Colorado has now passed, and other states are likely to pass, Right to Try legislation which declares as a matter of state law that terminally ill patients have a right to use medication that has been approved for safety, but not necessarily for efficacy, by the FDA. The current FDA drug approval process is long and cumbersome, and untold thousands of people die, and far more suffer, every year, while drugs and treatments that could help them are being tested to FDA specifications. Right to Try would let people who are going to die anyway try drugs that might improve their conditions—or might not. But it makes clear that it’s their body, and should be their choice.
Who could oppose such a compassionate and common-sense reform? The pharmaceutical bureaucracy and its supporters. And while their arguments are couched in the dispassionate tones of scientific objectivity and rationality, those arguments boil down to a cruel, indeed, unethical exploitation of sick people who lack the political strength to protect themselves.
Take this clip from a CNN debate. In it, former FDA Commissioner Andrew von Eschenbach says that the reason for legally forbidding terminally ill patients from obtaining safe experimental medicines is “to make sure that they are getting the right thing in the right way.”
But what does that mean? Who has the right to ensure that I “get the right thing in the right way”? Shouldn’t I have that right? There’s no doubt that, for instance, my diet could be improved—I eat a lot of fast food. Should the FDA have the power to dictate to me what meals I can eat, in order to ensure that I “get the right thing in the right way”? I watch some pretty lousy quality television sometimes. Should the government control what choices I make in order to ensure that I “get the right thing in the right way”? Or, even worse, should the government dictate what I eat or watch, not for my own benefit, but in order to ensure that other people eat and watch “the right thing in the right way”? Said plainly, what Dr. von Eschenbach means is that the government should dictate what people ingest in order to ensure that they ingest what the government approves of: you have no right over your own body, no right to make your own medical choices—you should just do what bureaucrats tell you, because they know, as you do not, what is “the right thing,” and “the right way.”
This is not a scientific question at all. This is a question of morality and political philosophy. Whose body is it to make mistakes with? Is it mine, or is it Dr. von Eschenbach’s?
Even more explicit is David Gorski’s post on the Science Based Medicine Blog. Putting aside his incendiary and inaccurate political smears, Dr. Gorski’s argument against Right to Try is: “Just because a drug has passed phase I trials does not mean that it is effective. It does, however, frequently mean that the drugs have significant side effects. Indeed, determining those adverse events is part of the entire reason that we do clinical trials in the first place.” To allow terminally ill patients to access experimental therapies is bad because it would throw off the testing that might prevent “the premature diffusion” of those therapies.
In other words, the snail-pace of current testing regimens should remain in place because we need a control group for clinical trials. That control group consists of the people who are prohibited from accessing the experimental therapies while the tests drag on.
Now, I won’t stoop to Dr. Gorski’s ad hominem—I’ll grant that he has the best motives in mind: trying to prevent bad therapies from entering the market. We should all be able to agree on that; none of us is pro-quackery. The problem is that the testing regimen he has in mind implicitly includes denying human beings access to drugs they would choose to take if they could, in order that those people can be used as a baseline against which to test experimental results. What is that? That is a form of human medical experimentation without those people’s consent. It is every bit as much an experiment on a human subject as the Tuskegee experiments were—just couched in the polite guise of bureaucratic paperwork.
Interestingly, Dr. Gorski has written quite powerfully about the history and ethics of human medical experimentation: “Key to finding the balance,” he says, “is to respect patient autonomy and to provide true informed consent that accurately balances risks versus benefits and to protect patients from any form of coercion.” But where’s the respect for autonomy and consent with a testing regimen that denies people access to medications they would prefer to take because The State has determined that the only legally acceptable method for drug approval is one in which they are—so sorry!—simply given no say?
There’s no denying that broader access to experimental medicine will have risks and may make testing more complicated in some ways. But is that grounds for ignoring the role of consent and ridiculing the concept of patient autonomy, as Dr. Gorski does, as “an ideological purpose rooted in libertarian politics”? Is that justification for ignoring the ethical principle of justice—and maintaining a system whereby exceptions are allowed on an ad hoc, arbitrary, politically-motivated basis, rather than on a single, principled foundation? Is that a justification for the government telling people what drugs—safe drugs, mind you!—they may take and may not—and not for the benefit of the patient himself, but for the benefit of others, in violation of the principle of beneficence? Dr. Gorski minimizes all of this as “false hope.” But whose hope is it, anyway?
It’s sad that otherwise rational people are crossing the line of paternalism and ignoring the hard-won ethical principle of autonomy. Right to Try is not fundamentally about scientific testing regimens. It’s about patient freedom of choice. It’s a question of whether you own your body, or whether others have the right to dictate to you what is the “right way” for you to take medicine that might help you.
Disclosure: My wife, Christina Sandefur, is an attorney with the Goldwater Institute. I have often worked with the Institute (though not as an employee) since I agree with the work that they do.
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