TORONTO - The beleaguered World Health Organization came under renewed attack Friday for its handling of the H1N1 response, with a prominent medical journal alleging scientists with financial ties to drug companies influenced the contents of pandemic guidelines going back as far as 1999.
In particular, the BMJ (formerly known as the British Medical Journal) questioned the role three American and British scientists played in the writing up of guidelines that warned that countries which did not stockpile antivirals ahead of a pandemic would not be able to buy the drugs during one.
The BMJ article, written in collaboration with a London-based organization called the Bureau of Investigative Journalism, also criticized the WHO for insisting on keeping secret the names of the 16-member emergency committee that advises Director General Dr. Margaret Chan on the H1N1 pandemic.
Journal editor Fiona Godlee said the questions that have arisen have left the Geneva-based global health organization with "its credibility ... badly damaged."
"WHO's response to these concerns has been disappointing," Godlee wrote in an editorial that accompanied the article, released overnight Friday.
"Although Margaret Chan has ordered an inquiry and WHO has stressed its commitment to transparency, her office has turned down requests to clear up concerns about potential conflicts of interest."
The WHO has commissioned a review of the global response to the pandemic. The effort is being led by Dr. Harvey Fineberg, chair of the U.S. Institute of Medicine, who wrote the definitive report on the U.S. government's response to the swine flu outbreak in 1976.
Fineberg said in a release that the committee welcomes the opportunity to learn from the BMJ report, and another issued Friday by the Council of Europe.
"These reports raise questions about potential, inappropriate influences on WHO decision-making in the assessment and response to the 2009 H1N1 pandemic and, more generally, question practices employed by WHO to guard against conflict of interest among its expert advisers," he said.
"These topics are among those that will be fully considered by our review committee."
Though the BMJ article raises questions about a variety of WHO actions, a key complaint in the article relates to a document entitled "WHO Guidelines on the Use of Vaccines and Antivirals during Influenza Pandemics." It was published in 2004 but was based on consultations that took place in October 2002.
Three members of the committee that drew up the document are Dr. Frederick Hayden of the University of Virginia, Dr. Arnold Monto of the University of Michigan and Dr. Karl Nicholson of Leicester Royal Infirmary in England. All are acknowledged influenza experts, with extensive knowledge in the areas of antivirals and vaccines.
All three have at one time or another had financial dealings with Hoffman-La Roche and-or GlaxoSmithKline, makers of the flu drugs Tamiflu and Relenza respectively. (GSK also makes flu vaccine.) In some cases those dealings were financial support for clinical trials though in some cases they included speaking fees paid by the drug companies.
All three told the BMJ they had disclosed their ties to the WHO, which requires anyone taking part in a consultation to disclose potential conflicts of interest.
The eventual vaccine and antiviral report did not include the conflict of interest disclosures of committee members. Gregory Hartl, a WHO spokesperson, could not say why that was, but said it is current practice to publish the disclosure statements of people who take part in WHO consultations.
"Leaving aside the question of what declarations experts made to WHO, one simple fact remains: WHO itself did not publicly disclose any of these conflicts of interest when it published the 2004 guidance," argued the BMJ article, written by features editor Deborah Cohen and Philip Carter, a journalist with the Bureau of Investigative Journalism.
"It is not known whether information about these conflicts of interest was relayed privately to governments around the world when they were considering the advice contained in the guidelines."
(In a declaration of competing interests at the end of their article, Cohen disclosed the WHO had covered her expenses for talks she gave at two conferences. Carter said he had no competing interests.)
The list of other participants in the meetings that led to the 2004 report shows representatives of a variety of international public health agencies and governments were involved in the process. Countries with membership on the committee included Canada, Brazil, Thailand, the United States, Australia, New Zealand, Switzerland, Zimbabwe, China and Japan.
Hartl said the committee drawing up the guidelines was much bigger than the three scientists. He suggested there were 20 members, though the report lists 22.
"And I've never heard when three out of 20 is a majority," Hartl said from Geneva.
"The 20 people there were from ministries of health, public health agencies, academia -- from both developed and developing countries. Each of them bring a small part of a big puzzle together."
The guidelines drafted based on the consultations were then put out for public consultation and were posted on the WHO's website for six months, he said, adding the agency received hundreds of comments that were reviewed and considered in the process of drawing up the final document.
"From that point of view we are confident that there was no undue influence exerted," he said.
That view was echoed Friday by a leading infectious diseases expert, who dismissed the suggestion the three scientists or WHO might have acted improperly.
Before commenting, Dr. Michael Osterholm declared he has no ties with WHO or the pharmaceutical industry.
"I have no horse in this race except the truth," said Osterholm, who is director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.
"I have no concerns whatsoever that there was any conflict of interest here. And that I can't say for many other areas of medicine. But I can with this situation. I think that they were completely above board on this."
Osterholm said the pool of expertise on influenza and antivirals at the time the guidelines were drawn up was so small "that for the WHO to not call on these individuals would have been a serious subject matter expert mistake."
"Having said that, all of the appropriate recusals and identification of conflicts of interest were made. And in the imperfect world we live in today, that's as good as it gets."
The BMJ article was released the same day as a scathing report from the health committee of the Parliamentary Assembly of the Council of Europe, a human rights watchdog based in Strasbourg, France.
The group, which is not a European Union body, accused the WHO and European governments of exaggerating the risk of the H1N1 pandemic and making secretive decisions that benefited the pharmaceutical industry.
