Delaware Media Group: Sleazy MECC of the Month

As pressure continues to build on various medical organizations to curb industry funding of CME, the companies and their MECC minions (MECC = Medical Education Communication Company) continue to churn out infomercials with the ACCME stamp of approval.

The sleazy "MECC of the Month" is the Delaware Media Group. Here is how they describe themselves on their home page:

“Delaware Media Group
Custom Health Care Communications

Delaware Media Group (DMG) is a fast-growing health care communications/education company that specializes in providing customized communications vehicles to suit your marketing and continuing education needs and goals and enhance your relationships with key customers in the health care community.”

The fact that DMG pairs “marketing” with “continuing education needs” in their promotional material pretty much says it all. This is an outfit whose raison d’etre is to help drug companies sell their products.

Their major marketing vehicle is a pseudo-journal called “Counseling Points” . Each issue focuses on a different topic of interest to the supporting drug company. Who actually creates the content is always confusing, however. For example, I was just sent the June 2010 issue of Counseling Points, entitled "Challenges in Schizophrenia: Overcoming Nonadherence and Preventing Relapse in Schizophrenia."

In the increasingly rare real world of medical education (doctors honestly imparting their clinical wisdom to other doctors), there is an “article” and there is an “author.” The author is an academic doctor who came up with the idea for the article, wrote it, and sent it somewhere for publication. You can trust the content because you know who wrote it and why.

But in the world of industry-funded CME, articles become “activities,” and a basic 9 page piece on the treatment of schizophrenia suddenly requires a whole army of staff: three “faculty” (in this case, three psychiatrists--Christoph Correll, John Kane, and John Lauriello), nine “planners” and “managers” (a smattering of nurses, pharmacists, medical writers, and logistics coordinators), two “co-sponsors” (the “Annenberg Center for Health Sciences” and Delaware Media Group), one collaborator (“Postgraduate Institute for Medicine”), and of course, propping up the entire charade, the commercial supporter, in this case Janssen.

So who actually wrote the darn thing, you might ask? It’s impossible to say in this musical chairs game of “content creation.”

Speaking of content, what does this article have to say? Very little that is surprising. The main points are the following:

1. Schizophrenic patients often don’t take their medications, and there are a bunch of reasons why.

2. When schizophrenic patients stop taking their medications, they get worse.

3. Here are some helpful tips on how to keep your schizophrenic patients on their medications. This section begins with a half page on psychoeducation and cognitive behavioral therapy, followed by two beefy pages on long-acting injectable antipsychotics. And guess what? The major manufacturer of these drugs happens to be Janssen, which funded this article. Janssen markets both Risperdal Consta and Invega Sustenna.

I know this topic well. I read the entire article, and I found nothing in it that was inaccurate. Nor did I find any blatantly biased statements about Risperdal Consta or Invega Sustenna being better than its competitors. The bias is much more subtle. For example, they discuss their arch-rival Zyprexa Relprevv only once, and here’s what they have to say: “As in the presumed cause of olanzapine palmoate postinjection delirium and sedation, there is always a chance that an injected drug can reach the venous space instead of the muscle.”

Wow—there's a portrait of olanzapine that doesn’t exactly make me want to rush out and start prescribing it. But here's what they left unmentioned: This side effect occurs in only 0.07% of injections (see the reference here). That means only 7 out of 10,000 injections, making it a very rare side effect. This additional information would have been a helpful clarification. But it wouldn't have made its competitor look quite as lame--which is why they left it out.

No, there is nothing inaccurate in the article. Just like drug company ads in journals, everything is carefully vetted to be completely accurate, but, just like advertisements, it is just as carefully crafted to increase prescriptions of the company’s products.

And this is why relying on pharmaceutical companies to pay for our CME is such a dangerous game--there is no longer any difference between advertisement and education.

Carlat on NPR's "Fresh Air"

For those who are interested in topics dwelt on in this blog and in my book Unhinged, please check out my interview on the NPR show Fresh Air, which was aired on Tuesday July 13, and is available on the NPR website here. Give it a listen. Hopefully I was fairly articulate, although it's hard to know when you are sitting alone in a studio with a giant microphone staring you in the face and an engineer cheering you on behind a window in the control room!

I found the host, Dave Davies (who was filling in for Terry Gross), extremely informed and I am perpetually impressed by the quality of programming on NPR. Today I was on another NPR show called Radio Boston, hosted by Meghna Chakrabarti (listen to it here) and again was amazed at the production quality and the intelligence of the questioning. Next time pledge week comes around for your local NPR affiliate, I urge you to pony up.

Food Stamps for Doctors: Mass Legislature Votes Today

Today, the Massachusetts legislature will consider a measure introduced by House speaker Robert DeLeo to repeal the historic drug company gift ban law enacted only two years ago. Why? Because wealthy restaurant owners are lobbying to return the state to the days when it was a haven for wining and dining doctors.

The interesting thing is that doctors themselves have resigned themselves to the law, and have largely embraced it. For example, Partners Healthcare, which includes both Mass General Hospital and Brigham and Women’s, forbids its staff from accepting any drug company meal, on site or off-site, and has banned its faculty from giving “educational” talks at restaurants (read their policy here).

It’s rather embarrassing that Massachusetts lawmakers have decided to ignore Harvard Medical School’s example, and are instead receiving their health policy instruction from restauranteurs. The most vocal of these nouveau medical ethics gurus has been Steve DiFillippo, owner of the Davio’s chain of Northern Italian Steakhouses, Avila’s, and a new line of Davio’s frozen foods. Below is a picture of Steve posing with Mayor Menino at the opening of one of his restaurants.

Last April, DiFillippo appeared on WGBH's Greater Boston to present his own version of Medical Ethics 101: “Besides my parents," he said, "who do I trust the most? It’s my doctor. I trust my doctor to go to an educational dinner where it's doctor on doctor and learn about the drug. And recommend the right drug.”

Emily Rooney: “You don’t think they are going to be unduly influenced?”

Steve DiFillippo: “We’re talking about doctors. You know, they go to doctor school for 12 years…to become a doctor. I think I can trust my doctor to make an educational decision.”

I appeared with DiFillippo on that program. What viewers did not see was that in the pre-show lounge, DiFillippo was working the crowd. Speaker Robert Deleo happened to also be in the lounge, where he was waiting to be interviewed about his effort to legalize casino gambling in Massachusetts. DiFillippo planted himself by his side and groused about how much income restaurants were losing from the ban on free meals for doctors. It was an eye-opener for me, seeing the political process in action. DeLeo and DiFillippo obviously knew one another from somewhere. They shook hands, they smiled, they chatted--it was the ancient machinery of wealth multiplying itself by rubbing up against power.

Evidently, DiFillippo’s knew what he was doing, because within three months, DeLeo had introduced legislation to repeal the gift ban. I assume that the Speaker has his heart in the right place in that he wants to stimulate the Massachusetts economy. Unfortunately, he is willing to trade ethics for money, both in his successful championing of casino gambling (a shady recreational pursuit which has ruined several of my patients’ lives) and now in his willingness to allow drug companies to resume bribery-as-usual of Massachusetts doctors.

If you happen to be a doctor looking forward to a bright future of free meals, here is a portion of Davios’ steakhouse offerings. Lick your chops!

Former Emory Psychiatrist Criticizes Nemeroff

Dr. John Nardo, a former director of the psychiatry residency at Emory University, recently wrote the following letter to Adriane Fugh-Berman (founder of the website PharmedOut.org) concerning Dr. Charles Nemeroff. With Dr. Nardo's permission, I am publishing the letter in order to contribute to the ongoing debate about Nemeroff and particularly about his controversial recent appointment as the chair of the University of Miami's Department of Psychiatry.

Dear Dr. Fugh-Berman,

I am a retired Psychiatrist/Psychoanalyst in Georgia. After my Psychiatry residency at Emory [1974-1977], I stayed on the faculty while pursuing Psychoanalytic Training, and within a year found myself directing the Psychiatric Residency [for the next 8 years]. It was a hard time in Psychiatric Education. State, Federal, Private Hospitals, and Institutional support was evaporating as the "Community Mental Health" movement waned and Managed Care began its rise. When our aging Chairman retired, our new Chairman came full of zeal for drug research. After a year, I read the tea leaves, gave up my tenure, and moved to private practice - a dinosaur early in my career. I stayed on the faculty but mostly taught in the Community and in our Psychoanalytic Institute [in the Department of Psychiatry]. It was a fine career, even if it wasn't the one I planned.

The new Chairman was moving up, and so soon after I left, he moved to Administration. He replaced himself with the infamous Dr. Charley Nemeroff, which is why I'm writing. Meeting Dr. Nemeroff made me feel a lot better about changing gears. He seems, as you might imagine, a charlatan - very smart but always working a deal. He brought in Pharm money, so the residency was revitalized. That made Emory happy. He spent most of his time on the road, doing his CME thing, his political thing, whatever. I had another life, but watched my friends who had stayed roll their eyes. I will admit to some gleeful feelings when he was finally exposed and deposed in 2008. The rest of the world just found out what many in Atlanta had always thought.

I must say that I was dumbstruck when he was hired as Chairmen at Miami and I began to follow things more closely. Retirement allows such things. I was surprised how much feeling it all brought back. I was not an anti-biologist way back when. I had come to Psychiatry from a career in a research oriented academic internal medicine specialty. It wasn't Charley's orientation that bothered me, it was that I thought his research was at best trivial. It took me a while to figure out that it was his Pharm connections that lead to his success - that and his political connections [like the recent business with Dr. Insel at the NIMH].

Knowing my interest in all of this, last week my friends filled my email box with reports of the brochure for the GPPA [Georgia Psychiatric Physicians Association] Summer CME Meeting in August.

There he was, the featured speaker. So in spite of Dr. Goldschmidt's [Dean at Miami] reassurances, Charley is doing CME with this topic, "Management of Bipolar Disorder: Problems and Promises" - the operative word being "Promises." "Charlie committed to me that he would never make these mistakes again, and I am scrutinizing his activities to make sure that that remains the case," he said [Dr. Goldschmidt]. "As far as I can tell, Charlie does not engage in that type of behavior anymore, and I can tell you that if he was, I would know it."

There are no COI disclosures on the GPPA web site or in the brochure for the Conference Funding or for Charley, nor on the web site set up for COI by the University of Miami. I wrote asking about that. From the GPPA, I was told, "Thank you for your message. Financial disclosures from all faculty members are printed in the participant syllabus and included in the first slide of each speaker's presentation at the meeting. We have not received disclosures from all faculty at this point, which is why they are not published until the meeting. Is there a particular speaker you're wondering about? I'd be happy to share whatever information we have." I responded "Dr. Nemeroff," and never heard anything back. I wrote the University of Miami [twice] and finally got "Your question has been forwarded for response."

I was tempted to sign up for the GPPA and going to hear him just to see if he'll actually do it again, to see if "Promises" are the Atypical Antipsychotics in Depression, drugs made by companies that pay him. That's what he has done in the past. But pleasantly for me, there's a nice vacation already planned during that time, and frankly, sitting through one of Charley's talks again seems like a punishment for sins committed in some former lifetime. But whether he does it again or not, for the poster child for COI infractions [and worse] to be giving a CME with no COI disclosures is bad enough in its own right.

I'm an old guy that lives in a log cabin in the Georgia Mountains, so my muckraking resources are limited. I've written about it on a blog I keep for friends. That's the extent of my power these days. So I'm passing it on to you for whatever use it might be, or to pass on yourself if you can think of anyone else who might be interested. I've already written Dr. Carroll of HealthCare Renewal and Evelyn Pringle who is doing a series on this topic.

I appreciate the work you and PharmedOut are doing on this front, and wish you well in your attempts to do something about the PHARM invasion. In my specialty, that invasion has been particularly virulent, maybe fatal.

John M. Nardo MD

University of Michigan Bans Industry Funded CME

As originally reported in a New York Times article last week, with more coverage today in Med Page Today, the University of Michigan School of Medicine has decided to end all industry support of CME as of January 1, 2011. According to the dean of the medical school, "the decision was based on a review of literature about the influence on clinical faculty of industry-funded CME." Apparently the decision was made after a series of "town hall meetings" at the university and after the Chairs of the academic departments voted to end commercial CME.

We are witnessing a very gradual falling of the dominos, since U Michigan is now the fourth major medical institution in the U.S. to end commercial support of CME. In February of 2008, the Sloan Kettering Memorial Cancer Center in New York gave commercial CME the heave-ho (see my coverage here); East Carolina University's Brody School of Medicine is rapidly weaning its CME programs of industry support, to the point where currently only 0.75% of their CME budget is from industry; and Kaiser Permanente's mid-Atlantic region (which covers about 500,000 patients in Maryland, Virginia, and Washington DC) does not accept industry funding of CME. The new information on Brody School of Medicine and Kaiser was shared this past Friday at Pharmed Out's Prescription for Conflict conference at Georgetown University

Meanwhile, Stanford University is trying to distance itself from industry influence on CME, but is having a hard time giving up its addiction to the cash. While the dean had announced in August of 2008 that Stanford would no longer allow companies to sponsor specific courses, recently the University accepted a $3 million block grant from Pfizer for CME initiatives that would focus in certain specific areas of medicine, areas in which Pfizer markets pharmaceuticals. Presumably, Pfizer will have no influence on the content of the courses, but this is a line we have heard many time before, generally from for-profit Medical Education Communication Companies. Unfortunately, the firewall between the drug companies' promotional agendas and the educators' offerings inevitably thins out, especially when it dawns on the grantees that if the sponsors doesn't like the content of the courses, they'll find someone else to fund the next time granting decisions are made. As if to emphasize this economic reality, the Pfizer grant is actually structured as sequential one million dollar grants to be spread out over three years, presumably with the option of reassessment before the next payment is made. You can read details of the Stanford grant in their proposal to Pfizer here.

Carlat cynicism aside, it is commendable that Michigan has taken this courageous and principled step, and let us hope that other universities take note.

Latest Issue of Bioethics Journal Spotlights Ghostwriting

The current issue of the journal Bioethics focuses on the problem of ghostwriting in the medical literature and is well worth a read. At this point, the main three articles on the topic appear to be free (at least I was able to gain full text access today, and I have no subscription to the journal.)

The first article, by Tobenna D. Anekwe at Harvard School of Public Health, argues that ghostwriting is in fact a form of plagiarism. While ghostwriting is sometimes called "honorary authorship" in order to make it seem acceptable, Anekwe makes the following interesting point:

"Yet honorary authorship is a form of plagiarism
because it entails claiming authorship for work that
was done by others. The twist is that, here, the corporation
(the willing ‘victim’ of plagiarism) actually wants the
scientist to ‘steal’ its work and publish it as his or her
own. But surely this one difference makes industry ghostwriting
no more acceptable. Honorary authorship should
be frowned upon by the research community in the same
way that other types of plagiarism are frowned upon. Yet
it remains unclear from their policies whether universities
view this practice as being as serious as other forms of
plagiarism."

The second article, by Sismondo and Doucet at Queens University in Ontario, describes the insidious process known as "ghost management:"

"In this article, we present evidence that pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles. Ghost management allows the pharmaceutical industry to shape the literature in ways that serve its interests."

This fascinating trifecta is rounded out by a commentary penned by Carl Elliot and Amy Snow Landa at the University of Minnesota. The authors conclude that both ghostwriting and ghost management are unethical practices and will be difficult to regulate until the medical education companies and physicians who collude with the process feel the sting of litigation:

"Given the amount of litigation against the pharmaceutical industry in recent years, some of which has resulted in record-breaking penalties, it is surprising that no litigation has been directed towards medical writers, medical communications agencies, or the physicians who sign their names to ghosted articles. Maybe this is because these players are seen as mere instruments in a much larger marketing enterprise, or maybe it is simply that their pockets are not as deep. But if a few high-profile lawsuits were successfully aimed in their direction, it is a good bet that the practice of ghostwriting would come to a sudden halt."

Well said.

Uh Oh! Thomas Insel gets pulled into Nemeroff's World

One truism of professional life is that some favors, no matter how alluring, should be politely turned down. The trick is predicting which bestowers of favors spell D-A-N-G-E-R, and which do not. Unfortunately, it looks like Dr. Tom Insel, the director of the National Institute of Mental Health, made the mistake of accepting multiple favors from Charles Nemeroff, and he is now paying the price.

Several media outlets have covered this developing saga, or scandal, or Greek tragedy (following the analogy of the Trojan horse, the most famous examples of bad judgment in gift-accepting). The best and most thorough coverage is in this article in The Chronicle of Higher Education, which broke the story. Also, see today's coverage in the Washington Post, and ongoing coverage in Health Care Renewal.

Here's the digest of key events. Charles Nemeroff is a psychiatrist and researcher who makes friends easily, gives great talks, and exudes charisma and power. He's probably a genius and has an encyclopedic knowledge of neuroscience. Unfortunately, he has shown repeatedly that he is willing to bend institutional rules and play loose with the truth in order to accomplish his various financial and professional objectives. His self-imposed trials and tribulations are well known to readers of this blog.

The Low Points:

--2002: Nemeroff co-authored a review article saying wonderful things about an investigational antidepressant, mifepristone, without disclosing that he had a significant financial stake in the product. Nemeroff said that he would have disclosed the conflict of interest if the journal had only asked him to: "If there is a fault here, it is with the journal's policy." (see this coverage in the New York Times).

--2006: Nemeroff co-authored a positive review article about vagus nerve stimulation. The Wall Street Journal soon reported that Nemeroff neglected to disclose his significant financial relationships with Cyberonics (the maker of VNS), and that the article itself was possibly ghost-written by a medical writer hired by Cyberonics. This time, Nemeroff could not convincingly blame the journal, because he was the journal's editor-in-chief! He was soon forced to quit the post. (See my article covering the debacle here).

--2007: Nemeroff co-authored an industry-funded CME supplement to the journal CNS Spectrums which his "co-author" Linsey Devane called "ridiculous" and "inaccurate," and he claimed that Nemeroff had encouraged him to be involved "for the sake of selling CME time." (See my coverage here). Eventually, the ACCME determined that the article violated its Standards for Commercial Support because it was biased in favor of the Bristol-Myers Squibb's drug EMSAM.

--2008: Both the New York Times and the Wall Street Journal simultaneously broke the story that Nemeroff had consistently failed to disclose payments from GlaxoSmithKline for promotional talks, even while he was in charge of an NIH grant studying the company's drugs. This led to Nemeroff's resigning his chairmanship of the Emory University Department of Psychiatry.

Given Nemeroff's track record, I am surprised that Tom Insel agreed to endorse his standing with the NIH to Dr. Goldschmidt, the dean of University of Miami's medical school. The proper thing would have been for Insel to politely decline to discuss Nemeroff at all. In today's Washington Post, Insel is backtracking, saying that "I didn't recommend him" for the Florida job. But Goldschmidt's recollection of the phone conversation was that Dr. Insel "confirmed to me that Charlie was absolutely in fine standing" with the NIH, according to the Chronicle for Higher Education.

What a mess for Insel, for the University of Miami, for the NIH, and once again, for Charles Nemeroff. Now Senator Grassley is involved and is requesting all relevant information concerning the relationship between Insel and Nemeroff. Presumably, Insel's lapse of judgment in this matter was a result of his long-time friend "Charley" calling in favors--but exactly what those favors are will be determined once the documents are released.

File this under: "To be continued...."