Showing posts with label COI. Show all posts
Showing posts with label COI. Show all posts

Nov 24, 2010

Physician-Industry Relationships Debated on AC360


Here's an excerpt of an exchange between a reporter from ProPublica (of recent repute for spearheading the initiative to consolidate data on payments to physicians), a former pharmaceutical sales representative who became a whistle-blower and Dr. Tom Stossel from Harvard Medical School / Brigham & Women's Hospital.  


Interesting exchange ... be sure to vote after viewing the video!



Who won the debate?



Sep 18, 2010

Guest Post: Industry Funding of CME

The last post highlighted a Boston Globe article regarding the role of industry funding in continuing medical education ... in response to the Globe article, I receive this hypothetical interaction between a CME instructor and an attendee that I couldn't resist sharing:

CME REGISTRANT: "What are your credentials to teach this session?"

INSTRUCTOR: "I am a board-certified cardiologist and I have no financial conflicts to report"

CME REGISTRANT: "What will I be learning today?"

INSTRUCTOR: "Evidence-based best practices to open a clogged coronary artery. Let's begin. First, you hold the flint in your dominant hand and strike it sharply with the iron chisel until a sharp edge is fashioned. Be careful with the sparks and stone chips. This technique has been around a long time and is very well described....."
CME REGISTRANT: "What about angioplasty?"

INSTRUCTOR: "Ah, I see the catheter rep has paid you a visit. Angioplasty is a relatively new procedure and the risks are not yet fully understood, nor the long term outcomes. We have much more extensive experience with flint-making. The angioplasty companies are disease mongerers and by using the classical technique, you make a powerful statement that you cannot be bought."

CME REGISTRANT: "Please excuse me, I'm downloading intravascular ultrasound images on my iPhone for a case tomorow......"

INSTRUCTOR: "Please be sure to attend this afternoon's session where I will give an engrossing lecture, 'Fire: Going Beyond Sterilization', you won't want to miss it".

CME REGISTRANT: "Thank you...."

-Anonymous Guest

Sep 16, 2010

People Who Have The Most Expertise ... Are the People Who Work With Industry - Steven Nissen, Cleveland Clinc



The debate over the role of industry funding in continuing medical education (CME) continues on the pages of the Boston Globe this week.  


The article highlights a new company, Lighthouse Learning, that was formed by Dr. Martin Samuels, a neurologist from the Brigham & Women's Hospital and Harvard Medical School, who has a little experience in the field.  In fact, the article highlights that he was the medical director of M/C Communications until last year "when he said he decided that commercial support created an unacceptable conflict."


The curriculum will be developed by 11 specialists, many from Harvard, who will not be allowed to teach other courses funded by drug companies, "to further insulate them from industry influence."  


And the company's advisory board will also help them keep influence peddling in check. The board includes reputable names such as Dr. Joseph Martin, former Dean of Harvard Medical School, who will review the curriculum directors' other relationships with industry.  


(Note: Dr. Martin was also highlighted in a provocative NY Times article earlier this year which highlighted that under the new conflict of interest rules implemented at Partners HealthCare, Inc., he will no longer be able to accept the >$200,000 per year compensation for serving on the Board of Directors at Baxter International.  Interesting, that he will be watching over relationships at Lighthouse).


Non-MD, Dr. Eric Campbell, a vocal critic of industry, noted that Lighthouse may find it more difficult to separate themselves from industry influence than they expect.  He suggests "that companies can offer to pay doctors' tuition to attend certain courses, thereby exerting influence that way."



Oddly, in the article Non-MD-Campbell is noted for "specializing in conflict of interest" but seems unaware of the pharmaceutical industry's own conflict of interest policy, which states that:


"Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty healthcare professionals attending CME, either directly to the individuals participating in the event or indirectly to the event’s sponsor (except as set out in Section 9 below). Similarly, funding should not be offered to compensate for the time spent by healthcare professionals participating in the CME event."


The final quote from Dr. Steve Nissen, who needs no introduction, sums up the issue quite accurately:


"The biggest name people, the people who have the most expertise and are going to draw an audience -- they are the people who work with industry."



Aug 25, 2010

Who's Has More Control Over Prescribing -- Pharmaceutical Companies or Insurers?

Here's an article from MedPage Today about a Consumer Reports telephone survey assessing perceptions of physician-industry relationships.  It starkly contrasts a recent article in their blog (MedPage Today's KevinMD), which highlights the influence of insurers on prescribing.


It's worth (re-)reading the article on the influence of insurers first, then comparing it the one below ... you be the judge of who is wielding the most influence.


1. Insurer influence on prescribing, Read more...


2. Industry influence on prescribing ...



Patients Wary of Doctors' Relationships

By Kristina Fiore, Staff Writer, MedPage Today
Reviewed by
August 24, 2010
Review
Many patients taking prescription drugs believe that pharmaceutical companies have too much influence over their physicians' prescribing practices, according to a new survey.

A telephone survey of more than 2,000 U.S. adults by Consumer Reports found that the majority of those currently taking medications -- 69% -- had such concerns.

About half of the medication-users believed that their doctors were too eager to write a prescription when other nonpharmacological options are available.

"On the one-to-one level, many patients trust their physicians," Lee Green, MD, MPH, of the University of Michigan, told MedPage Today. "But I see a lot of skepticism out there and it's well-founded."

Jerome Kassirer, MD, professor of medicine at Tufts University in Boston and former editor of the New England Journal of Medicine, said trust between a doctor and a patient "is absolutely essential in getting patients to believe what their doctors are telling them. ... Any kind of loss of trust between doctor and patient is deleterious."
That could mean patients don't heed instructions about taking their medications, according to physicians interviewed by MedPage Today.

The findings come from a telephone survey of 2,022 patients in the U.S., with the final analysis based on 1,154 responses from those adults currently taking prescription drugs.

On average, those patients reported routinely taking four different medications.
Almost half of the patients taking medications who were surveyed (47%) thought that gifts from pharmaceutical companies influenced their doctor's choice of drugs.
Most of them (81%) were concerned that physicians engaged in practices that resulted in being rewarded by pharmaceutical companies for writing lots of prescriptions for the company's drugs -- a practice that is illegal, according to Randy Wexler, MD, MPH, of the Ohio State University.

"Unfortunately, I have found this fear expressed in my own research," he told MedPage Today.

But Green said this practice is more likely to occur among specialists because their smaller numbers make it easier to keep track of the drugs and devices they prescribe.
Surveyed patients were also worried about their physicians acting as paid spokespersons for drug companies (72%), speaking at industry conferences (61%), and getting free meals (58%).

Their fears may not be unfounded -- given that pharmaceutical companies are increasingly targeting primary care doctors rather than high-profile academicians to spread the word about their drugs. (See On the Stump: When Academics Are Out of the Picture).

Green said pharmaceutical companies are increasingly turning to eloquent community physicians, partly because academic doctors "are asking too many questions." Many academic institutions have also set new rules against such conflicts of interest (See Conflict-of-Interest Policies: A Detailed Look)

Kassirer said the physician "who works in the community may not be as informed about the drugs and might be more willing to follow the line of the pharmaceutical company in telling others how to use those drugs."

Indeed, 66% of patients reported receiving free samples of prescription medications, and 41% felt their doctors prescribed newer and more expensive drugs over proven generics.

Eroding trust, especially combined with rising costs of medications, could spur compliance issues, researchers say.

The survey found that monthly out-of-pocket patient spending is around $68 -- and 14% of patients spend more than $100 of their own money every month on prescription drugs.
In the past year, 27% of patients said they failed to fully comply with their medication regimens, most commonly skipping a prescription fill (16%), taking expired medication (12%), skipping a dose (12%), cutting pills in half (8%), or sharing pills ($4).

This combination of circumstances "provides some with the ability to rationalize why a specific medication does not have to be taken," said Wexler. "That can be very dangerous in the setting of many chronic diseases such as diabetes, high blood pressure, hypertension, and high cholesterol."

More than half of patients feel that their doctors don't consider their ability to pay when they prescribe. In fact, 64% of survey respondents didn't learn how much the prescription would cost them until they picked it up at the pharmacy.

Only 6% were informed of the costs of prescription drugs while in their doctor's office.
Physicians are hardly the lone party at fault.

About 20% of patients reported asking their doctor for a drug they saw advertised on television. And physicians complied with those requests 59% of the time.
Still, physicians should take steps to make it clear to patients that they're free of conflicts of interest, Green said.

Kassirer said physicians can avoid being on speakers' bureaus, and discourage pharmaceutical representatives from coming into offices bearing free lunches and free samples. They should also "eliminate all evidence of pharma largess from their offices -- no pens, no pads, none of that."

He also cautioned that it's up to patients "to be alert to these things."
Wexler added that it's "reasonable for patients to ask their physicians what, if any, arrangements they have with outside vendors, and what that relationship is."
"If the physician will not discuss it," Wexler said, "then it is time to find another physician."
This article was developed in collaboration with ABC News. 




Jul 8, 2010

Gift Ban Repeal: How They Voted

As covered in the last post (HERE), the Massachusetts House of Representatives passed its version of the economic development bill yesterday. Normally, such an event would garner little interest locally and zero interest nationally. However, this particular bill could easily be a watershed moment for the conflict of interest movement that distinguishes Massachusetts as both the state with the most strict regulations on pharmaceutical/device maker marketing and the only state to repeal such regulations!

Of interest to the "locals" living under the regulations is how our public servants weighed-in on the issue. Below is the "Yea and Nay No. 427" report for a proposed counter-amendment which would have removed the "gift ban" repeal (thereby leaving the ban intact). For those that contacted their legislator, here's the moment of truth! A "yea", or a "Y" next to their name, means they think the gift ban should remain in effect. 


And for those that enjoy the nitty-gritty of politics, here is a transcript of the debate as reported by the State House News.  Mostly rehashed arguments, but interesting nonetheless to peer inside the process:



GIFT BAN PRESERVATION: Rep. Wolf offered an amendment striking section 105.

Rep. Wolf said the bill would repeal the gift ban we passed and the governor signed that does not allow the wining and dining of people in the medical industry and has restrictions and parameters around which information and education can take place between pharmaceutical companies and members of the medical profession. The provision was put into the original bill to keep the costs of pharmaceuticals down.

Many years ago Congress overturned previous bans to advertise pharmaceuticals and we see them advertised every day. A number of activities go on that are part education and are done at great expense of the companies and add to the expense of pharmaceuticals. Keeping down health care costs is the unfinished business of health care. The amendment hopes to not allow a provision to go down the drain so quickly after we passed it. I don't think we have had much of a chance to test out the ban. It's ludicrous to think that members of the industry might not be able to pay for their dinners. Think about what it would be like if we get rid of the bans we have with lobbyists. All hell would break loose. I don't think this is any different. Special interests going in and having the potential for increased health care costs is not in the interests of our constituents.

Rep. Dempsey said he opposes the amendment. I thank the members for their hard work today. The bill is a much better bill because of all of your hard work, bipartisan efforts. The amendment is one in which many members have passionate feelings about. We respect the sentiment around what we did a couple of years ago. At the time the discussion was centered on cost containment and if we could limit marketing efforts by pharmaceutical companies and the amount on educational dinners that that is somehow going to help us reduce the cost of prescription drugs. I never really believed that our efforts would actually lead to a reduction in cost but I did think it would elevate the discussion about the need for ethical behavior. It has served a useful purpose and been positive in enlightening folks to think about those issues. This has not saved any single person in the commonwealth a dime in what they are paying for prescription drugs.

It's a great theory that it will translate into reduced costs. I haven't seen it. I don't think anybody has seen it. If a publicly traded company is going to reduce its marketing budget it will be shifted to neighboring states or go into the dividend they are paying their shareholders. It's not coming back to the consumer. What we know is we have seen the loss of some convention business. It does not get the attention it deserves but we have seen a reduction in medical training and clinical research. The ban we have adopted has sent out a message, a chill on opportunities for training and clinical research. This has had an impact on the restaurant business but more importantly on clinical research. It's one of our natural strengths. The time has come to rethink this law. I hope the amendment is not adopted.

Rep. Lewis said he supports the amendment. I understand the intent is to help restaurants but this is not the best way to achieve this goal and we should not repeal this gift ban. We have more than 97 percent of residents now covered by insurance. The big challenge we now face is health care costs, which are causing significant hardship to our constituents. The share of family income dedicated to health care has gone from 7 percent to 17 percent. Costs are the biggest challenge facing local, state and the federal government. Prices of widely used drugs rose 50 percent from 2000 to 2006. Why is a gift ban necessary to address costs? The products offered are critical to patient health and safety but the financial relationship can steer providers away from the patients' best interests. About $9,000 is spent marketing each doctor in the United States. All of this spending is aimed at influencing prescribing behavior. A physician has a conflict if they are being paid by the company marketing the drug. The gift ban helps ensure that profits do not come before patients. More biotech is relocating to Massachusetts. There has not been a drop in convention business in Massachusetts that can clearly be attributed to this gift ban. The convention center is expanding to accommodate demand. BIO has announced its return to Boston in 2012. The gift ban is not the sole solution to rising costs and I hope before the end of the session we will take up a bill to address health care costs. It is an important component of the strategy to contain costs. It has been in place for just one year. Industry, hospitals, physicians and DPH have invested time and effort to implement the law. Rather than leaving Massachusetts, the health care industry has continued to invest and expand. Now is not the time to repeal the gift ban.

Rep. Lewis requested a roll call and there was support. Time was 6:33 p.m.

Rep. Bradley opposed the amendment. He said he wanted to give some facts. The unintended consequences of the law have been devastating and has wiped out hundreds of jobs. It has cost us at least one major convention. It's the most restrictive law in the nation. It is not a level playing field. This business is in jeopardy moving forward if business is lost to other cities. We will see a loss of jobs and tax revenues. A manager at the Seaport Hotel talked to a company from Buffalo and he said the regulations here are too onerous and that they will not come here. Also, the Mass. Convention Center now includes language in shows that allows cancellations without penalty.

Rep. Provost said she supported the amendment and noted other states are looking at gift bans. Private institutions have adopted their own bans on gifts and even on interpersonal meetings between their staff and representatives of the pharmaceutical and medical device industry. Harvard Medical School has adopted a disclosure policy for their professors, who must disclose financial interests they may have with pharmaceutical companies. No meetings were pulled out of Boston because of the law, according to an industry publication. BIO is coming to Boston in 2012. There is no evidence really that this is a loss to business. This is something to which the industry has accommodated itself and is the wave of the future. The selling of drugs and devices is not just about the bottom line. We are losing sight of patients, the individuals who come to doctors for the highest standard of care and the necessity that patients trust their doctors to consider their situation on the merits and that prescribing practices come first from the view of what is best for patients. The director of the GIC, to which we all belong, has contacted us and asked us not to repeal the gift ban. We would send the message that any law we passed, however well considered, that's up for grabs if it brings business in the door.

Rep. Feingold said sometimes when we pass laws there are unintended consequences and I am not sure we thought about medical device companies and the important role they play. I have a couple in my district. It is causing doctors to shy away to come and get trained on these devices. Understand that these companies don't have to be here. They can go to Berlin or London. We are competing against an international market. The bill we passed has had a chilling effect on the medical device industry. We have hotels that were 90 percent filled and are now 50 to 60 percent filled. If the federal government banned advertising for pharmaceuticals that would be a step in the right direction.

Rep. Malia said it's painful to listen to some of the inaccuracies. We have a crisis in medical costs. I don't think the pharmaceutical industry has been hurting over the past few years. They spend somewhere near $7 billion on marketing. I can't tell you how many times I answered the door of a pharmacy in a Boston hospital and there would be drug detailers. It was amazing. Some were nice people with degrees in education. They were not doctors or pharmacists, some were. And they would ask over and over again for time to talk to me. I said I am not a doctor or pharmacist. They had just delivered lunch to meetings, from favorite restaurants. It went on, pens, tie clips, pads of paper, everything with their names on it. I don't think it's changed much. I am very concerned about the fact that we need to stay focused on what is the most serious economic concern we have in this state, meeting our obligation for our health care costs. Repealing this ban will not help that at all. I urge you to support this amendment.

The chair opened a roll call on the Wolf amendment. Time was 6:58 p.m.

BY A ROLL CALL VOTE OF 40-108, AMENDMENT WAS NOT ADOPTED.

Jul 7, 2010

Not a Done Deal ... But Still a Big Deal


 
Believe it or not, the Massachusetts House of Representatives just passed its version of the economic stimulus bill with an amendment that would repeal the so-called "gift ban" intact. The bill now heads to conference committee where the differences will be hammered out. The fate of the repeal is unsure, at best, but regardless of the outcome, this sends a strong signal to other states considering enacting (similarly ludicrous) legislation.  Could the false premises of the COI movement finally be in question?

Here are some additional details on the economic stimulus bill and gift ban repeal debate from the State House News:

STATE CAPITOL BRIEFS - EVENING EDITION - WEDNESDAY, JULY 7, 2010 STATE HOUSE NEWS SERVICE

HOUSE STRIKES GIFT BAN IN EFFORT TO BOOST BUSINESS Reversing course on a new law aimed at diminishing the influence on doctors of pharmaceutical and medical device companies, the House on Wednesday voted to strike the so-called gift ban law, which critics say has hurt commerce in the medical and restaurant industries.  An amendment to preserve the ban attracted 40 votes, with 108 against.   

The elimination of the gift ban was included in economic development legislation that cleared the House 145-4 and now needs to be reconciled with a Senate bill in a conference committee.  

Critics of the ban said it was discouraging out-of-state interests from doing business in Massachusetts and said the ban had not led to demonstrable reductions in health care costs.  
  
Supporters of the ban said the state had already heavily invested itself in implementing it and needed to give the law more time to work itself out.  Ban supporters also said other states were pursuing similar bans and predicted the law could help reduce health care costs and ensure that the interests of patients, not drug and device makers, are the top priority for physicians.  

Speaking against the ban were Reps. Garrett Bradley (3rd Plymouth), Brian Dempsey (3rd Essex), and Barry Finegold (7th Essex). Pushing to preserve the ban were Reps. Alice Wolf (25th Middlesex), Ruth Provost (27th Middlesex), Jason Lewis (1st Worcester), and Elizabeth Malia (11th Suffolk). 

Jul 3, 2010

AAMC Confirms Physicians Have No Self-Control

The Association of American Medical Colleges has released the third report in a three-part series on how physicians should practice medicine, how they should behave, and with whom they should and shouldn't interact.

“In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making goes beyond the previous two AAMC reports, which were concerned with conflicts of interest (COI) in medical education and research, and tackles "individual or institutional financial interests in the patient care setting."

A book could be written in response to this report, but for the sake of your sanity, this will be a hyper-condensed commentary and only focus on two points.  First, the rationale used by the AAMC to justify this endeavor.  Second, an issue addressed in the report that easily trumps the rest of its topics but is inadequately addressed: The influence of reimbursement structure (i.e., insurers) on clinician behavior.

Point #1: The Timeless Rationale
Keeping with COI literature tradition, the report begins by extolling the benefits of collaboration, then quickly moves into the myriad reasons it should never occur. Apparently, it’s the preponderance of psychological literature that supports nullifying physician-industry interactions:

"The psychological research shows that ... when individuals stand to gain by reaching a conclusion they tend to unconsciously and unintentionally weigh the evidence in a biased fashion ... furthermore, the process of weighing evidence can happen beneath the individual's level of awareness.  This research explains how even well-intentioned individuals can succumb to conflicts of interest and why the effects of conflicts of interest are so insidious and difficult to combat."

There you have it ... you didn't mean to do it, you couldn't control yourself. Sound familiar ... it looks strikingly similar to recent quote in the NY Times regarding industry funding of CME (previous blog coverage is HERE). And once again, the same tired JAMA articles are cited to support these claims (Dana & Loewenstein 2003; Wazana 2000). You get the picture; their argument for them to regulator you is solid.

Point #2: Reimbursement and COI
With all the focus on how pharmaceutical companies and device manufacturers are influencing, swaying, biasing, and bribing physicians to use their products, is seems that the elephant in the room feels a little neglected -- the insurance companies, of course.  However, the AAMC took the bold leap to at least mention the possibility that reimbursement structure might influence practice decisions (they actually should get credit for this).

As they put it “the fundamental impact of payment mechanisms have on clinical decision processes must be recognized.  Although the evidence is neither extensive nor conclusive, it is clearly suggestive of ethical challenges” and “associations have been reported between compensation mechanisms and resource utilization [which happens to be the whole purpose of pay-for-performance] that may imply some erosion of medical professionalism.”

They may be on to something here. When payment (reimbursement or withhold) is determined by whether a particular therapy or treatment strategy is utilized, and is devoid of patient-level considerations, it seems like the insurer is teetering close to the precipice of bias, influence, or whatever you like to call it. 

Luckily, the AMA has decided to take issue with some insurer practices and is mounting a well orchestrated effort to let the public and policymakers know that there is a lot of room for improvement in insurance land. Take a read through the Insurer Code of Conduct (HERE) they recently released.  It may be small step, but it’s a step in the right direction.

Jun 28, 2010

Physician-Industry Relationships: The Battle Rages On

For those that have been following the conflict of interest (COI) movement (i.e., efforts to sever physician-industry interactions), it's been a particularly busy week.  The annotated NY Times article below describes several recent developments. Hope the commentary sheds some light on what's happening behind the text in this article:

Debate Over Industry Role in Educating Doctors
By NATASHA SINGER and DUFF WILSON
Published: June 23, 2010

In the latest effort to break up the often cozy relationship between doctors and the medical industry, the University of Michigan Medical School has become the first to decide that it will no longer take any money from drug and device makers to pay for coursework doctors need to renew their medical licenses.

University officials voted to eliminate commercial financing, beginning next January, for postgraduate medical education, a practice that has come under increasing scrutiny from academics, medical associations, ethicists and lawmakers because of the potential to promote products over patient interests.

[Note that no data are cited to support this assumption, rather a "potential" is cited. A common practice among COI policymakers: No data = No problem.]

Dr. James O. Woolliscroft, dean of Michigan’s medical school, said leading faculty members “wanted education to be free from bias, to be based on the best evidence and a balanced view of the topic under discussion.”

While the financing in question amounts to as much as $1 million a year at Michigan, commercial payments for industry speakers and courses nationwide come to about $1 billion, nearly half the total expenditure for such courses.

The debate over whether the medical profession should develop an industry-free model of postgraduate education is a delicate one. A conference at Georgetown University on Friday, called “Prescription for Conflict,” will highlight the arguments on both sides through presentations by federal health officials, professors from leading medical schools, hospital executives and a Senate investigator.

[The title alone should suggest that "both sides" will not be represented at the conference. If that isn't convincing enough, maybe the organizers, PharmedOut, will help clarify.  Interesting side note, this organization is fully funded through pharmaceutical settlement money. No incentive to blow a whistle there.]

Already this year, the debate has led to public squabbles as doctor groups have squared off over proposals for new restrictions on industry involvement in the courses known as Continuing Medical Education, or CME. The accrediting body for postgraduate medical education, for example, recently said it would no longer grant credit to doctors for attending medical meetings that feature industry employees presenting product research.

The decision was met with howls of dissent this month from some doctors, including the director of the National Institutes of Health and the president of the American Heart Association, who said it would unfairly cut physicians off from scientific knowledge.
On the other side of the argument, a leading medical ethicist asserted that the prohibition did not go far enough. Dr. Bernard Lo, lead author of a 2008 Institute of Medicinereport on conflicts of interest, said private doctors and academic physicians who are paid to speak for drug companies should be barred from presenting educational material at accredited conferences. “Mouthpieces for their products,” he called them.

Private medical education companies, which receive money from drug makers to produce such courses, and some doctors who lead the courses, disagree that industry financing or speakers lead to bias. They say that company-financed programs provide a vital service, keeping doctors up to date on the latest and most effective treatments.

“We present what we think is the state-of-the-art of the management of the disease,” said Dr. Rafael Fonseca, deputy director of the Mayo Clinic Cancer Center in Scottsdale, Ariz., who gives 20 to 30 such courses a year, about half for universities and half for commercial medical-education companies. “The accusation that there is bias is not substantiated.”

[Not stated here, but Rafael is a steering committee member of ACRE, the organization launched to support physician-industry collaboration.]

Continuing medical education has become a big business in the United States, with more than 700 accredited providers. Total spending on such courses peaked at $2.5 billion in 2007, including a record $1.2 billion paid by companies, according to the Accreditation Council for Continuing Medical Education, a nonprofit regulatory group. It has declined slightly since then as the academy introduced new limits on industry involvement.

Thomas Sullivan, president of the Rockpointe Corporation, a medical education company that has received millions of dollars from drug companies, said the accreditation system is built with checks and balances to prevent industry influence over course selection or content. The courses themselves are intended to improve patient care, he said, not to promote a particular brand of treatment.

“We are really not trying to increase prescriptions,” said Mr. Sullivan, who writes a blog called Policy and Medicine. “It’s more about giving better care.”

[Spoke with Tom yesterday -- his private leer jet was being serviced so he couldn't meet live -- and he reiterated that with the stringent ACCME guidelines (which are not a few lines on a single-page) the issue of whether industry should be able to fund CME truly is sensational journalism at its best.]

But Dr. Michael Steinman, an associate professor of medicine at the San Francisco V.A. Medical Center who has studied the use of medical education as a marketing strategy, said that companies face an inherent conflict of interest. “The course providers have a subtle and probably unconscious incentive to put on courses that are favorable to industry because they know where their bread is buttered,” he said.

[Since your bias is unconscious, well established by psychosocial research (1 article published in JAMA that reviewed studies from legal journals), you must let someone else control your tendencies for you.]

Even so, there is a paucity of rigorous science investigating the potential for commercial bias in continuing medical education courses.

[HERE'S THE ADMISSION THAT NONE OF THIS IS BASED ON ANYTHING OTHER THAN PURE SPECULATION.]

Support for such courses point to a few studies in which the majority of doctors who attended the programs reported that they perceived the events to be free of commercial bias.

But Dr. Steinman, who conducted one of the studies, said that related research in social science demonstrates that people who receive gifts often feel obliged to return the favor. “Industry wouldn’t be paying billions of dollars to do this stuff if it didn’t benefit them,” he said.

The debate became heated at a meeting this month when some of the nation’s top doctors learned of the decision by the accrediting council to deny doctors educational credit if industry employees presented findings at the fall meeting of the American Heart Association.

Dr. Francis S. Collins, N.I.H director, criticized “the breathtaking sweep to squash something that is really important to us, which is the science that’s going on in the private sector.”

Dr. Clyde W. Yancy, president of the heart association, said he was mounting “a vigorous appeal” to the accrediting group. Although the policy might affect less than 1 percent of the total presentations, he said, it would ban significant and peer-reviewed scientific advances.

But Dr. Murray Kopelow, chief executive of the accrediting council, said the policy applies only to company employees who talk about products, not those who lecture on basic science or research methodology.

“Science done by industry can be reported by industry if it isn’t anywhere close to advertising, promotion or making a market for a product,” he said in an interview Wednesday.

[The ACCME and AHA came to an agreement and industry scientists will be allowed to present their work at CME events. Will the NY Times write about that?]

The accreditation council first began insisting that courses should be “free of the control of a commercial interest” in 2004, but some medical organizations like the heart association have been protesting since a clarification last year that banned industry employees from talking about their business lines at accredited events.

As medical groups shun some industry money, doctors may face higher course fees, said Dr. Paul R. Lichter, director of the University of Michigan Kellogg Eye Center. His department has not accepted industry financing for such courses for decades, he said. Next year, the entire medical school plans to eliminate commercial financing for the programs. “This can be done,” Dr. Lichter said. “It’s what we are used to that makes it difficult to change.”

But Dr. Steinman, who conducted one of the studies, said that related research in social science demonstrates that people who receive gifts often feel obliged to return the favor. “Industry wouldn’t be paying billions of dollars to do this stuff if it didn’t benefit them,” he said.

The debate became heated at a meeting this month when some of the nation’s top doctors learned of the decision by the accrediting council to deny doctors educational credit if industry employees presented findings at the fall meeting of the American Heart Association.

Dr. Francis S. Collins, N.I.H director, criticized “the breathtaking sweep to squash something that is really important to us, which is the science that’s going on in the private sector.” Dr. Clyde W. Yancy, president of the heart association, said he was mounting “a vigorous appeal” to the accrediting group. Although the policy might affect less than 1 percent of the total presentations, he said, it would ban significant and peer-reviewed scientific advances.

But Dr. Murray Kopelow, chief executive of the accrediting council, said the policy applies only to company employees who talk about products, not those who lecture on basic science or research methodology.

“Science done by industry can be reported by industry if it isn’t anywhere close to advertising, promotion or making a market for a product,” he said in an interview Wednesday.

[
The ACCME and AHA came to an agreement and industry scientists will be allowed to present their work at CME events. Will the NY Times write about that?]

The accreditation council first began insisting that courses should be “free of the control of a commercial interest” in 2004, but some medical organizations like the heart association have been protesting since a clarification last year that banned industry employees from talking about their business lines at accredited events.

As medical groups shun some industry money, doctors may face higher course fees, said Dr. Paul R. Lichter, director of the University of Michigan Kellogg Eye Center.
His department has not accepted industry financing for such courses for decades, he said. Next year, the entire medical school plans to eliminate commercial financing for the programs.

“This can be done,” Dr. Lichter said. “It’s what we are used to that makes it difficult to change.”

Jun 25, 2010

Massachusetts Considering Lifting "Gift Ban", Really?

The unpredictable times continue in Massachusetts ... few would have predicted that Ted Kennedy's seat in the Senate would be filled by a truck-driving, male-modeling republican from a town best known for its immense factory outlet stores rather than political dynasties. 

Similarly, few would have predicted that the Massachusetts House of Representatives would be attempting to repeal the hotly contested "gift ban" (Chapter 305 of the Acts of 2008) that, among other things, made it illegal for physicians to take a pen or have coffee with someone from the pharmaceutical or medical device industry.

Citing concerns from the biotech and medical device communities as well as the convention center and restaurants, the House leadership released its version of the state economic stimulus plan which would lift the ban. The media is in a flutter. locally and beyond the Baystate.  The Boston Herald (HERE), Boston Globe (HERE), and WSJ Heatlh Blog also covered the story today (HERE), and more continue to emerge.

Many are wondering if the Scott Brown "phenomenon" wasn't a fluke ... could things really be changing? We'll soon find out.  If nothing else, this bold move sends a strong signal to other states that may be considering similar bans and to those that have been riding the conflict of interest wave (which is finally getting some push-back, HERE).

Media Coverage
  • Boston Business Journal

  • Boston Globe

  • Boston Herald

  • WSJ Health Blog

  • Jun 9, 2010

    WSJ Op-Ed: Two Steps Forward in the War Against Cancer


    The former deputy commissioner of the FDA (2005-2007) writes a insightful Op-Ed in today's WSJ (HERE) on a topic already blogged about the short tenure of the Med Policy blog (HERE): Attacks on physician and industry research collaborations threaten the future of clinical research and medical innovation.

    Dr. Gottlieb starts by highlighting some of the exciting news coming out of the American Society of Clinical Oncology meeting in Chicago including novel BMS and Pfizer medicines that help patients with advanced melanoma and fatal forms of lung cancer, respectively.  Then describes contributions made by both academia and industry to make these, and other, innovative products a possibility.

    Obviously it's always exciting when promising new medicines emerge, especially in this transitional period where the viability of drug pipelines is questioned on a regular basis.  It's also nice to highlight how industry and academia are part of the solution.  But neither of these concepts are particularly novel and may not justify a WSJ Op-Ed.  What does stand out in this piece is Dr. Gottlieb's recognition that activists bent on severing all collaboration between industry and physicians put all of this at risk.  Most are too busy milling about in their own worlds to see where this path is leading.  Luckily Dr. Gottlieb took this important opportunity to look beyond the flashy headlines and send this important warning:

    "Most ominous, the journey from lab to treatment is at risk from activists' and regulators' growing suspicion of the collaboration between the academic researchers who uncover basic science and the drug industry that is able to design and manufacture medicines."