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Evil collaboration between Medtronic and FDA

Paul Alper points us to this news article by Jim Spencer and Joe Carlson that has this amazing bit:

Medtronic ran a retrospective study of 3,647 Infuse patients from 2006-2008 but shut it down without reporting more than 1,000 “adverse events” to the government within 30 days, as the law required.

Medtronic, which acknowledges it should have reported the information promptly, says employees misfiled it. The company eventually reported the adverse events to the FDA more than five years later.

Medtronic filed four individual death reports from the study in July 2013. Seven months later, the FDA posted a three-sentence summary of 1,039 other adverse events from the Infuse study, but deleted the number from public view, calling it a corporate trade secret.

Wow. I feel bad for that FDA employee who did this: it must be just horrible to have to work for the government when you have such exquisite sensitivity to corporate secrets. I sure hope that he or she gets a good job in some regulated industry after leaving government service.

11 Comments

  1. Paul Alper says:

    One of the side effects of the Iraq war’s improved head gear was the increased number of spinal injuries. Soldiers who would have died of a head injury in combat survived and needed to be treated. Infuse is a bioengineered bone growth product made by Medtronic

    http://www.nytimes.com/2009/07/29/business/29device.html

    “that stimulates bone growth, was cost-effective in spinal fusions when compared with using bone grafts, the traditional material.”

    Apparently, there is money to be made via Infuse:

    “Between 2003 and 2007, Dr. [David] Polly [of the University of Minnesota] received more than $1.14 million in fees and expenses from Medtronic, those records show.”

    “The medical school knew he was a company consultant, but under the school’s rules Dr. Polly had to acknowledge only that he received more than $10,000 annually. Medtronic paid him about $350,000 that year alone in expenses and fees, the records show.”

    “A transcript of that hearing shows that he identified himself at the hearing as a representative of a professional medical group, the American Academy of Orthopedic Surgeons. He did not note his ties to Medtronic, according to the transcript.

    The documents released Tuesday also indicate that for his appearance at the hearing, Dr. Polly billed Medtronic $6,000.”

    “He is the second former Walter Reed doctor to come under scrutiny by Senator Grassley. The other, Dr. Timothy R. Kuklo, published a study of Infuse’s use on Walter Reed patients that a British medical journal retracted in March after an Army investigation concluded that he had falsified its results.”

    Information about Kuklo’s weird behavior–he falsified the signatures of supposed coauthors–may be found at

    http://www.wsj.com/articles/SB125063055283141169

    “Medtronic, which paid him as a consultant nearly $800,000 over the past three years until early this year, said Dr. Kuklo is on ‘inactive status’ as a consultant.”

    In 2015, Medtronic moved its headquarters from Fridley, Minnesota to the Republic of Ireland.

    • Andrew says:

      Paul:

      At least when my Ph.D. advisor consulted for the cigarette companies, everyone knew what side he was on!

      • Oxnard says:

        Is it as clear that these guys, given that this has really bad optics, are literally on the side of death?

        • Andrew says:

          Oxnard:

          They seem to be on the side of hiding adverse events, which seems similar to the cigarette companies hiding their knowledge of the dangers of smoking.

          • Jacob says:

            If only it were that easy. Cigarettes have no medical value, and the companies that made them didn’t/don’t also produce real medicine. Medical devices, as a class, can’t be described that simply. Some work, others don’t, they all have adverse effects to some degree or another, so informed consent is the name of the game. Obviously the company should have reported these events more promptly, but “medical device companies are literally on the side of death” is not a logical conclusion from one incident from one device.

            Side note: Andrew, you know your blog has comment threading now right? You don’t need to address commenters by name when replying.

            • Andrew says:

              Jacob:

              1. I never said anyone is “on the side of death.” I did say that hiding adverse events is evil, but being evil doesn’t mean you’re “on the side of death.” I assume that, all other things being equal, this FDA dude does not want people to die. He just feels that, in this case, the corporate trade secret is more important than informing the public. Evil (in my opinion) but I have no opinion on whether he’s “on the side of death.”

              2. Yes, but threading can sometimes mess up so I find it helpful to address commenters by name.

            • Paul Alper says:

              “If only it were that easy. Cigarettes have no medical value, and the companies that made them didn’t/don’t also produce real medicine. Medical devices, as a class, can’t be described that simply.”

              Perhaps not quite that simple. One reason given by smokers for not quitting is the fear of gaining weight. I recall the ads that said, “Instead of a sweet, reach for a Lucky.” To make sure, I relied on Wikipedia for support,
              https://en.wikipedia.org/wiki/Cigarette_smoking_for_weight_loss#.22Reach_for_a_Lucky.22

              “Borrowing from the 19th century slogan of Lydia Pinkham’s Vegetable Compound, ‘Reach for a Vegetable,’ that was marketed towards women for the alleviation of menstrual discomfort, Lasker and Lucky Strike launched the “Reach for a Lucky Instead of a Sweet” campaign in 1925, followed by ‘For a Slender Figure—Reach for a Lucky Instead of a Sweet’ in 1928.[21] The print advertisement was disseminated by Edward Bernays throughout the fashion industry in numerous fashion magazines and daily newspapers featuring slender Parisian models and proclaiming the dangers of sugar consumption.[22] Famously, Amelia Earhart would also serve as a spokeswoman for the “Reach for a Lucky” campaign.”

              Read on to see how “the National Confectioners Association fired back at Lucky Strike, threatening legal action and publishing anti-cigarette literature that asserted the importance of candy in a balanced, healthy diet.”

  2. Rahul says:

    Snark aside, the tension between regulatory disclosure & how-to-protect-confidential-information seems very real in many other areas today: e.g. It used to be that you came up with a new amazing cleaning fluid or lubricating oil or whatever and kept its composition a secret. No more. MSDS (Material Safety Data Sheets) make it very hard to hide what ingredients one uses.

    Similarly EPA disclosures force details of your chemical process into public domain. etc. Emission regulations make a lot of data about process yields publicly available to competitors.

    It is going to be interesting how this shapes the future. Perhaps this will reduce the use of trade-secrets & confidential-information in favor of more aggressive & indiscriminate patent filing. Which I’m not sure is entirely good.

    • Jacob says:

      The number and nature of adverse events shouldn’t be considered a trade-secret (and I’m 99% sure it’s not, typically studies like this are made public), at least not once a device has gone to market. When a person uses a drug or medical device they should know what it does. That means knowing both intended and unintended affects. We’re not even talking about an ingredients list here necessarily, just adverse events which have been observed.

      • Rahul says:

        Yes, I agree, in this case. I was making a comment about a more general case. Having to work for the government and yet to retain sensitivity to corporate secrets may not be entirely misplaced.

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