COVID-19: In the Race for a Vaccine, Biopharmaceutical Companies Showing Moral Imperative Ira J. Bedzow, Ph.D. Angela Rossetti, M.B.E., M.B.A.
Photo Credit: Mark Vergari/The Journal News
Yaron Hadari, with Shy Therapeutic, works on tissue cultures in his work space at the BioInc@NYMC incubator on Dana Road in Valhalla.
Pressure continues to mount on biopharmaceutical companies to find a vaccine to prevent and a treatment to cure COVID-19. Individuals and governments are putting most — if not all — of their hope on the biopharmaceutical industry to cure them of their viral and economic woes. Only a vaccine will bring us out of future economic peril and a cure will save thousands from death. Unfortunately, nature does not give up its secrets easily. In normal times, development of new pharmaceuticals or even the repurposing of existing ones is a long process. Part of the reason is based on the rigor of the scientific method. It takes time and repeated trials to prove that a drug actually works as intended. The other part is the need for safety. We cannot allow “cures to be worse than the disease itself.” Under all circumstances, biopharmaceuticals must meet these two high bars: safety and efficacy. But there is an added, enormous challenge for biopharmaceutical companies today. With the death toll mounting and economies sputtering, this work must be done at unprecedented speed, all the while encumbered by operational challenges. Scientists cannot easily work remotely. Devoting full staff to drug discovery and development may not be possible, since critical personnel may not be available due to illness. Disruptions in the supply chain may hinder research by being unable to deliver needed research supplies. And lurking just beneath the surface of the challenges of discovery, development, production and distribution, is another hurdle: unrealistic expectations for speed of a cure by the public coupled with long-standing negative public perception of the industry. Bad actors such as Martin Shkreli, who jacked up the price of an old drug by 5,000% and was sentenced to seven years for securities fraud, are not representative of the
industry, despite the fact that his actions secured an enormous amount of inflammatory press. The truth is, fewer and fewer biopharmaceutical companies hold deeply to the Friedman doctrine, the dogma that a corporations’ sole responsibility is to its shareholders (i.e. maximizing returns) and that companies have no social or public responsibility. Those that do, such as Shkreli’s company, tend to be formed for financial gain, not for socially redeeming purposes. Today, more and more companies are balancing the legitimate corporate responsibility for profitable operations with social responsibility. Shareholder interests increasingly coexist with corporate goals to advance public health. The moral stance and social values of a biopharmaceutical company matter to society — and to companies themselves. Examples of this are seen with Gilead’s donation of 1.5 million doses of Ebola drug remdesivir (sufficient for 14,000 courses of treatment), and Regeneron’s submission to the FDA of a triple antibody cocktail for Ebola that may have potential to prevent or treat COVID-19. These drugs may or may not work, but the industry is testing them at a speed never before seen. ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) is a collaboration of the federal government and the biopharmaceutical industry designed to prioritize vaccine and drug candidates, streamline clinical trials, coordinate regulatory processes and/or leverage existing assets to rapidly respond to the COVID-19 and future pandemics. This is part of the whole-of-government, whole-of-America response the administration has led to beat COVID-19. This collaboration not only benefits society; it benefits the industry as well. Collaboration may help diminish the public’s suspicion of the biopharmaceutical industry’s motives. Under normal circumstances, drug discovery and development may take as long as two decades and cost $1-$2.6 billion. Today’s pace has greatly accelerated: Vaccines that previously took 20 months to go from genetic sequencing to human trials are now taking fewer than five months to accomplish the same progress. BIO, an industry organization of biopharmaceutical companies, reports that as of April 13, nineteen companies are working on vaccines, fourteen companies on therapeutics, and three companies on better diagnostics. Out of both necessity and collaboration, the biopharmaceutical industry is moving forward with new discoveries and new tools to address the devastation of COVID-19. In recognizing the public need of the day, biopharmaceutical companies that rise to the occasion will change public perception of the industry. The public, which has ranked the pharmaceutical industry as one of the least admired American industries, may end up seeing it as the savior of our way of life. As appeared in LoHud on May 4, 2020.