Category Archives: Arthur Caplan

Liability for Failure to Vaccinate

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By Art Caplan

Measles are breaking out all over Britain.  Getting fewer headlines is the fact that measles are back in the USA too.  In fact they are in our region.  A mini-epidemic is raging in Brooklyn.  Measles for cripes sake!  The disease that many of us over 60 had as kids that should never occur is back with a vengeance.  The reason for the diseases reappearance is simple—failure to vaccinate.  Maybe it is time to get tough on those whose choices put others at risk.

For decades, there has been a safe, effective vaccine that works exceedingly well against the measles–95% full protection for a kid who has been vaccinated– and nearly equally well at preventing transmission to others.  The more people have been vaccinated the tougher it is for measles to gain a foothold.

NY City health officials have reported 30 cases so far–26 in Borough Park and four more in Williamsburg.  The NY Daily News reports that the consequences of this outbreak have been dire:

“There have been two hospitalizations, a miscarriage and a case of pneumonia as a result of this outbreak,” a Health Department spokeswoman said. “All cases involved adults or children who were not vaccinated due to refusal or delays in vaccination.”

So far the outbreak has been among religious Jews some of whom shun getting the vaccine for their kids out of fear it causes autism Dr. Yu Shia Lin of Maimonides Medical Center in Borough Park told The News.

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Caplan: Stop Critiquing the DSM 5

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Art Caplan has a new column out in Time that takes a different stance on the DSM-V, compared to all the criticism the revisions have recently received:

The critics are going way too far. The DSM is often described as “the bible of the mental health field”—an unfortunate misnomer that leaves it open to attack. It should really be called “The best we know so far about mental disorders” or perhaps “Our best effort to properly classify complicated human behavior.”

But a bigger problem is that the editors don’t know how to defend against the attacks.

Read the full column here.  And some competing commentary here and here.

Caplan on Cloning Human Embryos

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Art Caplan has a new column out spurred by the announcement that researchers at Oregon Health Sciences University have successfully cloned human embryos.  Recognizing the possible ethical concerns and calling for immediate bans on human reproductive cloning (not cloning for stem cell research), Caplan hopefully notes: “Through cloning you can take a disabled or sick person’s DNA from one of their body cells, insert it into a human egg from which the DNA has been removed, fuse the cell electrically (the technique used in Oregon) and create an embryo from which cells can be grown that are identical matches to what the sick or disabled person needs.”

Take a look at the full column here.

Art Caplan on Plan B and Kermit Gosnell

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Art Caplan has a new Viewpoint article out in Time discussing Plan B’s impact on late trimester abortion:

Gosnell was a stop of last resort for woman late in their pregnancies. They sought an abortion past the point of fetal viability — a choice illegal in Pennsylvania and throughout the United States. For these women, Gosnell and his ilk are their only option.

But regardless of the outcome of Gosnell’s trial, the need for late trimester abortion is going to disappear. Even surgical abortion will be a thing of the past, as the abortion clinic slowly gives way to pharmaceutical abortion.

More and more women will be using cheap and readily available emergency contraception, not abortion. The FDA just announced that Plan B can be sold over-the-counter to buyers as young as 15. Other women will use mifepristone when they choose to end a pregnancy within the first seven weeks. They won’t be faced with the choice of a third trimester abortion because they will be able to easily access pharmaceutical options. The awful horror of Gosnell will disappear not as a result of legislation or protests or even trials but as a result of affordable pills that are easy to use.

Take a look here.

When Ethics Collide

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[Posted on behalf of Nancy Dubler and Art Caplan]

Surprising that for a week there was constant news from Boston.  Minute by minute we heard details of carnage, searching, killing, lock down and capture.  Now, pretty much, silence.

The suspect, captured in a boat in a backyard in Watertown, is now both a prisoner and a patient.  That has proved, historically and most recently, to be a difficult dual status for physicians to address.  It is hard for those who want to interrogate him.  And hard for those who wish to initiate his arraignment and prosecution.  But they along with the rest of us must wait.

Prison and jail health care present an anomaly for medical caregivers.  The goals of medicine are to diagnose, cure and comfort.  The goals of the justice and correctional systems are to confine, try, sentence and punish.  These are not only mutually exclusive goals but, they make strange and strained bedfellows when the two must work together.

We know one can coopt the other.  American doctors who agreed that torture could continue, without killing the prisoner, during recent years when water-boarding was a clear part of the anti-terror arsenal, violated their oaths as physicians to attend only to the medical, physical and emotional needs of the patient…to do no harm.

In the same vein, on July 17, 2008, the AMA articulated its policy about executions clearly and unambiguously — “requiring physicians to participate in executions violates their oath to protect lives and erodes public confidence in the medical profession. A physician is a member of a profession dedicated to preserving life when there is hope of doing so. The use of a physician’s clinical skill and judgment for purposes other than promoting an individual’s health and welfare undermines a basic ethical foundation of medicine — first, do no harm”.  Yet physicians do participate in executions often using their respect for the criminal justice system as their rationale.

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New Support for the SUPPORT Study in NEJM

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The New England Journal of Medicine has two new commentaries out on the SUPPORT study and arguing that OHRP has things all wrong – in a dangerous way.

From the editors:

“[OHRP's] response is disappointing, because it does not take into account either the extent of clinical equipoise at the time the study was initiated and conducted or that the consent form, when viewed in its entirety, addressed the prevalent knowledge fairly and reasonably. At the time, as explained in the principal investigator’s response to the allegations and in a related letter to the editor in the Journal, there was no evidence to suggest an increased risk of death with oxygen levels in the lower end of a range viewed by experts as acceptable, and thus there was not a failure on the part of investigators to obtain appropriately informed consent from parents of participating infants. Through hindsight (and essentially faulting investigators for not informing parents up front of a risk later uncovered by the trial itself), the OHRP investigation has had the effect of damaging the reputation of the investigators and, even worse, casting a pall over the conduct of clinical research to answer important questions in daily practice. . . . The OHRP has a duty to investigate questions of research impropriety, but we strongly disagree with their determination of inadequate informed consent in this case.”

And from Art Caplan and David Magnus:

“With regard to SUPPORT, the OHRP is asking that research be described as riskier than it really is and is suggesting that the parents were duped into enrolling their frail infants in dangerous research. Not only is that not true, but it also poses substantial risk to the conduct of valuable comparative effectiveness research both for premature infants and for the general public who continue to face too many treatments where uncertainty prevails about what is best.”

There is also a letter to the editor from the SUPPORT study group themselves.

What do you think – is this OHRP’s latest version of its checklist debacle, or are they right here?

Caplan on the Myriad Patent Case

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[Posted on behalf of Art Caplan]

On January 7, 1610 Galileo Galilei, the Italian physicist and astronomer, aimed his new invention, the telescope, at the sky and became the first human to observe three of the moons orbiting the planet Jupiter.  His discovery created a sensation since he had shown that there were objects in the universe that were not circling the Earth – throwing into doubt the view that his church, the Roman Catholic church, taught that the Earth was the center of the universe.

If Galileo had been alive today he might have been working for a private science company.  If so there is little doubt that they would have insisted he seek a patent for the marvelous telescope that revealed amazing secrets about the world.  If that company had been Myriad genetics they might have insisted that he not only patent the telescope but also everything he found when he looked through it, including Jupiter and its moons.  In a way, that is what Myriad did when in 1994 it, along with the University of Utah, sought a patent on an association scientists had discovered between a set of genetic mutations and a high risk of developing breast cancer.

The patents Myriad received have earned the company a pretty penny.  They have had a monopoly over all genetic testing for breast cancer for nearly two decades.  Doctors and patients have complained bitterly that Myriad’s high priced tests have limited access for many women and hindered efforts to conduct research that might have more rapidly improved the accuracy of testing.

I think the Myriad patents should not have been awarded.  Nor should any patent that relies solely on looking at genes as they exist in nature and finding associations with the risk of getting a disease.  The standard for a patent is not discovery but making something useful out of a discovery.  Patenting genes is too close to trying to patent the moons of Jupiter which Galileo discovered but did not create.  Myriad’s early patent arguably hindered the willingness of others to aggressively explore better tests for a terrible disease.  Other patents on other gene sequences could have the same effect.

If Myriad discoveries the equivalent of the genetic testing telescope then great—let them have their patent.  But finding what is out there in nature be it Jupiter, the moon, or a sequence of genes gets you a place in history but not a patent.

Twitter Round-Up (3/31-4/6)

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By Casey Thomson

This week’s slightly belated round-up concerns palliative care across cultures, the threat and problems of over-prescribing, and Big Pharma’s failure to create prices with the patient in mind. Read on for more from this week’s round-up.

  • Alex Smith (@AlexSmithMD) retweeted a piece on the lessons learned by Dr. Vvjeyanthi “V.J.” Periyakoil on how to approach palliative care for patients from a variety of backgrounds in ways that both extend life and fulfill the desires of the patient (in particular, reducing pain). (4/3)
  • Alex Smith (@AlexSmithMD) also retweeted an opinion piece in the NYT about the growing trend towards self- and over-medication, and the problems of overextending definitions of medical ‘conditions.’ As the piece’s author summarized: “The D.S.M. would do well to recognize that a broken heart is not a medical condition, and that medication is ill-suited to repair some tears.” (4/3)
  • Daniel Goldberg (@prof_goldberg) retweeted a link on two new wrongful death lawsuits against the NFL, which claim that the NFL withheld knowledge of the risks associated with concussions from players, that have been added to the string of other brain injury lawsuits filed against the league. (4/3)
  • Daniel Goldberg (@prof_goldberg) additionally retweeted a blog post on the striking results of a new study comparing male and female mortality amongst counties in the United States. While male mortality increased in only 34% of counties from 1992-1996 to 2002-2006, female mortality increased in 42.8%. This brings up questions concerning the cause of this demographic and largely geographic inequality, and what such a differential could mean on the health of dependents (children). (4/3)
  • Daniel Goldberg (@prof_goldberg) posted another article that put the recent New York “True Cost” campaign in historical context. The article called the campaign a “modern manifestation of…anxieties about the ‘contagion’ of working class and poor communities,” comparing it to the World War II-era venereal disease campaigns and the case of Typhoid Mary as all moralizing weapons aiming to instill shame rather than promote actual solutions to public health concerns. (4/4)
  • Arthur Caplan (@ArthurCaplan) linked to his own discussion of the problem with Novartis and India, noting that emphasis has been wrongly placed on patents when the concern should be on pharma’s hesitancy to create a pricing strategy that can provide medications for those who cannot afford huge prices. This unwillingness to do so, he claims, is violating a moral obligation. (4/4)

Event – NY SAFE Act: What Does It Mean for Mental Health Providers and Their Patients?

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New York State’s SAFE Act: 

“What Does It Mean for Mental Health Providers and Their Patients?”

Wednesday, May 1, 2013; 5:00pm-8:00 pm 

ALUMNI HALL B, NYU School of Medicine

Sponsored by the NYU Division of Medical Ethics and the Department of Psychiatry
Co-Chairs: Arthur L. Caplan, PhD and Elizabeth Ford, MD

Please RSVP to  jessica.oyola at nyumc.org

Click through to see the working agenda.

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Caplan on “Truth Serum”

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Art Caplan has a new column out at CNN on the court-approved use of a “narcoanalytic interview” as part of (alleged) Colorado theater shooter James Holmes’ competency evaluation.  Caplan’s take?

“There is no drug that is going to shed trustworthy light on Holmes’ state of mind last year when, police say, he donned a gas mask as well as full body armor and grabbed a rifle, a pump-action 12-gauge shotgun and at least one .40-caliber semiautomatic pistol to launch a heinous attack. No drug can tell us what he was really thinking.

In giving permission to use drugs, the judge has opened the door to a line of defense in which Holmes’ lawyers can argue that if drugged, he is being forced to testify against himself against his will.”

 Take a look.

Caplan on Pediatric Anthrax Vaccine Trials

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Art Caplan has a new column responding to the latest report from the Presidential Commission for the Study of Bioethical Issues.  Take a look:

A top-level commission has just released a new report on the morality of studying the safety of an anthrax vaccine in children, with an eye toward treating kids in the event of a terror attack.

The report, issued Tuesday by the Presidential Commission for the Study of Bioethical Issues, is quite thoughtful. It concludes that no testing should be considered unless the risk to kids is minimal. But it also represents a study of an experiment that has no chance of happening — ever. The commission has wasted its time. There is not a chance that a sufficient number of American parents are going to sign up their kids for the safety testing of an anthrax antidote.

Keep reading…

Caplan on Guns, Mental Health, and NY State Law

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In a new article (free registration required), Art Caplan discusses recent gun control legislation passed in New York state.  Take a look at the full piece, but here’s an excerpt:

The NY SAFE Act requires individuals who own a handgun or an assault rifle to recertify their permits every 5 years; limits the capacity of ammo clips to 7 shots; clarifies and broadens the definition of assault weapons to restrict their sale; and requires nearly all gun transfers between private parties to be conducted through a federal firearms licensee, subject to a federal National instant Criminal Background Check. These are predictable, if tough to enact, actions when it comes to guns. What is somewhat surprising is that the law imposes new duties on mental health care professionals that will also be very difficult to implement.

Under the New York legislation, mental health professionals are required to report to local mental health officials when there is reason to believe a patient is likely to engage in conduct that will cause serious harm to himself or herself or to others. This information will then be cross-checked against a new gun registration database. If the patient possesses a gun, his license will be suspended and law enforcement will be authorized to remove the person’s firearm.

Kendra’s law, enacted in 1999, is extended for 2 years—through 2017. This law gives judges the authority to require people to regularly under-go outpatient psychiatric treatment. Under the NY SAFE Act, the period of mandatory outpatient treatment is extended from 6 months to 1 year.

There has long been a legal obligation in most states, generated by the famous 1976 Tarasoff case in California, that mental health care professionals disclose a threat of violence to an identifiable third party if they think the threat is credible and the act imminent. Both before and after Tarasoff, there have been ethi-cal and clinical obligations. The new NY SAFE Act would transcend New York State’s mental hygiene statute granting an “authority to warn” into a legal duty if the clinician believes that firearms may be involved. The problem is that there is not much evidence that mental health workers are particular adept at predicting violence. It remains to be seen if this reporting duty will produce greater public safety in New York.

Caplan on “$10,000 to Abort?”

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Art Caplan has a new column up discussing the surrogacy agreement gone awry (noted by Judy Daar below) in which a surrogate was offered $10K to abort the fetus upon discovery of abnormalities.  Take a look.

We’ve also had other discussions of this issue at Bill of Health, from Dov Fox’s recent post on abortion of disabled fetuses to Glenn Cohen’s post on Mitt Romney’s son’s abortion contract.

Twitter Round-Up (2/16-2/23)

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By Casey Thomson

This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:

  • Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
  • Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
  • Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
  • Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
  • Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
  • Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
  • Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
  • Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)

Twitter Round-Up (1/27-2/7)

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By Casey Thomson

Even the surprisingly resurrected Richard III (on the Twitter-sphere, anyway) appreciates bioethics concerns. Read on to find out more about Richard III’s eagerness for patient confidentiality and other updates in this week’s (extended) Twitter round-up:

  • Stephen Latham (@StephenLatham) included a link to his blog post challenging Andrew Francis’ recent claim that penicillin was the central drug spawning the sexual revolution of the 1960s. While penicillin may have facilitated the widespread acceptance of pre-marital relations, it was The Pill that “translat[ed] that newfound sexual freedom into sexual equality.” (1/28)
  • Dan Vorhaus (@genomicslawyer) posted a summary video regarding the Neanderthal baby story that rocked the internet in the past few weeks, as reported by Taiwan’s Next Media animation. (1/28)
  • Michelle Meyer (@MichelleNMeyer) shared a news report on Israel’s recent admittance to giving birth control to Ethiopian Jewish immigrants, frequently without either consent or knowledge. Concerns first arose after an investigative journalist began to explore why birth rates in the community had fallen so drastically and seemingly inexplicably. (1/28)
  • Arthur Caplan (@ArthurCaplan) linked to a piece explaining the future implications and consequences of the guidance requiring schools to make “reasonable modifications” in order to include students with disabilities in either general athletic programs or provide them with parallel opportunities. The guidance, while a potential huge move forward for individuals with disabilities, nonetheless will be nothing without “tough and honest conversation about financing and revenue – and soon.” (1/28)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article showing the return of the “invisible gorilla” from the 2010 book, but this time in the fake CT scans shown to both expert radiologists and volunteers alike. The gorilla was large in size compared to the typically indicative nodules, and was unmistakably a gorilla, but yet 20 out of the 24 radiologists failed to see the gorilla. It’s a frightening real-life example of what the original study’s jargon terms as “inattentional blindness.” (1/29)
  • Kevin Outterson (@koutterson) live tweeted the Pew meeting concerning new antibiotic development pathways for limited populations. See the string of tweets on his Twitter page for further details of how the meeting proceeded. (1/31)
  • Daniel Goldberg (@prof_goldberg) shared a link describing the first scientific evidence suggesting that doctors can “truly feel” their patients’ pain. The study, done by Harvard researchers, used brain scans to indicate activated regions of physicians’ brains during a simulated interaction with patients. (2/1)
  • Frank Pasquale (@FrankPasquale) linked to a story on the problems associated with over-prescribing amphetamine-based medications, particularly to teenagers and young adults. While focusing on the individual story of an aspiring medical student named Richard Fee, the author delves into the underexposed side effects of often overzealous prescribing and the surprisingly casual attitude that most Americans hold towards this medication. (2/3)
  • Frank Pasquale (@FrankPasquale) also posted a piece inspired by the talk surrounding World Cancer Day on the problems related to cancer treatment in developing countries. Contrary to being solely a problem of so-called developed nations, cancer remains an issue globally – including such cancers that are caused by an infectious agent. Fighting the false notions – that cancer in developing nations is minimal, that it is always not “catchable,” and that enough care (particularly vaccines) is being delivered – is essential to reducing the global inequity in cancer treatment. (2/4)
  • Michelle Meyer (@MichelleNMeyer) retweeted the (supposedly resurrected and technologically adept) Richard III’s tweet regarding publication of details surrounding his newly-identified bones: “Hmmm not so happy about my physical attributes being discussed in public. What happened to patient confidentiality ???” (2/4)
  • Daniel Goldberg (@prof_goldberg) shared a report on a new study that found a correlation between low self-esteem and female body representation and obsession in “chick lit.” The report noted that the results suggested a possible “intervention tool” by having characters seek support from friends and family for such body concerns. (2/5)
  • Michelle Meyer (@MichelleNMeyer) retweeted a graphic eloquently summarizing one of the simplest and most potent arguments in favor of vaccination, and arguably the greater biopharmaceutical industry. (2/6)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.