Healthy Skepticism Library item: 486

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Basu I.
India's clinical trials and tribulations
Asia Times Online 2004 May 23
http://www.atimes.com/atimes/South_Asia/FG23Df03.html

Full text:

The potential is huge, multinationals are willing and Indian companies are eager. Moreover, it is a type of outsourcing that is not likely to draw the protests of the anti-outsourcing brigade in rich economies. Yet even as India increasingly emerges as a preferred destination for outsourcing clinical trials – testing of new drugs on humans – the country may also be heading toward providing the greatest source of human guinea pigs for the global drug industry.

A spate of unfortunate events over the past few years has brought to the fore the rampant practice of conducting unethical and even illegal clinical trials in India, which is fueling immense concerns culminating into a huge public outcry over the regulatory authorities’ failure to check such practices, and even lawsuits.

For instance, in early March, the Supreme Court of India hauled up two top biotech companies in India, the Hyderabad-based Shanta Biotech and Bangalore-based Biocon India, for “openly conducting illegal clinical trials of new drugs on unsuspecting patients” after a litigation filed by the Aadar Destitute and Old People’s Home, a Delhi-based social organization. This non-governmental organization (NGO) alleged that the two companies had conducted improper clinical trials of Streptokinnese – a new clot-busting drug used in heart attacks – last November without requisite permissions (of the Genetic Engineering Approval Committee), as a consequence of which eight people lost their lives.

Although the Streptokinnese case was a shocking revelation, it wasn’t an isolated one. According to Monthly Index of Medical Specialities in India, an independent pharmaceuticals journal, more than 400 women who had been trying in vain to conceive were enrolled in 2003 without their knowledge or consent to take part in clinical trials across India to see if a drug called Letrozole induced ovulation. Letrozole used in India was copied (with permission) by Sun Pharmaceuticals, a large Indian generic drug company, from a patented product of the same name of Novartis, which the multinational drug maker introduced globally for solely treating breast cancer and not for any other use in any country, including India. A complaint on the Letrozole case, too, was filed in the Supreme Court by yet another Delhi-based NGO.

And in 2001, another trial that made headlines involved the clinical trial of nordihydroguairetic acid, a chemical with anti-cancer properties that was tested by a regional cancer-treatment center (RCC) in the Indian state of Kerala for a US-based researcher then associated with Johns Hopkins Hospital in the United States. The drug was allegedly tried on 26 unsuspecting cancer patients, two of whom died. Subsequently, a 60-year-old woman was again included for a trial for which the RCC provided five doses of the experimental drug, worth Rs10,000 (about US$200), free. The woman’s condition turned critical as well before the fifth dose, although she escaped death.

These instances indicate that in the absence of adequate regulations and proper laws, a developing country eager to cash in on the opportunities of globalization can be used for indulging in rash and risky practices. A recent survey of 200 health researchers globally that was commissioned by the former US National Bioethics Advisory Commission and published in February’s edition of the Journal of Medical Ethics revealed that a quarter of clinical trials conducted in developing countries did not undergo ethical review.

However, in India particularly, unethical and illegal clinical trials are most rampant and are conducted without fear because, say critics, there is no law to safeguard the interests of volunteers, while regulatory authorities,“by design or default”, fail to take action against such trials.

The moot question then is, why are multinational drug companies increasingly preferring India to other poorer countries to outsource their clinical research and trial needs? Almost all top names, including Novo Nordisk, Aventis, Novartis and GlaxoSmithKline, have started running clinical drug trials in India lately, while some, such as Eli Lilly and Pfizer, which started much earlier, conduct tests on a number of their new drugs. Besides, a variety of both India-based and global contract/clinical research organizations that specialize in outsourced clinical trials management are working to expand India’s clinical-trials business. These include Quintiles, Omnicare, PharmaNet and Pharm-Olam (all US-based).

The simple answer is India’s huge billion-plus population and cheaper costs. According to a study by Rabo India Finance, a subsidiary of the Netherlands-based Rabo Bank, India’s huge patient population also offers vast genetic diversity, making the country “an ideal site for clinical trials”. For example, India has the largest pool of diabetic patients, with more than 20 million citizens suffering from the ailment – small wonder that insulin is one of the most researched drugs in the country. Moreover, many in the country’s large poor-patient population are “treatment naive”, which means they have never received drugs for treatment – a fact that simplifies patient enrollment and trial management. Besides this, the country also offers other facilities, such as nearly 700,000 specialty hospital beds, 221 medical colleges and skilled English-speaking medical personnel.

But obviously, India’s most significant offering is cost savings. “More than 40% of drug development costs are incurred in clinical trials and India offers immense savings on that aspect,” says Alok Gupta, country head for life sciences and biotechnology of Yes Bank, adding, “and importantly the trials can get done fast”. Indeed, the cost-savings opportunity in the country is irresistible. For instance, in the US, trials for a standard drug can cost about $150 million, whereas the Rabo Bank study estimates that drugs could be tested in India for as little as 60% of that price.

Indian industry sources say that clinical-trials outsourcing is a “tempting” opportunity for the country’s drug industry. In 2002, clinical trials were reckoned to have generated $70 million in revenues for the industry, which could grow to $200 million by 2007 and anywhere between $500 million and $1 billion by 2010. Globally, clinical research was estimated to be a $5 billion to $6 billion market in 2002, and according to Kiran Majumdar Shaw, chief executive officer of Biocon, it is expected to touch $10 billion by 2005. However, a study done in 2003 by Connecticut-based Business Communications Co says US-based spending on clinical trials is growing fast – at 12% per year – and should generate $26.5 billion by 2007.

This is why local industry sources feel that despite the ills, India should embrace and encourage drug trials and research in India. But there are better reasons as well. Rajesh Jain, managing director of Panacea Biotec Ltd, a prominent drug maker, says that for a country like India, the potential benefits of clinical research are far more than its hazards. “It brings in the best in industry practices in clinical research for the benefit of our population’s health-care needs while exposing the medical community to global processes and standards,” he says, adding: “If we are to benefit from the fruits of modern research, we, too, should be willing to pay the same price.”

Nevertheless, rattled by the recent deaths and the public outcry, India’s regulators have started sitting up. The Drug and Controller General of India (DCGI) said last week that beginning in September, it will put in place inspection systems to track the progress of drug trials from beginning to end. There will also be a new set of rules “to emphasize incorporating good clinical-practices protocols”, a DCGI release said.

Industry critics are now hoping that the DCGI efforts will be the first step in making clinical trials more accountable in the country.