Science is the way out of the pandemic—and America’s researchers are working hard to bring COVID-19 vaccines, therapeutics, and diagnostics to the public, ASAP. But ensuring the public’s trust in those new medical products is essential. In an open letter to industry colleagues, BIO leaders explain what everyone involved needs to do.
BIO leaders released an open letter to their biopharmaceutical colleagues articulating principles to ensure the “integrity, transparency, and objective assessment” of COVID-19 clinical data and secure public trust in new medical products developed in response to the pandemic. (Here’s the letter.)
These are the five core principles:
- Clinical trials should be conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects.
- Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer review journals. Companies that need to release data in advance of publication should do so thoughtfully and not through press release alone.
- The U.S. Food and Drug Administration (FDA) should maintain its historic independence as the gold-standard international regulatory body, free from external influence.
- The appropriate use and distribution of any new products should be data-driven, including through data collected during longer-term studies.
- Political considerations should be put aside by leaders of both parties and they should “reassure the public that politics will not influence the development and approval of new medicines.”
“We urge all parties involved in the development, review, approval, and distribution of COVID-19 therapeutics and vaccines to commit themselves to these principles,” write the eight signatories, including BIO Chair Dr. Jeremy M. Levin, Chairman and CEO of Ovid Therapeutics; BIO Vice Chair Paul Hastings, President and CEO of Nkarta Therapeutics, Inc.; BIO President and CEO Dr. Michelle McMurry-Heath; and several past BIO leaders.
Why it matters: “As data begin to emerge from clinical trials of an array of vaccines and therapeutics, we believe that it is important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value,” they continue. “We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency, and objective assessment of new data as they emerge.”
What they're saying: "We want the public to believe and to trust what we are doing," Dr. Levin told STAT News. "This is not just the current administration of BIO. This is the totality of decades of the industry speaking at this moment saying we believe that science and medicine need to stand out."
View from BIO's Chairman, Jeremy Levin: "At this moment in time there is nothing more important or critical for the American public than to fully trust the manner in which our industry explores new scientific frontiers and analyzes data from critical clinical trials. Our nation should never have to worry that politics interferes with rational data and fact-driven scientific process, and the exploration and validation of clinical trial data. Even the appearance of political intrusion is detrimental. It undermines public confidence in our industry. It also offers an opportunity for those that already need a reason not to believe in our intent and commitment to science and medicine to doubt us further. That is why we made this declaration at this moment."
Learn more about what the biotech industry is doing to combat COVID-19.