Saturday, August 13, 2005

The Gleevec Story: Part 2

This is the second part of the article. See below for Part 1.

The pharmaceutical industry and other ancillary industries which depend on modern allopathic medicine make only a weak pretense at being anything but profit making entities. This is fine as long as the physician acts as the intermediary between them and the patient, determining objectively when a patient really needs a particular pharmaceutical product.

However what has dramatically changed over the last two decades or so is that with the advent of globalisation and the birth of the multinational corporation, pharmaceutical companies find that in addition to stupendous profits, globalised trade also allows them to wield enormous amounts of power to influence international and local trade policy as well as the decision making capabilities of healthcare institutions and individual doctors. Time and again they have used this power to further their interests even when their decisions have adversely affected people’s access to essential medicines.

The only effective tool to influence a profit driven corporation is one that reduces profit. The need of the hour is to build a strong consumer movement which can protect itself through effective mechanisms that put pressure on big pharmaceutical corporations. World over it has been shown that when confronted with resolute consumers determined to ensure fair marketing practices, corporations have rarely risked profit endangering bad publicity and in many cases have backed down.

Doctors everywhere have a clear choice ahead of them. Whether to side with corporate bodies and become in effect corporate doctors with six figure salaries and a full range of pharmaceutical sops but no power to stand up against a corporate decision or whether to side with their patients and demand that people’s needs are put before profits, a position which guarantees a lower pay scale, more work, greater freedom and a fuller sense of job satisfaction.

This is a choice that our current system of medical education which is conspicuous in its silence about ethical issues and a strong economic and political understanding of the pharmaceutical industry leaves us ill-equipped to make.

Thursday, August 11, 2005

The Gleevec Story: Part 1

This is the first part of an article which I wrote for Raw Nerves, our nascent college newsletter. The second part is soon to follow.

On April 17, 2001 a new drug called Gleevec was officially announced by Novartis, the second largest drug company in the world. Gleevec or imatinib which is its pharmaceutical name works by interfering with the pathways that signal the growth of tumour cells. Overnight the drug revolutionised the treatment of CML (chronic myeloid leukemia) as well as GIST (gastro intestinal stromal tumours). The scientific community was greatly excited by the development of such signal transduction inhibitors and there was hope that soon similar drugs could be used to treat various other types of cancer.

Imatinib turned out to be extremely good news for the 24000 patients who are diagnosed with CML every year in India. As per existing patent laws in India, which allowed patenting of the manufacturing process but not the final product, imatinib was soon produced by nine different generic manufactures and was made available to patients at Rs. 9000-12000 per month. This was in glaring contrast to the Rs. 1,20,000 per month which was the cost of the branded Gleevec sold by Novartis.

In 2004 things took an ugly turn when Novartis managed to secure from the Patent Controller an EMR (Exclusive Marketing Right) for Gleevec. Almost immediately the Madras High Court was forced to order six of the generic manufactures of imatinib to stop production based on a case filed by Novartis. The decision spelled death for a majority of CML patients who could not afford the Rs 1,20,000 for the branded Gleevec.

To make matters worse in December 2004 the Central Government tried to push through a piece of legislation known as the 3rd Patent Amendment Bill in order to meet India’s commitment to the World Trade Organisation’s TRIPS Agreement which required that we amend our patent laws to allow for product patenting. Such a law would make EMRs like the one granted to Novartis standard practice for any new drug and would prevent people from accessing cheaper generic versions.

Health activists around the world were quick to recognise the potentially disastrous implications of the amendment and organised themselves under the banner of the Global Campaign against the Indian Patent Amendment. Protests were organised in Europe and North America as well as throughout India.

After many modifications the final version of the Bill was finally accepted by the President on 7 April 2005. The Bill ushered in a product patent regime in India but allowed generic manufacturers like those of imantinib who had made “significant” investment to continue production after a “reasonable” royalty has been paid to the patent holder such as Novartis. Such vagueness of the terminology can be easily exploited in favour of the patent holders. In many cases generic manufacturers were reluctant to restart production fearing lawsuits from the patent holders or unreasonably high royalties.

Under the new law, if the next signal transduction inhibitor drug which works against another form of cancer was discovered, then the patent holder, in most cases a large pharmaceutical corporation will have the exclusive right to market it for the next 20 years. In the presence of such a monopoly they will be able to get away with exorbitant prices.

The story of Gleevec highlights a growing phenomenon in modern day medical practice. That the health of our patients can be adversely affected by trends in globalised trade and that in order to safeguard our patient’s health doctors will have to understand and be active participants in a worldwide movement to counter the ill effects of globalisation.