It’s often cited that it costs more and more billions to bring a drug to market. Erooms law is Moores law backwards. Countervailing forces like regulation are blamed for this phenomenon. (The author of this piece seems ludicrously positive on the past success of pharma while I think the reality is that LDL lowering drugs are disappointingly non-efficacious and aspirin is just a masker of problems in the body. I say this mostly in response to the better than the Beatles argument which seems to treat human health as some sort of a solved problem.)
My own theory is more radical. The whole practice of drug discovery in the pharmaceutical industry is flawed on a fundamental level. The body is a finely tuned machine more complex then any man made machine. It is so complicated that we simplify it to a comical degree. We come up with ideas like “the bad cholesterol” in heart disease or “the bad COX” in pain relief. We then come up with chemicals that will hopefully impact our chosen villain. However both Cox-1 and Cox-2, LDL and HDL are manufactured by the body and function as components in tiny machines not chemical waste products or some spice like salt which needs to be reduced to make a tomato sauce taste better. Moreover we often do not even know why a chemical like LDL is reduced by a compound so it is difficult to anticipate side effects. As science has advanced we have gotten better at showing just how efficacious our drugs aren’t but also how frequently they have side effects. It’s not only that drugs are expensive and time consuming to bring to market but also that they are now more frequently withdrawn. It may sound like heresay to some but I doubt magic pills with strong benefits are even really out there to be found. It’s unlikely there’s a particular acid that you could open up the hood of your car and pour in that would have that great of a benefit. This is not a condemnation of all medicine just the general current paradigm of pharmaceuticals that are supposed to effect a disease process. Antibiotics have a use, so do vaccines and surgery and the reason they work is clear. But in general the approach of medicine needs a paradigm shift that treats the body as a machine. In the future we won’t treat depression by just adding serotonin or heart disease by lowering LDL. We will instead rewire the brain and repair the plumbing of the circulatory system. The earliest pharmaceutical drugs were things like opium and cocaine I’m sure they sailed through regulatory hurdles in development but what is really the point they were never very good. Modern antidepressants some how increase the risk of suicide.
I don’t like analogies but I think this is an apt one. We are working with a car we inherited which is our body. We are only beginning to understand how it works. Its as if your doctor was a mechanic for a space ship. Rather than saying you have a broken muffler the mechanic would be in the position of well we added this chemical into the gas tank and we found a statistically significant result that most people did see a reduction in noise from the muffler after this treatment. It later turns out that it was just the right small amount of sugar added to the gas tank to slow the engine down without junking it. Isn’t the “miracle drug” metformin just agitating the liver in a similar fashion? In a new paradigm we will know how to replace the muffler (stem cells) or even build a better one with biomedical engineering.
So in sum I have a libertarian bias and would prefer we went as far as to do away with the FDA. But I don’t think its fair to blame them for the rising cost and general lack of success in today’s pharmaceuticals. I also don’t think the garbage the industry marketing machine has been jamming down our throats is just too tough to top. I think we’re moving from unconscious incompetence to conscious incompetence.