In a letter to the commission, Republican State Sens. Curt Vanderwall, John Bizon and Mike Shirkey argued against regulation, saying it should be made available in as many places as possible, especially in northern Michigan and the Upper Peninsula, where no FACT accredited hospitals are located.

Vanderwall, who testified against the regulation and is chair of the Senate health policy committee, said he doesn't believe restricting access, especially in northern Michigan, is in the best interests of patients.

"I'm just very concerned right now that we're going to limit access to care," Vanderwall said at the Sept. 19 commission meeting. "I appreciate the cost of the drug. I understand that. As you know I work very hard to make sure and we have things that are going to address some of these drug costs. But in this situation I really feel that we need to make sure that we follow the federal standard and allow the free market to play."

Besides Vanderwall, seven other organizations objected to the proposed standards, including the Cancer and Hematology Centers of Western Michigan in Grand Rapids; the Alliance for Regenerative Medicine; the Biotechnology Innovation Organization; and Celgene, a biopharmaceutical company that manufactures one of the CAR T-cell medications.

Arguing in favor of regulation, Greg Yanik, M.D., a pediatric hematologist-oncologist at Michigan Medicine in Ann Arbor, estimated about 300 patients annually in Michigan would qualify for IECT therapy.

"We're not talking 3,000, we're not talking 30,000," Yanik said. "Do we want unregulated access where let's say 100 hospitals can each treat three patients? No. I really firmly believe that the SAC recommendations will probably end up with 10 to 20 hospitals and those with fairly large oncology group practices each treating 15 to 20 patients."

Yanik said in his 30 years as an oncologist, he has never seen such a toxic combination of agents involved in the therapy protocol. He said the potential benefits are great, but the risks are even higher.

"I'm Roman Catholic. Every patient I give CAR T or these IECT therapies to, right before I treat, I go like this (making the sign of the cross and saying a prayer)," he said. "That tells you how serious I feel about this therapy."

In March 2018, Karmanos became the first cancer center in Michigan to offer CAR-T therapy for an aggressive type of non-Hodgkin Lymphoma. The FDA approved CAR T-cell for lymphoma in October 2017.

Pam Darling, 65, a homemaker in Spring Lake, was one of the early recipients of CAR T-cell cancer treatment at Karmanos. She told Crain's in 2017 she found a lump on her neck and it went to her primary care physician, who recommended she see an oncologist.

After three outpatient chemotherapy treatments and then a radiation treatment, Darling said, the cancer, diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma, became very aggressive.

"I looked at stem cell transplant therapy, but that didn't go through. My oncologist recommended CAR T-cell and I was told by Blue Care Network that Karmanos was the only hospital doing that at the time," Darling said.

In May 2018, Darling began treatment at Karmanos. She spent three weeks at Karmanos, the last two in the intensive care unit.

"I was totally out of it. I had no idea where I was. I couldn't breathe, and they put me on a ventilator," said Darling, adding that after she was discharged she had to stay at a hotel room at MotorCity Casino for four days until Karmanos doctors cleared her to travel home.

"I took a CT scan in May, and they said there was no cancer there. It could come back, but (Abhinav Deol, M.D) said if I passed the year mark with no cancer, I have a good chance at it not returning," Darling said.

On whether she believes hospitals should be tightly regulated, Darling said that is a tough question to answer.

"I would want a place like Karmanos to go get this treatment. It is very difficult, and I was impressed with the medical team," she said. "It was expensive to travel. I will tell you that. I wished I could have it done in Grand Rapids, if they had it at the time. Before, I probably would have wanted to go to a hospital that is closer. But knowing what I know now, I would want it to be" like Karmanos.

Deol said CAR T-cell therapy is a one-shot treatment that has a good chance at putting the patients' disease in remission. But because it is a new procedure, data is scant on success rates.

"Following CAR T therapy, we're seeing initial positive response rates in the range of 80 percent; and long-term response rates, approximately one year or longer, up to 45 percent," Deol said in a statement. "As more data becomes available, we hope to see an even longer time in remission."

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Battle brews over how tightly to regulate new cancer treatment - Crain's Detroit Business