On the menu today: After 57 days in office, Joe Biden hasn’t gotten around to filling a pretty darn important position when it comes to coronavirus response; Politico comes close to giving Florida governor Ron DeSantis that long-awaited apology; and the Biden administration grapples with another Weed Agency.
The Most Important Biden-Administration Fight You’ve Heard Almost Nothing About
It’s easily overlooked with the Meghan Markle and Alexi McCammond drama, and in a world in which the Pentagon metaphorically declares war on Tucker Carlson, but . . . Joe Biden still hasn’t nominated anyone to be commissioner of the Food and Drug Administration yet. That is a strange delay for an administration that keeps telling us it’s relentlessly focused on the pandemic.
Biden is a little behind his predecessors; Donald Trump nominated Scott Gottlieb to be FDA commissioner on March 10, 2017, and Obama nominated Margaret Hamburg to be commissioner on March 11, 2009 — and obviously, they didn’t take office during an all-consuming global pandemic. A little more than a week ago, six former FDA commissioners wrote a letter to Biden, urging him “to prioritize securing its leadership team, including through seeking the formal nomination and confirmation of an FDA Commissioner. The agency’s experienced staff and its science-based regulatory processes will play a critical role in helping the nation confront the evolving pandemic.”
The FDA commissioner is usually one of those administration jobs where your name appears in the news headlines on your first day and on your last day — and very rarely in between. But the FDA’s decisions have probably never been more consequential or loomed larger in Americans’ minds.
Just in the past few days, the FDA decided to limit the use of monoclonal antibody treatments developed by Regeneron and Eli Lilly due to concerns that the medications are not effective against new strains of SARS-CoV-2, permitted marketing of at-home COVID-19 tests, and postponed a Trump-ordered review of old regulations. And of course, everyone’s wondering when AstraZeneca and Novavax will submit their vaccines for emergency-use authorization, and how quickly the FDA will sign off on using them on Americans.
Clearly, the FDA is functioning under acting commissioner Janet Woodcock, but you figure Biden would either want to formally make her the administration’s choice or get someone else he prefers in there. In the past, as head of the FDA’s drug-evaluation office, Woodcock earned praise from the likes of Tom Cotton, suggesting she would, at a minimum, no face unified Republican opposition.
But according to Politico, if formally nominated, Woodcock may face significant Democratic opposition:
Dozens of addiction treatment and anti-opioid groups have led the way, zeroing in on her tenure as head of the FDA’s drug division during a period where the opioid crisis grew into a full-blown epidemic. The organizations blame Woodcock for presiding over too many opioid approvals during that era, and for the agency’s failure to rein in drug makers pushing the painkillers — a politically explosive accusation that many FDA experts have rushed to refute, yet that nevertheless has jumped to the Senate.
Over the past several weeks, Sens. Maggie Hassan and Ed Markey have voiced concerns about Woodcock’s work on opioids, an issue that a spokesperson for Hassan said has been relayed directly to Biden officials as well.
Sen. Joe Manchin of West Virginia — a state hard-hit by the addiction epidemic — also privately signaled resistance to a potential Woodcock nomination, according to a person familiar with the Senate discussions. The pushback has prompted fears that several Democrats would come out against Woodcock if Biden nominated her, forcing the administration to rely heavily on Republicans to secure her confirmation.
In an op-ed in USA Today, Gerald Posner, who wrote a book about the pharmaceutical industry and the opioid epidemic, detailed Woodcock’s decisions on opioids and argued, “The Biden administration should avoid rewarding any government official who contributed to the opioid crisis having become the most lethal prescription drug epidemic in American history.”
If Biden formally nominates Woodcock, I wonder if Senate Democrats would give her grief during a confirmation hearing over the FDA’s approval of the emergency-use authorization for hydroxychloroquine last year. In an interview in April, she suggested that the FDA was doing the best it could in some extraordinary circumstances:
Do you worry that hydroxychloroquine overuse threatens to undermine the standard FDA review process and the respect that the public has for that process?
Well, Plaquenil [the brand-name version] is an approved product that’s been around for 40 to 50 years and when clinicians started using it under certain circumstance and are still using it in all kinds of situations, even prevention. We approved the EUA [Emergency Use Authorization] for a Bayer drug that wasn’t approved in the U.S. and a couple of other hydroxychloroquine drugs during a time when there was tremendous demand and people with lupus and other autoimmune diseases were having trouble accessing the drug because of the demand.
We were clear that an Emergency Use Authorization is not an FDA approval in any shape or form. We simply said it’s possible from the in vitro data this may have a beneficial effect and the benefits may outweigh the risks.
But you’re right. People see the Emergency Use Authorization and may misinterpret it, although the data we have shows there was widespread use of this for Covid-19 well before that.
If I asked whether you had second thoughts about the EUA, would you say ‘no?’
Given the circumstances, I would say we did the best we could.
By mid June, the FDA had concluded that, “it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks. Accordingly, FDA revokes the [emergency use authorization] for use of HCQ and CQ to treat COVID-19.”
In the scientific journal Nature in February, Woodcock painted a picture of COVID-treatment research that was messy, disorganized, rushed, and duplicative:
The most important finding in our assessment is that the vast majority of trials of therapeutics for COVID-19 are not designed to yield actionable information; low randomization rates and underpowered outcome data render matters of safety and efficacy generally uninterpretable. Many of these trials are classified as phase II (Fig. 3), indicating procedural barriers to the generation of pivotal data. Especially within the urgent context of the pandemic, rapid screening and seamless phase II–III transitions should facilitate efficient go/no-go decision-making that will preserve resources and optimize enrolment. Notably, we observed great duplication of effort among registered trial arms, with multiple small trials studying similar interventions in similar populations.
The question of whether the FDA is being too cautious or not cautious enough in approving potential treatments and drugs is not going away. Even after Americans get their COVID-19 vaccinations, we’re still probably going to need regular booster shots. Johnson & Johnson, Moderna, and other manufacturers of the current vaccines are working on new ones specifically designed to fight the emerging variants.
Biden himself apparently envisioned his administration bringing lots of new breakthroughs and treatments to Americans. Back in June 2019, Biden told Americans: “I promise you, if I’m elected president, you’re going to see the single most important thing that changes America: We’re going to cure cancer.”
As I noted at the time, the good news is we’ve made remarkable strides in cancer treatments, from surgery to chemotherapy to immunotherapy to stem-cell transplants to photodynamic therapy. The bad news is there are more than 100 types of cancer, and different treatments have different levels of effectiveness on patients. A blanket cure for all types of cancer is not outside of our reach because we elected the wrong president or aren’t spending enough money on the problem. A blanket cure for all types of cancer is outside of our reach, for now, because cancer is a darned complicated disease with a lot of varieties, and the target is always changing.
Ron DeSantis Gets Closer to Receiving His Apology
Rich Lowry, May 20, 2020: “Where Does Ron DeSantis Go to Get His Apology?”
Politico, apparently. Its evening newsletter, last night:
. . . after 12 months in which he was pilloried as a reckless executive driven more by ideology than science, dogged by images of crowded beaches and bars and derided as “DuhSantis,” “DeathSantis” and “DeSatan,” Florida has fared no worse, and in some ways better, than many other states — including its big-state peers.
The most controversial policies DeSantis enacted — locking down later and opening up earlier, keeping nursing homes closed to visitation while insisting schools needed to be open to students, resisting intense pressure to issue a mask mandate — have ended up being, on balance, short of or even the opposite of ruinous.
Now . . . will anyone in the national media learn anything from this experience?
The White House Deals with a Different Weed Agency
Apparently, you can’t work in Joe Biden’s White House if you’ve smoked marijuana. Who wants to tell him about Kamala Harris?
ADDENDUM: On Wednesday, I checked in on Texas’s coronavirus-case numbers.
The day before the state’s mask mandate ended, March 9, Texas had 5,119 new cases of COVID-19, 126,404 active cases of COVID-19, and 168 new deaths from COVID-19. (This figure bounces around a lot; it was 69 on March 8 and 231 on March 12.)
On Thursday, March 18, Texas had 3,485 new cases, 111,359 active cases, and 194 deaths.
Critics of Greg Abbott insist that it’s too early, and weeks or months from now, we’ll see the ruinous result of ending the statewide mask mandate.
Of course, they’ve been saying similar things about Ron DeSantis for the past year, too.