In my last two blogs, I have tried to outline the complexity of the problem when it comes to affordability of medicines in India. In this post, lets take a look at a few factors that confound the solution space if our goal is to create an affordable healthcare system for the country.

The genesis of this entire discussion stems from the prevailing perception that doctors somehow, under the influence of pharmaceutical companies, nudge poor patients toward more expensive branded medicines when cheaper, unbranded alternatives, which work as well as the branded drugs do exist.

In a 2017 Social Science & Medicine article, authors Chirantan Chatterjee & Ajay Bhaskarabhatla  show that in cardiovascular medicines, 129 million scripts (8.1% of the total) in the 2008-2011 period were irrational, meaning there was no good scientific reason for these 129 million prescriptions. Another study published in 2013 says that most physicians were unaware of the active pharmacological ingredients (APIs) of 20% these irrational drugs.  CDSCO’s own expert committee report from last year showed that a large majority of the 1000 odd irrational medicines it evaluated had no scientific basis. Clearly, these irrational drugs do exist and are being prescribed by our medical fraternity. The question is why? To what extent do we hold the practitioners accountable when they prescribe these drugs (most of which are promoted extensively, and therefore more expensive) or the regulator who allowed these drugs to get to the market in the first place? Whose interests was the regulator protecting when it allowed these companies to market them? Certainly, not the citizens of this country.

In 2007, I co-founded and ran a company named Sciformix  where we hired recent medical graduates to conduct analysis of Adverse Events and prepare reports for regulators in US, EU and Canada. My observation from those days was that these recent medical graduates had very little knowledge of pharmacology, phramcokinetics and pharmacodynamics, which is a required part of the medical education curriculum. Concepts such as dose-response, average retention time, maximum concentration of the drug in the body etc were alien to them. On average, we had to invest about a year in retraining them in basic medicine before they became productive. This speaks to the quality of education we impart to our doctors. Therefore, I am not surprised that the study referred to above found that about a fifth of our medical fraternity doesnt know what the active ingredients are in the medicines that they are prescribing. I am sure that with clinical experience, these folks do develop a better understanding of drugs are metabolized in our bodies.

The role of the industry in influencing the medical fraternity into prescribing their “latest and greatest” products was something we already discussed.

The flip side of the argument is that we all do not metabolize drugs in the same manner. Our physiology, our life-style choices and our metabolism all play a key role in how effective a particular drug is to treat an ailment. For this discussion, let us take the extreme case of narrow therapeutic index drugs. Two years ago, I was the co-author on a peer-reviewed paper that discussed how Levothyroxine,  Budeprion, and Methylphenidate behave very differently depending upon the formulation. Despite being approved as bioequivalent, we found subtle and significant differences in therapeutic response to these drugs primarily based on the way they were formulated. Experienced clinicians know what to look for in our vitals and properly titrate the dosage or  switch it to a different formulation based on their observations in the best interest of the patient.

So this begs the question whether we want to take away the freedom of our physicians to determine which formulation is best suited to our unique physiology based on their clinical experience? Do we want to throw the baby out with the bath-water?

Clearly, there are some (well, around 20%) bad apples, that the data shows. However, to prevent these bad apples from prescribing these expensive, irrational drugs, do we want to mandate the whole medical fraternity to write prescriptions for “generic” knowing well these variations exist among formulations and are thoroughly documented? And I am not even bringing substandard drugs into the discussion yet, which we know are a large percentage of our drug supply, thanks to the US FDA and even the CDSCO, which acknowledged last year that approximately 10% of the supply procured by government funded facilities were substandard. That is a whole another ball of wax. Is this what we want our policy makers to do? Let us pause and consider this for a moment.

Let us stop deluding ourselves that the solution to our problem is as simple as mandating doctors to write “generic” prescriptions. We created this problem with decades of complacency and inaction and cannot expect it to disappear overnight. This needs thoughtful, data-based analysis, a long term vision and a lot of perseverance to look at the facts and then make a realistic and implementable policy.

Speaking of the medical fraternity, I was amused by their response to this issue. Conversations on Twitter center around the word “should” in the way they advise their members to write prescriptions. I do have a basic question for the MCI though. Knowing that 85% of the drug supply has never been tested for therapeutic efficacy in our country, how do you justify issuing the guideline you did with the hippocratic oath that you took when you obtained a licensed to practice medicine? I guess no one asked them that!