WHO had financial ties to GlaxoSmithKline and Roche when it issued flu pandemic guidelines

The World Health Organization (WHO) put its credibility on the line by keeping secret the names of its key flu committee members. Medical journals, governments and national public health agencies want to know why WHO ignored well-known conflict of interest rules when drafting global influenza pandemic guidelines.

Charges of undue industry influence have been nagging the WHO for some time. Now a joint investigation by the British Medical Journal and the Bureau of Investigative Journalism reports that flu experts who helped WHO draw up plans for dealing with pandemic flu were paid consultants to GlaxoSmithKline and Roche, the companies that manufacture zanamivir (Relenza) and oseltamivir (Tamiflu), and which stood to gain the most financially from the pandemic announcement made by WHO Director General Margaret Chan in June 2009.

“The number of victims of H1N1 fell far short of even the more conservative predictions by the WHO. It could, of course, have been far worse. Planning for the worst while hoping for the best remains a sensible approach. But our investigation has revealed damaging issues. If these are not addressed, H1N1 may yet claim its biggest victim—the credibility of the WHO and the trust in the global public health system.” – Deborah Cohen, features editor, BMJ, Philip Carter, journalist, The Bureau of Investigative Journalism, London , June 3, 2010

As a result of WHO recommendations, governments around the world stockpiled these drugs. Many developing countries cut funds for HIV/AIDS and other public health threats in order to stockpile Tamiflu and Relenza upon the WHO’s warning of an impending pandemic.

"The investigation reveals a system struggling to manage the inherent conflict between the pharmaceutical industry, WHO, and the global public health system, which all draw on the same pool of scientific experts," according to the BMJ   article.

WHO has routinely dismissed the questioning of its ties to industry from medical journals, national public health organizations and governments alike as conspiracy theories.

As a result of the investigation into industry influence at WHO, some regulators at the U.S. Food and Drug Administration have begun to distance themselves from the decision to approve the drugs. 

According to the BMJ investigation, “Michael Elashoff, a former employee of the FDA, was the statistician working on the zanamivir account. He told the BMJ how the FDA advisory committee initially rejected zanamivir because the drug lacked efficacy.

“After Dr Elashoff’s review (he had access to individual patient data and summary study reports) the FDA’s advisory committee voted by 13 to 4 not to approve zanamivir on the grounds that it was no more effective than placebo when the patients were on other drugs such as paracetamol. He said that it didn’t reduce symptoms even by a day.

"When I was reviewing the data, I tried to replicate the analyses in their summary study reports. The issue was not of data quality, but sensitivity analyses showed even less efficacy," he said. "The safety analysis showed there were safety concerns, but the focus was on if Glaxo had demonstrated efficacy." Dr Elashoff’s view was that zanamivir was no better than placebo—and it had side effects. And when the FDA medical reviewer made a presentation, her conclusion was that it could either be approved or not approved. It was a fairly borderline drug.

BMJ reports a similar situation at the European Medicines Agency which approved the drugs for markets in Europe.

"What was unclear and is still unclear is what is the impact of Tamiflu on serious complications” Pekka Kurki of the Finnish Medicines Agency told BMJ. “Circulating influenza was very mild when Tamiflu was developed and therefore it is very difficult to say anything about serious complications. The data did not clearly show an effect on serious complications—it was not demonstrated by the RCTs."

"We discussed the same issues that are still discussed today: does it show clinically significant benefits in treatment and prophylaxis of flu and what was the magnitude of the benefits presented in the RCTs?....The data show that the effects of Tamiflu were clear but not very impressive.”

The BMJ authors concluded, “The number of victims of H1N1 fell far short of even the more conservative predictions by the WHO. It could, of course, have been far worse. Planning for the worst while hoping for the best remains a sensible approach. But our investigation has revealed damaging issues. If these are not addressed, H1N1 may yet claim its biggest victim—the credibility of the WHO and the trust in the global public health system.”

BMJ 2010;340:c2912