[Ip-health] Nature Medicine: WHO report on drug development marred by big pharma leak (Feb)

[Sophie Bloemen]

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WHO report on drug development marred by big pharma leak

The World Health Organization (WHO) has come under fire after an internal e=
mail surfaced showing that a pharmaceutical lobbying group had access to a =
confidential draft report on the financing of drug research and development=
. WHO officials have defended the integrity of its decision process, but cr=
itics say that a clear industry bias has tainted the agency's commitment to=
 the developing world. "I find this incredibly disturbing," says Tido von S=
choen-Angerer, director of the campaign for access to essential medicines a=
t M=E9decins Sans Fronti=E8res (Doctors Without Borders) in Geneva. "It's a=
 clear indication that [big pharma] had room to influence the report."

The WHO established an expert working group in November 2008 to assess near=
ly 100 proposed ways to encourage research and access to medicines for dise=
ases affecting the developing world. Last year, the 24-member panel met sev=
eral times in person, held two webbased public hearings and prepared a repo=
rt that the group planned to present at the World Health Assembly in Geneva=
 in May. Confidential parts of that report, however, seem to have fallen in=
to the hands of the International Federation of Pharmaceutical Manufacturer=
s & Associations (IFPMA), a Geneva-based lobbying group that represents top=
 drug makers including Pfizer, Novartis and

GlaxoSmithKline. A dossier posted in December on Wikileaks, a website that =
anonymously publishes sensitive information, included the draft report, a c=
omparative analysis of the submitted proposals and three internal IFPMA doc=
uments. "We received this document confidentially and we would kindly advis=
e you to not share it outside of our industry network," an undisclosed send=
er wrote to the IFPMA's public health advocacy committee in an email dated =
1 December 2009. The email goes on to call the report "in line with most of=
 the industry positions," before noting that the IFPMA will keep monitoring=
 the WHO's progress "should any input be requested from friendly [working g=
roup] members."

For many critics, this suggests that the foul play runs deeper than just a =
sneak peak of private documents. With public policy groups WHO report on dr=
ug development marred by big pharma leak voicing dismay that they were kept=
 away from the negotiating table, industry may have had an undue and undisc=
losed role in quashing promising proposals that would challenge its busines=
s model.  "The leaked email gives the impression the IFPMA had a firm hand =
on the process," says Sophie Bloemen, European projects officer for Health =
Action International, an Amsterdam-based policy advocacy group. "This commi=
ttee that was created was a step backwards," adds James Love, director of K=
nowledge Ecology International, a Washington, DC-based group pushing for bi=
g intellectual property reform. He says that the working group was, by desi=
gn, too supportive of business. "It was old school; it was status quo; it w=
as antichange." Bloemen agrees, saying that there was no transparency in ho=
w the experts were selected for the group.

But working group member and report coordinator Mary Moran, a health policy=
 expertat the George Institute for International Health in Sydney defends t=
he credibility of the report. She maintains that she was not personally pre=
ssured by the IFPMA, that none of the other expert panelists voiced unexpec=
tedly pro-industry views during their meetings and that a range of stakehol=
ders were consulted during the preparation of the report. One working group=
 member, who asked to remain anonymous, speculates that the IFPMA email was=
 a self-serving attempt to make the lobbying group seem more impressive to =
its associated member companies. IFPMA officials declined to comment for th=
is story.

Following the leak, the working group released its now finalized report on =
15 January. It endorses 11 ways to increase investment, better allocate fun=
ds and lower the costs of innovation for diseases common in the developing =
world. These include a new consumer tax on consumer goods, cash prizes and =
the harmonization of regulatory pathways. It also includes a tax on pharmac=
eutical companies that had been included in the leaked draft report but not=
 in a public summary of the group's work released in late December. WHO off=
icials say they are now investigating who was behind the leak. A WHO spokes=
woman says that although disciplinary action will be taken against any inte=
rnal staff who acted as moles, there are likely to be few options for recou=
rse if the leaks came from independent working group members.

Regardless of IFPMA's actual role, the damage to the credibility of the wor=
king group and its report has already been done. Without the controversy, W=
HO member states would probably have rubber stamped the report's recommenda=
tions when it gets tabled in May, says Moran. But now, "I'm not sure that w=
ill happen anywhere near as quickly, or perhaps not even happen at all."

Asher Mullard, London

nature medicine volume 16 | number 2 | february 2010