Last week at the State of the Union address, President Obama introduced the masses to something called Precision Medicine. Generally speaking, it is a theory that we should customize and tailor medical treatment for each individual. Of course, that’s exactly what we should do and the direction we should go.
Western doctors have a few tools at their disposal to treat their patients:
- Lifestyle change advice
That’s about it. So let’s think about which tools are most effective.
Doctors aren’t so great at getting people to change their lifestyle in a significant way. Most medical students get one or two lectures in behavioral modification. Western medical doctors just aren’t experienced in this kind of intervention. It’s a much bigger initiative than the three office visits the average American makes to the doctor every year. Doctors are terrible at preventing lifestyle diseases, but great at fixing things when they are structurally broken.
Doctors are getting better and better at surgeries and procedures. If you have a structural problem, we’re increasingly using more computers, robots, cameras, 3D imaging, 3D printing, technological instruments and such to get you all fixed up and on your way. Doctors, their hardware, and their procedures work magic and it’s only getting better. Exciting times indeed. Those lucky surgeons!
Now we’re left with medications. For the last 15 years or so, the FDA has approved a very small number of new drugs that are actually new drugs. It’s been around 10 new kinds of drugs (“new molecular entities”) every year for the past 15 years or so. It costs between $2.6 billion and $11 billion dollars to develop a new drug, which has increased roughly 150% in the past decade. It takes roughly 12 years to go from first test to medical cabinet. And the chance of approval from formal pre-clinical testing to approval is 1 in 5,000. Keep in mind, the definition of a drug according to the FDA is a substance that causes an intended effect in the human body that’s better than placebo. It can be 5% better or 90% better. As long as it’s statistically significantly better than a placebo and has been demonstrated as “safe” for humans. But even the most popular drugs have very little actual effect on the population. It takes over 500 people taking Lipitor to prevent one death or serious medical complication. There’s an axiom in medicine that for most medications, 1/3 of people are helped, 1/3 of people are not affected, and 1/3 of people are harmed by a medication’s side effects.
Personalized medicine wants to target the 2/3 of people who are not affected or are harmed by medications. If we can know who won’t respond or will be harmed by a medication, we can try another medication. And therein lies the rub. If we reduce a medication’s potential market by 2/3, we have to significantly increase the number of medications in our arsenal. But the cost of developing new drugs is becoming prohibitive and the economics of new drug development can’t sustain an increasingly smaller market all enabled by “Precision Medicine."
We sure are in a pickle.