Harvard Study: Multivitamins Effective in Thwarting AIDS progress

Harvard Study: Multivitamins Effective in Thwarting AIDS progress

Thu, 1 Jul 2004

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.php

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.php

Contact: Vera Hassner Sharav
Tel: 212-595-8974

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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
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

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