Glaxo to pay $ 3 Billion for Largest Health Fraud in US - was the headline. On closer scrutiny, this news item opened a whole new can of worms in a company which hitherto had a formidable reputation in the pharmaceutical industry. Drugs were marketed based on “research” findings which were falsified, manipulated and misrepresented to market drugs and make a fast buck at the expense of the patient. What is particularly shameful is the fact that the chain of events could not have occurred without the complicity of the medical fraternity along the way.
Doctors presented the papers with fudged data for publication; supposedly well informed editors of peer review journals scrutinized these papers before publishing them; based on these fraudulent publications, other doctors were urged to prescribe these drugs, often with inducements of Hawaiian holidays. And in all this, the unfortunate patient was at the receiving end purely because he placed his trust in a system that was meant to look after his welfare.
In such instances one is immediately prompted to wonder what the situation is in India. The short answer is pretty gruesome. By sheer coincidence, at about the same time, the 59th Report of the Parliamentary Standing Committee on Health and Family Welfare was presented to both Houses of the parliament on May 8. The 118-page long report brings out in detail the irregularities on the part of the Central Drugs Standards Control Organisation (CDSCO) — the apex authority mandated with the task of regulating drugs in the country. In the ten years period between January 2001 and November 2010, the CDSCO approved 2167 drugs. Of these the files of three drugs could not be traced. By strange coincidence, these relate to antibiotics which are not approved for use in many developed countries.
In 11 drugs, the requisite trial protocol was not followed; either the phases were not adhered to or the required minimum number of patients not tested at the required number of centers. In 33 cases there was no attempt to even conduct trials. When the opinion of experts was sought, the so called experts were located in a cluster in Delhi and the reports were identical, word for word; suggesting that the reports were fed to the experts.
In some cases, instead of investigating the application, the drug manufacturer was advised to obtain a certificate and present it; obviously inviting dubious reports.13 of the approved drugs are not permitted for sale in US, Canada, Britain, EU and Australia.
In the face of such crass corruption, what defences do the patient and indeed the honest unsuspecting practitioner have? Obviously in a situation where the appointed authority does not give a damn, the innocent end user has to develop protective measures independently. All new drugs must be viewed with suspicion. The patient must not hesitate to ask his doctor whether the drug is a new innovation and whether there is an older tried and tested alternative. A variety of pain killers (COX-II inhibitors) were introduced as the wonder drugs without any side effects and within a matter of a few years withdrawn because of dangerous complications.
Unfortunately, official disregard for the health of the general public extends beyond the realms of pharmaceutical products. It is well established that 90 per cent of oral cancers are caused by gutkha, of these 30 per cent will die. Yet the Supreme Court has observed that gutkha is a “food” product and precipitated a war between the Ministry of Health (MoH) and the Food Safety Standards Authority of India (FSSAI). The latter wants gutkha to be banned as a harmful substance.
The MoH in its wisdom wants the FSSAI to set “safety standards “for gutkha; a preposterous proposition, obviously with an eye on the fact that it is a Rs.8000 crore industry, and more ridiculous in view of the existing COTPA law of the same MoH. The existing ban in four states is difficult to implement unless there is a nationwide ban by central legislation.
In short until we get some semblance of responsibility and accountability from the health ministry in India, it is every man (woman and child) for himself.