back surgery product linked to conflicted incomplete research

Before bone morphogenetic protein-2 was introduced to the market in 2002, health care professionals in Pittsburgh and throughout the country were mesmerized by the product. Studies suggested the back surgery product would revolutionize medicine.

BMP-2 did just that, but the feat was accomplished differently than most people expected. Rather than creating a 100 percent success rate in fusing spines without complications, the product was associated with skepticism and scandal. Many professionals questioned whether corporate-funded research that was carried out by financially conflicted doctors could be trusted.

Did health care professionals knowingly introduce defective medical products to the market, or were the doctors involved in the testing too invested to see the potential pitfalls of the promising new product? Either way, their research led surgeons to recommend unnecessary surgery risks.

It’s tough to know. However, patients can rest assured that the downfall of BMP-2 will bring much-needed changes. Some medical experts have suggested that the controversial outcomes of BMP-2 “promise that the business of developing new medicine and treatments will become more transparent and credible.”

Even in the past few years, the health care professionals who presented information about new medical products did not discuss how the conclusions about a product’s safety or effectiveness were reached.

With BMP-2, a small group of doctors was primarily responsible for writing and presenting information about the back surgery product. However, the doctors failed to link BMP-2 to serious complications, including “cancer, infections, the painful growth of unwanted bone and sterility in men.” The same group of doctors writing the papers was also receiving tens of millions of dollars in royalties from Medtronic, the company marketing BMP-2.

Even so, much of the information presented by the doctors did not mention the financial incentives. When it was mentioned, it was disclosed so vaguely and cryptically that it was effectively meaningless. Many professionals were unaware of the doctors’ financial conflict of interest, and those professionals made life-impacting decisions based on the information featured in the medical research.

Back surgeons want high fusion rates, and to do that, they must use aggressive techniques and cutting-edge technologies. The chief of spine surgery at one hospital acknowledges that money also factors into the picture. “Big operations make more money for surgeons, companies, and hospitals, and that can be a real motivator.”

Back surgery is risky, but many people know a successful surgery could positively change the remainder of their lives. But when patients are persuaded by surgeons who are motivated as much by money as they are by patients’ best interests, they may unknowingly agree to dangerous, unnecessary operations.

The BMP-2 saga has been unfortunate. However, if it leads to better transparency in medical reporting — as medical experts suggest it will — that would be a good and much-needed change.

Source: Journal Sentinel, “Fallout from back surgery product prompting reforms,” John Fauber, Dec. 29, 2011

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