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Bush and Big Pharma Team Up to Discredit WHO and Generic Medicines: Drug Companies' Influence on Health Care Policy Worsens Global AIDS Crisis
by Robin Gross, IP Justice (May 3, 2005)


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

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&contenttype=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.

Pharmaceutical Industry Donations & Continuing Medical Education
Pharmaceutical Industry Donations & Policy Think Tanks and Advocacy Groups
Pharmaceutical Industry Support for Patient Groups/Promotion of Prescription Drugs
Pharmaceutical Industry Donations & Charitable Conduits to Doctors
Pharmaceutical Industry Donations & Influencing Prescribing Guidelines

Pharmaceutical Industry Disclosure Practices