September 5, 2016 1:32:15 am
EpiPen is an auto injector device that delivers a precise dose of epinephrine, a hormone that is naturally produced by the adrenal glands. Epinephrine triggers a “fight or flight” response in the body to deal with allergic reactions that can be potentially life-threatening. While a range of allergies — triggered by seafoods, nuts, bee stings, some pets etc. — can be tackled relatively easily in most people, in some individuals, a serious emergency called anaphylaxis may develop, in which the airways swell and close. Epinephrine acts by increasing the heart rate and blood pressure, and prevents or reverses cardiovascular collapse. No other drug has such wideranging effects on almost all systems of the body. The injectors are marketed under the names EpiPen® and EpiPen Jr® , brands owned by the US-based pharma major Mylan.
When Mylan acquired EpiPen from Merck KGaA in 2007, the wholesale price of the product was less than $ 100 for a two-pack. The company has since raised the price steadily, crossing $ 600 (more than Rs 40,000) in May, and boosting sales to about $ 1 billion, as per a Bloomberg News report last year.
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In the US, where EpiPen has been the most prescribed epinephrine auto injector for 25 years, there has been an uproar. Politicians and celebrities have added their voices to the chorus, and Democratic presidential candidate Hillary Clinton has announced plans to “aggressively” address “unjustified, outlier price increases”. Mylan has argued that it has spent a lot in bettering the product, and much of the margins actually go to the players at various levels of the supply chain. Facing the heat, however, the company last month announced, first, steps to increase financial assistance for EpiPen and then, oddly, a generic version of its own product costing half as much as the branded injector. This was unusual because the product is still under patent — anger, however continues in the US, where Mylan now faces an inquiry by a committee of Congress.
EpiPen’s pricing has been criticised as the ultimate symbol of corporate greed. Epinephrine itself is extremely cheap — just that to be a life-saver, it must be delivered quickly and in the correct dose. This is difficult for someone in the throes of a severe allergic reaction, and this where EpiPen’s ready, quick, jab to the thigh comes in — even a child can do it by herself.
The other issue is epinephrine’s inherent lack of stability — and people who need the auto injectors must stock up afresh every year, discarding unused products. That raises costs even more.
The Indian Situation
There are no authentic studies but experts agree that the burden of allergies in India is rising in terms of both prevalence and severity. “…Allergic diseases comprise asthma, rhinitis, anaphylaxis, drug, food and insect allergy, eczema and urticaria and angioedema. Approximately 20% to 30% of total population suffers from at least one of these in India,” wrote Dr Rajendra Prasad, Director of Dr Vallabhbhai Patel Chest Institute, and Raj Kumar, Head of the National Centre of Respiratory Allergy Asthma and Immunology in the Indian Journal of Chest Diseases and Allied Sciences in 2013.
EpiPen is not available in India. The company had some years back applied for permission to market the product in India, but without clinical trials. Following recent changes in clinical trial regulations, and in the three-tier regulatory structure, there is even greater importance on clinical trials in India before a drug is marketed, except in very special cases. The technical committee that looks into drug licences did not agree to EpiPen being sold without trials. Until a few years back, some agencies imported the device with a markup, but chemists say supplies have now dried up.
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