2,644 died during clinical trial of drugs in 7 years: Govt to SC - Times Of...

http://articles.timesofindia.indiatimes.com/2013-04-25/india/38816045_1...

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2,644 died during clinical trial of drugs in 7 years: Govt to SC

Dhananjay Mahapatra, TNN Apr 25, 2013, 09.13AM IST

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Tags: Novartis

| Ministry of Health | clinical trial of drugs

NEW DELHI: As many as 2,644 people, called subjects, died during the clinical trials of 475 new drugs on human beings in last seven years and only 17 of the medicines were approved for marketing in India, the Centre has informed the Supreme Court. Responding to allegations by NGO, Swasthya Adhikar Manch, in its PIL that Indians were used as guinea pigs by foreign pharmaceutical majors for human trial of their new drugs, the Union health and family welfare ministry said of the 57,303 enrolled subjects, 39,022 completed the clinical trials.
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"Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials," health secretary Keshav Desiraju said in an affidavit on behalf of the ministry of health and family welfare. "Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials," he said. Clinical trial of two drugs - Bayer's Rivaroxaban and Novartis's Aliskiren vs. Enalapril accounted for maximum number of deaths. Bayer's Rivaroxaban was first used for human trials in 2008 resulting in death of 21 of which it claimed that only five were related to clinical trial but it has till date paid compensation to kin of only two. Two years later, the same drug was again put on human trial and this time 125 deaths were reported, of which it was stated that five were related to clinical trial. Novartis used the investigational product listed as Aliskiren vs. Enalapril last year and it resulted in death of 47 of which only one has been attributed to clinical trial of the new drug. Only another clinical trial of new drug on humans, Sun Pharma's Paclitaxel injection concentrate for nano-dispersion, registered a double-digit death figure (12) during the last seven years. Majority of the pharmaceutical companies, whose drugs were permitted for clinical trial on human beings, were of foreign origin. The secretary promised to the court for stringent regime on clinical trials on the

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2,644 died during clinical trial of drugs in 7 years: Govt to SC - Times Of...

http://articles.timesofindia.indiatimes.com/2013-04-25/india/38816045_1...

recommendations of the Parliamentary Standing Committee, which faulted the Drugs and Cosmetics (Amendment) Bill, 2007. He said: "On the advice of the ministry of law, the health ministry has proposed to withdraw the 2007 Bill and introduce a new Bill in its place after incorporating the recommendations of the Standing Committee. Accordingly, the ministry will introduce Drugs and Cosmetic (Amendment) Bill, 2013 in Parliament during the Budget session." On January 3, the apex court had pulled up the Centre for its insensitivity to scores of deaths and serious adverse effects to thousands during clinical trial of new drugs and asked the health secretary to monitor implementation of the supervisory and scrutiny mechanism for human experiment of new drugs. Referring to a parliamentary committee's stinging report pointing out involvement of foreign pharmaceutical multinational companies in a big way in the clinical trial of new drugs and the need for a thorough review of the existing mechanism, a bench of Justices R M Lodha and A R Dave had said, "The government has slipped into a deep slumber and doing nothing." It was about to issue an order banning all fresh clinical trial of new drugs on humans, but additional solicitor general Siddharth Luthra had pulled out the government from an embarrassing spot by promising that the health secretary would personally monitor implementation of the new stricter regime.
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The health secretary stressed the importance of clinical trials of new drugs on humans. "During the last 40 years, about 900 drug molecules of different therapeutic categories have been approved for marketing in India. Out of these 900, only seven drug molecules have been discovered and approved in India. Rest of them are discovered and developed in other countries like US, EU, Japan after going through complex process of research and drug development including clinical trial in human beings," he said.
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2,644 died during clinical trial of drugs in 7 years: Govt to SC - Times Of...

http://articles.timesofindia.indiatimes.com/2013-04-25/india/38816045_1...

Readers' opinions (177)

Sort by: Newest | Oldest Alben Sigamani (Bangalore, Karnataka) 26 Apr, 2013 12:22 AM To The Chief Editor Being a national newspaper that claims to have the largest circulation and readership should take care to not make news purely to create a sensation, but has the ethical responsibility of telling the people the truth. Your title says 2644 deaths in clinical trials but the reporter himself says that only 80 of them were attributable to clinical trials. So your title is clearly misleading. Clinical Trials are always done with the approval of an Institutional Ethics committee, regulatory approval and informed consent of the participants of clinical trials. Agreed we do have challenges with higher illiteracy rate and there have been instances of misguiding people to participate in clinical trials. But Indians have never been subjected to the brutal intentional harms that have happened in the past in many of the developed countries. Currently there are very effective guidelines that prevent and protect intentional harm to human beings when they are participating voluntarily in a clinical research study. In fact they are given much better care than their fellow patients who have the same illness but are not part of a clinical trial. Deaths in clinical trials are important outcomes. They are captured in detail in all clinical trials. Only in a clinical trial would you know the exact time, date and possible cause of death. Unlike in real world, where there is no proper documentation of deaths, in a clinical trial, the investigator and the sponsor take every effort to understand the sequence of events that led to the death of its participant. This is important for the trial and is also a ethical requirement. All these events are reported to the DCGI in a timely manner and also captured in detail at the site. That is why the DCGI was able to produce the details to the Supreme court and that is the information you have published in the newspapers. If your intention is to protect the population of this country, please publish facts. You mention names of clinical trials and some of the drugs that were tested in them. Why do you not report the number of patients that participated in these trials, how many of them received the treatment and of them how many lives were saved. It is only through well conducted clinical trials, advances in medicine happen. Not doing randomized controlled trials that will lead to dangerous, spurious, ineffective medications entering into the market and you will never know when someone close to you will be affected by this situation. Will you not seek the most advanced treatment available for treating a stroke or a heart attack if it involves you or a next of kin. How do you think the doctor will know for sure that he/she is choosing the best medicine. So my humble appeal to you and all leading newspapers that plan to publish this report, - please do not do this with the intent of killing clinical research in India, because that is clearly "suicidal". Raviraj Pardeshi (Nagpur) replies to Alben Sigamani 26 Apr, 2013 11:34 AM Sir, Well done. The inputs like this are essential. In fact, the NGO who is getting the information through RTI, should visit the sites where the trials are being conducted and should see the fact how they are conducted. Majority of the clinical trial participants would not have received proper medical care, had not they been a part of trial. Also, the same NGO should realize that the drug(s), if marketed will be available to them or their kin. They should respect and salute all those who keep themselves at some risk in order to know that the drug is safe and useful. Shweta (Brookfield) 25 Apr, 2013 10:22 PM Exploitation of Indian population, really bad Sasi Kumar (Kottayam) 25 Apr, 2013 10:21 PM We all know that the governments at the Centre and in states have no value for human life when they are Indian! Remember, we took no action when an Indian was killed in Italy. Now that they are dead, will the government at least fne the companies heavily for doing tests without permissions? So that, possibly, more deaths can be prevented? Or, will the government continue to sleep till the next elections? Swati Sharma (Noida, India) 25 Apr, 2013 08:45 PM

so sad Siddhi Kamraj (Peace Planet) 25 Apr, 2013 06:30 PM

Its so sad....did people who opted for testing knew about it...or were they briefed on the possible outcome and then taken into tests! I don't think so....Its Inhumane. Zeenat (Kanpur) replies to Siddhi Kamraj 26 Apr, 2013 12:53 AM sister siddhi, leave testing ,solve my problem. how you convinced your parents to marry a Hindu Boy.Please guide,if it is necessary to change Religion and name as you did after marriage. READ ALL COMMENTS

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