There’s an old saying that most citizens find scary, “I’m from the government and I’m here to help!”
Even worse is what is happening now when the federal bureaucracy says, “I’m from the government and I’m here to make sure you’re not helped.”
As chronicled in the Academy Award winning movie, “The Dallas Buyers Club,” the U.S. Federal Drug Administration is taking far too long to approve promising new drugs and treatments, and is limiting clinical testing of these potential cures in a way that is not only heartless, but we would say is patently immoral.
This needless foot-dragging by the FDA for approvals has been long reported, but it’s getting worse.
A June 2012 study by BCG showed that when compared to the European Union for new drug approvals between 2000 and 2005, the FDA averaged a 38-month delay over their European counterparts — more than three years! New numbers from 2006 to 2011 show the FDA delays have lengthened compared to the EU approval to now average 47 months longer. That means U.S. terminally ill patients are waiting nearly for four years longer to receive the same innovative drugs and treatments as patients throughout Europe.
Except for far too many patients and families, that 47-month wait is too long for hope or for survival. Either they succumb to their illness or after another 47 months of FDA-caused delay, they’re simply too ill to be helped.
Thankfully, new hope emerged for these Arizona terminal patients and their families this month when a bare majority in the Arizona House of Representatives passed House Concurrent Resolution 2005 — the “Right to Try” referendum. (The resolution is pending in the Senate.) 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.
We brought this referral idea to policymakers after extensive qualitative and quantitative voter testing. Nearly to a person in multiple Arizona focus groups, participants emotionally and passionately told tales of loved ones facing these decisions and being denied certain treatments, and of their desire to have the right to decide for themselves.
An Arizona survey conducted by Wilson, Perkins, Allen, showed 79 percent of all voters supporting the potential ballot measure. Every demographic group tested was widely in favor, but none more so than registered Democrats, with 87 percent of Democrats expressing support and 64 percent showing strong support. Only 7 percent of Democrats opposed the ballot measure.
So how is it that every Arizona House Democrat voted against the “Right to Try” referral? How is it that nearly every one of these Democrats proclaim to be “pro-choice” for decisions to terminate a pregnancy, but not in favor of a patient’s personal choice to seek potentially life extending new drug treatments?
If the “Right to Try” referral makes it to the ballot, voters will pass it. Legislators who oppose “Right to Try” will face a potential voter backlash this November, as this is likely to be one of the few bills voters can relate to and remember.
More importantly, these legislators will have to look terminally ill patients and their loved ones in the eye and try to explain how they know better what’s good for them, in essence once again saying, “I’m from the government and I’m here to make sure you’re not helped.”
— Chuck Warren and Tim Mooney are partners in the public affairs firm Silver Bullet LLC.