by David Isaacs
To be fair, when Julie Leask performed an in-depth analysis of mainstream news reports in Australia, she found that around 95% were pro-immunisation, which is the same proportion of parents who immunise their children.
People are often concerned that television programs like Katie Couric’s have a deleterious effect on HPV vaccine uptake. It is not clear whether or not Jenny McCarthy blaming MMR vaccine for her son’s autism on Oprah decreased uptake of MMR vaccine or whether Katie Couric’s program affected HPV vaccine uptake. But when anti-immunisation views are aired on mainstream media the message is likely to be disseminated on social media.
Does this affect vaccine uptake? Julie Leask and colleagues analysed millions of exposures to Twitter in the United States between 2013 and 2015 and found that media controversies explained 68% of the variance in girls’ uptake of the first dose of HPV vaccine. (Other factors known to affect uptake include race, ethnicity, education, income and interactions with the health system.) Tweets about Katie Couric had a particularly high correlation with poor vaccine uptake. Uptake was lower in American States where safety concerns, misinformation and conspiracies comprised a higher proportion of Tweets and correlated better with vaccine uptake than the factors mentioned above. The authors concluded that vaccine coverage is low in States where negative opinions about HPV vaccines are popularised by mainstream media and spread by social media. This does not prove the TV programs caused the poor uptake, only that the message spreads and may be used to reinforce anti-vaccination sentiment.
The second reason put forward to explain the difference in uptake of HPV vaccine in Australia and the United States relates to the way the vaccine was introduced in America. The pharmaceutical company Merck applied successfully to the Food and Drug Administration (FDA) to have its HPV vaccine, Gardasil, fast-tracked using a process usually reserved for urgent treatments for serious diseases. This allowed Merck to position itself ahead of its British rival, GSK, which was trying to market its own HPV vaccine, Cervarix. If this fast-tracking had not been approved, Gardasil and Cervarix would have been approved simultaneously by the FDA three years later. Free trade is not necessarily fair trade.
After gaining FDA approval, Merck lobbied State legislatures to add the vaccine to those required for school enrolment. This attempt to politicise the issue of HPV vaccination backfired spectacularly. Political disputes blocked legislative mandates in all but one State. The country became further polarised, dividing according to opinions on whether giving HPV vaccine to girls would encourage them to practise unsafe sex.
No such outcry had accompanied the earlier uneventful introduction of hepatitis B vaccine into United States schools, even though hepatitis B virus can also be transmitted sexually. But hepatitis B vaccine was introduced through the usual public health avenues and family doctors were well informed. In the case of HPV vaccine, Merck’s financially driven lobbying bypassed the normal avenues, sidelining public health officials and family doctors in favour of its own marketing.
As we’ve heard, trust is an essential component of immunisation uptake – particularly when it comes to the introduction of new vaccines. Here trust was taken out of the hands of the family’s doctor and invested in an unknown person who told people about the new HPV vaccine in an advertisement. The obvious assumption was that the person in the advertisement was a paid employee of the vaccine company Merck, and that what they said about the vaccine had to be taken in the light of a significant pecuniary conflict of interest.
Misunderstandings about hepatitis B
Since 1982, hepatitis B vaccine has been given to over 500 million people around the world. Its introduction to the United States might not have been controversial, but in France case reports were published suggesting a possible link between hepatitis B vaccine and multiple sclerosis (MS).
MS is a rare condition affecting young adults aged 20 to 40, women more often than men. The cause is unknown, but an abnormal immune response to infection is one theory, although no studies have ever formally connected MS with hepatitis B infection. It is likely the reported link between MS and the vaccine was mere coincidence, due to the large number of hepatitis B vaccine doses given to young adults at the very age when the first symptoms of MS often occur. But that coincidence was difficult to prove.
In 1998, the French Ministry of Health temporarily suspended the school-based adolescent hepatitis B vaccine program while investigations were conducted, but continued to immunise all infants, and adults at special risk.
The French decision was misunderstood and misinterpreted as a ban on all hepatitis B immunisation. Subsequent studies strongly suggest that hepatitis B vaccine does not cause MS. France introduced catch-up immunisation of high school students without mishap. Other countries have routinely continued to immunise adolescents as well as newborns against hepatitis B.
Seeking reliable advice
Trust is a fragile concept in this age when unwelcome facts are dismissed as ‘fake news’ and scientists are derided. Rumours about harms from immunisation are bound to arise from time to time, and the internet is fertile ground for all sorts of unfounded ideas.
Most people have learned to treat what they read on the internet and social media with suspicion. Why would we put opinion above scientific analysis? On the other hand, if experts disagree, how do we know which ones to trust?
It seems logical to believe the experts we consider the most trustworthy, the most plausible, the most comprehensible and the least likely to be influenced by conflicts of interest. If almost all experts agree, it is improbable that the few dissenting experts are correct.
When asked where they get trustworthy information about immunisation, most people say their family doctor. Trust is one of the key elements in the doctor–patient relationship. Parents generally know and trust their family doctor and rely on him or her to give sound advice. Patients who trust their doctors feel better, behave more healthily and report a better quality of life than those who do not.
There is less polarisation about immunisation than some would have us believe. Most of us do trust our doctors, and almost all doctors are pro-immunisation. Most people recognise the benefits of immunisation for their own children and feel good about being part of a community that immunises enough children to prevent the spread of infections. One shot for all, and all for one.
CHAPTER 13
Immunisation and ethics
Recently, when I was on call for cases of paediatric infectious diseases, I was asked to see an infant who was desperately ill with fever, convulsions and shock. The infant had meningitis and survived, but was left with massive brain damage, likely to result in lifelong spastic cerebral palsy.
The mother told one of our young doctors that her child was unimmunised. Meningitis vaccine is included in the routine immunisation schedule, so this child’s meningitis and brain damage were almost certainly preventable. The mother’s explanation to the stunned young doctor as to why she did not immunise her infant was far from coherent: a friend at church had a baby who’d had a reaction to a vaccine, and some members of the congregation were opposed to immunisation. She was not clear if the church itself was against immunisation, although my inquiries suggest no church group is formally opposed to immunisation.
At this point we were faced with a number of ethical dilemmas. Should we pursue the issue of non-immunisation with the mother? One reason to do so would be to try to persuade her to immunise this infant against infections such as pertussis and influenza that could kill a child with cerebral palsy. A second reason would be to convince her to immunise any future children. A third would be to explore the situation at the church and try to alter the church community’s perceptions about immunisation before another disaster occurred.
The danger of discussing it with the mother at that stage was that, whether or not she acknowledged it, she must inevitably feel guilty that her decision had altered the course of her child’s life and adversely affected her family’s future. That is a huge b
urden to carry.
Parents in the same situation often appear to deny guilt and say it was fate or God’s will. Whether or not the child recovers, they rarely get the child immunised with the vaccines they have missed; presumably to do so would be to admit to having made a bad decision.
It is not a doctor’s job to confront people with blame and lay guilt on them; surely that is highly likely to do more harm than good and is, therefore, unethical. Would even raising the subject of immunisation with the mother and listening to what she said be a form of accusation?
There are further ethical considerations. I am writing a book on immunisation and contemplating whether to include this story in a chapter on ethics. Is the story sufficiently identifiable that I would be infringing confidentiality if I did not get the parents’ permission before publishing? Is the very way I approached the whole tragic situation with this mother and baby affected by my writing the book? In other words, do I have a significant conflict of interest?
The great Greek physician Hippocrates (whom we’ve already heard a lot about) deals with confidentiality in the Hippocratic Oath: ‘And whatsoever I shall see or hear in the course of my profession, as well as outside my profession in my intercourse with men, if it be what should not be published abroad, I will never divulge, holding such things to be holy secrets.’ Health professionals have a moral obligation to respect privacy and confidentiality, and patient confidentiality is something I have considered and endeavoured to preserve whenever I have told clinical stories in this book.
In the end we decided not to discuss immunisation with the mother at the time of her child’s acute illness, although for the child’s sake we will discuss immunisation with her when she brings her child back for follow-up.
The Hippocratic Oath
Hippocrates is often called the Father of Medicine. He came from the Greek island of Kos and lived roughly 2500 years ago. He founded the Hippocratic School of Medicine, which was instrumental in establishing medicine as a distinct discipline in ancient Greece. Before Hippocrates, medicine and philosophy were intertwined; after Hippocrates, a physician belonged to a separate profession.
As is already evident from the number of distinct diseases he recognised and described, Hippocrates was a brilliant clinician. But even more importantly, Hippocrates and his colleagues developed a code of behaviour for physicians that they enshrined in the Hippocratic Oath. Such depth of thought went into this code that medical students graduating as doctors in most Western countries swear to adhere to modern versions of the same oath. Its principles include:
•agreeing to do the best for one’s patients
•avoiding under- and over-treatment
•remembering that there is art to medicine as well as science; warmth, sympathy and understanding may outweigh the surgeon’s knife and the chemist’s drug
•admitting when one doesn’t know
•calling in colleagues for advice when necessary
•respecting patient privacy
•not playing God
•‘preventing disease wherever I can, for prevention is preferable to cure’
•‘remembering that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm’.
These last two – our obligation to prevent disease and to look after everyone in our society – are particularly relevant to immunisation.
Ethics – from the Greek ethos, meaning ‘habit’ or ‘custom’ – also dates back to the ancient Greek philosophers. Medical philosopher Ian Kerridge has described ethics as the way we feel we ought to behave. This is different from law, which is how we are permitted to behave. Ethics affects how all of us conduct our lives, every day. A parent’s decision about whether or not to immunise their children has a large ethical component, but so does the way they speak to their children, the way they feed them, the things they allow or don’t allow them to do, and so much more.
Doctors and nurses frequently face difficult ethical decisions that may permanently affect their patients and their patients’ families. For that reason, medical students and qualified doctors study what health professionals call bioethics – ethics as it relates to health. Studying bioethics does not tell us what to do, but it helps us analyse and reflect on problems in a more structured way than just going with a gut feeling or saying, ‘It feels right’ or ‘It doesn’t feel right.’
Hippocrates might have elaborated principles of medical practice 2500 years ago, but some doctors throughout history have decided that those principles did not apply to them. During World War II, the Nazis purged Germany of over 6000 Jewish doctors and used only non-Jewish German doctors. At the end of the war, the United States military held trials of doctors accused of participating in Nazi human experimentation and mass murder. At the first of these, at Nuremberg in 1946, 20 doctors stood trial. Seven were acquitted, four were sentenced to death and hanged, and the rest were sent to prison for 10 to 20 years. Josef Mengele – responsible for some of the worst atrocities, including vicious and often fatal studies on twins – fled from Auschwitz concentration camp to South America and was never captured.
The United States might have accused Nazi doctors of treating Jews as sub-human, but they did not have to look further than their own country for a similar example. From 1932 until 1972, the United States Public Health Service conducted the Tuskegee Study of Untreated Syphilis in the Negro Male. In return for participating in a study of ‘bad blood’, 431 poor African-American sharecroppers in Alabama known to have syphilis were told they would be given free treatment and free burial insurance (a particularly sinister embellishment). The Public Health Service callously observed, bled and studied the men in order to elucidate the natural history of syphilis. Even after penicillin became available in the 1940s and was known to cure syphilis, the ‘Health Service’ did not treat either the men or their partners.
The study only came to light through the courage and persistence of a whistle-blower. Peter Buxtun, a Czech-born Jewish social worker and epidemiologist, was 27 when he was employed by the United States Public Health Service in 1965 to interview patients with sexually transmitted diseases. He was appalled when he learned about the Tuskegee experiment. In 1966 Buxtun filed an official protest on ethical grounds.
The Public Health Service ruled that the experiment should continue, because the results were not complete. Buxtun protested again, with the same result. In desperation, he leaked news of the study to the Washington Post; the headline news story finally led to the termination of the study in 1972. It was not until 1997 that President Bill Clinton held a ceremony at the White House for survivors of the Tuskegee study, to whom he said:
What was done cannot be undone. But we can end the silence. We can stop turning our heads away. We can look you in the eye and finally say on behalf of the American people, what the United States government did was shameful, and I am sorry . . . To our African-American citizens, I am sorry that your federal government orchestrated a study so clearly racist.
Tainted research
The actions of the Nazis and the doctors at Tuskegee are extreme examples of so-called ‘tainted research’, in which knowledge is obtained through research that could be seen as unethical.
The different ways in which hepatitis B and hepatitis A are transmitted was elucidated in some highly controversial research undertaken in the 1960s by Dr Saul Krugman and colleagues at Willowbrook. These experiments are famous or infamous, depending on one’s view of their ethics, then and now.
Although the name conjures up images of weeping willows and bubbling brooks in verdant pastures, the Willowbrook State School was actually an institution on Staten Island, New York, for children with intellectual disabilities. Saul Krugman and his researchers deliberately infected children with biological material from subjects with hepatitis. The children were either given suspensions of faecal matter to drink or were injected with serum.
While this research had e
thics committee approval at the time, and all the children’s parents consented to their inclusion in the studies, Dr Krugman and his team were later heavily criticised for being unethical. My scientist father wrote ironically that he had found similar results with his experiments on ‘volunteer mice’. Residential places in Willowbrook were scarce and participation in the study gave priority, thus constituting an inducement to enrolment, which ethicists argue constrains choice. However, some doctors argued then and even now that the benefits of the research outweighed the harms to the children.
Most people, when asked whether we should use knowledge from unethical research, think knowledge is knowledge and should not be ignored, although they also say we should make changes to try to prevent unethical research from being conducted in future. Many would condone the use of vaccines originally developed from the research conducted at Willowbrook – but almost no one today would condone the acts perpetrated by the Nazis and at Tuskegee.
Foetal cell lines
There has also been some ethical controversy over the development of several commonly used vaccines because the viruses used to make these vaccines are grown on cell lines derived from embryonic fibroblast cells. Fibroblasts are cells needed to bind skin and connective tissue. Cell lines are kept going for many years by growing them in liquid on the inner surface of glass bottles. After a few days, when the cell layer gets quite thick, the cells are lifted off the surface using a dissolving enzyme such as trypsin, diluted with more liquid and put in extra bottles: a process called ‘splitting’.
The original embryonic fibroblast cells used to develop vaccines against hepatitis A, rubella and zoster, and to develop one type of rabies vaccine, came from the elective termination of two pregnancies in the 1960s. The original cell lines, much propagated since, are still in use.
No new foetuses or foetal cells have been involved since the 1960s. But for some people, the original use of foetal tissue means that the vaccine is forever contaminated and should be opposed on ethical grounds.