ACRO detailed its concerns about the new draft in a letter to Indian Ministry of Health Family and Welfare (MHFW) secretary Arun Panda last week, arguing that ethics committees are not best placed to make such determinations, particularly if the institutions with which they are affiliated could be impacted by their decisions.
The US-based organisation’s other major worry is that ethics committees lack the scientific and medical knowhow necessary to accurately identify SAE causation and, hence, the level of compensation appropriate.
John Lewis, ACRO’s VP of told Outsourcing-pharma.com that: “EC’s have no particular expertise in causation and certainly no expertise in compensation calculations. Causation should be determined largely by scientific and medical professionals and compensation by people with expertise in this area, like insurance or law.
Instead ACRO believes a Central Drugs Standard Control Organisation (CDSCO) approved expert panel – including an investigator, representatives of the sponsor and CRO involved and two non-affiliated medical experts – would be a better option.
Lewis said “We have no problem with the EC being represented on some type of independent panel to determine causation and compensation…[which] would only be needed when there is some disagreement over the cause of death and if a panel cannot reach a decision there should be an independent appellate system to make a final determination of causation.”
Media and political criticisms
ACRO’s reaction is understandable given that its members conduct around two thirds of the clinical trials that take place in India each year.
The organisation’s comments also come as the contract research sector in India faces considerable media and political criticism about how trials are conducted in the country – particularly in relation to how the families of people who die or who are injured in trials are compensated.
Just this week the AFP and the BBC reported that 12 doctors have been fined by the Madhya Pradesh state government for failing to gain patient consent during trials in the city of Indore.
And, according to a report in The Hindu, one former government minister has called for “stringent action” to “eliminate the gross violations of the law in the conduct of clinical trials of which the Indore trials are a classic example.”
The US media has also been critical.
This week the Washington Post reported that a Madhya Pradesh government probe – which is presumably different from the one covered by the AFP and the BBC although no further details are given - found that six doctors had violated ethical standards in gaining consent.
The article goes on state that: “Across India, 1,700 people who participated in clinical drug trials died between 2007 and 2010, the government’s drug regulatory agency said, although no autopsies were carried out to determine the causes of the deaths.”
This prompted criticism from ACRO, which published a rebuttal story on its website.
Lewis told Outsourcing-pharma.com that: “There is little or no original reporting here or any new information added to these articles. It is lazy journalism. More to the point, stating that there were 1,700 deaths in clinical trials is completely irrelevant.
“The absolute number of deaths in clinical trials is going to be driven by the total number of people who participate and their health status. People with terminal illnesses are going to die whether or not they are in a clinical trial so an absolute number is meaningless.
The more relevant statistic – Lewis argues - is the number of people who die as a direct result of their participation in a clinical trial due to a trial procedure, an investigator’s negligence or deviation from protocol or some other factor was a direct cause of death.
“The real question,” he said “is how many deaths occurred as a direct result of the clinical trial. For journalists – and Indian politicians - this is an inconveniently smaller number” adding that – between 2007 and 2010 - compensation was paid to the families of 22 people who died during studies.