A Thorough Analysis of the Case Against Dr. Andrew Wakefield by Mary Holland, JD

Introduction

If you’ve heard Dr. Wakefield’s name — and you probably have — you’ve heard two tales. You’ve heard that Dr. Wakefield is a charlatan, an unethical researcher, and a huckster who was “erased” from the British medical registry and whose 1998 article on autism and gastrointestinal disease was “retracted” by a leading medical journal. You’ve also heard a very different story, that Dr. Wakefield is a brilliant and courageous scientist, a compassionate physician beloved by his patients, and a champion for families with autism and vaccine injury. What’s the truth?

Who is Dr. Andrew Wakefield?

Dr. Wakefield graduated from St. Mary’s Hospital Medical School of the University of London in 1981; he was one in the fourth generation of his family to study medicine at that teaching hospital. He pursued a career in gastrointestinal surgery with a specialty in inflammatory bowel disease. He became a Fellow of the Royal College of Surgeons in 1985 and was accepted into the Royal College of Pathologists in 2001. He held academic positions at the Royal Free Hospital and has published over 140 original scientific articles, book chapters, and invited scientific commentaries.

Background on The Controversy

In the early 1990s, Dr. Wakefield began to study a possible link between the measles virus and bowel disease. He published a 1993 study, “Evidence of persistent measles virus infection in Crohn’s disease” and co-authored a 1995 article published in The Lancet, “Is measles vaccine a risk factor for inflammatory bowel disease?” At roughly the same time, Dr. Wakefield wrote an unpublished 250-page manuscript reviewing the available scientific literature on the safety of measles vaccines. He was rapidly emerging as one of the world’s experts on measles vaccination.

The Allegations against Dr. Wakefield

The highly publicized, multi-year, multi-million dollar prosecution against Dr. Wakefield alleged that:

Failure to Disclose Payment from Litigators

Dr. Wakefield accepted 55,000 pounds to conduct a study for the class action suit regarding vaccines and autism. This was a research grant from which Dr. Wakefield personally received no compensation. Dr. Wakefield did not start this study until after the case series for the Lancet 12 had been submitted. Legal documents prove that Dr. Wakefield’s hospital knew about this study and knew about the amount of money he received, most of which went to pay the salary of a designated laboratory technician. Documents further demonstrate that Dr. Wakefield disclosed in a national newspaper over one year before publication of the 1998 article that he was working with the litigators. Dr. Horton, editor of The Lancet, had been informed and should have been well aware of Dr. Wakefield’s role in the vaccine-related litigation before the publication of the 1998 article.

“Medical Necessity” and Ethical Clearances

The Lancet 12 were sick. Each child was administered tests with the intent to aid that child. The hospital administration was fully aware of the tests being conducted and made no objections. Because all of the tests were “clinically indicated” and not for research purposes, no ethical clearance beyond what Prof. Walker-Smith already possessed was required. Notably, no patient, parent, or guardian has ever made accusations against Dr. Wakefield or testified against him for ethical violations or medically unnecessary procedures. Dr. Wakefield and his colleagues reject the GMC’s ruling that the tests for the Lancet 12 were unnecessary.

The Lancet 12’s Referrals

The GMC charged that the children were referred through the litigation effort and not through ordinary medical channels. This is incorrect. Parents started contacting Dr. Wakefield long before the litigation started, and independently of it. Since the litigation study was not yet started by the time The Lancet study was completed and submitted to the journal, this finding is false. Dr. Wakefield and his colleagues reject that claim; the families contacted them directly because of their medical expertise.

Control blood samples from a child’s birthday party

Dr. Wakefield arranged for control blood samples from healthy, typically developing children to be taken at his son’s birthday party. Most of the children’s parents were medical colleagues and friends. He did this with the children’s and parents’ fully informed consent and gave the children 5 pounds each for their trouble. The procedure was undertaken by an appropriately qualified doctor using a standard technique. The children were happy to be helpful and went on to enjoy the birthday party. While this is admittedly an unconventional method of collecting control blood samples, it hardly amounts to “serious professional misconduct” or an ethical breach warranting delicensure. The GMC’s description of this incident as an example of “callous disregard” for children’s distress seems to be a gross exaggeration. Indeed, the U.K. High Court of Justice exonerated Professor Walker-Smith in March 2012, and the Lancet journal has suggested that it is considering reversing its retraction.

The Meaning of The Wakefield Prosecution

What, then, was this high-profile prosecution really about? If there was no scientific fraud, no undisclosed financial conflicts of interest, no ethical breaches in performing tests on sick children, and no complaints from patients or their families, then what was the big deal? Did the international scandal and multi-million dollar prosecution proceed merely to chastise a doctor for drawing blood from children at a birthday party, with their consent and their parents’ consent? Of course not.

Dr. Andrew Wakefield

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