The Center for Practical Bioethics Weighs In on Proposed “Right to Try” Legislation in Kansas

A perspective from John G. Carney’s (President, Center for Practical Bioethics) based on testimony before the House Committee on Health and Human Services (HB 2004, Right to Try)

Most of us would agree that the “Right to Try” legislation proposed in the State of Kansas is appealing in the world of ideas and the realm of rhetoric where personal freedom and the pursuit of limitless aspirations are admirable ideals. But the world of reality bends its merits to questionable decisions that may disrupt the safe delivery of care to the most vulnerable population that healthcare professionals are called to serve.

In bioethics we recognize the deep-seated human impulse to rescue the imperiled, which is what this legislation seeks to do. However, we also grudgingly acknowledge that we could not run our businesses, public and private services or health care systems while indulging this impulse without limits. Furthermore, it is also widely accepted that “spectacle ethics” that turn individual cases into cause célèbre should not dictate public policy – no matter how heart-breaking they are. In the real world, there are good reasons to think that the “Right to Try” legislation should not be pursued despite our natural impulse to rescue.

While the popular framing of this issue characterizes interventions as miraculous and life-saving, there is little to no evidence that the interventions actually result in a good or “hoped for” outcome. We are not bound to provide a treatment that offers no benefit. In fact, it is a violation of our moral duty to do so.

Proponents may argue, if there is some evidence in the first phase of the clinical trial process that the patient may benefit from this treatment, then we should allow them access in the face of their impending death. Urgency is a given in these instances and experts argue that impending death is a criterion that allows for special consideration in these cases. But we are also obliged to consider the facts before arguing for new legislation to provide that consideration. 

Recent efforts within the FDA clearly demonstrate the agency’s attention to this issue. The FDA has updated and expanded its expedited processes for accommodating requests for access to drugs under development called Investigational New Drug (IND) Application. FDA Commissioner Dr. Margaret Hamburg has reported that in FY 2013, the most recent year for which data are available, nearly 100% of all applications submitted were approved (974/977) and many of those requests processed within hours of submission.

FDA has further pledged to continue to streamline its efforts despite its mandate to ensure safety and efficacy. For individual states to adopt legislation that circumvents the process of safety and efficacy places undue burdens on private business and manufacturers. Drug and medical device companies have repeatedly expressed concerns about their ability to handle and process the applications diverted from the FDA.

Furthermore, drug manufacturers are under no obligation to provide access to their products. The effects of unlimited access to drugs that have only been through Phase One clinical trials cannot be known and subverts the scientific process. In turn, accommodating appeals by individual patients ultimately diverts private business interests on the basis of questionable practices.

The substantive ethical and practical problems associated with this bill, coupled with the fact that these instances are exceedingly rare (estimated to be about 5 cases a year in Kansas), raise serious doubts about its merits. Significant and promising collaborative efforts are underway, such as the ALS Emergency Treatment Fund, that offer far more hope to patients than “Right to Try.”

The agencies that provide for our safety and ensure the efficacy of treatments operate in the real world, as does the legislature. Despite our natural need to rescue the imperiled, this committee and this body retain the responsibility to legislate with prudence and wisdom.

John G. Carney, President and CEO
Center for Practical Bioethics

Chronic Pain -- The Invisible Public Health Crises

Chronic Pain -- The Invisible Public Health Crises

A Call for Moral Leadership

“I am an invisible man. No I am not a spook like those who haunted Edgar Allen Poe: Nor am I one of your Hollywood movie ectoplasms. I am a man of substance, of flesh and bone, fiber and liquids- and I might even be said to possess a mind. I am invisible, simply because people refuse to see me.”
- Ralph Ellison

Ralph Ellison’s famous novel, The Invisible Man, starts with this passage, which also reminds me of the problem of chronic pain. The Institute of Medicine (IOM) report, Relieving Pain in America, documented the more than 100 million Americans (almost 1 in 3 and surely someone whom you know and love) suffers from chronic pain, at an economic cost of $6 billion and an incalculable psychological cost. We named pain as a “disease” because of its profound effects on the brain and its interference with multiple domains of the quality of life of sufferers. The committee identified chronic pain as a public health problem, given the sheer numbers affected, and the opportunities to intervene to prevent acute pain from becoming chronic pain. However, the report is now almost four years old, and it is fair to say has not really moved the needle in doing what we implored in the IOM report—“changing the way in which pain is judged, managed and perceived.” Why is that?

Because pain is subjective -- and therefore difficult to measure by the usual medical tests -- it is often doubted. As someone once said, my pain is real, your pain is in doubt. Also, we live in profound cultural ambivalence about pain. Cultural icons such as  Julius Caesar and Albert Schweitzer have been quoted as saying that pain is worse than death, but there is also an ethos of “no pain, no gain.” Medical interventions, particularly powerful opioid drugs such as morphine and oxycodone, although essential to manage acute and persistent pain, come with a cost of many side effects and may induce psychological dependence in some. Persons in pain and their doctors fear addiction, although we do not truly know the risk of addiction in persons taking opioids who have not abused recreational or illicit drugs. For these and other reasons, on an individual and societal level, we prefer to ignore the problem of chronic pain, unless confronted by it in our personal lives.

So how do we advance the moral imperative to address pain and suffering in contemporary medical practice, as required by our ethical codes and professional oaths? How do we bring the invisible suffering of so many to light and work to alleviate it? I think we commit ourselves to five big goals:

1. We advocate for more and better science to understand the underlying neuroscience of pain production and modulation. This requires advocacy at the NIH and other federal agencies to fund worthy science related to pain mechanisms and clinical trials of pain treatments.

2. We advocate for more and better drug development, including the creation of abuse deterrent opioid formulations and novel non-opioid based analgesics. This will require advocacy for effective public-private partnerships between the pharmaceutical industry, academia and federal agencies.

3. We advocate and demand better education of health care professionals to live up to their obligations to be competent and to attend to pain and suffering in their patients. We also advocate for better public education so that persons suffering with chronic pain understand that this is a disease, and not subject to quick fixes.

4. We advocate and demand better policy solutions to provide sustainable and patient-centric interdisciplinary pain treatment programs that truly address patient and provider needs. 

5. Finally, we need effective collaboration on a shared policy agenda between pain specialists and substance abuse specialists to advocate for comprehensive, rehabilitation-focused care for chronic pain, and greater access to substance abuse treatment for those persons who have a dual diagnosis of chronic pain and addiction.    

These are my thoughts. What do you think?

Richard Payne, MD
John B. Francis Chair, Bioethics
Center for Practical Bioethics

Esther Colliflower Professor of Medicine and Divinty
Duke University