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Right-to-try laws, as currently formatted, offer terminally little but false hope

Are right-to-try laws a good idea? They are rapidly spreading throughout the country, first in Colorado, then Missouri and Louisiana, and, just recently, Michigan and Arizona. Similar laws are under consideration in New Jersey and Delaware.

At first glance these bills seem worth enacting. They promise terminally ill patients with no treatment options that they can try experimental therapies in their efforts to save or extend their lives. Of course we want to help people who are dying — be they in the United States or West Africa — so a bill that gives people access to possible treatments sounds great.

The problem is that these bills actually offer only smoke and mirrors, which terminally ill patients certainly do not need. In fact, some of these bills may harm the very patients that those backing the right-to-try concept say they want to help.

How can this be? The answer lies in what the bills actually say. They are quite similar in content from state to state and are all based on a model bill put out by the Goldwater Institute, a conservative think tank based in Arizona. According to the language of the model bill: “A manufacturer of an investigational drug … may make available and an eligible patient may request the manufacturer’s investigational drug … under this act. This act does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.”

So patients may ask, and companies may provide — if they want. And elsewhere in the model bill, it says, “A manufacturer may … (r)equire an eligible patient to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.”

How does this differ from the situation facing the dying today? Not at all.

All patients, regardless of age, gender, income level, nationality or access to healthcare, may request access to an investigational drug from the company developing it. These requests are normally channeled through the patient’s doctor, so some patients — those who do not have access to high-quality healthcare — probably never know that there may be investigational drugs that might be relevant to their disease and never discuss this with their doctors. This is a problem, but right-to-try laws offer no solution, stating only that doctors will not get in trouble for recommending or being involved in the use of an investigational product.

This is a red herring: No doctor has ever gotten in trouble for recommending that patients consider trying an investigational product. The only time we know of anyone getting in trouble is when other problems were present, such as fraudulent claims about the investigational product’s curative power.

Even if you cannot find a doctor to channel your request for an investigational product to a company, you can make your own request, provided you find some way — on the phone, on social media, through the local news media — to contact the company. Again, this poses problems, because not everyone is able to navigate the media or the Internet successfully. But again, right-to-try laws do not help fix this situation.

Another problem is the fact that many people lack knowledge of what drugs and devices are being developed by which companies for which diseases and conditions and thus do not know where to begin making a request. Yet again, this is a situation that right-to-try laws do not address.

In fact, the only difference between the current situation and the situation as it would be under a right-to-try law is that suddenly drugs, biological products (such as stem cells), or devices that have gone through Phase I testing (safety testing, normally on healthy people) would be considered quasi-therapeutic agents, even though they have not been tested for efficacy. Terminally ill patients would have to sign a form testifying that they understand the drug is experimental and has not been shown to work in humans — which would indicate that the drug is not therapeutic. At the same time, under the model law and several of the state bills, “eligibility for hospice care may be withdrawn if the patient begins curative treatment with the investigational drug.” It is fundamentally wrong to make dying patients ineligible for hospice because they want to try an experimental drug.

Nobody wants people to die, and everyone is in favor of terminally ill patients having hope of a recovery or a remission. If right-to-try laws saved people, we would support them. However, minus their Food and Drug Administration bashing and rhetorical flourishes, the bills offer nothing new. Likewise, if right-to-try laws gave patients a reasonable basis for hope, we would support them — but again, they offer nothing new, and we think it is, at best, unkind to offer the terminally ill and those who love them false hope.

This false hope, coupled with the fact that hospice care may be withdrawn from those who need it, makes it clear that right-to-try offers the dying little that is new and may leave them worse off.

Alison Bateman-House and Arthur Caplan are members of the New York University Working Group on Compassionate Use.

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