Don't be Averse to Clinical Trials, Fix the System

A panel report, as reported in Mint today, shows the much suspected irregularities in the drug controller’s office. This specific committee report is about the drug approval process, but I want to raise a related issue here, of clinical trials.

I know, given the herd mentality, a fresh backlash against clinical trials will begin in the press and civil society and that can only cause more harm to healthcare at large. While this is a fresh blow, the health ministry said yesterday that the guilty in the poorly conducted clinical trials of human papilloma virus (or cervical cancer) vaccine in AP andGujarat, which were suspended in April 2010, would face punitive action if the investigation proves it. If and when that happens (the committee of experts ruled out direct linkage between the deaths and the trials when they put in their final report saying that “the cause of death in all cases could not be established with certainty”) it would not only bring justice to the affected families but absolve, at least to some extent, the field of clinical studies of the sins it has been heaped on. This case could set a precedent for punishing the guilty, medical and non-medical staff.

Just because the Indian regulatory regime is inadequate and incompetent (particularly in evaluating protocols), it doesn’t mean we paint the entire field in disrepute! As I was reporting for this story on cancer care and HCG in ForbesIndia, Dr R Badwe, director of Tata Memorial Centre in Mumbai earnestly requested more public understanding, especially from media, in dispelling misconceptions about clinical research.

It’s true most of the clinical trials that we hear of are conducted by pharma companies, either directly or through CROs but the impression one gets from outside is that everyone participating is a guinea pig. That’s not true, research is mistaken as experimentation. I’ll come to the missed (or soon to be missed opportunities) in a bit but just looking the industry numbers, it’s clear that the projection that McKinsey had made in 2006 about the industry being $1 billion by 2010 hasn’t come true. Assocham had predicted thatIndiawould garner 15% of the global trails, but the reality isIndiaaccounts for just about 1% of global trials today. The country did not gird up for the exploding market.

China,Braziland Eastern European countries are benefiting more from it. Recently, the Australian government announced tax credits particularly for preclinical and human clinical trials that will be brought into effect retroactively from mid September 2011. It means a company can get back between 15 cents and 45 cents of every dollar spent.

As far as the business is concerned,Indiais losing the plot.

Now, the academic progress and health benefits: clinical research in general and clinical trials in particular, is the way medical science progresses. While there may be stray incidents of medical research done unethically, the checks and regulations, some in place now and more to come, will ensure that good clinical research practices (GCP) are followed by all researchers. After all, there are a number of studies which conclusively prove that patients who are part of clinical trials end up with superior care than they would get otherwise, primarily because every small step and action in clinical trials follow a set protocol, says Dr CS Pramesh, associate professor and convenor of Thoracic Oncology Diseases Management group at TMC in Mumbai.

“Bad media coverage and uninformed, sensationalistic reporting will be the proverbial last straw on the camel's back and combined with ill-advised policy making, could spell the death of clinical research and consequent medical progress in the country,” says Dr Pramesh.

Take for instance head and neck cancer: disease of the poor; it’s most prevalent inAsia. The pharma industry is not interested in developing new treatment for these patients. The onus therefore lies on the academic head and neck specialists to develop these trials. Thankfully a beginning has been made. But sustained opposition to clinical research and bad press would deter doctors from taking up these studies in academic institutions.

Then there’s the issue of finding cost-effective treatments which pharma industry is not very interested in as profits are low. Dr BS Ajaikumar of HCG says even trying low doses of very expensive cancer drugs like Avastin, -- say a 1-2 mg-dose as opposed to the standard 10 mg dose that is sold by pharma companies at an astronomical price -- have shown great improvements in patients. He says if hospitals, teaching or otherwise, keep trying such regimens, many innovative results can be obtained. “But inIndiawe are just followers. We only follow the Western clinical studies’ outcomes,” he says.

In cancer, doctors are not curing everybody, at least not in the non-toxic way. So, clinical research is an absolute must! Radical mastectomy (in breast cancer) was never challenged for over a century. “Now standard care is lumpectomy or breast conservation,” Alan Hatfield, executive vice president, Clinical Research, Piramal Healthcare, and a former longtime practicing physician from the National Cancer Institute, US.  “Hundreds and thousands of women across the world have participated in trials to bring the best of care in breast cancer.”

To cite another example, treatment of advanced lung cancer has been revolutionized by new targeted therapy (oral tablets as an alternative to conventional chemotherapy which has much higher side effects). The results from Asian countries with this treatment is far superior to that seen in the west because lung cancers in Asians harbor a genetic mutation much more frequently than in the west which makes these tumors more responsive to the targeted therapy. Isn’t this a clear benefit of clinical trial?

Furthermore, says Dr Pramesh, by blindly following the results of clinical research done in the west and extrapolating those results to our patients, we might actually be erring grossly as ethnic and genetic differences could make these results inapplicable in our setting. “Ultimately, it will be patients who suffer the most by a slowdown of clinical research in the country.”

Unarguably, some regulatory and local IRB Accreditation issues still need to be addressed. But the collective effort should be to fix the system, not abandon it.

The thoughts and opinions shared here are of the author.