In his 1989 farewell address, President Ronald Reagan described his eponymous “revolution” as “the great rediscovery of our values and our common sense.”
It is time for another such epiphany.
Since the stinging defeat of Mitt Romney in 2012, Republicans have searched for ways to bring lofty discussions about liberty and freedom, skepticism about Big Government and overreaching regulation, down to the ground, where real people live. They need to convince the overworked mother trying to make mortgage payments and the fellow worried about helping his kid through college that GOP principles can make their lives easier. That their programs are rooted in good, old-fashioned common sense, and that they have a heart.
The Goldwater Institute is pushing an initiative that fits that bill, and that can serve as a teaching moment for Republicans. It’s The Right to Try, as in granting terminal patients the right to try experimental medicines that might just save their lives. This seems a no-brainer. How can a benevolent government deny people living under a death sentence access to unapproved medications – drugs that have passed Phase One FDA trials (meaning they have been investigated for toxicity and dosage) but that have not yet jumped all hurdles for widespread approval?
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The answer is a balky and overburdened Food and Drug Administration can and does deny people the right to try experimental drugs and therapies by putting up bureaucratic barricades. To gain access to drugs not yet approved is not impossible, but it is difficult and time-consuming.
In some instances, the patient dies while the cumbersome process of obtaining a so-called “single-patient investigations new drug application” or “IND” -- requiring some 100 hours of doctor-provided paperwork and the permission of the relevant pharmaceutical company -- unfolds. Most people are prisoners of the official vetting of new medications, a decades-old process that entails clinical trials costing on average $800 million dollars and taking ten to fifteen years to complete. Nimble it is not.
Some 40 percent of those diagnosed with cancer scramble to get into clinical trials, but many fail to make the cut because they are ineligible or live too far from the hospitals organizing the tests. Only about 500 people a year receive the single-patient access to potentially life-saving drugs. That leaves many folks out in the cold.
Surveys of medical specialists have consistently concluded that the FDA approval process for new drugs and therapies needs overhaul. One such poll in 2007 showed that more than three-quarters of orthopedic surgeons thinks the review process is too slow, and 73 percent thought that FDA-caused delays hurt patients. Surveys of oncologists, as might be expected, reveal equal impatience.
Notwithstanding widespread agreement that the FDA should do more to help those seriously ill, critics warn that The Right to Try might encourage doctors to prescribe medications that are downright dangerous. With all due respect, and not meaning to channel Hillary Clinton, a dying person might well ask, “What difference at this point does it make?”
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A more serious concern is that if individual carve-outs became too common, many people might decline to join clinical trials where they might be given a placebo instead of a possible cure. It seems, however, that such trials are not available to most patients.
The FDA has broad authority to investigate and regulate radiation from microwave ovens, counterfeit medications, menthol cigarettes, preparedness against bioterrorism, the materials that go into tongue depressors, TV ads for pharmaceuticals, the colors in cheek blush, what constitutes a “dietary supplement,” the development of vaccines, and – almost as an afterthought – all drugs.
Just in the past couple of weeks it has ordered the recall of raclette cheese found to contain salmonella, contaminated organic mangos, “Poparoons” from Lily Bloom’s Kitchen that fail to list milk as an ingredient, GemStar infusion pumps for potential malfunctions and collagen and Vitamin C products that were unapproved. The FDA employs nearly 15,000 people and has an annual budget just shy of $5 billion. In short, it is a mammoth bureaucracy, and not especially available to individuals fighting a fatal disease.
Lest you think this is a small issue, there are nearly 600,000 cancer deaths each year in the U.S. An estimated 1.4 million people in the
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Because earlier efforts to change federal policy limiting access to unproven drugs failed, the Goldwater Institute is pushing to introduce legislation state by state to rectify this problem. In Arizona, Colorado, Louisiana and Missouri, voters will soon have the opportunity to vote on bills that would skirt the FDA approval process, and allow terminally ill patients access to unapproved drugs. The Goldwater folks think other states will likely soon follow.
Why is the Right to Try a good issue for the GOP? Because not allowing fatally sick people the opportunity to try anything and everything that might help them survive flies in the face of common sense – much like trying to create jobs by raising the minimum wage and driving up the cost of labor. Or, attempting to slow the growth of healthcare spending by providing free health insurance to 30 million more Americans. Or, granting teachers tenure – a job for life – and expecting them to work with the same zeal as those who must constantly prove themselves. Or not raising the retirement age when people are living longer. Or demanding our industries switch to higher-cost fuels when cheap energy is one of our greatest competitive advantages today. Common sense flew out the federal government window years ago, but it has been especially MIA in the Obama administration.
The Right to Try shows that compassion flows not only from federal spigots. Some problems require small solutions – not giant new pieces of legislation or the sloth-like rumblings of a massive bureaucracy. This will shock the Big Government types -- but individuals can often make their own decisions quite independent of guidance from Uncle Sam, relying on long-time values and native common sense. That sounds like Ronald Reagan, doesn’t it?
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