Arizonans will vote on right-to-try drugs measure
Arizona voters this fall will be asked to decide whether terminally-ill patients should have access to experimental drugs that have not yet been fully reviewed by the Food and Drug Administration.
Pushed by the Goldwater Institute, the ballot measure in Arizona, along with bills in Colorado, Louisiana and Missouri, would give patients and their doctors a way to circumvent the FDA’s lengthy drug-approval process.
The bills have been compared to “Dallas Buyers Club,” the acclaimed film starring Matthew McConaughey as an AIDS patient who defied the FDA and smuggled drugs into Texas for other patients who were desperate for treatments during the early days of the AIDS crisis.
Advocates of the “Right to Try” movement describe it as a way to cut through the federal government’s bureaucracy and get patients access to experimental drugs after other medical options fail to slow or halt disease.
“This cuts through a little bit of the red tape that puts up roadblocks (for patients),” said Kurt Altman, senior attorney with the Goldwater Institute. “There’s an opportunity to access something that’s experimental that can help (patients) when nothing else will.”
Critics say the bill may bring false hope to patients and their families and slow down the drug-approval process and distract companies that already test experimental drugs in controlled studies. Critics also say some experimental drugs could cause harmful side effects in terminally-ill patients when palliative care that offers comfort would be more appropriate.
“This could be a real distraction from what needs to be done,” said Ray Woosley, founder and former president of the Critical Path Institute in Tucson, which works to make the drug-development process more efficient. “The states should leave this up to the Food and Drug Administration. Every case is going to be different. The landscape will change for each drug. It’s the kind of thing the FDA needs to monitor.”
The Arizona Legislature passed a resolution allowing voters to decide in November whether drug companies should have the option to provide experimental drugs, biological products or medical devices to terminally-ill patients who request them.
Drug companies would have the option of either charging or providing free access to drugs or devices that have not been approved by the FDA, and health-insurance companies wouldn’t be required to cover any costs associated with the drugs or devices.
The resolution would allow only experimental drugs that had passed a Phase 1 clinical trial, a review often made up of small studies that test the safety of drugs administered to humans in escalating doses. That means Arizona consumers would potentially have access to drugs that had not yet passed larger randomized trials that test both a drug’s safety and effectiveness.
Although the Arizona resolution does not impose requirements on drug manufacturers or insurers, it would prevent a state licensing board from disciplining doctors for recommending that a patient take an experimental drug. Any state official or employee who blocked a patient’s access to an experimental drug or device would be guilty of a Class 1 misdemeanor.
The FDA already has a “compassionate use” process that allows patients with a serious or life-threatening disease to seek experimental drugs outside the normal clinical-trial process. But critics say the FDA program can take too long for a patient to get timely access to an experimental drug.
If a patient needs emergency access to a drug, a doctor can call the FDA’s 24-hour hotline and obtain authorization over the phone, according to FDA spokeswoman Stephanie Yao. Otherwise, the FDA usually decides a case within 30 days after a doctor submits a completed application requesting a drug or device on behalf of a patient.
The FDA statistics show that it approved an average of 1,031 out of 1,037 requests each year over the past four years. Those figures likely do not reflect the total number of patients seeking experimental drugs. Doctors or patients can choose not to submit an application because a company refused to voluntarily provide an experimental drug. The FDA can’t force a company to provide an experimental drug.
State Rep. Phil Lovas, the Peoria Republican who sponsored Arizona’s Right to Try resolution, said far too many terminally-ill patients don’t have access to experimental drugs that may help them.
“There may be drugs that can help them,” Lovas said. “Unless they’re in a clinical trial or can get emergency use, you really have few options.”
Families who have attempted to secure promising drugs for loved ones know how frustrating the process can be.
Tucson resident Tracy Canter lost her mom, Toni Sodersten, to breast cancer after Sodersten joined a clinical trial in California.
Sodersten, a Bisbee artist, had exhausted all treatment options for her type of breast cancer, which had spread to other parts of her body. Her doctor informed her that a then-experimental drug treatment called TDM-1 was being tested in a clinical trial. The doctor helped arrange Sodersten’s participation in the study at a site in Redlands, Calif.
Sodersten had to drive to Southern California with family members every three weeks, a lengthy road trip that became burdensome for a treatment that came too late because her cancer was too far along. She decided to discontinue the clinical trial and take hospice care. She died in October 2011.
Canter said she doesn’t know whether earlier and more convenient access to the drug would have extended her mother’s life, but she believes the treatment was administered to her mother too late. The drug treatment, marketed as Kadcyla, was approved by the FDA in 2013 for the type of breast cancer her mother had.
Canter testified before the Arizona Legislature about her mother’s challenges in obtaining the medication in a timely manner. She hopes voters approve the initiative so other patients who face similar circumstances will have more timely access to experimental drugs.
“You have to have hope,” Canter said. “If you’ve gone through everything and there’s nothing left, there is no reason not to try.”