There Will Be A Tomorrow. Research Must Be Part Of It.
By
Leonard Zwelling
It is my understanding that a single individual in one of the MD Anderson South Campus research buildings has tested positive for the coronavirus. Without letting the people in that building know and certainly without giving ample warning to the rest of the research community and without sufficient input from that community, the leadership of MD Anderson shut down all lab-based research, including the research in Smithville, 100 miles away. Many animals have been sacrificed and undoubtedly valuable work has been lost.
It is also my understanding that a big chunk of clinical research is shut down. There is no support staff to conduct clinical research and phase one studies will not accrue new patients. Even phase 2 and 3 protocols will be hard-pressed to accrue new patients with the support staff mostly at home.
Let’s understand a few things about research.
- Research is not an option. MD Anderson has as one of its major missions the performance of all kinds of research. If there is “One MD Anderson,” that includes research. Yes, there may be curtailing of much of that research in this uncertain time, but to shut it down completely? How wise is that? Much valuable and potentially science-altering investigation will not be done until when? Was there no way to arrange some kind of continuity plan with the lab-based investigators or did the scientific leadership of MD Anderson just not think of that a month ago when where this was going was obvious to most of us? Or did the research leadership opt for a salvage strategy, only to be vetoed by the president?
- Clinical research saves lives. You cannot have a cancer center without clinical research. If it requires that a skeleton crew be pressed into service to make sure potentially life-saving studies continue AND accrue new patients, so be it. You never know which clinical study will lead to a breakthrough and you cannot just stop this kind of research while the coronavirus runs its course, whatever that happens to be. That’s what cancer centers do. That’s what doctors do.
This is no time for the leadership of American oncology to back away from making progress against a disease that actually has already killed thousands, cancer. If MD Anderson is not doing clinical research, it may as well close up shop and start being a general hospital. Clinical research is the lifeblood of Anderson. The leadership has to figure out a way to continue human subjects research, even under these adverse circumstances.
If what they fear is protocol violations and reprimands from the federal government, let’s not forget that the FDA Commissioner is a cancer researcher. He gets it. If you have to call the Office of Human Research Protections and ask for absolution because of a protocol error, I do believe that office will understand. Cancer patients can’t wait until the coronavirus threat is gone. They need therapy now and if they qualify for a trial, they ought to be allowed to register and go on study.
Finally, there may well be a bigger object in the way of clinical research in these uncertain times—the drug companies whose monetization of intellectual property is counting on well-done trials for FDA registration purposes and to get to market. Call the companies. Talk to them. This is where the FDA and OHRP ought to be leading. They should give anyone absolution who is trying to help a patient as long as a patient registered on a trial qualifies.
I am appalled at the willingness of the leadership of academic institutions to forego research. There has to be a way.
There must be a vision for the future after covid-19. Research directly speaks to the future. There needs to be a plan to keep the research enterprise whole in this trying time. Yes, it will be hard. It will be worth it.
Come on people, MD Anderson can do this. Research matters. It must continue.
And on the matter of the degree to which the response fits the threat, consider this:
