PeterZ wrote:Daryl,
http://www.fdareview.org/03_drug_development.phphttp://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/A major part of the cost of drugs are the R&D requirements. It takes 11-14 years to bring a new drug to market. The chart indicates only 8% of compounds are actually approved by the FDA. Yet testing all of them costs money. Who pays for that research if the pharmaceutical company is prohibited from charging for those expenses? The second link gives you some idea of average R&D investment and the number of drugs approved.
If there is no incentive to spend a decade and a half trying to find a new drug with a 92% of failure somewhere along the way, very few researchers would do it. Then if they succeed the company may have exclusivity for less than 10 years. The patent is often granted before clinical or even preclinical trials to prevent others from competing. So a 20 year patent may only provide less that 10 years of exclusive use of an approved drug.
Agreed.
R&D is expensive and if we want new drugs we have to pay for it. The FDA keeps demanding more clinical trials, larger clinical trials, longer clinical trials, more comprehensive clinical trials. You wind up with better science at the end but there is a cost. A huge one in $$$$$ but also a hidden one of patients waiting for a medicine. There will never be 100% certainty that the medicine is effective and does not contain unacceptable side effects (serious low incidence side effects are very difficult to spot). At what certainty level should we release the drug 80%, 90%, 95%, 99%? Each increasing demand results in higher costs a significantly longer wait time while the clinical trials to support it are conducted. And even then there is no certainty that some 1/10,000 or 1/100,000 side effect won't derail the drug if it is serious enough.
Note the thing that ticks me off is the Martin Shkreli's of the world. He is a hedge fund manager and his business plan was: don't bother with R&D with it's high costs and failure rates. Buy an already approved generic instead. One for such a tiny indication that there is only a single manufacturer. Make sure it's a life threatening indication so people must buy the drug. Raise the price from $13.50/pill to $750/pill, literally overnight. Pure profit. They counted on how slowly the FDA would approve any competitor's facility to keep them going for years. (For a pharmaceutical manufacturer, the FDA approves each step of the process, and must inspect the new plant etc. It takes forever.).
He's not the only one. There are others they just aren't so dumb as to be so obvious. A more typical smarter evil profiteer raises the price slowly in increments, so it's less obvious what is happening.
On the bright side - even without government interference, he lost out. He missed that compounding pharmacy manufacturers don't need the individual process approved, so they could start competing within months. (Compounding pharmacies make drugs for individual patients with special needs, for example those allergic to inactive ingredients typically found in tablets etc. They don't have to have each individual step approved because they are making medicines tailored to an individual and a single facility may have literally 1000s of processes each for a different patient).