Lub-dub, Lub-dub, Lub-dub...KA-CHING!

In a fascinating series of articles released yesterday, ProPublica details how a heretofore obscure medical organization, the Heart Rhythm Society, pulls drug and device company cash in hand over fist. You'll find the main article here, along with links to several companion pieces, my favorite being this devilishly fun interactive piece in which you can click on graphics of cardiologists sprinting to various industry-funded events and exhibits. Each time you click on a cardiologist, you get a list of the sugar daddy companies, along with details of how much was spent on what. It's more amusing than playing Angry Birds.

The bottom line is that nearly half of the $16 million in income received by the Heart Rhythm Society in 2010 was from companies producing heart devices and drugs. Not being a cardiologist, I can't judge how much the money has influenced the various treatment guidelines and CME programs the society has created. In written responses to ProPublica, the society's president and president-elect deny that there is any problem whatsoever:

"The society has sufficient measures in place to prevent undue influence from industry or introduction of industry bias into HRS-sponsored educational programs, research, scientific documents and policy initiatives."

I suggest you read all their responses to ProPublica's questions. There is an unmistakeable whiff of defensiveness and deception. There are certainly many questions that are answered circuitously or not answered at all.

Look, having undergone a cardiac procedure myself a year and a half ago, I'm all for cardiologists learning all they can and collaborating with industry when needed. But after reading ProPublica's allegations, along with the Heart Rhythm Society's flat-footed responses, I was left with the sense that there is more greed at work here than a sincere desire to improve the profession.

ACCME Seeks to Hide Drug Company Disclosures in the Fine Print

In an absolutely perplexing move, Dr. Murray Kopelow and the ACCME are proposing a revision to their Standards for Commercial Support that will undermine those standards. Currently, when an education company solicits money from industry to underwrite a course for doctors, they must disclose this inherent conflict of interest, and they often do so by printing the company's logo somewhere.

As an example, in Medscape's current online course called Diagnosis and Treatment of Major Depressive Disorder: Performance Improvement, you can see very clearly on the home page that the course is paid for by Eli Lilly:

This tells you that the course is likely to biased in favor of a Lilly product, and that you should hightail your way to a different website. But since it is offering you 20 free CME credits, you might be tempted to take the course. If you do, you will at least know that you should evaluate the content very carefully for bias.

Of course, simply displaying the supporter's name is hardly full disclosure. In my opinion, the supporter should be required to provide more information, including:

--The name of the product(s) marketed by the supporter that might be relevant to depression (in this case, Cymbalta and Symbyax.) Disclosing this is crucial, because many doctors do not know exactly which products a particular company markets, and therefore may not realize how the company has a financial stake in the CME program.

--The amount of money the supporter has paid the educational company to create the CME course. The more money that is at stake, the larger is the incentive for a company to bias the program in favor of the supporter's drug. Did Lilly pay Medscape $100,000 or $1,000,000 for this course? If it was $1,000,000 (and I'm guessing this figure is closer to the true amount), a learner would reasonably become even more skeptical about the scientific validity of the course.

But instead of increasing disclosure, ACCME is proposing a decrease in disclosure. They are, quite literally, proposing that all disclosures get buried in the fine print.

You can read the proposal here. The proposed new wording is:

“The provider’s acknowledgment of commercial support as required by SCS 6.3 and 6.4 under Standard 6 of the ACCME Standards for Commercial Support must only state the name of the company supplying the commercial support, in text format only. Disclosure cannot contain corporate logos and cannot mention or describe any other units within the commercial interest’s corporate structure.”

I assume that ACCME's motivations are pure--apparently it believes that it has already succeeded in scrubbing all commercial bias from CME courses, and that there is one loose end to tie up, which is getting rid of company logos. But the organization has deluded itself. In fact, commercial bias continues to be rampant throughout the CME world, and this proposal will be a great gift to drug companies and their education company sidekicks.

Any MBA will tell you that the best marketing uses advertising that doesn't look like advertising. That way, the customer does not realize that there is a hidden agenda. Commercial CME already is advertising disguised as medical education--this new proposal will make that disguise even more impenetrable.

House Votes to Repeal "Physician’s Oyster and Wine Takeaway" (POWT)

Hungry Massachusetts doctors seeking a return of free fine dining were salivating yesterday after the House voted to repeal the 2008 Physician’s Oyster and Wine Takeaway (POWT) Act, otherwise known as the Massachusetts Gift Ban. The fate of this mean and stingy bill now rests with the State Senate, which blocked a similar repeal effort last year.

The despicable POWT Act has forced Massachusetts physicians to pay for their own dinners at restaurants such as Davio’s, where an average entrée is 30 to 40 bucks, a chunk of change that our doctors simply cannot afford. Davio’s owner Steve DeFillipo has been on the forefront of anti-POWT lobbying efforts. In fact, he appeared on the Emily Rooney Show last year to debate the repeal effort with a local psychiatrist/blogger (see that blogger's coverage here).

Simply put, physicians need this food subsidy, because in Massachusetts, the median physician income is a paltry $216,700, according to the Massachusetts Medical Society. This is only 7 times the median Massachusetts income of  $30,751. Those who say that doctors are “10 times richer” than other people are engaging in ridiculous hyperbole.

The fact is, your doctor is hungry and shouldn’t have to pay for his own meal after having gone through medical school and residency. You try getting paged at 3 AM and to put an NG tube through someone’s nostrils. These are punishing experiences and doctors deserve special compensation.

Furthermore, as the Massachusetts Restaurant Association has pointed out so eloquently,


 "Restaurants provide much-needed seclusion from the everyday demands and distractions of the workplace. Medical practitioners and physicians are particularly taxed by time constraints and conflicting responsibilities."

Yes, commoners escape workplace demands by going home at 5 or by taking a stroll through a park during lunch. But doctors need raw oysters and wine after a hard day of work—plenty of it, free, and with fawning pharmaceutical reps complimenting them on their knowledge of vintages.

Hopefully the State Senate will realize that Massachusetts doctors have stronger ethical compasses than Massachusetts politicians, who since 2009 have been barred from receiving anything of value from lobbyists. Lawmakers are, indeed, vulnerable to inappropriate influence from meals and other gifts. But physicians would never prescribe more Abilify after enjoying a steak dinner funded by Bristol-Myers Squibb. After all, they’re doctors!

More coverage:

-CommonHealth Blog (WBUR)
-Boston Globe
-Health Care For All
-CBS BNET

"Performance Improvement" CME, Brought To You By Medscape and Eli Lilly

Performance Improvement CME has become all the rage in the world of continuing medical education. Otherwise known as PI CME, it is being touted by the AMA as the next big thing in medical education. You can read an AMA white paper about it here.

Not all medical specialty organizations actually require that physicians complete PI CME, but they are moving toward this. The American Board of Psychiatry and Neurology now requires something similar, which they call "self-assessment" CME, and it requires a robust program of medical learning to doctors, along with a minimum of 100 CME questions. There's more to it than that--I had to learn about it in order to get Carlat Publishing approved for it.

It's fine with me, thought it is another annoying hurdle for CME providers and for doctors, but maybe in the end it will force doctors to keep their knowledge more up to date. The problem is that there are no regulations regarding who can support these new and elaborate programs. Obviously, as you can see from the screen shot above, or by following this link, Medscape is already exploiting commercial funding. This is a PI CME program called "Diagnosis and Treatment of Major Depression: Performance Improvement." It is funded by Eli Lilly, maker of the antidepressant Cymbalta. I haven't gone through the program yet, but I'm willing to bet that there will be a lot talk about pain in depression. 


I hope someone out there can investigate this Lilly/Medscape joint endeavor to see whether it is biased or unbiased. Let me know your thoughts!

A New Smoking Gun in the APA Textbook Fiasco

A new piece of evidence has been unearthed by Phyllis Vine of MIWatch that the Nemeroff/Schatzberg textbook was indeed ghostwritten by STI, Scientific Therapeutics Information. Somehow, Vine was able to unearth STI's "portfolio" of publications, even though the company has since removed the incriminating pages.

I suppose APA might still hold to its guns, presumably by arguing that STI did no more than help to coordinate the project, perhaps by funnelling funds from SmithKlineBeacham to the American Psychiatric Press. That would be a stretch.

You can look at the suppressed web page yourself here. It is filled with the usual suspects--mostly industry funded supplements of various medical journals, including the Journal of Clinical Psychiatry, the preeminent producer of pseudo-CME supplements. Aside from the Nemeroff/Schatzberg book, STI also displays a book on the management of lipid disorders and a book on fungal infections.  Perhaps an enterprising reader of this blog will track down the funders and writers of those books.

This is all part of STI's portfolio. What is a "portfolio"? It is "A set of pieces of creative work collected by someone to display their skills, esp. to a potential employer." In this case, Nemeroff and Schatzberg got to not only claim the textbook as part of their own portfolios, but presumably they got paid for the honor. Niiiice.

 

APA Admits Ghostwriting, Prints Corrected Textbook Cover...

...in a fantasy world, that is.

The first version is the "corrected" Nemeroff/Schatzberg cover, followed by the current cover. Thanks to John Nardo, who corrected the inaccurate attributions on one of his recent blog postings.

Like a Bad Penny, the Nemeroff/Schatzberg "Textbook" Problem Returns

Do you remember the hoopla a few months back about a textbook apparently ghostwritten by medical writers hired by the makers of Paxil? Charles Nemeroff and Alan Schatzberg were the identified authors, but a letter was posted on the internet showing that STI, a medical writing company, had written a first draft of the textbook. See my posts here and here about the issue. The textbook, as published, ended up being a veiled advertisement for Paxil.

The APA responded by denying wrongdoing in the organization's official newspaper here. They claim possession of various documents proving that the textbook was not ghostwritten. The obvious rejoinder is, "show me the documents." This is exactly what psychiatrists Robert Rubin, Bernard Carroll, and professor Leeman McHenry asked Psychiatric News in this letter to the editor. They make the following entirely reasonable request:

"We call on the APA/APPI to release all the key documents. The contract between STI and GSK will reveal how much influence GSK had on the content and tone of the book, and the role of GSK in approving drafts. Correspondence between Drs. Nemeroff and Schatzberg and STI will make it clear whether they followed the contract.  Transparency also requires release of any GSK marketing/ business plans for the Handbook; the legal release form transferring ownership from GSK to the ‘authors’ and APPI; marketing activities of GSK sales representatives detailing the Handbook; and correspondence among all parties regarding the “unrestricted” educational grant."
 
Psychiatric News has refused to publish it. Here is their rejection letter.

I don't think this issue is going away. It's time for the APA to prove to the world that they were not complicit with a drug company in publishing a "textbook" that artfully hid Paxil's side effects.