Recently in Regulation Category

NEW YORK - (BUSINESS WIRE) - According to Prevention Magazine's 13th annual national survey Consumer Reaction to DTC Advertising of Prescription Drugs, consumers are paying attention to the FDA regulated "fair balance" mandate between risk and benefit information on all DTC ads; the majority believe pharmaceutical advertising in magazines and television is presented "both fair and balanced." Conducted by Prevention, Men's Health and Women's Health magazines, published by Rodale Inc., with technical assistance from the U.S. Food and Drug Administration's Division of Drug Marketing, Advertising, and Communication (FDA-DDMAC), the survey is one of the primary consumer studies informing the FDA's stance on DTC issues.

For five consecutive years in a row, consumers reported consistent balance of awareness and attention paid to both risks and benefits in TV and magazine ads.

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



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.

FDA Launches Bad Ad Program

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Read about it, comment here on our site.

General article with background
FDA announcement
Key points
Reuters news coverage


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.
Coalition Executive Director John wrote this OpEd piece published on March 15th by MM&M.

First paragraph: If you or your clients have sent promotion materials to FDA recently for prepublication review, or -- God forbid -- have been the recipient of a DDMAC Warning Letter, you know that FDA's DDMAC has assumed a very aggressive enforcement posture.


The Coalition and Med Ad News are collaborating on a series of podcasts by John Kamp, Coalition Executive Director, on topics vital to the healthcare communication industry.  The fourth podcast, "Approach with Caution" is now available for download. In this segment Mr. Kamp talks about social media why legal departments will continue to voice strong resistance to going too far, while he also acknowledges the great opportunity social media hold in improving the industry relationship and reputation with consumers.
All four podcasts can be downloaded here: http://downloads.pharmalive.com/

Coalition and Med Ad News Present Healthcare Podcasts

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You can visit Pharma Live's Med Ad News Web site to download two podcasts on healthcare issues by John Kamp, the Coalition's Executive Director.

The first is on the defeated but still looming ad tax bill.  The second is an overview and analysis of the "New FDA".

You can download them here: http://downloads.pharmalive.com/

Med Ad News plans to present three more podcasts in this series.

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