Should I or should I not?
I popped in hydroxychloroquine in a prophylactic dose. I also got myself tested and was thankfully COVID -ve.
Sanjay Nagral
Apr 17, 2020, Mumbai Mirror
Let me begin with a confession. Three weeks ago, I suddenly found out that the hospital I work with had a coronavirus case, which was detected long after admission for an unrelated problem. And that I could be a contact of some of the health workers who were exposed. Hydroxychloroquine was being discussed as an effective drug. You could say panic or peer pressure, I popped in hydroxychloroquine in a prophylactic dose. I also got myself tested and was thankfully negative.
Having done that, I started checking out the ‘evidence’ for hydroxychloroquine. Some reliable organisations were quiet. Others questioned the small number of French and Chinese studies that reported its efficacy. Overall, the scientific community seemed circumspect. There were calls to start ‘randomised controlled trials’, and to wait for results to be published in ‘peer reviewed’ journals. Even today, if one uses ‘evidence-based medicine’ as the parameter, the drug doesn’t make the grade. Therefore, the recommendations for its use by the Indian Council of Medical Research and the BMC even for a subset of patients doesn’t stand strict scientific scrutiny. And Donald Trump’s public grandstanding on the issue is nothing but his characteristic horseplay.
But wait a minute. Why not take a drug which is cheap, available and may have some benefit when there is nothing else that is effective? And what’s all this ‘evidence’, ‘randomised controlled trials’ and ‘peer review” that the high priests of science are insisting on? Will it not be too late? And doesn’t an individual who feels threatened by the disease have personal liberty to take a tablet?
Medicine is not an exact science. It cannot be. For years it was based on observation, experience and gut feeling. Some of the bizarre treatments offered in the past now look like witchcraft. In the 20th century, doctors absorbed the larger idea of scientific proof. Somewhere along the way it was also felt that many popular treatments were causing more side-effects than benefits; rather, some of them were simply placebos. In the 1990s, a small movement took shape called ‘Evidence Based Medicine’ or EBM. Led by a David Sackett, a Canadian physician who later worked at Oxford, it based medical decisionmaking on evidence from well-designed research. Today, the Cochrane Library and Collaboration, founded in the memory of Scottish physician Archie Cochrane, another leading figure in EBM, is now the world’s largest source of EBM. Soon medical journals were forced to publish studies only after vetting by other neutral experts in the field, a process called ‘peer review’. So, is modern medicine now all evidence based? Of course not. But the EBM movement created peer pressure to incorporate evidence in day-to-day clinical work. If you are no longer given enemas for fever or put on strict ‘bed rest’ for a backache, it’s the contribution of EBM.
The randomised controlled trial is a fascinating advancement in scientific enquiry. If one observes that a drug has benefits for a disease, it could be because of a placebo effect, the passage of time, other factors impacting the disease or even the bias of doctors who hope to see improvement. Two random groups of patients with similar backgrounds and diseases are created. While one group gets the drug, the other just a placebo. In some situations, the patients are not told what they are receiving and the researchers observing them are not told what was given to whom (called blinding) to eliminate bias. And then the impact in both groups is assessed to see a difference with the help of statistical tools. A ‘randomised controlled trial’, in some cases ‘blinded’, is now considered the gold standard for evidence. Leading journals largely publish studies that satisfy these conditions. Interestingly, this year’s Noble prize awarded to Abhijit Banerjee and his two colleagues was for applying the randomised controlled trial model to social sector interventions.
Why is ‘evidence’ important? It allows governments to fund and allow only proven drugs and interventions, especially those involving public health. For example, areas like vaccines, cancer screening (which nations heavily invest in) need scientific support. It helps doctors to decide what treatment to choose when there are multiple ones on offer. Finally, it could even help patients to decide what’s best for them.
India has a specific challenge in the form of its traditional systems of medicine. Very early in the corona epidemic, acircular from the AYUSH Ministry suggested traditional drugs to ‘boost immunity’. Traditional medicine is popular as in some ways it is more holistic, cheap and friendly. Some Ayush drugs have been subjected to randomised trials. We need to do more of this. But a school of thought in Ayush suggests there is no need for them to be subjected to the parameters of ‘modern’ medicine when they have been around for thousands of years and have widespread support. This is a tricky argument with no easy answers as traditional medicine often overstates its case.
The corona pandemic will severely test evidence-based medicine. When people are dying, it is difficult to tell them to wait for quality evidence. And when governments want to be seen to be doing something, it gets even worse. There is an on-going global effort to fast track trials and publications. Meanwhile, what have I decided about my hydroxychloroquine course? I haven’t consumed this week’s dose and am waiting with bated breath. If you read my column next week you will know how I am doing.