:: November 2009

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Highlighted Article

Experts Conclude Pfizer Manipulated Studies “The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company. Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers. One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.” “

Guidelines

NGC - Advance directives: protecting patient's rights. (2003)

Internet Sites

Featured site

NIH - Bioethics Journals

AMA - Principles of Medical Ethics, June 2001

Healthy Skepticism

Media Doctor

NIH - Bioethics Journals

PharmedOut

Red Flags

Related Topics - Highlighted Articles

Patient Safety

Journal Commentary Labels FDA 'Timid and Toothless' " Ä These controversies, Okie wrote, 'have raised questions about the agency's ability to fulfill one of its fundamental missions -- to ensure that the benefits of prescription drugs outweigh their risks.' Ä In February 2004, one medical reviewer was prevented from presenting his findings linking the use of antidepressant drugs in youth with increased suicidality, and FDA whistleblower Dr. David Graham was told to alter the conclusions of his Vioxx study."

Evidence-Based Medicine

Of mites and men: reference bias in narrative review articles (THE JOURNAL OF FAMILY PRACTICE 2005) "Background: Citations in scientific articles may tend to favor the views presented. We studied whether there is such reference bias in narrative review articles that discuss interventions against house dust mites for people with asthma. Ä We conclude that narrative review articles on house dust mites and asthma are severely biased in their selection of references and very unreliable in their intervention recommendations. This finding may be generalizable, since there is no reason to believe that physicians specializing in asthma should be more biased than others when they write reviews."

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General Information

	General Information
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. “