U.S. Government & VC Investing: Should It Happen?

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 hereor find the submission form at the end of any First Opinion essay.

The story

“Don’t cut NIH and NSF budgets — let the government invest like a venture capitalist“By Sahand Hormoz

The response

Harvard biology professor Sahand Hormoz argues that the federal government should repeal the Bayh-Dole Act — the bipartisan 1980 law that allows academic research institutions, federal laboratories, and small companies to own and manage inventions they made from federally funded research — and instead retain “a share of IP generated through NIH and NSF grants.” This, he claims, “would allow the public to directly benefit from the science it pays for.”

That is deeply wrongheaded. The government doesn’t function as a venture capitalist. No VC would fund fundamental research to expand the frontiers of science as the government does. What Hormoz misses is that because the Bayh-Dole Act allows universities to own and manage resulting discoveries for commercial development, venture funds are willing to support the entrepreneurial small companies that drive our economy. These companies assume enormous risk doing so, and when projects fail (as they often do), it is the entrepreneurs, not the public, that take the hit. Yet the public benefits from the Bayh-Dole system are enormous. Academic technology transfer enabled by the Bayh-Dole Act has yielded more than 200 drugs and vaccines, 18,000 startups, $1 trillion in U.S. GDP, and 6.5 million jobs — a massive return on taxpayers’ investment. Hormoz himself notes “every $1 of NIH funding generated $2.56 in economic activity” and that “each $1 of federal research money boosts private R&D investment by $8.38 over the following decade.”

The genius of the Bayh-Dole system is that it decentralized technology management from Washington into the hands of those who know the technology the best — those who create it. When bureaucracy controlled the system, as Hormoz seems to prefer, not a single new drug was developed and 28,000 inventions were gathering dust on the shelves. That’s no longer the case. In 2002, the Economist Technology Quarterly called Bayh-Dole: “Possibly the most inspired piece of legislation to be enacted over the past half century. … More than anything, this single policy measure helped reverse America’s precipitous slide into industrial irrelevance.” The Economist concludes: “A goose that lays such golden eggs needs nurturing, protecting and even cloning, not plucking for the pot.”

That’s pretty good advice if we want to preserve our lead as the world’s leading source of innovation.

— Joseph P. Allen, executive director, Bayh-Dole Coalition

The story

“My sister and I each gave our brother a kidney — and faced health consequences decades later,” by Jane Zill

The response

The recent piece “My sister and I each gave our brother a kidney — and faced health consequences decades later” presents an incomplete representation of living kidney donation. While we sympathize with the family’s experience, the fact is that there exist decades of clinical evidence showing that it is safe and low risk for an individual to donate their kidney. While undoubtedly there are exceptions to the rule as is always the case with medical procedures, we remain concerned that highlighting the rare exceptions, rather than the overwhelming safety and lifesaving outcomes of living kidney donation, endangers the tens of thousands of individuals on the kidney waitlist who are in desperate search for a living donor at this moment. Efforts to reduce the number of living kidney donors increase the already fraught state of our transplant system and increase the threat to the future of transplant care.

Every day, more than a dozen individuals die waiting for a kidney transplant. Because there will never be enough deceased donors to meet the demand from those with kidney failure, living donation is the only path where the supply can begin to match the need. Modern surgical advances, along with the current thorough pre-donation evaluation, have drastically reduced the risks; for example, recent studies have shown a mortality rate of less than 1 in 10,000 (which is better odds than the average worker driving to the office) and less than 1% will develop kidney failure. While the proven health risk of living kidney donation is minimal, logistic and financial barriers remain, and donors are too often forgotten soon after donation.  A better system would ensure donors do not have to shoulder too much alone and are more closely followed post-transplant.

As medical practitioners, advocates, and leaders, we must strive to build a more robust, efficient, and safe kidney transplant system. That means providing financial (cost reimbursement) and long-term clinical support, ensuring lifetime follow-up beyond the current mandate of two years, and removing the practical and economic barriers that discourage potential donors from stepping forward.

— Andy Howard, chairman of Kidney Transplant Collaborative

The story

“Six former CDC vaccine advisory committee chairs warn: We risk losing access to life-saving immunizations,” by Grace Lee, Nancy Bennett, Jonathan Temte, Carol Baker, Myron Levin, and José Romero

The response

The authors of this essay are to be lauded for tackling this issue. Leadership in the scientific community is sorely needed to counter the unwise policies of this administration, including removing ACIP members and creating barriers to the approval and use of vaccines with established efficacy and safety profiles. These misguided policies will lead to the resurgence of common infectious diseases that were once eradicated. The resurgence of cases will result in unnecessary morbidity and fatalities. This could threaten not only the U.S. domestic population, but in this era of global travel, could endanger the world’s population. Firing the ACIP is unscientific, unwise, and unsafe, and those who are making these decisions do not have the requisite expertise to do so. The medical community needs to speak up to advocate for the public’s health and welfare.

— Dina Stolman, M.D., M.S.P.H., retired

The story

“Private sector, philanthropy can’t replace Trump administration science cuts,” by James Alwine and Gregg Gonsalves

The response

As a semi-retired veteran of the biopharmaceutical industry, I wish to emphasize the critical point that these atrocious, irrational, spiteful, and unconscionable cuts to American biomedical research funding will have a potent downstream impact on the development of new medicines. Taking a flamethrower to biomedical funding will severely curtail the rapid progress being made in treating cancer, autoimmune diseases (including Alzheimer’s disease), cardiovascular disease, COPD and asthma, and many other serious chronic illnesses that can now be treated with highly specific biological products manufactured in living cells that target the root causes of human diseases. The possibilities for treating human diseases at their molecular roots are endless, but they cannot be implemented if these draconian measures are fully realized. What a historical travesty to relinquish the position as the global leader in biomedical research. I shiver at the thought that today’s and tomorrow’s scientists may not have the privilege of enjoying the incredible opportunities I had in my years at Amgen. I feel this tragedy down in the deepest recesses of my bones.

— Drew N. Kelner, Ph.D.