Tag Archives: drug trials

Latest Developments, July 23

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In the latest news and analysis…

Legal first
The Globe and Mail reports that a Canadian court has ruled that Canada’s HudBay Minerals can be sued in Canada over alleged human rights abuses in Guatemala:

“The decision opens the door to other cases in which companies could face liability on their home turf for incidents that happen overseas.
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In the Guatemalan lawsuits, one case involved the alleged beating, machete hacking and killing of a local Mayan community leader who voiced opposition to the mine: Adolfo Ich Chaman. Another man was shot and now uses a wheelchair. There are also allegations that 11 women were gang-raped by men in mine security uniforms.”

Mortal sin
The New York Times reports that UK pharmaceutical giant GlaxoSmithKline’s ethical lapses in China may go well beyond recent bribery allegations:

“The [auditors’] report revealed that the drug’s project leader belatedly learned the results of three studies of ozanezumab in mice. During their investigation, auditors came across six studies whose results had not been reported, even though early trials in humans were already under way.
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‘If that’s true, it’s a mortal sin in research requirements,’ said Arthur L. Caplan, the head of the division of medical ethics at NYU Langone Medical Center. He served as the chairman of an advisory committee on bioethics at Glaxo from 2005 to 2008. ‘No one could approve human trials without having that information available, scientifically or ethically. That’s kind of a Rock-of-Gibraltar-sized ethics violation.’ ”

Bad treaties
Lee Sheppard writes in Forbes that the Organisation for Economic Co-operation and Development’s new “action plan” on corporate tax avoidance, endorsed by the G20, is unlikely to help poor countries:

“Multinationals are doing business and extracting resources from poor countries without paying for the costs of their activities or otherwise contributing to the cost of government. Insufficient corporate tax payments are not the full extent of their depredations.
A couple decades ago, many developing countries signed OECD model treaties with developed countries that are home to multinationals. They didn’t realize the full ramifications of the concessions they were making. They were told that a tax treaty is good for inbound investment. The fact is that multinationals will do business in any country where there is money to be made, tax treaty or not. Ask Brazil, which has no tax treaty with the United States.
Developing countries should not sign OECD model tax treaties.”

Criminal words
The Independent reports that a French politician is under investigation for “apologising for crimes against humanity” after allegedly making anti-Roma comments:

“Gilles Bourdouleix, who is also the MP for Cholet, near Nantes, made the comment after 150 traveller caravans moved on to a municipally owned field near his town on Sunday.
The gypsies refused requests to move on and made Nazi salutes at the mayor, according to reports. A regional newspaper, the Courrier de L’Ouest, reported that Mr Bourdouleix then turned away and said: ‘Maybe Hitler didn’t kill enough of them.’ ”

Secret war
Foreign Policy reports on what appears to be an undeclared, escalating and illegal war waged by the US in Somalia:

“Last year, according to [the UN Monitoring Group for Somalia and Eritrea], the United States violated the international arms embargo on Somalia by dispatching American special operations forces in Russian M-17 helicopters to northern Somalia in support of operations by the intelligence service of Puntland, a breakaway Somali province.
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Two U.S. air-charter companies linked to American intelligence activities in Somalia have increased the number of clandestine flights to Mogadishu and the breakaway province of Puntland by as much as 25 percent last year.
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The flights — which have not been reported to the U.N. Security Council — suggest a further strengthening of American cooperation with Somalia’s National Intelligence Agency in Mogadishu and the Puntland Intelligence Service, which has been cooperating with U.S. counterterrorism operations for more than a decade.”

Corrupting perceptions
The Center for Global Development’s Alex Cobham argues that Transparency International’s oft-cited corruption ranking of countries provides “an unhelpfully distorted reflection of the truth”:

“[University of Minnesota law professor Stuart Vincent] Campbell writes that, in contrast to the [Corruption Perceptions Index] ranking which in 2010 put Brazil 69th, behind Italy and Rwanda, ‘The 2010 Global Corruption Barometer [based on a broader survey of Brazilian citizens] found that only 4 percent of Brazilians had paid a bribe, which is a lower percentage of bribe-givers than the survey found in the United States or any other country in Latin America.’
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The CPI embeds a powerful and misleading elite bias in popular perceptions of corruption, potentially contributing to a vicious cycle and at the same time incentivizing inappropriate policy responses. The index corrupts perceptions to the extent that it’s hard to see a justification for its continuing publication. For the good of the organization, its important aims and the many people committed to its success, Transparency International should drop the Corruption Perceptions Index.”

Raw deal
Oxfam’s Jennifer Lentfer reproduces US Congressional testimony, including that of NFL star Anquan Boldin, on whether there is such a thing as an “African resource curse”:

“Meanwhile, the community that lost its land sees little benefit from the enormous mine in what was once their backyard. No percentage of the revenue from the mine, which is bigger than several football stadiums and brings in untold revenues, ever makes its way back to the community. The mining company did leave the community with one gift though. Because the mining company also took ownership of the community’s water source, they built a brand new well in the middle of the community. They now have access to water whenever the company decides to turn on the water (which is rare), and assuming they’ve paid their monthly bill to the mining company. This is the definition of a raw deal.”

Latest Developments, December 19

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Dividend arbitrage
The Bureau of Investigative Journalism says it has uncovered a “huge tax avoidance trade” run by some of London’s biggest banks, which may be costing European governments nearly $800 million per year.
“Markus Meinzer, applied researcher and analyst at the Tax Justice Network, said: ‘This issue highlights a structural flaw in our current international financial system. Governments refuse to institute robust transparency and cooperation mechanisms in view of aggressive financial sector lobbying and because of the bizarre, yet largely unchallenged view of alleged benefits flowing from competition between states.’ ”

Fighting dependency
The Guardian reports Nigeria is looking to reduce its dependence on foreign food, such as wheat and rice imports, and to rely more on locally grown cassava in an effort to boost the nation’s agriculture sector.
“Billed as a central part of the new administration’s ‘transformation’ agenda – a sign of how badly Nigeria needs fixing – proposals in a preliminary budget to slash a $68bn import bill include a 100% levy on rice and wheat imports next year. Wheat costs the government a staggering $3.9bn annually, while Nigeria is the world’s largest rice importer – at a cost of $6.25m a day – even though its climate is ideal for rice growing.
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According to the UN’s Food and Agriculture Organisation, Africa has more than doubled cereal imports over the past three decades, a trend some countries have begun trying to reverse through proactive policies. In Uganda, for instance, rice output more than doubled in the space of four years after a 75% tax was imposed on imports. The duty also spurred the construction of new mills, lowering the price of locally refined rice. Malawi, meanwhile, one of Africa’s poorest countries, reversed its food deficit in just two years through a targeted subsidy programme that helped finance fertiliser for farmers.”

Drug tests
The Inter Press Service reports on the current state of international protections for human subjects of medical research.
“Fourteen patients died during the trials, which were conducted [by French and US pharmaceutical companies in a Bhopal hospital without the informed consent of the subjects] between 2007 and 2010. Drugs and treatments resulting from those trials have since been approved for sale in Europe and the U.S., according to a report in the Independent.
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European law states that drugs tested in violations of protections guidelines such as the Declaration of Helsinki should not be granted market authorisation in Europe. [Annelies] Den Boer said [clinical trials watchdog] Wemos, with support of members of the European parliament, hopes to push the [European Medical Association] to block unethically tested drugs from the European market.
The U.S. Food and Drug Administration (FDA) abandoned the Declaration of Helsinki in 2008.”

Undeclared money
The Indian Express reports India is considering legal action against HSBC for allegedly encouraging customers to move undeclared money to its branch in Geneva.
“No prosecution or court cases have been filed. Reason: despite an official communication being sent by the [Central Board of Direct Taxes], HSBC Bank in Geneva has given no official acknowlegement of the data handed over by French authorities and without this endorsement from the Swiss or detailed banking transactions, officials feel the cases may collapse in economic offence courts.
But with the account-holders revealing that their Geneva accounts were being ‘operated’ from New Delhi by bank officials — both for deposits and withdrawals — and the balances were not reflected in their tax returns, a fit case for filing a prosecution against the bank itself may be made out.”

Brandeis tipping point
Yale University’s Ian Ayres and UC Berkeley’s Aaron Edlin argue the level of inequality in the US – the latest statistics show “the average 1-percenter” earns 36 times more than the median household – must be capped for the sake of the country’s democracy.
“Enough is enough. Congress should reform our tax law to put the brakes on further inequality. Specifically, we propose an automatic extra tax on the income of the top 1 percent of earners — a tax that would limit the after-tax incomes of this club to 36 times the median household income.
Importantly, our Brandeis tax does not target excessive income per se; it only caps inequality. Billionaires could double their current income without the tax kicking in — as long as the median income also doubles. The sky is the limit for the rich as long as the “rising tide lifts all boats.” Indeed, the tax gives job creators an extra reason to make sure that corporate wealth does in fact trickle down.”

The ‘trust me’ concept
The Washington Post reports the Obama administration’s increasing reliance on drone strikes may have resulted in 2,250 deaths in Pakistan over the last three years, but there is precious little information about the strategy or its results.
“Even outside experts who believe the program is legal find the secrecy increasingly untenable. ‘I believe this is the right policy, but I don’t think [the administration] understands the degree to which it looks way too discretionary,’ said American University law professor Kenneth Anderson.
‘They’ve based it on the personal legitimacy of [President] Obama — the “trust me” concept,’ Anderson said. ‘That’s not a viable concept for a president going forward.’ ”

Cost of doing business
Drawing on new information concerning the killing of 24 Iraqis by US troops, the Guardian’s Gary Younge issues a call to fight Iraq War revisionism that downplays the invaded country’s suffering.
“When he heard the news, Major General Steve Johnson, the American commander in Anbar province at the time, saw no cause for further examination. ‘It happened all the time … throughout the whole country. So you know, maybe, if I was sitting here [in Virginia] and heard that 15 civilians were killed I would have been surprised and shocked and done more to look into it. But at that point in time I felt that it was just a cost of doing business on that particular engagement.’ ”

Latest Developments, November 7

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Energy governance
Former NATO secretary general Javier Solana and the ESADE Center for Global Economy and Geopolitics’ Ángel Saz-Carranza make the case for a system of global energy governance, arguing that neither an unregulated market nor current multilateral institutions are up to the task.
“Owing mainly to its environmentally negative externalities, an unregulated energy market is not a useful governing mechanism, because it is unable to internalize the environmental costs. It has been calculated that the most contaminating energy sources would have to pay a 70% tax to reflect their negative externalities.
A substantial lack of information in this field is another reason why the free market doesn’t work. Often, as with the properties of a gas reserve, for example, information is technically difficult to obtain. In addition, governments consider natural resources to be strategic and don’t release information about them. Finally, time frames related to energy are usually long: centuries for environmental effects or decades for investments to pay off. Thus, energy must be governed through a system of cooperation and regulation.”

Covert war
The Bureau of Investigative Journalism’s Pratap Chatterjee argues the CIA must prove that two Pakistani boys, aged 12 and 16, who were killed last week in a drone strike posed an imminent threat to US security or else it is guilty of murder.
“Over 2,300 people in Pakistan have been killed by such missiles carried by drone aircraft such as the Predator and the Reaper, and launched by remote control from Langley, Virginia. Tariq and Waheed brought the known total of children killed in this way to 175, according to statistics maintained by the organisation I work for, the Bureau of Investigative Journalism.”

First, do no harm
The University of London’s Donna Dickenson writes about the recent discovery that American researchers intentionally infected hundreds of Guatemalans with syphilis in the 1940s, and she warns against ethical complacency today as more and more clinical drug trials are conducted in poor countries.
“In fact, one should view the Guatemalan study, with its incontrovertible horrors, as an extreme example of the biggest ethical problems in research today. Now, as then, richer developed countries are able to put pressure on weaker, poorer ones.
A report in 2010 revealed that foreign citizens made up more than three-quarters of all the subjects in clinical trials conducted by US firms and researchers. The US Food and Drug Administration inspected only 45 of these sites, about 0.7 per cent. There is no suggestion that Third World patients are deliberately being made ill when research is outsourced – unlike in the Guatemalan case – but that does not attenuate the inherent vulnerability of populations lacking basic medical care or experiencing epidemics.”

Investment agreements
The Guardian reports on bilateral investment treaties and how their investor-state dispute mechanism is a powerful and increasingly popular tool for transnational corporations to sue governments whose policies threaten their profits.
“There is growing concern among legal experts and the countries hit by these legal cases that the investment regime, made up of a patchwork of bilateral investment treaties and multilateral agreements, favours corporations over the public interest, puts sovereignty at stake, is chronically lacking in transparency and accountability and has been mis-sold to many developing countries that only realise exactly what they have signed up for when they get sued.
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In the last 15 years multinational corporations have increasingly recognised the potential of the ISDM, and this area of law – in which lawyers and arbitrators can command fees of $500 an hour and more – has seen a rapid expansion. A UN report in 2010 noted that 57% of all known cases have been brought in the last five years, with growing numbers of law firms opening large, dedicated sections.”

Affordable medicine
Intellectual Property Watch reports the Medicines Patent Pool, whose goal is to improve access to effective HIV/AIDS treatments in poor countries, has responded to criticism of a deal it signed with a major pharmaceutical company earlier this year.
“The Pool said in its response that the Gilead deal is not a template for the future, and that it includes more countries in its scope than any other HIV licence to date. The response also details how the licence does not undermine flexibilities contained within the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It also seeks to address concerns related to production of generic products in India and elsewhere.”

Ethical oil
Nobel laureates Jody Williams and Desmond Tutu argue one of their own, US President Barack Obama, will take “one of the single most disastrous decisions of his presidency concerning climate change and the very future of our planet” if he approves construction of the Keystone XL pipeline that would transport oil from Canada’s controversial “tar sands” to the Gulf of Mexico.
“The claim that Alberta’s fossil fuels are “ethical” because Canada is a friend is a specious ploy aimed at perpetuating the world’s addiction to fossil fuels. There is no such thing as ethical fossil fuel, regardless of geographical origin. The ethical choice is to move as quickly as possible away from fossil fuels, period.”

Roadmap for sustainable development
The UNDiplomatic Times’s Bhaskar Menon calls for a specific course of action to be mapped out at next year’s Rio+20 summit in order to actually undertake the radical changes needed to achieve sustainable development.
“The [UN] secretary-general’s report submitted earlier this year to the committee preparing for the [Rio+20] conference noted that to succeed in ‘fundamentally shifting consumption and production patterns onto a more sustainable path’, public policy would have to extend ‘well beyond “getting prices right”’.
However, it did not say what specific policy measures would be necessary. Indeed, nowhere in the massive body of documentation the United Nations has produced since it convened the first Environment Conference in 1972 can we find a single analysis of that issue.”