CILLA is a cheerful 15-year-old girl from a poor farming family. She is a diffident girl, but also strong and independent enough to bear a week alone in hospital. During that week, Cilla endured repeated blood tests and a bone marrow puncture, swallowed pallid hospital food - dispensed like medicine from a stainless steel trolley - and listened quietly, as doctors and nurses pushed her around and talked about her from the end of her bed.
Cilla was found to have Chronic Myeloid Leukaemia (CML), a cancer of the blood. People with CML can be cured of the cancer, if they take a designer drug - a "magic bullet" called Glivec. Cilla responded well to Glivec: her blood has become normal and she has returned to her Form Three class.
Cilla hopes that, after completing her studies, she will be able to look for work, shop for clothes, and tease young men, like other young women in her village. She plans to have a family of her own one day.
Cilla's dreams have been founded on Glivec. This celebrated little capsule has revolutionised treatment for CML. Before Glivec became available in 2002, the only hope for cure for patients with CML was bone marrow transplantation. This entailed entering a lottery of finding a donor, and then going on the long, frustrating waiting list at understaffed government hospitals. The alternative was to pay hundreds of thousands to private hospitals in Malaysia or abroad. It goes without saying that most patients died from CML before Glivec appeared.
Cilla is unaware of the fate of the many people with CML who died because they never had access to Glivec. Cilla knows, however, that Glivec has made her feel well. She has recovered, without hair loss and infertility, the usual side effects of chemotherapy. Cilla feels no shyness about her looks, when she goes to school.
Crushing hopes
Yet Cilla's hopes, and those of hundreds of other Malaysians taking Glivec, are crumbling. Cilla has been taking her Glivec free of charge from a government hospital. If she were forced to buy the drug herself, she would have to pay almost RM10,000 per month; her family's monthly income is less than RM500.
Glivec must be taken every day without fail, for an indefinite period. Many patients have been taking Glivec for years, with no prospect of stopping the drug. Since 2002-3, Novartis has provided Glivec free of charge to deserving patients in Malaysia, such as Cilla.
In a shocking and distressing turn of events, Novartis made a announcement in early November that it will terminate the access of Malaysian patients to the Glivec International Patient Assistance Program (GIPAP) - under which people like Cilla receive free Glivec - by the end of the month.
Novartis is now applying pressure on the Malaysian government to buy Glivec for poor patients with CML such as Cilla. The Malaysian Ministry of Health has agreed in principle to buy Glivec, but has not provided any budget allocation for this huge cost. As a result, poor patients like Cilla are running low on stocks of Glivec and are missing doses, because the supply of Glivec to hospitals has been restricted. Newly diagnosed CML patients face panic and uncertainty whether they will have access to Glivec.
Malaysian patients with CML are angry and confused, because Novartis had not consulted the patients nor their doctors before making this announcement. The announcement by Novartis appears to be aimed at forcing the Malaysian Ministry of Health to come up with a budget to pay for Glivec, even though no budget allocation has been approved so farf.
"The Ministry of Health agreed that it should plan to pay part of the cost of Glivec for Malaysian patients," explained a leading Malaysian cancer specialist, "but we all know that there is no budget available this year, and that it takes many months for government allocations to be approved."
Cilla, and 800 other Malaysian patients depending on Glivec, have no say in this debate - the supply of their life-saving medicine is in jeopardy, and their fate is being decided by Novartis.
Empty promises
In 2002, Novartis established the Glivec International Patient Assistance Program (GIPAP) to supply free Glivec to people with CML all over the world, who could not otherwise afford the expensive medicine. Novartis promised, pledging charitable intentions, that "no patient that needed the drug would go without it".
The patent for Glivec, and all the wealth that derives from it, is owned by Swiss pharmaceutical giant Novartis. Novartis was born in 1996 from the union of Ciba and Sandoz; at the time, it was the largest corporate merger in history. Novartis has a staggering income of around US$6 billion, or RM20 billion, a year - greater than the Gross Domestic Product (GDP) of many countries; in fact, the annual income is 16 times the GDP of tiny Timor Leste. Glivec is the second highest selling drug for the company. Glivec sales, mostly in wealthy countries, enriched Novartis by US$2.8 billion (RM9.5 billion) in 2005.
Critics have alleged that Novartis used the "free" GIPAP supplies to introduce Glivec into new markets around the world, then pressured CML patients to lobby their respective national governments to buy Glivec. After a few years of free Glivec, a large number of patients would be reliant on Glivec to keep the cancer at bay. However, any government would find buying Glivec from Novartis would be a tremendous burden.
The New York Times warned in 2003 that the "free" Glivec program was skewed towards making money from richer national governments: "in the 49 poorest countries, where Novartis estimates that 9,500 patients could be helped by Glivec, the program has reached 11 people, according to the latest count. In wealthier countries like South Korea, Hong Kong and New Zealand, Novartis, meanwhile, has encouraged patients who have received free drugs to become advocates, pressing public health systems to pay high prices for the drug. One company document declared that drug donations - along with media campaigns and legal tactics -- were part of a concerted plan to win reimbursement for Glivec." ("Drug maker's vow to donate cancer medicine falls short", New York Times June 5, 2003)
Wealthy governments such as Singapore's and Hong Kong's have subsidised the cost of Glivec for some of their CML patients. Novartis has been compensated handsomely for giving out free Glivec for the first few years in these countries. But it is obvious that Malaysia is not in the financial league of Hong Kong or Singapore, and Malaysia's government should not be forced to join them in paying for Glivec.
Pushing hard for profits
Why has Novartis chosen to push so hard for the Malaysian government to pay for Glivec at this moment in time, even at the risk of a public relations disaster in Malaysia? Perhaps part of the answer lies in the paradoxes of globalisation, which have made it easier for Novartis to enter markets such as Malaysia, and have thrown up obstacles in its path at the same time.
Novartis is a colossus, towering above the shoulders of other giants in the industry. However, the company has been stung by several setbacks in recent months, notably an Indian court ruling that has opened the door to cheap generic versions of Glivec, in line with the World Trade Organization (WTO) trade-related aspects of intellectual property rights, or TRIPS, rules. TRIPS rules allow poor countries like India to produce generic versions of certain drugs patented in other countries, but not patented in India - Glivec being one example.
A Madras High Court ruling in August 2007 allowed jubilant Indian generic manufacturers to sell their own versions of Glivec, at 10% of the price charged by Novartis. This ruling may have contributed to a fall in Novartis profits to US$1.6 billion in the third quarter of 2007, compared to profits of US$1.8 billion in the thrid quarter of 2006.
India is the world's leader in producing cheap generic drugs, used to treat poor people everywhere, including people with HIV/Aids - a vital lifeline, according to Nobel laureate Mdecins Sans Frontires (Doctors Without Borders).
Multinational pharmaceutical giants have fought to stop Indian companies from producing these generic drugs, in an attempt to safeguard Big Pharma's patented monopolies, their main source of income.
Novartis must be concerned that a generic version of Glivec will soon find its way to Malaysia. It is possible Novartis is moving quickly to persuade the Malaysian government to start buying Glivec, to forestall competition from generic versions.
Cilla continues to hope for a bright future. Big Pharma gave Cilla and others a brief period of hope, rolling out easy promises. Now hope is fading fast as the cancer patients run out of Glivec. As Big Pharma pushes for big profits in Malaysia, it is clear that Big Pharma has the power to give hope, and crush hope too.
SI YING PAIN is a medical practitioner from Sarawak. Comments and feedback can reach Rentakini by emailing [email protected]
