No need for a new agency at HHS
Advanced Research Projects Agency for Health would replicate existing programs at NIH -- without their safeguards
In 2008, the New Scientist magazine ran a brief article noting the Defense Advanced Research Projects Agency’s greatest hits and misses over its first half century. On the positive side, the government’s willingness to invest in blue sky projects gave us the internet, GPS and advanced semiconductors. Where would today’s high-flying tech companies be without them?
But DARPA also invested in mechanical elephants to clear land for jungle tarmacs in Vietnam, a “damn fool” project its director scrapped so no one would ever hear about it. In the 1970s, the agency invested in psychics who claimed they could carry out remote espionage. But the magazine’s top-ranked bust was DARPA’s 1990s attempt to build nuclear weapons from the very expensive metal hafnium, claiming, without proof, that it wouldn’t generate radioactive fallout.
All the experts who testified today before the House Energy and Commerce Committee in favor of setting up an independent Advanced Research Projects Agency for Health (ARPA-H) noted DARPA’s great successes. No one mentioned its failures.
But failures there will be, especially when it comes to advanced medical technologies. Unlike the Pentagon’s failures, they will no doubt receive far more public scrutiny, especially when their costs begin running into the billions of dollars. The Biden administration has proposed a $6.5 billion appropriation for the new agency, a near doubling of the annual appropriate currently given to the National Center for Advancing Translational Sciences at the National Institutes of Health (NIH), which is already tasked with doing the same thing being asked of the new ARPA-H.
Why is an entirely new agency needed? The experts hailed its streamlined process for making out-on-a-limb investments. Peer review only slows the process. They repeatedly denigrated NIH’s ability to identify and invest in cutting edge projects, which no one rebutted because no one from NIH had been asked to testify.
The experts that appeared included Dr. Brett Giroir, who once worked at DARPA and led the Trump administration’s COVID test-development program. He, along with the other experts, insisted the new agency, which has bipartisan support and appears headed for passage, become a separate entity outside NIH.
“The role of NIH is to create knowledge, which it does well. We’re asking ARPA-H to do something completely different,” said Dr. Geoffrey Ling, a retired military medical officer who is now CEO of On Demand Pharmaceuticals. Best known for managing the project at DARPA that developed the first brain-controlled prosthetic arm, Ling said the government’s role in these far-out projects is to “de-risk” them for the private sector, which “is actually quite conservative.”
At least he got that part right. NIH has a long history of investing in projects that private industry is unwilling to pursue. It has often played the key role in translating basic science insights developed by agency-funded scientists into practical technologies that can lead to new drugs, devices, diagnostic tests and medical equipment. I included many of those developments from the 20th century in my 2004 book “The $800 Million Pill,” which is still in print.
NIH still engaged
In recent decades the development side of R&D has largely been taken over by venture capital-funded biotechnology companies. But NIH or NIH-funded scientists still develop technologies that are breeding some of the most exciting breakthroughs in modern medicine. Look no farther than CAR-T immunotherapy for many cancers or the agency’s RADx (Rapid Acceleration of Diagnostics) initiative that helped scale up rapid COVID-19 testing.
DARPA, meanwhile, also has played a role in developing advanced medicines. They include the mRNA technology behind the Moderna and Pfizer-BioNTech COVID-19 vaccines.
So, do we really need a new agency outside NIH or any of the other existing structures? NIH’s mission statement calls for the $40 billion agency to provide “leadership and direction to programs designed to improve the health of the nation by conducting and supporting research in the causes, diagnosis, prevention, and cure of human diseases.” Not just basic research into the causes of disease, but their cures. If Congress thinks it is failing at the second part of that issue, insist the new leader chosen to replace the departing Frances Collins make it a higher priority.
As I noted in last week’s post
on the Biden’s administration new cancer moonshot program, an independent agency within HHS will become subject to the same pressures that biotechnology and pharmaceutical companies, patient advocacy organizations and academic medical centers currently exert over existing biomedical research programs. What will be missing will be a process where experienced researchers get to evaluate whether the science behind any given project has advanced to the point where success, if not guaranteed, is at least plausible.
Who’s bullying whom?
Another unfortunate side effect is that it will also provide politicians with another lever for exerting their influence over the grant-making process. Remember hydroxychloroquine? One got a taste of where that might lead from one of the Republican backbenchers raising questions at today’s hearing.
Rep. Earl Leroy “Buddy” Carter of Savannah, Georgia, the only registered pharmacist in Congress, used his five minutes to rail against “bullying” by the Biden administration to get people to get vaccinated and wear masks. This medical professional also wants people to seek their own cures for Covid.
“The administration bullied Americans into not using ivermectin, calling it a horse de-wormer,” he said. “Actually, it has worked for many people. It’s been effective.”
(See at 2:50:16)
For the record, the Food and Drug administration has not authorized ivermectin for Covid and recommends against its use. “Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing,” the agency says.
I take all of these points, esp about failures at DARPA. But having looked closely at the NIH SBIR program (for the NAS studies), I was disappointed by NIH's lack of interest in using the program to assess its own evaluation process, and by the overly academic focus of what should have been a program focused on commercialization. I'm not convinced that business as usual is the only way forward, although creating a new bureaucracy doesn't seem an especially promising approach either. your criticisms are well taken.
I take all of these points, esp about failures at DARPA. But having looked closely at the NIH SBIR program (for the NAS studies), I was disappointed by NIH's lack of interest in using the program to assess its own evaluation process, and by the overly academic focus of what should have been a program focused on commercialization. I'm not convinced that business as usual is the only way forward, although creating a new bureaucracy doesn't seem an especially promising approach either. your criticisms are well taken.