AIDS and the Corruption of Medical Science
In "Out of Control" (Harper's
Magazine; March 2006), journalist
Celia Farber uses a story about nevirapine, a key drug in the US African AIDS
program, to demonstrate the corruption that can underlie AIDS research. Nevirapine,
developed by Boehringer Ingelheim in the 1990s, is said to reduce the incidence
of AIDS/HIV in infants with HIV+ mothers. Farber says that Canada rejected
nevirapine in 1996 and in 1998 because it showed no effect on HIV viral load
and CD4 counts and because of its toxicity. The FDA, however, gave the drug
conditional approval in 1996, allowing its use in combination with other HIV
drugs. Sloppy research, corporate-friendly government agencies, and AIDS activist
groups that are often partially funded by pharmaceutical companies underlie
nevirapine's continued acceptance even though its actual risk/benefit
HIVNET 012, a National Institutes of Health (NIH)-funded trial is the basis
for nevirapine's acceptance. Originally, this study was designed to be
a Phase III, randomized, placebo-controlled study, involving 1500 Ugandan women
(32+ weeks pregnant) with HIV-1. One arm would receive a dose of nevirapine
at onset of labor, with a single dose given to the infant two to three days
after birth. In a second group, mother and baby would receive AZT. AZT, a DNA
chain terminator, was originally developed as a cancer drug in 1964. At first,
AZT's toxicity kept it from being used. It is now accepted as a means
of preventing maternal-fetal HIV transmission. HIVNET 012 originally included
two placebo groups of 250 women each to act as controls. In actuality, HIVNET
012 evolved into an unblinded comparison of nevirapine and AZT with 626 mother-infant
The Lancet published HIVNET's preliminary
results on September 4, 1999. Early findings said, "Nevirapine lowered the
risk of HIV-1 transmission
during the first 14-16 weeks of life by nearly 50%." Both nevirapine
and AZT were reportedly "'well-tolerated'" with a similar
number of adverse events. Boehringer Ingelheim decided to use the study to
obtain FDA licensing for nevirapine. The company sent a team to Uganda to be
sure that all was in order for an impending FDA inspection. To the company's
dismay, the team reported "loss of critical records" and "serious
non-compliance" with FDA regulations regarding reporting of serious adverse
Because the NIH had funded the study, the Division of AIDS (DAIDS) at the National
Institute of Allergy and Infectious Disease hired its own independent auditor,
Westat. Westat discovered that the researchers had downgraded all serious adverse
events to fit a "local" standard. Farber says that the data was
skewed so that any death that did not occur within a specific time frame either
was not reported or was listed as a "serious adverse event." The
results were further compromised because half the infants were concurrently
enrolled in a study testing the effect of vitamin A on HIV transmission. Studies
have shown that vitamin A supplementation can have a beneficial effect.
Upon learning about these problems, the FDA told Boehringer to withdraw its
application for licensing, or it would be publicly rejected. The company did
so, but DAIDS wrote the study's results in a positive light. Jonathan
Fishbein, director of the Office for Policy in Clinical Research Operations
at DAIDS at the time, asked for whistle-blower protection in March 2004, after
publicly questioning DAIDS continuing support for nevirapine use.
If nevirapine's effectiveness – in comparison to AZT – is
in question, its toxicity is not. PACTG 1022, another NIH study, compared nevirapine
to nelfinavir in pregnant women. The journal JAIDS (July 2004) reports, "'…the
study was suspended because of greater than expected toxicity and changes in
nevirapine-prescribing information." "FDA Public Health Advisory
for Nevirapine (Viramune)," dated January 19, 2005, warns about liver
toxicity. Farber provides other evidence of its toxicity in her Harper's article.
Farber says, "The HIVNET cover-up can only be understood within the larger
political context of AIDS." When AIDS and cancer patients lobbied the
FDA to approve potential treatments more quickly, research guidelines and ethics
were relaxed. The underlying belief is that any new treatment is better than
nothing; but as Richard A. Deyo, MD, and Donald L. Patrick, PhD, explain in
their book Hope or Hype, that is often untrue. Medical research is a major
industry. Richard Strohman, professor emeritus of Biology, University of California-Berkeley,
told Farber: "Before the biotech boom, we never had this incessant urging
to produce something useful, meaning profitable. Everybody is caught up in
it. Grants, millions of dollars flowing into laboratories, careers and stars
being made. The only way to be a successful scientist today is to follow consensus.
If you're going to produce something and put it on the market you don't
want any goddamn surprises. You've got the next quarter to report, and
you don't want any bad news….Science has totally capitulated to
corporate interests. Given their power and money, it's going to be very
hard to work our way out of this."
Farber C. Out of control: AIDS and the corruption of medical science. Harper's
Magazine. March 2006: 37-52.
Lee C. Protection denied in NIH dismissal. The Washington Post.
December 29, 2004: A17. Available at www.whistleblowers.org/html/nih_drug_safety.html.
March 20, 2006.
Antibiotic Therapy & HIV in Africa
The antibiotic co-trimoxazole (trimethoprim-sulfamethoxazole)
is being used to reduce mortality attributed to AIDS in Africa. Co-trimoxazole
used to prevent and treat Pneumocystic carinii pneumonia, an opportunistic
infection that affects those in the early stages of immune suppression. Its
benefit for Africans with HIV, however, is not restricted to those with pneumonia.
Clinical trials in Côte d'Ivoire during the 1990s demonstrated
that prophylactic use of the antibiotic reduced hospital admission rates
for HIV-infected African adults with high CD4 cell counts and reduced death
rates among HIV-infected adults with pulmonary tuberculosis. The researchers
credited the benefits to reductions in bacteria infections, malaria, and
isosporiasis (a parasitic infection caused by a protozoa, genus Isospora).
This study led to a recommendation to use the antibiotic prophylactically
throughout Africa with one reservation: the authors were uncertain about
co-trimoxazole's effect in regions with high levels of bacterial resistance
to the drug.
A large study, published in The Lancet (November
20, 2004), confirmed that co-trimoxazole prophylaxis was beneficial in Zambia,
an area with high levels
of in-vitro bacteria resistance. The researchers tested the HIV status of 851
children with symptoms linked to HIV infection, such as lymphadenopathy, hepatosplenomegaly,
failure to thrive, recurrent pneumonia, oral candida, and parotitis. They obtained
parental consent to enroll 541 of the 699 HIV-positive children between March
14, 2001 and January 8, 2003. The researchers found that the group receiving
a daily dose of co-trimoxazole had 23% fewer hospital admissions and 43% fewer
deaths than the control group that took a placebo. Because of the marked benefits,
the data and safety monitoring committee recommended stopping the trial early
(October 2003) so that children in the placebo group could also receive the
As in the earlier Cô/te d'Ivoire study, those involved in the Zambian
trial cannot attribute co-trimoxazole's benefits solely to its effect
on P. carinii pneumonia. In fact, the Zambian researchers were unable to confirm
a single case of P. carinii among the participants who received the antibiotic.
Co-trimoxazole apparently affects fungal, parasitic, and malarial infections
as well as bacterial infections. The study's authors hope that co-trimoxazole
prophylaxis, along with nutritional support, will be given to all African children
with symptoms of HIV infection. Co-trimoxazole costs $7 to $12 per child for
one year's treatment.
Chintu C, Bhat GJ, Walker AS et al. Co-trimoxazole as prophylaxis against opportunistic
infections in HIV-infected Zambian children (CHAP): a double-blind, randomized,
placebo-controlled trial. The Lancet. November
20, 2004;Vol 364:1865-1871.
Coghlan A. Cheap antibiotic slashes AIDS-related deaths. NewScientist.com (online)
Available at www.newscientist.com/article.ns?id=dn6692& print=true. Accessed
at February 28, 2006.
Cannabis & AIDS
Cannabis Therapeutics in HIV/AIDS, edited by Ethan Russo, MD, profiles the
risks and benefits of medicinal marijuana use for people with AIDS. In the
US, about one-third of people who are HIV+ or have AIDS use cannabis for
therapy, according to anonymously published surveys. Smoking marijuana quickly
relieves nausea and vomiting. In addition to its antiemetic effect, marijuana
stimulates appetite, making it very helpful for those with AIDS-wasting syndrome.
This common manifestation of AIDS involves an involuntary weight loss of
more than ten percent of body weight along with fever, diarrhea, and/or fatigue
for over 30 days.
In 1992, the FDA approved a synthetic version of THC, one of the cannabinol
found in marijuana. This Schedule III drug, Dronabinol, stimulates appetite;
but since it is taken orally, the patient has to be able to keep from vomiting
it up. Even when retained, Dronabinol works more slowly than inhaled marijuana.
It also has more side effects, and the effective dosage is more difficult to
control than inhaled marijuana. Dronabinol is also quite expensive.
The one well-confirmed drawback of inhaled marijuana is respiratory damage.
A single marijuana cigarette contains four times the tar of a tobacco cigarette
with the same weight. Smoking an average of three to four joints per day causes
extensive tissue abnormalities in respiratory tissue, equivalent or greater
than that found in someone who smokes 22 tobacco cigarettes per day. In addition
to possible respiratory damage, some cannabis is contaminated with bacteria
and fungi such as Aspergillus and Klebsiella pneumoniae, providing additional
hazards for the immune-compromised.
In his chapter, "Harm Reduction Associated with Inhalation and Oral Administration
of Cannabis and THC," Franjo Grotenhermen offers several strategies for
reducing the risks associated with smoking marijuana. The first is to use a
cannabis strain with a high THC content. The higher the THC content, the fewer
puffs required for relief of symptoms. Studies with HIV/AIDS patients have
found that daily doses of 2.5-20 mg have effectively relieved nausea, vomiting,
and undesired weight loss. One puff of a joint with a ten percent THC content
provides about 5 mg of THC. A high-quality source of cannabis, free of contaminants,
is essential for those using it medically. Even so, patients are warned against
holding their breath after inhaling because the practice increases the likelihood
of respiratory damage and does not increase cannabis' effect. Grotenhermen
also recommends the use of pipes or other inhalation devices that reduce tar
intake. California NORML (National Organization to Reform Marijuana Laws) and
the Multidisciplinary Association for Psychedelic Studies (MAPS) have researched
the use of an electric vaporizer that heats cannabis just short of combustion.
This releases the THC while substantially reducing toxins freed at higher temperatures.
To further reduce the risk of smoking marijuana, Grotenhermen suggests alternating
between eating it and inhaling. Oral dosing with marijuana, however, is difficult
because so many factors affect absorption, and doing so has a delayed effect.
Eleven states have medical marijuana laws: Alaska, California, Colorado, Hawaii,
Maine, Montana, Nevada, Oregon, Rhode Island, Vermont, and Washington. These
laws regulate the medical use of marijuana and prohibit state and local officials
from arresting medical marijuana patients and their providers and from seizing
their marijuana plants. The US Supreme Court, however, upheld the federal government's
authority to seize plants and prosecute medical marijuana users and providers
in these states in its decision on June 6, 2005, concerning Gonzales v. Raich.
This decision maintains the status quo: states have a right to regulate medical
use, and the feds have the right to regulate practices that may affect interstate
commerce. Activists are working for federal legislation that would prohibit
the use of federal money to prosecute those medical marijuana users who follow
their state laws.
Marijuana Policy Project. US supreme court rules on medical marijuana. Available
at www.mpp.org/raich/ Accessed March 6, 2006.
Russo E. Cannabis Therapeutics in HIV/AIDS.
Binghamton, New York: The Haworth Integrative Healing Press; 2001.
How accurate are HIV tests? Rodney Richards, PhD, an organic chemist who worked
on HIV testing for the biotech company Amgen (formerly known as Applied Molecular
Genetics) says the Enzyme-Linked Immunosorbent Assay (ELISA), Western Blot,
p24 antigen, and PCR and branch DNA (bDNA) viral load tests are hampered
by the lack of a "gold standard." HIV has never been directly
isolated in such a way that manufacturers can prove that a positive test
result means that the virus is present in a sample.
ELISA and Western Blot look for antibodies, not a specific virus. In his
interview for Zenger's Newsmagazine (2001), Richards acknowledges the work
writer Christine Johnson, who identified over 60 factors that can cause false-positives
in these tests. Antibodies to herpes, hepatitis, and malaria, and conditions
such as pregnancy or having a flu vaccination can produce a positive result.
Richards says that "every diagnostic test for any germ that's based
on antibodies has the same problem. It's a well-recognized problem attributed
to what's known as 'cross-reactivity.' In other words, antibodies
to germ A may coincidentally react to germ B."
If the ELISA test is positive, US standard of care recommends testing with
the Western Blot. The Western Blot consists of a series of proteins, believed
to be unique to HIV, on a strip. If antibodies stick to the protein, that band
can be seen. If the Western Blot gives a negative result, the ELISA results
are discounted as a false positive. These proteins, however, may not be so
unique. In an article for Alive and Well (May 2004), Matt Irwin, MD says that
gp24, which is the protein most often used as definitive evidence of HIV, has
been found in people with other conditions, including people with generalized
warts, cutaneous T-cell lymphoma, and multiple sclerosis.
In the early days of HIV testing, at least 50% of healthy blood donors who
tested positive on ELISA also had antibodies that triggered one or more bands
on the Western Blot, according to Richards. Various health and government institutions
selected banding patterns that "minimized the numbers of blood donors
testing positive and maximized the numbers of people in risk groups testing
positive." Criteria for a positive HIV result on the Western Blot – which
is considered more reliable than the ELISA – varies from country to country
and, sometimes, from agency to agency within the same country. Richards says
manufacturer inserts for HIV tests make no claims that the results correlate
with the actual presence of HIV. The package insert for Roche Diagnostic Systems' Amplicor
HIV-1 Monitor Test Kit (June 1996) reads: "The Amplicor HIV-1 Monitor
test is not intended to be used as a screening test for HIV or as a diagnostic
test to confirm the presence of HIV infection." Genetics Systems ELISA
package insert (2000) reads: "The risk of an asymptomatic person with
a repeatedly reactive serum sample developing AIDS or an AIDS related condition
is not known." Cambridge Biotech Western Blot package insert (1998) says, "The
clinical implications of antibodies to HIV-1 in an asymptomatic person are
not known." Yet, life and death decisions are based on the accuracy of
PCR (polymerase chain reaction) and related tests (QC-PCR and the branched
NDA test) are used to measure viral load, a technique for monitoring AIDS progression.
PCR replicates a tiny segment of DNA until a million copies exist. Researchers
believe that the bits of DNA (not intact viral particles) that they are replicating
belong to HIV. Irwin points to studies that show high viral load numbers often
do not correlate with any sign of an active, infectious virus. Science writer
Christine Johnson says, "As it stands right now, bDNA uses QC-PCR as
a gold standard; QC-PCR uses regular PCR as a gold standard; regular PCR uses
antibody tests as a gold standard; and antibody tests use each other. I have
noticed time after time that studies which are 'verifying' an HIV
antibody test will invariable state that they evaluated the performance of
their test on samples which are known to be TRUE-POSITIVE or TRUE-NEGATIVE.
How did they know this? It's simple: Without a gold standard, they didn't."
Conlan MG. Rodney R. Why the "HIV tests" can't tell you whether
you have HIV. Zenger's Newsmagazine. 2001. Available at www.healtoronto.com/rodney_richards2.html.
Accessed on March 6, 2006.
Irwin M. Questions on HIV-antibody tests. (reprinted from VirusMyth.net,
edited and updated for Alive & Well, May
2004) Available at www.aliveandwell.org/html/questioning/questions_hiv_antibodies.html.
Accessed on April 5, 2006.
Johnson C. Viral load and the PCR. Continuum. November 2001. Available at www.virusmyth.net/aids/data/chjtests5.htm.
Accessed on March 11, 2006.
Learning Immune Function Enhancement
Learning Immune Function Enhancement (L.I.F.E.), a San Diego-based program
for people living with HIV, addresses factors known to strengthen and weaken
the immune system. The program includes basic body care. It emphasizes a
need for full, relaxed breathing, restful sleep, moderate exercise, and good
nutrition along with drinking enough water. It also encourages participants
to avoid alcohol, cigarette smoking, risky sexual behaviors that lead to
repeat infections, and unnecessary exposure to toxins and drugs (including
antibiotics and steroids), which wear down the immune system. L.I.F.E. also
draws on research that has identified several immune-boosting psychological
and social factors.
Psychological factors have a powerful effect on immune response. The very
first co-factor listed on L.I.F.E.'s web site (www.shanti.org/life/cofactors.html)
is "Belief about HIV Disease and Health Progression." Beliefs – whether
conscious or unconscious, accurate or inaccurate – affect emotions. The
body responds to emotions with a cascade of hormones and neurotransmitters.
Emotional states, especially unresolved grief and depression, can suppress
the immune system. Survival stress (the body's response to perceived
threats to safety or security) is also detrimental if it continues over the
long term. Continual worries about housing, finances, and other basic needs
are one source of sustained stress. Learning coping skills to deal with life
events helps to mitigate stress. Focusing on positive, personally cherished
goals is another antidote to stress. Such goals can give meaning to life and
support the will to live. "Research shows that long-term survivors of
an AIDS diagnosis typically have clear life goals and pursue them with action," according
to L.I.F.E.'s web site.
Social relationships are another key. The immune system thrives on having at
least one relationship that feels safe and supportive. Another key immune-enhancer
is self-assertion, "the ability to ask clearly for what you want and
to say no to what you don't want." L.I.F.E. says that having good
communication and a sense of collaboration with health care providers is another
way to promote immune and overall health. The life-enhancing feeling of connection
to others can be expanded through volunteer work and acts of altruism and through
spirituality. L.I.F.E. defines spirituality as "an appreciation of the
interconnectedness of life and a desire to be part of something larger than
yourself." In addition to teaching people how to include these immune-enhancing
co-factors in their lives, L.I.F.E. is collecting data on its program. The
California State Office of AIDS and the CDC have given L.I.F.E. grants to conduct
a clinical trial on the program's effectiveness in boosting immunity
and reducing risky behaviors.
Wilson JJ. Boosting your immune response – helpful suggestions. (Excerpted
from Lilipoh). Available at http://www.healthy.net/scr/Article.asp?Id=718.
Accessed on March 1, 2006.
of Maitake Mushroom ß-glucan
Supplements derived from the Maitake mushroom (Grifola frondose) can stimulate
the immune system, according to a mouse study in the peer-reviewed Journal
of the American Nutraceutical Association (2005;8(3)). The study compared Grifton-Pro
Maitake D Fraction (MDF), a highly-purified ß-glucan; Maitake Gold 404,
a ß-glucan-protein complex (MTG); and lentinan, a well researched, mushroom-derived
glucan that acted as a control. Beta glucans have been isolated from yeast,
mushrooms, and seaweed. Their effect on the immune system has been the subject
of numerous studies.
In this study, mice received MDF, MTG, or lentinan orally or by injection (intraperitoneal)
at different doses. The researchers looked at several markers, including monocyte
levels, phagocytosis (the digestion of foreign substances and bacteria by monocytes),
T-cells, Interleukin-1 (IL-1), Interleukin-2 (IL-2), tumor necrosis factor-a
(TNF-a), and apoptosis. They learned that the Maitake-derived supplements have
several effects on the immune system. Oral doses of MDF, MTG, and lentinan
(100 µg of glucan/mouse for 14 days) produced "significant stimulation
of phagocytosis." Injected delivery of MTG and MDF had a somewhat greater
effect. MTG stimulated phagocytosis at injected levels as low as 2.6 µg/mouse.
Lentinan required doses of at least 50 µg for a significant effect, and
MDF required at least 100 µg before a significant result occurred. IP
injections of the Maitake-derived supplements also significantly increased
the number of CD4-positive cells. (CD4 cells are T-cells that carry CD4 glycoprotein
on their surface. They help produce the antibodies that make IL-2, a protein
with several immunologic functions that include increasing activated T-cell
levels.) Injected lentinan and injected MDF produced significantly higher levels
of IL-2 than the control, Concanavalin A. Concanavalin-A is used in immunology
to stimulate T-cell production. MTG was slightly less effective than Concanavalin-A.
MTG and MDF, administered by injection, resulted in higher levels of IL-1ß secretion
than lentinan produced. The elevations appeared within 30 minutes. Interleukin-1ß enhances
the growth and differentiation of phagocytic ß cells. The researchers
found little effect on TNF-a production (tumor necrosis factor-a). They also
found no apoptosis (cellular self-destruction) among breast, lung, or prostate
cancer cells when exposed to these glucans.
Vetvicka V, Vetvickova J. Immunostimulating properties of two different
b-glucans isolated from maitake mushrooms (Grifola frondose). JANA.
2005; 8: 33-39. Available
at www.ana-jana.org/members/journals/JANAVol_91.pdf. (Note:
5.6 MB .pdf. Huge file. Suggest you right click and download to your hard
rather than wait for it to load in your browser.) Accessed on February
Massage & the
Massage therapy is known to relax skeletal muscle, increase blood and lymph
circulation, and reduce anxiety. Within the last five years, researchers
have begun investigating its effect on immune function in several small studies.
A study, reported in Psychosomatic Medicine, found that a one-hour massage
increased white blood cell count and natural killer cell activity in nine
healthy, first- and second-year female medical students (age range 21-25).
The students were anxious about an academic exam, scheduled for the day after
the massage. Standard Swedish massage strokes of light to moderate pressure,
designed to encourage relaxation and increase circulation, were used. This
study showed no significant change in the number of T-cells. Three other
studies look at the effect of massage on HIV+ people. A small study by G.
Ironson and T. Field (International Journal of Neuroscience. 84:205-217)
had two cohorts. In the first cohort, ten HIV+ and ten HIV- men received
a 45-minute massage (set protocol) each day for one month. The second cohort
of 13 HIV+ men also received a 45-minute massage each day for a month. These
men were then studied for an additional month during which they received
no massages. Blood draws, 24-hour urine collections, and saliva samples,
as well as psychological questionnaires to measure anxiety and mood, were
completed before the first massage and after the last massage. Results showed
a significant decrease in anxiety and cortisol levels after massage. Also,
relaxation significantly increased as did natural killer cell activity and
A study in the Dominican Republic compares the immune response of HIV+ children
(aged two to eight) who have massage therapy to those enjoying a friendly visit
(control). Children in the massage group had 20-minute sessions with a massage-trained
nurse, twice a week, for 12 weeks. Children in the control group spent an equal
amount of time visiting (i.e., reading, talking, playing quiet games) with
a nurse. Blood was drawn before the first session and at the end of the 12
weeks. "Children in the control arm had a greater relative risk of CD4
count decline (>20%) than massage-treated children (RR=5.7, p=0.03). Lymphocyte
loss was also more extensive in the controls (p<0.02), and more of the control
group than the massage group lost >50 CD8 lymphocytes (p=0.03)."
A third study divided 42 HIV+ people into four groups. One group received a
45-minute overall body massage once per week. The second group also received
a weekly massage and engaged in supervised aerobic exercise on two other days
each week. The third had a weekly massage plus a weekly session of bio-feedback
stress management, and the fourth acted as a control. Researchers measured
peripheral blood levels of CD4+ lymphocytes, CD8+ lymphocytes, CD4+/CD8+ lymphocyte
ratio, and natural killer cells. Participants also completed a quality-of-life
assessment. The researchers found no significant change in lymphocyte or natural
killer cell levels for any group. However, the group that had a weekly massage
and biofeedback stress management used significantly fewer health care services
and had a more favorable perception of their own health. It would be interesting
to see if the massage-biofeedback combination is more effective than biofeedback
by itself. The lack of effect on immune factors in this study makes me wonder
if the type of massage or the addition of a second session per week are factors.
Birk TJ, McGrady A, MacArthur RD, Khuder S. The effects of massage therapy
alone and in combination with other complementary therapies on immune system
measures and quality of life in human immunodeficiency virus (Abstract). J
Altern Complement Med. 2000 Oct; 6(5):405-14.
Shor-Posner G, Miguez MJ, Hernandez-Reif M, Perez-Then E, Fletcher M. Massage
treatment in HIV-1 infected Dominican children: a preliminary report on the
efficacy of massage therapy to preserve the immune system in children without
antiretroviral medication (Abstract). J Altern Complement
Med. 2005 June;11(3):393-4.
Stark T. Massage therapy is associated with enhancement of the immune system's
cytotoxic capacity. Available at http://medicine.wustl.edu/~compmed/research/mas00.html.
Accessed on February 28, 2006.
Zeitlin D, Keller SE, Shiflett SC et al. Immunological effects of massage therapy
during academic stress. Psychosomatic Medicine. 2000; 62:83-84.
Vitamin Therapy for African Women
Vitamin therapy delays the progression of AIDS in African women, according
to a New England Journal of Medicine study (July 1, 2004). Researchers enrolled
1078 HIV-positive, pregnant women in Dar es Salaam, Tanzania, over a two-year
period starting in April 1995. The women were randomly assigned in blocks
of 20 to one of four groups. The first group received vitamin A (30 mg of
beta carotene, plus 5000 IU of preformed A). The second took a multivitamin
without vitamin A, consisting of 20 mg of vitamin B1, 20 mg of vitamin B2,
25 mg of vitamin B6, 100 mg of niacin, 50 µg of vitamin B12, 500 mg
of vitamin C, 30 mg of vitamin E, and 0.8 mg of folic acid. The third group
received the multivitamin with vitamin A in doses listed above, and the fourth
took a placebo. In addition, all women received standard doses of antenatal
folic acid and iron. Women in the two groups receiving vitamin A were given
an additional oral dose of vitamin A (200,000 IU) at delivery. All women
who became pregnant after May 1998 were given open-label multivitamins throughout
pregnancy because of its marked effect on reducing adverse outcomes. They
returned to their assigned regimen after delivery.
Although Tanzania's standard of care recommends that children receive
a dose of vitamin A every six months, trial results showed that maternal vitamin
A supplementation increased HIV transmission to children. The study's
data and safety monitoring board recommended that vitamin A be discontinued
from the trial regimen in September 2000.
The researchers note in their article, "Among
HIV-infected US men, the relationship between vitamin A intake and HIV disease
progression and mortality was U-shaped, suggesting that both low and high levels
of intake are potentially harmful."
The group that received multivitamins had higher CD4+ levels and significantly
lower viral loads than those on placebo. (Vitamin A combined with the multivitamin
was less effective.) Women taking the multivitamin had less fatigue, fewer
acute upper respiratory tract infections, fewer rashes, and fewer oral and
gastrointestinal problems associated with HIV/AIDS. These women were also less
likely to reach WHO stage 4 or die of AIDS-related illness than those taking
a placebo. I wonder if the inclusion of minerals known to support the immune
system (i.e., selenium, zinc) in the multivitamin formula would increase this
benefit. Retail prices for a year's supply of the multivitamins used
in the trial average about $15 per person.
Fawzi WW, Msamanga GI, Spiegelman D et al. A randomized trial of multivitamin
supplements and HIV disease progression and mortality. NEJM. 2004; 351(1):
23-32. Available at http://content.nejm.org/cgi/content/full/351/1/23. Accessed
on February 28, 2006.
Nano S. Vitamins found to slow AIDS in African women. The
NC). July 1, 2004; A8.