Between Hope and Fear
Page 31
Hilleman was a workaholic. He frequently combined his personal and professional lives, perhaps never more than when his five-year-old daughter, Jeryl Lynn, awoke with a sore throat in the early hours of a spring morning in March 1963.45 As an expert virologist, Maurice immediately realized that her sore throat was accompanied by a swelling neck, the telltale sign of the mumps. Knowing that nothing could be done for her other than supportive care, and despite being a single parent (his wife had died of breast cancer just four months before), Hilleman immediately drove to his laboratory and returned with some sterile equipment. He swabbed Jeryl Lynn’s throat and immediately returned to work, seeing the material scraped from his daughter’s upper esophagus as an opportunity to create an attenuated version of the mumps vaccine.46 Indeed, the Jeryl Lynn strain of mumps remains a staple of the vaccine armamentum around the world. Independent of this early contribution, Jeryl Lynn herself has also contributed to public health, albeit from a different angle. After completing a BA at Brown and an MBA at the Wharton School of Business, Jeryl Lynn began a career at Merck and later became the chief financial officer at a variety of successful biotechnology companies.47
The source of Hilleman’s samples for a measles vaccine was not quite as close to home; they came from John Enders. When we last left Enders, he had developed a vaccine from a sample obtained from young David Edmonston. This vaccine was a good first step but tended to convey undesirable side effects such as rashes and fever. Upon receiving a sample of the attenuated version from Enders, Hilleman applied his well-worn techniques and further weakened the virus while retaining its ability to elicit protective immunity. Indeed, the resultant Moraten strain of the virus is an acronym for “more attenuated Enders” and still serves as the basis for the vaccines used today.
A very similar story surrounds the rubella vaccine. Hilleman further refined an existing rubella virus vaccine and introduced a safer version in 1969 (although the rubella component was later replaced with another virus developed by Stanley Plotkin that demonstrated even greater safety).48, 49 Two years later, Hilleman and Merck combined these three safer versions of the measles, mumps, and rubella vaccines into a single injection that was appropriately named MMR. The emphasis, bordering on obsession, that Hilleman devoted to increasing the safety of the measles, mumps, and rubella vaccine was ironic, given how his creations were misrepresented in the years to come.
Maurice Hilleman would undoubtedly be even more appalled to know that nemeses such as measles, mumps, and rubella are again on the rise. To understand this, we again turn our attention to the anti-vaccine movement, which seized upon the MMR vaccine following its failure to turn the public against DPT. This struggle may seem familiar as it involves some familiar faces and arguments.
Fake News
The Lancet is one of the most revered medical journals in the world. This medical periodical was founded in 1823 by Thomas Wakley, an English surgeon who frequently railed against medical incompetence and privilege.50 Wakley joined an impressive group of politicians, physicians, and attorneys to create a publication intended to decry the frauds and charlatans of the medical community. As evidence of success, the journal became subject to multiple libel suits in the years following its founding (though most were successfully defended). Over time, its reputation grew, and the impact of the Lancet ranks second only to that of the New England Journal of Medicine. Given this rich history and adherence to fact, it is truly ironic that the Lancet disseminated what may be the most notorious and arguably most dangerous fraud in medical history. Despite overwhelming evidence to the contrary and very public stripping of his professional credentials, the mastermind behind this deception has continued to profit from the propagation even as the damage toll rises. Tragically, thousands and perhaps millions of children throughout the world are increasingly at risk of death or disability from diseases that are thoroughly avoidable. It is to this fraudster that we now turn.
Andrew Wakefield was born on September 3, 1957, the son of two upper-middle-class physicians, one of whom specialized in neurology.51 As a member of the gentry growing up in the affluent town of Bath, Wakefield attended the best schools that would accept him. He obtained his medical degree in 1981 from the St. Mary’s Hospital (the same institution that has housed reputable scientists such as Sir Alexander Fleming, a discoverer of penicillin, and Lord Moran, Winston Churchill’s personal physician).
Wakefield began practicing medicine at the tender age of twenty-six. Seeking to make a name for himself, he became interested in research, first coming to the widespread attention of the English medical community in 1993. While employed with the Bowel Disease Study Group at the Royal Free Hospital School of Medicine in London, Wakefield wrote a report claiming a link between measles virus infection and Crohn’s disease.52 Using samples from a small number of patients (a total of twelve), Wakefield claimed that persistent measles virus infection contributed to the inflammation associated with Crohn’s disease, an autoimmune disorder. Despite the small number of samples involved in the study, which should have raised questions about its reproducibility, the scientific and medical community embraced this work. This outcome does not reflect the design, execution, or interpretation of Wakefield’s study as much as it reflects the fact that the community investigating Crohn’s and other inflammatory bowel diseases was desperate for a breakthrough and grasped at the study as a potential inroad to future improvements. As often happens in science, Wakefield’s hypothesis that persistent measles virus infection causes Crohn’s disease was completely debunked by 2001 and many precious resources and time were devoted to disproving it.53
Such an outcome itself is not necessarily an indictment, as peer review and reproducibility are the hallmarks of the scientific method and commonplace in medical research. However, what followed flies in the face of good methodology. Wakefield’s true damage to public health would arise in 1998 as a follow-up to his discredited study.
On February 28, 1998, Wakefield published a bombshell report in the Lancet.54 This study reported the findings of a study of twelve children and claimed that regressive development disorders were linked with chronic entercolitis and, in particular, with MMR vaccination. This study, like his previous report on Crohn’s disease, was based on a small population of twelve children. His study linked impaired neurological development with MMR vaccination in eight of twelve children evaluated. Translated into a more user-friendly headline that was broadcast throughout the world: Autism is caused by a chronic infection of the gut in general and with immunization with the MMR vaccine in particular. In just under 3,000 words (2,857 to be precise), Wakefield made a claim whose negative reverberations and implications for public health were propelled by numerous television interviews and amplified by the full mobilization of the public affairs resources of his employer, the Royal Free Hospital of Hampstead, which was bathing in the glow of publicity generated by one of its young stars.
Given rising concern and sensitivity surrounding the subject of autism, a disease that had been quickly rising in prominence and coming to the attention of many for the first time in the months prior to Wakefield’s report, the negative publicity of Wakefield’s small study expanded like a nuclear chain reaction. To understand how and why this claim is both patently false and actively harmful, it is necessary to introduce the concepts behind these bold assertions.
Misunderstandings, Hopes, and Frauds
The disease captured by the word autism today is one of the most emotionally charged diagnoses in the English language. The meaning of the word itself has changed over time in parallel with our understanding of the disorder. As originally described in 1919 by the Swiss psychiatrist Eugen Bleuler, and remaining as the first definition used by the Oxford English Dictionary (the OED), autism is “a condition or state of mind characterized by patterns of thought which are detached from reality and logic, formerly sometimes regarded as a manifestation of schizophrenia or other psychiatric illness.”55 Though now recognized to be a flawed inte
rpretation, Bleuler reasoned that the disease was characterized by an “autistic withdrawal of the patient to his fantasies against which any influence from outside becomes an intolerable disturbance.”56
Over the next few decades, our understanding and description of autism have been subject to many refinements, most famously by the Viennese child psychiatrist Hans Asperger, who lives on eponymously in the naming of one form of the disorder. The current definition of autism, again citing the OED, is “A neurodevelopmental condition of variable severity with lifelong effects which can be recognized from early childhood, chiefly characterized by difficulties with social interaction and communication, and by restricted or repetitive patterns of thought and behavior.”57
As our understanding of autism has increased, the disorder is now understood to represent a wide spectrum of symptoms, ranging from relatively mild impairments of social interaction and communication skills to truly incapacitating disruptions in neurodevelopment. Likewise, behavioral traits can range widely from repetitive activities to the extreme, savant-like recollection as stereotyped by Dustin Hoffman in the 1988 Hollywood hit Rain Man.
In the years following the premiere of Rain Man, reports of the disease skyrocketed. Whereas fewer than one case of autism per thousand children had been registered in 1997, this number ballooned fivefold over the following decade.58 Like many aspects of this baffling disease, the reasons for the increased incidence are unclear but many explanations have been invoked.
With many medical conditions, increased public awareness can cause an upsurge in reporting as more patients, parents, and physicians appreciate that disparate symptoms may be part of a larger disease or spectrum. Indeed, a 2015 report in the British Medical Journal assessed children in Sweden who had been diagnosed with the disease between 1993 and 2002.59 The report concluded that while the prevalence of the disease had not changed, its diagnosis had increased dramatically. Stated another way, the likelihood of getting the disease had not changed, only its diagnosis had. On one hand, this is a positive finding and suggests that the disease rates have been stable and that our ability to detect autism is improving, which can translate into providing patient care. The flip side is that increasing diagnosis rates have increased the level of anxiety about the disease manifold. Importantly, this Swedish study indicated nothing about causation, which will occupy much of the remainder of our story.
With many neurological and psychiatric impairments, assessing causation is challenging, if not impossible, a fact that will dominate the remainder of our story. However, Wakefield’s 1998 Lancet report offered a simple and much-needed hope to desperate parents of those affected by the disease. The problem, according to Wakefield, was the MMR vaccine.
There was only one problem with Wakefield’s conclusion: his data were fabricated. Worse still, especially for the parents duped into making decisions about their children’s health and well-being, the motivations behind the paper were far more dubious than might have been imagined.
Scientists tend to be a rather quiet and cautious lot, trusting in the process of the scientific method (discoveries verified or refuted by peer review and additional studies). Compounded by the technical nature and specialized language of different scientific fields, researchers can sometimes come across to the general public as uncommunicative or uncommitted. Fortunately, this is not so with journalists, and our story now turns to an aggressive and successful investigative reporter whose beat included the pharmaceutical and public health fields.
Left and Right
Brian Deer is an investigative reporter who graduated with a degree in philosophy from the University of Warwick in Coventry, England. This location is unintentionally symbolic, as Coventry was the site where Leofric, Earl of Mercia, founded a monastery in 1043.60 While Leofric is not a household name, his wife is: Lady Godiva. According to legend, Godiva rode nude through the streets of Coventry as a protest (actually more of a dare) directed at Leofric to relieve the tax burden on the people of Coventry. Although the lore has it that most of the townspeople averted their gaze to avoid despoiling Godiva, a tailor by the name of Tom snuck a look; and in doing so, gave birth to the popular notion of a Peeping Tom. As conveyed by a decline in vaccination in the first two decades of the 21st century, a failure to see the truth is far more dangerous than shielding your eyes. This fact was brought to the world’s attention by a graduate of a university located in Godiva’s Coventry.
Following Brian Deer’s graduation, he sought a career as a writer.61 The University of Warwick has a reputation as a progressive campus, and Brian’s early writing career reflected his immersion within a liberal campus culture. After joining a collective and publishing a few pieces in radical left-wing magazines, Brian learned about opportunities to publish freelance articles in a health care journal. This provided an income and allowed him to continue working for liberal causes. For example, an article arguing for the rights of homosexuals within the British National Health Service, published in 1979, was progressive in its political views and would be thrust to the forefront with the emergence of the HIV/AIDS crisis months later.62 Over time, Deer’s reputation for hard-driving opinion pieces, with emphasis upon public health issues, led to a job offer at the Times (London).
The Times was founded in 1785 and is one of the most popular dailies in the United Kingdom, with a print circulation of almost a half million in 2016 (all the more remarkable given the demise of the print media over the past two decades). The center-right Times formed an unexpected home for a left-leaning investigative journalist, who focused his articles on social issues, including but not limited to poverty, child abuse, and homelessness. Although these articles were generally well received, Deer realized his most widely read articles touched upon revelations of medical scams, and his reporting progressively became more investigative than opinion-based.
Among Brian Deer’s early breakthrough investigations was the revelation that an eminent British scientist by the name of Michael Briggs had fabricated research pertaining to the safety of contraceptive pills. Briggs had made a name for himself by publishing an enormous amount of research, as well as writing books with his wife, about the safety of contraceptives.63 As Deer exposed in an article for the Sunday Times on September 28, 1986, the work was entirely fabricated.64
A few years later, Deer broke a story on an antibiotic known as Bactrim or Septra. The story graced the front page of the Sunday Times on February 27, 1994 and exposed the fact that the drug had been implicated in more than a hundred deaths in England alone.65 Later that year, Deer revealed that the will of Henry Wellcome, founder of the British pharmaceutical powerhouse Burroughs Wellcome, essentially allowed a charitable foundation to retain control over a pharmaceutical empire and its profits (the same foundation and company sued in the DTP trials).66 Although Deer has similarly investigated many other aspects of public health, his work on vaccine safety has arguably had greatest impact, saving the lives of thousands, if not millions, worldwide.
As you may recall from our vignette about Gordon Stewart’s skepticism toward vaccines, the DTP vaccine was the subject of a series of lawsuits throughout the world, but the British trials were among the most widely covered and deeply litigated. Upon learning that Judge Murray Stuart-Smith had summarily dismissed the claims put forth in Loveday v. Renton and Wellcome Foundation, Deer, as a knee-jerk reaction and perhaps reflecting some remaining concerns with the Wellcome Foundation, “wrote a piece snootily dismissing the judge’s finding, substituting my own opinion.”67 The piece appeared in the April 3, 1988 edition of the Sunday Times, and Deer began receiving messages of adoration from anti-vaccinators.68
Shortly thereafter, Deer had a fateful encounter with Margaret Best, who had won £2.75 million in damages against a DPT vaccine manufacturer. An intensive interview revealed inconsistences suggesting that Margaret wasn’t telling the truth about her child’s experience in suffering from neurological damage following immunization.69 Thereafter, Deer began questioning his assump
tions about vaccines. Diving deeper, Deer assessed all of the data about the DPT vaccine that he could, consulted with experts and, after a ten-year investigation, concluded the vaccine did not cause brain damage (thus aligning himself with Stuart-Smith’s verdict). His work led to an award-winning expose in the November 1, 1998 edition of the Sunday Times.70 This piece revealed scams being perpetrated by attorneys who preyed upon families that were convinced that DTP jabs had caused their children to suffer brain damage.
Deer’s understanding of vaccines increased further following his 1999 exposure of a bogus HIV vaccine, AidsVax, being developed and bankrolled by the World Bank, the World Health Organization, and the American Centers for Disease Control and Prevention.71 This investigation not only revealed that the highly touted vaccine was ineffective but also suggested it might accelerate or worsen an already deadly disease. Having had his fill of reporting on immune-modulating frauds, Deer was “sick to death of vaccines” and looking to stories on anything except that subject.72 Little did he realize that his work on vaccines had barely begun.
In late 2003, Brian Deer began hearing rumors about Andrew Wakefield, the high-born physician who published the blockbuster findings linking the MMR vaccine to autism.73 Similar to how the story with DPT unfolded, Deer interviewed one mother who claimed there was a link between MMR vaccine and autism, but again he did not find her story convincing. He then began conducting what he referred to as a “forensic interview” with the mother about the circumstances that linked MMR to autism. Deer quickly concluded her recollections “contradicted Wakefield’s paper.” Based on his past experiences with DPT and the instincts that distinguish the most gifted investigative reporters, what Deer believed would be a “three-week work” ballooned into a detailed investigation that exposed a “100% scam” by Wakefield that Deer describes as a greed-motivated “heist.”74