IMA “opinion poll” figures: Fictitious or Fudged?

There has been a controversy regarding the recent Indian Medical Association (IMA) survey on nimesulide, commonly prescribed for pain and fever, which has said that it is safe for patients of all ages. The IMA had initiated a survey three months ago after it was reported in the media that the drug triggers liver disorders. It has found that the drug has "minimal side-effects like nausea and vomiting" and the benefits of taking nimesulide outweigh its adverse effects. More than 50 doctors country-wide participated in an opinion poll organised by the IMA and submitted data on the use of nimesulide on nearly 5.3 lakh patients who were categorised into different age groups. The opinion poll conducted by the Indian Medical Association calling it `safe' may not end the controversy over the drug yet, as medical researchers have questioned the process and some leading doctors have directly written to the Drug Controller of India to ban its use as, with the exception of one or two countries, no country in the world allows the use of this drug in children, particularly infants.

Editor of the Monthly Index of Medical Specialities, Dr. C.M. Gulhati says:

  • The total membership of IMA is claimed to be about 1,50,000. It has not been disclosed as to the number of doctors approached to fill the questionnaire. Hence, the response rate cannot be determined.
  • There is no information on the selection criteria in choosing 50 doctors out of 1,50,000. Geographical location, speciality information, private/government/hospital attachments are not known.
  • Fifty out of 4,00,000 practising doctors in terms of percentage comes to 0.0125% - statistically totally inadequate to conduct any poll on any issue and reach any conclusion.
  • Participants were asked to give "approximate" number of patients seen annually in the past 1-10 years who were administered nimesulide. Since doctors do not keep even current records, the question of referring to 1-10 years old records does not arise. It is obvious that figures were filled based on memory. It is doubtful if any doctor can remember the number of patients administered nimesulide in 1994; much less classify them into various age groups (0-1 year; 1-5 years; 5-12 years, 12-30 years, 30-60 years and > 60 years).
  • As per the report, 50 doctors saw 5,29,792 patients in all, and the age groups were as follows:
    0-1 year 1,70,917
    1-5 years 1,58,528
    5-12 years 1,09,589
    12-30 years 31,149
    30-60 years 34,089
    Over 60 25,520
    The total comes to the following:
    Infants and children (0-12 years) = 4,39,034 or 83% of total patients
    Adults = 90,758 or 17%.

    IMA membership is mixed, predominantly general practitioners (GP). The above ratio does not fit into any practice whether GP or specialist practice.

    Furthermore, the manufacturers’ audited sale figures are in reverse: 86% adult dosage form and 14% paediatric. The two group of figures i.e. consumption and sale are poles apart. Also, paediatric formulation was launched in 1996; so the figure should be more downwards.
  • All the 50 doctors are unlikely to be administering nimesulide for the past 8 years (i.e. since 1994-95 when the drug was launched). Let us take the middle figure of 4 years and see the results:

    Average number of patients given nimesulide per year: 5,29,792/ 4 years = 1,32,448 by 50 doctors
    Average number of patients given nimesulide per year per doctor = 2649
    Total number of doctors in active clinical practice = 4,00,000
    Total number of patients given nimesulide in one year by all doctors = 2649 x 400000 = 105,96,00,000 (106 crore i.e. more than the total population of India)
    Average cost: Rs. 20 per patient.
    Total cost for all patients given nimesulide = Rs. 20 x 106 crore = Rs. 2120 crore per year
    Fact: The total average sale (over last 8 years figures) of nimesulide is only Rs. 800 crore for 8 years i.e. Rs. 100 crore per year while the consumption is Rs. 2120 crore per year i.e. 2120% more.
    Figures just do not add up.

Professional bodies of doctors anywhere in the world do not determine adverse drug reactions. In all developed countries there exists a scientifically structured system of collecting data on the side effects of drugs once they are marketed.

Nimesulide is an American drug discovered by a company called 3M Riker Pharmaceuticals. For reasons that have never been made public, the molecule was never launched in US but sold to Helsinn, a Swiss company. Helsinn could not launch the molecule in its home turf (Switzerland) because of regulatory reasons. It licensed the same to Boehringer for the Italian market where it was launched in 1985. Italy is known to be a "soft" country on regulatory matters. Nimesulide is not an essential life-saving drug for a life-threatening illness. Scores of alternative painkillers and fever lowering agents are available. When United States, Britain, Canada, Australia and over 80 per cent of the countries in the world can live without nimesulide, why should Indian public be exposed to the known and so far unknown adverse effects of this unessential drug?