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No violations in Bhopal televancin (Vibativ) trial: Quintiles

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Tuesday, August 10, 2010, 20:02 This news item was posted in Clinical Trials category and has 0 Comments so far.

No ethical violations involved and proper procedures were followed in the course of antibiotic televancin trial conducted at the Bhopal Memorial Hospital and Research Centre (BMHRC) in Madhya Pradesh, stated clinical trial major Quintiles.

“All approvals were obtained from the relevant regulatory bodies and ethics committees before the trial began,” the North Carolina, US-headquartered Quintiles has stated.

Recently, India’s drug regulator has ordered a probe into one of the clinical trials that were conducted at Bhopal Memorial Hospital and Research Centre (BMHRC) following reports that the unethical drug testing on gas tragedy victims led to the death of three patients.

It was reported earlier that several drugs unrelated to the conditions suffering due to the exposure to methyl-iso-cyanate (MIC) gas leak by the Bhopal tragedy victims unethically.

Ass many as seven different drugs were being tested in Bhopal gas tragedy victims at BMHRC between 2004 and 2008 and at least 10 deaths occurred during these trials, reports said.

One of such medicines reportedly being tested in Bhopal gas tragedy victims was antibiotic televancin developed by Theravance Inc of US. Televancin is currently sold under the brand name Vibativ in certain markets.

The Drug Controller General of India (DCGI) has issued an order to the Bangalore office of Quintiles Transnational Corp., the world’s largest pharmaceutical services company, to audit the human clinical trial.

“We will audit the data available with the company following the completion of the trial,” a health ministry official was quoted as saying.

Clinical trial audits were supposed to begin in September but following the news of the trials at BMHRC, the ministry has advanced them to start next week.

Theravance and its contract clinical research organization (CRO) Quintiles completed the trial in India in June 2007 after having screened eight subjects for the trial, while only four completed the trial. During the one-year period of the trial, three deaths occurred.

The Bhopal Memorial Hospital and Research Centre, which was set up in the year 2000, with the objective to provide super-speciality treatment to the Bhopal gas tragedy survivors.

The research centre was also carrying out studies on long term effects of methyl-iso-cyanate (MIC) poisoning.

Over the years, the Bhopal Memorial Hospital and Research Centre has become a testing laboratory for various new drugs from MNCs which are in no way connected to the adverse effects of MIC gas poisoning.

Instead of encouraging new therapies which could alleviate their suffering, the unsuspecting victims of the Bhopal MIC disaster, are being exploited as testing animals for untested drugs with unknown effects, reports alleged.

In places like Bhopal, which are considered disaster areas, the medical research should be aimed at developing solutions to effectively deal with the problems resulting from the event and similar such events in future and not drug studies that are non-specific to the event.

Reports also alleged that the trials of the medicines with unknown efficacy and side-effects are often conducted on patients non-professional manner. The standard practice guidelines for clinical trials set by the Indian Council for Medical Research (ICMR) — the apex policy making body under the government of India –does not allow mixing medical care with clinical studies.

If an investigative medicine is given to the patient the the investigator physical should inform the patient about the possible effects and side-effects of the drug to the patient. In certain cases where in the patient is too illiterate to make an informed decision the “informed consent” from the patient should be obtained by a third party such as a neutral, independent physician or in the presence of an NGO.

ICMR code of conduct in clinical trials also restrict the studies using new drugs in patient populations with reduced autonomy. The patients should be free to decide on the drugs to be administered on them by the medical practitioners.

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