Prescription for Conflict: CME Funding from Big Pharma to Big Placebo

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It seems like every day we run into people and groups who believe in something that scientific evidence has disproved.  Often their beliefs are based on anecdote; I had a relative or friend who, someone who worked at, instances of misbehavior and then attempt to apply that antidote to an industry or class of people.

Alternative Medicine

Alternative medicine has for years been at odds with modern medicine, carefully placing mistrust of cures in an attempt to bring back nostalgia and natural alternatives.

Americans each year spend $34 billion dollars on alternative treatments.  Many American’s invest their lives savings to extend life using such placebos as ginko, econacia, and Acai.

According to a recent TED video and book Denialism: How Irrational Thinking Hinders Scientific Progress, Harms the Planet and Threatens Our Lives  by Michael Specter on the Dangers of Science Denial we have made terrorists out of scientists developing life saving medicines such as vaccines.  It is amazing how people demonized big pharma only to “leap into the arms of big placebo.”

Georgetown CME Meeting

This summer, in an attempt to discredit modern innovative strategies for educating physicians, PharmedOut a pro-alternative medicine anti pharma group under the umbrella of Georgetown University will be holding a conference titled: Prescription for Conflict: Should Industry Fund Continuing Medical Education?”

The conference, which is being held at Georgetown University, is billed as a joint effort between Georgetown University Medical Center, the Kennedy Institute of Ethics, and Georgetown University Law Center without mention of PharmedOut. 

The event, which is taking place on Friday, June 25, 2010, from 8:00am-5:30pm, will explore the issues and debate the question of whether the pharmaceutical industry should fund CME.

Looking at the agenda, the event has a number of speakers that are mostly anti-industry activists, in addition to anti modern medicine topics such as “Those Who Have the Gold Make the Rules: Drug Companies and Medical Knowledge,” and “What’s Known About Industry Influence on Continuing Education of Prescribers?”

The faculty with a few minor exceptions are well published on their opinions that pharma is composed almost entirely of evil doers and should be punished and prevented from being involved on any level of supporting medical education with the exception of blind funding.

Seemingly, in an effort to try and balance the program, the agenda also includes a short section to discuss the Pros and Cons of Industry-Funded Education, which is moderated by Alicia Mundy of the Wall Street Journal and includes:

 Murray Kopelow, MD, MBA, Chief Executive Accreditation Council for Continuing Medical Education,

David Davis, MD, Senior Director, Continuing Education and Performance Improvement, Association of American Medical Colleges,)

Mike Saxton, MEd, Consultant,

Douglas Melnick, MD, MPH, Physician, Los Angeles, CA (guy from the PharmedOut video on competitive intellegence) 

Adriane Fugh-Berman, Associate Professor Georgetown University Medical Center (PharmedOut Director).

The problem with the section is there are only neutral, con’s and regulators on the panel.   It is disingenuous to consider if any pro postion were added to the panel (as an attempt to show balance) that it would some how make the entire 8 hours of the meeting devoted to attacking industry support of CME credible.  

A supporter of commercial support would garner as warm a reception as Nancy Pelosi addressing a Tea Party rally.

That balance is completely eliminated however, when the program concludes with a segment on whether “Industry-free CME is a Sustainable Model?”


Accordingly, the background of this inherently biased conference to eliminate 50% of CME—the percent of CME funded by industry—deserves a closer look, as do the particular background beliefs of the course director and Dr. Fugh-Berman and her organization PharmedOut.

PharmedOut

Created as part of a 2004 settlement for unlawful marketing, PharmedOut is funded through the Pfizer Neurotin Settlement – the Attorney General Consumer and Prescriber Education grant program. As their website claims, the group is an independent project run by physicians for physicians and other prescribers to:

 

  • Document and disseminate information about how pharmaceutical companies influence prescribing

 

  • Provide access to unbiased information about drugs; and

 

  • Encourage physicians to choose pharma-free CME

 

To achieve these goals, the group provides lectures at Grand Rounds, meetings, conferences, and medical student events (Lecture Topics), and provides access to free, web-based, pharma-free CME. They even claim that they offer enough free CME for any physician in the U.S to fulfill annual CME requirements without taking industry-funded courses.

PharmedOut is led by a team of physicians and academics, with the Principal Investigator being Dr. Fugh-Berman, and the Project Manager is Alicia M. Bell MS. (small group)

Our cause for concern begins with Dr. Fugh-Berman’s interest in promoting the explicit use of alternative medicines as a way to essentially eliminate modern drugs and advanced devices.  Her long held believes in anecdotal evidence spills over into her PharmedOut group.

As the author of the 5-Minute Herb and Dietary Supplement Clinical Consult (Lippincott, Williams and Williams, 2003), and Alternative Medicine: What Works (Williams and Wilkins, 1997), participants in this conference will experience severe bias against modern science based medicine.

Moreover, any attempts to highlight the benefits of industry funded CME and industry collaboration will almost certainly be drowned out by the overwhelming emphasis this conference places on eliminating it.

Dr. Fugh-Berman

Her Georgetown University profile notes that she is an Associate Professor in the Complementary and Alternative Medicine Master’s program, Department of Physiology and Biophysics, Georgetown University School of Medicine.

Dr. Fugh-Berman’s current research focuses on the rational use of both conventional and complementary therapies. teaches courses on the History of Conventional and Alternative Medicine in the U.S.; Herbs and Nutritional Supplements; and Critical Readings within the first basic sciences master’s program in complementary and alternative medicine in the United States.

It also states that she consults on herbs and dietary supplements for various federal and state agencies, and is a member of the Government Accountability Project drug fact squad.   As a paid consultant doing work for agencies, how is her work any different from consulting for pharmaceutical companies?

Essentially she is advocating for the end of one industry, to bring about the increased use of another industry, namely alternative medicine, one in which she has designated a significant amount of her time, resources and research to. Some may consider that a “conflict of interest.” Taking a closer look at Dr. Fugh-Berman’s work, her ongoing list of publications (type her name) that support alternative medicine and criticize the drug industry and use of drugs to help treat patients is troublesome.

On Alternative Medicine she has authored scientific publications such as:

Don’t be ‘mis-led’: few herbal products have been implicated in lead poisoning.

Bioidentical hormones for menopausal hormone therapy: variation on a theme.

Treatment of fibroids: the use of beets (Beta vulgaris) and molasses (Saccharum officinarum) as an herbal therapy by Dominican healers in New York City.

Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials.

St John’s wort and major depression.

Is St. John’s wort (Hypericum perforatum) an effective antidepressant?

Complementary and alternative medicine in the management of pain, dyspnea, and nausea and vomiting near the end of life. A systematic review.

Dietary supplements and natural products as psychotherapeutic agents.

Complementary and alternative medicine needs an evidence base before regulation. 

Aparently she is against regulation for unregulated alternative and complementary medicince but supports futher regulation of the already highly regulated pharmaceutical companies.

In the area of percieved pharmaceutical company practices she has also written extensively.

Do new drugs increase life expectancy? A critique of a Manhattan Institute paper.

Is long-term use of antismoking drugs consistent with public health goals or pharmaceutical marketing goals?

Off-label promotion, on-target sales.

Key opinion leaders: Thus are our medical meetings managed.

Prescription tracking and public health.

In one article in the British Medical Journal (BMJ), she asserts that “pharmaceutical companies manipulate prescribing,” and that “pharmaceutical firms are not interested in presenting information important to prescribers, unless it is also important to the drug industry.” These kinds of unsubstantiated claims are a disservice to physicians and the practice of medicine. Doctors who prescribe a particular kind of medicine do so based on their clinical experience, knowledge of the research and data, and based on their patients preferences after all risks and benefits have been explained.

Drug companies give data and information to doctors to assist them in giving their patients more options for treatment and newer innovations that can save lives. While sometimes the cost of these new drugs is more expensive, that’s how all generics started and just the nature of drug development.

With regards to CME, Dr. Fugh-Berman asserts that “corporate support of CME courses, meals, and treats are not merely just rewards for being hardworking, dedicated doctors.” What are they then? While she thinks that such events are a way for the drug industry to get physicians to use particular drugs more, the reality is doing so actually helps patients. Despite the fact that a particular drug may be more expensive, doctors voluntarily choose to attend industry funded CME events, and they are well aware of the funding nature and presentation of evidence.

There is no “illusion of the relationship between medicine and the drug industry” as she states. Instead, there is a partnership between physicians and pharmaceutical companies to develop new drugs that will continue to advance medicine and technology, and CME is the best way to educate and train other physicians about such breakthroughs.

Dr. Fugh-Berman’s belief that the drug industry downplays the “benefits of diet or exercise, or the relationship between medicine and pharmaceutical companies” is misguided for two reasons. First, it is clear that with the present obesity crisis, diet and exercise are ineffective and almost hopeless. Second, with five drug companies creating public databases about payments to physicians, and the Sunshine Act, companies are now crystal clear.

In another article in PLOS she calls for a prohibition of drug and device advertisements in medical journals because they can bias clinicians who “rely on medical journals for scholarly articles and the latest information on drugs and devices.” Why should there be a different standard for advertising in medical journals than for car commercials that pollute out air or cheeseburgers that make our country severely obese?

In another article, she discusses her experience speaking at conferences organized by MECs. Despite her participation, she claims that such “unconflicted presentations serve as cover to the ‘‘message talks’’ by reassuring the audience that all of the speakers are objective.” Although she acknowledges that these talks “are not obviously advertising, and may mention a targeted drug, without emphasis, as one of several reasonable choices” she still criticizes them. In fact, she claims that the talks are used to “convince doctors that a particular condition is underdiagnosed or undertreated, or that an invented disease exists, or that medical management is a sound alternative to surgery, or that a currently used therapy is fraught with problems.”

What kind of highly trained physician, who voluntarily chooses to attend a CME event, knowing it is sponsored by industry, could be “convinced” of an invented disease? Such remarks are unwarranted.

She is also a frequent guest blogger with articles such as: 

Mind Force Secrets Hypnosis Blog : IBS: Irritable Bowel Syndrome Healed Through Hypnosis   August 6, 2009

Coral Calcium: How to lose weight without diet and exercise

She is the darling of the alternative medicine crowd and quoted frequently on websites such as Just Juice and  Herbal Remedies.com.

My understanding is that Dr. Fugh-Berman is a kind, sincere and energetic person.  She truly believes our lives would be better by using alternative medicince.   It is encouraging that she has devoted efforts into reviewing alternative therapies and has argued against some of the most outragous claims such as bust enhancing herbal products. 

Also give her credit in figuring out how to raise funds from the Neurotin Settlement to pay for her anti industry “research” and for bringing together many of the critics of commerical support of CME in one place.

Conclusion

The idea that industry funded CME is under the “control of the drug industry” is an extreme misstatement for two obvious reasons. First, it is not in the CME providers best interest to violate ACCME standards of commercial support, the FDA guidance and contracts with supporters that specifically state that to receive the funds you must follow the rules on bias, fair balance and disclosure.

Second, only half of CME today is funded by industry, and to suggest that this half can be dropped or replaced with something else that will not negatively affect physicians training, patient outcomes, or innovation has not been studied yet and constitutes a naive proposal.

Ask yourself this: if you or a loved one were dying of cancer, would you want to have your physician educated on medicine developed in collaboration with industry to treat it or a stopwatch and some herbs? 

Which do you prefer CME supported by pharmaceutical and medical device companies who spend billions to determine the safety and efficacy of their drugs and devices or talks supported by netraceuticals which spend little to nothing on research?  It is in societies best interest for the only source of information on medicine to come from payers such as insurance companies and the government.

Since 1900 medical innovation has added 25 years to our life spans.  In 1900 you had to worry about dying from disease such as small pox, polio and pandemic flu.   If one got a simple infection they died.   Lets not forget that those pesky pharmaceutical companies develop products that save our lives. 

A thoughtful discussion on the changes that have taken place in CME to ensure that education is fair balanced and independent would have benefited everyone, too bad this conference missed that opportunity.

 

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