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Aktuell im WWW => *** PRESSEMELDUNGEN *** => Topic started by: Krik on December 12, 2019, 08:26:53 AM
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Consumer Health Digest #19-48
December 8, 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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Prohibited drug found in dietary supplements
Piracetam has been touted as a brain-enhancing substance despite poor evidence of its efficacy. Although it is not approved as a drug and is prohibited as a dietary supplement ingredient in the United States, U. S.-based researchers were able to purchase two samples of each of 12 brands of piracetam products online from sellers they identified through a Google search.
[Cohen P and others. Presence of piracetam in cognitive enhancement dietary supplements
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2755291
. JAMA Internal Medicine. doi:https://doi.org/10.1001/jamainternmed.2019.5507, Nov 25, 2019]
Five of those brands were labeled as dietary supplements. Chemical analysis revealed that the piracetam content ranged from 85% to 188% of the labeled dosage. The researchers noted that (a) known adverse effects of piracetam include anxiety, insomnia, agitation, depression, drowsiness, and weight gain, and (b) the effects of the doses found, particularly in elderly consumers with poor kidney function are unknown.
They concluded:
"Our findings demonstrate that even after the FDA rejected an application to market piracetam as a new supplement ingredient, the drug was nevertheless introduced into the marketplace. Despite FDA warning letters, the products remain on the market. Until the law governing supplements is reformed such that products adulterated with drugs can be effectively removed from the market, clinicians should advise patients that supplements marketed as cognitive enhancers may contain prohibited drugs at supratherapeutic doses."
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Complications attributed to intravenous colloidal silver
A report has been published about three people whose condition worsened after receiving multiple intravenous infusiions at a "wellness center" for alleged Lyme disease
https://www.quackwatch.org/01QuackeryRelatedTopics/lyme.html
. Each was eventually seen by a hematologist and found to have copper-deficiency-induced anemia with abnormal blood cell counts. One patient was then treated successfully with supplemental copper apheresis
https://www.merckmanuals.com/professional/hematology-and-oncology/transfusion-medicine/therapeutic-apheresis
and an antidepressant. The other two patients refused apheresis and follow-up with the hematologist. After the authors of this case series complained to the Texas Medical Board, the initial treating physician agreed to voluntarily surrender his medical license.
[Natelson EA and others. Anemia and leukopenia following intravenous colloidal silver infusions—clinical and hematological features, unique peripheral blood film appearance and effective therapy with supplemental oral copper and apheresis
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6745401/
. Clinical Case Reports 7:157-1762, 2019]
The authors concluded:
"As this report illustrates, the use of infused colloidal silver as a primary or adjunctive therapy to treat alleged Lyme disease or other systemic infections must be condemned as both ineffective and with predictable long‐term toxicity. Silver administered by the intravenous route is more toxic than that associated with oral preparations because of both higher dose and the apparent inability of the body to excrete this material, resulting in continuous prolonged and profound intravascular colloidal silver exposure."
Quackwatch has additional information <https://www.quackwatch.org/01QuackeryRelatedTopics/PhonyAds/silverad.html> about colloidal silver's risks and lack of therapeutic value.
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More stem cell product distributors warned
The U.S. Food and Drug Administration (FDA) has expressed concerns to three more stem cell marketers:
* Liveyon Labs Inc
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/liveyon-labs-inc-588399-12052019
. of Yorba Linda, California, received a warning letter about deviations from good manufacturing practices.
* RichSource Stem Cells
https://www.fda.gov/media/132931/download
, Inc., of Boca Raton, Florida, was told that it was illegal to market their products for treating asthma and various painful conditions.
* Chara Biologics, Inc
https://www.fda.gov/media/133215/download
. of Woodland Hills, California, was told that it is illegal to market their products for treating patients for autism and traumatic brain injury.
The FDA has also issued a safety alert
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products
about clinics across the U.S., including some that market unapproved stem cell treatments, that market unapproved products said to contain exosomes—a type of particle released from cells in the body. FDA's safety alert warns about multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with such products.
[FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
https://www.fda.gov/news-events/press-announcements/fda-sends-warning-companies-offering-unapproved-umbilical-cord-blood-products-may-put-patients-risk
. FDA news release, Dec 6, 2019]
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Synovia marketers settle FTC charges
Colorado-based A.S. Research, LLC (ASR) and its owners, Stephen J. Young and Michael K. Ledeboer, have agreed to a proposed Federal Trade Commission (FTC) settlement order
https://www.ftc.gov/system/files/documents/cases/2-1_proposed_order.pdf
that:
* halts the deceptive tactics they allegedly used to mislead consumers into thinking their dietary supplement called Synovia could treat arthritis and alleviate joint pain.
* bars the defendants from using deceptive testimonials.
* bars the defendants from misrepresenting the results of any scientific study or endorsement.
* requires them to disclose any material connections they have with endorsers.
* imposes a judgment of more than $4.1 million against the defendants
* partially suspends the monetary judgment after they pay $821,000, which the FTC may use to provide refunds to defrauded consumers.
According to the FTC's complaint
https://www.ftc.gov/system/files/documents/cases/1_-_complaint.pdf
, defendants:
* promoted 30-capsule bottles of Synovia nationwide through newspaper ads, bulk mailers, and their own websites.
* featured consumer testimonials that were often phony, including one showing a user who purportedly "gave away his walker" after using Synovia.
* falsely claimed that consumers needed to pay extra for a version of Synovia containing an added ingredient to increase pain relief and speed joint repair, when in fact all purchasers received that product.
* falsely claimed that Synovia would pave the "pot holes" in damaged joints, replace expensive injected medications, and reduce arthritis pain by 95 percent.
[FTC stops marketers from making false arthritis treatment claims
https://www.ftc.gov/news-events/press-releases/2019/12/ftc-stops-marketers-making-false-arthritis-treatment-claims
FTC press release. Dec 5, 2019]
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Anti-robocall bill nears passage.
Last week the U.S. House of Representatives passed a bill (S.151) that should greatly reduce the nuisance of spoofed robocalling. Consumer Reports urges everyone to ask their Senators to vote for it.
https://action.consumerreports.org/20191209roboforwardmnbxg39
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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)
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