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Journalism of Courage
‘‘I’VE lost everything trying to battle this illness,’’ shudders P Sundaram (name changed), resting in his cramped two-room home in Bhandup, a Mumbai suburb. The 59-year-old was devastated when he was diagnosed with Chronic Myeloid Leukemia (CML), a cancer of the white blood cells, back in 2002. His condition has improved, he says, after a year’s treatment with a locally manufactured drug.
Doctors agree. Though they admit they cannot predict the long-term impact of the drug, they have told Sundaram it is fighting the cancer better than anything else he has taken.
While doomsayers are unlikely to be proved right in their prediction that generic drugs will disappear altogether come January 1, 2005, theoretically, the only option for Sundaram and others like him — the estimated prevalence of CML in India is 15,000 patients every year — would be the imported brand Gleevec (Glivec in India), produced by Swiss pharma major Novartis.
Introduced in India in 2002, the cost of the drug is Rs 1,20,000 per month.
TO protest against law amendments that will bar local drug companies from manufacturing patented products through a different process, Mumbai-based NGO Cancer Patients’ Aid Association (CPAA) filed a writ petition in the Supreme Court in September 2004. The petitioners challenged Novartis’ exclusive marketing rights (EMR) for Gleevec.
Novartis’ EMR, acquired in November 2003, prevents competitors from duplicating and selling the same compound — Imanitab Meyslate — under other brand names and at cheaper prices for five years. In essence, it means the pharma major has a monopoly over Gleevec.
‘‘It’s illegal for Novartis to ask for exclusive rights, since Imanitib is a pre-1995 molecule. For patients who cannot afford their prices, local drugs are the only way to prolong life,’’ says Dr Purvish Parikh, professor and head, medical oncology, Tata Memorial Hospital, Mumbai.
Prior to the EMR, nine Indian companies were making this drug. Six of them — Ranbaxy, Cipla, Sun Pharma, Camlin, Emicure and Intas — have been barred from further production by the Madras High Court, while Shanta Biotech and NATCO are among the three still producing the generic drugs.
The CPAA petition says that the absence of low-cost versions of the drug would mean denial of the right to life enshrined in Article 21 of the Constitution. The association has also sought government price control over life-saving drugs.
But Novartis is not open to price controls. ‘‘Since 3,000 patients receive the drug free, we see no reason for price control,’’ says a company spokesperson.
WATCHING the unfolding patent drama closely are the 3,000 patients on the Glivec International Patient Assistance Program (GIPAP). Novartis’ altruistic initiative is a rare effort in the pharma industry.
Chosen on the basis of medical and economic criteria, the beneficiaries include Laxman Waskar, a leukemia patient. ‘‘The tablets are miracles. I feel much better after taking them,’’ says the 29-year-old screen-printer. The six-pills-a-day he receives under GIPAP are a part of routine now. His blood count is better, his spleen is no longer enlarged, and he has more energy.
BUT questions are being raised about the term of this scheme. ‘‘Will they support these patients throughout their lives? And what about the many others who are in as dire need?’’ asks Y K Sapru, founder-chairman of CPAA.
Quizzed on the future of the free drug scheme, the Novartis spokesperson would only say, ‘‘Following the launch of the generic Imanitab, the GIPAP was modified between May and December 2003. Newly diagnosed patients were asked to avail of generic manufacturers’ assistance programmes.’’
