Glaxo In Developing Countries: GSK’s Indian Guinea Pig Kids…


REP GLAXO

It’s interesting to note that GSK were named as one of RepRisk’s most controversial companies in 2013. That’s 5 years after CEO Andrew Witty took the helm and promised that all of GSK’s bad behavior was from ‘another era’. This fabled era which Witty keeps harping on about perhaps relates to GSK’s illegal an unethical behavior under Witty’s predecessor JP Garnier.

However, Andrew Witty was a high ranking corporate executive during JP’s reign and has been with GSK since 1985, therefore it’s kind of puzzling that he would try to allude that GSK’s unethical behavior has nothing at all to do with him or his leadership, surely as an employee of some 40 years, Witty would have some knowledge of what GSK get up to?

Furthermore, even after GSK settled a 3 Billion dollar fine (from the brave and courageous whistle-blowing claims of previous GSK employee Greg Thorpe) in 2012- which apparently were to put an end to GSK’s corruption and bribery era- they were still named as one of the most controversial companies of 2013. They attained this accolade from their various ethical and moral transgressions such as a half a billion dollar fine (and sentencing of GSK staff from) their vast bribery network uncovered in China and US office of fair trading accusations in relation to Seroxat and Wellbutrin violations etc, in 2013.

One of the most disturbing aspects of the RepRisk report is Glaxo’s testing of vaccines on young girls in India-

See the following links for more on this-

http://www.pharmaceutical-technology.com/news/newsgsk-msd-accused-of-conducting-illegal-vaccine-trials-on-indian-girls

GSK, MSD accused of conducting illegal vaccine trials on Indian girls

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8 January 2013

Gardasil

Indian activists have accused GlaxoSmithKline and MSD Pharmaceuticals of conducting illegal tests of their HPV vaccines on tribal girls in Andhra Pradesh and Gujarat.

The Supreme Court said on Monday that the local activists filed a public interest litigation (PIL) alleging that the companies tested two unproven HPV vaccines designed to prevent cervical cancer – gardasil and cervarix – on 24,000 girls, including 44 patients at the Maharaja Yeshwantrao Hospital.

Of these 44 patients tested, 10 were male, said the report.

The Times of India reports that the PIL, filed by Kalpana Mehta of Indore, Nalini Bhanot and V Rukmini Rao representing Gramya Resource Centre for Women, alleges that the testing led to adverse effects on the girls’ health.

Seven girls allegedly died during the vaccine trial.

Justice S Radhakrishnan and Justice Dipak Misra have directed the Union government to immediately file its reply on the issue.

The Christian Medical College, Vellore, has also been asked by the apex court to examine the medical records of the girls in question.


November 18, 2013 9:13 am

Vaccination scandal taints reputation of India drug trials

About 72,000 Indian women die each year of cervical cancer, a disease caused by the human papillomavirus. Many of these deaths are preventable by vaccines already widely used in the US, Australia and Europe, and included in their recommended immunisation protocols.

In 2009, Path, a US-based health charity, launched a project funded by the Bill and Melinda Gates Foundation to study the cost and feasibility of incorporating HPV vaccines, produced by Merck and GlaxoSmithKline, into India’s public sector immunisation programme.

However, the programme to vaccinate 14,000 adolescent girls from poor families ran into trouble after seven died soon after their vaccinations. The ensuing media and political storm – highlighting sensitivities around drug trials in the developing world – has contributed to the restrictions on such studies, affecting both Indian and global pharmaceutical companies.

The causes of the girls’ deaths were never established or conclusively linked to the HPV vaccine. But serious questions were raised over whether the participants’ parents – many of whom were illiterate – had given informed consent, and whether the project adequately tracked any adverse reactions.

In August, an Indian parliamentary committee set up to probe the issue concluded the Path project was a clinical trial in all but name and that the organisation had used “subterfuge” to avoid the “arduous and strictly regulated process” of such a trial.

The committee report said many of the girls’ consent forms had apparently been signed by school principals and hostel wardens, and expressed scepticism that the girls’ parents were fully briefed on the pros and cons.

The committee also found there was no rigorous process to track adverse events, leading to “gross underreporting”. It came down hard on Indian government agencies for alleged dereliction of duty.

“The safety and rights of the children in this vaccination project were highly compromised and violated,” the report said.

It also claimed that Path’s “sole aim was to promote the commercial interests of HPV vaccine manufacturers, who would have reaped windfall profits had Path been successful in getting the HPV vaccine included” in India’s immunisation protocols.

Path called the parliamentary report an “inaccurate characterisation of this important work” and said it disagreed with its “findings, conclusions and tone”.

The organisation said the HPV project was driven by its belief that “poor and low-income girls in India should not be deprived of the right or access to this proven, life-saving and safe vaccine that wealthy and middle-class girls in India and around the world have access to through the private market and other public immunisation programmes”.


Home GlaxoSmithKline accused of illegally administering vaccines leading to the death of children in India

http://www.australiannationalreview.com/indian-sc-raps-government-inaction-illegal-drug-testing/

GlaxoSmithKline accused of illegally administering vaccines leading to the death of children in India

Apr 4, 2016

 By: Atreyee Chowdhury

 

drug testing
The Indian Supreme Court has sought answers from the government in a case involving tribal children, who were allegedly inducted into a drug trial without their consent years ago, and died because of the consequent reactions. The court criticised inaction on the government’s part and gave it a month’s time to respond.

Some children out of a group of selected children died after being injected with Merck’s Gardasil vaccine. The vaccine is manufactured by GlaxoSmithKline.

According to some campaigners, a study, promoted by Bill and Melinda Gates Foundation, failed to obtain consent from children or their parents before they were administered with the drug. The allegations, if proved, would mean that the drug companies conducted an illegal drug trial on the children.

The petitioners also asked judges to look into the way trials were conducted with Merck’s new cervical cancer vaccine, Gardasil 9. Research by MailOnline, revealed that some children showed abnormal symptoms after they were administered the drug. Gardasil 9, is expected to generate £1.2 billion a year in sales.

The Indian Council of Medical Research (ICMR) had in 2010, asked state governments to suspend the cervical cancer control vaccination programme for girls after four deaths and complications among 120 girls were reported. The girls complained of stomach disorders, epilepsy, headaches and early menarche.

An investigation by an Indian parliamentary committee had previously concluded that the trials amounted to a serious breach of trust and medical ethics. Merck and GSK have both been ordered to respond to the allegations made by campaigners.

After taking into consideration the arguments from campaigners, the judges also ordered the government to produce an opinion on the issue of liability and compensation, which was welcomed by lawyers.

Speaking to Daily Mail, Kerry McBroom, one of the lawyers, said, ‘It is a very encouraging development that the judges are now discussing accountability and not just accountability but also compensation, so the tone of the hearing today was very positive for us because it’s clear from all the parties, including from government reports, that there were, at best, serious irregularities and, at worst, gross violations of fundamental human rights.’

The court expressed its unhappiness that the government had not come out with concrete action following the parliamentary committee’s findings. It gave the government a month to explain what action had been taken to investigate and what efforts had been made to obtain the consent of those taking part in the trials.

Gardasil is a drug that is used to prevent cervical cancer, which is the second most common type of cancer in women and kills more than 265,000 people every year according to Cancer Research UK.

 

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