Answering critics who accuse drug companies of reaping obscene financial reward for little that is innovative, a conservative think tank investigated how the companies turned publicly funded science into therapies for cancer, hypertension and arthritis.
A report being released today by the Manhattan Institute for Public Policy states that without drug company expertise, taxpayer-funded science would have languished.
The study looked at 32 drugs, or classes of several drugs to treat the same ailment, and what private industry contributed to their development.
“We find that for the discovery and/or development of all or virtually all of the thirty-two drug classes discussed . . . the contributions of the private sector were crucial,” the report states. “All or almost all the drugs discussed . . . would not have been developed or, at best, would have been delayed significantly in the absence of private sector scientific discoveries.”
A number of critics allege that drug companies get a “free ride” on public investments in scientific research without making major contributions themselves, said Benjamin Zycher, lead author of the report. The critics charge that rather than turning out innovative new therapies, drug companies spend millions of dollars only to offer consumers new versions of already existing products, also known as “me too drugs.”
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Drug development
A review of 35 drugs found how often drug companies contributed to each stage of development.
SCIENTIFIC CATEGORY | NUMBER
Basic science: Biological processes, etc.7
Applied science: Converting research into a drug, etc.34
Clinical improvement, manufacturing protocols, etc.28
SOURCE: Manhattan Institute for Policy Research
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One of the more high-profile critics specifically mentioned in the report is Dr. Marcia Angell, former editor of
The New England Journal of Medicine and author of the book “The Truth About the Drug Companies.”
The Web site of the Food and Drug Administration, which reviews all drug applications and determines what should be allowed to market, indicates that 80 percent of all drugs approved in the past decade were classified as unlikely to be an improvement over existing drugs, Angell said yesterday.
“Sure they put pills in the bottle and distribute it and put it in a dosage form that is useful, but they expect to be rewarded as though they are the source of innovation,” said Angell, who had not seen the Manhattan Institute's report.
But drug industry advocates said one need look no further than San Diego to see just how innovative pharmaceutical and biotechnology companies can be.
Cancer drugs Rituxan, Avastin and Sutent and diabetes drugs Byetta and Symlin, which all came out of San Diego's biotechnology sector, are nothing close to “me too,” but they are some of the most innovative drugs out there, said Tim Ingersoll, a spokesman for Biocom, the biotechnology industry trade group in Southern California.
Neither side of this debate disputes the important role that government-funded research plays in drug discovery, especially the work funded by the National Institutes of Health, Zycher said.
To test the theory of the drug-industry critics, Zycher and two colleagues set out to document just how much brainpower the drug companies invest in creating new therapies. Their documentation does not include financial investment.
Zycher and two analysts for the Tufts Center for the Study of Drug Development, Joseph A. DiMasi and Christopher-Paul Milne, studied drugs that other studies considered blockbuster or essential drug developments of the past few decades. They also looked at the top prescribed drugs of 2007.
The authors found that science funded by the NIH tends to be concentrated in the basics of disease biology, biochemistry and the disease process. The goal of that work is to identify targets in the body that could be susceptible to future drug candidates, the report states.
Then the drug companies step in and create a molecule that would hit those targets and treat the disease. The companies work on these compounds to make them more efficient and exact, with fewer toxic side effects.
And, finally, the drug companies conduct expensive clinical trials to determine the safety and efficacy of the drug.
These findings, Zycher said, should be helpful in the ongoing debate over national policies aimed at lowering drug costs to consumers, including the importation of drugs from overseas, federally negotiated prices and changes to the patent system that would erode intellectual property in pharmaceuticals.
“The report shows that all of those policies, were they to be implemented, would have an effect on reducing prices received by the drug companies and therefore have the effect of reducing the incentive to invest in the research and development of new medicines,” Zycher said.
Industry critics concede that companies bring important skills to drug development, including the ability to take a drug molecule and develop it so that it can be absorbed by the body and not have toxic effects.
But it is a mature industry, which is why consumers are seeing three and four or more drugs for the same indications, said Merrell Goozner, a former journalist who wrote “The $800 Million Pill,” a book critical of drug companies.
The pipeline for new drugs, which is fed by publicly funded research and takes decades, is not coming up with the biological targets for new drugs to meet some of the most devastating diseases, Goozner said.
“All the things they really need new drugs for – Alzheimer's, cancer, neurodegenerative diseases – these are things we don't have a basic scientific understanding of yet to enable us to intervene,” Goozner said.
And there, he said, lies the area of investment that really needs to be studied.
Terri Somers: (619) 293-2028; terri.somers@uniontrib.com
