Map of life expectancy at birth from Global Education Project.

Friday, January 26, 2024

Calling out the bullshit

Yes, it is expensive to run the clinical trials needed to get approval of new drugs. However, as people seem to be very skilled at missing the point, the profit motive does not cause drug companies to spend that money in ways that optimize public benefit. As a matter of fact, the cost of drug development and trials is completely unrelated to the price of drugs


Abstract

Importance  Drug companies frequently claim that high prices are needed to recoup spending on research and development. If high research and development costs justified high drug prices, then an association between these 2 measures would be expected.

Objective  To examine the association between treatment costs and research and development investments for new therapeutic agents approved by the US Food and Drug Administration (FDA) from 2009 to 2018.

Design, Setting, and Participants  This cross-sectional study analyzed 60 drugs approved by the FDA between January 1, 2009, and December 31, 2018, for which data on research and development investments and list or net prices were available. Data sources included the FDA and SSR Health databases.

Main Outcomes and Measures  The primary independent variable was estimated research and development investment. The outcome was standardized treatment costs (ie, annual treatment costs for both chronic and cycle drugs, and treatment costs for the maximum length of treatment recommended for acute drugs). Standardized treatment costs were estimated separately using list and net prices obtained from SSR Health at the time of launch and in 2021. To test the association between research and development investments and treatment costs, correlation coefficients were estimated and linear regression models were fitted that controlled for other factors that were associated with treatment costs, such as orphan status. Two models were used: a fully adjusted model that was adjusted for all variables in the data set associated with treatment costs and a parsimonious model in which highly correlated variables were excluded.

Results  No correlation was observed between estimated research and development investments and log-adjusted treatment costs based on list prices at launch (R = −0.02 and R2 = 0.0005; P = .87) or net prices 1 year after launch (R = 0.08 and R2 = 0.007; P = .73). This result held when 2021 prices were used to estimate treatment costs. The linear regression models showed no association between estimated research and development investments and log-adjusted treatment costs at launch (β = 0.002 [95% CI, −0.02 to 0.02; P = .84] in the fully adjusted model; β = 0.01 [95% CI, −0.01 to 0.03; P = .46] in the parsimonious model) or from 2021 (β = −0.01 [95% CI, −0.03 to 0.01; P = .30] in the fully adjusted model; β = −0.004 [95% CI, −0.02 to 0.02; P = .66] in the parsimonious model).

Conclusions and Relevance  Results of this study indicated that research and development investments did not explain the variation in list prices for the 60 drugs in this sample. Drug companies should make further data available to support their claims that high drug prices are needed to recover research and development investments, if they are to continue to use this argument to justify high prices.

 

In case you don't know much about statistics, this is as zero of a correlation as you will ever get. I mean no association at all, zip, zilch, nada.

 

And I might add that the basic research to identify biological mechanisms that are likely targets for pharmaceutical intervention, and to identify candidate drugs or biologicals, is mostly done by NIH-funded investigators in universities. The drug companies then appropriate the knowledge to develop their products.  There is a better way to do this.

1 comment:

Minister of Truth said...

Cervantes,

You have complained, but have offered up no proposed solution.

What do you suggest?