Tag: pharmaceutical industry

Bioethics for Breakfast: Can Pharmaceutical Cost Control Be Achieved Ethically with Surgical Precision?

Bioethics for Breakfast Seminars in Medicine, Law and SocietyPaula Cunningham and Craig Hunter presented at the February 6th Bioethics for Breakfast event, offering perspectives and insight on the topic “Health Reform: Can Pharmaceutical Cost Control Be Achieved Ethically with Surgical Precision?”

This year’s Bioethics for Breakfast series is focused on a central theme: “Is There a Cure for Our Sick Health Care System?” The series is generously sponsored by Hall, Render, Killian, Heath & Lyman.

There is virtually unanimous agreement among health policy analysts that something must be done to control health care costs, especially pharmaceutical costs, which are often a major burden for the elderly. Consumers and taxpayers are also demanding that health care costs be controlled and reduced, most often with regard to drugs. This is why the recent focus has been on the price of drugs. However, any practical proposal to reduce drug health care costs has been denounced as rationing and/or as a threat to medical innovation. The result has been political inertia and economic exuberance (for for-profit health care corporations), with $3.8 trillion in U.S. health spending in 2019 and projections of $6.0 trillion total health spending for 2027. What forms of drug-related health care cost control are you willing to accept for yourself and those you care about? What do you see as the ethical challenges that must be addressed by any effort to control such health care costs, especially for the elderly?

Speaker Paula Cunningham, State Director of AARP Michigan, highlighted the struggles that people in Michigan face regarding the price of prescription drugs, noting that some individuals travel to Canada because the cost there is drastically lower. Cunningham shared the AARP “Stop Rx Greed” campaign as an example of their advocacy work in this area. She also noted that there are several pieces of legislation being worked on in Michigan and at the national level, such as an importation bill, that would reduce prescription drug costs. She finally stressed that this issue is not just about data and facts, it is about people’s lives.

Speaker Craig Hunter, Director of Specialty Program Outcomes and Analytics for CVS Health, brought industry expertise to the discussion and provided an economic perspective on the issue. He shared three main points, the first being that we need to rethink the question “can medical outcomes be achieved ethically with surgical precision?” because economic structures in the U.S. are not set up in a way that drives synergy. Hunter then discussed the need for structural changes to encourage creative solutions. When asking those in attendance if they believed that drugs in the U.S. are a public good, a minority responded in agreement. Hunter pointed out that this question has been answered very differently in other countries. Finally, Hunter noted that, regardless of “right or wrong,” the market is responding to its own stimulus; the business has been incentivised for certain outcomes.

Attendee questions and comments came from a variety of perspectives, including physicians, legislative staff, and community leaders. There was discussion of direct-to-consumer advertising, drug patents, and the barriers that exist for the consumer within this complex system.

About the Speakers

Paula Cunningham
Paula Cunningham, MLIR, is State Director of AARP Michigan, which has more than 1.4 million members. She is former President of Lansing Community College, and in the business community was CEO of Capitol National Bank. She serves on numerous boards, including, but not limited to, Davenport University and McLaren Health Systems-Lansing. Paula is in the Michigan Women’s Hall of Fame and was the first African American woman in the country to be president of a majority owned bank.

Craig Hunter
Craig Hunter is the Director of Specialty Program Outcomes and Analytics for CVS Health, providing leadership and oversight for outcomes-based financial reconciliations negotiated across specialty drug and patient management products. Previously Craig worked at Eli Lilly, first as the Lead Outcomes Scientist for the U.S. Alzheimer’s and Oncology franchises, and later leading U.S. Outcomes Customer Engagement. Additional previous experience includes time consulting as well as Primary Investigator for a USAID-funded project examining the intersection of traditional and western medicine in South Africa. Craig earned his MPP from the University of Chicago and a BA in Communications (Rhetoric)/Political Science from Furman University.

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.

Botox for Millennials?

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

By Devan Stahl, PhD

When I was in my mid-twenties I went to my physician to have a mole on my face removed. Before my dermatologist began the procedure, however, she suggested I consider another procedure: Botox. Botox for someone my age was “preventative,” she explained; if I could not move my facial muscles, I was less likely to develop wrinkles. To add insult to injury, she held up a mirror and pointed out all the lines on my face when I frowned (which I was doing at that moment, irked that my doctor was trying to push Botox on me). The experience was unsettling. Our culture is saturated with impossible beauty standards for women, but I did not expect my doctor to perpetuate these standards or to try to make money off of my potential insecurities.

I had nearly forgotten about this experience until last month, when my social media and online streaming services were inundated with advertisements for Botox® and Juvéderm® fillers that smooth wrinkles and plump lips. The advertisements were clearly geared toward millennial women such as myself. The ads push messages of personal empowerment. “My lips are my vocal advocates for self-acceptance,” one model says. “Command it, boss it, #juvedermit,” reads the tagline.

The drug company Allergan produces both Botox and Juvéderm, which some have deemed “cosmeceuticals” or cosmetic pharmaceuticals. According to news reports, Allergan’s aim over the next year is to increase sales to millennials as more products come on the market. According to a spokesperson for the company, they aim to “educate and empower consumers to do what is right for them when it comes to aesthetic treatments.” This push means that millennials are likely to see an increasing number of targeted ads that play upon social norms of beauty and youth to sell injectable toxins that have unknown long-term side effects. And although the short term risks might be seen as minimal (including pain at injection site, trouble breathing or swallowing, double vision, drooping eyelids, and more), studies have shown that when advertisements rely upon idealized forms of beauty to market cosmeceuticals, the social and psychological risks of not using the product detract from its known physical risks.

Botox and fillers are part of a multibillion dollar beauty and anti-aging industry in the U.S. According to a 2017 report by the American Society of Plastic Surgeons, 7.2 million Botulinum Toxin Type A procedures are performed in the U.S., which is up almost 800% since 2000. Although Botox and fillers have traditionally been used by an older demographic, millennials (ages 20-34) make up a fast growing demographic of Botulinum users. This means big money for companies like Allergan. The effects of Botox only last 4-6 months and cost around $300 to $400 a session. Their consumer potential means millennials are now being aggressively targeted by doctors (both dermatologists and dentists) as well as pharmaceutical companies. The pitch to these mostly wrinkle-free patients is that Botox will prevent wrinkles from forming, “it is best to clean your room before it gets dirty,” claims one dermatologist.

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Image description: A still from a Juvéderm® video advertisement shows a young woman touching her face with two fingers; text reads “SMOOTH IT Juvéderm® XC.” Source: JUVÉDERM IT : JUVÉDERM®/YouTube.

Beauty expectations for women have always been high, but some have speculated the turn to cosmeceuticals by young women has likely increased as a result of celebrity endorsements (Kylie Jenner famously announced she is a frequent user of lip fillers) and social media platforms such as Instagram that allow users to filter pictures. As Botox and other cosmeceuticals become more mainstream (and Allergan hopes they will by producing not only advertisements, but also blogs and podcasts), social norms are beginning to change such that young women are feeling increasing pressure to use biomedical technologies to preserve and enhance their youth. Cosmeceuticals increase the pressure on women to look young and cultivate feelings of inadequacy, according to Dana Berkowitz, author of Botox Nation: Changing the Face of America. Young women begin Botox because of their fear of looking older, even before they begin seeing major age-related changes in their faces.

The appeal of the technological fix is powerful to both men and women, young and old, in a culture that prizes youth and attractiveness. The reasons people use Botox and other anti-aging procedures are multi-faceted and should not simply be reduced to mere vanity. According to Berkowitz, young women claim Botox helps them get ahead in the workforce, helps them to feel good about themselves, and is common place in certain sectors of society. Whatever the reasons, however, the result of the normalization of cosmeceuticals is that aging is becoming increasingly pathologized, and our anxieties surrounding the natural aging process are likely to increase. “It is really up to you,” one Botox ad proclaims: “You can choose to live with wrinkles. Or you can choose to live without them.” Those who refuse to use cosmeceuticals are thus complicit in the dreadful aging process. Pharmaceutical companies and even some doctors are keen to encourage and capitalize on our aging insecurities.

Devan Stahl photoDevan Stahl, PhD, is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Pediatrics and Human Development in the Michigan State University College of Human Medicine.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, February 7, 2019. 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. Stahl: Making Martyrs of Our Children: Religious Exemptions in Child Abuse and Neglect Cases; Mass Shootings, Mental Illness and Stigma; Disability and the Decisional Capacity to Vote

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Web of Interests Surrounding Medicines Makes Patient Access Increasingly Difficult

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.

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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 Modification; Defining 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

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“Ask your doctor” – or just check Instagram?

This post is a part of our Bioethics in the News seriesBioethics in the News logo

By Robyn Bluhm, PhD

A couple of months ago, Kim Kardashian posted – and then quickly deleted – and then reposted – an Instagram advertisement promoting a morning sickness drug.

If this story sounds familiar, it may be because she did the same thing, for a different drug by the same manufacturer, in 2015. For the first post, the FDA issued a warning to the drug’s manufacturer, saying that the drug did not include information, e.g., about risks, required for pharmaceutical advertisements. Kardashian then posted a revised version that included the information missing in her initial post.

Direct-to-consumer (DTC) marketing of pharmaceuticals is not new. DTC marketing has been permitted in the U.S. by the FDA since the early 1980s, though it became much more common after 1997, when a number of restrictions on ad content were lifted. Since then, the use of these ads has greatly increased; in 2016 pharmaceutical companies spent $5.6 billion on ads, a 9% increase from the previous year.

Kim Kardashian Instagram post
Image description: Kim Kardashian’s Instagram post from June 20, 2018, showing a photograph of Kardashian holding a bottle of Bonjesta. Image source: @kimkardashian/Instagram.

Celebrity endorsements are also not new; they date back to the 18th century when Josiah Wedgwood used the patronage of the British royal family and other aristocrats to distinguish his china from competitors’. According to Megan Smith-Mady, one of the earliest uses of celebrity endorsement for pharmaceuticals had Mickey Mantel promoting an arthritis drug on TV talk shows. (YouTube actually shows him doing a commercial about athlete’s foot in 1976, though it’s best not to click on that link.) Smith-Mady also notes that the FDA responded quickly to this campaign, worried that viewers might not recognize that he was getting paid to promote the drug.

Since then, the relationship between celebrities and health care marketing has become more common – and more complicated. There have been many instances of celebrities appearing in commercials for medications (prescription or otherwise), and also of endorsing various medical devices and services related to health care.

Given all of this, Kardashian’s Instagram post is nothing new. Or is it? There is also reason to think that the use of social media in advertising for medical products may raise new ethical issues. For one thing, most countries do not permit DTC marketing of pharmaceuticals; in fact, Kardashian’s post includes a note saying that it is “for U.S. residents only.” Using social media is a way of getting around advertising bans.

Another thing to consider is the potential to target a younger market than can be reached with, for example, television or magazine ads. Not only do popular TV and film celebrities tend to have a strong social media presence and lots of followers, but celebrities whose fame is built entirely on social media platforms are becoming more common. One study found that respondents aged 13-24 were more likely to say that they would buy a brand or a product recommended by a YouTube star than by a traditional star. And while digital stars don’t (yet?) have the fame of “traditional” celebrities, top YouTube stars have Q scores (a rating of the familiarity and appeal of a celebrity) that are comparable to some traditional stars. Another study suggests that more children and teens consider social media celebrities to be role models more than they are influenced by musicians and actors.

Finally, I want to go back to the concern raised about Mickey Mantel’s talk show appearances – that it wasn’t clear that he was getting paid for his comments. In one sense, that worry now seems quaint; I think we are much more skeptical now about celebrity endorsements. And, in fact, some of Kardashian’s followers were less than impressed by her advertisement.

In another sense, though, new forms of online media do seem to complicate the relationships among information, marketing, medicine, and entertainment. Consider this: I first learned about the Instagram post via Bioethics.net, a site run by an academic bioethics journal. It linked to an article by Art Caplan, a well-known bioethicist (and one whose relationship with the media has been subject to attention). Caplan’s article appeared in LeapsMag, a new online publication focusing on news in the life sciences. On its “about” page, the publication hastens to describe itself as “an editorially-independent online magazine,” though you have to scroll down to find out that the reason it seems to be protesting its independence too much is that it was created by Bayer and is “the first magazine for mainstream readers created by a pharmaceutical company.”

But wait – there’s more. In looking online for information about Bayer and Leaps, I also found out that the company is currently feuding online with the makers of a new Netflix documentary, The Bleeding Edge. The movie documents problems in the medical device industry, and Bayer’s Essure contraceptive device is one of the central cases discussed (Bayer actually decided, for purely business reasons, to stop marketing the device the week before the documentary premiered. It’s worth noting, too, that Bayer released a “fact check” on the movie the day The Bleeding Edge premiered on Netflix, based on its April screening at a film festival.) And this feud is being covered by Variety, which started as a trade magazine for the entertainment industry, but now has a website and a Twitter following that vastly outstrips its print circulation.

What do I make of all this? I’m honestly not sure. I recognize that there are important differences between a documentary film and an Instagram post, even if both are reaching audiences through new online media. And I also recognize that there are arguments both for and against DTC marketing of pharmaceuticals. But it seems clear that the way that we get information about health and medicine is changing. Pharmaceutical companies are definitely paying attention to online media, so bioethicists should be, too.

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 6, 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. Bluhm: Antibiotics: No Clear Course; To Floss or Not to Floss? That’s not the question

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Dr. Cabrera and team published in ‘Neurosurgical Focus’

Laura Cabrera photoCenter Assistant Professor Dr. Laura Cabrera and co-authors Hayden M. K. Boyce, MD, Rachel McKenzie, and Robyn Bluhm, PhD, have an article in the August 2018 issue of Neurosurgical Focus. “Conflicts of interest and industry professional relationships in psychiatric neurosurgery: a comparative literature review” stems from the authors’ Science and Society at State (S3) project, “Psychiatric Interventions: Values and Public Attitudes.”

Abstract: Objective: The research required to establish that psychiatric treatments are effective often depends on collaboration between academic clinical researchers and industry. Some of the goals of clinical practice and those of commercial developers of psychiatric therapies overlap, such as developing safe and effective treatments. However, there might also be incompatible goals; physicians aim to provide the best care they can to their patients, whereas the medical industry ultimately aims to develop therapies that are commercially successful. In some cases, however, clinical research may be aiming both at improved patient care and commercial success. It is in these cases that a conflict of interest (COI) arises. The goal of this study was to identify differences and commonalities regarding COIs between 2 kinds of somatic psychiatric interventions: pharmacological and neurosurgical.

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

To learn more about this study, listen to Laura Cabrera, Robyn Bluhm, and Rachel McKenzie on the Center’s podcast, No Easy Answers in Bioethics: Public Perception of Psychiatric Interventions: Cabrera, Bluhm, and McKenzie – Episode 5.

Greed Is God: The Divine Right to Avaricious Drug Pricing

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

By Leonard M. Fleck, PhD

Some recent headlines worth noting: “U.S. Prescription Drug Costs Are a Crime,” “Americans Say They are Suffering as Drug Costs Continue to Rise,” “When $65,000 for a Drug is Applauded.” There were also headlines about Trump saying he was going to do something about unconscionable drug prices. This sounded like fake news, so I passed over those headlines.

At a recent health insurer conference, David Mitchell, president of Patients for Affordable Drugs, was quoted as saying, “The system is not working right, and it starts with drug companies setting the price. But everybody in the system is making more money on the higher retail price – PBMs (Pharmacy Benefit Managers), insurers, doctors administering drugs in the office … It’s exacerbated down the supply chain.” Mitchell has multiple myeloma with drug costs of $400,000 per year.

In 2001, imatinib (Gleevec®) made the cover of Time magazine. Imatinib is used to treat chronic myelogenous leukemia (CML). Over 70% of patients treated with this drug were still alive after ten years. The cost of the drug in 2001 was $36,000 per year. By 2017, the cost of the drug had risen to $146,000. Nothing changed about the drug during that interval. Production costs were the same; no additional research was necessary. Patients, however, were economic captives. Greed works.

Human life is priceless. That was the theme of a pharmaceutical video ad from a couple years ago. The implicit theme was that if your friends and family were unwilling to pay $100,000 for a drug for an extra year of life, they were obviously heartless, unethical atheists. Recall the drug sofosbuvir for hepatitis C, the $1000 per pill drug. Gilead Sciences bought the drug for $11 billion from a small research company. Sales of the drug in year one came to $10.4 billion, thereby recouping the entire cost of its “research.” It cost $10 per pill to make the drug. Gilead could charge $100 per pill, which yields a profit of 900%. However, human life is priceless, so it is more ethical to make a profit of 9900%. Greed is clever.

money pills 2 Lisa Yarost flickr
Image description: an orange pill bottle is shown on its side with capsules spilling out onto a white surface. The capsules are transparent and filled with shredded U.S. currency. Image source: Lisa Yarost/Flickr Creative Commons.

More than 90 targeted cancer therapies have FDA approval with costs per year or per course of treatment from $100,000 to $250,000 or more. They treat metastatic cancer; none of them is curative, generally yielding gains in life expectancy measurable in months, not years. For example, palbociclib (Ibrance®) is used to treat hormone-receptor positive advanced breast cancer. In treatment-naïve patients the cost per Quality-Adjusted Life-Year (QALY) gained is $768,498, while in patients who failed earlier treatments the cost per QALY is $918,166. These are cost-effectiveness figures.

In the United States, an intervention is judged cost-effective below $100,000 per QALY. The National Institute for Health Care Excellence (NICE) in the UK initially refused to include palbociclib as a covered medication in the National Health Service, but reversed that decision after price concessions. Congress, however, is prevented by law from permitting the use of cost-effectiveness as a basis for excluding a drug from Medicare coverage. This law was a product of intense lobbying by the pharmaceutical industry in 2006 using as an “ethical argument” that no patient should be denied access to a safe and effective drug merely because of price. Medicare was also forbidden by law (same lobbying effort) from either dictating the price of a drug or using its 44 million covered lives to extract huge price discounts from pharmaceutical companies in the way European countries do. Greed is politically savvy.

Pharmaceutical companies claim massive research costs. The Tufts Center for the Study of Drug Development claimed a successful cancer drug costs $2.6 billion. Dr. Jerry Avorn, faculty in the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School, has critically assessed that work and concluded a more honest number is about $650 million. These debates make it appear that enormous analytical accounting work goes into justifying the price of a drug. However, the Wall Street Journal (no apologist for left-wing anti-pharmaceutical rhetoric) reported how the price of Ibrance was initially set at $9,850 per month in 2015. A bunch of executives sat around a table, looked at what insurance companies were willing to pay for comparable cancer drugs, and set the price accordingly. Before that price was made public, these executives noted that the price of everolimus (Afinitor®) had just been raised by $1,300 per month ($14,350). They were concerned they had set the price too low. Greed fell short there.

Overall, however, greed is amply rewarded. Researchers Vinay Prasad and Sham Mailankody looked at ten cancer drugs with development costs of $9 billion. Those ten drugs have generated revenue of $67 billion thus far, with years remaining on their patents. Greed pays well.

Pharmaceutical companies have purchased expensive academic talent to justify the cost of their drugs, such as Precision Health Economics (PHE), founded by Tomas Philipson, Dana Goldman, and Darius Lakdawalla, all full professors at the University of Chicago or the University of Southern California. In one article, “The Long-Term Impact of Price Controls in Medicare Part D,” associates of PHE found that proposed price controls would reduce the life expectancy of the cohort born 1991-95 by two years. In addition, “We find that price controls would reduce lifetime welfare by $5.7 to $13.3 trillion for the US population born in 1949-2005.” (Moreno G et al.) Those are scary numbers, relative to which cost-effective numbers of hundreds of thousands of dollars for various cancer drugs are economic crumbs. PHE has been intensely criticized in one ProPublica essay. Greed is seductive.

It is hard to imagine Big Pharma being inundated with warm fuzzies from the general public. However, Big Pharma has millions of zealous adherents ready to mount the legislative barricades on their behalf. 83% of patient-advocacy organizations received funding from the pharmaceutical industry and 36% have an executive from one of these firms on their board. Efforts to control drug prices are denounced as rationing or as threats to further life-saving innovation. Further, these drug companies are perceived by patients as being generous and compassionate because they provide coupons worth thousands of dollars each to patients faced with high co-pays. If a patient needs a $65,000 drug and has an unaffordable co-pay of $15,000, it is good business sense to cover that $15,000 cost to obtain $50,000 from the insurance company for a drug costing $5000 to produce. Greed is compassionate (toward the insured).

Compassionate greed has become a political, economic, and ethical reality, perfectly congruent with the Gospel of Prosperity. Health and wealth will be yours if you have unshakeable faith in the innovative grace of Big Pharma and respect their God-given right to price drugs at heavenly prices. If you prefer not to pray at the altar of Big Pharma, consider sending a copy of this essay to your member of Congress.

Fleck smallLeonard M. Fleck, PhD, is a Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Philosophy 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, April 5, 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.

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Dr. Fleck presents at Michigan State Medical Society Conference on Bioethics

Len Fleck photoCenter Professor Dr. Len Fleck presented at the 20th Annual Michigan State Medical Society Conference on Bioethics, held on November 12, 2016 in Ann Arbor. The theme of the conference was “Ethical Issues in the Pharmaceutical Industry: Current Controversies and Challenges.” Dr. Fleck’s presentation was titled “Curing Hepatitis C: Whose Cost? Whose Responsibility?” Dr. Fleck discussed several ethical and policy issues around the drug Sofosbuvir, otherwise known as the $1000 pill. This is a drug that requires 12 weeks of treatment at a cost of about $100,000.

There are about 3.2 million Americans who are Hepatitis C (HCV) -positive. About 30% of those individuals do not know they are HCV-positive. Unlike most drugs on the market today, this drug is actually curative for up to 95% of patients treated. But the cost of treating all Americans who are HCV-positive at current prices would be $300 billion.

About 800,000 HCV-positive individuals are covered by Medicaid. No Medicaid program can afford to provide this drug to all HCV patients without a massive shifting of resources that would be neither just nor justified. The relevant medical facts are that HCV could result in life-threatening liver problems for as many as 70% of these patients, but these outcomes would typically be ten to thirty years after infection (if ever). Many of these individuals will die of something else, which is one reason why Medicaid wants to avoid paying to treat these individuals. Also, the Medicaid population “churns” a lot from year to year, primarily because many individuals are successful in getting jobs and getting out of poverty. Consequently, someone else would become responsible for paying for the drug (if they have a job with employer-sponsored insurance). To limit costs most Medicaid programs require recipients of the drug to have advanced liver fibrosis, Stage F3 or F4. This is ethically problematic because Sofosbuvir will cure their HCV but not stop disease progression. Consequently, 7% of F3 patients will die of complications of liver disease and 22% of F4 patients will suffer that fate. This is not at all ethically or medically congruent with the way heart disease or cancer or other chronic degenerative conditions would be treated in these patients.

Dr. Fleck concluded three things: (1) The price of Sofosbuvir is unconscionable; there is no ethical or economic justification for that price. (2) Medicaid programs would be on sounder ethical ground if treatment were initiated no later than F2 where 3% of patients would still die of liver complications. (3) The deeper source of the ethical issues in this case is the fragmentation of the American system for financing access to needed and effective health care. That fragmentation encourages the diffusion and disavowal of responsibility for meeting the health care needs of these patients.

Pharmacological and Neurosurgical Psychiatric Interventions: Through the Looking Glass

Laura Cabrera photoCenter Assistant Professor Dr. Laura Cabrera is the Team Leader on the project “Psychiatric Interventions: Values and Public Attitudes,” funded by the Michigan State University group Science and Society at State (S3). Dr. Cabrera’s team members are Dr. Robyn Bluhm of the Philosophy Department and Lyman Briggs College, and Dr. Mark Reimers of the Neuroscience Program and the College of Human Medicine.

home_1On October 28, 2016, Dr. Cabrera and team held the workshop “Pharmacological and Neurosurgical Psychiatric Interventions: Through the Looking Glass” as part of their S3 project. Participants included faculty, health professionals, researchers, and students from multiple institutions across the state.

The aim of the workshop was to bring together an interdisciplinary group of individuals with common interests, specifically in social and ethical issues within psychiatry. The workshop was useful as a way to obtain feedback regarding the pilot data that the team has been gathering and analyzing. Moreover, the workshop served as an opportunity to foster further collaborations and explore other grant proposal venues, as well as explore issues that need to be addressed regarding somatic psychiatric interventions.

The first session in the morning opened with two keynote presentations. First, Dr. Jed Magen, Associate Professor and Chair of the Department of Psychiatry, presented a talk entitled “Why We Don’t Know Much.” Dr. Magen addressed key issues related to pharmacological interventions in psychiatry, such as what the limits are of disease entities, the role of the pharmaceutical industry, and the importance of not only considering somatic psychiatric interventions, but also considering psychosocial approaches. The second presentation was by neurosurgeon Hayden M.K. Boyce of Spectrum Health, who spoke on “Ethical Considerations for DBS in Psychiatric Disorders.” Dr. Boyce’s presentation touched on five main issues: the complexity in deciding which areas to target, ethical treatment in trial, clinical trial design, issues connected to personality changes as well as issues around agency, and resource allocation.

During the question and answer session the discussion revolved around topics such as whether deep brain stimulation was particularly problematic in ways that pharmacological interventions where not, changes to self, and issues of uncertainty.

The second session presented the first part of the results of the project “Psychiatric Interventions: Values and Public Attitudes.” Dr. Bluhm talked about the aims, methods and results of the academic literature analysis. Session three covered the second part of the project results, in which Dr. Cabrera presented the aims, methods and results of the online public comment analysis. The final session transitioned to a large group discussion, in which the participants debated various relevant issues connected to somatic psychiatric interventions, such as the role of values and risk, the meaning of treatment refractory, and validation of the disorder. This last session also served as a space to discuss conceptual and practical issues related to how to move forward with the project.

To learn more about Science and Society at State and their funded projects, visit s3.msu.edu.

Why not more research into preventing cancer?

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Tom Tomlinson, PhD

Why are so much money and effort put into research aimed at curing cancer, and so little devoted to preventing it?

Three professors think they have at least part of the answer, as explained in a recent New York Times article (Why Preventing Cancer Is Not the Priority in Drug Development). They report that between 1971 and 2011, there were 12,000 research trials for drugs to treat patients with later stage cancer and a 90% chance of dying in five years; but only 6,000 for earlier stage patients with a 30% chance of dying. Even more starkly, 17,000 trials enrolled patients with recurrent cancers and low chances of survival, compared to 500 studying cancer prevention, where success would potentially yield much more benefit for more people (Budish, Roin and Williams).

In other words, the most money is being spent in pursuit of the least benefit for the fewest people. Why is this?

At great risk of over-simplifying, their answer is pretty simple: the commercialization lag. This is the time span between obtaining a patent for a new drug, and getting FDA approval to market it. The 20-year patent clock starts ticking when the patent is granted, but a company doesn’t begin to make money until the FDA allows sales. The shorter the commercialization lag, the more time available to amass a profit before your blockbuster goes generic.

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Image description: blue pills are spilling out of a pill bottle that is on its side. Image source: Flickr.

So how does this affect cancer drug development? If the measure of success (and FDA approval) is increased cancer survival, success can be determined most quickly in those already likely to die soon. Compared to a group of cancer patients with a 1-year life expectancy, it will take 10 times as long to detect success in a group with an average life expectancy of 10 years. This is why the commercialization lag adversely affects the profitability of research to prevent cancer or to treat it in its early stages, and so discourages such research.

Understandably, the authors of the report then discuss remedies that mitigate the effects of the commercialization lag—e.g., identifying “surrogate endpoints” that can be detected much sooner, are strongly associated with increased survival, and allow for earlier FDA approval.

I’m sure they would admit that there are other factors discouraging early-stage and preventive cancer research. Here are several that occurred to me, some of which have an ethical component.

1. Enrolling early stage patients in a trial of a new, as yet unproven cancer drug could be ethically treacherous, if there is already a standard treatment regimen supported by evidence. The cleanest design would assign some patients to the new drug and others to the standard of care, and this would be especially necessary if the surrogate end point also occurred among patients receiving conventional treatment. But this would mean that the proven treatment was being deliberately withheld from the experimental group, or delayed until the surrogate end point window closed. The interests—even the vital interests—of this group would be sacrificed for the advancement of medical knowledge. Of course, we would require that they give their informed consent to being exposed to that risk. But the quality of such consent would be highly suspect, given that it is so clearly at odds with their self-interest. These are the concerns that underlie the principle of “equipoise”—that the arms of an experiment should be roughly comparable in terms of their potential risks and benefits. (See Declaration of Helsinki, #30.)

This doesn’t mean that it is always ethically impossible to conduct research on early-stage cancer, just that it will probably be ethically more challenging to design such trials.

2. Another challenge is enrolling an adequate number of participants, especially for research on agents to prevent cancer. Studies of potential preventive drugs for cancers that occur later in life and at relatively low population rates will require large numbers to be enrolled for long periods of time to detect a statistically significant effect. If the study agent carries side effects, or burdens of compliance with the research regimen, it may discourage enrollment and encourage later drop outs.

We might address this problem by enrolling people already at high risk for cancer, which will reduce the numbers required to detect an effect. This strategy probably raises no special issues for people whose increased risk is outside their control, like women and men with one of the BRCA genetic variants carrying much higher risk of breast cancer.

But how about a study focusing on preventing lung cancer, which enrolls heavy smokers to more easily achieve scientific feasibility? Its feasibility in part depends on whether the subjects continue to smoke. And the goal of the study—to determine whether the new drug reduces the risk of smoking—may indirectly encourage participants to continue smoking. This would be due to the “therapeutic misconception,” the well-documented belief among many research participants that the experimental intervention offers a much higher likelihood of benefit than the evidence suggests (Lidz et al.).

3. And this example takes me to my last question. Would developing a whole armamentarium of drugs to prevent cancer be an unalloyed good? Of course, it’s almost certain that these drugs will carry their own side-effects and risks, as the pharmaceutical company TV ads constantly remind us; and these risks will be experienced by large numbers of people who never would have gotten cancer in any event. And for this reason, preventing cancer in this way could end up costing much more in total than treating it, as Louise Russell pointed out back at the dawn of time (Russell).

But even setting aside these complications, I would still worry about the effects that ready availability of such drugs would have on other approaches to preventing cancer, like behavior change and environmental clean-up.

If we could all just take our pills as directed, would we in the process be eroding our sense of our personal and political responsibility for the causes of cancer, and if so would that be too high a price? I’m not sure how to answer those questions. I hope you might have some ideas.

Tom Tomlinson, PhD,tomlinson is Director of the Center for Ethics and Humanities in the Life Sciences and a Professor in the Department of Philosophy 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, February 4, 2016. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Former Center for Ethics Director Howard Brody joins spring Bioethics Brownbag & Webinar Series

bbag-iconEconomism and the Unavoidable Activism of Bioethics

Examining medicine’s relationship with the pharmaceutical industry, and how health policy and cost containment in the U.S. may persuade one of two things: first, bioethics was born out of social activism and cannot escape its activist tendencies; second, an ideology (called economism, neoliberalism, and various other names) has seized control of much of American political and popular thought, and allows little space for a robust debate and analysis of many of the issues bioethics ought to be most concerned about. An unavoidable need for activism in bioethics today is to take on this ideology, reveal its defects, and call for alternative frameworks of thought that will allow important bioethical issues to be addressed in a more fruitful way.

mar26Join us for Dr. Brody’s lecture on Tuesday, March 26, 2013 from noon till 1 pm in person or online:

In person: The lecture will take place in East Fee Hall on MSU’s East Lansing campus, in room E4 (first floor next to bookstore lobby area). 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!

Howard Brody, MD, PhD, is Director of the Institute for the Medical Humanities and the John P. McGovern Centennial Chair in Family Medicine at the University of Texas Medical Branch in Galveston. His most recent books are The Future of Bioethics (2009) and The Golden Calf: Economism and American Policy (2012). Before moving to UTMB in 2006 he spent 26 years in the Center for Ethics and Humanities in the Life Sciences and the Department of Family Practice at MSU. Much of his recent work addresses the interface between bioethics and health policy, especially ethical cost containment and medicine’s relationship with the pharmaceutical industry.

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