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A Bizarre Claim of Right to Try

By ARTHUR CAPLAN, KELLY MCBRIDE FOLKERS, and ANDREW MCFADYEN DONALD TRUMP, RIGHT TO TRY

A patient with glioblastoma recently received an experimental cancer vaccine at the University of California, Irvine. Notably, this is being hailed as the first case of someone utilizing the Right to Try Act of 2017. ERC-USA, a U.S. subsidiary of the Brussels-based pharmaceutical company Epitopoietic Research Corporation, says it provided its product, Gliovac, to the patient at no cost. The vaccine is currently undergoing Phase II clinical trials. A handful of people in Europe have received access to it through “compassionate use.” This patient did not qualify for ongoing clinical trials in the U.S. The patient, who remains anonymous, is the first known individual to receive an experimental medicine that has not been approved by the FDA, as permitted under the federal right to try law.

Glioblastoma is a nasty cancer – John McCain and Ted Kennedy passed away after battling the disease for just over a year. We believe that patients with terminal illnesses, like those with glioblastoma, should have every reasonable tool at their disposal to treat their disease.

That being said, we’ve argued before that right to try laws are not the best way to help desperate patients. They still aren’t. The number of cases claimed to date is exactly one. And, further examination of what we know about this case does not make a strong argument for the widespread usage of the right to try pathway.

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The NFL’s Conflicted Relationship With Doctors

NFL injuryToo often doctors, trainers and other health care professionals who work for professional sports teams are accountable only to their teams and, especially, team owners. To keep their jobs they have to keep coaches, general managers, fans and billionaire investors happy.

This situation has created an intolerable ethical mess in which athletes’ health is too often their lowest priority. It is time to fix that.

Concussions are giving professional football, hockey and other sports a huge headache these days. The implication is that the NFL, NHL and their doctors long knew that “getting your bell rung” was bad for an athlete’s brain but said nothing.

Now a group of former NFL players are suing the league claiming that they were given powerful painkillers and anti-inflammatory drugs to keep them on the field. They say no one ever warned them about the long-term dangers of addiction, horrible side-effects or playing injured while drugged to withstand pain.

The eight plaintiffs, led by 1985 Superbowl champions Richard Dent, Jim McMahon and Keith Van Horne, say the league “recklessly and negligently created and maintained a culture of drug misuse, substituting players’ health for profit.”

Team doctors and trainers “were handing out drugs like it was Halloween candy,” says the group’s attorney Steve Silverman. Among the drugs said to be given freely were Toradol, Percocet, Vicodin, Ambien, Prednisone and Lidocaine. The eight players estimate they were given “hundreds, if not thousands” of pills through the course of their careers.

None of this comes as a surprise to sports fans, especially those of a certain age, who remember the NFL, NHL, MLB, NASCAR, FIFA, pro cycling and NBA of the ’70s, ’80s and ’90s when doctors and trainers kept athletes going at any cost with any pill, salve, injection, bandage, device or inhaler they could get their hands on.

“Just win, baby” was the guiding ethical principle of the era and doctors and trainers put aside their oaths and codes to make sure stars played, their team won, the fans were happy and the owners renewed their contracts for another season.

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Mandela’s AIDS Legacy of Silence and Courage

Even the greatest among us can stumble.

As the world mourns the passing of Nelson Mandela, it is important to look at the one area where the iconic former president of South Africa slipped — AIDS. The most outstanding moral figure of our age did not do what was needed as HIV began to destroy the country he loved. But his actions after he realized his failures are an important part of his legacy.

South Africa is beset with the worst epidemic of HIV in the world. According to the United Nations, out of a South African population of just over 51 million, 6.1 million of its citizens were infected with HIV in 2012, including 410,000 children under the age of 14. An estimated 240,000 South Africans died in 2012 from AIDS. There are 2.5 million children orphaned because of the disease. The grim social, economic and medical toll AIDS has exacted on Mandela’s country is almost beyond description.

In 1990, when Mandela was released from a 27-year prison sentence, the rate of HIV infection among adult South Africans was less than 1 percent. When the anti-apartheid activist was elected president four years later, AIDS was on it way to being an out-of-control plague, with infection rates doubling every year. In 1998, the rate of HIV infection among adults in South Africa was almost 13 percent, with 2.9 million people HIV positive.

Mandela and his party were more or less indifferent to AIDS throughout his five-year tenure. There were other huge challenges in rebuilding the new post-apartheid nation — but the indifference was not just a matter of priorities. Mandela and his party did not want to admit they had a problem.

Why they did not take prompt action to slow the epidemic’s spread is not clear. Perhaps Mandela and his people — like United States President Ronald Reagan and his administration in the 1980s — found the disease and its modes of transmission too repellent to acknowledge. Maybe they did not want to tarnish the new state with a problem that at the time carried so much stigma and shame.

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Addressing Unapproved Meningitis Vaccine at Princeton

Emergency doses of a meningitis vaccine not approved for use in the U.S. are likely to be on the way to Princeton University to halt a meningitis outbreak that has already sickened seven students. There are approved meningitis vaccines available, but they do not protect against Meningitis B—a strain not covered by the shots given in the U.S. and not a strain prevalent here.

Government health officials said Friday they have agreed to import Bexsero, a vaccine licensed only in Europe and Australia that does protect against meningitis B.  And that decision seems entirely reasonable given the threat that this nasty strain of meningitis poses.

That said, the question arises — what should those getting the vaccine be told?  Are they being offered a proven vaccine, an experimental vaccine, a vaccine believed to be the best choice given the threat of an epidemic or something else?  Can a student, campus worker or faculty member refuse the vaccination and stay in school or in a dorm?  Should those who have visited the campus recently be tracked down and offered the vaccine?  If people do refuse should they identify themselves in anyway as unvaccinated and to whom?

In general when using a drug or device that has not been approved by the FDA or other federal advisory agencies those who are offered the vaccine should be treated more as research subjects than patients.  They should be told all the facts about the vaccine, why it has not been approved in the U.S. and about the all too real threat that meningitis poses.  They should be given the opportunity to ask questions.  There is a duty to try and monitor those who get the vaccine or a representative sample of such persons, to watch for both efficacy and safety.  Vaccine refusal might be accepted, herd immunity could help in this regard, but university officials will need a policy concerning refusers and where they ought to go to study, live and work until the potential epidemic subsides.

Using a vaccine very likely to be safe and effective to stave off an outbreak of a nasty disease makes good moral sense.  However, it is important to treat emergency use as such and to do what can be done to inform subjects, track the results in those who are vaccinated and to find a path for those who will not accept vaccination.

Arthur Caplan, Ph.D. is head of the Division of Bioethics at New York University Langone Medical Center. This post originally appeared in bioethics.net blog.

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