Tuesday, July 2, 2013

Pioglitazone banned in India - The doom awaits!

Dear Editor,

As a doctor and diabetologist, I would like to present some facts and different aspect of pioglitazone (anti-diabetes drug), which is recently banned by Indian Health Ministry and is being cursed without concrete reasons.


1) India is diabetes capital of the world along with China. Diabetes management has very less options, one being pioglitazone. It is probably most potent and effective oral drug option amongst the five available groups, sixth being insulin.

2) An estimated 30 lakh (probably more) Indian diabetic population must be on Pioglatazone combinations. It is cheaper and massively effective drug, which helps in preventing many diabetes related complications in a long run.

3) Every drug has side effects. In that case, all other diabetes medicines should have been banned too. Why just Pioglitazone? - Metformin causing lactic acidosis and liver abnormalities, Sulphonylureas causing cardiac abnormalities, the so called gliptins (on which patients are supposed to be shifted, post pioglitazone ban) causing pancreatitis and it's cancer. Insulin itself causing dangerous hypoglycemia and fluid retention, every anti-diabetic should have been banned. In that case, the nation's diabetics would freely be left to the mercy of the quacks.

But thankfully, doctors are trained to prescribe above drugs (including pioglitazone) with caution by screening appropriate patient group.

4) Raised sugar itself is a pro-cancerous state. Meaning, if sugars are uncontrolled, it can itself lead to many cancers, along with other complications of diabetes. Banning pioglitazone (citing one in thousands bladder-cancer incidence) is a joke. It is a crime. The people behind this serious and ridiculous decision should be thoroughly investigated and subjected to legal action. Moreover, there is not enough clinical data worldwide to support the ban.

5) Even developed countries like US and UK have not banned the drug (where the research on pioglitazone takes place). US has even gone a step further and has approved pioglitazone along with a combination pill with linagliptin (even though the combination drugs are not approved in US).

6) Pioglitazone is endorsed and recommended by all major guidelines of diabetes management - ADA (American diabetes association), EASD (Europe) and IDF (International diabetes Federation). Indian doctors follow the above guidelines while managing diabetes.

The Pioglitazone ban has come as a rude shock to the doctors. I am not even trying to imagine the financial loss to various pharma industries. However, the major calamity still awaits! The people who will suffer the most are the economically challenged patients, currently excellently controlled on pioglitazone.

The sudden stoppage of pioglitazone will seriously disturb patient's blood sugars, as it is the only major insulin-sensitizer drug available. Even shifting the patient to the so called costly drugs, wouldn't help much as none is as effective as pioglitazone. Moreover, their site of action at molecular level is much different.

The impact - Millions of patients with good control on pioglitazone will experience rise in sugars over next one to six months, which will make them prone to serious complications related to diabetes including infections, renal failure, foot amputations and deaths. Who takes the blame for it? Many poor patients will deny shifting to costly Gliptins (additional Rs 20-40 per day along with cost of other medicines). Do you expect a farmer to pay such a hefty amount on a daily basis to manage diabetes?

Moreover, in an already under-insulinized country like India, where people are reluctant to accept insulin injection-pricks, how would you convince a stable person with raised sugars post stopping pioglitazone to shift to insulin injections on a daily basis? This would again lead to more complications and deaths.

I request you to investigate this issue and give it a larger coverage in the media to save thousands of impending complications and deaths due to banning pioglitazone.

The ban on pioglitazone must be revoked on an urgent basis.

Regards,

Dr Amit Rajput
MBBS, MD(med), D.Diab
Consultant Diabetologist
Diabetes Clinic, Jalgaon (Maharashtra)


P.S.
Related web links :
http://www.pharmabiz.com/NewsDetails.aspx?aid=76178&sid=1
http://indiawires.com/24462/news/national/a-scam-in-governments-ban-on-diabetes-drug-pioglitazone/