[Ip-health] Washington Times Op-ed: The Innovation Agenda

[Sarah Rimmington]

The 'innovation agenda'
TODAY'S COLUMNIST
The Washington Times
By Robert Goldberg
March 5, 2007



    Nancy Pelosi has a knack for the ironic. In unveiling what she
called her party's "Innovation Agenda," the speaker from American Samoa
proclaimed: "America (is) the breeding ground for the innovations and
inventions that increased our prosperity, enhanced our lives, and
protected and advanced our freedoms. That dynamic and virtuous cycle of
innovation is what secured our status as world leader, and that status
has remained unchallenged -- until now."
    Little did we know that the challenge Mrs. Pelosi was referring to
is the Democratic Party itself. In January, Rep. Henry Waxman, touting a
Families USA study, promised that direct government negotiations with
drug companies would save Medicare $190 billion, enough money to pay for
every senior's out-of-pocket drug costs as well as expanding health
insurance for kids and rehab for Britney Spears. The savings disappeared
when it became evident they were only achievable if Medicare robbed
seniors of access to many lifesaving drugs.
    Democrats are still short the money. So they plan to get it by
stopping that virtuous cycle of innovation in biotechnology. The Murtha
plan for stopping the troop "surge" in Iraq is being peddled as a
"support-the-troops plan." The Access to Lifesaving Medicines Act,
offered by Mr. Waxman, Sen. Charles Schumer, Sen. Hillary Rodham Clinton
and Republican Rep. Joanne Emerson, creates generic versions of biotech
drugs to free up money for social programs. It is shrewdly devised as a
consumer-protection measure. But in the process, Mr. Waxman and others
weaken drug safety and patent-protection standards to enrich the generic
drug industry.
    Ironically (again) in touting the Innovation Agenda, the speaker
from Samoa proclaimed: "Essential to our pre-eminence is the protection
of intellectual property. Our agenda commits to protecting the
intellectual property of American innovators worldwide." But this does
not occur when it stands in the way of expanding the welfare state.
Recently the military dictatorship running Thailand following the advice
of anti-intellectual property activists (who care more for shredding
corporate patent rights than protecting human rights in Thailand), said
it would use its government pharmaceutical organization (GPO) to make
generic copies of the heart drug Plavix and two HIV drugs, Kaletra and
Stocrin. It has also threatened to seize the patent of 11 new drugs
including Lipitor and Gleevec. Thailand claims it needs to make or
import generic drugs to treat everyone with every disease. The junta,
which has military monitors in every pressroom, received a warm
endorsement from Mr. Waxman. All hail the Revolution.
    Mr. Waxman and other Democrats cloaked their efforts in the concern
that giving generic companies the license to produce these drugs will
make medicines affordable for all. In fact, in 2002 Thailand's GPO
failed to meet the World Health Organization's drug-quality standards.
Worse, the drugs were so shoddy that they caused drug resistance,
forcing patients to take a second regimen of drugs that raised overall
infection rates and treatment costs. And even then, most of the $3
million worth of drugs are exported. The percentage of infected Thais
receiving treatment is among the lowest in the developing world.
    So what if generics don't really increase access to effective
medicines? That's not the goal. Weaker intellectual property protection
allows the Thai junta to line its pockets with the proceeds made from
copycat products it can sell at huge margins, money it can then turn
around and spend to reward cronies and buy political support. Similarly,
the so-called Access to Life-Saving Medicine Act simply asserts it is
scientifically safe to both produce generic clones of biotech drugs and
switch people from the biotech products they are using to generic
versions. Making similar but not exact versions of biotech drugs or
vaccines that have the same clinical benefit without all the early
clinical work required for an innovator product will be possible in the
near future. But the Waxman-Clinton-Schumer bill is based on 40-year-old
science. And it demands no testing of comparison products before or
after they are marketed. Worse, it dictates to the FDA that the products
must be approved as interchangeable.
    Ironically, the same group of legislators who claim the FDA is
unable to maintain the safety of existing drugs is pushing this
legislation. Indeed, Mr. Waxman claims he is "justifiably skeptical of
any effort to weaken the standards which assure that our food is safe
and our medicines are safe and effective."
    Out of nowhere and not because someone asked them to, Express
Scripts (which manages drug benefits and would benefit from cheaper
biotech products) did a study estimating the savings from follow-on
biologics. In what will be news to most biotech firms, the "study"
assumes that many biotech products have already lost patent protection
and those products will immediately lose market share when the rest of
the products do. The estimated savings over ten years -- $70 billion --
coincidentally adds up to the amount required to expand the child's
health insurance program.
    I wouldn't count on it. The FDA approved a comparison human growth
hormone product called Omnitrope in 2006 based partially on data from
Pfizer's growth product, Genotropin. But Omnitrope also underwent years
of clinical tests. During these tests researchers discovered 60 percent
of children developed infections with Omnitrope. The company had to do
more studies and adjust its production process before it was approved.
Omnitrope was never launched in America. In Europe, it has less than 1
percent of the market.

    Robert Goldberg is vice president of the Center for Medicine in the
Public Interest.


--
Sarah Rimmington
Project Attorney
Essential Action, Access to Medicines Project
Washington, DC
Office: (202) 387-8030 x34
Mobile: (202) 422-2687