You can always tell that defenders of a dangerous and irresponsible law have nothing to offer when they resort to flagrant misrepresentation to make their case.
Step forward, Nathan Nascimento and David Barnes of the Koch brothers network.
Nascimento and Barnes are representatives of the Koch brothers group’s Freedom Partners Chamber of Commerce and Generation Opportunity, respectively. They were sufficiently ticked off at my takedown of one of their hobby horses, a federal “right-to-try” law, to complain about it in a letter to the editor, published Thursday.
If they had a legitimate point to make, they would have made it. Instead, they chose to misrepresent my column, presumably to conceal their real intention.
Here’s what they wrote:
“Imagine being terminally ill, exhausting all available options, and being told you shouldn’t have the right to try experimental treatments because they may be ‘hazardous to your health.’ Columnist Michael Hiltzik argued that.”
The distinction goes to the heart of what this law, which is also being pushed by Vice President Mike Pence, really is about.
It’s not about “freedom for the terminally ill,” as Nascimento and Barnes want you to think. That’s just window dressing, tugging on your heartstrings to conceal the Kochs’ true agenda: launching an attack on the Food and Drug Administration, which is in their libertarian crosshairs because it protects the nation’s pharmaceutical users from unsafe and ineffective nostrums through the use of regulation. If this law gets passed, as the Kochs wish, programs to ensure the safety and efficacy of drugs administered to all patients, not just the terminally ill, will be seriously undermined.
Regarding the treatments themselves, no one would know whether they might be hazardous because they would not have to be vetted adequately for safety by the FDA. Under the law, they must have passed phase 1 trials to be eligible for right-to-try treatments. Phase 1 trials, however, are a very coarse screen for safety and efficacy, sometimes based on fewer than 30 subjects. Most drugs that pass phase 1 trials actually turn out to be “too unsafe or ineffective for clinical use,” researchers from NYU have reported in the Journal of the American Medical Assn.
That’s an important consideration because one of the provisions of the Nascimento/Barnes/Koch law would prohibit the FDA from using results of right-to-try treatments as evidence in further tests of the safety and efficacy of the drugs. In other words, the terminal patients fed these nostrums wouldn’t know whether they’re safe, and if the treatments indicate they’re unsafe, you won’t know either.
This is another transparent bit of misdirection. They exaggerate the likelihood that the experimental treatments might work, and minimize the financial consequences for patients and families. But they don’t mention that the law they’re promoting immunizes drugmakers, doctors, experimenters or pharmacies from liability lawsuits for pushing untried drugs on desperate patients.
Nor do they acknowledge that insurance companies typically don’t cover experimental treatments (and couldn’t be required to, under this law). Patients seeking right-to-try treatments would be financially on their own, vulnerable to snake oil purveyors who may be operating under the shield of this law.
Are financial hardships really “trivial”? Families could go bankrupt pursuing these treatments, left without not only the presence and comfort of loved ones suffering a terminal disease, but the resources needed to carry on after their death.
Finally, Nascimento and Barnes scoff at the FDA’s existing program to serve terminally ill patients who have tried all other possible treatments. The FDA receives about 1,000 requests for this expedited access a year, and on average approves more than 99%. But the agency retains oversight of the treatments, including the physicians administering them, and can use the results of these treatments to judge the efficacy and safety of the experimental drugs. The treatments must be monitored by institutional review boards, and doctors are subject to malpractice lawsuits if they do something wrong.
In short, the agenda of Nascimento and Barnes isn’t about medicine or compassion. It’s ideological, pure and simple. Their intention is to chop down the forest of regulations that protect you and me from unscrupulous doctors and clinics, all in the name of “freedom.” The law they’re pushing truly is hazardous to our health, which is exactly what I wrote. If Nascimento and Barnes really believed that was incorrect, would they have to misrepresent my words to make their case?