Medicine’s Collusion with False Hopes: Rights to try, false hope, and the spine of the profession

Bioethics in the News logoThis post is a part of our Bioethics in the News series

By Marleen Eijkholt, JD, PhD

Imagine your loved one is dying. You have heard about an intervention out there, somewhere, that could help—you think. Not trying this intervention for and on your loved one would seem insane, as who knows, there could be a chance for a cure. Without trying it, your loved one’s death is certain. But by trying it—who knows—this intervention might be the miracle for your beloved. Why not try?

Though death ultimately takes all, most of us resist a final exit for both our loved ones and ourselves. Pursuits to forestall death can take the shape of family’s quests for experimental treatments, like in the Charlie Gard case, or they can come by insisting on a “full code” for a terminally ill loved one who is on their deathbed. This rescue impulse (by unbridled hope) encourages health care professionals as well to marshal all available resources in attempts to circumvent the inevitable.

Where “right to try” creates false hope, I submit, however, that that the health care profession (HCP) has an obligation to avoid collaborating in, participating, propagating or augmenting false hope. By not speaking up against such requests, health care providers precipitate a harm, i.e., the false hope harm (FHH). As such, the HCP should show courage, and show spine to resist more broadly unreasonable “rights” to try.

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Image description: an illustration depicts a white whale above a sea of orange waves. The whale is in a net that is being held up by orange birds. The background is blue. Image source: Matthias Töpfer/Flickr Creative Commons

I call for an active stance from the HCP against populist legislative initiatives, such as the latest U.S. Senate’s “right to try” bill. In the same way, I call for an active stance against unrealistic patient and family requests for rights to try, including resuscitative efforts in terminally ill patients or other demands for non-beneficial treatments. My position thus supports the providers’ prudent approach in the tragic Charlie Gard case, as described at the end of this post. The FHH can best be countered by courageous advocacy from the profession.

Earlier last month, the U.S. Senate passed a “right to try” bill, and if the House approves this legislation, the bill would allow terminally ill individuals to access experimental drugs not yet available on the regular market. Once a drug has passed Phase I drug testing, an individual could petition the pharmaceutical company for access to that experimental drug. This bill also provides protection for pharmaceutical firms. The legislation restricts the FDA from using right-to-try-related adverse outcomes in determining a drug’s safety. Accordingly, the bill limits “penalizing” pharmaceutical companies for their “generosity” in offering access.

A discouraging stance against “right to try” legislation is tricky. It is telling that “right to try” legislation has been dubbed “feel good” legislation, and thirty-nine states already have such legislation, including Michigan. Although there are proponents of these laws, I contend that these laws are “rhetorical pleasers” more harmful than beneficial. Criticism directed at “right to try” legislation focuses on several concerns, including its potential to undermine the clinical trial system and the belief that ultimately such laws only serve the elite. Some critics address false harm arguments, although these concerns are mostly different from mine. Critics argue that the legislation creates false hope, because pharmaceutical companies are less than eager to share their innovative pharmaceuticals, and are afraid of right-to-try-associated risks and harms that might lead to scientific and drug development setbacks. Patients, therefore, most often are unable to obtain access to the medications, so their hope for a “miracle drug” is in fact unfulfilled. Without actionable pathways, patient access cannot be guaranteed. (Indeed, in Michigan, Bridge Magazine suggests that the legislation has failed to change the status quo, and no one has sought access.)

My proposal that the HCP should stand up against unreasonable rights to try comes from my belief that these laws create FHH instead of real benefit. “Right to try” legislation generates false hope as the sought after experimental interventions are unlikely to benefit the patient. Although the legislation requires the drug to have passed Phase I clinical trial safety testing, this measure does not amount to a guarantee that the medication offers benefit. A Phase I clinical trial is safety focused, conducted in a very controlled environment, and in fact many treatments fail to demonstrate benefit outside that controlled environment.

The federal legislation is therefore an even more troublesome example of “feel good” legislation, as it propagates and augments FHH. It endorses the idea that pursing experimental treatment is both feasible and reasonable. Equally, it supports the notion that as long as one has the means, one should have access to try. Most importantly, by limiting FDA oversight, it undermines safeguards and trust in the system, and creates more room for FHH, giving pharmaceutical companies nearly a free reign.

Standing up to false hope is painfully hard, especially in the face of persuasive, emotionally vivid stories. Who would want to deny anyone hope for a miracle? Charlie Gard’s parents wanted to try a new treatment for their son, but their providers refused access. While their son was tragically dying, they were helpless to avert the inevitable. They heard about a treatment in the U.S. and appealed for access. But the UK doctors refused to endorse their appeal and the Court eventually prevented Charlie Gard’s parents from taking their son to the U.S. for treatment. A compassionate intuition could be: provided Charlie did not feel pain, why would there be anything wrong with them pursing this treatment in the U.S.? His parents had sufficient funds to cover related costs, so their pursuit would not further tax the social system. Experts suggested that there was a zero percent chance of health benefits for Charlie, but who can really know zero percent if you haven’t tried? We can never exclude miracles, can we? Even though this drug was not past Phase I, it had shown marginal benefit in other kids with illness that were related to Charlie’s, so safety wasn’t hard to prove.

I propose that if providers would have allowed Charlie to leave for the U.S., their endorsement would have exploited vulnerable individuals; they would have collaborated in FHH. The providers took the right and courageous action. Not speaking out against FHH passively supports initiatives that are more harmful than beneficial, and speaking out requires an active positioning of individual providers—optimally supported by the larger body of HCPs. I submit that this should extend to participating in requests for non-beneficial treatment requests like resuscitative efforts on dying patients. The medical profession rests on elements of trust, guidance, expertise and collaboration. Absent health care providers’ courage to deny treatment, we are doomed to see a further erosion of that profession. Without provider action against “right to try,” under legislation or requests in the clinic, medicine is at risk of further drifting into consumerist medicine, where money, fear, and privilege turn health care (and providers) into hostages of patient demands.

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Marleen Eijkholt is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Obstetrics, Gynecology and Reproductive Biology in the Michigan State University College of Human Medicine. Dr. Eijkholt is also a Clinical Ethics Consultant at Spectrum Health System.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, October 5, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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What level of risk will be tolerated for interventions that are developed for treating “pre-diseased” patients?

bbag-blog-image-logoCrossing the Biology to Pathobiology Threshold: Distinguishing Precision Health from Precision Medicine

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Diseases have long been defined by their symptoms, and therefore patients have typically been treated when they are symptomatic. However, through advances in “omics,” wearable sensors, insertable microscopes, liquid biopsies, point-of-care pathology, and other innovations, it is possible to make a molecular diagnosis prior to apparent symptoms. These tools will enable a transition from Precision Medicine where the molecular etiology is determined after symptoms appear, to Precision Health in which the molecular etiology of diseases can be anticipated and symptoms averted. However, is it ethical to treat “asymptomatic disease” and at what cost to the healthcare system? What level of risk will be tolerated for interventions that are developed for treating “pre-diseased” patients? Since many of these assays will predict likelihood of disease and not absolute progression to disease, what level of certainty is needed to intervene at all? Medicine is being redefined and we are behind in understanding what is meant by the simple terms health and disease.

October 11 calendar iconJoin us for Dr. Contag’s lecture on Wednesday, October 11, 2017 from noon till 1 pm in person or online.

Dr. Christopher H. Contag is the chair of the inaugural Department of Biomedical Engineering and founding Director of the Institute for Quantitative Health Science and Engineering at Michigan State University. Dr. Contag is also Professor emeritus in the Department of Pediatrics at Stanford University. Dr. Contag received his B.S. in Biology from the University of Minnesota, St. Paul in 1982. He received his Ph.D. in Microbiology from the University of Minnesota, Minneapolis in 1988. He did his postdoctoral training at Stanford University from 1990-1994, and then joined Stanford faculty in 1995 where he was professor in the Departments of Pediatrics, Radiology, Bioengineering and Microbiology & Immunology until 2016. Dr. Contag is a pioneer in the field of molecular imaging and is developing imaging approaches aimed at revealing molecular processes in living subjects, including humans, and advancing therapeutic strategies through imaging. He is a founding member and past president of the Society for Molecular Imaging (SMI), and recipient of the Achievement Award from the SMI and the Britton Chance Award from SPIE for his fundamental contributions to optics. Dr. Contag is a Fellow of the World Molecular Imaging Society (WMIS) and the recent past President of WMIS. Dr. Contag was a founder of Xenogen Corp. (now part of PerkinElmer) established to commercialize innovative imaging tools for biomedicine. He is also a founder of BioEclipse—a cancer therapy company, and PixelGear—a point-of-care pathology company.

In person: This lecture will take place in C102 East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Can’t make it? All webinars are recorded! Visit our archive of recorded lecturesTo receive reminders before each webinar, please subscribe to our mailing list.

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New commentary from Dr. Cabrera in September ‘American Journal of Bioethics’

Laura Cabrera photoCenter Assistant Professor Dr. Laura Cabrera is co-author of a new open peer commentary in the September issue of The American Journal of Bioethics. The article, “Environmental Neuroethics: Bridging Environmental Ethics and Mental Health,” was written by Adam J. Shriver (University of British Columbia), Laura Cabrera, and Judy Illes (University of British Columbia).

The full text is available online via Taylor & Francis (MSU Library or other institutional access may be required to view this article).

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Introducing the No Easy Answers in Bioethics Podcast

no-easy-answers-podcast-logoNo Easy Answers in Bioethics is a new podcast series from the Center for Ethics and Humanities in the Life Sciences in the Michigan State University College of Human Medicine. Each month Center for Ethics faculty and their collaborators discuss their ongoing work and research across many areas of bioethics—clinical ethics, evidence-based medicine, health policy, medical education, neuroethics, shared decision-making, and more. Episodes are hosted by H-Net: Humanities and Social Sciences Online.

In Episode 1, Center Director Dr. Tom Tomlinson and Assistant Professor Dr. Devan Stahl discuss the Patient Preference Predictor (PPP), a tool they are developing that could potentially supplement advance directives or surrogate decision makers for patients, or that could aid decision making for the “unbefriended” patient who has no family or friend to make their wishes known. Could the PPP be even better than a patient’s family member at predicting what a patient may want in a given scenario?

Listen to Episode 1 now on H-Net

This episode was produced and edited by Liz McDaniel in the Center for Ethics. Music: “While We Walk (2004)” by Antony Raijekov via Free Music Archive, licensed under a Attribution-NonCommercial-ShareAlike License. Full episode transcript is forthcoming and will be available on the Center’s website.

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Antibiotics: No Clear Course

Bioethics in the News logoThis post is a part of our Bioethics in the News series

By Robyn Bluhm, PhD

It’s something we’ve all been told: be sure to finish taking your antibiotic prescription. Don’t just stop when you begin to feel better. Doing so, we’re warned, may mean that the bacteria causing the infection have not been completely eradicated. Once treatment stops, they will begin to multiply again, causing a relapse. Worse, it may result in the development of antibiotic-resistant bacteria, which is dangerous both to the individual taking the medication and to the public as a whole.

But a recent article in The BMJ argues against this common wisdom, saying that advice to “complete the course” is not evidence-based—and that doing so may actually have the opposite effect of increasing, rather than decreasing, the risk of antibiotic resistance.

antibiotics package photo

Image description: a pack of antibiotics with a green arrow pointing toward “Your first day’s dose”–two pills are missing and four remain unopened. Image source: Joseph Nicolia/Flickr Creative Commons

I find this piece—and reactions to it in on the journal’s website—interesting for bioethics because it illuminates the complex relationship between evidence and patient care. The article recommends changing treatment practices because of evidence that they may do more harm than good, but doesn’t really have a plan for what to change them to. This conundrum leads the authors of the article to make some interesting, but incomplete, suggestions related to physician-patient communication and shared decision-making. The commentaries on the paper challenge both the authors’ claims about the available evidence and their suggestions about sharing doubts about current practice with patients.

Changing Clinical Practice?
The randomized controlled trial (RCT) is currently thought to be the “gold standard” of evidence in medicine. It is not uncommon for discussions of medical evidence to cite examples of treatments that were in common use before an RCT was conducted, that were then shown by the trial to be useless or even harmful. This time last year, I blogged about a report that suggested that there is no evidence that flossing your teeth has any benefits. In response to this report, a number of people suggested that we should just stop flossing. In the late 1980s, a large RCT showed that two drugs commonly used to treat arrhythmia actually increase the risk of cardiac death and the authors recommended that their use be discontinued.

The question addressed in the BMJ paper is more complex than either of these cases. The recommendation is not to stop using antibiotics altogether, but to change the way that they are used. And the recommendation is not based on RCTs, but on the lack of evidence for current practice; on the flawed reasoning that linked early discontinuation with antibiotic resistance; and on evidence that overuse of antibiotics is actually the most important causal factor in the development of resistance. The authors identify only seven conditions for which researchers have conducted RCTs that directly compared a shorter with a longer course of treatment. Moreover, even in cases where the shortest effective course of an antibiotic treatment for a health condition has been identified, it’s not possible to extrapolate from this situation to the use of other antibiotics, or the use of that antibiotic for other diseases.

The authors of the BMJ paper do emphasize that more evidence is needed. But until that research has been done (if it ever is done), it’s not clear how doctors should change their current prescribing habits. As the discussion in the article makes clear, the answer to this question will depend on a number of factors, including the kind of infection and the specific antibiotic being used. Moreover, it will depend on the individual patient, as “patients may respond differently to the same antibiotic, depending on diverse patient and disease factors” (p. 2).

Talking with Patients
Given the number of factors that might affect patient outcomes, it would not be surprising if the authors of the article were unwilling to make specific recommendations for clinical practice. In fact, they don’t make a recommendation in terms of what doctors should prescribe for their patients. Instead, they end their paper with a section titled “How should we advise patients?” While prescribing a medication regimen certainly counts as giving a patient advice (at least implicitly), they couch their discussion in terms of general communication strategies, rather than of specific practice guidelines. In this section of the paper, they suggest that part of the reason that the traditional advice to “complete the course” has been so resilient is that “it is simple and unambiguous, and the behavior it advocates is clearly defined and easy to carry out” (p. 3). In addition to recommending further research on the appropriate dose of antibiotic, the authors also recommend research to identify “the most appropriate simple alternative messages” (p. 3). One possibility is to tell patients to stop when they feel better–exactly the opposite of what we have generally been told. More immediately, however, they say that doctors should begin to educate patients about the problems with the traditional advice, telling them that antibiotic overuse is the real problem that leads to antibiotic resistance. They suggest that honesty about our current lack of knowledge is better than “simply substituting subtle alternatives” such as the instruction to “take exactly as prescribed” (p. 3).

Take as directed…
A number of the commentaries on the BMJ website express frustration with the article–and with the situation it describes. Some of the commentaries emphasize that the article title is misleading or that the article itself overstates the conclusion that can be drawn based on the available evidence. Others worry that patients will take this article (and the media coverage that suggests that they should stop taking their antibiotics when they feel better) as license to ignore their doctor’s recommendations. One commenter even suggests that patient-centered decision-making is dangerous, and an illusion, when there is still medical debate on a topic. Yet many also agree that there is a problem with current practice.

The problem is that, if Llewelyn et al. are even close to correct, there is no clear direction for physicians or for patients. Confusingly, this seems like a case in which the growing evidence leave us knowing less, rather than more.

Robyn Bluhm photoRobyn Bluhm, PhD, is an Associate Professor in the Department of Philosophy and Lyman Briggs College at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, September 7, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

Note: some articles linked in this commentary may require MSU Library or other institutional access to view the full text.

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How do we explain to patients what genetic test results might mean for their baby when they have only been validated in other populations?

Bioethics Brownbag & Webinar Series logoExpanded Carrier Screening for an Increasingly Diverse Population: Embracing the Promise of the Future or Ignoring the Sins of the Past?

Event Flyer

Race and ethnic groups have been tracking heritable conditions endemic within their communities for decades, but past public health screening programs—e.g., sickle cell testing for African Americans 1970s—were adopted with little thought to scientific accuracy or potential discrimination. Currently, carrier genetic testing is generally offered under professional guidelines aiming to balance potentially clinically actionable information with concerns about healthcare costs and patient anxiety: recommended testing on the basis of family history, self-reported race or ethnicity, or for a condition deemed worthy of universal screening. But some private companies have begun to offer expanded carrier screening, testing all conditions for all patients. Scientists at one such company reported in 2016 in JAMA that expanded carrier screening might increase detection of potentially serious genetic conditions. But what are the implications of returning ancestry information when patients seek medical advice? How do we explain to patients what results might mean for their baby when they have only been validated in other populations? This talk will explore policy options at the intersection of race, reproduction, and commercial use of data.

sept-13-bbagJoin us for Kayte Spector-Bagdady’s lecture on Wednesday, September 13, 2017 from noon till 1 pm in person or online.

Kayte Spector-Bagdady, JD, MBioethics, is a Research Investigator in the Department of Obstetrics and Gynecology at the University of Michigan Medical School and also leads the Research Ethics Service in the Center for Bioethics and Social Sciences in Medicine (CBSSM). Her current research explores informed consent to emerging technologies with a focus on reproduction and genetics. Kayte received her J.D. and M.Bioethics from the University of Pennsylvania Law School and School of Medicine respectively after graduating from Middlebury College. She is a former drug and device attorney and Associate Director of President Obama’s Bioethics Commission.

In person: This lecture will take place in C102 East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Can’t make it? All webinars are recorded! Visit our archive of recorded lecturesTo receive reminders before each webinar, please subscribe to our mailing list.

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Announcing the Fall 2017 Bioethics Brownbag & Webinar Series

bbag-icon-decThe Center for Ethics and Humanities in the Life Sciences at Michigan State University is proud to announce the 2017-2018 Bioethics Brownbag & Webinar Series, featuring a wide variety of bioethics topics. The fall series will begin on September 13, 2017. You are invited to join us in person or watch live online from anywhere in the world! Information about the fall series is listed below. Please visit our website for more details, including the full description and speaker bio for each event.

Fall 2017 Series Flyer

sept-13-bbagExpanded Carrier Screening for an Increasingly Diverse Population: Embracing the Promise of the Future or Ignoring the Sins of the Past?
How do we explain to patients what results might mean for their baby when they have only been validated in other populations?
Wednesday, September 13, 2017
Kayte Spector-Bagdady, JD, MBioethics, is a Research Investigator in the Department of Obstetrics & Gynecology and leads the Research Ethics Service at the Center for Bioethics & Social Sciences in Medicine at the University of Michigan Medical School.

oct-11-bbagCrossing the Biology to Pathobiology Threshold: Distinguishing Precision Health from Precision Medicine
What level of risk will be tolerated for interventions that are developed for treating “pre-diseased” patients?
Wednesday, October 11, 2017
Christopher H. Contag, PhD, is a John A. Hannah Distinguished Professor of Biomedical Engineering and Microbiology & Molecular Genetics, Chair of the Department of Biomedical Engineering, and Director of the Institute for Quantitative Health Science and Engineering at Michigan State University.

nov-29-bbagProspects, Promises and Perils of Human Mind-Reading
What are the prospects for such technology to be widely used?
Wednesday, November 29, 2017
Mark Reimers, PhD, is an Associate Professor in the Neuroscience Program in the College of Natural Science at Michigan State University.

In person: These lectures will take place in C102 (Patenge Room) East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Can’t make it? Every lecture is recorded and posted for viewing in our archive. If you’d like to receive a reminder before each lecture, please subscribe to our mailing list.

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