On Stephen Colbert, Super PACs, and Industry-Supported CME

The current New York Times Magazine carries a fascinating and quite hilarious profile of Stephen Colbert, of the Colbert Report. Colbert is well known for his parody of a know-nothing rabidly conservative Republican commentator—but according to the article he has taken his comedy into the real world, involving himself directly in those shady instruments of electioneering known as “super PACs.”

For those who haven’t followed super PACs, they are the political equivalent of the CME industry’s Medical Education Communication Companies (MECCs). Super PACs can take unlimited amounts of money from corporations, then turn around and use the money to promote candidates of their choosing—with the stipulation that they are not directly “coordinating” with their favorite candidates, whatever that means.  Analogously, MECCs can take unlimited amounts of money from drug companies, then turn around and use the money to pay doctors to promote the company’s products—with the stipulation that they cannot coordinate their CME courses directly with drug companies, again, whatever that means.

In both examples, a third party is being used by corporations to circumvent an inconvenient regulation. In the case of super PACs, companies can circumvent Federal  Election Commission (FEC) rules that limit campaign contributions to a maximum of $2500 per individual (super PACs can accept millions from individuals). In the case of MECCs, drug companies circumvent ACCME Standards for Commercial Support forbidding direct payments to doctors for CME, by laundering the money in the form of  educational grants to third party CME companies.

Colbert, in an effort to expose how corrupt super PACs are, has actually started his own super PAC, entitled "Americans for a Better Tomorrow, Tomorrow."  As quoted in the Times article, Colbert facetiously defends his and other super PACs by pointing out that they are “100 percent legal and at least 10 percent ethical.”

I’ve never heard a better characterization of industry-supported CME.  Let’s hope that Colbert continues his unorthodox lessons in the ways of money, corporations, and corruption.  For his next project, I suggest he start his own MECC, named, perhaps, “The Institute for Healthcare Education and Prescription Promotion.” 

APA Threatens to Sue "dsm5watch" Website

I just read Bernard Carroll's interesting post on the Health Care Renewal Blog about the latest DSM-5 brouhaha. It appears that the American Psychiatric Association has sent a "cease and desist" letter to a website critical of the DSM-5. The site was called "dsm5watch," but the APA argues that using DSM-5 in the blog title is an infringement of their trademark. The owner of the blog, Suzy Chapman, having no funds to tussle with APA lawyers, simply changed the name of her site to dxrevisionwatch, which, she says, has resulted in much less traffic.

Is the APA simply protecting its ownership of a lucrative franchise, or is it engaging in something more insidious, what Dr. Carroll calls the "SLAPP maneuver," an acronym for "strategic lawsuit against public participation"? I'm guessing that APA would have had little problem with the site if it were cheerleading the DSM-5 process. It all seems rather heavy-handed to me. After all, the New York Times appears to have no problem with the anti-Times site called TimesWatch. In a democratic society, healthy dissent and debate is part of the package. It may be annoying, but that doesn't excuse the bullying tactics that the APA has chosen.

The Gig is Up: The Sunshine Act Will Include CME Payments to Doctors

Those of us who have followed the progress of the implementation of the Physician Payment Sunshine Act have been acutely aware of one potential loophole: drug companies might try to hide payments to doctors for industry-supported CME activities. That’s because these payments are not "direct" payments to doctors, but rather indirect payments.

In a 2007 op/ed piece for the New York Times, I referred to this arrangement as a money laundering scheme: “Essentially, this is a new twist on that well-known instrument of corruption, money laundering. Drug companies don’t directly pay doctors to teach courses. Instead, they pay someone else to cut the checks. Similarly, the drug companies don’t explicitly tell doctors to say good things about their products. Instead, they hire a company to write good things about their products and to pay doctors to deliver the messages.” 

Nothing substantial has changed about this cloak and dagger payment process since 2007—other than the fact that the total amount of commercial support for CME has dropped substantially, from a high water mark of $1.2 billion in 2007 to $830 million in 2010—a decrease of  37%. But $830 million is still a chunk of change, and some unknown portion of that sum is paid directly to physicians by the CME provider.

Therefore, those of us in favor of transparency were able to breathe a sigh of relief when CMS recently unveiled its proposed regulations. Drug companies will, in fact, be required to report payments that flow through third party entities and end up in doctors’ pockets, as long as the company is aware of the identity of the doctor. And how could they not be aware? ACCME requires all CME programs to publically disclose the identities of both the industry supporter and the faculty—meaning that companies will eventually always know which doctors end up partaking of their “educational grants.”

In closing this loophole, CMS officials were hardly acting on their own—they were simply implementing the Sunshine Act as it was approved by Congress. In fact, if you look at the text of the Act, it is hard to imagine any reasonable interpretation other than CMS's. Here’s the crucial opening paragraph of the law, which sets the context for the entire Act:

“On March 31, 2013, and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer that provides a payment or other transfer of value to a covered recipient (or to an entity or individual at the request of or designated on behalf of a covered recipient), shall submit to the Secretary, in such electronic form as the Secretary shall require, the following information with respect to the preceding calendar year….” (my italics).

The language is technical, so let's unpack it a bit. “Applicable manufacturer” means a drug or device company. “Transfer of value” means giving a doctor anything of value, including cash, meals, and gifts.  “Covered recipient” means a physician, dentist, podiatrist, optometrist, or chiropractor—all of which are professionals covered by the law. So far, the law is saying, in common parlance, “Any drug company that gives money or something else of value to a doctor…will have to report this to the government.”

But the framers of the Act went out of their way to acknowledge that sometimes these payments are indirect, and that such indirect payments should be reported as well. How else could you interpret all the language in parentheses: “ …Or to an entity or individual at the request of or designated on behalf of a covered recipient.”  To translate again: the Act is saying here that drug companies must report payments to any “entity” (eg., a MECC, a medical society, a non-profit organization) that takes payments from drug companies when those payments are actually “designated” for a “covered recipient”, ie., a doctor.

It seems quite clear, but of course both drug companies and those MECCs dependent on drug company grants are viewing this issue differently--see, for example, Tom Sullivan's take in this article on his blog Policy and Medicine. So stay tuned. Hopefully CMS will stick to its guns and issue final regulations that will not allow drug companies to cast a shadow on a major source of physician payments. Let the sun shine in!

Conflict of Interest--From a Patient's Perspective

This month's issue of Health Affairs carries this fascinating article (free full text) written by a woman with MS who found out her neurologist made $300,000 in speaking and promotional activities in 3 years.

The writer, Maran Wolston, also happens to be a professor of medical ethics, so she renders her personal story in a particularly thoughtful way. When she first met her neurologist 5 years ago, she found out that he was being paid to do clinical trials of MS drugs, which gave her some pause--but she chose to stick with him because she thought his involvement in research might lead to better care. He invited her to participate in a trial he was doing, but after learning about the possible side effects, she declined. Six months later, he told her that her disease had worsened, and recommended Copaxone, a drug that required self-injections daily or every other day. While it caused fewer side effects than some generic alternatives, she found the injections very painful, and after several months she stopped it--and her neurologist agreed this is was a good idea. 


But a year later, he found she had worsened again, and recommended the drug Tysabri. She researched it and learned about a checkered FDA approval history, and more alarmingly a rare but potentially deadly side effect. It was then that a friend told her about the Minnesota database of drug company payments to doctors. She learned that her neurologist had been paid $300,000 over 3 years by the makers of both Copaxone and Tysabri. 


I like how thoughtfully she responded to this information:


"In fact, I have no idea whether my neurologist’s advice and judgment were affected by his relationships with the drug industry. But because I was his patient, the effect of those relationships was not a theoretical question—an issue to be bantered about over coffee or in the seminar room. It would have been foolish of me not to consider the possibility that the relationships were affecting my care. Having MS is difficult enough. The last thing I needed was to worry about whether my neurologist was acting in the best interest of the drug companies or in the best interest of me, his patient."

To find out what happens next, go read the article at the source in Health Affairs. The bottom line is that transparency, once it is implemented as part of the Physicans Payment Sunshine Act, will mean different things to different people. But ultimately, it will improve our health care system, because it will help to clarify when incentives are appropriately based on patient welfare, and when they are based more on money.

(Thanks to WBUR's Commonhealth blog for alerting me to this article).

Eli Lilly's "Pain TV": Are they serious?

Sometimes in the CME field you come across something that seems so embarrassing for everybody involved that you just have to shake your head and wonder what they were thinking. So here is the link to Medscape's ACCME Accredited Category 1 CME activity called "Pain TV", supported by an "unrestricted educational grant" from Eli Lilly, manufacturer of Cymbalta, which recently won the FDA indication for chronic musculoskeletal pain--in addition to its indications for depression, generalized anxiety disorder, diabetic neuropathic pain, and fibromylagia. According to Pharma Marketing Blog, each new indication means another $500 million in the bank for the company.

To ensure that it will gain its windfall, Lilly has teamed up with Medscape, several academics on speakers bureaus for multiple companies, and lord knows what other ancillary production and medical writing companies, to produce a lavish 12 part series called "Pain TV" in which they will "educate" doctors about how to diagnose lots of patients with chronic pain, and how important it is to treat it. Will they blatantly push Cymbalta as the very best treatment? Of course not, since that would reveal the promotional intent of this CME program. Instead, they will teach us about the horrors of pain, the dangers of opiates, and about a new non-addictive treatment with a recent FDA approval for the condition that Lilly is paying millions to educate doctors about.

Maybe Cymbalta is, indeed, a miracle drug for chronic pain. Maybe all pain patients would benefit enormously from it. I'm not a pain specialist, and therefore I am in no position to judge the relative advantages or disadvantages of Cymbalta for pain. I'm certain there are thousands of complicated studies in the medical literature that have some bearing on whether Cymbalta is the go-to medication for this condition--and I am also certain that reasonable doctors would disagree about the relative merits of these studies. Accredited CME is supposed to be a way for doctors to learn about best medical practices from unbiased and credible colleagues. Unfortunately, I'm assuming that doctors who are paid by Lilly (indirectly via Medscape in this case) will have an overwhelming financial incentive to emphasize the strengths of Cymbalta and the weaknesses of its competitors--which is the very definition of commercial bias. It doesn't mean that Pain TV isn't of some educational value--many promotional activities can be quite educational. Just don't pretend that it meets ACCME's criteria for accredited CME.

I am certain that this is not the kind of CME that the AMA's new ethics guideline condones: "For the most part, accepting support from a company or permitting participation by an individual when there is an irreducible financial interest would not be ethically acceptable."

But then again, maybe I'm misreading the intent of these guidelines. Perhaps the AMA would be all for a CME activity in which Lilly funds a 12 part TV show highlighting a disease state for which it happens to have a treatment all dressed up and raring to go.

FDA Slams Viibryd: Better Sexual Profile Claim “Not Supported by the Data”

The September 2011 issue of the Journal of Clinical Psychiatry created history in two ways.

First, the journal published this article written by FDA staff critically reviewing the efficacy and safety data of Viibryd, a new antidepressant that the same FDA staff had just approved.

Second, it was not just any journal that published the article, but the Journal of Clinical Psychiatry. Why is this so historic? Anybody who has followed this blog over the years has noticed a certain…shall we say, skepticism...toward many of the articles published in JCP, especially those published in its industry-funded supplements. But in this case I'm happy to give the journal kudos for having the courage to publish an article critical of an antidepressant made by a company that pays for drug ads.

Not that any of this information is truly new. Back in April of 2011, my own Carlat Psychiatry Report actually scooped JCP on this issue, when Jim Phelps and I reported in this article that Viibryd-funded authors had tweaked sexual side effect data to make the drug appear “cleaner” than its SSRI competitors.  (Some of this tweaking, interestingly enough, occurred in the pages of the Journal of Clinical Psychiatry).

In fact, as we reported and as this new paper elaborates, the studies proved nothing at all about Viibryd’s side effects, because they artfully omitted a crucial element—the inclusion of a comparator SSRI known to cause sexual dysfunction.

The other claim put to bed by the FDA is the idea that Viibryd is quicker to work than other antidepressants. This was based on one of Forest’s trials which showed that Viibryd separated from placebo by week one. The FDA’s article pointed out two problems. First, this data was from Trial 04, which was only one of two large trials submitted as part of the new drug application. In the other trial, Trial 07, Viibryd did not separate from placebo until week 4. Second, neither trial compared Viibryd with an already approved SSRI, meaning that no statements can be made about the new drug working faster than any other drug.

It’s nice to see the FDA stepping up to the plate and proactively publishing articles that dispel company-spread rumors about drug effectiveness. And it’s also great that a usually industry-friendly journal like JCP would publish this.

New Study: Biomarkers are Cool, but Nearly Useless for Predicting Alzheimer's

Everybody would like to find a brain scan or a blood or spinal fluid test to predict Alzheimer's disease. Such objective tests seem inherently more reliable than the clinical interview.

Recently we've seen various studies identifying biomarkers for predicting who will develop Alzheimer's. The problem is that most of the studies are merely suggestive, though they are so complex that they create a veneer of definitiveness. The usual technique is a sort of statistical fishing expedition. First, you identify a group of people who are at risk of developing Alzheimer's. Second, you collect boatloads of data, such as from brain scans, blood draws, or spinal fluid specimens. Third, wait a couple of years to see which patients develop Alzheimer's. Finally, have a computer sort through dozens--sometimes hundreds--of possible biomarkers until you find one, or a combination  of several, that correlate with developing Alzheimer's.

There are many variations on this theme, of course, but this is basically how biomarker research is done. The problem is that the more biomarkers you test, the higher the risk that you'll find a correlation that isn't a valid biomarker--but is just a random finding that has little to do with Alzheimer's.  In order to test the utility of biomarkers, you have to choose a few likely candidates, and see if they actually predict Alzheimer's...and you have to compare the predictive power of the expensive biomarkers with the cheap old fashioned method--the clinical interview.  Amazingly, almost no such studies have been done--and not a single study has compared multiple types of biomarkers with the clinical interview. That is, until now. 

An article published in the latest issue of the Archives of General Psychiatry compared specific neuroimaging findings and spinal fluid markers with a clinical interview. Over a two period, the researchers found that only three variables were able to significantly predict which patients would develop Alzheimer's: two clinical measures of memory, and one neuromaging finding--the thickness of a part of the temporal lobe. By far the most important predictor of cognitive decline was a combination of a brief survey of activities of daily living and 5 minute paper and pencil test. These two combined explained 50% of the variance in outcomes, which is a very large number in these kinds of studies.

The bottom line is that if you want a test to predict whether a patient is going to progress from mild cognitive impairment to Alzheimer's, stay away from the needle.  A careful clinical interview, repeated over time, is overwhelmingly more effective than these expensive tests.