Experimental COVID treatment may have saved ND woman's life; husband wants more to receive it
Doctor cautions drug's role in success unclear, says more data needed
JAMESTOWN, N.D. — Linda Schuttenhelm is at her home in Jamestown these days recovering from a serious battle with COVID-19.
Not long ago, however, she was in a Fargo hospital near death as her husband, Mark, scrambled to convince hospital and federal officials that an experimental drug that has shown promise as a weapon against COVID-19 should be allowed to help his wife fight the disease.
His efforts were successful, and his wife received the drug.
Now, Schuttenhelm is on a mission to convince the Food and Drug Administration to make the drug — called leronlimab — more readily available to others suffering severe COVID-19 symptoms.
A doctor at Sanford Health in Fargo who treated Linda Schuttenhelm and who worked with the FDA to secure leronlimab for her, says he is happy she is recovering.
But he also stressed that the role the drug may have played in that recovery is unclear.
"We have had apparent success with this patient and I'm happy she did well, but I'm not going to let my ego get ahead of myself. I still want to stick to science and I still want to see data," said Avish Nagpal, a doctor who specializes in infectious disease who is also the medical director for infection prevention at Sanford Health.
Nagpal said collection of helpful data can be accelerated if significant numbers of COVID-19 patients take part in randomized control trials of drugs like leronlimab, which he said is the best way to arrive at safe and effective treatments people can trust.
Randomized control trials involve two groups of patients, with one group given the drug to be studied and the other a placebo.
Such trials resulted in the COVID-19 vaccines now being administered around the country and Nagpal said that "great medical success story" highlights how the country can achieve great things when everyone works together.
"I think we need to do the same thing with treatments," Nagpal added.
Mark Schuttenhelm said he is grateful for the help his wife received at Sanford Health and for the fact she was allowed to have leronlimab, a treatment he believes was instrumental in her recovery.
Schuttenhelm has sent several email letters to Janet Woodcock, acting commissioner of the FDA, urging that the agency do what it can to make leronlimab more widely available.
In one email to Woodcock, Schuttenhelm described his family's COVID-19 ordeal this way:
"The emotional pain you are feeling is nearly unbearable," he wrote.
"You get daily phone updates from her doctors. The rest of the time you pray the phone does not ring, for fear it will be the call. The call you dread. The call that will change your life forever," he added.
In the same letter, Schuttenhelm shared how his desperation lifted after his wife was allowed leronlimab and she began to feel better.
"My wife is one of the lucky ones," Schuttenhelm wrote, adding they were able to get leronlimab using the FDA's Emergency Investigational New Drug procedure.
Schuttenhelm told Woodcock that at one point his wife was placed on a ventilator and that she was not expected to survive.
He said after receiving the experimental drug his wife was eventually weaned from the ventilator and he said she is happy to be alive and working to regain her strength.
"What is the FDA waiting for?" Schuttenhelm asked Woodcock in his letter.
In a phone interview, Schuttenhelm said Woodcock responded to one of his emails, letting him know she was happy that his wife is recovering.
However, Schuttenhelm said Woodcock did not say whether approval of wider use of leronlimab was forthcoming.
Schuttenhelm said he believes few people, including many within the medical community, are aware of leronlimab and its potential, or that the FDA has a special process people can use to receive the drug.
He said even if access is granted through the Emergency Investigational New Drug process, shipping of the drug can easily take a week, time Schuttenhelm said many critical patients do not have.
"If the drug was approved and stocked at the hospital pharmacy, the patient can get it quickly," he said.
Linda Schuttenhelm, who remembers very little of her COVID-19 ordeal, expressed gratitude for everyone who helped her through it.
"I would just thank all those who prayed for me, the doctors, nurses, and therapists who cared for me, and my husband for never giving up on me. Miracles do happen, and I'm proof," she said.
CytoDyn, the company that makes leronlimab, says it acts as "a viral-entry inhibitor" for human cells and notes that the FDA has granted the company fast track designation to explore the drug's potential to treat HIV and metastatic cancer.
Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans, according to CytoDyn, which recently announced it delivered supplies of the drug to a Philippine hospital to be given to critically ill COVID-19 patients as part of a clinical study.
Patients in the Philippines who have received leronlimab include the country's former president, Joseph Estrada, who was given the drug under a special permit.
Estrada, who is in his 80s, was reportedly placed on a ventilator at one point, but is now said to be recovering from COVID-19.
According to CytoDyn, no strong safety concerns have surfaced involving leronlimab, including treatment for COVID-19.
Nagpal said that safety record was one of the factors he considered when he helped to secure leronlimab for Linda Schuttenhelm's treatment.
He stressed, however, that leronlimab has been used as a COVID-19 treatment in a relatively small number of people and he said the FDA has asked CytoDyn to provide more trial data, something he said "is a very responsible thing for the FDA to do."
Schuttenhelm said he understands it may be too early for the FDA to approve leronlimab in all COVID-19 cases, but he said it should be an option in cases like his wife's, when people are intubated and critical care is necessary.