Durk Pearson & Sandy Shaw’s®
Life Extension NewsTM
Volume 15 No. 7 • November 2012


COST/BENEFITS STUDY

Public Spending on Biomedical Research:
How Many Extra Lives Saved With Treatments
Funded By Taxpayers’ Money

An interesting analysis1 was published in a recent Science on increased public support for biomedical research on certain diseases and the effects of the extra spending on the number of drugs developed to treat those diseases. The author compiled longitudinal data from six sources, including a commercial database of pharmaceutical R&D, and National Institutes of Health project descriptions and awards. She analyzed how the effect of spending on 67 different diseases affected the number of drugs being developed to treat those diseases. “Consistent with prior research, analysis of grants awarded from 1975 through 2006 showed that a sustained 10% funding increase targeting a specific disease led to a 4.5% increase in the number of drugs targeting that disease entering Phase I clinical trials, with a lag of up to 12 years. In contrast, she found no evidence that changes in the allocation of funds across the NIH disease portfolio affect industry’s decisions to invest in Phase III clinical trials for treatments for those diseases. Thus, NIH funding influences the early stages of drug discovery and testing but may not affect the later, more costly stages of drug development.”

What this says to us is that the FDA’s approval process is a gigantic roadblock preventing the development of drugs after they have made it to the relatively cheap Phase I (which requires a relatively small number of subjects for a safety study after doing previous work in cell cultures and, especially, animal models and finding the drug safe and apparently effective in those studies). By the time a drug has reached Phase III, the drug company has to conduct further studies, which require a huge amount of money (the cost of taking a drug from initial research to FDA approval now costs $3 billion or more). Hence, it is virtually impossible for drug companies to take most potentially useful drugs that have reached Phase I through the development process. Many valuable therapies are thereby dropped out of the process (with only the drugs with the most profit potential being further developed due to the need to recover these huge costs) and, of course, the “lost” drugs are invisible to the general public and the media, which have no idea how much the FDA costs in terms of restricting the numbers of different treatments available and the countless people who have died as a result. The largest pharmaceutical companies benefit from this regulatory scheme as it makes it pretty nearly impossible for small and medium sized companies to compete with them.

As we see it, we (the general public and the two of us) would be much better off if the FDA acted as an advisory agency, providing information and leaving the decision-making to doctor and patient, or, if that is politically impossible because the public demands some level of government drug regulation, the FDA could approve for safety, not for efficacy (just as the agency did before 1965), and leave further decision-making to doctor and patient. We know of no evidence that Americans have more effective drugs now than before the 1965 changes (the Kefauver Amendments to the Food & Drug Act) giving the FDA the power to regulate efficacy. It is the 1965 efficacy requirements that have made it such a lengthy and enormously expensive process to take a drug deemed safe (at least in relation to the risk of the untreated disease) to the market.

Reference

  1. “Spend for a Cure?” edited by Mueller and Cruz, Science 336: 1620 (2012).

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