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Consumer Health Digest #18-35
September 2, 2018

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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Chelationist sued for Medicare fraud

Federal prosecutors have filed a False Claims Act complaint
http://www.casewatch.net/civil/adams/complaint_2018.pdf
in the U.S. District Court in Atlanta against Charles C. Adams, M.D.; Charles C. Adams, M.D., P.C. d/b/a Full Circle Medical Center and Personal Integrative Medicine PLLC in Ringgold, Georgia.
[The United States files False Claims Act complaint against Charles C. Adams, M.D., and affiliated entities
https://www.justice.gov/usao-ndga/pr/united-states-files-false-claims-act-complaint-against-charles-c-adams-md-and
USAO press release. Aug. 31, 2018]

The complaint alleges that Adams and/or his companies:

* Submitted hundreds of false claims to Medicare for chelation therapy
http://www.quackwatch.org/01QuackeryRelatedTopics/chelation.html
with edetate calcium disodium, a drug approved for treating lead poisoning, to treat Medicare beneficiaries who did not have lead poisoning.

* Used the results of widely discredited "provoked" urine tests
https://www.chelationwatch.org/reports/provoked.shtml
to tell patients that they had "heightened" levels of heavy metal that chelation could reduce, thereby alleviating medical problems such as high blood pressure, poor circulation, and premature aging, even though Medicare desn't cover such uses.

Edetate calcium disodium has a black box warning
http://www.chelationwatch.org/safety/versenate_ppi.pdf
that it is "capable of producing toxic effects that can be fatal." The complaint stated that "provoked urine tests are unreliable, potentially dangerous, and should not be utilized in diagnosing heavy metal poisoning."

At least ten state licensing boards, including Georgia's, have taken regulatory action
http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/urine_toxic.html
against doctors who have used provoked testing as a prelude to chelation. No disciplinary action has been taken against Adams, but his physician profile
http://www.gaphysicianprofile.org/profile.ShowProfileAction.action?lic_nbr=045378
at Georgia's Composite State Board of Medical Examiners indicates that he settled a medical malpractice case in 2008 for $450,000 and another in 2010 for $237,500.

His profile lists his specialty as internal medicine, but he is not board-certified. Adams is the president of the International College of Integrative Medicine, a nonprofit group that features "affordable introduction and advanced training in heavy metal toxicology and chelation therapy." He became certified in Integrative and Holistic Medicine in 2011 by the Board of Integrative and Holistic Medicine, but neither this board nor such a specialty are recognized by the American Board of Medical Specialties, which is the standard-setting agency for the scientific medical community.

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Complaints filed to stop use of unproven stem cell treatments

At the request of the U.S. Food and Drug Administration, the U.S. Department of Justice has filed civil complaints charging two companies with manufacturing and marketing stem cell products without FDA approval and proof of safety and efficacy.
[Department of Justice files complaints against Florida and California companies to stop use of experimental stem cell drugs on patients
https://www.justice.gov/opa/pr/department-justice-files-complaints-against-florida-and-california-companies-stop-use
DOJ press release 18-606. May 9, 2018]

One complaint
http://www.casewatch.net/fda/court/us_stem_cell/complaint_2018.pdf
was filed against US Stem Cell Clinic LLC, of Sunrise, Florida, US Stem Cell, Inc., and company officers Kristin Comella and Theodore Gradel.

The other complaint
http://www.casewatch.net/fda/court/california_stem_cell/complaint_2018.pdf
was filed against California Stem Cell Treatment Center Inc., of Rancho Mirage and Beverly Hills, California, Cell Surgical Network Corporation, and company owners Elliot Lander, M.D. and Mark Berman, M.D. 

The complaints allege:

* Both defendants manufacture "stromal vascular fraction" (SVF) products from patient adipose (fat) tissue, which they market as stem cell-based treatments for a host of serious conditions and diseases.

* The Florida defendants promote their products as treatments for Parkinson's disease, spinal cord injuries, stroke, pulmonary disease, and traumatic brain injury. But at least three patients have suffered severe eye injuries following treatment for macular degeneration with their SVF product.

* The California defendants promote their products as treatments for cancer, pulmonary disease, arthritis, stroke, ALS, and multiple sclerosis. But at least five patients have suffered adverse events.

###

Herbalife sued by distributors

Eight former Herbalife distributors have filed a class action complaint
https://casewatch.net/civil/herbalife/rodgers/complaint_2017.pdf
against Los Angeles-based Herbalife
https://www.mlmwatch.org/04C/Herbalife/herbalife00.html
in the U.S. Southern District Court in Florida.

The complaint states:

* The company uses misrepresentation to sell access to emotionally manipulative events that have 200 to 20,000 attendees.

* The events use labels such as "Circle of Success," as a guaranteed pathway to life-changing financial success with Herbalife's multi-level marketing <https://www.mlmwatch.org/01General/mirage.html> business opportunity.
* Each of the plaintiffs distributors has spent thousands of dollars attending events, but they received no benefits from doing so contrary to frequent claims by Herbalife that: "If you go to all the events, you qualify for everything – you will get rich."

The plaintiffs are seeking damages and injunctive relief against "the corrupt organization of individuals and entities who sell, operate and compel participation in the Circle of Success."

An Associated Press report states that the case might eventually involve more than 100,000 plaintiffs.
[Anderson C. Herbalife distributors claim events were a sham
https://www.bostonglobe.com/business/2018/08/21/herbalife-distributors-claim-events-were-sham/kBCaR20q6QgguLVYaadikN/story.html
Boston Globe. Aug. 21, 2018]

In pretrial motions, Herbalife's attorneys argued that the plaintiffs had signed contracts mandating arbitration of any disputes rather than trial in court.
[Pickett A. Herbalife seeks to arbitrate potential $1 billion class action
https://www.courthousenews.com/herbalife-seeks-to-arbitrate-potential-1-billion-class-action/
Courthouse News Service. Aug. 21, 2018]

###

Sexual enhancement marketing halted

The U.S. District Court in New Jersey entered an order of permanent injunction against three marketers who claimed without relevant clinical evidence of safety and effectiveness that their unapproved and misbranded drug products could treat or prevent serious conditions, including erectile dysfunction, impotence, and prostatitis (swelling and inflammation of the prostate gland):

S Hackett Marketing LLC doing business as Just Enhance
R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance
Roger Thomas, president and founder of R Thomas Marketing LLC.

The defendants are required to stop distributing the products unless they comply with the Federal Food, Drug, and Cosmetic Act. The products, which were sold to consumers using more than 100 websites, were misbranded because they did not include adequate directions for use and their labels omitted material information. Some of the products were found to contain undisclosed sildenafil, the active pharmaceutical ingredient in the prescription drug Viagra, which can pose serious health risks to patients with underlying medical issues, such as heart disease and high blood pressure.
[District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619083.htm
FDA News Release. Aug. 30, 2018]

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

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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