physician conflicts of interest not being reported

One concern in the corporatization of medicine is that many physicians, and especially academic physicians, have significant financial relationships with drug and medical device companies. A recent study found that it was pretty infrequently that these potential conflicts of interest (COI) were disclosed in journal publications (see conflicts of interest unreported jamasurg2018 in dropbox, or doi:10.1001/jamasurg.2018.2576 ).

Details:

-- from the 2015 Open Payments Database (OPD), 10 surgical and medical device companies and 10 physicians receiving the highest compensation from each of these companies were evaluated.

-- Articles by these physicians were identified in PubMed and the presence of an associated COI declaration was assessed

-- the 100 physicians: 88% men were paid a total of $12,446,969, a median of $95,993

-- 50% of the authors were faculty at academic institutions

-- of 100 physicians, OB/GYN’s were the most common (15%), then anesthesiologists (9%), general surgeons (8%) and orthopedic surgeons (8%)

Results:

-- 412 articles were published by these physicians in 2016, with a mean of 4

-- 225 (54.6%) of the articles were relevant to the general payments received by these authors

    -- 84 of these 225 relevant publications (37.3%) had the potential COI declared by the authors

-- only 64 of these 100 researchers published articles during 2016, and 55 of the 64 authors (86%) had at least one publication without declaring the associated COI

-- no statistically significant difference in COI notification was found comparing academic vs nonacademic physicians; and, if academic, between academic rank of the authors (54% were professors, 16% associate professors, 30% assistant professors) or physician specialty

Commentary:

-- in 2015: 570,524 payments with a total value of $326,863,647 were paid to 139,087 physicians by the 10 large surgical and medical device companies in this report. So, as a perspective, the $12,446,969 paid to these 100 physicians is less than 4% of the total payments made !!!!

-- Medtronics paid the highest amount of physicians, with 263,372 general payments and the total value of $187,446,743 (Stryker Corporation came in 2^nd place with 1/3 of that amount, $61,956,819)

-- potential conflicts of interest between clinicians and industry abound, and these may subtly affect prescribing or utilization practices:

    -- as many as 94% of physicians in the US receive some form of benefit from an external company, with food and beverage being most common. And many studies have shown that even minor gifts can affect clinical practice

    -- for researchers, the results of their studies may be biased, with perhaps more favorable reporting of outcomes

        -- as mentioned in many blogs, when industry is involved in designing a study, they may well choose endpoints that are most likely to be advantageous to their drug, such as including coronary interventions along with major stroke, MI, cardiac death as a combined endpoint. BUT from a clinical perspective, these individual endpoints should not be given equal weight. The results of such a study may just be: "clinical benefit seen in study of drug xxx", though such "benefit" may be exclusively in a much less important component of the combined endpoints, and conceivably mask increases in very important clinical endpoints.

        -- or, as also commented in prior blogs, the cardiovascular benefits of a new medication may be distorted because the control group was given an increased amount of medications with known adverse cardiac effects (eg see http://gmodestmedblogs.blogspot.com/2015/12/empagliflozin-good-and-bad.html  )

        -- or the study comparisons may not make real clinical sense: e.g. the IMPROVE-IT trial comparing simvastatin 40 mg plus ezetimibe vs simvastatin 40 mg, since most practicing clinicians would 1^st optimize statin therapy prior to adding ezetimibe: see http://gmodestmedblogs.blogspot.com/2015/06/improve-it-trial-ezetimibe.html . and ezitimibe plus rosuvastatin 40mg may not have significant added benefit to rosuvastatin 40mg by itself

        -- our bottom line here is that companies will tend to design studies that will improve their bottom line, and may not be the best or most useful science

-- some prior authors have suggested that COI disclosures should be standardized across journals, meetings, and institutions. Some specific suggestions include:

    -- developing and implementing clear and specific guidelines on COI reporting across these venues

    -- all potential COIs by authors need to be reported, independent of their perceived conflict with the investigation, and an unbiased 3^rd party should decide on the relevance of those disclosures

    -- COI statement should be clear in the abstract as well as the full text, given that many people do not have access to full text articles or may only have time to read the abstract.

    -- The Open Payments Database (OPD, as above) should be improved, given inaccuracies in the current database. For example one study showed that 32% of neurosurgeons were misclassified for other specialties.

    -- The ICMJE (the International Committee of Medical Journal Editors) suggests that “interactions with ANY entity that could be considered broadly relevant to the work” should be disclosed for the 3 years before article submission. JAMA editors go one step further: “disclosures are not limited to the specific products, devices, tests, and services mentioned in a manuscript, and that all relationships with products, devices, tests, and services used in management of a condition are considered relevant and should be disclosed management”

--it seems in the above study that it was basically surgical specialties involved.  There were in fact some medical/pediatric clinicians on their list. I assume that this surgical slant overall is because the surgeons reap the largest largess (excuse the alliteration…), both in their general incomes and in these ancillary incomes (though still remarkably large to us mere mortals). And the device makers make their biggest profits from their devices used by surgeons and interventional medical specialists.

so, this is a very real concern. we clinicians have an onslaught of clinical articles to digest, most are funded and many designed by drug or device companies, it is often hard to find out about conflicts of interest (buried in the full article, which we often don't have time to read), and, as evident above, even with extreme scrutiny, the actual COIs seem to be infrequently stated.  sort of gives a big benefit to industry over science and perhaps the social good.....

geoff

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