Are You Systematically Engaged in Performance Improvement in Your CME Operation?
My brother has worked industry for over 30 years. Many of those years he has been directly engaged in improvement initiatives. Now, in his own business, he works with many types of enterprises, including healthcare, helping them identify and engage in ways to improve their operations. He also teaches these skills to students in a business college in the Midwest.
In training situations he is fond of asking those in attendance, “How many of you had a perfect day at work yesterday? A day in which everything went perfectly where there were absolutely no problems, no issues, zero hassles”. You know, not one person has ever raised their hand saying that was my day. Then he asks this, “How many of you went to work yesterday with the intention of doing a bad job?” Again, no one raises their hand. Then he asks, “How many of you are engaged in a conscious effort to improve or start improving something that went wrong at work yesterday?” Again there are no hands raised. What does this say about how we approach our work? Everyday we can count on something going wrong. We do not go to work everyday intentionally to do a bad job. Yet, everyday we do nothing systematically to improve our work world.
Our customers, those we serve in CME, are required to engage in improvement efforts to earn CME credit. They have to be engaged in efforts to improve their capability to practice (competence), their actual performance, or the health status of the patients they care for. As an ACCME accredited provider we have to measure those improvements.
Most CME providers I talk to are not engaged in a systematic, sustainable, repeatable effort to improve their own CME operation. What better place to learn how to develop improvement skills in our customers than to engage in improvement efforts in our own CME operation?
Here is an invitation. My brother (the one I mentioned earlier) is going to work with me on this. We are looking for five people interested in learning, and then participating in a four month pilot test of a systematic sustainable, repeatable approach to improving their CME operation. It is also an approach you can teach physicians to use in PI CME or any improvement initiative in their practice setting. We will learn this approach by participating in a series of four one hour discussions on Go To Meeting. No charge to you. After the orientation, we will use a page created Facebook to communicate our progress, ask questions, share experiences, and, ultimately share our outcomes. If you would like to participate in the pilot project contact me at ctlassoc@mindspring.com.
I firmly believe that if we adopt this approach to improvement we can transform a CME operation, we can provide physicians an effective approach to improvement efforts in their practice, and we can generate data demonstrating that our CME program is a strategic asset in our organization.
Add comment November 8, 2009
CME In the News and Blogs: Week of November 1st, 2009
OK. I admit it. To get something other than the evil influence of industry on continuing medical education or some congressional hearing examining pharma payments to physicians, or a crack down by ACCME on non-complaint CME providers related to commercial support or disclosure, etc., I put my own Blog entries in this weeks summary. Maybe this brief diversion will get some of us thinking about how we can do a better job of serving our physician constitutes and continuously improving our CME operation.
CME Providers: Adopt an Improvement Program in Your CME Operation.
Conversations in CME October 31, 2009
Accredited CME providers are required to measure change (improvement) in physician competence, performance or patient outcomes. What does this mean? It means CME providers are expected to be integrally involved in health care quality improvement. I think the best way to learn how to be effective in this improvement environment is to adopt a “culture of improvement” in our own CME operations.
Read More:
A National Model to apply to our Overall CME Program Improvement?
ACCME requires all accredited CME providers to “Evaluate the effectiveness of its overall CME program and make improvements to the program” (Element 2.5). So how do we do this improvement stuff? I hear this question asked over and over. I hear interesting variations in the interpretation of what this means. We can change that ambiguity. We can adopt a common approach to program improvement.
NOTE: This isn’t a news or blog item but if you are interested go muck around in YouTube with search terms we might find interesting as CME providers. Here is one I found by entering “physician performance improvement”.
The Role of Physicians Performance Measures in Quality Improvement
Renal Physician Association www.renalmd.org
You tube contributes to help physicians understand performance improvement.
OK. Back to what is important. Ranting about pharma involvement in CME. Here is another one for you.
Aren’t You Glad Your Doctor Completed Pharma’s CMEs?
For OpEdNews: Martha Rosenberg – Writer, Sunday Nov. 1st.
“Raise your hand if you’ve breathed a sign of relief seeing your doctor had a CME certificate next to the medical school diploma on the wall………….
CMEs are supposed to be monitored by the Accreditation Council for Continuing Medical Education (ACCME) but like Standard and Poor’s and Moody’s stock ratings funding comes from the client side so buyer beware.
Did your doctor pass, Bipolar Disorder: Individualizing Treatment to Improve Patient Outcomes, Part 2 “taught” by Trisha Suppes, MD, PhD and offered by CME Outfitters?
Suppes is a Professor in Stanford’s Department of Psychiatry and Behavioral Science and funded by Abbott, AstraZeneca; GlaxoSmithKline, Janssen, Novartis, Pfizer, Wyeth, Bristol-Myers Squibb, Eli Lilly, Shire and four more pharma companies.
Author Note: While this is not a CME related article, this points to another reason there is continuing mistrust surrounding alleged relationships between pharma and physicians.
Amgen sued by US states over alleged “kickback scheme” for Aranesp
First WordSM
Mark Todoruk October 30, 2009
Amgen is facing a lawsuit in the US over allegations that the company offered kickbacks to medical providers to increase sales of Aranesp (darbepoetin alfa), the New York Attorney General’s office announced. The litigation, launched by 14 states and the District of Columbia, contends that Amgen conspired to offer incentives, such as weekend retreats and nonexistent consultancy agreements, to increase prescriptions for the product.
New York Attorney General Andrew Cuomo also explained that the lawsuit accuses Amgen of encouraging the healthcare providers to seek reimbursement from third-party payers, including Medicaid, for supplies of the anaemia drug that they obtained at no cost. The multi-state legal action joins a whistleblower complaint filed in another federal court in 2006 over allegations that Amgen illegally marketed Aranesp.
In response to the latest news, Amgen commented that it believes “the allegations are without merit.”
CME Reform from People Who Don’t participate in CME.
Pathophilia By bmartin on November 3, 2009
There is a particular irritation to be found in the criticism of continuing medical education (CME) by a nonphysician. There is even more irritation to be found in the criticism of CME by a purveyor of sociology. There may be practical benefits of the so-called science, but its merits have eluded me in a life that’s had its fill of academia.
In the latest issue of JAMA—a journal becoming known for its overbearing editorials—sociologist Eric Campbell, PhD, and health economist Meredith Rosenthal, PhD, condemn the current state of physician CME by applying general critiques from the landmark Flexner Report of 1910. They also advocate investment in something they call “physician human capital,” a term adapted from economists to convey the medical knowledge and skills that are required to provide “high-quality, efficient, and cost-effective care.”
Editors Note: I kinda like this assessment.
Add comment November 6, 2009
Let’s Adopt a National Model for Overall CME Program Improvement
ACCME requires all accredited CME providers to “Evaluate the effectiveness of its overall CME program and make improvements to the program” (Element 2.5). So how do we do this improvement stuff? I hear this question asked over and over. I hear interesting variations in the interpretation of what this means. We can change that ambiguity. We can adopt a common approach to program improvement.
Having a systematic, sustainable, repeatable approach to improvement can be done by each of us regardless of the size or scope of our CME program. Doing so would:
- Create a common nomenclature we could use to communicate about our improvement initiatives.
- Develop a common skill set and approach to improvement we could implement in any setting.
- Produce sustainable improvements in our CME operations we could share with colleagues in other settings that would raise the quality bar for everybody.
- Be a systematic way to evaluate the effectiveness of our overall CME program we could use to show value to our organization and report to the ACCME.
- Be a systematic way to continuously make improvements to our overall CME program we could use to show value to our own organization and report to the ACCME.
Such an approach to improvement does not have to be an expensive or extremely time consuming effort. Adopting a simple, systematic, sustainable, repeatable approach to improvement is within our reach. An increasing number of healthcare settings around the country are engaged in such efforts right now. Industry has been doing this for decades.
Interested in becoming an early adopter? Contact me at ctlassoc@mindspring.com to learn about getting started in transforming your CME operation into a culture of improvement and join in the effort to create a common national approach to CME program improvement.
Add comment October 31, 2009
CME Providers: Adopt an Improvement Program In Your CME Operation
The ACCME requires that all CME be directly involved in improvement. Accredited CME providers are required to measure change (improvement) in physician competence, performance or patient outcomes. That doesn’t mean all CME providers have to offer learners education designed to meet the AMA format of PI-CME. But accredited providers are required to show a report of the evaluation data and information about changes in physician learners’ competence, performance and/or patient outcomes. What does this mean? It means CME providers are expected to be integrally involved in health care quality improvement. I think the best way to learn how to be effective in this improvement environment is to adopt a “culture of improvement” in our own CME operations. We should:
- adopt a systematic, sustainable, repeatable approach to improvement;
- use the tools employed in improvement initiatives to improve our own CME operations;
- expect that every person in our own CME operation is engaged in targeted improvement efforts;
- transform our overall CME programs into improvement focused operations.
We must learn these skills. We must integrate a systematic, sustainable, repeatable approach to improvement in our CME operation. As a result of our own improvement efforts the CME operation will be well positioned to become an effective strategic asset in many efforts designed to improve health care delivery.
If you are interested in learning an approach you can use to establish an improvement program in your CME operation contact me at ctlassoc@mindspring.com.
Add comment October 31, 2009
CME in the News and Blogs
Here are a few things that were in the media this past week regarding our “profession”. Pharma funding, bias, and one lone call for pharma involvement in CME.
For those of you who are aware of the ruckus caused by the Emory Psychiatrist who received very large payments from pharma for various activities found objectionable by Sen Grassley, he is leaving Emory.
CME in the News and in the Blogs Week of October 26th
Exploring the Future of CME Funding
Medical Meetings
By Dave Kovaleski Oct 26, 2009
The question of how to fund continuing medical education went from a hot topic to a scorching one since the Institute of Medicine’s Conflict of Interest in Medical Research, Education, and Practice Committee announced last spring that it was time to develop a new model. So it’s no surprise that a panel of CME experts took on the perennial problem at the 20th Annual national Task Force on CME Provider/Industry Collaboration in Baltimore, October 14-16.
In a session called “Beyond the Tipping Point: Future Options for Commercial Support Funding,” moderator Melinda Steele, MEd, CCMEP, director, office of CME at Texas Tech University Health Sciences Center, Lubbock, put forth four funding options for the panel to discuss: 1) the current model, 2) a model free of commercial support, 3) directed pooled funding, and 4) nondirected pooled funding. Directed pooled means that funds could be sent to a pool, but directed to a specific need. A nondirected pooled approach would see CME funds sent to a general fund.
Doctors’ Presentations Help Patients
Thomas P. Stossel – Opinion
Milwaukee Journal Sentinel (JS Online) October 26th, 2009
“Despite arguments to the contrary, doctors should be paid (Editorials, “Get off the gravy train,” Oct. 7). They should be paid to bring specialized knowledge and experience to their patients. They also should be paid to bring specialized knowledge and experience to their colleagues.
Both exchanges create value and improve patient health. Hollow accusations should never obscure this fact. Promotional presentations by physicians should not be banned; they should be celebrated, for patients’ sake.”
Read More
Physicians See Very Little Bias in Online CME, Says Survey
By Barbara Bein
AAFP News Now 10/30/2009
“A recent survey of physicians who participated in both commercially and noncommercially supported online CME activities found that participants perceived little commercial bias associated with CME activities, regardless of the funding source.”
According to “Low Rates of Reporting Commercial Bias by Physicians Following Online Continuing Medical Education Activities,” in the September 2009 issue of The American Journal of Medicine, 99 percent of the physicians surveyed said online CME activities were “presented objectively and free of commercial bias.”
Add comment October 31, 2009
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.
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.
Read more:
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.
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.
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.
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.
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.
Add comment October 26, 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 3 comments 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
