In July the Food and Drug Administration asked the U.S. Department of Justice to pursue a criminal investigation to determine whether San Diego-based Metabolife International, Inc., a leading seller of products containing ephedrine in combination with caffeine, made false statements to the FDA regarding the existence of adverse event reports. The FDA claims Metabolife has refused and resisted FDA's efforts, including unsuccessful litigation, to get the reports. The agency itself has collected reports of over 100 deaths associated with ephedrine products marketed as "dietary supplements."
In a letter dated August 15th to Department of Health and Human Services Secretary Tommy Thompson, Sidney Wolfe, MD, director of the Public Health Research Group wrote that in April 1998 Michael Ellis who was then president of Metabolife responded to a call from the FDA for comments concerning the abuse potential, actual abuse, medical usefulness, and trafficking of ephedrine. According to Wolfe, Ellis wrote in his letter that "Metabolife has never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356" and "consequently, since there had been no serious adverse reports [AERs] of any sort, there had been no such reports of overuse or abuse of the product."
In a letter dated August 15th to Secretary Thompson, Metabolife President David Brown denied that Michael Ellis knowingly or willfully made any false statement to the FDA. The letter claims that Metabolife is releasing files to the Secretary that "do not in any way demonstrate that ephedra is unsafe or poses any health problems." The letter mentions that between early 1997 and September 2001 it received 400,000 calls to a toll-free number that appears on the Metabolife 356 label "primarily for the purpose of assisting customers with weight control questions and to help consumers properly use the product," that 13,000 of the calls "reported certain health-related issues" and that approximately 80 "even mention the primary categories of potential concern that FDA has identified (i.e. seizure, heart attack, stroke, death)." Brown's letter also calls for stricter regulation of the ephedra products industry.
According to an Associated Press article, an attorney for Metabolife said 100 to 200 other reports deal with people who were hospitalized. The article also notes that Eugene Thirolf, a senior Justice Department official, wrote the FDA that court records from private lawsuits against Metabolife suggest the company had received reports of serious illnesses among ephedra users before Ellis's April 1998 comment to the FDA. [Criminal investigation sought for diet supplement seller. USAToday.com 10/15/02.]
Two years ago, after receiving three separate donations totaling $150,000 that he solicited from Metabolife, Gov. Gray Davis of California vetoed legislation that had already been weakened by lobbying from the supplement industry that would have required a warning label on products like Metabolife 356. He stated that such products in interstate commerce should be regulated instead by the federal government. But in 1997 when Pete Wilson was California governor, the Department of Health Services placed warnings on a dieters' tea product after it was linked to 11 deaths and 67 illnesses nationwide. And under Davis, California's Department of Health Services issued a public warning about an herbal prostate remedy and persuaded the manufacturer to recall it. In July Davis signed legislation to limit greenhouse gas emissions from automobiles, the first state legislation of its type. In August, following the announcement of the federal investigation of Metabolife, Davis said that he would sign legislation that would ban the sale of ephedrine products to minors. [Morain D. Despite warnings, Davis took no action against Metabolife. Los Angeles Times 8/17/02, p. A1, A20.]
In August, Bill Simon, the Republican who was running for Governor against Davis, acknowledged that he accepted a contribution of $10,000 from Metabolife Chairman W. R. Bradley. He also accused Davis of "putting people's health and lives at risk" by vetoing the legislation that would have put warning labels on Metabolife products. Simon was quoted: "I am not for sale. Unlike Gray Davis, I can't be bought." [The skinny: Simon took diet-drug funds. AP 10/20/02.]
In November, Davis was re-elected as California Governor.
Dutch conglomerate and specialty foods company Royal Numico announced that it will sell Rexall Sundown, the largest supplier of vitamins and supplements to Wal-Mart stores. Numico blamed Rexall Sundown, which it acquired in 2000 for $1.8 billion, and GNC, the supplement retail operation it acquired in 1999, for the conglomerate's $1.45 billion third-quarter loss. Palm Beach Post staff writer Phil Galewitz reported (Nov. 12) that analysts estimate that the company, whose brands include Met-Rx, CarbSolutions, and Sundown Vitamins and Herbs, will sell for between $200 million and $400 million.
In July 2000 FTC charged Rexall Sundown with making false and unsubstantiated claims for its Cellasene product as a purported cellulite treatment. In March 2002 a Camden County jury returned a verdict in favor of New Jersey consumers in a class-action that alleged Rexall Sundown had marketed and labeled its Calcium '900' and Calcium 1200 products in violation of the New Jersey Consumer Fraud Act.
The promoters of a massive 900-number, pay-per-call scheme known as the "Miss Cleo" psychic hotline have agreed to a stipulated court order requiring them to forgive an estimated $500 million in uncollected bills; return to consumers all uncashed checks; cease all pay-per-call activity; investigate and resolve promptly any consumer complaint they receive; and pay the Federal Trade Commission (FTC) $5 million. The agreement settles charges from the FTC that Access Resource Services, Inc. (ARS) and Psychic Readers Network, Inc. (PRN) and their officers Steven L. Feder and Peter Stolz:
Cold reading is the technique used by people who claim to be psychic to convince others that they have abilities such as communicating with the dead. It involves making vague statements such as common names, ailments, and life events. People seeking assistance have opportunities to make connections to the statements and give information to the psychic without realizing it. High Nielsen ratings of nationally syndicated television programs Beyond With James Van Praagh and Crossing Over With John Edward, which claim to show communications with the dead, depend on audiences who are ignorant about cold reading.
On Halloween the ABC Primetime Thursday television program demonstrated how cold reading works. It recruited an audience of twenty volunteers who were open to the possibility of communicating with the dead to judge a test of the psychic abilities of Ian Rowland (who actually teaches around the world about cold reading). Rowland provided readings that were convincing to the studio audience. At the end of his performance he revealed that he himself does not believe he has psychic abilities. Nevertheless his confession did not change the beliefs of some audience members that his readings were meaningful communications with the dead. The ABC News Web site has a report about the broadcast.
DEMAND CHARACTERISICS INFLUENCE FALSE BELIEFS
In a paper presented at the 1961 American Psychological Association convention, Martin T. Orne of Harvard Medical School discussed how demand characteristics influence subjects' behavior in psychology experiments. Demand characteristics are all the cues that subjects receive about the hypotheses to be tested. It is important to control for such cues because subjects often try to perform in ways that validate researchers' hypotheses. Orne also attributed some people's reactions to hypnosis and sensory deprivation to demand characteristics.
Orne's paper is reprinted in the October 18, 2002 issue of the online journal Prevention & Treatment. (See http://journals.apap.org/prevention/volume5/toc-oct18-02.html) along with nine commentary papers and an introduction. In one commentary, "Demand Characteristics and the Development of Dual, False Belief Systems," NCAHF board member Loren Pankratz, PhD discusses the influence of demand characteristics outside of experiments. For example, he argues that when people claim to offer psychic readings, the responses of their subjects encourage false beliefs in the reader which are in turn passed back to create false beliefs in the subject. Dr. Pankratz discusses the tendency of clients to selectively recall correct "psychic" responses (i.e., hits), which provide an emotional wallop, and fail to recall incorrect "psychic" responses (i.e., misses). He also suggests that demand characteristics influence the development of false beliefs of so-called recovered memory therapists and their patients.
Comment: Demand characteristics may help to elicit enthusiastic testimonials by patients and providers for a variety of nostrums and irrational health services.
A woman who claims to provide naturopathic treatment out of her home in Van Nuys, California and her assistant were charged on October 30th with involuntary manslaughter and practicing medicine without a license in connection with the death of a man who went to them for treatment of a rash, the Los Angeles County District Attorney's office announced. Reina Isabel Chavarria, 48, and Margarita Montes, 28, were each charged with one count of unauthorized practice of medicine with the allegation that the victim suffered great bodily injury, and one count of involuntary manslaughter. (Naturopaths are not licensed in California.) If convicted, each could be sentenced to a maximum of nine years in state prison.
According to Los Angeles police, Roberto Alonso Caceres, 54, began convulsing after being administered an injection at Chavarria's home. A friend of Chavarria's flagged down Van Nuys area officers and directed the officers to Caceres's location. Police discovered that he was unresponsive. A rescue ambulance was summoned. Los Angeles Fire Department Paramedics arrived and transported Caceres to a local hospital where he was pronounced dead. Authorities said Caceres had sought treatment from Chavarria for a rash.
The Los Angeles Times provided details about the story [10/30 latimes.com; 10/31, p. B3]. According to Caceres's son, medical doctors couldn't seem to cure the rash, which caused him to miss so much work as a handyman that his employer threatened to fire him. Caceres heard about Chavarria from a popular morning show on a Spanish-language radio station and traveled from his home in Santa Ana for her treatment. Police said that the first time Caceres sought Chavarria's treatment, he paid $310 and was given ointments and pills, which did not cure the rash. He received two injections costing $140 on a return visit. Montes told Caceres and his wife that the first injection was vitamin B12. Caceres looked nervous and Montes offered the second injection of an unknown substance. When Caceres became ill, Chavarria and Montes refused to call for emergency help and forced Caceres and his family out of the house. The prosecutor is waiting for the results of toxicological tests to determine the cause of death.
The Times described the yard of Chavarria's home as containing statues of the Virgin Mary, Jesus, and angels. Investigators said they found in the "treatment room" candles, religious figurines, and what appeared to be a shrine of voodoo dolls, with likenesses of saints and the Virgin Mary. A dog slept on the table where injections were given.
Detectives called for the public's help in locating other possible victims and additional information about the defendants.
The Washington Poison Center in Seattle reported five cases of argyria that came to its attention within a two-month period. This condition, in which silver accumulates in the skin, is characterized by a permanent gray-blue skin discoloration. The cases included a 66-year old woman and her husband who used a naturopathic hydrolyzed silver treatment for three years and a 37-year old male who drank an herbal tea containing silver for some ten months.
Another husband and wife sought help two years previously for chronic symptoms from a naturopath, who recommended various dietary supplements including one that contained a silver preparation. Most of their symptoms continued as before except they developed a bluish-gray discoloration of their faces and hands.
[Hori K, Martin, TG, Rainey P, Robertson WO. Believe it or not-silver still poisons! Vet Human Toxicol 44(5):291-292;2002.]
Montana Libertarian candidate for U.S. Senate Stan Jones, 63, developed argyria according to the Associated Press [abcnews.go.com 10/3/02]. Jones reportedly started taking colloidal silver in 1999 because he feared Y2K disruptions might lead to a shortage of antibiotics. He said his skin began to turn blue-gray about a year ago and that he no longer takes the product, which he made for himself.
Wal-Mart, one of the largest employers in the United States, announced that it will drop chiropractic coverage from its employee benefit plan. The American Chiropractic Association, which greatly exaggerates what chiropractors can do and which protects the interests of chiropractors who practice pseudoscientific healthcare, is encouraging its members to complain to: H. Scott Lee, President, CEO, Wal-Mart Stores, Inc., 702 SW 8th Street, Bentonville, AR 72716. NCAHF has sent President Scott congratulations.
Jessica Crank, 15, died of a rare bone cancer on September 15, four months after her mother Jacqueline Crank decided to rely on Jesus instead of following advice from workers at a Lenoir City, Tennessee clinic to take her to the emergency room of the University of Tennessee Medical Center in Knoxville. Jessica reportedly had a basketball-sized tumor on her shoulder. Jacqueline was arrested by Lenoir City Police in June. She and preacher Ariel Ben Sherman, identified as Jessica's "spiritual father," have been charged with aggravated child abuse and neglect charges and may face murder charges. An attempted resurrection of Jessica at her September 18th funeral by Sherman and members of his New Life Ministries was unsuccessful. Attorneys for Sherman and Jacqueline Crank claimed that Jessica supported the decision not to be taken to the doctor. In 1984 Sherman was charged in Oregon with five counts of child abuse and convicted of criminal mistreatment. [Schabner D. No cure for cancer. ABC News.com10/3/02.]
No consistent associations between psychological coping styles and cancer outcomes were found in a systematic review of 26 prospective observational studies addressing survival from cancer and 11 studies addressing recurrence from cancer. The researchers concluded that no good evidence supported the development of psychological interventions to prolong survival. They cautioned against making people with cancer feel pressured into adopting particular coping styles to improve survival or reduce risk of cancer recurrence. [Petticrew M. Bell R, Hunter D. Influence of psychological coping on survival and recurrence in people with cancer: systematic review. BMJ 325:1066-1075;2002.]
A Stark County (Ohio) Family Court judge ruled that it did not constitute neglect for parents of a 7-year-old boy with acute lymphoblastic leukemia (ALL) to stop his chemotherapy after three months of a 3_-year treatment plan and start him on so-called holistic treatment. Theresa and Greg Maxin have taken their son Noah to Rene Blaha, MD in Lancaster, Ohio for treatment. Dr. Blaha is board certified in family practice. He also has certification by the American Board of Holistic Medicine (ABHM), which is not approved as a specialty board by the American Board of Medical Specialties.
According to news reports, the Maxins took Noah off chemotherapy because they feared it would destroy Noah's immune system. They claim that Noah's holistic treatment is non-toxic and builds the immune system. Noah's holistic treatment is described as addressing body and mind. It includes unspecified "natural" medicines plus dietary measures, such as avoiding sugar and dairy products, and drinking lots of fluids to flush out unspecified "toxins."
Judge David Stucki ruled that it was the Maxins' right to carefully research and select an alternative treatment. He said: "These are not parents who refused medical treatment or who elected to take Noah to a witch doctor or a shaman."
However, the rationale for the treatments the Maxins selected is no more plausible than anything offered by witch doctors or shamans. No objective evidence suggests that so-called holistic methods could be any better than no medical treatment or the ministrations of shamans or witch doctors at improving the chances for children with ALL for long-term survival.
According to the National Cancer Institute:
The improvement in survival for children with ALL over the past 35 years is one of the great success stories of cancer treatment. In the 1960s, less than 5 percent of children with ALL survived for more than five years. Today, about 85 percent of children with ALL live five years or more.
[Associated Press, 11/18/02; Gross A. Beacon Journal (Akron) 11/15/02; 11/19/02]