Real Medical Research vs. TV Melodrama
Real Medical Research vs. TV Melodrama
07.12.12 | By
The other night, I watched a new police procedural on television. While the ultimate "bad guy" was a murderer who was part of a love triangle, at least one nefarious character under suspicion for the crime was a drug company scientist. According to the plot, he was desperate to hide bad test results that would have invalidated his life's work and kept a new blockbuster diabetes medicine from patients.
Trite tripe and fantasy. That well-worn subplot, of course, is the product of a not terribly original imagination - one that militantly ignores what biopharma research companies do and how they do it, but also the real world process of new medicine exploration and development.
I write this after reading a fascinating front page story in this morning's New York Times detailing some interesting and potentially important advances being made in understanding the biology and genetics of Alzheimer's disease. This story is about real science and real scientists, what they do and how they do it. More importantly, it reminds us all of how long, intensive, exhilarating and, yes, defeating the new medicine development process can be.
The core of the piece is about early stage research into some interesting genetics that may help some people avoid Alzheimer's even if they have other genetic or health propensities that might lead to their contracting the condition. The thing to remember, of course, is that it will likely take many years, much more research, and a huge investment of time, resources and money to create a useful medicine or treatment from this research.
I'd like to make two other points that this story reminds me of. First, this kind of research is not the product of some lone scientist at a lab bench somewhere in isolation. Cutting-edge research described in today's story requires cooperation among patients, academic and government researchers and countless biopharma research sector scientists. It takes place in many sites globally and with many skilled individuals intimately involved in every development, success and failure.
Failure is the second thing. In a weak TV plot, the failure of a potential new medicine is a reason for murder. In reality, failure is an expected part of the process and it is how we - in industry - and everyone learns. You can't create new therapies without some failure. From the private development side alone, we know that for every five to 10,000 chemical compounds examined as a possible new medicine, only one ever makes it all the way to approval by the FDA for patient use (see PhRMA's Chart Pack page 19).
That's a lot of failure, and - as today's Times story reports - it can happen late in the process, after years of investment, research and development (keeping in mind that the average development time for an approved medicine is 10 to 15 years and can cost, on average, more than $1.2 billion - see Chart Pack pages 19 & 22). Certainly, especially when it happens late in development, that is a disappointment to those working on a medicine as well as the patients who are waiting for it, but that is the core risk of all new medical research and development.
Critically, science is not an either/or proposition. Even if a potential new medicine falls short of the effectiveness needed for approval, does not mean that all of the research was for nothing. All research and all tests, regardless whether early in the process or in a Phase III clinical trial, help us better understand genetics, biology, chemistry and how diseases function. All research, success and failure, leads to new ideas and new approaches - ideas that may prove to be the ultimate cure for a terrible condition like Alzheimer's.
As I said above, today's Times story is hopeful, but there's a long way to go. Fortunately, in biopharma research companies, academic and government labs, and hospitals around the globe, there are men and women willing to go the distance to help end the suffering.