First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.
To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.
The story
“The progressive campaign against biomedical innovation,” by Vrushab Gowda and Brian J. Miller
The response
It is disappointing when scholars from reputable academic institutions enter a fact-free zone to make policy arguments. Sadly, this is exactly the line of argument that Gowda and Miller have recently pursued. They accuse the Biden-Harris administration of having “both stifled innovation and made it harder for drugs to reach patients.” I believe that it is worth looking beyond the tired pharma talking points and made-up simulation numbers to what is happening on the ground.
Let’s begin with direct investments in research and development. From 2021 through 2023, the NIH budget increased 13.9%. That compares well to the three pre-pandemic years that saw a 14.5% rise. In addition, the Biden-Harris administration oversaw the creation of ARPA-H that began with a $1 billion investment that has increased to $2.5 billion in 2024. The National Science Foundation budget has grown 15.2% under the Biden-Harris administration. That compares to 10.8% in the prior administration.
Gowda and Miller next rail against the new approach to establishing negotiated prices for a limited set of single source drugs that have been exclusively on the market for at least nine to 13 years. They refer to Medicare drug “administered” prices. To the extent that they actually mean the limited number of drugs that will have negotiated prices, it seems that the real objection is that the authors have a preference for prices administered by monopolists that have evaded competition to prices administered through a negotiation process.
As proof of the problems created by these administered prices, they put great weight on a “early modeling study” from the University of Chicago while ignoring the estimates by the Congressional Budget Office and other scholars. Two years into a period that was viewed by some as the start of a “nuclear winter” for pharmaceutical R&D, it may be worth examining the experience to date in light of the dire predictions that the authors appear to subscribe to. Industry R&D spending has continued to grow and is expected to reach $204 billion for the full year 2024. My colleagues and I have examined merger and acquisition activities, another investment mechanism for bringing new products to market, and found continued high levels of activities including those involving early-stage products and those developing small molecule drugs. Our results are consistent with findings by the Congressional Budget Office. These results have also been confirmed in Wall Street analyst reports.
Especially telling is commentary in earnings calls by large pharmaceutical companies that run counter to the claims made by Gowda and Miller. For example, Merck stated the following:
“In summary, our science-led strategy is delivering compelling proof points that we are creating a sustainable innovation engine that with continued clinical success will lead to a more diversified portfolio of growth drivers over the next decade and beyond,” (Merck Q1 earnings call).
In fact, contrary to the authors’ claims it appears some firms are redoubling investments in R&D to compensate for any revenue reduction stemming from the Inflation Reduction Act (IRA).
“So I think it’s important to recognize that while IRA has an impact in the middle of the decade, we feel very good about being able to more than compensate for that with a very young and attractive growth profile coming from our growth portfolio and the pipeline.” (BMS Q1 Earnings call)
Examining the facts on the ground offers a different view of the industry and R&D policy than those asserted by Gowder and Miller based on ideology in the absence of facts.
— Richard G. Frank, the Brookings Institution
The story
“A new Trump administration will further loosen already-lax rules on supplements,” by S. Bryn Austin and Amanda Raffoul
The response
S. Bryn Austin and Amanda Raffoul mischaracterized the dietary supplement industry as unregulated and reckless. As Committee for Responsible Nutrition (CRN) president, I must correct this misinformation and highlight the industry’s strong commitment to safety, consumer trust, and regulatory compliance. Dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA), with FDA oversight including Good Manufacturing Practices (GMPs), adverse event reporting, and labeling standards. CRN has long supported strengthening this framework by advocating for tools like a federal supplement registry and increased FDA resources to combat illicit products.
The unsubstantiated claim that supplements contribute to eating disorders lacks evidence. CRN’s review of studies finds no causal link, and Austin’s own research fails to support her assertions. Broader factors—such as societal pressures and untreated mental health issues—are the real drivers, yet the authors unfairly scapegoat the supplement industry. The alarmism extends to misrepresentations about FDA enforcement and industry-funded research. The FDA routinely takes action against illegal products, and industry-supported studies meet rigorous standards, contrary to the dismissive “pseudoscience” label. State proposals to restrict access to weight management and muscle-building supplements are misguided. Such policies penalize responsible adults and stigmatize safe, FDA-compliant products. Vague legislative definitions risk overreach, impacting everyday products like multivitamins. Alarmist comparisons to “Big Tobacco” or “Big Sugar” only undermine informed discussions about supplements.
The dietary supplement industry prioritizes safety through science-backed claims, third-party certifications, and consumer education. Rather than fearmongering, collaboration among regulators, researchers, and health advocates is key to improving public health. The industry welcomes scrutiny and seeks balanced dialogue — not unfounded attacks that mislead consumers and ignore societal challenges. It’s time to focus on facts, not fear.
— Steve Mister, Council for Responsible Nutrition