Right to Try Bill Approved in Colorado

Right to Try

Lawmakers in Louisiana, Missouri, and Colorado have passed “Right to Try” legislation. “Right to Try” allows terminally ill patients to take experimental drugs not yet approved by the Food and Drug Administration (FDA).

Families of dying patients have lobbied for access to drugs not yet approved by the FDA. Waiting for approval takes years and time is something terminally ill patients do not have to spare. Families have become frustrated in having to wait for FDA approval while their loved ones die.

Nick Auden of Denver suffered from melanoma. Under the “Right to Try” legislation, Auden could have received an experimental drug not yet approved by the FDA; however, he died in November 2013 at the age of 41.

Amy Auden, Nick’s widow, said there are experimental drugs that can save lives. Access to them must be expanded.

Amy and Nick tried lobbying two drug companies to allow Nick to try an experimental treatment that had moved outside clinical trials. Neither drug had received FDA approval. Both Amy and Nick understood there was no guarantee the experimental drug would help cure his melanoma. What the Auden’s wanted was permission to enter into the treatment before FDA approval and Nick passed away.

Supporters of “Right to Try” now have a slight ray of hope. Patients attempting to navigate the bureaucratic FDA red tape must pass what is known as compassionate use guidelines to become eligible for “Right to Try.” Lawmakers in Louisiana, Missouri, and Colorado have passed “Right to Try” legislation in their states. To date, only Governor John Hickenlooper has signed the “Right to Try” bill into law. The governors of Missouri and Louisiana need only sign their state bill to make them law.

Senator Irene Aguilar who cosponsored the “Right to Try” bill in Colorado, said when someone is terminally ill, the patient wants anything that can help. Gaining access to drugs that are not FDA approved has become an insurmountable obstacle.

Skeptics have called the “Right to Try” a feel good campaign. Drug companies do not have to provide documentation that their drug cures anything. Granting access to medications not yet approved by the FDA is dangerous; however, desperate families may allow a sick loved one to try a new treatment.

In 2003, a federal judge denied terminally ill patients the right to access investigational medicine. When appealed to the Supreme Court, the justices declined the case letting the lower court decision stand. By passing the “Right to Try” on the state level, families with terminally ill loved ones are attempting to bypass the federal system.

Dr. David Gorsky, a surgical oncologist and blog editor for Science Based Medicine said the FDA is responsible for regulating drug development. The “Right to Try” does not do anything to change that policy. A drug company would not do anything to jeopardize a drug that has gotten past the clinical stage of development. Companies spend millions of dollars to bring medicines to the market and none of them want the FDA to reject their drugs.

There is evidence that the “Right to Try” can work. Four-year-old Josh Hardy has beaten cancer four times. He now has a virus that can cause heart and kidney failure. After receiving three doses from an experimental drug called brincidofovir, Josh can now sit up, do homework and play board games with his brothers. Brincidofovir has reduced adenovirus levels in his blood from 250,000 copies per milliliter to 367 copies per milliliter.

His mother, Aimee Hardy said she was beside herself with the results. The drug worked quickly and effectively. Without it, her son would have heart and kidney failures. Josh no longer has bleeding in his intestines and stomach.

Originally, Chimerix, the company that makes brincidofovir, refused to give Josh the drug. It was only after the Hardy family mounted a social media campaign that the FDA permitted the Hardy’s access to brincidofovir.

Even with the virus leaving his body, Josh’s kidneys remain in danger from previous approved treatments. Currently, he has to undergo dialysis three times a week. His mother said if she had gotten permission for her son to take brincidofovir, the problem could have been avoided.

The “Right to Try” may not be the panacea that allows patients with a life threatening disease to find cures. When someone becomes ill, they, along with family members and friends, will seek anything that might help the patient. With “Right to Try” legislation passed by lawmakers in Louisiana, Missouri, and Colorado and the bill signed in Colorado, people facing a certain death will have a chance to take unapproved FDA medications that could save their lives.

By Brian T. Yates

Washington Post
NBC News

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