Yesterday I addressed the relative amounts that the pharmaceutical industry spends on research and development as opposed to other expenses. But there’s still another way to address the veracity of their claim that we need to give them massive amounts of money in order to create novel, important drugs.
In the last part of my previous post, I explained how FDA data shows that the vast majority of newly approved drugs are not real improvements over what we already have. How much work do pharmaceutical companies devote to those drugs in terms of research, however?
In 2001, Darren Zinner published a study in Health Affairs that addressed this very question. Here’s what he did in plain English. He looked at all clinical patent applications in 1998, and carefully examined all the scientific research cited in those applications. It’s important to remember that this would include all research, not just those for approved drugs, so it even includes the research for drugs not getting to market. He then classified where that research was done. Here’s what he found:
The majority of research cited in patent applications was done in academic centers. Some more was done in other non-profit or government research centers. Only 15% of the research was done by industry. That’s not a very compelling argument for the indispensable contribution of industry to research.
This work has been repeated in slightly different ways. In 2001, Public Citizen got their hands on an internal study done by the NIH, where they had looked at the top five selling drugs from 1995. For completeness sake, these included Zantac, Zovirax, Capoten, Vasotec, and Prozac. Please note – I’m not disputing the importance of those drugs. The NIH then looked at the relevant published research for the development of those drugs (and their sources). Can you guess what they found?
NIH found that “NIH-funded research played a critical role in drug discovery in each of these cases.” In all, U.S. taxpayer-funded researchers conducted 55 percent of the published research projects leading to the discovery and development of these drugs (and foreign academic institutions 30 percent). “Researchers at U.S. universities and at NIH contributed by discovering basic phenomena and concepts, developing new techniques and assays, and participating in clinical applications of the drugs.”
In the case of the hypertension drugs captopril and enalapril, the NIH concluded that the drugs were developed thanks to public U.S. research projects and five foreign academic studies. Only three significant studies were conducted by the drugs’ patent holders, Squibb and Merck.
Furthermore, four of the taxpayer-funded studies were deemed “key” and six of the studies were referenced in the industry’s work. The studies sponsored by the patent holders for these two drugs were of less consequence – none were considered “key” by the NIH. In fact, for the five drugs it studied, the NIH deemed only one industry study “key.” (Public Citizen acknowledges the fact that academics generally have greater incentive to publish research than industry scientists.)
The similarities from the two studies are convincing. About 15% of research comes from industry. Over half was from NIH-funded labs. If you drill down even more, and look only at key papers for discovery or development, only one of the seventeen papers in this category came from industry. Again, it’s hard to make an argument that the industry contribution is so terribly important that it justifies never reducing the amount we’re spending on drugs at all.
Please not that I am not asking for us to abolish drug companies, nor minimizing their potential importance in certain areas. As infrastructure for bringing research from the lab to the real world, they do reasonably well. They also obviously make and transport the drugs well. But let’s not over-emphasize their importance in research and development – which is always what they do to justify the expense of drugs.
Medical R&D at the turn of the millennium. Zinner DE. Health Affairs. 2001 Sep-Oct;20(5):202-9.
Rx R&D Myths: The Case Against The Drug Industry’s R&D “Scare Card” by Public Citizen (2001).