Interesting info:
https://www.powerlineblog.com/archives/2020/03/brian-sullivan-what-is-to-be-done.php
Our friend Brian Sullivan is the founder and chief executive officer of a sophisticated biomedical company. In commenting on the Wuhan virus and related issues, John and I have been guided by his review of the literature and his analysis of the data. I asked Brian for his thoughts following yesterday’s confusing White House task force briefing with FDA Commissioner Stephen Hahn. Brian has responded as follows:
In the White House briefing yesterday, FDA Commissioner Stephen Hahn described the FDA’s approach to investigating the efficacy of treatments for Wuhan virus. He didn’t sound like a man on a mission.
As President Trump and others have articulated, we are at war. Our current strategy requires Americans to fight in the trenches and suffer severe economic hardship. This approach is not sustainable over the next 12 months while we wait for a vaccine. To survive in the meantime, the federal government needs to scale its efforts to find treatments that reduce the risk of death from this virus as soon as possible.
Dr. Hahn is serving as the equivalent of a military general in the war effort. He is the point person responsible for leveraging the resources of the federal government to investigate the various treatment options. He cannot fall captive to the same bureaucratic tangle that hampered development and deployment of Wuhan virus tests.
The President clearly is pushing the FDA to move quickly, but he also appeared hesitant to direct the FDA more forcefully. Given the stakes, it is entirely appropriate for the President to direct the FDA to achieve a specific goal – provide the American people with efficacy data by the end of the April on the most promising treatments.
To accomplish this, Dr. Hahn and the FDA need to make some quick decisions and then enable steps that often take months to get completed in days.
1. Select and build teams for the most promising treatment candidates to study and eliminate roadblocks to approving the trials.
The candidates would likely be: 1) Chloroquine or Hydroxychloroquine; 2) Gilead’s anti-viral, Remdesivir; and 3) human convalescent sera. The good news is that three trials are already underway for Remdesivir. A team led by Johns Hopkins researcher, Arturo Casadevall, has already submitted an application to the FDA to study human convalescent serum, which contains the antibodies in blood from recovered patients. This could boost immunity of newly infected people. It is the approach used to combat measles and mumps 100 years ago. According to the team, though, as of yesterday, they have not heard back from the FDA on their application. That application should get turned around immediately. A chloroquine trial is the simplest to move forward in some ways but it needs a clinical team to lead it and take ownership. Publicly call for leading infectious disease doctors to volunteer over the next 24 hours to lead this trial or assign the head of the NIH to lead the effort.
2. Approve the use of a central group of patients who could serve as controls.
Each of the different drugs needs must have results compared to a control group of patients who don’t receive the treatment in order to determine whether they are effective or not. If these drugs are studied in an uncoordinated, independent fashion, each drug trial would need its own control groups of patients. Since each drug must study three different types of patients – patients with severe disease, moderate disease, and ones in close contact with diseased patients – this would mean nine patient control groups would be required. Enrolling the thousands of patients required for these control groups will slow down enrollment significantly, delaying availability of results.
To eliminate this inefficiency, the FDA could mandate that the clinical teams leading these trials establish common eligibility criteria for each patient group so that data from each control group could reliably be compared to the data from the patient groups who receive the different study drugs. This would address one of the biggest obstacles to getting data quickly.
3. Streamline the pathway for approving and activating trials.
Under normal circumstances, it can take months for a trial to get the approvals needed to start enrolling patients. The FDA needs to define a pathway that enable clinical sites to initiate patient enrollment within a week. Again, we are at war.
4. Leverage the clinical trial infrastructure Gilead has already established for the other drug trials.
The longest lead time item for many trials is creation of the protocols and database needed to manage patients and their data. Under normal circumstances, this can take months. Since Gilead is already recruiting patients, they have protocols and a database in place. The FDA should encourage (force) Gilead to offer these tools to the other trial teams.
5. Coordinate trial sites.
The FDA needs to ensure these trials aren’t competing for hospitals and patients in counterproductive ways. Gilead is already in the field and can provide feedback to the FDA and the other clinical teams about obstacles that need to be addressed. All the clinical teams need to be aware of what the others are doing and adjust accordingly.
The FDA is naturally a cautious agency, but we are at war and the agency needs to adapt. Dr. Hahn’s remarks yesterday suggested he has not adapted his mindset to this reality. President Kennedy laid out a goal of landing a man on the moon by the end of the sixties. The stakes today are much higher than a space race. President Trump must tell the FDA that their goal is to get data by the end of April. We can absolutely achieve this.