Comment

Clinical trials are assuming dangerous proportions in India, with infants dying due to medical negligence and in unexplained, doubtful conditions.

In the last six months, there have been at least two instances where faulty clinical trials have been blamed for the untimely death of several babies. And in both the cases, the corporate world has shown a marked insensitivity to the tragic incidents. Not a single pharmaceutical company comes forward to build confidence and explain what went wrong and what could be done.

In the case of the paediatric deaths reported in August at the All India institute of Medical Sciences, the premier medical institution formed a committee in a jiffy and gave clean chits to the parties involved.

Wyeth, which has been at the receiving end of the Drug Controller General of India due to the death of a child following clinical trials of its famous Prevenar vaccine, pleaded that the vaccine was administered 200 million times in the last seven years. Wyeth also promised to share more information about the incident along with its partnering clinical research company GVK Bioscience.

We will wait to see the information that has been volunteered by Wyeth unless it is forgotten like many other human tragedies.

The bigger questions: Why it was left to the drug controller to tell the media about the case and why Wyeth did not inform about the incident itself.

Taking a moral high ground is easier said than done. If government departments are scrutinised under the provisions of the Right to Information Act, the same should hold for private entities as well.

However, Wyeth’s claim is the most defensive that could have come. A company that likes to keep away from media will have to be more prepared to prove that the trials of Prevenar in India adhered to all the laid down good clinical practices norms.

Unfortunately, unlike in the US, public outrage in India, mostly backed by NGOs, dies down before relevant files could be moved and even senior government officials mysteriously go into hibernation after raising an alarm against companies.

All these stakeholders tend to forget that human lives are far more precious than cost savings in researching the drugs in India and the speed with which those reach the market. Beyond tossing numbers about the potential of the clinical research business in India, no one feels the need to understand that lack of tight controls and supervision of experimental drugs can cause havoc in terms of public perception about pharmaceutical companies.

Many within the drug industry know that in the US, a few politicians do not differentiate between a cigarette company and a pharmaceutical company — an uncalled for and humiliating notoriety to an industry that works to save lives.

The Indian drug industry, known to be cut-throat and deft in circumventing legal provisions by adding or deleting active ingredients to escape government devised price controls, can very well take the poor population for a ride and administer them with drugs that may harm them terminally. Though nothing substantial has come to light, we do not have a transparent system to prove otherwise.

Multinationals, though more legally bent, also have the compelling need to hasten their drug trials. In the end, we may see many more drugs in the market, but each of them may have a questionable track record for safety or efficacy profiles.

The Japanese are for long appreciated as the best regulators, though they might be slower in approving drugs to be sold in their country.

Like the Japanese, we need to be alert about the reality that something as fashionable as an “emerging clinical trials industry” deal with drugs that are being tested on naive populations to ascertain its safety, its effect in dealing with a disease and its tolerability with the rest of the body organs.

Large global pharmaceutical associations are now reported to have formed a uniform disclosure code for the clinical trials sponsored by them. That information essentially provides description of the trials, their purpose and locations, the stage of the disease, and most importantly, the contact details of the investigators. This is perhaps one of the boldest moves by multinational companies to restore confidence in them.

Indian companies should also take the cue and volunteer information about their trial details. If faith can be restored and the elements of perceived deceit can be weeded out, clinical trials will be seen as a means to discover drugs that cure rather than kill people.