GlaxoSmithKline once again are embroiled in scandal in which babies and children were allegedly used as 'laboratory animals'.
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.
GlaxoSmithKline 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. To read the rest of the article click here.
According to a US Group, 'Consumer Alert' the World Health Organization (WHO) have caved into the United States and the junk food industry by deleting support for policies that promote the production and marketing of fruit, vegetables and legumes.
This was achieved by the deletion of a passage in the draft document of the WHO's Global Strategy on Diet and Physical Activity. The original document urged Countries to offer incentives for producing, marketing and transporting fruit, vegetables and other healthy produce... but it has now been removed after intense lobbying in Washington by food manufacturers.
There is no doubt in my mind that much of the obesity problem stems from clever advertising targeted at pre school children. The children become conditioned that eating is a 'fun' thing and the taste is what counts and very little education is given to the fact that we should 'eat to live' not 'live to eat'.
Beware if you are a big eater of eggs. You may be getting more in your egg than you bargained for! According to a report in the UK Guardian one of the main drugs found in eggs is Lasalocid which is an anti-biotic that is said to have no direct effect on humans.
However, similar drugs have been reported to cause severe illness, including paralysis and increased breathing and heart rates, and death in livestock such as cattle, turkeys and sheep. Lasalocid, commercially produced since 1977, has also accidentally poisoned dogs.
Tests carried out on eggs by the government's Veterinary Medicines Directorate show residues were found in 12% of samples last year, up from 1% in 1999. To read the full article please click here.
But, mass produced eggs from hens in cramped conditions have risks. Apart from the antibiotics that are administered to them via their food there are other additives given to them to improve the color of the yoke with unknown long term effects.
But, don't be put off eggs. If you can, buy organic eggs which are free from these additives. If you can't get organic eggs, go for free range eggs.
UK firm tried HIV drug on orphans (Full Article)f1
GlaxoSmithKline embroiled in scandal in which babies and children were allegedly used as 'laboratory animals'.
Antony Barnett in New York
Sunday April 4, 2004
The Observer
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 children.'
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Activists Say WHO Caved in on Anti-Obesity Plan (Full Article)f2
Tue Apr 20, 2004 01:13 PM ET
GENEVA (Reuters) - Consumer activists on Tuesday accused the World Health Organization (WHO) of "caving in" to the United States and the junk food industry after the U.N. agency revised its blueprint for tackling obesity worldwide.
They said a draft of WHO's Global Strategy on Diet, Physical Activity was weakened by changes including deletion of a passage urging states to offer incentives for producing, marketing and transporting fruit, vegetables and other healthy produce.
The plan aims to promote healthy foods and lifestyles amid soaring death rates from cardiovascular disease and diabetes.
The draft, revised since a debate by WHO's executive board in January, was issued on Monday after officials studied suggestions and objections from member states and food industry lobbyists.
"The WHO caved into the United States and the junk food industry by deleting support for policies that promote the production and marketing of fruit, vegetables and legumes," the U.S.-based group Commercial Alert said in a statement.
"The advertising and junk food industries should be happy because it doesn't encourage countries to ban junk food advertising to children," the non-profit group added.
Critics say Washington bowed to pressure from its powerful food industry to water down the plan.
WHO's 192 member states, who ordered the strategy drawn up two years ago, are due to endorse a final document at their annual assembly in May.
Poor diets and physical inactivity are among the major causes of noncommunicable diseases -- cardiovascular disease, type 2 diabetes, cancers and obesity-related conditions -- which WHO says now account for 60 percent of 56.5 million preventable deaths a year. The toll is set to rise to 73 percent by 2020.
According to the World Heart Federation, 1.1 billion adults and 22 million children under age five are obese. In the United States, two-thirds of adults are overweight.
The WHO plan states simply that governments "can influence prices through taxation, subsidies or direct pricing in ways that encourage healthy eating and lifelong physical activity."
While recommending that people limit intakes of fats, sugar and salt, it does not lay down specific targets or recommend taxing such goods.
"We do recommend that fiscal policies take into account public health considerations. We leave it to countries to decide what those specific policies will be," WHO's project manager Amalia Waxman told Reuters.
At least 30 minutes of regular, moderate physical activity "on most days" is also recommended to reduce the risk of cardiovascular disease and diabetes, colon and breast cancers.
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Danger warning after increase in drug residues found in eggs (Full Article)f3
James Meikle, health correspondent
Wednesday April 14, 2004
The Guardian
The safety of chicken eggs is being called into question by opponents of intensive farming, who say as many as one in eight may contain residues of a veterinary drug that are potentially harmful to humans.
People on diets involving high egg consumption, including the Atkins diet, those with heart conditions and babies might be at particular risk, according to a report from the Soil Association, the organic food and farming charity. It says government agencies should advise such "vulnerable" consumers how they could limit the amounts they eat pending research into the issue.
The allegations come a few weeks after egg producers congratulated themselves for having solved the salmonella problem that dogged the industry during the 1990s.
The government's Food Standards Agency, which has seen the report, yesterday said it was "disappointed" with the way the egg industry was dealing with drug residues, although it insisted there were no immediate health concerns. It is considering the problem and whether tougher action is needed.
The authors of the Soil Association report say they can find no direct evidence of potential poisonous effects on humans from lasalocid, an antibiotic that is not even licensed for use in egg-laying birds. But they add that checks have never been made.
The drug is allowed in poultry raised for meat providing control measures are followed. Yet tests on eggs by the government's Veterinary Medicines Directorate show residues were found in 12% of samples last year, up from 1% in 1999.
Similar drugs have been reported to cause severe illness, including paralysis and increased breathing and heart rates, and death in livestock such as cattle, turkeys and sheep. Lasalocid, commercially produced since 1977, has also accidentally poisoned dogs.
Test results suggest consumers may be eating up to three million eggs a day containing residues, the report says. It accuses the food agency of underestimating consumption by some groups.
Cross-contamination at feed mills is often blamed for the problems by government veterinary inspectors, who have recently found the drug in organic eggs for the first time. Similar mix-ups may happen during transport and on farms.
Lasalocid is regarded by the government as a food additive rather than a growth-promoting antibiotic over which there are EU-wide controls. That means no "safe" limits have been fixed on residues.
Richard Young, policy adviser to the Soil Association and co-author of the report, said: "We believe that eggs contaminated at the high levels found in some samples last year pose real risks to some vulnerable consumers ... until this drug is banned, those most at risk should limit the amount of egg eaten ... and consider buying organic eggs since these have to be the safest option."
The report recommends that parents should avoid feeding conventionally produced eggs, or products containing them, including infant formula milk, to babies under a year old.
Children over that age should have no more than four eggs a week, while adults suffering or who have suffered heart arrhythmia should have no more than two eggs a day.
The Veterinary Medicines Directorate said it was targeting tests at producers where there were known to have been problems with residues. Therefore its figures should not be extrapolated to all eggs. Many other EU countries did not even test for such residues, it added.
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