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.

New Feature: CME Rogue's Gallery

We've been beefing up the Carlat CME Institute, a website whose mission is to support excellence in non-industry-funded CME. Our latest feature is the "CME Rogue's Gallery" in which we keep a running list of the most blatantly promotional CME programs that cross our path. Currently we are spotlighting a program funded by Mylan Pharmaceuticals to increase prescription of the MAOI EMSAM, and a program created by Stephen Stahl, funded by Avanir, to increase prescriptions of Nuedexta.

Please visit the site and nominate your own entries to the CME Rogue's Gallery.

Dr. Stahl's Medical Writer Fights Back

Dr. Stahl's controversial post on the evils of pharmascolds and antipsychiatry has attracted nearly as many comments as all of his prior blog posts combined. Most of the comments have been highly critical of his viewpoint. But we have yet to hear a response from the man himself. However, his medical writer, Debbi Ann Morrissette, PhD, has just mounted a spirited rebuttal to my comment. At the end of her comments, she writes that she will try to post it as a comment on my blog, but she fears that it will not show up because, in her words (and her capitalization): "MOST COMMENTS THAT ARE NOT "ANTI-PHARMA" ARE CENSORED THERE AND NOT POSTED WHEN SUBMITTED." Well, I can assure her that I very rarely reject any comments on my blog--unless they use extreme profanity or appear to be libelous. Just to save her the trouble of registering with Google, I will post her entire comments as a regular blog entry below.

The following was originally posted on August 31, 2011 by Debbi Ann Morrissette, PhD, as a comment on Dr. Stahl's blog post, "Are future psychiatric treatments doomed? Be careful what you ask for...you just might get it."

Re: Are future psychiatric treatments doomed? Be careful what you ask for...you just might get it.
FACT CHECK - KEEPING THEM HONEST
Dr. Carlat posted the following comment but fact checking shows that he has his facts wrong. See fact checking in CAPS below his various assertions:

August 27 comment:

Dr. Stahl: Your rant is long on rhetoric but short on fact.

Your key argument appears to be that increasing regulations on pharmaceutical marketing techniques have led to the drying up of the CNS pipeline. While you provide no evidence to back up your argument, there are many reasons to question this.

CARLAT ASSERTION:
1. Other fields of medicine have seen a boom in new agents--diabetes, oncology, and cardiology are examples. New rules in academic medical centers limiting participation in speaker’s bureaus, access to drug reps, and gifts from drug companies have applied in these fields as well as psychiatry--but appear not to be limiting innovation.

FACT:
ALL FIELDS OF MEDICINE HAVE SEEN A DECLINE. 50% FEWER NEW MOLECULAR ENTITIES (NMEs) WERE APPROVED IN ALL THERAPEUTIC AREAS IN THE LAST 5 YEARS COMPARED TO THE PREVIOUS 5 YEARS (PAUL S ET AL). In 2007, for example, only 19 NMEs (including biologics) were approved by the FDA, the fewest number of NMEs approved since 1983, and the number rose only slightly to 21 in 2008. 21 new drugs were approved by the FDA in 2008, and 24 in 2009 (Paul S, et al, Nature Reviews Drug Discovery 2010, 9:203-214

CARLAT ASSERTION:
2. In psychiatry, many potentially novel agents have been developed and tested during the "pharma-scold" era but have failed in clinical trials because they have simply not worked, not because medical schools have told their faculty not to accept money to tout them. Examples are numerous, and include Substance P antagonist and mifeprestone for depression, J & J's anti-amyloid bapineuzumab for dementia (along with many other anti-amyloid agents from other companies), and Lilly's anti-glutamate agent mGlu2/3 for schizophrenia.

FACT: ALTHOUGH SEVERAL SUBSTANCE P ANTAGONISTS HAVE BEEN DROPPED FROM DEVELOPMENT, CONTACTING THE COMPANIES DIRECTLY REVEALS THAT MIFIPRISTONE IS STILL IN PHASE III; THAT BAPINEUZAMAB IS VERY MUCH ALIVE AN MOVING AHEAD IN MANY LARGE TRIALS WITH WYETH/PFIZER/ELAN/JNJ, AND THAT THE LILLY mGLUR 2/3 IS VERY MUCH ALIVE IN PHASE III

CARLAT ASSERTION:
3. Drug companies have introduced many psychiatric medications over the last two decades, but they have made the business decision to invest heavily in me-too agents, some of which, such as Pristiq and Invega, are embarrassingly blatant patent-extenders with no clear advantages over existing agents. Perhaps if companies had invested more resources into developing truly novel compounds, they wouldn’t be in the pickle they are in.

FACT: THE SUBSTANCE P ANTAGONISTS WERE NOVEL, AS WERE THE CRF1 ANTAGONISTS, NEUROKININ 2, NEUROKININ 3, BETA 3 AGONISTS, AND MANY OTHERS THAT FAILED TO SHOW CONSISTENT EFFICACY. AGOMELATINE IS NOVEL AND FACES AN UNCERTAIN FUTURE IN THE US BECAUSE OF POTENTIAL HEPATOTOXICITY. OVER A DOZEN NOVEL MECHANISMS WERE ADDED ON TO ANTIPSYCHOTICS TO TEST COGNITIVE IMPROVEMENT, FROM 5HT6, TO NICOTINIC AGONISTS, AMPAKINES, MANY MORE. THE FACT IS THAT INDUSTRY IS PUNISHED FOR PURSUSING TRULY NOVEL COMPOUNDS AND REWARDED FOR ME TOOS.

The reason that some companies are pulling out of CNS drugs is not because of the Carlat Blog (though I’m flattered that you believe I have so much clout) but because the brain is incredibly complex mechanism and we yet to work out the basic neurobiology underlying mental illness. As a psychiatrist, I prescribe drugs all the time and I know both their promise and limitations. Far from being “anti-psychiatry,” I would welcome novel drugs to ease my patients’ suffering.

Please show us some evidence for your position. That would be better than more low blow ad hominem attacks on those of us who are trying to improve the pharmaceutical industry by making it more ethical.
By Daniel Carlat on Saturday, August 27, 2011

THIS MAY BE A BIT THIN SKINNED ON DR. CARLAT'S PART AND IS FACTUALLY INCORRECT. DR. STAHL'S POST STATED THAT THE SITUATION DELIGHTED ANTIPSYCHIATRY AND PHARMASCOLD BLOGS BUT HE DID NOT MENTION ANY PERSON, AND STATING THAT THOSE BLOGS (AS WELL AS SOME OF THE COMMENTS ABOVE ON THIS BLOG) HAVE ANTIPSYCHIATRY, ANTIMEDICATION AND ANTI-PHARMA COMMENTS IS SELF EVIDENT, AND DOES NOT COMPRISE AN AD HOMINEM ATTACK.

ALSO, CORRECTING ERRORS HERE BY DR. CARLAT IS NOT AN AD HOMINEM ATTACK. ON THE OTHER HAND, CALLING DR. STAHL THE ENEMY, ACCUSING HIM OF GOING OFF THE DEEP END, HAVING BLOGGERS ACCUSE HIM OF BEING MENTALLY ILL, SAYING THAT HE HARMS PATIENTS BY DIAGNOSING MENTAL ILLNESS AND TREATING WITH MEDICATION ON THE OTHER HAND, ARE AD HOMINEM.

I WILL TRY TO POST THIS SET OF FACT CHECKS ON THE CARLAT BLOG, BUT MOST COMMENTS THAT ARE NOT "ANTI-PHARMA" ARE CENSORED THERE AND NOT POSTED WHEN SUBMITTED, SO IT PROBABLY WILL NOT BE SEEN THERE.