Research Ethics Blog

Here’s an update to a troubling story I published here almost a year ago. Dr. Andrew Wakefield was a senior lecturer in the Departments of Medicine and Histopathology at The Royal Free Hospital (a teaching hospital in London) and a consultant in experimental Gastroenterology. Last year, when I published the original blog entry, Dr. Wakefield was in the midst of being investigated for medical misconduct, in a “fitness to practice” panel hearing of The General Medical Council in the UK. The hearing was centered around a Feb 1998 Lancet article in which Wakefield made various claims about autism, the MMR vaccine and inflammatory bowel diseases. Since the publication of that Lancet article (which, as of today, has been retracted by the journal), vaccination rates in the UK have plummeted and Wakefield has been viewed as the scientist “poster-boy” of sorts for the supposed link between autism and vaccination. You can read more about it in my initial blog entry here.

The longest medical misconduct inquiry ever conducted by the General Medical Council has now come to an end, and as Brian Deer of the Sunday Times reports, they confirmed more than 30 charges against Wakefield.

Here is a link to the Sunday Times story: ‘Callous, unethical and dishonest’: Dr Andrew Wakefield

The panel’s findings were astounding, both in their number and substance. More than 30 charges were found proven against Wakefield. For him alone they ran across 52 pages. Embracing four counts of dishonesty — including money, research and public statements — they painted a picture of a man not to be trusted. Other proven charges included nine of mistreating developmentally challenged children: causing invasive “high-risk” research to be carried out without ethical approval and against their best clinical interests.

The panel ruled that Wakefield caused three children to undergo lumbar punctures without clinical reason. Three more rulings said he had breached his employment contract at the hospital’s medical school which forbade him from involvement in patient care. He was also found to have shown “a callous disregard” for the “distress and pain” of children to whom he paid £5 in return for blood samples at his son’s fifth birthday party.

This is arguably one of the “worst case scenarios” we imagine in the field of research ethics. While we’re appropriately concerned with a myriad of ethical problems such as ghostwriting, undeclared conflicts of interest, breaches of confidentiality and the like, conducting research on vulnerable children without ethics approval is clearly one of the worst and most tragic cases we can think of. The resultant harm in this case, however, is not limited to the children and families Wakefield used in his “research”. I’m thinking of two additional harms that may well have resulted, surely in part, from the Wakefield case.

First, there is the societal effect that the condemned research has had. Vaccination rates in the UK (and other countries) have significantly decreased. The lack of clarity about this issue has polarized communities of parents with autistic children, creating “us” and “them” camps of parents and families. Serious misunderstandings abound, both about autism and about vaccination. As I said in my original posting last year, it’s difficult to hold Wakefield solely responsible for these problems. However, in part, his research spearheaded this movement for many (especially in the UK) and he has continued to promote his findings, despite considerable objections and serious questions from the scientific community.

The second kind of harm I’m thinking of is harm to the research community in general. It’s challenging enough for highly trained researchers and clinicians to sort through the vast collection of research articles and findings on this topic, that range from high-quality, valid, reliable and trustworthy to questionable, unreliable, invalid and simply untrue. For a lay person or concerned parent to try to sort through this topic and figure out what constitutes “good” versus “bad” data is beyond challenging. Now, this case may result in discredit and distrust of researchers, thus further “muddying the waters” for lay persons trying to figure out whose data to trust and whose to dismiss.

~ by Nancy Walton on February 2, 2010.

Posted in by Nancy Walton