Saturday, April 30, 2016

Eculizumab makes a guest appearance in India!

Recently, doctors at Medanta Hospital, Gurgaon, including Medical Advisor to The Atypical HUS India Foundation, Dr. Sidharth Sethi were faced with a 12 year old boy that had the classic signs of Atypical HUS - hemolytic anemia, thrombocytopenia and uremia. Other conditions were ruled out and aggressive Plasmapheresis initiated. The boy stabilised and was discharged. A complement factor assay was normal.

The boy fortunately was an American citizen. Eculizumab was procured from Alexion Germany with co-ordination by the American Embassy. The cost of the drug was presumably covered by the boy's insurance company in the US. A complete genetic analysis was done in France which also did not identify any known genes implicated in aHUS. Subsequently, Eculizumab was withdrawn and the boy continues to do well. The entire sequence of events was recently published in the Indian Journal of Nephrology and an initial version can be found here.

 The article states some important things:
  • "... the high cost of the drug and the uncertainties surrounding the natural history of aHUS in patients for whom eculizumab prevented the progression to end‑stage renal disease, raise the question of whether life‑long treatment is warranted for all patients with aHUS. Given that the natural history of aHUS differs depending on the underlying genetic abnormalities, treatments could be tailored on the basis of an individual’s complement genetics. Life-long treatment may be appropriate in patients with aHUS who have mutations associated with poor outcomes (e.g. CFH or C3/CFB gain‑of‑function mutations). We also carefully planned to stop eculizumab in our patient, since he had no major genetic mutations, with a normal complement panel."
  • "The nonavailability of the drug in India raises ethical concerns. HUS being a common cause of acute kidney injury in children in India should get timely and appropriate management with lifesaving eculizumab or PEs. To improve the availability of the drug in Indian market, and subsequently decrease the cost of drug, collaboration among medical experts and health authorities must occur in order to implement a feasible plan of action."

Sunday, April 17, 2016

National Dialysis Program: There is a tide in the affairs of men...

Dr. Vivek Jha, one of India's most respected nephrologist has written a blog in BMJ that talks about the newly announced National Dialysis Program. He makes some very important points:

  • "A countrywide programme to identify and treat earlier stages of kidney disease so that advanced disease can be prevented must be developed"
  • "A well designed national service should be a hybrid programme, with a pragmatic mix of HD and PD"
  • "Parallel support should be provided for transplant surgery and post-transplant immunosuppression."
  • "The ideal payment model should be based on a combination of process and outcome measures."
Some states in India already provide free dialysis to patients who are below the poverty line. However, these program lack a process by which quality can be measured and good quality rewarded. This gives no incentive for the dialysis service providers to give good quality which obviously, comes with a cost. Many providers skimp on basic things and this results in very poor outcomes with patients surviving for abysmally short period of time on dialysis.

If outcomes are measured, the mortality and morbidity of patients on dialysis utilising such schemes would reveal some shocking details. This is why it is very important to get this new program right. The Government must involve people like Dr. Jha and others to ensure that they get this right the first time. If the broad contours of the program are designed badly, it would be very difficult to course-correct later.

India is at a very important juncture when it comes to healthcare policy. There is a unique opportunity that may not present again. If the Government handles this well, we could have a scheme that could genuinely help the vast ESRD population. If the opportunity is squandered, we will have only ourselves to blame.

"There is a tide in the affairs of men, 
Which taken at the flood, leads on to fortune. 
Omitted, all the voyage of their life is bound in shallows and in miseries. 
On such a full sea are we now afloat. 
And we must take the current when it serves, or lose our ventures."

- William Shakespeare

Wednesday, April 13, 2016

When it comes to a fistula, don't abandon what can be fixed

The human body has four sites in the body where an AV Fistula can be made which are comfortable. When we've exhausted all these options, then other options can be explored but these are not comfortable for a patient to get dialysis. The initial four I talked about are in the two hands (two each). Then if and when you run out of these, options in other parts of the body such as the legs can be explored. I have even seen a picture of a woman having a fistula on her stomach.

When you have such limited options, it is important that the initial four sites be preserved as much as possible. In India, unfortunately, I see a lot of fistula sites being abandoned at the hint of the slightest problem. This is due to the lack of experienced and proficient vascular surgeons.

In developed countries, everything possible is usually done to repair a fistula that is giving problems. In India however, the trend is to abandon the site and create a new fistula. In the past, dialysis patients were not expected to live too long. So, the thinking probably was, that anyway by the time the patients would exhaust his fistula site options he or she may not be alive. However, these days, increasingly, survival rates are higher and you find a lot of patients living longer lives on dialysis.

This makes it all the more important for our mindsets to change.

I was sent a link by two people yesterday which prompted me to write this post. The article talks about saving a fistula that is giving problems rather than abandoning it. The article mentions this facility being available in Medanta Hospital in Gurgaon. I am sure other good vascular surgeons in other cities would also have similar expertise. It is important that such centres are set up and the overarching intent should be to preserve fistula sites wherever possible.