Swine flu patient .
(photo credit: Ariel Jerzolomiski)
Key scientists advising the World Health Organization on planning for a swine flu (h1N1) pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance these scientists were preparing, a joint investigation by the BMJ (British Medical Journal) and the Bureau of Investigative Journalism revealed on Friday.
A year ago, the WHO, an agency of the UN, coordinated the actions of governments around the world to fight H1N1, declared the new strain of swine-origin H1N1 as a pandemic, encouraging vaccination and giving daily press conferences. Its advice induced governments around the world to stockpile billions of dollars of antiviral drugs. Yet these conflicts of interest have not been publicly disclosed by the WHO, the British Medical Journal//Bureau of Investigative Journalism probe said. Despite repeated requests, the WHO “has failed to provide any details about whether such conflicts were declared by the relevant experts and what, if anything, was done about them,” the authors said.
Israel’s Health Ministry followed the WHO’s recommendations, with Prime
Minister and formal Health Minister Binyamin Netanyahu ordering the
purchase of 7 million doses of vaccine and enough antiviral medications
to cover the entire population at a cost of about half a million
shekels. However, most of these were left unused because most Israelis
declined to be vaccinated, and the H1N1 complications were mild enough
in most people to make the antivirals unnecessary. No comment was
available over the weekend from senior ministry officials who were
involved in handling the H1N1 pandemic.
The new report echoes a highly critical inquiry by the Council of
Europe, whose findings were also published on Friday and fueled
suspicions that the drug industry was able to exert undue influence on
the WHO’s decisions about the swine flu pandemic and the mass
stockpiling of drugs.
The investigation found that the WHO’s 2004 guidance on the use of
antivirals in a pandemic was prepared by an influenza expert who had
received payment from the Basel-based Hoffmann–La Roche, manufacturers
of oseltamivir (Tamiflu), and the London-based GlaxoSmithKline,
manufacturers of zanamivir (Relenza), for lecturing and consultancy
work. The guidance concluded that “countries should consider developing
plans for ensuring the availability of antivirals” and that they “will
need to stockpile in advance, given that current supplies are very
In addition, the investigation found two other scientists who prepared
annexes to the WHO 2004 pandemic guidelines had recent financial links
to Roche. Authors Deborah Cohen of the British Medical Journal
and Philip Carter of the Bureau of Investigative Journalism maintained
that the WHO “did not publicly disclose any of these conflicts of
interest when it published the 2004 guidance. It is not clear whether
these conflicts were notified privately by WHO to governments around
the world, many of which followed its advice.”
This “lack of transparency,” they continued, “is compounded by the
existence of a secret ‘emergency committee’ that advised WHO’s
director-general Margaret Chan on declaring an influenza pandemic.
Significantly, the names of the 16 committee members are known only to
people within WHO, and as such their possible conflicts of interest
with drug companies are unknown.”
The WHO has denied that any industry influenced the scientific advice
it received. It also says it takes conflicts of interests seriously and
has the mechanisms in place to deal with them. But the British Medical Journal
and the Bureau suggest that WHO seems not to have followed its own rules for the decision-making around the pandemic.
“And, despite repeated requests, the WHO has refused to provide any
information about the conflict of interest declarations made to it,
leaving the investigation to wonder whether major public health
organizations are able to manage the conflicts of interest that are
inherent in medical science effectively,” the joint report stated.
Cohen and Carter wrote that the WHO’s response to criticism “is also
disappointing, given WHO’s track record of standing up to industry. In
the late 1970s, WHO sparked two iconic clashes with multinational
companies over the marketing of breast milk substitutes in the
developing world and the setting up of the Essential Drugs Programme.
Both issues set WHO at loggerheads with the US, where these industries
had major holdings. Partly in response to WHO’s position, America
withdrew contributions to WHO’s budget.”
In an accompanying editorial, British Medical Journal
editor-in-chief Dr Fiona Godlee wrote that “the WHO’s credibility has
been badly damaged” and that recovery will be fastest if it “publishes
its own report without delay or defensive comment, makes public the
membership and conflicts of interest of its emergency committee and
develops, commits to, and monitors stricter rules of engagement with
industry that keep commercial influence away from its decision-making.”
On the basis of their own investigation and those of others, they said
the answer to the question about what to do about conflicts “is now
inescapable... No one should be on a committee developing guidelines if
they have links to companies that either produce a product – vaccine or
drug – or a medical device or test for a disease. The same, and more,
must apply to committees making major decisions on public health. Where
entirely independent experts are hard to find, experts who are involved
with industry could be consulted but should be excluded from
decision-making. The US has made important progress with its Sunshine
Act and other legislation. European legislation on managing conflicts
of interest is long overdue,” Cohen and Carter concluded in their paper.