The original study, by Andrew Wakefield (pictured), purported to show that vaccines trigger the onset of autism in some children. His findings inspired an international movement of parents and doctors who claim they saw the same thing: A seemingly healthy child regress into autism days or weeks after receiving a scheduled vaccination. They claim that drug companies, the CDC, the FDA and international health authorities have concealed or obscured data that supports Wakefield's findings.
The political environment around autism has become extremely difficult for anyone who argues that the evidence actually shows the opposite: just because autism symptoms arise at the same time vaccines are given does not mean the two events are linked.
The BMJ's new report shows that Wakefield's study wasn't just unethical, nor was it simply wrong. It was engineered, for financial gain, by a group of activists who already believed that vaccines cause autism, the BMJ says.
It's worthwhile reading for managers in the drug business too, as they rely on similarly professional-looking data that is vulnerable to research fraud: One of Pfizer (PFE)'s Celebrex researchers was convicted of fraud in 2010 and a GlaxoSmithKline (GSK) researcher on Paxil was imprisoned the same year. The lesson is a dismal one: Science businesses have institutionalized systems -- such as peer review and result reproduction -- to catch innocent mistakes. They don't have systems to detect outright fraud.
The fraud that Andrew Wakefield (pictured) perpetrated on The Lancet is shocking by any standards. The BMJ author, Brian Deer, wrote:
Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation.You can read an editorial summary of it here and the full text here. Originally, Wakefield reported in a 1998 paper for The Lancet on 12 children whose symptoms of autism appeared suddenly after they were given the MMR jab. Twelve years later, in 2010, The Lancet made a weaselly, non-transparent retraction of the study after it emerged that Wakefield had conducted the research unethically by not disclosing his conflicts of interest (he was given Â£435,643 by a law firm to get evidence against vaccines).
The basis of the new BMJ article is simple: Putting the previously reported ethical problems of Wakefield's study aside, the author asks whether any of the data in it were accurate. Deer compared the actual medical records of the 12 children in the study with what Wakefield reported, and found they were not. For instance, there were apparently 13 children in the study originally, but Wakefield reported on only 12 of them. As for the rest, 11 of the 12 families blamed the MMR before Wakefield found them. Within that group, the maximum time to onset for their autism symptoms was a "forensically unhelpful" four months after the jab. So Wakefield picked eight of those families whose cases were described as appearing up to 14 days after the jab.
And even that was not true. For most of the children, the appearance of their symptoms was unrelated to the timing of their MMR vaccine. Here's who was actually in the study:
- Child 1: Vaccinated at 12 months of age and had normal development milestones until 18 months. Wakefield's paper said onset of autism symptoms occurred seven days after the MMR jab.
- Child 2: Symptoms began "about six months" after the MMR. Was sent to Wakefield by JABS, an anti-vaccine group. The mother of Child 2 ran a group called "Allergy-induced Autism." Wakefield reported symptoms emerged two weeks after MMR.
- Child 3: Received MMR at 14 months; symptoms appeared 15 months after that.
- Child 4: Admitted to the study after advice from anti-MMR campaigners. Had developmental delays before MMR.
- Child 5: Had symptoms at 11 months but received MMR at 16 months.
- Child 6: History of bowel problems prior to MMR. Brother of Child 7.
- Child 7: Not diagnosed with autism. Brother of Child 6.
- Child 8: Admitted after advice from anti-MMR campaigners. Had developmental delays before MMR.
- Child 9: Parents were contacts of the anti-vaccine activist mother of Child 2.
- Child 10: Parents were contacts of the anti-vaccine activist mother of Child 2.
- Child 11: Symptoms appeared gradually and started before MMR.
- Child 12: Enrolled by a JABS activist.
This ought to be the final nail in the coffin of the idea that vaccines cause autism -- an idea so dangerous that it literally threatens children's lives, per the BMJ:
Although vaccination rates in the United Kingdom have recovered slightly from their 80% low in 2003-4, they are still below the 95% level recommended by the World Health Organization to ensure herd immunity. In 2008, for the first time in 14 years, measles was declared endemic in England and Wales. Hundreds of thousands of children in the UK are currently unprotected as a result of the scare.So how does this affect Big Pharma? Turns out one of Wakefield's frauds was borrowed straight from the drug company playbook: ghostwriting. There were 10 coauthors on the Lancet paper, none of whom appear to have checked Wakefield's work before it was published. That's exactly how Wyeth, Forest Labs (FRX), Pfizer (PFE), and GlaxoSmithKline (GSK) generated their own studies in the past (see related stories below).
- As Supreme Court Eyes Vaccines/Autism Debate, the Science Points Only One Way
- Ghosts in the Machine: Wyeth's $100K Budget for Sex Experts and Asian Spin Doctors
- Inside Pfizer's Ghostwriting Shop: Friendly Drug Studies for Just $1,000
- Forest's Lexapro Ghostwriting Budget Was $100K; Emory on the Payroll
- Inside GSK's CASSPER Ghostwriting Program