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

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31–34 of 34 posts

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

#31
Here's another example:

There's oragenics, which developed a vaccine against dental carries - a disease that affects 5 billion people. Something that i'm sure everybody would really like to have.

And this is why we don't have it ? In their own words:

" Regulatory Status:

We initiated our first Phase 1 clinical trial in April 2005, but we found it difficult to find subjects who fit the trial’s highly cautious inclusion and exclusion criteria, particularly with respect to the subjects’ lack of dentition. We concluded this trial early after enrolling only two of the 15 planned subjects. The FDA then recommended that we revise the protocol for the evaluation of ten healthy male subjects, ranging from 18 to 30 years old and with normal dentition, in an institutionalized setting. After we submitted additional information, the FDA issued a clinical hold letter in June 2007 for the proposed trial with the attenuated strain, citing the need for a plan with respect to serious adverse effects; a plan for the eradication of the attenuated strain in trial subjects’ offspring; and a required pregnancy test for female partners of subjects. We submitted additional protocols in response to the FDA’s concerns. In August 2007, the FDA issued a clinical hold letter with required revisions to the protocol for offspring of subjects. We submitted a response to the clinical hold letter in September 2007, and the FDA removed the clinical hold for our Phase 1 trial in the attenuated strain in October 2007.

While we commenced a Phase 1b clinical trial for SMaRT Replacement Therapy during the first quarter of 2011, the very restrictive study enrollment criteria required by the FDA made the enrollment of candidates meeting the restrictive criteria difficult. Due to the enrollment difficulty we encountered with our initial our Phase 1a clinical trial and now with our phase 1b clinical trial, we determined to discontinue pursuit of our Phase 1b clinical trial."

Such a shame.

http://www.oragenics.com/?q=cavity-prevention

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

#32
post #26
post #21

Earlier quoted context omitted.

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.

Nobody is gatekeeping access to health information. You can go online and try and correlate your test results with the information that's out there.

What the FDA prevented was a company profiting from selling a diagnostic service that wasn't proven.

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

#33
post #22

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.…

Couldn't that device be used off-label?

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

#34
post #22

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.…

I know an M.D. who travelled to Germany to get a medical implant (for himself) that's not yet approved in the U.S., even though it meant paying $90K out of pocket.
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