Contact: Michael Kelley
(602) 633-8965
MEDIA ADVISORY: STATE LAWMAKERS TO GREEN-LIGHT BILL THURSDAY GIVING DYING PATIENTS ACCESS TO EXPERIMENTAL DRUGS
The current system takes nearly $1 billion and a decade to bring a new drug to market
Arizona legislators are poised to green-light legislation in committee Thursday that would pave the way for terminally ill patients to access experimental drugs not yet cleared for market. Known as the “Right to Try” Act, similar bills are currently being considered by lawmakers in Colorado, Louisiana and Missouri, and legislators in California and Massachusetts have expressed interest.
Designed by the Goldwater Institute, the Right to Try Act would enable terminally ill patients who have exhausted all of their available treatment options to access experimental drugs that have been deemed safe but whose efficacy has yet to be determined. Under the current system, even after an investigational drug has passed the Food and Drug Administration’s Phase I (the testing phase during which safety is established), it can take an additional six or more years for the drug to be approved for market–even if clinical trials are yielding promising results.
And while many patients facing terminal illness attempt to get into those clinical trials, the vast majority cannot, because they are too far along in their illnesses or because of other factors. 40{010c6536f15f83a69f09c4467fdfb4a5656804feab27fe0dec71ed1e80da306f} of cancer patients pursue admission into clinical trials, but only 3{010c6536f15f83a69f09c4467fdfb4a5656804feab27fe0dec71ed1e80da306f} succeed. Last year, more than 500,000 Americans died from cancer alone.
According to Christina Corieri, a health care policy analyst at the Goldwater Institute, the tragedy is that many of the drugs terminal patients can’t access today will be saving the lives of future patients just a few years from now.
“The sickest Americans don’t have the luxury of time to wait for these drugs to come to market through the traditional process,” said Corieri. “The Right to Try Act puts the decision about whether to try an experimental treatment back where it belongs: in the hands of patients and their doctors.”
If passed by both chambers of the Arizona Legislature, the Right to Try Act will still have to be approved by Arizona voters in November. Lawmakers considering the reform in other states are pursuing statutory changes that could take effect in just a few months without voter approval.
Here are some examples of how the current drug approval process is failing America’s sickest:
· Ninety-seven percent of the sickest patients CAN’T get into clinical trials. While clinical trials often represent a terminal patient’s last hope, most are prevented from participating. Forty percent of cancer patients want to get into a clinical trial, but only 3 percent succeed in doing so.
· While a narrow exception (called “expanded access”) exists through which patients may apply to the FDA for access to investigational drugs, the process is difficult and burdensome. Between late 2011 and autumn 2012, a mere 904 patients successfully petitioned and gained access to experimental drugs through this mechanism.
· It takes a doctor nearly three entire work-weeks to fill out an application for expanded access. This means that only patients with significant means or other resources are able to marshall the manpower needed to navigate the application process.
· Over 75 percent of doctors believe that the current system has hindered their ability to adequately treat patients. In a poll of medical professionals, 80 percent of neurologists and neurosurgeons, 78 percent of orthopedic surgeons, 77 percent of oncologists, 71 percent of cardiologists, and 58 percent of emergency room doctors reported that the federal government has prevented them from providing their patients with the best possible care.
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For more information or to arrange an interview, please contact Michael Kelley at 602-633-8965 or mkelley@goldwaterinstitute.org. The Goldwater Institute has an onsite VideoLink studio for rapid cable hook-up to national television networks.
For more in-depth information about the Right to Try Act, please visit: Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of their Treatment
