If you’re a woman above 30, chances are you’ve spent at least some time before a mirror, silently palpating your breasts, checking for lumps. Chances are you’re not even sure what the lump will feel like, and whether you will recognise it if you come across it, and what it will mean for the months and years after. The only solace lies in each passing second that you do not find the lump, and in the hope that you cling to with leechlike efficiency that this of all cancers, is curable.
Before most movies in the cinema, nowadays, there is the interminable view of tar-filled lungs, a black sponge dripping evil into a glass, Mukesh who has mouth cancer and who (we are told) did not make it. Eradicating mouth and lung cancer is being prioritised — and this is commendable —but perhaps, we should also have more public service ads talking about breast cancer. After all, it is the most common of all cancers and more women die of it than from any other cancer. This is despite the fact that it is curable.
Many deaths take place in countries with low resources, where women simply do not have the money to buy medication. For such a common cancer, the medication is expensive. Take Trastuzumab, the antibody that fights HER2+, a fierce form of breast cancer. It is used as a first line or advanced form of treatment and in India, it is currently available only as Roche’s Herceptin. Each vial costs Rs 70,000. A woman with breast cancer will have to take 12 such vials. A bleak scenario — but some hope spills through because Roche had to give up their patent on Trastuzumab earlier this month. The Campaign for Affordable Trastuzumab, which has been fighting this cause for a year, says it has been long overdue. More than a million women have been diagnosed with HER2+ cancer in the six years that this patent has been in force, with less than 10 per cent of them able to access the drug.
While the patent for Trastuzumab may no longer be in force, there are currently no approved biosimilars for it in India. (Biosimilars are officially approved versions of biopharmaceutical products that are created by other players after patent expiry.) An estimated 25,000 new cases of HER2+ breast cancer are added every year. According to the Tata Memorial Hospital, a recent study of breast cancer risk in India revealed that 1 in 28 women will develop breast cancer during her lifetime. The stakes are huge — millions of human lives — and the government needs to move quickly on getting other companies to produce the drug and make it available at reasonable prices.
But according to a campaign press release, Trastuzumab is not the only case where patent barriers are tyrannical. “Our work reveals a consistent pattern of bureaucratic manoeuvres to delay and deflect legal challenges to patents held by some favoured players. There is an urgent need for review and strengthening of the system for screening applications and awarding patents, as well as closer oversight of the functioning of patent offices,” says the release. The campaign plans to focus on this. In the meantime, it is trying to get the health ministry to talk to smaller companies, support development and fast-track the approval process. Currently, the approval process is indefinite.
One of the hurdles in the way of others coming forward with the drug are biosimilar guidelines, says campaign coordinator Kalyani Menon-Sen. “They privilege the bigger companies and put huge financial burden to prove exact similarity. These are very complex molecules and the non-therapeutic molecules don’t need to be the same. The guidelines should be reviewed and changed.” Menon-Sen is currently neck deep in reading biosimilar guidelines from other countries so that they can make recommendations. She points to the ways in which big pharma retain monopoly: “Both Biocon and Roche signed off on the draft of the biosimilar guidelines — that says a lot!”
And there is more at stake here than ideology. If the campaign is successful, there could be cheaper breast cancer drugs in the market by 2014. By that, we’re looking at a 95 per cent price drop. Women with breast cancer could benefit from a drug that is Rs 5,000 per dose rather than Rs 70,000 per dose, says Menon-Sen. That’s something worth fighting for.