Sunday, September 25, 2011

Clinical trials claimed almost 1,600 lives (officially) in India in just 3 yrs

The disturbing article published in Indian Express on 25th September 2011. It says, “nearly 1,600 people died during clinical trials of drugs conducted by various multinational pharmaceutical companies in the 2008-10 period but the compensation was paid only in 22 cases, according to the Directorate General of Health Services (DGHS)”. The cost of 22 lives of those who volunteered in such clinical trials is just Rs 53.33 lakh ($ 112,000). Most of the volunteers hardly have any idea about the risks. They also do not get many of the safeguards, enforced in any developed country, to protect their health, mainly after trials. According to the RTI reply, the number of registered clinical trials in the country from 2007 to 2010 stood at 1,502.

While outsourcing drug trials save significant money for the pharmaceutical companies, the cost of human lives and suffering for both the trial participants in developing countries and drug users in developed countries is likely to be horrendous. Many have questioned how appropriate and ethical it is to test drugs intended for the American and European markets in developing countries. Duke University`s recent report, Ethical and Scientific Implications of the Globalization of Clinical Research, labeled clinical trials in developing countries as scientifically questionable and morally inappropriate. The study noted that genetic and other population differences could render results that did not apply to the target population. The report also raised concerns over the role money might play in recruiting poor volunteers. As recently as 1990, only 271 trials of drugs intended for American use were being conducted in foreign countries. By 2008, the number had risen to 6,485. According to a National Institutes of Health (NIH) database 58,788 such foreign trials have been conducted in 173 countries outside the United States since 2000. In 2008 alone, 80 percent of the applications submitted to the FDA for new drugs contained data from foreign clinical trials.

India is increasingly being used not only by big pharma and other biotech companies from abroad, but also by many highly dubious Indian companies in areas like clinical trials, testing (and production) of transgenic crop varieties, “research” on harmful chemicals etc. Another such industry is asbestos, widely used in India. Most of the countries in the world had banned asbestos. India is yet to ban its use, production and import despite many reports to show its damaging impact on environmental and public health. One such report says India is on the cusp of a devastating asbestos cancer epidemic. There are many such industries operating successfully and with impunity in India.

Leave alone the smaller players, who operate under the radar, even the big Indian companies are alleged to having increasing involvement in such practices. In March 2004, 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". One can watch this interesting TV documentary to know more about it, how it works.

Our aspiring future scientists and young talents suffer from such practices in the name of research. Academic research also gets affected by the power of such businesses. It has huge long term negative consequences, even in terms of manpower development and quality of research. We need to keep in mind that quality of Indian research is steadily declining since 1996, when systemic data collection started, despite of huge increase in funding and number of new institutes established by both Government and private entities.

It seems that anything is justified in post-1991 India in the name of investment and / or research. It gives our political masters and industry captains the opportunity to advertise their successes, to both Indian and global audience, with a huge cost to the country and its future scientific potential.

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  1. Anonymous10:12 AM

    It is not only the clinical trials that need attention but also the whole range of issues involving these big multinational drug companies.
    Starting from pricing a drug, tax evasion, jacking up of "R&D" costs, taxing consumers in one country (mainly in US) to comply with laws of other pro-people governments in other developed countries are few such illegal and/or unethical practices these drug companies routinely undertake.
    Check this article to know more about it. The Great Billion Dollar Drug Scam- methods used by multinational drug corporations to control markets - and lives.

  2. Anonymous5:16 PM

    Almost all top names, including Novo Nordisk, Aventis, Novartis and GlaxoSmithKline, Eli Lilly and Pfizer have started running clinical drug trials in India. 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). Almost all of them are involved in using mostly unethical, sometimes downright criminal activities in the name of clinical trial; as mentioned in the link in the blog:

  3. Just today's news, published in Times of India (20th. December 2011):
    "In an outrageous act bound to dismay the medical ethics community, as many as 233 mentally ill patients in Indore were subjected to clinical trials to check the efficacy of various drugs, including 42 patients for Dapoxetine, a drug used to cure premature ejaculation.
    Significantly, the doctors involved had taken the approval for the trials from independent ethics committees attached to private hospitals both within and outside the state, thus bypassing the Mahatma Gandhi Medical College's own institutional ethics committee.
    Chouhan's reply, tabled in the assembly, mentioned the names of five mental hospital doctors involved in the trials - Ramgulam Rajdan, V S Pal, Ujwal Sardesai, Abhay Paliwal and Pali Rastogi.
    However, two doctors mentioned in the CM's reply claimed they had done no wrong. "We did the trial in private clinics, so we took the approval from independent ethics committees," said Dr V S Pal. Asked why the MG Medical College's own institutional ethics committee was bypassed, he refused comment.

    Dr Abhay Paliwal, another doctor named, said, "We are allowed to conduct clinical trials at private clinics. We have followed all DCGI and ICMR norms." According to him, it was not necessary to go to the medical college's ethics committee as the trials were conducted at private clinics.

  4. 12 doctors in drug trial racket let off with Rs 5,000 fine in Madhya Pradesh.
    No wonder India is so favored destination of such dirty, so-called R&D businesses!

  5. Anonymous10:50 AM

    Must read your article leisurely,
    I'm a "Aranyak" lover from Sri Lanka.

  6. It’s really wistful news. The practice of Clinical Trials in India must be changed so that the lives of many people can be shielded.

  7. Many clinical research in India generally conduct clinical trials on interested people and many loss their life in the research process.


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