By Yogi Aggarwal
Drug trials, the new buzzword in the pharmaceutical industry in India, are posing a danger to those who are coaxed or fooled into allowing themselves to be tested on for new drugs. This compelled Justice RM Lodha of the Supreme Court, while hearing a petition, to observe: “Uncontrolled clinical trials are causing havoc to human life. There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far.”
Drug trials are a necessary part of the research a company has to do before it releases a new formulation, and the objection is not to the testing but to the lack of ethical guidelines followed in the country. These are laid down in the Helsinki Declaration issued by the World Medical Association. Following this, similar guidelines were introduced in India by the Indian Council of Medical Research (ICMR). But there is no law that makes the guidelines binding on those involved in conducting trials. The basic premise of a clinical trial is that a subject should participate voluntarily and since this is not done with the largely poor people on whom the trials are conducted, they will continue to be done unethically.
Since the people are not told of the risks, the death toll is unacceptable. The World Health Organisation (WHO) showed that 2,031 people died in drug trials between 2008 and 2011. While 438 deaths were reported in 2011, 668 died in 2010, 637 in 2009 and 228 in 2008, according to WHO’s international clinical trial database.
Drug companies contend that only a small fraction of these deaths is directly because of the trials and have paid compensation to only 22 of those who died so far, but the WHO data was further substantiated by the Drugs Controller General of India (DCGI). One news report alleges that of the 668 deaths in 2010, 158 were reported in trials conducted by Sanofi Aventis, a pharmaceutical company based in France, and 139 during the trials of Bayer, a Germany-based firm. These companies claim only 25 deaths were trial related.
The Parliamentary Standing Committee on Health and Family Welfare, in its report tabled in May 2012, alleged a nexus among drug makers, Central Drugs Standard Control Organisation (CDSCO) officials and experts who grant opinions on the use of drugs. The panel had found that CDSCO had approved 33 drugs (out of a randomly selected sample) for use in India without any country-specific clinical trials.
Though the earliest clinical trials in India were conducted in 1995 by Eli Lilly and Pfizer with many other pharma giants following in 2000, the really big push came in 2005 with the introduction of patent protection laws. India attracts multinational companies to clinical research because of its ethnically diverse pool of patients, low literacy, poor regulation, and low costs of conducting clinical trials which can bring down R&D costs by 60 percent.
The drug trials are mainly for third phase of testing. Yet India accounts for just five per cent of the clinical trials being conducted worldwide or under one billion dollars, but this is growing at a phenomenal 65 percent annually.
Worldwide, some 70 percent of total R&D costs is spent on conducting trials. In 2010, US biopharmaceutical research companies invested some $60 billion on R&D. Clinical trials are conducted in four phases. It is the third phase which is most expensive. Conducted on 1,000 to 3,000 patients, it confirms the therapeutic benefits of a new drug and accounts for 30 to 35 percent of the total R&D spend.
Multinational drug companies, therefore, outsource the third phase of trials to countries of Latin America and Eastern Europe, besides India, China and Russia, where costs are much lower. About 50 percent of the new drug applications submitted in the European Union and the US say trials are being done in these countries.
Corruption, poor regulation and connivance by supervising doctors are among the reasons for the loss of life or health because of drug trials in the country. Besides this many drugs are approved without conducting clinical trials on India patients. These may include drugs released by reputed multinational companies.
In government-run hospitals, which provide low cost treatment to the poor, there are claims that illiterate patients are often being used for drug trials without their knowledge. The first rule of informed consent is ignored. Besides many doctors make money on this since they are paid on the basis of the number of trials they conduct, without any penalty for those who are harmed or die because of the trials.
There is no provision in law for the punishment of a sponsor company or responsible doctors found guilty of unethical practises. In none of the unethical drug trials uncovered in the past any stringent punishment has been imposed on the liable party.
When compensation is paid to the next of kin of those dead it is pathetically low. For instance, one multinational company paid compensation of around Rs 2 lakh in India while the same company paid Rs 84 lakh to the kin of victims in the equally poor country of Nigeria.
The contract research organisations which conduct most of the trials also take advantage of poor regulation by not doing them properly, saving time and money, leading to adverse consequences for those undergoing the trials. What’s needed is criminal proceedings and penalties for those who are negligent or fail to follow ethical norms.
Already some 350,000 people have been part of these drug trials, many of them because they are being paid or because they think they are getting free medicine. Their numbers will increase as the number and intensity of drug trials increase. Unless regulation is tightened and penalties made severe for those who do not follow norms, the unnecessary loss of life would increase. We have to get our act together on this as on many other issues is another scandal born of negligence, crassness and corruption could break out in the country.