WEB POSTED 1-19-2000

 
Doctors call for more scrutiny of vaccines

by Askia Muhammad
White House Correspondent

WASHINGTON-(http://www.finalcall.com)�Otherwise healthy Black, Latino and Native American children may be unwitting guinea pigs in the rush to get medical vaccines approved and into the marketplace, according to documents obtained from the U.S. government by the San Jose Mercury-News and confirmed by The Final Call in interviews with researchers and medical ethicists.

While Americans of all races, ethnic groups and income levels benefit from vaccines which stop the spread of diseases, at least eight out of 14 vaccines approved in the United States since 1990 were tested disproportionately among lower-income minority group members, a late December report in the newspaper revealed.

Most researchers believe widespread vaccination is essential to the maintenance of public health, and few vaccine tests have caused any severe side effects.

But other practitioners suggest that tainted vaccines are responsible for the epidemic spread of AIDS and other diseases. "Certainly there have been some health benefits reported from the vaccine programs, but I think under-reported has been the adverse reactions and the long-term liability that all of us may suffer from," Dr. Abdul Alim Muhammad, Nation of Islam Minister of Health and Human Services and a prominent AIDS researcher, told The Final Call.

"For us to read a story that Blacks and Hispanics are being targeted disproportionately for vaccine trials: Hey, what else is old? This is the way it has been done since Day One."

Dr. Leonard Horowitz, author of "Emerging Viruses: AIDS & Ebola�Nature, Accident, or Intentional?", said a highly prevalent attitude existed among the top vaccine researchers who conducted early trials among minority populations. That attitude was, he said, "If we don�t halt infectious diseases in the Black populations and Hispanic populations, then your white middle class populations are going to be at risk. That was, in and of itself, a racist and largely propagandist ideology that was articulated during formative vaccine trial conferences and public health conferences, and therein lies the greatest problem."

But Isabel Claxton, a spokeswoman for a leading vaccine maker, Merck & Co., said ethnic and racial imbalance in vaccine testing is "meaningless" in and of itself. "It�s only a problem if they were victims ... if there was some conspiracy to use them as guinea pigs," she told the Mercury News. "But there is not. Our trials are mutually beneficial."

Dr. Horowitz, nevertheless, argues in his book that the worst viral infectious diseases in the 20th Century may have been man-made. "Far more than a medical science problem," Dr. Horowitz argues, viral epidemics are "a political problem."

"I think that�s overstating it," said Dr. Michael Viola, a medical researcher at the State University of New York at Stony Brook, who is appointed to cancer departments at several university medical centers. "I don�t think that people doing this kind of work are quite as mean-spirited as (Horowitz) portrays them. Plus, the fact that the government has stepped in pretty heavily. Still, there are problems."

Those problems, Dr. Viola concedes, spring from evidence of suspicious targeting of specific groups for medical testing. "Vaccines used to be tested on prisoners because they were a captive population," he said. Unfortunately, he continued, "there was coercion implied" in such tests.

The reason prison populations were targeted, he said, is the same reason why researchers now single out some of the large HMOs which have been involved in the recent vaccine testing of children. "It was a large group of people who could be vaccinated easily, and who were at high risk of developing infectious diseases. But, in our present understanding of the ethics of clinical trials, it�s completely unacceptable, because there�s enormous coercion for prisoners to go along. There isn�t really free consent," said Dr. Viola.

Another well known test which "raised a lot of eyebrows," according to Dr. Viola, was the original Hepatitis-B vaccine.

Some doctors suggest there were batches of Hepatitis-B vaccines which were contaminated with HIV and specifically introduced to several vulnerable populations, including homosexual men in New York, San Francisco and Los Angeles, and to poor villages in Africa. That allowed AIDS to gain entrance in large numbers into the human population, they argue.

The most troubling test, however, involved children and a polio vaccine in the 1950s.

"In the early live polio vaccine preparations there was a contaminating virus called SV-40," said Dr. Viola. "It�s a simian virus. They grew the polio (vaccine) in monkey cells, and those monkey cells were carrying another virus which got into the vaccine."

The problem with SV-40, he said, was that it caused cancer in some animals. A large group of people who got SV-40 with their polio vaccine have been monitored for a long time, and it seems that the virus didn�t do anything harmful to them, he continued, but it did frighten many people so that some extraordinary precautions have been put into place.

A simian virus, a so-called "green monkey virus," is linked to the mystery surrounding the spread of AIDS in Africa.

The federal government has been hesitant to get into the debate over where vaccines should be tested. The Food and Drug Administration (FDA) recommends that medical products be tested on a diverse group of people, but has no way of comprehensively tracking the race of test participants.

"You raise many, many issues," FDA spokesperson Lenore Gelb told The Final Call concerning the initial report in the Mercury-News. "SV-40 ... was a situation many, many years ago, where there was a test, and as soon as it was discovered that there was this possibility (of contamination), steps were immediately taken" to correct the problem.

"We wouldn�t approve a vaccine unless we thought it was safe and effective for the population," she said.

The federal government is concerned, however, about the "informed consent" process in order to help assure that patients understand what they are getting into. A report to President Jimmy Carter in 1979 from a commission of medical experts on protecting human research subjects called for extra care when research involves "vulnerable subjects" such as the poor, mentally ill, or racial minorities."

"Informed consent" is the area about which Dr. Viola�who is himself active in conducting clinical cancer trials�is most alarmed.

"The thing that is really clear is that industry has no ethical impulse on this issue," said Dr. Viola. "You can�t leave it to industry to set up the guidelines. And while universities and medical centers should, they are so bogged down they can�t see the forest for the trees. There has to be some other regulatory agencies which will exist to protect people."

Dr. Lewis Marshall, a Howard University medical school faculty member, agrees.

Vaccines and other medical testing needs to be more "democratic," and more should be done to improve the oversight process performed by local "institutional review boards," which must first approve any tests conducted at a particular medical center, Dr. Marshall said in an interview.

"These review boards have only a few minutes for each study. A lot of it is based on who presents the information, what they present, what esteem that individual has in that institution. There are a lot of flaws in the policies we have nationally, and this (discussion) is an opportunity to influence and change the policy, at least to create some thought about how things are done."

But the risks, especially those borne by minority group members, are "understated," according to Dr. Marshall. "It�s the same old problem: Minorities share the brunt of the risk."

"I think that the forces of what is called the �New World Order� have genocidal intentions against huge populations throughout the world," said Dr. Muhammad. "Many of the so-called newly emerging diseases that we�re faced with, that the world never heard of before�not just AIDS, but things like Alzheimer�s, attention deficit disorder, minimal brain-damage-syndrome, fibril myalgia, Gulf War Syndrome�there�s a whole list of new diseases that seem to be vaccine related.

"This is one of the most dangerous things that has ever been done to the human population in the history of the world and we don�t know what all of the outcome is going to be," Dr. Muhammad said.