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DonaldWashington ago

'Big pharma' and clinical trials’
SCIENCE MUSEUM UK
- Pharmaceutical companies spend large sums on developing new drugs.
- Guidelines were introduced to regulate clinical trials on humans. These were the Nuremberg Code, developed after the Second World War; the 1966 Helsinki Declaration; and the 1974 establishment of the US National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research.

 

Ugly past of U.S. human experiments uncovered
NBC
FEB 2, 2011

  • “Shocking as it may seem, U.S. government doctors once thought it was fine to experiment on disabled people and prison inmates. Such experiments included giving hepatitis to mental patients in Connecticut, squirting a pandemic flu virus up the noses of prisoners in Maryland, and injecting cancer cells into chronically ill people at a New York hospital.”
  • “Much of this horrific history is 40 to 80 years old, but it is the backdrop for a meeting in Washington this week by a presidential bioethics commission. The meeting was triggered by the government's apology last fall for federal doctors infecting prisoners and mental patients in Guatemala with syphilis 65 years ago.”
  • “U.S. officials also acknowledged there had been dozens of similar experiments in the United States — studies that often involved making healthy people sick.”

 

Testing Drugs on the Developing World
THE ATLANTIC
FEB 27, 2013

  • The purpose of clinical trials is to find out if the newest wonder drug is all that wonderful, and what kind of side effects we humans might expect. It worked on animals, but will this drug kill people, and/or turn them green? Every warning you see on a label is there because a test subject -- or 50 of them, or 500 of them -- have suffered that side effect.

 

Hansjorg Wyss
Billionaire CEO of Synthes USA
In 2009, top executives at Synthes were indicted by U.S. Attorneys for Eastern Pennsylvania for using an untested calcium-phosphate-based bone cement on human patients without the authorization from the Food and Drug Administration, which resulted in the deaths of three people. Wyss was not indicted but four of Synthes' top executives were convicted and sentenced to prison terms.

 

‘Three people died in illegal human experiments carried out by John Podesta backer's firm’
WASHINGTON EXAMINER
OCT 31, 2016

  • Podesta, who was White House chief of staff under President Bill Clinton, and Wyss have been financially linked for years. Among the Swiss billionaire's largest gifts in recent years have been those made to the Center for American Progress.
  • Gurney, a former U.S. attorney, said, “Mr. Wyss was a highly involved owner of Synthes. The record shows that at the very beginning, it was he who made some of the very critical decisions that put the company on its ultimate pathway.”

 

‘Bad to the bone: A medical horror story’
FORTUNE
SEP 18, 2012

  • When medical device company Synthes decided to illegally test a bone cement on people, the results were disastrous. A disturbing tale of corporate crime and punishment.
  • Synthes not only disregarded multiple warnings that it was flouting the rules, but also brushed off scientists’ cautions that the cement could cause fatal blood clots.

 

Examples of unethical trials – SOMO

Trials on foster care children in New York (1997-2002)
Location: New York, New York USA
Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID), US National Institute of Child Health and Human Development (NICHD), Genentech, MicroGeneSystems, Lederle-Praxis Biologicals
- Phase I and II clinical trials were conducted on HIV-infected children and infants in the guardianship of New York City Agency for Children's Services (ACS), living at Incarnation Children’s Center in Harlem, a foster care facility under contract with ACS. The ACS provided consent for their participation. Children were forced to take the experimental medication that made them severely ill and had potentially lethal side effects.

 

Guinea Pig Kids
BBC
NOV 29, 2004

  • HIV positive children - some only a few months old - are enrolled in toxic experiments without the consent of guardians or relatives.
  • The city's Administration of Children's Services (ACS) does not even require a court order to place HIV kids with foster parents or in children's homes, where they can continue to give them experimental drugs.

 

’New York's HIV experiment’
BBC
NOV 30, 2004
- Jacklyn Hoerger's job was to treat children with HIV at a New York children's home. - But nobody had told her that the drugs she was administering were experimental and highly toxic.

 

ART treatment interruption trials (2003–2008) (DART trial)
OXFORD JOURNALS
Location: Uganda, Zimbabwe, Côte d’Ivoir
Sponsors: UK Medical Research Council (MRC), Rockefeller Foundation, GlaxoSmithKline, Gilead, Boehringer-Ingelheim

 

Tenofovir trials on HIV transmission (2004–2005)
THE LANCET
Location: Cameroon, Thailand, Nigeria
Sponsors: Gilead, US CDC, Bill and Melinda Gates Foundation

 

SFBC Miami Test Center (2000-2005)
FLORIDA TREND*
MAR 1, 2007
Location: Miami, Florida, USA
Sponsors: Pfizer, Merck & Co, Johnson & Johnson, Schering-Plough, Theravance, Purdue Pharma, AstraZeneca, and others

 

Risperidone trials in India (2003?)
Location: Gujarat, India
Sponsors: Johnson & Johnson
Drug trials outsourced to India
BBC
APR 22, 2006

 

  • During a trial for the treatment of acute mania, psychiatric patients were taken off their existing medication and told that it was discontinued and no longer available. They subsequently received risperidone or a placebo. This was controversial because the patients receiving a placebo could suffer unnecessary harm by being taken off their medication. One patient explained that he signed a form because the doctor required it, but had no idea that he was participating in a clinical trial.