Professor Adrian Hill leads the Oxford team who were one of the front runners in the race to develop a successful vaccine. His team’s vaccine, ChAdOx1 nCoV-19, looks extremely promising. Prof Hill said a few month’s back that he felt there was an 80% chance it could form the basis of an effective vaccine by September.
So why is he now saying that there is only a 50% chance of having any result at all?
The reason is that it’s becoming increasingly hard to recruit the 10,000 adults and children the study needs. As he told the Daily Telegraph –
“it’s not a race against the other guys. It’s a race against the virus disappearing, and against time.”
Hill’s team is working with AstraZeneca to develop the vaccine, and the UK government has already signed up for up to 100 million doses.
Just last month, AstraZeneca were hoping for answers on vaccine efficacy in June or July. It now seems the process could take far longer, unless transmission rates stay high.
Falling transmission rates may seem like a good thing, but those who fall into the category of extremely vulnerable, really need a viable alternative to solitary confinement.
One way out of the mire is to intentionally infect healthy volunteers with a weakened version of Covid-19. These so-called “human challenge studies” (HCS) are somewhat controversial – especially as some of the participants would, by design, receive a placebo followed by the virus.
This does seem to be somewhat stretching the 3rd principle of GCP – that the rights, safety and wellbeing of the trial subject is more important than the interests of science or society.
In April, the US FDA was sent a letter from 35 US Representatives urging it to take nothing off the table in searching for a Covid-19 treatment – including HCS. They see no inherent ethical problem in HCS, believing the benefits outweigh the risks.
The US vaccine expert, Stanley Plotkin, and New York University bioethicist, Arthur Caplan, argue for HCS in upcoming article for the journal, Vaccine. They argue that if the normal process is followed it –
“…normally takes months to years, during which SARS-2 will infect and possibly kill millions.”
They see human challenge trials as a way of speeding things up.
On the one hand we have US President Donald Trump – who applies the quick-fix logic of a businessman surrounded by staff to handle details. Sometimes suggesting weird, off the wall things can be just what’s needed to boost innovation. As long as people don’t then take matters into their own hands and try swallowing bleach because they think the President suggested it!
On the other hand, we have the tried and tested approach of Good Clinical Practice and rigorous double-blinded trials. These are the bedrock of medical research and represent the safest way forward. However, double blinds become problematic where there is no “standard” treatment to compare with a test drug.
Doctors at the sharp end of pandemics like Covid-19 are faced with a stark choice – try something they think might work or carry on trying to support the patient until the recover. Some of the earliest Covid-19 patients in China, were given the anti-retroviral drug, lopinavir–pitonavir, and the rheumatoid arthritis drug, Actemra (tocilizumab).
The important point here, is that the drugs were controlled and the patients observed. There are no placebos in the true sense – the control group were given ventilation and other support but not specific control drugs.
This approach has been followed in other pandemics, and The WHO’s Covid-19 trials are not double-blind because they argued that they needed to balance rigor with speed.
We all know the story of the tortoise and the hare. Rushing full tilt into drug testing can actually delay things according to Rebecca Li, executive director of the Multi-regional Clinical Trial Center at Harvard University.
She points out that the vast majority of experimental drugs do not succeed. Without properly reviewed and planned trials, researchers risk going down rabbit holes and wasting valuable research effort. It is hard not to get carried along by the overriding sense of urgency that is gripping the healthcare sector, but this does not mean ethics should go out of the window.
Sure, rely on the most efficient ethical review tools at your disposal to reduce wasted time but don’t throw the baby out with the bathwater. If you can find ways to speed up peer view processes for example – use them!
Italy recently introduced a new law following a 10 fold increase in the number of children contracting measles in April 2017, compared to the previous year. Known as the Lorenzin law, children must now receive 10 mandatory vaccines covering various diseases before attending school. Children aged 6 and under will be excluded from nursery and kindergarten without proof of vaccination. Older children won’t be banned from school but their parents risk receiving a €500 fine if they send their children to school without the appropriate vaccinations.
This controversial law comes in a bid to raise the country’s plummeting vaccination rates from below 80% to the World Health Organization’s target of 95%. This latter figure represents the percentage of people that need to be vaccinated in order to protect the population as a whole and prevent outbreaks of contagious diseases. A vaccination rate of 95% should provide “herd immunity”. This term is based on the belief that if enough people in a population are vaccinated, the remaining minority will in turn be protected.
Being too young, having a weakened immune system or being allergic to ingredients contained in a vaccination are all reasons why certain members of a population may be unable to receive vaccinations. It is these people who rely on herd immunity to avoid otherwise preventable infectious diseases. However, are these grounds substantial enough to impose mandatory vaccinations on the rest of the population?
An increasing number of parents would argue that they are not. These members of the growing anti-vaccination movement are reluctant to have their children vaccinated for fear that it will result in unwanted, and potentially fatal, side effects. As a result, they often strongly believe that whether their children are vaccinated or not is their decision, and should not be determined by the government.
Furthermore, there are certain members of the population that may wish to withhold from receiving vaccinations for religious reasons. The use of animal-derived gelatine and human fetus tissue pose the largest concerns here. Imposing mandatory vaccinations on these individuals could go against deeply embedded religious beliefs and remove their sense of autonomy.
With all of these various stances in mind, the ethical implications of mandatory vaccinations is certainly open for debate. Whatever your beliefs are, it should be remembered that the decision to get vaccinated or not is one that has consequences for the rest of the population.
This article is the second part of a two part series on the anti-vaccination movement. To read the first instalment please click here.
Here at Infonetica we have been developing systems to manage the ethical review process for over ten years. With the ethics debate widening, our Ethics Review Manager (ERM) software can manage the processing of ethical decisions for a wide range of organisations.
Originally discovered by a researcher from Osaka University in 1987, gene editing could potentially be used to eliminate heritable diseases through deleting or changing certain coding in embryos. However, the technology involved in this editing is still in the experimental stages, and as such is currently banned in most countries. There is a fear that the changes in DNA could be passed on to future generations, with unpredictable side-effects.
It appears as though these fears are about to be put to the test for the first time in history, as a scientist in China has recently claimed to have produced the world’s first genetically-edited babies. This is yet to be verified, however, if confirmed it could have immense ethical and moral implications.
He Jiankui, a professor from The Southern University of Science and Technology in Shenzhen, is claiming to have edited embryos for seven couples during fertility treatment. According to him, one pregnancy has resulted from this so far.
Jiankui revealed that all of the men in his experiment had HIV while all of the women did not. However, the fathers’ infections are deeply suppressed thanks to standard HIV medicines. Simple methods exist to prevent them from infecting their offspring.
The existence of these treatments mean that the scientist’s intervention was not aimed at preventing HIV transmission. Instead, he hoped to provide the offspring with protection against the disease, reducing their chances of contracting it during their lifetime.
This breakthrough intervention has raised many ethical questions.
Experts worry that we won’t know the full consequences of this gene editing until we can study future generations of the offspring concerned. Even if the editing works perfectly, people without normal genes may be at a greater risk of contracting other viruses.
Ethical questions have also been raised regarding consent. With the consent forms referring to the experiment as an Aids Vaccine Development Programme it is likely that the participants were not made fully aware of the potential risks of the study.
What is particularly shocking is the fact that Jiankui’s work remained a secret for so long. He did not register the clinical trial with Chinese authorities until November, long after the study had begun.
As a country that has been at the forefront of gene editing for several years, China has failed to update its regulations at the same pace, to reflect the risk of gene editing. A 2003 ‘ethics guidance’ document bans the use of research embryos for reproduction. However, the punishments for violations of this regulation remain unspecified.
While China have declared He Jiankui’s work a violation of their law, the incident serves to highlight a concerning gap in their ethical review processing.
“First, they are bred specifically for the programme and then 25% of them don’t make the grade – those pups then have to be rehomed. And they are going into a system which is already bursting full of dogs that need to find a new home, so that’s overloading the rehoming problem.”
Ms Webster went on to assert that guide dogs should be phased out, as the animals are unable to consent to work. She appreciated that the blind need to be guided but believes ‘the future of that is technology’.
However, with no technological advancements in the guiding of blind people on the horizon, how ethical is the practice of guide dogs?
The answer is very ethical, at least according to The Guide Dogs for the Blind Association.
This guide dog training charity explain that the training process is fun, as it is centred on reward-based training methods. This method uses praise when dogs successfully complete a task. Dogs always have the choice to take part.
On the rare occasion where a dog appears to not suit the guiding role, they are identified by the trainers who then work to find an appropriate alternative path for them. Commenting on this process, a spokesperson for the charity explained:
“We have a fantastic relationships with the UK’s other assistance dog charities, so we work with them to find jobs for these dogs as other types of assistance dogs for those who need them, or our dogs have also become sniffer dogs for police forces. Where we can’t find an alternative working role for our dogs, we find them loving homes – often with the dog’s puppy walker, or with another of our dog-focused volunteers.”
The charity’s website explains that they work with owners to determine the right time for a guide dog to retire – usually at around the age of 8. They then give the owner the option to keep the retired guide dog and begin training with a replacement guide dog. If this is not appropriate then they can either nominate someone suitable to rehome the retired guide dog, or the dog can be rehomed through the charity’s formal rehoming process.
With almost 5,000 guide dog owners currently residing in the UK, it is clear that the need for guide dogs isn’t going anywhere anytime soon. However, this debate certainly generated some food for thought.
It is well accepted that children are not just miniature adults and so ideally should only receive drugs that have been tested in paediatric trials. However, there is also evidence that the difference between male and female patients can be just as important.
Sleeping pill, Ambien, is a good example of a drug that works differently in men and women. The US Food and Drug Administration (FDA) discovered that men metabolize the drug much faster than women. This led to the FDA cutting recommended doses for women by half.
Even the humble aspirin has very different effects on men and women in terms of lowering risk of heart disease.
Findings like these prompted the FDA to release a set of guidelines to the pharmaceutical industry detailing the exceptions for excluding a gender from clinical trials, such as testing a prostate cancer medication or other male or female-specific drug. In theory, women have been included equally in drug studies since 2001.
However, a report in the journal, Cell Metabolism, suggests that there is still a long way to go to eliminate the gender gap in medical trials. According to the report, there is still a tendency to treat the sexes as equivalent, ignoring how fluctuations of sex hormones in experimental settings impact outcomes.
The authors of this article are not alone – an article published in the journal, Cancer, also points to a gender bias in oncology trials – excluding those cancers that only present in a single sex of patient of course.
I have written before about the massive under-representation of ethnic minorities in drug trials and the actions to address this in the US. However, the difference between male and female patients is less widely reported.
Is this, as some article have suggested, because things like periods and menopause make female trial participants a more unpredictable proposition? I certainly hope not.
I suspect is it largely the fact that white, middle-aged men are the easiest (and therefore cheapest) group to recruit. Recruitment is one of the most time-consuming and expensive parts of a drug trial – failure to recruit means the whole trial will collapse.
Trials have a responsibility to investigate a drug’s effect on a sample that is as close to the target market as is practically possible. It means ensuring trials are design to account for the difference between male and female patients.
Sports can often be identified as a mixing pot of individuals, but how much diversity is there really in the world of sports. Can people of all backgrounds, ethnicities and genders really expect to reach the highest levels of professional international sport? Are women in sport given a level playing field?
With Özil’s recent resignation from German international football and the ongoing efforts to establish significant endurance races in women’s cycling, producing little fruit, is it time to ask the question: have we really come as far as we think we have? And if not, what can we do to change that?
The Tour de France’s independent organiser, Amaury Sport Organisation (ASO), finally responded to campaigners, (who’d been asking for a Tour de France comparable event for women) when in 2014 they introduced ‘La Course’ an endurance cycling event for women. But just four years later, in 2018, when the race was reduced to a 1 day, single stage event, for some it felt as if they’d taken a step backwards.
Many are asking why it’s so difficult to establish a multi-stage endurance race for women, when a men’s race has been running for over a century. Kathryn Bertine, the former pro cyclist, claims it’s ‘blatant sexism’, but others argue that it’s a logistical and financial challenge to create a Tour de France event for women.
As the Tour de France is an independently run event there’s no governing body, meaning not only is there no committee to launch an appeal to, but there is a less defined ethical conundrum and it’s perhaps a ‘business is business’ approach that campaigners have to battle.
Whilst the Giro Rosa, a women’s annual multi-stage event held in Italy consisting of 10 gruelling stages, looks like a great alternative, it pales in comparison to the men’s 21 stages. It’s also run at the same time as the Tour de France, which limits exposure and possibly sponsorship for female riders.
So why is it that women’s endurance cycling isn’t getting the investment it should? With four time Olympic Champion, Laura Kenny, saying it’s as if the progress the women’s peloton was making has been ‘taken away’, is it still acceptable to blame a ‘business decision’ for a lack of equality in women’s cycling? Is this just a symptom of a wider problem relating to women in sport?
Sports can often be identified as a mixing pot of individuals, but to what extent is there diversity in professional sports? Can people of all backgrounds, ethnicities and genders really expect to reach the highest levels of professional international sport?
With Özil’s recent resignation from German international football and the ongoing efforts to establish significant endurance races in women’s cycling, producing little fruit, is it time to ask the question: have we really come as far as we think we have?
And if not, what can we do to change that?
In July, Mesut Özil announced his departure from the Germany squad. He cited racism and hatred as the reasons for his withdrawal from the team. But he received mixed reactions. Whilst some, like ‘Kick It Out’, the anti-discrimination charity, called the abuse he faced ‘disgraceful’, others such as Uli Hoeness, the president of Bayer Munich, choose to focus his comments on his, in his view, poor performance on the field, rather than concentrating on the topic of racial hatred.
While the racism that Özil cites, sadly isn’t anything new, it’s the regularity that we see it in sports, that’s starting to become alarming. The increased openness with which people are voicing such views, means it’s even more imperative that governing bodies clamp down on this kind of behaviour. Avoiding the issue, won’t make it go away and is unlikely ot have an impact on diversity in professional sports.
What has the potential to make this issue more complex is Özil’s heavily criticised picture with Turkish president, Tayyip Erdoğan. With some claiming that the picture demonstrates Özil’s support for Erdoğan and his political agenda, one that some argue contradicts German values, perhaps we should be delving deeper and asking wider questions like, do we expect footballers to be politically impartial? And, is support of a politician (which Özil denies) an excuse to invoke racial hatred, rather than criticism of their political views?
With Özil saying ‘I am German when we win, but I am an immigrant when we lose,’ perhaps we should consider the importance of equality, diversity and inclusion in sport and consider what we can do to better protect our staff and players from discrimination and hate.
If you want to learn more why not take our Equality, Diversity and Inclusion course! If you want to better manage your ethical processes in your sports institution have a look at our intuitive Ethics management software Ethics RM.
The anti-vaccination movement is a relatively new, largely US phenomenon. It has been roundly criticised in medical circles. However, it stems from a desire (albeit perhaps misguided) of parents to do what’s best for their children.
The anti-vaccination movement has snowballed from one, now totally discredited, paper into an internet full of half-truths and outright lies.
Don’t get me wrong, the internet is a largely immensely positive thing. However, giving people the opportunity to “research” subjects they know nothing about by consulting sources who have no need to be unbiased is not liberating. It is the exact opposite!
So what strategies are OK to use to persuade parents that vaccines are not only safe (relatively) but essential, rather than a tool of state control?
The argument that, without widespread vaccination, herd immunity cannot protect the few who cannot be vaccinated has been used. The counter argument is that parents see this as putting their child at risk to protect the greater good – as Mr Spock once said “the needs of the many outweigh the needs of the few, or the one.”
Even the argument that the main beneficiary of vaccination is the child themselves can be disputed as a biased statement produced by corrupt medical big business.
Several have already been tried, from refusing access to schools, to removal of state benefit payments. However, parents who decide not to vaccinate are often relatively well off so these don’t always carry the bite they may otherwise do.
Many organisations are keen to support patents’ right to ethical and religious freedom against such draconian measures. Unsurprisingly, many lawyers are also keen to help uphold choice, for the right price. This does not mean the anti-vaccination movement is winning.
Some physicians in the US are even withholding healthcare provision unless a child is properly vaccinated.
Unfortunately, all of these measures seem to have one principle victim – the child themselves. The poor kid is already far more likely to get a potentially fatal, preventable diseases, now they won’t get proper schooling or medical care.
This is equivalent to around 2% of the trials examined using statistical tools to identify anomalies hidden within the data. The authors of the study into anaesthesia trials point out that there could be many reasons for these anomalies – such as poor trial methodology, but clearly fraud is a possibility too.
All of these trials had been published in prestigious journals, including: Anaesthesia; Anaesthesia and Analgesia; European Journal of Anaesthesiology; Journal of the American Medical Association; and the New England Journal of Medicine.
John Carlisle, a consultant anaesthetist at Torbay Hospital, carried out the analysis. He had previously used similar statistical tools to discover a high profile case of scientific fraud involving a Japanese anaesthesiologist who was found to have repeatedly fabricated data.
The tool works by comparing the baseline data, such as the height, sex, weight and blood pressure of trial participants, to known distributions of these variables in a random sample of the populations. This is a test hyperlink
Carlisle reviewed data from 5,087 clinical trials published during the past 15 years. He concluded that 90 published trials had underlying statistical patterns that were unlikely to appear by chance in a credible dataset.
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“For 50 years, WWF has been protecting the future of nature. The world’s leading conservation organization, WWF works in 100 countries and is supported by 1.2 million members in the United States and close to 5 million globally.”Kanye West, Producer.
The data in 43 of the trials had only about a one in a quadrillion chance of having occurred by chance.
I wonder how long it will be before a statistical tool is developed to massage falsified data so it is harder to detect? Not that I’m a pessimist of course…