National Post | 8 March 2016
A Canadian co-authored study critical of the human papillomavirus vaccine (HPV) has now been permanently spiked by a prestigious medical journal, with one outside expert suggesting it contained numerous “gross errors.”
The small animal study had actually been accepted by Vaccine and published online, then pulled temporarily last month by the editor, who had it peer-reviewed a second time — an unusual sequence of events.
The paper concluded that mice injected with the Gardasil HPV vaccine exhibited behavioural abnormalities and suggested putting a curb on mass programs to immunize girls against the cancer-causing virus.
A new notice on the journal’s website says the article has been permanently withdrawn because of “serious concerns” about its scientific soundness and claims in it that are unjustified.
“The paper … has a seemingly excessive number of gross errors in both methodology and analysis,” said a scathing critique by one of three unnamed reviewers, described by the editor as international experts.
Other scientists had earlier panned the study. A top immunologist told the National Post last month it was “really a poor paper” that should never have been accepted.
But Yehuda Shoenfeld of Tel-Aviv University, the lead author who is known for research questioning the safety of vaccines, reacted angrily to the latest development.
He accusing the journal’s editor – Dr. Gregory Poland, a Mayo Clinic scientist — of having a conflict of interest because of work he has done for Merck, Gardasil’s manufacturer.
The researchers may even consider legal action against Vaccine, Shoenfeld told the National Post in an email exchange.
“This reflects an unusually unorthodox and unprofessional conduct from the journal and seems to be part of a pharmaceutical industry push-back to any critique of the Gardasil vaccine,” he wrote in a letter to Poland.
“To simply retract a paper which reports a result that one does not like makes a mockery of the whole review process.”
‘To simply retract a paper which reports a result that one does not like makes a mockery of the whole review process’
Poland has disclosed that he is chairman of the safety-evaluation committee for Merck’s investigational vaccine trials, and does consulting for the company.
Shoenfeld’s study was sponsored by the Dwoskin Foundation, a U.S. charity that mostly funds research on purported vaccine safety problems.
Poland said by email he would not comment on the episode, but the conflict-of-interest charge was “without basis,” given that the paper was killed after a review by external experts.
The two types of HPV vaccine now on the market have been shown effective at preventing strains of the virus causing 70 per cent of cervical cancers. About 1,500 Canadian women are diagnosed with the cancer annually, 380 dying from it.
Large studies of recipients worldwide – including one published this month on 200,000 Alberta girls who got the shots — have found no sign of serious safety problems. Infectious-disease, public-health and oncology doctors and scientists are virtually unanimous in supporting the product.
The two University of British Columbia researchers who contributed to the HPV paper — Christopher Shaw of UBC’s ophthalmology department and post-doctoral fellow Lucija Tomljenovic — are well known for work that has linked vaccines to neurological problems.
Shaw said the second round of reviews of the paper contained some valid points that the authors could have addressed if given a chance, and some “trivial” criticisms. None should have doomed the study, he said.
“It is pretty hard to ignore the subject of the article (Gardasil) and Dr. Poland’s ties to Merck,” he said Tuesday.
But his research, which is also heavily backed by Dwoskin, has come under question before, with the World Health Organization and a U.S. Centers for Disease Control committee publishing tough critiques.
The UBC pair and their Israeli colleagues are scientific outliers, producing questionable research that can needlessly scare parents, said Dr. Monika Naus, medical director of the B.C. Centre for Disease Control’s immunization programs.
“It’s one thing when a member of the public stands up on a soap box,” she said. “(But) this is irresponsible science by scientists. These are people who have PhDs behind their names … It causes fear.”