A judge ordered Millard Fillmore Suburban Hospital last week to give a Covid-19 patient an experimental treatment, and her family and attorneys say they believe that saved 80-year-old Judith Smentkiewicz's life.
The drug Ivermectin – a pill sometimes used to treat children with head lice or to rid dogs and cats of worms – is not yet approved by the federal government for use against Covid-19. But Smentkiewicz's son and daughter call it “a miracle drug” in their court papers.
So do her attorneys, Ralph C. Lorigo and Jon F. Minear.
“This lady was on a ventilator, literally on her deathbed, before she was given this drug,” Lorigo told The Buffalo News about Smentkiewicz, a Cheektowaga resident. “As far as we’re concerned, the judge’s order saved this woman’s life.”
Lorigo said one doctor at the hospital allowed the patient to be given the drug, but after she had been given one dose, another doctor at the hospital refused to allow further doses. He said family members went to court to force the hospital to resume treatment with Ivermectin. State Supreme Court Judge Henry J. Nowak sided with them.
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Dr. Thomas A. Russo, one of the region’s leading experts on infectious diseases, said he was glad to hear that Smentkiewicz is doing better, but he said people should never jump to conclusions about Ivermectin or any other drug based on one patient’s outcome.
“There are some indications that this drug may have some merit in treating Covid-19 ... Yes, it is possible that it helped this woman,” Russo said. “But the trials and testing are ongoing. We don’t have definitive data yet to show it does help. Presently, it is not recommended as a treatment for Covid-19.”
Russo is the chief of infectious diseases at the University at Buffalo's Jacobs School of Medicine and Biomedical Sciences. He has no involvement in the Smentkiewicz case.
The patient’s son, Michael Smentkiewicz, said hospital officials had told him and his sister, Michelle Kulbacki, on Dec. 31 that their mother’s chance of survival – as an 80-year-old Covid-19 patient on a ventilator – was about 20%.
He said doctors at the hospital also told the family that Smentkiewicz would probably be on a ventilator in the Intensive Care Unit for at least a month.
“We did a lot of our own research, we read about Ivermectin ... The results sounded very promising, and we decided we had to try something different,” Michael Smentkiewicz said. “We pressured the doctor in the ICU to give it to her. He finally agreed.”
On Jan. 2, Smentkiewicz was given her first dose of Ivermectin, and according to court papers filed by her family, she made “a complete turnaround.”
“In less than 48 hours, my mother was taken off the ventilator, transferred out of the Intensive Care Unit, sitting up on her own and communicating,” Kulbacki said in a court affidavit.
But after her mother was transferred to another hospital wing away from the ICU, doctors in that unit refused to give her any more doses of the drug, and her condition quickly declined, the family said in court papers.
“We were astounded when they refused to give her any more doses,” Michael Smentkiewicz said. “That’s why I called Ralph Lorigo and we took the hospital to court.”
Kaleida Health, which operates the hospital, opposed the family’s request in court. Lorigo said Kaleida attorney Michael J. Roach argued to Judge Nowak that doctors – and not the courts – should be making decisions about medical care.
On Jan. 8, Nowak ordered the hospital to “immediately administer the drug Ivermectin” to Smentkiewicz, court papers show.
“But the judge also told us verbally that Judith’s family doctor would have to write a prescription for Ivermectin, which he did,” Lorigo said. “In 46 years as an attorney, I’ve never seen another case where a family had to get a court order to continue a treatment that had already been started by a hospital.”
Michael P. Hughes, spokesman and chief of staff for Kaleida Health, said the health care company is "aware of this family’s position," but he declined to discuss details because of federal privacy laws and because the case has become "a legal matter."
Roach, the hospital attorney, declined to comment, telling a reporter to call Hughes.
Michael Smentkiewicz said Thursday that his mother’s condition has improved again since the Ivermectin treatments resumed.
“She called me (Wednesday) night. Her voice was raspy, but it was so exciting to hear her voice,” he said. “She is sitting up in bed. She’s off the ventilator, but she has a canula in her nose, providing supplemental oxygen.”
He added that a doctor from the hospital told him Thursday that his mother appears to have "turned the corner" in her fight against the virus.
Michael Smentkiewicz said he also believes the power of prayer helped his mother.
“We have not been able to see her since she was taken to the hospital by ambulance on December 29, and that has been hard on all of us,” he said. “Family flew in from all over the country to be here. On New Year’s Eve, about eight of us held a little prayer service for her, out in the hospital parking lot. Even though we couldn’t be with her, we felt that it was important to be on that property, praying for her.”
Ivermectin has some passionate supporters in the medical field, but the U.S. Food & Drug Administration says the drug has not yet been approved for use in this country as a Covid-19 treatment.
“While there are approved uses for Ivermectin in people and animals, it is not approved for the prevention or treatment of Covid-19,” the federal agency says on its website. “You should not take any medicine to treat or prevent Covid-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source … Additional testing is needed to determine whether Ivermectin might be appropriate to prevent or treat coronavirus or Covid-19.”
Some doctors feel the government should move much more quickly to approve Ivermectin as a treatment for the virus that has killed nearly 400,000 Americans.
Dr. Pierre Kory, who heads an association of critical care doctors, testified before Congress in December, asking federal agencies to prevent "needless deaths" by speeding up its testing and research on Ivermectin.
Smentkiewicz's family describes her as an "amazing woman," a retired secretary who raised two children as a single mother. They said she still works five days a week, cleaning houses.
Russo, who urges caution until the government gets more data about Ivermectin, said he “absolutely” understands why Smentkiewicz’s family was so insistent that Kaleida doctors give her the drug.
“I think we all can understand where this family was coming from,” Russo said. “From their point of view, desperate times call for desperate measures.”