On February 2, 2010 a most unusual action was taken by the editor of the British medical journal The Lancet. To a worldwide media fanfare he announced that an article published in 1998, “Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis,and Pervasive Developmental Disorder in Children” had been retracted.

Retraction of a scientific article is an infrequent occurrence. The vast majority of retractions are initiated by the authors themselves after discovering an error in the published data. Retraction of a published article by other parties is a rare occurrence and is most commonly done when it is discovered that data was fabricated (made up) or falsified. That was not the case in the article in question. In fact, the recent Lancet retraction may be unique in the history of scientific publication, and it is likely to have a chilling effect upon honest scientific discovery and debate.

Behind the controversy lies a group of conditions that are known collectively as Pervasive Developmental Disorder (PDD). Those conditions include autism, Asperger’s syndrome, Rett syndrome, childhood disintegrative disorder, and pervasive developmental disorder not otherwise classified (PDD-NOS). Autism is the most well-known. Asperger’s syndrome and PDD-NOS are believed by many to simply represent a different level of severity of the same condition. Rather than attempting to make a more specific diagnosis some prefer to simply state that the individual has an autism spectrum disorder.

Rett syndrome has a clearly defined genetic basis; an abnormality of a gene that controls a protein critical to brain development. The gene is located on the X chromosome. Boys, who have only one X chromosome rarely survive infancy, dying shortly after birth. Girls, who have an extra, normal, X chromosome display varying degrees of developmental delays. The cause (or more likely causes) of the other autism spectrum disorders is uncertain.

There is no clearly defined cause for other pervasive developmental disorders. No genetic basis has been found. While some believe that a genetic susceptibility exists that is triggered by environmental factors, there is no evidence to support this contention. It is likely that environmental factors are responsible for most cases of PDD.

Autism typically presents within the first two years of life. It may be present at birth or it may develop during the second year of life. Childhood disintegrative disorder by definition presents after the age of two and before the age of ten. Asperger’s syndrome is generally not recognized until a child starts school and begins to interact with other children.

What the conditions have in common is a lack of normal social development. This is most severe in autism and least noticeable in Asperger’s syndrome. In childhood disintegrative disorder the child develops normally through the first two years of life before regressing and losing skills previously acquired.

Children with autism typically fail to respond to the calling of their names. They tend to avoid eye contact and often appear to be in their own world, unresponsive to external stimuli. Most autistic children resist being held or cuddled and prefer to play alone. Speech development is delayed and words that are learned for a time may subsequently be lost. An autistic child often performs repetitive movements or rituals, such as rocking back and forth. He or she is likely to become disturbed with any disruption of their routine. An autistic child tends to move constantly and while being excessively sensitive to light touch may be oblivious to pain.

A child with childhood disintegrative disorder develops normally to a point, but then regresses and loses previously mastered skills. The loss may occur suddenly over a few days or develop more gradually. Some of the skills that may be lost are the ability to say words or speak in sentences, the ability to understand what is being said by others, or the ability to interact socially with others. Physical development may also regress with loss of bowel and bladder control and loss of ability to perform motor skills such as using a spoon or catching a ball.

Asperger’s syndrome presents in many ways. Central to the syndrome is an inability to act appropriately toward others. This may mean being unable to wait one’s turn when conversing, an inability to recognize the significance of body language or the tone used in speaking, and inappropriately avoiding eye contact or staring at others. Motor development may be delayed causing the child to have difficulty learning to catch a ball or ride a bicycle.

Children who are given a diagnosis of PDD-NOS have developmental challenges, but they do not meet the criteria for inclusion in one of the other categories. Symptoms that lead to this diagnosis are highly variable.

It has been observed that the prevalence of pervasive developmental disorders has increased dramatically since 1980. The exception is Rett syndrome, which remains rare, being present in approximately 1 in 15,000 infants. This is not surprising, as it is the only condition that has a clearly defined genetic basis. The stability of Rett syndrome incidence speaks against a genetic basis of the other disorders, which are rising at an alarming rate.

Autism was first described in 1943. The prevalence of autism in 1966 was reported to be 4 – 5/10,000 live births. This number remained stable until 1980, when the number of children with autism began to increase. By 1996 the prevalence in children in Atlanta was found to be 34/10,000. The most recent survey of the United States Autism and Developmental Disabilities Monitoring Network performed in 2006 found the average prevalence of autism to be 90/10,000 live births. That is an astounding 20 fold increase over the past three decades!

Many have argued that the increase in autism spectrum disorders is due simply to improved diagnosis and reporting of the condition. While public awareness of autism has certainly increased in recent years I cannot accept that diagnostic skills have improved 2,000 percent since 1980. I was aware of autism and capable of recognizing the condition when I graduated from medical school in 1972.

Some suggest that the increase is due to some children who were previously classified as mentally retarded now being labeled autistic. Researchers from Columbia University addressed this issue in 2009 and determined that changes in classification could account for only 25 percent of the observed increase in children said to be autistic.

The rise in PDD figures prominently in the retraction of the Lancet article. In the 1990s parents began to bring children with PDD who also had diarrhea and abdominal pain to the Royal Free Hospital in London for evaluation by a leading group of gastroenterologists (stomach/intestinal specialists). The head of the team was Dr. Andrew Wakefield.

The gastroenterologists performed a thorough evaluation on each child, seeking to identify the cause of the intestinal problems. The parents granted permission for the studies that were performed, and the ethics committee of the hospital reviewed and approved the proposed studies. In 1998 the group reported their findings in the Lancet article.

The children had progressed normally to a point and then regressed in their development. They were found to have inflammation in their large intestines and enlarged lymph nodes surrounding the bowel. The physicians called their findings “Ileal-lymphoid-nodular hyperplasia and non-specific colitis”.

The physicians stated that the intestinal abnormalities and behavioral regression could have occurred by chance, but they suggested the possibility that the intestinal findings and developmental changes represented a unique, previously unreported, condition. They also reported that the parents of 8 of the 12 children evaluated had stated that their child’s symptoms appeared shortly after the child had received a MMR vaccine.

The authors explicitly stated, “We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described.” The article concluded, “We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunization. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.”

The Lancet article was not a study to determine the relationship of autism to the MMR vaccine. It did not conclude that the MMR vaccine was responsible for the developmental regression and the appearance of the intestinal problems. It was simply a straightforward reporting of the findings of their examinations.

That is what makes the Lancet’s retraction of the article unique. The authors did not falsify their findings. They did not fabricate a story. They did not draw any conclusions. They only reported their observations and suggested that research be conducted to determine the significance of their findings. That is the manner in which all scientific advances proceed. Observations lead to a hypothesis. The hypothesis is tested and found to be either true or false. The tests often lead to other hypotheses, which are then tested and knowledge continues to evolve.

In retracting the article the editors of The Lancet issued a strong warning to researchers – offering an unproven hypothesis is unacceptable and will not be tolerated. In doing so they have given notice that the scientific method, as it relates to medical research and the understanding of disease is dead.

What triggered the unprecedented retraction and the death of legitimate medical research? It is a tragic but interesting story.

While the article did not state that MMR immunizations cause the syndrome of developmental regression and intestinal inflammation it accurately reported that 2/3 of the parents reported that symptoms appeared shortly after their child had received a MMR shot. This understandably raised concern in the minds of other parents and a slight decrease in the MMR immunization rate followed.

Apparently this was unacceptable to the manufacturers of vaccines. In 2004 the Sunday Times published an article written by a freelance journalist, Brian Deer, who received his information from Medico-legal Investigations, an entity funded solely by The Association of British Pharmaceutical Industries. The article accused Dr. Wakefield and his colleagues of unethical conduct in their evaluation of the children in their report. The Sunday Times is managed and owned by James Murdoch who is a member of the board of GlaxoSmithKline.

Deer subsequently filed a complaint against the physicians with the British General Medical Council, which oversees medical practitioners in the United Kingdom. After an investigation lasting 2 ½ years and costing in excess of 1 million pounds the GMC found Dr. Wakefield and two of his colleagues guilty of unethical practices and had treated children with a “callous disregard” for the distress and pain the children might suffer.

The GMC refused to allow a single parent or child to testify at the hearing. They disregarded evidence that the physicians had received approval for the evaluations from the hospital’s ethics committee. Nevertheless, news reports hailed the verdict as proof that no connection between the MMR immunization and the syndrome of developmental regression and intestinal inflammation exists.

An appeal on behalf of the physicians has been filed, but the GMC ruling and the Lancet retraction have made it clear that certain areas are “off limits” in the brave new world of progressive medicine. Hypotheses are not to be formed based upon observations, but on the basis of political correctness. In the twenty-first century it is not permissible to challenge the safety of childhood vaccinations, even when there is ample reason to do so.

In the wake of the 1998 case report several researchers have published studies that fail to show an association between MMR vaccination and autism. That should not be cause for punishing the physicians for reporting what parents had told them about the relationship of the MMR vaccine and the onset of their children’s symptoms. The close ties between Brian Deer, his publisher, and the GMC to the British pharmaceutical industry suggest that the successful attempt to discredit the authors of the 1998 case report was waged to discourage other physicians from expressing concern about the safety of childhood vaccination schedules.

The official stance of the medical community is that vaccines have been proven to be safe beyond a shadow of doubt and to question current immunization practices is tantamount to child abuse and a threat to society. The fact is that research on the safety of childhood vaccines is largely lacking, and the relatively few studies that have been done have yielded conflicting results.

The highly regarded Cochrane Collaboration, an international not-for-profit and independent organization that reviews the medical literature and reports its finding on a wide variety of topics published a review of MMR research in 2005. The authors concluded, “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

The need for studies on vaccine safety was pointed out by Laura Bono, one of the featured speakers at the April 2007 the Institute of Medicine workshop called “Autism and the Environment: Challenges and Opportunities for Research.” Bono stated:

Because it (the cause of autism) is the environment, we need to leave no stone unturned. There is a growing body of evidence implicating vaccine overload, mercury and aluminum from vaccines. Thousands of parents agree with this research. They watch their children regress after being vaccinated. Their autistic children have been diagnosed with heavy metal poisoning and immune system dysfunction and when treated, get better.”

Concerns about vaccinations include the inclusion of the heavy metals mercury and aluminum, the administration of multiple vaccines during a single session, and the timing of vaccine administration. Studies exist that support each of these concerns.

The mercury preservative, thimerosal, was removed from most childhood vaccines in 1999, but it continues to be used in influenza vaccines given to infants and children. A comparison of children receiving the hepatitis B vaccine prior to the removal of thimerosal found a nine fold increase in the incidence of autism compared to children who had not received the vaccine. A 2009 study reported that reflex development was delayed in macaques given a single thimerosal-containing hepatitis B vaccination at birth.

Aluminum is found in nearly all childhood vaccines, and the total load administered to a child can be substantial. Aluminum is a known nervous system toxin, which has been shown to have adverse effects on development. Advocates of the use of aluminum in vaccines point out that aluminum is also present in breast milk. Dietary aluminum exposure is quite different than exposure by injection, however. Only 1 % of the aluminum taken orally is absorbed from the intestinal tract; an injection delivers 100 %. When absorption is taken into account an infant receives only 0.4 mcg of aluminum per liter of breast milk or 2 mcg from a liter of formula.

In 1997 a study of the effects of injected aluminum in newborns was published in the New England Journal of Medicine. Premature infants who were maintained on IV solutions with higher aluminum content showed lower mental development scores than those given solutions from which aluminum had been removed. The most marked change was noted in those infants who received in excess of 450 micrograms of aluminum over the course of their care.

As a result of this and other studies the FDA set a limit of 25 micrograms (mcg) of aluminum per liter of intravenous feeding solution. The rationale for this restriction is, “aluminum content in parenteral (injectable) drug products could result in a toxic accumulation of aluminum in the tissues of individuals receiving total parenteral nutrition therapy. Research indicates that neonates (newborn infants) and patient populations with impaired kidney function may be at high risk of exposure to unsafe amounts of aluminum.”

Given the FDA’s stand on aluminum in feeding solutions it is strange that no such limitation has been placed on the aluminum content of vaccines. Hepatitis B vaccine, which is administered to every newborn before it leaves a hospital or birthing center, contains 250 mcg of aluminum. One month later a second dose is given, meaning that the infant has already exceeded the amount of aluminum found to cause a loss of mental development. At two months of age the baby receives 225 to 975 mcg of aluminum depending upon which brands of vaccines are used. Since the vaccines are repeated at 4 and 6 months of age the total amount of aluminum exposure from routine vaccinations far exceeds the amount that is considered safe if administered as an intravenous feeding.

Several studies have shown a distinct difference in outcome depending upon age at the time of immunization. Researchers from the University of Manitoba found that the risk of developing asthma was cut in half if the first dose of DPT vaccine was given after 4 months of age instead of two months, as is recommended. Children who received their first DPT dose before two months of age were sixty percent more likely to present with asthma later in life. British researchers found that delays administration of both the DPT and MMR vaccines resulted in a lower incidence of hay fever later in life.

The reaction to the 1998 Lancet article may have been more intense, but it seems that every article that suggests a possible link between a vaccine and an adverse outcome is treated with contempt. Rather than giving the findings serious consideration the official response is to rationalize why the vaccine is not at fault. Children and parents are not served by an industry that refuses to investigate legitimate concerns and vilifies those who express them. What the Cochrane group discovered about the lack of research into the safety of the MMR vaccine is true of all vaccines. Given the current research climate I do not expect to see vaccine studies anytime soon. Next month I will explore another risk factor for autism and suggest ways parents can minimize the risks associated with vaccines given to their children.