Representatives of pharmaceutical giant, Merck, will face a hearing today in India’s Supreme Court over the company’s alleged practice of using young girls from poor tribal communities to test its controversial anti-cervical cancer drug, Gardasil, as well as a new version due out this year.
According to the Daily Mail, an Indian government committee found that Merck tested its Gardasil drug on children as young as nine years old without informing their parents. The committee concluded that these practices amounted to a serious breach of trust and medical ethics amounting to child abuse and were “a clear cut violation of the human rights of these girl children and adolescents.”
According to legal affidavits filed with the Supreme Court, none of the children involved in the trial were told they were taking part in a drug trial. In fact, their parents were allegedly told that their children would be getting a “successful foreign medicine”. The trials targeted the poor and vulnerable, and those children who suffered health problems as a result of the vaccine were given no health care or compensation.
“Documents lodged with India’s Clinical Trials Registry [CTR] reveal that trials of the drug – which during testing was known as V503 – also took place in the UK and 25 other countries,” the Mail reports.
This latest controversy also involves a similar vaccine, Cervarix, produced by GlaxoSmithKline, as well as the non-profit group, PATH, which organized the trials with the backing of the Bill and Melinda Gates Foundation.
Seven girls died before the trials were halted although the drug firms insist their deaths were not linked to the vaccine.
Many other children who were given the drug without their knowledge reportedly suffered problems such as weight loss, fatigue, dizziness and menstrual problems.
“In one trial more than 1,000 out of 7,071 subjects reported suffering headaches, with more than 200 reporting dizziness up to 15 days after the vaccination,” the Mail reports. “According to Merck, 305 people reported ‘serious adverse events’ and 321 reported new medical conditions ‘potentially indicative of systemic autoimmune disorders’.”
In fact, the company’s own report warns that some of the same adverse effects associated with the former version of Gardasil will be present in the latest version, known as Gardasil 9. These include deep vein thrombosis, immune system disorders, gastrointestinal disorders and nervous system disorders such as Guillain-Barré syndrome and motor neuron disease.
Jackiey Budden, mother of the reality TV star Jade Goody, who died in 2010 of cervical cancer, was outraged by the way Merck conducted these trials, saying that the testing of the drug on unsuspecting young children was “not right.”
“Vaccination is a good idea but it shouldn’t be tested on kids,” she told the Mail. “It is difficult because you want to save lives but it is not right to do it on children that young. They should be able to make up their own minds if they want to test it out.”
The new Gardasil vaccine which is designed to protect against the strains of Human Papillomavirus responsible for 90 per cent of cervical cancers, has just been approved for use in the U.S. and is due to be released this year.
Click here to learn more about the dangers of the Gardasil vaccine.
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