Consumer Health Digest #02-14

Your Weekly Update of News and Reviews
April 2, 2002

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. 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.

FDA warns again about kava. The U.S. Food and Drug Administration has advised consumers that kava products pose a risk of severe liver injury. Kava (Piper methysticum) is a plant native to islands in the South Pacific where it is used to prepare a traditional beverage. Products containing kava are promoted for relaxation (e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal symptoms and other uses, but FDA has not determined whether they are effective. Kava products have been associated with liver-related injuries—including hepatitis, cirrhosis, and liver failure—in over 25 reports of adverse events in other countries. Four patients required liver transplants. In the U.S., FDA has received a report of a previously healthy young female who required liver transplantation, as well as several reports of liver-related injuries. Most cases occurred among people who regularly used high doses or combined it with alcohol.

The FDA advises kava users who experience signs of illness associated with liver disease to consult a physician. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Nonspecific symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite. [Kava-containing dietary supplements may be associated with severe liver injury. FDA consumer advisory, March 25, 2002]

Although herbal products marketed with health claims are really drugs in disguise, the Dietary Supplement Health and Education Act of 1994 classifies them as dietary supplements. This bill, spearheaded through Congress by Senators Orrin Hatch and Tom Harkin, was designed to weaken the FDA's ability to protect consumers from false claims made for herbal and dietary supplement products. The millions of consumers who have been economically or physically harmed as a result should consider these two senators partially responsible for what happened.

Phony doctor sentenced for cancer drug scam. In March 2001, a federal jury convicted Thomas Ronald Theodore, of Forestdale, Massachusetts, on nine counts of mail fraud and three charges of violating the federal Food, Drug, and Cosmetic Act. On March 1, 2002, Theodore was sentenced to 121 months in prison followed by 3 years of supervised release, and was ordered to pay $1.5 million in restitution to his victims. The evidence presented at the trial showed that between 1993 and 1995, Theodore and an associate solicited about $2 million of investments in a company called Private Biologicals Corporation (PBC) by claiming they they had invested a promising new drug called "LK-200." Theodore also misrepresented himself as a medical doctor. In reality, "LK-200" was not discovered by him but was simply a new name for a preparation that had been used in cancer research in the 1970s and 1980s. From 1993 through 1995, PBC produced it in an unregistered laboratory in Woburn, Massachusetts. To disguise its place of manufacture, Theodore initially arranged to ship LK-200 to the Bahamas for re-shipment to the United States, but, in 1994, PBC's employees began shipping it directly.

Theodore claimed to have received a medical degree from the Universidad Centro de Estudios Technologicos (CETEC). This school was listed in the World Health Organization Directory of Medical Schools, which enabled its graduates to sit for exams that permitted its graduates to enter postgraduate medical training and ultimately obtain medical licensure in the United States. But in 1984, the Dominican Republic closed CETEC after its dean and several associates were convicted of mail-fraud involving the fraudulent sale of degrees. Based on his alleged attendance at CETEC, Theodore obtained a Massachusetts license and worked at three Massachusetts hospitals. In 1987, he was convicted of mail fraud for falsely claiming to be a doctor and his license was revoked. However, he continued to assert that he had a valid medical degree. See Quackwatch for additional information.

Chiropractor to be imprisoned for illegally marketing carpal tunnel device. Paul F. Fulk, D.C., an Ohio chiropractor, has been sentenced a year in prison and ordered to pay a $3,000 fine in connection with marketing an unapproved medical device called the CTD-Mark I. In December 2000, Fulk and an associate (Earnie S. Philpot) had pled guilty to conspiring to obstruct an FDA investigation, and the corporations they operated (Para Tech Industries and Therasys) pled guilty to conspiring to defraud the FDA of its authority to regulate the distribution of medical devices. Philpot was sentenced to three years probation and a $2,000 fine; and the companies were ordered to pay restitution totaling $211,102.30. Some chiropractic Web sites have falsely claimed that the device was an effective alternative to surgery. See Chirobase for additional information.

Chiropractor in personal injury ring sentenced to prison. On February 25, Roberto Roman, D.C., of San Dimas, California, was sentenced to one year and one day in federal prison, followed by a year of supervised release. Roman, who treated patients that had been referred to him by personal injury attorneys, admitted that he cashed checks written by them but but did not report the income on his tax returns. The checks cashed in 1995 and 1996 totaled $497,000. In December he had pled guilty to charges of filing false corporate income tax returns for his practice. This case is the product of an ongoing investigation being conducted by IRS Criminal Investigation into income tax violations by attorneys, doctors, patient-recruiters ("cappers"), and administrators in connection with the filing of personal injury claims. So far, about 60 individuals have been convicted of various charges. [El Monte chiropractor sentenced to one year for filing false tax returns. Press release No. 02-038, U.S. Attorney for Central California, Feb 25, 2002]

Google adds news search capacity. Google, the Internet's premier search engine, is beta-testing the ability to locate recent news reports from its "Advanced Search" page. For maximum efficiency, set and save your preferences before searching.

Consumer Health Digest adds associate editor. William M. London, EdD, MPH, has joined the staff of Consumer Health Digest as associate editor. Dr. London, a health educator, is a former NCAHF president and now serves as the group's program director. The newsletter, which is 15 months old, now has 5,000 subscribers.

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This page was posted on April 2, 2002.