In a controversial study released this week, Tufts University’s Center for the Study of Drug Development estimates that the cost to bring a new drug to market exceeds nearly $2.6 billion. The study, which was 40% funded by industry, has been criticized for overestimating these costs in favor of industry and misrepresenting some cost estimates. While we will not know fully the extent of the methodology of the study until later in 2015 when it is published in a peer-reviewed journal, these preliminary findings were released in advance and have already begun to spur debate.
However, irrespective of these criticisms, I believe that the study does have merit and brings an important issue forward — is the FDA stifling innovation with excessive fees and paperwork? Are smaller, less well funded researchers/corporations unable to significantly contribute without partnering with big pharma? Who will ultimately bear the increased cost of drug development?
Innovation is what has always made healthcare in the U.S. great — it is what separates us from the rest of the world. For decades, the U.S. has been able to attract talent from throughout the world and this has resulted in numerous “game changing” breakthroughs in medicine. Through continued development of new drugs, new technologies and new ways to better treat disease, we are able to improve outcomes and reduce death from preventable disease. The U.S. has always been a place where others from around the world have come to incubate and grow ideas. Now, it appears that innovation must come at a substantial cost — the increasing capital required for drug development as well as taxes on medical device companies only serve to squeeze out the “small guys with big ideas” and limit our ability to continue to produce new, more effective therapies and cures. In addition, these additional costs to the pharmaceutical industry are not simply added to their bottom line — they are pushed on to the healthcare consumer as well as federally-funded healthcare plans. Ultimately, the taxpayer bears the brunt of the increased cost.
The process of drug development is long and arduous. Government regulation, politics and greed have served to make it even more difficult. Physicians in academic medicine, scientists, pharmacologists and leaders in industry have learned to partner and share ideas in order to bring basic science principles from the bench to the bedside — ultimately translating ideas into cures. Certainly, big pharma is in place to make profits and increase market share. But as costs increase, many drug makers are putting less and less profit back into research and development. Growth can become stagnant and new ideas may never reach the bench or bedside. Federally-funded research — such as NIH grants — face big cuts and budgets are often embroiled in political battles. Legislators use research dollars as bargaining chips and fund projects that appeal only to a particular interest group or a group of favored donors. We must find a better way to promote medical innovation and reward research. We must find better ways to choose the most promising projects for funding. We must be good stewards of the R & D dollar and make every single investment count.
As with most things in medicine, we must always pause and remember to focus on the patient. Advocating for the patient suffering with disease is the reason most of us became involved in medicine in the first place. Whether the study from Tufts overestimates the cost of development or not, it should still serve as a wake up call to us all. We must work to control the cost of developing new therapies — we must limit excessive taxation, we must promote entrepreneurship and begin to fix the current system of FDA approval for new therapies. We must separate politics from medicine and streamline processes — eliminate paperwork and promote efficiency — if we are to continue to lead the world in medical innovation. We must continue to make room for the “small guy with the big ideas” — if we do not, ultimately it will be our patients that suffer in the end.