They bought doctors–how many paid the price?
People in pain usually want one thing–something simple, but not always easy–to stop being in pain.
So they turn to people they trust–their doctors, backed by the FDA and innovative companies–to get help.
They place their full confidence in drugs and devices that are supposed to be safe. That have been deemed effective. That have been approved by our very own government.
But that trust and confidence is not always deserved. Sometimes simple greed gets in the way.
A Senate Finance Committee investigation recently said they believe that they’ve found evidence that glowing studies about a spine fusion product were written and edited with the close involvement of the company that made the product. The doctors who “wrote” the studies were paid millions. The benefits of the product were grossly overstated. And concerns about serious complications were outright eliminated from the studies.
In a 15-year period, it’s claimed that Medtronic paid out $210 million to 13 doctors listed as co-authors on a series of 11 papers about their spine fusion product, Infuse. In fact, the lead author alone has received a cool $6.4 million from the company between 1998 and 2010. They also made payments to two corporations associated with the authors.
Medtronic’s marketing department had a heavy hand in collaborating with the authors. And here’s a shock: This kind of “ghostwriting,” while frowned upon, isn’t even illegal!
Sure, it more or less guarantees that doctors and patients will get misleading information. And it, of course, means that medical decisions are going to be made based on studies that marketers had a heavy hand in presenting. But hey, it’s legal!
Back in January 2002, a spine surgeon spoke glowingly of Infuse before an FDA panel as they weighed whether or not to approve the product. He said he had no financial interest in the product and had not been paid for his appearance at the meeting.
An email trail tells a far different tale, though. Medtronic worked with a PR firm to prepare the surgeon’s speech. He also received “consulting” payments from the company a year earlier and was finally hired as the VP of Medical and Clinical Affairs at Medtronic in 2007.
In 2002, the marketing team asked that study authors “make a bigger deal” out of Infuse’s pain relief benefits. Another email trail reveals that a marketing employee was involved in editing a complete list of complications from a key 2005 article about Infuse. The complications involved whether or not the fused area would actually be sound and included fractures and migration of the implant.
There is also evidence that they tried to weaken safety rules for a trial that would allow the participants to continue even if they experienced swelling in the neck. The FDA warned about this very issue in 2008 when they said that Infuse shouldn’t be used in cervical spine fusions. Such use had been linked to swelling leading to airway compression. Some people even ended up needing emergency tracheotomies.
This kind of thing went on for 15 years. And the Senate investigation found that there were problems that, according to one physician, should have been reported ten years ago. Instead, the corruption and harmful misinformation was allowed to continue.
Of course, Medtronic is denying the findings. They claim the “vast majority” of the payments were royalties instead of consulting payments. They say the Senate is being unfair.
But the truth is in the paper trail.
In the end hundreds of people were hurt when articles influenced by Medtronic said surgery patients weren’t harmed by excess bone growth. Some of those folks required more surgery, and some live in constant debilitating pain.
Despicable.
And sadly this is not an isolated incident. It’s just that Medtronic got caught.
However the good news is that the Senate is trying to combat this shameful practice with new legislation. The Physician Payments Sunshine Act will require drug and device companies to disclose payments starting early next year. Members of the committee are also hoping that medical journals will become more proactive in policing what’s going on within their pages.
I’m not sure how many doctors will be recommending Infuse after these revelations. But, to be realistic, we’ve already seen the marketing magic that Medtronic can accomplish with a couple hundred million dollars and they might work hard to keep this story under wraps.
Infuse was presented as a better alternative to the standard surgical technique of using a small amount of a patient’s own hip bone for fusing vertebrae. That claim has since been strongly challenged, and this story of corruption only serves as further warning. If you’re facing the possibility of surgical spine repair, you should know that the older option of using your own hip bone seems to truly be the best one.
And if you’re not ready to go under the knife, you can also look into a treatment that dates back to Hippocrates. It’s called prolotherapy, and Dr. Wright first wrote about it back in 2005. You can learn more about prolotherapy, which uses injections of a sugar-based solution to prompt the body’s own healing abilities, at www.prolotherapy.com.
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Sources:
“Medtronic Helped Write, Edit Positive ‘Infuse’ Spine Studies,” Medpage Today (medpagetoday.com)
