Consumer Health Digest #20-34
Your Weekly Update of News and Reviews
August 30, 2020
Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H., with help from Stephen Barrett, M.D. 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.
Herbalife to pay $123 million to resolve criminal charges. Multilevel marketing company Herbalife Nutrition, Ltd. has entered into a deferred prosecution agreement to resolve federal charges that it conspired over a ten-year period to bribe Chinese officials and falsify its accounting records to promote and expand its business in China. Under the agreement, Herbalife admitted to violations of the Foreign Corrupt Practices Act and promised to pay penalties totaling more than $123 million. By 2016, Herbalife's business in China accounted for $850 million, which was about 20% of its worldwide annual net sales. [Herbalife agrees to pay $123 million to resolve Foreign Corrupt Practices Act case. US Attorney's Office for the Southern District of New York news release, Aug 28, 2020] MLM Watch has an archive of information about Herbalife collected over more than 30 years that includes regulatory actions and lawsuits against the company.
Promoter of suppository to treat cancer indicted. A 28-count indictment against Patrick Charles Bishop, 54 alleges that:
- Bishop purchased, manufactured, labeled, marketed, sold, and distributed drug products purportedly containing a peptide called PNC-27 that has not been approved to treat any disease.
- No clinical trials in the United States on human beings have been conducted to determine the efficacy, safety, or potential risks or side effects of PNC-27.
- Using the business name Best Peptide Supply, LLC, he obtained the peptide from GL Biochem, a manufacturer based in China, to whom he paid more than $600,000 in 2015 and 2016.
- He repeatedly assured that manufacturer that he would use the peptide solely for laboratory research purposes, but he and others used the peptide to make homemade suppositories in his kitchen in Birmingham, Alabama and at a warehouse he rented in nearby Pelham.
- The facilities were not sterile and did not comply with current good manufacturing practices.
- Customers who purchased suppositories from Bishop reported finding pieces of hair in their suppository packs.
- He used the business name Immuno Cellular Restoration Program, Inc. to sell PNC-27 products to others.
- He and others marketed the PNC-27 drug products to "alternative medicine" doctors, cancer patients, and others as an effective treatment for cancer.
- He sold the products to Hope4Cancer, which operates "alternative" cancer clinics in Mexico.
- He and others took steps to conceal these activities from the FDA and others.
- He described his distribution of PNC-27 products as part of a research effort, and made false representations to FDA personnel and others to the same effect.
Bishop is charged with conspiracy, fraudulently introducing adulterated drugs into interstate commerce, fraudulently introducing misbranded drugs into interstate commerce, fraudulently obtaining pre-retail medical products, creating false documentation for those products, and knowingly possessing and trafficking in pre-retail medical products that he obtained by fraud. [Birmingham man indicted on conspiracy and fraud charges for making unapproved drug products in his kitchen and warehouse and marketing and selling them as a cancer treatment. US Attorney's Office for the Northern District of Alabama news release, Aug 26, 2020]
Severe hypoglycemia outbreak followed male enhancement product use. The Virginia Department of Agriculture and Consumer Services (VDACS) and the Virginia Department of Health (VDH) have identified 17 patients who developed severe hypoglycemia within 48 hours of consuming V8, a tablet sold as a male enhancement supplement in convenience stores in central Virginia. Most V8 samples obtained from the patients and convenience stores were found to contain 90 to 100 mg of the oral hypoglycemic drug glyburide, which is five to ten times higher than the dosage used to treat diabetics. The samples were also found to contain the erectile dysfunction drug sildenafil. An outbreak of hypoglycemia affecting 150 persons in Singapore in 2009 was also linked to counterfeit sildenafil contaminated with glyburide. [Ross JA and others. Outbreak of severe hypoglycemia after ingestion of a male enhancement supplement — Virginia, August–November 2019. MMWR 69:740–743, June 19, 2020]
Dietary supplements against COVID-19 scrutinized. A review of the rationales and evidence for using vitamin C, vitamin D, zinc, elderberry, and silver products to prevent or treat COVID-19 has concluded that evidence is lacking and discourages reliance on dietary supplements. [Adams K. and others. Myth busters: dietary supplements and COVID-19. Annals of Pharmacotherapy, May 12, 2020]
FDA Commissioner blasted for political cowardice. Eric Topol, M.D., the editor-in-chief of Medscape, has accused FDA Commissioner Stephen Hahn, M.D. of making COVID-19-related policy statements based on pressure from the Trump Administration rather than on science-based information. In an open letter that detailed what Hahn has done wrong, Topol concluded:
You have one last chance, Dr Hahn, for saving any credibility and preserving trust in the FDA at this critical juncture amidst the pandemic. You need to organize a press conference and tell the truth. Tell Americans exactly how you were pressured to make a breakthrough announcement. Tell all of us how you completely misrepresented the facts about convalescent plasma, and not hide this with the obscurity of technical terms such as relative and absolute differences. Tell us that you are capable and worthy of this pivotal leadership position and that you will not, under any condition, authorize a SARS-CoV-2 vaccine approval before the full Phase 3 completion and read-out of a program.
Otherwise, you need to resign. We cannot entrust the health of 330 million Americans to a person who is subservient to President Trump's whims, unprecedented promotion of unproven therapies, outrageous lies, and political motivations. You have two choices to do the right thing. We cannot and will not rest until you make that choice. [Topol E. Dear Commissioner Hahn: Tell the truth or resign. Medscape, Aug 31, 2020]
This page was posted on August 30, 2020.