Children Die in an Outsourcing Boom

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By J. Sri Raman

Stories of children's deaths do not shock India too much. Over 2.1 million kids die every year in the country before they reach the ripe age of five, according to a count by the United Nations Children's Fund (UNICEF) in its State of the World's Children 2008 report. The fate of 49 babies, however, fell in a different category.

They died during clinical trials at New Delhi's All-India Institute of Medical Sciences (AIIMS), which it is obligatory for the nation's media to describe as either "premier" or "prestigious," during the last two and a half years. The institute parted with this news in response to a query from a non-profit organization that sought it under a recently enacted law investing the citizen with a "right to information."

The AIIMS pediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since January 1, 2006. As if to soften the impact of the information, the institute added that the deaths amounted to a 1.18 percent mortality rate.

The belated announcement of the unmourned baby deaths has brought to light a major issue that sections of the media and the middle class - busy hailing India's "economic boom" - have preferred to ignore. Can they continue to evade the issue of the outsourcing of clinical trials of drugs and therapies by the US and other Western pharma giants and the outrageous health and human costs of such operations?

The man who has made it a public issue minces no words about the meaning of the cradle deaths - the guinea-pig role reserved for the country's poor in the scheme of things of the elite set on making India a glittering "economic power." Rahul Verma, founder of New Delhi-based Uday Foundation for Congenital Defects and Rare Blood Groups, reiterates that he and his foundation were mainly concerned about the "socioeconomic conditions" of the strata that provided the tender subjects of the clinical trials.

The AIIMS did not answer his question on this count, but Verma points out that the poor of India alone could be tempted by the trials as they could not afford private medical care, while public heath care was in a pathetic state. The institute provided no information about the reasons for the babies' deaths, their ages or their gender, since he had not specifically asked for it.

Talking on the telephone to Truthout, Verma confided that he had named his foundation after his son Uday, suffering from congenital defects and undergoing surgical treatment since his birth just two an a half years ago. "You can watch your father die, but not your child die," said Verma. He cannot watch the children of the poor die, either, only to save research and development costs for some of the world's richest merchants in medicare.

Verma finds particularly "scary" the fact that such a big proportion of the babies were under one year old. It troubles many medical practitioners that the trials of at least two of the drugs involved should be conducted on even the age group of one to 16 years. The drugs - olmesartan and valsartan, meant for reducing blood pressure - have never been tried on patients below age 18, according to Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties.

In a media interview, he asks: "Is hypertension in this age group a problem in India? If yes, what is the incidence and prevalence? If it is not a major problem, why conduct a trial in India and put children at risk without any benefit?"

The AIIMS tragedy has also raised questions afresh about the official moves afoot to make such clinical trials even easier and more common than ever - all as a part, of course, of an Indian economic miracle in the making. Powerful lobbies for local industry have long pleaded for steps to liberalize the trials, arguing that the country's earnings from them could increase tenfold if annoying obstacles were out of the way. The plea has not gone unheeded.

The plea is for revising present regulations of the trials, conducted in three phases. Phase I trials test a drug's safety on healthy volunteers. Phase II and III trials test larger numbers for the drug's efficacy, besides collecting information on its safety and effective doses. Phase IV trials are conducted once the drug is marketed to monitor for its safety in larger populations.

According to Schedule Y of India's Drugs and Cosmetics Act, permission is given for international clinical trials in India one phase behind the rest of the world. If a drug is going through Phase III trials elsewhere, for example, it can be tried only in Phase II trials here. Phase I trials of new drug substances discovered in other countries can be conducted in India if data of the Phase I trials in other countries are already available.

All this will change if the regulations undergo the planned revision. Trials may then be conducted in the same phase as elsewhere. According to the interim report of the expert government committee: "Comprehensive revision of Schedule Y, that prescribes requirements of clinical trials, has been undertaken in order to harness (the) country's potential to participate in global multi-centric clinical trials."

Concurrent-phase trials will open up the scope for multi-centric trials at all phases, currently not possible here. They, however, will also expose Indians to greater risks since Phase I trials will be permitted - and since the people have much less access to proper health care.

According to one report, meanwhile, the Confederation of Indian Industries is pushing for "automatic approvals" of all applications with the Drug Controller-General of India if not cleared within a stipulated time frame. The health of the poor is too petty a consideration for corporates in a hurry.

The first reaction of the government in New Delhi to disclosure of the babies' deaths was predictable: Health Minister Anbumani Ramadoss announced the setting up of a committee to investigate the entire affair and submit a report soon. Only two days later, however, he told a newspaper: "The AIIMS is a renowned research institution. The children must have died because they were already very ill."

At a public function around the same time, while promising a review of the clinical trial process, the minister added: "We can have a broad discussion on the subject in the country, but at the same time, I would say that India has become the hub of a lot of research activities, which is the need of the hour."

How proud should a patriotic Indian wax in this case that is so very different from outsourcing in software or other areas? The pharma firms make no secret of what lures them to India. Sandhya Srinivasan, of the Indian Journal of Medical Ethics, cited an eloquent example in an article four years ago. Wrote she: "A huge population with a diversity of diseases that are untreated - yes, that is the 'India Advantage' identified by iGate Clinical Research International, commenting that India represents a largely untapped resource for clinical trials." That the ill in India are largely "drug naive" (meaning "untreated") is an added attraction.

iGate (with US headquarters in Pittsburgh, Pennsylvania) notes that India has "40 million asthmatic patients, about 34 million diabetic patients, eight to ten million people HIV positive, eight million epileptic patients, three million cancer patients" among other categories. What a mouth-watering prospect for pharma majors, especially considering the poverty of this pool! Add to that the bonus of illiteracy and semi-literacy of the subjects of the trials that make it so easy to obtain "informed consent."

Just a few figures suffice to explain the glee among the global pharma players and their local partners over the clinical-trial cooperation. The average cost of bringing a new drug to market is estimated at $1 billion. Human clinical trials are the most expensive phase of drug development. As much as 60 percent of the costs can be cut by holding the trials in a country such as India.

On the other side, Global consultancy McKinsey and Company estimates that, by 2010, global pharma majors will spend around $1 billion to $1.5 billion just for drug trials in India. As many as 139 new trials were outsourced to India last year, putting it well ahead of China, which had 98. The market value for clinical trials outsourced to India is estimated to stand at $300 million, having increased by 65 percent over last year.

What does India - as distinct from some of its industries, institutions and individuals in important positions - gain? The World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects lays down: "Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research." Doctors in India, who have tried to translate this into practice, say that they got only verbal assurances from the multinationals in this regard and very little beyond. The prohibitively priced drugs under trial, in any case, are beyond the reach of the poor Indians.

The harm that can be done by the trials, however, is far from hypothetical. In 2002, a trial in India, along with 31 other countries, of Novo Nordisk's diabetes drug ragaglitazar had to be suspended after a pre-clinical trial in mice revealed that the compound caused urinary bladder tumors. In 2003, it was reported that researchers from India-based Sun Pharmaceuticals had given the anticancer drug letrozole to 430 young women to see if it would induce ovulation, despite the fact that the drug is known to be toxic to embryos.

The deaths in the AIIMS are just the latest in a long series of cases worldwide that raise serious questions over outsourcing in clinical trials. We can only watch with concern whether the fate of the child victims will make the rulers of a "rising India" (as they advertise it) act like responsible adults.