A win-win battle- Nepali Times

To the surprise of many people, improvement in cancer treatment which had remained stagnant for decades is finally taking off, and revolutionary treatments, if you have the financial means, are now available.

In 1971 US President Richard Nixon declared war on cancer by signing the National Cancer Act. Nixon's administration had hoped that unlike the disastrous war in Vietnam, the fight against cancer would be a more popular campaign leading to a quick victory. More than 40 years later, Nixon's crusade which brought this dreaded disease into the limelight by providing more political and financial support for research, diagnosis, and treatment seems to have finally made an impact.

Even though treatment for cancer boils down to burn (radiation), slash (surgery), or poison (chemotherapy), research has now made it possible to deploy highly targeted relatively non-toxic agents guided by genetics. This therapy not only includes drug, but also substances called monoclonal antibodies which have brought about important, therapeutic advances. For example Trastuzumab, sold under the trade name Herceptin, is a monoclonal antibody which is now effectively used to treat certain types of breast cancer. Monoclonal antibodies for common cancers such as lung and colon cancer are also available these days.

Imatinib (sold as Gleevec in the US, Glivec in Europe and Australia, and Veenat in India), used against a special kind of leukaemia called chronic myeloid leukaemia (CML), is the poster boy for new cancer drugs which are different from monoclonal antibodies.

Gleevec costs about US $50,000 per patient for a year, but due to the generosity of people from abroad and a Western drug company, hundreds of patients with CML in Nepal obtain this effective drug for free. Gleevec's working mechanism is genetic based, so unlike other cancer drugs which indiscriminately kill off all dividing cells (hence people on chemotherapy may go bald), Gleevec targets particular cancer cells.

Many other cancer drugs like Herceptin are very expensive and not freely available to patients in countries like Nepal. Manufacturing these new cancer drugs in developing nations is difficult due to long-standing patency laws. Western governments and drug companies claim that these stringent laws need to be in place to make new drug discoveries possible. However, as expensive cancer therapy becomes more and more effective, difficult ethical questions will arise for which there will be no easy, clear-cut answers.

1. A Nepali
Recent estimates of cost and time to bring a new therapy to market is $2.2 billion and approximately 14 years, and this cost and associated risk is borne entirely by the private sector (biopharmaceutical companies). That is why there is intellectual property (patents) to provide incentives to invest in such risky undertakings. Developing countries like Nepal will never be able to afford the latest cutting-edge medicines. Even in developed countries like the United States, the cost is borne by insurance companies or by government programs (Medicare and Medicaid). Individual patients or their families canot afford to pay the costs even in the U.S. Cancer drugs like Gleevec and Herceptin are even more difficult to afford beacuse these are biologics (not small molecule drugs). When small molecule drugs go off patent, the costs of generics can drop significantly (pennies to a dollar), whereas off patent biologics will still be very expensive to get regulatory approval and to manufacture (best estimates are 70 cents to a dollar) as a biosimilar (equivalent to a generic for a small molecule drug). Thus, Gleevec worth $50,000 per patient per year, if sold as a biosimilar, will likely cost $35,000 per patient per year. There is no way people in the developing world (or even in developed world without insurance or government assistance) can afford such high costs of treatment. Furthermore, biologics are very difficult to manufacture and to maintain quality because of high variability, unlike chemistry-based small molecule drugs which are more stable. What all of the above means is that for people in Nepal, the only hope to have access to such cutting edge therapies is if some large biopharmaceutical company donates drugs for humanitarian/ethical reasons, or if a large foundation like the Gates Foundation decides to subsidize the cost of the therapy for sick people in poor nations.

Posted on: 17 SEPT 2012 | 12:27 AM NST