Bioethicist Art Caplan: Why a New Alzheimer’s Drug Isn’t A No-Brainer

A new piece by contributor Art Caplan on NBC News:

Biogen, a Cambridge, Massachusetts biotech company, announced last week that early tests of their new drug aducanumab, a monoclonal antibody, had shown impressive results in treating those with early stage Alzheimer’s disease. The drug significantly reduced the amyloid plaque buildup in the brain that is associated with Alzheimer’s.

In a very early stage safety test aducanumab slowed the cognitive decline and dementia associated with Alzheimer’s in people. On the Mini Mental Status Exam, a widely used measure of cognitive function, people at risk of Alzheimer’s who got a placebo lost around 3 points over a year. But those who got the lowest dose of aducanumab worsened by just two points and those who got a higher dose lost less than a point.

Biogen was so excited by the early results in 166 volunteers that it is going to try to go directly to a much bigger clinical trial of the drug. Wall Street was very excited too—Biogen’s stock price shot up 10 percent. […]

See the full article here.

Bioethicist Art Caplan: UK Man, His Surrogate Mom and Their Baby Are Family

A new piece by contributor Art Caplan on NBC News:

A British high court has permitted Kyle Casson, a single man, to adopt an eight-month-old boy who was carried and delivered by a surrogate — Casson’s own mother.

To diagram this family tree, Casson, 27, technically adopted not his son but his brother because the woman who carried the baby to term is, legally, the mother. That also means that Casson’s mom gave birth, technically, to a son and a grandson at the same time.

Biologically, the child is her grandson.

The ruling traverses an array of ethical twists and turns. Let’s start with the more common fault lines. […]

Read the full article here.

Bioethicist Art Caplan: Why Are Guns a Taboo Topic on Campaign Trail?

A new piece by contributor Art Caplan on NBC News:

Guns are a medical issue — no matter how often the NRA denies it. Eight national health groups, including the American Academy of Pediatrics, just released a joint statement echoing that sentiment.

But among the barrage of media questions leveled at politicians on the presidential campaign trail, no one is asking the contenders about firearms. The topic appears to be strangely and entirely off limits.

Everything else seems to be fair game: Do you think President Obama loves this country? What do you think about vaccines? Do you believe in evolution? Did you embellish anything on your resume? Do embryos have rights? Are you too old, fat, short, ill-tempered, religious, atheistic, feminist, or in the pocket of your donors to make a good President? […]

Continue reading here.

Naturopaths — Not What The Doctor Ordered For Vaccine Exemptions

A new piece by contributor Art Caplan in Forbes:

There are lots of reasons why measles, having gone to Disneyland, is enjoying a comeback around the United States and Canada. Unfounded fears of autism scare some parents. Others buy the daffy conspiracy theory that pharmaceutical companies are just pushing vaccination to make a buck. Some parents invoke religious concerns despite that fact that hardly any religions think vaccination is bad and most teach that it is an obligation in order to protect children and the vulnerable in the community.

One key reason behind falling vaccination rates is that if you believe any of the above untruths it is very easy to get an exemption. Most states let you out on religious or philosophical grounds. Every state excuses you or your kids for health reasons. So you might presume those ducking vaccines get approval to dodge vaccination from physicians. Uh uh. In 17 states, D.C. and Puerto Rico naturopaths, healers who believe in a mishmash of nutritional medicine, botanical medicine, naturopathic physical medicine including chiropractic manipulative therapy, rolfing, iridology, and homeopathy among other New Agey philosophies can get licenses in their state. There are thousands practicing in the United States. Put aside the issue of why states are recognizing these ‘healers’ who rely on an evidence base only a few steps above astrology and palm-reading. The fact is in many states a naturopath can excuse a child from vaccination. And since many naturopaths take a pretty dim view of vaccination they give a lot of exemptions. […]

Read the full article here.

Art Caplan: Revoke the license of any doctor who opposes vaccination

A new opinion piece by Art Caplan, via the Washington Post:

Amateurs and hucksters are not the only people telling parents not to vaccinate their children. Unfortunately some doctors — men and women sworn to the Hippocratic Oath — are purveying junk science. They say that vaccines cause autism, as in the famous case of Andrew Wakefield, whose study drawing the link has been retracted. Or that measles isn’t that bad, so your child can skip the shots, as Jack Wolfson, a cardiologist in Arizona, says, adding that “the facts” show vaccines to be full of “harmful things” like “chemicals.” Or that, according to some parents, vaccines cause “profound mental disorders,” as Sen. Rand Paul, an ophthalmologist, warned before he walked the statement back. Or that vaccines cause “permanent disability or death,” in the words of Bob Sears, a pediatrician in California.

Thankfully, only a few physicians in America have embraced fear-mongering in the middle of this dangerous and costly measles epidemic. They deserve a place of honor next to climate-change skeptics, anti-fluoridation kooks and Holocaust deniers. They doubt the facts, ignore established evidence and concoct their own pet theories. They shouldn’t be allowed near patients, let alone TV cameras. But because their suggestions are so surprising and controversial, they often find themselves on cable news shows and in news reports about the “anti-vaxx” crowd. Their power, therefore, is radically disproportionate to their numbers. […]

Read more here.

Art Caplan: Is It Ethical to Create Babies From Three DNA Sources? Absolutely

A new piece by Art Caplan, via Wired:

The House of Commons in the U.K. has now voted to permit mitochondrial DNA replacement, which enables babies to be born who have DNA from three people.

Mitochondria are the batteries of our cells that provide energy for cell division and growth. We get ours from our mother’s genes. If there is a defect in a mother’s mitochondria, it can have devastating consequences for her children, resulting in almost certain death. But, by extracting a mitochondrion from a healthy donor egg, scientists are now able to conduct a miniature organ transplant on the cellular level to create a healthy baby through in vitro fertilization. Such a baby has its parents’ genes, except for one small but crucial portion obtained from a donor.

If the House of Lords also approves, Britain will be the first nation to authorize the procedure. The United States is studying mitochondrial transplants. A series of meetings began last week at the Institute of Medicine at the request by the Food and Drug Administration.

To continue reading, click here.

Art Caplan: Ebola, Measles And Chris Christie’s Inconsistent Healthcare Beliefs

A new piece by Art Caplan on New Jersey Governor Chris Christie’s recent statements, via Forbes:

New Jersey Governor and likely presidential candidate Chris Christie is responsible for the current measles outbreak in the United States. Well that is a bit of a stretch – but not by much. The Governor just can’t figure out where he stands in balancing the public good against individual rights.

When Ebola reached his state last October in the form of Kaci Hickox, a nurse who had treated Ebola patients in West Africa, Christie ordered her held in a plastic tent near Newark with no running water, reliable heat or any other amenities. Hickox had no symptoms. She knew she was not infectious. She said she did not want to be quarantined in inhumane circumstances like a criminal.

Christie did not budge. “I have no reason to talk to her,” he said. “… I understand that she didn’t want to be there. She made that very clear from the beginning but my obligation is to all the people of New Jersey and we’re just going to continue to do that.”

Continue reading

Art Caplan: A Minor Can’t Refuse Chemotherapy

A new piece by Art Caplan on why he believes a minor can’t say no to chemotherapy, on NBC News:

A 17-year-old girl, listed in court papers only as Cassandra C., is in protective custody at a Connecticut hospital where she is being forced to undergo chemotherapy treatment that she says she does not want. Americans strongly value the right to refuse medical care.

We are all familiar with situations in which Jehovah’s Witnesses say no to life-saving blood transfusions, patients refuse any more surgery or artificial ventilation, and ill people forgo proven medical interventions to follow alternative care.

But those cases involve competent adults.

Cassandra is 17 — still a minor. Should she have the right to say no? I don’t think so.

Continue reading

Art Caplan: Support Nurse Who Resisted Force-Feeding at Guantanamo

Art Caplan has a new piece supporting the nurse who resisted force-feeding at Guantanamo, on NBC News:

Lost in all the talk about the CIA’s history of brutal interrogation tactics after Sept. 11 is this: A real live case involving a U.S. Navy nurse on trial for what he did not do at the notorious Guantanamo prison.

The nurse, in his 18th year in the Navy, volunteered to serve at Guantanamo, where some of those being held prisoner went on hunger strikes. They were following a long tradition going back to the H-Block Irish hunger strikers in Britain who found no other way to protest their internment and prison conditions but to refuse food.

The Navy brass at Gitmo decided that these prisoners were going to eat. They dragged them out of their cells, put them in full body restraints, shoved a tube through their nose and down into their stomachs and force-fed them with artificial food.

Read the full article here.

Arthur Caplan on Hyperbaric Oxygen Therapy

Art Caplan has a new piece on hyperbaric oxygen therapy over at NBC News:

Hyperbaric oxygen therapy. Have you ever heard of it? The Internet sure has.

Centers and clinics tout the benefits of sitting in a tank breathing 100 percent oxygen at higher than atmospheric pressure for treating autism, infant brain trauma, multiple sclerosis, chronic fatigue, cerebral palsy and many other conditions.

There’s just one problem: There is no solid evidence that hyperbaric oxygen therapy does anything for any of these disorders.

Read the full article here.

Art Caplan on Companies Paying for Egg Freezing

Over at Medscape, Art Caplan has a new video critiquing some companies’ new policies to pay for women to freeze their eggs:

Facebook and Apple recently announced a new perk for female workers. They will pay to freeze their eggs, a benefit that has sparked an appropriate ethical controversy.

There is no doubt that some women at these companies will think it is a great benefit, and they are glad to have it. But I am afraid that things aren’t so simple.

Part of the reason that those companies offer egg freezing is that they don’t want women distracted from their careers by having children. One way to manage both career and motherhood is to freeze your eggs. But freezing eggs is not simple, nor is the choice to do so…

Watch the full video here.

Art Caplan on Ebola Quarantines

Over at his NBC News column, Art Caplan proposes a different approach to quarantining ebola “heroes.”

How to combat fear? Honor these heroes by giving them paid R &R, with their partner if they so choose, for 21 days. Give them a vacation in the guise of quarantine. Give them a reason to want to go back to fight Ebola. Give other doctors and nurses a reason to emulate them. Build or buy a nice hotel for these heroes.

And more, on why a general quarantine is a bad idea:

When officials respond to panic with quarantine they basically say they can’t trust public health officials, science and the ethics of doctors and nurses. There is no substitute for that trust. None. If state and city officials undermine trust out of panic or politics, then they destroy the best weapon we have to control Ebola — good science implemented by heroes.

NYULMC: Compassionate Use Could Impact Long-Term Medical Benefits

A new working group at the NYU Langone Medical Center has issued preliminary findings from their studies on the research ethics of compassionate use. Among their findings include:

  • Biotechnology companies have no legal or regulatory obligation to provide access to unapproved treatments on the grounds of compassionate use. Some companies allow access under the guidance of well thought out policies; some companies decline to allow access; some companies grant access but have no set guidelines; and some companies change their practices midstream as a result of public pressure. This lack of uniform policy is confusing to those seeking unapproved treatments.
  • Contrary to widespread perception, the U.S. Food and Drug Administration (FDA) is not an obstacle to those seeking compassionate use. In fact, the FDA almost always defers to the company that is developing the unapproved treatment to decide whether to grant compassionate use acces.
  • The “human impulse” to help patients facing insurmountable odds motivates both the general public’s support for compassionate use and so-called “right to try” laws to help gain access to unapproved treatments. However, increasing access to unapproved therapies may prove detrimental in the long run to longstanding and effective research and clinical trial systems through which interventions are proven effective and safe, and given regulatory approval.

You can learn more about the working group and read more of their findings here.

Art Caplan: Is It Fair That Americans Received the Ebola Treatment?

Art Caplan has a new video on Medscape laying out the principles behind rationing limited supplies of experimental ebola treatments. As he explains:

I believe the answer to the question of who should receive the drug is: people we can both learn from and potentially help the most. I believe those are the 2 values we use when trying to ration access to an experimental drug. If we do not learn whether something is safe and effective, then we have missed an opportunity, even in the middle of an epidemic, to find out whether it is worth giving out drugs that are new, untested, and unapproved. People who should be included are those who can be observed and kept under surveillance — not for a day or a week but probably for months and years. That favors people who are not in rural villages. That favors people who will have access to hospital facilities. Those criteria will drive the selection of who receives a new, unapproved drug.

Click here to see the video and read more.

Art Caplan: WHO Ethics Committee on Ebola Just a Start

Art Caplan has a series of new opinion pieces out on the WHO ethics advisory committee meeting that approved the use of experimental drugs to treat patients ill with Ebola.

He suggests deeper exploration of issues of informed consent, corporate responsibility, and resource allocation in this blog post for The Health Care Blog. As he writes in his piece in NBC News Health:

It is important that the WHO committee affirmed the morality of compassionate use. This addresses the concern that any use of unapproved drugs is inherently exploitative. But there are huge ethical issues that still remain unaddressed and unanswered regarding experimental interventions.

In the wake of the Canadian government’s offering 1,000 doses of an experimental Ebola vaccine to the stricken nations, he also extends the argument from allocation of treatment to allocation of prophylaxis in this opinion piece in NBC News Health:

It is ethically appropriate in the midst of a deadly contagious epidemic to try both untested treatments and experimental preventative vaccines that have shown some promise in animals and no safety issues. But with only 1,000 doses of vaccine available, who should get them? And what do they need to be told?

The most ethical way to distribute limited experimental vaccine, is, as the WHO ethics group noted, with an eye toward collecting information on safety and efficacy. Rather than just handing out vaccine to a small group of people in countries that have seen Ebola outbreaks, it is important to learn as much as possible about whether the vaccine has any efficacy in humans and is safe.

You can read more at the links above.

Art Caplan: Ebola Treatment Distribution is Troubling

Amidst news from Spain that a 75-year-old Catholic priest has received the experimental treatment ZMapp for Ebola, Art Caplan critiques what he describes as the “bad science” behind choosing its recipients:

ZMapp is not the answer to the Ebola epidemic ravaging West Africa. There is no chance of getting a significant amount of this drug made for many months. Deploying more health care workers, face guards, moon suits, gloves and antiseptic, along with restrictions on travel and burying the dead, is the only way to get the epidemic under control. […]

The fact that a 75-year-old has been given the scarce drug is especially disturbing, not because he is 75 but because 75-year-olds do not have strong immune systems — something very important in battling a virus like Ebola. Moreover 75-year-olds often have other medical problems that complicate the ability of scientists to figure out if the drug is safe and if it is really working.

In testing unapproved, highly risky drugs like ZMapp, it is crucial that recipients not be so sick that they may well die regardless of whether they get the drug or not. Indeed, the recipients ought not be very sick so that side-effects can be seen and efficacy determined. To do that, doctors need to be able to monitor experimental subjects for months to make sure the drug does not damage their livers or cause any other fatal side-effect. So not every person infected with Ebola makes for the best recipient — younger, those more recently infected and those who can be closely monitored are among the “best” candidates.

You can read more of Art Caplan’s perspective on NBC News Health here.

Art Caplan: Why do two white Americans get the Ebola serum while hundreds of Africans die?

As the WHO announced today that medical ethicists will convene next week in New York to discuss the use of experimental medicines in the West African Ebola outbreak, Art Caplan has a timely new opinion piece in the Washington Post asking why only white American victims of the Ebola outbreak have been treated with an experimental serum. Caplan argues that the decision was a question of economics:

The reasons for different treatment are partly about logistics, partly about economics and, partly about a lack of any standard policy for giving out untested drugs in emergencies. Before this outbreak, ZMapp had only been tested on monkeys. Mapp, the tiny, San Diego based pharmaceutical company that makes the drug stated two years ago: “When administered one hour after infection [with Ebola], all animals survived…Two-thirds of the animals were protected even when the treatment, known as Zmapp, was administered 48 hours after infection.”

But privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists—better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists. […]

But it’s about more than logistics. Drugs based on monoclonal antibodies usually cost a lot—at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free. It is likely that if they were going to donate drugs, it would be to people who would command a lot of press attention and, thus, investors and government money for further research—which is to say, not to poor Liberians, Nigerians or Guineans. […]

To get Caplan’s full perspective, read the full article.

Art Caplan: The Real Reasons for Worrying About Ebola

Art Caplan has a new opinion piece on NBC News responding to the recent media coverage of Ebola. He makes the case that although this has been the worst recorded outbreak of the disease, citizens of developed countries have little reason to panic:

Ebola is not going to run amok in downtown Boston, Cape May or Myrtle Beach or anywhere else in the U.S. It is running amok in poor African nations because local authorities did not have the will or the resources to respond quickly, because no one confronted local funeral customs that expose people to Ebola, mainly because the world did not care much if hundreds died in poor, politically insignificant nations.

The harsh ethical truth is the Ebola epidemic happened because few people in the wealthy nations of the world cared enough to do anything about it.

Read the full article.