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LATEST NEWS UPDATES | Lack of compensation norms for clinical trials results in exploitation of poor patients-Khomba Singh

Lack of compensation norms for clinical trials results in exploitation of poor patients-Khomba Singh

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published Published on Aug 21, 2012   modified Modified on Aug 21, 2012
-The Economic Times

Drug companies paid as little as 50,000 as compensation to families of volunteers who died during clinical trials for new medicines last year, leading to sharp criticism about the paltry sums being handed out and growing clamour among health groups for more stringent guidelines on new drug trials. 

According to government data accessed by a healthcare activist through an RTI query, Germany's Fresenius Kabi paid 50,000 each to the families of two patients who died during clinical trials of its cancer drug paclitaxel while Ahmedabad-based clinical research organisation Veeda paid an identical amount to a patient who died during trials of its drug code-named MT 102.

In India, 483 people died during clinical trials in 2011. But compensation was paid only to 16 volunteers because their deaths were found to be due to clinical trials and not because of other factors such as normal progression of existing illness.

The compensation in most fatalities varied between 50,000 and 3 lakh. Maximum damages of 5 lakh were paid by Pfizer for a patient who lost his life while participating in the study of tascotinib, a rheumatoid arthritis drug.

"An amount of 50,000 for a death victim is disgusting," said Dr Anand Rai, an Indore-based healthcare activist who got the compensation details from the health ministry through an RTI application.

At present, India does not have set norms for calculating compensation figures. Earlier this month, the country's drug controller issued draft guidelines for fixing compensation in cases of injury or death during clinical trials. These draft norms seek to fix the payment based on income, education and severity of the disease or injury suffered by the trial victim.

Drugmakers say the compensation is decided by their ethics committees, which consist of external experts, as prescribed by Indian rules. They say most volunteers who die in these trials are terminally ill and had agreed to try new drugs in the hope of extending their life span.

They point out that patients participating in such clinical or drug trials usually suffer from diseases that have limited or no treatment options, and deaths are more likely due to disease progression or complications.

The conduct of clinical trials in India and other countries has been a controversial issue because these tests often blur the lines between scientific progress, health imperatives, ethical issues, and commercial interests.

Clinical trials among both healthy and sick volunteers are necessary for finding new cures and for checking the safety and efficacy of new medicines.

Unreasonable Norms can Affect Drug Discovery

Even after a new drug has been developed, Indian rules require the medicine to successfully complete the trials process in the country before it is launched here. Unreasonable regulations can arrest the process of drug discovery as well as delay the launch of new medicines in the country.

At the same time, concerns have been voiced about volunteers in India and emerging markets being used as 'guinea pigs' by foreign drug companies and clinical research organisations that wish to take advantage of the cost arbitrage.

India's clinical research market is projected to more than double to cross $1 billion by 2016, driven by a large, easy-to-access population and cost arbitrage of up to 30-50% over the US, according to research and consulting firm Frost & Sullivan.

In May, the Parliamentary Standing Committee released a scathing report on the functioning of the Drug Controller General's office that exposed lapses in drug approvals, and alleged that a nexus exists between companies and regulatory authorities.

Fresenius Kabi India MD & CEO Rakesh Bhargava said the compensation for the death of the two volunteers who participated in its clinical trials was decided by its ethics committee. The ethics committee consists of independent doctors, scientific experts and representatives of civil society.

Bhargava said the patients who died were cancer victims. "Most cancer patients are terminally ill and agree to try new drugs in the hope of extending their life expectancy," he added.

A Sanofi Aventis spokeswoman said patients participating in its clinical trials were usually suffering from a disease that had either limited or no treatment options, and that their deaths were more likely due to disease progression or complications and rarely because of drug or clinical trials. She said in the last four years, there were four cases where the company's physicians felt the deaths 'could' have been due to the drug itself.

"This was still doubtful because all the patients had advanced metastatic cancer that in itself has very short life expectancy," she said, adding that the compensation was decided by the company's ethics committee.

A Sun Pharma spokesman also said the compensation was decided by its ethics committee. "This trial was in advanced breast cancer patients in whom the disease had progressed to the terminal stage," he said.

Pfizer India said the standards followed in clinical trials in India by the company were no different than for trials conducted in the US, EU, or elsewhere in the world. These include policies on informed consent, independent review, and post-study care. The company's spokeswoman said the compensation was decided by the ethics committee.

Health groups, however, have criticised drug companies and clinical research organisations for flouting drug trial guidelines and not sharing adequate information with volunteers about possible compensation in case of adverse affects as well as potential dangers of participating in the tests.

"Nobody knows what is going on in these trials as they are done in a close and non-transparent manner among CROs, sponsors and investigators. Whatever compensation they are giving is because of noise that has been created about these trials. And what about those participants who would have got severe side-effects as a result of the trials?" said Delhi-based NGO AIDAN's founder co-ordinator, Mira Shiva.

Rai said the ethics committees that determine damages were far from independent and were "under pressure" from sponsor companies. "In several cases, the committee member is also the investigator of the clinical trial. And why is it that the ethics committee members usually happen to be from the city where the drug company sponsoring the trial is based?" he said.

In 2011, Pfizer in Nigeria paid $175,000 (about Rs 95 lakh today) each to four families of children who died of meningitis after the American company gave them its experimental anti-meningitis drug.

But medical experts say it is difficult to compare compensation amounts for different cases. According to YK Gupta, national scientific coordinator of the Pharmacovigilance Programme of India, multiple factors such as nature of the clinical trial, disease profile of the patient, age and income levels have to considered.

"But the law should adequately protect the patient who has volunteered for the cause of humanity," Gupta said, adding that India should not become a hub for clinical trials simply because of lax regulations and low costs.

The Economic Times, 21 August, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/Lack-of-compensation-norms-for-clinical-trials-results-in-exploitation-of-p


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