Arizona Terminal Patients' Right to Try Referendum, Proposition 303 (2014)

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Proposition 303
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Type:State statute
Referred by:Arizona Legislature
Topic:Healthcare on the ballot
Status:Approved Approveda
2014 measures
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November 4
Proposition 122Approveda
Proposition 303 Approveda
Proposition 304 Defeatedd
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Local measures
The Arizona Terminal Patients' Right to Try Referendum, Proposition 303 was on the November 4, 2014 ballot in Arizona as a legislatively-referred state statute, where it was approved.

The measure will allow investigational drugs, biological products or devices to be made available to eligible terminally ill patients. The term "investigational" refers to medical treatments that have completed phase one of a clinical trial but have not yet been approved for general use by the Food and Drug Administration and remain under investigation in clinical trials.[1][2]

The measure was primarily sponsored by Rep. Phil Lovas (R-22), Rep. John Allen (R-15), Rep. Sonny Borrelli (R-5), Rep. Paul Boyer (R-20), Rep. Tom Forese (R-17), Rep. Adam Kwasman (R-11), Rep. David Livingston (R-22), Rep. Ethan Orr (R-9), Rep. Lisa Otondo (D-4) and Rep. Carl Seel (R-20) in the House, where it was known as House Concurrent Resolution 2005. The approved resolution was filed with the Arizona Secretary of State on April 16, 2014.[1][3]

Election results

Below are the official, certified election results:

Arizona Proposition 303
ResultVotesPercentage
Approveda Yes 1,111,850 78.47%
No304,97121.53%

Election results via: Arizona Secretary of State

Text of measure

Ballot title

The official short title for Proposition 303 was:[4]

Use Of Investigational Drugs, Biological Products And Devices

A CONCURRENT RESOLUTION ENACTING AND ORDERING THE SUBMISSION TO THE PEOPLE OF A MEASURE RELATING TO THE USE OF INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS AND DEVICES.[5]

Ballot summary

The full ballot summary was as follows:[6]

ALLOWS A MANUFACTURER TO MAKE AVAILABLE TO AN ELIGIBLE TERMINALLY ILL PATIENT, A DRUG, BIOLOGICAL PRODUCT OR DEVICE THAT HAS SUCCESSFULLY COMPLETED PHASE ONE OF A CLINICAL TRIAL BUT HAS NOT BEEN APPROVED FOR GENERAL USE BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION.

A "yes" vote shall have the effect of allowing a manufacturer to make available an investigational drug, biological product or device to an eligible terminally ill patient. It exempts a physician from regulatory action based solely on the physician's recommendation of the drug, product or device to the eligible terminally ill patient and classifies, as a class 1 misdemeanor, any attempt by a state official, employee or agent to block access of the investigational drug, biological product or device to an eligible terminally ill patient.

A "no" vote shall have the effect of retaining the current law regarding the availability of an investigational drug, biological product or device that has not been approved for general use by the United States Food and Drug Administration. [5]

Ballot format

The ballot format was as follows:[7]

AZProp3032014.png

Full text

The full text of the measure can be read here.[7]

Background

Food and Drug Administration logo.png

In May 2014, Colorado became the first state to pass a "Right to Try" law, followed by Louisiana. A similar law was unanimously passed in Missouri, as well, and was signed into law by Governor Jay Nixon on October 8, 2014.[8] These laws are sometimes referred to as "Dallas Buyers' Club" laws in reference to the 2013 film of the same name. Right to try laws have received bipartisan support across these states.[9][10] Additionally, a similar law was introduced in the U.S. House of Representatives, called the Compassionate Freedom of Choice Act of 2014. It would have amended the Food, Drug and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients."[11]


PBS News Hour, "'Right to try' gives terminal patients access to new drugs," June 21, 2014

Bioethicist Arthur Kaplan has spoken strongly against right to try laws. He has argued that the FDA is not the main hurdle to dying patients who want to participate in experimental treatments. Kaplan offers five reasons why such laws are ineffective at providing access to experimental treatment.[12]

  1. The laws are restricted to terminally ill patients, and ignore patients "who are going blind, becoming demented or losing their ability to walk."
  2. Without a good doctor to guide a patient through the possible research opportunities available, the law will not have any affect.
  3. The law does nothing to address the expense of the drugs. "Drug and device companies are under no obligation to give patients anything — no matter how sick they are."
  4. Patients might have to travel to receive experimental treatments. The laws do not address that hurdle.
  5. The law does not track doctors who enroll patients in experimental trials, and some doctors may have a financial incentive to enroll patients in such trials, even if they have bad outcomes. This means there is no way to hold them "accountable if they cause a lot of people to die more rapidly or painfully."

Supporters of right to try legislation, however, counter that the FDA process for gaining access to experimental treatments is cumbersome and complicated to navigate. They see right to try laws as a way to reduce the amount of red tape that terminal patients have to cut through to receive treatments. Frank Burroughs, founder of the Abigail Alliance for Better Access to Experimental Drugs, has addressed some of the concerns regarding patients not knowing the full risks they undertake when receiving experimental treatments. He said, "We’re talking about ‘promising’ drugs. Patients are much smarter and savvy [sic] than they get credit for."[13]

Analysis by Legislative Council

Proposition 303, the "Right To Try Act", would allow a terminally ill patient, with the recommendation of the patient's physician and a determination by the patient's physician that no comparable or satisfactory United States Food and Drug Administration approved treatment options are available, access to medications or treatments made available by a manufacturer that have not completed the full United States Food and Drug Administration approval process. In consultation with the patient, the patient's physician must determine that the probable risk to the patient from the medication or treatment is not greater than the probable risk from the disease or condition prior to recommending the medication or treatment. The eligible patient must give written informed consent for the use of the investigational drug, biological product or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian must give written informed consent on the patient's behalf.

An "investigational drug, biological product or device" is defined as a drug, biological product or device that has successfully completed phase one of a clinical trial, but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial.

The manufacturer may provide the investigational drug, biological product or device with or without charge to the eligible patient and may require the eligible patient to participate in data collection relating to the use of the investigational drug, biological product or device. A health care insurer may provide coverage for an investigational drug, biological product or device, but neither a health care insurer nor any state agency is required to provide such coverage.

A state regulatory board may not take any action against a physician's license based solely on the physician's recommendation for, prescription for or treatment with the investigational drug, biological product or device. A state agency may not take any action against a health care institution's license based solely on the institution's participation in the treatment or use of the investigational drug, biological product or device.

An official, employee or agent of this state who blocks or attempts to block access of an eligible patient to an investigational drug, biological product or device is guilty of a class 1 misdemeanor.[5]

—Legislative Council, [7]

Support


Phoenix Councilman Sal DiCiccio interviews Christina Corieri, Healthcare Policy Analyst with the Goldwater Institute about the "Right to Try," initiative on the November ballot. PHX TV, "Phoenix Councilman Sal DiCiccio, 'On The Issues,'" May 12, 2014

Officials

Primary sponsors

Cosponsors

Organizations

  • Your Right to Try
  • Arizona Correctional Peace Officers Association[16]
  • Research for Life[17]

Indiviudals

HCR 2005 "Yes" votes

The following members of the Arizona State Legislature voted in favor of placing this measure on the ballot.[18][19]

Note: A yes vote on HCR 2005 merely referred the question to voters and did not necessarily mean these legislators approved of the stipulations laid out in Proposition 303.

Senate

House

Arguments

In an Arizona Capitol Times editorial, Chuck Warren and Tim Mooney argued for this measure to be placed on the ballot, saying,

A referral to the ballot for all Arizona voters to decide, “Right to Try” would allow terminal patients who have explored all other options to make their own decision to try a drug or treatment that has already received the FDA’s Phase One clearance. That means the FDA has already determined that the new drug or treatment is safe and ready to check for efficacy.
“Right to Try” requires a physician prescription and monitoring. It doesn’t require insurance companies to pay for the treatments, but doesn’t exclude them from doing so. It ensures that patients are cognizant of the risks involved. [5]

—Chuck Warren and Tim Mooney, [20]

Christina Corieri of the Goldwater Institute told the House Reform and Human Services Committee,

To access these treatments, patients must either go through a lengthy FDA exemption process or wait for the treatments to receive FDA approval, which can take a decade or more and cost hundreds of millions of dollars. [...] Sadly, over half a million cancer patients and thousands of patients with other terminal illnesses die each year as the bureaucratic wheels at the FDA slowly turn. [5]

—Christina Corieri, [21]

Rep. Phil Lovas (R-22) said,

Please support Prop 303!

As the sponsor of this ballot measure, I am writing to ask for your support. I was proud to sponsor this proposal in the legislature because I believe that a terminally ill patient should have every opportunity to try and save their own life. What will this ballot measure do? It will remove a federal government barrier and give those who are terminally ill access to investigational drugs prior to FDA approval because these patients often can’t wait 7-10 years for the FDA to approve a potentially life-saving drug. Here’s an example. Let’s say you or a loved one has cancer. You have exhausted all FDA approved options and your prognosis is dire. What can you do? Right now you have two choices: Either get into a clinical trial or get approval from the FDA expanded access program in order to use these non-approved but promising drugs. But here’s the problem. Only about 3% of terminally ill patients can qualify for clinical trials. And if you can even get into a clinical trial, you still have a 50% chance of receiving a placebo. And when it comes to expanded access being granted, for the last year of available data, less than 1200 patients were approved by the FDA . Remember 500,000 people die of cancer each year. Similar bills have been signed into law in Colorado and Louisiana. We in Arizona are sending it to the ballot because getting your approval is important for this historic change in medical policy. If you or a loved one had a terminally ill disease, wouldn’t you want every option available to try and save your life or theirs? Vote yes on Prop 303.[5]

—Rep. Phil Lovas, [7]

Dr. Michael A. Smith of Phoenix said,

Voters should vote yes on Prop 303

I support Proposition 303, Arizona's Right to Try, because I see that it will give those with no other alternatives hope for a chance at an extended life. As a health provider I have seen people not only physically, but mentally devastated when all treatment options have been exhausted. As a son, I have personally felt the pain as my mother left the country she loved in order to seek treatments that were not yet approved by our Federal Food and Drug Administration. Problems within our countries drug regulatory system quickly become apparent as you watch your sick loved ones board a plane, solely for treatment abroad. The Federal Food and Drug Administration, and the regulatory process that they abide by, force new drugs through such rigorous standards that drug testing can take as long as fifteen years from inception to production. We should never bypass safety standards, but the federal bureaucracy is unbelievable. From my own personal experience, I know that this can be far too long and cumbersome of a process when there are people with no other options who are ready to try to save or extend their lives. Proposition 303 will help bring these patients and these possibly lifesaving or extending drugs together in a manner that will be supported and supervised by the patients' physician. This will maintain the integrity and security of our medical process, while giving hope to patients like my mother who had tried everything else. I whole-heartedly support Proposition 303, Arizona's Right to Try.[5]

—Dr. Michael A. Smith, [7]

According to the League of Women Voters of Arizona, arguments in support of Proposition 303 included:

1. It requires a physician and monitoring and makes sure the patient knows the risks.
2. To access treatments, patients either go through a lengthy FDA exemption process or wait for FDA approval. Thousands die each year as bureaucratic wheels slowly turn.
3. It would allow terminal patients who have explored other options to make their own decision to try a drug that has received FDA Phase One clearance[5]

—League of Women Voters of Arizona, [22]

Campaign contributions

Two PACs registered with the secretary of state's office in support of Proposition 303: Your Right to Try and Right 2 Try in Support of Prop. 303. As of the final reports on December 4, 2014, the two committees had raised over $124,000. Your Right to Try was fined $10 for filing one of the reports a day late.[23][24]

PAC info:

PAC/ballot measure group Amount raised Amount spent
Your Right to Try $116,009 $100,250
Right 2 Try in Support of Prop. 303 $8,075 $6,133
Total $124,084 $106,383

Top contributors:

Donor Amount
Goldwater Institute $107,000
Enhanced Medical Imaging $5,000
Lincoln Heritage Life Ins. Co. $2,000

Opposition

Officials

HCR 2005 "No" votes

The following members of the Arizona State Legislature voted against placing this measure on the ballot.[18][19]

Note: A no vote on HCR 2005 meant that a legislator did not want to refer the question to voters and did not necessarily mean these legislators disapproved of the stipulations laid out in Proposition 303.

Senate

House

Arguments

Rep. Gonzales voted against the measure, stating, "it preempts federal law."[21]

David Weissman, a Rose Law Group health care and employment attorney, did not argue against the measure. However, he did share concerns over it conflicting with federal laws, saying,

[...] the impact of this revision to the law on terminally ill patients and their ability to make their own choices may not be so positive. As for the ballot resolution, it seems hard to argue with a proposal that provides certain individuals with the opportunity for a possible cure or at least a chance to prolong life, so long as it can be reconciled with federal law. At the end of the day, let’s hope that our state’s legislators and voters take steps that strike a balance between adequately protecting our citizens and easing the pain and suffering of the terminally ill. [5]

—David Weissman, [21]

Surgical oncologist Dr. David Gorski has raised concerns about "right to try" legislation, saying in regards to the U.S. House bill,

Most investigational drugs that make it past phase I trials still end up failing. The chances for doing harm far exceed any chance for benefit. Drugs with seemingly miraculous activity against cancer, like Gleevec, that show up in phase I clinical trials are exceedingly rare. Indeed, HR 4475 says nothing about whether the clinical trials the investigational drug or device being to be used in terminally ill patients has undergone even need to show promise or not. Under HR 4475, a drug that completely failed in phase I clinical trials by showing unacceptable toxicity (for example) could be distributed to a terminally ill patient as long as the patient is told that the drug failed phase I clinical trials.[5]

—Dr. David Gorski, [25]

According to the League of Women Voters of Arizona, arguments in opposition to Proposition 303 included:

1. It does not address expense of drugs. Drug and device companies are under no obligation to give patients anything. End of life medical expenses can leave family members burdened with substantial debt.
2. Without a good doctor to guide a patient through possible opportunities available, the law will not have any effect.
3. It does not track doctors who enroll patients in trials which have bad outcomes. No way to hold them “accountable if they cause a lot of people to die more rapidly or painfully.”[5]

—League of Women Voters of Arizona, [22]

Reports and analyses

Berman Institute of Bioethics

An article examining recent state "right to try" legislation efforts was written by Dr. Yoram Unguru for the Berman Institute of Bioethics at Johns Hopkins University. The article highlighted that terminal patients can already apply to the Food and Drug Administration for compassionate use, which allows terminal patients to use "a non-clinically proven agent" by petitioning the FDA. These applications are considered on a case-by-case basis and can take a long time to be approved or rejected. Dr. Unguru also pointed out that such laws could provide some incentive to drug companies to, in effect, test drugs that they might not otherwise be able to test. He said further, "Moreover, some companies might petition doctors to refer terminal and potentially desperate patients who may not be the ideal candidate for a particular drug. One might also imagine doctors being offered certain incentives to do so." Despite these challenges, Dr. Unguru suggested there are several ways to make more experimental treatments available to terminal patients.[26]

Read the full article here.

Media editorial positions

See also: Endorsements of Arizona ballot measures, 2014

Support

  • The Arizona Republic said,
This proposition does not risk public safety. It does not endanger the validity of trials necessary to judge a new treatment's efficacy. It raises no constitutional questions. But it provides doctor-confirmed hope to the terminally ill. This is easy to support.

[5]

Arizona Republic, [27]

  • The News-Herald said,
Just in case voters are sitting on the fence, let us help you down off that skinny rail. There is every reason to support Arizona Proposition 303 in the voting booth on Nov. 4...In all fairness, Prop. 303's detractors' hearts are in the right place, but why rob the very sick of an opportunity to get well, even if it's iffy? They worry that such a law could open the doors for greedy quacks to prey on desperate patients with expensive drugs that don't work. Critics also insist that it's wrong to give patients false hope because the chances of doing harm with unapproved pharmaceuticals far exceeds any potential benefit.

We say it’s really none of their business. [5]

News-Herald, [28]

Opposition

  • The Sierra Vista Herald said,
We’re all for individual liberty, but the language of the proposition lacks several important protections for people who are in vunerable [sic] situations. Requirements should be added to define experimental treatment costs, and doctors who employ these untested procedures should be on record and accountable for their recommendations. The law should also require the involvement of a medical professional to guide a terminally ill patient through the process.

[5]

Sierra Vista Herald, [29]

Polls

A poll done by Wilson, Perkins, Allen, which was cited by Chuck Warren and Tim Mooney, showed 79 percent of all voters supported the potential ballot measure before it was officially going to the ballot. The poll found 87 percent of Democrats expressed support and 64 percent strong support, while 7 percent opposed the ballot measure.[20]

Path to the ballot

See also: Arizona legislatively-referred state statute & Laws governing ballot measures in Arizona

Legislatively-referred state statutes can be placed on the ballot in Arizona by a simple majority in both the House and the Senate. The measure was referred to the 2014 ballot after being approved by the House on March 4, 2014, and the Senate on April 15, 2014.[2]

Arizona Right to Try Referendum HCR 2005 House Vote
ResultVotesPercentage
Approveda Yes 31 57.41%
No2342.59%
Arizona Right to Try Referendum, HCR 2005 Senate Vote
ResultVotesPercentage
Approveda Yes 23 79.31%
No620.69%

See also

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Suggest a link

External links

Additional reading

References

  1. 1.0 1.1 Arizona Secretary of State: Election Information, "2014 Initiatives, Referendums & Recalls," accessed May 19, 2014
  2. 2.0 2.1 Arizona Secretary of State: Election Information, "Full text of HCR 2005," accessed May 19, 2014
  3. Open States, "Arizona HCR 2005," accessed May 19, 2014
  4. Arizona Secretary of State, "2014 General Election Ballot Measures," accessed July 1, 2014
  5. 5.00 5.01 5.02 5.03 5.04 5.05 5.06 5.07 5.08 5.09 5.10 5.11 5.12 5.13 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributed to the original source.
  6. Arizona Secretary of State, "Attorney General Approval of 2014 Ballot Measures," accessed September 8, 2014
  7. 7.0 7.1 7.2 7.3 7.4 Arizona Secretary of State, "2014 What's on My Ballot? Arizona's General Election Guide (Ballot Propositions & Judicial Performance Review): Proposition 303," archived September 27, 2014
  8. KBIA.org, "Missouri Becomes Third State To Enact 'Right To Try' Drug Law," October 8, 2014
  9. PBS News Hour, "Colorado first state to pass ‘Right to Try,’ or the ‘Dallas Buyers’ Club’ law," May 19, 2014
  10. Associated Press, "States Move to Expand Experimental Drugs for Some," May 17, 2014
  11. U.S. Congress, "Summary: H.R.4475 — 113th Congress (2013-2014)," accessed May 22, 2014
  12. NBC News, "Bioethicist: 'Right to Try' Law More Cruel Than Compassionate," May 18, 2014
  13. The Washington Post, "‘Right to Try’ laws spur debate over dying patients’ access to experimental drugs," May 16, 2014
  14. East Valley Tribune, "Brewer back 'right to try' ballot measure," September 26, 2014
  15. KCSG television, "Prop 303 Right to Try endorsed by Sen. Kelli Ward," October 6, 2014
  16. KCSG, "Prop 303 endorsed by Arizona Correctional Peace Officers Association," September 23, 2014
  17. KCSG television, "Research for Life endorses Arizona's Prop 303," October 2, 2014
  18. 18.0 18.1 Legiscan, "Roll Call: AZ HCR2005," accessed November 1, 2014
  19. 19.0 19.1 OpenStates.org, "House Vote on HCR 2005," accessed November 1, 2014
  20. 20.0 20.1 Arizona Capitol Times, "Your ‘Right to Try’ belongs on Arizona ballot," March 27, 2014
  21. 21.0 21.1 21.2 Rose Law Group Reporter, "Life and death in the Arizona Legislature; Rose Law Group Employment attorney David Weissman weighs in on bills’ moral issues," February 16, 2014
  22. 22.0 22.1 League of Women Voters of Arizona Education Fund: Voter Guide, "PROPOSITION 303: USE OF INVESTIGATIONAL DRUGS; BIOLOGICAL PRODUCTS; DEVICES “RIGHT TO TRY ACT," accessed September 28, 2014
  23. Arizona Secretary of State, "Campaign Finance Report: Your Right to Try, October 31, 2014 Report," October 31, 2014
  24. Arizona Secretary of State, "Campaign Finance Search - Ballot Measures," accessed December 6, 2014
  25. Science Based Medicine, "The Compassionate Freedom of Choice Act: Ill-advised “right to try” goes federal," April 27, 2014
  26. Berman Institute of Bioethics, "Right to Try?" May 19, 2014
  27. Arizona Republic, "3 Arizona ballot initiatives in 3 words," October 7, 2014
  28. News-Herald, "Sitting on the fence? Come down, on Prop. 303's side," October 14, 2014
  29. Sierra Vista Herald, "OUR VIEW: Three 'no' votes on Nov. 4," September 20, 2014