posted on April 4, 2004 01:59:03 PM new
Orphans and babies as young as three months old have been used as guinea pigs in potentially dangerous medical experiments sponsored by pharmaceutical companies, an Observer investigation has revealed.
British drug giant GlaxoSmithKline is embroiled in the scandal. The firm sponsored experiments on the children from Incarnation Children's Centre, a New York care home that specialises in treating HIV sufferers and is run by Catholic charities.
The children had either been infected with HIV or born to HIV-positive mothers. Their parents were dead, untraceable or deemed unfit to look after them.
According to documents obtained by The Observer, Glaxo has sponsored at least four medical trials since 1995 using Hispanic and black children at Incarnation. The documents give details of all clinical trials in the US and reveal the experiments sponsored by Glaxo were designed to test the 'safety and tolerance' of Aids medications, some of which have potentially dangerous side effects. Glaxo manufactures a number of drugs designed to treat HIV, including AZT.
Normally trials on children would require parental consent but, as the infants are in care, New York's authorities hold that role.
The city health department has launched an investigation into claims that more than 100 children at Incarnation were used in 36 experiments - at least four co-sponsored by Glaxo. Some of these trials were designed to test the 'toxicity' of Aids medications. One involved giving children as young as four a high-dosage cocktail of seven drugs at one time. Another looked at the reaction in six-month-old babies to a double dose of measles vaccine.
Most experiments were funded by federal agencies like the National Institute of Allergy and Infectious Diseases. Until now Glaxo's role had not emerged.
In 1997 an experiment co-sponsored by Glaxo used children from Incarnation to 'obtain tolerance, safety and pharmacokinetic' data for Herpes drugs. In a more recent experiment, the children were used to test AZT. A third experiment sponsored by Glaxo and US drug firm Pfizer investigated the 'long-term safety' of anti-bacterial drugs on three-month-old babies.
The medical establishment has defended the trials arguing they enabled these children to obtain state-of-the-art therapy they would otherwise not have received for potentially fatal illnesses.
However, health campaigners argue there is a difference between providing the latest drugs and experimentation. They claim many of the experiments were 'phase 1 trials' - among the most risky - and that HIV tests for babies were not a reliable indicator of actual infection and therefore toxic drugs could have been given to healthy infants. HIV drugs are similar to those used in chemotherapy and can have serious side-effects.
Vera Sharav, president of the Alliance for Human Research Protection, said the children had been treated like 'laboratory animals'.
'These are some of the most vulnerable individuals in the country and there appears to be a policy of giving drug firms access to them,' she said. 'Throughout the history of medical research we have seen prisoners abused, the mentally ill abused and now poor kids in a care home.'
Sharav has urged the US Food and Drug Administration to investigate and has demanded full disclosure of all adverse effects suffered by the children, including deaths. Brooklyn Democrat councillor Bill de Blasio is also demanding that New York's Administration for Children's Services, which approved the trials, reveal who gave consent and on what grounds.
Glaxo has confirmed it provided funds for some of the experiments but denied any improper action. A spokeswoman said: 'These studies were implemented by the US Aids Clinical Trial Group, a clinical research network paid for by the National Institutes of Health. Glaxo's involvement in such studies would have been to provide study drugs or funding but we would have no interactions with the patients.
'Generally speaking, clinical research is carefully regulated in the US and it would be the responsibility of the appropriate authorities to ensure all subjects in a clinical trial provided appropriate, informed consent to conform with all local laws and regulations regarding legal authority in the case of minors.'
The Incarnation trials were run by Columbia University Medical Centre doctors. Columbia spokeswoman Annie Bayne said there had been no clinical trials at Incarnation since 2000 and that consent for the children was provided by the Administration for Children's Services, which uses a panel of doctors and lawyers to determine whether the benefits of a trial for each child outweighs the risks. 'There are many safeguards in the system. HIV is eventually a fatal disease, but drug therapy has lengthened life significantly,' said Bayne.
A spokesman for Incarnation said: 'The purpose of the trials was to test the efficacy of HIV medication ... These trials were based on scientific evidence of their potential value in the treatment of HIV-infected childre
posted on April 4, 2004 02:02:21 PM new
Feds won't warn parents about vaccine
Contains mercury eliminated from other shots due to health concerns
Posted: April 3, 2004
1:00 a.m. Eastern
The government has decided not to warn parents a mercury-laced preservative virtually eliminated from other vaccines because of health concerns will be included in flu shots given to hundreds of thousands of infants and toddlers this fall.
The decision by the U.S. Centers for Disease Control and Prevention to recommend the shots with the preservative thimerosal – despite the pleas of parent activist groups – apparently conflicts with recent federal heath warnings about exposure to mercury, the Los Angeles Times reported.
Thimerosal is about 50 percent ethyl Mercury, a potent neurotoxin that has been removed from other childhood vaccines.
The CDC has added flu shots to its list of recommended vaccines for all young children.
Mercury-free flu vaccines will be available, for about $4 more per shot, but if the CDC were to warn parents, it might create a shortage resulting in some children not being immunized, the Times said.
The agency asserts, "The available scientific evidence has not shown thimerosal-containing vaccines to be harmful."
Nevertheless, the CDC has ordered up to 2 million doses of thimerosal-free vaccine to make sure it meets the demand by health departments.
CDC senior scientist Roger Bernier explained, though, that stating a preference for thimerosal-free vaccines "would drive the demand even more aggressively."
That isn't necessary, he said, because there is no proof of harm – an assessment backed by the American Academy of Pediatrics.
But parent advocates are fuming, according to the L.A. paper.
Barbara Loe Fisher, co-founder of the National Vaccine Information Center, charges that by not advising parents, the government is "violating the precautionary principle which reminds doctors that, when in doubt, take an action which minimizes the risk of harm."
Rep. David Weldon, R-Fla., said the CDC's actions constitute "medical malpractice."
The congressman, a physician, plans to introduce a bill to ban thimerosal in childhood vaccines.
Weldon said he would not allow his son to have the shot with mercury, the Times said, which is used to prevent the growth of bacteria and fungi in vaccines.
Thimerosal was the preservative of choice until 1999, when the U.S. Public Health Service and the academy of pediatrics called on drug firms to voluntarily remove it as a precaution.
Some parent groups and researchers believe thimerosal has contributed to a sharp increase in reported rates of autism and other neurological disorders in children.
Many scientists and vaccine makers insist, however, exposures are too low to have an effect and ethyl mercury can be more easily eliminated from the body than methyl mercury, which is produced by industrial emissions.
But Boyd E. Haley, chairman of the department of chemistry at the University of Kentucky, believes it is "preposterous and ridiculous" for the government to warn about methyl mercury in fish but sanction injecting ethyl mercury into children.
The CDC decision, which will be officially published later this month, is "unconscionable," Haley said, according to the Times. "If it were my grandson or my granddaughter, there's no way in hell you'd give them a vaccine containing thimerosal."
Dr. Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health, told the Times "it would make life much easier for everybody if there wasn't the thimerosal in the vaccines."
But he added: "I personally am not concerned."
Halsey, who sounded the alarm about thimerosal in 1999, contends the situation now is different. The 1999 appeal referred to immunizations of infants, up to 6 months old, while flu shots with thimerosal would deliver only a 25-microgram dose to children 6 months and older.
So the exposure would be lower "in terms of the amount that's given and the size of the child," he told the Times.
posted on April 6, 2004 06:24:39 AM new
Disease centers won't issue mercury alert over flu shots
Infants, toddlers at risk, say critics who argue vaccine may not be safe
Hundreds of thousands of infants and toddlers who get flu shots starting this fall could be exposed to a mercury-laced preservative that has been all but eliminated from other pediatric vaccines because of health concerns.
Saying there is no proof of harm from exposure to the preservative thimerosal, officials with the U.S. Centers for Disease Control and Prevention have confirmed that they won’t advise parents and doctors to choose a mercury-free version of the flu vaccine.
This year, flu shots are being added to the government’s “recommend” list of vaccines that should be given to all young children. The CDC’s decision, made despite pleas from parent activist groups and some experts, appears to be at odds with recent federal warnings about exposure to mercury, a potent neurotoxin, and with the government’s successful effort to see mercury removed from other childhood vaccines.
The mercury-free flu vaccine will be more expensive — by about $4 per shot — because it is somewhat harder to make in large quantities than the alternative. If the CDC were to warn parents, demand for thimerosal-free shots would rise, possibly squeezing supplies. Some experts said there was a greater risk in infants and toddlers failing to be vaccinated against the flu because of a shortage than in their being vaccinated with shots containing mercury.
CDC executives wouldn’t discuss their decision, but said in a statement that “the available scientific evidence has not shown thimerosal-containing vaccines to be harmful.”
The American Academy of Pediatrics, which has a membership of 57,000 physicians, is backing the CDC.
But the agency has come under attack from some parent groups. By not advising parents and physicians, the government is “violating the precautionary principle which reminds doctors that, when in doubt, take an action which minimizes the risk of harm,” said Barbara Loe Fisher, co-founder of the National Vaccine Information Center, a parent-led group that promotes safer vaccines.
Preservatives are used by drug companies to prevent the growth of bacteria and fungi in their vaccines.
Some parent groups and researchers believe that thimerosal has contributed to a sharp increase in reported rates of autism and other developmental disorders in children. But vaccine makers and many scientists dispute the connection.
The CDC orders mass quantities of vaccine for state and local health departments that immunize low-income children. Paradoxically, the agency has ordered up to 2 million doses of thimerosal-free vaccine for the coming fall to be sure there is enough for health departments that request it, said Roger Bernier, senior scientist with the CDC’s immunization program.
Dr. Margaret Rennels, who chairs the pediatric group’s committee on infectious diseases, cited manufacturers’ estimates that nearly one-third of a vaccine is lost in the process of removing thimerosal and in packaging the preservative-free version. “It is the judgment of pediatric disease specialists that it would be better to have a third bigger supply given the lack of evidence of harm from thimerosal,” she said.
It’s unclear, however, if high demand for preservative-free vaccine would in fact disrupt supplies.
Three companies produce flu vaccines for the U.S. market. Only one, Aventis Pasteur Inc., a subsidiary of French pharmaceutical giant Aventis SA, is licensed to make the medicine for children as young as 6-24 months.
Aventis makes thimerosal and thimerosal-free vaccine at its Swiftwater, Pa., plant. Len Lavenda, director of public affairs, said Aventis encourages parents who are concerned to ask their doctors to order thimerosal-free vaccines. The company believes “we will be able to produce a sufficient amount” of mercury-free vaccines, Lavenda said, “providing we’re notified early enough.”
