Web of Interests Surrounding Medicines Makes Patient Access Increasingly Difficult

Comments open through November 1

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

By Jennifer Carter-Johnson, PhD, JD

A recent New York Times article described the problems that patients are having gaining access to a new class of cholesterol reducers, called PCSK9 inhibitors. This difficulty extends not just to the uninsured but also to patients with insurance. The drug costs are exorbitant, listing as more than $14,000 per year for a drug that may need to be taken indefinitely. Insurance companies are balking at paying so much for the new drug when cheaper cholesterol reducers are available. Patients for whom the old cholesterol reducers do not work are forced to jump through many time-consuming hoops – mountains of paperwork, proof that other drugs have failed, and appeals after initial denials of coverage – before drug coverage approval for the PCSK9 inhibitors.

It is easy to blame the drug companies in this situation. Why must they charge so much?!?! This question has become more common considering recent news stories about drug company price increases designed only to increase profits. But high drug costs are only one obstacle for patients to access drugs. Insurance coverage dictates cost of drugs to patients from nominal co-pays to out-of-pocket self-funding. Attempts to address one issue without addressing the entire web of interests is doomed to failure.

8122717537_c2d86c7df9_h

Image description: A close-up photograph of a spider web that is covered in water droplets. The web takes up the entire frame and is in focus, the background is blurred and includes green and purple tones. Image source: nils.rohwer/Flickr Creative Commons

Drug Companies and Federal Regulations

Drugs cost money and time to develop and produce. All drugs must undergo scrutiny from the U.S. Food and Drug Administration, where drug developers must prove both the safety and efficacy of the potential drug before it is sold. The process takes on average 12 years between lead compound identification and final approval, and often costs close to a billion dollars absent streamlined approval processes for certain rare diseases. The billion-dollar cost estimate includes the cost of research for the failure of the many compounds that enter clinical trials but are deemed either unsafe or ineffective for the disease to be treated.

Thus, drug companies charge prices to recoup this huge research investment. Prices also pay for manufacturing and advertising as well as profit margins of close to 20% to fuel further investment. While there are mechanisms in place to incentivize generic drug manufacturers to enter the market and decrease prices through competition, branded drug companies have strategies to delay generic entry that have come under recent legal scrutiny.

Private Insurance and Federal/State Medical Programs

While drug costs are high due to the myriad factors described briefly above, patients are often insulated from some of those costs by insurance companies that cover the cost of drugs. Insurance comes in a variety of forms. Private insurance may be procured on the open market or through employer coverage. In the latter, the employer may cover some or all the costs of the insurance. Senior citizens rely on the Federally-sponsored Medicare program for medical coverage, though private supplements insurance policies are also the norm. Those too young for Medicare and too poor for private insurance (with or without an employer subsidy) are forced to rely on state Medicaid programs.

Unfortunately, not every insurance plan covers every drug. Insurance companies produce a formulary of covered drugs for each plan. The insurance plan negotiates a price, often significantly cheaper than the drug’s list price, that it will pay the drug manufacturer. More expensive drugs may require insurance pre-approval and multiple rounds of paperwork from the prescribing doctor.

Insurance companies have an incentive to reduce the usage of expensive drug alternatives. For private insurance companies, that incentive is profit. In fact, for-profit insurance companies know how to play this game quite well; many have profits in excess of 6 billion dollars. Medicaid and Medicare programs have limited budgets for all medical costs including drugs. While increased Medicaid funding for states offered through the Affordable Care Act was effective in decreasing uninsured rates, government funding is always in flux due to political pressures.

Doctors and Pharmacists

Doctors have great discretion in prescribing drugs. While doctors hold their patients’ health as the highest goal, knowledge of insurance (or its lack) may influence the doctor’s choice of drugs. Denial of a drug may well mean many, many more forms for a doctor who wants to make sure her patient has the best, most expensive drug. Doctors who do this for multiple patients could soon find themselves spending as much time on drug paperwork as medical care. Many doctors have taken to giving samples of drugs – left by drug companies as part of their advertising budgets – to patients who cannot afford the drug but need it.

Pharmacists exist at the epicenter of the patient’s dilemma. Patients often find out that insurance is not covering the drug when the pharmacist explains the situation. More troubling is the fact that drug prices are sometimes cheaper for a patient without insurance. For instance, a patient may have a twenty-dollar co-pay, but the drug may only cost ten dollars. For years, pharmacists have been subject to “gag clauses” in contracts between pharmacies and pharmacy benefit managers that prevent them from disclosing to the patient the cheaper alternative. Recent legislation signed this month has banned this practice.

Patients

Caught in this web of diverse and conflicting interests are the very people for whom drugs are created and vetted and prescribed – patients. Drug manufacturers must be able to recoup costs, but if no one can afford the drug how will they make sales? Additionally, drug pricing is a convoluted process that varies between insurance policies, pharmacies, and branded or generic formulations. Insurance coverage is often dictated by employer, age, or resources. Lack of coverage for a specific drug might mean the patient is faced with choosing a different drug or a different job. But asking about insurance formularies during a job interview would be quite difficult even if switching jobs in the midst of a medical crisis were possible. On the other hand, determining drug needs in advance is almost impossible. Finding a doctor with the time to work with a patient on an involved approval process is becoming more difficult given the increasing shortage of doctors in the United States.

Sitting in the center of this web of interests, patients have the most to gain and the most to lose from any overhaul of our drug system. It is impossible to fix all the problems by focusing only on the problems in one area. Unfortunately, patients are also a very small voice in the web that includes pharmaceutical companies, insurance companies, and medical professionals.

Jennifer Carter-Johnson photo

Jennifer Carter-Johnson, PhD, JD, is an Associate Professor of Law in the College of Law at Michigan State University. Dr. Carter-Johnson is a member of the Michigan State Bar and the Washington State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 1, 2018. 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.

More Bioethics in the News from Dr. Carter-Johnson: Humanity in the Age of Genetic ModificationDefining The Spectrum of “Normal”: What is a Disease?Dawn of False Hope: Spread of “Right To Try” Laws across the U.S.Designing Children: Patents and the Market are not Sufficient Regulation

Click through to view references

Posted in Bioethics in the News, Uncategorized | Tagged , , , , , , , , , | 2 Comments

Bioethics for Breakfast: Values at the End of Life: The Logic of Palliative Care

Bioethics for Breakfast Seminars in Medicine, Law and SocietyRoi Livne, PhD, presented at the Bioethics for Breakfast event on October 4, 2018, offering perspective and insight on the topic “Values at the End of Life: The Logic of Palliative Care.” Leonard Fleck, PhD, moderated this session.

Over the past forty years, “the end of life” has become the center of extensive economic, policy, ethical, and medical discussions. Health economists measure and evaluate its cost; ethicists debate the morality of various approaches to “end-of-life care”; policymakers ponder alternative “end of life”-related policies; and clinicians apply a specialized approach (hospice and palliative care) to treat patients whom they diagnose as being at “the end of life.” How are those many-faceted conversations emblematic of this particular moment in history? How are the limits of what can be done, both medically and financially, to prolong life communicated to severely ill patients and families? Dr. Livne’s analysis drew from a combination of historical and ethnographic work conducted with palliative care clinicians in three California hospitals.

Roi Livne
Roi Livne is an Assistant Professor in the Department of Sociology at the University of Michigan. He received his PhD in sociology from the University of California, Berkeley in 2016. An economic sociologist at heart, he studies everyday economic life and its somewhat awkward intersections with morality. His book, Values at the End of Life: The Logic of Palliative Care is forthcoming this February in Harvard University Press. The book develops a historical and ethnographic account of the deeply personal relationships between financial considerations, emotional attachments, and moral arguments that motivate end-of-life decisions in American hospitals. Livne’s other research is on the techno-politics of sovereign debt management. He has published in the American Sociological Review and Socio-Economic Review.

About Bioethics for Breakfast:
In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Ethics to partner on a bioethics seminar series. The Center for Ethics and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.
Posted in Bioethics Events, Friends of the Center, Outreach, Uncategorized | Tagged , , , , , , ,

Dr. Fleck facilitates occupational and environmental medicine workshop at Michigan conference

Leonard Fleck photoCenter Acting Director and Professor Dr. Len Fleck held a workshop at the annual Michigan Occupational Health Conference in Grand Rapids, MI on September 28. Dr. Fleck’s workshop was on “Occupational and Environmental Medicine: Ethical Challenges.”

The primary ethical challenge for physicians in occupational medicine is the dual loyalty challenge. More specifically, they are employed by (or contracting with) some large company to address health issues related to employees. In the workshop itself, attendees considered several concrete examples of this challenge, in particular, what might be regarded as emerging challenges related to emerging genetic technologies. A concern in many workplace situations that involve numerous chemicals is the health and safety of workers. Some workers may be susceptible to serious medical disorders related to such exposures for genetic reasons, but the required exposure might have to be over a prolonged period of time. An employer might offer to pay for whole genome sequencing to identify workers with such risks, in part for morally sound reasons (not wanting to cause avoidable harm to these workers), in part for more selfish economic reasons (not wanting to be at risk for large future health costs). An occupational physician would receive that information, and be expected to pass it along to an employer (who paid for it).

However, there are privacy rights that seem to be at risk; there are also issues of respect for patient autonomy. One worker, in the example Dr. Fleck gave to the audience, was found to be at 30% increased risk for colorectal cancer after ten years of exposure to a specific chemical. He did not want the physician to report that genetic vulnerability to his employer for fear of losing his job. He was willing to accept the risk. What is the right thing to do, all things considered? Several physicians said their responsibility extended only to determining “fitness to work.” And this worker was not going to drop dead next month or next year as a result of this vulnerability. So they would not report that result. Others asked about the details of the agreement with the company. Should the occupational physician strongly counsel this patient? One response was that this was the job of the primary care physician that this individual might have. In brief, discussion was vigorous and interesting.

Posted in Bioethics Events, Center News, Uncategorized | Tagged , , , , , , ,

Dr. Cabrera will help guide ethical development and use of electrical-based psychiatric treatments

Laura Cabrera photoA team led by Center Assistant Professor Dr. Laura Y. Cabrera will examine the ethical concerns, beliefs, and attitudes of psychiatrists, patients, and healthy members of the public, including caregivers, regarding the development and use of psychiatric electroceutical interventions (PEIs).

The U.S. National Institutes of Health BRAIN Initiative has awarded a four-year, $1,414,478 grant to the Michigan State University team, which also includes Professor Aaron M. McCright (Sociology), Associate Professor Robyn Bluhm (Philosophy and Lyman Briggs College) and Associate Professor Eric Achtyes (Director of the College of Human Medicine Division of Psychiatry and Behavioral Medicine).

Using electrical stimuli to treat psychiatric conditions, PEIs offer great promise in addressing the profound suffering related to such disorders. While PEIs have been available in various forms for years, divergent perceptions among medical professionals, patients, and the broader public have impeded their wider adoption in practice. Key stakeholders’ concerns, beliefs, and attitudes also might affect the future adoption of novel, more invasive PEIs. As new PEIs emerge in the neurotechnology landscape, it is urgent to understand such concerns and related social policy choices.

“This grant could not come at a better time, and we are grateful to the National Institutes of Health for recognizing the importance of this issue and supporting our proposal,” said Dr. Achtyes, who has seen firsthand the benefits of such treatments.

Cabrera-McCright-Achtyes-Bluhm

Pictured left to right: Laura Cabrera, Aaron McCright, Eric Achtyes, Robyn Bluhm.

Dr. Cabrera, whose research focuses on neuroethics and is leading the effort as the Principal Investigator, said, “I am delighted for this exciting opportunity to lead our team of experts and work together towards the sustained ethical development and translation of this type of psychiatric treatment.”

The significance of this work lies in anticipating potential future policy challenges in ways that will both effectively safeguard sustained ethical PEI development and translation, and benefit individuals affected by mental health disorders.

“One strength of our project is that we have experts from philosophy, neuroethics, psychiatry, and sociology working closely together. So, the insights we generate will likely transcend typical disciplinary boundaries and hopefully will be more meaningful to key stakeholders,” said Dr. McCright.

Please visit the Center’s website for updates on this project.

Posted in Center News, Research, Uncategorized | Tagged , , , , , , , , , , ,

Medical workforce diversity research published in ‘Medical Education’

Karen Kelly-Blake photoLibby Bogdan-Lovis photoAn article from a multi-institution research team led by Center Assistant Professor Dr. Karen Kelly-Blake and Assistant Director Libby Bogdan-Lovis has been published in the September 2018 issue of Medical Education.

In “Rationales for expanding minority physician representation in the workforce: a scoping review,” the authors discuss “rationales for and approaches to expanding under‐represented minority (URM) physician representation in the medical workforce” found in their scoping review of fifteen years of literature.

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

Dr. Kelly-Blake and Libby Bogdan-Lovis further discussed their article in an interview for the Medical Education podcast series.

Related items from the Center:

Posted in Articles, Center News, Publications, Research, Uncategorized | Tagged , , , , , , ,

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

Tom Tomlinson photoCenter Professor Dr. Tom Tomlinson has a new commentary in the September 2018 American Journal of Bioethics. In “Getting Off the Leash,” Dr. Tomlinson discusses “digital medicines” and what such technologies mean for patient privacy. He asks questions such as: do patients have a right to deceive their clinicians? Why would patients be deceptive?

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

Posted in Articles, Center News, Publications, Uncategorized | Tagged , , , , ,

Dr. Fleck facilitates ethics workshop at Michigan pediatrics conference

Leonard Fleck photoOn September 14, Center Professor and Acting Director Dr. Leonard Fleck and Dr. Kenneth Pituch, MD, ran an ethics workshop at the Michigan Chapter of the American Academy of Pediatrics (MIAAP) 68th Annual Conference. The workshop, “Ethical Challenges in the Care of Seriously Ill Children,” focused on two cases: a growth attenuation case, and a Trisomy-18 newborn case.

The growth attenuation case involved a 7-year-old boy with severe developmental delay related to a CMV infection in utero. Parents are middle-aged and “not in great health.” They requested growth attenuation hormone therapy so that they would be able to manage the care of their child for many more years. No one doubts that they are devoted parents. The relevant ethical considerations concerned the best interests of this child and parental rights to make medical decisions for their children. On the face of it, it looks like the parents are making this decision for their benefit, i.e., easier care management for this child. While this is true, as the discussion brought out, it is also the case that this would be in the best interest of the child as well. More specifically, this child will not be deprived of any life experiences as a result of growth attenuation because of his severe developmental delay. Hence, growth attenuation does not represent a harm to this child.

Dr. Fleck and Dr. Pituch’s other case involved a Trisomy-18 newborn. In the past these children had dismal prospects. Virtually all of them died before age one, most often because of cardiac anomalies. Today, complex surgeries can be done on these children, all of which are risky. Consequently, some of these children can survive into their twenties, though this will be with severe cognitive deficiencies. The ethical challenge for pediatricians is determining what sort of conversation to have with parents regarding treatment or non-treatment options. In the case discussed, this was complicated by the fact that a representative of a Trisomy-18 support group contacted these parents one day after the birth to “assure” them that they did not have to choose non-treatment. The problem with these support groups is that they tend to be excessively optimistic and do not know the medically relevant and ethically relevant details associated with prospects for a particular infant. This can complicate the conversation that a pediatrician must have with these parents, and can potentially sow the seeds of distrust. What would clearly be the ethically and practically wrong thing to do would be to tell these parents to pay no attention to these support groups. Overall, the discussion in this workshop was lively and thoughtful.

Posted in Bioethics Events, Center News, Uncategorized | Tagged , , , , , , ,