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Consumer Health Digest #18-15
April 15, 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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FDA warns against dangerously high-dose caffeine products

The Food and Drug Administration issued a  guidance for industry
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM604319.pdf
to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. It announced that highly concentrated caffeine products can contain caffeine in amounts equivalent to caffeine in 20 to 28 cups of coffee and that the agency intends to remove these illegal products from the market.

[FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604485.htm
FDA press release, April 13, 2018]

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Pharmacist and assistant sentenced in massive drug compounding fraud

A pharmacist and his assistant have been sentenced in the largest health care fraud case to go to trial involving Tricare, the health care program for military service members and their families. Serge Francois, who owned and operated Atlantic Pharmacy and Compounding in Pompano Beach, Florida, was sentenced to 204 months in prison to be followed by three years of supervised release. Francois's employee Patrick Tonge, 42, of Southwest Ranches, was sentenced to 188 months in prison followed by three years of supervised release. Each  was also ordered to pay $31,259,252 in restitution. According to evidence presented at trial:

* Francois and Tonge conspired with so-called marketers who paid physicians to write prescriptions for expensive topical medications that cost up to $17,000 a bottle. As the pharmacist-in-charge, Francois was responsible for the compounded medications, which were made in-house.

* Francois, Tonge and their co-conspirators sent numerous refills to patients who did not request them and without charging them for required co-payments; and then submitted claims to Tricare and the Federal Employee Health Benefit Program.

* Francois and Tonge paid the marketers from the profits received for each prescription.

* The marketers, in turn, paid the physicians, some of whom never saw the purported patients.

A federal jury found Francois guilty of conspiracy to commit health care fraud, twelve counts of health care fraud, conspiracy to pay kickbacks in connection with a federal health care program, five counts of paying kickbacks, and twelve counts of money laundering. In addition, he was found guilty of eight counts of introducing misbranded drugs into interstate commerce, four counts of making false statements related to health care matters, and one count of making a false statement on a DEA form. The jury found Tonge guilty of the same conspiracy charges, eleven counts of health care fraud, three counts of paying kickbacks, and two counts of money laundering.
[Pharmacist and pharmacy employee sentenced for involvement in over $30 million health care fraud
https://www.justice.gov/usao-sdfl/pr/pharmacist-and-pharmacy-employee-sentenced-involvement-over-30-million-health-care
U.S. Attorney’s Office press release, March 12, 2018]

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UK health agency renews fluoridation support

Public Health England has issued a new monitoring report about water fluoridation in some parts of England. It concludes that water fluoridation is a safe and effective public health measure to reduce dental decay.
[Public Health England. Water Fluoridation Health Monitoring Report for England 2018
http://www.dentalwatch.org/fl/uk_2018.pdf
PHE Publications, Gateway Number 2017777, March 2018.]

The report's summary for laypersons states:

* Five-year olds in fluoridated areas were much less likely to experience tooth decay, and less likely to experience more severe decay than in non-fluoridated areas.

* The chances of needing tooth removal at a hospital because of decay were also much lower in fluoridated areas.

* Children from both affluent and economically deprived areas benefited from fluoridation, but children from relatively deprived areas benefited the most.

* Dental fluorosis (mottling of teeth), at a level that might affect the appearance of teeth, was observed in 10% of children/young people examined in two fluoridated cities. However, there was no difference in concerns about appearance between those in fluoridated and non-fluoridated cities.

The researchers found no convincing evidence that fluoridation produced higher rates of hip fracture, Down's syndrome, kidney stones, bladder cancer, or osteosarcoma (a bone cancer).

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CFI opposes religious-based discrimination against patients

The Center for Inquiry has urged the U.S. Department of Health and Human Services to withdraw a proposed rule
https://www.federalregister.gov/documents/2018/01/26/2018-01226/protecting-statutory-conscience-rights-in-health-care-delegations-of-authority
expanding the ability of religiously affiliated health care providers to refuse "any lawful health service or activity based on religious beliefs or moral convictions."
[Protecting statutory conscience rights in health care
https://www.centerforinquiry.net/docs/HHS%20COMMENTS.pdf
Center for Inquiry, 2018] CFI is particularly concerned about:

* undermining the Title X requirement in federally funded programs for providers to offer non-directive pregnancy options counseling and referrals upon request for all options including pregnancy termination

* women suffering pregnancy complications being denied access to miscarriage management and sterilization services

* medical discrimination against members of the LGBTQ community

* patients turned away from church-run hospitals without being told where they can receive the care they need

[HHS must reject rule granting religious license to discriminate against patients
https://www.centerforinquiry.net/newsroom/hhs_must_reject/
CFI press release, March 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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