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High cost of research and development causes less investment by pharmaceutical firms.
High cost of research and development causes less investment by pharmaceutical firms.
The significant investment of both time and financial resources into long term cancer research has caused pharmaceutical firms to underinvest in new cancer-fighting drugs, a recent study indicates.
Researchers from MIT found that late-stage cancer drugs are less expensive to develop than earlier-stage cancer drugs. This fact is partially due to late-stage drugs extending survival for shorter durations.
As a result, clinical trials for these drugs are completed more quickly, which provides manufacturers with more time to control patented drugs in the marketplace, the study noted.
"There is a pattern where we get more investment in drugs that take a short time to complete, and less investment in drugs that take a longer time to complete," co-author and MIT economist Heidi Williams said.
The consequences of this lack of investment is staggering. In the year 2003 alone, 890,000 life-years were lost among people diagnosed with cancer, according to the study. Williams added that the public sector is more willing to invest in long-term projects than is the private sector due to the incentives faced by the private sector.
Researchers examined 4 decades of data from various sources to encompass more than 200 subcategories of cancers at different stages of development. The researchers first established the greater investment in short-term drug research was a result of shorter clinical trial durations.
It was found that, in part, clinical trials use biomarkers to estimate eventual outcomes instead of mortality to establish efficacy. The researchers found that in some cases where surrogate endpoints were included in cancer clinical trials, there were relatively more trials and a greater financial investment into research.
"When you have good surrogate endpoints, you see a dramatic increase in R&D investment, which means lives saved," said Benjamin Roin, assistant professor at the MIT Sloan School of Management.
Researchers suggest a series of policy adjustments to improve long-term research on cancer drugs. First is the use of surrogate endpoints, at least initially, to determine if wider use of surrogate endpoints is useful for additional cancer.
Second is increased public funding for the research and development of anti-cancer drugs, as this funding isn’t influenced by pressure from private sector shareholders. Currently, 6 preventative cancer drugs were developed as a result of public funding or relied on surrogate endpoints.
“No individual private firm wants to come in and provide all of the evidence that you need to validate a surrogate endpoint, because once one is validated, that's going to be used by all of the firms on the market,” Roin said.
The third policy change suggests changing terms for patents to run from the time the drug reaches the market instead of from the patent filing date. The FDA, however, can grant exemptions to extend drug patents to account for the R&D time.