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Author Topic: FDA says it will increase stem cell clinic regulation  (Read 988 times)

Omegafant

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  • Posts: 846
FDA says it will increase stem cell clinic regulation
« on: September 11, 2017, 11:21:46 AM »

[*quote*]
Consumer Health Digest #17-35
September 10, 2017

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.html
.,with help from William M. London, Ed.D., M.P.H
http://www.calstatela.edu/faculty/william-m-london
It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making. Its primary focus is on health, but occasionally it includes non-health scams and practical tips.
###

FDA says it will increase stem cell clinic regulation

FDA Commissioner Scott Gottlieb, M.D., has announced that the FDA “will be stepping up enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit."
[FDA warns US Stem Cell Clinic of significant deviations
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573431.htm
FDA news release, Aug 28, 2017]

The agency also posted a warning letter
http://www.casewatch.org/fdawarning/prod/2017/us_stem_cell.shtml
issued to US Stem Cell Clinic of Sunrise, Florida and its Chief Scientific Officer, Kristin Comella, for marketing unapproved stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products.

A recent FDA inspection found that the clinic was processing stem cells derived from body fat and administering the product both intravenously or directly into the spinal cord of patients to treat Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease, heart disease, and pulmonary fibrosis.

In a parallel action, at the FDA's request, U.S. Marshals seized five vials of live vaccinia virus vaccine that had been used or were awaiting use to create an unapproved stem cell product for cancer patients. The FDA's announcement noted that this vaccine is reserved only for people at high risk for smallpox (such as some members of the military) and has considerable potential for harm.
[FDA acts to remove unproven, potentially harmful treatment used in 'stem cell' centers targeting vulnerable patients
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm
FDA news release, Aug 28, 2017]

###

Bill seeks to legalize MLM pyramid schemes

H.R. 3409
https://www.congress.gov/bill/115th-congress/house-bill/3409
,deceptively titled the "Anti-Pyramid Promotional Scheme Act of 2017,"

appears to be crafted to weaken government protection against multilevel marketing companies, such as Herbalife, that emphasize recruiting rather than retail sales.

The bill's proponents claim that it will provide greater clarity to consumers and companies as to what is and what is not a pyramid scheme. Experts on pyramid schemes, however, believe that the wording is vague and tricky and will have the opposite effect.

[Vander Nat P. H.R. 3409: Protecting pyramid schemes, not consumers
https://www.truthinadvertising.org/h-r-3409-protecting-pyramid-schemes-not-consumers/
Truth in Advertising Web site, Aug 16, 2017]

A similar bill introduced last year died in committee.

###

Quack muscle test debunked

Quackwatch has posted a report on the bi-digital O-ring test (BDORT), a variant of applied kinesiology
http://www.chirobase.org/06DD/ak.html
that is claimed to provide information about internal organs by testing finger strength.

To perform the test, the patient positions the thumb and another finger of one hand together to form a circle ("O-ring") while his other hand holds a sample tissue of an internal organ.

The practitioner then places his fingers into the circle and tries to pull the patient's fingers apart. Proponents claim that whether or not the circle can be forced open reflects the health status of the patient's organ that corresponds to the tissue sample.

BDORT was developed in the early 1980s and patented in 1993 by Yoshiaki Omura, M.D., Sc.D., a physician/acupuncturist who worked in New York City during most of his professional career.

BDORT is closely related to Quantum Reflex Analysis, which is also discussed in the report.

[Barrett S. Some notes on the bi-digital O-ring test and Quantum Reflex Analysis
http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/bdort/overview.html
Quackwatch, Sept 10, 2017]

The idea that muscle-testing can determine the status of the body's organs or provide a basis for treating health problems is preposterous. Despite this, thousands of practitioners use such tests.

###

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http://www.ncahf.org/digest17/index.html

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=================================

Stephen Barrett, M.D.
Consumer Advocate
287 Fearrington Post
Pittsboro, NC 27312

Telephone: (919) 533-6009

http://www.quackwatch.org (health fraud and quackery)
[...]
[*/quote*]
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Omegafant

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Omura ist ein besonders niederträchtiger Scharlatan
« Reply #1 on: September 11, 2017, 01:13:10 PM »

In der Akte

"TG-1 * Transgallaxys Forum 1 > Die Drahtzieher / Hintergruende und Methoden > Die Akte Dr. Hildegard Schreiber "

sieht man einen Nutznießer von Yoshiaki Omuras Betrugsmethoden: Hildegard Schreiber. Ich zitiere:
 

http://www.transgallaxys.com/~kanzlerzwo/index.php?topic=1145.0

[*quote*]
Hildegard Schreiber lügt
« on: July 10, 2006, 05:24:38 AM »

Hildegard Schreiber lügt. In ihren vielen Hinterlassenschaften im WWW findet man viele ihrer Lügen. So zum Beispiel in dieser Webseite:

http://www.eurotinnitus.com/de/amalgam1.htm

Zitat daraus:

[*QUOTE*]
---------------------------------------------------------------------------------------
Nachweismethoden für Quecksilber

Neben den üblichen Labormethoden zum Nachweis in Blut, Stuhl und Urin oder der Haaranalyse ist der Nachweis möglich mit:

- Bioresonanzmethoden

- Elektroakupunktur nach Voll oder ähnlichen Verfahren, auch mit

- kinesiologischen Methoden


Mit diesen kann das Quecksilber nicht ausgeleitet werden. Mit Elektroakupunktur verschiebt man das Quecksilber in die Zellen, es ist dann nicht mehr nachweisbar, aber noch vorhanden und keineswegs ausgeleitet. Man kann mit o.a. Methoden nur das im Gewebe vorhandene Quecksilber nachweisen, jedoch nicht das in den Zellen vorhandene Quecksilber. Das ist nur nach Provokation mit Koriander und nach Übertritt ins Gewebe mit o.a. Methoden testbar.

Das grüne Korianderkraut und seine aromatischen Inhaltsstoffe wurden in amerikanischen Studien von Dr. Klinghardt und Prof. Dr.med. Y. Omura, New York, empirisch angewandt zur Entfernung des Hg`s von denn Ionenkanälchen. Wenn sich dann das Quecksilber im Blut und im Gewebe befindet, kann es mit kinesiologischen und radiaesthetischen Methoden nachgewiesen werden.
---------------------------------------------------------------------------------------
[*/QUOTE*]
[*/quote*]

Das ist so hanebüchen falsch, das gibt's gar nicht.

Wo hat "Prof. Dr.med. Y. Omura" eigentlich seinen Professoren-Titel her? Barrett in

[Barrett S. Some notes on the bi-digital O-ring test and Quantum Reflex Analysis
http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/bdort/overview.html
Quackwatch, Sept 10, 2017]

schreibt, Zitat:

http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/bdort/overview.html

[*quote*]
Omura's Background

Omura's 1982 book, Acupuncture Medicine: Its Historical and Clinical Background, if accurate, indicates that despite the strangeness of many of his ideas, his credentials and academic activities included many that were respectable:

[***quote***]
Yoshiaki Omura is a physician, educator, electrical engineer and experimental physicist. He was born in 1934 in Japan and came to the United States in 1959, after finishing his B.Sc., M.D. and internship, and beginning his surgical residence at Tokyo University Hospital. He has been an American citizen since 1979.

In 1958, Professor Omura received his M.D. from the School of Medicine, Yokohama City University (1954-58). While serving as a research fellow in cardiovascular surgery and later as a surgical resident physician at the Cancer Institute of Columbia University, he also did his postgraduate study of experimental physics at Pupin Laboratory, Columbia University (1960-63). In 1960, Professor Omura introduced the first course in the United States on biomedical electronics at the Electrical Engineering Department of Manhattan College as a Visiting Research Professor, and continued teaching and research until 1999. In 1965, he received his Sc.D. (Medicine), from the Department of Pharmacology at the College of Physicians and Surgeons, Columbia University, on the pharmacoelectrophysiology of single cardiac cells. . . . He was a member of the New York State Board of Medicine from 1986 to 1996. . . .

His academic affiliations include Adjunct Professor, Department of Pharmacology, Chicago Medical School, 1982-1993; Adjunct Professor, Department of Community and Preventive Medicine, New York Medical College,. . . . His current associations with professional organizations include Diplomate of the American Academy of Pain Management . . . and Life Fellow of the Royal Society of Medicine of England [2].
[***/quote***]

The full biography as well as considerable information about Omura's beliefs about acupuncture, can be seen online by clicking on the book title in the references below. I have not been able to check the accuracy of the reports about his credentials.
[*/quote*]

"I have not been able to check the accuracy of the reports about his credentials." Das war alles noch in der Vor-WWW-Zeit. Kein Wunder, daß Barrett nichts finden kann. Die Unis rücken sowieso keine Informationen raus. Im WWW könnte man nur etwas finden, wenn gedruckte Texte aus Büchern und Zeitungen und Magazinen gescannt und OCR-ed wurden und dann zum Beispiel bei Google oder Websites von Universitäten auftauchen.

Wie kann Einer, der so viel Forschung macht und an Unis arbeitet, so einen irren Schrott von sich geben wie Yoshiaki Omuras? Okay, in Deutschland haben wir ähnliche Fälle, darunter einen Werkstoffkundler, der voll ins Esoterische diffundiert ist.
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