Kids this time of year may be chanting “no more pencils, no more books,” but so will physicians at the Hospital of the University of Pennsylvania, which recently decided to ban even the smallest of gifts from pharmaceutical sales reps to its physicians, according to this article from Boston.com. From the article:

Freebies as piddling as pens and notepads — typically festooned with the brand names of expensive new drugs — will be forbidden starting July 1. So will the free pizzas and catered meals that drug reps, or “detailers,” often bring along when marketing their products. New rules are also being imposed on donations and endowments.

“Favor is not just being curried with the physicians, there’s shmoozing with the staff as well,” said Dr. Patrick J. Brennan, Penn health system’s chief medical officer. “It’s become part of the culture, but we’re attempting to set a different tone.”

This post from Blogborygmi should gladden the heart of any CME provider. The story concludes:

In those heady days after graduation last year, nothing else would make the point so succinctly to this newly-minted intern: We were done with medical school, but we weren’t done being students.

Beautiful! Thanks, Nick. Read it here.

From a press release:

Reed Exhibitions has agreed to acquire Contemporary Forums Inc., a leading producer of medical education events for nurses, physicians and other healthcare professionals. Based in Dublin, CA, Contemporary Forums will produce 35 events this year in 14 states, serving more than 12,000 healthcare professionals.



Dwight Stump and Margaret Blair, co-founders of Contemporary Forums, will remain with the company as president and vice president. They and their staff of 26 will continue operations in their current location.

According to Legal Week, the Czech Republic has overhauled its drug advertising rules, including some related to meetings. From the article:

The amendment further specifies the difference between scientific congresses and promotional meetings. Hospitality can be provided in connection with both types of meetings if it is commensurate with the nature of the meeting, secondary to the main purpose of the meeting, and extended only to healthcare professionals (i.e. not to their spouses or families).

The law also encompasses rules around samples, nurse training (they can be trained on specific instruments if need be, and they can go to educational meetings, as long as they don’t focus on promoting prescription-only products), and other advertising-related issues. It was instigated, the article says, to bring the Czech Republic more in line with the EU on healthcare matters.

The latest Grand Rounds are up online at Dr. Emer’s Parallel Universe. Enjoy!

New legislation in New Jersey now requires physicians and other healthcare workers to inform pregnant women about postpartum depression, and to screen new mothers for the condition, according to this article in PsychiatryOnline. Of course, along with new laws comes new CME. From the article:

Nancy Block, M.D., past president of the NJPA, served on the Professional Education Subcommittee as representative to the Medical Society of New Jersey. Block said that the subcommittee consisted of a range of health care professionals who developed a “Webinar” or a Web-based video to teach physicians, including psychiatrists, nurses, psychologists, social workers, and other health care professionals such as lactation consultants and Lamaze instructors not just about postpartum depression, but also peripartum mood disorders. Continuing medical education credit is available to those who take the 70-minute course online.

Here’s a new twist—from a press release:

Boston, MA, May 18, 2006 - This week, David Longmire, M.D., an Alabama neurologist and specialist in neuropathic pain evaluation and management, filed a lawsuit against Warner-Lambert, Inc. and its parent company, Pfizer, Inc. (NYSE: PFE) for fraudulent misrepresentation, concealment and deceit. The lawsuit was filed in the Circuit Court of Franklin County, Alabama, by co-counsel Paul W. Shaw, Brown Rudnick Berlack Israels LLP, Robert A. Griffith, Gargiulo/Rudnick LLP and Michael L. Weathers, Attorney at Law.



This lawsuit arises out of a May 13, 2004 prosecution in which Warner-Lambert and its Parke-Davis division, acquired by Pfizer in 2000, pled guilty to charges that it criminally violated the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 331 et seq. associated with its marketing and sales practices for an epilepsy drug known as Neurontin.




Related to the 2004 case, Dr. Longmire’s lawsuit charges that Warner-Lambert defrauded him by exploiting his medical expertise and reputation and luring him to unwittingly participate in a deceptive scheme to market Neurontin for certain unapproved uses, commonly known as “off-label” uses. These uses included post-herpetic neuralgia, painful diabetic neuralgia, anxiety disorder, social phobias, and bipolar disorder. As a result of the fraud, Dr. Longmire’s name has been included in multi-district litigation lawsuits, thereby impugning his reputation among his colleagues and peers and calling his integrity into question.




According to the plaintiff’s attorneys, Warner-Lambert tried to avoid the federal statutes and regulations that make it illegal for a manufacturer to promote off-label product usage by engaging in a number of fraudulent marketing schemes to promote the sale and use of Neurontin for off-label conditions. One of Warner-Lambert’s fraudulent schemes involved using physicians to promote the off-label use of Neurontin, because off-label promotional prohibitions do not apply to physicians, who can treat a medical condition with any prescription drug that would benefit the patient. Part of this fraudulent and deceptive scheme targeted neurologists and other pain specialists throughout the USA,

including Dr. Longmire, to leverage their experience with the use of Neurontin for pain. These physicians were falsely told that Warner-Lambert intended to apply to the FDA for approval for the expanded use of Neurontin in the treatment of neuropathic pain.




Warner-Lambert provided study grants, solicited the targeted physicians to publish articles supporting the expanded use of Neurontin to reduce pain, and, through seemingly independent medical education companies, invited these physicians to speak at so-called consultants’ meetings and educational events. Warner-Lambert represented that it was gathering the studies and articles as part of its effort to obtain clinical data to support an FDA application for approval of Neurontin as a treatment for certain types of neuropathic pain.




Unknown to the targeted physicians, including Dr. Longmire, Warner-Lambert had little or no intention of actually presenting either the results of the studies or the publications to the FDA. Also unknown to the targeted physicians the seemingly independent medical education companies were actually controlled by Warner-Lambert to further this scheme.




For a copy of the complaint, please contact: Lisa Murray at 617-856-8509 or lmurray@brownrudnick.com.

I haven’t heard (and don’t expect to) the other side of the story, but felt this was worth passing along. Interesting, eh?

David Shaw over at B or Not 2B talks about min’s Sales Executive of the Year Awards breakfast he attended. While his post is mainly about advertising and media, he also says this of keynoter Donna Campanella, director/team leader, media for Pfizer:

Emotionally recounting her mother’s struggles with Alzheimer’s, she described tearing DTC ads for Alzheimer’s medications from magazines, and using these as the basis for discussions with the doctor. “There’s nothing like the power of DTC advertising when it really changes people’s lives.”

Exactly—and that’s what makes it both a powerful marketing tool for pharma and something that CME providers should keep track of. In addition to hearing those messages themselves, docs also have patients coming in using these ads as “the basis for discussions.” Could these patient discussions outweigh the fair, balanced, unbiased, and evidence-based information they learned in a CME activity? I wouldn’t rule it out. In fact, I’d count it as a potential barrier to implementing what they learned during an activity, along with the other barriers I wrote about in my March/April issue Medical Meetings editorial.

This article from BusinessWeek is scarily eye-opening—and a clear reminder of the importance of keeping CME evidence-based. From the article:

he carved out a niche showing doctors at specialty society meetings that their cherished beliefs were dubious. “At each meeting I would do the same exercise,” he says. He would ask doctors to think of a typical patient and typical treatment, then write down the results of that treatment. For urologists, for instance, what were the chances that a man with an enlarged prostate could urinate normally after having corrective surgery? Eddy then asked the society’s president to read the predictions.



The results were startling. The predictions of success invariably ranged from 0% to 100%, with no clear pattern. “All the doctors were trying to estimate the same thing — and they all gave different numbers,” he says. “I’ve spent 25 years proving that what we lovingly call clinical judgment is woefully outmatched by the complexities of medicine.” Think about the implications for helping patients make decisions, Eddy adds. “Go to one doctor, and get one answer. Go to another, and get a different one.” Or think about expert testimony. “You don’t have to hire an expert to lie. You can just find one who truly believes the number you want.”

According to the New York Times, The American Society of Hypertension is under fire for a $700,000 grant it recieved from three pharma companies.

The same three companies — Merck, Novartis and Sankyo — also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs.

The article goes on about the “monetization of medicine” and assumes there was some breach of ethics involved. But the society received those grants as unrestricted, from my reading of the article, and there’s no indication that they didn’t follow all the rules in developing the curriculum. Though there was this bit:

Dr. Alderman, a professor of medicine and epidemiology at the Albert Einstein College of Medicine in the Bronx, is one of several doctors who withdrew from a group formed by the society to write the new blood pressure definition.



He complained that the definition was derived from a hodgepodge of opinions not supported by hard science, and also questioned whether the society of 1,600 could insulate itself from the drug company donations it used to operate.

That’s the crux of the matter, to me anyway. Was the definition was based on evidence, and if so, what level of evidence? And how was it presented to the docs who attended these meetings? Was it fair and balanced? Commercial support of CME (it doesn’t say whether these meetings were certified or not) is nothing new or shocking. Ditto the question about whether commercial support inherently biases the content. That’s why we have so many safeguards in place. If they weren’t in this instance, then shame on them; if not, what’s the problem? Either way, it’d be nice if the article factored that into its coverage.