Drug Discovery: Are Business and Science Diametrically Opposed?
The business and science of innovation are challenged by a recent article in British Medical Journal entitled "Pharmaceutical research and development: what do we get for all that money?"
The business and science of innovation are challenged by a recent article in British Medical Journal entitled “Pharmaceutical research and development: what do we get for all that money?”
Pharmaceutical companies’ research and development (R&D) strategies have come under scrutiny with the release of a
Dr. Light is a psychiatry professor at the University of Medicine and Dentistry of New Jersey, a visiting researcher at Princeton, a network fellow at Harvard University, and a senior fellow at the University of Pennsylvania's Center for Bioethics. Dr. Lexchin works at the School of Health Policy and Management at York University in Toronto. They have each done many health research studies about the cost of developing medicines, some of which were used to support their argument in their most recent BMJ article.
Focus on R&D
Citing research from various sources, Drs. Light and Lexchin argue that pharmaceutical companies have a hidden agenda when it comes to deciding which drug targets to pursue. Rather than focusing on the development of therapeutically and pharmacologically innovative materials, the authors allege that pharmaceutical companies are too heavily invested in churning out variations of existing drugs in order to secure company profits. They also state that often these drugs do not substantially benefit patients. They note that of the 218 drugs that received FDA approval from 1978 to 1989, only 34 were determined in
The problem with the current pharmaceutical business model, according to the authors, stems from the lack of funds allocated to the discovery of new molecules. Drs. Light and Lexchin claim that based on data extracted from company and government reports, companies were found to spend only 1.3% of revenues on basic research. The ratio of money spent on basic research to marketing is 1:19. According to the authors, profits depend more on the extension of existing patents and the restriction of free market competition from generics than on breakthrough research.
The answer to making safer, more cost effective pharmaceuticals relies on fewer approvals, Drs. Light and Lexchin write. They believe that restricting the approval of products to those that are medically necessary will force drug companies to address unmet medical need. They also suggest the exploration of a market incentive that differs from that of traditional patent protection: drug innovation would be rewarded by large cash prizes rather than by patent royalties.
Building a Sustainable Pharmaceutical Model
Many business analysts and patient advocates would agree with the authors’ conclusion that pharmaceutical companies are more motivated to develop financially lucrative medications than less profitable but more globally impacting medical solutions. In a lecture unrelated to the study, Thomas Pogge, PhD, director of the Global Justice Program, Leitner professor of philosophy and international affairs at Yale University, and founder of
Despite evidence presented by Drs. Light and Lexchin suggesting that drug companies are restricting innovation through their marketing strategies, scientists who have worked directly on drug discovery, such as Derek Lowe from the blog
Dr. Lowe also points out, like Dr. Pogge, that marketing a drug is necessary to its survival, and marketing, in principle is meant to create a profit. Spending money on marketing helps makes the drug generate revenue and balances out the largely unprofitable business of research and development. “Complaining that the marketing budget is bigger than the R&D budget is like complaining that a car’s passenger compartment is bigger than its rudder,” wrote Dr. Lowe in a
Finding a Drug Target is Just the Beginning
Neither the BMJ article, nor the criticisms it drew, offered guidelines by which “successful” drugs should be measured or judged. Is the extension of life by a few months enough for a drug to be considered a success, even if the drug does nothing to prevent disease progression? Proving the value of a new molecular therapy usually occurs late in the development game, and much is invested in this process.
What we do know is that scientific inquiry and pharmaceutical innovation are not always predictable—and sometimes, the drug discovery process reveals the wrong answers. The trend in clinical studies is currently on personalized medicine and the discovery of riskier, genomics-based candidates. Discovering a potential drug target, although exciting, is just the beginning of the (expensive) R&D process, notes Dr. Lowe. We are pushing the limits of our current scientific understanding of the major disease related biological pathways, and solving the productivity challenge requires an increase in the rate of basic scientific discovery and biological understanding.
Perhaps medications that are considered “clinically minor” by some have been awarded FDA approval because they were easier to develop or had more discrete clinical end points; these factors would effectively make a drug’s clinical impact simpler to evaluate. The inherent complexities of genomics-based drug candidates and the chronic diseases they treat should be considered when evaluating the health impact of a medication and the strategies that were employed in the search for clinically major, blockbuster pharmaceuticals.
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