When approved by the U.S Food and Drug Administration in 2002, Medtronic’s bone graft product, InFuse, was seen as a medical breakthrough. InFuse eliminated the need to remove patient bone from the hip in spinal fusions and could, instead, use InFuse to promote bone growth.
InFuse is a synthetic—genetically engineered—recombinant human Bone Morphogenetic Protein (rhBMP-2) approved for specific uses. Meant to stimulate spine growth in patients suffering from lower spinal degenerative disease, InFuse is approved for use in one type of spinal surgery and some dental procedures. InFuse has never been approved for use on the upper, or cervical spine, where it is now widely used in off-label procedures.
Research initially supporting the use of InFuse has been found to be biased and two recently completed independent studies found that InFuse provides no significant benefit over traditional bone grafting. Some one million patients have received InFuse, according to a The Chicago Tribune editorial. The broader issue involves a lack of transparency between science and medicine, which impacts research independence and feasibility concerning new treatment and procedure efficacy, according to the Tribune.
As we’ve long stressed, financial relationships between device and drug 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, device and 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.
These relationships 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 The New York 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 industry 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 and use devices and other medical products in riskier and unapproved ways.
One important example of how conflicts of interest can affect patient safety was seen with Medtronic’s InFuse debacle. 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.
Some changes are expected on August 1, explained the Tribune. Drug, device, and medical supply makers must, under the federal Physician Payment Sunshine Act, compile data on payments they make to physicians who use and promote their product in new product development. As of March 2013, manufacturers will be required to disclose who is being paid and how much they are being paid, according to the Tribune.
The hope is that, in the face of kickbacks and other debacles, and given the relationships that have been formed between researchers and drug makers, increased transparency in medicine will provide consumers and their physicians with meaningful information.