Don’t let pharmaceutical companies exploit the COVID-19 pandemic

THIS WEEK WE PASSED yet another somber milestone: 13 million global cases of COVID-19. Over 25 percent of confirmed infections are in the United States. While the global scientific community races towards a potential vaccine, optimistic that it can be widely distributed by early 2021, 300 million Americans remain vulnerable to a virus that has overwhelmed our healthcare system, erased 30 million jobs, and cost trillions of dollars (and counting).

Until a safe and effective vaccine exists, we can only control this pandemic through a massive public health intervention to increase social distancing and the use of masks, and with the development of a widely-available treatment able to decrease the severity of illness and the burden on the healthcare system.

To date, the Food and Drug Administration (FDA) has approved only one drug to treat COVID-19 — a broadly active, pre-existing antiviral compound called remdesivir. A study sponsored by the National Institutes of Health showed that remdesivir reduced the recovery time for patients hospitalized with COVID-19 from 15 to 11 days. Based on those results, manufacturer Gilead Sciences applied for an emergency use authorization from the FDA and began scaling up manufacturing and distribution capacity.

In an “open letter” announcing the drug’s global release, Gilead’s CEO Daniel O’Day acknowledged both remdesivir’s promise as a treatment (“the first antiviral to have demonstrated patient improvement in clinical trials for COVID-19”) and the accompanying “significant responsibility that comes with pricing.” Gilead apparently interpreted that responsibility to require a price of $390 per dose ($2,340 per treatment course) for those on Medicare or Medicaid, and $520 per dose ($3,120 per treatment course) for private health insurance patients. A generic formulation will be made available for developing countries priced at $64 per dose ($384 per treatment course). Meanwhile, independent scientists estimate that manufacturing remdesivir costs a mere $0.93 per dose.

Sadly, such an enormous gap between actual production costs and ultimate price for consumers is not uncommon in the biopharmaceutical industry. Attempting to justify this margin, Gilead invokes a common argument that it seeks such vast profits “to maintain long-term research in antivirals and to invest in scientific innovation that might help generations to come.”

In this case, we have already paid for the “scientific innovation” related to developing remdesivir. Collaborating with government-funded researchers, Gilead initially developed remdesivir for the treatment of hepatitis C, ultimately pushing forward with a different antiviral medication, sofosbuvir, selected from the compounds studied. Gilead’s profits for sofosbuvir topped $28 billion in its first 5 years post-approval.

Pharmaceutical companies often incorporate the cost of clinical trial design and implementation into their pricing models. In the case of remdesivir, the American taxpayer assumed the cost of the pivotal clinical trial to study its effectiveness for COVID-19. The National Institute for Allergy and Infectious Diseases funded both the study itself and the subsequent data analysis. Combined with the US government’s role in the discovery of remdesivir as an antiviral agent, one could make a convincing argument that the federal government should have a legal right to assume co-ownership over the compound’s patent and leverage that ownership to ensure affordable access for everyone.

Unfortunately, none of this will happen. Gilead Sciences has a long record of maintaining inflated pricing for drugs while delaying the manufacturing of generic equivalents. By law, the FDA lacks authority to negotiate drug prices. Congress has failed to enact the legislative overhauls necessary to bring meaningful accountability and transparency into the drug development process. Now, a medication developed in collaboration with government scientists, studied with federal funds, and with the potential to decrease disease severity and protect American hospitals, will instead add to the overwhelming cost of healthcare and bring billions of dollars of profits to Gilead Sciences.

No one should profit off of a pandemic. The federal government has tremendous power to accelerate the pace of scientific development through investment. It must also have the power to ensure that the products of that investment — vital medications — are available and affordable for everyone. If we realize and harness this power to protect public health, we can fix this broken system. We can, finally, put people over profits. Our national fight against COVID-19 could improve public health outcomes for everyone – and not merely the pharmaceutical industry’s bottom line.

Robbie Goldstein, a primary care physician and infectious disease specialist, is a Democratic candidate for Congress in the 8^th Congressional District.