Reports of adverse effects (AEs) of complementary and alternative
medicine were solicited from 1521 general practitioners (GPs)
and from members of the general public. 686 ($45) of GPs responded.
37% of respondents gave 291 reports of non-serious AEs, 78 (11%)
of respondents gave 96 separate reports of serious events. Of
these, 28 cases were direct AEs of manipulative therapies--mostly
manipulations of the spine--and 21 were indirect AEs involving
misadvice/misdiagnosis by homeopaths. Analysis of 121 AEs from
the general public revealed that 32 people had consulted a doctor
for their AE and 7 (6 to manipulation and 1 to acupuncture) could
be confirmed by medical records.
[Abbott et al. "Uncovering suspected adverse effects of complementary and alternative medicine," Internat J Risk & Safety Med, 1998;11:99-106.]
Antitheft systems and metal detectors may interfere with the functioning of electronic medical devices such as pacemakers and implantable cardiac defibrillators, FDA informed cardiologists, neurologists, and other doctors recently. The agency received at least 44 adverse event reports in the past 10 years, according to the Sept. 28 safety notification, in which anti-theft systems (also called electronic article surveillance systems) and metal detectors appeared to interfere with implantable pacemakers, implantable cardioverter/ defibrillators, and spinal cord stimulators. FDA believes that other electronic medical devices may also be affected. Reported effects of interference have included chest pain in pacemaker users, unintended shocks to patients with implantable cardioverter/ defibrillators, and pain and jolts--and in one case a fall that resulted in injury--due to overstimulation from spinal cord stimulators. Also reported were shifts in pacemakers' pulsing rates and unwanted changes of implantable cardioverter/ defibrillators to "monitor only" mode.
In the letter, FDA recommended that doctors tell their patients about some precautions they can take: Know that in many commercial establishments, anti-theft systems may be hidden or camouflaged in entrances and exits so they are not readily visible. Do not stay near the anti-theft system or metal detector longer than necessary and do not lean against the system. When being scanned with a hand-held metal detector, warn security personnel that you have an electronic medical device and ask them not to hold the metal detector near the device any longer than is absolutely necessary; or ask for another form of personal search. FDA asks health-care practitioners to report any adverse events related to electromagnetic interference with electronic devices to FDA's MedWatch program. The entire safety notification letter can be found on FDA's Website: fda.gov/cdrh/safety.4html.
Serious Product Problem? Report It
Health professionals can report serious adverse reactions or other product problems to the product's manufacturer or directly to FDA's MedWatch program. A MedWatch report can be made by mail: by using the postage-paid MedWatch form; by phone: 800-FDA-1088 (800-332-1088); By Fax: 800-FDA-0178 (800-332-0178); by Internet: fda.gov/medwatch/. Call the 800 number or visit the Website for forms or for further assistance. FDA encourages consumers to report through their doctors, but if they prefer, they may submit the MedWatch form themselves.
Comment: Many quack diagnostic and treatment devices are electronic or pseudo-electronic. Some are legally manufactured but then modified and can be dangerous. One such case was prosecuted in Washington County, Iowa. Does anyone know if the following problems have been encountered with non FDA approved devices?
Confirming Mayo Clinic research, FDA has identified impurities
in certain dietary supplements that might be related to the illness
eosinophilia-myalgia syndrome (EMS). The supplements, some 5-hydroxy-L-tryptophan
(5HTP) products, are being used for insomnia, depression, obesity,
and, in children, attention deficit disorder. While the significance
of FDA's finding remains unknown, the agency believes vigilance
towards these products is warranted. FDA is unaware of any recent
illnesses associated with 5HTP products being sold as dietary
supplements; however, the widespread promotion and use of these
products began only recently.
In 1991, an impurity associated with 5HTP, called Peak X, was identified in one case of EMS. Impurities similar to Peak X also were found in L-tryptophan that was associated with a 1989 epidemic of EMS. Also, the medical literature includes reports of 10 previous EMS cases worldwide associated with 5HTP products. The exact cause of the 1989 and 1991 cases of EMS remains unclear.
EMS is a serious illness characterized by a rise in certain white blood cells and severe muscle pain. The national Centers for Disease Control and Prevention has identified more than 1,500 cases of EMS, including 38 deaths, associated with L-tryptophan.
FDA is working with CDC and the National Institutes of Health to monitor use of 5HTP products and is consulting with professional and patient groups. The agency encourages the public to report serious adverse reactions to the agency's MedWatch program. To report adverse reactions, professionals and consumers can call 1-800-FDA-1088 (1-800-332-1088). Doctors and other health-care professionals also may send the information by fax to 800-FDA-0178 (800-332-0178) or by mail using postage paid form to FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.
Comment: FDA's legal definition of supplements now includes many substances. This definition includes vitamins; minerals; herbs, botanicals, and other plant-derived substances; and amino acids (the individual building blocks of protein) and concentrates, metabolites, constituents and extracts of these substances.
A man who posed as a doctor and claimed to have hundreds of thousands of patients worldwide was put out of business after FDA officials discovered the impostor had been diagnosing and treating nonexistent conditions and purchasing and selling unapproved drugs since 1989. Edwin E. Kokes, owner of Independent Testing Labs of Grand Island, Neb., was sentenced Aug. 19, 1998, in the U.S. District Court for the District of Nebraska to two and a half years in prison and three years of supervised release for sending unapproved drugs and diagnostic analyses through the mail. He also was fined $5,000 and ordered to pay $80,000 in restitution to his victims. According to the case agent in FDA's Office of Criminal Investigations, the 63-year-old Kokes generated nearly $1 million in seven years by claiming that he could diagnose and treat such medical conditions as AIDS, cancer and allergies from hair and fingernail samples. He boasted of his "technologically advanced laboratory," in which he analyzed hair and fingernail samples with what he termed a "laser" received from a friend at NASA and other hand-held devices, such as an electron microscope. He also told potential patients that the products he sold and various treatments he conducted in his office could cure their diseases, often offering them at inflated prices. Questions surrounding Kokes' wrongdoings first surfaced during a 1993 FDA Minneapolis district office investigation of another self-proclaimed but uncredentialed physician, Karl Brunkow. Following complaints received about Brunkow's practice, FDA investigators posing as patients learned that Brunkow sent samples of his patients' hair to Independent Testing Labs, Inc, in Nebraska, and that he treated his patients based on hair analyses conducted by the laboratory's owner, Edwin Kokes. During the investigation, an FDA investigator submitted several hair samples and one fingernail sample from himself and one other person to Kokes' laboratory. From these samples, each of which cost between $25 and $50, Kokes not only identified allergies, toxic blood levels, and problems with glands, reproductive organs, and the liver and kidneys, but he did so for three different people. He then prescribed his products--Zymex, Immuplex and M-Bone--all drugs that FDA has not approved. FDA's Forensic Chemistry Center in Cincinnati analyzed the M-Bone product and found it to be diluted sulfuric acid, a strong irritant, which Kokes was selling for up to $300 per 4-ounce container. Records reviewed later in the investigation revealed that one of Kokes' patients had complained to him that her skin was burned after he advised her to apply the M-Bone topically. At one stage of the investigation, FDA investigators submitted guinea pig hair to Kokes, and from that analysis, he diagnosed human diseases. FDA could find no evidence that Kokes was a licensed physician, chiropractor or osteopath, even though he always referred to himself as a doctor and signed his name "Edwin E. Kokes, UMM [ultramolecular medicine], Ph.D," according to case documentation. Other titles he assumed included "Dr." and "CRA," which stands for contact reflex analysis. Kokes also claimed to have been a surgeon during the Korean War.
FDA's case agent, who did not have ovarian cancer but told Kokes that she did, met with him undercover after he falsely confirmed her diagnosis from a hair sample she had sent him to analyze. He told her he had cured 400 to 500 AIDS patients and 97 percent of the 3,000 to 4,000 ovarian cancer patients he had treated with his products. In addition, he told her he often advised individuals with real, known diseases, such as cancer, not to seek traditional medical treatment or continue legitimate medicines prescribed by their doctors. He claimed that traditional treatments could cause the cancer to worsen or even cause death. The agent said Kokes also went on record as saying that he advised his patients not to tell their medical doctors about his treatment plans and convinced some of his patients to sign a waiver to keep office visits and conversations with Kokes from being disclosed to investigators. During sentencing, defense attorneys argued that Kokes should not be sent to prison because he suffered from delusions and personality disorders and had no grasp of reality. However, a psychiatrist for the prosecution stated that Kokes did not appear to be delusional or psychotic but instead tended to make exaggerated statements. He said the fact that Kokes decided to legitimately register his business as a corporation with the state of Nebraska showed he was thinking rationally. Kokes pleaded innocent in June 1996 to 11 counts of mail fraud and one count of using a fictitious name or title, but he reversed his plea in September 1997 as part of a plea agreement that allowed all but one count of mail fraud to be dropped. Kokes received the maximum penalty allowed under the plea agreement. The U.S. Attorney's Office in Minneapolis declined to prosecute Kokes' accomplice, Karl Brunkow, now deceased, because of his age--92--at the time of the investigation. --Carol Lewis
Comment: The various definitions of quackery can really be used on this case. "A psychiatrist for the prosecution stated that Kokes did not appear to be delusional or psychotic but instead tended to make exaggerated statements."
A California juice company was fined $1.5 million after pleading guilty to 16 misdemeanor criminal charges related to a 1996 outbreak of dangerous Escherichia coli O157:H7 bacteria. One child died and 14 other children were seriously sickened after drinking the company's fresh, unpasteurized apple juice. The fine is one of the largest ever imposed in FDA history for a food injury case, and the criminal conviction by federal prosecutors is one of the first ever obtained in a large-scale outbreak of infectious pathogens. Odwalla Inc., of Half Moon Bay, agreed in a criminal plea bargain in July to pay the fine and serve five years of court-supervised probation. The plea agreement, filed in the U.S. District Court for the Eastern District of California, also requires Odwalla to implement a Hazard Analysis and Critical Control Point (HACCP) plan in its facility. HACCP is a food safety system that identifies potential food safety hazards and specifies controls for preventing these hazards. A $250,000 portion of the fine will be divided between a charitable organization, Safe Tables Our Priority (STOP), and the food safety research centers of the University of Maryland and Pennsylvania State University. The funds will be used to raise consumer food safety awareness and research the safety of fresh produce. The tainted juice affected consumers in Colorado, California, Washington state, and British Columbia. Fifteen children who drank the juice developed the life-threatening condition hemolytic uremic syndrome (HUS), a leading cause of kidney failure in children. One of the children, a 16-month-old Colorado girl, died from HUS-related multiple organ failure. At least 51 others were sickened, but to a lesser degree. Food safety experts say survivors of this strain of E. coli may have significant health problems for years. In late October 1996, FDA received word that the health departments from the three affected states had identified an E. coli O157:H7 outbreak. Washington state health officials also told FDA that using DNA "fingerprinting" methods, they had clustered 15 related cases of E. coli infection in which all the victims had reported drinking Odwalla apple juice. When notified of these findings, Odwalla began a recall Oct. 31 of all its apple juice products. At the same time, FDA launched a 14-month investigation. An investigator with FDA's San Francisco district office, Helen Hamaoka, inspected the Odwalla plant and collected apple juice samples, which were shipped to FDA's analytical laboratory in Seattle. Tests showed the samples were negative for E. coli O157:H7. Hamaoka noted, however, that the company had ignored safety standards by centering its product testing more on shelf life than bacterial contamination. On Nov 5, 1996, FDA's Seattle district laboratory analyzed samples of juice found in an Odwalla warehouse in Washington state. One sample that came from juice processed around Oct. 7, 1996, tested positive for E. coli O157:H7. The laboratory analysis enabled FDA to link the E. coli outbreak positively to Odwalla juice.
As part of its criminal investigation of Odwalla, FDA's Office of Criminal Investigations began interviewing former Odwalla employees, suppliers, and others familiar with company operations. Their comments indicated that Odwalla had in the past had numerous deficiencies in its sanitation procedures. For example, accepted industry practice calls for use of a chlorine solution for washing and sanitizing fruit, but Odwalla had stopped using chlorine and was instead using phosphoric acid, which may not be effective as a fruit wash. OCI also learned that the U.S. Army had rejected a contract with Odwalla in June 1996 after Army analysis identified a high bacterial count in an Odwalla product. OCI also discovered that a consultant hired by the company had uncovered Listeria and other bacterial contamination in the processing plant during weekly microbiological tests he conducted between May 1994 and December 1995. OCI learned that Odwalla initially tried to identify and eliminate the source of the Listeria contamination but ultimately focused on extending shelf life without ever conclusively solving the contamination problem. Records showed that Odwalla had used an inferior grade of apples, which may have made the juice more prone to contamination. After determining that Odwalla's operations created an environment within which E. coli O157:H7 could exist, OCI's investigation centered on determining the source of the contamination. Though officials could not pinpoint the exact source, several theories emerged. Among them: The apples used to make the juice were contaminated with animal fecal material. The wooden crates used to ship the apples were contaminated. Odwalla employees failed to wash their hands properly after using the bathroom and before returning to production areas. As part of the consent decree, Odwalla implemented a HACCP plan whose provisions include: maintaining sanitary conditions to avoid food contamination, a written sanitation control program run by a qualified manager, a comprehensive employee training program in areas such as proper food handling and personal hygiene. In June 1997, Hamaoka inspected Odwalla again and took juice samples and swabs from the company's equipment for analysis. The samples proved negative for E. coli, and Hamaoka noted that the company had begun using more effective sanitation methods. FDA will continue to inspect Odwalla regularly to ensure HACCP compliance. [FDA Consumer, Jan-Feb, 1999]
Comment. Some classic investigations from FDA files. Look how long it takes to investigate, report and prosecute even after fatal outcomes. The company is still in business, bottoms up.
On April 28th, 1999, the Science Panel on Interactive Communication and Health, an independent body convened by the U.S. Department of Health and Human Services (HHS), released its final report, Wired for Health and Well-Being: The Emergence of Interactive Health Communication. The report, a landmark analysis of the emerging field of interactive health communication, identifies specific opportunities for reducing risks and expanding benefits associated with these new technologies. "Emerging communication tools, such as the Internet, can help us spread the prevention message and promote health in ways that previous generations could only dream of," stated U.S. Surgeon General David Satcher. In the foreword to the report, he wrote, "The rapid development of new technologies, coupled with the explosive growth of the Internet, brings opportunities for people to find interactive information, education, and support that is tailored to their needs and preferences." The Science Panel was convened to examine the potential impact of health communication technology on the health of the public and to accelerate its appropriate development, use, and evaluation. The Panel coined the term "interactive health communication" (IHC) to refer to the use of information or communication technology to access or provide health information, guidance, and support. IHC includes health-related Web sites and non-networked software applications. The Science Panel proposed four broad strategies for ensuring that IHC will enhance health and healthcare: 1) strengthen the evaluation and quality of applications, 2) improve basic knowledge and understanding of IHC, 3) enhance capacity of people to develop and use IHC, and 4) improve access to IHC for all populations. They concluded that IHC has great potential to improve health but may also cause harm. Their report, Wired for Health and Well-Being, outlines the potential for inaccurate, inappropriate, or poor design to result in harmful health outcomes. "To date, there has been little evaluation or quality control of IHC because applications have developed faster than theory and assessment tools," stated Science Panel Chair, David Gustafson, PhD, of the University of Wisconsin-Madison. "With so many consumers relying on health information on the Web, we need to ensure that we do no harm." "This consensus report is a clarion call to all stakeholders - application developers, consumers, health professionals and healthcare organizations, policymakers, and others - to work together and leverage the potential power of IHC to improve health, reduce health disparities, and contain healthcare costs," stated Science Panel Study Director Thomas Eng, VMD, MPH.
A central area of concern outlined in the report is the lack of public disclosure of information for consumers to judge the credibility of the health information they are viewing and to make informed decisions. Withother consumer products, such as pr ocessed foods and cars, essential information about the identity of the producer and content of the product are routinely disclosed. The Science Panel proposes that application developers and sponsors routinely post such information on their Web sites or other applications, and offers an "evaluation reporting template" and "disclosure statement," available free at www.scipich.org, to help implement this practice. "Consumers should be informed shoppers when it comes to the Internet," stated Mary Jo Deering, PhD, Director of Telehealth at the Office of Disease Prevention and Health Promotion, HHS. She pointed out the availability of pre-selected quality online health information resources for consumers, including information on fraud and quackery, at www.healthfinder.gov, the federal government's health portal. The Science Panel is comprised of 14 nationally recognized experts from a wide variety of disciplines related to interactive technologies and health: medicine, human-computer interaction, public health, communication sciences, educational technology, and health promotion. The panel conducted its analyses over two and a half years and published six articles that recently appeared in the American Journal of Preventive Medicine and the Journal of the American Medical Association (see press kit). The Science Panel and its Web site at www.scipich.org are managed by the Office of Disease Prevention and Health Promotion (ODPHP), HHS. The entire report, adapted for Web viewing, is posted at www.scipich.org/pubs/finalreport.htm. The public can order a copy for a $10 handling fee by calling the ODPHP's Communication Support Center at 1-800-336-4797.
Comment: Getting reliable health information has been challenged by the Internet but now a major government report has some suggestions to help.
COPPELL, TEXAS, MARCH 5: Mannatech Inc. tells consumers scientific studies show its nutritional supplements are safe, promote good health and are even covered by a health insurance plan. Investors get another story. In documents for its initial public stock sale last month, Mannatech told potential buyers it doesn't know if its products are safe, or even if they work. Stephen Boyd, a physician who is Mannatech's international medical director, praises its supplements in a recorded message for prospective customers. He says the products facilitate the body's ability to heal itself and are "inherently non-toxic." Coppell, Texas-based Mannatech warned in the share-sale prospectus, however, that there is no assurance its products, "even when used as directed, will have the effects intended, or will not have harmful side effects." "Why are they telling consumers one thing and investors another," asked Stephen Barrett, a medical doctor and chairman of Quackwatch Inc, a not-for-profit organization that monitors healthcare fraud. "A company has a responsibility to determine its products are safe and effective before it sells them." Company executives declined to comment about the products, which are sold through more than 400,000 independent agents nationwide and in Australia. The company, which has plans to expand in the UK and Japan, had sales of $122.9 million for the first nine months of 1998. Mannatech's president, Sam Caster, speaks on a recorded message about a patent-pending Mannatech product called Ambrotose, which is blended from eight sugars and costs $39 for a bottle of 60 tablets.
"Ambrotose transcends all forms of malady because it supplies the body with those unique components that truly allow the body to heal itself," Caster says. In its IPO filing, Mannatech cautioned investors that its MVP product, marketed for weight control, contains ephedrine, a substance the U.S. Food and Drug Administration has linked to heart attacks, strokes and death. There are no warnings in the company's literature for consumers about MVP. The FDA, which has received more than 800 reports of adverse events associated with ephedrine, has proposed banning its sale for weight control. While Mannatech says it has an eight-member scientific team, its monthly magazine recently said there are no double-blind, placebo-controlled studies of the type used by drug companies establishing that its products work. It said it spent 0.25 percent of sales on research and development between 1995 and 1997, or about $667,000. Mannatech offers consumers insurance called MannaCare that reimburses up to 50 percent of the cost of its supplements. It also provides full medical, dental and vision coverage for premiums of up to $9,120 annually.
The insurance is offered through U.S. Alliance, a Crofton, Maryland, insurer that said it's unlicensed in the state. "There wasn't an insurer they met with in the last three years that would reimburse" for Mannatech products, said Walter Nieves, president of U.S. Alliance. "That's why they came to me." Nieves said he doesn't need a license because his plan is exempt from state regulation. Regulators aren't sure. Maryland insurance regulators yesterday ordered Nieves to explain why he isn't violating state criminal law that forbids insurance sales by unlicensed companies. "We regard this as an urgent matter requiring an immediate response," said Dennis Carroll, Deputy Insurance Commissioner. Mannatech's President Caster, 48, is no stranger to product promotion or the inquires of state officials. In 1991, his Eagle Shield Inc. claimed its Electracat device would repel insects and other pests by emitting high-frequency vibrations. The Texas Attorney General disagreed. "The device is a hoax and stands on the same scientific footing as a perpetual motion machine," said Assistant Attorney General William Goodman, who won a permanent injunction against Caster and Eagle Shield in Travis County District Court. Caster agreed to stop selling the Electracat, not make unsupported scientific claims about any other product and pay $125,000 in investigative costs.
Two years earlier, Caster and Eagle Shield were accused of deceiving consumers by claiming their Eagle Shield Radiant Barrier was a scientific breakthrough in home insulation and provided significant savings in energy costs. The Texas Attorney General got a court order banning such claims after arguing the product had been available for more than 40 years and that the energy-saving claims were false. Caster and the company agreed not to make more false statements, and Eagle Shield filed for Chapter 11 bankruptcy protection. Caster co-founded Mannatech in 1993 and took it public last month. Nearly half the 5.3 million shares went unsold at the self-underwritten initial public offering on Feb. 11. Only 3.1 million shares were sold, half owned by insiders including Caster. So who drove up Mannatech's shares from $8 at the sale to 44 1/2 two days later, valuing the company at more than $1 billion? John Coffee, professor of securities law at Columbia University Law School, suspects they were so-called day traders, who bought because the stock was moving up and they thought theycould sell for a quick profit. "They weren't interested in the fundamentals," he said. Mannatech's fundamentals include current liabilities that exceeded assets on Sept. 30 by $11.3 million. Its net tangible book value before the offering was $493,000, or 2 cents a share. Sales increased 11 percent in the first nine months of 1998 from the year-earlier period. That's down from the pace of 1996 to 1997, when sales grew 67 percent. Earnings fell 3 percent in the first nine months of 1998. From 1996 to 1997, earnings grew 48 percent annually, with profit in 1997 of $10.6 million, or 50 cents a share. Mannatech's shares traded today at 11 7/16, cutting the company's value to $270 million.
Reprinted by permission.