Archive for September, 2009
A Call for a Standard Approach to PI CME
The American Medical Association has approved a framework physicians can use to engage in performance improvement and earn CME credit. The framework is useful but guidance for how to engage in effective performance improvement initiatives that will result in sustainable change is missing in the framework. In fact, the simplicity of the model may be a disservice to the physician wanted to engage in effective performance improvement efforts. But there is a solution. The solution is to adopt a nationally accepted standard for the implementation of PI CME initiatives. I think is a good idea.
Continue Reading Add comment September 27, 2009
GSK and CME Funding Restrctions
This story has created a torrent of interest in the blogs and news outlets in the past few days. Google “GSK and CME” and you will see what I mean. This is yet another of the great number of stories we have been seeing for a long time related to industry involvement with CME. It seems to be the major topic of interest to writers and bloggers following CME issues.
GlaxoSmithKline Changes Doctor Training Policy
Associated Press – Sep. 21, 2009
RESEARCH TRIANGLE PARK, N.C._British drugmaker GlaxoSmithKline PLC is making major changes in its spending on training programs for doctors, fees paid to doctors for consulting, and even political contributions.
The changes include immediate bans on all corporate political contributions and on using commercial medical education and communication companies to run programs teaching doctors about medical treatments.
Those programs often promote a drug maker’s new, generally expensive drug and give little information about its risks or how well it compares to older, cheaper drugs.
The moves come as congressional investigators, consumer groups and the media ratchet up criticism over the increasing influence drug and medical device makers wield over the practice of medicine.
Add comment September 23, 2009
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.”
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)
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.”
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.”
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.”
Add comment September 21, 2009
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).
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.”
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.”
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.”
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.”
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.
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.”
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.”
Add comment September 4, 2009
