What is it about Texas? It’s where the former British doctor and medical researcher Andrew Wakefield made his home after his now-notorious paper claiming an association between the measles, mumps and rubella (MMR) vaccine and autism was discredited and declared fraudulent.
And now Texas is the new home of another figure at the center of an explosive medical ethics controversy: bioethicist Glenn McGee.
This latest controversy, like the Wakefield one, has plenty of peculiar twists and turns. I suspect, however, that most of the details are probably too “in house” to be of interest to anybody other than other bioethicists. But the McGee controversy should concern us all. For it underscores a serious problem that continues to plague many areas of medicine: an unwillingness to deal effectively with financial conflicts of interest.
Such conflicts of interest eat away at the public’s trust in their medical institutions.
“My guess is that most citizens assume that when bioethicists write or speak about drugs or treatments, it does not occur to them that bioethicists might be trying to defend or advance corporate interests,” wrote University of Minnesota bioethicist Leigh Turner in an e-mail exchange with me on Tuesday. Leigh was among the first of his colleagues to start tweeting and blogging about McGee’s conflicts of interest earlier this month. Another U of M bioethicist, Dr. Carl Elliott, wrote about the controversy for Slate last Friday.
“If bioethicists have a reason to exist it is because they can write about ethical issues related to medicine, health care, and biotechnology and not serve as mere mouthpieces of industry,” Turner added.
‘A startling career move’
The current McGee controversy (he’s had others in his past — see Elliott’s Slate article) started last December, when he took a job as president for ethics and strategic initiatives at Celltex Therapeutics in Houston. And he did so without giving up his position as editor-in-chief of the American Journal of Bioethics (AJOB), a publication he founded in 1999.
McGee’s career move to Celltex was “startling,” writes Nature reporter David Cyranoski:
McGee’s new employer comes with a great deal of baggage. CellTex, which was founded last year and as yet has no website, licenses stem-cell technology from Seoul-based RNL Bio. The South Korean company has made a business out of taking fat cells from people, processing them in a way that they say increases the number of mesenchymal stem cells, and then reinjecting them in an effort to treat conditions such as spinal cord injury.
McGee already had a connection with RNL Bio. In 2010, two patients died following injections of RNL’s cells. McGee, working for stem-cell lobby group the International Cellular Medicine Society, based in Salem, Oregon, helped to conduct an investigation into the company. This concluded that only one of the two cases was likely to be related to the injections, and because the patient understood the risk the company was not culpable.
Not a job for a bioethicist
“I have never before heard of a case in which a bioethicist investigated deaths connected to a company and then subsequently went to work for that company’s business partner,” said Turner in his e-mail exchange with me. “[It] raises questions about the thoroughness by which a bioethicist investigated the death of two patients.”
But, added Turner, a reputable bioethicist shouldn’t be working for company like Celltex to begin with:
CellTex and RNL Bio together operate a facility in Texas that takes adult stem cells from fat tissue of customers, processes and banks the cells, and then injects or administers the cells back into clients. The cells are clinically unproven, non-FDA-approved, and nothing is known about their safety and efficacy. And yet, CellTex charges customers for these so-called treatments that could in fact cause harm.
Glenn McGee, by becoming a President at CellTex, has taken a position at a company that appears to operate much like for-profit, unregulated stem cell clinics in China, Costa Rica, the Dominican Republic, India, and Russia. The only message that a bioethicist working at such a company should have for his employers is to insist that they immediately stop administering unproven, non-FDA-approved stem cells into customers. Under no circumstances should such a business charge customers for interventions that could be completely ineffective or harmful. If the company has an intervention with genuine potential it should be evaluated in the context of randomized controlled trials, be subject to FDA oversight, and not be sold to customers until the FDA approves it for specified uses in humans. And if CellTex refuses to accept this analysis of company practices, the only decent thing for a bioethicist concerned with patient safety to do is to quit.
Working as a bioethicist for a business such as CellTex risks providing ethical cover — the appearance of ethical oversight — for unethical business practices that could harm the company’s customers.
‘What are these people smoking?’
And what about the future of McGee’s bioethics journal? Last week, as the controversy grew, McGee said he was stepping down as editor-in-chief, although apparently not as a result of any demand from his London-based publisher, the Taylor and Francis Group. Also, one of the two new editor-in-chiefs, it was announced, will be McGee’s wife, Summer Johnson McGee, who is currently the journal’s executive editor. Summer McGee also worked with her husband at the Center for Practical Bioethics in Kansas City, Mo., where he held the John B. Francis Chair in Bioethics before taking his current job with Celltex. According to John G. Carney, president and chief executive officer for the center, Glenn McGee left his post there on Nov. 15 and Summer McGee completed her contract work with the center by the end of the year.
Dr. John Lantos, director of the Children’s Mercy Bioethics Center in Kansas City and a past president of the American Society for Bioethics and Humanities, resigned from AJOB’s editorial board last week, stating that AJOB had lost credibility “in ways that tarnish not just the names of people associated with it but also the reputation of the entire field of bioethics.”
“If, as we’ve been told, Taylor and Francis really asked Glenn McGee to stay on as Editor once he’d taken a job at Celltex, and if they really believed that the resulting conflicts-of-interest were manageable, one must wonder about both their judgment and their mission,” Lantos wrote. “Imagine that the Editor of the New England Journal took a job as Vice President at [the pharmaceutical company] Merck, and the Mass Medical Society asked him to stay on as Editor, opining that the conflicts of interest would be manageable. One might rightly wonder, ‘What are these people smoking?’”
Yes, one does rightly wonder that — and more.
Correction: An earlier version of this story misstated McGee’s role at the Center for Practical Bioethics and missed the fact that Summer McGee left the center in late 2011.
Unlike the Wakefield fiasco, I suspect Glen McGee won’t attract a team of loyal supporters who will defend him in every news story.
As I suspect will happen in 3…2….1…any time now here.
What’s with Texas, indeed. Here’s another story: A psychiatrist from Texas was the lead investigator for the federal government’s Star*D study of anti-depressants. Turns out he was on the take from Forest Pharmaceuticals, maker of Celexa.
A recent news story on a lawsuit against the psychiatrist said that “bias was the result of kickbacks, bribes, and other improper financial inducements that were paid by Forest to Dr. John Rush, the principal investigator of the study, and to one or more of the project’s other investigators.
The complaint alleged that this conflict of interest not only caused the selection of Celexa as the only antidepressant employed in the first part of the study, but also led to falsification and overstatement of the effectiveness of Celexa in the study’s published result.”
http://www.bna.com/whistleblower-claims-forest-n12884907568/
And lo and behold, the author has fled to Singapore!
“The complaint reported that 10 of STAR*D’s authors, including Rush, have disclosed in journal articles that they had received money from Forest and that in the summer of 2008 Rush left the University of Texas, moved to Singapore, and was replaced as the STAR*D P.I.”
Ethics conflict of interest
The sad part of this problem is that its not known to people that need to be protected: families of sick people that will grasp at any straw, having no idea that the treatment may be ineffective.
Bad judgment
I don’t agree with Mr. Turner’s contention that a corporation is no place for a bioethicist–bioethicists can be of great use in reviewing study protocols to identify potential ethical snags. There is no problem with that as long as the company and the bioethicist can agree to stick to ethics. Hard, but not impossible.
That being said, a bioethicist that has corporate ties has no business in general bioethics. Not teaching and not editing. Once your paycheck is written by a company with a specific monetary goal, it puts anything more general at risk of being contaminated by that money. That mistake should be obvious to anyone with “ethicist” in their title.
Bioethicists & reporters avoid clinical proof of MMR injury
Falsehoods about Dr. Andrew Wakefield are listed in his defamation lawsuit against the UK reporter and journal.
http://www.courthousenews.com/2012/01/04/BritMedJ.pdf
Here’s how the GMC framed Doctors Wakefield, Walker-Smith and Murch:
http://www.cryshame.co.uk//index.php?option=com_content&task=view&id=125&Itemid=135
Meanwhile many families in the UK and US have clinical documentation of their children’s gastrointestinal damage from the MMR vaccine; see the books “Silenced Witnesses” and “Silenced Witnesses II.”
http://www.cryshame.co.uk//index.php?option=com_content&task=view&id=65&Itemid=213
When Dr. Wakefield asked a vaccine manufacturer’s rep to investigate MMR injury, his reply was “We don’t have to.” And they don’t — thanks to legislation bought by industry, copy-and-paste reporters who indulge biases, and bioethicists who look the other way.
I’m afraid…
Andrew Wakefield is a quack of the highest order. Not only have there been many studies finding no evidence of his claims (and none with any credibility supporting them), but he got his “data” unethically in the first place. In otherwords, the only relation to bioethics that Wakefield has is the lack thereof.
As predicted: a Wakefield supporter
Wakefield wasn’t framed.
One can read day after day of the GMC transcripts. Mr. Wakefield committed several instances of dishonesty and unethical behavior.
The sanction document is here:
http://www.gmc-uk.org/Wakefield_SPM_and_SANCTION.pdf_32595267.pdf
One section I’ll quote:
“The Panel considers that Dr Wakefield’s conduct in relation to the facts found falls seriously short of the relevant standards and that suspension would not be sufficient or appropriate against a background of several aggravating factors and in the absence of any mitigating submissions made on his behalf. Dr Wakefield’s continued lack of insight as to his misconduct serve only to satisfy the Panel that suspension is not sufficient and that his actions are incompatible with his continued registration as a medical practitioner.”
Mr. Wakefield engaged in a research program to collect data from disabled children as part of planned litigation in the UK. He failed to obtain ethics panel approval before starting the program. He subjected children to invasive tests which were not in their clinical interests but were for the purposes of his research program.
If Mr. Wakefield’s defamation suit is allowed to go ahead (he is suing UK residents and business from Texas), he will likely face an anti SLAPP charge. Given how weak his arguments are I expect he would lose.
“Meanwhile many families in the UK and US have clinical documentation of their children’s gastrointestinal damage from the MMR vaccine”
Why couldn’t the attorneys for the Omnibus Autism Proceeding (vaccine court) find any of these children? They presented three test cases which were “not even close” to proving vaccine injury caused their conditions.