“Right to Try” aims to limit bureaucracy for Colorado’s terminally ill

For Amy Auden, the fight to gain faster access to drugs not fully sanctioned by the Food and Drug Administration did not end last fall when her husband lost his two-year battle to Stage 4 melanoma.

“We needed hope but didn’t receive it through our battle. I want others to have opportunities to gain access to medication that can potentially be helpful,” said Auden, who along with her husband, Nick, gained national acclaim in an unsuccessful quest to persuade two pharmaceutical companies to grant them access to an experimental drug to treat his cancer.

The battle for Auden, who lives in Lone Tree, did not come directly with the FDA, but with pharmaceutical companies. Still, an effort in Colorado to grant faster access to experimental drugs for terminally ill patients is important to the widowed mother of three young children, as it could have prompted the drug companies to provide the medication to Nick had laws been in place in the state explicitly granting rights to patients for access to these drugs outside of clinical trial.

The proposed “Right to Try” legislation aims to take much of the bureaucracy out of the process for patients in search of hope as they have exhausted all medical options to cure an illness. Patients would be allowed to use experimental drugs — formally known as investigational drugs — biological products or devices.

The FDA allows terminally ill patients to try experimental drugs and treatments under its “compassionate use” rule. The rule grants patients on a case-by-case basis the opportunity to use investigational drugs outside of a clinical trial. But patients and families often run into trouble. Seeking approval can be a cumbersome process because families must find a doctor to fill out the lengthy FDA application for “compassionate use,” which takes up time that a patient might not have.

Pharmaceutical companies must agree to supply the drugs. Then the FDA reviews the application before approving or denying it.

“It can take months to get the copious amounts of paperwork done,” said Christina Corieri, a health care policy analyst for the Goldwater Institute, a libertarian-conservative public policy think tank that helped write the legislation. “People have a fundamental right to have easier options to save their lives.”

Bipartisan legislation

The bipartisan measure in Colorado passed through a House committee last week and is making its way through the chamber. If it’s passed into law, patients would no longer have to fill out applications with the federal government to receive investigational drugs.

The legislation has language that specifically outlines that patients who are residents of the state must receive a recommendation from a physician, that health insurance companies are not required to provide coverage and that manufacturers may provide the drugs without compensation.

Many health care organizations have remained neutral on the proposal.

Much like medicinal marijuana statutes, patients would have the right under state law to gain access to the drugs. A spokesperson for the FDA declined to comment on the legislation, saying only that the administration did not have a position.

“This bill addresses granting more options to patients in a faster effort to save lives,” said Rep. Joann Ginal, D-Fort Collins, the sponsor of the bill. No states have such statutes, but similar legislation is working its way through statehouses in Arizona, Louisiana and Missouri this year.

Her co-sponsor, Rep. Janak Joshi, R-Colorado Springs, who is a retired physician, calls the proposal “a matter of life and death.”

Both Ginal and Joshi said the only opposition they’ve seen to the bill resulted from concerns from hospitals because they must adhere to federal laws and regulations that exist to ensure that patients are administered safe and appropriate medications. Moreover, concerns have come from physicians worried they might be sued for prescribing the drugs.

Exemptions included

Amendments to the current measure provide exemptions to hospitals and aim to protect physicians from being sued — a move that caused the Colorado Hospital Association to shift its opposition to the bill to neutral status, said its spokesman Kevin Downey.

The Center for Hospice and Palliative Care and Colorado Medical Society are also neutral on the measure. The Hospice Center, said its lobbyist, fully supports patient choice, though the center does have reservations about the measure in that patients could be making decisions under a false sense of hope, and neglecting necessary palliative care. The Colorado Pharmacists Society has not taken a position on the bill.

The Audens, through a widely viewed online petition called “Save Locky’s Dad,” were unable to convince pharmaceutical companies Merck and Bristol-Myers Squibb to provide Nick the drug known as anti-PD-1, which teaches the immune system to attack cancer. Bristol-Myers Squibb cited safety concerns, and Merck said it just didn’t have enough of the drug to give to him.

Auden said she believes they were not granted the drugs because the manufacturers were concerned that if something adverse had happened outside the clinical trial, they would have had to report it to the FDA.

Moreover, Auden said that while the current bill does not solve the issue of compelling the drug companies to provide experimental medications, it’s a step in the right direction.

“It gives patients more of a chance to get the medicines they need, to possibly cure an illness,” Auden said. “For the patients, for their families, it offers some hope.”

Kurtis Lee: 303-954-1655, klee@denverpost.com or twitter.com/kurtisalee