According to a press release from Biomedical Market Newsletter, the Food and Drug Administration is planning to:

& revisit controversies surrounding the promotion and marketing of medical products, plus promotional claims made in advertisements and at trade show exhibitions. Journal ads and fliers may be targeted next. Medical product manufacturers can expect to witness a beefed-up presence of FDA and/or other government officials, collecting possible evidence of alleged violations. These may include such “no-no s” as promoting unapproved claims, or unclear language that describes the current status of unapproved products.

While this should make exhibitors and other suppliers increase their scrutiny of their practices at shows, it also means that show organizers who aren t responsible for the FDA compliance or lack thereof of their exhibitors/sponsors may have more FDA officials on their show floors. Even if it s not the show organizer s responsibility, it still doesn t look so hot when there s a writeup about FDA violations that occurred on your conference’s show floor in the Wall Street Journal.

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A reader commenting on >Pharma in the hot seat again made a good point: “As a CME provider… Let’s not blame the pharma companies for everything; they market this way because it works. Regulations have changed & it is far more difficult for pharma to support lavish programs. However, the doctors still demand the same level of treatment. it will take a paradign shift from the doctors before this will change.”

Funny she should mention that the docs still want the perks pharma no longer can provide–that’s exactly what we found in our Annual Physicians Survey. Here’s an excerpt on what the physicians surveyed said:

A re-run of Dr. Marcia Angell s March appearance on “60 Minutes” last night reminds me of a recent article in BusinessWeek that also quoted Dr. Angell and the accusations she makes against pharma in her book, The Truth about Drug Companies: How They Deceive Us and What to Do About It. She claims that drugmakers have become “the main sponsors of clinical testing and physician education and are also a critical source of funding for the Food & Drug Administration.”

While the “60 Minutes” episode focused on importing drugs from Canada, in the BusinessWeek article, she says:

“Drug companies finance most of the continuing medical education of doctors, as well as meetings of professional societies. They lavish all manner of gifts on doctors in practice, including dinners in luxurious restaurants and trips (ostensibly for educational purposes) to exotic resorts. And they provide speakers and meals for interns and residents in teaching hospitals.



“The profession should acknowledge that this is all a form of marketing, which adds to the prices of prescription drugs. Doctors should take responsibility for their own education and buy their own meals.”

Whether you re a CME provider or in industry, be prepared to defend your practices better yet, get proactive and tell the media about all the safeguards you have in place to ensure the separation of promotion from education on both sides of the fence. Regardless of the PhRMA Code, the OIG Guidance, the latest revision of the Standards for Commercial Support, Stark II, and whatever new regulations come down the pike, this issue is not going to go away–and the best defense is a good offense.

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Even though the pharma giant s spokespeople keep insisting that it had already disseminated all its clinical trial data at meetings and other means including negative data GlaxoSmithKline PLC still “agreed Thursday to release negative data on the safety and effectiveness of its drugs to settle a lawsuit by New York’s attorney general that accused the pharmaceutical maker of misrepresenting data on prescribing its antidepressant drug Paxil to children& The London-based company is the first major drug maker to agree to disclose all its studies. The company also will pay $2.5 million to the state as part of the settlement.”

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It s interesting to see two items related to this show up in one day (see below). In this one, the International Network of Cholesterol Skeptics take issue with the recently revised cholesterol-lowering guidelines, saying they will “result in millions more people being placed on statins” putting them at risk for side effects unnecessarily.”

Among those the group accuses of helping “hype” statins are “medical opinion leaders who have, unfortunately, become little more than paid advertorials.” While the ACCME Standards for Commercial Support and Essential Areas and Their Elements should eliminate this perception of bias for ACCME-accredited activities, obviously there is still a perception out there that faculty are little more than paid shills for the drug companies.

What can this industry do to change that perception once and for all?

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A while back, Medical Meetings posed what I think is an interesting question: Are CME providers being used by the pharmaceutical industry to legitimize a treatment for conditions that aren’t really diseases such as irritable bowel syndrome?

At the time, most providers didn t seem to think so, but it may be time to revisit the issue, now that the Royal College of General Practitioners in the U.K. is bringing up the issue again. It seems they are “worried that “the practice of  disease-mongering within the pharmaceutical industry could put publicly funded health care systems at risk.” Further, it says, “the RCGP argues that pharmaceutical companies classification of conditions such as hypertension and depression as abnormal are not in the interests of patients and serve only to reward the industry itself.”

Do you agree with the provider who said, “I think that& disease state CME [is] only helping the health care delivery system”? He cites erectile dysfunction as an example. “By diagnosing ED, we are& intervening earlier in the diagnosis and treatment of peripheral vascular disease,” he says. “There are 20 examples like this for every one that may seem specious.”

Or do you fall more into the camp of this provider: “While I have no direct experience in this particular initiative, I would look into the  disease of overactive bladder. Its appearance seems coincidental with the introduction of various products to treat it”?

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As CMI pointed out recently, the trend toward companies using preferred vendors is alive and well. To prove the point, pharmaceutical giant Eli Lilly has officially joined the preferred hotels crowd. According to the BTN article: “Major pharmaceutical firm Eli Lilly & Co. during the past 18 months developed, negotiated and implemented a preferred meetings hotel program and mandated its use by internal meeting sponsors. Almost all of the firm’s nearly 1,000 domestic meetings now use one of four preferred chains, allowing the company to negotiate standard contracts with favorable rate, service levels and conditions.”

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St. Jude Medical, a global cardiovascular device company, had a problem it had to distribute educational documents to its 1,000 field personnel within 60 days to meet specific regulatory requirements. So they took to the Web, using the IntraLearn Software Corp. s e-learning infrastructure and QuickCompliance, an e-learning company that provides compliance courses to the healthcare industry, to meet the aggressive schedule.

According to a press release: “In the 8 months since the project began, St Jude Medical has more than 2,000 registered students and the total number of learners is expected to grow to 5,000 or more.”