NPR's Science Friday: The Science of Clinical Psychology

NPR's Science Friday with host Ira Flatow will feature a segment, The Science of Clinical Psychology, that will broadcast Friday, December 4th, 2009.

Description:

How solid is the science behind clinical psychology? A group of practitioners suggests a new accreditation system for clinical psychological research training programs may be necessary to help ensure that the methods used by clinical psychologists are up-to-date and backed by scientific research. Not everyone agrees that approach is warranted, however. We'll talk about it.

Guests
Richard McFall
Executive Director, Psychological Clinical Science Accreditation System
Professor Emeritus, Department of Psychological and Brain Sciences
Indiana University, Bloomington
Bloomington, Indiana

Bruce Wampold
Professor and Chair, Department of Counseling Psychology
Clinical Professor, Department of Psychiatry
University of Wisconsin, Madison
Madison, Wisconsin

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Big Pharma's Crime Spree

Alliance for Human Research Protection reports:

BIG PHARMA'S CRIME SPREE is a riveting report by David Evans in the current
issue of Bloomberg Markets Magazine relying on recent criminal legal
settlements. It leaves no doubt about the fact that Big Pharma's buiness
practices are defined by criminal activities. Finding cures is not even
remotely a consideration for this industry, as it would present a financial
conflict of interest.

shorter version:
http://www.bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA&pos=10

"Across the U.S., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death. Since May 2004, Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses."

"About 15% of drug sales in the U.S. are for unapproved uses without adequate evidence the medicines work." The widespread off-label promotion of drugs for untested, unapproved uses is a manifestation of a health-care system that is dysfunctional as it is costly. Americans are paying exorbitant prices for drugs that put their lives at increased risk of death. Indeed, a conservative estimate by the
Institute of Medicine (2000) is 106,000 preventable deaths from non-error adverse prescription drug effects.

In September 2007, New York-based Bristol- Myers paid $515 million-without admitting or denying wrongdoing-to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases.

The evidence is inescapable: "Marketing departments of many drug companies don't respect any boundaries of professionalism or the law," says Jerry Avorn, a professor at Harvard Medical School. Indeed, rather than having a deterrent effect, the number of Big Pharma high profile criminal settlements is increasing and the settlements are getting bigger.

Bloomberg documents how companies such as Pfizer and Eli Lilly--each has been prosecuted repeatedly for the same crimes--are, if anything, emboldened as repeat offenders--ignoring FDA admonitions, as well as promises made to the Department of Justice not to break the law.

In January, 2004, "the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses. New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company's lawyers assured prosecutor Michael Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes. What Loucks, who's now acting U.S. attorney in Boston, didn't know until years later was that Pfizer managers were breaking that pledge not to practice so-called offlabel marketing even before the ink was dry on their plea."

"Jeff Kindler, who became Pfizer's general counsel in 2002, supervised the lawyers who made the promises to prosecutors. By 2004, Kindler increased the compliance budget 12-fold."

"What Pfizer's lawyers didn't tell the prosecutors was that Pfizer was at that moment running an off-label marketing promotion using more than 100 of its salespeople" who were pitching Bextra for pain, a use the FDA explicitly forbade Pfizer to promote! In 2001, the FDA had rejected Pfizer's application to market Bextra for pain because in clinical trials the drug had shown it could cause heart damage and death.

In her guilty plea (March 30, 2009), Mary Holloway, a Pfizer regional sales manager for the Northeastern US, acknowledged that her team promoted Bextra to doctors without disclosing the risks, and also acknowledged that her team "had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn't mention the increased risk of heart attacks in their marketing..."

Kindler became chief executive officer in 2006. In Pfizer's ethics guide, he says stories about misbehaving companies and executives abound. "Pfizer truly stands apart," he says. "I am proud of our record."

Instead of being held accountable for criminal marketing practices Pfizer and its corporate divisions engaged in, on Oct. 1, Kindler was elected to the board of the Federal Reserve Bank of New York.

ESCALATING PENALTIES
Includes criminal fines and civil penalties. Source: Court records

RAP SHEET
Pharmaceutical companies paid about $7 billion in fines or penalties for
illegal off-label marketing during the past five years. Here are some of the
biggest.

COMPANY DATE OF PENALTY DRUG(S) Amount MILLIONS

Pfizer September 2009 Bextra, others
$2,300.
Lilly January 2009 Zyprexa
1,415.
Serono October 2005 Serostim
704.
Purdue May 2007 Oxycontin
634.
Cephalon September 2008 Actiq, Gabitril, Provigil
425.
Schering-Plough August 2006 Temodar, Intron A
435.
Pfizer (Warner-Lambert) May 2004 Neurontin
430.

Source: Bloomberg / Federal court records

The amounts of Eli Lilly's fines and penalties have soared during the past 25 years.

$25,000 APRIL 1985: Pleads guilty to 25 misdemeanors for misbranding
Oraflex.
$36,000,000 DECEMBER 2005: Pleads guilty to one misdemeanor count for
misbranding Evista.
$1,415,000,000 JANUARY 2009: Pleads guilty to one misdemeanor count for
misbranding Zyprexa.don't

But those fines are tiny compared to the revenues from criminally marketed
sales:
Eli Lilly Zyprexa sales from criminal marketing yielded the company $36
billion from 2000 to 2008.

And Pfizer's recent $2.3 billion settlement in fines and penalties for the illegal marketing of Bextra, Geodon, Zyvox and Lyrica pales in comparison to the $16.8 billion the company garnered from its criminal marketing of these drugs. Indeed, the total penalties Pfizer has paid in settlements--$2.75 billion, since 2004--is but 1% of the company's revenue of $245 billion from 2004 to 2008.

Dr. Avorn points out that "The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients."

Despite the fact that in five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking Zyprexa for dementia-twice the death rate for those taking a placebo--Lilly aggressively marketed the drug for off-label use in children and the elderly.

Even more shameful than the pharmaceutical industry's blatant criminal practices, drug companies "find ready and willing partners in physicians"
who wantonly prescribe dangerous drugs for untested, off-label uses for cash
kickbacks.

Bloomberg reports that "Pfizer's marketing program offered doctors up to $1,000 a day to allow a Pfizer salesperson to spend time with the physician and his patients." If profits "uber ales" is the overriding goal, and human casualties are viewed as so much shrapnel, then Big Pharma has been hugely successful-billions in sales and hundreds of thousands buried.

In 2004, Neurontin sales reached $2.12 billion-- according the prosecutors' sentencing memo, 94% of those sales came from off-label use.

Much like the large financial institutions, Big Pharma companies are shielded by the rationale, "too big to fail." The government is reluctant to use the ultimate sanction which would put an end to criminal marketing-namely, a felony conviction that would render a company's drugs ineligible for reimbursement by state health programs and the federal government.

However, "a legal fig leaf" allows a parent company (such as Pfizer) to continue to receive government federal reimbursement for hazardous drugs that have been criminally marketed--even as one after another of the company's subsidiaries has pleaded guilty.

Pfizer and its executives have thus successfully avoided criminal culpability while paying the settlements but maintaining that it was not responsible for the illegal actions of the dozens of companies it acquired--actions that continued after Pfizer acquired them:

Bloomberg reports: "From 1995 to 2005, Pfizer purchased more than 20 companies. Since 2004, companies that are now Pfizer divisions have pleaded guilty to off-label marketing of two drugs. Pfizer continued off-label promotions for these medications after buying the firms, according to Pfizer's Sept. 2 guilty plea and FDA correspondence with Pfizer.

Pfizer first stepped into an off-label scheme in 1999, when it offered to buy Morris Plains, New Jersey-based Warner-Lambert Co. Prosecutors charged that Warner-Lambert marketed Neurontin off-label between 1995 and 1999.
Warner-Lambert admitted doing so for one year in a May 2004 guilty plea for
which Pfizer paid $430 million in fines and penalties."

Despite all this, "Pfizer maintains its good standing with such agencies because its subsidiaries, Warner-Lambert and Pharmacia-Upjohn, and not the corporation itself, entered the guilty pleas to felony charges."

While Big Pharma executives have evaded justice, Scott Harkonen, one former CEO of a small company, InterMune, has been convicted of illegal marketing of its only drug, Actimmune, for uses not approved by the FDA. He's out on bail, awaiting sentencing.

"As prosecutors continue to uncover patterns of deceit in off-label marketing by pharmaceutical companies, millions of patients across the nation remain in the dark."

Doctors have become pill pushers who blindly prescribe the latest, most expensive medications based on deceptive marketing by drug company salesmen.

The result is documented in hundreds of thousands of preventable drug-induced deaths, and unsustainable healthcare expenditure. What's especially disturbing is that nowhere in the proposed healthcare reform bills are life-threatening crimes by pharmaceutical companies in collusion with doctors who abuse their medical prescribing licenses even addressed.

Expanded Bloomberg Market Magazine version with tables, side-bars, upon request

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

Risky Psychosurgery Given Optimistic Spin by New York Times

The Alliance for Human Research Protection reports:

True to an ignoble tradition of lending its "authoritative" front page to promote psychiatry's most radical experimental approaches to dealing with patients disabled by mental illness, today's front and center article in The New York Times, "Surgery for Mental Ills Offers Both Hope and Risk," by Benedict Carey, sends an optimistic positive spin on psychiatry's current spade of experimental brain surgeries. A large photograph--rather than compelling evidence--attempts to lend the story significance.

The article acknowledges that the new surgeries are not backed by new scientific evidence of their benefit to justify the serious risks involved: "The great promise of neuroscience at the end of the last century was that it would revolutionize the treatment of psychiatric problems. But the first real application of advanced brain science is not novel at all. It is a precise, sophisticated version of an old and controversial approach: psychosurgery, in which doctors operate directly on the brain."

Indeed, Paul Root Wolpe, a medical ethicist at Emory University, acknowledges the high risk experimental procedures that patients are being put through: "We have this idea - it's almost a fetish - that progress is its own justification, that if something is promising, then how can we not rush to relieve suffering?"

But, Dr. Wolpe reminds readers, "It was not so long ago, he noted, that doctors considered the frontal lobotomy a major advance - only to learn that the operation left thousands of patients with irreversible brain damage. Many promising medical ideas have run aground, and that's why we have to move very cautiously."

Despite "large gaps" in the neurosurgeons' understanding of the brain circuits they are operating on, several surgeries are currently being promoted: cingulotomy, capsulotomy, brain stimulation (DBS), and radiation(gamma knife surgery)--all pose high risk for patients with little demonstrable evidence of success.

In cingulotomy, doctors drill into the skull and thread wires into an area of the brain called the anterior cingulate. "There they pinpoint and destroy pinches of tissue that lie along a circuit in each hemisphere that connects deeper, emotional centers of the brain to areas of the frontal cortex, where conscious planning is centered."

"This circuit appears to be hyperactive in people with severe O.C.D., and imaging studies suggest that the surgery quiets that activity."

The evidence to justify the risks does not exist: neurosurgeons proceed on what "appears" and imaging studies that "suggest" but do not demonstrate.

In capsulotomy, "surgeons go deeper, into an area called the internal capsule, and burn out spots in a circuit also thought to be overactive."

Surgeons who perform DBS, sink wires into the brain but leave them in place. "A pacemaker-like device sends a current to the electrodes, apparently interfering with circuits thought to be hyperactive in people with obsessive-compulsive disorder (and also those with severe depression). The current can be turned up, down or off, so deep brain stimulation is adjustable and, to some extent, reversible."

The technique described in the Times article is called gamma knife surgery. "Doctors place the patient in an M.R.I.-like machine that sends beams of
radiation into the skull. The beams pass through the brain without causing damage, except at the point where they converge. There they burn out spots of brain tissue..."

Underscoring the danger these latest neurosurgical procedures pose, Dr.Darin D. Dougherty, director of the division of neurotherapeutics at Massachusetts General Hospital and an associate professor of psychiatry at Harvard, put it more bluntly." Given the history of failed techniques, like frontal lobotomy, if this effort somehow goes wrong, it'll shut down this approach for another hundred years."

The evidence, from a small long-term follow-up study, reported by the respected Swedish Karolinska Institute in the Archives of General Psychiatry, [1] found that 50% of 25 patients treated with any of the commonly used surgeries for OCD, showed that response rates did not differ significantly between surgical methods.

"Only 3 patients were in remission without adverse effects at long-term follow-up."

"One of the 9 patients undergoing radiosurgery (patient 20) developed a right-sided radiation necrosis with subsequent apathy, memory problems, and executive dysfunction. Another (patient 10) developed a brain edema that reached its peak size 1 year after surgery; the patient was hospitalized with symptoms of apathy, incontinence, and seizures. At long-term follow-up, urinary incontinence, apathy, and executive problems persisted. In both cases, complications may have been caused by too high a radiation dose. Another patient who underwent multiple thermocapsulotomies (patient 8) had persistent urinary incontinence at long-term follow-up. Symptoms of apathy and poor self-control for years afterward."

"A mean weight gain of 6 kg was reported in the first postoperative year. Ten patients were considered to have significant problems with executive functioning, apathy, or disinhibition. Six of these 10 patients had received high doses of radiation or had undergone multiple surgical procedures."

Conclusions: "Capsulotomy is effective in reducing OCD symptoms. There is a substantial risk of adverse effects, and the risk may vary between surgical methods. Our findings suggest that smaller lesions are safer and that high radiation doses and multiple procedures should be avoided."

The invariably positive claims made by proponents of neurosurgery are likely explained by the inherent bias of these stakeholders. As Dr. Christian Ruck, the lead author of the Swedish paper, published in the Archives of General Psychiatry correctly notes:

"An inherent problem in most research is that innovation is driven by groups
that believe in their method, thus introducing bias that is almost impossible to avoid."

So why, did the New York Times once again, see fit to publicize admittedly
high risk, radical surgical procedures that demonstrably cause at least half
of the patients serious long-term debilitating adverse effects that
undermine their quality of life? [2]

Reference:

1. Christian Rück, MD, PhD; Andreas Karlsson, MS; J. Douglas Steele, MD,
PhD, MRCPsych; Gunnar Edman, PhD; Björn A. Meyerson, MD, PhD; Kaj Ericson,
MD, PhD; Håkan Nyman, PhD; Marie Åsberg, MD, PhD; Pär Svanborg, MD, PhD
Capsulotomy for Obsessive-Compulsive Disorder: Long-term Follow-up of 25
Patients. Arch Gen Psychiatry. 2008;65(8):914-921.

2. See NYT Archive on psychosurgery:
http://www.psychosurgery.org/news-opinion/archives-of-the-new-york-times/
For example, in 1948, the Times reported: "A revolutionary discovery about
mental illness, which has already resulted in surgical cures with no
apparent ill effects for a group of asylum inmates who had been considered
hopelessly insane, was revealed to a specially called meeting at the New
York Society of Neuro-surgery yesterday." SURGERY RESTORES 'INCURABLY'
INSANE: Revolutionary Brain Operation Called Topectomy Removes Tissues in
Certain Areas Mar 19, 1948.

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

Happy Thanksgiving from the Society for Humanistic Psychology

Matthew Ashdown and Brad Morris, who call themselves "The GratiDudes," started a dance they call "the Gratitude Dance" out of a moment of celebration at a coffee shop in Victoria, BC. We can hardly imagine a better way to put yourself in the spirit of Thanksgiving! Have a wonderful Thanksgiving holiday, and blessings to you and yours.

Is Psychotherapy Behind The Times, Or Just What You Need?

Tamara McClintock Greenberg, Psy.D. at Psychology Today reports:

Let's say that you, the average person, have an emotional problem you want help with. You decide that you need not only the opinion of an objective third party, but the expertise of a psychological professional. You look for therapists either by a personal referral or through your health insurance network. You find someone who has an opening for an appointment and you go to your first session. How do you know that this therapist can really help you?

This is the subject of a recent Washington Post article by Timothy Baker, Richard McFall and Varda Shoham. This provocative commentary claims that many doctoral programs in psychology are not training qualified practitioners who can adequately conduct psychotherapy. As a consequence of their education, few therapists are trained in clinical practices that are considered more effective than conventional therapy, for example, exposure therapy for post-traumatic stress disorder or other behavioral modification methods. The authors go on to report that "graduate programs in psychology do not select science oriented students to begin with and do not train students to understand and use science once they are involved."

But what is the science of psychology?

For many therapists these days, science in psychology is ubiquitous with cognitive and behavioral therapy approaches. CBT is often recommended for an array of common mental disorders. However, there is no overwhelming evidence that CBT is the most effective treatment for many complex mental illnesses that we therapists see in our clients and patients. In an important article on this topic, Ronald Levant (2004) observes that "ideal" CBT patients tend not to be the ones that show up in our offices everyday, and that the theories behind CBT don't explain what it is in psychotherapy that helps people get better.

For example, Levant points out:

-Specific techniques account for about 15% of how we explain therapy outcomes.

-"Therapeutic relationship" (involving a patient's feelings about their therapist as a person, and what is shared among all therapeutic techniques) accounts for about 30% of therapy outcomes.

-Randomized Controlled Trials on which CBT studies are based, may lack external validity (meaning they don't generalize to the real world), because manuals are used in studies that often don't mirror what is said to patients in real world practice.

-The majority of patients are excluded from typical studies. Why? Because to participate in these studies, an emotional condition has to meet specific criteria. Patients recruited for these studies can only have one "Axis I disorder," such as depression, generalized anxiety disorder, panic disorder, and post-traumatic stress disorder. Yet, less than 20% of all mental health patients have only one Axis I disorder. Comorbidity excludes over 75% of patients in most studies because many individuals have more than one kind of psychological disorder; for example, many people with depression also have generalized anxiety disorder, based on our diagnostic system.

So what this all means is that although CBT is useful for some patients, most of the people who come to us for treatment have multiple and complex conditions. In my clinical practice, many of my clients are confronting demands related to aging and/or illness. These real world problems are what cause people to experience many kinds of symptoms, often those that cannot be addressed by straightforward CBT approaches. Many of my patients simply don't have the energy to do all that's required for cognitive behavioral therapies, which often requires "homework," the practice of particular skills, not to mention the stress associated with the "exposure therapy" referred to by the Washington Post authors.

The Baker, McFall and Shoham article ends by saying there are many "highly effective treatments" for mental disorders. Their critique implies that anything not "scientific" shouldn't be considered as a valid way to carry out psychotherapy. However, there is ample research supporting a variety of different approaches to psychological issues and conditions.

CBT offers great tools for changing unwanted behaviors, and when I see how some people benefit from them, I am grateful that these methods are available. But this is a small minority in my practice. And in my experience, long-term approaches, such as psychodynamic psychotherapy, are more effective for most of the people who come to therapy for real change. An In Press article in the American Psychologist by Jonathan Shedler describes how a "one size fits all" approach for psychotherapy is simply incorrect. Equally as important, longer-term approaches have scientific backing too.

Unfortunately, Baker, McFall and Shoham conflate the issue of scientifically informed psychotherapy with the differences in training between the different doctoral degrees.

As for the Psy.D./Ph.D. controversy, which I expect will be an ongoing issue, my experience as a psychotherapist, educator and writer of psychology is that these debates have a perennial nature. And now, with the precarious future of both healthcare and clinical research, it is not surprising that this issue is being debated again. In such an uncertain climate, threats to our profession can feel overwhelming. Just last week, Medicare announced potential cuts for specialist services. We are all worried about what the current healthcare bill and the economic climate will mean for the treatment of our patients. While I do not blame the authors of the Washington Post article for expressing their views, to do so by critiquing one small aspect of the vast field of psychological research and discrediting the intensive education of Psy.D. programs does a disservice for all of our friends and neighbors seeking psychological help and treatment.

For more comments and discussion of the Washington Post article, see Letters To The Editor, including a response from James Bray and Norman Anderson of the American Psychological Association.

References

Levant, R. (2004). The Empirically Validated Treatments Movement: A Practitioner/Educator Perspective, Clinical Psychology: Science and Practice, 1(1), 219-224.

Shedler, J. (2009) The efficacy of Psychodynamic Psychotherapy. American Psychologist, In Press.

READ ARTICLE HERE

Radical Evil: Robert Stolorow on the Work of Richard Bernstein

At The Huffington Post, Robert D. Stolorow has written an introduction to Richard Bernstein's philosophical research on the phenomenon of evil. Here is an excerpt. Follow the link at the end of the article to read the rest of the article:

Richard Bernstein, professor of philosophy at the New School for Social Research, has written an important philosophical inquiry into the phenomenon of evil (Bernstein 2002), an inquiry that will be of great value to psychoanalysts as they confront the problem of evil both in their consulting rooms with their patients and in their personal lives as citizens of planet earth. The writing of this book was motivated by the need to comprehend the unprecedented atrocities wrought by totalitarianism in the twentieth century, as epitomized by the horrors of Auschwitz. In agreement with Hannah Arendt, Hans Jonas, and Emmanuel Levinas, Bernstein claims that "Auschwitz signifies a rupture and break with tradition, and that 'after Auschwitz' we must rethink both the meaning of evil and human responsibility" (p. 4). To that end Bernstein embarks on a series of "interrogations" or "critical dialogical encounters" (p. 4) with the conceptions of evil developed by Kant, Hegel, Schelling, Nietzsche, Freud, Levinas, Jonas, and Arendt. The inquiry is a hermeneutic rather than a metaphysical one, aiming not at a theory of evil but at a conceptual understanding of what we mean by evil. In the process, Bernstein gives us a wonderful overview of the history and basic concepts of moral philosophy and moral psychology.

CONTINUE ARTICLE HERE

Drug Companies Used Physician Education to Push Pills

Brian Vastag -- a science journalist for publications such as the Washington Post, U.S. News and World Report, and JAMA -- has just published on his blog an outstanding article on the influence of drug companies on continuing medical education. The article is reproduced in its entirely here:

A scientific journal recently commissioned this story from me, but after I reported and wrote it, the journal killed it. I think it’s an important story that serves the public good, so I’m posting it here to get it on the record.

Drug makers routinely exploited continuing education seminars as opportunities to market pills to doctors, company documents reveal.

Continuing medical education (CME) has exploded into a $2.3 billion business in the United States, with nearly half of the funds pouring in from drug and medical device manufacturers. Physicians must complete a certain number of CME courses each year to retain their medical licenses.

Today, the large pharmaceutical companies say their CME dollars support only independent education, with no input from the companies. But as recently as 2004, the documents show, marketing personnel played key roles in developing the seminars, treating CME as one element of their comprehensive sales plans.

“It is very clear…that continuing medical education has been used as marketing, and I think it continues to be,” said Allan Coukell, director of the Pew Prescription Project, which seeks to reduce or eliminate conflicts of interest in medicine.

For instance, GlaxoSmithKline’s “2003 Tactical Plan” – a marketing document – for their antidepressant Paxil lists $92 million in expenses, including $4.3 million for CME, $30 million for consumer advertising and $17.4 million for free samples. The plan includes “desired” CME topics, such as “anxiety symptoms/disorders in women” and “treating depression & anxiety in hispanic population.” The plan also proposes a “CME Tour” reaching 6,000 doctors, and provides detailed topics to be covered. The company prepared similar strategies for 1999 through 2004, according to the documents, which were uncovered by Senator Charles Grassley (R, Iowa), in his ongoing investigation of the drug industry.

A spokeswoman for GlaxoSmithKline, Mary Anne Rhyne, declined to answer questions regarding the documents.

Forest Laboratories, Inc., deployed similar strategies to push Lexapro, a Paxil competitor. One goal of the 2004 Lexapro plan: “More sponsorships of CME, increased level of speaker programs…and peer selling.” The plan includes $9 million for national and regional “CME symposia,” to be run by a for-profit company, CME Inc. Also included: $600,000 to pay for six “special reports,” to be labeled as CME: “A reporter from…CNS News, Psych Times, and the Journal of Clinical Psychiatry will be sent to cover key Lexapro data” at medical meetings, the document reads.

A third drugmaking enterprise, a partnership between Merck and Schering-Plough, dumped $64.5 million into CME courses on “cardiovascular risk management and/or cholesterol control and/or Vytorin” from 2004 through early 2008, a time when the companies were heavily promoting Vytorin, their soon-to-be-troubled anti-cholesterol pill. The funds were distributed in 1,930 individual payments to universities, professional societies and for-profit CME companies.

Companies improperly promoting products via CME may run afoul of the law, said Lewis Morris, the counsel to the inspector general of the Department of Health and Human Services. During a July hearing of the Senate Special Committee on Aging, chaired by Herbert Kohl (D, Wis.), Morris said, “A number of significant cases have involved allegations that funding for ‘educational support’ was a pretext for the payment of kickbacks” to physician-speakers who promoted off-label, or unapproved uses, of certain drugs. For instance, in 2004, Pfizer and Warner-Lambert paid the U.S. government $430 million to settle claims that the companies “corrupted the physician education process by fraudulently sponsoring ‘independent medical education’ events” on unapproved uses of Neurontin, an anti-epilepsy drug, Morris testified.

The 2003 Paxil marketing documents show that GlaxoSmithKline planned to market the drug for an unapproved indication – pre-menstrual dysphoric disorder, or PMDD – 10 months before the FDA approved that specific use of the drug. The November 2, 2002 plan lists “anxiety symptoms in PMDD” as a “desired topic” of the CME seminars the company funded. But the FDA did not approve Paxil for PMDD until September 2, 2003. As Morris noted in his testimony, promoting an unapproved use of a drug is illegal under the Food, Drug, and Cosmetics Act.

Pfizer learned that lesson in a huge way last month when the Department of Justice announced the company had agreed to pay $2.3 billion – the largest criminal fine of any kind in U.S. history, according to the department – for illegally marketing several drugs, including its anti-inflammatory Bextra.

Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education, which certifies CME providers, said his group tightened its rules in 2004. The rules now prohibit drug and device makers from directing educational content or even suggesting topics for courses. “We felt it necessary to define the bright line of what independence is,” he said.

Still, momentum is growing for an outright ban on industry-funded CME and a return to a system where physicians pay their own way, like lawyers and other professionals. The Institute of Medicine and the Association of American Medical Colleges support such a ban, and over the past two years, Stanford University, Memorial Sloan Kettering Cancer Center and the American Psychiatric Association have weaned themselves from the industry CME teat. Still, such funding comprises a critical slice of the budget pie for many professional groups. For example, the American Academy of Family Physicians, which claims 64,000 members, receives 8% of its operating budget from industry CME funds. President Ted Epperly said that AAFP follows ACCME guidelines and assiduously maintains a “firewall” between CME funding and content. “We believe this relationship can be managed,” he said. “It must be transparent and above board. You cannot have anybody telling you what the content ought to be, who the speaker ought to be.”

Where does Industry CME Money Go?

In 2008, drug and device companies spent $1.04 billion on continuing medical education in the U.S.

Where it went:

Hospitals: $39.5 m

Professional Societies: $202.5 m

Universities: $225.7m

For-Profit CME Companies: $463.4m

Other: $104 m

Source: Accreditation Council for Continuing Medical Education

-- Brian Vastag

READ BRIAN VASTAG'S BLOG HERE