Tuesday, June 30, 2009

Psychiatry’s DSM-V Process: Now A Bar Room Brawl

Psychiatry’s diagnostic manual is due for a revision. But what began as a group of top scientists reviewing the research literature has degenerated into a dispute that puts the Hatfield-McCoy feud to shame.

The latest installment in this remarkable episode of American psychiatry involves an editorial by Dr. Allen Frances, the chairman of the committee that created the current version of the the DSM, the DSM-IV. The editorial has not even been officially published (it is in press at Psychiatric Times) but already it has made the rounds of the blogs and is being read and debated widely. Now, the APA has just released this rather stunning response.

Those who are not in psychiatric circles might find their eyes glazing over a bit as they read these articles. But we are witnessing here something dramatic and important. Psychiatry is wrestling with its identity, and in the process is creating the next set of ideas that will guide how real people are diagnosed and treated for years to come. The stakes for everybody are high.

In his editorial, Dr. Frances criticizes the evolving DSM-V on multiple levels, and makes the following claims:

--The process of writing the manual is less transparent and less inclusive than the process he oversaw when he chaired the DSM-IV committee.

--The underlying science of psychiatry has not advanced enough to merit the kind of extreme makeover proposed by the DSM-V chairpeople:

"The simple truth is that descriptive psychiatric diagnosis does not need and cannot support a paradigm shift. There can be no dramatic improvements in psychiatric diagnosis until we make a fundamental leap in our understanding of what causes mental disorders. The incredible recent advances in neuroscience, molecular biology, and brain imaging that have taught us so much about normal brain functioning are still not relevant to the clinical practicalities of everyday psychiatric diagnosis. The clearest evidence supporting this disappointing fact is that not even one biological test is ready for inclusion in the criteria sets for DSM-5."

--The main change being proposed—the official inclusion of a series of rating scales into the diagnostic criteria—is poorly conceived because busy clinicians will reject this extra paper-work.

--Other proposed changes in DSM-V will make it too easy to over-diagnose a range of conditions:

“The result would be a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatment--a bonanza for the pharmaceutical industry but at a huge cost to the new false positive "patients" caught in the excessively wide DSM-V net. They will pay a high price in side effects, dollars, and stigma, not to mentions the unpredictable impact on insurability, disability, and forensics.”

Frances’ article is compelling, not only because of the substance of his arguments but because of his clear and forceful writing style. With each sentence, you get a sense that this man has carefully thought through all of these issues and is passionately concerned about the future of his field.

The APA’s response, on the other hand, is a weird mixture of bureaucratese and mean-spiritedness. The bureaucratese I can understand—after all, this is a letter crafted by committee. But the nasty tone of the response is astonishing and undignified.

The APA gets off to cringing start by calling Frances and his colleagues liars:

“The commentary “A Warning Sign on the Road to DSM-5: Beware of its Unintended Consequences” by Allen Frances, M.D., submitted to Psychiatric Times contains factual errors and assumptions about the development of DSM-V that cannot go unchallenged. Frances now joins a group of individuals, many involved in development of previous editions of DSM, who repeat the same accusations about DSM-V with disregard for the facts.”

Wow. Can’t grown men have disagreements with one another without resorting to this kind of language? I might have started with something more like, “The commentary “A Warning Sign on the Road to DSM-5: Beware of its Unintended Consequences” by Allen Frances, M.D., is a thought-provoking critique of the DSM-5 process. While we respect and appreciate Dr. Frances’ leadership in American psychiatry over the years, we disagree with several of his points.” (Note to APA--send me all future "defense letters" for editing, at no charge).

After this, there are six paragraphs addressing some of Frances’ specific points. We hear that the DSM-V process has actually been “the most open and inclusive ever” and that the much villified “confidentiality agreement” was created to protect intellectual property rather than to keep proceedings secret. There is a defense of the usefulness of symptom rating scales: “Recent studies underscore the readiness of clinicians in both primary care and specialty mental health settings to adopt dimensional instruments on a routine basis.”

And there is a reasonable reminder of why some changes in the criteria are needed: “Clinicians complain that the current DSM-IV system poorly reflects the clinical realities of their patients. Researchers are skeptical that the existing DSM categories represent a valid basis for scientific investigations, and accumulating evidence supports this skepticism.”

But after a brief, not terribly convincing rebuttal of the merits of Frances' argument, the writers decide to conclude by getting mean and personal again. This time, they accuse Dr. Frances of being deceptive in not disclosing his financial interests in DSM-IV (he is co-author of one book that teaches doctors how to use the manual). Then, they opine that Frances’ real motive in criticizing DSM-V is not a desire to improve diagnosis, but simply greed.

“Both Dr. Frances and Dr. Spitzer have more than a personal “pride of authorship” interest in preserving the DSM-IV and its related case book and study products. Both continue to receive royalties on DSM-IV associated products. The fact that Dr. Frances was informed at the APA Annual Meeting last month that subsequent editions of his DSM-IV associated products would cease when the new edition is finalized, should be considered when evaluating his critique and its timing.”

In other words, Dr. Frances wrote his editorial because he was just informed that once DSM-V is published, the APA will no longer publish new editions of books introducing psychiatrists to the outdated DSM-IV. Somehow, I doubt that this was exactly a news flash to Dr. Frances.

It is disturbing that the APA and DSM leadership would accuse Dr. Frances and his colleagues of being greedy, deceptive, and dumb. Who do they think they are--bloggers?

Thursday, June 25, 2009

Team Grassley, a Lawyer's Eye View

You might love him or you might hate him (I'm obviously one of his fans), but either way Senator Charles Grassley and his passionate staff have shaken up the world of medicine and have made "conflict of interest" a household term.

Recently, I read this article published on the website LawyersandSettlements.com that provides a succinct rundown of Team Grassley's accomplishments. Lawyers, of course, are particularly big Grassley fans because each one of his investigations creates instant jobs for dozens of attorneys on various sides of the issue. Thus, you can count on them to be particularly vigilant and accurate monitors of the COI body count as it rises. For the confused, the overwhelmed, or the plain curious, this article makes for a nice fact sheet.

Wednesday, June 24, 2009

The APA, Power, and the Exclusion of Dissent

Dr. Doug Bremner has a fascinating but unsettling post about colleagues disinviting him to co-author an academic paper, because they were upset by this blog post he had written.

I have no idea how deep this issue goes, and there is always more to everything than meets the eye, but I do have my own recent personal experience of being shunned by the academic establishment, and I thought this would be an opportune time to tell that story.

As some of you know, in 2008 I was elected by those liberal Massachusetts psychiatrists to be one of four state representatives to the American Psychiatric Association. This means that I attend monthly meetings of the council of the Massachusetts Psychiatric Society, as well as quarterly meetings of the New England region (called “Area 1”) of the APA.

One of the things that happens when you get into a leadership position in a big organization is that you find out that there are dozens of committees and task forces and this is where all the real work takes place. Sometimes you get appointed by a powerful person, like former president Nada Stotland, who appointed me to a couple of committees, one of which was the task force leading to the APA’s decision to phase out industry supported CME at the annual meeting. Other times, you end up in committees via informal protocol.

Thus, for example, if you are on one of the APA Area councils (which I am), you may be invited to serve as an “Area council liaison” to a given committee. One of these committees is the “APA Steering Committee on Practice Guidelines.” As you can see here
, this committee is composed of about 24 people, seven of whom are liaisons from each of the seven Areas of the APA. It’s an important committee, because it is in charge of reviewing and approving any new practice guidelines. The practice guidelines then filter their way out into the community of mental health professionals and influence how patients are treated.

Recently, my Canadian colleague Joseph Berger announced that at some point over the next year, he would be replaced on the Area 1 committee by one of his colleague, and that therefore his slot on the Practice Guidelines Committee would be open. I expressed an interest in it, because sifting through practice guidelines and the research upon which they are based is basically what I do for a living as the editor of The Carlat Psychiatry Report. Dr. Berger was happy to find an eager volunteer, and he graciously made some email introductions to the various players involved.

Here’s where things began to go sour. I heard through this or that grapevine that some of the practice guidelines committee members were concerned about my “conflicts of interest.” I was surprised, since a recent study had found that 90% of members of three major work groups of the committee had conflicts of interests (COIs) with pharmaceutical companies.

Obviously, COIs per se are not forbidden. But perhaps I represented a special case, because, while I have no drug industry relationships, I publish what might be considered a competing publication. Perhaps they were concerned that I would spy on their process to improve The Carlat Psychiatry Report.

But I found out that the concern was about something else entirely. Somebody on the committee said that I had embarrassed members of the DSM-V committee by publishing something on my blog. I wracked my brain for what this could be. Finally, while on my morning jog, it came to me.

Back in October of 2008, I posted this article reviewing the breaking news about the extent of Dr. Charles Nemeroff’s undisclosed conflicts of interest at Emory. There were almost 30 comments on that posting, and one of the commenters, who was anonymous, left the following comment:

“A reminder that a further feature of pseudoacademic pseudopsychiatry is that the group noted by Dr. Gitlow defines the diagnoses we use, and defines them of course in a way that not only maximizes drug treatment, but shapes them according to the interests of particular drug corporations. One recent example only: Dr. Schatzberg has been campaigning at the APA DSM V committee meetings to dilute the criteria for major depression with psychotic features, so that the drug his company manufactures for the condition might attain broader use.
October 5, 2008 8:17 PM”

I confess that I don’t scrutinize every single one of the comments that are left on my blog. I publish just about any comment that comes in, as long as it is not profane or completely off-topic, and I make no guarantee that comments are accurate. I also often disagree vehemently with commenters. That’s called healthy debate.

At any rate, somebody in the higher APA echelons saw this comment, and I was told that it inaccurate, and that my publishing it reflected poorly on both myself and on the APA.
While under no legal obligation to do so, in order to soothe hurt feelings, I decided to delete the comment, and announced the fact in this post.

Well, no good deed goes unpunished, and somebody on the practice guidelines committee is still sore about the incident and believes this shows I am a loose cannon and that my presence would inhibit free discussion on the guidelines committee.

Actualy, if anything, I would think that the presence of someone who has been at the forefront of ethics reform efforts would help to legitimize and improve the APA guidelines process.

The episode is profoundly disappointing to me personally, because I have a particular interest in making the currently dry guidelines more readable and therefore more likely to be read by practicing psychiatrists.

But it is also disappointing to me as a member of the APA, because I would have thought that the tent of the organization is big enough to tolerate the rubbing of shoulders between people who may disagree strongly on some topics. Psychiatrists, of all professionals, should know that avoiding confrontation is rarely the road toward health, whether psychological or organizational.

Thursday, June 18, 2009

Geodon Ineffective for Bipolar Depression; or, Watch ClinicalTrials.gov in Action!

According to results recently posted by Pfizer on ClinicalTrials.gov, the antipsychotic Geodon is not effective for the treatment of depression in patients with bipolar disorder.

Atypical antipsychotics, like Geodon, are all FDA-approved for the manic phase of bipolar disorder, but only Seroquel is approved for treating bipolar depression, though just how effective it is remains controversial.

The Geodon results are noteworthy because the only reason we even know about them is that drug companies are now required to post the results of clinical trials on the clinical trials registry. This was a requirement of the FDA Amendments Act of 2007; before this act, companies could voluntarily post the protocol of a research study on the registry, but it was not compulsory and there was no requirement that they ever publish the results. The FDAAA, among other things, both make it mandatory for companies to post new trials on the registry, and, even more significantly, required that they actually post the results of those trials. This latter requirement did not kick in until September of 2008.

In the past, companies have simply buried research results if they showed that their drugs were ineffective. For example, Erick Turner and his colleagues published this paper in the New England Journal of Medicine showing that drug companies had selectively published only the positive findings regarding antidepressant drugs. Specifically, companies had published 94% of all their positive studies of antidepressants, but only 38% of their negative studies; furthermore, even most of the published “negative” studies had been spun so that once in print they appeared to be far more positive than they were.

From the standpoint of a psychiatrist trying to figure out which drugs work, the bottom line was this: if I relied on the published medical literature for information (and what else can I rely on?), it would seem as though 94% of all antidepressant trials are positive. But if I had access to the suppressed data as well, the true figure is that only about half--51%--of trials are positive.

To come back to Geodon, before FDAAA, Pfizer would presumably have either not published the results of the recent bipolar depression studies, or would have published them as falsely positive. Doctors would have continued to prescribe the drug in this condition under the false assumption that if one atypical antipsychotic is effective (Seroquel), then they must all be effective.

Here is a very brief run-down of the two studies, both of which were placebo-controlled, double blind, multi-site trials of patients with bipolar disorder I who were depressed when they entered the studies. One of them, identified as study NCT00282464, was a 6-week flexible dose study comparing Geodon with placebo, and the other one, NCT00141271 was
a fixed dose trial comparing both high and low dose Geodon with placebo.

The studies were complex, with many different outcome variables assessed, but the bottom line is that neither of them managed to show that Geodon was significantly more effective than placebo on the primary depression rating scales. Will the results be spun in various ways to make them look good? You betcha. We will undoubtedly see publications coming out of this data that will emphasize certain outcome scales, at certain time-points, in certain kinds of patients, etc…. The data will be tweaked to nth degree.

But at least we now have a law on the books requiring companies to post the data for all to see, so that we may judge for ourselves whether published papers are accurate renditions of the data. For that, we should be grateful to both Congress and to former President Bush, who signed the legislation into law.

Tuesday, June 16, 2009

The AMA, Going Reagan, Turns to Bean-Counting Again

It’s a “there you go again” moment for the American Medical Association.

We learn from CNN’s Elizabeth Cohen’s twitter page that the biggest standing ovation given to Obama by the AMA House of Delegates was in response to this line:

“You did not enter this profession to be bean-counters and paper-pushers. You entered this profession to be healers – and that’s what our health care system should let you be.” (Here is the entire text of the president's speech.)

It is ironic that this sentiment in particular moved the AMA so, considering that the organization’s actions at the meeting so far indicate that bean counting—that is, counting their hard-earned money—is exactly why these doctors entered the profession.

First, they announced that they would not support an optional public insurance plan, because it might mean less money for doctors (though they appear now to be trying to recant that statement). They are basing their opposition on figures showing that Medicare pays doctors 20% less than private health plans, and therefore an expanded Medicare-like public insurance program might mean less money in their bank accounts.

A pay cut? Outrageous!

Here’s a news flash: all the players in the health care industry—doctors, hospitals, and insurance companies—are going to have to accept pay cuts if we want to bring health care spending under control. The AMA’s posture of knee-jerk opposition to anything that smacks of financial sacrifice gives it the look and feel of a reactionary organization, which is how they looked when they hired Ronald Reagan for "operation coffee cup" in its ill-fated effort to defeat Medicare in 1965.

Second, the AMA, yet again, has decided that its own ethics committee just doesn't understand medical ethics, at least when it comes to the topic of industry funding of continuing medical education. This is an issue I have covered here and here. One year ago, the first time the AMA read CEJA's report on CME (CEJA being the Council on Ethical and Judicial Affairs), the delegates rejected it because it announced the bad financial news that industry funding of education for doctors represents an unresolvable conflict of interest and therefore has to go.

Now, a year later, a new CEJA, under a new chair, introduced a new report, this time saying that industry funding of CME can continue, but it is still “ethically preferable” for doctors to pay for their own education. Apparently even this watered down version of medical ethics is unacceptable to the AMA, because defining industry-free CME as "preferable" might slow down the flow of industry cash, so they rejected it, referring it back to CEJA for more extreme dilutions. You can read the particulars on the Policy and Medicine blog.

Presumably, the next report will not dare to even mention ethics and industry funding in the same breath. I predict that the entire report will be brief and to the point: “Industry funding of CME is necessary for the public health.” Now that’s the kind of sentiment any bean-counting doctor can get behind!

Thursday, June 11, 2009

Margaret Soltan on Zachary Stowe

The irrepressibly to-the-point Margaret Soltan has a nice post about the Zachary Stowe fiasco on her University Diaries blog. The commenters, too, are eloquent, subscribing to the dictum that brevity is the soul of wit. I suggest you surf on over to her site.

Other coverage of the affair can be read in the Fierce Pharma blog, the Chronicle of Higher Education blog, and the Atlanta Journal Constitution.

Wednesday, June 10, 2009

The Latest Conflict of Interest Poster Child: Dr. Zachary Stowe

The latest casualty of Charles Grassley’s investigations of conflict on interest is Zachary Stowe of Emory University.

Dr. Stowe is probably the most well known researcher in the risks of breastfeeding while taking antidepressants, and it is sad to see his reputation taking a nose-dive with these revelations.

The news originally broke in this article in the Wall Street Journal
, but if you can’t stand the idea of actually paying for content you can find some of the same information for free on this post on the WSJ blog.

The bottom line is that Stowe has run into the same ethical problem as his boss Dr. Nemeroff—he was taking public NIH money to conduct research, while at the same time giving dozens of promotional talks for a company that stood to benefit from the results of that research.

Specifically, GlaxoSmithKline (makers of Paxil and Lamictal) paid Stowe $154,400 in 2007 and $99,300 during the first 10 months of 2008.

When I first saw this story I was rather unfazed and wasn’t even sure it was worth blogging about. Another academic using his NIH-supercharged credibility to make a bundle by hiring himself out to the highest bidders? Yawn, right?

But when I started to look through the publicly available documents, I realized there’s a bit more to this story than meets the eye.

For one thing, Stowe appears to have been deceptive during a recent deposition, when he claimed that on top of his $232,000 Emory salary, he earned an additional 20 – 30% more doing work for pharmaceutical companies. But wait a minute--if he made $154,400 from GSK alone in 2007, by my calculation this is already 66% more salary than he got from Emory. And Stowe did work for lots of other companies as well. Here is his disclosure from a Medscape CME gig he did in March 2007:

Disclosure: Zachary N. Stowe, MD, has disclosed that he has received grants for clinical research, grants for educational activities, and has served as an advisor or consultant to GlaxoSmithKline, Wyeth, and Pfizer. Dr. Stowe has also disclosed that he has served as an advisor or consultant for Bristol-Myers Squibb. Dr. Stowe has also disclosed that he has served on the speaker's bureau for GlaxoSmithKline, Wyeth, Pfizer, and Eli Lilly.

Who knows how much money he was also getting from Wyeth, Pfizer, Bristol-Myers Squibb and Eli Lilly? He may very well have doubled his Emory salary, or more.

Furthermore, the $154,400 disclosed by GSK does not include all the cash they paid Stowe through laundered CME money. For example, here is a CME program
Stowe did for Medscape that was funded by GSK. The program is entitled “Long-term health risks of antiepileptic drugs in women” and is essentially a commercial for using Lamictal in pregnant women with bipolar disorder. In it, Stowe begins by saying nasty things about Lamictal’s competitors, Depakote and Tegretol, and then minimizes a large study showing that Lamictal causes cleft palate. I’m sure he got paid a lot for this, and that he did plenty of other similar CME programs that are scattered somewhere throughout the internet.

But wait! There’s more!

We learn from a remarkable series of emails furnished by GSK to Grassley that Stowe gets pretty agitated when he doesn't get enough promotional money. Look at Attachment C of Grassley’s letter
if you’d like to follow along here.

First, sometime in August of 2003, a GSK rep emails Stowe that he is “sincerely sorry” but that they have to cancel two scheduled talks (that would have been $2500 a pop, his usual rate) in Wisconsin because attendance was too low.

On 8/19/09, Stowe responds politely, but says that this late cancellation presents "two problems." As it turns out, Stowe schedules only 4 days per month to give talks for drug companies, and the cancellation meant that “others are denied speaking engagements.” He then asks, “What provisions do you propose for my compensation for my lost time?”.

Stowe's second problem is that he had apparently been coordinating this GSK gig with a meeting at the American College of Obstetrics and Gynecology and he would now have to arrange a new flight at the last minute. He believes, therefore, that GSK owes him: “Given the circumstances I think GSK should book and cover the costs of the trip up as well…”

I guess I can understand Stowe’s being upset about a last minute cancellation of a lucrative speaking gig. If he had already paid for a plane ticket for that, then of course GSK would owe him that money. But that’s not the case here. Stowe was apparently planning to mooch off some aspect of the GSK travel to defray some costs associated with a meeting he was planning to go to anyway. Without the GSK money, he now has to pay his own way entirely, and so he wants GSK to fund those costs, even though it has nothing to do with GSK!

You can imagine that whoever got this email was not very happy, and didn’t respond as quickly as Stowe wanted. So Stowe sends off another email on 8/27/03, again pretty polite, admitting that he had once rescheduled these talks, and that since maybe his recheduling affected the attendance, he would settle for getting paid only $2500 for a talk he never gave, rather than insisting on $5000 for two talks he never gave.

But still no reponse from GSK. Stowe fires off another missive on 9/13 saying he was sorry the programs “didn’t work out” and wants to make sure they have his address for a check.

Again, utter email silence from GSK—what lousy handlers they are! So on 9/18, Stowe lets it rip. Warning that he is “no longer in a compromising mood,” he is now demanding $4500, not just $2500, and points out that “you are still getting a $500 discount” because he usually gets $5000 for two talks.

On the same day, he emails a colleague, apparently someone higher up in his department (a wild guess: Nemeroff?) to complain about the issue:

“REP NO RESPONSE – need your input or direction where to take this….I emailed the rep 3 times now with no response, because I had originally rescheduled this from an earlier date I told the rep that I would be okay with the 2,500 instead of the full 5,000 for the last minute cancellations (which I thought was very nice of me). She has failed to respond to 3 emails and I am getting slightly agitated, in fact to the point that she can just find the full 5,000 since my compromise has been ignored. I know that this has no business on your radar screen, but need a name of who to go to. Thanks for your help- talk to you soon. Any feedback on the Miami gig yet?”

I don’t know what the “Miami gig” meant, but I hope he got $5000 out of it!

Finally, on 9/19, somebody from the company responds, saying they will “take care of it.” According to Grassley, eventually Stowe received some compensation, but we don’t know exactly how much.

What to make of all this? It's a creepy insider's look at how entitled our key opinion leaders became at the height of the drug company gravy train in the early to mid 2000's. The only good news is that it is all coming to a screeching halt. According to the WSJ, Stowe has been formally reprimanded by Emory and ordered to cease his promotional talks. Of course, Emory recently announced a new policy that bans such practices anyway, so this may be a bit of overkill.

Monday, June 8, 2009

When Greed Happens to Good People: Atul Gawande's Solution to the Health Cost Crisis

You might have already seen Atul Gawande’s piece in the New Yorker called The Cost Conundrum. It has been covered in the excellent Century Foundation Blog, Taking Note.

In it, he tackles one of the problems at the core of our nation’s health care cost crisis: greedy doctors, or rather, greed-inducing incentives for good doctors. In this blog, I’ve looked at how greed has distorted the decisions doctors make when they are providing education to other doctors. It’s not that the key opinions leaders are bad people, but they are responding as rational human beings to perverse economic incentives. If you put yourself in a situation where you can make thousands of dollars for omitting certain points about a drug during a talk, chances are that you will, indeed, omit those points. The solution, in this case, is to remove the problem incentive (that is, stop accepting industry money for medical education), and the doctors will no longer be tempted to bend the truth.

Gawande looks at this same kind of greed from another perspective, and arguably a more important one. How does the allure of money actually affect the medical decisions doctors make about your care?

He starts his investigation by focusing on the small Texas city of McAllen, population about 130,000
. He finds that McAllen has the surprising distinction of being one of the most expensive health care markets in the country. In 2006, according to Gawande, Medicare spent $15000 per enrollee, more than twice the national average.

Gawande spends the rest of the article wondering why. Is it because people in McAllen are twice as sick as those in other cities? No—McAllen has lower than average rates of cardiovascular disease, cancer, asthma, HIV, infant mortality, and injury. McAllen has essentially the same demographics and health statistics as El Paso county, 800 miles to the north, but El Paso’s Medicare expenditures were only half that of McAllen's--$7504 per enrollee.

Perhaps doctors in McAllen are ordering more tests because they are more afraid of malpractice suits than other doctors? But that doesn’t make sense, because Texas has passed one of the toughest malpractice laws in the country, capping pain-and-suffering awards at $250,000. The number of lawsuits has plummeted, said one cardiologist interviewed by Gawande.

Finally, Gawande meets with a hospital administrator who is willing to speak frankly (though anonymously). It turns out that at some point over the last 15 years, doctors in McAllen developed a thirst for profit. Rather than seeing their practices as noble professions that also happened to provide them with a good income, they began to view their practices as income streams. Doctors began buying imaging centers and surgery centers, and found that they could profit greatly by referring patients to their own treatment centers for expensive tests. In some cases, Gawande heard stories of blatant corruption, such as doctors demanding huge fees from hospital executives for steering patients to their hospitals. One doctor, for example, reportedly asked for $500,000 per year as a kickback for sending the hospital his business.

A marketing rep for a home health agency told Gawande that doctors have requested kickbacks for sending patients to home health agencies as well:

“Doctors have asked her for a medical-director salary of four or five thousand dollars a month in return for sending her business. One asked a colleague of hers for private-school tuition for his child; another wanted sex.”

What in God’s name has happened to the doctors of McAllen, Texas? Somehow, they have embraced the culture of money, just as the key opinion leaders in psychiatry and other fields jumped onto the gravy train of industry-funded medical education. Gawande interviews Woody Powell, a Stanford sociologist who has studied the “anchor tenant” theory of economic development. Just as an anchor tenant store will dictate the character of an entire mall, so will an anchor tenant university or hospital or physician foreshadow the culture of a community. To quote Gawande:

“About fifteen years ago, it seems, something began to change in McAllen. A few leaders of local institutions took profit growth to be a legitimate ethic in the practice of medicine. Not all the doctors accepted this. But they failed to discourage those who did. So here, along the banks of the Rio Grande, in the Square Dance Capital of the World, a medical community came to treat patients the way subprime-mortgage lenders treated home buyers: as profit centers.”

Dr. Lester Dyke, a cardiac surgeon in McAllen, and one of the few doctors to publicly criticize its health care system, tells Gawande that “Medicine has become a pig trough here….We took a wrong turn when doctors stopped being doctors and became businessmen.”

In the last part of his article, Gawande outlines some solutions, highlighting organizations and communities that have kept health costs below the national average while achieving some of the highest quality-of-care scores in the country. These include the Mayo Clinic in Minnesota, the community of Grand Junction, Colorado, Kaiser Permanente in Northern California, the Geisinger Health System of Pennsylvania, the Marshfield Clinic of Wisconsin, and Intermountain Healthcare of Salt Lake City.

The key to all these systems is creating financial incentives to coordinate care, rather than to simply order as many tests and procedures as possible. Such a system, he believes, is possible in the context of either a single payer system or a mixed private and public insurance system, as is more likely to be the outcome of Obama’s health care reform efforts. More important than the specifics of health care reform, concludes Gawande, is “whether we are going to reward the leaders who are trying to build a new generation of Mayos and Grand Junctions. If we don’t, McAllen won’t be an outlier. It will be our future.”

Friday, June 5, 2009

Spurred by Nemeroff Debacle, Emory Reforms Ethics

According to the Atlanta Journal-Constitution, Emory University School of Medicine has announced a new ethics policy that, among other things, forbids any Emory faculty from speaking for drug companies and bans gifts from industry.

You can read the updated ethics policy here.

Regarding industry-funded CME, the report makes the intriguing statement that:

"Revisions in national and School of Medicine guidelines and policies on continuing medical education are underway. Therefore, this policy currently contains only limited revisions at this time."

I assume this is an oblique reference to the recent hard-hitting report from the Institute of Medicine, which has recommended that a new system of CME funding be developed within two years that will prevent direct industry funding of courses.

At any rate, Emory's updated ethics code still allows its faculty to speak at industry-supported CME events, but does not allow such courses to occur in any Emory-affiliated buildings. In addition, the policy states that:

"Preferably the event will have more than one industry sponsor, and possibly an institutional cohost."

Thursday, June 4, 2009

Behold the Pri-Med Empire

Oddly enough, the day after I posted an article about the scandal involving Partners, Harvard, Jack Connors, and Pri-Med, I received the postcard below inviting me to attend Pri-Med's Boston event in November. As you can see, the affiliation between Harvard and Pri-Med is prominently displayed. However, what is not mentioned is that most of the conference consists of industry-supported symposia. In fact, not a single drug company name is printed on the brochure, although in small print on the back of the card is the following statement, buried in the middle of the program's overall description: "Learn in a smaller setting and earn additional AMA PRA Category I Credit on the Pre-Conference Symposia Day and at the Industry-Supported Symposia. Separate registration and ticket are required."

It makes it sound like the industry symposia are a small part of the conference. Nothing could be further from the truth. According to this study of the Pri-Med courses published in the Journal of Continuing Education in the Health Professions, the conference consists of 27.5 hours of non-sponsored lectures by Harvard faculty, versus 43.5 total hours of industry supported lectures, which also give the attendees free meals. Furthermore, according to the study, the industry-funded courses focused almost exclusively on a small subset of medical topics for which the sponsoring companies market a new product. Durng the 2000-2001 academic year (soon after Jack Connors bought the company), the 103 industry symposia covered 30 different topics (primarily related to diabetes and arthritis), while the Harvard courses covered 133 topics.

The industry symposia ignored rather important topics such as: preventive screening, pediatrics, cancer, child abuse, problem drinking, skin problems, and technology resources for clinicians. Sorry, but there's just no money in these topics.

Pri-med Brochure p 1

Pri-med Brochure p 1 dcarlat

Other side

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Tuesday, June 2, 2009

Harvard Med School, Jack Connors, and the Manipulation of Power

Sunday’s Boston Globe reported yet another conflict of interest problem in medicine. This one, however, is on a scale that will astonish even the most jaded observers of recent events.

According to two-time Pulitzer Prize winning journalist Steve Kurkjian, Jack Connors, the chairman of the board of Partners Healthcare, never bothered to inform the board that he was the major owner of a drug industry funded CME empire. The company, M/C Communications, runs the lucrative Pri-Med courses, a series of industry-funded symposia that reach 35,000 doctors per year.

According to the article, Connors bought the company (with an investment group) for $13 million in 2000, and sold it for a whopping $450 million in 2004, personally making $250 million in profit from the deal.

So what? Jack Connors is a successful businessman and entrepreneur. There’s nothing wrong with flipping a company and making a tidy sum in the process, right?

Generally speaking, that’s true. In this case, however, there was a web of undisclosed relationships that enabled Connors to make that kind of money. Connors is neither a physician nor an educator. But he knows advertising, having co-founded Hill Holiday,
the main advertising firm for Partners. The way advertisers become rich is by finding rich companies and promising them a lucrative market for their products. In the world of industry-funded CME (which is merely a deceptive form of promoting industry products), that lucrative market consists of doctors. The more doctors you can attract to your courses, the more you can charge the drug companies that fund those courses. The best way to attract doctors is to promise them gold-plated medical education, and nowhere does this gold shine more brightly than at Harvard Medical School.

By being chairman of the board at Partners, Connors had access to the key decision makers at Harvard Medical School, access that would have easily allowed him to negotiate deals on behalf of his company, M/C Communications. According to the Globe article, M/C has an “exclusive commercial relationship” with Harvard Medical School. The Pri-Med website is quick to make drug companies aware of this fact:

“Because of our relationship with Harvard Medical School, clinicians are drawn to our conferences and the opportunity to engage with peers and learn about the latest advancements in the medical community.”

Did Connors actually exploit his position with Partners to hawk medicine’s equivalent of Boardwalk and Park Place to drug companies? He denies it, saying that he was only a “passive investor” and that he never spoke to Harvard’s dean about his company. Maybe he is telling the truth here...but then again, maybe not. Connors certainly damages his own credibility when he defends his decision not to disclose his ownership of M/C Communications to the Board:

“Connors said he was under no obligation to disclose his ownership of M/C Communications to the Partners board. He said that while there is an "affiliation" between Harvard Medical School and the two Partners hospitals, there is no formal contract between them.”

This is like saying that when two people marry there is not really a contract between them, only an “affiliation.”

Apparently, Connors has studied the Bill Clinton playbook of wordsmithing . Partners was literally founded in 1994 by Harvard’s two main teaching hospitals, Mass General and Brigham and Womens.
There may be no “formal contract” between Partners and Harvard, but without the Partners hospitals, Harvard Medical School would have all the power, money, and prestige of a local community college.

Former Partner’s board members interviewed by Kurkjian were dismayed to learn about Connors’ odd opinion about appropriate disclosure—unfortunately, they opted to remain anonymous, perhaps fearing repercussions from Connors.

W. Micheal Hoffman, who is a specialist in corporate conflict of interest policies, explained to the Globe why this is a major PR problem for Partners:

"That's not good governance," said Hoffman, noting that M/C's relationships with Harvard Medical School and the pharmaceutical industry were close enough that Partners trustees should have discussed it. He said the board could have placed restrictions on Connors's private ventures or even demanded that he choose between his for-profit enterprises and his nonprofit chairmanship. Or, he said, after vetting the issue, the board could have decided to take no action.
"People are going to think that the trustees have either a laissez-faire or old-boy network attitude toward conflicts of interest," Hoffman said. "And Partners can only lose with that attitude out there."

All in all, this is a remarkable--if nauseating--example of the manipulation of power at the highest level of American medicine. Kudos to Kurkjian and the Globe for printing it. This is the kind of investigative journalism that we will lose if our newspapers go under—so keep up your subscriptions!