Policy and Medicine

Doctors Under the Influence -- CBS

click to play video

The discussion to promote the Physician Payment Sunshine Act has gone Prime Time on CBS Evening News along with stories running on CBS and Newsweek questioning the ethics of physicians working with pharmaceutical and device manufactures.

In a very unfortunate case, a family who lost their doctor due to suicide and is suing the pharmaceutical company Pfizer for selling Zoloft.  Apparently their physician accepted speaking fees on behalf of Pfizer, the maker or Zoloft.

They quote an unpublished study by the University of Quebec that showed alleges that drug company payments are as high as $57 billion a year, covering consulting fees, speaking fees on drugs, and medical seminars on the benefits of drugs. 

This is quite a high number given the size of the industry. This is a huge exaggeration and quite unlikely to be anywhere near what they are quoting.  But hey, this is CBS news and anything goes.

Apparently Senator Grassley is “also looking at the money drug companies pay doctors for academic research”.  He is investigating some 20 top medical schools -- including Harvard, Stanford, and other Universities.

They quote the Grassley statement a week ago about Joseph Biederman, MD, "who's research has led to huge increases in bipolar diagnosis in children and the prescriptions to treat those children”. He is being asked why he allegedly failed to report $1.6 million in fees from drug companies. Dr. Beiderman noted to CBS that some of the industry money he accepted was "not personal income" and "his life work is devoted solely to rigorous and objective study".

This is an apparent attempt to make the industry as whole look bad.  According to Senator Grassley "it raises a flag to me that they may have something to hide", it raises a flag that the university doesn't care."

According to Senator Grassley, fixing this problem is complicated because "some" relationships between doctors and drug companies are legitimate and necessary to achieve breakthrough therapies.  Senator Grassley says that the answer is more public information.

American researchers are ill prepared for this type of political and media on-sought.

I favor some type of disclosure bill for direct payments to physicians, but this type of political and public humiliation of our top physicians makes me question the long term use of this type of information. As we see more disclosure, are we in for endless floggings in the press of American's top researchers.  This will only undermine researchers and manufactures integrity at the expense of patient care.

The parents of Candace Downing, are dealing with a great loss, and their anger is understandable, but I am not sure that it is not misplaced. In the 90's many of the AIDS activists were angry at the pharmaceutical companies working to develop drugs for AIDS but failing in trials.  There are many other broken parts of our healthcare system including re-imbursement that prevents physicians from spending the necessary time with patients and families to really explore more complicated solutions to complex problems.

Are Perks Compromising MD Ethics? (CBS News)

Doctors Under the Influence? (BusinessWeek)

Doctors Under the Influence -- BusinessWeek

Doctors Under the Influence? In BusinessWeek a story of two New Jersey based physicians who have worked tirelessly for the last twenty years helping patients quit smoking and are now being questioned on their recent motives.

In a recent Annals of Internal Medicine Article around the long term use of drugs to facilitate smoking cessation, Dr. Michael B. Steinberg and Dr. Jonathan Foulds of UNDMJ disclosed that they are paid by manufacturers of smoking-cessation products for speaking and consulting. Among those companies is Pfizer (PFE), whose controversial drug Chantix the researchers mentioned favorably, along with other treatments.

No Good Deed Goes Unpunished.

These two researchers have for many years toiled in the unglamorous field of smoking cessation, with little personal compensation and continuous exposure to second hand smoke to help patients overcome their smoking habits and ultimately save lives.

Steinberg and Foulds encountered an obstacle that helped inspire their article advocating long-term drug use. They found many insurance companies wouldn't reimburse for Chantix, which costs about $100 a month, or for other less expensive antismoking products.

Steinberg and Foulds reasoned that if they compared nicotine use with diabetes, rather than with alcoholism or other addictions, they might help change insurers' thinking. Diabetes causes many of the long-term problems that nicotine addiction does. "We wanted to compare it to a disease that's well-covered," says Foulds, "and alcoholism isn't well-covered."

According to the article the two physicians gave a dozen or so lectures at $900/each to promote Chantix and received $30,000 for a study.   This does not sound like unreasonable compensation.

In the article BusinessWeek quotes:

Over the past decade, financial ties between doctors and companies have proliferated, prompting concern that treatment is distorted by industry money. The solution that has been widely embraced is disclosure of funding sources. But the rules are inconsistent and mostly voluntary. Moreover, disclosures typically are made in medical journals, conferences, and other venues that patients tend not to see.

Pfizer hasn't taken a formal position on whether doctors should disclose funding sources to patients. Cathryn M. Clary, vice-president for external medical affairs, says she fears too much transparency will create confusion. "The more information that's out there, the more difficult it will be for patients to process," she says. Pfizer instructs the researchers it pays to disclose their compensation when speaking at professional conferences. It also recently began disclosing grants for medical education on its Website.

Smoking is a serious problem. It is the main cause of the two most prolific killers, Heart Disease and Cancer. 

This type of fear mongering is likely to lead to significantly greater deaths than the small number of depressed people as a result of using drugs for smoking cessation.

I am not sure where it will all end but if the media and government wants to stop all clinical trials, speaking and consulting to ensure that the information is pure then perhaps all our clinical research will head east to China and India where the business environment is much more favorable.

In an Opt Ed, BusinessWeek published two opinions on this issue:

Halt the Pharma Freebies

ACCME Senator Kohl Get's in the Act

The ACCME received a letter from Senator Kohl, Chairman of the US Senate Special Committee on Aging, concerned about the size of support of CME from commercial supporters, the perceived influence they may have on physician prescribing patterns.

In particular they are concerned with CME courses to encourage physicians to use their products for potentially controversial medical practices.

Apparently one company is supporting CME around herpes tests for pregnant women, a practice that is not supported by ACOG, CDC or the US preventive services taskforce.  According to the Senator the anti viral therapy is potential dangerous to the baby.

“I am troubled by any attempt to persuade physicians to use a drug treatment for any reason other than the patient's condition and the drug's effectiveness in treating it.”

Therefore, it was with great interest that the Committee took note of the ACCME's credentialing standards and practices for CME courses.

“In an effort to better understand the ACCME's credentialing standards and practices for CME courses, please provide us with the following documentation and information:

1.) a copy and written description of the accreditation process for CME courses;

2.) any criteria the ACCME uses, as part of the accreditation process, regarding the scientific validity of course content;

3.) any mechanisms the ACCME has in place to ensure that no undue influence by any industry is being exerted through CME courses; and

4.) any further plans the ACCME may have in place to develop such mechanisms.

Please respond fully to this request by close of business on Friday, July 7, 2008.”

The ACCME and their providers have gone to great lengths to ensure the scientific validity, and no undue influence by industry and are currently working to strengthen their system even further.  The Senator should be pleased by what he receives from the ACCME.

Letters from Senator Grassley: A Scarlet Letter

In a letter from Senator Grassley to Stanford University covered by Businessweek, Drugmakers and College Labs: Too Cozy? and the Wall Street Journal Blog, Grassley Questions Stanford Psychiatrist’s Industry Ties .

The Senator alleged in the Congressional Record that the Chairman of the Department of Psychiatry at Stanford, Alan Schatzberg, MD failed to report to Stanford some payments from 2000 to 2006 from Eli Lilly (LLY) and Johnson & Johnson (JNJ) for consulting and other services.

Grassley also chastised Dr. Schatzberg for not fully informing the university about the value of his personal stake in a drug development company he co-founded—although the psychiatrist appears to have followed Stanford's disclosure rules.

"I am concerned that Stanford might not have been able to adequately monitor the degree of Dr. Schatzberg's conflicts of interest," Grassley said in a June 23^rd letter to Stanford President John Hennessy that was published in the Congressional Record. The senator suggested the university reexamine its disclosure policies.

But a letter from Stanford to Senator Grassley shows that he did in-fact, disclose his payments from both Elil Lilly and Johnson and Johnson, and that the Senators staff had perhaps made a mistake:

1. Statement that Dr. Schatzberg had not disclosed a $22,000 payment from Johnson & Johnson in 2002. Dr. Schatzberg did disclose this payment to the University and reported it to the Committee. He disclosed the $22,000 payment from Janssen, the wholly-owned subsidiary of Johnson & Johnson that made the payment.

2. Statement that Dr. Schatzberg did not report the $52,134 that Eli Lilly disclosed for 2004; however, Dr. Schatzberg disclosed three different sources of compensation from the company for that year: less than $10,000 for advisory board, $10,000 to $50,000 for consultation, and $10,000 to $50,000 for honoraria. Together, this disclosure fully accounts for the 2004 payments from Lilly. A chart attached to the letter states that Dr. Schatzberg had not disclosed receiving a payment from Eli Lilly in 2007. That is simply an error. Dr. Schatzberg did disclose that payment, both to Stanford and to the Committee.

3. Other discrepancies noted in the letter may be the result of differences in record

keeping between Stanford and pharmaceutical companies, the fact that companies' fiscal years may differ from Stanford's and misunderstandings by the Committee.

In a follow-up letter Stanford stated:

“Schatzberg did disclose in writing his ownership of the Corcept stock and its actual value, so Stanford did know the value of his stock based on his disclosures to the university.” 

According to another article in CBSNews.com, Senator Grassley is investigating some 20 top medical schools – including Harvard, Stanford and the University of Cincinnati “for under reporting the income top researchers are getting from the drug industry.”

Senator Grassley is using this information to promote his Physician Payment Sunshine Act .

In his floor statement, the Senator opens about one other doctor who reported $10,000 when in fact he received $14,000, a four thousand dollar difference between the University and the company, hardly the stuff to condemn a man from the floor of the senate.

In the interest of fair play we encourage Senator Grassley and his staff to verify with the institutions and physicians in question prior to publishing their names and offenses in the Congressional Record. It is the least we owe these dedicated researchers if we want others to go into the research in the future.

Medicare Bill 2008: Update

On June 25 2008 - The House has passed a bill just in the nick of time that will result in Medicare payments to doctors not being cut, as was originally planned to be the case.

Doctors who treated Medicare patients were about set to be paid an average of 10% less in forms of reimbursements by the government, a fact that would've caused quite an uproar.

The bill was passed by a vote of 355-59, a fact that will result in doctors who treat Medicare patients not receiving less reimbursement money.

Instead, the money will be taken from money given to private health insurance companies, a fact that will ruffle their feathers quite a bit.

It is estimated that in the US more than 600,000 doctors treat patients on the Medicare program. Reimbursement rates were to be adjusted as of July 1, in conjunction with the exceeding of targeted spending goals.

President Bush has stated that he will veto the bill if it makes it out of the Senate

Last night the Senate failed to get the 60 votes to invoke cloture and end debate, thereby stopping the bill, the vote was mostly along party lines with 9 Republican's voting in favor of the bill:

http://www.senate.gov/legislative/LIS/roll_call_lists/roll_call_vote_cfm.cfm?congress=110&session=2&vote=00160

CQ Updates has a good analysis of the situation

To give you some background on the love going around the Senate, you have to read this evenings consecutive press releases by Senator Grassley::

Thursday June 26, 2008

7:51pm

Senator Grassley just delivered the following statement.

Floor Statement of U.S. Senator Chuck Grassley of Iowa

Ranking Member of the Committee on Finance

Cloture motion on H.R. 6331, the Medicare bill

Thursday, June 26, 2008

Mr. President, here we are again.  Once again, the Senate is being asked to vote to proceed to a bill written on a partisan basis.  Once again we are being asked if we want to agree to a process where no amendments are allowed.  Once again we are being told to “take it or leave it.”

The damage this is doing to the ability of this body to function is extraordinary.  It shouldn't be this way.  It doesn't have to be this way.

During the last several years, the Finance Committee has produced numerous bipartisan health care products.  In 2003, Senator Baucus and I joined together, defied the long odds against us, and produced a Medicare Prescription Drug bill.  In 2005, we worked together on a relief package in the aftermath of Hurricane Katrina.  In 2006, we passed the Tax Relief and Health Care Act.  In 2007, we worked together on a bipartisan SCHIP reauthorization bill.  We also passed the Medicare, Medicaid, and SCHIP Extension Act of 2007.  For years, the Finance Committee has been the model of how a committee can work on a cooperative, bipartisan basis.

I think we work best when we work together.  For some reason, that hasn't seemed to be the case this year.  I've tried to work this year to get a bill that could get signed into law.  I personally think the White House has drawn lines in the sand that are unreasonable.  However, the President holds the veto pen, and if this bill passes today, we will see it used.

I tried to work towards a bill that could get signed.  Obviously, that was not a path the majority could follow.  Even after the first cloture vote failed in the Senate, I tried to get a bipartisan compromise that could be signed into law.  That effort was abandoned when the House voted to support the bill that the Senate couldn't get cloture on.

When we were in charge around here, I can say we certainly didn't appreciate it when the House Ways and Means Committee tried to dictate terms to the Senate.  When Ways and Means Chairman Thomas tried to roll the Senate, I defended the bipartisan Senate position.  When I was Chair of the Finance Committee, I don't recall our bipartisan efforts being determined by House votes.  To the contrary, I think we worked together in spite of House votes.

And let's be clear about another thing.  The House vote went the way it did because members were assured the Senate was going to fix the problems in this bill.  They are counting on us to fix it so we have a bill the President will sign.  They are right about one thing though; this bill does need to be improved.   

The bill that the Democrats are trying to pass is woefully lacking in what it provides rural America.  I'd like to call out one specific provision.  Senator Harkin and I have worked extensively on a provision for the so-called “tweener” hospitals.  These are hospitals, which are too large to be critical access hospitals, but too small to do well under current Medicare payment systems.  We had a provision to improve payments to these hospitals, but it's not in the House Democrats' bill.  A vote for cloture misses an opportunity to provide critical assistance to rural hospitals all over this country.  I'm sure Senator Harkin and others are as disappointed as I am by this omission.

Voting for this bill accomplishes nothing.  It won’t become law.  How much clearer can we be about that?  To keep the pay cut for doctors from happening, we have to defeat this motion so that we can sit down and finally produce a bill that can become law.  To improve Medicare, we have to produce a bill that can become law.  To make sure beneficiaries continue to have access to essential therapy services, we have to produce a bill that can become law.  To help beneficiaries, we have to produce a bill that can become law.  To preserve access to durable medical equipment for seniors, we have to produce a bill that can become law.

We have to be allowed to do our work in the U.S. Senate.  We have to be allowed to produce the best bill possible through bipartisan compromise.  Let's show that we can still work on a cooperative basis.  We have to defeat this motion so that we preserve the right of the Senate to have input on legislation, that we aren't simply a rubber stamp for the House.  We should defeat this motion so we can show that bipartisanship is not dead on important health care issues that matter to millions of people who depend on us as stewards of Medicare.

So let's do the right thing and vote no.  Vote no so this body does not abdicate it duties under the Constitution.  Vote no so we can get a bill done this week that can become law.  Vote no so we can get the job done.  A yes vote accomplishes nothing today.

Thursday June 26, 2008

9:34pm

Sen. Chuck Grassley, ranking member of the Committee on Finance, made the following comment after the Senate failed to invoke cloture on the House Medicare bill and the Senate majority leader blamed Republicans:

"The Senate leader's take-it-or-leave-it approach and on-the-floor election-year calculations hurt doctors and seniors.  It's past time for the Senate to act responsibly and work out a bipartisan bill to avert an unfair cut in the reimbursement rate for doctors who treat Medicare patients."

JAMA: Everyone's a little bit biased (Even the JAMA Editor)

What do studies on important medical topics, such as the percentage of African countries that belong to the United Nations, a US News and World Report study on who should pay legal costs, counting coins and accounting decisions, doing in JAMA? 

The answer is simple. The Editor of JAMA, Katherine De Angelis, MD thinks this unrelated research means that doctors are corrupted by physician-pharmaceutical relationships. 

In a commentary published this week in the JAMA tilted: Everyone’s a little bit biased (even physicians)

“Medical schools and professional medical associations have developed policies and guidelines in response to increasing concerns over potential conflicts of interest.

While many physicians agree with these concerns, some view conflict-of-interest policies as affronts to their integrity and an indictment of the ethical conduct of the profession as a whole. These individuals believe that their training as scientists and their devotion to professionalism protects them from external influences that might bias their opinions.

However, this view may be based on an incorrect understanding of human psychology. Conflicts of interest are problematic, not only because they are widespread but also because most people incorrectly think that succumbing to them is due to intentional corruption, a problem for only a few bad apples.

In this Commentary, we argue that succumbing to a conflict of interest is more likely to result from unintentional bias, something common in everyone. We review studies in neuropsychology, behavioral economics, cognitive psychology, and clinical epidemiology to illustrate this point.

What this commentary and all others on this issue have failed to point out, is why only conflicts of interests due to interaction with commercial interests are the only ones that are “problematic”.  They all ignore all the other biases that may exist. We should consider other biases before we call for the elimination of just one type:

A)   the bias for ordering patient tests and procedures to prevent lawsuits

B)   the bias for staying on managed care formulary to avoid additional paperwork (regardless of whether the patient may be served by another treatment)

C)   the bias of those physicians who are serve as paid legal witnesses either for the plaintiffs or the defendants

D)   the bias to gain an NIH grant

E)   the bias by faculty to publish regardless of weather or not they have anything important to say

F)    the bias by the government purchasers to save money on medical expenditures

G)   the bias created by physicians in managed care organizations to follow “prescribed medicine”

H)   bias to prescribe or perform procedures based on what you learned in medical school, regardless of how long ago that was

I)     the bias created by being part of a group, taken to resort location at the expense of foundation to specifically write a report against bias

J)    the bias of a doctor with a small prescription CME business, who advocates elimination of commercial support of CME, which in the end would help his business

This is by no means an exhaustive list.  Is there any logical reason why these biases should not be considered as “problematic”?

For instance, once I took my son to a day clinic for an ear infection. The physician (must have been 80 years old) pulled out a card with 10 drugs listed on it (apparently whatever you come in with to his practice you get one of the 10 drugs). He wrote him up for Accute Otitis Media and sent me home with a prescription for a strong anti-biotic, which I threw in the trash and the ear ache resolved on its own.  That doctor had a bias towards those ten drugs. Does that make him evil? It is doubtful that any of those drugs were pushed on him by a pharmaceutical rep at least for a very long time.

I agree, everyone has biases, but I think that it is ridiculous to think that they can’t be managed. 

If we were to spend all our time trying to eliminate bias, we would not be able to live, as we would say: hey I have a bias against spinach….

One very amusing instance is that I won’t wear pink shirts. Yesterday, I was away at a meeting and wanted to work out. I forgot to pack my t-shirt.  I was on the way out the door of the hotel where I was staying to go buy a t-shirt down the street. A colleague offered to loan me an extra polo shirt he had.  After dinner he loaned me the shirt to use and yes, it was a pink polo. The next morning I worked out rather uncomfortably in the pink polo. I was uncomfortable at first but got over it. I have overcome that bias (at least for the time I worked out) needless to say we can all manage our bias. That is what we do every day. 

The article goes on to challenge disclosure as a means of managing conflict and quotes the study on students counting coins and estimating them as justification for why disclosure is inadequate.

Full disclosure, by itself, may have the perverse effect of making professionals more biased rather than less. This is not to say that conflicts of interest should be hidden but rather that disclosure may not be the solution. Even where disclosure does not make advice worse, the huge body of research on anchoring (where advice is often disclosed as being randomly generated, yet it still impacts judgment) suggests that disclosure is often unlikely to serve as sufficient warning. If a disclosure that some advice is randomly generated does not completely undo the influence of that advice, other disclosures (especially those in fine-print legalese) might similarly fall short. Moreover, even where disclosure is better than no disclosures, it may cause indirect harm by replacing more effective solutions. Surowieki¹³ summarized this problem by noting, "Transparency is well and good, but accuracy and objectivity are even better. [The profession] does not have to keep confessing its sins. It just has to stop committing them."

Unfortunately the evidence they provide has very little do with physicians and practice. Sort of like saying that the results of a study of mechanics show they like 57 Chevy’s and this translates that all doctors (male or female) like 57 Chevy’s.

The writers go one to summarize that:

“Bias is not a crime, is not necessarily intentional, and is not a sign of lack of integrity; rather, it is a natural human phenomenon. Like the research participant with the split brain, everyone is likely capable of rationalizing beliefs and denying influences that bias them. The most important action physicians can take as a profession is to recognize this.

So now that we have established that everyone has biases, that it is not a crime (oh, how benevolent of them to do so) that it is a “natural human phenomenon”, perhaps we should all take a deep breath and say hey, I can overcome that bias and I don’t have to eat that spinach after all.

This article is not exactly the kind of research or commentaries one would expect from a serious journal such as JAMA, but perhaps the editor Katherine DeAgelis, MD may be a little bit bias herself. Just a little.

IMS vs. Vermont: Free Speech but only in the Interest of the Government

Free Speech but only in the interest of the Goverment.

This is exactly what the NLARX has stated in their press release about the filing of the “Friend of the Court Brief” for the IMS versus Vermont Case:  That the law “serves substantial governmental interests”.

The Vermont law S. 115 restricts the sale of prescription drug information that identifies prescribers and patients; services like IMS, Versipan and Walters Kluwer, Health sell this information to manufactures to assist in targeted marketing.  The Vermont Law is a similar law to one struck down earlier this year by the First Circuit Court in Boston. The law has been temporarily repealed until 2011 or until the courts decide on the constitutionality of the law (for more information).The date for the court hearing is July 28^th in Brattleboro, VT.

On Monday, June 23^rd several organizations sent in their “Amicus” Friend of the Court Briefs including the Coalition for Healthcare Communications.

In the Coalition Brief they point out “that Vermont cannot ban one class of speakers from the marketplace of ideas and information while at the same time allowing other speakers without violating the First Amendment.” That this bill was hastily put together to undermine the courts’ decision in the New Hampshire Case.

They also point out that this information is used for research and to develop information regarding the safe uses of drugs and serves the public interest.

The statue if not overturned, government will resort to tactics used here to restrict the data and communication of other commercial speakers.   

“If the Government is capable of violated free speech by selectively releasing its own data, surely it violates free speech by regulating the manner in which third parties release theirs.”

In the brief created by NLARX and Community Catalyst, they use language like societal justifications (code for if they market drugs and devices governments spend more money), and governmental interests (code for saving money).  They go on to describe marketing practices that “promote irrational drug selection” (code for branded drugs versus cheep generics). 

It is interesting to note that government is always looking to save money and not necessarily in the best interest of patients.  The groups that will be most affected by these types of legislation are those who live in rural areas like Vermont, New Hampshire and Maine (which passed these laws) who’s physicians are least likely to learn of new and more effective medications without access to industry.

The courts have been right in their protecting the first amendment, it is in everyone’s interest for as much information on medical therapies to get into the hands of physicians and patients.  The competition of ideas about what is best for patients in fought on a level playing field, and is more important than the governmental interest of saving dollars.  Our patients deserve more informed healthcare professionals not those who have only been spoon fed what the government thinks is important for us to know.

Massachusetts S2660 – The Sun is Shining in San Diego

Recently, we reported that it would be cloudy for the Massachusetts delegation at BIO 2008. Massachusetts S2660 – San Diego Here We Come.

According to the State News Service, The controversial Senate plan (S 2660) which forbids gifts from pharmaceutical companies to health care workers appears unlikely to survive intact, as Massachusetts state leaders have caught an earful from industry executives while attending an international biotechnology convention this week.

The plan’s leading proponent, Senate President Therese Murray, said researchers have told her the ban would prevent productive interactions between doctors and researchers who are trying to treat the same diseases.

“It’s something that we didn’t discuss when we did it, because we were looking purely at gifts to doctors,” Murray said in a telephone interview with the News Service. “But the fact is that some of these companies do bring researchers and doctors together to go over the latest research.”

“Through what we did, in their explaining, there are many things they won’t be able to do that are important to science,” she said.

Murray said she still wanted increased transparency requirements and an end to excessive gift-giving.

“If we can work out some kind of language that still allows the science but stops the egregious marketing, then I think we’ll be OK, but it’s going to take a little time,” she said.

Murray, Gov. Deval Patrick, and House Speaker Salvatore DiMasi urged an international audience of 250 people here Wednesday to forge business partnerships in Massachusetts.

While the majority of feedback about Massachusetts has been positive, DiMasi said, some pharmaceutical companies have voiced worries about the gift ban, which Murray has pushed as part of her health care cost control package.

The restriction would be the country’s strongest, forbidding all gifts of value from pharmaceutical company agents to health care workers or the workers’ families. The pharmaceutical industry has fought back, arguing the gifts often allow doctors to learn more about products, and that the ban would have a chilling effect on the industry’s growth here.

Murray reported that most of the pushback she has heard has come from research firms, saying, “It wasn’t Big Pharma, these are research scientists.”

She said prospective reforms could include requiring doctors who write in medical journals to disclose whether and how they were compensated. “There has to be transparency and there has to be some kind of language that protects the consumer, and the state, frankly,” she said.

One newspaper the Quincy Patriot Ledger notes that “Murray said she expects the House will release its version of the bill by the end of June, leaving only one month before lawmakers adjourn from formal sessions for the year on July 31.”

It is important for all state legislators considering these “gift bans” to consider the “unintended consequences “of such bills.  We applaud Senator Murray and the other leaders from Massachusetts for being open minded on this issue, and believe that they are now focused on the right things (better medicine and more transparency without penalizing scientific exchange of information).

   

Asked about the gift ban at a forum in Boston this morning, Patrick chief of staff Doug Rubin said the administration was taking a "wait-and-see approach" and picking up the issue would be “premature.”

Macy Conference - Missed Opportunity

We see the Conference as a missed opportunity. This is how the chief executive officers of the major CE accrediting bodies describe the Macy Conference.

Last November a group of 40 academics gathered in Bermuda for four days to discuss the current state of Continuing Education in the Health Professions and their recommendations for the future.  In May they published their final conference proceedings:

Continuing Education in the Health Professions:  Improving Healthcare through Lifelong Learning. 

The Chief Executives of the three major accrediting bodies the Accreditation Council for Continuing Medical Education (ACCME), the American Nursing Credentialing Center (ANCC) and the Accreditation Council for Pharmacy Education (ACPE) issued a response to the Josiah Macy, Jr. Foundation. (Letter to Josiah Macy Foundation)

The CEO’s went out of their way to describe the report as flawed and “disagree with, or take exception to, most, if not all, of the Conference Proceedings.”

This is a reaction to the inflammatory language used in the report which goes out of its way to belittle medical education in the US.

Our concern stems from our observation that neither the Conference, its observations, its assumptions, its conclusions nor its recommendations seem to be based on the facts and circumstances that we know to be extant in our three professions’ continuing education, or continuing education accreditation systems, today.

According to the CEO’s many of the statements made in the report are outdated:

These statements reflect concerns that we, as CE accreditors, had 5-10 years ago. Over this past decade we have made significant changes to our systems to address these concerns. Therefore, we question the reliability and validity of the evidence base from which these statements are made.

Specifically they had issues with several of the key findings of the Macy Conference on the state of education:

Conference finding #1: Too much CE relies on a lecture format and counts of hours of learning rather than improved knowledge, competence and performance. 

The CEO’s found quite the contrary:

Data from our organizations show that the CE accreditation systems have integrated new formats of continuing education and that CE providers are utilizing these formats within their CE programs. For example, almost 50% of the continuing medical education enterprise is not didactic in nature.

Conference Finding #2: Too little attention is given to helping individual clinicians examine and improve their own practices.

Conference Finding #3: Insufficient emphasis is placed on individual learning driven by the need to answer questions that arise during patient care.

Again the CEO’s are firm in that: Continuing education is entirely about answering questions that arise in professional practice as the source of the needs data that drives the education.

Conference Finding #3: CE does not promote inter-professional collaboration, feedback from colleagues and patients, teamwork, or efforts to improve systems of care.

CEO’s take issue with the validity of this statement:  It is not valid for the Chairman’s Summary to say “CE does not promote inter-professional collaboration”. Our three organizations have worked productively and collaboratively for many years to bring order and efficiencies to CE accreditation.

Conference Finding #4: CE does not make adequate or creative use of Internet technology, which can help clinicians examine their own practice patterns, bring medical information to them during patient care, and aid them in learning new skills.

CEO’s rightly note that there is a plethora of internet based CME.  Published quantitative data, which we know the Macy conference participants had access to prior to the Conference, do not support these statements. For example, in CME since 1998, there has been a reported 24-fold increase in the number of Internet CME activities (to 93,582 in 2006); a 68-fold increase in physician participants (to 2.4 Million in 2006), and a 62-fold increase in non-physician participants (to 1.5 Million in 2006).

Also in this rebuttal includes the total bias of the Macy Conference towards “Point of Care CE”, they correctly pointed out that Up-to-Date, a commercial service that was very involved in the outcome of the conference epically the conference summary.

We find that the Conference Chairman’s Summary, the Conference assumptions along with the Conclusions and Recommendations directly and indirectly specifically promote “Internet point-of-care learning.” We observe that persons in a position to control the content of the Conference and its derivative written products have personal financial relationships with a proprietary entity marketing such product. These financial relationships were not disclosed in the Conference Chairman’s Summary although we note that the Proceedings now have a list of Statements of Potential Conflicts of Interest. We ask, “Did the Macy Foundation manage this conflict of interest during the conference development process? Were steps taken to resolve this conflict of interest prior to the Conference?”

Conference Finding #4: There is too little high quality scientific study of CE.

We are not sure of the validity of this statement. A “Pub Med” search on ‘continuing education’ produces over 35,000 citations which range through a myriad of relevant topics. We are not aware of a published meta-analysis of all this literature that has drawn the conclusion that “There is too little high quality scientific study of CE.”

Finally, we believe that the Conference presents broad opinions and offers some dramatic changes for the CE enterprise, yet provides little evidence to support the need for, or the desirability of these recommendations. Some of the conclusions and recommendations for the future of CE would be better characterized as expressions of what is already in place.

We find it disappointing that the Conference seemed to be unaware of the current state of continuing healthcare education.

We see the Conference as a missed opportunity.

The Macy Foundation Conference brought together a group of important people without a universal understanding of the current CE delivery system or its outcomes -- but with firmly held beliefs about what the deliverables of the system should be.

The CEO’s found that though they disagree with the recommendations, many of the deliverables described by the participants of the Macy Foundation Conference could have useful applications. They could easily be packaged as benchmarks by which we could evaluate and monitor our CE systems. They could provide a future framework for organizational and system self-assessment and improvement.

Our industry benefits from its broad range of participants and providers, the Macy Conference reflects only a small minority of providers (mostly academic faculty, no representation from specialty societies, medical communication companies, state level providers) and therefore the CEO’s were correct in firmness of their response. 

The CEO’s belief and position is that everything can be improved.

As we work together to bring about high quality medical education for healthcare providers it is important not to discredit the hard work and diversification that everyone before us has done to make this the best medical education system in the world.

We have written extensively on this issue:

Macy Report -- Filled in the Blanks

Macy Report -- The World is Flat

AMA CEJA – Back to the Drawing

Today the AMA House of Delegates soundly rejected the CEJA recommendations Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine and sent them back for further study and without objection.  This closes this chapter on the issue of funding for Continuing Medical Education.

Earlier in the day the Reference Committee on Amendments to Constitution and Bylaws, “recommended for referral” what was formerly identified as CEJA Report 1, so that it will not be presented on the house floor for a vote.

However, because the Reference Committee did not  “recommend for not adoption”,  CEJA can revise and (improve) their report for presentation at a later meeting as soon as this time next year.

We don’t believe however, given the strength of almost unanimous opposition to the recommendation, that this issue will come back to the House of Delegates anytime in the near future.

At the reference committee hearing on Sunday only two speakers spoke in favor of adoption of the report; the current CEJA chairman Mark Levine, MD (according to our sources he is retiring after this meeting) and one other physician who apparently speaks against everything given the opportunity. 

One interesting note, according to one source when Doctor Levine stood up at the support microphone to present the report, he told the Chairman of the reference committee Dr. Raymond Christenson, that he would not take up much time given all those who were behind him in favor of the proposal, at which the chairman noted, Dr. Levine there is no one behind you, so take your time.

Almost 40 individuals representing most of the major constituencies at the AMA, came to the microphone to speak out against this report. The First speaker was the President of the Organization of State Medical Association Presidents (OSMAP) speaking on behalf of the state medical associations, others from the Medical Student Section (MSS) (which gives us hope given the extreme stances that the American Medical Student’s Association has taken on issues similar to this one), The Minority Affairs Consortium (MAC), the National Medical Specialty Societies and many more.    John Kamp the executive director of the Coaltion for Healthcare Communications, noted conflicts of interest exist in all circumstances and that the treat of lawsuit by trial lawyers, creates a conflict of interest in physicians in the way they practice and ordering what tests.

One exceptionally compelling testimony came from the Edward Langston, MD, Chairman of the AMA Board of Trustees who gently urged Dr. Raymond Christensen, Chairman of the Reference Committee to “accept the Committees recommendation for referral” and by doing so “preserve the sanctity of CEJA” (largely because the report on which the recommendation was based, was so biased against any value to collaboration).

Thanks to all the groups who recognize the value of collaboration and took the effort to speak out against this report by working hard to develop very thoughtful positions on the issue. 

We wish Doctor Levine well in his retirement, and though we don’t agree with his proposed recommendations for change, we admire and share his commitment to improving the practice of medicine and dedication to patient care.

As we move on we need to recognize that the most important issue is that doctors learn and implement the most up to date medicine regardless of who supports it.