Random Thought: FDA Approval

[sportsnut3007]

When will we attack the fda. I am tired of them dragging their feet with new stuff. Im not saying be crazy, but lets quicken the process tremendously. I talked to a rep from spinal kinetics the other day and she was saying they are still trying to get an fda trial for their disc. Come on fda, get off your asssssssss and get this going and lets make these trials in to 2 categories. one semi approved for any who wants it after like a year. Second part after their normal 4 years or whatever.

[Justin]

When will we attack the fda. I am tired of them dragging their feet with new stuff. Im not saying be crazy, but lets quicken the process tremendously. I talked to a rep from spinal kinetics the other day and she was saying they are still trying to get an fda trial for their disc. Come on fda, get off your asssssssss and get this going and lets make these trials in to 2 categories. one semi approved for any who wants it after like a year. Second part after their normal 4 years or whatever.

SN, I understand where you are coming from. The FDA is definitely a double-edged sword.

[MDE]

There is no benefit to the FDA to release a product. The only thing that can happen by approving a product faster is that it is MORE likely (because of a less intensive study) that the product will harm patients.

Believe me, I have been very anxious waiting for my own device approvals through the FDA to release things so they can start benefiting people, however you have to be very careful. New things like the M6 and Freedom discs may be great and really provide a significant improvement to the patient, however you cannot justify implanting thousands of them without doing long term follow ups on a limited number of patients. The European MDD is a different style of regulatory system which allows technology through faster, however it also relies on the companies to "do the right thing". In the US, this style of system just won't work based on companies willing to "take risks" with patients to make money.

That sounds terrible, but it's been proven time and time again.

Everyone wants the newest latest technology (And my job is to make that tech), however you need to be very scrutinizing with long term follow ups. In the end, you can make the fanciest device in the world that SHOULD do everything, but if patient outcomes show that it is not beneficial when compared to fusion, it should not be used. Science based, and more specifically Patient Outcome based medicine is the best approach.

An example (leaving the company out of it) was a recent indictment of several executives based on conducting unauthorized clinical trials which resulted in several patients deaths.

People tend to lose sight of the big picture when they're in pain and want the best option.

[sportsnut3007]

In response to the european style of approval not working in the usa. The freedom lumbar and the spinal kinetics discs are both made here in the usa, yet europe seems to trust these companies testing. I know there is risk of course with faster approval, but when it comes to really key medical things i think the process should move alot faster. For cosmetic stuff Im all for super testing etc. Also, even if there isnt less testing done, at least when a company contacts the fda lets get it moving asap instead of hassling around. Maybe we need to hire more fda staff to get this stuff moving alot faster.

[Justin]

There is no benefit to the FDA to release a product. The only thing that can happen by approving a product faster is that it is MORE likely (because of a less intensive study) that the product will harm patients.

Believe me, I have been very anxious waiting for my own device approvals through the FDA to release things so they can start benefiting people, however you have to be very careful. New things like the M6 and Freedom discs may be great and really provide a significant improvement to the patient, however you cannot justify implanting thousands of them without doing long term follow ups on a limited number of patients. The European MDD is a different style of regulatory system which allows technology through faster, however it also relies on the companies to "do the right thing". In the US, this style of system just won't work based on companies willing to "take risks" with patients to make money.

That sounds terrible, but it's been proven time and time again.

Everyone wants the newest latest technology (And my job is to make that tech), however you need to be very scrutinizing with long term follow ups. In the end, you can make the fanciest device in the world that SHOULD do everything, but if patient outcomes show that it is not beneficial when compared to fusion, it should not be used. Science based, and more specifically Patient Outcome based medicine is the best approach.

An example (leaving the company out of it) was a recent indictment of several executives based on conducting unauthorized clinical trials which resulted in several patients deaths.

People tend to lose sight of the big picture when they're in pain and want the best option.

Greg, I agree wholeheartedly with your points made above. Long-term data and patient outcomes are what truly matter. Like Greg briefly mentioned, Spine Patients in pain want a viable yesterday. I completely understand this, as I have spent quite a few years in debilitating pain. Unfortunately, new technology in spine surgery does not always equal "superior products and outcomes." Patient safety is paramount.

In response to the european style of approval not working in the usa. The freedom lumbar and the spinal kinetics discs are both made here in the usa, yet europe seems to trust these companies testing. I know there is risk of course with faster approval, but when it comes to really key medical things i think the process should move alot faster. For cosmetic stuff Im all for super testing etc. Also, even if there isnt less testing done, at least when a company contacts the fda lets get it moving asap instead of hassling around. Maybe we need to hire more fda staff to get this stuff moving alot faster.

Inherent in any clinical trial is the need for time: time for scientific study, time for enrollment, time for patient follow-up, etc. Pushing devices / drugs through hastily can be disastrous and we've seen this in recent years here in the United States. I felt like I was "painted in the corner" when I needed surgery at 23--either a two-level lumbar disc replacement or a spinal fusion. Personally, I had to explore other options outside of the US based on FDA study inclusion / exclusion criteria in 2003 and my outcome was great for 5 years of pain-free life (and I'm doing well again after having another lumbar issue addressed surgically in May 2009).

The unfortunate thing for you and me SN is that we have age playing against us. We are young and the interventions / devices that are options to use aren't inherently foolproof. I don't know I will will fair 10, 20, or even 30 years down the road, but I am thankful everyday I get up without pain.

[jss]

Gentlemen, great points all the way around. I'd also favor an accelerated approval process (in some cases). I believe that there are two ways to preserve the FDA's ultra-cautious approval process and still speed up approval of some devices (like the M6).

Of course the FDA requires, in the case of ADR devices, a two year follow up with patients in the study. As many devices in FDA trials have been in use in other countries for sometimes years, there already exists volumes of data in those countries for the devices in question. Someone "just" has to develop a process to mine that data from those that have received the devices under study.

Another change that could be made regards foreign trials. There is precedent for medical device manufacturers performing European trials according to EU rules and FDA rules simultaneously, as opposed to performing an EU trial, and then an FDA trial. Then when it becomes the US's turn to get the device, much of the work and elapsed time is already done. I realize that doing that is probably much more difficult that it seems, or all EU trials would also be an FDA trial.

[MDE]

I would agree that this would make sense, and in some forms, the FDA is moving towards international standards. (very very slowly) However, like your last line stated, it's just not that simple. FDA requires that the trials be held in the US because of a few factors. One of which is that US patients are not European patients... and the same is true for Surgeons. The standard of care is very different between europe and the US. Surgeons Patient outcomes are also judged differently. In europe a partial reduction in pain is deemed a successful case, where as in the US, patients tend to expect more.

Almost every company that does a trial over in the EU does it to collect data to provide the FDA for their PMA. Their focus is usually on getting the product approved in the US (because they can make much higher profit margins in the US) which going through Europe has proven to be the fastest method... In the past.

Unfortunately for most of you, regulatory options are actually moving the opposite direction. EU is shutting this open door for products as of the middle of march. It will become MUCH more difficult to get CE registration for implants, especially without clinical data. I predict this will result in more companies doing clinical trials in China/India and South America (mostly Argentina). Europe is switching to a similar "Substantial equivalency" style system that the FDA uses which requires providing clinical data that your device works better than other already approved devices. This will slow the approval process significantly in Europe, which will also effect the US.

[sportsnut3007]

Well that is really depressing news mde lol. I hope we get these mesoblast stemcells going soon asap. I see no risk besides of course transmission of diseases, which is a risk but really probbably not one.

[jss]

... I predict this will result in more companies doing clinical trials in China/India and South America (mostly Argentina).

You know, during the process that eventually resulted in me going to Spain for a pair of M6's, I was surprised to learn that the M6 was not (as of Sept'09) approved for use in India or Costa Rica?! I just assumed that the Indian's would let you implant a roofing nail and call it an ADR. I don't know what their standards are, but fortunately the Indians seem to be more stringent than I had figured.

... Europe is switching to a similar "Substantial equivalency" style system that the FDA uses which requires providing clinical data that your device works better than other already approved devices. This will slow the approval process significantly in Europe, which will also effect the US.

I don't know how accurate the claims, but I read a year or so ago that the EU approval process was faster in part because the investigational process/device had only to be proven safe, not effectual. If that is true, that is what is being changed?

MDE, would you define a couple of terms for the less knowledgeable of us (me).

PMA - ???
CE registration - ???

Thanks, Jeff

[sportsnut3007]

I definitely see the point for testing. However, what this does is enable those with the funds to go over seas to get treatment, which is most likely superior. If we just have the attitude that new technologies are more likely worse or not supposedly "proven" better then I guess we never would have had any artificial knees or hips here in the states. And yes I know there were some disasters early on most likely with these implants in the long run. Hopefully the european adjustments are not too restricting, thus slowing the approvals here in the USA. Also, I hope that the FDA expedites the new biological repairs coming around the corner. As one can see from my posts, I am a huge advocate of this Mesoblast Stem Cell technology. I understand there is a risk of some type of cancer probably or disease that could be passed to the receiver, but I highly doubt this to be the case. I do not want to miss out on this stuff when it clearly exists. If something did not exist at all and I had to get another procedure before it did exist, it would suck but not as bad as if the biological answer existed but yet I was not allowed to get it because of FDA rules. I continue to be amazed by the progress we are making in stem cells. I once thought I wouldn't possibly need them until maybe my 50's when I started getting grey hair. I had thought I would grow old with no medical issues and see a new world with a vast array of stem cell therapies. However, I could benefit dramatically from this technology right now at the age of 27. I feel fortunate as of now compared to most on here as my disc issues in comparison are not yet as bad. I do have some pain on a daily basis, but I do not need any strong pain medicine as of yet. I fear that day may come soon though and that is why I am pushing hard for the Mesoblast stemcells. PS I plan on writing the FDA soon and encourage those with spine issues to push for this Mesoblast Stemcell stuff too. I dont know exactly what I will do, but I do plan on doing more than just writing one letter. This may be silly, but i want to start a mini revolution to help get this Mesoblast Stemcell stuff through the fda and then covered by the insurance companies. Come on FDA, expedite this amazing technology!!! Write the FDA!!!