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Increased Drug Transparency Sought

Jul 1, 2013

More and more, transparency in medicine is being called for, especially in the face of a number of issues involving kickbacks and concerning the relationships between researchers and drug makers.

A recent New York Times exposé focused on Dr. Peter Doshi, a Johns Hopkins University postdoctoral fellow, who, although not a physician, has been instrumental in getting Big Pharma to release records on some of the world’s most popular medications. In collaboration with other researchers and activists, Doshi is working to release and publicize information on clinical trials.

Information from clinical trials, under today’s system, is not ever fully released. Some information may be released in medical journals; however, in many cases, researchers involved have financial ties to the companies manufacturing the drugs being tested, noted the Times.

As a result of Doshi’s work, GlaxoSmithKline said it would share detailed information from every global clinical trial it has conducted since 2000. The data, noted the Times, have not yet been released but does amount to over 1,000 clinical trials and 90 drugs. Also, the European Medicines Agency (EMA), which oversees drug approvals for the European Union (EU), is looking into a policy in which trial data would be publicized upon drug approval.

The financial relationships between pharmaceutical makers and the health care industry have led to enormous controversy. Critics maintain that such relationships create conflicts of interest that could unduly influence everything from research findings to prescribing practices. Patients are no longer the primary focus in health care decisions, especially given that drug makers have long marketed their products using promotion strategies encouraging so-called “consultative” relationships with physicians in which doctors are brought back and paid to use industry’s products and promote them to their colleagues.

While relationships are forged between Big Pharma and physicians under the ruse of moving innovation and education forward, these relationships are, actually, a component of broader promotional strategies meant to increase sales, according to a prior report by The Wall Street Journal.

While physicians may believe their clinical judgments are not influenced by these partnerships, medical data reveal a trend in which patients are endangered and health care costs rise. For example, a prior Times review revealed that some 25 percent of all physicians have accepted cash from drug and device makers and about two-third accepted meals in exchange for advice and speaking engagements. That Times report also revealed that physicians working with industry tend to prescribe drugs in riskier and unapproved ways.

Medtronic’s InFuse is a key example of how conflicts of interests can affect patient safety. A recently released dual review revealed that the product—largely used in unapproved ways—provided limited benefits. In fact, the bone graft product was found to cause potential harm, such as a small increased risk of cancer, and worked no better than traditional bone grafts.

Medtronic had commissioned Yale University researchers to conduct independent studies of InFuse, allegedly in response to a June 2011 report published by The Spine Journal, which charged that the device maker failed to reveal that InFuse could cause potentially critical complications.

U.S. Food and Drug Administration (FDA) and the U.S. Senate Finance Committee had found problems with most of the initial Medtronic-supported InFuse research used to promote the product. Doctors and researchers wrote at least 11 medical journal reports about InFuse – and 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.

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