In 2007 Skeptic magazine ran an article debunking the myth of the connection between vaccines and autism , and we were hoping that by now this sad tale of pseudoscience would have died a slow death as researchers continue to find no link whatsoever between the two. Sadly that is not the case. In fact, thanks to Playboy model Jenny McCarthy, mother of an autistic child, the myth has gained cultural traction as never before, as she and her partner, the comedian Jim Carrey, make the media rounds and appeal to the heart strings of the public, burying the science in a tsunami of emotion. So we return again to the topic with our SkepDoc, Harriet Hall, M.D., demolishing the myth once and for all.

Vaccines & Autism

A Deadly Manufactroversy

by Harriet Hall, MD, “The SkepDoc”

During a question and answer session after a talk I recently gave, I was asked for my opinion about the vaccine/autism controversy. That was easy: my opinion is that there is no controversy. The evidence is in. The scientific community has reached a clear consensus that vaccines don’t cause autism. There is no controversy.

There is, however, a manufactroversy — a manufactured controversy — created by junk science, dishonest researchers, professional misconduct, outright fraud, lies, misrepresentations, irresponsible reporting, unfortunate media publicity, poor judgment, celebrities who think they are wiser than the whole of medical science, and a few maverick doctors who ought to know better. Thousands of parents have been frightened into rejecting or delaying immunizations for their children. The immunization rate has dropped, resulting in the return of endemic measles in the U.K. and various outbreaks of vaccine-preventable diseases in the U.S. children have died. Herd immunity has been lost. The public health consequences are serious and are likely to get worse before they get better — a load of unscientific nonsense has put us all at risk.

The story is appalling. It involves high drama, charismatic personalities, conspiracy theories, accusations, intimidation, and even death threats. It would make a good movie. It does make a good book: Dr. Paul Offit has explained what happened in Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure.1 I can’t tell the whole story here, but I’ll try to cover the highlights as I understand them. I’ll include some new revelations that were not available to Offit when his book went to press. As I see it, there were 3 main stages to this fiasco:

The MMR Scare

In 1998 a British doctor named Andrew Wakefield published an article in the respected medical journal The Lancet2. He did intestinal biopsies via colonoscopy on 12 children with intestinal symptoms and developmental disorders, 10 of whom were autistic, and found a pattern of intestinal inflammation. The parents of 8 of the autistic children thought they had developed their autistic symptoms right after they got the MMR vaccine. The published paper stated clearly: “We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue.”

“Falsehood flies,

and the truth comes limping after.”

— Jonathan Swift

Despite this disclaimer, Wakefield immediately held a press conference to say the MMR vaccine probably caused autism and to recommend stopping MMR injections. Instead, he recommended giving the 3 individual components separately at intervals of a year or more. The media exploded with warnings like “Ban Three-in-One Jab, Urge Doctors.” The components were not available as individual vaccines, so people simply stopped immunizing. The immunization rate in the U.K. dropped from 93% to 75% (and to 50% in the London area). Confirmed cases of measles in England and Wales rose from 56 in 1998 to 1348 in 2008; two children died. In one small hospital in Ireland, 100 children were admitted for pneumonia and brain swelling caused by measles and three of them died. So, 14 years after measles had been declared under control in the U.K. it was declared endemic again in 2008.

Wakefield’s data was later discredited (more about that later) but even if it had been right, it wouldn’t have been good science. To show that intestinal inflammation is linked to autism, you would have to compare the rate in autistic children to the rate in non-autistic children. Wakefield used no controls. To implicate the MMR vaccine, you would have to show that the rate of autism was greater in children who got the vaccine and verify that autism developed after the shot. Wakefield made no attempt to do that.

His thinking was fanciful and full of assumptions. He hypothesized that measles virus damaged the intestinal wall, that the bowel then leaked some unidentified protein, and that said protein went to the brain and somehow caused autism. There was no good rationale for separating and delaying the components, because if measles was the culprit, wouldn’t one expect it to cause the same harm when given individually? As one of his critics pointed out: “Single vaccines, spaced a year apart, clearly expose children to greater risk of infection, as well as additional distress and expense, and no evidence had been produced upon which to adopt such a policy.”

item of interest…

Wakefield had been involved in questionable research before. He published a study in 1993 where he allegedly found measles RNA in intestinal biopsies from patients with Crohn’s disease (an inflammatory bowel disease)3. He claimed that natural measles infections and measles vaccines were the cause of that disease. Others tried to replicate his findings and couldn’t. No one else could find measles RNA in Crohn’s patients; they determined that Crohn’s patients were no more likely to have had measles than other patients, and people who had had MMR vaccines were no more likely to develop Crohn’s. Wakefield had to admit he was wrong, and in 1998 he published another paper entitled “Measles RNA Is Not Detected in Inflammatory Bowel Disease.”4 In a related incident, at a national meeting he stated that Crohn’s patients had higher levels of measles antibody in their blood. An audience member said that was not true — he knew because he was the one who had personally done the blood tests Wakefield was referring to. Wakefield was forced to back down.

In 2002, Wakefield published another paper showing that measles RNA had been detected in intestinal biopsies of patients with bowel disease and developmental disorders.5 The tests were done at Unigenetics lab. Actually, Wakefield’s own lab had looked for measles RNA in the patients in the 1998 study. His research assistant, Nicholas Chadwick, later testified that he had been present in the operating room when intestinal biopsies and spinal fluid samples were obtained and had personally tested all the samples for RNA with a polymerase chain reaction (PCR) test. The results were all negative, and he testified that Wakefield knew the results were negative when he submitted his paper to The Lancet. Chadwick had asked that his name be taken off the paper. So the statement in the paper that “virologic studies were underway” was misleading. Virologic studies had already been done in Wakefield’s own lab and were negative. Wakefield was dissatisfied with those results and went to Unigenetics hoping for a different answer.

Soon Wakefield’s credibility started to dissolve. The Lancet retracted his paper. Richard Horton, editor of The Lancet, described the original paper as “fatally flawed” and apologized for publishing it. Of Wakefield’s 12 co-authors, 10 issued a retraction:

We wish to make it clear that in this paper no causal link was established between (the) vaccine and autism, as the data were insufficient. However the possibility of such a link was raised, and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.

Attempts to replicate Wakefield’s study all failed. Other studies showed that the detection of measles virus was no greater in autistics, that the rate of intestinal disease was no greater in autistics, that there was no correlation between MMR and autism onset, and that there was no correlation between MMR and autism, period.

In 2001 the Royal Free Hospital asked Wakefield to resign. In 2003, Brian Deer began an extensive investigation6 leading to an exposé in the The Sunday Times and on British television. In 2005 the General Medical Council (the British equivalent of state medical licensing boards in the U.S.) charged Wakefield with several counts of professional misconduct.

One disturbing revelation followed another. They discovered that two years before his study was published, Wakefield had been approached by a lawyer representing several families with autistic children. The lawyer specifically hired Wakefield to do research to find justification for a class action suit against MMR manufacturers. The children of the lawyer’s clients were referred to Wakefield for the study, and 11 of his 12 subjects were eventually litigants. Wakefield failed to disclose this conflict of interest. He also failed to disclose how the subjects were recruited for his study.

Wakefield was paid a total of nearly half a million pounds plus expenses by the lawyer. The payments were billed through a company of Wakefield’s wife. He never declared his source of funding until it was revealed by Brian Deer. Originally he had denied being paid at all. Even after he admitted it, he lied about the amount he was paid. Before the study was published, Wakefield had filed patents for his own separate measles vaccine, as well as other autism-related products. He failed to disclose this significant conflict of interest. Human research must be approved by the hospital’s ethics committee. Wakefield’s study was not approved. When confronted, Wakefield first claimed that it was approved, then claimed he didn’t need approval. Wakefield bought blood samples for his research from children (as young as 4) attending his son’s birthday party. He callously joked in public about them crying, fainting and vomiting. He paid the kids £5 each.

The General Medical Council accused him of ordering invasive and potentially harmful studies (colonoscopies and spinal taps) without proper approval and contrary to the children’s clinical interests, when these diagnostic tests were not indicated by the children’s symptoms or medical history. One child suffered multiple bowel perforations during the colonoscopy. Several had problems with the anesthetic. Children were subjected to sedation for other non-indicated tests like MRIs. Brian Deer was able to access the medical records of Wakefield’s subjects. He found that several of them had evidence of autistic symptoms documented in their medical records before they got the MMR vaccine. The intestinal biopsies were originally reported as normal by hospital pathologists. They were reviewed, re-interpreted, and reported as abnormal in Wakefield’s paper.

All the reports of measles RNA in intestinal biopsies came from one lab, Unigenetics. Other labs tried to replicate their results and failed. An investigation revealed that:

Unigenetics found measles RNA with a test that should only detect DNA.

They failed to use proper controls.

The lab was contaminated with DNA from an adjoining Plasmid Room.

Duplicate samples that disagreed were reported as positive.

Positive controls were occasionally negative and negative ones positive.

The lab was never accredited.

It refused to take part in a quality control program.

When tested by an outside investigator, it failed to identify which coded samples contained measles virus.

The investigator said “I do not believe that there is any measles virus in any of the cases they have looked at.”

The lab is no longer in business.

So both Wakefield and his study have been completely discredited. He moved to the U.S. and is now working in an autism clinic. He has many followers who still believe he was right.

The Mercury/Thimerosal Scare

In 1998, U.S. legislation mandated measuring mercury in foods and drugs. The data came in slowly, and by 1999 the FDA had learned that infants could get as much as 187.5 mcg of mercury from the thimerosal in all their vaccines. They were concerned because mercury is toxic. Mercury poisoning caused the Minamata disaster in Japan; however, that was methylmercury and the mercury in vaccines was ethylmercury. The amount of mercury in vaccines was within recommended guidelines. EPA guidelines for permissible mercury exposure were based on methylmercury and were conservative — they were keyed to protect the most vulnerable patients, fetuses. There were no EPA guidelines for ethylmercury, but it was considered to be far less dangerous because it is eliminated more rapidly from the body.

Two mothers of autistic children published their own “research” saying that the symptoms of autism were identical to those of mercury poisoning.7 I don’t agree. You can look up the descriptions of mercury poisoning and autism and draw your own conclusions. I don’t see how anyone could confuse the two — their presentations are entirely different, with only a few symptoms that could be interpreted as similar.

Thimerosal is a preservative that allows vaccines to be sold in multi-dose vials. It contains ethylmercury. It was tested and found to be safe before it was added to vaccines. Animal studies showed no adverse effects. In 1929 in Indiana it was tested as a treatment in a meningitis outbreak — adults injected with 2 million mcg (10,000 times the total amount in all children’s vaccines) didn’t develop symptoms of mercury poisoning.

A study from the Seychelles showed that children getting high doses of methylmercury from fish did not develop neurologic symptoms. A study of children in the Faroes who were exposed in utero to whale meat highly contaminated with methylmercury showed subtle neurologic abnormalities (not autism), but a causal connection was not clear because the fish there were also contaminated with PCBs. The World Health Organization concluded:

The theoretical risk from exposure to thimerosal has to be balanced against the known high risk of having no preservative in vaccines. Therefore, WHO, UNICEF, the European Agency for Evaluation of Medicinal Products (EMEA), and other key agencies continue to recommend the use of vaccines containing this preservative because of the proven benefit of vaccines in preventing death and disease and the lack of data indicating harm.

In 1999 the U.S. removed thimerosal from vaccines. Why? The decision was not based on evidence but on one person’s opinion. Neal Halsey railroaded the committee and threatened to hold his own press conference if they didn’t do what he wanted. He meant well. His passion convinced the other committee members to invoke the precautionary principle — essentially bending over backwards to prevent any possible harm from a high total body burden of mercury from a combination of diet, environmental and vaccine sources. He didn’t even consider autism: he was only concerned about possible subtle neurologic damage.

They announced their decision in words guaranteed to confuse the public and create suspicion: “current levels of thimerosal will not hurt children, but reducing those levels will make safe vaccines even safer.” A 2007 editorial8 in The New England Journal of Medicine stated:

Although the precautionary principle assumes that there is no harm in exercising caution, the alarm caused by the removal of thimerosal from vaccines has been quite harmful. For instance, after the July 1999 announcement by the CDC and AAP, about 10 percent of hospitals suspended use of the hepatitis B vaccine for all newborns, regardless of their level of risk. [Because a thimerosal-free hepatitis B vaccine was not available.] One 3-month-old child born to a Michigan mother infected with hepatitis B virus died of overwhelming infection.

It went on to point out:

The notion that thimerosal caused autism has given rise to a cottage industry of charlatans offering false hope, partly in the form of mercury-chelating agents. In August 2005, a 5-year-old autistic boy in suburban Pittsburgh died from an arrhythmia caused by the injection of the chelating agent EDTA. Although the notion that thimerosal causes autism has now been disproved by several excellent epidemiologic studies, about 10,000 autistic children in the United States receive mercury-chelating agents every year.

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A further insanity has been perpetrated by the father-and-son team of Mark and David Geier. They claimed that autistics have premature puberty and high testosterone levels (there is no evidence that this is true). They hypothesized that testosterone forms sheet-like complexes with mercury in the brain (there is no evidence that this is true), preventing mercury’s removal by chelation. Their solution? They administered the drug Lupron to lower testosterone levels to supposedly facilitate mercury excretion. The treatment amounts to chemical castration.

Lupron is sometimes ordered by the courts to chemically castrate sex offenders, and it is used to treat precocious puberty and certain other medical conditions. It is not a benign drug. It can interfere with normal development and puberty and can put children’s heart and bones and their future fertility at risk. The treatment involves painful daily injections and costs $5000 to $6000 a month. The Geiers use 10 times the recommended dose. The company that makes Lupron does not support its use for this purpose.

Like Wakefield, the Geiers have been accused of professional misconduct. They built their own lab in their basement and formed their own institute to conduct Lupron studies. Then they formed their own Institutional Review Board (IRB) to approve studies. IRBs are required by law and must follow strict guidelines to ensure that studies are ethical and to protect the rights of subjects. The IRB they formed was illegal. They packed the board with friends and relatives: every single member of this IRB was either one of the Geiers, an anti-thimerosal activist, a Geier associate, or a lawyer suing on behalf of “vaccine-injured” clients. One was the mother of a child who was a subject in the research. Even worse, they let the principal investigator sit as the chair of the IRB overseeing his own research protocols. Oh, and the IRB wasn’t even registered until 2 years after the research was done.

Mark Geier has made a career of testifying as an expert witness in autism cases. He has not impressed the judges. Here are a few of the judge’s comments:

“Seriously intellectually dishonest”

“ … not reliable or grounded in scientific methodology and procedure … his testimony is subjective belief and unsupported speculation.”

“I cannot give his opinion any credence.”

“ … a professional witness in areas for which he has no training, expertise, and experience.”

When thimerosal was removed from vaccines, there were no studies showing that it was harmful. After its removal, study after study showed that it was not harmful. But activist groups didn’t let the new evidence interfere with their beliefs.

Anti-vaccine groups have viciously attacked medical doctors and researchers for simply stating what the current scientific evidence shows. They accuse them of being shills for “Big Pharma” or covering up for government agencies, and they call them offensive names; but they don’t stop there. They threaten people who write about the scientific evidence, and they threaten their children. Dr. Offit, the author of Autism’s False Prophets, received a direct death threat that got the FBI involved. He had to use a bodyguard and cancel a book tour. One threatening phone call ominously demonstrated that the caller knew Offit’s children’s names, ages, and where they went to school. Another scientist who received threats was so afraid for her children’s safety that she vowed never to write anything about autism again. One anti-vaccine activist had the bad grace to accuse science blogger Orac of lying when he said he was mourning his mother-in-law’s death from cancer. She refused to believe he could be sorry his mother-in-law died because he’s not sorry about supporting vaccines that kill children.

There was no thimerosal in any vaccine except the flu vaccine after 2002. The “mercury militia” expected autism rates to drop, thereby proving the mercury connection. Autism rates rose. Instead of relinquishing their belief, they made implausible attempts to implicate new sources of atmospheric mercury, from cremations of bodies with mercury amalgam fillings or from pollution wafted across the Pacific from China.

The Vaccines-In-General Scare

If the MMR scare can be attributed to Andrew Wakefield and the mercury scare to Neal Halsey, the next stage of hysteria is epitomized by Jenny McCarthy, actress and anti-vaccine activist extraordinaire.

Jenny’s son Evan is autistic. At first she subscribed to the fanciful notion that she was an Indigo mother and Evan was a Crystal child. Indigos are “difficult” children who are alleged to possess special traits or abilities such as telepathy, empathy, and creativity, and are said to represent the next stage in human evolution. Many of them fit the diagnosis of attention-deficit/hyperactivity disorder (ADHD). Crystal children represent an even more advanced evolutionary step. They are “so sensitive, so vulnerable to the world around them, that they go inward, disconnect as best they can from even humans and do their best to survive in a world where they really don’t yet fit.” They are often diagnosed as autistic.

After a while McCarthy gave up on that fantasy and accepted that Evan was autistic. She became convinced that vaccines had caused his autism. She treated him with unproven dietary restrictions, anti-yeast treatments, and supplements, and claims to have cured him. She thinks her “Mommy instincts” are more valid than science. She says “My science is Evan, and he’s at home. That’s my science.” She realizes that withholding vaccines will lead to the deaths of children. As quoted by Time magazine:

I do believe sadly it’s going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it’s their f___ing fault that the diseases are coming back. They’re making a product that’s s___. If you give us a safe vaccine, we’ll use it. It shouldn’t be polio versus autism.

She and her partner Jim Carrey have spoken out at every opportunity on talk shows, on the Internet, and through books and public appearances. When someone questions Jenny’s beliefs her usual tactic is to try to shout them down. She is supported by maverick doctor Jay Gordon, who values listening to parents over science and who supports a delayed vaccine schedule not because of any evidence but just because he thinks it’s a good idea. On one talk show, a pregnant mother with several autistic children tried to tell Gordon that her child who had the worst autism was the one who had not been vaccinated. He not only refused to listen to what she was saying but tried to drown her out, loudly insisting she mustn’t vaccinate the new baby.

A member of Quackwatch’s “Healthfraud” online discussion list reported sitting next to Evan’s paternal grandmother at a dinner. Grandma said Evan’s symptoms of autism were evident before he was vaccinated, and he is not doing as well as Jenny says. Grandma is writing her own book — I look forward to its revelations.

Jenny and her cohorts claim they are not anti-vaccine, but they are certainly a good facsimile thereof. The goalposts keep moving. First it was the MMR vaccine, then it was thimerosal, then it was mercury from all sources, then it was other vaccine ingredients, then it was too many vaccines, then it was giving vaccines too early. They will not be satisfied until science can offer a 100% safe and a 100% effective vaccine proven to have no side effects of any kind even in a rare susceptible individual. That’s not going to happen in this universe.

The other vaccine ingredients that have been questioned include formaldehyde, aluminum, ether, anti-freeze, and human aborted fetal tissue. Scientists have explained over and over that these ingredients are either not present in vaccines or are harmless, but activists ignore the facts and keep making the same false claims. Formaldehyde is harmless in small amounts and is even produced naturally in the human body. Aluminum is an adjuvant used to increase the efficacy of vaccines, and is not harmful. Ether might be used in the manufacturing process but is not present in the vaccines. There is no ethylene glycol or even diethylene glycol in vaccines. (Anti-freeze is ethylene glycol.) And to obtain enough virus to make a vaccine, the virus must be grown in tissue cultures that were originally derived from monkey, chicken, or sometimes human fetal cells; but there is no human or animal tissue of any kind present in the vaccine itself. Apple trees grow in soil, but there is no soil in applesauce.

Some anti-vaccine websites perpetuate the myth that infectious diseases were already disappearing and that the vaccines had nothing to do with it. Those myths are easily dispelled by historical data. Vaccine critics ignore the large body of evidence from incidents around the world where as the vaccination rate dropped, the rate of disease rose; and when the vaccination rate rose again, the disease rate dropped. No one can seriously deny the effectiveness of vaccines. They are the most impressive accomplishment of modern medicine.

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Giving up the known benefits of vaccines because of a vague hypothetical possibility of risk is a poor trade-off. We were able to eradicate smallpox, and we ought to be able to eradicate all the diseases that are spread solely by human-to-human contact. Once enough people have been vaccinated to eradicate the disease, no one will ever have to be vaccinated for that disease again. Smallpox is long gone; polio and measles are next on the list. Polio had been reduced to only 3 countries a few years ago. Then Nigeria stopped vaccinating due to rumors that the vaccines were an American plot to sterilize their children or give them AIDS. The polio rate soared and the disease broke out to several other countries, as far away as Malaysia.

When the rate of immunization reaches a certain level, the population is protected by what we call herd immunity. It means there are not enough susceptible people for the disease to keep spreading through a community. In many places the herd immunity has already been lost. It is only a matter of time before diseases break out again. One traveler from a country with polio could reintroduce the disease into the U.S. Lowered vaccination rates endanger even those who have been vaccinated, because the protection is not 100%. People who are immunosuppressed, chronically ill, or too young to have been vaccinated are also put at risk. Parents who choose to delay vaccination are prolonging their children’s period of risk. And they are endangering everyone else’s public health.

Scientists had been urged to “listen to the parents.” They did listen to the parents and then conducted research to test the parents’ hypotheses. There were various kinds of studies in different countries by different research groups. The results were consistent:

10 studies showed MMR doesn’t cause autism

6 studies showed thimerosal doesn’t cause autism

3 studies showed thimerosal doesn’t cause subtle neurological problems

Now it’s the parents who won’t listen to the scientists.

Autistic children and their parents are being misled and victimized with useless, untested, disproven, expensive, time-consuming, and even dangerous treatments. Despite the evidence that mercury doesn’t cause autism, children are still being treated with IV chelation to remove mercury — at least one child has died as a result. Along with Lupron injections for chemical castration, children are being treated with secretin, restricted diets, supplements of all kinds, intravenous hydrogen peroxide, DAN (Defeat Autism Now) protocols, cranial manipulation, facilitated communication, and other nonsense. One family was strongly urged to take out a second mortgage on their home so they could buy a home hyperbaric oxygen chamber.

The real tragedy is that all this hoopla is diverting attention from research into effective treatments (usually behavioral) and into the real causes of autism (almost certainly genetic, with environmental triggers not ruled out).

An anti-anti-vaccine backlash is now afoot. Outbreaks of vaccine-preventable diseases are being reported. Scientists are speaking out. Blogs like Respectful Insolence and Science-Based Medicine have covered the subject in depth. The Chicago Tribune published an exposé of the Geiers.9 Even Reader’s Digest has contradicted Jenny. They said that vaccines save lives and do not cause autism and they stressed that the science is not on Jenny’s side. Let us hope that sanity will prevail before too many more children die from vaccine-preventable diseases. They are dying now. The Jenny McCarthy Body Count webpage is keeping track of the numbers.

References