Health Impact News Editor Comments: Last year we covered the NBC News Dateline’s story regarding the FDA drug approval process, and their use of clinical research organizations in India that are used to conduct human trials on new drugs by major pharmaceutical companies. To test the drug approval process, NBC Dateline setup a fictitious medical company and then put together a plan to conduct drug trials on a drug that was identical to Merck’s Vioxx. Vioxx is now banned world-wide after causing an estimated 60,000 deaths, in what was possibly the most dangerous drug to ever make it to the market. Could such a dangerous drug be approved again? Dateline proved that indeed it can, thanks to unscrupulous practices in India where profit is valued over human lives. Watch the shocking undercover reports here: Are FDA Approved Drugs Safe? Don’t Bet Your Life On It!
Finally, the India Supreme Court has taken action against these clinical research companies!
India’s Supreme Court Orders End to Illegal Clinical Trials
by Vera Sharav
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
In the past decade India has emerged as a preferred site for drug trials by multinational pharmaceutical companies. India is said to have the largest pool of “naive” patients–i.e., untreated–in many disease areas, including caner and diabetes.
A non-governmental organization filed a public interest lawsuit in February 2012 complaining about unregulated clinical trials of new drugs conducted in India by multinational pharmaceutical companies.
India’s news outlets report that on Thursday, January 3, the Supreme Court heard the complaint and castigated the Union government “for being negligent in curbing illegal clinical trials despite the deaths of at least 2,374 persons who had undergone the dubious testing for unregistered drugs between 2007 and 2012.”
A parliamentary report estimated that currently 150,000 people are enrolled in clinical trials in India. It estimates that between 2009 and 2012, there were 352,475 people in India enrolled in pharmaceutical tests. That may change.
The Court stated: “The drug trials are creating havoc to the country.”
The Court admonished the government for negligence: “You have to protect the health of the citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stopped.”
The Court excoriated the government for foot dragging and using diversionary tactics:
“You can get back to the court but what about those people who are losing their lives in such clinical trials. People who lost their lives can’t get their lives back. It is very easy to form a committee or a commission. It is done just to divert people’s attention on the issue. It is the best way to divert attention on important issues.”
The BMJ notes that in April 2010, the Indian Council of Medical Research suspended a phase V post-licence clinical trial of vaccines against the human papilloma virus (HPV) amid allegations that the trial had violated rules on informed consent. As many as 25 000 girls in Andhra Pradesh and Gujarat received the vaccine.
The violation came to light when seven girls who received the vaccine died.
For recent in-depth investigative reports about large scale unethical drug trials conducted on India’s poor who have become human guinea pigs,
see: BBC News re-posted at: http://www.ahrp.org/cms/
see also, a two-part investigative report by LiveMint & The Wall Street Journal at: http://www.ahrp.org/cms/
It would appear that the judiciary is the only institution in India that cares about human rights and inhumane exploitation of India’s population.
Vera Sharav
India West: Supreme Court Flays Center for not Stopping Illegal Clinical Trials
Jan 03, 2013
The Supreme Court on Thursday slammed the Center for its failure to stop illegal clinical trials of untested drugs by multinational companies, saying the drug trials are creating “havoc” in the country and causing death of many citizens.
The apex court said that the government has gone into “deep slumber” on the issue and has failed to put in place proper mechanisms to stop “rackets” of multinational companies, which are conducting illegal clinical trials. A bench of justices R.M. Lodha and A.R. Dave said in its interim order that all clinical trials will be done under the supervision of the Health Secretary at the Center.
“You have to protect health of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stayed,” the bench said, asking the government to handle the “menace” on an urgent basis. It pulled up the government after it was contended that various committees have been set up to look into the issue and that it will come back to the court after getting suggestions from them.
“You can get back to the court but what about those people who are losing their lives in such clinical trials. People who lost their lives can’t get their lives back,” the bench observed. “It is very easy to form a committee or a commission. It is done just to divert people’s attention on the issue. It is the best way to divert attention on important issues,” the bench said
The court said that the government is “shying away” from responding to its queries while noting that the affidavit filed by the Center was not in consonance with its earlier order. On October 8, last year, the apex court had sought the reply of the Centre and various state governments on the allegation that human beings were being used as guinea pigs for clinical trials by drug companies.
It had directed the Union government to come out with details of the deaths, if any, and the side effects and compensation, if any, paid to the victims or their family members. The court’s direction came during the hearing of a public interest litigation (PIL), filed by NGO Swasthya Adhikar Manch, alleging large-scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests
The bench had, however, refrained from passing any blanket ban on the trials and, instead, sought a comprehensive reply from the Center on various issues. The NGO had alleged that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states. However, the Madhya Pradesh government had contended that the states cannot be faulted for the tests as the permissions for trials were granted by the Central government without consulting them.
The argument, however, did not impress the bench which had pointed out that the said clinical trials were conducted in state governments’ hospitals whose employees and doctors were under the control of the respective state governments. It had then proceeded to issue notices to all the states, through their chief secretaries, for their responses and posted the matter for further hearing after eight weeks.
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