GlaxoSmithKline embroiled in scandal
Vivian Stamp | 12.04.2004 01:22 | Bio-technology | Health | Social Struggles | London
GlaxoSmithKline embroiled in scandal in which babies and children were allegedly used as 'laboratory animals'
SHOCKING
http://observer.guardian.co.uk/international/story/0,6903,1185305,00.html UK firm tried HIV drug on orphans
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.'
Vivian Stamp
Comments
Hide the following 4 comments
another article along similar lines
12.04.2004 11:53
In New York's Washington Heights is a 4-story brick building called Incarnation Children's Center (ICC). This former convent houses a revolving stable of children who've been removed from their own homes by the Agency for Child Services. These children are black, Hispanic and poor. Many of their mothers had a history of drug abuse and have died. Once taken into ICC, the children become subjects of drug trials sponsored by NIAID (National Institute of Allergies and Infectious Disease, a division of the NIH), NICHD (the National Institute of Child Health and Human Development) in conjunction with some of the world's largest pharmaceutical companies - GlaxoSmithKline, Pfizer, Genentech, Chiron/Biocine and others.
The drugs being given to the children are toxic - they're known to cause genetic mutation, organ failure, bone marrow death, bodily deformations, brain damage and fatal skin disorders. If the children refuse the drugs, they're held down and have them force fed. If the children continue to resist, they're taken to Columbia Presbyterian hospital where a surgeon puts a plastic tube through their abdominal wall into their stomachs. From then on, the drugs are injected directly into their intestines.
Captain Wardrobe
Liam scheff
12.04.2004 12:09
both the stories are the of the same care home liams was 6 months ago...
evn the first poster used the picture from the scheff article...
c'mon credit where credit is due...
anyway...
no matter ...insignificant,
considering the ramifications
Human Experiments are going on in the free world
& in occupied territory
what do you think the Blackwater special ops
mercenaries were doing shooting people in Falujah?
TESTING NEW WEAPONS
Captain Wardrobe
pfizer world [hee hee]
12.04.2004 12:24
Named PfizerWorld, the park will be comprised of a combination of rides, entertainment, and educational exhibits, geared at both adults and children. "It will be a collage of information and fun," McKinnell remarked. Ride names already proposed include The Gonococcal Caves and Heart Attack Mountain.
Also planned are a series of cute animal characters for the park, designed to excite children about science and health. With names such as Alan the Alcoholic Allagator and Diana the Diabetic Dog, each character would have a theme disease that would then serve as a bridge to information regarding a specific Pfizer product. "What better way to educate kids about Viagra than with Mo the Impotent Mouse?" a Pfizer PR spokeswoman told us. Pfizer has already contracted toy manufacturer Hasbro to release a series of PfizerWorld dolls and action figures to accompany the live characters.
McKinnell fended off early criticism that the park was merely an excessive advertising ploy. "Despite what one might be thinking, this is not a extravagant corporate ploy designed to trick the easily led masses into using our overpriced drugs despite the availability of cheaper, more effective alternatives. Our only interest is in educating the public. And if Pfizer gets a little free advertising along the way, well, of course we won't complain."
Also of some concern was the source of the 12 billion dollars needed to build PfizerWorld. One insider remarked, "Who do you think will be paying for this monstrosity? All those CEO's and politicians? No no, that money is coming right out of the public's pockets. This has to be the biggest racket this nation has seen since the JFK assassination, but all it's going to take is one look at those huggable little animals and everyone will decide that they just don't give a damn."
Despite the visible presence of the Bush administration during the announcement, government officials and politicians were surprisingly tight-lipped. "My only comment on the issue is that both the president and I support any endeavor to teach young people about capitalism...wait...I mean about health" Cheney remarked as he was hurried into the presidential helicopter.
Pfizer is scheduled to break ground on the project in about two months, with an estimated completion date of Spring 2003.
Captain Wardrobe
cheney is one sick puppy
12.04.2004 12:32
The Guardian [London, UK]
December 21, 2002
US blocks cheap drugs deal - Cheney's intervention threatens pact to help
poor countries after big firms lobby White House.
By Larry Elliott and Charlotte Denny.
Dick Cheney, the US vice-president was last night blocking a global deal to
provide cheap drugs to poor countries, following intense lobbying of the
White House by America's pharmaceutical giants.
Faced with furious opposition from all the other 140 members of the World
Trade Organisation, the US is refusing to relax global patent laws which
keep the price of drugs beyond reach of most developing countries.
The White House was last night holding out as the minutes ticked towards
the mid night deadline set by the WTO for a deal to be struck that would
permit a full range of life-saving drugs to be imported into Africa, Asia
and Latin America at cut-price costs.
Sources in Geneva said last night that the negotiating strategy was coming
straight from the White House with Mr Cheney seizing the reins from
America's trade negotiator, Robert Zoellick.
Mr Zoellick helped broker a deal on affordable drugs at the WTO's meeting
last year in Doha under which developing countries were promised they would
be able to override patent laws in the interest of public health.
However, America's drug industry has fought tooth and nail to impose the
narrowest possible interpretation of the Doha declaration, and wants to
restrict the deal to drugs to combat HIV/Aids, malaria, TB and a shortlist
of other diseases unique to Africa.
Trade officials in Geneva last night that they were not optimistic about a
deal being reached and that failure could push the Doha agreement, which
covers everything from cutting farm subsidies to introducing more
competition into services, to the brink of collapse.
Out of 144 WTO members, the current draft "already has the support of 143",
said Brazil ian diplomat Antonio de Aguiar.
America's drug industry expressed confidence yesterday that its lobbying of
the Bush administration would pay off.
"I don't have any indication that the US is changing its position on that
at all," Shannon Herzfeld of PhRMA, the organisation representing leading
US pharmaceutical companies, told Inside US Trade, the specialist trade
magazine.
The industry argues that it spends billions a year on drug research and
that if copycat companies can override their patents and manufacture drugs
at bargain prices, research will dry up.
However, aid agencies lobbying on behalf of poor countries pointed out that
the cut-price drugs will only be sold in countries which could not afford
to buy them at first world prices. They accused the White House of being in
the pocket of big US drug corporations.
"The joke in Geneva this morning is that they couldn't make a decision
because the CEOs of Merck and Pfizer were still in bed," said Jamie Love,
director of the Consumer Project on Technology, a US lobby group.
Aside from HIV/Aids, drug companies do almost no research into the diseases
on the US shortlist. The list excludes diseases like cancer, asthma and
pneumonia which are killers in the developing as well as the developed world.
"The drug industry is saying that any disease that is profitable [to big
pharmaceutical companies] won't be included," said Mr Love.
A deal on cheap drugs is seen as essential to keep developing countries
engaged in the trade round, which was started at the behest of the US and
the EU just over a year ago.
Poor countries were signalling last night that they would be prepared to
walk away from the table, rather than accept the limited deal on offer from
the US.
Africa welcomes Cheney-led drugs deal
Leaders speak of great opportunity
by Kieren McCarthy
African leaders spoke with barely hushed tones of exuberance today as it became clear the US vice-president Dick Cheney had been behind a decision to allow poor countries across the world to pay full price for life-saving drugs.
Despite the US administration stated policy of protecting the world against all the bad people in it, Mr Cheney personally intervened when he realised that under WTO plans, poorer countries would be forced to pay low prices for drugs that would save millions of people.
"We don't want to risk upsetting these countries," Cheney said. "Which is exactly what will happen if we embarass them but not asking for the same price that we pay here in the US."
Pharmaceutical companies are also known to be distraught that they can't get the drugs to Africa, Asia and Latin America cheaper. "My whole life I have been trying to make drugs that enable people to live better and for longer," explained the CEO of Pfizer. "My dream is that the work we do can benefit the whole of mankind but now I hear that because Africa has insisted on paying the same price as everyone else, they won't be able to afford many of our drugs and so millions will needlessly die. It's terrible, I only wish I could do more."
It is little comfort to the big drug companies that they will see their profits rise thanks to enforced patent laws across the world, but they are not downhearted. "Okay, so we lost this one," the CEO of Merck told us. "But we're not beaten. We're gonna go back to the labs and try to create a whole new set of drugs before the patents run out. God willing, we shall overcome these obstacles."
Ironically, it costs the drug companies barely anything to produce the drugs and they could almost hand them out free without it significantly impacting their financial situation, but under the law they are forced to charge dozens of times the drugs' value.
Dick Cheney explained why the deal was so personally significant to him: "It is very important post *** Nine Eleven™ *** that the world sees that we are not a bullying nation, we are not a destructive nation, we have the whole world's concerns on our shoulders and we shall not falter in making this planet a better place for all."
Since many countries will be only be able to afford an eigth of the drugs they need, health experts say that Africa could become the most efficient health system in the world. "Africa is set to take the lead in world health," one told us. "Over-prescription is a massive problem in the West, with billions of drugs being needlessly purchased and consumed every year. With such a huge shortfall in supply, the Africans will have to come up with innovative and radical methods to keep patients alive. This is a very exciting time."
NOTE: *****[in the original story abovethe words 911 are trademarked!!!!]
Bush & Cheney: Multimillion-Dollar Men
The Bushes maintained trusts worth up to $1.1 million for each of their daughters, much of it in stocks that included Cisco, the Gap, IBM, Microsoft Corp., Procter and Gamble and Pfizer Inc.
The bulk of the assets amassed by the Cheneys is held in just seven investment funds — totaling between $15 million and $75 million. The vice president's assets also included undeveloped real estate in McLean, Va., worth $1 million to $5 million.
Captain Wardrobe