Putting Together a Search Party for Better Covid-19 Treatments
(Bloomberg Opinion) -- Most of the public discussion about regaining our health and our wealth in the Covid-19 era is centered on the need for a vaccine. But vaccine development is expensive and highly uncertain. While we wait, people are dying and costs are piling up. More attention must be given to developing drugs to treat those who become ill.
Analysis I have done with colleagues Susan Athey (economics of technology professor, Stanford Graduate School of Business), Richard Frank (professor of health economics, Harvard Medical School) and Jonathan Gruber (Ford professor of economics, MIT) suggests the repurposing of generic drugs that have already been proved safe and effective in treating other diseases is an important part of the solution, and there is an urgent need for government support. More than 100 generic drug candidates have been identified as having promise to treat the symptoms of Covid-19. Some are already being tested for their effectiveness. A focus on repurposing generic drugs would give researchers more shots on goal in the game of drug discovery, improving the odds that a winning treatment will emerge.
Generics offer many advantages: They can be easily produced without fear of violating intellectual property protections, they have established safety profiles and thus are more likely to receive approval from the Food and Drug Administration, and they can more rapidly come to market by skipping early stages of testing and going directly into phase 3 clinical trials. Repurposed generics also offer the possibility of a low price after development, increasing access among budget constrained payers and patients worldwide.
That is, however, an important barrier to developing repurposed generics for Covid-19: There’s no money in it. Lack of patent protection evades innovators ability to charge much above the cost of production and distribution. Thus, many promising generic products remain unexplored because innovators view the revenue potential as small compared with the development costs and the risks.
Then there’s the challenge of identifying enough patients to successfully complete the requisite clinical trial to establish the drug’s effectiveness. Teams evaluating drugs compete to recruit Covid-19 patients, and shortages of new patients eligible for tests are now emerging. This is in part because so much attention has been placed on hydroxychloroquine, despite very limited evidence supporting its effectiveness in treating Covid-19. Two hundred trials have been initiated investigating this drug’s use with little coordination among them, using up the pool of available patients.
The federal government can take a powerful leadership role in repurposing off-patent drugs for Covid-19 and other pandemics. It can build on successful models that the U.S. government has used to develop drugs to fight past threats, including anthrax.
Government involvement ensures domestic access to such treatment in the face of similar efforts by other nations; indeed, the U.K. government has already invested in generic drug repurposing in the Recovery Trial, leading to the use of the steroid dexamethasone to treat Covid-19 infections and setting off a race among government and medical providers to acquire enough of the low-cost steroid to treat patients worldwide.
We believe creation of a repurposed generic development program is essential. This program would build on an existing public agency infrastructure, but would rely principally on public-private partnerships with established academic laboratories, clinical development networks and drug manufacturers.
In the first phase, the program would fund studies aimed at identifying promising drug repurposing targets, paying prizes to innovators for successful candidates. In the second, the agency would coordinate clinical trials, playing a critical “air traffic control” function to ensure that the set of trial subjects are best allocated to test promising Covid-19 therapeutics. This might entail the use of trials that study many promising drug candidates all at once, leveraging the limited set of patients for maximum learning about drug safety and efficacy.
Finally, the program would contract private companies to manufacture promising drug candidates, paying costs plus a premium to ensure sufficient capacity for the exploration of new uses without undercutting the adequacy of supply for existing uses. Critically, this manufacturing would begin during the trial process, ensuring timely availability and continued supply for those who need the generic to treat other diseases. The government could preference investments in American manufacturing capacity to ensure adequate national supply and allow local communities to capture the economics benefits of such investments.
We estimate the total cost per therapeutic successfully developed and produced from this effort would amount to $200 million; that’s a small investment relative to the amounts the U.S. has already committed to novel vaccine development with much less probability of success and track record of safety.
Covid-19 is an all-out attack on our lives and our economy. We need a proportionate all-in response. Generic drug repurposing should be part.
This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
Rena Conti is an associate professor in the Department of Markets, Public Policy and Law at Boston University Questrom School of Business and associate research director of biopharma and public policy for the Boston University Institute for Health System Innovation and Policy, in Massachusetts.
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