The “Right to Try” Controversy: When S...
Right to Try legislation, which was recently passed in the United States, gives terminally ill people access to highly experimental drugs not yet approved by the government. The new legislation deals with drugs in so-called Phase One trials, which are experiment mostly to determine a potential treatment’s toxicity.
“One of the challenges with Right to Try is that we don’t have a lot of guidance about whether these should be through formal protocol … and as a result we won’t have the rigorous follow-up on how well patients do on a given drug,” says Dr. Mikkael Sekeres, Director of the Leukemia Program at Cleveland Clinic Cancer Center. Dr. Sekeres also points out that the Right to Try approach makes it much more difficult to keep track of patient response and side effects in contrast to a formal clinical trial.
People such as Dr. Sekeres who oppose “Right to Try,” fear that it exposes people to harmful and ineffective treatments, without the added benefits to science and society. Dr. Sekeres says he’d much rather have people enroll in clinical trials or request what are known as single patient INDs (investigational new drug). This is a formal proceess on behalf a single patient in which a doctor requests access to a drug or treatment that is not yet approved by the FDA.
Learn more about SurvivorNet's rigorous medical review process.
Right to Try legislation, which was recently passed in the United States, gives terminally ill people access to highly experimental drugs not yet approved by the government. The new legislation deals with drugs in so-called Phase One trials, which are experiment mostly to determine a potential treatment’s toxicity.
“One of the challenges with Right to Try is that we don’t have a lot of guidance about whether these should be through formal protocol … and as a result we won’t have the rigorous follow-up on how well patients do on a given drug,” says Dr. Mikkael Sekeres, Director of the Leukemia Program at Cleveland Clinic Cancer Center. Dr. Sekeres also points out that the Right to Try approach makes it much more difficult to keep track of patient response and side effects in contrast to a formal clinical trial.
People such as Dr. Sekeres who oppose “Right to Try,” fear that it exposes people to harmful and ineffective treatments, without the added benefits to science and society. Dr. Sekeres says he’d much rather have people enroll in clinical trials or request what are known as single patient INDs (investigational new drug). This is a formal proceess on behalf a single patient in which a doctor requests access to a drug or treatment that is not yet approved by the FDA.
Learn more about SurvivorNet's rigorous medical review process.