September 2009

DRUG DISCOVERY AND DEVELOPMENT:

The Cost and Duration of Drug Discovery Must Decrease

The United States certainly has its share of crazed fanatics. Some of them are absolutely determined to kill the prospects of reducing the cost of receiving healthcare in this country.

There are people who are actually saying that those who want to avoid throwing piles of cash at private insurance companies, which are out to make a profit instead of covering the cost of reasonable healthcare, are "fascists" who want to euthanize grandma. I am not joking.

Huh. They seem to have foiled my diabolical plan.

Bringing us back to the rational world, it's clear that the cost of healthcare in the United States is enormous, and is continuing to increase. Although the first approach towards changing this sorry state of affairs must be to institute universal public healthcare, there are other approaches that can (and should) be taken as well.

Is biomedical research money being put to maximum productive use?

One approach is to evaluate whether or not the research effort enabled by funding agencies that provide money for biomedical research in the United States is being used as efficiently as possible. Various public and private agencies are showering money on biomedical research in the United States today.

The current total is to the tune of $100 billion (USD) annually. This is double the amount shelled out ten years ago, after adjusting for inflation.

However, the development of new medical therapies is not keeping pace with this windfall. This suggests that biomedical research in the United States may be becoming less productive, and that the cost and duration of drug discovery must decrease if the maximum public health yield is to be wrung out of the money put up by funding agencies.

Ray Dorsey (University of Rochester, New York) and coworkers have carried out a study relevant to this issue. They have identified the agencies that fund the different medical disciplines, determined whether or not this funding is correlated with need, and analyzed productivity across disciplines.

Number crunching.

The scientists' study was based on data from 1998 to 2005. This is a long period of time, enough for new drugs to make it through the (appropriately) slow drug approval pipeline in the United States.

They evaluated nine therapeutic medical fields. Among them are cardiovascular, cancer, and neuroscience therapy.

The fields were broadly defined (with the exception of HIV/AIDS). In other words, depression, stroke, and substance abuse all fall within the scientists' neuroscience category.

They evaluated biomedical research funding from the National Institutes of Health (public financing), drug companies, and medical device and biotechnology companies (the ten largest, which were not drug companies). Additionally, 17 of the largest relevant nonprofit organizations were also evaluated.

The correlation between funding source, and national (United States) and global disease burden, was unraveled through data from the World Health Organization. The number of new approved drugs was obtained from Food and Drug Adminstration data.

Who is shelling out money, and to which medical fields?

The scientists found that financial support (after adjusting for inflation) of biomedical research is increasing across therapeutic disciplines. The windfall ranges from a 43% funding increase (respiratory) to a 369% increase (gastrointestinal).

Drug companies gave the most money overall (e.g., to cancer research). However, the National Institutes of Health gave the most money to a few fields, e.g., HIV/AIDS.

Biotechnology funding was directed most strongly at cancer research. Medical device companies directed their money most strongly at cardiovascular research.

Perhaps not surprisingly, the scientists found that private money was directed most strongly at medical conditions most common in the United States. In contrast, public money (the National Institutes of Health) was directed most strongly on medical conditions more relevant on the overall global level.

Private companies are in business to make money, for better or worse. There's little or no profit to be made from people who cannot pay for medical treatment.

Biomedical scientists must reduce the cost and duration of drug discovery.

It's clear that biomedical research is being flooded with more money than has been available previously. One would expect that more drugs would result from this increased funding.

This turns out not to be the case. New drug approvals in the United States are not growing any faster, and in fact the development of new drugs has decreased over the past decade by almost 50%.

These results don't mean that biomedical scientists in the United States are becoming lazy. They also should not be used as a reason to demand that the Food and Drug Administration speed up new drug approvals; thorough studies of drug safety and efficacy are very important for public health.

What the scientists propose is that other methods need to be evaluated to speed up drug discovery, and to decrease the cost of doing so. One place to start may be to apply old drugs for new purposes, thereby reducing the cost and length of time needed for drug safety evaluation.

Such financial considerations will only increase in the future, at least in the present economic climate (United States in particular). As with so many other problems, biomedical research will get nowhere without money, but it is imperative that scientists figure out how to most effectively use the money they already have.

for more information:
Dorsey, E. R., Thompson, J. P., Carrasco, M., de Roulet, J., Vitticore, P., Nicholson, S., Johnston, S. C., Holloway, R. G, & Moses III, H. (2009). Financing of U.S. Biomedical Research and New Drug Approvals across Therapeutic Areas PLoS ONE, 4 (9) DOI: 10.1371/journal.pone.0007015