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Unlike PhD-trained scientists, physicians and other healthcare professionals must be licensed to practice medicine and are annually required to participate in continuing medical education courses (CME), seminars and lectures. CME training is required by medical licensing agencies to insure that healthcare practitioners are update to date with the latest clinical practices and informed about medical development within their respective fields. 

While all medical licensing agents require CME training, they do not fund or provide any of the content or learning materials required to implement that training. Historically, pharmaceutical, biotechnology and medical devices/diagnostic companies have underwritten the development for most CME courseware. Critics of this practice suggest that this represents clear conflict of interest concerns. And, in recent years, regulatory authorities like the US Food and Drug Administration, the American Medical Association and others have begun to agree with these suppositions. Consequently, the regulations that guide CME writing have drastically changed in recent years causing confusion among CME training providers and writers.

Despite growing concerns about the regulatory aspects of CME, there is still a high demand for persons who develop and write CME materials. While CME training is primarily geared towards physicians and other healthcare professionals, most of the content and training materials are prepared by PhD-trained scientists. Although a PhD in the life sciences is not an absolute requirement, many CME providers are beginning to hire persons with advanced degrees as developers and writers. Unfortunately, becoming a CME writing professional is not as easy as it sounds and requires some additional training beyond the PhD to break into the field. 

To that end, I recently became aware of a company called InQuill Medical Communications that offers training to life scientists interested in pursuing careers in CME writing. In addition to their courseware, InQuill offers a paid internship program to selected program graduate. The company is run by Johanna Lackner Marx who has over 15 years of experience in medical writing and developing and writing CME materials.

For more information about their training programs and some free information about careers in CME, please click here.

In the spirit of full disclosure, BioJobBlog is affiliated with InQuill. However, despite my over ten years of experience as a medical and science writer, I have had limited success in landing CME writing gigs because of my lack of formal writing and regulatory training in this area. That said those of you who may be interested in pursuing a career as a CME writer may benefit from the InQuill program!

Until next time...

Good Luck and Good Job Hunting!!!!!

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As part of their licensure requirements, all physicians and other healthcare providers (HCPs) in the US must participate in continuing medical education (CME). CME requirements are established on a state-by-state basis HCPs who fail to meet annual quotas face reprimand, censure and possibly loss of their medical licenses. As you may imagine, CME is a big business and, not surprisingly, there is no dearth of CME content developers and providers. Unfortunately, CME course development costs are high and, despite state mandated licensure requirements, no one seems to want to sponsor or underwrite the CME development programs except drug and devices companies. Obviously, this creates the potential for monumental conflicts of interest mainly because physicians and other HCPs are drug and device company primary customers.

While I don’t profess to be an expert on CME rules and regulation, I know that the rules and regulations that guide CME content development have become increasingly restrictive over the past few years. In the past, drug and devices manufacturers were able to identify relevant product-related topics within certain therapeutic areas, engage a CME provider to create a curriculum and then offer a product-focused program to physicians. Today, drug companies aren’t allowed to create CME program built around specific products. Instead, CME developers compete for grant monies from drug and device manufacturers and are asked to create CME around relevant issues in certain therapeutic areas. Of course, most of the companies that award the grants have products in those therapeutic areas; but i digress. Companies that award the grants cannot participate or influence the content that appears in the CME programs. Of course this is impossible!

For example, several years ago I was working at an agency that received a “grant” from a client that was developing a new treatment for a virus-associated metabolic syndrome. While we weren’t allowed to highlight or suggest specific treatment options we did receive in direct and subliminal guidance (through various company channels) regarding messaging around content development. To that end, while the company wasn’t directly involved in content development, its medical affairs and marketing departments were “aware” of the content that we were developing. While this was appropriate and well within regulatory guidelines, it is not difficult to see that potential conflicts of interest and bias may have existed in this instance.

Over the last year or so, questionable medical writing practices and conflict of interest concerns about CME course development have come under intense scrutiny in the US Congress. Consequently, there have been ongoing and repeated calls to prohibit industry participation in CME content development. While this may be a great idea, if drug companies no longer are allowed underwrite or sponsor CME course development, there isn’t likely to be any CME in the future. And, if there is no CME, physicians and other HCPs won’t be able meet state-mandated CME requirements to maintain their licenses to practice? What a conundrum!

One solution to the problem is to require state governments, the American Medical Association, university medical schools, hospitals and other organizations (insurance companies?) to underwrite CME development costs! After all, these are the entities that require CME for HCPs to retain their licenses. While this is a perfectly logical solution to a vexing problem, don’t expect any of them to step up to the plate anytime soon. The bottom line: drug companies support and underwrite CME because they recognize that it is a viable marketing vehicle—albeit a subtle one—that is certain to improve product awareness and ultimately sales. For example, if Pfizer sponsors a CME program on erectile dysfunction at a high end resort in some exotic locale and, its logo or mention of a grant to develop the curriculum is acknowledged, it is not unreasonable to assume that physicians attending the course may possibly choose to prescribe Viagra over a competitor’s product. To make matters worse, CME sponsors often time help to defer costs of hotel accommodations, provide support for meals, and even sponsor receptions for physicians who attend CME training programs.

I suspect that some of you may be wondering why I am ranting and raving about CME today. Well, there was an article in today’s New York Times about Stanford Medical School receiving an unrestricted, three-year $3.0 million grant from Pfizer to develop unspecified new CME curricula for physicians. Philip Pizzo, MD, dean of Stanford’s medical school lauds this as the beginning of a new age in CME and suggests that Pfizer will have no say on how the grant monies will be spent. 

Dr. Pizzo contends that the “no-strings-attached” provisions of the grant will insure that the new curricula will be devoid of drug industry influence that has permeated CME courses in the past. Stanford plans to set up “unbiased programs” of postgraduate education on the Stanford campus rather than the industry-selected topics of the past that have been presented to rooms full of doctors at hotels and resorts.” While the new grant sounds promising, I wonder whether or not Stanford is going to disclose the amount of research funding it annually receives from Pfizer. Further, will faculty members who receive or previously have received research monies from Pfizer be prohibited from contributing to content development?  The point I want to make is that, despite Stanford’s good intentions and assertions to the contrary, there is no way to insure that there will be no bias or conflicts of interest in the new curriculum that is developed. 

Finally, I don’t think that there is any question that CME is essential to insure that Americans receive the latest and best possible medical treatments that are available. However, to insure farness and no bias, drug makers and device manufacturers should not be allowed to underwrite or participate in CME content development. This activity should be in the purview of not-for-profit entities (that don’t receive drug industry money) and state government agencies. Like it or not, we live in a quid pro quo society and drug and devices companies (like all “for profit” companies) don’t make investments unless there is an anticipated or guaranteed return on the investment!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Beginning in 2009, Eli Lilly and Merck will post in online databases all payments made to doctors for speaking and consulting services. According to an article in today’s New York Times, the postings will “likely include” the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments.

The lack of disclosure by physicians about their relationships with drug and medical devices companies have  plagued medical journals and continuing medical education programs for many years. For those of you who may not know commercial and business relationships (including consulting and speaker fees) are common between leading medical thought leaders and drug companies. In the last two decades alone, drug and device makers have made payments to tens of thousands of doctors and researchers in all medical specialties and areas of research. Critics of these practices (including the US Congress) are worried that this money could taint doctors’ research plans or clinical judgment when it comes to new drug/device approval. These concerns have prompted government agencies, medical journals and universities to look more closely at the deals. Many medical journals and granting agencies now require that physicians disclose all of their relationships to drug and device companies before their manuscripts and grants are reviewed.

Lilly and Merck’s decision to publicly disclose which physicians are on their payrolls is a step in the right direction. Full disclose and more transparency about the relationships between physicians and drug/devices makers is an important first step to limit subjectivity and conflict of interest issues when it comes to new drug/device approvals.

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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