Dr. Fleck presents at Great Lakes Biorepository Research Network annual scientific meeting

Leonard Fleck photoCenter Professor Len Fleck, PhD, was a keynote speaker at the Great Lakes Biorepository Research Network (GLBRN) Annual Scientific Meeting, held at Beaumont Hospital-Royal Oak Campus on November 3. The title of Dr. Fleck’s presentation was “Precision Medicine, Ethical Ambiguity,” summarized below.

What is precision medicine? A short answer would be getting beyond “one size fits all” drug therapy, with all the side effects and misfits that implies (e.g. traditional chemotherapy). Instead, medicine would stratify patients with a specific disease, such as some cancer, into subgroups so that therapy could be tailored to the specific genetic features of their cancer. The overall goal is to maximize the beneficial effects of an available therapy for a specific patient, minimize debilitating or dangerous side effects, and save money for the health care system. How could there be ethical problems with goals such as that?

The most significant problem relates to health care justice, the fair distribution of access to the fruits of precision medicine. The basic problem is that these targeted cancer therapies are extraordinarily expensive. More than 70 of these cancer drugs have been approved by the FDA since 2000.

  • Cost: $70,000–$200,000+ for a course of treatment.
    • One form of combination therapy is priced at $86,000 per month.
    • Kymriah for Acute Lymphocytic Leukemia (ALL) is priced at $475,000 for a one-time treatment.
  • None of these drugs is curative.
  • Median gains in life expectancy for patients is measurable in weeks or months for the most part.
  • Several hundred more such drugs are in the pipeline.
  • Fojo and Grady have pointed out that these drugs yield incremental cost-effectiveness ratios (ICERs) of several hundred thousand dollars to more than a million dollars per Quality-Adjusted Life Year (QALY).

Imatinib (Gleevec) was approved in 2001 for the treatment of Chronic Myelogenous Leukemia (CML). It is extraordinarily effective for the 70% of these patients who have survived at least ten years beyond diagnosis. It was priced at $36,000 per year in 2001, and must be taken indefinitely. In 2016 imatinib was priced at $146,000, even though nothing at all changed with regard to the drug itself. Another drug, Iclusig, was priced at $120,000 for a year in 2015. In 2016 the price was raised to $200,000. We will pass over in stunned silence at the obvious ethical issues here.

As a society that seeks to be just and caring in meeting health care needs we struggle to identify the ethical norms that should govern access to these targeted cancer therapies. Keep in mind that these drugs are for metastatic cancer, almost always a terminal diagnosis. Consequently, we often appeal to inchoate (and problematic) ethical intuitions. We appeal to the “rule of rescue,” “last chance therapies,” “the pricelessness of human life,” and the “visibility of desperate patients,” all of which seem to generate an ethical obligation to fund access to these targeted therapies. Unfortunately, that obligation runs out of ethical steam once insurance runs out. In health care, our sense of obligation has evolved to select for money.

Some sad conclusions: (1) No moral theories or “compelling” moral arguments are going to yield clearly satisfactory ethical resolution to these allocation/ priority-setting challenges. Not just cancer counts (ethically speaking). (2) Ultimately, given limited resources (money) for meeting unlimited health care needs we will have to rely upon fair and legitimate processes of rational democratic deliberation constrained by relevant clinical evidence and broadly endorsed considered judgments of health care justice. (3) For the foreseeable future, precision medicine will remain infected with clinical uncertainty, ethical ambiguity, disingenuous politicking, and byzantine economic accounting (not to mention pharmaceutical philandering).

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

Event Flyer

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.

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.