Vaccination as a social contract

L. Korn, et al.

PNASJun 2020, 117 (26) 

14890-14899; 

DOI: 10.1073/pnas.1919666117

Abstract

Most vaccines protect both the vaccinated individual and the society by reducing the transmission of infectious diseases. In order to eliminate infectious diseases, individuals need to consider social welfare beyond mere self-interest—regardless of ethnic, religious, or national group borders. It has therefore been proposed that vaccination poses a social contract in which individuals are morally obliged to get vaccinated. However, little is known about whether individuals indeed act upon this social contract. If so, vaccinated individuals should reciprocate by being more generous to a vaccinated other. On the contrary, if the other doesn’t vaccinate and violates the social contract, generosity should decline. Three preregistered experiments investigated how a person’s own vaccination behavior, others’ vaccination behavior, and others’ group membership influenced a person’s generosity toward respective others. The experiments consistently showed that especially compliant (i.e., vaccinated) individuals showed less generosity toward nonvaccinated individuals. This effect was independent of the others’ group membership, suggesting an unconditional moral principle. An internal metaanalysis (n = 1,032) confirmed the overall social contract effect. In a fourth experiment (n = 1,212), this pattern was especially pronounced among vaccinated individuals who perceived vaccination as a moral obligation. It is concluded that vaccination is a social contract in which cooperation is the morally right choice. Individuals act upon the social contract, and more so the stronger they perceive it as a moral obligation. Emphasizing the social contract could be a promising intervention to increase vaccine uptake, prevent free riding, and, eventually, support the elimination of infectious diseases.

Significance

Vaccines support controlling and eliminating infectious diseases. As most vaccines protect both vaccinated individuals and the society, vaccination is a prosocial act. Its success relies on a large number of contributing individuals. We study whether vaccination is a social contract where individuals reciprocate and reward others who comply with the contract and punish those who don’t. Four preregistered experiments demonstrate that vaccinated individuals indeed show less generosity toward nonvaccinated individuals who violate the social contract. This effect is independent of whether the individuals are members of the same or different social groups. Thus, individuals’ behavior follows the rules of a social contract, which provides a valuable basis for future interventions aiming at increasing vaccine uptake by emphasizing this social contract.

The research is here.

The Mistrust of Science

Atul Gawande

The New Yorker

Originally posted 01 June 2016

Here is an excerpt:

The scientific orientation has proved immensely powerful. It has allowed us to nearly double our lifespan during the past century, to increase our global abundance, and to deepen our understanding of the nature of the universe. Yet scientific knowledge is not necessarily trusted. Partly, that’s because it is incomplete. But even where the knowledge provided by science is overwhelming, people often resist it—sometimes outright deny it. Many people continue to believe, for instance, despite massive evidence to the contrary, that childhood vaccines cause autism (they do not); that people are safer owning a gun (they are not); that genetically modified crops are harmful (on balance, they have been beneficial); that climate change is not happening (it is).

Vaccine fears, for example, have persisted despite decades of research showing them to be unfounded. Some twenty-five years ago, a statistical analysis suggested a possible association between autism and thimerosal, a preservative used in vaccines to prevent bacterial contamination. The analysis turned out to be flawed, but fears took hold. Scientists then carried out hundreds of studies, and found no link. Still, fears persisted. Countries removed the preservative but experienced no reduction in autism—yet fears grew. A British study claimed a connection between the onset of autism in eight children and the timing of their vaccinations for measles, mumps, and rubella. That paper was retracted due to findings of fraud: the lead author had falsified and misrepresented the data on the children. Repeated efforts to confirm the findings were unsuccessful. Nonetheless, vaccine rates plunged, leading to outbreaks of measles and mumps that, last year, sickened tens of thousands of children across the U.S., Canada, and Europe, and resulted in deaths.

People are prone to resist scientific claims when they clash with intuitive beliefs. They don’t see measles or mumps around anymore. They do see children with autism. And they see a mom who says, “My child was perfectly fine until he got a vaccine and became autistic.”

Now, you can tell them that correlation is not causation. You can say that children get a vaccine every two to three months for the first couple years of their life, so the onset of any illness is bound to follow vaccination for many kids. You can say that the science shows no connection. But once an idea has got embedded and become widespread, it becomes very difficult to dig it out of people’s brains—especially when they do not trust scientific authorities. And we are experiencing a significant decline in trust in scientific authorities.

The info is here.

5 years old, and still relevant.

The ethics of pausing a vaccine trial in the midst of a pandemic

Patrick Skerrett

statnews.com

Originally posted 11 Sept 20

Here is an excerpt:

Is the process for clinical trials of vaccines different from the process for drug or device trials?

Mostly no. The principles, design, and basic structure of a vaccine trial are more or less the same as for a trial for a new medication. The research ethics considerations are also similar.

The big difference between the two is that the participants in a preventive vaccine trial are, by and large, healthy people — or at least they are people who don’t have the illness for which the agent being tested might be effective. That significantly heightens the risk-benefit calculus for the participants.

Of course, some people in a Covid-19 vaccine trial could personally benefit if they live in communities with a lot of Covid-19. But even then, they might never get it. That’s very different than a trial in which individuals have a condition, say melanoma or malignant hypertension, and they are taking part in a trial of a therapy that could improve or even cure their condition.

Does that affect when a company might stop a trial?

In every clinical trial, the data and safety monitoring board takes routine and prescheduled looks at the accumulated data. They are checking mainly for two things: signals of harm and evidence of effectiveness.

These boards will recommend stopping a trial if they see a signal of concern or harm. They may do the same thing if they see solid evidence that people in the active arm of the trial are doing far better than those in the control arm.

In both cases, the action is taken on behalf of those participating in the trial. But it is also taken to advance the interests of people who would get this intervention if it was to be made publicly available.

The current situation with AstraZeneca involves a signal of concern. The company’s first obligation is to the participants in the trial. It cannot ethically proceed with the trial if there is reason for concern, even based on the experience of one participant.

The info is here.

Pharma drew a line in the sand over Covid-19 vaccine readiness, because someone had to

Ed Silverman
statnews.com
Originally posted 7 Sept 20

Here is an excerpt:

The vaccine makers that are signing this pledge — Pfizer, Merck, AstraZeneca, Sanofi, GlaxoSmithKline, BioNTech, Johnson & Johnson, Moderna, and Novavax — are rushing to complete clinical trials. But only Pfizer has indicated it may have late-stage results in October, and that’s not a given.

Yet any move by the FDA to green light a Covid-19 vaccine without late-stage results will be interpreted as an effort to boost Trump — and rightly so.

Consider Trump’s erratic and selfish remarks. He recently accused the FDA of slowing the vaccine approval process and being part of a “deep state.” No wonder there is concern he may lean on Hahn to authorize emergency use prematurely. For his part, Hahn has insisted he won’t buckle to political pressure, but he also said emergency use may be authorized based on preliminary data.

“It’s unprecedented in my experience that industry would do something like this,” said Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. “But we’ve experienced unprecedented events since the beginning of Covid-19, starting with the FDA, where the commissioner has proven to be malleable, to be kind, at the foot of the president.”

Remember, we’ve seen this movie before.

Amid criticism of his handling of the pandemic, Trump touted hydroxychloroquine, a decades-old malaria tablet, as a salve and the FDA authorized emergency use. Two weeks ago, he touted convalescent blood plasma as a medical breakthrough, but evidence of its effectiveness against the coronavirus is inconclusive. And Hahn initially overstated study results.

Most Americans seem to be catching on. A STAT-Harris poll released last week found that 78% of the public believes the vaccine approval process is driven by politics, not science. This goes for a majority of Democrats and Republicans.

The info is here.

Ethics of controlled human infection to study COVID-19

Shah, S.K, Miller, F.G., and others
Science  07 May 2020
DOI: 10.1126/science.abc1076

Abstract

Development of an effective vaccine is the clearest path to controlling the coronavirus disease 2019 (COVID-19) pandemic. To accelerate vaccine development, some researchers are pursuing, and thousands of people have expressed interest in participating in, controlled human infection studies (CHIs) with severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) (1, 2). In CHIs, a small number of participants are deliberately exposed to a pathogen to study infection and gather preliminary efficacy data on experimental vaccines or treatments. We have been developing a comprehensive, state-of-the-art ethical framework for CHIs that emphasizes their social value as fundamental to justifying these studies. The ethics of CHIs in general are underexplored (3, 4), and ethical examinations of SARS-CoV-2 CHIs have largely focused on whether the risks are acceptable and participants could give valid informed consent (1). The high social value of such CHIs has generally been assumed. Based on our framework, we agree on the ethical conditions for conducting SARS-CoV-2 CHIs (see the table). We differ on whether the social value of such CHIs is sufficient to justify the risks at present, given uncertainty about both in a rapidly evolving situation; yet we see none of our disagreements as insurmountable. We provide ethical guidance for research sponsors, communities, participants, and the essential independent reviewers considering SARS-CoV-2 CHIs.

The info is here.

The race to develop coronavirus treatments pushes the ethics of clinical trials

Olivia Goldhill
Quartz.com
Originally posted 28 March 20

Here is an excerpt:

But others are more pragmatic. Arthur Caplan, director of NYU Langone’s Division of Medical Ethics says that when doctors are faced with suffering patients, it’s ethical for them to use drugs that have been approved for other health conditions as treatments. This happened with Ebola, swine flu, Zika, and now coronavirus, he says.

Some of the first coronavirus patients in China, for example, were experimentally given the HIV treatment lopinavir–ritonavir and the rheumatoid arthritis drug Actemra. Now, as the virus continues its rampage around the globe, doctors are eyeballing an increasing number of treatment possibilities—and dealing with the challenging ethics of testing their efficacy while making the safest choices for their patients.

Controlled trials—with caveats

When choosing to use an experimental treatment, doctors have to be as methodical as possible—taking careful note of how sick patients are when given treatment, the dose and timing of medication, and how they fared. “It’s not a study, not controlled, but you want observations to be systematic,” says Caplan.

If, after a couple of weeks and 10 or 20 patients the drug doesn’t seem to cause active harm, Caplan says scientists can quickly move to the first stage of clinical research.

Many of the current coronavirus clinical trials are based on those early experimental treatments. Early research on lopinavir–ritonavir suggests that the drug is not effective, though as the first study was small, researchers plan to investigate further. There are also ongoing trials into arthritis medication Actemra,  antimalarial chloroquine, and Japanese flu drug favipiravir.

While clinical trials typically take months to years to get started, Li believes the current coronavirus trials will set records for speed: “I don’t think they could go any faster,” she says. It helps that there are a lot of coronavirus patients, so it’s easy to quickly enroll study participants.

The info is here.

Ethical Concerns Raised by Illicit Human Experiments

David Tereshchuk
Religion and Ethics - PBS.org
Originally posted July 16, 2018

Institutional regulation in science – including medical science – is undergoing one of its periodic assaults by proponents of greater freedom in research. These proponents argue (most of them in entirely good faith, I should stress) that experimentation is often needlessly hampered by too much official control. Formal constraints, they say, can cramp the kind of spontaneous improvisation that leads to unexpected, sometime spectacular, breakthroughs.

As reported by Marisa Taylor of Kaiser Health News, it has been revealed that the federal Food and Drug Administration (who won’t officially confirm this) is pursuing criminal inquiries into an egregious case of medical experimentation – conducted illicitly in off-shore locations and in hotel rooms on American soil.

The procedures under investigation were self-styled drug ‘trials’ – apparently a last-ditch effort by a university professor of microbiology, William Halford who – knowing he was dying from an incurable cancer – evidently threw both professional caution and ethics to the winds. He embarked hell-bent on a test-program for a herpes vaccine he’d invented, but for which he hadn’t gained FDA approval – a program that involved injecting it into human subjects.

The information is here.

What Does an Infamous Biohacker’s Death Mean for the Future of DIY Science?

Kristen Brown
The Atlantic
Originally posted May 5, 2018

Here are two excerpts:

At just 28, Traywick was among the most infamous figures in the world of biohacking—the grandiose CEO of a tiny company called Ascendance Biomedical whose goal was to develop and test new gene therapies without the expense and rigor of clinical trials or the oversight of the FDA. Traywick wanted to cure cancer, herpes, HIV, and even aging, and he wanted to do it without having to deal with the rules and safety precautions of regulators and industry standards.

“There are breakthroughs in the world that we can actually bring to market in a way that wouldn’t require us to butt up against the FDA’s walls, but instead walk around them,” Traywick told me the first time I met him in person, during a biotech conference in San Francisco last January.

To “walk around” regulators, Ascendance and other biohackers typically rely on testing products on themselves. Self-experimentation, although strongly discouraged by agencies like the FDA, makes it difficult for regulators to intervene. The rules that govern drug development simply aren’t written to oversee what an individual might do to themselves.

(cut)

The biggest shame, said Zayner, is that we’ll never get the chance to see how Traywick might have matured once he’d been in the biohacking sphere a little longer.

Whatever their opinion of Traywick, everyone who knew him agreed that he was motivated by an extreme desire to make drugs more widely available for those who need them.

The information is here.

University could lose millions from “unethical” research backed by Peter Thiel

Beth Mole
ARS Technica
Originally published November 14, 2017

Here is an excerpt:

According to HHS records, SIU (Southern Illinois University) had committed to following all HHS regulations—including safety requirements and having IRB approval and oversight—for all clinical trials, regardless of who funded the trials. If SIU fails to do so, it could jeopardize the $15 million in federal grant money the university receives for its other research.

Earlier, an SIU spokesperson had claimed that SIU didn’t need to follow HHS regulations in this case because Halford was acting as an independent researcher with Rational Vaccines. Thus, SIU had no legal responsibility to ensure proper safety protocols and wasn’t risking its federal funding.

In her e-mail, Buchanan asked for the “results of SIU’s evaluation of its jurisdiction over this research.”

In his response, Kruse noted that SIU was not aware of the St. Kitts trial until October 2016, two months after the trial was completed. But, he wrote, the university had opened an investigation into Halford’s work following his death in June of this year. The decision to investigate was also based on disclosures from American filmmaker Agustín Fernández III, who co-founded Rational Vaccines with Halford, Kruse noted.

The article is here.

Peter Thiel sponsors offshore testing of herpes vaccine, sidestepping U.S. safety rules

Marisa Taylor
Kaiser News
Originally posted August 28, 2017

Here is an excerpt:

“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”

The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact, but also can be released through skin.

The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.

“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.

The article is here.

Measles, Vaccination, and the Tragedy of the Commons

By Katharine Brown
Bioethics Forum
Originally published on February 25, 2015

Here is an excerpt:

To understand why, think of vaccination and the quest for herd immunity as a collective action problem. Garrett Hardin’s “tragedy of the commons” illustrates the basic logic of collective action problems. Imagine that 50 farmers share common land (“the commons”) upon which they graze their sheep. The commons are lush, and so each farmer can easily allow four sheep to graze at a given time without depleting the resource. But imagine that each farmer seeks to maximize his own good (what economic theory refers to as “rational” behavior) and it is better for him to graze more sheep than fewer. The farmers will, in effect, be “free-riding” – in this case, taking more than their fair share of the common resource while benefitting from the restraint of others. The trouble is that, while adding one more sheep to the commons does not deplete the resource, adding 50 does. The combined actions of each farmer, acting rationally, leads to an outcome that is worse for all.

The tragedy of the commons reveals that what is good for the individual is at odds with what is good for all. This is the basic logic of collective action problems. We see a similar logic in the case of vaccines. If most get vaccinated, then everyone will be better off. But it would be best for any particular individual if all others got vaccinated and he or she did not.

The entire article is here.

To Protect His Son, A Father Asks School To Bar Unvaccinated Children

By Lisa Aliferis
NPR
Originally posted January 27, 2015

Here are two excerpts:

Rhett cannot be vaccinated, because his immune system is still rebuilding. It may be months more before his body is healthy enough to get all his immunizations. Until then, he depends on everyone around him for protection — what's known as herd immunity.

(cut)

Carl Krawitt has had just about enough. "It's very emotional for me," he said. "If you choose not to immunize your own child and your own child dies because they get measles, OK, that's your responsibility, that's your choice. But if your child gets sick and gets my child sick and my child dies, then ... your action has harmed my child."

The entire article is here.

I Don't Want to Be Right

By Maria Konnikova
The New Yorker
Originally published May 19, 2013

Last month, Brendan Nyhan, a professor of political science at Dartmouth, published the results of a study that he and a team of pediatricians and political scientists had been working on for three years. They had followed a group of almost two thousand parents, all of whom had at least one child under the age of seventeen, to test a simple relationship: Could various pro-vaccination campaigns change parental attitudes toward vaccines? Each household received one of four messages: a leaflet from the Centers for Disease Control and Prevention stating that there had been no evidence linking the measles, mumps, and rubella (M.M.R.) vaccine and autism; a leaflet from the Vaccine Information Statement on the dangers of the diseases that the M.M.R. vaccine prevents; photographs of children who had suffered from the diseases; and a dramatic story from a Centers for Disease Control and Prevention about an infant who almost died of measles. A control group did not receive any information at all. The goal was to test whether facts, science, emotions, or stories could make people change their minds.

The result was dramatic: a whole lot of nothing. None of the interventions worked.

The entire article is here.

Strong Beliefs About Vaccines Work Both Ways

By Kristina Fiore, Staff Writer, MedPage Today

Sometimes, Dr. Andrew Lieber has to tell his patients' parents that it just isn't working out.

When parents refuse to vaccinate their children in spite of his efforts to convince them of the benefits of immunity, he reluctantly cuts the cord.

"By four months, if I can't help you come to terms with the scientific fact that vaccines are helpful, then I've done about all I can do to educate you," Lieber, a pediatrician with Rose Pediatrics in Denver, told MedPage Today.

At that point, he'll tell them to find another doctor -- something he has to do "a couple times a year."

"I feel like I have a bigger responsibility to all the other kids walking through my waiting room," Lieber said.

Pediatricians appear to be increasingly taking this hard-line approach as parents make greater efforts to screen doctors for one whose vaccination philosophy matches their own.

According to a 2001 American Academy of Pediatrics survey, 23% of physicians reported that they "always" or "sometimes" tell parents they can no longer be the child's pediatrician if they won't get the proper shots.

The Academy doesn't have more recent survey data, but physicians say that they see plenty of their colleagues joining the ranks.

Lieber will sometimes work with parents to adjust the vaccination schedule -- "I'm willing to separate some vaccines by two weeks, whatever I can do to increase vaccination rates is good" -- but if an interviewer comes along wanting to cross all vaccines off the list, Lieber says No.

Few physicians question the ethics of this practice, especially in light of recent outbreaks such as pertussis in California and in certain communities within Brooklyn.

Indeed, the American Academy of Pediatrics has deemed it ethical to dismiss patients who refuse to get their children vaccinated, and offers a clinical guideline as well as an online toolkit on how to handle the pertinent issues.

"Physicians, like their patients, are moral agents," says Felicia Cohn, PhD, director of bioethics for Kaiser Permanente in Irvine, Calif. "Any physician may refuse an individual for moral reasons or may conscientiously object to providing particular treatments."

David Cronin, MD, a pediatrician with Medical College of Wisconsin in Milwaukee, says it's "entirely appropriate for a physician to refuse elective treatment to any patient. Being a physician does not obligate one to provide care to 'all comers.'"

Yet others say refusing to treat because of vaccine preference is indeed unethical because it punishes the wrong party. Samuel Katz, MD, of Duke University, says it's not right to refuse seeing a child "because it is the parent who is the problem, whereas the child merits medical care."

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