Recent: CME in the News and Blogs

CME in the Recent News

If you subscribe to the illogical conclusion that the most important things in CME are the things that get press and blog coverage then you will find the most important thing in our industry is the relationship between industry and the healthcare community. Here are some recent examples of what I mean.
U.S. Sen. Grassley: Says drug companies should disclose payments, seek greater transparency

IowaPolitics.com
Friday, October 23, 2009

WASHINGTON — Senator Chuck Grassley is continuing his campaign to establish transparency with the financial relationships between drug companies and medical professionals.

Grassley has conducted oversight and sought disclosure with physicians, especially those involved in influential taxpayer-sponsored medical research; medical journals containing ghostwritten articles; medical colleges; continuing medical education; and the patient advocacy community.

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CME outfitters: Guilty of Pro-Seroquel Bias, According to ACCME

The Carlat Psychiatry Blog
Monday, October 12, 2009

In ACCME’s testimony before the Senate Special Committee on Aging on July 29 of this year, Dr. Murray Kopelow, the chief executive of ACCME, defended the integrity of the embattled organization in part by pointing out that they have beefed up their enforcement of anti-commercial bias policies.
Here is a story that exposes an accredited provider for alleged non-compliance.

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Here is another blog from Health Care Renewal on the same topic
More of the same

ACRE Responds to CEJA Report Financial Relationships with Industry in Continuing Medical Education

Policy and Medicine
October 19, 2009

The Association of Clinical Researchers and Educators (ACRE), recently released their response to the AMA CEJA Report: Financial Relationships with Industry in Continuing Medical Education (1-I-09). Specifically, ACRE recommended that AMA House of Delegates reject the report or refer its recommendations back to committee. The report which includes some light editing from the report rejected by the House of Delegates this past summer needs to be rewritten from the beginning.

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Merck discloses a portion of US speaker fees

Medical Marketing & Media
October 20, 2009

Merck disclosed fees paid to US-based medical and scientific professionals who spoke at promotional medical education programs during the third quarter of 2009.

The first disclosure includes payments made to 1,078 patients between July 1, 2009 and September 30, 2009. Speakers during that period were paid an average of $1,548 per engagement, and participated in two engagements on average, according to the announcement. The company will disclose payments for the third and fourth quarters of 2009 in early 2010, at www.merck.com/speakerpayments.

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Extremely Low Rates of Bias Reported in Commercially Supported CME Activities

Policy and Medicine
October 20, 2009

The American Journal of Medicine (AMJ) recently produced a critical study titled: “Low Rates of Reporting Commercial Bias by Physicians Following Online Continuing Medical Education Activities.”

The study of over 1,000,000 physician CME participants, found very little reporting of bias (less than 1%) and no difference between bias reported in commercially supported vs. non supported CME activities.

The study was funded by Medscape, LLC, and written by employees of Medscape, and other authors who give a complete list of their disclosures in the article.

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Drug Companies Used Physician Education to Push Pills

Brian Vastag Science Journalist
October 20, 2009

Article Authors Note: A scientific journal recently commissioned this story from me, but after I reported and wrote it, the journal killed it. I think it’s an important story that serves the public good, so I’m posting it here to get it on the record. BV

Drug makers routinely exploited continuing education seminars as opportunities to market pills to doctors, company documents reveal.

Continuing medical education (CME) has exploded into a $2.3 billion business in the United States, with nearly half of the funds pouring in from drug and medical device manufacturers. Physicians must complete a certain number of CME courses each year to retain their medical licenses.

Today, the large pharmaceutical companies say their CME dollars support only independent education, with no input from the companies. But as recently as 2004, the documents show, marketing personnel played key roles in developing the seminars, treating CME as one element of their comprehensive sales plans.

“It is very clear…that continuing medical education has been used as marketing, and I think it continues to be,” said Allan Coukell, director of the Pew Prescription Project, which seeks to reduce or eliminate conflicts of interest in medicine.

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CME accreditation body plans exposure of courses violating drugmaker influence rules

FierceHealthcare: Daily News for Healthcare Executives
October 21, 2009

To remain certified, doctors must take continuing medical education courses each year. With about half of the $1 billion per year cost of these courses being picked up by pharmaceutical companies, questions have always lingered as to whether such sponsorships unduly influence physicians. That’s particularly the case, critics say, because the nonprofit that accredits course providers–the Accreditation Council for Continuing Medical Education–hasn’t done enough to police drug industry influence on such content.

This week, however, the accrediting group has signaled that it’s ready to take a tougher stand on the issue of pharma influence on CME content. The head of the ACCME said this week that he would soon be revealing a list of classes and companies that already have violated rules against imposing commercial bias on this content.

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CME In the News September 2009

Here are a few things about CME that have appeared in cyberspace in the last few weeks. I am sure most of you have seen the last missive frmm the ACCME. If not go take a look at the organizations web page.

Eliminating CME Conflicts Worth the Cost, Says Scully
By Jun Yan

Psychiatry News September 4, 2009
Volume 44, Number 17, page 1
© 2009 American Psychiatric Association

“Regulators may join the already-crowded debate over whether commercially funded CME is beneficial or detrimental to the medical profession and patients’ health.

The fact that the relationship between the industry and the medical profession is facing increasing scrutiny is not a bad thing,” James H. Scully Jr., M.D., APA’s medical director and CEO, told the Senate Special Committee on Aging at a hearing in late July. He was one of the medical leaders who testified at the hearing to express their knowledge and opinions about continuing medical education (CME)—specifically, whether funding from pharmaceutical and device companies, currently accounting for half of all funding for all CME programs in the United States, leads to biased information for physicians.”

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Physicians know FDA-OK’d uses for drugs half the time
Critics say doctors need better information and call for tougher action on off-label marketing.
By Kevin B. O’Reilly, AMNews staff. Posted Sept. 7, 2009.

American Medical News

This article starts by referring to a 2006 study reported in the Archives of Internal Medicine:

“A 2006 Archives of Internal Medicine study of 725 million prescriptions found that about one in five orders was written off-label — that is, for a condition that has not received the Food and Drug Administration’s approval as a safe and effective use of the drug. More than 70% of these off-label prescriptions were for indications in which the drug ordered had little or no scientific support.”

Later in the article you will find this assertion:

“Much of what doctors know about drugs comes from what they learn from the industry because the industry is out there actively communicating with doctors through sales reps or sponsoring continuing medical education programs.” (My emphasis)

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PHARMA GROUP SAYS: No more sponsored golf, other perks for docs
By Dona Pazzibugan
Philippine Daily Inquirer
First Posted 20:25:00 09/07/2009

The concern over relationships between industry and physician is not only a US concern. Read what one group in the Philippines is doing.

“Sponsored golf games and seminars in posh resorts here and abroad for doctors are no longer allowed among drug companies belonging to the Pharmaceutical Healthcare Association of the Philippines as it tried to police its ranks against unethical promotional activities.”

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Merck, Schering-Plough Spent Big on Medical Education
24-7 News
Date Published: Tuesday, September 15th, 2009

“A report says Vytorin makers Merck & Co. and Schering-Plough spent $60 million to fund medical education courses over the past four years. According to The Wall Street Journal, the drug makers made the payments to a small group of medical schools and health groups, including Harvard University and the American Heart Association.
The Merck and Schering-Plough Continuing Medical Education (CME) funding was disclosed in a report released by the Senate Special Committee on Aging. “These documents remove any doubt that, at least in this case, when drug companies fund continuing medical education, they see it as money well spent on marketing their latest blockbuster drug,” said Sen. Herb Kohl, D-WI, chairman of the Special Committee.”

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Here’s one for you. Another expose focused on the influence of pharma in medicine. This time it is on the practice of ghostwriting.

When stories extol drugs, maker may be behind it
By Kris Hundley, Times Staff Writer
St. Petersburg Times
In Print: Sunday, September 20, 2009

“Documents recently released in federal court cases against the drug company Wyeth have exposed one of the dirty secrets in the world of medical journals: the widespread practice of ghostwriting.

While doctors are named as the authors of articles about treatments and diseases, behind the scenes is a paid writer who is largely responsible for crafting the piece. Not only is the ghostwriter on the payroll of a drug company with interests in the topic, the company often reviews the manuscript before the physician sees it.
With publication in a peer-reviewed journal, the physician enhances his reputation and resume. The drug company gets its marketing message across by a supposedly unbiased author.

Meanwhile journal readers — doctors and their patients — have no inkling of the drugmaker’s role in shaping the information.”

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CME in the News Week of August 31st, 2009

Over and over the majority of the news items appearing in blogs, web news outlets, newspapers, etc. focus on questionable practices of pharma involvement in CME. This week Pfizer and Forest Laboratories get the attention. ACCME got a little attention this week. So you want to see what the public is hearing about what we spend our time doing? Lots of fodder for the anti-pharma involvement in CME proponents.

The ACCME Data Dumps
By bmartin on August 31, 2009 4:14 PM

Last Thursday the Accreditation Council for Continuing Medical Education (ACCME)—the organization that accredits other organizations to provide certified CME in the United States—released detailed data on 729 providers. In an e-mailed press release, the ACCME’s Chief Executive, Murray Kopelow, stated that these data were being made public in an effort to “increase the system’s transparency and accountability.”

Among the accredited providers, 124 (17%) received the designation of “Accreditation with Commendation” from the ACCME; 16 received commendation under the more stringent 2006 criteria, which is intended to foster providers’ participation in “institutional or system-wide initiatives” to improve the quality of healthcare (whatever that entails exactly).

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Documents Show Lexapro Promoted By Tens Of Millions In Doctor

Lunches, Lectures
“Forest’s 2004 plan for marketing Lexapro offers detailed information about how the company planned to direct this money to doctors.
“Under ‘Rep Promotional Programs,’ the document said the company planned to spend $34.7 million to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers over the course of one year.

“An entire section of the marketing plan, titled ‘Continuing Medical Education,’ outlines how the company intended to use educational seminars for doctors to teach them about Lexapro. The Senate’s Special Committee on Aging held a hearing in July on whether industry funding of medical education classes leads to tainted talks.”

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Forest’s Promotional Objective: Use CME to Sell Lexapro
The Carlat Psychiatry Blog
September1 2009

“We have known for some time that the actual purpose of industry-sponsored CME (continuing medical education) is to increase prescriptions of the supporter’s product. But few will admit it. The ACCME says that it accredits only CME that is unbiased and objective, even though half of it is paid for by the pharmaceutical industry. Leading medical societies appear to be willing to fight to maintain their God-given right to industry funding of CME until the world ends.”

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Document Details Plan to Promote Costly Drug
By GARDINER HARRIS
New York Times.
Published: September 1, 2009

Here is a paragraph in the article you should take note of:

“An entire section of the marketing plan, titled “Continuing Medical Education,” outlines how the company intended to use educational seminars for doctors to teach them about Lexapro. The Senate’s Special Committee on Aging held a hearing in July on whether industry funding of medical education classes leads to tainted talks.”

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Mother of God! Forest Labs Had Marketing Plan for Lexapro!
By bmartin on September 2, 2009 12:49 PM

“And gambling occurs in casinos. Yesterday Gardinar Harris of the NYT revealed that Forest Laboratories, the maker of the antidepressant escitalopram (Lexapro), had a 2004 marketing plan for the drug. Harris’s article,* which is made possible by government access to what was a confidential document from Forest, seems intended to generate a considerable amount of righteous indignation. But a review of the abridged plan, which is made available here, reveals nothing more than the usual strategies and tactics by pharma to achieve or maintain a drug’s market share—objectives that are, in fact, a company’s responsibility to its shareholders. Frankly if Forest’s Lexapro marketing team, circa 2003, is to be publicly chided, it should be for lack of originality.”

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Drug company paid MN doctors $754,127: Forest Laboratories paid 62 Minnesota doctors in 2008, a nonprofit group reports.
By JANET MOORE, Star Tribune
Last update: September 3, 2009 – 12:57 AM

“Minnesota doctors were paid thousands of dollars in speaker fees and other payments last year by a pharmaceutical company now implicated in a congressional investigation for its aggressive promotion of a popular antidepression drug, according to documents filed with the state and analyzed by a nonprofit group

“Forest Laboratories Inc. paid 62 Minnesota doctors at least $1,000 each in speakers’ fees, with 28 physicians receiving payments of more than $10,000, according to The Pew Prescription Project. All told, Forest paid Minnesota practitioners more than $750,000 in 2008.”

To check out drug company payments to doctors, go here.

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Pfizer Reaches Record Settlement with Feds; Yes, That Is $2.3 Billion with a ‘B’
By Douglas B. Farquhar –
September 2, 2009
FDA Law Blog
Hyman, Phelps & McNamara, P.C.

“…the marketing acts that allegedly resulted in the false claims for federal reimbursement included the following:
• The marketing team positioned Bextra for uses other than the approved uses, created and tested sales materials promoting those uses.
• The sales force marketed Bextra for unapproved uses, including drafting and distributing physician standing orders and hospital pain “pathways” that called for unapproved uses of Bextra.
• Pfizer and Pharmacia used “so-called” Advisory Boards, consultant meetings, and other forms of remuneration to promote Bextra for unapproved uses (Advisory Boards have been a particularly frequent target for federal government investigations).
• The sales force created sham requests from physicians for off-label information (the requests are supposed to originate from physicians without prompting from sales representatives).
• Distribution of drug samples for unapproved uses.
• Sponsoring supposedly independent CME (continuing medical education programs) that were not independent.
• Initiating, funding, and occasionally drafting articles for medical publications about unapproved uses of Bextra.”

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Pfizer to Pay $2.3 Billion, Undergo Annual Reviews for Off-Label Promotion
FDA News, Volume 6, Number 173, Friday September 4th 2009

Pfizer has agreed to a $2.3 billion settlement — the largest healthcare fraud settlement in Justice Department history — to resolve criminal and civil cases arising from the illegal promotion of several of its drugs. As a result of the investigation, the drugmaker is entering into a five-year corporate integrity agreement with the HHS Office of Inspector General that requires annual reviews of the company’s compliance program. Pharmacia & Upjohn, a Pfizer subsidiary, will plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding the anti-inflammatory drug Bextra (valdecoxib) with the intent to defraud or mislead and will pay $105 million in fines, Justice said in a press briefing Wednesday.

Big Pharma Paying Doctors to Promote Drugs: Where is the Line?
FindLaw’s Common Law

“…….. record-breaking fines against Pfizer offer an opportunity to examine recently surfaced information regarding marketing tactics employed in the pharmaceutical industry. Though the line is not always clear, the Pfizer settlement agreement shows that federal prosecutors believe many widely used marketing tactics to be illegal.”

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Sure. Go Ahead. Ban Pharma Money From CME.

Banning commercial support for CME appears to be a moral crusade for some, but at what cost? Ask, “Where the money will come from to allow physicians to have access to CME at a price they think they can afford or are willing to spend? Why me of course. The patient. Priceless.

CMPI conference on industry supported CME

We heard a little about the recent CMPI conference on industry supported CME. For those of us who could not attend, the presentations are posted here. It is worth taking time to listen to some of this. Dr. R. W. Donnell a hospitalist in Alaska provides a thoughtful summary of what he thinks are key points made during the meeting.

What is it going to take to get the issue of commercial support for CME resolved? Right now the “debate” over this issue consumes far to much attention. I suppose the next step will come from the ACCME when it makes policy decisions based on responses received from its Call for Comments on related issues. The comments have been posted and are worth a careful review.

All CME Must Have an Improvement Focus

Twelve reasons why all CME should move towards PI CME. Suggestions made Dr. Norman Kahn, Jr., Executive Vice President and Chief Executive Officer of the Council of Medical Specialty Societies. A new opportunity for accredited CME providers.

ACCME Releases Comments

Well, we should have expected this. It is a common practice of the ACCME to release information related to CME right before a meeting that will be attended by CME providers. At least this time the release is important to the content being discussed at the meeting. The AMA Task Force meeting starts tomorrow and the ACCME has published the responses received from the June and August 2008 calls for comment. It’s worth everybody involved in CME wading through this information. Policy changes can’t be far behind. Check it out here.

Pharma and Device Companies Funding CME? Why bother?

Suppose I own a pharmaceutical or medical device manufacturing company. You know what? I am going to shed providing support for accredited CME and I am doing it right now. My company does not need the extra hassles. Put yourself in their shoes and see if it makes sense to you.

There is Support for Industry Support of CME

Here is an interesting blog reporting on a meeting sponsored by the Center for Medicine in the Public Interest (CMPI) on industry support of continuing medical education (CME). Thanks to Marissa Seligman for actually presenting some data to support her point. However, I understand that some of the early speakers couldn’t present their data because of a technical problem with projection. Something the author of the report left out (thanks to Tom Sullivan of Policy in Medicine for pointing that out.) The author is correct. We don’t need name calling. We need evidence supporting all positions taken on this important issue. And the evidence needs to be from studies completed since ACCME instituted standards and guidance related to commercial support of CME to accredited CME providers. The Cervero study commissioned by the ACCME is a good start in this regard. If you have not read the Cervero review make a point to take the time to see what the evidence says.

Comments to ACCME from Two Key Stakeholders

Two very important responses to the ACCME “Call for Comment” on proposed changes to policies related to commercial support for CME were submitted to the ACCME this week. Both provide well considered agreement with some of the intentions of the ACCME recommendations. Equally important, are the questions posited to the ACCME and the disagreements offered in both comments. You’ll find the response from the Alliance for Continuing Medical Education here.The Council of Medical Specialty Societies has also provided a very thoughtful response to the ACCME.

The Alliance and CMSS represent key constituencies in CME. Let’s hope the rational and thoughtful observations and recommendations from the Alliance and CMSS are heeded by the ACCME.

For some interesting observations about both submissions visit Policy in Medicine.