ATW1H%ASUACAD.BITNET@oac.ucla.edu (Dr David Dodell) (09/12/89)
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3. Melmon KL. Preventable drug reactions: causes and cures. N Engl J Med
1971;284:1361-8.
4. Moore SR, Jones JK. Adverse drug reaction surveillance in the geriatric
population: a pre liminary view. In: Moore SR, Teal TW, eds. Geriatric drug
use: clinical and social perspec tives. New York: Pergamon Press, 1985:70-7.
5. Tanner LA, Baum C, Prela MC, et al. Spontaneous adverse reaction reporting
in the elderly for 1986. J Geriatr Drug Therapy 1989;3:31-54.
6. Montamat SC, Cusack BJ, Vestal RE. Management of drug therapy in the
elderly. N Engl J Med 1989;321:303-9.
7. German PS, Klein LE. Drug side effects and doctor/patient relationship
among elderly pa tients. J Soc Admin Pharm 1984;2:67-73.
8. Hypertension Detection and Follow-Up Program Cooperative Group. Five year
findings of the Hypertension Detection and Follow-up Program: I. Reduction in
mortality of persons with high blood pressure, including mild hypertension.
JAMA 1979;242:2562-71.
9. Amery A, Birkenhager W, Brixbo P, et al. Mortality and morbidity results
from the European Working Party on High Blood Pressure in the Elderly trial.
Lancet 1985;1:1349-54.
Health InfoCom Network News Page 10
Volume 2, Number 33 September 11, 1989
Epidemiologic Notes and Reports
Cadmium and Lead Exposure Associated with Pharmaceuticals Imported from
Asia -- Texas
In August 1988, the Texas Department of Health (TDH) investigated illegal
sales in rural west Texas of pharmaceutical drugs manufactured in Asia. These
drugs, identified by TDH and Food and Drug Administration (FDA) agents as
"chuifong tokuwan" (a pharmaceutical compound manufactured by the Nan Ling
Pharmaceutical Company of Hong Kong), are sold in pill form. Chuifong tokuwan
contains a drug combination (diazepam, indomethacin, hydrochlorothiazide,
mefenamic acid, dexamethasone, lead, and cadmium) that is not approved by FDA
and not legal for sale in or importation into the United States. The drugs
usually were repackaged and relabeled as "The Miracle Herb--Mother Nature's
Finest."
TDH tested 93 self-referred persons who had ingested the pills for
exposure to lead and cadmium. Of these, 57 (61%) were female; greater than 90%
were white non-Hispanics; the mean age was 55 years. Sixty-six (71%) reported
taking the pills to relieve symptoms of medical conditions such as arthralgias
(51%) and other pain (headache, stiff neck, back pain (26%)). Twenty-two (24%)
persons had elevated urine levels of cadmium; none had elevated levels of lead
(blood lead greater than or equal to 25 ug/mL). However, 39 (42%) persons had
elevated urine values for retinol-binding protein (RBP), a low-molecular-
weight protein indicative of renal tubular dysfunction (1-3). The mean urine
cadmium level for exposed persons was 1.8 ug/mL, compared with 0.5 ug/mL for a
nonrandom sampling of 14 unexposed persons. In exposed persons, 22 (24%) urine
samples tested for cadmium were greater than 2.5 ug/mL, the upper limit of
normal. None of the samples from unexposed persons had elevated values.
The chuifong tokuwan seized in this investigation was destroyed. The
investigation is continuing.
Reported by: D Baker, MS, Food and Drug Div, J Brender, PhD, Environmental
Epidemiology, KC Davis, Texas Dept of Health. Surveillance and Programs Br,
Div of Environmental Hazards and Health Effects, Center for Environmental
Health and Injury Control, CDC.
Editorial Note: Chuifong tokuwan first appeared in the United States in 1974.
Although it was banned by FDA in 1978, the drug is distributed illegally in
certain parts of the United States and is sometimes sold by mail. The primary
users of chuifong tokuwan in this study were long-time residents of Texas;
however, use of unapproved imported drug combinations is common among recent
immigrants to the United States, particularly those from Asia and Latin
America (4-7). Although these products are frequently perceived as relatively
harmless herbal "folk remedies," they often contain cortico- or anabolic
steroids; nonsteroidal anti-inflammatory drugs (NSAIDs); prescription
antibiotics, such as tetracycline and chloramphenicol; and controlled
substances, such as diazepam or narcotics, and have potentially serious or
fatal health effects.
Use of chuifong tokuwan may increase the body burden of cadmium and may
have contributed to renal tubular dysfunction in persons using this compound.
Through chronic exposure, cadmium can accumulate in certain organs,
particularly the kidneys. Both cadmium and several of the prescription
analgesics in chuifong tokuwan can cause renal tubular cell damage (8-11).
Cadmium can adversely affect function of the proximal renal tubules (3,8-10);
increased urinary protein excretion of low-molecular-weight proteins (e.g.,
RBP) is an early consequence of proximal renal tubular damage by cadmium
Health InfoCom Network News Page 11
Volume 2, Number 33 September 11, 1989
(2,3,9,10).
In persons who were also taking other medications, the analgesic
nephropathy associated with chronic use of many NSAIDs may have contributed to
renal tubular dysfunction (9,11). Alternatively, increased urinary RBP values
could reflect renal dysfunction related to the underlying illness (e.g.,
arthritis) for which many of the patients took this medication. However,
adverse effects on renal function have not been reported with use of either
indomethacin or mefenamic acid (the NSAIDs present in the pills analyzed),
even with prolonged use (11).
Cadmium is a cumulative toxicant, with a biological half-life of greater
than 10 years in humans (12). Medical evaluation, including urine cadmium and
urinary RBP values, is recommended for persons who have used chuifong tokuwan.
Additional renal-function evaluation should be included in the medical follow-
up of persons whose urinary RBP or urine cadmium values are abnormal.
Complex cultural and linguistic barriers necessitate cooperation with
traditional healers (e.g., acupuncturists, herbalists) and local leaders of
immigrant communities to inform these groups about the hazards associated with
use of specific products.
References
1. Kowal NE, Zirkes M. Urinary cadmium and beta 2-microglobulin: normal values
and con centration adjustment. J Toxicol Environ Health 1983;11:607-24.
2. Ormos G, Cseh J, Groszmann M, Timar M. Urinary beta 2-microglobulin and
retinol binding protein: individual fluctuations in cadmium-exposed workers.
Toxicol Lett 1985;27:59-64.
3. Kowal NE, Johnson DE, Kraemer DF, Pahren HR. Normal levels of cadmium in
diet, urine, blood, and tissues of inhabitants of the United States. J
Toxicol Environ Health 1979;5:995-1014.
4. Chan H, Billmeier GJ Jr, Evans WE, Chan H. Lead poisoning from ingestion of
Chinese herbal medicine. Clin Toxicol 1977;10:273-81.
5. Brearley RL, Forsythe AM. Lead poisoning from aphrodisiacs: potential
hazard in immigrants. Br Med J 1978;2:1748-9.
6. CDC. Folk remedy-associated lead poisoning in Hmong children--Minnesota.
MMWR 1983;32:555-6.
7. Lightfoote J, Blair HJ, Cohen JR. Lead intoxication in an adult caused by
Chinese herbal medication. JAMA 1977;238:1539.
8. Adams RG. Environmental cadmium and renal disease (Letter). Lancet
1981;1:845.
9. Boelaert J, Daneels R, Schurgers M. Cadmium, kidneys, and Belgian industry
(Letter). Lancet 1981;1:672.
10. Baker EL Jr, Peterson WA, Holtz JL, Coleman C, Landrigan PJ. Subacute
cadmium intoxication in jewelry workers: an evaluation of diagnostic
procedures. Arch Environ Health 1979;34:173-7.
11. Flower RJ, Moncada S, Vane JR. Analgesic-antipyretics and anti-
Health InfoCom Network News Page 12
Volume 2, Number 33 September 11, 1989
inflammatory agents; drugs employed in the treatment of gout. In: Gilman AG,
Goodman LS, Gilman A, eds. Goodman and Gilman's the pharmacological basis of
therapeutics. 6th ed. New York: MacMillan Publishing, 1980:682-728.
12. Lauwerys RR. Industrial chemical exposure: guidelines for biological
monitoring. Davis, California: Biomedical Publications, 1983:17.
Health InfoCom Network News Page 13
Volume 2, Number 33 September 11, 1989
Notice to Readers
Publication of Guide for Developing Policies for HIV-Infected Students
and School Staff
The National Association of State Boards of Education (NASBE) is one of 20
national organizations that receive assistance from CDC to help schools
provide effective health education programs to prevent the spread of human
immunodeficiency virus (HIV). NASBE has published a guide that CDC commends to
its readers: Someone at School Has AIDS: A Guide to Developing Policies for
Students and School Staff Members Who Are Infected with HIV.
To develop the guide, NASBE convened experts in medicine, public health,
education, and law* and has recommended scientifically and legally based
policy statements that local and state departments of education can use in
developing policies for HIV-infected students and staff. The guide addresses
infection control, HIV-infected students and school staff, confidentiality,
and HIV-antibody testing. The guide also includes resources for further
information about HIV education, discrimination, disease reporting,
policymaking, and crisis management.
Copies of the guide are available from NASBE, Publications Department,
1012 Cameron Street, Alexandria, VA 22314; telephone (703) 684-4000.
*Representatives of the following organizations participated in developing
and/or reviewing the guide: American Academy of Pediatrics, American
Association of School Administrators, American Bar Association, American
Federation of Teachers, American Medical Association, Association of State and
Territorial Health Officials, CDC, Council for Exceptional Children, Council
of Chief State School Officers, Intergovernmental Health Policy Project,
Michigan Department of Education, National Association of Elementary School
Principals, National Association of School Nurses, National Association of
Secondary School Principals, National Congress of Parents and Teachers,
National Education Association, National School Boards Association, U.S.
Department of Education, and U.S. Department of Justice.
Health InfoCom Network News Page 14
Volume 2, Number 33 September 11, 1989
===============================================================================
Dental News
===============================================================================
ADA Voices Concern Over "Whitening" Toothpastes
The American Dental Association is voicing its concern over several new tooth
whitening/bleaching products which have recently entered the market. The ADA
Council on Dental Therapeutics is aware of the existence of four brands: Epi-
Smile, White and Brite, Whiter Teeth and Smith White.
"We have very little information on the ingredients as used in these products
and no information on their safey," said Dr. Kenneth Burrell, council
secretary. The council has made inquires to the US Food and Drug
Administration and to the manufacturers on product content and safety, but has
not received significant information to date.
"We are concerned about products that use oxygenating agents as active
ingredients. There is some evidence that indicates that regular use of
oxygenating agents in the mouth can cause irritation of the soft tissues," Dr.
Burrell said.
According to Dr. Burrell, these products may really work and be safe to use
but at this point there is not enough evidence to make that conclusion. To
date, no such products have been submitted for inclusion in the Council on
Dental Therapeutics Seal of Acceptance Program, which requires clinical
studies of product safety and effectiveness.
The American Dental Association has received more than 300 calls from
consumers and dentists inquiring about these particular products, which are
being marketed both to dentists and over the counter to consumers.
Some of the manufacturers are contending that their product is considered
purely cosmetic and does not require FDA Approval. A spokesperson for the FDA
said its compliance division is investigating whether these products will be
considered cosmetics, drugs or devices under the FDA rules. Cosmetic products
have fewer premarket requirements than do therapeutic products.
The ADA is advising consumers to confer with their dentist about tooth
discoloration concerns. Professional cleanings and tooth bleaching by a
dentist are safe and commonly used procedures that can remove stains and
whiten teeth. In more difficult cases, tooth bonding with plastic resins and
veneers much like artificial fingernails can be used to improve tooth
appearance.
Consumers should also generally look for the ADA Seal of Acceptance when
purchasing dental hygiene products. "The Seal of Acceptance is the consumer's
assurance that the products has been thoroughly evaluated by the ADA Council
on Dental Therapeutics and has been found to be both safe and effective," said
Dr. Burrell.
Health InfoCom Network News Page 15
Volume 2, Number 33 September 11, 1989
===============================================================================
Articles
===============================================================================
HEART TRANSPLANT PROGRAMS INCREASE TEN-FOLD SINCE 1983;
BUT LACK OF DONORS LEAVES 929 ON WAITING LIST, ACCORDING TO NEW SURVEY
from the American Council on Transplantation
The number of heart transplant programs has increased by more than 10
times since 1983, and yet, the estimated number of patients waiting for a
transplant today is three times what it was in 1986, according to a new
government survey. A report by the Government Accounting Office (GAO)
prepared for Representative Fortney H. Stark (D-Calif.), Chairman of the
House Subcommittee on Health, reported there were 131 hospitals with approved
heart transplant programs at the end of 1988, up from just 12 in 1983.
However, while there were l,529 heart transplants performed in 1988 compared
to 172 in 1983, an estimated 929 patients remained on waiting lists, the GAO
found. The report also revealed 91 of the programs did not perform at least
12 heart transplants, the minimum number recommended by the 1986 Task Force on
Transplantation based on its conclusion there is a "positive relationship
between the number of heart transplants performed and patient outcomes."
However, the task force, recognizing there is a "lack of conclusive evidence"
relating to the number of transplants performed, added "that as data are
collected and analyzed, the appropriateness of this requirement could be
reassessed."
A total of 69 hospitals performed from 1 to 11 transplants while 22 did not
perform any in 1988, the GAO said. The principle reason cited in the report
for the low number of transplants at many hospitals and the long waiting list
is a lack of donors.
Of the 929 patients waiting, 20 percent had been on the waiting list six
months to a year; 10 percent were waiting a year or more; and another 5l5
patients died before a donor could be found, the GAO said. Hospitals surveyed
expressed optimism that recently enacted "required request laws" will
eventually help increase the organ supply.
The average cost of a heart transplant was about $ll5,000 in 1987, according
to the report, and most recipients were found to have private health insurance
that paid for most of the costs. For example, the Blue Cross and Blue Shield
Association reported that as of January 1989 "all but 1 of its 76 member plans
reimbursed for heart transplants" including the cost of immunosuppressive
medications.
Heart transplant patients covered under Medicare presently receive medication
reimbursement for only one-year, but that will change in 1990 when the
recently enacted Medicare Catastrophic Coverage Act of 1988 goes into effect
providing continual reimbursement, according to the report. Hospitals
surveyed estimated the cost of these medications averaged about $6,200 during
the second year after transplantation.
A demographic breakdown of those receiving heart transplants in fiscal
1988, conducted by the United Network for Organ Sharing (UNOS), revealed that
84 percent of transplant recipients were white; 8 percent black; 2 percent
Health InfoCom Network News Page 16
Volume 2, Number 33 September 11, 1989
Hispanic; and 6 percent other groups or their race was unknown, the GAO
reported. Seventy-seven percent of the recipients were male and 61 percent
were over 45 years of age.
(To obtain a complete copy of the report which is entitled Heart
Transplants: Concerns About Cost, Access, and Availability of Donor Organs
(GAO/HRD-89-61) write: U.S. General Accounting Office, Post Office Box 6015,
Gaithersburg, MD 20877. The first five copies of the report are free.
Additional copies are $2.00 each. There is a 25 percent discount on orders
for 100 or more copies mailed to a single address. Orders must be prepaid by
cash or by check or money order made out to the Superintendent of Documents.)
Health InfoCom Network News Page 17
Volume 2, Number 33 September 11, 1989
TISSUE TRANSPLANTS UP IN 1988
DESPITE INCREASED SCREENING FOR INFECTIOUS AGENTS
TO ASSURE SAFE TISSUE PROCURRED
from the American Council on Transplantation
The number of tissues transplanted in 1988 showed small increases in most
categories even though nearly half of the tissues donated were not
transplanted because of increased attention to donor selection criteria which
includes more stringent screening tests for known infectious agents being
implemented around the country, according to Jeanne Mowe, executive director
of the American Association of Tissue Banks (AATB).
The cautious screening takes place because tissue transplantation is an
elective procedure, and there is a responsibility to provide safe tissue, Mowe
explained. Tissue banks consider the tests vitally important to keeping the
public's trust. The new statistics reveal there were 5,200 skin transplants
in 1988 compared to 5,000 in 1987; 300,000 bone deposits in 1988 compared to
250,000 in 1987; 36,900 corneal transplants in 1988 compared to 35,427 in
1987; and 27,000 adult heart valve and 5,000 pediatric heart valves
transplanted in 1988 (1987 figures for heart valves were not available).
The reason the number of transplants did not decrease is due to increased
efficiency during the procurement process, Mowe said. The screening tests
eliminate the poor donor tissue and enhances the quality of tissue that is
obtained. "Tissue referrals are reported up all over the country but we are
constantly adding parameters that eliminate potential donors," Helen Leslie,
RN, director of Organ and Tissue Recovery Services at the Virginia Tissue Bank
(VTB) which is part of LifeNet, added. "For example, we ask 22 questions
regarding the medical and social history of each potential donor and then test
for AIDS, Hepatitis B, Hepatitis Core Antibody and HTLV 1. All must be
negative or the tissue will not be acceptable for us. We also require an
autopsy on all tissue donors."
Leslie noted that the VTB had 20% more donors in 1986 when they would
procure bone tissue from donors as old as 70 years of age. Now they will not
consider a bone donor older than 60 and the result, said Leslie, is greater
quality which in turn enhances the success of the tissue transplant.
Other tissues may be procurred from older donors and have good results,
depending on the overall health the donor, Leslie added. "The ideal donor is a
30-year-old male who was in excellent health and drank lots of milk as a kid,"
Scott Bottenfield, director of Laboratory Services at the VTB, explained.
Depending upon what type of grafts created, that one donor can provide as many
as 40 grafts in addition to the procurement of the solid organs.
In addition, new techniques in peridontal dentistry have created a need
for ground bone which, when transplanted, stimulates new bone growth.
Bottenfield said that one donor can provide as many as 150 to 200 vials of
ground bone weighing 1/4 to 1/2 gram each. Therefore, in reality, one ideal
donor may provide life saving organ transplants, and life enhancing tissue
transplants to as many as 250 different people.
The need for more and more testing to assure safe tissues has made it
increasingly important to properly train the individuals doing the evaluation,
Leslie pointed out. "We must ask the right questions and be assured that no
Health InfoCom Network News Page 18
Volume 2, Number 33 September 11, 1989
marginal donor slips through."
The improvement in graft survival and the technological breakthroughs,
coupled with increasingly stringent testing guidelines have created a rapidly
growing number of people who could benefit from a tissue transplant.
Writing in Foresight, the newsletter of the Eye Bank Association of
America, Tom Moore, EBAA president, summed up the issues surrounding recent
gains in organ and tissue transplantation: "Transplantation, like exploration
in outer space, is relatively new and dramatic. But with each passing year,
each exciting new development in organ and tissue preservation, surgical
procedure, and chemical control of rejection, public awe is replaced by quiet
and confident acceptance of transplantation as a medical therapy that works,
and will work even better in years to come as medical science continues to
perfect its tools and techniques...The critical need is for more organ and
tissue donors."
(To receive a copy of the testing guidelines recommended by the American
Association of Tissue Banks contact: American Association of Tissue Banks,
1350 Beverly Road, Suite 220A, McLean, VA 22101)
Health InfoCom Network News Page 19
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