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Written By: Editorial Team | Updated : June 2, 2014 4:30 PM IST
Angelina Jolie's double mastectomy following the fact that she had 80% chance of developing breast cancer was in the news recently. She is one of the fortunate few who could prevent falling prey to cancer thanks to genetic testing (the BRCA genes). Though the hype about Angelina Jolie's decision died down in a few days, the BRCA genes have been in the news constantly.
In a landmark ruling, the US Supreme Court announced that genes cannot be patented. We interviewed Dr. Prasad Raj Dandekar, a
renowned radiation oncologist at the L.H.Hiranandani Hospital in Mumbai about the implications of this ruling on genetic testing and what it could mean for the research industry.
How is genetic testing so important, especially so in the case of breast cancers?
It will now be possible to predict the risk of developing breast cancer in patients with family history of breast cancers easily and affordably by a blood test. Some of the patients with breast cancer have a variation in genes called BRCA1 and BRCA2 which significantly increases their chances of developing breast and ovarian cancers. A lady with BRCA gene mutation will have 85% chance of developing breast cancer and 45% of developing ovarian cancer in her lifetime. This is significantly higher that compared to women who are not BRCA gene mutation positive. Women who are detected to be positive can prevent cancer development by taking some hormone therapy such as tamoxifen, or undergoing prophylactic surgery like celebrity Angelina Jolie did or be on regular follow up to detect cancer at early stage. The key factor here is to detect women who are BRCA gene mutation positive and explain them the risks associated.
Is the test for the BRCA genes available in India? And more importantly, is it affordable?
A few months ago when the Angelina Jolie got her bilateral mastectomy done after testing positive for BRCA genes, I received a number of inquiries about the BRCA gene testing. Many patients were worried about outcome of their cancer or concerned about their daughters or sisters getting cancer. But the cost and time involved in doing this test was a major hurdle. Until yesterday the patent for this test was held by a single company in the USA and thus this test was prohibitively expensive for Indian patients. At the cost of nearly 4000$ it was out of reach for even most American women if insurance cover was not covering it. In India this test is available at select laboratories and costs nearly Rs. 65,000 to the patients.
What are the implications of the recent verdict on gene patenting by the US Supreme Court?
In a landmark verdict the USA Supreme court has ruled yesterday that no one can patent human genes, thus making the monopoly claims of the company who currently conducts the tests for BRCA invalid.
This is a major victory for patients and advocacy groups for breast cancer since now this test can be made commercially available at a significantly lower cost and more number of patients could afford it. This will help us to identify women who are at a higher risk of developing cancers and thus many of these cancers can be prevented, saving many lives. Genetic testing for cancers such as breast cancer will be available for even poor patients and will not be limited to rich patients such as Angelina Jolie. Within hours of the verdict, some of the labs in the USA have slashed their rates for BRCA gene testing by 75%!
Apart from the cost and the availability of the ruling on the BRCA genetic testing, are there any other implications you can foresee?
This verdict also has a significant impact on cancer research and new drug development. Most of the research labs could not test for BRCA genes in patients earlier due to the patent. Now a wide spread research looking in to role of BRCA genes and cancers is feasible, without fear of being sued by the patent holding company. Thus a multi gene testing for cancers could be possible with inclusion of BRCA genes. Nearly 3500 to 5000 patents are held by major companies for naturally occurring genes and genetics researchers had great limitations due to inability to explore patented genes. Due to this verdict all the patents will be invalidated and will pave way for wider research in genetics of cancer and many other genetic diseases.
What does this mean for the companies who invested in genetic research? Do they still have any incentive to do so?
There was a silver lining for the industry also in this verdict that the court has allowed patents for the other processes involved in the application of genetics. Even though genes cannot be patented, the use of genes in diagnosis or treatment as well as ways of isolating the gene could be still patented. Thus this verdict will encourage the pharmaceutical companies to pursue genetic research and come up with better treatment and diagnostic options. There is some criticism of this decision that the interest in genetic research may reduce due to loss of financial benefit, but the current level of academic interest and new inventions will hopefully avoid such a negative impact.
This win win decision will have a long standing impact on the research, diagnosis and treatment of patients as well as on the way pharmaceutical industry operates.
Read more about causes, symptoms, diagnosis and treatment of breast cancer.
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