Proposition 303 would allow a terminally ill patient, with a doctor’s recommendation, to try medicine and treatments that have not received full approval by the U.S. Food and Drug Administration. Paulina Morris, a supporter of the measure, and Joan Koerber-Walker, president and CEO of the Arizona Bioindustry Association, will discuss the pros and cons of the “Right to Try” initiative.
Ted Simons: "Horizon's" Vote 2014 coverage continues tonight with a look at proposition 303, which allows a terminally ill patient to try medicine and treatments that have not yet received full approval by the U.S. food and drug administration. Here to debate the right to try proposition is Paulina Morris, a supporter of the measure who took her son to England for an experimental treatment, and Joan Koerber-Walker, president and CEO of the Arizona bio industry association. Good to have you both here. Thank you so much for joining us. What exactly does prop 303 call for and why do you think it's necessary?
Paulina Morris: Well, Ted, I think it's necessary because terminally ill patients in Arizona need to have access to experimental drugs that haven't made it through the full FDA process. They should have a right to try to save their own lives, to save their own families.
Ted Simons: Do they not already have that right? Is that procedure not already in place on the federal level?
Paulina Morris: They do have procedures, but they're not available to many people, a very few are able to access those drugs when they need them. These things happen overnight. Like it did to my son.
Ted Simons: And I want to get to your son in a second, but prop 303, why do you think it's not necessary?
Joan Koerber-Walker: To start off with, as we look across the existing process, the FDA's EAP process, it does work, and very rarely do they turn someone down. And that process is designed to both protect patients and to ensure that the ongoing clinical trials continue in a way that makes it clear that those drugs can get to patients if they are safe and effective, as quickly as possible. Every time we do a one-off, we potentially slow down the process for many patients.
Joan Koerber-Walker: The idea, though, as we've heard, that maybe not every Arizonan has access to the FDA approval, to the federal approval system. And doesn't seem to be like these folks have that option. Is that a valid argument?
Joan Koerber-Walker: Unfortunately that's not the case. If you look at the process today, a physician and always physician, the physician is the key with the patient, the physician is working with the patient, the physician identifies an opportunity, the physician goes to the drug company and makes the request for access to the drug or the medical device, that might help the patient. At that point today, the physician and the drug company go to the FDA and request an EAP. So that process already exists.
Paulina Morris: It will be even better with prop 303.
Ted Simons: How?
Paulina Morris: It allows a patient along with their physician and the drug manufacturer to decide whether that's the right drug for that child, or that adult. Whomever it is, with an informed decision to be able to save their life.
Ted Simons: For the critics who would say it's dangerous to treat with drugs or treatment, without enough study getting past the first phase only, there's a reason why it takes time for FDA approval. You say?
Paulina Morris: Too long. Too many years, hundreds of millions of dollars. Those drugs are not available when we need them. Our son was 11 years old when he was diagnosed with OSTEO SARCOMA. My husband and I did the research, did the homework, traveled to Mexico City, talked to physicians, in Israel and England and Germany and Italy about this drug. That was not available to our son in the United States. Something that could potentially save his life.
Ted Simons: For parents like this, what's the harm if it's a situation in which traditional chemotherapy in this case, or traditional treatment just aren't working, they've been tried, they haven't worked, what's wrong with trying something that may not have full FDA approval?
Joan Koerber-Walker: The challenge we're looking at is that in Paulina's case, and it was great outcome and I'm so happy for you.
Paulina Morris: Thank you.
Joan Koerber-Walker: You had the financial where withal, you had the resources to make those --
Paulina Morris: And I'm here for those children who don't have the financial resources. Who need those drugs now and in Arizona. I'm not here for politics, I'm not here for polls, I'm not getting paid to be here. I'm here for those children who don't have options, who can't travel. And I can't help it, I get emotional about it.
Joan Koerber-Walker: I get emotional about it too. When we look at those children, this piece of policy -- And my objection is not to helping patients get the best care.
Paulina Morris: But it is. People need the drugs right away. They can't wait 10 years.
Joan Koerber-Walker: I agree that we need to be able to speed up process. But this law does not provide for who pays for these drugs, it does not provide who pays for the medical care. So your family had the resources to be able to do what you did.
Paulina Morris: We made those decisions.
Joan Koerber-Walker: That's great. Some people don't have the option to make those decisions --
Paulina Morris: But they should have the trite try. They should have that chance. They should have some pull --
Joan Koerber-Walker: They also have the ability to know that those drugs are safe and effective. Wait. Because what we are looking at is that we are creating an alternate pathway that is a dead end. Because the drug companies --
Paulina Morris: How dare you say dead end? We went to another country for a drug for our son and you're telling me it was a dead end?
Joan Koerber-Walker: No. I'm saying this piece of public policy is creating a pathway where the people that you're being asked to go to are still governed by and responsible under federal law. And by preempting federal law, you put them in a position where they are not able to help the patient the way they would like to.
Paulina Morris: Patients can make informed decisions with their physician, with the drug manufacturer.
Ted Simons: Again, those against this idea say it does put doctors in legal -- Tenuous position legally, drug companies in legally tenuous positions because there is no FDA approval, and they could be liable if results or if problems come from non-tested drugs.
Paulina Morris: Ted, I understand those questions, but prop 303 addresses those problems. It gives the physician the right not to be involved in this. It has to be prescribed by a physician. It's an informed decision with the patient, the physician, the insurance company is not liable, the drug manufacturer does not have to make the drug available. These are choices. It's just the right to try.
Ted Simons: Can a physician, can a drug company be exempt from liability if --
Joan Koerber-Walker: Not under federal statute.
Paulina Morris: They don't have to participate. They don't have to be part of my son's treatment or anyone else's treatment --
Joan Koerber-Walker: That is correct, but when they do, when those corporations do, then they are potentially liable --
Paulina Morris: Just like in every other situation. Whether it's prop 303 or not.
Joan Koerber-Walker: No, that's not true.
Paulina Morris: Yes, it is. Every doctor is not immune from liability, or any drug --
Joan Koerber-Walker: We're not talking about malpractice here. What we're talking about is under federal statute there is a process that needs to be followed. If a case is tried in federal court, according to the deputy attorney general of the state of Colorado, who testified on this, and we have the testimony online -- They would lose.
Paulina Morris: Arizona is falling in line with other states who are passing this unanimously, such as Missouri, Colorado, Louisiana, Michigan has made an effort. 13 more states are going to bring this forward.
Ted Simons: Have we seen problems in any of those states that have passed this so far?
Joan Koerber-Walker: We have not, because it's very, very new, and 19 Colorado, Colorado is already making adjustments. Because they recognize the policy that they originally passed needed to be adjusted.
Paulina Morris: And people are speaking throughout the country, they're saying the process currently as it exists is not sufficient, so instead of opposing people's right to try to save their own lives, I wish you would try and help us develop a better process. Once this passes, it can be effective and get kids and our loved ones drugs right when they need it.
Joan Koerber-Walker: By doing what you did and creating a policy, I shouldn't say you, by the Goldwater policy statement that was put out there that is sparking these bills, and now this proposition, you are creating situations where there will be serious problems that have to be corrected, and time and effort that could have been focused on fixing the existing process is now going to be focused --
Paulina Morris: I'm not being paid by Goldwater. We're volunteers. My son is a volunteer. He's 13 years old; we're doing this to help other people. To try and put us under that umbrella or portray it in any other way, we're volunteers, we want to help other sick kids, other people who need the drugs --
Joan Koerber-Walker: That's great.
Paulina Morris: Give them a right to try to save their lives.
Joan Koerber-Walker: And we are all in agreement --
Paulina Morris: And Arizonans are smart enough to make informed decisions along with their physicians and drug manufacturers.
Ted Simons: Last word.
Joan Koerber-Walker: Last word is that when we look at the right to try, and I am speaking personally, not on behalf of any corporation, when we look at the right to try, what we're looking at is how do we get the best care for Arizona patients in the best way? And there are enough flaws in this piece of public policy that this is not the best way.
Ted Simons: OK. We have to stop it right there. Thank you both very much for joining us. Great debate.
Paulina Morris: Thanks very much.
Paulina Morris:Advocate, Proposition 303; Joan Koerber-Walker:President and CEO, Arizona Bioindustry Association;