Abigail Alliance: Doctor forges new treatment pathway for brother’s brain cancer
Updated: Feb 6, 2020
Interesting article from the Abigail Alliance:
Physicians are beginning to provide investigational therapies to terminally-ill patients who are not eligible to participate in clinical trials
Less than two years after losing his father, Dr. Benjamin Freilich was working feverishly to save the life of another family member..
His brother's glioblastoma — the most common and virulent form of brain cancer — had returned after surgery, radiation, and chemotherapy. He participated in a clinical trial, but the cancer persisted.
“I was very worried because he didn't have any effective treatment options left,” said Dr. Freilich, “but he refused to be told to just go home and die.”
Since few glioblastoma therapies are approved, patients ordinarily run out of treatment options shortly after their tumors return. Less than 10% of people are eligible to participate in a clinical trial or expanded access program.
But Dr. Freilich had done his research, and assembled a team of forward-thinking physicians to help his brother get access to an experimental brain cancer treatment known as Gliovac (ERC1671). Epitopoietic Research Corporation (ERC), the Belgium-based manufacturer of Gliovac, uses a patient's own tumor cells as well as donor tumor cells to create a personalized immunotherapy vaccine.
Dr. Freilich's brother and now other glioblastoma patients are receiving this immunotherapy under the new Right to Try law.
“This has made a huge difference for my brother,” said Dr. Freilich, “it has changed the trajectory of his disease.”
The official announcement of ERC’s Right to Try program comes as more physicians and companies have begun utilizing the federal Right to Try law to help terminally-ill patients access treatments before they are approved by the FDA.
"We are always clear with patients that the efficacy of these treatments is unknown," said Richard Garr, CEO of Access Hope, a contract research organization that is currently helping people with ALS (pALS) access investigational therapies under the Right to Try law. Garr anticipates providing unapproved treatments to 300 pALS over the next year.
Critics have discouraged use of the Right to Try law, arguing that patients should instead navigate the FDA's expanded access program, which does not require therapies to pass any safety tests. They have also backed a decision by Aetna to deny patients coverage for the direct costs of treatment under Right to Try.
"Expecting patients to pay for pre-approval access out of pocket will lead to unfairness, as not everyone will be able to do so, but I don't have a better solution," said Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania. "I don't think insurance companies should cover the costs."
Aetna is currently facing a class-action lawsuit for allegedly denying coverage of claims improperly.
"It's tragic that these people feel threatened by dying patients receiving access to treatments that give us hope," said Matt Bellina, a patient rights activist who has been receiving infusions of an experimental ALS therapy known as NurOwn at his local VA hospital.
Since last year's passage of the federal Right to Try law, patients and advocacy groups have pushed for insurers to cover some of the costs of access to experimental treatments.
This year, Rep. Jim Neely, a physician and legislator who championed Right to Try in Missouri and Washington D.C., introduced new legislation that would require insurance companies to provide such coverage.
Glioblastoma patients and advocates in New Jersey are hoping to push a similar bill through their state legislature next year.