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February 24, 2003
Mr. Allan H. (Bud) Selig, Commissioner
The Office of the Commissioner of Baseball
245 Park Avenue, 31st floor
New York, NY 10167
Dear Commissioner Selig,
The Feb. 17 death of Baltimore Orioles pitcher Steve Bechler has focused new attention on the dangers of ephedra, an herbal stimulant used for weight loss or bodybuilding that has also been associated with serious health problems. For the reasons outlined below, Consumers Union, the nonprofit publisher of Consumer Reports magazine, urges Major League Baseball to ban the use of herbal supplements containing ma Huang or ephedrine akaloids (collectively referred to as "ephedra" in this letter).
THE FDA AND OTHER HEALTH AUTHORITIES HAVE RECEIVED MANY REPORTS OF THE HARMFUL EFFECTS OF EPHEDRA
Dietary supplement products containing ephedra provide dubious health benefits while posing serious health risks to consumers, including athletes. From January 1993 through October 2000, the FDA received 1,398 reports of adverse events linked to herbal supplements containing ephedra, including 81 deaths, 32 heart attacks, 62 reports of cardiac arrhythmia, 91 reports of hypertension, 69 strokes and 70 seizures. (1) Complaints about herbal supplements containing ephedra constituted 42% of all dietary supplement complaints, and 59% of all reported deaths.(2) Those complaints likely represent only the tip of the iceberg, because the vast majority of adverse reactions to dietary supplements or medications are never reported to the FDA, or indeed, to any health professional or agency.
The American Association of Poison Control Centers (AAPCC) has reported a steadily increasing number of serious adverse events related to supplements containing ephedra over the last five years.
Recent data released by the AAPCC indicates that in the year 2001 alone there were:
· 812 reported events relating to exposure to dietary supplements containing ephedra as a sole ingredient, including 3 deaths, 103 adverse reactions, 10 "major effects" (defined as exhibiting signs or symptoms that were life-threatening or resulted in significant residual disability) and 139 "moderate effects" (defined as exhibiting symptoms or signs that were more pronounced, more prolonged or more systemic in nature than minor symptoms -- and where usually some form of treatment is indicated). Of the 812 exposures, 440 persons (54%) were treated in a health care facility. 48% of reported exposures occurred in individuals over 19 years of age.(3)
· 7,115 reported events linked to exposures to multi-botanical supplements containing ephedra as an ingredient, including 3 deaths, 1,075 adverse reactions, 87 "major effects" and 1,325 "moderate effects." Of the 7,115 exposures, 3,849 persons (54%) were treated in a health care facility. 43% of reported exposures occurred in individuals over 19 years of age.
According to an analysis released
by the Annals of Internal Medicine in February, products containing ephedra
accounted for 64% of all adverse reactions to herbal products reported to the
AAPCC in 2001. The researchers calculated relative risks for an adverse reaction
to ephedra compared with other herbs in the database and found huge (100-fold
or more) increases in risk for those taking ephedra.
THERE IS COMPELLING EVIDENCE THAT EPHEDRA POSES SERIOUS RISKS TO USERS
Two recent independent studies from well-respected academic centers, reported
in peer-reviewed journals, scrutinized adverse events reports filed with the
FDA between 1995 and 1999. In the reports, researchers found dozens of cases
of abnormal heartbeats, strokes and heart attacks that were likely related to
ephedra use.
Samenuk and others at the New England Medical Center in Boston analyzed almost
1,000 cases of possible ephedra toxicity submitted to the FDA. They reported
in a recent issue of Mayo Clinic Proceedings that untoward events were clearly
related to immediate prior use of the drug in 37 people, and that 36 of these
37 victims had taken the product according to the manufacturer's directions.
Sixteen suffered a stroke; 10 had a heart attack; and 11 died. The study concluded
that "ma Huang use is temporally related to stroke, myocardial infarction,
and sudden death; (2) underlying heart or vascular disease is not a prerequisite
for ma Huang-related adverse events; and (3) the cardio-vascular toxic effects
associated with ma Huang were not limited to massive doses." (4)
In the December 21, 2000 issue of The New England Journal of Medicine, Haller
and Benowitz from the University of California in San Francisco analyzed 140
cases of alleged ephedra toxicity that were reported to the FDA from 1997 to
1999. Abnormal heart rhythms, increases in blood pressure, stroke, sudden death,
and heart attack led the list. Of those reactions, 62 percent were thought to
be "definitely or probably" or "possibly" due to ephedra.
Eight of the 10 deaths were attributed to ephedra, including that of a 15-year-old
girl.
The few clinical studies that have been done to date are short-term and have
used small numbers of subjects. Adverse reactions included elevated blood pressure,
palpitations, chest pain, and extreme irritability. Dropout rates were high
in the ephedra-using volunteers.
MANUFACTURERS HAVE SUPPRESSED INFORMATION REGARDING EPHEDRA-RELATED ADVERSE
EVENTS
Strong evidence has now emerged that manufacturers of dietary supplements containing
ephedra may have been concealing substantial numbers of consumer complaints
regarding their products:
· On August 15, 2002, the Justice Department disclosed that it was investigating whether Metabolife (a major manufacturer and distributor of ephedra products), had made false statements to the FDA regarding the existence of consumer complaints about its products. On the same day, Metabolife announced that it would turn over 13,000 consumer health complaints or "adverse event reports" to the FDA.(5) After analyzing the Metabolife adverse events reports, the special investigations division of the House Committee on Government Reform concluded that 2,000 of the 13,000 reports were "significant" effects, including three deaths, 20 heart attacks, 24 strokes, 40 seizures, 465 episodes of chest pains and 966 reports of heart rhythm disturbances.(6)
· Two years ago, depositions in a lawsuit in San Francisco against E'ola (a Utah-based multilevel-marketing firm) regarding a death allegedly linked to ephedra revealed that the company had received 3,500 customer complaints about one of its ephedra weight-loss products. According to the San Francisco Chronicle, none of the complaints were ever disclosed to the FDA.(7)
While it isn't clear how many other manufacturers and sellers of ephedra products may be suppressing information regarding potential health effects, those examples do not inspire confidence that serious health impacts arising from the use of herbal supplements will be promptly reported to responsible health authorities under a voluntary reporting system. This also underscores the dangers of allowing herbal medicines in the marketplace without premarket safety testing and a rigorous post-marketing surveillance system. Those are very serious problems that badly need to be addressed by the Congress and the FDA without additional delay.
PUBLIC AND PRIVATE ENTITIES ARE
ALARMED BY EPHEDRA'S DANGERS, AND ARE TAKING ACTION TO PROTECT CONSUMERS
While the FDA has thus far failed to act to protect the public health from these
dangerous products, other entities from Canada and Western Europe, to states
and localities across the United States, are working to protect the public from
injury and death.
· Canada, the United Kingdom and Germany all prohibit sales of ephedra, while other European countries allow the sale of ephedra products only by prescription.
· At least ten U.S. states, and several local governments have imposed various restrictions on ephedra sales, such as requiring a prescription, outlawing sales to minors, or limiting the maximum dose. For example, in its last legislative session, California prohibited sales of products containing ephedra to minors, required "clear and conspicuous warning labels, and required products to display the toll-free telephone number for FDA Medwatch so that consumers can report adverse events.
· In February, the Suffolk County, NY board of legislators voted to ban the sale of herbal supplements containing ephedra to both children and adults, the strongest law of its type in the nation. Consumers Union is urging other counties to follow Suffolk County's lead and adopt similar local and statewide bans, pending further action by the FDA and Congress.
· The American Medical Association has called for the FDA to remove products containing ephedra from the marketplace.
· The National Collegiate Athletic Association, the International Olympic Committee, and the National Football League have already banned the use of ephedra-containing products.
· According to information recently released by Public Citizen Health Research Group, from 1997 through part of 2001, as many as 33 members of the U.S. military have died in ephedra-related deaths. Those who died were between their early 20s and early 40s and were reportedly in good health. As a result, the Army and Air Force military exchanges have removed such products from military commissary shelves worldwide. (8)
· In November, Twinlab Corporation, a major herbal supplement manufacturer based in Hauppauge, NY, announced in would stop all sales of products containing ephedra as of March 2003, because of "escalating insurance costs and regulatory uncertainties."· In January, 7-Eleven and its major dietary supplement supplier, EAS, announced they were ending sales of herbal products containing ephedra at 7-Eleven's 5,300 retail convenience stores.
As a national consumer organization, Consumers Union believes consumers -- including professional and amateur athletes -- should immediately stop using products containing ephedra, and educate themselves and others about the serious dangers of these products. Further, we believe consumers should discuss the use of any herbal supplement with their physician prior to taking it, and promptly report any adverse reactions such products to their physician and to the FDA Medwatch database.
Compared to the adverse event data that have accumulated for products containing ephedra, certain prescription drugs have been withdrawn from the market for fewer and less serious adverse events. We urge Major League Baseball and other professional sports organizations to act now to protect athletes from the known and widely acknowledged hazards of ephedra, by banning the use of herbal supplements containing ephedra by baseball players in all training and professional sporting events.
Sincerely,
| James
Guest President Consumers Union |
Marvin
M. Lipman, MD, FACP Chief Medical Adviser |
______
(1) FDA Special Nutritional Adverse
Event Monitoring System (SN/AEMS), FDA Analysis of FDA Data 1/93 - 2/01, Attachment
1 to 9/5/01 Petition by Public Citizen Health Research Group, available at http://www.fda.gov/ohrms/dockets/dailys/01/Sep01/091001/cp00001.pdf
(no period).
(2) Id..
(3) American Association of Poison Control Centers, 2001 Annual Report of AAPCC
Toxic Exposure Surveillance System, also reported in American Journal of Emergency
Medicine, Vol. 20, No. 5, September 2002, p. 439. Available at: http://www.aapcc.org/Annual%20Reports/01report/2001%20TESS%20tables%2022ab.pdf
(4) Samuenk, D. et al. Adverse cardiovascular events temporally associated with
Ma Huang, an herbal source of ephedrine. Mayo Clin Proc . 2002;77:12-16.
(5) Neergaard, L. Feds investigate top ephedra seller, Associated Press, August
15, 2002.
(6) Crabtree, P. Metabolife understated danger: firm glossed over complaints
about herb ephedra, panel told. San Diego Union Tribune, October 9, 2002.
(7) Howe, K. FDA Stops Tracking Herbal Remedies: Agency says it doesn't have
the funding to assess adverse reactions, San Francisco Chronicle, February 14,
2000, p. A1.
(8) Testimony of Sidney M. Wolfe, MD, Director, Public Citizen Health Research
Group, Before Senate Governmental Affairs Committee, Subcommittee on Oversight
of Government Management Hearing on Dangers of Ephedra, October 8, 2002.
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