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FDA对科罗拉多一诊所的干细胞产品Regenexx的临床应用进行管制，并和美国司法部一道提起诉讼，案子尚未判，焦点最近却落在了FDA向法院提交的文件中，FDA在其中称干细胞是药物，而且管制的原因之一竟然包括“到科罗拉多州进行Regenexx治疗的行为会打击其他州由FDA批准的药物的使用市场”！
% }% @/ o9 {1 [3 w) @这两个理由一个也没说到点子上，FDA这是咋了？1 ^8 m& N# i1 a5 T0 I1 j, Q( ]7 A" `6 @
& j5 K: \" H1 lThe Huffington Post
% \; _- b* G. h+ H2 aStem Cell Treatment Offered At Oceanside Clinic Despite Controversy In Colorado j" T# G+ C, j2 P
Posted: 02/ 1/2012 11:23 am 2 |9 ^% H% j7 p4 q% |" `
7 a# }! }" S L: O! oDoctors at a Southern California clinic have announced that they are “licensed and trained” to perform a stem cell treatment pioneered by a Colorado group that is being sued by the U.S. Justice Department and Food and Drug Administration.8 m/ X# @: w9 ]9 [( d% F' O2 u! \
9 O+ ], U+ ^* W# m0 _; g: MThe FDA has asked a federal judge to stop the Denver-area doctors from performing a Regenexx procedure, which involves removing stem cells from a patient’s bone marrow, expanding them in a special solution and re-injecting the cells at the site of an injury.
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The federal lawsuit, which was filed in August 2010 and is ongoing, contends that Regenerative Sciences is selling an unapproved product that has not been prepared in a safe manner.8 @. q$ j) R) u# X X$ G2 i
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Physicians from Regenerative Sciences in Colorado have said in court papers that they agreed to stop performing the procedure while the case is argued in court. Attorneys for Dr. Christopher Centeno, director of the Colorado group, and his partners say the FDA lawsuit should be stricken because the procedure constitutes the “practice of medicine,” which is not regulated by the FDA." r5 U8 B* k4 N
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The Health Link Medical Center, an Oceanside clinic, is advertising on its website that as of January, its doctors are “trained and certified” by the Colorado team. For its part, the Colorado clinic lists the Oceanside facility as part of its Regenexx Procedure Network, which also includes clinics in New Jersey, New York and Pennsylvania.1 L6 b! i& ^5 h9 E
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The Health Link website says the California clinic is the first in the state to be “licensed” to perform the Regenexx procedures by the Colorado team.+ H$ k6 _$ Z) I4 N' y- }
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“Their stem cell orthopedics experience is unrivaled and they are physician leaders in stem cell therapy for orthopedic injuries in terms of research presentations, publications, and academic achievements,” the website says.
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The California clinic says its Regenexx services are for patients in chronic pain who are seeking an alternative to surgery.8 Y, B/ J9 K; V( F
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Andrew Ittleman, a Miami attorney who is representing Regenerative Sciences, emphasized that the FDA is suing the firm over one procedure that is not being performed in California. Ittleman said the FDA is concerned about the group’s process of adding a growth enhancer to increase the number of stem cells taken from a patient before re-implanting them. He said the California procedure does not include use of the growth enhancer., p7 V. n* Y- B' x
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The California treatment, he said, “has very little, if anything, to do with the procedure” that’s subject to the FDA lawsuit.
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Ed Anselmo, manager of the Health Link clinic, also said the California group plans to draw tissue from patients' bone marrow, separate the stem cells and re-inject them at the site of an injury. He said the team will not perform the procedure that involves expansion of patient cells in a solution, which is being done at a Regenexx-licensed Cayman Islands clinic. “You can’t do that in the U.S.,” Anselmo said.
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& C6 v! Z7 I pAn FDA spokeswoman asked about Regenerative Sciences and licensee Health Link said the agency doesn't comment on open investigations.
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- z4 T' d' L, i) k0 O% O& r$ sWhile promising stem cell treatments are making headlines nationwide on a weekly basis, most of them are part of highly structured clinical studies affiliated with major universities. The studies take years and cost millions of dollars, and they are aimed at proving that new therapies are safe and more effective than a placebo.5 f+ n7 T) l' Z# w% ~6 ?& @
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Stem cell treatments for leukemia patients are among the only FDA-approved and commonly used therapies.# D' V l% c) y
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Widespread criticism has cropped up around stem cell tourism, or the sales of promising – but unproven and expensive – treatments, usually overseas. Critics say those offering the services exploit the hopes and fears of vulnerable patients who are desperate for a miracle. Supporters of such therapies, though, are critical of the painstaking and costly process of proving medications safe and effective in America.
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/ J) p6 `7 v2 QThe Regenexx lawsuit is among the first the FDA has brought regarding a stem cell therapy offered in the U.S. An expert who filed a declaration for the FDA wrote that the Regenexx procedures did not go through the kind of rigorous testing that leads to widespread acceptance in medicine.
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George F. Muschler, an orthopedic surgeon and professor at Case Western Reserve University in Ohio, reviewed several case studies and a safety study that Regenexx doctor Centeno published in scientific journals. The studies reported the benefits of his treatments, which are meant to remedy unhealed fractures and torn muscles or tendons.& G) i. w' O) Y) F' k6 n
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Muschler found faults with the reports’ methodology, scope and oversight, noting that the series of studies “may be degenerating into an undisciplined and unfocused and even groping and wishful fishing expedition.”
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8 U8 X7 K A2 }& \) jHe concluded that the “cultured cell product has not been tested in a single adequate and well-controlled clinical study for any of the indications for which it is being promoted and used. … It is my strongly held view that (Regenerative Sciences) is exposing patients to medical risk without any reliable scientific evidence of therapeutic benefit.”
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The FDA has issued criticisms of its own, calling the Regenexx product “adulterated” because of shortcomings it uncovered during facility inspections. The FDA also says the sales and transport of the cells violates a federal law regulating prescription medications.
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: q; U% q3 U5 TAttorneys for Regenerative Sciences say in legal documents that the procedure falls under state powers because it “constitutes the practice of medicine,” overseen by the medical board.; R& h. \5 r+ T9 V) U0 b$ c- _) g) r
h7 O# |5 q% Z% U" |! V: b“Additionally, the Procedure has been examined by the Colorado Board of Medicine and has been determined to be fully compliant with Colorado-state law,” court records say. The Regenerative Sciences website includes the testimonials of patients who say they benefited from the treatment.$ q W* z: w+ B( Q/ D3 j
h* K' p, P, t5 WDan Wood, a spokesman for the California Medical Board, said physician use of stem cell treatments falls under the purview of the FDA.$ ]" y# N+ u/ p1 p1 |% `
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The Liberty Voice % D9 x& w& W: j& z: @! m. l
FDA: Your Stem Cells are a ‘Drug’ & We Can Regulate Their Use
2 ~7 _- D6 k# y. o w4 |$ q/ c7 iAdded by Bryce Shonka on February 1, 2012.2 z# z' L; J. o; i) ~3 O! e
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In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!
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: Q$ C; G7 H2 jWe wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.
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The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:) ~. y0 I/ H3 }6 T- `! d
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Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!) T/ a1 C8 ]4 b
The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”# I" J: Y- J9 E! Y; Y0 a8 \
$ m ?# ^4 Y( ~) B% ]We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.% c0 t1 A. ~) V) `. B! f
# D, Y0 \) v. D, }7 yThis time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.
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' B W5 D+ [/ d( x. G. @The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits…
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! V7 |; j. H+ D3 `- NGizmodo" X' Y( B" `9 O6 X) v
According to the FDA, Your Stem Cells Are Now Drugs! X: P. k! W% \: k
Feb 1, 2012 10:20 PM
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In recent court filings, the Food and Drug Administration has asserted that stem cells—you know, the ones our bodies produce naturally—are in fact drugs and subject to its regulatory oversight. So does that make me a controlled substance?& a, V0 T6 x& K& ?8 u3 c$ j
# ~* y* J, h/ ^The bizarre controversy revolves around the FDA's attempt to regulate the Centeno-Schultz Clinic in Colorado that performs a nonsurgical stem-cell therapy called Regenexx-SD. It is designed to treat moderate to severe joint, tendon, ligament, and bone pain using only adult stem cells. Doctors draw your blood, spin it through a centrifuge, extract the stem cells and re-inject them into your damaged joints. It uses no other drugs. No drugs means no FDA oversight and that does not sit well with the administration.3 D' B% y+ E/ m0 q- t% b5 l. K
: H6 y/ ^. l1 w, q. O* aThe FDA has since argued that a) stem cells are drugs and b) they fall under FDA regulation because the clinic is engaging in interstate commerce. That's right, a process performed at the clinic using the patient's own bodily fluids constitutes interstate commerce because, according to the administration, out-of-state patients using Regenexx-SD would "depress the market for out-of-state drugs that are approved by FDA."; i# s$ n+ \. N
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Funny, that sounds less like the FDA protecting the health and safety of US citizens and more like the FDA protecting its drug turf. The two parties have been at odds for over four years now, so we may have a while until we know if every American has in fact become a regulatable good subject to government regulation. 6 d+ }5 T# b3 F8 V
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发表于 2012-2-2 16:21
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