Here's another horrific article.

Shows who the players are in working to keep murdering people by
DENYING access to treatment.

        George M. Carter

**
http://www.ipjustice.org/WHO/Report050305.html
IP Justice Report*
Bush and Big Pharma Team Up to Discredit WHO and Generic Medicines:
Drug Companies' Influence on Health Care Policy Worsens Global AIDS
Crisis

By IP Justice Executive Director Robin Gross
3 May 2005

I.  UN/WHO Prequalification Program for HIV/AIDS, Malaria and
Tuberculosis
The United Nations created its prequalification program for essential
medicines in March 2001 to combat the use of low-quality drugs in the
developing world.    Managed by the World Health Organization (WHO)
with support from UNAIDS, UNICEF, UNFPA, and the World Bank, the
project's goal is to facilitate access to medicines that meet
international standards of quality, safety, and efficacy in the fight
against HIV/AIDS, malaria, and tuberculosis.

Through the prequalification program, WHO is able to prescreen the
most urgently needed medicines, saving national drug regulatory
authorities from duplicating the process.  Between 30%-50% of
countries do not have a functional or fully resourced national agency
for approving medicines, so the UN's prequalification program fills a
crucial need to prescreen certain life saving medicines on an
international level in a non-political manner.  Many international
(e.g. Global Fund to Fight AIDS, Tuberculosis and Malaria - GFTAM,
UNICEF) and national aid agencies rely on the list of prescreened
medicines generated by WHO to know which medicines are safe to
purchase for their aid programs.

Under the UN prequalification program managed by WHO, top world health
experts place certain medicines through a rigorous testing and
approval process.  The basic principles for determining the quality of
medicines including fixed-dose combination (FDC) drugs at WHO are the
same as those used by the USA Food and Drug Administration (FDA) and
the European Union National Regulatory Agencies.  Indeed some of the
world's best national drug regulatory authorities participate in WHO
prequalification assessments to set unified international standards of
safety, efficacy and quality for medicines.  Although, some
international health experts contend that WHO's standards for
prequalification are unnecessarily high and restrict the market to
only a handful of drugs that might otherwise serve as suitable
treatment for dying people.

Over 42 million people are infected with HIV around the globe  and
more than half live in sub-Saharan Africa.  According to WHO, only 8%
of those in need receive any medicines at all.  Médecins Sans
Frontières (MSF), a group of volunteer doctors working in the public
interest said that, "due to lack of generic competition, much-needed
second-line medicines are already two to 12 times more expensive than
the most affordable WHO-recommended first-line generics."[1]  The NY
Times reported in 2004 that money shortages and drug patent wars keep
antiretroviral AIDS medicines out of the reach of 90% of the world's
poor who need them to survive.

WHO's prequalification process does not inquire if the medicines
presented for approval are patented or generic versions; and has so
far, prequalified 42 brand name drugs and 61 generics, including
triple combination antiretroviral AIDS medicines.

Fixed-does triple combination AIDS drugs combine into a single pill
three antiviral drugs e.g. stavudine, lamivudine, and nevirapine.  A
regimen of these three medicines purchased separately from patent
holders Bristol-Myers Sqibb, GlaxoSmithKline, and Boehringer-Ingelheim
requires taking 6 pills each day.  Other triple FDCs do exist but are
less used.  The fixed-dose combinations allow people to more easily
take the 3 medicines in 1 pill twice daily.  According to MSF,
combination AIDS drugs cost around US$221 a year for 2 pills a day as
compared to brand name drugs that cost around US$562 a year for 6
pills a day.  The lowest price triple FDC costs US$167 per year
(Aurobindo), but is not yet prequalified by WHO.

In order to meet WHO's rigorous standard for pre-approval, generic
medicines must demonstrate inter alia "bioequivalence," which means
that when they get into the body, their concentration pattern in blood
must be essentially the same as the brand name versions.
Bioequivalence studies are used to prove the therapeutic
interchangeability of generic drugs with originators. International
consensus among health experts is that good quality generics are just
as safe and efficacious as the 4-5 times more costly brand name drugs.

Medical journal The Lancet published a report in July 2004 that
further, "documented the quality, safety, and effectiveness of a
generic fixed-dose antiretroviral combination in an African
setting."[2]  The French National Agency for Research on AIDS (ANRS)
concluded that its study's results, "lend support to the use and
funding of generic fixed-dose combinations as first-line
antiretroviral treatment in developing countries."  A year earlier,
the safety and effectiveness of generic antiretroviral drugs regimes
was established in an Indian setting.[3]

Considering health care professionals' acceptance of generic medicines
and their ability to treat tens of millions more people than expensive
brand name drugs, it is no wonder that much of the developing world is
eager to obtain access to generic medicines in their battle against
AIDS and other diseases.

II.  US Attack on WHO Prequalification and Generic Medicines

A.  US Pharmaceutical Industry Funded Misinformation Campaign

The US pharmaceutical industry has adopted the strategy of using "junk
science" to discredit public confidence in generic medicines in order
to create greater profits for the major pharmaceutical companies
selling brand name patented drugs.

The US pharmaceutical companies' misinformation campaign on the safety
of generic medicines represents its latest attempt to steer profits
toward brand name drugs after it failed largely (but not completely)
to use patent rules under international trade agreements to accomplish
this objective earlier.

Like many large industries, the powerful US pharmaceutical industry
has enjoyed a long tradition of corporate lobbying to influence public
policy choices in its favor.  For example, one of the industry's most
successful tactics has been to fund "research institutes" that
commission "pseudo scientific" studies or publish articles to advocate
for public policies that promote the industry's profit interests.  A
real world consequence of the pharmaceutical industry funded
misinformation campaign is that it creates confusion among developing
country regulators and AIDS patients.  False attacks on the safety and
quality of generic medicines leads to prejudice against generics,
which can become enshrined in national drug policies to the detriment
of public health.  For example, according to experts at the Global
Fund, despite health officials' approval of generic medicines, Romania
and Chile instituted national drug policies to only purchase brand
name drugs, drastically reducing the number of patients that can be
treated.

Often emotionally charged terms like "copy cat", "knock-offs", or
"pirated" are employed to describe and discredit generic medicines.
But legally speaking, generic medicines are not violators of
intellectual property laws; they are totally legal where they are
produced.  

Generally, patent laws are national, so the legitimate extent of reach
of a drug patent is its nation's borders, although some countries have
agreed to enforce each others' drug patents through agreement.  But
international treaties allow for national laws that permit the
manufacture and importation of generic versions of patented medicines
under compulsory licenses.  So attempts to characterize generic
medicines as illegal or unethical are themselves disingenuous and
false. Moreover, it has to be realized that there is nothing common
between patent laws and science about the medicines quality, safety
and efficacy. It is mostly a commercial rather than scientific issue.

1.  Eudoxa and American Enterprise Institute Invent "Scandal" at WHO

In August 2004, Swedish-based special interest advocacy organization
Eudoxa issued a press release calling for WHO Director-General J.W.
Lee to resign because of its de-listing of several prequalified
generic medicines.  Eudoxa is a for-profit business that was
incorporated in Stockholm in 2000 and is run by five people, none of
whom are health care professionals.  Most international health experts
agree that WHO's de-listing of certain medicines pending proper
documentation demonstrates that the WHO prequalification program has
been successful in promptly handling data discrepancies posing
potential public health risks. Yet the pharmaceutical industry sought
to capitalize on WHO's de-listing by characterizing it as a "scandal"
through companies such as Eudoxa who unjustifiably urged the
resignation of WHO Director-General Lee.  If the industry had been
consistent in the light of recent Vioxx "scandal" it had to demand US
FDA Commissioner resign as well.  Notably, US FDA did not take
proactive actions in this case whereas WHO did.

Eudoxa claims to actively collaborate with the Brussels-based
organization Centre for a New Europe, which maintains close ties to
the Bush White House.  Eudoxa is also closely connected with the
International Policy Network (IPN), who's stated mission is to
establish and support right-wing think tanks internationally, to
organize policy conferences and campaigns, and to plant articles in
the media.  IPN mainly advocates against environmental protections,
but also campaigns on health care, intellectual property rights
(arguing against the parallel importation of patented medicines), free
trade, and sustainable development policies.

The conservative American Enterprise Institute for Public Policy
Research has also been active in perpetuating the misinformation
campaign to discredit the WHO prequalification program and generic
medicines.  In particular, IPN's Director from 2001-2003, Mr. Roger
Bate, now a fellow at AEI, published a number of misleading articles
that promote brand name drugs and undermine the UN's prequalification
project for approving generics.  In one article, Mr. Bate attacked the
international aid organization Médecins Sans Frontières, accusing MSF
of being "adept at manipulating the WHO into following certain
approaches and practices."[4]  Advocating that the US government
should only purchase brand name patented drugs, Mr. Bate argues,
"brand-name drugs are of high quality.  But generics are a different
matter."[5]

Building upon sister organization Eudoxa's meme, IPN recently upgraded
WHO to "scandal-plagued" in the latest media attacks on generic
medicine where Mr. Bate labeled WHO as a "dismal failure."[6]  IPN's
media campaign criticizes WHO's "widespread use of knock-off AIDS
drugs" and even calls into question continued public funding of WHO.

Like IPN, AEI is closely linked to the US "right wing" politically and
to corporate giants financially.  AEI was founded in 1943 and is
dedicated to spreading a conservative ideology including limited
government, private enterprise, and strong national defense.  In 2000,
AEI's annual budget was $17 million, mostly from corporate
contributions and donations from conservative family foundations.

AEI personnel include a number of heavy-weight Republican insiders. US
Vice-President Dick Cheney's wife, Ms. Lynne Cheney, is a Senior
Fellow with AEI; as is former Speaker of the US House Republican Newt
Gingrich, and rejected Reagan Supreme Court nominee Robert Bork.
Alumni of AEI include former US President Gerald Ford, former US
Secretary of State George Schultz, and conservative US Supreme Court
Justice Antonin Scalia.

2.  Conservative "Think Tank": the Hudson Institute

Sharing a number of conservative Board Members with AEI is perhaps the
most persistent campaigner against generic medicines, the powerful
Indiana based Hudson Institute, a hard right-wing activist "think
tank" and publicity firm established in 1961.

According to financial information published in the Hudson Institute's
Annual Reports, the pharmaceutical industry is one of its main
financial supporters.  Besides large cash donations, annual reports
reveal that drug company executives have consistently sat on the
Hudson Institute's Boards of Directors and Trustees and oversaw its
policy development on health care issues.

The Hudson Institute's stated mission is "to educate policymakers and
opinion leaders."  It advertises its services by claiming that "our
scholars regularly contribute to major publications … [and] our policy
experts frequently appear on major television networks throughout the
world …".  Or to put it in other words, "your company's position or
perspective can appear in the major press as 'objective news' if you
hire the Hudson Institute to 'spin' it."

Notably, the Hudson Institute is same special interest advocacy group
that was hired by the tobacco lobby decades ago to write and publish
articles that would create confusion over the negative health care
effects of cigarette smoking.  Now, the Hudson Institute employs the
same strategy of public misinformation to discredit affordable generic
medicines in order to increase the sale of patented drugs to the
benefit the US pharmaceutical industry.

Recent tobacco-related litigation has uncovered key insider documents
detailing the interaction and close relationship between the tobacco
industry and US policy research/advocacy organizations.  As early as
1971, the Philip Morris Corporation hired the Hudson Institute to
create and promote "junk science" in an attempt to "debunk" the
negative health effects of tobacco.  One recently discovered hand
written document discusses strategies for fending off critics,
including using "politicized science" designed to "create doubt in the
eyes of the public  in science; in politics; in risks," of cigarette
smoking.  A Hudson Institute report was one of two reports that were
recommended for commissioning in the tobacco industry's secret
document to promote it junk science.  For decades, joint projects
between Philip Morris and the Hudson Institute were often
made-to-order.  Characterized as "scientific lobbying", the Hudson
Institute's strategic model of influencing public policy is intended
to "communicate [with] scientists," to "work the 'walls' of
[scientific] meetings," and to "influence protocols of new
research."[7]  The special interest group is even known to have used
this same strategy on behalf of the agri-chemical lobby (another major
funder of the Institute) to discredit the safety of organic food.

The Hudson Institute also relies heavily on its personal and
professional contacts in politics and private industry, which exist at
the highest levels.  Its Board of Trustees includes a number of famous
conservative political figures including Dan Quayle, Richard Perle,
Conrad Black, and Rudy Boschwitz, a major G.W. Bush campaign
fundraiser.  Other Hudson Board Members have included Alexander Haig,
Allan Hubbard (former Bush classmate and another major fundraiser),
the President of the US Chamber of Commerce Thomas Donahue, and
Chairman of the Republican-affiliated Washington, D.C. lobbying firm
Bergner Bockorny, Jeffrey Bergner.  Senior Fellows at Hudson have
included former US Secretary of Education William Bennett, CNN editor
Ed Turner, and conservative politician Pierre Du Pont.  Of the 35
board members, 17 are the current or former heads of major US
corporations.  

Pharmaceutical companies such as Eli Lilly have been consistently well
represented on Hudson's Board of Trustees and Directors.

In 2002, the Hudson Institute's budget was about $7 million.  Since
2000, the Hudson Institute's Annual Reports show major funding from
pharmaceutical corporations including Eli Lilly, Merck, Novartis,
Pfizer, Bristol-Myers Squibb, and the powerful lobby group, the
Pharmaceutical Research and Manufacturers of America (PhARMA).  Other
large financial supporters of the Hudson Institute have included major
oil and agro-chemical corporations and ultra-right-wing family
foundations.  The Hudson Institute's program areas and policy
initiatives overlap with its corporate donors' financial interests.

According to IRS forms, the Institute's Senior Fellows are paid
between $100,000 - $200,000 to engage in "pseudo scientific" research
and advocacy.

Wife of advisor to US President Reagan, Ken Adelman, Ms. Carol C.
Adelman joined the Hudson Institute in March 2000 as a research fellow
and promoted the pharmaceutical industry's cause in both Congress and
public opinion.  Ms. Adelman has since published a number of
misleading articles condemning generic medicines and attacking the WHO
prequalification program.  The Wall Street Journal published one of
her advocacy pieces on 9 December 2004 that accuses the WHO and MSF as
having "endangered almost as many with their strategy of using
unproven and outmoded drugs in developing nations to combat AIDS and
malaria."[8]  The industry-funded lobbyist contends that these
"outmoded knockoff AIDS drugs … can kill in other ways."

Like the articles planted by IPN and AEI, the Hudson Institute claims
concern for the safety of AIDS patients taking generic medicines,
while the policies it promotes means that AIDS drugs will never reach
African patients.  According to MSF, "like arsonists masquerading as
firefighters, Ms. Adelman's Hudson Institute and other industry-funded
groups pretend to have the best interests of the patients at heart
while treating their needs with contempt and blatantly disregarding
medical ethics and evidence-based science.  People with AIDS need
affordable and effective treatment, not massive disinformation."[9]

In her "research," Ms. Adelman has consistently denied that drug
patents can create a health problem for developing countries,
dismissing such concerns as "the global health babble."[10]  The
Hudson Institute published a report in 2004 that claimed that generic
AIDS drugs are more expensive than brand-name patented drugs.[11]
Since the report was funded by the US pharmaceutical industry and made
claims that fail to pass the "giggle test", no one took the report
seriously.  But since the industry promoted it heavily in the media,
MSF issued a response, "the Hudson Institute's report is not credible"
and published a detailed statement that refuted the pharmaceutical
lobbyist's claim.[12]

Other Hudson Institute fellows promoting the pharmaceutical industry's
positions have included former New York Lt. Governor Betsy McCaughey,
who stated that generics are "yesterday's drugs" and "favoring
generics over newly developed pharmaceuticals is bad public
policy."[13]  And Mr. Jeremiah Norris, another outspoken Hudson
Institute fellow, recently stated that WHO is "assisting in the
expropriation of private property" for using generic medicines to
address the AIDS epidemic in Africa.[14]  

Like the others advocating on behalf of the pharmaceutical industry,
Mr. Norris fails to mention that international legal rules for drug
patents explicitly authorize the manufacture and use of these
essential medicines.  Nor can drug patents be considered "private
property" in the legal sense, as they are only temporary and limited
monopoly grants intended to further public purposes.  And patent
rights are forfeited under "patent misuse" legal theories as
punishment for abusing a patent grant to the detriment of the public
interest.

In a well-publicized statement from August 2004, the Hudson Institute
demanded that WHO establish a panel to re-evaluate the continuance of
the prequalification project.  Although the statement said that
Eudoxa's demand for the resignation of WHO Director-General Dr. Lee
was "premature and unwarranted," it falsely accused WHO of using
"sub-standard products" that "cast serious doubt on its ability to
pre-qualify AIDS drugs."[15]

Also affiliated with the Hudson Institute, Mr. James K. Glassman's
opinion piece from April 2004, "Bush Critics Imperil Africa's AIDS
Victims," further undermines public confidence in antiretroviral AIDS
therapy.

3. "Tech Central Station" Published by Lobbyists DCI Group

A website that publishes many of the articles that attempt to
discredit generic medicines is Tech Central Station (TCS).  TCS was
started in 2000 by Mr. James K. Glassman, who also runs the American
Enterprise Institute and is affiliated with the Hudson Institute.  TCS
is published by the powerful Washington, DC Republican lobbying firm
DCI Group to promote its clients' causes.  On its website, TCS lists
some of its top corporate sponsors including pharmaceutical giant
Merck and the Pharmaceutical Research and Manufacturers of America
(PhARMA), one of the country's largest and most influential trade
associations.

TCS describes itself as a place "where free markets meet technology,"
which ironic since TCS publishes articles calling for stronger
government monopolies on who can make medicines.  With close ties to
the Bush White House, DCI Group is able to advance its corporate
clients' agendas in government; and DCI Group can also promote its
clients in the media through TCS and other outlets.  Before starting
TCS, Mr. Glassman published a financial column for the Washington
Post, but the publication ended the relationship due to his conflicts
of interest.

DCI Group is known to fund a number of right-wing think tanks, issue
advertisements, and fake citizens groups to promote its clients'
agendas.  It is linked to a number of industry-funded coalitions that
pose as grassroots organizations and steer public policy choices
toward the interests of its clients.   Through TCS, the pharmaceutical
industry is able to publish "news" and "analysis" under the appearance
of a neutral third party that falsely claim generic medicines are
unsafe.

B.  US Protectionist Policy Undermines Global Public Health

1.  Lack of US Funding and Technical Support for WHO

The Bush Administration has slashed funding and refused other
desperately needed support for the UN's prequalification program and
the global fight against AIDS.  Although the US Congress appropriated
$550 million for the Global Fund to Fight AIDS. Tuberculosis and
Malaria in 2005, the Bush Administration reduced funding to only $200
million. The Global Fund money has never been used to support WHO
prequalification but has been used to procure medicines that have been
prequalified by WHO.

The US has never supported the UN's prequalification program, either
financially or through human resources.  European, Canadian,
Australian, and Swiss drug regulatory agencies have sent the bulk of
scientists to make the WHO prequalification assessments solid.

One of WHO's biggest obstacles is raising the funds it needs to carry
out its global health care mission.  Health care leaders worry that
the US government is intentionally trying to politically and
financially hamstring WHO into becoming an ineffectual organization.

Unlike other major national drug regulatory agencies, the US FDA is
not allowed to participate in WHO's prequalification program by
providing technical expertise or other support.  According to a WHO
spokesperson, individuals within the FDA have volunteered to work with
WHO to approve medicines, but the Bush Administration sent
instructions that the FDA officials not cooperate with WHO.

The Bush Administration also refuses to provide any financial support
for the WHO's "3x5 program", an effort to treat 3 million AIDS
patients in developing countries by the end of 2005.  Some health care
experts question whether the US' refusal to financially support the
"3x5 program" is in direct retaliation for WHO's approval of several
fixed dose combination medicines.  WHO's approval of generic AIDS
medicines cuts into the desired profits of one of US President Bush's
major financial supporters, the US brand name drug industry.

2.  US President's Emergency Plan For AIDS Relief (PEPFAR)

At his 2003 State of the Union Address, US President George W Bush
announced his plan to spend $15 billion over the next 5 years to
prevent AIDS and provide care and treatment for those infected with
AIDS.  But the US President's Emergency Plan For AIDS Relief (PEPFAR)
is most accurately summarized as corporate protectionism for promoting
brand name drugs, a blind disregard for international consensus on the
safety of generic medicines, and unilateralist action on the global
stage.

Rather than support existing international aid efforts such as WHO,
President Bush's plan seeks to duplicate effort and establish new
bureaucracies to make it difficult to purchase generic medicines.

Despite the international consensus to the contrary, the Bush
Administration maintains its opposition to generic medicines as an
issue of drug safety, even though the WHO prequalification process is
just as rigorous as the FDA approval process and some say more
stringent.   It is well known that the pharmaceutical lobby was among
the Bush Administration's largest campaign contributors.  Undoubtedly,
PEPFAR will direct much of the $15 billion public funds back to
certain drug companies.

According to the Health Global Access Project (Health GAP), if the
Bush Administration purchased WHO-approved fixed-dose generic AIDS
medicines, it could treat four times the number of patients and reduce
the number of daily pills from 6 to 2.

US Ambassador Randal Tobias, former CEO of US pharmaceutical giant Eli
Lilly, and now head of the new US State Department Office of the
Global AIDS Coordinator, argues that the Bush Administration has
concerns over the quality, safety and effectiveness of the drugs,
which have not been approved by the US FDA.  Global health experts
charge that US Ambassador Tobias has consistently undermined
international quality standards set by the WHO and wrongfully claimed
that providers of triple combination AIDS medicines in developing
countries may be endangering the lives of their patients.  Ambassador
Tobias' persistent questioning of the quality of generic
antiretroviral medicines in the face of international consensus to the
contrary raises further questions about whether the Administration's
close ties with the pharmaceutical industry negatively influences
global AIDS policy.

The US Congress called a hearing on PEPFAR's prescription drug policy
on March 4, 2004 where US Congresswoman Barbara Lee (D-Cal) told US
Ambassador Randall Tobias that she was concerned about the program's
inability to use "generic medicines including fixed dose combinations
as a way to reduce costs and to increase drug adherence rates and in
resource limited settings."  Congresswoman Lee told the Bush
Administration's AIDS tzar, "we should be utilizing the existing drug
recommendations of the WHO, rather than seeking to reinvent the
wheel."

Responding to growing international criticism, the FDA announced a
special approval process for generic drugs in May 2004, and approved a
single triple combination AIDS medicine in 2005.  AIDS and health
advocates decry the new FDA approval process as wasteful for
duplicating the existing work of WHO health officials by those with no
experience in developing countries.  US Congressman Waxman said he was
"disappointed that [Bush's] plan does not involve cooperation with the
World Health Organization."

Procurement rules for the US Agency for International Development
(USAID), which actually disperses the funds for the Administration's
program, state that when purchasing medicines, the US must be the
"preferred source and origin" of the drugs.  Under the purchasing
rules, "exceptions to the US source/origin rule cannot be made if the
pharmaceutical product is covered by a current US patent unless
'express authorization' is obtained from the patent holder.  This
requirement cannot be waived."  This USAID policy will ensure that
PEPFAR becomes a giant slush-fund for the US pharmaceutical industry
with little money spent on more affordable generics.

Indeed a draft report by US Congressional investigators from the
Government Accountability Office found that the US government is
paying double the cost for many of the medicines in its global AIDS
program, as compared to other international aid organizations.  The
October 2004 report was the first independent comparison of AIDS drug
prices internationally.  The report blamed the Bush Administration for
refusing to buy less expensive generic versions of medicines and said
the cost difference means that President Bush's $15 million global
AIDS fund will not be able to treat as many people as it might
otherwise.

The Bush Administration has further learned that PEPFAR's "donation"
of AIDS drugs to needy developing nations can also be useful in
extracting much desired, and completely unrelated internal policy
"choices" from these countries.  For example, in order to receive AIDS
medicines under PEPFAR, the US secretly imposed a condition that any
recipient country must promise to never exercise its legal right to
take any US military personal to international criminal court for
their wrongdoings.  During PEPFAR's first round of grant negotiations,
the African nation of Lesotho refused to agree to this term, so the
country was not included in PEPFAR's initial group of medicine
recipients.

3.  US Organization of "Health" Meeting to Question Prequalification

The Bush Administration called for a meeting of health officials in
Botswana in 2004 to re-open the debate on the safety and efficacy of
generic fixed-dose combination AIDS medicines.  International health
care experts warned that the move was really an attempt to undermine
the UN/WHO prequalification process and discredit generic medicines.
The final Botswana meeting was widely criticized by international aid
organizations (including the Catholic Relief Services Consortium) for
ignoring established science that accepts generics.  At the Botswana
meeting, it seemed that the US aimed to propose new standards for WHO
prequalification of medicines that were even more stringent than the
FDA rules.[16]  But not only did the meeting fail to discredit generic
medicines as hoped, it also fueled a growing international backlash
against US global AIDS policy.  Richard Holbrooke, CEO of the 140
multinational Global Business Coalition on HIV/AIDS, even criticized
the move, saying that the Bush Administration's protection of the
pharmaceutical industry was "tearing apart all the good work that
people are doing" to fight AIDS.

Hundreds of signatories of a March 26, 2004 letter to the
Administration's AIDS Tzar, former Eli Lilly CEO Randall Tobias, said
the real purpose of the Botswana meeting was to "justify the use of
expensive, more complex branded treatment regimens" and to promote the
Administration's "efforts to use bilateral assistance programmes to
lock generics out of developing countries."  Over 300 international
organizations including Amnesty International, Physicians for Human
Rights, Médecins Sans Frontières, and Oxfam signed the letter in
protest of a political meeting, thinly disguised as a scientific
meeting.

In a bi-partisan effort, US Senators Edward Kennedy (D-Mass) and John
McCain (R-Ariz.) sent a joint letter to US President Bush "strongly
urging" him to reconsider his policy and accept WHO-approved generics.

In a separate March 26th letter to Bush, US Congressman Henry Waxman
(D-Cal), the second ranking Democrat on the House Energy and Commerce
Committee said adopting the US' Botswana proposal would be a "tragic
mistake" because it would "impede access to the low-cost drugs needed
to save the lives of millions of people living with HIV in developing
countries."  Representative Waxman said the Bush Administration was
"trying to set standards for Indian generics higher than those" for US
made equivalents.   Representative Waxman told President Bush, "these
pharmaceutical companies are among your strongest political
supporters, having contributed US$40 million to your political party
of the last 5 years.  They should not be dictating policy on US
efforts to fight HIV/AIDS in Africa and elsewhere."

It is likely that the international attention and support to WHO
resulted in the final outcome of Botswana meeting being not different
from the basic principles that WHO used to prequalify the triple FDC.
Thus, the question remains what was the real purpose of this exercise
and whether the reasons of having it had more complicated background
than it is perceived.

4.  US Measures Against WHO and Generics at 2004 WHO General Assembly

i.)  US Opposes "Expanding" Prequalification Project and "Inexpensive"
Medicines in General Assembly Resolution

The lack of US support for the UN/WHO prequalification program is
widely known.  But it was never so apparent as at the 57th Annual
World Health Assembly in May 2004, when the US delegation opposed
language in a General Assembly Resolution requesting that the Director
General "expand" the UN/WHO prequalification project.  As a result,
the language to expand the project quietly disappeared from the
proposed resolution overnight.[17]  The Bush Administration's
delegation to the meeting, led by former drug company CEO Ambassador
Tobias (now under consideration for heading up the World Bank), also
successfully opposed language in the resolution that would have
promoted access to "inexpensive" drugs.

ii.) US Delegation at General Assembly Consists of Pharma Lobbyists
and Conservative Politicians

Included in the official US governmental delegation to the 57th WHO
General Assembly meeting in May 2004 were three representatives from
the pharmaceutical industry funded "think tank," the Hudson Institute,
including Ms. Carol Adelman.  International health experts complain
that the US delegation at the WHO General Assembly did not consist of
health care practitioners, and instead included mainly members of the
pharmaceutical lobby or "ultra-right-wing" politicians like William R.
Steiger.

Godson of former US President George HW Bush, William R. Steiger, 34,
serves as the special assistant to the US Secretary of Health and
Human Services, and has polarized the department.  William Steiger's
father was a prominent Wisconsin Republican Congressman who gave US
Vice-President Dick Cheney his first political job.

Fresh out of college and without any health care or medical
experience, the younger Steiger, was soon named as Tommy Tompson's
representative to the WHO board and as an advisor on global AIDS
policy for the Bush Administration.

Dr. Steiger has been criticized for running the HHS Department and his
Office of Global Health Affairs with an "iron fist", stifling
scientists and squeezing academic freedom with bureaucratic control.
Dr. Steiger has angered AIDS activists by opposing generic medicines
and with his strict enforcement of the Bush Administration's policy to
emphasize sexual abstinence in AIDS prevention programs.  At the July
2004 AIDS Conference in Bangkok scientists and policy makers stated
that the Bush Administration's policy of promoting abstinence over
condoms was a major setback in the global fight to control the
disease.

According to Science Magazine, Dr. Steiger advocated new policies at
the department that were quickly labeled pro-industry.[18]  For
example, in May 2001 he ordered HHS civil servants who had been
negotiating the US position on a treaty to curb tobacco smoking, to
suddenly change course from endorsing the treaty, and instead oppose
the treaty's restrictions on tobacco and any new tobacco taxes.

Dr. Steiger was a top member of the US delegation at the 2004 WHO
General Assembly meeting that opposed expanding WHO's prequalification
and inexpensive medicines.  At the meeting, the Bush Administration
official was accompanied by representatives from the Hudson Institute,
who advised the General Assembly's drafting committee member from the
US.

iii.)  World Leaders Condemn Use of "Free Trade" Deals to Prevent
Generics

Rules under the World Trade Organization (WTO) confirm countries'
right to issue compulsory licenses to permit the manufacture or import
of generic versions of patented medicines.  But the Bush
Administration pressures developing countries to adopt bilateral "free
trade" agreements, which then force them to relinquish these
development safeguards and prevent their access to generic medicines
in times of emergencies.

World leaders including French President Jacques Chirac have sharply
criticized the US policy of using bilateral trade agreements to
circumvent WTO legal safeguards that ensure poor nations can access
life-saving medicines.  In a statement at the July 2004 International
AIDS Conference in Bangkok, Chirac said that the policy of forcing
developing countries "to drop these measures in the framework of
bilateral negotiations would be tantamount to blackmail."

The WHO General Assembly Resolution from May 22, 2004 "urges Member
States, as a matter of priority … to encourage that bilateral trade
agreements take into account the flexibilities contained in WTO TRIPS
Agreement and recognized by the Doha Ministerial Declaration of the
TRIPS Agreement and Public Health…"

In earlier negotiations, the US Trade Representative's Office failed
to obtain certain measures into TRIPS that would have limited its
flexibilities to use generic medicines.  Now the US strategy for
inducing foreign nations to change their drug patent laws is called
"competitive liberalization."  This "divide and conquer" strategy has
proven effective in overpowering developing countries through
bilateral "free trade" agreements that force the much desired changes
in foreign countries' laws.

Although Thailand has emerged as world leader for tackling its AIDS
epidemic by providing triple combination generic medicines, Thailand's
ability to continue providing affordable drugs is now under threat
from a proposed "free trade" agreement with the US.  In March 2002,
when the Thai Government Pharmaceutical Organization began making the
3 medicines in 1 pill, the cost dropped from $500-$750 per person for
monthly treatment to only $30 per month, per person.

Despite this enormous progress in treating its AIDS population,
Thailand is now forced into high stakes negotiations with the Bush
Administration over the right to use generic AIDS medicines at all.
Talks in the US  Thailand "Free Trade" Agreement (FTA) began in June
2004 and are scheduled to conclude in 2005.  The proposed FTA contains
similar terms regarding drug patents that Singapore and Latin American
countries have faced in recent FTA's with the US.

Under the current proposal, both the US and Thailand would be required
to increase the number of years that a pharmaceutical company can
patent a drug to 25 years.  Such an extended term goes beyond current
international trade rules of a 20-year patent term.

Besides the increased health crisis that accepting these terms will
cause in Thailand over its ability to treat its AIDS sufferers, the
agreement would also harm patients in neighboring poor countries such
as Burma, Laos, and Cambodia, who rely on Thailand's supply of generic
medicines.

In a move that would extend the monopoly of US pharmaceutical
companies, the US also requires that test data on medicine be kept
secret under the "free trade" agreement.  And the agreement would
lower the standard for treating an intellectual property violation as
a criminal offense for which imprisonment can be imposed, instead of
as a civil offense.

The overwhelming desire for access to affluent US consumers gives
developing countries virtually no bargaining power against the US when
the Bush Administration decides it wants to conclude a trade pact with
another country.  And negotiators in foreign state departments have
learned that they can obtain many favored protectionist provisions of
their own in exchange for accepting the US's rules on intellectual
property rights in bilateral deals.  The Bush Administration continues
to increase pressure on developing countries, despite the WHO General
Assembly Resolution that condemned forcing developing countries,
through bilateral trade deals, to relinquish their legal rights under
TRIPS Doha safeguards to produce generic medicines.

III.  Partnership Between Big Pharma and Bush Administration Worsens
Global AIDS Crisis

The coordinated activity and close business ties between the
pharmaceutical industry, the Bush Administration, and "news makers"
such as those at the Hudson Institute or Tech Central Station can have
a powerful effect on discouraging generic medicines.  

For the millions of people living with AIDS in poverty stricken
countries, access to generic medicines is a matter of life or death.  

The $15 billion President Bush promised to fight AIDS could treat 4-5
times as many people if the funds are used to purchase generic
medicines.  But that is unlikely.  The US pharmaceutical industry
maintains a tight association with the hard-right wing of the
Republican Party and on Bush's health care policies such as favoring
sexual abstinence while de-emphasizing condom use, and discrimination
against generic medicine in favor of expensive patented drugs.

The pharmaceutical industry's ability to purchase misinformation
campaigns and policy initiatives that favor patented drugs grossly
distorts public health policy for the worse.  There are real world
consequences when millions of sick people are unable to obtain
medicine because drug patents keep the price of the medicine out of
reach.

The marriage between the pharmaceutical industry, public relations
firms, and the Bush Administration reveals how deeply corruption has
become part of the fabric of health care policy making.

The Bush Administration's eagerness to squeeze developing nations
into signing free trade agreements that prevent them from providing
medicine to AIDS patients is a misguided policy objective motivated by
greed.  It is a dangerous sign of how far democracy has degraded when
health care policies are set by the profit interests of large drug
companies at the expense of AIDS patients, and US officials refuse to
acknowledge science in order to promote the products of campaign
contributors.

The global health crisis demands change.  We need government health
officials with training and experience in providing health care and
who consider the health of the patient as the primary interest to be
served.  We need more doctors and fewer politicians evaluating and
purchasing medicines.  We need more disinterested scientists and fewer
drug company CEOs setting global health care policy.  We need AIDS
policies based on science, rather than profit and conservative
political ideology.

*  IP Justice thanks CPTech (www.cptech.org) for a small contribution
to support IP Justice's efforts to monitor the WHO prequalification
process.

[1] "MSF: Global AIDS Treatment Efforts Not on Track" January 27,
2005, available online at
http://www.accessmed-msf.org/prod/publications.asp?scntid=2712005231239&contentt
ype=PARA&
[2] Laurent, C, Kouanfack, C, et al. "Effectiveness and Safety of a
Generic Fixed-Dose Combination of Nevirpapine, Stavudine, and
Lamivudine in HIV-1-Infected Adults in Cameroon: Open-Label
Multicentre Trial," Vol 364, The Lancet 3 July 2004.  Available online
at http://www.thelancet.com/journal/vol364/iss9428/contents
[3] Kumarasamy N, Solomon S, Chaguturu S, et al. "The Safety,
Tolerability and Effectiveness of Generic Antiretroviral Drug Regimes
for HIV-Infected Patients in South India," AIDS 2003; 17:2267-69.  
Available online at
http://www.thelancet.com/journal/vol364/iss9428/contents
[4] "Are All Generic Drugs Equal?" By Roger Bate, Tech Central
Station, 28 October 2003.
[5]  "Will US Opt for Copies or Generics? Bush AIDS Plan" By Roger
Bate, Business Day, 30 October 2003.
[6]  "WHO Needs Reform, Not More Money" By Roger Bate, Star Tribune,
19 October 2004.  See also "Unsound Generic AIDS Vaccines Have Caused
Untold Misery to Millions" By Roger Bate, Telegraph Online, 6 December
2004.
[7] "Third Party Corporate Advocacy" Case Study No. 2: Philip Morris
Co. and the Hudson Institute
[8]  "Deadly Medicine" By Carol Adelman, The Wall Street Journal, 9
December 2004.
[9]  "Carol Adelman's Claims About Generic AIDS Medicines Are
Deliberately Deceptive and Dead Wrong" by Medecins Sans Frontieres
International Council President Dr. Rowan Gillies, 14 December 2004.
[10]   "Patent Falsehoods" By Carol Adelman and Jeremiah Norris,
American Outlook, Spring 2003.
[11]  "Myths and Realities on Prices of AIDS Drugs" By Carol Adelman,
Jeremiah Norris, S. Jean Weicher, The Hudson Institute 2004.
[12]  "Medecins Sans Frontieres Responds to Hudson Institute Report on
Drug Prices" [date 2004].
[13]  "Hidden Costs of Generic Drugs" By Betsy McCaughey, American
Outlook Today, 23 July 2002.
[14]  "What's Mind is Mine; What's Yours is Negotiable" By Jeremiah
Norris, Tech Central Station, 12 August 2004.
[15]   "World Health Organization Must Establish Panel to Restore
Agency's Reputation, Salvage Global AIDS Treatment Programs" By Carol
Adelman and Jeremiah Norris, The Hudson Institute, 26 August 2004.
[16] "Scientific and Technical Principals for Fixed Dose Combination
Drug Products"
[17] Comparison of text of draft AIDS/HIV Resolution A57/A.Conf. Paper
No.3 Rev.1, 20 May 2004 with the final WHO General Assembly Resolution
WHA57.VR/8 on 22 May 2004 reveals the deletion of phrase "and
expanding" after the word "strengthening" WHO's prequalification
program in its request to Director General.
[18]  "The Man Behind the Memos: US Official William Steiger has been
criticized for making life harder for scientists in international
health research and policymaking.  He says he has strengthened the
field," Vol. 305 Science Magazine, 10 September 2004.


TABLE OF CONTENTS
I.   UN/WHO Prequalification Program for HIV/AIDS, Malaria and
Tuberculosis Medicines
II.  US Attack on WHO Prequalification and Generic Medicines
    A.  US Pharmaceutical Industry Funded Misinformation Campaign
        1.  Eudoxa and American Enterprise Institute Invent "Scandal"
at WHO
        2.  Conservative "Think Tank": the Hudson Institute
        3. "Tech Central Station" Published by DCI Group
    B.  US Protectionist Policy Undermines Global Public Health
        1.  Lack of US Funding and Technical Support for WHO
        2.  US President's Emergency Plan For AIDS Relief (PEPFAR)
        3.  US Organization of "Health" Meeting to Question
Prequalification
      4.  US Measures Against WHO and Generics at 2004 WHO General
Assembly
            i.)  US Opposes "Expanding" Prequalification Project and
"Inexpensive" Medicines in General Assembly Resolution
            ii.)  US Delegation at General Assembly Consists of
Pharma Lobbyists and Conservative Politicians
            iii.)  World Leaders Condemn Use of "Free Trade" Deals to
Prevent Generics
III.  Partnership Between Big Pharma and Bush Administration Worsens
Global AIDS Crisis