[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
Letters to Clinton and Binder Re: EPO
I have had requests to to the text of the letters Ralph Nader and CPT
sent to President Bill Clinton and Gordon Binder (Chairman of the Board
and Chief Executive Officer of Amgen), regarding Amgen and EPO. Here
they are. Jamie
Ralph Nader
P.O. Box 19312
Washington, DC 20036
Ralph@essential.org
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
202.387.8030, love@cptech.org
http://www.cptech.org
April 16, 1998
President Bill Clinton
The White House
Washington, DC
Dear President Clinton:
We are writing to ask for an investigation concerning the possible
suppression of an important public health invention. In this respect we
are attaching copies of our April 16, 1998 letter to Gordon Binder,
Chairman of the Board and Chief Executive Officer of Amgen Inc., the
company which currently markets EPOGEN® which is Amgen's trademark for
its recombinant human erythropoietin, or EPO.
Our concern is the following. Public health researchers, supported by
public funds, have identified a mechanism to reduce a patient’s loss of
EPO during treatment, significantly reducing the amount of EPO a patient
needs to take. This invention has the potential to save consumers
hundreds of millions of dollars per year, and to make EPO more broadly
available to patients who cannot currently afford the drug.
The invention was developed at Lawrence Berkeley Laboratory (LBL), a
national laboratory, and was supported by grants from the National
Institutes of Health (NIH). According to the inventor and LBL officials
involved in attempts to commercialize the invention, Amgen was
approached several years ago about research which would solve an
important problem in treating patents for anemia – the natural discharge
of EPO into the urine which requires patients to take large doses of
EPO. This problem is particularly important for patients with immature
renal systems such as infants and children. The LBL invention involves a
protein binding factor which may eliminate entirely the need for the
purchase of EPO for some patients, and for other patents the invention
would reduce the needed doses of EPO. The inventor believes this may
reduce by half the average doses needed for EPO – a very expensive drug
which can cost several thousand dollars.
LBL staff believe Amgen is hostile to the commercialization of this
invention simply because it would significantly reduce demand for EPO --
a product which generated $1.16 billion for Amgen in 1997. Other U.S.
and European biotechnology companies have reportedly expressed concerns
that Amgen would oppose the development of the invention through costly
and time-consuming litigation, and would withhold important intellectual
property licenses from firms which made efforts to commercialize this
invention.
Public health concerns should be paramount in determining which
therapies are available to consumers. Amgen’s EPO product was made
possible by decades of public funded research on EPO, and Amgen has
benefited also from subsidies from EPO’s designation as an Orphan Drug
and other public programs to support the biotechnology industry. Amgen
is currently seeking support from public institutions to obtain
additional intellectual property rights on gene research and EPO.
We are appalled at the reports that Amgen, a company which has so richly
benefited from public research, would not respond responsibly to public
health research that would benefit patients. The fact that the client
population most affected are children underscores the ethical issues
that you must address.
We ask that you investigate every aspect of this matter, to determine if
there are indeed barriers to the development of the LBL invention, and
if so, whether Amgen’s actions run counter to antitrust laws, and also
whether are there are other remedies available to address this issue.
As part of this investigation, we specifically ask that you determine
how Amgen currently benefits from government subsidies to the
biotechnology sector, and if it would be appropriate to withhold
publicly supported intellectual property rights or research support for
a company, if that company refuses to address legitimate and important
public health concerns.
Finally, we ask that the U.S. Patent and Trademark Office, the U.S.
Trade Representative, the Department of Health and Human Services and
the Federal Trade Commission evaluate U.S. positions in trade
negotiations on intellectual property rights, and determine if
provisions on compulsory licensing that exist in the WTO, NAFTA or the
proposed Multinational Agreement on Investments permit governments to
adequately address public health concerns.
We also ask you to consult the World Health Organization (WHO) to
determine what steps if any WHO recommends to address this or similar
public health problems, and we urge the United States to support the
World Health Assembly Executive Board Resolution EBl0l.R24, on the WHO
Revised Drug strategy, that urges member states:
(2) to ensure that public health rather
than commercial interests have primacy in
pharmaceutical and health policies and to
review their options under the Agreement on
Trade Related Aspects of Intellectual
Property Rights to safeguard access to essential
drugs;
We look forward to receiving a response from your office on this matter.
We also invite your staff to attend a meeting on intellectual property
rights and health care that will be held on May 7 and 8, 1998, in
Washington, DC. Information about this event is available on the
Internet at http://www.cptech.org/may7-8.
Sincerely,
/s/
Ralph Nader
/s/
James Love
This letter is on the Internet at http://www.cptech.org/pharm/amgen.html
Ralph Nader
P.O. Box 19312
Washington, DC 20036
Ralph@essential.org
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
202.387.8030, love@cptech.org
http://www.cptech.org
April 16, 1998
Gordon Binder
Chairman of the Board
and Chief Executive Officer
Amgen Inc.
Amgen Center
Thousand Oaks, CA 91320-1789
Via fax: 805/447-1010
We are writing to express our concern over reports that Amgen is opposed
to the development of an invention that significantly reduces the amount
of Erythropoietin (EPO) needed to treat anemia. The invention was
developed at Lawrence Berkeley Laboratory (LBL), which was supported by
the National Institutes of Health (NIH), Lung, and Blood Institute grant
HL 22469, and received U.S. Patent 5625035. According to the inventor,
Gisela K. Clemons, of Berkeley, CA, this dates back to research done in
1991, and the inventor and the LBL have engaged in extensive discussions
with Amgen regarding the significance of the invention, and the benefits
to EPO patients. According to the inventor and LBL officials involved in
attempts to commercialize the invention, Amgen has declined to further
test the invention, and other U.S. and European biotechnology companies
have expressed concerns that Amgen would oppose the development of the
invention through costly and time consuming litigation, and would
withhold important intellectual property licenses from firms which made
efforts to commercialize this invention.
The invention would reduce the amount of EPO needed by patients
suffering from anemia, including premature infants and those with anemia
due to kidney failure, AIDS related illnesses or other diseases, or
surgery needs. According to the inventor, this invention may eliminate
entirely the need for the purchase of EPO for some patients, and for
other patients the invention would significantly reduce the needed doses
of EPO. It is possible that the invention would reduce by half, on
average, the amount of EPO needed by those suffering from anemia.
As you know, the commercial development of EPO benefited from decades of
government funded research on Erythropoietin. Amgen is also expecting to
benefit from government funded research in other areas, and has recently
approached government funded research laboratories for assistance in
further research relating to the use of EPO. Amgen has benefited due to
generous tax credits from manufacturing goods in Puerto Rico, the Orphan
Drug Tax Credit, and the Research and Development Tax credit and from
other government subsidies.
As a result of all these subsidies by taxpayers, Amgen has benefited
richly from the commercial development of EPO, which produced 1997 sales
of $1.16 billion. According to the Amgen 10K report, gross margins on
EPO and Amgen’s other products are greater than 86 percent.
Researchers and licensing officials at LBL believe Amgen is opposed to
the development of the new binding protean technology because such an
invention might reduce by half the average doses of EPO needed by
current anemia patients.
We would like to know from you if Amgen is indeed resisting the
deployment of a valuable public health invention simply to protect the
revenues it receives from EPO patients. If Amgen is not trying to
suppress this invention in order to protect its profits, then what is
Amgen doing to further develop this important discovery?
Sincerely,
/s/
Ralph Nader
/s/
James Love
This letter is on the Internet at http://www.cptech.org/pharm/amgen.html
--
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
love@cptech.org | http://www.cptech.org
voice 202.387.8030, fax 202.234.5176