A San Diego private equity firm’s foray into Right to Try treatments is raising red flags among some medical ethicists, who say it may represent the kind of profiteering they feared the fledgling federal law would invite.

Vivaris Capital is raising money to launch a chain of outpatient cancer clinics in the U.S. called United Cancer Centers, which they say will be the first medical system to offer care under the Right to Try law enacted in May 2018. The system will be run by the owners of an alternative medicine hospital in Mexico.

“We’re really trying to bring hope to patients that right now don’t have many other options,” said Christopher Mizer, Vivaris’ CEO. “We’re doing that in partnership with the existing standard of cancer care. We’re not trying to compete with that. We’re trying to give them an option that’s now currently available because of Right to Try.”

Right to Try, a program touted by President Donald Trump, allows eligible patients access to investigational drugs that have completed Phase 1 clinical trials but have not yet been approved by the Food and Drug Administration. Champions of the measure say it expands options for patients who haven’t responded to traditional cancer care. Critics warn it removes important dosing and safety measures and creates an opportunity for vendors to make money off of desperate patients.

Vivaris says it needs to raise at least $10 million to open the first clinic under its United Cancer Centers venture in Nashville, which leaders hope to open this fall. All told, the group wants to raise $100 million to open five clinics in five years. It’s raising the funds by offering investors a structured financial product that combines debt and equity components.

United Cancer Centers’ leaders say the clinics will offer much more than just Right to Try drugs. Patients will receive a full array of services, including personalized treatment from immunologists, geneticists, nutritionists and psychologists. The clinics will not perform surgeries or radiation therapy, and they plan to partner with hospitals for those treatments.

That’s where ethicists raise concerns. The federal Right to Try law includes language preventing anyone who makes, distributes, prescribes or dispenses the investigational drugs from charging patients more than their direct costs. However, that doesn’t apply to the other services providers might offer.

“You can’t charge for the drugs themselves, but you can make a profit on all the services used to deliver the drugs, and that’s the loophole that I was afraid was going to tempt bad actors to try to peddle these things as a way to make money,” said Dr. Steven Joffe, a pediatric oncologist and interim chair of the department of medical ethics and health policy at the University of Pennsylvania Perelman School of Medicine.

Joffe said he suspects Right to Try might not actually be an important component of the care that will be offered through UCC, but that it’s being used as branding to get people in the door.

Ed Clay, UCC’s co-founder, said in a statement that UCC will charge for its services just like hospitals and clinics do. Patients will pay upfront membership fees, which will cover a portion of their Right to Try drugs and treatment from its team of specialists, as well as a smaller monthly fee for ongoing support.While insurers aren’t likely to pay for the actual Right to Try drugs, Clay said he thinks they will cover the immunotherapies, genetic and genomic testing, nutrition and psychological counseling that UCC will provide. He said that’s especially true for chemotherapy and checkpoint inhibitors.

“We believe the membership model is better because it allows patients to receive immediate access and not have to wait for insurance approval,” he said. “Still, most additional services will be covered under insurance. It’s just a faster process.”

Any time private equity is involved in an endeavor, it suggests a strong profit motive, said Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania.

“My concern is a company like this would be feeding on that type of desperation and might not be helping people to make the best-informed decisions,” she said. “There’s a lot of possibility for exploitation.”

The FDA already provided access to investigational products under a program referred to as expanded access or compassionate use, which existed prior to Right to Try.

Clay said UCC will obtain drugs through expanded use when it can’t do so using Right to Try. He said he believes Right to Try simplifies the process of obtaining the drugs and therefore grants access to them faster.

Like Right to Try, expanded access also requires the drugs be provided at cost, but the FDA has to sign off on prices in advance. That’s not the case with Right to Try, so Fernandez Lynch said it is still possible middlemen could overcharge for the drugs.

“For Right to Try, technically, you set the charge,” she said. “You decide what’s reasonable. You say, ‘This is what’s within the regulations,’ or you say, ‘To hell with it, we’re going to charge what we want.'”

UCC was formed by the owners of CHIPSA Hospital in Tijuana, Mexico, which was founded on a nutritional therapy designed to boost the immune system. Many U.S. cancer patients have created GoFundMe pages to raise money to get care there.

“United Cancer Centers is like CHIPSA 10.0,” Clay said.

UCC’s website touts microbiome profiling for cancer patients, which there is no evidence for, Joffe, the pediatric oncologist and medical ethicist, said. The CHIPSA Hospital’s website says it offers probiotics and detoxification for gut health, which Joffe said raises more red flags. He worries UCC will offer treatments that are not evidence based and thus won’t be covered by insurers.

This isn’t first example of a business model that appears to try to profit off of Right to Try, said Patricia Zettler, an associate professor in Ohio State University’s College of Law and member of its Comprehensive Cancer Center. One company announced it would test Right to Try drugs and sell the data to drug companies, she said.

“This kind of commercial venture playing off of Right to Try—even if it’s not clear how much Right to Try access is actually going to be part of the care that patients receive—is one of the exact fears that many who have been concerned about Right to Try for a long time have had, that it’s opening the door to marketing unproven interventions to patients.”


Source: Private equity’s Right to Try venture raises ethics questions

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