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A Busy Week in “COI World"

William Sacks

Vice President, COI Product Management

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Open Payments

The last few weeks have been eventful ones for those who monitor the Conflicts of Interest “ecosystem”. On September 30, the Center for Medicare and Medicaid Services (CMS) published the long awaited “Open Payments” database (http://www.cms.gov/openpayments/index.html), putting more than four million items online in an almost incomprehensible jumble of tables that had to be cross referenced and searched using tools that, to be generous, were not the most user friendly or responsive.

The data included remuneration and other exchanges of value from August to December, 2013 from pharmaceutical and medical device companies to physicians, medical schools and other providers. Those with the wherewithal to download and analyze the 150+ megabytes of data posted in seven distinct database files began to provide some analysis within a few days.

The database included 4.4 million payments totaling $3.5 billion. More than half a million doctors and about 1,360 teaching hospitals received at least one payment. In the initial online publication, up to 40 percent of the data had identifying information redacted, due to questions about its accuracy. (That data will supposedly be cleaned up and reported next year.) In a fact sheet reported online, officials reported that data on an additional $1.1 billion in payments had been withheld altogether, either because data was disputed, or because of “delays in publication” of that data.

That said, it was still possible to glean some interesting information from the data. Medical doctors and teaching hospitals received 69% and 25% respectively of the payments reported. The remaining six percent was shared by dentists, osteopaths, optometrists, podiatrists and chiropractors.

Over the last year there was a lot of discussion between CMS and providers about how to report payments from industry for research. Many of these concerns were not resolved in time for publication, and more than 90% of those payments had identifying information redacted.
Information was also redacted on 56% of arrangements that involved physician ownership, including partnerships, equity participation, stock options etc. This may reflect confusion over reporting requirements and/or problems identifying individuals with similar names. CMS has indicated that this data will be reported accurately by next year.

Royalty and license payments paid to physician and hospital inventors accounted for 31% of the $976 million of “General Payments”. Twenty-one percent (21%) of these payments were for promotional talks, which the government calls “services other than consulting”. Meals accounted for 3.5 million of the 4.4 million payments reported, but accounted for less than 10% of the expended dollars. In addition, doctors were paid for more than 200,000 trips by companies in the five months reported.

A New Scorecard

Also released in the same week as the ”Open Payments” data was the annual American Medical Student Association (AMSA) Conflict of Interest Scorecard (http://www.amsascorecard.org/), which has been expanded from grading only medical schools to include a cross section of over 200 teaching hospitals and medical schools on their conflict of interest policies and practices. The AMSA scorecard and other factors have prompted many organizations to improve their COI policies over the years, and this year’s version reports significant improvement, with 35 organizations receiving an “A” grade, and 111 receiving a “B”. Five years ago, only 9 organizations received an “A” grade, and 36 a “B”.

Still, the AMSA reported there was much room for improvement. Only 44% of surveyed institutions had model policies related to ghostwriting and honorary authorship. Forty-three percent (43%) had model policies related to acceptance of gifts, 42% had model policies related to consulting arrangements, and only 40% completely prohibited industry paid meals of any nature or value.

New Findings

On the research front, a study was published in the Annals of Internal Medicine (http://annals.org/article.aspx?articleid=1911121) that showed that investigators examining the efficacy of prophylactic treatments for influenza (such as Tamiflu or other neuraminidase inhibitors) were far more likely to have positive results if they had financial interests in the companies producing the drugs. Of eight (8) studies performed by investigators with financial conflicts, seven (7) had positive results. On the other hand, of 29 studies performed by investigators with no financial conflict of interest, only five (5) were favorable. The study concluded that “Reviewers with financial conflicts of interest may be more likely to present evidence about neuraminidase inhibitors in a favorable manner and recommend the use of these drugs than reviewers without financial conflicts of interest.”

So there you have it:

(1) Evidence of the problem in the published research, which has demonstrated once again that financial conflicts of interest can have deleterious effects on the delivery of the highest quality evidence-based medical treatment;

(2) Initial (if troubled) efforts to mitigate the problem in the long awaited actions by the federal government to increase transparency in the financial arrangements between medicine and industry;

and finally:

(3) Indications of improvement over time, as indicated in the AMSA Scorecard, which reports slow but steady improvement in the efforts to identify and manage the inherent conflicts of interest that are likely to continue for a long time to come.

Not a bad few weeks.