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Bioethicist Art Caplan: Right-To-Try Laws For The Terminally Ill Are Bad Policy

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A new piece by Bill of Health contributor Art Caplan in Forbes:

Nathan Nascimento thinks that right-to-try laws aimed at the terminally ill are sound public policy. He is wrong.

Mr. Nascimento’s commentary misrepresents the complexities of the drug development process and the issues surrounding granting access to experimental medicines before they have been fully tested.

The overarching issue, despite his rhetoric to the contrary, is that the safety and efficacy profile of a new medicine is not sufficiently understood until after the drug has completed at least a pivotal Phase 3 clinical trial.

The underlying principle of every clinical development program is to understand, via testing first for safety usually in a small number of patients afflicted with the target condition, and, subsequently, in increasing numbers of patients, the benefits as well as the risks of new medicines. Like it or not, this is a time-consuming, expensive, but appropriate and necessary process. […]

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Bioethicist Arthur Caplan: Using Genetically Modified Mosquitoes To Fight Zika Is The Right Thing To Do

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A new piece by Bill of Health contributor Art Caplan on Forbes:

When most of us think of mosquito control, we think of repellent, sprays and DEET. You might think long sleeves, window screens or mosquito control trucks, too. We’ve gotten pretty used to the idea that mosquitoes live around and among us–even when those mosquitoes carry diseases like West Nile, dengue, malaria and Zika. The best we can do to avoid their pesky, and sometimes lethal, bites is make our bodies unreachable or unappetizing.

The Zika outbreak sweeping through South America, Central America, Mexico and the Caribbean–and steadily moving north–has made mosquito control a top priority for national and international leaders, including the CDC and WHO. Transmitted primarily by the bite of the female Aedes aegypti mosquito, Zika has been linked to microcephaly in babies born to mothers infected during their pregnancies, as well as Guillain-Barré syndrome, which causes paralysis and even respiratory failure. Zika can get into the blood supply. A few cases of Zika appear to have been sexually transmitted. […]

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Bioethicist Art Caplan – About Time: FDA Overturns Ban On Gay Men Donating Blood

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A new piece by Bill of Health contributor Art Caplan on Forbes:

In 2001 one of my goals as the chair of the Federal government’s Advisory Committee on Blood Safety and Availability was to get the ban on gay men donating blood overturned. The ban made no sense ethically or scientifically. The ban stigmatized gay men, and insisting on a lifetime prohibition for even one sexual encounter, condom or no condom, made no scientific sense. Finally, almost 15 years later, the FDA has joined the rest of the Western world and dropped the lifetime prohibition.

The FDA still insists on a one-year ban on having sex with another man even though today’s testing is very reliable for detecting HIV and other diseases at six months. Still, at a time when blood donations are falling and demand is rising, getting more donors into the supply side is a very good thing. […]

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Bioethicist Art Caplan: Shkreli Isn’t to Blame For High Drug Prices in U.S.

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A new piece by Bill of Health contributor Art Caplan on NBC News:

Should we care about Martin Shkreli, the man I call the “Wolf of Pharma Street”? His hoodie-wearing perp walk sparks outrage, but he is diverting attention from far bigger and more important systemic problems regarding the cost of drugs for all Americans.

Shkreli, the former Turing Pharmaceuticals CEO, has been indicted by the feds for allegedly running a Ponzi scheme to keep his various drug company investments afloat.

Before the feds came calling to charge him with securities fraud, Shkreli had secured the manufacturing license for Daraprim which is used to treat nasty, often fatal protozoal infections in, among others, those with AIDS. Shkreli, grinned, flipped the rest of humanity the bird, and raised the 62 year-old drug’s price by 5,500 percent; from $13.50 to $750 per tablet overnight — thus retiring the “Biggest Jerk in Health Care Award” forever. […]

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Bioethicist Art Caplan: Cruz or FDA – Who do you trust with your health?

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Bill of Health contributor Arthur Caplan and his colleagues have a new piece up on The Hill Blog:

Sen. Ted Cruz (R-Texas) not only wants to be your president; he wants to decide what medicines you can get. On Dec. 10, Cruz and Sen. Mike Lee (R-Utah) introduced legislation intended to speed up Food and Drug Administration review of drugs and devices that have been approved in certain foreign countries. The Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act would require FDA to approve or reject within 30 days of application any drug or device that has been approved in a “trusted” foreign country — specifically, Canada, Australia, Israel, Japan, and the European Union members. Should the FDA reject an application, Congress can override the agency. […]

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Bioethicist Art Caplan: Engineering the Better Baby

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Bill of Health Contributor Arthur Caplan has a new article in Project Syndicate:

There should no longer be any doubt about whether humans will one day be genetically modified. A new tool – called CRISPR – is already being used to edit the genomes of insects and animals. Essentially a very sharp molecular knife, CRISPR allows scientists to carve out and insert genes precisely and inexpensively. It is only a matter of time before it will be used to engineer our descendants – eliminating many dangerous hereditary diseases in the process.

To be sure, this eventuality is being hotly debated. The main arguments against genetic modification of human embryos are that it would be unsafe and unfair, and that modification would quickly go beyond efforts to reduce the incidence of inherited maladies. But, ultimately, none of these reasons is likely to be persuasive enough to stop the technology from being widely used. […]

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Bioethicist Art Caplan: No time to waste – the ethical challenges created by CRISPR

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Bill of Health Contributor Art Caplan has a new article in EMBO Reports:

The term “CRISPR” has gained a lot of attention recently as a result of a debate among scientists about the possibility of genetically modifying the human germ line and the ethical implications of doing so. However, CRISPR is not just a method to edit the genomes of embryonic cells, as the public discussion might have implied; it is a powerful, efficient, and reliable tool for editing genes in any organism, and it has garnered significant attention and use among biologists for a variety of purposes. Thus, in addition to the discussion about human germ line editing, CRISPR raises or revives many other ethical issues, not all of which concern only humans, but also other species and the environment.

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Bioethicist Art Caplan: Science Anyone?

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Bill of Health Contributor Arthur Caplan has a new piece up on bioethics.net. From the piece:

Plenty of pundits are analyzing the Wednesday night GOP debate in terms of who won and who lost. They are missing the point. There was a huge loser in the back and forth among the contenders—the public health of the American people. Why?–the resurrection in the debate of the heinous canard that vaccination causes autism.

Donald Trump led the assault on the health of our children by proclaiming that “”We’ve had so many instances … a child went to have the vaccine, got very, very sick, and now is autistic.” Really? Donald produce your evidence or get your racist, misogynist, birther, comb-over tushy out of the race. There is no evidence that vaccines cause autism. None. No one should tolerate outright lying that puts vulnerable kids at risk from a would-be President. So Donald show us your proof or leave Americas kids alone. […]

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Bioethicist Art Caplan: Marco Rubio And The GOP’s Dangerous Misconception On When Life Begins

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Bill of Health Contributor Art Caplan has a new piece up on Forbes:

Does human life begin at conception? For Marco Rubio and some other politicians now running for the presidential nomination in the GOP herd, the answer is yes. There is no doubt in their mind about when life begins. Amazingly despite indifference to science regarding other matters like evolution and climate change, they invoke science on behalf of their advocacy of what might best be called “conceptionalism.” And given what science shows the law must protect every new life.

Those lobbying for conceptionalism aim to outlaw all abortions, no matter how an embryo is conceived. Even if a mentally ill 12-year-old woman is raped by her predatory father, killing an embryo, if one results, ought not be a legal option in their view. When life begins at conception murder is never an option, Rubio and his fellow-travelers aver. [..]

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Bioethicist Arthur Caplan: Euthanasia in Belgium and the Netherlands: On a Slippery Slope?

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Bill of Health Contributor Art Caplan and Barron Lerner have a new piece up in JAMA Internal Medicine:

The slippery slope is an argument frequently invoked in the world of bioethics. It connotes the notion that a particular course of action will lead inevitably to undesirable and unintended consequences. Saying no to the original action, even if that act is moral in itself, may, in light of the slope that looms, be the ethical thing to do.

Slippery slope arguments have been especially pervasive in discussions of euthanasia, in which physicians actively end patients’ lives, and physician-assisted dying (or physician-assisted suicide), in which physicians supply medications to patients that enable them to end their own lives. The concern, fueled by the German experience with racially motivated euthanasia in the last century, has been that approving either of these procedures for a few individuals will inevitably lead to overuse and abuse. […]

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