DEPARTMENT OF HEALTH AND HUMAN SERVICES
The Secretary of Health and Human Services
Washington, D.C. 20201
July 10, 1995
The Honorable Gil Gutknecht
House of Representatives
Washington, D.C. 20515-2301
Dear Mr. Gutknecht:
Thank you for your letters to me and senior officials of the Public Health
Service requesting responses to twelve questions relating to HIV and AIDS. I
apologize for the delay in responding.
Enclosed is a detailed response to each of your questions and supplemental
material from published reports discussing HIV as the causative agent of
AIDS.
I hope this information is helpful to you.
Sincerely,
Donna E. Shalala
Enclosures
Response to Questions from Congressman Gil Gutknecht
Question
1. I am told that:
a) there is not a single documented case of a health care worker (without
any other AIDS risk) who contracted AIDS from the over 401,749 American AIDS
patients in 10 years;
b) the partner of AIDS patient Rock Hudson, the wife and 8-year old daughter
of late AIDS patient Arthur Ashe, as well as the husband of the late AIDS
patient Elizabeth Glaser are HIV and AIDS-free:
What is the scientific proof that AIDS is contagious?
Response
Regarding health care workers with AIDS, through December 1994, the Centers
for Disease Control and Prevention (CDC) had received reports of 42
documented and 91 possible occupationally acquired cases of HIV
infection/AIDS among health care workers in the United States. Of the health
care workers with documented HIV seroconversions after occupational exposure,
38 had exposures to blood from an HIV-infected person, 1 to visibly bloody
fluid, 1 (sic) to an unspecified fluid, and 2 to concentrated virus in a
laboratory. The health care workers with possible occupationally acquired
AIDS /HIV infection have been investigated and are without any other
identifiable behavioral or transfusion risks.
Regarding scientific proof that AIDS is contagious, before the discover of
HIV, evidence from epidemiologic studies involving tracing of patients' sex
partners and cases occurring in blood recipients clearly indicated that the
underlying cause of the condition was in infectious agent. Infection with
HIV has been the sole common factor shared by AIDS cases throughout the world
among homosexual men, transfusion recipients, persons with hemophilia, sex
partners of infected persons, children born to infected women, and
occupationally exposed health care workers.
Although HIV is the underlying cause of AIDS, much remains to be known about
exactly how HIV causes immune deficiency. However, this incomplete
understanding does not indicate that the virus is harmless. Why some persons
exposed to HIV become infected while others do not is also not known, but
this is likely related to the amount of virus in the exposure and the route
of entry (e.g., more than 90 percent of persons transfused with an
HIV-infected unit of blood become infected).
Question
2. Is there any study showing that HIV-positive American men or women--who
are not on recreational drugs, or AZT, or received transfusions--ever got
AIDS from HIV? Are there any documented cases of tertiary heterosexual AIDS
transmission: AIDS transmitted to a non-risk group heterosexual who in turn
transmits AIDS to another non-risk group heterosexual?
Response
A copy of the CDC HIV/AIDS Surveillance Report is enclosed. Thousands of
cases of AIDS have been reported in children as well as in adults, who report
no behavioral or transfusion risk. No patient received AZT prior to the
mid-19080s when this medicine was developed, when many AIDS cases had already
been reported. CDC does not track "tertiary heterosexual AIDS transmission,"
but heterosexual transmission of HIV is increasing in the United States.
Question
3. After more than ten years of intensive research and over 100,000 papers
published on HIV/AIDS, is there a study that proves that HIV is the cause of
AIDS?
Response
Yes. Prospective and retrospective cohort studies in San Francisco and
Africa have shown that HIV causes AIDS.
Question
4. How do you explain HIV-free AIDS cases (I am told there are over 4,621 on
record) beyond renaming the 'ICL'?
Response
CDC developed an AIDS surveillance case definition to monitor severe
opportunistic infections and other illnesses occurring in persons with HIV
infection. Although these conditions are highly specific to HIV, in rare
instances they can appear in persons with other causes of immune suppression.
A person who is not infected with HIV and who does not have immune
suppression has an extremely low risk of developing these symptoms. over the
last decade, only about 100 cases of opportunistic infections with immune
deficiency have been identified in the United States in persons without HIV
or other known causes of immune deficiency, such as chemotherapy. Idiopathic
CD4+ T-lymphocytopenia (ICL) differs from HIV infection both immunologically
and epidemiologically. There is no evidence in the immunologic or
viral-culture studies performed in these patients or about their family
members or blood donors to suggest that a transmissible agent causes this
condition. Please refer to the enclosed journal articles which detail the
extensive scientific investigation of this topic.
Question
5. If infectious HIV is the cause of AIDS, why is Kaposi's sarcoma--the
signal disease of AIDS--exclusively observed in male homosexuals?
Response
The cause of Kaposi's sarcoma appears to be a newly described herpes-like
virus; the tumor is much more common in person with severe immunodeficiency
such as that caused by HIV infection. While most cases have been reported
among men who have sex with men, cases have been reported among women and
among men who acquired HIV infection through exposures other than
male-to-male sexual contact. In addition, Kaposi's sarcoma has also long
been recognized among elderly men of Italian or Ashkenazi Jewish descent and
among the Bantus of Southern Africa, before the emergence of AIDS.
Question
6. Why are there long-term survivors (12-15) years of HIV? (Is there
medical precedent for a fatal virus with such a long latency period>) Are
long term survivors generally people who do not use recreational drugs and
AZT?
Response
Approximately half of the HIV-infected adults develop AIDS within 8 to 10
years of infection with HIV, while others are diagnosed after that period.
As with any disease with a long and variable period between infection and
illness, it is possible that other factors may play a role in disease
development. Extensive epidemiologic and laboratory studies of HIV-infected
persons have failed to identify any consistent factor, including drug use,
malnutrition, or coinfections with other organisms, that reliably accounts
for the rapid or slow development of AIDS. Some individuals effectively
combat this viral illness for a longer period of time than others.
Question
7. How does the medical community explain the fact that the median life
expectancy of American hemophiliacs has increased from 11 in 1972 to 27 in
1987, although 75% were infected by HIV in the decade before 1984?
Response
The life expectancy of persons with hemophilia has increased primarily due to
the availability of safe clotting factor products. Actually, for persons
with hemophilia, deaths decreased in the 1970s and early 1980s and increased
tremendously during the late 1980s and 1990s, as affected persons moved into
the later stages of HIV disease.
In the last several years, the number of AIDS cases resulting from recent
receipts of HIV-infected blood or blood components has declined. This
decline represents the virtual elimination of this route of transmission by
routine screening of blood donors for HIV antibody, which was begun in 1985.
This absence of AIDS cases associated with screened transfusions is, in
itself, remarkable proof that preventing HIV infection can prevent AIDS.
Question
8. Can federal efforts ignore the theory that recreational drugs and AZT
cause AIDS considering that 30% of all American AIDS patients are intravenous
drug users, and that nearly all others are users of oral recreational drugs
and/or AZT, ddI or ddC?
Response
Scientists the world over consider objective evidence the standard by which
theories are judged. There is no evidence that injecting drug use alone with
uncontaminated equipment results in infection with HIV or AIDS. There is
also no evidence that oral recreational drugs are causative agents of HIV
infection in nearly 15 years of studying HIV and AIDS. AIDS was discovered
many years before the introduction of zidovudine (AZT, didanosine (ddI), or
zalcitabine (ddC). The overwhelming evidence indicates that HIV causes AIDS
and that use of contaminated equipment for injection of drugs is one major
route of transmission of HIV.
Question
9. Considering that there is little scientific proof of the exact linkage of
HIV and AIDS, is it ethical to prescribe AZT, a toxic chain terminator of DNA
developed 30 years ago as cancer chemotherapy, to 150,000 Americans--among
them pregnant women and newborn babies--as an anti-HIV drug?
Response
The scientific evidence linking HIV and AIDS is overwhelmingly convincing.
AZT is an antiviral compound that has clearly been shown to reduce perinatal
transmission of HIV by about two-thirds. Scientific studies have shown that
AZT benefits patients who have AIDS as well as HIV infection. Failure to
make this treatment available to HIV-infected pregnant women and other
individuals with HIV disease would be unethical.
Question
10. Is there any scientific precedent of a virus causing an autoimmune
disease? What do Kaposi sarcoma, lymphoma, dementia, cervical cancer, and
wasting disease have to do with immune deficiency? If HIV never claims more
than one out of 1,000 cells every other day and the body replaces at least 30
out of 1,000 during the same period, how does HIV damage the immune system?
Response
Kaposi's sarcoma, lymphoma, and cervical cancer are manifestations of an
inadequate immune response which is hastened by HIV-related immunodeficiency;
dementia results from a direct effect of HI
V on the CD4-containing glial cells of the central nervous system; wasting
disease is due to compromise of the epithelial cells of the gut which are
normally loaded with CD4, impairing their ability to absorb nutrients. When
the immune system is missing one or more of its components, the result is an
immunodeficiency disorder. Temporary immune deficiencies can develop in the
wake of common viral infections, including influenza, infectious
mononucleosis, and measles. Immune responses can also be depressed by blood
transfusions, surgery, malnutrition, and stress. AIDS is an
immunosuppressive disease, not an autoimmune disease, as it is caused by a
virus that infects immune cells. HIV infects a great many of the host's
cells. Recent evidence from two laboratories shows that HIV rapidly kills
large numbers of vital lymphocytes every day, paving the way for a variety of
immunologic shortcomings. There appears not to be any true "latent" period.
The precise mechanism of cell death following HIV infection remains a topic
for research.
Question
11. In how many American AIDS cases was HIV actually found? How many
presumptive diagnoses of HIV have been recorded? Do HIV antibody tests
cross-react with other microbes, viruses, vaccines or other natural or
artificial substances?
Responses
Evidence of HIV infection is found in virtually every AIDS patient who is
tested. The presence of HIV antibody is the primary criteria (sic) that
clinicians look for when diagnosing persons with HIV disease.
The currently licensed tests are among the most accurate diagnostic tests
available in the field of medicine. HIV infection is diagnosed based on the
detection of antibodies to HIV in the patient's serum. The complete test
includes several steps: the screening enzyme immunoassay (EIA) test and a
confirmatory test such as Western blot or immunoflourescence. These assays
are highly sensitive and specific tests. For a postive result, a specimen
must be shown to be reactive on tow or more EIAs as well as the confirmatory
test used. Use of this approach to HIV detection yields nearly 100%
predictability.
There are instances of false positives with the screening (or EIA) tests, but
these should be resolved using the confirmatory assays. No presumptive
diagnoses of HIV infection are accepted. The most common cause of EIA
false-positive results is increased levels of autoantibodies, such as
rheumatoid factor or antinuclear antibodies. These occur mainly in patients
with autoimmune diseases such as lupus or rheumatoid arthritis.
Question
12. Considering the history of the HIV=AIDS hypothesis and its inability to
come up with a cure, vaccine or effective treatment for AIDS in the past ten
years, how much money has been spent by government agencies on
alternative-hypothesis AIDS research (i.e. Duesburg (sic), Root-Bernstein,
Lo)?
Response
>From 1981 through 1983, the risk factors and cause of AIDS were sought.
Since that time, most research has focused on HIV because the scientific
evidence so clearly indicates that it causes AIDS. CDC and NIH did
exhaustive research on the ICL cases and found that they were not linked with
AIDS or HIV or one another. AIDS prevention programs continue to be based on
our understanding of scientifically defined HIV transmission modes because
prevention of AIDS is prevention of HIV. To deviate funds from
scientifically sound findings to those that lack evidence would be
unconscionable. The ICL investigation is an example of a study that would
have detected causes of AIDS other than HIV, if they were to exist. WE
estimate that $850,000 was expended on the investigation of ICL, of which
$585,000 were laboratory costs.
©COPYRIGHT, AIDS Authority; reprinted with permission