November2008

American Medical Writers Association (AMWA) Annual Conference 2008

Nov 1, 2008
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By Robert Hand (robert.hand@rxcomms.com)

Under the title “Setting the Pace,” the American Medical Writers Association (AMWA) held its 68th Annual Conference on October 23–25 in horse country, Louisville , Kentucky . More than 1000 medical communicators with a wide range of expertise and interests attended. This year, AMWA offered a full programme of 97 certificate and non-certificate workshops, as well as 38 open sessions in which panels of experts addressed issues of concern to present and potential medical writers.

The Walter C. Alvarez Award, for excellence in communicating healthcare developments and concepts to the public, went to T.L. (Tedd) Mitchell , MD , President and Medical Director, The Cooper Clinic, Dallas Texas . His witty and entertaining address was, “Move Yourself: Getting Americans Back on the Path to Good Health.” Mitchell tweaked the host state for the conference, noting that it has the highest tobacco consumption in the United States . In an illustration of absurdity, he showed a picture of men using the escalator rather than the stairs on their way to a gym, ostensibly for exercise. Another showed before-and-after pictures of Michelangelo’s David; “before” was the familiar slim young man, and “after” was an electronically altered image showing a chubby, middle-aged man with voluminous love handles. Mitchell presented a series of charts documenting the epidemic of obesity and other health problems. His message was clear: we all need to take individual action to maintain our physical fitness and reduce the risk of serious, preventable health problems.

AMWA’s highest award, the Harold Swanberg Distinguished Service Award, for major contributions to medical communication and the medical profession, went to Norman Grossblatt, the man behind the Board of Editors in the Life Sciences (BELS) exam for editors. Grossblatt’s speech was a reminiscence called, “A Life in the Day of a Manuscript Editor” (no, that’s not a typo!) that recounted the many technological changes that have advanced the editing process over recent decades. From the days of handwritten mark-ups of paper manuscripts he recalled the development of early copy machines yielding pages that were of questionable quality and quickly became brittle and discoloured. (And how many people remember the purple mimeograph?) Since those days, tremendous technological advances, such as the replacement of typewriters by computers, have eliminated much of the paper and speeded the review process, with reviewers able to review manuscripts entirely on screen and circulate their comments instantly via e-mail. The result is a process that is vastly different from that of a few decades ago. On the other hand, the current process still requires real human beings to do the actual editing.

Further information about AMWA can be found at www.amwa.org .

Editors note: Robert Hand is a former president of the Delaware Valley Chapter of AMWA.

Drug makers gift disclosures: the ethics issue

Nov 1, 2008
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By David Woods (david.woods@rxcomms.com)

Drug company Eli Lilly has said that it will start disclosing the amounts of money over $500 that it pays to physicians – and other firms are likely to follow suit one jump ahead of a US Congress that is planning to mandate such transparency.

145Research has shown that payments to doctors can influence behaviour. As Dr. Arthur L. Caplan (pictured left), director of the University of Pennsylvania’s Center for Bioethics, puts it: “[Disclosure] is a good thing because we have a great deal of evidence that gift-giving can influence behaviour in terms of prescriptions, publishing positive findings but suppressing negative findings, and generating enthusiasm for new drugs.” He cites the extreme example of Emory University ‘s Dr Charles Nemeroff, a psychiatrist who, according to Health Care Renewal, raked in hundreds of thousands of dollars as a paid speaker on behalf of drug marketers, and denied these earnings while running a government-funded project meant to evaluate some of the products of his commercial sponsors.

Dr. Caplan believes that “the ethical handwriting is on the wall.” In an interview with HOC , he said that even small gifts can sway doctors, and he cites articles in the Journal of the American Medical Association and the New England Journal of Medicine underscoring that. His own article “All gifts great and small”, which appeared in the American Journal of Bioethics (3, 2003:39–46), gives further weight to that contention – and policy makers, he says, are starting to pay attention. Caplan believes that Congress will enact disclosure legislation shortly after the new president is sworn in on 20 January.

So what can pharmaceutical companies do if legislation shuts the door on how they can forge useful relationships with the medical profession? Dr Caplan believes there are four ways:

  1. Rethink the traditional approaches of sponsoring dinners and trips, and focus on building useful websites for physicians; perhaps something similar to the SERMO approach (see HOC December 2007) – a social networking initiative involving physicians whose real life clinical experiences can be made available to pharma.
  2. Hold conferences and peer-reviewed public meetings for healthcare associations.
  3. Maintain registries of research, which would be a useful service for both physicians and patients.
  4. Think ahead to putting medical information on YouTube, etc, and make sophisticated information advertisments for doctors – turn DTC into DTDoc

Is $500 a suitable threshold for disclosure? Dr Caplan believes it is; he also thinks that device manufacturers should be included in any disclosure mandates.

144With legislators and even medical associations such as the AMA and the Association of American Medical Colleges looking for a zero tolerance approach to drug company handouts to physicians, the industry would be well advised to develop a Plan B if it wants to influence physicians and stay within ethical boundaries.

Otherwise, recipients of drug company gifts might decide to do what one Minnesota hospital chain did. They swept them all up in 20 shopping carts and shipped them off to the West African nation of Cameroon.

Direct-to-Consumer Advertising – in Europe?

Nov 1, 2008
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By Mary Gabb (mary.gabb@rxcomms.com )

143Since 1996, DTCA has existed only in the USA and New Zealand , but recent declarations from the European Commission (EC) suggest that the rules governing pharma communication with patients may be loosened.

In October, both the Wall Street Journal (WSJ) and the Financial Times (FT) reported intriguing recommendations from the “High Level Pharmaceutical Forum”, a 3-year programme run by the European Union to address specific public health considerations regarding pharmaceuticals and to promote industry competitiveness while sustaining national healthcare systems. The Forum was the brainchild of Günther Verheugen, the Vice President of the European Commission and Commissioner for Enterprise and Industry. The FT also reports that Mr Verheugen is drafting legislation to formally ease marketing rules for pharma.

Concerns about DTCA in Europe emerge from one of the Forum’s three mandates: that patients and citizens need access to better information on disease states and available drugs. But who should provide that information? Both the WSJ and FT report that proposed new rules would weaken the existing strict limits on pharma-provided information to patients. Under the new proposed rules, “objective and unbiased” print and on-line information about drugs would be permissible, but direct advertising would not.

But who determines what is objective and permissible? Where is the line drawn between information and advertising? What role would the European Medicines Evaluation Agency (EMEA, a European equivalent of the US Food and Drug Administration) play?

Efforts to have Mr Verheugen answer those questions were unsuccessful. Queries to his press officer were unanswered and his spokesman stated that “our experts are still working on this and will not be available for the coming weeks.”

The published final conclusions and recommendations from the Forum clearly state that “the ban on advertising of prescription medicines to the general public should continue”, but it also names the industry as one of the relevant players in healthcare that should ensure high quality information for patients.

Thus, it is not clear exactly what the EC is proposing and, if agreed to, when the changes would be implemented. But this discussion does suggest a possible change in attitude toward the role of pharma in providing healthcare information in Europe.

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