Doctor Who Started Vaccine, Autism Debate in Ethics Row

Parent activists who say vaccines can trigger autism, and scientists who say that hypothesis has been discredited, agreed on one point last week.

It won't change their debate if Dr. Andrew Wakefield -- the British doctor known widely for sparking international fear that vaccines cause autism -- loses his medical license for unethical behavior.

Wakefield has been found guilty of acting unethically during the time he conducted the famous, and now retracted, 1998 case report of 12 children that questioned if a childhood vaccine caused a new form of autism.

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The United Kingdom's General Medical Council concluded Jan. 28 that Wakefield participated in "dishonesty and misleading conduct" while he conducted the 1998 research. Most of the findings against Wakefield are breaches of standard ethical codes meant to keep bias out of scientific journals.

But, according to one of the findings against the doctor, Wakefield took blood samples from children at his own child's birthday party, and paid them five British pounds for their trouble.

On Feb. 2, the Lancet retracted Wakefield's paper, explaining in a statement: "Following the judgment of the UK General Medical Council's Fitness to Practice Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect ... in particular, the claims in the original paper that children were 'consecutively referred' and that investigations were 'approved' by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record."

"In some ways I think it's irrelevant," said Dr. Paul Offit, chief of the Section of Infectious Diseases at Children's Hospital of Philadelphia, who has been twice threatened with lawsuits for critical statements he has made of Wakefield's work.

"His hypothesis was that by combining the MMR into a single shot that it was somehow weakening the immune system, causing the measles part of the vaccine to travel to the gut and cause damage, " Offit said.

That theoretical damage, according to Wakefield's hypothesis, could then theoretically travel into the bloodstream and cause (theoretical) damage to the brain -- perhaps causing autism symptoms.

"It created a firestorm," Offit said.

Parent advocacy groups jumped on the possibility of vaccines as a cause, or at least that gastrointestinal symptoms were a unique problem to children with Autism.

"The Autism Society strongly supports funding research into gastrointestinal pathology, as well as any links between this pathology and the symptoms of autism," the advocacy group said in a statement. "In this field, Dr. Wakefield's contributions to our families and members are greatly appreciated and there are many who support him in his research efforts."

The GMC panel also found Wakefield responsible for an ethics breach because he wrote that the children involved in the case report were referred to his clinic for stomach problems, when Wakefield knew nearly half of the children were actually part of a lawsuit looking into the effects of a measles-mumps-rubella (MMR) vaccine. Some children didn't have stomach issues at all.

The GMC also found that Wakefield failed to disclose he was paid in conjunction with the lawsuit, or that he had a patent related to a new MMR vaccine in development when he submitted the 12-child case report to be published in a scientific journal.

Wakefield declined an interview with ABCNews.com, but issued a statement saying, "The allegations against me and against my colleagues are both unfounded and unjust and I invite anyone to examine the contents of these proceedings and come to their own conclusion."

Wakefield was found "proven" to have committed the ethical breaches by the GMC Fitness to Practice Panel, but his time before the government is not over yet.

On April 7, the GMC is scheduled to decide whether these breaches constitute "serious professional misconduct" and if so, how Wakefield will be reprimanded or whether he will lose his license.

Wakefield and his former colleagues may see their fate hanging on the April decision, but the public may not agree.

Scientists who say Wakefield's hypothesis has been discredited long ago with large studies finding no link between vaccines and autism view the ethical breaches as an interesting, but meaningless, side point.

Similarly, the parent groups who stood behind him in rallies and in press statements say his theories have led to anecdotally successful treatment in their children and also doubt that a finding by the GMC will change any minds.

Are Dr. Wakefield's Ethics Irrelevant?

When the public got word of Wakefield's work, worried parents skipped vaccines, and the percentage of children who were not vaccinated in the United States rose from 0.77 percent in 1997 to 2.1 percent in 2000, according to an article by Dr. Michael Smith in the journal Pediatrics.

A similar drop-off in vaccinations occurred in Britain, weakening overall immunity and putting those who are too young to get vaccinated at risk for measles, mumps or rubella.

Although the U.S. Centers for Disease Control declared the United States cleared of measles in 2000, fewer vaccinations brought back the disease in a 2008 outbreak.

At least 131 cases were reported to the CDC, and 11 percent of the cases were hospitalized. A handful of children in Britain died of the measles around the time of the U.S. outbreak.

Scientists Investigate Vaccine, Autism Connection

Offit said that scientists didn't sit idly by after the news broke in 1998.

"People spent millions and millions of dollar looking at this hypothesis that he raised," he said.

But according to Offit -- and international studies supported by the CDC as well as a 2004 review of large international studies by the Institute of Medicine -- high-quality studies could not confirm Wakefield's hypothesis about vaccines.

Parent Groups Still Supporting Dr. Wakefield... and His Work

Although Wakefield's original hypothesis did not mention mercury, a row also arose over whether a mercury-based preservative called thimerosal found in other vaccines cause autism. As a precaution, California Gov. Arnold Schwarzenegger and several other governors banned mercury from childhood vaccines in 2004. But autism rates have only increased since then.

"He had his day in scientific court, this is his day in ethics court," said Offit.

Robert Field, an expert in health care ethics and a professor of law and public health Drexel University in Philadelphia, agreed that the charges against Wakefield posed ethical issues.

In light of the ethical charges brought against Wakefield, 10 of the original 13 authors of the 12-child article issued a retraction.

Yet, like Offit, Field did not believe the current charges would influence the way scientists viewed Wakefield's hypothesis.

"Taking blood samples without the consent would be a serious ethical and legal violation in the United States and even more so if children were involved," Field said. But, "independent of the autism and vaccine issue, that is unethical behavior. I would also say that counseling parents to avoid vaccines for fear of autism would also be unethical."

Field said it was unethical because, "there is no evidence, even after numerous scientific investigations, of a link between vaccine and autism."

Parents like Rebecca Estepp of Talk About Curing Autism and anti-mercury activists like Theresa Wrangham, say these current charges are irrelevant not because Wakefield's hypothesis has been proved or disproved. Instead, groups like Talk About Curing Autism, the Autism Society and SafeMinds, say they still appreciate Wakefield's work.

"The number one point we were making, kids with autism have gastrointestinal issues. We know this," said Theresa Wrangham, president of SafeMinds -- an organization that dedicated to eliminating neurological damage in children from exposure to mercury. "Our kids are in distress, and this is a recognized area that needs research."

Dr. Wakefield's Legacy Still Debated

Wrangham said bringing up Wakefield on charges of unethical conduct would only "chill" other researchers who want to investigate issues such as vaccine's link to autism, or the mercury additive in vaccines thimerosal.

"Do I think the book is closed on thimerosal? No," Wrangham said.

Estepp, Talk About Curing Autism's manager of strategic planning, agreed with Wrangham in that the charges against Wakefield may lead doctors away from researching vaccines, or gastrointestinal problems in children.

"What comes down at the end of the day is that Dr. Wakefield continued his research," said Estepp. "The things that he has found and the different treatment models that have come about from those findings are the things I've seen improve my son."

Indeed, Wakefield left England since the original 1998 article and has since set up an alternative research and treatment organization called Thoughtful House in Austin, Texas.

Estepp correctly noted that it wasn't a complaint from a parent of the 12 children, but an investigation by U.K journalist Brian Deer that opened up questions into Wakefield's actions.

"In my eyes Dr. Wakefield's work was the foundation of my son getting better," said Estepp.

"The thing that I'm worried about as a parent with a child of autism… is if you are a scientist and you stumble upon something controversial, we now know that scientists can see that their careers or their livelihoods are at stake," she added.

But doctors like Offit warn that not every doctor who goes against the status quo is necessarily a brilliant outlier.

"Science is full of mavericks," said Offit, pointing to stories of genius such as Galileo in which the maverick is originally thought to be heretical and is cast out by the scientific community only later to be vindicated by scientific evidence.

"But the history of science is also filled with mavericks that have this heretical notion that is dead wrong," he said.

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