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	Outsourcing pharmaceutical testing, unbeknownst to patients by AFP, Der Spiegel, The Lancet & agencies   Germany launches investigation into human trials scandal, by Rob Hyde. (The Lancet)   Germany"s pharmaceutical sector will cofund an investigation following claims that East German patients were recruited without proper consent into drugs trials. Rob Hyde reports from Bremen.   Medical historians from Berlin"s Charité hospital have begun an investigation into drug industry clinical trials done in the former German Democratic Republic (GDR) in the 1980s after allegations emerged to suggest that there might be ethical issues with the studies.   A recent report by the German magazine, Der Spiegel, claims to have obtained records that prove that major drug companies such as Bayer, Hoechst, and Roche, made huge payments to the GDR to undertake clinical trials in East Germany. Governed by the Socialist Union Party of Germany (SED) and its hard-line Marxist-Leninist ideology, the cash-strapped communist regime is supposed to have allowed these drugs firms to test more than 600 products on more than 50 000 individuals. Most of these participants allegedly had no knowledge they were taking part in clinical trials, during which some patients died.   The magazine claims to have gained access to a mixture of unpublished files belonging to individual doctors and three state institutions of the Soviet-backed GDR. These include East Germany"s Health Ministry, its Institute for Drug Regulatory Affairs, and even its feared Ministry for State Security, the notorious Stasi.   Speaking to The Lancet, the director general of the Association of Research-Based Pharmaceutical Companies (vfa), Birgit Fischer, said it was necessary to actively engage in the investigation to establish facts. “So far there are no confirmed cases of illegal or illegitimate practices. It is for exactly this reason that we are engaging in the research project: to find out what really happened—no questions should remain open in the end.”   “We therefore definitely must research all of this. There needs to be a really open but also fair debate. In Germany the debate simply consists of unclear claims and accusations so far, and the issue of clinical trials has been scandalised. It is a very prejudiced approach to the issue.”   The scientific investigation will be overseen by the German Federal Ministry of the Interior (BMI). While the BMI will fund 70% of the project, the remaining 30% will be split between four parties. These include the vfa, the Federal Foundation for the Reappraisal of the SED Dictatorship, the Berlin Chamber of Commerce, and the German Medical Association (BÄK).   Speaking to The Lancet, president of the BÄK, Frank Ulrich Montgomery said the controversial Spiegel article should not be considered gospel. “Bayer tested nimodipin in the GDR, and the magazine claimed that this left the patients [with addiction to alcohol] suffering from acute delirium, and therefore incapable of comprehending the situation they were in. But to me it is clear that they were disorientated as they were undergoing a special form of detoxification. Had they not received drugs to reduce blood pressure in the brain then they would have endured an extremely rough, unpleasant time.”   “In Germany, if there is a claim made, then a form of damage must be proven. But in this case, based on the information we have at the moment, I cannot see any. We just need more information and more facts. None have really been provided here.”   Germany"s drug industry is constantly stressing the importance of establishing facts and also their commitment to engaging in a debate. When approached by media, however, individual drugs companies are largely refusing to give interviews in which these facts can be debated. http://www.spiegel.de/international/germany/western-drugmakers-tested-medicines-on-unwitting-east-germans-a-899594.html   July 2013   Outsourcing pharmaceutical testing, unbeknownst to Indian patients, by Jacob Chamberlain.   Multinational pharmaceutical companies are treating patients in India like "lab rats," distributing untested drugs for research purposes without the patients informed consent, Agency France-Presse highlighted on Thursday in a report pulling from personal accounts.   The issue is ongoing and widespread and has been subject to a Supreme Court Case in India — which led Supreme Court judges R.M. Lodha and A.S. Dave to state, "There has to be some sense of responsibility. Human beings are treated like guinea pigs."   Pharmaceutical companies often go to India where the rules are less strict and the testing procedures subsequently far less costly.   "In Europe and the United States the laws are pretty strict. India, on the other hand, makes for a less restrictive destination for drug trials because the regulator lacks teeth," said health campaigner Amulya Nidhi, who works for the Swasthya Adhikaar Manch group, which is fighting on behalf of many of the pharmaceutical trial victims.   As a result, "many desperate and poor people in India are unwittingly taking part in clinical trials for drugs by Indian and multinational pharmaceutical companies that outsource the work to unregulated research organizations," AFP reports.   Such was the case with Niranjan Lal Pathak, the center of the AFP article, who was offered free treatment for a heart complaint at his local hospital. The medicine, unbeknownst to him, turned out to be an untested drug called Atopaxar, developed by Japan-based pharmaceutical company Eisai for anxiety disorders. Pathak was the victim of a drug trial without his informed consent.   His family says that Pathak is now suffering from extreme dementia—a side effect of the drug.   "He barely recognizes us. His life is finished and so are our hopes to see him healthy and happy again," a family member told AFP.   "The label on the medicines often does not specify that it is meant for trial, and vulnerable people end up being used as lab rats," said Nidhi.   The problem is rampant, according to AFP, while India"s lawmakers are currently mulling over amendments to the Drugs and Cosmetics Act that would place the responsibility on companies that are supposed to oversee the trials. However, no time-frame has been given to pass the act.   Recent reporting by The Times of India showed that up to 2,600 "human guinea pigs" have died in the past seven years during drug trials by foreign pharmaceutical corporations.   According to the paper, trials of 475 drugs took place during that time but only 17 of them were actually approved for marketing in India.   Clinical trials of two drugs—Bayer"s Rivaroxaban and Novartis"s Aliskiren vs. Enalapril—accounted for the most deaths and were repeatedly used despite widespread fatalities.   In 2011, Al Jazeera documented this growing trend over the last decade, showing US pharmaceutical companies who have moved their testing operations overseas to cut costs. The "costs," however, are externalized on low income patients around the world—with deadly results. Watch below: http://www.commondreams.org/headline/2013/07/11-2
	Modern South Africa is not a perfect society by Ronnie Kasrils Guardian News & agencies South Africa   June 2013   South Africa"s young people today are known as the Born Free generation. They enjoy the dignity of being born into a democratic society with the right to vote and choose who will govern. But modern South Africa is not a perfect society. Full equality – social and economic – does not exist, and control of the country"s wealth remains in the hands of a few, so new challenges and frustrations arise. Veterans of the anti-apartheid struggle like myself are frequently asked whether, in the light of such disappointment, the sacrifice was worth it. While my answer is yes, I must confess to grave misgivings: I believe we should be doing far better.   There have been impressive achievements since the attainment of freedom in 1994: in building houses, crèches, schools, roads and infrastructure; the provision of water and electricity to millions; free education and healthcare; increases in pensions and social grants; financial and banking stability; and slow but steady economic growth (until the 2008 crisis at any rate). These gains, however, have been offset by a breakdown in service delivery, resulting in violent protests by poor and marginalised communities; gross inadequacies and inequities in the education and health sectors; a ferocious rise in unemployment; endemic police brutality and torture; unseemly power struggles within the ruling party that have grown far worse since the ousting of Mbeki in 2008; an alarming tendency to secrecy and authoritarianism in government; the meddling with the judiciary; and threats to the media and freedom of expression. Even Nelson Mandela"s privacy and dignity are violated for the sake of a cheap photo opportunity by the ANC"s top echelon.   Most shameful and shocking of all, the events of Bloody Thursday – 16 August 2012 – when police massacred 34 striking miners at Marikana mine, owned by the London-based Lonmin company. The Sharpeville massacre in 1960 prompted me to join the ANC. I found Marikana even more distressing: a democratic South Africa was meant to bring an end to such barbarity. And yet the president and his ministers, locked into a culture of cover-up. Incredibly, the South African Communist party, my party of over 50 years, did not condemn the police either.   South Africa"s liberation struggle reached a high point but not its zenith when we overcame apartheid rule. Back then, our hopes were high for our country given its modern industrial economy, strategic mineral resources (not only gold and diamonds), and a working class and organised trade union movement with a rich tradition of struggle. But that optimism overlooked the tenacity of the international capitalist system. From 1991 to 1996 the battle for the ANC"s soul got under way, and was eventually lost to corporate power: we were entrapped by the neoliberal economy – or, as some today cry out, we "sold our people down the river".   What I call our Faustian moment came when we took an IMF loan on the eve of our first democratic election. That loan, with strings attached that precluded a radical economic agenda, was considered a necessary evil, as were concessions to keep negotiations on track and take delivery of the promised land for our people. Doubt had come to reign supreme: we believed, wrongly, there was no other option; that we had to be cautious, since by 1991 our once powerful ally, the Soviet union, bankrupted by the arms race, had collapsed. Inexcusably, we had lost faith in the ability of our own revolutionary masses to overcome all obstacles. Whatever the threats to isolate a radicalising South Africa, the world could not have done without our vast reserves of minerals. To lose our nerve was not necessary or inevitable. The ANC leadership needed to remain determined, united and free of corruption – and, above all, to hold on to its revolutionary will. Instead, we chickened out. The ANC leadership needed to remain true to its commitment of serving the people. This would have given it the hegemony it required not only over the entrenched capitalist class but over emergent elitists, many of whom would seek wealth through black economic empowerment, corrupt practices and selling political influence.   To break apartheid rule through negotiation, rather than a bloody civil war, seemed then an option too good to be ignored. However, at that time, the balance of power was with the ANC, and conditions were favourable for more radical change at the negotiating table than we ultimately accepted. It is by no means certain that the old order, apart from isolated rightist extremists, had the will or capability to resort to the bloody repression envisaged by Mandela"s leadership. If we had held our nerve, we could have pressed forward without making the concessions we did.   It was a dire error on my part to focus on my own responsibilities and leave the economic issues to the ANC"s experts. However, at the time, most of us never quite knew what was happening with the top-level economic discussions. As s Sampie Terreblanche has revealed in his critique, Lost in Transformation, by late 1993 big business strategies – hatched in 1991 at the mining mogul Harry Oppenheimer"s Johannesburg residence – were crystallising in secret late-night discussions at the Development Bank of South Africa. Present were South Africa"s mineral and energy leaders, the bosses of US and British companies with a presence in South Africa – and young ANC economists schooled in western economics. They were reporting to Mandela, and were either outwitted or frightened into submission by hints of the dire consequences for South Africa should an ANC government prevail with what were considered ruinous economic policies.   All means to eradicate poverty, which was Mandela"s and the ANC"s sworn promise to the "poorest of the poor", were lost in the process. Nationalisation of the mines and heights of the economy as envisaged by the Freedom charter was abandoned. The ANC accepted responsibility for a vast apartheid-era debt, which should have been cancelled. A wealth tax on the super-rich to fund developmental projects was set aside, and domestic and international corporations, enriched by apartheid, were excused from any financial reparations. Extremely tight budgetary obligations were instituted that would tie the hands of any future governments; obligations to implement a free-trade policy and abolish all forms of tariff protection in keeping with neo-liberal free trade fundamentals were accepted. Big corporations were allowed to shift their main listings abroad. In Terreblanche"s opinion, these ANC concessions constituted "treacherous decisions that [will] haunt South Africa for generations to come".   An ANC-Communist party leadership eager to assume political office (myself no less than others) readily accepted this devil"s pact, only to be damned in the process. It has bequeathed an economy so tied in to the neoliberal global formula and market fundamentalism that there is very little room to alleviate the plight of most of our people.   Little wonder that their patience is running out; that their anguished protests increase as they wrestle with deteriorating conditions of life; that those in power have no solutions. The scraps are left go to the emergent black elite; corruption has taken root as the greedy and ambitious fight like dogs over a bone.   In South Africa in 2008 the poorest 50% received only 7.8% of total income. While 83% of white South Africans were among the top 20% of income receivers in 2008, only 11% of our black population were. These statistics conceal unmitigated human suffering. Little wonder that the country has seen such an enormous rise in civil protest.   A descent into darkness must be curtailed. I do not believe the ANC alliance is beyond hope. There are countless good people in the ranks. But a revitalisation and renewal from top to bottom is urgently required. The ANC"s soul needs to be restored; its traditional values and culture of service reinstated. The pact with the devil needs to be broken.   At present the impoverished majority do not see any hope other than the ruling party, although the ANC"s ability to hold those allegiances is deteriorating. The effective parliamentary opposition reflects big business interests of various stripes, and while a strong parliamentary opposition is vital to keep the ANC on its toes, most voters want socialist policies, not measures inclined to serve big business interests, more privatisation and neoliberal economics.   This does not mean it is only up to the ANC, SACP and Cosatu to rescue the country from crises. There are countless patriots and comrades in existing and emerging organised formations who are vital to the process. Then there are the legal avenues and institutions such as the public protector"s office and human rights commission that – including the ultimate appeal to the constitutional court – can test, expose and challenge injustice and the infringement of rights. The strategies and tactics of the grassroots – trade unions, civic and community organisations, women"s and youth groups – signpost the way ahead with their non-violent and dignified but militant action.   The space and freedom to express one"s views, won through decades of struggle, are available and need to be developed. We look to the Born Frees as the future torchbearers.   * Mary Robinson delivered the Tenth Nelson Mandela Annual Lecture in Cape Town. While speaking frankly about the challenges South Africa faces, from crime and corruption to extremes of wealth and poverty, she expresses her faith that this young democracy has the ability to address its problems and continue its process of transformation that has so inspired the wider world. http://www.theelders.org/article/freedom-truth-democracy-citizenship-and-common-purpose Visit the related web page
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