After claiming the fruits of painstaking research by public institutions, private collaborators are now influencing pharma pricing mechanisms
The recent Supreme Court judgment denying Novartis, a multinational pharmaceutical company, continuing patent rights over Glivec, a potent anti-cancer drug, has brought several lesser known facts to light.
It is not as if Novartis financed the entire research that led to the discovery and development of Glivec in 2002. The National Cancer Institute (NCI), a division of the National Institutes of Health (NIH) in the United States, funded the lion’s share. For the NIH it was but one in a chain of many path-breaking achievements beginning in 1968. That year, the head of the section of Biochemical Genetics at the NIH, Dr. Marshall W. Nirenberg, was a joint winner of the Nobel Prize in Medicine for discovering the key to deciphering the genetic code.
What needs to be noted is that both the NIH and the NCI are public institutions funded by taxpayers monies and by personal grants. The motivation to set up these institutions was never profit but the desire to use the fruits of research to ensure a long and healthy life for all populations: “long-term, basic scientific research rather than sharply focused quests for treatment and disease prevention.”
It is not easy for a research institution to start at the top and stay there. In India, the All India Institute of Medical Sciences (AIIMS) was set up in New Delhi, in 1956, by an Act of Parliament. It was to be a centre of excellence which would foster teaching and research. Unfortunately, it soon became a treating hospital for everything barring, “burn cases, dog-bite cases and patients suffering from infectious diseases.” It is, therefore, not surprising that despite the many notable contributions it made over the years, the research it did never quite measured up to the standard required to produce a Nobel laureate. This is what NIH laboratories and the units it funded in universities across America were able to do consistently over a period of time. The research undertaken was not inspired by a need to respond only to the changing epidemiological picture of the United States and limit its benefits to U.S. citizens alone. The NIH conducted research on malaria, leprosy, sanitation, dietary deficiency diseases, etc., which were typically problems of less developed countries. This is not surprising, as the NIH was, from inception, geared towards long-term, basic scientific research. The NCI on the other hand was persuaded to engage in clinical trials, beginning in 1952 with the administration of the Pap smear test to 150,000 women in the U.S.
In the late 1980s and early 1990s, NIH and NCI scientists began to treat cancer patients with gene therapy based on research done on mice. By 2001, they had developed a genetic test that distinguished between two types of hereditary breast cancers caused by mutations. This was followed in the opening decade of this century with the discovery of Glivec and a vaccine for the prevention of cervical cancer. It did appear that “sharply focused quests for treatment and disease prevention” were now taking centre stage. Private pharmaceutical companies were now quick to spot an opportunity for making profits by partnering with the NCI. This is why when Glivec was finally ready for use, it was Novartis that claimed patent rights and reaped huge monetary benefits, masking the contribution made by the NCI. This model, predictably, is one that is far from beneficial to the end users — patients and national health systems who not only end up paying huge amounts for drugs like Glivec, but also for drugs with limited efficacy which are nevertheless hyped and prescribed thanks to the powerful pharma lobby.
Today, not only are institutions like the NIH and the NCI turning over the fruits of basic research to private collaborators who in turn dictate the terms on which they will be made available to the public, but priorities too are changing with less engagement abroad. It is philanthropic foundations like the Melinda and Bill Gates Foundation that are now stepping in to fill the gap. In India, on the other hand, research continues to be a stillborn child with more and more emphasis on second-hand treatments and cheaper drugs that promise a lucrative return as the incidence rates of non-communicable diseases soar in the less developed world.
Despite the fact that the U.S. and India are not comparable in terms of research, the health systems in both countries are in a sorry state. By ceding ground to pharmaceutical lobbies, America has significantly nullified the huge research advantage that the NIH gave it. As a result, Americans not only have a poorer health status than Europeans, but also pay a much higher price for their drugs than Europeans do. In India, on the other hand, the health system is laid low because there is hardly any high-end research taking place. This places us at the mercy of pricing mechanisms influenced by international drug companies.
The sad result is that cancer patients in India, as well as those around the world, despite the respite created by the recent Supreme Court judgment, will continue to inhabit a hostile universe. Drug prices will keep on rising to satisfy the greed of those who manufacture them with little relation to what is conscionable. A warning shot has already been fired by oncologists who argue that the costs of cancer drugs and treatments are fast becoming unaffordable and that unless corrective actions are taken, a crisis is very near and very real.
Harmala Gupta is founder-president, CanSupport.