The Problem with Drug Monopolies: Ethics and Money

How the Government Could Punish That Hedge Fund Bro Who Wanted to Raise a Drug’s Price 5,000 Percent

By Jordan Weissmann

Slate.com

Originally published September 22, 2015

Here is an excerpt:

Assuming his conscience doesn't send Daraprim's price all the way back to $13.50 a tablet, Shkreli will be able to get away with his price gouging for a simple reason: Even though the drug's patents are long-expired, nobody else makes it. Thus, he has an effective monopoly over a life-saving treatment that lacks an alternative. One could argue that this speaks to the fundamental flaws of American oversight of the pharmaceutical industry. While the rest of the developed world uses price controls to keep medication affordable, the U.S. allows drug companies to charge whatever they please, with the hope that once their patents expire, competition from generics will drive down costs. To some slight extent, that's worked—about 8 out of every 10 prescriptions filled in this country are for generic drugs. But as production has become concentrated in the hands of fewer and fewer manufacturers, the prices of some generics have rapidly risen in recent years. And the costs of some specialty medications, like Daraprim, have skyrocketed.

The entire article is here.

There Is No Excuse for How Universities Treat Adjuncts

By Caroline Fredrickson
The Atlantic
Originally published September 15, 2015

Here is an excerpt:

To say that these are low-wage jobs is an understatement. Based on data from the American Community Survey, 31 percent of part-time faculty are living near or below the federal poverty line. And, according to the UC Berkeley Labor Center, one in four families of part-time faculty are enrolled in at least one public assistance program like food stamps and Medicaid or qualify for the Earned Income Tax Credit. Known as the “Homeless Prof,” Mary-Faith Cerasoli teaches romance languages and prepares her courses in friends’ apartments when she can crash on a couch, or in her car when the friends can’t take her in. When a student asked to meet with her during office hours, she responded, “Sure, it’s the Pontiac Vibe parked on Stewart Avenue.”

Naomi Winterfalcon, who teaches at Champlain College in Burlington, Vermont, is happy that she was able to get another job this year and stay off food stamps for the summer. A recent study shows that a large portion of universities and colleges limit their adjuncts’ teaching hours to avoid having to provide the health insurance now required for full-timers under the Affordable Care Act.

The entire article is here.

'Disruptive' doctors rattle nurses, increase safety risks

Jayne O'Donnell and Laura Ungar
USAToday
Originally published September 20, 2015

Here are two excerpts:

Disruptive behavior leads to increased medication errors, more infections and other bad patient outcomes — partly because staff members are often afraid to speak up in the face of bullying by a physician, Wyatt says. That "hidden code of silence" keeps many incidents from being reported or adequately addressed, says physician Alan Rosenstein, an expert in disruptive behavior.

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Most experts estimate that up to 5% of physicians exhibit disruptive behavior, although fear of retaliation and other factors make it difficult to determine the extent of the problem. A 2008 survey of nurses and doctors at more than 100 hospitals showed that 77% of respondents said they witnessed physicians engaging in disruptive behavior, which often meant the verbal abuse of another staff member. Sixty-five percent said they saw nurses exhibit such behavior.

Most said such actions raise the risk of errors and deaths.

About two-thirds of the most serious medical incidents — those involving death or serious physical or psychological injury — can be traced back to communication errors, according to a health care accrediting organization called the Joint Commission. Getting nurses and other medical assistants rattled during surgery can be a big safety risk, Bartholomew says.

The entire article is here.

Self-injury Is the Eighth Leading Cause of Death in the United States

By Ian R. H. Rockett and Eric D. Caine
JAMA Psychiatry. Published online September 16, 2015.

This Viewpoint discusses the false dichotomy of separating suicides from fatal self-injurious acts that are labeled “accidents” or “unintentional” deaths.

Establishing a person’s intention to die has been a central element separating suicides from fatal self-injurious acts that are labeled “accidents” or “unintentional” deaths. We argue that this is a false dichotomy—certainly at the level of populations—that masks the overall magnitude of fatalities arising from deliberate, self-destructive behaviors. In so doing, it mutes the urgency for demanding effective preventive interventions and is particularly problematic as the nation experiences a persisting and growing epidemic of opioid and other drug-poisoning deaths. Firearm trauma and hanging/asphyxiation, the leading methods of suicide, typically generate ample forensic evidence for assuring accurate determinations by medical examiners and coroners. However, corroborative evidence is less available for poisoning, the third leading method of suicide overall, and first among women. Parenthetically, we acknowledge that the Centers for Disease Control and Prevention use “unintentional injury" in lieu of the term accident for surveillance and prevention purposes. However, medical examiners and coroners remain bound by statutes in using “accident” as 1 of 6 manner-of-death entries (homicide, suicide, accident, undetermined, natural causes, and unknown) that alternatively appear on death certificates.

The entire article is here.

Is mental health 'parity' law fulfilling its promise?

By Jenny Gold
Kaiser Health News/CNN
Originally posted on September 20, 2015

Here is an excerpt:

The so-called parity law, which was intended to equalize coverage of mental and other medical conditions, has gone a long way toward eliminating obvious discrepancies in insurance coverage. Research shows, for instance, that most insurers have dropped annual limits on the therapy visits that they will cover. Higher copayments and separate mental health deductibles have become less of a problem.

But many insurers have continued to limit treatment through other strategies that are harder to track, according to researchers, attorneys and other critics. Among the more murky areas is "medical necessity" review -- in which insurers decide whether a patient requires a certain treatment and at what frequency.

Kamins is among a small group of people around the country to file lawsuits alleging federal or state parity laws were violated when patients with mental illness were held to a stricter "medical necessity" standard than those with other medical conditions.

The entire article is here.

Reducing Bounded Ethicality: How to Help Individuals Notice and Avoid Unethical Behavior

By T. Zhang, P. O. Fletcher, F. Gino , and Max Bazerman

Executive Summary

Research on ethics has focused on the factors that help individuals act ethically when they are
tempted to cheat. However, we know little about how best to help individuals notice unethical
behaviors in others and in themselves. This paper identifies a solution: instilling a mindset of
vigilance. In an experiment, individuals playing the role of financial advisers recommended one
of four possible investments to their clients. Unbeknown to these advisers, one of the funds
under consideration was actually a fraudulent feeder fund of Madoff Investment Securities.
Results from this empirical study demonstrate that instilling vigilance by asking individuals to
indicate their suspicions prior to making a decision was critical to helping them notice fraudulent
behavior and act on that information. In contrast, committing to a decision prior to contemplating
suspicions precluded individuals from subsequently integrating critical information about the
fund’s fraudulent activity. We extend these findings to other interventions aimed to help
managers notice unethical behavior.

The entire paper is here.

What the FDA’s approval of “pink Viagra” tells us about the problems with drug regulation

by Julia Belluz
The Vox
Originally published on September 18, 2015

Here is an excerpt:

The episode raised hard questions about the changes wrought by the patient movement and other reforms that have followed. There were excellent reasons for the FDA to bring HIV-positive patients into its deliberations in the 1980s — they provided a crucial perspective that the agency's in-house scientists and officials lacked. But these days, some critics argue that those listening sessions have been hijacked by drug companies. As I found in my reporting, the patients who had lobbied the FDA to approve pink Viagra were often sponsored by the drug's manufacturer.

"The role of pharma in patient groups in the contemporary era is entirely fraught," says Yale Law School's Gregg Gonsalves, who was once one of those HIV activists in the 1980s. "[Drug companies] learned from the early days of the AIDS epidemic that the patient community could be useful allies, and they've poured money into patient groups here in the US and around the world."

So is the FDA approving drugs too easily? Has the push for speed and efficiency now undermined the agency's ability to protect public health? To find out, I took a closer look at the approval of "pink Viagra," which offers a vivid illustration of just how much the FDA has transformed over time — and why those changes worry many experts.

The entire article is here.

State board proposes discipline for University of Oregon psychologist over record release in rape case

The Associated Press
Originally published September 25, 2015

A state licensing board is proposing a $5,000 fine, a reprimand and ethics training for the head of the University of Oregon’s counseling office.

The proposed discipline, announced Friday, stems from allegations that Shelly Kerr released a student’s counseling records to the UO’s lawyers without the student’s permission. The student sought counseling after she said she was raped by three basketball players.

The rest of the article is here.

Dignity is a useless concept

It means no more than respect for persons or their autonomy

By Ruth Macklin
BMJ. 2003 Dec 20; 327(7429): 1419–1420.
doi:  10.1136/bmj.327.7429.1419

Appeals to human dignity populate the landscape of medical ethics. Claims that some feature of medical research or practice violates or threatens human dignity abound, often in connection with developments in genetics or reproductive technology. But are such charges coherent? Is dignity a useful concept for an ethical analysis of medical activities? A close inspection of leading examples shows that appeals to dignity are either vague restatements of other, more precise, notions or mere slogans that add nothing to an understanding of the topic.

Possibly the most prominent references to dignity appear in the many international human rights instruments, such as the United Nations' universal declaration of human rights. With few exceptions, these conventions do not address medical treatment or research.

The entire article is here.