Pharma Urged To Clean Up Its Act In India

The BMJ has published a detailed report this week about how pharmaceutical sales representatives are screening people in India in return for prescriptions for their products. It also addresses the growing popularity of free “health camps” for poor people in India.¹

But what’s the current situation facing clinical trial organizers in India? And what relevance does this research have for clinical researchers? To find out, Applied Clinical Trials asked the author of the BMJ article, freelance journalist Frederik Joelving from Copenhagen, Denmark, some additional questions.

ACT: Do you think sales reps are also involved in, or influencing, the conduct of clinical trials of new drugs or devices in India? And are any of these reps medically trained or qualified?

Frederik Joelving, journalist

Joelving: It’s not my impression that sales reps are involved in or influencing the conduct of clinical trials for new drugs or devices in India. But I’m basing this only on the fact that none of the many reps that I have talked to over the years has brought up clinical trials.

Post-marketing studies are a different matter; reps definitely are involved in some of those. I’m told many such studies lack a scientific rationale and basically serve only marketing purposes. Patients will be put on a company’s product, which they have to purchase themselves, and the doctor will collect rudimentary data and in return receive a fee. I mentioned this briefly at the end of a Reuters investigation from September 2012.²

Some reps have technical training, though most don’t. Many have a bachelor’s degree in science or pharmacy, but I’ve never heard of an Indian rep with a medical degree.
 

ACT: Can you provide any more information of relevance to organizers of clinical trials in India?

Joelving: There have been a lot of issues with informed consent not being truly informed. Remember, many people in India are poor and have zero health literacy. They don’t understand that participating in a trial may not mean getting effective medicine for free. So there is a huge potential for abuse, and companies need to create safeguards against that.

In addition, there has been controversy over what happens when participants suffer adverse effects or complications during or after the trial. The risks need to be spelled out, and participants need to know if they will be covered or not if they have problems. Finally, companies need to consider if they will continue to pay for participants’ medicine after the trial ends. If they won’t, they need to clearly explain that to patients who need long-term treatment.
 

ACT: Could you tell us more about the health camps you describe in the article?

Joelving: The health camps may be arranged in different ways. Many reps are required by their companies to conduct a certain number of health camps every month, so they will approach various doctors to do a ‘patient camp’ in his or her office. The companies may also tie up with NGOs (non-governmental organizations) to do so-called ‘mega camps’, which attract hundreds of visitors. And occasionally, individual doctors may ask companies to pitch in with screening and diagnostic testing at health camps that they themselves are organizing, either because they are true believers or because they want to grow their business.

ACT: What response are you hoping for from the global pharma industry?

Joelving: I would like the global pharmaceutical industry to clean up its act in India. For a long time, India has been like the Wild West for drug companies, with very little regulation and enforcement and high levels of corruption. Global drugmakers have a big share of the market and they could change things for the better if they wanted to. The problem is their sales would take a hit.

As for the health camps, the companies appear to be breaching national regulations, and I’m not even considering the bribery aspects of their activities. When I talk to public health experts about these unchecked screening programs, they are really worried about the impact they are going to have. They say it’s going to cost a lot of money to test and treat people who don’t need it, and we don’t know what the net effect on the nation’s health is going to be.

References

India’s “health camps”: the drug rep will see you now. BMJ 2015;351:h6413 doi: 10.1136/bmj.h6413.

See http://www.reuters.com/article/2012/09/17/us-india-pharma-kickbacks-idUSBRE88G0I820120917