Avoiding Unforced Errors in the Bio/Pharma Industry

A lesson of the COVID-19 pandemic is the need for accurate, unbiased, science-based evidence to support public and personal health decisions. As a society, we sometimes have a difficult time embracing this concept.

Too often, announcements—both good and bad—about diagnostic testing, the spread of the virus, and the development and manufacturing of vaccines were packaged to meet specific messaging agendas by bio/pharma companies, policymakers, and the media.

For years, drug companies routinely released press announcements to industry and investor communities about the status of drug candidates in advance of peer or regulatory review. The intense public interest in the progress of COVID-19
vaccine candidates placed these announcements in the spotlight, with some negative consequences.

Recently, the data and safety monitoring board (DSMB) overseeing AstraZeneca’s COVID-19 vaccine candidate raised an alarm that the company’s March 22, 2021 press release (1) reporting initial data from a Phase III clinical trial included outdated efficacy data. The National Institute of Allergy and Infectious Diseases (NIAID) urged the company “to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible” (2). AstraZeneca released updated data on March 25, 2021 in another press statement (3).

In a March 23, 2021 interview with ABC News, Anthony Fauci, NIAID director, noted that the AstraZeneca candidate “is likely a very good vaccine”, but the inaccurate information in the press release was outdated and a bit misleading; Fauci characterized the confusing press statements as “an unforced error” (4).

Don’t mix the messages

A science-by-press-release approach with its dangerous and embarrassing implications is unfortunately making its way to the business and scientific press.

In the past few months, the editors of BioPharm International have seen a new, disturbing trend: the influx of press announcements, articles, and commentary from drug companies and industry suppliers that are strictly self-promotional and have little to no objective, scientific, or technical value for readers. We’ve received pitches about obscure products with no application for drug development, quotes from executives that extoll the virtues of their business, and promises for technical articles that turn out to be repurposed marketing literature.

Business publications such as BioPharm International rely on the industry supplier market for financial support; however, the industry suppliers need independent publications to reach the qualified audience that seeks the technical insight and analysis provided by experts in pharmaceutical sciences. Attempts to substitute marketing or advertising messages for substantive science- and technology-driven information can backfire.

Many forms of messaging are available; using the most appropriate form for the intended purpose will increase the potential for the message to be heard and acknowledged.

Share the story of your company’s capabilities and products in paid advertising and content marketing programs. Contribute to the credibility and independence of advancing bio/pharm science by sharing objective, non-promotional information about drug development, formulation, manufacturing, and quality processes by authoring a technical article to Pharmaceutical Technology.

The editors welcome objective, informative editorial driven technical articles authored for BioPharm International by experts at bio/pharmaceutical companies, regulatory authorities, industry suppliers, and consultants on process and formulation development, manufacturing operations, drug delivery, packaging, labeling, and distribution. View the editorial guidelines at https://biopharminternational.com/editorial_info.

References

1. AstraZeneca, “AZD1222 US Phase III trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis,” Press Release, March 22, 2021.
2. NIH, “Data and Safety Monitoring Board (DSMB),” Press Release, March 23, 2021.
3. AstraZeneca, “AZD1222 US Phase III Primary Analysis Confirms Safety and Efficacy,” Press Release, March 25, 2021.
4. M. Vann, “Fauci Calls ‘Outdated’ Data in AstraZeneca’s US Vaccine Trial ‘Unfortunate,’” ABCnews.com, March 23, 2021.

About the author

Rita Peters is the editorial director of BioPharm International.

Article Details

BioPharm International
Vol. 34, No. 4
April 2021
Page: 6

Citation

When citing this article, please refer to it as R. Peters, " Avoiding Unforced Errors in the Bio/Pharma Industry," BioPharm International 34 (4) 2021.