Scientific Disagreements

"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."
"To simply retract a paper which reports a result that one does not like makes a mockery of the whole review process."
Dr. Yehuda Shoenfeld, Tel-Aviv University

When the medical journal Vaccine published a study critical of the use of the human papillomavirus vaccine [HPV] co-authored by two researchers from the University of British Columbia, and led by Dr. Shoenfeld, the response from other scientists was hugely critical of their findings. Their research involved mice injected with the Gardasil HPV vaccine, and they reached the conclusion that the behavioural abnormalities the research mice exhibited might present as reason enough for further research, placing a curb on its use.

Joe Raedle/Getty Images   Academics — some funded by pharmaceutical companies, others by anti-vaccination organizations — are at odds over whether the new study has any value

 

In some Canadian provinces mass programs were inaugurated to immunize girls against the cancer-causing virus, and at a later date, an initiative to immunize boys as well  took place. A highly regarded immunologist regarded the study as one that should never have been accepted, since it was, in his opinion, "really a poor paper". The journal editor, Dr. Gregory Poland, himself a Mayo Clinic scientist, decided to withdraw the study and initiated a second peer review because of concerns brought to his attention.

An unambiguous comment from one of three reviewers whose name was not released, but whom the editor of the journal speaks of as an international expert was particularly scalding in the heat of his proffered opinion that "The paper ... has a seemingly excessive number of gross errors in both methodology and analysis".

The lead author of the paper permanently withdrawn because of concerns relating to claims that appeared unjustified along with a perceived lack of scientific rigour, is rather unhappy about the situation. Yehuda Shoenfeld, known in the field for his research questioning the safety of vaccines, accused Dr. Gregory Poland, the journal's editor, of a conflict of interest. Dr. Poland, it seems has been employed on a contract basis by Merck, the manufacturer of Gardasil.

On his part, Dr. Poland has admitted he is chairman of the safety-evaluation committee for Investigational vaccine trials for Merck, and he also consults for the pharmaceutical company. The Dwoskin Foundation, an American charity known for funding research on possible safety problems with vaccines funded Dr. Shoenfeld's study. Dr. Poland has responded that conflict-of-interest charges were "without basis".

He certainly has placed himself in an ethically compromised position, however. And there is validity in the charge by Dr. Shoenfeld; how can anyone on retainer by a pharmaceutical company objectively act in the best interests of science when his employer's product is being brought into question? It is true that research peers in the field of immunization disagree with the findings of the three researchers who wrote the study in question, but isn't science all about questioning the status quo and looking for answers?

Two types of HPV vaccine are on the market and are considered to be generally effective in prevention of the virus that causes 70 percent of cervical cancers. Of the number of women diagnosed with the cancer on an annual basis, almost one-third die of its effects. Global studies find no indication of serious health safety problems emanating from the use of the vaccines. Infectious-disease, public-health and oncology doctors and scientists have reached unanimity in support of the vaccine.

Christopher Shaw of University of British Columbia's ophthalmology department and post-doctoral fellow Lucija Tomljenovic, known for work linking vaccines to neurological problems are the two UBC researchers who contributed to the HPV paper. Dr. Shaw points out that the second round of reviews of their paper brought to the fore some valid points that could have been addressed if the authors had been given the opportunity.

"It is pretty hard to ignore the subject of the article (Gardasil) and Dr. Poland's ties to Merck", he commented. He's right there. The value of the study's observations and recommendations may be in question, but there is little question that Dr. Poland has effectively neutered his own scientific credentials through his work with the pharmaceutical giant. Caesar's wife must be above suspicion. And any scientist who prides himself on the quality of his work should also take care not to compromise perception of that quality.

The three researchers who produced the paper now withdrawn from publication are considered to be outliers in the scientific community linked to immunization and the safety of vaccines. "It's one thing when a member of the public stands up on a soap box. (But) this is irresponsible science by scientists. These are people who have PhDs behind their names ... It causes fear", points out Dr. Monika Naus, medical director of the B.C. Centre for Disease Control immunization programs.

Getty Images   A single dose of the controversial HPV vaccine