Relative to what?
I believe that drugs and devices should be relatively safe, relatively effective and relatively economic compared to allowing disease to proceed untreated. If we don't consider "Relative to what?" it is not meaningful to use terms like safe and effective.
There are lies, damned lies, statistics and press releases. We have a huge problem in life sciences and politics of telling people what they want to hear and then disappointing them when we don't deliver. Does the public understand that an adverse event of one out of 20,000 scripts written is not going to be found in an economical clinical trial? Does the public even know that each individual prescribed a drug for the first time is in a clinical trial with N = 1? We need a far more honest and realistic approach or our negative thinkers will further discourage innovation. We all can identify articles and even entire books that have expressed the following points of view:
--The pharmaceutical industry is interested only in profiteering from the sick.
--The FDA approves drugs too quickly and they are unsafe.
--The FDA approves drugs too slowly and they are therefore unavailable to me.
--There is a conspiracy between the FDA and pharma/biotech/device companies.
--The cost of drugs is outrageous.
None of these sentiments are an absolute truth and rarely are they expressed relative to alternatives. As a scientist, it is unsettling to read in a newspaper that drug A has twice the likelihood of drug B to be associated with a cardiovascular adverse event and have no context about the benefit of either drug or even the incidence of the event in question for B vs. a comparable untreated population. When I read articles of this type, my intracranial pressure goes up for more than four hours and I must consult a physician. On the other side of the coin, we read how mice are cured of obesity and cancer. With unbounded optimism many run to buy neutraceuticals that are just an edge more effective than grass clippings. Let's face it, we don't like probabilities or the reality they represent. We want answers that are true or false and nothing in between. The more we learn about biology the less we understand. Each decade we study things we didn't know existed the decade before. This truth is not going to end anytime soon.
The interfaces between money and innovation and speed are huge challenges just as are those between regulators, companies and patients. It's time to have an honest conversation across these six fences. The FDA is in an impossible position and the pharma industry is not much better, having a reputation today similar to that of Congress or the Taliban. Regardless, we scientists plod away. Ultimately, the fruits of the human genome project, proteomics, metabolomics, monoclonal antibodies, stem cells, pharmacogenomics, nanomaterials and the like will be picked. We promised too much too fast. We're now at the hard slog of making reality meet press releases. We'll get there. Like for a lottery, in life sciences 'you have to play to win'. When we "go negative" investors get rattled and stay away. In 2008, can we restrain ourselves to more common sense by thinking "relative to what?" and balancing the dialog between unbounded doom and exuberance?