Linda Griffiths’ ALS regularly makes itself known in the form of something else she no longer is able to do.
She accepts the new life the disease has forced her into, but she won’t call it a death sentence. Not yet.
Less than a year ago, Griffiths, of Golden Valley, was diagnosed with amyotrophic lateral sclerosis, an incurable disease that attacks nerve cells in the brain and spinal cord, robbing patients of their ability to move and eventually, even to breathe. Most die within two to five years.
Griffiths’ body is deteriorating rapidly, and standard treatments have been limited to muscle relaxers and antidepressants, along with stretching routines and massages from her husband, Jim.
An experimental drug called GM604 has showed positive results in a small sampling of test patients, but has not yet been approved by the Food and Drug Administration. Griffiths, 56, says she is running out of time and would like to try it: “If I’m going to die from this disease, my feeling is, give me a chance, at least.”
Under the proposed Right to Try Act, patients like Griffiths who are diagnosed with terminal illnesses would gain easier access to drugs, procedures or medical devices that are still undergoing clinical trials. If the bill is approved by the Legislature, Minnesota would join five states in passing the Right to Try Act. An additional 26 states have introduced similar bills this year.
The movement started with the Goldwater Institute, a Phoenix-based conservative and libertarian think tank.
Under the bill, the medications still must pass the first and most exhaustive phase of FDA clinical trials, and patients must have a physician’s signoff.
Manufacturers are not obligated to supply any drug, treatment or procedure.
“At its core, it is a personal freedom and choice effort to allow patients who have been told they’ve exhausted all of their options with a terminal disease to try investigational medications,” said Craig Handzlik, state policy coordinator at the Goldwater Institute. “This allows patients to say ‘I know there are risks here, but I really want to try it, and the only definite outcome if I don’t try is death.’ ”
The government allows dying patients to take experimental drugs under what’s called “expanded access,” or “compassionate use.” But Right to Try advocates say the bureaucratic red tape and the waiting period of months and sometimes years often is longer than the patient’s life expectancy.
Not everyone favors greater access, even for terminal patients. Dr. Steven Miles, a bioethicist at the University of Minnesota, said the movement is merely an attempt at deregulation. The first phase of FDA testing, he said, is to determine whether the drug shows immediate toxicity. The second phase determines whether it actually works, while the third phase measures long-term harm and benefit. The end result could be patients desperate to try anything, regardless of whether it works. The same thing happened during the peak of the AIDS epidemic, Miles said.
“We can take down all the federal protections, but at what point do we want some oversight, or do we want this to become the Wild West of providers selling miracles?”
Although the bill defines terminal illness as “an advanced stage of a disease with a terminal prognosis and no known cure,” Miles is concerned that it isn’t more specific. Another key omission has him concerned.
“What happens to kids under this bill?” he said. “It’s not limited to adults; it essentially empowers parents to choose nonvalidated therapies for their kids.”
Cost of living vs. cost of dying
At a recent hearing, the bill’s House sponsor, Rep. Nick Zerwas, R-Elk River, assured Health and Human Services Committee members that the state, drug companies and doctors would bear no liability for whatever went wrong with experimental medications.
Kurt Altman, National Policy Advisor for the Goldwater Institute, said the measure does not pre-empt federal law, citing a 2006 Supreme Court ruling that upheld Oregon’s right-to-die law over federal challenges. This same legal concept would apply to Right to Try.
It’s too early to determine whether the law has benefited anyone, Altman said, given that it’s less than a year old. There have been no legal challenges to it.
The Minnesota Medical Association has been neutral on Right to Try, so long as doctors are protected from liability.
Since insurance rarely covers experimental treatments, Rep. Joe Mullery, DFL-Minneapolis, said he worries that taxpayers would be expected to foot the bill for emergency room or other costs should such treatments go wrong. Altman said that even if a patient doesn’t receive an experimental drug, hospital visits will take place anyway as terminal patients receive end-of-life care.
Mullery was unsatisfied, and said he would like language added to protect taxpayers.
“There could be a lot of triggers to other emergency services that are far in addition to what we would put in for a person who’s dying. Often a person who’s dying in these circumstances actually doesn’t cost that much, whereas this could trigger a whole bunch of costs.”
Zerwas, who was born with a heart condition and says he is alive today because of experimental surgery, was indignant.
“I was 15 years old and I’d picked out who was going to be my pallbearers and who was gonna read at my funeral, and the doctor said ‘No, there’s one last thing we can try,’ ’’ he said. “That’s what this bill is about, and I’m sorry, but I have a very difficult time with the idea that it’s cheaper to send someone home to die.”
Tell me when
It’s not hard to see the love between Linda and Jim Griffiths.
“Tell me when,” he says softly, as he stretches the atrophied muscles in her right leg. In lighter moments, they finish one another’s sentences with punchlines.
“I would give up a kidney, I would give up a lung, I’d do anything for her,” Jim said.
Neither of them cries when they talk about her condition. They’re way past that point. But the sadness is palpable when they talk about one of their more difficult moments just a few weeks ago. Her doctor’s appointments often are scheduled so early-stage patients don’t interact with more late-stage patients. But a scheduling mix-up recently left Linda and Jim in the waiting room surrounded by patients on respirators and feeding tubes, unable to move anything but their eyes. It was devastating.
“You know that it’s going to happen, but to actually see it so up close and personal …” she said, trailing off.
Linda Griffiths, who initially fought using a cane and walker until she realized the safety they provided actually gave her more freedom, wanted to take control. She began researching experimental drugs and found GM604, which is in its second phase.
She learned that in clinical trials, seven of eight ALS patients saw their disease progression slowed or stopped. Her neurologist hasn’t said much about it — withholding judgment because it’s in the experimental phase.
Griffiths said she’s willing to try the drug or others like it, even at the risk of side effects.
She points to the first stage of testing mandated under Right to Try — if the drug, for instance accelerated her symptoms, it wouldn’t have made it to the next stage. She knows that GM604, or any other experimental ALS drug, may not be for her. But to a dying person, hope can be everything.
Griffiths also wants to provide that hope for those who come after her.
“There are other diseases this could help,” she said.
“Cancer patients, Parkinson’s. I mean, ALS is not the only life-threatening disease out there. It happens to be the one I have, but it’s not the only one.”