Drug trials : India’s crisis of confidence

Reuters reports that in the last decade fewer children are dying of leukemia most likely due to advances in new drug combinations. However, infants are still getting a more aggressive form of the disease as a result of which survival rates are lower than those for young children and adolescents.

In spite of the strides made in medicine and supportive care, most would agree that the quest for new treatments for intractable medical problems such as childhood leukemia has to continue, even accelerate.

But in recent years, it appears that a crucial part of this process- the  testing of these new treatments on human subjects to prove their safety and efficacy – is experiencing a serious crisis of confidence in India. Continue reading “Drug trials : India’s crisis of confidence”

Pfizer’s Nigerian nightmare. Or is it the other way around?

Children who participated in an allegedly botched Pfizer drug trial in Nigeria in 1996 may still have their day in an American court. The US Supreme Court has refused to block a suit brought against Pfizer by their families. The plaintiffs contend that Pfizer tested its experimental antibiotic Trovan during a meningitis epidemic in Nigeria without following due process of written informed consent. Nor did it warn the families of the drug’s side-effects or inform them that an approved drug was being distributed free by an aid organisation nearby. It also allegedly administered a low dose of a control (approved) antibiotic to make Trovan seem more efficacious.  Some children in the trial died while others suffered lasting damage. See here for details.

Pfizer – which has denied all wrongdoing – had insisted that the lawsuits should be filed in Nigeria not the US but the plaintiffs allege that Nigeria’s “corrupt” courts will not deliver justice. Pfizer has already paid the Nigerian government $75mn to settle claims.

This is a case that India should follow closely to its logical conclusion. To know why, look no further than Bhopal to see how good the country is at protecting its people. Now put that together with the pace of drug trials in the country and the absence of adequate oversight.

The media and clinical trials

WatchdogThe Drug Information Association (DIA) recently had a webinar with international participants on the ethical issues arising around clinical trials in individuals with reduced autonomy (like children, very sick people incapable of taking decisions, the mentally ill, prisoners etc).

One of the subjects discussed was the media’s role in clinical trials. One participant wanted to know if national media in India feel a responsibility to educate the public about clinical research in general, in addition to reporting when things go wrong. I don’t know for sure but I suspect this question stems from a feeling in some quarters that media gives too much play to botched or allegedly botched trials. But does little to help the cause of ethically-conducted trials that bring drugs and other medical interventions to market.

Here are my thoughts.

The media have viewed themselves primarily as watchdogs given the acceleration of clinical trials done in India, and it’s emergence as a business opportunity in the absence of sufficient regulatory oversight and action.  The Indian government’s abysmal spends on both healthcare financing, and infrastructure-building means that there could be many who will participate in trials only for free treatment without completely understanding what they imply. That is very conceivable though the degree to which this happens may not be known.
While the DCGI’s office has taken some positive steps like making the registration of clinical trials on ctri.in compulsory it still has a long way to go on subjects like trial audits, and oversight of ethics committees. Importantly, it is not transparent about outcomes of regulatory action, a must-do if it has to inspire faith in its ability to regulate.
There also haven’t been enough champions for trials outside the CRO and drug industry. This is important if the media have to view clinical trials as an activity that could lead to social good.
Finally, I am not sure whether there is enough being done to engage the local language media which has a wide-ranging influence on opinions and perceptions on the subject.  GCP in Hindi, Tamil,  or Marathi anyone?