| > Many of their discoveries are reformulations of older drugs meant to allow a repatenting and re-marketing of old ideas. I think you're confusing evergreening, which is a real problem, with the number of NME's that are being generated. NME's are "new molecular entities", or totally new formulations. >Many of the new supposedly breakthrough drugs do not provide significant improvements in mortality, but do cost huge amounts of money so that they can recoup their investment. Low hanging fruit has been taken and newer methods of discovering safe and effective drugs are needed. You might find this shocking, but pharma is a dying business. Companies are divorcing their drug development departments into separate businesses so they can fail gracefully. The blockbuster drugs that can recoup the investment of looking for a needle in a haystack aren't coming any more. >If, as these statistics imply, you can show that the drugs and other changes in medical care that provide positive changes to quality of life and mortality are coming from government research significantly more so than other sources then why subsidize private research, why protect the private drug development system that results in outrageously priced drugs, why waste 2/3rds of research money to produce such a disproportionately small portion of the advancements in medical knowledge? This is absolutely, 100% totally and COMPLETELY false. The government IS NOT INVOLVED IN DRUG RESEARCH. Honestly, period. They can't afford it! It costs a billion dollars to whittle 10,000 drug candidates into 1 FDA approved drugs. NIH grants aren't even 1% of that cost. The government is not responsible for very much actual drug development at all. They don't own or fund the labs. They fund the schools that do the work on the lower level theory, on the tools and concepts that will one day be commercially viable. Private labs handle the vast majority of all new molecular entity discovery, pre-trial, trial, etc. They have the money, labs and teams capable of handling it -- NIH funded labs often don't! Here's a list of NME's for 2013 so far: http://www.fda.gov/drugs/developmentapprovalprocess/druginno... Remember, the FDA is the gatekeeper and these companies research thousands and thousands of candidates looking for something that they can statistically prove safety and efficacy of to the FDA, and the FDA gets to decide. As you can see from that list, the FDA doesn't allow new molecules out very often. |
Some people have argued that maybe those 2/3 should be tax money too. Its a bit weird situation where the state already pays for 1/3 of the R&D, and then on top of that give state enforced monopoly in 20 years periods for those who invest in the other 2/3 (additional monopoly period is also granted by the FDA after an successful drug trial). State enforced monopoly is often describe as tax raised outside congress control, and has its history and name (letters patent = royal decree) from that purpose.
One question we should ask is what the industry brings to the table if we took away all state funded involvement. Is it more efficient to bring competition through patent grants rather than direct research and development grants? Do we get larger and more spread out pool of investment that could not happen without a few blockbuster drugs to get gambling money? We should ask for data which prove that the current method (1/3 of the funding and granted state monopolies) is the best use of tax money. Maybe at least demand some kind of high standard when a company take research supported by the 1/3, and claim a new invention based on already known and disclosed techniques. The India model is to demand an increased efficiency, beyond showing that the modification of the old drug is novel.