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.

Has Stephen Stahl Gone Off the Deep End? You Decide.

A reader of my blog alerted me to this rambling blog post by Stephen Stahl on his NEI blog. I've pasted his article and my response below--or you can read the whole thing on his site. I’ll be curious to hear your thoughts. 

Here is Dr. Stahl’s post, dated August 23 2011:

"Are future psychiatric treatments doomed? Be careful what you ask for...you just might get it."

Nobody likes drug companies these days. Worse than tobacco companies and big oil companies! Supposedly they have ruined CME and have corrupted psychiatric experts as consultants, lecturers and research grant recipients! Drug companies only engage in expensive patent extension gimmickry and offer no true innovations! Let’s criminalize the marketing of psychiatric drugs, levy billions in fines to Pharma, force out their CEOs and even make them and their Pharma collaborators take the “perp walk” on their way to court in chains and orange jumpsuits and in front of the cameras! Get out of our professional societies! Get out of our journals! Get out of our medical centers! Good riddance!!!

Well, if that is what we have been asking for, we are now getting it. Drug companies have already largely pulled out of our meetings, our live CME and our medical centers. Next, the Pharma-scolds want Pharma to stop doing even legally sanctioned FDA activities such as peer-to-peer dinner meetings (many academic faculties now banned by their medical schools from participating), sampling by sales reps (many clinical centers ban reps), and legal freebies (no coffee or bottled water even allowed in Massachusetts let alone a book). If these Pharma nay-sayers and payors had their say, the new “American Textbook of Psychiatry” would be the Physicians Desk Reference with religious adherence to following the label. This in a field where over half of legitimate practice is off label! And this is progress? 

Pharma have heard these protests loud and clear and are now pulling out of psychiatric research. Two of the biggest defectors are the two British companies Astra Zeneca and GSK, who have shuttered all their laboratories for mental health research for good, closing facilities all over the world including those the US, UK and Italy and elsewhere. Also, Pfizer bought Pharmacia/Upjohn and closed their CNS research center in Kalamazoo, Michigan; bought Parke Davis and closed their CNS research center in Ann Arbor, Michigan; bought Wyeth and closed their CNS research center in Princeton, NJ; and then for good measure closed their own CNS research center in the UK. Merck closed their CNS research center in the UK where I worked in the 1980s, then bought Organon/Schering Plough and closed their CNS research center in the UK/Scotland for good measure. I could go on and on. This has had a devastating impact especially on the US and the UK. In fact, the UK has gone from a leader in CNS Pharma Research Centers, to having no big Pharma CNS research at all, with thousands of unemployed R and D scientists there and no prospect of CNS therapeutic innovation coming from their shores in the foreseeable future. 

Undoubtedly this is to the great delight of the anti-psychiatry community, lights up the antipsychiatry blogs (e.g., Carlat, http://carlatpsychiatry.blogspot.com/ ), who attract the Pharmascolds, scientologists and antimedication crowd who believe either there is no such thing as mental illness, that medication should not be used, or both. Did you know that psychiatric illnesses are pure inventions of Pharma and their experts to treat patients that do not exist with drugs that are dangerous and do not work with the purpose only of profiting themselves? Stop the profits! Make mental illness go away by legislation and committee! Treat human mental suffering with love and peace and all will be well! Who needs mental health professionals and their diabolical drugs anyway? 

If you were in the Pharma business, would you work with psychiatry anymore? So, we have gotten what many of us have asked for. No Pharma. But that also means no new drugs. This has sparked a crisis in mental health therapeutic research worldwide but especially in the UK and US. The UK in fact is having a crisis meeting at the Royal Society of Medicine in August, where I am attending with about a dozen others, including the head of the NIMH from the US, the head of the MRC from the UK, and various UK and US academic and industry leaders to discuss what we should do about this. The last time I went to such a meeting was in 1987, where I co-chaired a meeting on this same topic with the famous Paul Janssen (now deceased), the prize winning inventor of Haldol, Risperdal, Fentanyl, Lomotil, and more. At that time I stated that the future could not be more promising (Stahl 1987). What a difference 25 years makes! Returning now to the same Royal Society of Medicine with others, but now with our collective tail between our legs, we are stating that “things could not be worse.” Were the last 25 years of mental health treatments discoveries so worthless as to discard these efforts for the future? Once you stop things, it takes a long time to start it up again. David Nutt, UK psychiatrist extraordinaire and a good friend who will be at the meeting at the RSM, is recently quoted in the UK press as saying, "What we have forgotten, and must not forget, is if we stop this research we will have a dead space of 20 to 30 years before we can re-tool again.”

If we shut down, then we and our patients with depression, schizophrenia and other mental illnesses lose hope for any improvement in their situation in our lifetimes. I still think we can innovate (Stahl 2006), but we need a new model and I will get back to you with suggestions from the Royal Society of Medicine meeting when I return. Some good ideas are coming mostly from Europe as the US is still intent on shutting down Pharma. As a former Lilly president told me recently, “We will someday be a great Chinese drug company.” To reverse this trend and keep this industry in the US, we can try to support innovation through the NIH, and I have volunteered to serve on advisory committees on new drug development if that ever gets off the ground; but this NIH drug development effort is now threatened by the current US budget austerity. We can try to do it though academia, or small companies. The ECNP (European College of Neuropsychopharmacology) of which I am a member has some creative ideas which I strongly support such as trying to persuade drug companies to share the information they already have, putting details of their research and unused potential drug discoveries into a "medicines chest" that outside organizations can exploit, with the ECNP providing insurance against any potential litigation. Medicines for brain disorders take longer to develop than for other conditions - on average, 13 years - and there is a high failure rate. It looks like the UK and the Europeans are much more active in trying to resuscitate mental health therapeutics, while we in the US remain hell bent on destroying what is left of it. We can join the British and the Europeans and move forward, or we can completely kill this industry and wait a decade or two, while experiencing no progress and thus leave a legacy of no innovation and no apparatus to innovate. We will have to see if our children or grandchildren who become mental health professionals want to rebuild a Pharma industry that is interested in mental health or if yet another industry leaves the US for good.

Be careful what you ask for. You might just get it.

Here is my response, dated August 27, 2011:

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.

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.

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.

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.

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 an incredibly complex mechanism and we have 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.

Syracuse Restaurant Becomes "Pharmaceutical Dinner Facility"

In a rather embarrassing attempt to raise revenues, a restaurant in Syracuse, New York, is now explicitly marketing itself as a purveyor of drug company dinners.

Francesca's Cucina, "Located in the heart of Syracuse's Little Italy," according to its website, offers a private banquet room, a private outdoor courtyard, and regular tables and a bar to drug companies wanting to use fine food and alcohol to convince doctors to prescribe their drug over a competitor's drug.

Massachusetts passed a law banning such tactics in 2009, and I have posted about restaurants' unsuccessful efforts to repeal that law. In one post, I coined the term "trickle down deception" to describe restaurant owners' rationalizations of drug company dinners. This is the unfortunate process in which otherwise moral business owners blind themselves to the ethical implications of their decisions. The deception supply chain trickles down from manipulative promotional plans of drug companies to hired gun doctors, restaurants, advertising companies, medical writing companies, etc.... Basically, if the money's out there, someone will grab it.

I'm assuming that Francesca's Cucina makes a bundle on these dinners, considering the fine meals they are encouraging drug reps to buy doctors:

Yes, as they say on their website, "Francesca's Cucina is the premier facility for pharmaceutical dinners in the greater Syracuse area." It's a sad state of affairs when a restaurant brags about such a thing.

Hat tip to Steve Balt, MD for alerting me to this website.

A Blood Test for Depression? Really?

This month's Psychiatric Times has an interesting article (requires a subscription) about putative blood tests for diagnosing schizophrenia and depression. Because most of my patients have either depression or anxiety, I skipped to the section on a new depression blood test marketed by Ridge Diagnostics. Called the "MDDScore," the test measures 10 biomarkers, including cortisol, brain-derived neurotrophic factor, prolactin, and several other chemicals I never heard of. According to the Psych Times article (which was based on a presentation at the APA's annual meeting in May), the test has been validated by comparing 80 depressed patients with 50 healthy individuals. A test score of 6 to 9 was "highly predictive" of depression, and statistically differentiated the depressed from the healthy.

But I'm skeptical about this test. Why? First, none of the data have been published in a peer-reviewed journal, though I presume some have been submitted. Second, how useful is a depression blood test if all it can do is to differentiate depressed people from healthy people? I'll wager that my teenaged daughter would be just as accurate as the MDDScore in differentiating a depressed person from a healthy person based on a 5 minute conversation. Imagine buying an electromagnetic field detector to determine whether a shirt is red or blue. Sure, it will work, but the eyes can do it more quickly and for free. 

Here are a couple of crucial questions for Ridge Diagnostics, and for any company hawking a depression blood test:

1. Can the MDDScore differentiate depression from any other psychiatric disorder, such as anxiety disorders, adjustment disorders, bipolar disorder, substance use disorder, ADHD, and psychotic disorders? I'm pretty certain that the necessary studies have not been done. If the test cannot distinguish different psychiatric problems, then the MDDScore is simply a non-specific "biomarker" for emotional difficulties of all stripes, and would be essentially useless.

2. Does the MDDScore detect depression as well as the PHQ-2, which consists of two simple questions: "During the past month have you felt depressed or down? During the past month have you been bothered by having little interest or pleasure in doing things?" A high score on these two questions is 83% sensitive and 92% specific for depression (see reference here). Can this $745 blood test even approach these numbers?

Until Ridge Diagnostics can provide compelling answer these two questions, the money paid for the test is, more than likely, money down the drain.

The Biggest Chantix News: Pfizer's $12.3 Million Buys No News

By now most of you have heard about this recent study linking the use of Pfizer's anti-smoking drug Chantix with a small increase in heart attacks and arrhythmias. The meta-analysis of 14 double-blind controlled trials indicates that in patients without a history of heart disease, Chantix increases the rate of serious cardiac events from 0.82% of those assigned to placebo to 1.06% of those on Chantix. This is not a huge increase, but considering the millions of people who are prescribed the drug yearly, it could amount to a large public health problem.

Another piece of big news (to those of us who follow the world of industry-supported CME) is the fact the Pfizer-funded smoking cessation program, CS2day (Cease Smoking Today) doesn't mention the study on its website. Recall that CS2day was announced with much fanfare in 2008, when Dr. George Mejicano convinced Pfizer to pay $12.3 million for a national CME program to educate doctors about how to help patients quit smoking (see the Medical Meetings article here). The program was quickly criticized for not disclosing Chantix's many side effects in one of its CME programs.

Given that this new meta-analysis is hitting most major news outlets, you would think that the multi-million dollar CME website could find a writer to post something about the study. But apparently this is something Pfizer would prefer that physicians not get continually medically educated about.

File under: CME programs that are noncompliant with AMA's new ethical guidelines.

Apres le Deluge: The CEJA Spin Cycle Begins

When the AMA adopted the 5^th version of the CEJA report on industry-funded CME, it seemed clear that this was an ominous and very bad sign for the future of industry-funded CME. I already posted my take on the report here (short version: say goodbye to most industry CME). Now we are beginning to see how industry supporters are responding. Basically, they are saying, or maybe just desperately hoping, "Feh! It's no big deal."

 

They were singing a different tune before the vote. As was true for the prior CEJA CME reports, MECCs (medical education communication companies) and their supporters maligned the document. The Alliance for CME, the main trade organization for MECCs, had released this statement recommending that many sentences in the recommendations be stricken—essentially any sentence that challenged the status quo.  

ACRE, a relatively new organization composed of physicians who  vigorously defend financial relationships with drug companies issued what amounted to a white paper calling for the rejection of the report. ACRE found so many things wrong with CEJA 5.0 that its critique ran three pages longer than the report itself.

A couple of weeks before the vote, Medical Meetings magazine published an editorial by columnist and MECC owner Stephen Lewis angrily attacking CEJA as being an “oxymoron” because it “seems to have forgotten the critical link that exists between ethics and evidence.”

And five days before the vote, Thomas Sullivan, the owner of the MECC Rockpointe, who writes the influential pro-industy blog Policy and Medicine, reviewed and agreed with the Alliance for CME’s position that the CEJA report be canned.

So much for the run up. Now that the report has been adopted, industry advocates appear to be quickly distancing themselves from these prior alarmist views about CEJA.

Two days after the vote, Thomas Sullivan was almost celebrating. Headlined “AMA CEJA 2011: AMA House of Delegates Approves Report – Now Emphasis on Value of CME in Patient Care,” his post was nonchalant. Far from seeing this as a threat to industry funding, Sullivan now argued that the report “merely reflects an alignment of AMA policies on CME with the ACCME, HHS OIG, and the PhRMA and AdvaMed Code of Ethics.  Commercial support of CME will still remain a valuable resource for CME providers to help keep physicians up to date on the latest breakthroughs and treatments.”

Medical Marketing & Media, a publication financially dependent on pro-industry stakeholders, published an article that appeared to be journalistic coverage of the decision but which was essentially an editorial saying "don't worry, be happy." The article emphasized that CEJA 5.0 does not call for an “all out ban” on industry funding, but instead “places the moral onus on physician presenters to disclose to learners their financial interests in the topic they are speaking about.”

Derek Warnick, an industry CME director and blogger, responded with an entertaining and thoughtful post in which he concludes that “If I had to guess (OK, I don’t HAVE to guess, but I’m going to anyway), I would say that CME providers may be asked to provide a little more documentation about faculty selection and conflict resolution processes, but I don’t anticipate any major shake-ups.” 

Meanwhile, the only person whose opinion anyone cares about has remained silent. That would be Murray Kopelow, the director of ACCME. If you email ACCME for his response (as I did) you will receive the following official statement: “We are currently reviewing the CEJA Recommendations and the Board of Directors will be deciding on any next steps.” The next board meeting is July 21 in Chicago, so we will probably not get any response until they publish their Executive Summary of that meeting, probably a month or so after it occurs. 

Meanwhile--into the void--let the spinning continue. 

AMA Votes to Discourage Commercial Support of CME

Something huge happened yesterday at the American Medical Association House of Delegates meeting in Chicago. Although the meaning of what happened will be spun throughout the blogosphere, twittersphere, and schmuckosphere, the bottom line is that the AMA just voted most commercial funding of CME out of existence.

Specifically, the delegates voted to approve a report of the AMA ethics committee that calls for a near elimination of industry support for CME. The report is entitled "Financial Relationships with Industry in Continuing Medical Education," and can be read in its entirely here.

It is a 12 page report, and CME geeks like me will want to pore over every word, but the essence is found on page 8 under "Recommendations." The third paragraph makes the intent of the AMA explicit:

"CME that is independent of funding or in-kind support from sources that have financial interests in physicians‘ recommendations promotes confidence in the independence and  integrity of professional education, as does CME in which organizers, teachers, and others  involved in educating physicians do not have financial relationships with industry that could influence their participation. When possible, CME should be provided without such support or the participation of individuals who have financial interests in the educational subject matter." (emphasis added)

What this means is that the AMA now expects that most CME courses will meet two criteria:

1. No commercial support for the activity.

2. Faculty teaching the CME should have no financial relationships (such as being on speakers' bureaus) with drug or device companies.

The report does allow for some exceptions to these criteria: "At times it may be impossible to avoid a financial interest or extraordinarily difficult or even  impossible to mitigate its potential impact on an educational activity." They cite examples such as courses involving the use of very expensive material, such as cadavers or sophisticated equipment. Also, they allow that in some remote parts of the country it may be acceptable to take industry money to fly out experts to teach doctors. However, in that same "exception section," they reiterate that: "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."

What happens next? Since the AMA literally defines "AMA PRA Category 1 Credit" for the ACCME, any company that deviates from the recommendations of this report will be non-compliant with ACCME's criteria for CME. ACCME itself will have to revise its Standards for Commercial Support to clarify that in most cases, commercial support is no longer allowed.

None of this will happen overnight, of course. But you can bet that medical societies and medical education companies that are dependent on commercial support are, even as you read this, holding emergency conference calls with their attorneys to figure out what they need to do next. 

We have finally entered the era of post-deception medical education. Congratulations to the AMA.