[Ip-health] A plan to develop a Zika vaccine runs into controversy, as questions swirl about price and conflicts of interest

Kim Treanor kim.treanor at keionline.org
Fri Nov 17 10:20:46 PST 2017


https://www.statnews.com/pharmalot/2017/11/17/nih-zika-vaccine-conflicts/

A plan to develop a Zika vaccine runs into controversy, as questions swirl
about price and conflicts of interest
Ed Silverman in Stat News on 17 November 2017

Yet another battle may erupt over a Zika virus vaccine and the extent to
which drug makers should be allowed to benefit from products that are
developed — at least in part — with taxpayer funds. There is an added twist
in this case, however, in the form of potential conflicts of interest.

Let’s start at the top: Last month, the National Institutes of Health
announced plans to issue an exclusive license to a privately held company
called PaxVax to develop a Zika vaccine. Few details were disclosed, but
the move is now prompting demands from advocacy groups that the federal
government should not award an exclusive license or, if it does, should
ensure that any vaccine is priced so it is accessible to Americans.

[snip]

“There is considerable evidence that the grant of exclusivity is not a
reasonable and necessary incentive to promote innovation and further
development of a Zika vaccine,” wrote Doctors Without Borders and Knowledge
Ecology International in comments filed with the NIH. “…An exclusive
license can be a barrier to ensuring a Zika vaccine will be available and
affordable to all who need it.”

[snip]

In comments to the NIH about a PaxVax license, the advocacy groups were
specific about pricing.

They want PaxVax to agree to market a vaccine in the U.S. at a price no
higher than the median price charged in other countries with large a gross
domestic product and at least half of U.S. per capita income. They also
want PaxVax to disclose steps it will take to make a vaccine available at
an affordable price in countries with demonstrated need.

[snip]

The KEI advocacy group, which was active in pushing the Army to extract
better licensing terms from Sanofi, filed a separate comment with the NIH
to say that an exclusive license with PaxVax has the “appearance of a
conflict of interest.”

Two years ago, Cerberus Capital Management spent $105 million to purchase a
majority interest in PaxVax. Stephen Feinberg, who heads the fund, donated
about $1.5 million to Rebuild America Now, a Super PAC that supported
President Donald Trump.

Also, Ken Kelley, who founded and previously ran PaxVax, has been working
as a White House Presidential Executive Fellow since 2015. According to his
LinkedIn page, Kelley is advising the BARDA director as well as the
director of the Vaccine Research Center of the National Institute of
Allergy and Infectious Diseases, which is the NIH unit considering whether
to issue an exclusive license to PaxVax.

“The potential of a conflict of interest between interested parties in
PaxVax and parties within the federal government calls for a higher level
of transparency into the transfer of any publicly funded technology,” KEI
said in a statement.

-- 
Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670 <(202)%20332-2670>



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