not as an indication of poor research. Rector agrees and provide the letter.
• Dental School Dean sends an “anonymous” fax to a journalists showing “retraction”
• Anonymous fax has ‘sender number’ and this was uncovered by the University Board.
Danish Saga IV
• The authors managed to keep their right to publish, but had to keep silent on the news and abandon their right to defend themselves publicly.
• Situation backfires– Dental School Dean fired– Rector left when his term was over.
Danish Saga (documentation)
Newspapers:– Dandy dropper sag mod Aarhus Universitet (Dandy drops case against
Conflict of interest and Paxil• Paxil ($55 million/year)• 2.1 million US youngsters had Paxil prescribed• “Spitzer sues drug giant for deceiving doctors” (Nature, 2004)• Not disclosing four negative studies• “If 20 studies are done, one is likely to show significance by
chance. If that’s the only one to get published, and I don’t know that there were 19 other studies with different results, it really skews the perception and ultimately alters clinical care” Dr. David Fassler – pediatric psychiatrist.
“The messenger under attack --intimidation of researchers by
“A tipping point of sorts may have occurred in the spring of 2004. … legal action filed by attorney general of the state of New York, Eliot Spitzer, on June 2. The AG accused the giant drug firm GlaxoSmithKline of fraud.
Howard Brody, Hooked, 2007
June 2, 2004
“The researchers had to file a Freedom of Information request with the US Food and Drug Administration. And the information they finally received was imcomplete: crucial data were missing for several studies that failed to find a significant benefit of the drug compared with the placebo.”
“Require international cooperation and enforcement by regulatory authorities”
p. 1 Natuire
Paxil ($55 mil/yr)• 2.1 million US youngsters had Paxil prescribed• “Spitzer sues drug giant for deceiving doctors”
(Nature, 2004)• Not disclosing four negative studies• “If 20 studies are done, one is likely to show
significance by chance. If that’s the only one to get published, and I don’t know that there were 19 other studies with different results, it really skews the perception and ultimately alters clinical care”
Roche plunges on poor trial resultBy Miles Johnson Published: April 23 2009 03:00 | Last updated: April 23 2009 03:00
Roche , the Swiss drugmaker, suffered its biggest one day fall in 19 years yesterday after a disappointing clinical trial for one of its key treatmentsFinancial Times
Lipid Lowering Drug and Mortality
Mortality
Drug 68 (3.57%) 1839
71 (3.74%)Placebo
1906
1900
+ -
JAMA, 1984
1828
NNT=591
It is now indisputable that lowering cholesterol with diet and drugs can actually cut the risk of developing heart disease and having a heart attack
“…the tobacco industry’s strategy was embodied in a script written by lawyers. Every tobacco company executive in the public eye was told to learn the script backwards and forwards, no deviation allowed. The basic premise was simple –smoking had not been proved to cause cancer. Not proven, not proven, not proven –this would be stated insistently and repeatedly. Inject a wedge of doubt, create controversy, never deviate from the prepared lines.”
A question of intent – David KesslerFull page add in NYT November 29, 2004
Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality.Miller ER, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E.The Johns Hopkins School of Medicine, and The Welch Center for Prevention, Epidemiology and Clinical Research, The Johns Hopkins Medical Institutions, Baltimore, Maryland 21205-2223, USA. [email protected] Intern Med. 2005 Jan 4;142(1):37-46. Epub 2004 Nov 10.
NYT,Tuesday January 22,2008 NYT,Tuesday January 22,2008
• Freedom of information act was required• Two drugs could not be investigated• Missing data
True fulfillment .. will require international collaboration and enforcement by regulatory authorities – an unprecedented degree of organization and commitment. It is a daunting goal, but one worthy of the struggle
Nature Editorial Vol. 452 7183 6 March 2008
Laws and regulations
• Registries of RCTs
• FDA panels have to disclose conflicts of interest
• Authors & researchers have to disclose conflicts of interest
• Limits on gifts
• University policies
• Journal policies
• Professional organization policies
Conflicts of interest may bias findings
• Follow the money• Conflicts of interest can bias findings• Look for evidence of independent DSMB• Establish Data and Safety Monitoring Board
(DSMB)• Look of assurances in terms of policies of
journals, professional organizations, research institutions, etc.
FudgingNORWEGIAN RADIUM HOSPITALNovel approach: Jon Sudbø simply invented his test subjects.
Nature 439, 248-249 (19 January 2006) | doi:10.1038/439248bDoctor admits Lancet study is fictionEmma Marris
Mean Days to failure (sd) 212 (200) 179 (191) 0.453
Median days to failure 163 118
Interquartile range of failure 73 127
Intervention 08NOV99-14APR09 07MAY05-23FEB10
“There is no way of knowing who is right because we don’t have the data,” said Dr. Kevin J. Bozic, a professor of orthopedic surgery at the University of California, San Francisco.
“While producers of implanted heart devices have a voluntary system in which outside panels investigate problems, American makers of orthopedic devices do not” NYT - June 20, 2010