Tuesday, May 12, 2009

Medical Devices

Bad Back Investments

The New York Times has reported New Jersey’s Attorney General, Anne Milgram, announced a settlement with medical device maker, Synthes.

The consumer fraud case alleged that the device maker paid researchers, in company stock, to recommend their ProDisc artificial spinal disk. Although Synthes agreed to the settlement, “in the interest of a speedy resolution to the inquiry,” they did not admit to any wrongdoing.

The settlement stipulates that Synthes is to “disclose any future payments or investments held by doctors involved in researching its products.”

In a statement, Ms. Milgram said:

“It is outrageous that doctors who are testing, and in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make these devices…”

Upon further investigation, it was learned many doctors had investments in the company and that Synthes and doctors had failed to disclose such conflicts to the FDA. In a letter to the FDA and members of Congress, Ms Milgram, criticized the agency for their lack of regulating financial conflicts of interest.

In 2008, The New York Times wrote an article about the ProdDisc and a clinical study that involved almost 240 patients. The research took place at 17 centers; “doctors at about half of the 17 research centers involved in the study… stood to profit financially if the Prodisc succeeded…” Their report to the FDA did not include an “unusually large number of patients,” some of whom had unfavorable outcomes. See: Financial Ties Are Cited as Issue in Spine Study - New York Times

Stay tuned. The Attorney General’s office will be looking into other conflicts of interest within the medical device industry; they have already issued subpoenas to several major device makers.

For the full story see: Medical Device Maker Settles With New Jersey - NYTimes.com

Question: After reading this, how confident would you be about back surgery? Or any surgery? How do you feel about the passage of the Medical Device Safety Act? What else can we do to protect our health and wellbeing?

Hat tip: REED ABELSON, NYT, Published: May 6, 2009


  1. Sadly this is an all too often occurrence today. The justification? Of course it is to make sure that more needy patients get the wonderful products that are available today with the added benefit of more profit and thereby more new wonderful products to needy patients.

    It’s and ever increasing cycle that focuses on industry success on the backs of increasing patient risk.

    Dianne, to answer your questions I would sum it up this way. We must have the Medical Device Safety Act to save the pharmaceutical industry from themselves. They are there own worst enemy.

  2. Great post, Dianne. Thank you!

    As noted in the thread below, there are House hearings today on device preemption. Thus the flurry of the other stuff we've seen in the past few days.

    I happen to know several people who had terrible experiences with Prodisc. I understand it's the "big numbers" that matter, and comparative efficacy, safety, results compared with older approaches such as spinal fusion.

    But what I really wonder is this: Would any of us be able (psychologically) to ask a surgeon whether s/he had a financial interest in devices that might be used as we were rolled in (or beforehand)?

    Unlike with drugs, any surgery involves a large number of devices. There is obviously no viable way a patient could "check these out" before a procedure, and almost no one would be motivated to try, even if they could.

    So we come back to trust, which is where we began.

    All the more reason, in the view, that preemption is an even more dangerous policy in the device than in the drug arena. I agree with Jaynesday's last point. Both industries are digging their graves via preemption, even if they imagine otherwise. And that also means an enormous disaster for all of us, as I've said many times.

  3. Justice makes this point in another post,

    "Actually, the whole point of posts that are critical, at least here, is to support the industry through policy choices that, in the long view, most of us view to be in its interests. Which also means ours."

    Has the industry lost the capability to make good choices?

    Maybe the problem is that the industry really believes that anything good it does for itself (policy, promotion, marketing, profit, etc) is automatically good for the consumer. At least their paid promoters wish to make this the point. Of course, it's their job.

    They may have even crossed the line in their thinking. That thinking being that even fraud is acceptable for the "greater good".
    The basic (published) premise is - the more we can grow and produce, the more consumers we can enlist, the more good we can do.

    Therefore anyone who raises questions, or supports policy that might reduce their capacity to produce is harmful to possible future consumers.

  4. Yes, it is easy to get into the "what's good for General Motors" mindset and marketing. And we are watching in real time what is happening to General Motors.

    Imagine Merck, Pfizer, et. al. also sliding into bankruptcy. Obviously, the scenario should not be used as a threat--as it is by preemptors--so that we beg and coo in response to whatever they do or attempt to do.

    But it would be a disaster for a great many people who are, indeed, "innocent bystanders"--including the great majority of pharma employees and all the rest of us.

    So that's what I mean when I say that that there is a level at which industry's most vital interests, and ours, are the same.


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