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There are some good responses on this blog with the exception of Paul Knoepfler who wants to keep on "protecting" patients while not listening to them. If you haven't made a comment, please do so. I think many PhD's are under the delusion that they are actually medical doctors.
Responses to “ U.S. District Court rules that stem cells are drugs ”
Federal court gives FDA explicit power to regulate stem cells as drugs: start of new era? | Knoepfler Lab Stem Cell Blog Says:
July 25th, 2012 at 8:09 pm
[...] story has been reported in the media at New Scientist and Scope Blog. You can read over the key [...]
Paul Knoepfler Says:
July 25th, 2012 at 9:39 pm
For more thoughts on what today’s court ruling means, check out my lab’s blog post: http://tinyurl.com/d3cjse8. Hint. It’s not a witch hunt or great conspiracy, but an effort to protect the patients.
Paul Knoepfler PhD
UC Davis School of Medicine
A new turn in FDA versus Regenerative Sciences lawsuit | Stem Cell Assays Says:
July 26th, 2012 at 7:35 pm
[...] Refuting potential downsides to stem cell drug court ruling (Knoepfler Lab Stem Cell Blog) U.S. District Court rules that stem cells are drugs (Scope [...]
July 26th, 2012 at 7:38 pm
Yes it is an effort to protect the patients, but like almost all past efforts by the FDA to protect patients it will harm by delaying worthwhile treatments far more patients than it helps by preventing bad ones.
July 26th, 2012 at 7:51 pm
Too bad. Progress will now be glacially slow. How can the FDA approval process work for individual modifications of stem cells? since each patient is unique, would a clinical trial be needed before each treatment? There needs to be a new regulatory regime for this that does not run to thousands of pages. Not likely with the current crew.
Oh well. At least the work will get done in Asia.
July 26th, 2012 at 8:35 pm
what happened to NOW and “keep your government hands off of our bodies”? stunningly silent during leftist administrations
July 26th, 2012 at 8:42 pm
What if a person doesn’t want the government protecting them? Isn’t that a decision for the patient?
July 26th, 2012 at 9:34 pm
They’re not drugs, they’re taxes!
July 26th, 2012 at 10:00 pm
This is not an effort to protect the patients. This is an effort to show everyone “who’s the man’. The FDA loves to be boss.
July 26th, 2012 at 10:49 pm
This is not about patient protection, it is about patent protection. It is an attempt on the part of the FDA to protect the value of key influence group patents that would be nearly worthless if stem cell extraction, proliferation and re-introduction were a common and simple doctor’s office procedure.
It makes me wonder: If the FDA is looking out for the influence groups, who is looking out for the people?
Kevin P. Says:
July 27th, 2012 at 12:14 am
Wow. This will greatly damage research into individualized stem cell treatments if each treatment requires FDA approval. The approval will take ten years, and the patient will likely be dead by then. The same result that we get today with life-saving pharmaceuticals – the patients are dead, but at least they were not given potentially unsafe drugs!
July 27th, 2012 at 1:47 am
This is wrong. The only people this ‘helps’ is the FDA employees and the Pharmaceutical companies.
Two organizations I don’t think need that much help.
Research will now be glacially slow.
Barbara Hanson Says:
July 27th, 2012 at 11:17 am
This is an effort to protect patients? Come on. This is an effort to protect the self interests of many in the industry who refuse to listen to patients. State licensing of physicians and mandatory malpractice insurance already protects patients. We want access to our own stem cells. This should be a decision between a patient and his or her own doctor. Patients will now be forced offshore or to clinics doing treatments under the radar. I urge patients to become very vocal. Instead of protecting patients, this ruling will be a death sentence for many. Heart transplants didn’t even require this type of regulation! Doctors should be alarmed at this type of ruling as well. What type of intrusive regulatory measures will be next for them?
First treatment in 2007. Pioneering ever since.
I just wrote this on the scope blog today, however it was removed. Maybe because I was too harsh. I may have to tone it down.
One example below, we have one of the hundreds of treatments being done today with stem cells with promising results and with proof being safe.
June 11, 2012 (Philadelphia) — In an early study, an experimental stem cell procedure helped 15 teens with type 1 diabetes stay off of insulin injections for about 1.5 years, on average…
Below are the real figures on insulin drug sales for pharmaceutical companies.
Over the next 20 years, the WHO predicts that worldwide insulin sales will grow from $12B to $54B: doubling in the US, tripling in the EU, and expanding 12 fold in the rest of the world.
You can not use that treatment above as a medical procedure, because it is considered a drug by the FDA. Do you think the large pharmaceutical companies are going to pursue this treatment? Think again!
I am not even mentioning the current successful stem cell treatments for cardiac muscle repair. Imagine how much the pharmaceutical companies can potentially lose in drug sales as well.
Bottom line, autologous stem cell treatments will be stalled and regulated to prevent billions of dollars in drug sales being lost. Wake up folks, this is not meant to protect the public’s best interest! They want to keep you ill, terminally ill, or disabled to sell you their prescription drugs.
Last edited by LLL6521; 07-31-2012 at 02:24 PM.
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