Wednesday, August 24, 2011

Two Approaches to Cancer Studies

Two studies related to the prevention and treatment of cancer will commence in the US and the UK, respectively. The pilot phase of the Stratified Medicine Programme led by Cancer Research UK with support from the public, private, and charitable sectors seeks to provide the first nationwide genetic testing program for cancer patients. Collection and analysis of 9000 samples will be tested for a range of mutations in order to create targeted approaches to cancer treatment for six common cancers: breast, bowel, lung, ovarian, prostate, and melanoma. Existing patients derive the benefit of the targeted tests while researchers generate more data in order to understand underlying genetic factors.

Although the program is in its infancy, one must also ask if access to such personalized treatment is feasible on a national scale. Are such diagnostic techniques and treatments en masse reasonable or attainable? Theoretically, it should be possible to integrate such practice with a reasonable cost savings to the UK National Health Service. According to Harpal Kumar, CEO of Cancer Research UK, targeting medications to specific populations would drive costs down.

"The problem at the moment is that it takes $1bn to get a drug to market and 15 years or more. That is the justification for the pharmaceutical industry charging high prices… If on the other hand by the time you get to phase 2 you know exactly which patients it is going to work on, you only put those patients through and instead of 10% you get an 80% response rate… You get a licence on the basis of the data and don't have to go to phase 3 [a trial involving thousands of people]. That saves vast sums of money and years of development. What that does to the business model is it means you can justify charging lower prices because it cost a lot less in the first place." The Guardian, 22 August 2011
A second concern would be the privacy of patients' health data. According to Cancer Research UK patient, treatment, and outcome data will be provided in a "pseudonymised electronic format." Although research can be conducted without identifying information, the genetic information derived from such tests is, in effect, personally identifying, so can it ever be truly be considered anonymous?

In contrast to the UK study, a longitudinal US study (Cancer Prevention Study-3) sponsored by the American Cancer Society (ACS) will follow 300K people with no personal history of cancer for twenty years in order to understand lifestyle, environmental, and genetic factors that cause or prevent cancer. Unlike the UK study, the ACS study seeks to prevent cancer rather than treat it. The study will collect blood samples, waist measurements, and surveys from study participants. Research subjects derive no direct benefits from the study compared to the UK study; however, ethically speaking the study's website cites specific measures indicated to ensure privacy:
• label your data with a unique identification number when it is collected
• store your blood sample, survey data, and other study materials separately from all personal identifying information (like your name, address, and social security number)
• limit access to any identifying information to authorized study personnel only
• keep study documents in a locked, limited access research storage room
• have all staff sign confidentiality forms and undergo training in research ethics
• have all Volunteers sign confidentiality forms
• not share results with your family, your doctor, your employer, any insurance company, or other third parties and we will keep your records private to the extent allowed by law
--Jimmy P. Daruwala


References

Cookson, Clive. Genetic test promises cancer gains. The Financial Times, Retrieved 23 August 2011.

Boseley, Sarah. Cancer research in 'golden era,' says charity chief. The Guardian, Retrieved 22 August 2011.

Cancer Research UK. Cancer Research UK Stratified Medicine Programme Calls: Frequently Asked Questions, Retrieved 23 August 2011.

American Cancer Society. Cancer Prevention Study 3, Retrieved 24 August 2011.

American Cancer Society. Confidentiality and Ethics CPS-3. Retrieved 24 August 2011.

No comments: