Right-to-try law

Right-to-try laws are U.S. state laws that were created let terminally ill patients try experimental therapies (drugs, biologics, devices) that have completed Phase 1 testing but have not been approved by the Food and Drug Administration (FDA). Because the laws do not require pharmaceutical manufacturers to provide the therapies that patients are seeking,[1] their value has been called into question.

States with right-to-try laws

In May 2014, Colorado became the first state to pass a right-to-try law.[2] As of April 2016, 26 states have enacted such laws: Alabama, Arizona, Arkansas, Colorado, Florida, Idaho, Illinois, Indiana, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, North Carolina, North Dakota, Oklahoma, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia, and Wyoming.[3]

Proponents

Right-to-try laws are immensely popular with both citizens and legislators, as they are viewed as offering terminally ill patients one last chance at saving their lives. The chief advocate of right-to-try laws is the Goldwater Institute, a libertarian think tank based in Arizona, which created the legislation template on which the state laws are modeled.[4] Kurt Altman, national policy adviser for the Institute, has said that right-to-try laws return control of medical decisions "back to a local level".[5] Other proponents include patients and their families, as well as patient advocate groups.[6] Supporters of these laws sometimes describe them as "Dallas Buyers Club" bills, a reference to a movie about an American man with AIDS who smuggled unapproved treatments from foreign countries to fellow patients.[7] Some have likened the efforts of terminally ill patients to procure unapproved drugs in development to those of ACT-UP and other AIDS organizations of the 1980s.[8]

Critics

Right-to-try laws have been called unethical by bioethicists including Arthur Caplan, Alta Charo, Rebecca Dresser, and others. They argue that the laws do not require companies to provide the drugs being sought, and, as companies are often reluctant to do so,[9] the laws should be considered toothless legislation that offers only false hope to dying people.[10][11] Even if the laws worked as intended, they would be problematic to critics. Because the laws require only that drugs have completed the first of three phases of clinical testing, there is no data on the efficacy of the drugs, especially in very sick people. There is also no safety data on how they would affect very sick people. This makes true informed consent on the part of the patient impossible, because informed consent entails, first, knowledge of the pros and cons of a proposed treatment and then a decision made in light of those pros and cons.[12] Some states’ right-to-try laws also put patients at risk of losing hospice or home health care,[13] and the costs surrounding treatment can be prohibitive, something right-to-try laws do not fix. Bioethicist Alta Charo called the laws “a simplistic way of going after much more complicated issues.”[14] Medical and health experts have also voiced concerns. If the laws were to grant patients access to unapproved drugs, they could hasten death or cause increased suffering.[15] Peter Temin wrote that “there is always a chance that any given drug will fail to cure a condition or will induce an adverse reaction,” such as becoming sick, or sicker, or even dying.[16] Drugs that are not fully studied may lead to more adverse reactions in patients. The laws would also reduce much needed FDA oversight of drug regulation.[17] Another criticism is that right-to-try laws are unconstitutional, because they involve states making rules that would contravene federal legislation.[18] Various authors have predicted that right-to-try laws would be struck down if they were taken to court.[19][20]

Future

There have been no substantiated cases of anyone receiving treatment because of a right to try law.[21] And a 2014 paper in JAMA Internal Medicine argued that right to try laws “seem likely to be futile.”[22] Despite this, the laws remain wildly popular, and state legislators continue to introduce bills; as of April 2016, 19 states have right-to-try bills under consideration. In July 2015, a federal right to try bill was introduced, but there has been no movement on it since then.[23]

References

  1. ↑ Turkowitz, J (January 11, 2015). "Patients Seek 'Right to Try' New Drugs". New York Times. Retrieved August 14, 2015.
  2. ↑ "'Right to Try' Law Gives Terminal Patients Access to Drugs Not Approved by FDA" (June 21, 2014). PBS NewsHour. Retrieved August 14, 2015.
  3. ↑ "Oregon 24th State to Enact 'Right to Try' Law". Oregon's KTVZ.com. August 13, 2015. Retrieved August 14, 2015.
  4. ↑ "Goldwater Institute Right to Try Model Legislation" (PDF). Retrieved February 19, 2016.
  5. ↑ Monir, M (February 19, 2015). "States Move to Give Terminally Ill 'Right-to-Try' Drugs". USA Today. Retrieved August 14, 2015.
  6. ↑ Harada, T (May 9, 2014). "Afflicted Have the Right to Try". Atlanta Journal-Constitution. Retrieved February 19, 2016.
  7. ↑ Turkowitz, J (January 11, 2015). "Patients Seek 'Right to Try' New Drugs". New York Times. Retrieved August 14, 2015.
  8. ↑ Andriote, J-M. "Who Decides? 'Right-to-Try' Law's Unacknowledged, Deep Roots in AIDS Activism" (May 22, 2014). Huffington Post. Retrieved February 19, 2016.
  9. ↑ Dennis, B, Eunjung Cha, A (May 15, 2014). "'Right to Try' Laws Spur Debate Over Dying Patients' Access to Experimental Drugs". Washington Post. Retrieved August 14, 2015.
  10. ↑ Munz, M (May 20, 2015). < "Missouri's 'Right to Try' Law No Guarantee Patient Will Get Experimental Drugs". St. Louis Post-Dispatch. Retrieved February 19, 2016.
  11. ↑ Bateman-House, A, Caplan, A (August 13, 2015). "All Hat, No Cattle—The False Hope of Right to Try Laws". Harvard Health Policy Review. Retrieved February 19, 2016.
  12. ↑ Bateman-House, A; et al. (September 17, 2015). "Right-to-Try Laws: Hope, Hype, and Unintended Consequences". Annals of Internal Medicine. Retrieved February 19, 2016.
  13. ↑ Kearns, L, Caplan, A (April 29, 2015). "Right-to-Try Legislation Punishing". Albany Times Union. Retrieved February 19, 2016.
  14. ↑ Leonard, K (November 18, 2014). "Seeking the Right to Try". U.S. News & World Report. Retrieved August 14, 2015.
  15. ↑ Gorski, D (July 21, 2014). "The False Hope of 'Right to Try' Metastasizes to Michigan". Science-Based Medicine. Retrieved February 19, 2016.
  16. ↑ Temin, P. Taking Your Medicine: Drug Regulation in the United States. Cambridge: Harvard University Press. pp. 1–2.
  17. ↑ Silverman, E (October 12, 2015). "'Right to Try' Laws Wrong to Skirt FDA". Boston Globe. Retrieved February 19, 2016.
  18. ↑ Yang, T; et al. (July 20, 2015). "'Right to Try' Legislation: Progress or Peril?". Journal of Clinical Oncology. Retrieved February 19, 2016.
  19. ↑ Adriance, S (December 4, 2014). "Fighting for the 'Right to Try' Unapproved Drugs: Law as Persuasion". Yale Law Journal. Retrieved February 19, 2016.
  20. ↑ Farber, D; et al. (May 22, 2015). "How State Right-to-Try Laws Create False Expectations". Health Affairs Blog. Retrieved February 19, 2016.
  21. ↑ Ross Johnson, S (October 17, 2015). "Despite Political Support, State Right-to-Try Bills Show No Takeup". Modern Healthcare. Retrieved February 19, 2016.
  22. ↑ Zettler, P, Greely, H (December 1, 2014). "The Strange Allure of State 'Right-to-Try' Laws". JAMA Internal Medicine. Retrieved February 19, 2016.
  23. ↑ "H.R. 3012". 114th U.S. Congress, 1st session.
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