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Consumer Health Digest #18-30
July 29, 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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Federal agencies issue kratom warnings

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Drug Control and Prevention (CDC) are warning consumers not to use products that contain Mitragyna speciosa, commonly known as kratom. Kratom grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. It is commonly consumed for its stimulant effects and as an opioid substitute. It has been aggressively promoted as a harmless, non-addictive herbal that can help addicts to safely wean themselves off heroin or prescription opioids. Favorable news reports have featured testimonials.
[Jaklevic MC. News stories about kratom, an herbal 'opioid alternative,' wrongly prioritize propaganda over science
https://www.healthnewsreview.org/2018/03/news-stories-about-kratom-an-herbal-opioid-alternative-wrongly-prioritize-propaganda-over-science/
HealthNewsReview.org, March 12, 2018]

However, no clinical trial evidence supports this claim and some products are contaminated with Salmonella.
[FDA and kratom
https://www.fda.gov/newsevents/publichealthfocus/ucm584952.htm
FDA, May 26, 2018]

In addition:

A 2014 survey
http://www.drugandalcoholdependence.com/article/S0376-8716(14)00793-5/fulltext
in Malaysia of 293 regular users of kratom found that nearly all respondents experienced withdrawal symptoms found in opioid withdrawal.

In 2016, Morbidity and Mortality Weekly Report
https://www.cdc.gov/mmwr/volumes/65/wr/mm6529a4.htm
reported cases linking kratom exposure to psychosis, seizures, and deaths, and (b) mild, moderate, and life-threatening medical outcomes reported in 660 phone calls to U.S. poison control centers from 2010 through 2015.

The CDC has issued four reports Salmonella infection outbreaks linked to contaminated products. A total of 199 people in 41 states were affected. No deaths were reported, but 38% percent were hospitalized.
[Multistate outbreak of salmonella infections linked to kratom (final update).
https://www.cdc.gov/salmonella/kratom-02-18/index.html
CDC, May 24, 2018]

The FDA has reported that as of April, contamination has been found in 37 different kratom-containing products.
When kratom is marketed as a dietary supplement, the manufacturer is supposed to submit a New Dietary Ingredient Notification demonstrating that the product will reasonably be expected to be safe. The FDA has announced that evidence is lacking to establish that kratom or derivative products can meet this standard.
[FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597649.htm
FDA News Release, Feb 21, 2018]

In February, the FDA announced the voluntary recall and destruction of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. The FDA has also encouraged all companies marketing kratom for human consumption to take similar steps. Since April, the agency has taken regulatory action against several other companies because of contamination. It also has warned others to stop marketing 
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607903.htm
kratom-containing drug products with unproven claims regarding opioid addiction and withdrawal, pain, lowering blood pressure, cancer, and reducing nerve damage caused by strokes.
[FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608447.htm
FDA News Release, May 22, 2018]

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FDA warns against contaminated synthetic cannabinoid products

The FDA has announced that hundreds of people have been hospitalized in 10 states and several deaths have resulted from the use of unapproved, synthetic cannabinoid products that have been contaminated with brodifacoum, a long-acting anticoagulant commonly used in rat poison. Brodifacoum can cause severe bleeding. The unapproved products are being illegally marketed at convenience stores and gas stations as marijuana substitutes under names such as "K2" and "Spice." Such products pose risks not only to individual users, but also to the U.S. blood supply if blood donors have used these products.
[Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614027.htm
July 19, 2018]

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“Holistic" dentist facing dental board action

The Washington Dental Quality Assurance Commission has charged Alireza Panahpour, D.D.S., with unprofessional conduct in his treatment of a patient. The board's complaint
http://www.casewatch.net/board/dent/pana/charges_2018.pdf
notes that

(a) he performed four "cavitation" operations on a patient's upper and lower left jaw even though a panoramic x-ray showed no infection or other abnormal findings, and
(b) during one of the operations, Panahpour injured a nerve in the jaw that caused the patient to have long-term numbness. The patient who filed the complaint also filed a civil suit which alleged that the surgery should not have been performed because no cavitations existed.

The suit resulted in a $471,975 judgment against Panahpour, who had previously been sued for fraud and/or malpractice at least ten times.

The "cavitation" concept
http://www.quackwatch.org/01QuackeryRelatedTopics/cavitation.html
is promoted by a small number of dentists who claim that most facial pains and even pains and diseases located far from the mouth are caused by cavities ("cavitations") within the jaw bones. Advocates claim they can cure the patient by locating and scraping out the affected tissues. They may also remove all root-canal-treated teeth, most of the vital teeth close to the area where they say a problem exists, and even parts of the jawbone.

In some cases, the surgery has resulted in severe infection and a lifetime of pain. Quackwatch has a comprehensive report on Panahpour's background and activities
http://www.quackwatch.org/11Ind/panahpour/overview.html

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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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