House Bill 701—Rep. Lisa Mazur’s revolutionary expansion of New Hampshire’s “Right to Try” laws—will soon reach the desk of Gov. Kelly Ayotte.
Named the “John Lewicke and Michael Yakubovich Right to Try Act” after two state legislators who are fighting life-threatening illness, HB 701 will make New Hampshire one of the top states in the country, rivaled only by Montana, for patients like John and Michael to access experimental treatments.
While HB 701 contains many cutting-edge reforms, two parts of the bill are starting to catch the attention of the biotech industry.
First, the bill will allow terminally ill patients to sign robust waivers of civil liability. Although “Right to Try” laws exist on paper across the country—allowing dying patients to waive all regulatory enforcement—manufacturers and doctors who want to provide experimental treatments still face the threat of career-destroying civil liability if these treatments go awry. The specter of liability has rendered most Right to Try laws completely useless.
One leading Right to Try advocate, Dr. Bess Stillman, has testified that, after she identified a promising experimental treatment that might have saved her late husband, Jake, their doctors found it “less risky to let Jake die [than to treat him].” For the same reason, the 2017 federal “Right to Try” law, which did not include a robust civil liability waiver, has only ever been used about a dozen times in the country. The FDA’s more popular “compassionate use” protocol takes too long to be effective for many patients.
Under the Lewicke and Yakubovich Act, any patient who is certified by two physicians to have a terminal illness, and who cannot be saved by an FDA-approved treatment, will be able to complete a process of informed consent and waive most civil liability in order to receive the cutting-edge treatments they want.
Secondly, one under-discussed feature of the Lewicke and Yakubovich Act is that dying patients will be able to waive the “Phase 1 requirement.” Most Right to Try laws still contain the absurd mandate that a Phase 1 clinical trial, in which a therapy is tested on humans, must be completed before a desperate, dying patient can receive it.
While the Phase-1 requirement sounds well-intentioned, good intentions are no comfort to the many parents I’ve spoken with whose children are dying of rare genetic illnesses.
The Phase 1 requirement has become archaic as America enters a fast-moving, revolutionary new epoch in biotechnology. What if a dying patient wants to receive personalized gene-editing or try a highly-promising new treatment that has been tested only in monkeys? In New Hampshire—so long as there is doctor supervision and informed consent—they will soon be able to.
Critically, these protections can be offered to individual dying patients as well as those who come to New Hampshire to participate in clinical trials. The Lewicke and Yakubovich Act will therefore offer biotechnology innovators a competitive “New Hampshire advantage.”
If Governor Ayotte signs HB 701 and makes New Hampshire a national hub for treating terminal illness, how much business might she bring to the state?
Here’s one estimate of the market opportunity. The highest-spending 5 percent of the US population accounts for about 50 percent of total healthcare spending. While there is no reliable measure of how much is spent treating terminal illness, Americans in their final year of life account for about 5 percent of total US medical spending—a number that does not include patients who are years from death. With nationwide annual healthcare spending now likely above $5 trillion, New Hampshire could cultivate a market of perhaps $125 billion per year—a number similar to some mid-tier national economies and larger than the state’s annual GDP—by attracting 5 percent of terminally-ill American patients to receive care in New Hampshire.
The Granite State is already off to a strong start. Under Mayor Jay Ruais, Manchester is growing as a biotechnology hub, with innovator Dean Kamen christening the Manchester Millyard area “Re-Gen Valley” and “the epicenter of an industry to manufacture organs.”
One major player in Re-Gen Valley—United Therapeutics—has been developing a breakthrough technology that could be a perfect fit for the Lewicke and Yakubovich Act: their artificially-grown “UHeart.”
Since the beginning of organ transplants, doctors have been interested in repurposing animal organs to save human lives—a practice that would avoid endless waitlists and exploitative organ-harvesting. In fact, the first-ever modern heart transplant used a chimpanzee heart. While the heart did beat for an hour, the human patient’s immune system eventually rejected it, leading to the patient’s death.
Revivicor, a subsidiary of United Therapeutics, is now solving this problem by genetically modifying pig organs to avoid rejection by the human immune system. Revivicor’s “UKidney” has been approved for clinical trials in humans and is already being used to save human patients in Boston.
The next frontier in the field is Revivicor’s “UHeart,” which has already been transplanted into some living people. Revivicor is now preparing the UHeart for a full clinical trial in humans, potentially saving the lives of thousands of Americans now waiting for heart transplants.
While Revivicor grows the UKidney and UHeart in Virginia, and has already begun testing the UKidney in Boston, New Hampshire still has a chance to out-edge Boston on the UHeart.
With United Therapeutics already a major presence in the Manchester Millyard, New Hampshire should be a shoo-in as the site of human trials for the UHeart. As our state enacts some of the best legal protections in the country for terminally ill patients, Governor Kelly Ayotte and Mayor Jay Ruais should court Revivicor and invite them to conduct human trials here.
By making New Hampshire a hub of biotechnology innovation, we can fully leverage the New Hampshire advantage, unleash a flourishing industry in the state, and help to save lives here and across the country.
