Tuesday, August 26, 2008

Stanford's Dean Announces Tougher CME Policy

According to a story by Gardiner Harris in today's New York Times, Stanford University will announce a new policy intended to make it harder, if not impossible, for drug companies to influence the content of CME courses.
To quote from the article:

On Tuesday, Stanford plans to announce that it will no longer let drug and device companies specify which courses they wish to finance. Instead, companies will be asked to contribute only to a schoolwide pool of money that can be used for any class, even ones that never mention a company’s products.

With its approach, Stanford becomes the sixth major medical school — including those at the universities of Massachusetts, Pittsburgh, Colorado, Kansas and California Davis — to form schoolwide pools for university contributions to medical education, according to the Prescription Project, a nonprofit organization that largely opposes industry financing of medical education. The
Memorial Sloan-Kettering Cancer Center, meanwhile, has banned all industry support for its doctor classes.

For an in depth explanation of Stanford's new policy, as well as an interesting description of the process leading up to its adoption, see Stanford Dean Philip Pizzo's statement here. Here are the key points:

1. The new policy is based on the work of a Task Force on Industry Support of CME which provided the Dean with a menu of options, including the possibility of banning all industry funding.

2. The impetus for the Task Force included several reports on industry funding of CME that I've covered in earlier postings, including the AMA's CEJA proposal, the Macy Foundation report, and the recommendations of the American Association of Medical Colleges (AAMC).

3. While the policy is described in the New York Times as prohibiting companies from specifying which courses they finance, the actual policy wording is disturbingly more nuanced, and appears to allow companies to at least specify the therapeutic areas to be supported. Here is the passage of most relevance to this critical issue, with the my highlighting:

At the same time, the School recognizes that industry may wish to provide CME program support that is not designated to a specific subject, course or program but that is intended for use in a broadly defined field or discipline or field of study. Accordingly, if such support from industry for CME is received it must be directed to the Office of Continuing Medical Education. The Office of Continuing Medical Education will be responsible for coordinating and distributing funds for CME programs in the following general categories: medical, pediatric and surgical specialties; diagnostic and imaging technologies and disciplines; health policy and disease prevention; or other areas approved by the Office of CME. Such industry support cannot be designated for a specific course or program, but every effort will be made to direct support, as appropriate, to the specified general areas of interest, as noted above.
While this new policy is absolutely a step forward, the devil will be in the details of how it is implemented by Stanford's CME Office.

6 comments:

Sara said...

I attended several lectures at Stanford given by a famous -- and very popular -- sleep researcher. The theme of his message was good in that it emphasized the dangers of sleep deficit but later I learned at least one of his courses receives funding from the makers of Ambien and it's true that he was praising Ambien in his lectures and even referred to his own use of the drug. He emphasized how safe (and harmless) it is which I now know is somewhat misleading at best. Still I guess we have to applaud this somewhat half-hearted step of trying to limit influence at Stanford. Medical schools have gotten darn used to all the pharma money and it's going to take a lot to break the habit.

Martina said...

Editorial

Nature Neuroscience 11, 983 (2008)
doi:10.1038/nn0908-983

Credibility crisis in pediatric psychiatry
Abstract

Our understanding of the neurobiology and treatment of psychiatric illness in children remains poor. Prominent psychiatrists have now been accused of concealing the extent of their financial ties to the drug industry. We urgently need to encourage more science in this area and we need vigorous regulation to restore some neutrality to the field.


http://www.nature.com/neuro/journal/v11/n9/pdf/nn0908-983.pdf

Gina Pera said...

Sara,

I assume you're talking about Dr. Dement.

People who've come to ADHD support group meetings say the Stanford Sleep clinic advised surgeries to remove soft throat tissue, saw their jaw in half, and all kinds of other 16th Century-sounding remedies for so-called obstructive sleep apnea—all before ever screening for ADHD.

We now have good evidence that dopamine plays a role in restless-legs syndrome (which isn't a joke) and sleep apnea, but the "sleep experts" have been slow to acknowledge this. And if they do, it's so they can develop novel dopamine-targeting drugs, instead of using existing ones. (Territory and grants.)

Many people with alleged obstructive sleep apnea have ADHD/dopamine-related issues with sleep regulation. (Yes, the throat opens while we're sleeping, thanks to signals to/from the brain regarding oxygen levels. When that signal processing doesn't happen in a timely manner, sleep apnea is a result. Of course, there are allegedly exceptions due to slack muscle tissue, obesity, etc. but I've seen no good data that rules out dopamine regulation in these people, too.)

CPAP machines are typically recommended first, despite the fact that many patients with ADHD do not follow through on using them or that the machines don't mitigate all or even most symptoms. But the machines obviously are lucrative for someone.

Do so-called "sleep experts" acknowledge ADHD's sleep issues and try stimulant medication, which actually helps many people with ADHD get the best sleep of their lives? No, because--my best guess--they don't want to cede ground to the ADHD specialists. Greed and arrogance at the helm of your healthcare decisions.

I sat through an afternoon lecture at Stanford where Dement spun his theories. Then his acolyte, Clete Kushida, took audience questions. I asked for his recommendations for patients whose untreated ADHD issues prevent good sleep. He said, "Yes, insufficient sleep can present as ADHD symptoms." He completely flipped my question around. They are bound and determined that it's the sleep insufficiency that causes ADHD, and will not consider the facts. (Their surgical brethren attempted to prove the same with pediatric tonsillectomies—that they would "cure" ADHD-- using an n of 12 and lousy, subjective follow-up.)

About 8-9 people came up to me afterwards, saying they'd been to the sleep clinic, did as instructed, and their ADHD symptoms weren't any better.

My long-winded point: yes, we really should be watching the medical device makers, too, not to mention the surgeons who'd rather saw someone's jaw in half rather than admit the problem might originate in the brain--and be highly and safely treated with a pill. A pill they don't have to re-invent.

James M. La Rossa Jr. said...

Sorry to toot our own horn, but the following journal articles are available on-line at http://www.medscape.com/index/list_3091_0 and are completely devoid of any sponsorship whatsoever. They were chosen SPECIFICALLY because there are no conflicts. Physicians have options; they may be harder to find, but they are out there:

*Are SNRIs More Effective than SSRIs? A Review of the Current State of the Controversy Serotonin-norepinephrine reuptake inhibitors may be modestly more effective than selective serotonin reuptake inhibitors in the management of depression. The current review examines research comparing these 2 medication classes in detail.
Psychopharmacology Bulletin, July 2008

*Patterns of Pharmacotherapy and Treatment Response in Elderly Adults with Bipolar Disorder Little research has examined current treatment of bipolar disorder among older adults. The current study provides data on prescribing practices as well as the efficacy of these practices.
Psychopharmacology Bulletin, March 2008

*The Revised Dopamine Hypothesis of Schizophrenia: Evidence From Pharmacological MRI Studies With Atypical Antipsychotic Medication Does the revised dopamine hypothesis have supporting evidence? This review evaluates fMRI studies that combine PhMRI and dopaminergic manipulation with atypical antipsychotics in schizophrenic patients.
Psychopharmacology Bulletin, March 2008

*Psychosocial Interventions for Bipolar Disorder: A Review of Literature and Introduction of the Systematic Treatment Enhancement Program Adjunctive psychosocial treatment appears to offer more positive outcomes for bipolar disorder than pharmacotherapy. The rationale for including psychosocial intervention in bipolar disorder relapse prevention and symptom management is described.
Psychopharmacology Bulletin, February 2008

*Concordance With Treatment Guidelines for Bipolar Disorder: Data From the Systematic Treatment Enhancement Program for Bipolar Disorder Concordance with treatment guidelines for psychiatric illness is generally poor. The current study examines medication and dose concordance after training in evidence-based care for bipolar disorder.
Psychopharmacology Bulletin, November 2007

*Do Antipsychotic Drugs Influence Suicidal Behavior in Schizophrenia? Antipsychotics can have a negative, null or positive effect on suicidality in schizophrenic patients. Whether and how antipsychotics affect suicidal behavior is reviewed in light of relevant research.
Psychopharmacology Bulletin, November 2007

*How Long Do Psychiatrists Wait for Response Before They Switch to Another Antipsychotic? There is little evidence to help physicians decide when to change antipsychotic medications in schizophrenia. The current study examines common practices among psychiatrists.
Psychopharmacology Bulletin, November 2007

therapyfirst said...

But what about the alleged leaders of our field, the American Psychiatric Association, who in their illustrious example-setting, makes physicians who are board certified since 1994 have to be recertified every ten years and now HAVE TO complete 30 CMEs a year (my state only makes me complete 25 a year-huh?).

I found a letter to the editor of the Association of American Physicians and Surgeons in the September 08 newsletter very interesting. I will rewrite it word for word, and you, the reader, define from it what you will:

"I'm in the miserable process of recertifying. Numerous vendors are eager to sell the credit hours needed to study for the test-which is taken at a center where examinees sit at computer terminals and are monitored, at a cost of $1500. Who profits? The APA. It sells the self study-based on a 2004 book that lauds nefazadone, which is no longer on the market. How do patients benefit when doctors forget current information to learn now out-dated information to pass the test? It will get worse when we need patient evaluations-as from angry dementia patients whom I advised to quit driving."
(the author then goes on for another paragraph to talk about the perils of EMR--electronic medical records--an issue not related to this blog but certainly an issue for all physicians in this millenium)
by Martha Leatherman, MD, from San Antonio, TX

Maybe her comments are not directed about pharma related CMEs, but I feel there is a tie in. If the APA, who not only feeds at the trough of pharma greed, but sells sites to sit there as well, can tie in pharma related info to the board recert, (hell, probably is a factor to Parts I and II now!) then what will docs do if we do not tow the pharma line to get our certs!?

Serious questions to serious issues!

just a thought.

James M. La Rossa Jr. said...

TF—my thoughts exactly. We used to charge $30.00 for three Category 1 credits in all of our journals. In 1997, I attended the APA meeting, where I got my hands on an APA CME workshop list and after doing the math, figured that MEMBERS were paying, on average, $127.00 per credit hour. (Not including travel and hotel costs.) Before the meeting was even over, we dropped our charge to $22.50, or $7.00 p/credit. Soon thereafter, we began to offer free CME, and many journals followed. I am not sure if many of the top journals still offer free CME.

Academic journals, like Psychopharmacology Bulletin, are hard-pressed to put CME within the journal because many of our articles are original research which should not be the subject of "testing." We do have an agreement to put a few articles per issue on-line for FREE CME credit, as you can note from my abovementioned posting.

I have spoken with DC about this. I would love to see him develop an electronic "CME Filing Cabinet" software where physicians can pull CME from a variety of electronic sources and store the tests on a database if they are ever audited. (I wanna see at least one of you guys get rich on figuring out this CME morass before I die!)

My view, as I've stated before, is that CME should NOT be mandatory, but should be treated like Category 2 CME—via the honor system. (Do you know that you are required to have credits every three years in Category 2 CME as well, but you are not audited on this because your journal reading and writing is assumed?! Isn't participating on this blog "education?")

Let "Free Market Principles" dictate who keeps up with the literature and who does not. I believe that physicians will always want to gather with colleagues at meetings, grand rounds and the like, where new medical information will be discussed. Doctors who don't keep up will be challenged by patients, who (like it or not) are becoming highly educated themselves. And God-forbid you are ever sued, the first thing the opposing lawyer will ask you on the stand is about your level of ongoing education. So, it is in everyone's best interest— legally, socially, and financially—to keep up with the literature. If society can't hold physicians (who've spent seven years of higher learning as is) to the honor system regarding their continuing medical education without worrying about a dimming of medical services, than we have more problems that the APA, the WPA, or the AMA can handle. Note there is no mention of the ACCME in the last sentence. They should be abolished. And that, friends, will be the end of that. Cheers, j.

ps--everyone please check out DC's link to the latest diagnosis -- Motivational Deficit Syndrome at http://www.youtube.com/watch?v=RoppJOtRLe4. You'll have a good laugh...promise. Well done Dr. Carlat!