peripheries

Money alone is not going to treat us out of the HIV epidemic

Why HIV “prevention does not work” has been the subject of recurrent discussions during the past weeks. It all started with a thought-provoking article published online by Frontiers in LA, “a one-stop source of content for Southern California’s LGBT community” (welcome to the Ghetto) by Michael Liberatore who wrote that “if pharmaceutical companies were supplying the cash to develop [HIV/AIDS] treatments, couldn’t they just as easily stall the development of newer, less profit-friendly treatments to assure that their bank accounts continue to swell?”

The article is worth reading and raises some serious questions, and though peripheries is no friend of the “Big pharma”, one cannot always agree with the columnist. Nevertheless, the recurring conversation was about the belief that money or drugs will “make prevention work” and “treat us out of the epidemics”.

Indeed, it is not just about money or the Pharmaceutical industry but about how the money is used. PEPFAR with its numerous and often criticised ties is a good example but there are many others. For example, in an interview for the Singapore-based network Fridae.com Jan Wijngarden emphasises some very important issues on how to do prevention in the MSM population which is more vulnerable than other to HIV infection. Wijngarden’s main point is that prevention has to reach those who are supposed to be reached and I would add something often overlooked, that the target need to have a stake in the fight.

When it comes to Africa where AIDS is “hyperpandemic”, bending the arm of the Big Pharma or throwing money at African Governments or local NGOs to buy drugs is one thing, but if there is no supply chain (from road to clinics and to nurses) or even no identified people to treat,or worse, no political will, it won’t work. We often talk about corporate responsibility but what about non-profit responsibility? It is often “implied and obvious” but how accountability is there in the non-profit sector? The one that goes beyond “we have provided ARV to 3 million people” (Are these people still on ARV? Alive? How is their health? Did that change something in their community? What was the impact on a larger scale?). In a paper on the impact of PEPFAR the authors, carefully underlining their own limitations, concluded that “After 4 years of PEPFAR activity, HIV-related deaths decreased in sub-Saharan African focus countries compared with control countries, but trends in adult prevalence did not differ.”

Accountability in the non-profit sector is finally being recognised and emphasised and it needs to be discussed further and translated into something real. Indeed, there are reasons to be afraid and sceptical when reading statement such as “UNAIDS estimates that the funds needed annually to deliver adequate prevention programs to sub-Saharan Africa alone would be approximately US$2 billion”. Lest we forget, several world economists (and rock stars) have been telling us that for some time that we “only” need to put X million dollars in African country Z to lift it out of poverty. 50 years and 3.5 trillion dollars later, the African people are still waiting for this to work. Meanwhile, GAP, Motorola and Armani are making profit selling (Red) branded products and rock stara are lecturing us, tax payers whose contribution to the World Bank and IMF, constitute the largest amount of money given to fight HIV/AIDS in Africa with various level of success.

We really need to think hard, look at what has been done during the last 25 year, probably throw away most of it and start again from the bottom: Who is most vulnerable ? Strikingly, MSM have just been “officially” recognized (or rediscovered) as most-at-risk at the last AIDS Conference in Mexico. What will make people practice safe sex? What will make someone vulnerable come forward to take an HIV test? What will make them accept to start treatment and adhere to it? How can treatment be delivered and patients reached, then how much will it cost, rather than blanket covering whole population with impersonal messages and dollars hoping the epidemic will treat itself out.

Re-stating the obvious, HIV prevention and treatment is a complex problem and as much as requesting more money to buy more drugs is much more appealing than requesting dollars to built roads, there is little point of shelving drugs that can be distributed or having brand new and shiny clinics in the middle of nowhere with no staff and no road leading to them.

Some governments have started to understand some of this. The UK Department for International Development (DFID) recently recognised that “Trade is critical for generating economic growth and reducing poverty. Without good quality infrastructure – roads, rail, and ports – the cost of trade and transport rises”. DFID Minister of State Gareth Thomas then announced “£100 million for the implementation of an innovative and comprehensive transport and cross-border trade reform programme along the ‘North-South Corridor’, combined with a broader package of regional trade-related reforms.” Recognizing that trade can’t happen without adequaye infrastructure comes late but is welcomed. It is regrettable that the Minister did not go one step further and recognised that the fight against HIV can’t be won without similarly good infracstructure and also aknowledge that trade development could contribute to the HIV/AIDS epidemic (both in a positive and negative way) and then implement along the North South corridor of trade a corridor of HIV prevention and treatment.

This is were mainstreaming HIV/AIDS (and the money to fight the epidemic) comes into the big picture, but we are not there yet. Money and drugs are still needed to fight AIDS, probably more than ever with increasing HIV prevalence, but what you do with it is as important if not more than as how much you get.

Access to life-saving medicines in Thailand: The US bullies are back

Access to life saving medicines is once more at the heart of trade negotiations between Thailand and the US. And again the US administration and businesses have chosen to bully the Thai government in advance of a meeting in Washington prior to the release of the Special 301 Report» that impacts on trade conditions between the US and its partners.

Compulsory licensing (CL) has been the casus beli of an ongoing battle started when the junta government led by Surayud Chulanont issued compulsory licences for antiretrovirals and anti-cancer drugs in September 2006 in accordance with the TRIPS agreements part of the Doha convention. These CL were not issued without difficulty and the pharmaceutical industry in its various emanations and stooges, was not prepared to give up without a dirty fight.

The ‘Empire’ did and is still doing its best to discredit, threaten and intimidate Thailand and as the USTR is reviewing the status of its trade partners in preparation of the next Special 301 report, the bullies suggested that Thailand status should be downgraded even further from the Priority Watch List (PWL) to the Priority Foreign Countries (PFC) listing. Such downgrading would only make it harder for Thai businesses to trade with US businesses.

Though Thailand’s decision to issues Compulsory Licences was not violating its legal obligations» under World Trade Organization rules (the previous 301 special report complained, without justification, that “the lack of transparency and due process exhibited in Thailand represents a serious concern”), the deception continues on the part of the pharmaceutical industry, US lobbyists (such as USA for Innovation which website has gone offline and was suspected to be one of former Prime Minister Thaksin’s incarnations) , lazy journalists, think tanks on the Pharma’s payrol , and zealot bloggers.

These self righteous and self appointed guardians of the US Intellectual Property consider that some kind of moral values (understand double-standard) prevail over international WTO agreements. Indeed they consider it fair for the US, a developed country, to use the TRIPS agreements to rip off third world and developing countries of their IP (and even developed countries), but that Thailand’s use of the same international treaty is totally unacceptable, unjustifiable and just plain “theft”. They also challenge the legality of previous CL since they were issued by a military government though neither the legality of these CL nor the sovereignty of the Thai government that issued them has ever been questioned by the US Administration. But to no avail, the Zealots continue to condemn those who condone the CL as colluding with the military. This is forgetting that in 1991-92, it is a military government led by Anand Panyarachun that implemented the 100% condom programme in Thailand’s brothels and amongst sex-workers, successfully preventing a generalised epidemic amongst the Thai population. If they were to follow their logic, they should also condemn the 100% condom programme.

More than two years after the first CL being issued and thousand of life being saved, deputy Commerce Minister Alongkorn Ponlaboot is torn between giving up under the lobbyist’s pressure and therefore putting the life of thousands at risk or taking a stand and fighting the bully back.

Let’s examine the recriminations of the American Businesses on IP rights violations in the pharmaceutical domain as summarised in the Bangkok Post.

• Thailand has unclear policy on compulsory licensing

What has happened since 2006 should show that Thailand has a very clear policy on CL, that of issuing CL on overpriced life-saving medicines using international WTO agreements: “The government will continue to impose compulsory licensing (CL) on essential but expensive drugs” as reported by The Bangkok Post. Compare that to recent CL issued by the US on F22 fighter parts or the Blackberry. Prime Minister Abhisit and the Public Health Ministry have made it clear that “The Public Health Ministry will enforce CL only when necessary by consulting with the private sector especially the Pharmaceutical Research and Manufacturers Association.”

• Thailand is likely to issue more CL without prior discussion with drug firms

Not only Thailand has in the past spent a lot of time talking to an often deaf Pharmaceutical Industry, but when it comes to issuing CL under the TRIPS agreement, Thailand is under no obligation to engage in preliminary talks. The US admninistration and Lobbyists are adopting here a very deceptive approach: they sould be well aware of the conditions necessary to issue CL since they are on the top of the list of country using the TRIPS to issue CL on a broad range of items (see above).

• Fake drugs in Thailand are rampant and punishment is light

Another deceptive approach to CL that consists in conflating generics with counterfeit drugs. As noted elsewhere, it “is like conflating sex work with trafficking. One provides services people want at a price they agree to pay, the other is illegal and dangerous. But waging war on the first is almost certainly going to make it harder to wipe out the second.”

Indeed fake drugs may be rampant in Thailand, but these have nothing to do with the right of a country to produce generic drugs, which are identical to and as efficient as brand names, with only the price as difference. Fakes are fakes.

• There is no protection of exclusive data in Thailand

This issues is a larger and more technical one. It refers to the data generated during the development of a new drug or of an existing drug for a different use. This data is very precious and usually belongs to the people who have produced it (often at a cost). It may for example comes out from a clinical trial conducted to test the efficacy of a drug against a placebo (an inactive compound). It is however common practice for this data to belong to all those who have been involved in its production. For instance, in the case of a clinical trial conducted in Thailand, with Thai volunteers ready to put their life at risk so that a pharmaceutical company can test a new drug, the data would belong to the industry and its Thai collaborators. The Thai government may even have a view that this data belongs to the Thai people.» Technically and as a consequence, all parties involved can use the data. What the Pharma wants is the exclusive use of data that have been generated on the back of volunteers in this case not considered better than guinea pigs.

• Thailand new Product Liability Act poses legal threat to drug companies that conduct clinical trials of new drugs in the country.

This is beyond belief. What the Liability for Damages Arising from Unsafe Products Act 2551 B.E. sets out is a law that provide protection to the consumer for damages caused by “Unsafe product” that “cause or may cause damage, regardless of whether it was caused by negligence during the production process or the design process or by no guidelines being given for storage, or warning, or information related to the product, or guidelines being given but in an incorrect manner or vaguely so as to be improper when considering the condition of the product, including the normal method of use and storage for the product.”

Similar laws exist in all Western countries and aims at protecting the people by preventing unscrupulous businesses to sale dangerous products. To suggest that such law poses a legal threat to drug companies says a lot about how the industry considers its market and the people who are ready to put their life at risk so that drug can be tested before being overpricely sold later.

There is therefore little of weight supporting the American businesse’s concerns other than them not being able to milk consumers and patients more than they already do. Following an uproar from advocacy and civil society groups at the news that the Thai government may relinquish on its rights to past and future issuance of CL before it meets with the United States Trade Representative (USTR) in Washington, Alongkorn Ponlaboot finally announced that “The Commerce Ministry has no policy and no right to stop further use of compulsory licences on additional drugs” and that “The government will continue to impose compulsory licensing (CL) on essential but expensive drugs.”

Alongkorn Ponlaboot deserves praise for standing against the U.S. bullies. But rest assured that the Pharmaceutical Industry and other lobbyists won’t stop here. There is much more at stake than the Thai market behind this war. The Thai may be leading the way and opening Pandora’s box from which will emerge further CL issued by bigger markets such as China. By trying to prevent CL in Thailand, it is their future interests in growing markets that they are trying to protect. But instead of fighting for outdated patenting system and IP rights they should better invest in developing new drugs (rather than recycling old ones or spending so much in PR) and on finding innovative ways to recoup their initial investment. It is probably too much asking.

The Lobbyist versus the people

Or the case of Thailand compulsory licensing vs. right wing pharmaceutical lobbyists

This article was written in May 2007, revised in June 2007 and minor edits were made on 17/11/08. I decided to republish it after my attention was drawn by the Wisdom of Whores to a recent opinion piece written by Roger Bate for the New York Times. In his latest article for the NYT, Bate conflates generic and counterfeit medicine finding another occasion to held high the flag of a sometimes unscrupulous pharmaceutical industry. The text below is a rather vitriolic piece that is however well referenced and documented. Access to life saving medicine is an issue I have at heart and I am afraid I have little tolerance for fantasy or corporate interests when it comes to saving life.

On 19 September 2006, the Royal Thai Army staged a coup against the government of caretaker Prime Minister Thaksin Shinawatra. Soon after, in November, the Thai Ministry of Public Health Mongkol Na Songkhla issued a compulsory license (CL) for the first-line Aids-fighting drug Efavirenz (Sustiva/Stocrin) manufactured by Merck, sparking a row that turned in to a war when in January compulsory licenses were issues for the heart disease drug Plavix, made by Bristol-Myers Squibb and Sanofi-Aventis, and Kaletra (Aluvia) a heat-stable HIV protease inhibitor made by Abbott Laboratories.

In February, Merck agreed to lower the price for Efavirenz to 700 baht per bottle from the pre-compulsory licence price of 1,400 baht. In contrast, Abbott Laboratories opted for a punitive reaction and withdrew its applications to market new drugs in Thailand. The rippling effect of Thailand’s CL soon propagated across the developing world. In May 2007, Brazilian President Luiz Inacio Lula da Silva signed a decree to issue a CL for Efavirenz and Brazil was promptly accused of an “IP opportunism” that threatens the US private property rights.

Back in 2006, the Intellectual Property war machine of the US Pharmaceutical industry was swiftly set in motion and a huge propaganda campaign started against Thailand’s decision to use the provisions contained in the international Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement signed at Doha in 2001.

One of the advocates of the Pharmaceutical Industry is Roger Bate, a resident fellow at the American Enterprise Institute (AEI). According to his bio at the AEI, “Economist Roger Bate researches U.S. and international aid policy in Africa and the developing world, evaluating the performance and effectiveness of USAID, the World Bank, the Millennium Challenge Corporation, NGOs, as well as other aid organizations and development policy initiatives.”

Roger Bate is a distinguished academics who holds a Ph.D. in economics and an M.Phil. in land economy from the University of Cambridge (UK), an M.Sc. in environmental and resource management from the University College, London University (UK) and a B.A. in economics from the Thames Valley University (UK).

Roger Bate has been a vocal if not vociferous contributor to the dispute opposing the US pharmaceutical giant Abbott and the Thai military-led government. He published a series of opinions, articles and reports both for the AEI, in the mainstream media and for online publications, disapproving of and condemning the Thai decision to use the TRIPS provisions.

With such academic credential, one could hardly be tempted to question Roger Bate professional integrity and expertise. But on a closer look it happens that his support of the pharmaceutical industry is often rooted in half truth, misinformation, bias and sometimes plain lies.

A brief Internet search on the American Enterprise Institute reveals that the AEI is an influential, pro-business right-wing think tank founded in 1943 by Lewis H. Brown. It is funded by one of the world’s largest oil companies (ExxonMobil) and has close links with the Bush Administration.

In February 2007, the London based newspaper The Guardian revealed that scientists and economists have been offered $10,000 each by the AEI to undermine a major climate change report due to be published by the UN’s Intergovernmental Panel on Climate Change (IPCC). The AEI sent letters offering payments for articles emphasising the shortcomings of the report. Such practices shed light on what kind of “Think Tank” the AEI is.

A review of the articles written by Roger Bate on the issue of compulsory licensing reveals a regular pattern that is epitomised in The Cost of Cheap Drugs, published on June 1, 2007. Right from the start, Roger Bate showed his ability to report well documented events with inaccuracy and questionable innuendo.

“In September 2006 the former Thai government was overthrown in a largely bloodless military coup”, wrote Bate in the opening line of The Cost of Cheap Drugs of a coup that was totally bloodless. Thailand has lived through numerous coups in the last 70 years and the purpose of such innuendo is unclear if it wasn’t to question the legitimacy of a decision taken in the interest of the public by a military junta. But lest we forget, Thailand successful fight against HIV was initiated whilst a similar junta was in charge of the country in the 90s and later lost steam under the Thaksin administration.

Roger Bate often indulges in partial and biased reporting for instance when emphasizing the reaction of Dr Margaret Chan, the director of the WHO, who, he wrote “…was shocked by Thailand’s move. Back in February, when she visited Thailand, she cautioned against such hasty action.” But at the World Health Organization’s annual summit in Geneva (14-23 May 2007) where intellectual property issues were prominent a resolution on “Public Health, Innovation and Intellectual Property” was adopted in plenary session of the 60th World Health Assembly encouraging the WHO Director-General to guide the process to draw up a global strategy to remedy the problem of IP, R&D and costs of drugs and to provide technical and policy support to developing countries for that purpose. In other words to provide support to the developing world to use and apply the TRIPS Agreements.

In her closing remark the allegedly “shocked” Dr. Chan commented that she was “fully committed to this process and have noted [the WHO member’s] desire to move forward faster.” She added that “We must make a tremendous effort. We know our incentive: the prevention of large numbers of needless deaths and suffering.”

Roger Bate also often refers to the corruption pervading the Thai Government Pharmaceutical Organisation (GPO, manufacturer of the GPO-vir) quoting “Mr Jaruvan Maintake”, Auditor General at the Constitutional Court of Thailand (whose appointment to this position had been the object of a controversy). (Note : Bate most likely wanted to refer to Mrs Jaruvan Maintaka, a women whose patronym is Maintaka, but he can be excused for the difficulty to transliterate Thai names and for being unfamiliar with Thai first name even though he writes a lot about Thailand.)

Further disinformation followed when Roger Bate recalled “a 2005 study by Thailand’s Mahidol University’s faculty of medicine [that] found at least 40% and up to 59% resistance in the 300 patients investigated.” Roger Bate teamed up with another Right Wing lobbyist group USA for Innovation who ran a libelous advert in the Bangkok Post earlier in 2007. USA for Innovation executive director is Ken Adelman, who also works for Edelman Public Relations Worldwide, which counts Abbott Laboratories as one of its biggest clients. Bate and Adelman were later contradicted by Wasun Chantratita, chief of Mahidol University’s virology and molecular microbiology unit, who said in the Thai newspaper The Bagkok Post (May 12, 2007) that, “the advert that cited his study was only half-true. He said the study on drug resistance was conducted in 2000 _ two years before GPO-VIR even existed. It focused on three individual original drugs _ Nevirapine, Lamivudine (3Tc) and Stavudine (d4T) _ not GPO-VIR. GPO started to produce GPO-VIR, which combines Nevirapine, Lamivudine and Stavudine, in 2002.” Then the GPO was seeking criminal-defamation action against USA for Innovation and was seeking 1bn Baht in compensation.

Bate often insists that, “even the Global Fund to Fight AIDS, Tuberculosis and Malaria, which has arguably shown enormous tolerance of the GPO, finally withdrew financial support last August”. Little mattered that the World Bank was planning to provide Thailand with a $750,000 three-year grant aimed at providing HIV-positive people with increased access to antiretroviral drugs and help address funding issues associated with the country’s universal health care system, as well as providing training for nurses and doctors in an effort to overcome the shortage of health care personnel in the country (The Nation, February 6, 2007). (Note: See here for an update on the global Fund position towards Thailand)

But again, Bate expressed his concerns that “cheaper drugs do not make cheaper healthcare if they don’t work properly.” Of course, as pointed out by Daniel Ten Kate in the Asia Sentinel (May 10, 2007), “USA for Innovation and other propaganda groups will never cite an August 2006 World Bank study that calls for Thailand to resist Big Pharma and use compulsory licensing to reduce HIV/AIDS drug costs by up to $3.2 billion by 2025. It also won’t refer to letters of support sent to the Thai government from the World Health Organization, UNAIDS and countless NGOs, including the Clinton Foundation headed by former President Bill Clinton.”

The picture would not be complete if Bate had refrained from nursing the myth that “World Trade Organization rules have made compulsory licenses available to poor countries suffering an epidemic. But Thailand is a middle income country, and, while a case may be made for HIV, heart disease, cholesterol and leukemia are not epidemics.” This ignores the assessment made by the Associate Director of Washington College of Law’s Program on Information Justice and Intellectual Property (PIJIP) which concluded that “Thailand’s issuance of compulsory licenses for three patented medicines is legal under domestic laws and complies with WTO rules, and Abbott’s decision to withhold its new products from the Thai population violates Thai antitrust laws” but also ignores that in its 2007 Special 301 Report the “United States acknowledges a country’s ability to issue such licenses in accordance with WTO rules”.

Bate should also well know that compulsory licenses issued under the TRIPS agreement are not limited to poor countries or situation of medical emergency since the USA have been using the same TRIPS agreements for their benefit in situation hardly close to medical emergencies ranging from patent related to the Blackberry device to Toyota hybrid transmissions and material used in F-22 fighter jets. Indeed the TRIPS agreement clearly states that each member is free to determine the grounds upon which such licenses are granted.

One can only expressed bewilderment with a lobbyist’s ability to broadcast so many inconsistencies, inaccuracies, biased and one-sided reporting, and fallacies in less than 800 words. Lacks of integrity and professionalism, partisanship, or genuine professional incompetence are the choices left to the readers. One is justified having reservations about the credibility of such lobbyist to contribute meaningfully and honestly to such an important debate.

Many other are perpetuating the same myths, printing the same fallacies and misleading the public, including Bibek Debroy, a professional economist, Secretary-General of the PHD Chamber of Commerce and Industry, India, and former consultant to India’s Ministry of Finance (Obsession with lower cost leads to deadly mistake, The Bangkok Post, December 6, 2006), Philip Stevens, director of the health programme at the International Policy Network, a corporate-funded, London-based development think tank (Licensing policy fatal for HIV/Aids sufferers, The Nation, February 14, 2007), USA for innovation, the Baker & McKenzie law firm (Compulsory drug licenses violate world trade treaty, The Bangkok Post, April 23, 2007), some serious news outlets such as the Wall Street Journal, the Financial Times and some less scrupulous professional who do not check their facts.

That these people and interest groups wish to support the Pharmaceutical industry is their right, but that they do so with lies, misrepresentation and misinformation is not acceptable.

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Tags: Compulsory License, Drug access, Pharma, Thailand

Want free phone calls? Learn about HIV!

The most controversial, if not the only controversial idea put forward by E. Pisani in her book The Wisdom of Whores, is what she sees as the next logical step after opt-out testing for HIV: requiring “people who are getting free AIDS drug to show up for prevention service, too.” She is well aware that activists who have ripened in a “culture of confidentiality” would be horrified.

Now imagine that this was happening, that to ensure that patients adhere to their treatment they receive each month free call time on their cellphone for taking their medicine. Outrage would be at the door, indignation at the window. However, this is what a team at the Massachusetts Institute of Technology has come up with to ensure that tuberculosis patients complete their six-month course of medication rather than them risking boosting the spread of drug-resistant strains by not taking their medicine regularly.

I don’t see anything outrageous in Elizabeth’s proposal. Counselling is customary for people affected with all sort of diseases such as cancer, obesity and mental disorders. HIV has been an exception and thought it is understandable why and how this exception has developed, I do believe that it now contributes to the stigma still associated with the disease. In the case of HIV it should be a duty to ensure that people affected understand and are well aware of behavioural risks associated with HIV transmission. Not only it will help them having a normal life and guiltless (sex) life but it will protect their sexual partners too, hence reducing the spread of the epidemics.

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Helping the NHS to get efficient medicines

The Sunday Times reports that “The National Health Service is providing dying cancer patients with drugs that are five times less effective than those available privately and is refusing to treat them if they try to buy medicines themselves.” For example, Sutent, and anti cancer drug used to treat kidney cancer that extend patient’s lives by 6 months but cost £2,200 a month compared to the standard NHS drug that cost £800 a month is not available on the NHS. Likewise, Erbitux, costing about £3,000 a month but more potent in reducing bowel tumours than irinotecan is 13 times more available to patients in France than in Britain.

So far the position of the NHS has been that patients paying for “top up” medicines would not be able to receive state-funded care. An alternative would be to allow “co-payment” whereby a patient is allowed to contribute to the cost of its treatment whilst benefiting from state-funded care with a risk to create a two-tiers NHS, though with the existing private sector, it would be more accurate to say a three-tiers NHS.

There is another solution, used by the Thai to provide treatment to people affected by HIV and by the USA to stockpile enough Tamiflu for an avian flux epidemics that never happened or for the production of an antibiotic (Cyprofolxacin) following the threat of mail-born anthrax attack: Compulsory licensing. In the former case CL was issued, in the two latter the threat was enough to ensure availability.

Nothing is stopping the government and the NHS to negotiate with the pharmaceutical industry and in doing so, to use all legal means available, including compulsory licensing.

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