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Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

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Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#21

Post by vitd »

fedups wrote: post #19
rayiner wrote: post #18

Earlier quoted context omitted.

They didn't "shut down" 23andMe. They stopped them from marketing unproven health diagnoses derived from the DNA tests.

I think it went beyond a marketing ban, unless 'marketing' extends to selling and displaying health related information.

You can still use 23 and Me to get your results, but you have to go elsewhere (like to your doctor) to interpret the results. They were basically giving patients a diagnosis without going through the proper legal work to be able to give diagnoses. It would be no different than some random person giving you a medical diagnosis without being an actual licensed doctor.

This was not a case of over regulation. It was pretty simple, and the FDA tried repeatedly to work with 23 and Me to bring them into compliance, but the company basically ignored the FDA's requests for meetings and information. They have nobody to blame but themselves, and what happened was good for consumers.

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#22

Post by mjfl »

A case study on FDA from my father, a cardiologist: A recent advancement in replacement heart valves reduces mortality rates from 10% in high risk patients (old and very unhealthy) to 0.9%, from 5% in medium risk patients to 0.4%. This studies were confirmed through clinical trials run by very well respected doctors. Nevertheless, the FDA still required their own set of trials to confirm the safety of the procedure. This was 5 years ago. The FDA first ran a set of trials, not on standard patients but only those that were deemed "inoperable". They spent a few years working that out and found that the device succeeded, but the approval was only given for patients that were inoperable. Then the FDA covered patients that were high risk, spent a few years and found again that the device was hugely beneficial in mortality rates and the device was approved for high risk patients. We are currently in the waiting for the FDA to approve the device for medium risk patients. In the mean time, my father had a medium risk patient who needed a valve replacement. He could not use the new device, so he sent the man to surgery for a standard valve replacement with 5% mortality risk. The man died on the table, becoming part of the 5%, and my father insists that he would have survived if they had been able to use the new procedure. In Germany there are less regulations, and so they have been using the new technique for 5 years with great success. Because of things like this, you'll commonly see medical procedures in Europe that are 5 years ahead of their counterparts in America, all because the FDA insists on using such plodding methods to verify safety.

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#23

Post by ska »

vitd wrote: post #21
fedups wrote: post #19

Earlier quoted context omitted.

I think it went beyond a marketing ban, unless 'marketing' extends to selling and displaying health related information.

You can still use 23 and Me to get your results, but you have to go elsewhere (like to your doctor) to interpret the results. They were basically giving patients a diagnosis without going through the proper legal work to be able to give diagnoses. It would be no different than some random person giving you a medical diagnosis without being an actual licensed doctor. This was not a case of over regulation. It was pret…

Correct. The 23 and Me decision was things working the way that they should.

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#24

Post by astazangasta »

cryoshon wrote: post #6

I've been on the science side of a number of FDA clinical trials for a few years now. The FDA is too conservative with many metrics, and too aggressive with others. The clinical trial pipeline is tortuously slow for everyone involved-- the EU equivalent agency has done a lot to accelerate the process fruitfully. Eclipsing these FDA malregulations is the problem of transparency; if the FDA forced clinical trials to pu…

>if the FDA forced clinical trials to publish 100% of their data rather than only the positive results, we'd have a better medicine producing industry.

I thought this was actually already the case with clinicaltrials.gov and it is apparently having a profound effect: http://www.nature.com/news/registered-clinical-trials-make-p...

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#25

Post by minthd »

kirsebaer wrote: post #16
minthd wrote: post #12

Earlier quoted context omitted.

Is there any realistic possibility Americans could use drugs approved in Europe ?

Any American MD can ask the FDA for "expanded access" to use a medication not approved by the FDA. 99% of the time the FDA grants expanded-access requests. However, a recent review in NEJM explained how it is time consuming and expensive to apply for expanded-access and often the pharmaceutical companies refuse to distribute the drugs even after the FDA grants expanded-access. http://www.nejm.org/doi/full/10.1056/NEJ…

Thanks. You really know this stuff.

Why is there dependence on drug companies ? distributing drugs bought in Europe or elsewhere is pretty easy.And as for drug companies being protected from american litigation - if they don't sell it on u.s. soil, they are not responsible in u.s. courts, right?

As for the process being complex and expensive, is there work being done to solving this, with regards to EMA approved drugs ?

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#26

Post by fedups »

vitd wrote: post #21
fedups wrote: post #19

Earlier quoted context omitted.

I think it went beyond a marketing ban, unless 'marketing' extends to selling and displaying health related information.

You can still use 23 and Me to get your results, but you have to go elsewhere (like to your doctor) to interpret the results. They were basically giving patients a diagnosis without going through the proper legal work to be able to give diagnoses. It would be no different than some random person giving you a medical diagnosis without being an actual licensed doctor. This was not a case of over regulation. It was pret…

This does highlight the effort to maintain the historic paradigm of health professionals as gatekeepers in the face of wider and easier access to health information.

Fortunately sources like snpedia.com still exist for those wanting to use their 23andme data to do their own exploring without an intermediary, should they choose.

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#27

Post by regressiveparty »

My experience with the FDA:

I'm "congenitally limb deficient" below the elbow. Grew up in the 90s using horrible myo electric prosthetic limbs that had 2 hour battery life and were in all practicality a glorified claw machine. I ditched that as soon as I realized they were actually a hindrance.

In 2006, there was a TED talk with Dean Kamen about a prosthetic arm developed by DARPA. It blew my mind and got me finally interested in wearing a prosthetic again. So much promise in a field that had been in a coma for the last 20 years.

That arm never happened. Why? Because it took the FDA 7 years to approve it. The project now is dead in water and the group responsible for building it is trying to literally give away their designs. Why did the FDA have to approve a prosthetic limb? Well, because it touches your skin. Yes, the silicon on the back had to be tested because of skin contact.

I'm now the lucky recipient of BeBionic 3 arm, which is great. Worst part about it? It uses radio frequency to control the hand and has a tendency to go haywire. I asked why they didn't just use Bluetooth and he said that would require another 2 years to get FAA approval. Ugh.

Anecdotal, I know.

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#28

Post by AnimalMuppet »

This is not an easy problem. If the FDA is too conservative, people will die who could have lived. If the FDA is too aggressive, a different group of people will die who could have lived. And no matter where the FDA is on the spectrum (insane extremes excluded), there are people in both groups who die. And there are people who cared for those in both groups, who scream about how the FDA is doing it all wrong, and who have diametrically opposed views on how the FDA should change.

Maybe the test should be whether the screaming is equally loud from both sides...

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#29

Post by crusso »

AnimalMuppet wrote: post #28

This is not an easy problem. If the FDA is too conservative, people will die who could have lived. If the FDA is too aggressive, a different group of people will die who could have lived. And no matter where the FDA is on the spectrum (insane extremes excluded), there are people in both groups who die. And there are people who cared for those in both groups, who scream about how the FDA is doing it all wrong, and who…

Maybe if the FDA were only making recommendations then people could decide for themselves whether to go with the doctor who advising an FDA-approved treatment vs going with some other doctor who is advising something else?

Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design

#30

Post by Vexs »

regressiveparty wrote: post #27

My experience with the FDA: I'm "congenitally limb deficient" below the elbow. Grew up in the 90s using horrible myo electric prosthetic limbs that had 2 hour battery life and were in all practicality a glorified claw machine. I ditched that as soon as I realized they were actually a hindrance. In 2006, there was a TED talk with Dean Kamen about a prosthetic arm developed by DARPA. It blew my mind and got me finally…

See, this just seems overly investigative. If they were physically fusing the arm to your body, sure, that's a reasonable time for the FDA to investigate. But just because it is related to your body in any way doesn't warrant that sort of careful consideration. Similarily, if the radio was controlling a pacemaker, I wouldn't want it using bluetooth, I'd want something FDA approved. If it's an arm, I probably wouldn't want bluetooth (stupid pairing issues....) but something like the xbee format would be great, not some proprietary and less reliable RF protocol.
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