For this sad tale of woe and intrigue check out the Health Care Renewal post by Roy Poses--
And then the New York Times article by Barry Meier that Dr. Poses links to:
Quick summary and attach "allegedly" in front of everything as none of this has been proven--a relatively small German firm, Biotronik, that makes pacemakers and implantable defibrillators, is now answering questions based on a trove of internal documents sent to the New York Times by a disgruntled former employee--an employee who claims he was fired because he complained about the corporate wrongdoing that his documents demonstrate. (The company protests that he's cherry-picked and that the documents don't tell the whole story.) PS-- a little change here in the usual script; usually it's a lawsuit or a Federal investigation for fraud that triggers release of these hidden documents.
The documents reveal a pattern of payola to get cardiologists to use Biotronik devices rather than one of their competitors'. The payola takes the form of "seeding trials"-- trials of no scientific value that are really excuses to get practitioners to enroll "subjects" for fees, and to promote the wider use of the company's product. (Biotronik sales officials even referred to these trials candidly in their internal documents as "unscientific studies.") Hiring physicians or their family members as "consultants" based solely on volume of product used or referrals for product use is the other major activity documented.
Here's a typical passage from Meier: "An implant specialist in Fullerton, Calif., Duane E. Bridges, became a consultant to Biotronik in mid-2008, company records indicate. The monetary volume of company products used by Dr. Bridges from early 2008 to early 2009 reached about $360,000, then jumped to $1.6 million over the next 12-month period, a greater than fourfold rise, the company data indicates. Dr. Bridges did not respond to comment; also a lawyer, Anthony Willoughby, who said he represented Dr. Bridges could not be reached for comment."
Also: "For example, in plotting strategies to gain sales at one California hospital, Biotronik officials suggested that an implant specialist, whose son and wife both worked for a competitor, might be wooed if Biotronik offered him concessions “such as studies or even the hiring of his son,” according to an internal company report."
The article also details a non-implanting cardiologist in Tucson, who was hired on as a Biotronik consultant and immediately informed his colleagues that he would not refer patients to them for implants unless they agreed to use Biotronik stuff. One of the area cardiologists to whom this doc referred patients (who was not apparently a paid consultant himself) increased his use of Biotronik devices eightfold, netting the company $1.1M in revenues.
Dr. Poses offers two astute comments. First, he notes that even people critical of financial ties with the drug and device industries tend to be less concerned about consulting relationships, and willing to give the doc the benefit of the doubt that the "consulting" is real and involves a true contribution of expertise in exchange for reasonable pay. He then notes that memos like those exposed here show that from the industry's point of view, "consulting" looks like bribery pure and simple. I would add a footnote--I expect if anything, and some of my surgeon colleagues agree, this is even more true in the device industry than in drugs. Why? Since device makers virtually never sponsor head to head trials, there's no scientific data as a rule as to which device is better. So if three firms sell similar devices, it's a wide-open arms race to get the docs to use your device and not the other guy's. The Biotronik memos seems to make clear that competition with other, bigger firms was the main driver behind these activities. (And incidentally reveals that almost for sure, the other firms were using the same tactics.)
Second point: Dr. Poses notes the by-now-pretty-tired excuse, that financial ties between docs and industry are required to promote scientific advance and innovation. It's quite clear that nothing about this entire Biotronik episode relates in any way to innovation.
Let me add my own two cents and bring up another huge point. Here is how Meier began his story: "The message from cardiologists was loud and clear, according to a top executive at a heart device company. The doctors wanted implant makers to produce more clinical trials of devices to help them generate income from research fees. To compete, 'we must be able to "answer the bell," ' wrote Thomas V. Brown, an executive vice president at the American subsidiary of Biotronik..."
In HOOKED I wrote about what seemed to be to be the saddest depths of professional ethics that physicians could fall to--not drug reps tempting physicians with generous payola to prescribe their products, but greedy physicians actually shaking down the reps for even more goodies and threatening to stop prescribing their drugs if they didn't come across. (To the point where even the drug reps felt ethically offended by the docs' behavior!) One has to conclude that a number of the cardiologists who ended up in the pockets of Biotronik were not seduced there by the big bad corporation; they pretty freely and eagerly crawled in. And what does that tell us about the state of professional ethics when these practices are permitted to flourish?
Monday, June 6, 2011
Who's at Fault: The Company or the Physicians?
Posted by Howard Brody at 8:57 AM
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My grandma had her pacemaker replaced. They were supposed to replace it with the same pacemaker.
Well, apparently medicare would only allow certain Medtronic devices, but neither my grandmother or mother (who has power of attorney) were told they were implanting a different device. However, they made it pretty clear they didn't want a different device.
It turned out she had a defective pacemaker. Not only was it pacing at bradycardic and tachycardic speeds when it was supposed to be set to 70 bpm, but her blood pressure was dangerously high. We took her to the doctor literally every day after the pacemaker implant, and the surgeon even opened her back up to check the device. We asked the doctor/surgeon if they could install the same device she had before, and he said it wasn't necessary as the pacemaker "was fine". It continued to malfunction and a few days later she had a stroke that left her paralyzed and bed bound for 8 months.
She is deceased now and in a better place, but I still wonder if medicare would only pay for the Medtronic device, or if the surgeon would only use Medtronic for whatever reason.
From my point of view, bad medical ethics are becoming more apparent all the time, and if this surgeon had some kind of connection to Medtronic, it honestly wouldn't surprise me. I'm not looking to blame anyone because it is what it is, and the surgeon did do the right thing by opening her up again and looking for a problem. These are just some internal questions that I have really never expressed. The whole ordeal before the stroke just seemed really strange.
Keep up your work. Many may not like you for questioning the establishment, but somebody needs to expose bad medical ethics and corrupton that just seems to be growing as the years pass by.
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