by Phil Calabrese
Human societies are pressed to find medicines and drugs to alleviate the prevalent ailments and diseases within their culture for the sake of longevity and health. As far in the past as two thousand years ago, Chinese herbologists used compounds found in nature to develop a successful system for diagnosing and practicing medicine. They were able to do so using a system based heavily on trial and error while doing the testing on themselves and keeping meticulous records. In contrast, modern day science’s technology driven approaches have led to a deep understanding of the molecular interchange between genes and proteins. In today’s world, there is a huge effort to be rational when it comes to finding novel, useful therapeutic targets and compounds. In the US, small sets of human subjects are tested and evaluated in clinical trials before a drug is deemed appropriate. But strangely enough, even if a drug makes it to market for a certain type of cancer, it doesn’t mean that everyone who has that type of cancer will respond to the drug.
One great promise of biotechnology is that medicine will one day be administered to an individual and tailored towards them based on their unique genomic or proteomic signature. However, many people wonder how reasonable this goal really is and some therapies are already expensive beyond reason itself. Take Erbitux, the genetically engineered monoclonal antibody for example. It is a colorectal cancer therapy that has been shown to exhibit some mechanism of action against the disease but costs $17,000 per month and it is only effective in roughly 20% of the population. This type of situation places a huge burden of cost on a collective pool of individuals - each contributing to what they may be disproportionately getting back from the healthcare system. Effective pre-screenings that are a few hundred dollars and evaluate if the therapy will be beneficial can provide cost effective way to alleviate this financial burden.
But getting a diagnostic to be used in the clinic takes a lot of research, product development and dollars. And even if the test results are backed by solid evidence, if they don’t fit into the timeframe and practical limitations built into a hospital’s workflow, they aren’t used. For example, if someone is diagnosed with a disease, a decision about surgery needs to be made within a window of time. If the patient’s sample can’t be taken, analyzed and given back to the clinic within that window, the hospital won’t use the test because of their established protocol in how they treat patients. Even if it saves the patient and the system from wasting $17,000 eighty percent of the time by taking a blood test that costs $300.
There are surely many challenges and obstacles to achieving the goals of personalized medicine. However, the vision of many pharmaceutical and biotechnology industry leaders is focused squarely in this realm. Although many times these types of ventures do not succeed, they will continue and when breakthroughs are made, people benefit. I hope we can use what we heard at the GoldLab Symposium to be more aware of the bigger picture at hand and become better as individuals at what we do to impact health and disease.