Increased Transparency on Drug Trials Sought

drug_trialsIn the face of a kickbacks and other debacles and given the relationships that have been formed between researchers and drug makers, transparency in medicine is being sought.

Peter Doshi, a Johns Hopkins University postdoctoral fellow has been instrumental in getting industry to release records on some of the world’s most popular medications, according to a recent The New York Times exposé. Doshi, collaborating with other researchers and activists, is working to release and publicize information on clinical trials. Today, information from clinical trials in not fully released. Although some information may be published in medical journals, in many cases, the researchers who are involved have financial ties to the companies that are making the drugs being tested, according to the Times.

It was Doshi’s work that prompted GlaxoSmithKline to announce that it would share the details from every global clinical trial it has conducted since 2000. Although the data has not yet been released, it comprises over 1,000 clinical trials and 90 drugs, the Times wrote. The European Medicines Agency (EMA), which oversees drug approvals for the European Union (EU), is working on a policy in which trial data would be made public upon drug approval.

As we’ve long stressed, financial relationships between pharmaceutical makers and the health care industry have provoked enormous controversy. Critics argue that these relationships create conflicts of interest that could unduly impact research findings and prescribing practices, creating a situation in which patients are no longer the primary focus in health care decisions. Meanwhile, drug makers continue to market their products using promotion strategies that encourage so-called “consultative” relationships with physicians. In these relationships, doctors are brought back and paid to use industry’s products and promote them to their colleagues.

Relationships created between Pharma and physicians are meant to move innovation and education forward but, are, in fact, part of broader promotional strategies meant to drive sales, according to a prior report by The Wall Street Journal. While physicians may believe their clinical judgments are not being influenced by these partnerships, data reveal a trend in which not only health care costs rise, but in which patients are being endangered. A prior Times review revealed that about 25 percent of all physicians have accepted cash from drug and device makers; some 2/3rds accepted meals in exchange for advice and speaking engagements. The Times report also revealed that physicians who receive money from drug makers also appear to practice medicine in different ways than physicians who do not accept industry gifts, and physicians working with industry tend to prescribe drugs in riskier and unapproved ways.

One important example of how conflicts of interest can affect patient safety was seen with Medtronic’s InFuse® debacle. U.S. Food and Drug Administration (FDA) warnings and a U.S. Senate Finance Committee discovered problems with most of the first Medtronic-supported InFuse® research used to promote the product—doctors and researchers who wrote at least 11 medical journal reports about InFuse® were paid some $210 million in royalties and consulting fees, according to Bloomberg Businessweek. Senate investigators charged that Medtronic intentionally manipulated studies to minimize the product’s adverse reactions and promote off-label use.

Medtronic commissioned Yale University researchers to conduct independent studies of InFuse®, allegedly in response to a June 2011 report published by The Spine Journal.The report charged that Medtronic failed to reveal that InFuse® could cause potentially critical complications. The findings of a the recent dual review revealed that the bone graft product was largely used in unapproved ways; provided limited benefits; was found to cause potential harm, such as a small increased risk of cancer; and worked no better than traditional bone grafts.

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