November 27, 2020
The credibility of pharmaceutical companies is on the line. Will they get it right?
This article originally appeared in The Globe and Mail.
By Professor Jillian Kohler, director of the WHO Collaborating Centre for Governance, Transparency and Accountability in the Pharmaceutical Sector and professor at University of Toronto’s Leslie Dan Faculty of Pharmacy and Jonathan Cushing, Head of Major Projects for Transparency International’s Health Initiative.
In the wake of the encouraging news about COVID-19 vaccine trials from Pfizer/BioNTech, Moderna and AstraZeneca, global attention is on pharmaceutical companies like never before. But in the understandable excitement, the companies in the spotlight risk overlooking a major opportunity: the chance to prioritize transparency and global health over profits, and build their credibility.
This will require a shift in how the industry operates, with increased focus on transparency and accountability in every step of the research and development process. The jury is still out on how far they are willing to go.
These four companies have shown an effort to increase transparency and accountability in their vaccine development efforts. Along with other pharmaceutical companies, they have pledged to “stand with science” and ensure that their vaccines undergo the accepted regulatory and safety standards before applying for approval or marketing authorization. In addition, Pfizer and BioNTech took a step further and joined Moderna by publishing their clinical trial protocol earlier than expected.
Historically, Pfizer has a 100 per cent clinical trial disclosure rate, meaning the results of its clinical trials have been published within 12 months of completion as per legal directives in the United States and the European Union. However BioNTech’s clinical transparency track record, albeit small, is not as strong, with the results from five out of its six clinical trials missing (four of which are overdue). Moderna has a similarly poor track record, with the results from all four of its completed clinical trials being overdue.
Furthermore, the four companies have faced legal action for patent infringement in relation to their respective COVID-19 vaccines. This adds to a growing number of lawsuits against Pfizer, which already has been subject to the largest pharmaceutical settlements in history in 2009, requiring it to pay US$2.3-billion for illegally promoting a range of its products, including Bextra, an anti-inflammatory drug the company marketed for certain usages and doses after it had been officially denied permission to do so by the FDA. Additionally, the U.S. Department of Defense launched an investigation into Moderna in September after it came to light that the company had failed to disclose federal funding in patent applications as required under U.S. law.
For both Pfizer/BioNTech and Moderna, the early vaccine data has been reported by press releases, an approach met by criticism, including by the editor-in-chief of the Lancet. This practice – as opposed to publishing the full data in a peer-reviewed medical journal – has been described by Dr. Peter Hotez of Baylor College of Medicine as “writing for their investors. … It’s being done in a way that’s oblivious to its public health impact and needs to stop.” Unsurprisingly, the positive news on the vaccine led to a nearly 15-per-cent increase in the price of Pfizer’s share and coincided with the CEO’s previously planned sale of 62 per cent of his stock (amounting to US$5.6-million). This move will only serve to undermine public trust and to buoy anti-vaxxers’ narratives.
Now more than ever, pharmaceutical companies need to uphold standards of social responsibility. For certain, it is challenging to mandate transparency from them while critical information can be shielded under the term “commercially sensitive information.” Still, billions of dollars in public funds have supported both the Pfizer/BioNTech and Moderna vaccine, either as research and development funding or as early investments. In the case of Moderna, bringing its vaccine to licence will have been entirely supported by public funds. Consequently, shareholders are not the only ones to whom pharmaceutical companies are accountable; the general public are also key investors.
Of note, 82 per cent of the global supply of the Pfizer/BioNTech vaccine and 78 per cent of the Moderna vaccine has already been bought by high-income countries through confidential bilateral agreements. These agreements undercut multilateral efforts such as COVAX, a global pooled procurement initiative established to guarantee a more equitable global distribution by ensuring vaccine doses for 20 per cent of participatory countries’ population. While AstraZeneca has joined COVAX, the three other companies have not, and have yet to announce how, or even if, they will take measures to ensure global equitable access to their vaccines.
To quote the CEO of Pfizer, Albert Bourla: “If you get it right, you can save the world. And if you don’t get it right, you will not.” But getting it right means much more than developing an effective vaccine – it demands transparency and accountability every step of the way, and a commitment to global equity in terms of deployment.
This is a watershed moment for the pharmaceutical industry as a whole. Let’s hope it embraces this opportunity and makes history for the right reasons.