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Benedict: 'Right to Try' laws have no merit

Imagine that you or a loved one are dying of an illness, and no currently approved treatment would be effective against that illness. Then you become aware of a new drug, medical device or biological treatment presently in clinical trials that just might help. Your doctor agrees, but since the new treatment has not yet cleared all the FDA hurdles, how are you supposed to get your hands on it? Are you doomed to die without even getting a chance to try it?

Never fear, say the 19 bi-partisan co-sponsors of House Bill 584 now being considered by the General Assembly of Maryland. House Bill 584 is subtitled Right to Try Act, and is promoted as a solution to the problem described above — dying patients who want access to drugs and devices still under investigation for efficacy. At first glance, it looks like a no-brainer — who could possibly oppose such a noble effort to help desperate folks who have run out of other options? But, as is so often the case with things political, the proposed law is deceptive at best and potentially dangerous at worst.

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The first bit of deception comes in the subtitle, "Right to Try Act." Give the bill a close reading and it will become obvious that no such right is conferred. Ethicist Arthur Caplan says it would be more accurate to call it a "Right to Beg Act." Under the act, patients and their physicians may request access from pharmaceutical or device manufacturers, but manufacturers or investigators are under no obligation to grant such access. If manufacturers or investigators do grant access, they may also "require an eligible patient to pay the costs of … the manufacture of the investigational drug, biological product or device." These costs could be quite high, effectively eliminating the poor from access.

Furthermore, the supposed "right" which the act claims to offer is a right patients and their physicians already possess under federal law. The FDA Expanded Access (aka Compassionate Use) Program exists for this purpose and approves over 99 percent of all such requests made. Despite claims to the contrary, using the FDA process is not especially burdensome and there is no evidence that it involves significant delays. In fact, the FDA has often worked with patients and physicians to speed up the process.

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So-called "Right to Try" laws have already been passed in over 20 states, but even the Goldwater Institute which originated and is promoting the legislation across the country admits that it hasn't actually helped a single patient to get access to treatment that they could not have gotten under existing law. So if the law is not really about helping patients, what is it about? It is about an attempt by the libertarian-leaning Goldwater Institute to exclude the FDA from its current oversight role. It is a political maneuver disguised as an effort to help the dying.

Some may say that getting the FDA out of the way is a good thing, and a little deception in going about it is just how politics work. Maybe so, but the actual text of the proposed law raises still other concerns. Language in the bill states that the patient's insurance company is not obligated to pay for the drug or device, or for "any care or treatments that may be necessary as a result of the use of the drug or device."

Furthermore, patients in hospice at the time they receive permission to use an investigational drug or device may lose their eligibility for hospice while they try the drug or device, despite the fact that in most cases the drugs or devices will do little to stem the progress of the illness or ameliorate the symptoms.

Finally, not only does the bill seek to eliminate FDA oversight, but it also does not require so much as a second opinion in order for patients to request and be granted access to investigational treatment. This creates the potential for unscrupulous or even criminal health care providers to persuade patients to try treatments which cannot possibly provide benefit, but may do harm.

The current system could be improved, but House Bill 584 won't do that. It is really just an attempt to do an end run around the FDA, promoted by a group that is trusting that most people won't look beyond the headlines and have no idea of how the current system actually works. If we want to improve the system, we should probably seek input from actual health care providers and ethicists familiar with the system, not ideologues at some think tank.

James L. Benedict is a scholar in residence at the Center for Healthcare Ethics at Duquesne University in Pittsburgh. He writes from New Windsor.

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