Research and development … innovative new drugs … “the life blood of the pharmaceutical industry.”
Tens of billions spent on research and what does Big Pharma have to show for their investment? What do the multi-million dollar a year CEO’s and executive teams have to show for their brilliance in delivering the much needed new treatments they keep promising? Not much, according to the FDA calendar for 2013 drug approval decisions chronicled in a recent article by Seeking Alpha (http://tinyurl.com/qjdyc3m). Moreover, based on their pay and bonuses (http://tinyurl.com/p57yt5o) CEO performance reviews obviously do not put much importance or weight on drug discovery or approvals.
Here’s my assessment.
From what I could determine, only five drugs (suvorexant, dabrafenib, tivozanib, dolutegravir, trametinib) discovered and developed by the sponsors are what I would consider “new”. GlaxoSmithKline developed and sponsors three of those five drugs and one was developed and sponsored by Merck. Two new drugs (efinaconazole and sofosbuvir) were acquired and then developed by the sponsors, Valeant and Gilead.
Six additional drugs scheduled for FDA decisions in 2013, are merely reformulations or new delivery systems for already approved drugs.
And finally, there are five, already approved drugs, awaiting new or expanded indications.
Think about that for a second. Tens of billions of dollars spent on R & D and technology acquisitions every year for decades and only seven new drugs. Every year PhRMA touts the thousands of new compounds in development, several hundred by disease state. How many Big Pharma company executives get up at the never-ending investor conferences to brag about their pipelines of new drugs coming? With more than a thousand drug or biotech companies, spending tens of billions of dollars year after year and we only get seven new drugs?
I would also point out that, from my perspective, only Merck and Glaxo qualify as Big Pharma. Ok, Pfizer is in the joint venture on dolutegravir, but still. Even if you throw in Cubist and Gilead, where are the rest of the Big Pharmas?
This is a sad commentary on disastrous pharmaceutical R & D productivity (and the lack thereof). More importantly, it’s a very scary picture for investors and worse for those with diseases for which there are few or no therapeutic options.
Perhaps Pharma will figure out that it is not more money that delivers breakthrough new treatments. Focused, high-level basic science expertise (not just academic degrees) and a deep multi-disciplinary understanding of the target disease are required to crack the drug discovery code. Unfortunately, for the past couple of decades, Big Pharma hasn’t valued discovery research. They would rather just write a check than do the hard work. And the results show.