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Aktuell im WWW => *** PRESSEMELDUNGEN *** => Topic started by: Krik on June 09, 2019, 12:18:49 PM

Title: Court rules against US Stem Cell clinics
Post by: Krik on June 09, 2019, 12:18:49 PM
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Consumer Health Digest #19-23
June 9, 2019

Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H
http://www.calstatela.edu/faculty/william-m-london
., with help from Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.html
. 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.

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Warning issued against dietary supplements containing vinpocetine

The U.S. Food and Drug Administration (FDA) is warning pregnant women and women who could become pregnant not to consume vinpocetine, an ingredient found in dietary supplements. The warning is based on data reviewed by the FDA, including a recent report
https://ntp.niehs.nih.gov/ntp/about_ntp/trpanel/2019/july/dart03_508.pdf
 by the National Institute of Health's (NIH) National Toxicology Program (NTP), suggesting that vinpocetine may cause miscarriages or harm fetal development.

Vinpocetine is a synthetically produced compound that is used in some products marketed as dietary supplements, either by itself or combined with other ingredients. Vinpocetine may be referred to on product labels as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract. Dietary supplements containing vinpocetine are often marketed without FDA approval for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss.
[Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine
https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing
. FDA news release. June 3, 2019]

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Court rules against US Stem Cell clinics

A U.S. District Court judge has issued a summary judgment
http://www.casewatch.net/fda/court/us_stem_cell/order_2019.pdf
against US Stem Cell Clinic LLC, of Weston, Florida; US Stem Cell Inc., of Sunrise, Florida; and their chief scientific officer Kristin Comella, Ph.D.

The judge ruled that the defendants adulterated and misbranded a stem cell drug product made from a patient's fat tissue, and that the FDA is entitled to an injunction.

The FDA initially raised concerns in a warning letter
http://www.casewatch.net/fdawarning/prod/2017/us_stem_cell.shtml
 issued in 2017 that US Stem Cell was marketing unapproved products and deviating from current good manufacturing practices.

The letter noted that the products were being administered intravenously or into the spinal canal to treat Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, pulmonary fibrosis, and other serious diseases. The clinic was also cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products, which put patients at risk for infections.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients cellular products without FDA approval.
[Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law
https://www.fda.gov/news-events/press-announcements/federal-court-issues-decision-holding-us-stem-cell-clinics-and-owner-adulterated-and-misbranded-stem
FDA news release. Jun 4, 2019]

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Naturopathy critic prevails in defamation suit

Former naturopath
https://www.naturowatch.org/
Britt Marie Hermes has announced that the District Court (Landgericht) of Kiel, Germany ruled against naturopath Colleen Huber who sued her for defamation over Hermes' expressed:

(1) opinions about the dubious treatments and human subjects research at Huber's cancer clinic in Tempe, Arizona, and

(2) suspicions that Huber was cybersquatting domains in her name.

[Hermes B. Justice prevails! Cancer quack Colleen Huber loses her defamation suit against me
https://www.naturopathicdiaries.com/justice-prevails-cancer-quack-colleen-huber-loses-her-defamation-suit-against-me/
. Naturopathic Diaries. Jun 3, 2019]

Hermes noted:

"I was able to stand up to Huber's legal thuggery because the science and skeptic communities rallied around me. The massive fundraising efforts
https://www.skeptics.com.au/features/britt-hermes-legal-costs-fundraising-campaign/
, led by Australian Skeptics, Inc., allowed me to cover my legal bills, so I could continue my PhD studies and focus on my pregnancy and birth of a healthy baby girl. (I actually found out I was pregnant the same day I learned of the lawsuit.) It is emotionally and mentally exhausting to go through a lawsuit. I thank all of you who donated to my legal defense fund from the bottom of my heart. Since there is a chance of appeal, please stay tuned."


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Critical thinking conference scheduled for July

NECSS 2019, a science and critical thinking conference produced by New York City Skeptics, the New England Skeptical Society, The Skeptic's Guide to the Universe, and The Society for Science-Based Medicine, is scheduled for July 11-14 at the Fashion Institute of Technology in New York City. Among the scheduled speakers are science-based medicine advocates Paul Offit, David Gorski, Clay Jones, Steve Novella. Early bird discount registration is available until June 14th
https://necss.org/


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Registration open for CSICON 2019

The Center for Inquiry's Committee for Skeptical Inquiry CSICON 2019 conference dedicated to science and reason is scheduled for October 16-20 at the Flamingo Resort Las Vegas. Several consumer health advocates are scheduled to speak at the conference. They include Britt Marie Hermes, Jann J. Bellamy, Janyce L. Boynton, Jen Gunter, Scott Lilienfeld, Loren Pankratz, and Kavin Senapathy. The full conference schedule, online registration, and information about discounted hotel rooms is available at csiconference.org
https://csiconference.org/

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

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

Telephone: (919) 533-6009

http://www.quackwatch.org (health fraud and quackery)
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