Friday, November 6, 2009

Is the FDA the Good Guy? The Bad Guy? Or Are They Just Trying to do Their Job?

Wednesday's 5-1 Vote by an independent panel for the FDA has raised some serious questions not only about how the FDA does its business, but also about our industry. TSB believes that our readers understand that the Fed's role in the process is to regulate firms that manufacturer medical devices, while at the same time, it "protects" the American public by ensuring the operating accuracy of a device. Device classifications depend not only on intended use, but also on indications for use. Yet, some of our readers feel that the process is criminal and its intent is to financially punish the industry? TSB must ask our readers, what is the role of the FDA? To paraphrase one of our bloggers, "it is to protect consumers and make sure the technology in question is safe and efficacious!" At the same time, the FDA is the gatekeeper to our industry's financial enterprise. Maybe the FDA is really not as hyper-protective as we would like to believe. If one looks at the Yin and Yang of this debate, maybe the FDA has been lax in their standards over the last few years? All our readers have to do is read about the Menaflex fiasco to understand the aberrant culture that exists at the Agency, or ask themselves is INFUSE a pharmaceutical product or a device?

As an industry, we have won many battles with the FDA by creatively tailoring language in the submission process on intent and indications of devices. If Dynamic Stabilization can play a role in the treatment of DDD by favorably altering the movement, and load transmission of the spinal motion segment without fusing the segment, is this a new modality of treatment? How is this a supplement or adjunct to fusion? Our readers must answer that question! If instability or abnormal movement is the main cause of back pain, fusion would alway be successful in relieving back pain, yet, this has not been the experience. With the introduction of pedicle screws, inter-body devices and the 360, successful fusion rates have increased, but have failed to improve the overall clinical success rates. TSB understands the argument that "potentially" this product could minimize adjacent disc degeneration by controlling motion, but how much motion? And how much load should be shared by the system to unload the damage disc? Did God create us equally in size, shape and looks?

Based on what one of our readers posted, it seems Zimmer itself is confused. What does "It offers a unique approach to stabilization and immobilization of the spine and pain relief" really mean? And what does " it provides immobilization and stabilization of spine segments" mean? Just attend the Castellvi program in the Keys, and one starts to wonder whether the surgeons themselves understand how to use this device. Do any of these panelist understand the discrepancy in the kinematics between the implant and the motion segment? Or, are they relying on the input of a cadre of academicians and biomechanical experts? Mainly Panjabi, Goel Ferraro, et al????

Put yourself in the position of the FDA. How difficult is it to discern what is clinically relevant and what is clinical marketing? Today, we have surgeons testifying on behalf of the companies and devices that have a vested interest in the products approval and success. Can one potentially lose their objectivity when millions of dollars are at stake? If you and I sat on the panel, what would be the first question we asked? I venture to say that most of you know the answer! Then, we would proceed to evaluate the technology and the data. What makes this such a hot topic is that Spine is always looking for a new product to build momentum, and TDA has lost some of the wind behind its sails. Spine is a burgeoning industry, based on its margins and profitability, that is why it has become the darling of Wall Street. Investors with and without any medical experience have infused a tremendous amount of capital and time into this product segment. Unfortunately, this is a product that needs time and retrospective clinical data to prove its efficacy. At the end of the day, if most of these patients end up with a fusion what have we accomplished? TSB wants to know what our readers believe?


  1. So what are the ethical or legal ramifications of a surgeon/investor implanting products from a company for which he is an investor?
    surgeon/investor/inventor implanting his product and getting royalties on the usage?

  2. Steve you can answer that question.. TSB is just facilitating the questions!

  3. M Man,

    Great post asking great questions. This is a very good discussion for our industry to be having.

    My short answer is that for now, they believe they are just doing their job. However, I see them trending towards "the dark side" over time as the culture of bureaucracy in Washington invades healthcare and business.

    If FDA makes even one mistake on an approval decision, I believe they will over correct by applying scrutiny beyond reasonable parameters when it comes to reviewing technology.

    I agree (from what I have read) that Zimmer did not clearly define the clinical benefit of the stand alone status of Dynesys. However, reading some of the comments from the review panel, one reviewer said they fully believe the product is safe as a stand alone device, but they are worried about its overall "long-term safety". HOW LONG??? Statistically, there are far too many factors to be able to conduct a study that "guarantees" effectiveness - which it seems is what they are after.

    This is where their lack of industry experience, business experience and life outside of academia is killing the advancement of technology. As much as we hammer doctors for having financial interests in products they are using, we have the polar opposite going on at FDA where these people have not stepped outside the classroom for 30 years, and have no concept of the money they are asking start-ups to produce to get FDA approval.

    At costs approaching 40-50MM for an IDE, more and more patients are going to end up with just fusion because the barriers to entry to produce innovative solutions are too high. We are not there yet, but is it possible that happens over the next decade?

    Spine is a product that needs time and retrospective clinical data to prove its efficacy, but there has to be a balance. FDA can protect consumers by not letting harmful technology on the market, but they can also do far more damage over the long term if they throw barrier after barrier in front of innovative companies.

  4. Steve- Many people have an automatic reaction to physician investors using a product in which they have invested. In reality, physician investors are necessary and without them start-up are much less likely to get off the napkin. It takes initial capital before non-physician angels much less venture investors take any interest. What savy investor would put their money into a medical product when no clinicians have endoresed the idea with their own money? Common sense would suggest that companies can manage the amount of influence these physician investors have to reasonable levels. Regarding royalies, physicians can't take royalties on their own sales. If they promote their royalty product ethically and responsibly, more power to them. Sure there are vagaries in this area, but we can't simply say that surgeons should be out of the medical device business.

    I agree with SpineSearch that part of the FDA problem is that the staffers involved lack any industry or clinical experience. The panel members are selected to fill the clinical gap but industry remains under represented. Even in an ideal situation the FDA has a difficult role. The public wants ready access to less expensive, innovative medical devices with no risk. If FDA approves something 'quickly' that later results in problems (e.g. Vioxx) they get hung out to dry. If they ask for long studies, industry can't afford to take the risk and we will end up limited to 'old' technology.

    If a product meets its predetermined, mutually agreed upon, success criteria, then it should be approved. The market will sort out the adoption. That may take some time but how else can we reasonably keep advancing the science while balancing cost. My bet is FDA will go against the panel- but its a small bet.

  5. David:

    An excellent point with regards to surgeons investing their own skin in the game. Years ago I was approached by a prominent surgeon that wanted to bring his IP to the market, unfortunately, when I asked that he infuse his own capital into the game, he refused. Eventually, the IP was sold to another company for a nominal amount. TSB has always agreed that "real" surgeon consultants need to be paid and differentiated from those that companies are only interested in buying market share, and that's where the challenge exists! Those individuals give everyone else a bad name. The inability of NASS, CSRA, SAS et al to police themselves is a major problem. But what can you expect when they themselves have evolved into a money making platform. Thanks for the commentary!

  6. the answer is simple: FDA needs to make the rules. We can talk all lifetime what the rules should be. BUT once they make the rules (i.e mutually agreed upon ide study)for a panel member to say (im paraphrasing) "the clinical data may be fine but i just dont understand optically the device and what it is supposed to do biomechanically" is criminal. That means there is no system meaning there are no laws just a dictatorship.

  7. We've covered this ground before on this blog . . . Dynesys or any other pedicle screw based dynamic system is NOT a treatment for DDD.

    The problem Zimmer ran into with the FDA is there was only one spine surgeon on the panel and he was the lone "yes" vote. I wouldn't be suprised if the FDA approves this in spite of the panel recommendation. It's fairly obvious several members of the panel didn't have a clue what a pedicle screw was much less a "non fusion" application

  8. home (& any FDA staffers that may be reading)

    Might the process be best served with two panel meetings? Most importantly would be a meeting before the study- when the sponsor submits the IDE. Something akin to the PDP process that's already available to industry but never used. As things can change over a study, a second panel meeting at the end would be useful to review the actual data- but only if there are significant, unexpected issues. However, that second panel meeting should have the same members as the earlier one so that there's consistency and accountability.

    Wouldn't this help everyone out?

  9. And while we are at it- add in the ability for the FDA and Sponsors to mutually select those panel members. The process could mimic jury selection. Obviously, no financial ties between panel members and the sponsor- but at least we wouldn't have the situation of one surgeon on the panel and nobody else knowing the pros/cons of dynamic stabilization.

  10. Asking if the FDA is a good guy is like asking if shit doesn't stink.

    Have you morons ever heard of a conflict of interest?

    The FDA is the best regulatory agency money can buy. I think it's time that you guys pull your heads out of your asses and admit that you work in a filthy and corrupt industry with the scruples of a pimp and the morals of a crack dealer.

    The FDA's medical device division is J&J's enforcement wing and a bribe and kickback clearing house for surgeons with its revolving door always turning.

    The notion that the FDA and the medical industry can be reformed and actually protect Americans gives the word laughable a new meaning.