Why does a drug company sponsor research?

By Sandhya Srinivasan

Does a pharmaceutical MNC sponsor research on the risk factors for breast cancer because it is altruistic, or because it markets a drug for this particular problem that costs a patient Rs 90,000 per month? Sandhya Srinivasan starts a new column on the impact of healthcare markets on you, the consumer/patient

In February 2010, newspapers carried reports on a study of cancer in Indian women. One thousand women attending breast cancer clinics at the Tata Memorial Hospital in Mumbai and the Jehangir Hospitalin Pune will be put through tests to identify their risk factors for ‘HER-2 positive’ breast cancer.

This is a type of cancer whose tumour growth is fuelled by excessive production of the HER-2 protein.  Apparently 30% of Indian women with breast cancer have HER-2 positive breast cancer, compared to 20% of breast cancer patients in the West. The study will try to understand the reasons for this difference.

The study is financed by the multinational drug company GlaxoSmithKline’s Oncology International Ethnic Research Initiative that funds research on breast cancer in Africa, Latin America and Asia.

No further details of the study are available on GSK’s websites or on the websites of the two hospitals. Nor is this study mentioned on the ICMR/WHO registry or on the US clinical trials registry.  Since as of June 2009 all trials in India must be registered on the ICMR registry before the first patient is enrolled, we can assume that no patients are yet enrolled for this study.

But in any case it is worth learning more about why GSK wants to sponsor a study on HER-2 positive breast cancer in India. Is it the purely altruistic desire to improve the understanding of ethnic factors in breast cancer and help reduce the impact of cancer in this part of the world?

The company’s interests

GSK happens to market the latest drug for HER-2 positive breast cancer. Lapatinib is a targeted therapy tailored to stop tumour growth in HER-2 positive breast cancer without affecting normal tissue.  It first received marketing approval in 2007, for use by patients with advanced cancer for whom the standard treatment – a drug called trastuzumab – had stopped working. In January 2010, the US FDA approved it for first-line treatment in advanced cancer, along with the drug letrozole, expanding the market of people for whom it could be used. It is believed to be in a neck-to-neck race with trastuzumab for a share of the HER-2 breast cancer drug market

India was one of the countries in which lapatinib was tested. After approval, it is available in India at what GSK has described as a “discounted” rate, Rs 90,000 a month. Patients who respond to the drug should take it for as long as it works – if they’re lucky, they will spend Rs 10,00,000 a year to stay alive.

New drugs work better but few can afford them

The success rate of cancer treatment doesn’t depend only on the stage at which the disease is diagnosed. It can also depend on what the patient can afford. The newer treatments seem to  get better responses, with fewer side-effects, and can dramatically improve chances of survival. But they are out of the reach of the vast majority of Indians.

Pfizer’s kidney cancer drug sunitinib costs Rs 196,000 for a 45-day course; Roche’s erlotinib, for patients with non-small cell lung cancer, after failure of at least one chemotherapy regimen, costs Rs 330,000 for a 3-month course. TrastuzumabbyGenentech/Roche costs Rs 130,000 per month to be taken for as long as it works. Roche’s rituximab for non-Hodgkins lymphoma is Rs 100,000 per injection for a course of 10-12 injections. Novartis’ imatinib is Rs 100,000 for a month’s treatment.  Cancer drugs can be sold at such unreal prices because they are out of price control. 

At such exorbitantly high prices, and in the absence of any significant medical insurance coverage, relatively few Indians with cancer can afford the new drugs. Still, the number of Indian patients who can afford the new drugs is large enough for drug companies to launch their drugs here.

India’s cancer drug market

A 2008 report by the drug industry consultants Decision Resources stated that the “Indian breast cancer drug market” would go from $35 million in 2007 to $64 million in 2010. The drivers: “rising disease prevalence, increasing wealth and growing disease awareness”.  A survey of Indian doctors found that they have started prescribing targeted therapies like trastuzumab and lapatinib. Though “premium prices are the major constraint for market uptake”, the report predicts that “India's fast-growing economy will drive demand for novel therapies with higher efficacy and fewer side-effects, which usually command high prices among the burgeoning middle class and higher-income breast cancer patients.”  

On the other hand, GSK’s lapatinib or Roche’s trastazumab could be used by the estimated 100,000 Indian women with HER-2 positive breast cancer.  But oncologists estimate that less than 0.5% of women who need either drug receives it. The Cancer Patients’ Aid Association describes the situation as a national emergency.

Battle for access

Despite this scenario, pharmaceutical companies have fought viciously to prevent others from manufacturing their drugs and selling them at more affordable prices. When Cipla started exporting generic formulations of patented AIDS drugs to African countries, Pfizer and other MNCs threatened the governments of these countries. The companies were eventually forced to back off by the Access to Treatment Campaign. Novartis filed a patent application for imatinib in order to stop a generic company from selling the same drug for Rs 8,000 a month. It lost the case. Most recently, Bayer tried, unsuccessfully, to prevent the DCGI from granting marketing approval for the anti-cancer drug sorafenib tosylate. This was done to delay generic production of the drug even once it went off patent. There are apparently some 350 patent applications from MNCs for cancer drugs pending in the Indian Patent Office.

For some years now, community groups and non-governmental organisations such as the Cancer Patients Aid Association and Medicins Sans Frontieres have been fighting legal battles against patent applications for drugs that should be available in India. They have also called for compulsory licensing to enable the production of patented drugs needed for a public health emergency. This is possible under the Trade Related Intellectual Property Rights agreement of the World Trade Organisation. 

The latest entrant to this campaign is the singer Yesudas. In January 2010, he filed a petition in the Kerala high court asking the state government to control the prices of life-saving drugs and provide them to poor patients free of cost. He sought a direction to implement the Provisions of National Pharmaceutical Policy and Health Policy and noted that there is no mechanism in place to fix and regulate the prices of medicines, especially anti-cancer drugs and life-saving drugs. The court has issued notices to the central and state governments and the drugs controller general of India.

CPAA gets dozens of calls every day from patients desperate for financial help in their treatment. Shubha Maudgal of the CPAA related the story of one man, the brother of a patient with chronic myelogenous leukaemia. Novartis’ imatinib had an almost miraculous impact and the patient became well enough to go back to work. But it cost Rs 100,000 a month, and had to be taken indefinitely. The family had sold whatever it could to pay for the drug. They loved their brother dearly, but had reached the end of their resources. What were they to do?

The high cost of cancer treatment and the absence of any meaningful state-supported healthcare forces most poor families to give up treatment, but many middle class families will even sell their homes to pay for the therapy.  

The clinical trial option

One option for cancer patients who cannot afford these drugs is to enter a clinical trial. Indeed, people may enter clinical trials in order to obtain treatment that they could not otherwise afford. Seriously ill patients who cannot afford good quality treatment are vulnerable to their doctors’ suggestions that they enter a clinical trial where the treatment will be free. The website of Jehangir Hospital makes the link between clinical trials and treatment access explicit with the announcement that the hospital’s status as a “leading Clinical Trial Center in India” has been “particularly beneficial for patients, since the hospital is able to quickly arrange for the latest cancer drugs for unresponsive cancers, even if they are not available in the Indian market”. In other words, clinical trials are promoted as a treatment option.

India is increasingly a site for testing the new cancer therapies. An analysis by the Centre for Studies in Ethics and Rights, Mumbai, of clinical trials in India found that more than 200 of some 1,000 clinical trials registered in India as of June 2009 were on cancer. There are at least 12 ongoing clinical trials in India for HER-2 positive breast cancer. Many of these trials test treatments that, if approved, will be too expensive for those people on whom the drugs were tested. The Indian government has not seen it fit to ensure that drugs found effective in a clinical trial are made available and affordable in the community and ethics committees reviewing these trial protocols have not seen this as part of their job.

Before January 2005, Indian regulations made it difficult for foreign researchers to do clinical trials here. Now, however, despite the low incidence of cancer compared to the developed world, in India “the vast number of very diverse and advanced cancer cases offers a unique opportunity for carrying out different trials in various parts of the country,” writes V Raina in the Annals of Oncology in October 2005.  DrRaina notes that Indian cancer patients have contributed to about one-fifth of patients in global clinical trials, and is the lead recruiting country, enabling fast completion of the trial. A network for cancer research is being established, of publicly funded centres in Delhi, Mumbai, Ahmedabad, Hyderabad, Bangalore and Thiruvananthapuram. These centres will be provided training in establishing standards of good clinical practices and research facilities.  

Research and the community

The Declaration of Helsinki is a document of the World Medical Association containing essential ethical standards for research. In the last decade or so, it has been the focus of heated discussions on issues related to research in developing countries that is sponsored by developed country organisations.  Paragraph 17 of the Declaration states: “Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or communityandif there is a reasonable likelihood that this population or community stands to benefit from the results of the research.”

GSK and other drug companies conducting research in India have an obligation to make known how exactly the research benefits Indians. In this case, a study on a particular condition is sponsored by the company marketing a drug for the same condition. And the drug is available in the country for a sum that few patients can afford. There is little reason to believe that GSK  – or, for that matter, any company testing similar drugs in India – will make their drugs available at an affordable price to all Indian patients. 

Infochange News & Features, March 2010