Category: Arthur Caplan

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Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

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By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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The National Anti-Vaccine Movement Heads to Hartford to Intimidate CT Legislators

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By Arthur Caplan and Dorit Rubinstein Reiss

As Connecticut’s Senate prepares to vote tomorrow on whether to repeal Connecticut’s religious exemption from school immunization mandates, out-of-state anti-vaccine activists are mobilizing to threaten and intimidate legislators to vote against the bill.

The legislators should hold firm, and pass the bill the Governor says he will sign. They must not let aggressive attackers stop them from acting to make Connecticut’s children safer. Legislators should show the out-of-state anti-vaccine movement that intimidation doesn’t work here.

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Bioethicist Art Caplan: A New Mind-Body Problem

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A new piece by Bill of Health contributor Arthur Caplan, with Lisa Kearns, in The Hastings Center Bioethics Forum:

Not since Rene Descartes gazed from his garret window in early 17th-century Paris and wondered whether those were men or hats and coats covering “automatic machines” he saw roaming the streets has the issue of personal identity and your cranium been of such import. Descartes feared a world that he alone occupied due to deception by the devil. Today we face a different mind-body challenge in the form of a devil we know: Italian neuroscientist Sergio Canavero. He recently announced that the first human head transplant is imminent.

For bioethicists, the moral critiques of this surgery practically write themselves: Are we merely our bodies? How can a person so ill as to wish to trade in his lifelong corporeal companion be considered competent to consent to such a drastic procedure? How can family members consent to donate a body that they could very well run into — and recognize — at the beach or gym? What if a left-handed person received a right-handed body? What if a lifelong Chicago Bears fan woke to find himself attached to the green-and-gold-tattooed torso of a former Packers fan? Would transplant recipients need to buy whole new wardrobes? Who will pay? […]

Read the full article here!

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. […]

Read the full post here.

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. […]

Read the full article here.

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. […]

Read the full article here.

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. […]

Read the full article here.

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. […]

Read the full post here.

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. […]

Read the full article here.

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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