[Ip-health] NIH Hearing

Fri, 7 Jun 2002 10:18:02 -0400

Following is the text of Congressman Sherrod Brown's opening statement for
yesterday's Commerce Health Subcommittee hearing on NIH funding priorities.
He asked NIH to provide written answers to questions about NIH-funded drug
products and the costs of clinical trials.

"Thank you, Mr. Chairman for holding this morning's hearing, and I want to
thank our witnesses for joining us today.  I want to extend a special
welcome to Dr. Bonow with the American Heart Association.  The Heart
Association has been working with my colleague, Mrs. Capps, on the STOP
Stroke bill.  I am pleased to be a cosponsor, and I hope we will see this
bill enacted into law.

"Congress will double the NIH budget by 2003.  It's rare for virtually all
members to endorse such a large increase in federal spending for one
purpose.  

"But when I think about the constituents I have met over the past 10 years
who rely on the research funded by NIH, doubling the budget is an easy sell.
I have met children who give themselves daily shots of insulin to treat
their diabetes; families who have lost a loved one to Lupus, or heart
disease, or duchenne muscular dystrophy.  I have a constituent in my
district who lost her husband to CJD three months after he woke up with a
headache. 

"Our increased investment at NIH affords even more opportunities to confront
these diseases.  I want to briefly touch on other aspects of NIH's role that
I hope we will devote more attention to during future hearings on NIH.

"I am interested in how NIH responds to a medical need that is not being
addressed by the private sector.  I have been told repeatedly by infectious
disease specialists that one area where such a gap currently exists is in
the development of new antibiotics. 

In April, 2000, FDA approved Zyvox, the first in a new class of antibiotics
to be approved in more than three decades. Yet we desperately need new
antibiotics to fight infectious diseases - like drug-resistant tuberculosis,
pneumococcus, and staphylococcus.  According to the WHO, too few new drugs
are being developed to replace those antibiotics that have lost their
effectiveness. 

"Doctors fighting drug-resistant TB in the developing world tell stories of
returning to antibiotics long ago put aside because of debilitating
side-effects, because the TB bacteria has become resistant to newer drugs.
An estimated 14,000 Americans die of resistant infections each year.  Tens
of millions world wide die of treatable infections.

"Instead of reverting to older drugs with greater side effects, we should be
encouraging drug companies to devote their considerable resources to
antibiotic R & D.   If private drug companies are unwilling to develop these
needed antibiotic drugs, this responsibility may fall to NIH.

"Another area I'm in interested is the role NIH invariably plays in the
economics and allocation of health care in the US.  Ideally, NIH could steer
clear of thorny issues like health care costs and access, and focus
exclusively on producing and supporting medical research.   

"Unfortunately, the agency's technology transfer policies have a direct
bearing on the return consumers receive on their investment in NIH.  When
NIH licenses the patent on an NIH-developed medical breakthrough like Taxol,
the agency's private sector partner is awarded a period of market
exclusivity.  During that exclusivity period, consumers pay monopoly prices
for a drug their tax dollars produced.   How long should the exclusivity
period be?  Affordability and access hinge on NIH driving a hard bargain.
This subcommittee has a responsibility to ensure that NIH is doing that.

"NIH also has the power to break the patent on any product that was
developed with US tax dollars.  That's admittedly a pretty big stick to use
to convince drug companies to stop over-charging US consumers. 

"If prescription drug inflation wasn't a major issue -- if American
consumers weren't paying two and three and four times more than any other
consumer for the same medicines -- I'm sure no one would look at that option
seriously.

"But prescription drug inflation is a major issue, and Americans are paying
more than any other consumer for the same drugs.

"NIH also has information on drug costs that this committee and this country
need.  You know how much it costs to develop a drug, inlcuding the cost of
failures. 

"You have the information necessary to reality-check the drug industry's
claim that R&D costs average $800 million per drug.

"If we want to respond appropriately to the public's outrage at prescription
drug prices, we need to understand how these prices relate to costs.
There's no way around it.  Because this hearing is not focused on the issues
I've raised, I obviously don't expect answers today.   I'll ask for written
responses, and share those responses with the subcommittee.  However, I hope
we can pursue these issues in a subsequent hearing.   

"Again, our investment in NIH is compromised when some Americans are priced
out of access.  Research, access, and costs are linked.  We cannot ignore
that," said Brown.

Congressman Brown will submit the following questions to NIH:

1. Because NIH invests heavily in basic research, the agency directly or
indirectly contributes to the development of most new drugs and biologics.
One way to get a more concrete picture of the US taxpayer's contribution to
commercially marketed drugs is to identify those products in which NIH has
intellectual property rights. (The federal government has intellectual
property rights to all drugs that are directly funded, in whole or in part,
by NIH)

Please provide the committee with a list of all drugs on the market in which
the federal government has intellectual property rights as a consequence of
NIH funding.  Please distinguish those products funded through an extramural
research project from those funded through an intramural research project.

2. Analysts at a Tufts University research center will soon publish a report
claiming that it costs an average of $802 million for research and
development of a new drug.  Approximately $500 million of the $802 million
is assigned to the costs of conducting clinical trials.  The NIH now funds
hundreds of clinical trials for cancer, AIDS and other illnesses.

Please tell the committee how much money NIH spends each year to fund
clinical trials, how many trials this funding supports, and the average cost
per patient for the NIH-funded clinical trials.   Please break this
information down by type of disease.

Given the known risks for Phase I, II and III trials, what does the NIH data
suggest the average cost of clinical trials are for a new drug for cancer,
AIDS or other severe illnesses?

3. Please inform the committee about any efforts by NIH to develop
antibiotics.

4. Are there any research projects underway to develop a new antibiotic to
treat TB?

5. If there are, can you tell the committee when this research began and its
progress?

6. If there are not any research projects on developing new antibiotics for
TB, can you explain why not?

-----Original Message-----
From: James Love [mailto:james.love@cptech.org]
Sent: Thursday, June 06, 2002 2:59 PM
To: ip-health@lists.essential.org
Subject: [Ip-health] EC missive ACCESS TO MEDICINES: BRUNDTLAND AND LAMY
PUSH AHEAD

This is a communication from the Trade Directorate-General of the European
Commission.

Attention:  Mr James  LOVE
            Director
            Consumer Project on Technology ( CPTech )
            USA
    Email:  love@cptech.org

ACCESS TO MEDICINES: BRUNDTLAND AND LAMY PUSH AHEAD

Dr Gro Harlem Brundtland, Director General of the World Health
Organization (WHO), on Thursday met Pascal Lamy, European Union (EU)
Trade Commissioner, to push ahead with the agenda to improve access
to medicines for developing countries.

Dr Brundtland commended Pascal Lamy for the spirit in which he is
conducting negotiations at the World Trade Organization (WTO) on
compulsory licenses for developing countries with limited or no
manufacturing capacity. She and Commissioner Lamy made the following
joint statement:

'WHO and the EU agree that WTO members need to find a sustainable,
balanced, and workable solution for these countries.  In the spirit
of the WTO Doha Ministerial Conference in 2001, the solution should
be applicable in the shortest possible time. The solution should
also be supportive of WTO Members' right to protect public health
and to promote access to medicines for all.

The Declaration on TRIPS and Public Health made at the launch of the
Doha Development Agenda underscores a pro-public health approach in
international trade. In its role as technical adviser on health
issues and access to medical technologies, WHO looks forward to
close cooperation with the EU.

WHO will also seek to co-operate closely, where appropriate, with
WTO and the World Intellectual Property Organization (WIPO) on
technical assistance to developing countries implementing the TRIPS
Agreement along the lines of the Doha Declaration.

Health care providers and consumers in the poorest countries need
the lowest possible prices to make essential medicines affordable to
all. We call for continued efforts by the international community,
research-based companies, and generic pharmaceutical producers to
achieve this on a sustainable basis.

The EU and WHO will continue to analyse the effects of abolishing
tariffs and taxes on medicines imported into developing countries.'

For more details on this topic, go to:

http://europa.eu.int/comm/trade/pdf/med_wd.pdf
http://trade-info.cec.eu.int/europa/2001newround/050-02-rev.pdf
http://europa.eu.int/comm/trade/csc/med.htm

European Commission, Trade DG, Information Unit
Email: eis@cec.eu.int
WWW: http://europa.eu.int/comm/trade
Fax:   +32-2-296-9854
To notify the European Commission of any changes to your contact
details, please quote the following reference number: 59SCS8

--------------------------------
James Love mailto:james.love@cptech.org
http://www.cptech.org +1.202.387.8030 mobile +1.202.361.3040

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