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Medical Ethics and Advertising

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NEWS:

Add More Facts to Drug Ads, Experts Urge “People could make better decisions about which drug to choose if all ads carried a facts box clearly stating the medication's pros and cons, a new study suggests.”

Cancer Studies With Industry Funding in 8 Top Medical Journals “Nearly 1 in 5 oncology research articles published in prestigious journals was funded by industry, raising questions about the "industrialization of clinical research," write the authors of a review published online May 11 in Cancer. But industry is needed to translate research into products, argues a critic of the review, who says that "bioethics" discussions detract from the main aim of seeking a cure for cancer. The review authors looked at 1534 cancer clinical-research studies published in 2006 in 8 prestigious medical journals, including the New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of Clinical Oncology, and found that 17% were funded by industry and 29% had some kind of conflict of interest. These studies also tended to have positive outcomes. They also found that 50% of the studies were government funded and 29% had philanthropic grant funding. … "We need to direct concerted effort to disentangle research endeavors from industry ties," Dr. Jagsi said in an interview with Medscape Oncology. Industry involvement in oncology research, or any medical research, always has the "potential" to influence the research, Dr. Jagsi said. "It would be wonderful if the vast majority of cancer research published in high-impact publications was publicly funded," she said, adding that more public funding of research is needed. … On the one hand, Dr. Jagsi wants to minimize industry-funded research. "If we wish to have truly unbiased research, then we need more publicly funded research. Disclosure of industry relationships or conflicts of interest is probably insufficient," she said. On the other hand, Dr. Stossel believes the collaboration between academia and industry is integral to the creation of therapeutic products. "Innovation will come from partnership between curious entrepreneurial researchers and industry. We need to promote that partnership," he said, adding that the biotechnology industry is the epitome of this dynamic. … The review also showed that, in a subset of 124 randomized trials assessing overall survival, studies with industry funding were more likely to report positive outcomes when a conflict of interest was present (P = .04) "Our study shows quite powerfully that when a conflict of interest was identified, there was a significant increase in the likelihood that a randomized trial would show a positive outcome," said Dr. Jagsi.”

Direct-to-consumer drug ads losing their punch

Drugmakers' push boosts 'murky' ailment “Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills recently approved as treatments and drowning out unresolved questions — including whether it's a real disease at all. … Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments. Experts don't doubt the patients are in pain. They differ on what to call it and how to treat it. Many doctors and patients say the drugmakers are educating the medical establishment about a misunderstood illness, much as they did with depression in the 1980s. Those with fibromyalgia have often had to fight perceptions that they are hypochondriacs, or even faking their pain. … "The underlying purpose here is really marketing, and they do that by sponsoring symposia and hiring physicians to give lectures and prepare materials," said Wolfe, who directs the National Data Bank for Rheumatic Diseases in Wichita, Kan. Similar criticisms have dogged drugmakers' marketing of medicines for overactive bladder and restless legs syndrome. Many of the grants go to educational programs for doctors that feature seminars on the latest treatments and discoveries. … While Goldenberg continues to diagnose patients with fibromyalgia, some of his colleagues have stopped, saying the condition is a catchall covering a range of symptoms. Dr. Nortin Hadler says telling people they have fibromyalgia can actually doom them to a life of suffering by reinforcing the idea that they have an incurable disease. "It's been shown that if you are diagnosed with fibromyalgia, your chances for returning to a level of well-being that satisfies you are pretty dismal," said Hadler, a professor at the University of North Carolina, who has occasionally advised health insurers on how to deal with fibromyalgia. … "At the end of the day I don't care how you categorize this — it's a legitimate condition and these people are suffering," Clauw said.”

Harvard Medical School in Ethics Quandary “In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects. Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments. “I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.” … But no one disputes that many individual Harvard Medical faculty members receive tens or even hundreds of thousands of dollars a year through industry consulting and speaking fees. Under the school’s disclosure rules, about 1,600 of 8,900 professors and lecturers have reported to the dean that they or a family member had a financial interest in a business related to their teaching, research or clinical care. The reports show 149 with financial ties to Pfizer and 130 with Merck.“

New Merck Allegations: A Fake Journal; Ghostwritten Studies; Vioxx Pop Songs; PR Execs Harass Reporters

Postmarketing Lessons to Learn From Vioxx Debacle “"If we are to detect harms early and protect the public's health while ensuring the availability of new clinically effective therapeutics, a system must be established that makes full use of all existing evidence," they add. Ross said that although the recent changes to US legislation go some way toward this goal, there is still much room for improvement. The Answer to a Question The tale of rofecoxib is inscribed in pharmaceutical history: an anti-inflammatory drug was introduced in 1999 and hawked as a safer alternative to traditional nonsteroidal anti-inflammatory drugs; its sales soon reached $2 billion annually. From 2000 onward, for four years, there were numerous analyses and endless rancorous debate about whether rofecoxib increased cardiovascular risk, with the company maintaining that it did not until, in September of 2004, the large APPROVE trial was terminated early because of an increased risk of cardiovascular events with rofecoxib compared with placebo; the drug was dramatically pulled from sale worldwide, the biggest withdrawal in pharmaceutical history. The results illustrate how critical it is to make all clinical-trial data available for independent research. "All along, Merck insisted there was no evidence that rofecoxib increased cardiovascular risk in comparison with placebo, until the APPROVE study," Ross explained to heartwire . "Our new analysis shows how the placebo-control-only clinical-trial data could have been used to identify the cardiovascular risk with the drug far sooner. The results illustrate how critical it is to make all clinical-trial data available for independent research," he stressed. “

ARTICLES:

JOURNAL ARTICLES:

Exposure of medical students to pharmaceutical marketing in primary care settings: frequent and influential. (Adv Health Sci Educ Theory Pract. 2009)

Marketing disease: is osteoporosis an example of 'disease mongering'? (Br J Nurs. 2009)

PUBLICATION ETHICS AND THE GHOST MANAGEMENT OF MEDICAL PUBLICATION. (Bioethics. 2009)

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