Recently in Conflict of Interest Category

National Institutes of Health (NIH) has proposed new rules to amend its regulations on the "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors".

The American Society of Clinical Oncology (ASCO) and the Association of Clinical Researchers and Educators (ACRE) have submitted formal comments to NIH citing objections and requesting that the agency not adopt the proposed rules without further discussion.

Read the ASCO comment here


Read the ACRE comment here

Find summary and analysis on Tom Sullivan's Policy and Medicine blog:
ASCO
ACRE
From Peter Pitts's Drugwonks blog: www.policymed.org

Please don't hold the Mayo

Peter Pitts
One of the more interesting subtexts surrounding King James' move to Miami is the negative economic impact it will have on the economy of Cleveland specifically and the Ohio in general. 

A similar subtext (albeit one that has been entirely ignored) is the negative economic impact the State of Michigan will experience following the University of Michigan's recent announcement that it will ban any industry-sponsored CME.

The Fighting Wolverines currently receive about $1,000,000 in such services.  And in cash-strapped Michigan that ain't chump change when libraries are being shuttered and teachers are losing their jobs.

And for what larger purpose?  The U-M's intent in banning industry funding for CME is "to dispel the risk or appearance of conflict of interest."

It will also result in less CME for the university systems physicians. The school expects the number of CME courses to decline "somewhat" as a result of the new policy.
 
(According to the ACCME, the university produced 499 separate CME activities last year, reaching more than 130,000 physicians.)

"Somewhat" less CME is not acceptable.  Does the university expect the taxpayers of Michigan to make up the difference - so that they can exult in their political correctness?

Since healthcare reform is about lowering costs, how will similar moves by other large public universities (motivated not by public health but by "perceived conflicts") be justified?

Speaking of Cleveland, in the January 2010 issue of Academic Medicine (Acad Med. 2010; 85:80-84.), four researchers from the Cleveland Clinic published a paper entitled, "The Effect of Industry Support on Participants of Bias in Continuing Medical Education."

The purpose of the study: "To obtain prospective evidence of whether industry support of continuing medical education (CME) affects perceptions of commercial bias in CME activities."

The method: "The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multispecialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support."

The study's conclusion: "This large, prospective analysis found no evidence that commercial support results in perceived bias in CME activities. Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present."

The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have adopted a new policy regarding the disclosure of conflicts of interest.

Here's the key paragraph:

"There is no inherent conflict of interest in the working relationships of physicians with industry and government.  Rather, there is a commonality of interest that is healthy, desirable, and beneficial.  The collaborative relationship among physicians, government, and industry has resulted in many medical advancements and improved health outcomes."

What a unique perspective -- a "commonality" rather than a "conflict" of interest.

We should all pay attention to our nomenclature.  It's not really about "conflict of interest" - it's about (as Secretary Sebelius correctly says) "interest."  And having an "interest" is not necessarily a bad thing - as long as you're transparent about it.

When it comes to CME and "interest," we need to weigh interest versus benefit. And, as with drugs and devices, we must consider the "safe use" of industry-sponsored CME.

"The best interest of the patient is the only interest to be considered."
-- William Mayo, MD



Proposes a Studied Approach to Identifying and Managing Potential Conflicts

Read more...

The Nadir of ACCME

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The following was written by Peter Pitts, blogger at www.drugwonks.com.  Comments are encouraged.

Once more into the abyss.

The Accreditation Council for Continuing Medical Education (ACCME), the national body that accredits medical education courses has decided that physicians and researchers who work inside the pharmaceutical industry will not be allowed to make medical education presentations at medical meetings.

 That effectively means that America's physicians will not be able to be instructed by many of the best and the brightest.

 And this is where nomenclature becomes important. It's not about "conflict of interest" - it's about (as Secretary Sebelius correctly says) "interest."  And having an "interest" is not necessarily a bad thing - as long as you're transparent about it. When it comes to "transparency," we need to weigh "interest versus benefit." Just like with drugs and devices, we must consider the "safe use" of transparency.

But transparency is no longer good enough for the ACCME - now they want purity - whatever that means.

When is a conflict not a conflict?  The answer, it seems - it when it's convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.

Who's pure and who isn't?  Here's the answer - nobody is 100% pure.  Not even Ivory Soap is 100% pure - and it floats!

In the February 7th edition of The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst.  Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.

Horton's main point is that we must dismantle the battlements and embrace of philosophy of "symbiosis not schism."  It's what's in the best interest of the patient.

The new dictate by the ACCME is the COI polloi out of control.  Consider the comments of healthcare icon and NIH director Francis Collins:

"It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector." 

Big Pharma hires the best.  And now America's physicians are being denied their counsel.

Do we really want to build the foundation of 21st century CME on the second best and the almost brightest?

 

"For a fourth time in a row, the American Medical Association House of Delegates (AMA-HOD) has sent the Council on Judicial and Ethical Affairs (CEJA) 1-A-10 report on Financial Relationships with Industry in Continuing Medical Education back for more work to CEJA. Perhaps this time they will get the message.

Despite strong opposition (3-1) from those who spoke at the reference committee, the AMA HOD Reference committee recommended CEJA for passage, but on the floor debate it was apparent that the House of Delegates was not in favor of this report as shown in them sending it back for the 4th time."  -- quoted from Tom Sullivan's Policy and Medicine blog.

Follow this link to read more, then come back here to comment.

Tom Sullivan has created a great summary of healthcare reform's effects on the healthcare communication industry. Click to read.

Comments are welcome and encouraged.
A study by the Cleveland Clinic's Center for Continuing Education showed that there was no correlation between the perception of bias and the commercial support status of an activity such as continuing medical education.


Comments are welcome here.

Study Finds CME Funding Doesn't Create Bias

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A new study by four researchers from the Cleveland Clinic showed that industry support of continuing medical education created no bias among participants.

The study is available here:CME_Kawczak_Acad Med.pdf

Healthcare industry expert Peter Pitts has enlightening comments on the paper in his DrugWonks blog on the Center for Medicine in the Public Interest Web site. You can view his comments here: http://drugwonks.com/blog_post/show/7182

We invite your comments! 

Interesting discussion on why corporate backing of medical research is NOT a bad thing:

Corporate Backing for Research? Get Over It!
John Tierney in the New York Times, Jan. 25, 2010

Hyperscrutiny of Academic-Industrial Relationships: Potential for Unintended Consequences
Tom Sullivan's Policy and Medicine Blog, Jan. 27, 2010

More thoughts on the issue on Tom Sullivan's Policy and Medicine Blog

Read about it and join the discussion here.





Continuing his "ongoing probe into conflicts of interest" Senator Chuck Grassley this week sent letters to the American Medical Association, Alzheimer's Association, the American Cancer Society and 30 other disease and medical advocacy organizations asking them to provide details about the amount of money that they and their directors receive from drug and device makers. Read more, including Senator Grassley's letter, in Thomas Sullivan's Policy and Medicine Blog.

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