While it seems like it’s been forever, it was only 27 months ago that the U.S. and most of the rest of the world had to shut down due to the coronavirus pandemic. Things were pretty scary for us all with some cities needing refrigerator trucks to temporarily house the large number of bodies of those who were dying daily. Miraculously, the biopharmaceutical industry provided deliverance with Covid-19 vaccines from Pfizer/BioNTech, Moderna, J&J and AstraZeneca (in Europe), thereby saving millions of lives.
(Photo by Joe Raedle/Getty Images)
Unfortunately, Dr. Robert Pearl in a general opinion piece “Why we overpay for drugs that underachieve”, can’t help but minimize this wondrous accomplishment in an article that had little to do with Covid-19.
“By following the rule of maximizing profits at minimal risk, pharmaceutical companies now routinely price and promote minimally effective drugs as if they were lifesaving medications. Even the highly effective Covid-19 vaccines – the most celebrated innovation of the 21st century – were brought to market with minimal risk. The federal government paid for much of the underlying development costs through decades of NIH-funded research and minimized the risks to companies by fronting $18 million as part of Operation Warp Speed.”
Let’s start with the view that these vaccines “were brought to market with minimal risk”. Pfizer, which has produced the majority of Covid-19 vaccines with roughly seven billion doses to date, took no money from Operation Warp Speed (OWS) to discover, produce or distribute its vaccine. Pearl seems to forget that mRNA vaccine technology was unproven at the start of the pandemic. Pfizer invested $2 billion upfront in developing the vaccine as well as building manufacturing plants necessary to produce this totally novel vaccine. Pfizer CEO Dr. Albert Bourla boldly said that, if this technology failed, the $2 billion investment “won’t break us”. Perhaps that was true. However, Pfizer had sales of $41.7 billion in 2020 so, had the mRNA work indeed failed, investors would not have been pleased. The contract that Pfizer had with OWS was for the purchase of 100 million doses of the vaccine should it successfully clear clinical trials and be approved by the FDA. Thus, there was no safety net for Pfizer had the vaccine failed.
Moderna, the second largest producer of Covid-19 vaccines, did take money from OWS. But at the start of the pandemic, Moderna was a struggling biotech company that, in its decade of existence, had yet to produce a product. Thus, it didn’t have the funds necessary to develop and manufacture its unproven vaccine. Thankfully, OWS funded this work which was critical in having a second vaccine at the height of the pandemic. This is exactly what the role of government should be in the time of a national crisis. Moderna also had a contract with OWS for 100 million doses of its vaccine should it also get approved by the FDA. However, had the mRNA vaccine failed, Moderna would also have faced financial difficulties given the importance of this platform to its future. So much for “minimal risk”.
The claim that the federal government paid for much of the underlying costs through decades of NIH-funded research is also a gross overstatement. First of all, venture capitalists (VCs) really drove the development of these vaccines. Research into the potential use of this technology had been ongoing for decades and progress was slow. It was not until the formation of Moderna and BioNTech, backed by tens of millions of dollars first by VCs then by becoming public companies, that the necessary breakthroughs were made to make mRNA vaccines a reality.
There is no doubt that research conducted and supported by the NIH is important across the entire drug discovery and development continuum. Senator Bob Dole, co-author of the Bayh-Dole Act that changed the face of the interaction between government and industry, wrote an important op-ed on the impact of this Act on the race for Covid-19 treatments. He described the need to spur the interaction between public and private research in order to bring patients the benefits of innovative science sooner.
“Many research institutions and universities are responsible for the kind of foundational discoveries and inventions that ultimately lead to innovative new cures and products. But it takes a massive investment and additional research and development by the private sector to bring these innovations to market. For every dollar the government spends, industry spends 10 – 100 times that amount.”
Comments like those made by Dr. Pearl trivialize the important life-saving work by the biopharmaceutical industry. Biopharmaceutical R&D is a high risk and expensive endeavor in which thousands of creative and hard-working scientists use their talents to try to cure the diseases of the world – and pandemics. This needs to be recognized and not minimized.
(John L. LaMattina is the former president of Pfizer Global R&D and the author of Pharma & Profits: Balancing innovation, medicines and drug prices published by Wiley.)