Harvard Study: Multivitamins Effective in Thwarting AIDS progress

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> JustSayNo

> Thu, 08 Jul 2004 02:47:57 -0000

> [sSRI-Research] Harvard Study:

> Multivitamins Effective in Thwarting AIDS progress

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

>

> A report in the New England Journal of Medicine may

> be the first

> serious challenge to the current accepted treatment

> of people

> infected with the HIV-virus. Those expensive and

> toxic cocktails of

> AIDS drugs may not be the only life-saving treatment

> as has been

> claimed. Scientists from the Harvard School of

> Public Health, who

> conducted a large multi-vitamin trial in 1,078

> pregnant women in

> Tanzania between 1995 and 1997. Follow-up was

> provided until August

> 2003.

>

> The New York Times, Washington Post report that the

> Tanzania study

> found that of the women who received the

> multivitamins 30% fewer died

> or progressed to full AIDS during the study than a

> group of women

> receiving a placebo. " The counts of CD-4 cells, the

> immune system

> cells that the virus attacks, stayed somewhat higher

> in the group

> that took multivitamins. That group also had fewer

> incidents of

> thrush, throat ulcers, inflamed gums, nausea,

> rashes, fatigue and

> other debilitating side effects. "

>

> An editorial praises the study design. However, we

> question the

> study for failing to follow ethical research

> standards-as mandated by

> the Declaration of Helsinki. Why did this

> experiment-which was, no

> doubt approved by an institutional ethics review

> board (IRB)--fail to

> test the experimental multi-vitamin treatment

> against standard AIDS

> treatment? Could it be that they feared what the

> results might be?

>

> Nevertheless, these Tanzania findings may, at last,

> break the iron

> triangle of pharmaceutical / medical / government

> research

> stakeholders who have set the treatment agenda for

> HIV-infected

> persons-including children and babies. If a regimen

> of cheap, readily

> available multi-vitamins was effective in reducing

> death rates and

> was accompanied by far fewer debilitating side

> effects, it will be

> difficult to justify current US AIDS treatment

> guidelines that focus

> entirely on expensive, multi-drug regimens.

>

> The Times reports that: " Three years ago, Dr. Andrew

> Tomkins of the

> Institute for Child Health in London gave

> multivitamins or placebos

> to 481 H.I.V.-infected men and women in Thailand.

> Although Dr.

> Tomkins followed the patients for less than a year,

> the group taking

> vitamins had " significantly " lower mortality,

> especially among those

> whose immune systems were weakest, he said. "

>

> The Alliance for Human Research Protection (AHRP)

> believes that these

> findings provide compelling confirmation for our

> concerns that some

> disadvantaged children diagnosed with HIV may have

> been victimized in

> experiments that subjected them to an array of toxic

> experimental

> AIDS drugs and vaccines in government sponsored

> clinical trials.

> See: New York Post

> http://www.ahrp.org/infomail/04/02/29.html

>

> A letter of complaint by AHRP, March 10, 2004, to

> the FDA and the

> Office of Human Research Protection, focused on the

> ethics of using

> foster care children in AIDS drug experiments--

> inasmuch as they have

> no parents to protect them or to refuse consent to

> research. These

> findings add an important dimension to our complaint

> which is:

> What justification is there for putting children

> through the misery

> of debilitating AIDS drug side effects-when a benign

> alternative

> treatment exists?

>

> The letter of complaint to the FDA and OHRP has

> prompted two federal

> investigations.

> See: http://www.ahrp.org/ahrpspeaks/HIVkids0304.html

>

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

>

>

----

> -

>

http://www.nytimes.com/2004/07/01/health/01AIDS.html?

> ex=1089259200 & amp;en=38

> 073c5c00fb4877 & amp;ei=5062 & amp;partner=GOOGLE

> July 1, 2004

> Daily Vitamin Can Thwart AIDS Progress

> By DONALD G. McNEIL Jr.

>

> A simple daily vitamin pill can delay the progress

> of AIDS in H.I.V.-

> infected women, an eight-year study by Harvard

> researchers has found.

>

> Vitamins are by no means a cure or a substitute for

> antiretroviral

> therapy, the researchers said. But for malnourished

> women in Africa

> or Asia with little hope of getting better drugs,

> vitamins are a

> cheap, safe way of giving them extra months of life

> and a little less

> misery before they die, the study, which is being

> published today in

> The New England Journal of Medicine, suggested.

>

> " The study is important for developing countries,

> especially for

> pregnant and postpartum women, who are a

> nutritionally vulnerable

> group, " said Dr. Lynne Mofenson, chief of the

> pediatric and maternal

> AIDS branch of the National Institute of Child

> Health and Human

> Development, one of the National Institutes of

> Health.

>

> Dr. Richard G. Marlink, who helps run treatment

> programs in six

> African countries as director of the Harvard AIDS

> Institute and

> scientific adviser to the Elizabeth Glaser Pediatric

> AIDS Foundation,

> said the study would prompt him to recommend

> vitamins for his

> patients.

>

> " This is exciting because it costs literally pennies

> and can ward off

> the time when you need to begin treatment with

> expensive and toxic

> drugs, " he said.

>

> The study, run by the Harvard School of Public

> Health and the medical

> school of Muhimbili University in Tanzania, followed

> 1,078 women in

> Dar es Salaam between 1995 and 2003. The women were

> recruited when

> they were pregnant. They had no access to anti-AIDS

> cocktails, so

> H.I.V. infection meant a sentence of eventual death

> from

> tuberculosis, meningitis, pneumonia, Kaposi's

> sarcoma or other

> opportunistic infections.

>

> About six million people in poor countries are

> already sick enough to

> need antiretroviral drugs, the World Health

> Organization estimates,

> and another 25 million or more will need them soon.

> Only about

> 400,000 are getting them.

>

> Efforts to increase that number have gone slowly

> because of high drug

> prices, fights over patents, a lack of money from

> donors, reluctance

> by African leaders to admit that their nations have

> epidemics and the

> inability of shattered health care systems to muster

> enough doctors,

> nurses and laboratories to safely deliver the drugs.

>

> Vitamins costing less than $15 a year might prolong

> the lives of

> people waiting for rescue, the study concluded. The

> supplements do

> not attack the virus, but enhance the body's own

> immune system,

> allowing it to do so.

>

> The vitamins were specially made for the study " but

> are quite easy to

> mass-produce, " said its lead author, Wafaie W.

> Fawzi, a professor of

> nutrition and epidemiology at Harvard. They

> contained about three

> times the recommended daily allowance of vitamin E

> and 6 to 10 times

> the allowance of C and B-complex vitamins.

>

> The supplements are not the first stopgap therapy

> proposed for the

> poor. In 2000, the World Health Organization advised

> that AIDS

> patients who were not on antiretrovirals get regular

> doses of

> cotrimoxazole, an antibiotic better known as

> Bactrim. That drug,

> which cost only about $8 a year in generic form,

> warded off secondary

> infections, which are often fatal. Largely because

> of the cost and

> the disorganization of African health care systems,

> that

> recommendation has not been widely adopted.

>

> The Tanzania study found that 30 percent fewer of

> the women who

> received the multivitamins died or progressed to

> full AIDS during the

> study than a group of women receiving a placebo. The

> counts of CD-4

> cells, the immune system cells that the virus

> attacks, stayed

> somewhat higher in the group that took

> multivitamins. That group also

> had fewer incidents of thrush, throat ulcers,

> inflamed gums, nausea,

> rashes, fatigue and other debilitating side effects.

>

>

> Nonetheless, vitamins were no cure. About a quarter

> of the women who

> received them still died or reached full AIDS during

> the study, and

> without antiretroviral treatment, virtually all can

> be expected to

> die in the next few years.

>

> The study had to be changed twice in midstream for

> ethical reasons,

> Dr. Fawzi said.

>

> Vitamin A was dropped from the supplements because

> researchers found

> evidence that it increased the risk that mothers

> would pass the

> infection to their babies.

>

> Also, when the authors had early evidence that

> multivitamins

> prevented fetal death and premature births, they put

> all the women in

> the study on multivitamins until they delivered.

> After that, the

> mothers went back on their previous regimens,

> without doctors or

> patients knowing whether they were on a placebo.

>

> The study confirms what researchers have suspected

> since the

> epidemic's early days, Dr. Marlink said.

>

> Many AIDS researchers noticed that vitamin-deficient

> patients

> sickened faster than well-fed ones, he said, but

> Americans who were

> malnourished usually had other problems, like drug

> and alcohol abuse,

> that made it hard to blame poor nutrition for their

> rapid declines.

>

> Three years ago, Dr. Andrew Tomkins of the Institute

> for Child Health

> in London gave multivitamins or placebos to 481

> H.I.V.-infected men

> and women in Thailand. Although Dr. Tomkins followed

> the patients for

> less than a year, the group taking vitamins had

> " significantly " lower

> mortality, especially among those whose immune

> systems were weakest,

> he said.

>

> Dr. Tomkins called Dr. Fawzi's study " particularly

> important " because

> many people are not yet in treatment despite the

> efforts of the

> Global Fund for AIDS, Tuberculosis and Malaria and

> " it's going to be

> a long time before everybody is, " he said.

>

> The women studied were poor but urban. Their diet

> was " not very rich,

> but not suboptimal, " he said, adding that rural

> women probably ate

> less well. But those who benefited from vitamins did

> so " regardless

> of whether they were undernourished or not, " Dr.

> Fawzi said.

>

>

> Copyright 2004 The New York Times Company

>

>

>

> See also: The Washington Post

> http://www.washingtonpost.com/ac2/wp-

> dyn/A18847-2004Jun30?language=printer

>

> Multivitamins Slow AIDS Effect in Study

> African Patients Had Deficient Diets

>

> By David Brown

>

> Washington Post Staff Writer

> Thursday, July 1, 2004; Page A03

>

> People infected with the AIDS virus who take

> multivitamins every day

> have a slightly slower progression of their illness,

> researchers are

> reporting today.

>

> The findings will be most useful in the developing

> world, where an

> effort is underway to treat millions of HIV-infected

> people and

> vitamins could be an easily implemented first step.

>

> The effect is not dramatic but is probably enough to

> warrant a

> recommendation that people infected with HIV take

> vitamins if their

> diet is potentially deficient, some experts said.

>

> Supplements " might buy time to allow people to go

> longer before they

> develop symptoms that require antiretroviral

> treatment, " said Lynne

> Mofenson, chief of AIDS activities at the National

> Institute of Child

> Health and Human Development. The institute paid for

> the study, whose

> results appear in today's New England Journal of

> Medicine.

>

> The beneficial vitamins were in the B family, as

> well as vitamins C

> and E. Curiously, vitamin A -- which has huge health

> benefits in

> undernourished children -- was of no help, and was

> possibly harmful,

> in HIV-infected adults.

>

> The new information comes from a study in the east

> African nation of

> Tanzania that began in 1995. About 1,000 pregnant

> women who were

> infected with HIV agreed to participate in an

> experiment to determine

> whether vitamin supplements could reduce

> mother-to-child transmission

> of the virus. Pregnancy increases the body's demand

> for vitamins, and

> many of the women were marginally nourished to begin

> with.

>

> They were randomly assigned to take vitamin A,

> multivitamins with

> vitamin A, multivitamins alone or a placebo. The

> vitamin doses were

> six to 10 times the U.S. government's recommended

> daily dietary

> intake.

>

> The study found that multivitamins alone decreased

> by about 40

> percent a baby's chance of dying soon after birth --

> mostly by

> reducing prematurity and low birth weight -- but the

> multivitamins

> did not cut the chance of acquiring HIV during birth

> or through

> breast-feeding. Vitamin A, however, increased the

> risk of acquiring

> HIV, and its use in the study was stopped when this

> became clear.

> Those findings were reported several years ago.

>

> The women in the study continued taking supplements

> after they

> delivered and were observed until the summer of 2003

> -- an average of

> about six years for the survivors.

>

> Over the whole period, 25 percent of the women

> taking multivitamins

> progressed to late-stage AIDS or died, compared with

> 31 percent of

> those taking the placebo. This means that for every

> 100 women taking

> multivitamins for six years, the lives or health of

> six would have

> been preserved, compared with 100 women not taking

> vitamins.

>

> Those numbers, however, do not fully reflect the

> benefit of

> multivitamins, said Wafaie W. Fawzi, a researcher at

> the Harvard

> School of Public Health, who headed the study.

>

> For example, supplements (minus vitamin A) reduced a

> woman's risk of

> progressing to moderate AIDS, or of developing oral

> ulcers and

> painful swallowing, by 50 percent. Supplements

> raised a person's CD4-

> cell count -- a key measure of immune status -- by

> 48 cells per

> milliliter of blood, and slightly lowered the amount

> of HIV

> circulating in the blood.

>

> In all, the effects of multivitamins were comparable

> to what was

> achieved by taking AZT alone in studies done during

> the 1980s when

> that was the only antiretroviral drug available.

>

> It is not yet known whether multivitamins have an

> additional benefit

> for people already on optimal three-drug therapy, or

> whether

> multivitamins are beneficial in populations in which

> there is little

> nutritional deficiency.

>

> C 2004 The Washington Post Company

>

>