The Debate around Implants

I was recently reading an article by Dr David Berger and an editorial by Prof Nundy, on the problems of the Indian medical system. These pieces got a lot of publicity and one of the main points highlighted was the callous attitude of the Indian vendors of medical devices / implants, machines or technology. These articles focus on the much-talked about monetary arrangements between doctors and medical device/implant vendors. As an anaesthesiologist with no personal experience of implanting any medical devices, I cannot comment on financial malpractices aspect. However as I read and reflected, considering my experiences over the past 36 years in the medical field, I realized the problem is much more basic. The murky circumstances surrounding medical devices/implants can be attributed, not surprisingly, to a paucity of information and medical evidence. Let me elucidate:

I was once asked to give my opinion on whether the coronary stent being prescribed by a cardiologist was good enough. This was a new stent and made by one of the largest global manufacturers. Consequently, it was also much more expensive (three times the price) than the hitherto widely used stent made by Indian manufacturers. As I thought about the question, I realized it was tough enough for me — with decades of experience in the field — to answer the question. A layman would obviously have no idea about the same. If my own physician advised me to take a decision on the two different types of devices, one of which is recent and several times costlier, and the other which is older but tested and cheaper, I would not be able to make a decision. I might think- the newer, ‘imported’ device probably sounds like a better device — I should not think about the price, health is the prime interest. Hence, I would probably trust my physician to choose what is best for me without bothering about cost because I want the best treatment! But who decides the best?And on what basis? Is it the local distributor or the company which manufactures it? Or do we trust the scientific studies done by centres in the Western world on a different population with a different health seeking approach and resources? Or should we go by anecdotal or theoretical knowledge? Sometimes in some lucky circumstances, we may have a single Indian medical centre’s experience…what is better or best? This is the (multi) million dollar question.

In the present times, manufacturers are pushing new products into a huge Indian market where it is only the opinion of the doctor, and not the evidence, that determines choice of treatment. In a majority of situations, there is no clinical trial, just trial and error. This happens without the benefits to a patient associated with use of such new products in trials in the Western world — for instance, free of cost device/implant, tracking and free treatment of any complications, travel reimbursements, and very close follow up.

From the point of view of the doctor prescribing the latest stent — when a vendor presents the stent as an advanced product with several improvements over the previously used devices, has some theoretical basis for it, and cites evidence from the Western population for its efficacy — straightforward goodwill dictates that the Indian patient should be given a chance to experience the benefits that their counterparts in the Western hospitals are seeing. That is what the Indian patient will demand. However this is where the physician must step in. Instead of being the ‘well-intentioned’ physician, she/he should focus on and help the patient realize some critical facts. Theoretical benefit often does not translate into clinical success — the field of medicine is well versed with that. Evidence should not be limited to manufacturer-sponsored studies — the stents being regularly used widely and frequently in the country they have been tested in? The epigenetics of the Western population is very different from the Indian population — we have different races and ethnicities, different disease conditions, different modifying factors and different severity — hence we should be wary of extrapolating anything without doing a safe trial in our own demographic.

So basically, even in the best-case scenario,we have a situation in which neither doctors, nor the patients have access to any sort of impartial knowledge which can help them objectively and truly which implant is better for the Indian patient. In this vacuum of knowledge, a ‘well-intentioned’ physician may think that going ahead with the latest implant may be the best for the patient (after all there is also no evidence to prove that it will hurt, and if it worked in the West we should use it here too).

Additionally, if we add in the nexus of doctors and corporates mentioned by Dr David Berger, the allegation that the patient’s interest is not front and center, we are in quite a soup.

So what do we do?

When in doubt, as scientifically and rationally motivated individuals, we turn to data. However, as of now, there is no organized data repository where the follow up of all the patients being inserted that particular device is being stored or made available for the follow-up or for future decision making regarding its use in particular subset of patients or particular clinical situation. So neither the physician nor the patient can make any rational decision on the efficacy of any of these implants.

The medical fraternity — the doctors, the medical institutes, regulatory authorities and of course the government — must recognize the need to have objective data and trials for our patients. As scientific individuals, we know that apples and oranges are not the same, hence we must advocate for our patients and their rights to advanced medical technology that is SAFE for them. A first step would be to ensure a compulsory registry (with onus on both the manufacturer / distributor as well as doctor implanting/prescribing the device) of all the implants used in patient management irrespective of the cost of the same. One can put a lower bar on the cost of these implants [for the registry], but the medical implant is an implant in the human body, and meeting criteria or safety and minimum standards is non-negotiable. Computerizing this data and making it available to the public would allow for much more evidence-based decision making. Moreover, this data could be linked with global research data and interesting conclusions could be drawn. This would also help our local Indian manufacturers to improve their offerings(if required) so as to compete with global manufacturers.

In our institute we have started tracking as well as auditing cardiac devices, as a first step. A beginning like this has to be made somewhere. And this isn’t difficult if we put it in perspective of our country’s rapid progress. When one can computerize the electoral process and the election in this huge country of a billion people– why not the medical devices that are changing the life for some of those billion?