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Consumer Health Digest #18-18
May 6, 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-londonwith help from Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.htmlIt 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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Beautician sentenced for illegal buttocks enhancement injectionsAna Bertha Diaz Hernandez, 47, of Monterey Park, California, has been sentenced to 24 months in federal prison for illegally injecting a woman identified as "I.T." with a liquid foreign substance in a series of treatments for buttocks enhancement costing thousands of dollars. Diaz pleaded guilty last July to receiving and delivering an adulterated and misbranded medical device. Diaz was also ordered to pay a $95,000 fine and $30,000 in restitution to I.T.
[Monterey Park woman sentenced to two years in prison for injecting foreign substance into woman for buttocks enhancement
https://www.justice.gov/usao-cdca/pr/monterey-park-woman-sentenced-two-years-prison-injecting-foreign-substance-womanUnited States Attorney's Office news release, Mar. 6, 2018]
Diaz told I.T. that the substance was a "natural product," at points claiming it was "lamb's fat." However, Diaz never told her customers that (a) the product was illegally smuggled into the United States from Mexico, (b) the product was a medical device unapproved for use in the United States for the purpose of enhancing buttocks or body contouring, and (c) she was not licensed in the United States to perform any such medical procedure. I.T. complained to the California Medical Board that the injected product migrated to her "back, hips, and legs." At Diaz's sentencing hearing, I.T. explained that she experienced a great deal of pain, suffered from infections and complications, and was hospitalized for more than three weeks due to the injections. She underwent a major surgery to remove the injected substance, received skin grafts to repair the damage, and will need further reconstructive medical procedures. She told the court that Diaz had lied to her and that she had believed Diaz's assurance that the product was safe and would never move.
The Los Angeles Times reported that (a) Diaz injected at least ten customers and earned at least $40,000 for her illegal conduct, (b) the injected liquid might have been silicone, (c) Diaz typically recommended 15 injections in each buttock plus amino acid shots to remove stretch marks, and (d) I.T. had spent $5,000 to $6,000 per visit.
[Blume H. Woman sentenced to prison after botched and illegal buttocks enhancement
http://www.latimes.com/local/lanow/la-me-ln-monterey-park-plea-20170731-story.htmlLos Angeles Times, Mar. 5, 2018]
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Rise and fall of “liberation therapy" for MS summarizedA new article by Dr. Stephen Barrett discusses the continued promotion of the "liberation procedure" to treat multiple sclerosis and other neurological conditions despite the implausible rationale proposed for it and the failure to show that it is safe and effective.
[Barrett S. Studies show that "liberation therapy" for multiple sclerosis doesn't work
https://www.quackwatch.org/08Misc/zamboni/overview.htmlQuackwatch, May 2, 2018]
"Liberation therapy," sometimes called Transvascular Autonomic Modulation (TVAM)
http://www.synergyhealthconcepts.com/tvam_transvascular_autonomic_modulation/is a surgical procedure proposed in 2006 by Paolo Zamboni, an Italian surgeon, to treat a hypothesized condition, "chronic cerebrospinal venous insufficiency" (CCSVI), supposedly linked to multiple sclerosis and other autonomic dysfunction diseases. It involves widening veins in the neck and chest. Barrett's report noted:
Studies in 2014 and 2017 found no association between narrowed veins and multiple sclerosis. In 2017, Zamboni conceded that the treatment doesn't work in treating multiple sclerosis based on results of a clinical trial that he headed. A study by other researchers also published in 2017 also showed that expanding veins did not relieve symptoms of multiple sclerosis.
In 2012, the Food and Drug Administration warned that the procedure was unproven and associated with reports of death; stroke; detachment and migration of stents; damage to the treated vein; blood clots; cranial nerve damage; and abdominal bleeding.
In 2017, FDA warned against additional uses of the procedure.
A lengthy investigative report published by the Milwaukee Journal Sentinel has concluded that about 30 doctors have performed unproven procedures for CCSVI but state licensing boards have given insufficient attention to this problem.
[Farber J and others. From hope to medical nightmare: Despite FDA warnings, state boards lag in taking action on controversial MS treatment
https://projects.jsonline.com/news/2018/3/28/state-boards-take-no-action-on-controversial-ms-treatment.htmlMilwaukee Journal Sentinel, Mar. 25, 2018]
Michael A. Arata, M.D
http://www.synergyhealthconcepts.com/dr_arata/who operates Synergy Health Concepts in Newport Beach, California is described on his office Web site as "the most experienced CCSVI physician in the United States, having performed over 1500 procedures."
In 2012, the FDA notified Synergy and Arata that their CCSVI research did not comply with federal regulations.
In 2016 and 2017, the FDA noted that he was still out of compliance and that proceedings were under way to disqualify him as an investigator.
In 2015, James McGuckin, Jr., M.D. signed a consent order in which he agreed to
(a) stop performing angioplasty or stenting for CCSVI or MS patients in the State of Washington,
(b) pay a $17,500 fine,
(c) issue refunds to certain patients,
(d) successfully complete an ethics course, and
(e) comply with monitoring provisions set by the Commission.
The Washington action triggered similar restrictions by licensing boards in Florida, Georgia, Illinois, Indiana, Louisiana, Maine, Maryland, New York, North Carolina, Texas, Tennessee, and Virginia.
McGuckin's Washington medical license expired in November 2015 and was not renewed, but he remains licensed in the other states.
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“Tijuana Tumor Terminator" Geronimo Rubio scrutinizedDr. Stephen Barrett has provided a detailed review of the background and activities of Geronimo Rubio, M.D. through the defunct American Metabolic Institute (A.M.I.) in La Mesa, Mexico and at the Rubio Cancer Center in Tijuana. The review addresses regulatory actions against A.M.I.'s San Martin Clinic, Rubio's criminal prosecution for insurance fraud and tax evasion, examples of patients unsuccessfully treated with Rubio's protocols, and why Dr. Barrett is skeptical about Rubio's therapeutic claims.
[Barrett S. A skeptical look at Geronimo Rubio, M.D. and his treatment programs
https://www.quackwatch.org/11Ind/rubio/history.htmlQuackwatch, Apr. 27, 2018]
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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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