Citizens' Issues
Clinical trial process to be further streamlined: Government

According to the Health Minister, the proposed Committee of Experts would give its recommendations for compensation in case of injury or death during clinical trials to the DCGI to decide the final amount within three months

New Delhi: Procedures for clinical trials in India will be further streamlined and a panel of experts set up to analyse the cause of injury or death and to recommend quantum of compensation to victims, the Government said on Thursday, reports PTI.
Replying to a Calling Attention Motion on the issue in Rajya Sabha, Health and Family Welfare Minister Ghulam Nabi Azad said the government proposed to strengthen the rules by incorporating certain new provisions soon.
He said the proposed Committee of Experts would give its recommendations for compensation in case of injury or death during clinical trials to the Drug Controller of India (DCGI), to decide the final amount within three months.
The Minister said the proposals include that "in case of injury, the sponsor will provide medical care to the person concerned as long as required" and "there would be specific provision in Rules for payment of compensation to the affected persons/their nominees for trial related injuries/death".
Azad said the investigator shall report all serious adverse events, including death, to the DCGI as well as sponsor company and Ethics Committee within 24 hours of occurrence.
The Minister also assured the members that the government was seized of the sensitive matter and was taking steps to further streamline the procedure for clinical trials.
He said as per available data, the number of Serious Adverse Events (SAEs) of deaths in clinical trials reported during 2010, 2011 and up to June 2012 are 668, 438 and 211 respectively. He, however, said the SAEs of death due to clinical trials were 22 and 16 in 2010 and 2011 respectively.
During the discussion initiated by P Rajeeve (CPI-M), members expressed concern over the increased deaths during such trials.
Azad said the government proposed to modify the Informed Consent Form to include the socio-economic background of the person participating in the drug trial and his/her nominee's address. Requirements and guidelines for registration of Ethics Committee would also be prescribed in the rules.
Noting that death during clinical trials has been taken very seriously by the Government, he said, "The Government has taken concrete steps to strengthen the approval procedures, monitoring mechanism for clinical trials as well as to ensure that safety, rights and well-being of persons participating in clinical trials are protected.
Azad said a number of measures have already been taken for streamlining the procedure for clinical trials including making registration of clinical trials in ICMR registry mandatory since 15 June 2009.
He said among the measures taken include setting up of 12 new Drug Advisory Committees comprising leading experts to advise the Central Drugs Standard Control Organization (CDSCO) in matters relating to approval of clinical trials and new drugs.
Six Medical Device Advisory Committees have been set up by the government and a general experts pool for medical device advisory committees has also been set up, he said.
Besides, applications of investigational new drugs (IND) which have never been earlier used on human beings are also being evaluated by the IND committee chaired by the Director General, Indian Council of Medical Research.
Azad said every approval for conducting clinical trials now includes a condition that in case of study related injury or death, applicant will provide complete medical care as well as compensation and statement to this effect should be incorporated in the consent form.


Kasab's mercy petition: Who will take the call, President or Home Minister?

While Pratibha Patil's regime was labelled as ‘merciful’ by some activists for pardoning as many as 35 death convicts, the former president says she took the decision only after receiving advice from the home minister. The question is will the new home minister Sushilkumar Shinde provide right advice in the case of Ajmal Kasab?

While there is a general perception that the president is the final authority to take a call on mercy petitions of death convicts, it may not be the case. As many as 11 mercy petitions of death convicts are pending before Indian President Pranab Mukherjee, however, during 2009-12, the ministry of home affairs (MHA) recalled 26 mercy petitions to review its advice. Acting on the reviewed advice from MHA, the then President Pratibha Patil decided on 18 cases, reveals a Right to Information (RTI) reply.


According to reply received by RTI activist, Subhash Chandra Agrawal, there are 11 mercy petitions pending before President Mukherjee, including that of Parliament attack accused Afzal Guru. At present there is only one file of Balwant Singh Rajoana, killer of former Punjab chief minister Beant Singh, pending with the MHA.


Even, former President Pratibha Patil admitted that she disposed the clemency petitions only after due examination on receipt of the aid and advice of the home minister. “All the 23 backlog cases pertaining to the terms of the former presidents were recalled and re-visited by the present home minister and fresh advice tendered for due consideration of the president. In all these backlog and fresh cases, the home minister has examined the mitigating and extenuating circumstances and spelt out specific reasons substantiating his considered advice,” said a release from the President’s Secretariat .


The release issued in June 2012, further says, “Article 72 does confer on the President the power to grant clemency. However, in the exercise of these powers, the President is not supposed to act on her own judgment but is mandated to act in accordance with the aid and advice of the Government in terms of Article 74 of the Constitution. The advice of the Government is binding on the Head of State. This has been authoritatively laid down by the Supreme Court. Thus, the power to pardon is a part of the constitutional scheme and not a private act of grace on the part of the President. When the President is expected to work as part of the constitutional scheme, the word, President, is an abbreviation for the Central Government.”


According to Mr Agrawal, every convict of a death sentence gets opportunities at different stages of trial till the Supreme Court, in rarest of rare-most cases, endorses the death sentence. “Latest RTI response reveals that 26 files of mercy petitions were recalled from Rashtrapati Bhawan out of which in most cases death sentence were reviewed by the MHA to be converted in to life sentence. It is unjustified to interfere so liberally with the Supreme Court decisions. System may be formulated whereby it may be made mandatory to hear family members of victims before pardoning convicts of death-sentence,” he said.


While delivering the death sentence to Pakistani terrorist Ajmal Kasab in the 26/11 Mumbai terror attack case, the Supreme Court pointed out that the object of the criminal law process is to find out the truth and not to shield the accused from the consequences of his wrongdoing.


A bench of justices Aftab Alam and CK Prasad said as long as the death penalty remains on the statute book as punishment for certain offences, including “waging war” and murder, it logically follows that there must be some cases, howsoever rare or one in a million, that would call for inflicting that penalty. “That being the position we fail to see what case would attract the death penalty, if not the case of the appellant,” the bench said.


Refusing to show any mercy to Kasab on account of his young age and illiteracy, the apex court observed, “…the offences committed by the appellant show a degree of cruelty, brutality and depravity as in very few other cases. It is already seen above that the appellant never showed any repentance or remorse, which is the first sign of any possibility of reform and rehabilitation.”


Kasab, the only Pakistani terrorist caught alive in the mayhem that killed 166 persons is lodged in Arthur Road Prison in Mumbai, was sentenced to death by a special anti-terror court on 6 May 2010, which was affirmed by the Bombay High Court on 21st February last year. Nine other Pakistani terrorists were killed by security forces in the operations.


Abnormally high delay in deciding mercy petitions and also subsequent execution in case of rejection of mercy petitions unnecessarily creates provocation including even state assemblies passing resolutions for pardon on religious and regional backgrounds says Mr Agrawal. “Even the division bench of the Supreme Court has expressed concern on such policy of indecision which is even torturous for convicted ones living in a life of uncertainty apart from creating unnecessary emotions and provocation, diluting fear against committing the crime. Rule should be to finally decide on mercy petitions within three months of their filing and hanging done within one week of rejection of mercy petition. Indecision can repeat incidents like infamous hijack of IC-814 at Kandhar to get death convicts like Afzal Guru and Kasab freed before being hanged,” the RTI activist added.


The question now is whether the newly-appointed home minister Sushilkumar Shinde would provide timely advice to the new President Pranab Mukherjee, a veteran in Indian politics, or keep the files pending.




5 years ago

President/Home Minister to endorse death penalty for Kasab is easy and will be supported by the vast majority in India. Only people who want abolishment of capital punishment, as many countries have done, will object, but I presume they are in minority. The problem for India is that we have some strong parochial forces, that want their kind not to face the gallows even for the most dastardly crime. Examples: Sikh terrorists/killers of Punjab CM and Indira Gandhi are supported by Akali dal, LTTE assasins of Rajiv Gandhi are supported by the Tamil Parties, Afzal Guru is supported by Kashmiri separatists and some muslims, even investigation of safron/hindu terror has been severely objected by BJP.
India has to stand firm against all such divisive and anti-national politics.

Death takes a policy: We answer questions from readers

The story of Joseph Caramadre moved dozens of ProPublica readers to debate the ethics of insurance and corporate behaviour

Readers reacted strongly — and thoughtfully — to our story about how a Rhode Island man recruited terminally ill people so he could cash in on lucrative annuity contracts offered by life insurance companies.
A few scorned Joseph Caramadre, now facing a 66-count criminal indictment, for what they saw as his exploitation of the terminally ill. Most saved their ire for the insurance companies and took less moral offense at Caramadre, noting that the dying participants received money, even if it was much less than Caramadre and his investors made.
Readers also raised some good questions; here are our answers. We will update as we get more.
How is this different from "Dead Peasant” insurance policies? via Dean Muller
So-called "dead-peasant” policies, or corporate-owned life insurance policies (COLI), involve companies taking out life insurance on their employees. This practice landed a number of companies in court a few years ago when employees complained that they didn't know what their employer was doing. More recently, Louisiana's legislature considered allowing the state retirement system to take out life insurance on state employees — as a way to reduce pension debt. The bill appears to have been dropped.
Regular life insurance covers an individual and is paid out when that person dies. Caramadre worked with variable annuities, which are different than life insurance. There are three players in a variable annuity contract: an investor, a beneficiary and someone called an annuitant. The annuitant acts as a "measuring life,” whose death triggers a payout — either the return of an original investment or the value of the investment account, whichever was greater — to the beneficiary. In Caramadre's case, the investor and the beneficiary were one and the same.
One potential similarity to the dead peasant policies involves the allegations made by prosecutors against Caramadre. They maintain that the terminally ill annuitants whose deaths triggered the payouts did not fully understand Caramadre's scheme or their role in it.
How did investors other than Caramadre make money on the scheme? via Justin Burke
There were two ways to profit. Caramadre's investors would put money into a variable annuity, which would then be invested in one of the funds offered by the insurance company. If the fund's value rose, so would the investment. Potentially it could grow to be worth more than the death benefit. But many of the companies also offered death benefit sweeteners, such as bonuses or ratchets. These could make the death benefit worth more than the original investment. For example, if the company offered a 6 percent bonus, investors who put in $1 million would automatically have $60,000 added to the death benefit. When the annuitant died, if the death benefit was greater than the amount of the investment account, the investor would pocket the bonus.
What exactly do prosecutors allege was illegal about this? via Chris
The indictment asserts that Caramadre and his associates obtained the identity information of terminally ill people without their knowledge or consent through misrepresentations and in some cases forgery. They then used this identity information to obtain millions of dollars from insurance companies and bond issuers. The indictment does not allege that the terminally ill people were defrauded of any money themselves. Rather, their identity information was misappropriated so that Caramadre and his associated could profit from their deaths.
Where did Caramadre come up with the $2,000 figure? via Zach
I don't know how Caramadre arrived at $2,000 for the initial payment. In an effort to identify people with terminal illnesses, Caramadre in 2008 advertised that he would give $2,000 to every dying person who contacted him whether or not they agreed to become an annuitant. According to court records, more than 150 received the $2,000. If they wished to participate, they received even more money, typically between $3,000 and $10,000 depending in part on how many contracts they did.


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