You can’t stand my points.
Fixed for accuracy.
And you support policies that make the public suffer. You must be proud.
Hi Zep,
Briefly read the article. Two thoughts:
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Again, there is a lot of talk about 21 CFR 1271 stifling the industry. But, again, only nonspecific lamentations are noted.
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The ICR/MPR argument is both erroneous and objectionable. It is erroneous because, by the authors’ use and definition of these terms, drug compounding is not drug production, but a medical procedure – after all, these products are neither mass produced nor mass distributed and, because these treatments are tailored specifically to each patient, the risks/benefits are best known to the physician providing therapy (I object to the authors’ assertion that “only” the clinician providing therapy can estimate the risk in ICR scenarios).
It is objectionable because it is the responsibility of the physician to ensure that their patient is able to understand the risks and provide consent for any treatment, be it experimental surgery or a prescription for 12.5mg HCTZ. The latter might not require as formal a process (e.g., an IRB-approved ICF), but it’s doubtful the authors are arguing that the “general assumption” about the safety of marketed pharmaceuticals means a physician can coerce or mislead a patient into taking any medication without issue.
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[quote=“Zeppelin795, post:298, topic:224450”]
Are you denying this happens and that the revolving door has nothing to do with it?[/quote]
I denying any knowledge of this, and am asking you to provide evidence.
I’m not being argumentative, I am literally asking you to please explain it more fully. I didn’t tie off my earlier post that well, but I was hoping to illustrate the ways in which clinical research is regulated, starting at the site-level. These expectations are just as robust at the sponsor-level, and we take them seriously enough to have departments dedicated to ensuring regulatory compliance.
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So medicinal marijuana - which is bringing relief to tens of thousands of people - would have become a reality in the policies you support?
More than likely…
More info. from the margins The Truth About Cancer: A Global Quest - Episode 7
Didn’t you say that no treatment should be available unless there was double-blind randomized studies for science to confirm efficacy?
Then why are the stem cell procedures being prevented in the U.S.? Especially when it has helped tens of thousands of people worldwide
An article from NPR on the subject. A Look At How The Revolving Door Spins From FDA To Industry : Shots - Health News : NPR
Another related article from statnews Drug industry thrives on the revolving door, researchers say
You may have not had any personal knowledge of this but it is well known in any field.
You must have an OCD revolving around the idea that we give a fuck.
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Hi Zep,
All due respect, I don’t think that it’s particularly fair to tell me that stem cell research is being hamstrung by FDA regulations, provide nonspecific examples in response to my request for specifics, then ask me why stem cell procedures are being prevented in the U.S. after I point out why your information wasn’t what I was looking for.
I’m not looking to disagree with your every post, and I think we can have a productive exchange, but it’s not something that can happen if you lump me in with someone who’s only here to prove you wrong.
How about this: is it an issue of cost? 21 CFR 1271.47(c) states that, “procedures must be readily available to the personnel in the area where the operations to which they relate are performed, or in a nearby area if such availability is impractical.” Is it that it’s just too expensive for some practices to purchase, house, maintain, and operate the equipment required to meet the safety standards of this part?
All I’m asking at the moment is that you please provide a source that cites a specific regulation from 21 CFR 1271 and then explains the ways in which it impacts the availability of these treatments.
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Also, how was your call with The Stem Cell of America folks? Do you mind my asking the general topics your discussion?
Thank you for providing these, btw.
More quackery from the nuts on the margins. The Truth About Cancer: A Global Quest - Episode 8
Yeah I have OCD for exposing the hypocrisy of a healthcare system more concerned with profits vs. caring about health. If you don’t give a fuck then just go away.
I’m not saying you disagree just to disagree. But one has to wonder why this is helping tens of thousands of people worldwide but is not available here in the U.S.? A lack of double-blind randomized studies is often cited as a reason. But where are all those studies for medicinal marijuana? Medicinal marijuana is legalized in 28 states plus D.C. It is giving relief to over 1MM people. Should they have continued to suffer until science caught up? I say no. Since stem cell therapy has helped many thousands of people around the world. Why should the American public suffer until it has double-blind randomized studies done to prove its safe and effective. When this treatment has already helped at least tens of thousands? In a for profit healthcare system profits are the number 1 concern. Everything else is second. So when a procedure threatens those profits it is time to circle the wagons including having your paid for whipping boys in the FDA do your bidding.
Man I feel so bad for those pharma companies.
You’re welcome. I just didn’t want you to think i was just making this up in my head. This is common knowledge.