We Must not Penalize Scientific Curiosity and Investigation
Drug development is expensive and failure is the norm. As a result, drug companies, investors and academic institutions are forced to make choices about how to spend money and time. Early on in discovery they may see signs of promise for a certain disease, but there might not be enough information to know if they have a candidate for a safe and effective drug. So institutions, both private and public, typically pursue a portfolio of candidates to a certain stage then select a limited number of drug candidates to advance to more costly stages of development, including human trials. Both scientific promise and likelihood of financial success influence these decisions. But a novel theory of liability making its way through the courts could create a penalty for making choices in scientific discovery.
In the case at issue, now being heard by the California Supreme Court, plaintiffs assert that the drug developer of the first drugs for HIV/AIDS should have had an obligation to develop a second similar drug faster than they ultimately did (both drugs were ultimately FDA approved). There is no claim the first drug was not safe and efficacious, just that the second version should have been studied sooner. But the company focused on developing advancements to the first drug, rather than developing another drug for the same condition. The plaintiffs say the company can be liable for not developing and marketing that second drug faster, which ended up being safer for some people.
Commercial practice and public policy discourage drug companies from developing drugs that are similar, unless there is a meaningful therapeutic advantage. These types of additional drugs are often called “me-too’s.” If insurers, either private or government, feel that two drugs are similar, they are often inclined to prefer one over the other on formulary and in payment even if one drug had a favorable safety profile. There are pricing penalties in Medicaid and Medicare that can be applied to two similar drugs. So these considerations factor into drug development decisions. Also, there are thousands of diseases with no drug treatment which are often a priority for drug developers.
It would be great to live in a world where financial considerations have no effect on the supply of treatments and all potential medicines were pursued. But the truth is many projects don’t get funded, including university research, government sponsored projects as well as private drug discovery. It is a sad day for patients when a promising therapy is not advanced.
Financial incentives and scientific promise direct drug developers and their investors to pursue opportunities where there is the greatest unmet need— thus, the highest likelihood of scientific and regulatory success, while also having a clear path for adequate reimbursement by payers. There simply is a more difficult hurdle for a financial return for a drug in which the disease has an existing treatment.
Therefore, it isn’t possible to fully comprehend the ramifications of pursuing this novel theory of liability on multi-candidate innovation – for drug discovery or any other type of innovation. For example, should car manufacturers be liable for not having a single airbag design in all cars? If so, then would they be liable for traffic injuries and fatalities if another airbag system under consideration may have prevented the injury? What the car manufacturers decided to fund investments in fuel economy and no investment in airbags? If the courts are engaged in making that tradeoff for society, then no progress is the safest path forward and invention becomes a risk.
Technological advances are allowing scientists to pursue an array of possible therapies for new and existing diseases. Artificial intelligence will allow scientists to interrogate an array of potential therapies quickly, however many of the signals they find will be spurious, or limited in applicability. Making that kind of interrogation a potential financial liability discourages investigation.
Lack of treatment for a condition is emotionally charged and can be devastating. Not all drugs work for everyone. Policies and precedent should, therefore, encourage curiosity and investigation. This novel theory of liability for not developing a product fast enough discourages identifying possibility for better options. The California Supreme Court should set things right and not uphold this precedent.
Kirsten Axelsen is an experienced biopharma industry executive, now a consultant and a visiting scholar with the American Enterprise Institute.
