Thursday, 13 September 2012

Let’s End this Trial by Fire

Need to Take a Rational View of Clinical Trials

I believe we need to address the issue of clinical trials not with blind emotion but with a rational understanding of the benefits and with greater compassion for those suffering for want of effective medicine.” 

Kiran Mazumdar-Shaw, CMD, Biocon

The drugs we use to treat any condition – from an innocuous cough to a life-threatening cancer – are the outcome of painstaking human clinical trials. These trials are the only way to credibly determine the safety and efficacy of drugs. Without trials there is no way pharmaceutical research can advance to improve disease management and the very quality of life.

Drugs go through several stages of development prior to human trials. The trials themselves are approved and regulated by government agencies and undertaken only after animal experiments prove their safety beyond any evidentiary doubt. Even then, the safety and efficacy of a drug on humans needs to be proven before it can go to market. Unpredictable outcomes are but natural in this process – no wonder then that they are known as ‘trials’!

The successful outcomes are of vital significance – for they not only help the patients involved in the trial but also transform the lives of hundreds of thousands who benefit from the commercial launch of such experimental drugs. Take some recent life-changing cancer drugs which have helped overcome what was thought to be an incurable condition – two such that readily come to mind are Herceptin for the treatment of breast cancer and Gleevec for the treatment of leukemia.

Needless Controversy
The recent controversy over clinical trials in India is worrisome. A series of articles in newspapers apparently aimed at tarnishing the entire clinical trials sector and some NGOs going to court with public interest litigations seem to be fuelling it. These individuals and entities are whipping up emotions by portraying only the darker side – showing how some terminally ill patients didn't survive a clinical trial. As the Indian Society for Clinical Research (ISCR) has said, those participating in trials are already afflicted. Their death, therefore, was not due to the drug. If they were terminally ill, the drug perhaps was not as effective as was anticipated.

It is important to note that many trials in India are Phase III trials which are global trials with a stringent common protocol for already well-tested drugs. Hence, the risks to patients are minimal. In any case, without a trial it is impossible to determine if and how a drug works. Factors such as racial characteristics, genetic make-up, and individual biochemistry also have a bearing on the outcome of a trial. Using Herceptin as a case in point, without a clinical trial it would have been impossible to learn that the drug is only useful for patients who have tumors that are HER2 positive.

In this entire discourse, what is really frightening is that we are succumbing to a herd mentality. Instead of addressing specific issues that need fixing in some clinical trials, the effort seems to be to tar all clinical trials with the same brush. Such knee-jerk reactions will only make much-needed new drugs inaccessible to more Indians.

Beyond the horror fiction, let us examine the reality of clinical trials in India.

Advantage India
India is seen to be an attractive hub for drug innovation based on our cost and skill base. Assocham had predicted thatIndiawould garner 15% of the global clinical trials opportunity. However, out of over 100,000 human trials being conducted in 178 countries, less than 2,000 (2%) are being done in India compared to over 9,000 (9%) inChina.

India has not been able to capitalize on its potential in clinical trials owing chiefly to a lack of credible regulation. The fact is that our current legal framework is strong enough to ensure transparency and ethical practices during the conduct of clinical trials. There can of course be improvements that can ensure that the best clinical research practices are followed.

The answer is not in shackling clinical trials – it will only result in denying better and cheaper drugs to millions of Indian patients. All drugs need to be tested on ethnic populations to ensure their efficacy; so Indian patients must have representation in trials. Genetic variations can result in different levels of drug efficacy and hence the need for local clinical trials. Eg. The cancer drug Iressa worked well in Japanese populations but not so in Caucasians which led to the identification of a gene mutation that determined response. Moreover, some diseases are more prevalent in India. These range from malaria and chikunguniya to tuberculosis, kala azar and head and neck cancer. Drugs for such diseases can be best tested in India.

Transparent Trials
Trials are conducted with the highest degree of transparency and with the complete consent of patients and families, disclosing not just potential benefits but also risks involved. As in any industry, there may be some black sheep – and they must be dealt with utmost severity. But that does not mean that the entire industry is suspect. Industry is conducting ethical clinical research, and the term “guinea pigs” being used for participating patients is a serious insult.

The reality is that uninformed media coverage can hinder clinical progress in India. We need to adopt a rational perspective of clinical trials – understand how they are run, realize their criticality to patients, and address issues objectively instead of asking to stop trials altogether.

One writer in a recent newspaper article suggested that poor patients should be given a higher compensation. Does the writer realize that this is tantamount to inducement? All human life is equally precious, so how does one price it? Compensation in any case should not just be fair but also equitable without discriminating between patients. A better way of compensation would be to provide patients who participated in a successful trial with free or subsidized drug for the rest of their lives.

Instead of dismissing clinical trials, we need to plug any loopholes and implement existing laws stringently to ensure that clinical trials are conducted with utmost transparency and diligence. I believe we need to address the issue of clinical trials not with blind emotion but with a rational understanding of the benefits and with greater compassion for those suffering for want of effective medicine. If we curtail clinical trials and pharma companies move to China,South Koreaand other East and South Asian countries – as they are doing – we will only end up hurting Indian patients.

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