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  | | | | | | | | | | | | | | | | | | | | | | | | | He has disappointed but not yet betrayed us, says the novelist in his verdict on the presidency Jay McInerney, 56, is the author of Bright Lights, Big City and Brightness Falls. His latest book is the short story collection How It Ended Last week I was at a party in a Manhattan art gallery attended by the inevitable mix of artists, journalists and wealthy art collectors. I ran into a friend, a painter, who is a strong supporter of the Democratic party, but she told me she wasn't donating money to the Obama campaign this year. "He's been a huge disappointment," she said. "Not one major Wall Street banker has been held accountable for the financial crash, and he's extended the Bush tax cuts on the wealthy. I just can't get enthusiastic about him. I don't even know if I'll vote." In another part of the room a group of art collectors, most of whom worked in the financial industry, were clutching plastic glasses of cheap white wine and complaining about Obama from the opposite end of the political spectrum. "He's a socialist," said one, a short, bald man who runs a huge hedge fund. "He hates people like us." His friends all nodded in agreement. "Socialist" is the nastiest thing you can say about an American politician in some quarters. For years the Republican party depended on the spectre of the evil Soviet Union to stir up nationalistic impulses and demonised the left as unpatriotic; many on the right interpreted the collapse of the Soviet bloc as proof of the bankruptcy of socialist principles. For his part, Obama has done precious little to deserve the "socialist" title – he has yet to repeal the massive Bush tax cuts to raise taxes on the wealthiest Americans – although his healthcare reform package, which cost him so much time and political capital to get through Congress, represents an expansion of government's role in the healthcare system. It's curious that Obama has managed to alienate the big bankers and brokers and investors, many of whom supported him in 2008, even as he has infuriated those who feel he hasn't been tough enough on Wall Street. The Dodd-Frank Act, pushed by Obama and passed largely by the Democrats in Congress in 2010, imposed restrictions and regulations on the financial industry but many of us feel that it was watered down and is largely symbolic. Many in the financial industry claim it has hurt their business but the fact is Wall Street has prospered, earning more in the first two and a half years of the Obama administration than during the eight years of Bush's presidency, according to the Washington Post. Bush initiated the bailouts that helped save the big banks during the meltdown of 2008 but Obama continued those policies, thereby probably saving the financial system from a major collapse. What disappoints many of us outside of Wall Street is the feeling that Obama hasn't been nearly as effective in bailing out the lower and middle classes. For someone who so inspired us with his soaring oratory during the last campaign, he has turned out to be a poor communicator during his first term, failing at crucial moments to explain and defend his policies. Even now, in this crucial election, his best and most articulate advocate has been Bill Clinton, who delivered a superb defence of Obama at the Democratic National Convention, despite the well-known tensions between them. Like Clinton, I believe that it is more important than ever that we give Obama another chance – the alternative seems to be a return to most of the failed policies of the Bush administration, including reducing taxes on the rich and reducing regulations on business. The best we can say about Obama's foreign policy record is that he's not George Bush, that he managed to end the absurd and unjustified war in Iraq. His escalation of the war in Afghanistan has been a failure – every foreign power to invade Afghanistan has been humiliated in the end. Sarkozy took the lead in rallying Nato to aid the Libyan rebels, and Obama's failure to aid the Syrian rebels seems increasingly like a betrayal of his stated ideals and a failure of leadership. And yet… the symbolism of an African-American president is still incredibly potent, even after four years. (Yesterday I spotted a poster in the window of a barber shop in the largely African-American South Bronx – a portrait of Martin Luther King under the caption "The Dreamer" beside a portrait of Barack Obama; caption: "The Dream".) He remains the most charismatic of world leaders. One gets the sense of a man who is comfortable in his skin, comfortable with his place in the world, of a man who generally means what he says, and says it elegantly. It's hard to get any sense of the personality of Mitt Romney, who seems like a robot with excellent hair. Obama may have lost some of his mystique, and disappointed many of us, but he hasn't yet irrevocably betrayed us, or his ideals, and he will probably get another chance to fulfil some of the great expectations of 2008.
 | | | | | | | | | | | | | | | | | | | | | | | | | Second death in Indiana reported as number of cases of fungal meningitis rises by 13 to 197 across the US Health officials have confirmed another death of a patient injected with a contaminated steroid shot, bringing the number of people killed in a growing outbreak of fungal meningitis to 15. On Saturday, Centers for Disease Control and Prevention (CDC) said the figure for known cases of the illness had hit 197, up by 13 on the previous day. The health scare's latest victim was identified as a patient in Indiana, a state that has now reported two deaths from the rare form of meningitis. In addition, CDC noted a case of an infection, thought to have been caused by an ankle injection, that has not been confirmed as meningitis. The outbreak has been traced to batches of methylprednisolone acetate – a steroid used commonly to ease back pain – that were prepared by the New England Compounding Center (NECC) and shipped to 76 clinics in 23 states between July to September. Investigators from the Food and Drug Administration (FDA) visiting the Massachusetts pharmacy compounder found a fungal contaminate in a sealed vial. They also found a "foreign material" in another, opened container. It has since emerged that the pharmacy compounder has a checkered history, and has been cited in the past for health and safety violations. Questions have also been asked over the regulation of the company by state authorities. Despite NECC's documented failings, clinics from across the US were able to order close to 18,000 doses of the steroid, prompting a large scale search for all those injected after the contamination came to light. On Thursday a woman from Minnesota became the first patient to sue NECC. The class action alleges that the NECC sale of "defective and dangerously contaminated" steroid shots, that caused "bodily harm, emotional distress and other personal injuries".
  | | | | | | | | | | | | | | | | | | | | | | | | | President spends Saturday on debate preparation while Republican rival hits campaign trail in battleground state President Barack Obama hunkered down for intensive debate preparation in Virginia on Saturday, as his Republican rival, Mitt Romney, continued his push to win votes in battleground states. Romney and his running-mate, Paul Ryan, hit the campaign trail in Ohio, a crucial barometer of voting intention and a must win for both candidates in the 6 November general election. Buoyed by a strong performance in the first presidential debate a fortnight ago, the Republican candidate has also made political capital in recent days over claims by vice-president Joe Biden that the White House had not been aware of requests to beef up security in Benghazi before last month's embassy attack. Yesterday, Romney accused Biden of "doubling down on denial" over the remark, which he made during a spirited debate with Ryan on Thursday. The Republicans claim that the vice president is misleading the American people by suggesting that he and the president were not informed of security concerns in the lead up to the assault on the US consulate in Benghazi, during which ambassador Chris Stevens and three other US citizens were killed. "We weren't told they wanted more security; we did not know they wanted more security," Biden said during the televised debate – a remark that is disputed by Romney and his supporters. The dispute has added to a a sense of creeping unease among Democrats, who have seen the president's poll lead eaten away over the last two weeks. The changing political wind has put added emphasis on the importance of a better performance by Obama in the second presidential debate, which is due to take place on Tuesday in New York. On Saturday, the Democrat flew to Virginia to engage in a series of mock debates, in preparation for the encounter with Romney. The president's public schedule has been cleared for the entire weekend, extending into Monday, as he attempts to avoid a repeat of the last debate, during which he was accused of not showing enough fight. Romney spent Saturday on the stump, concluding a week of campaign rallies. "I've had the fun of going back and forth across Ohio, and this week I was also in Florida and Iowa, I was in North Carolina and Virginia. And you know what? There is a growing crescendo of enthusiasm," Romney told an enthusiastic crowd at a sunset rally Friday. Polls suggest that in Ohio, Obama retains a slight edge amongst voters. In a bid to shore up his appeal amongst middle America, Obama returned to a theme of supporting US industry in his weekly radio address Saturday. Contrasting his backing of the auto industry to the position of Romney, the president said: "We refused to throw in the towel and do nothing. We refused to let Detroit go bankrupt." The Republican candidate opposed using government funds to help struggling US carmakers, a fact that Democrats have sought to highlight on a number of occasions. On Saturday, the Obama team also released a new TV advertisement which focuses on the successes of president's first term, including the saving of American autoworkers' jobs and the assassination of terror chief Osama bin Laden. The commercial is narrated by actor Morgan Freeman. He, alongside singer Bruce Springsteen, is adding a touch of glamour to the president's campaign as it heads into its final weeks. Next week, Springsteen will perform at an Obama rally in Ohio. Democrat strategists hope that his appeal amongst blue-collar workers will help their cause in winning over floating voters in the state. Ohio is seen as a crucial battleground to both candidates. If Romney fails to take the state, his path to the White House will be very difficult – no Republican candidate has won the presidency without first taking Ohio. Obama visited the state earlier this week before turning to the more immediate task at hand – stemming the slide towards Republican momentum through a strong performance at the second presidential debate. Tuesday's encounter will take the form of a town-hall debate, with candidates answering questions posed by members of the audience. The format should play into the hands of Obama, who often appears at ease in a more informal setting, especially in comparison to Romney, who can come across as aloof. But the Republican candidate has already bucked the predictions of political pundits once in a debate setting. Doing so a second time could further dent Obama's confidence in his chances of winning a second term.
  | | | | | | | | | | | | | | | | | | | | | | | | | US Coast Guard spokesman says all 22 passengers and crew-members of Neptune were rescued near Alcatraz Revellers aboard a floating wine bar in San Francisco had to be rescued late Friday, after the boat began sinking, threatening to dump an entire bachelor party in the drink. Nearly two dozen people were on the 40ft Neptune – which takes passengers on wine-tasting trips around Alcatraz Island – when it hit a shoal and began taking on water through a 1ft gash. The boat's captain was forced to abandon ship after experiencing difficulty navigating the vessel back to its pier. US Coast Guard spokesman Josh Dykman said a rescue team managed to get all 22 passengers and crew-members off the stricken vessel. There were no injuries. KGO-TV reported that amongst the passengers on San Francisco's only "floating wine tasting room" was a bachelor party. "We were only in the boat for maybe about 20 minutes or so," Matthew Rice, the party's guest of honour, told the station. "We were coming around Alcatraz checking it out and all of a sudden it was like boom, just like a big jolt and the next thing we knew the Coast Guard boats came in and got us off."
  | | | | | | | | | | | | | | | | | | | | | | | | | Maxim Bakiyev, who was arrested in London on Friday, is wanted in the US on fraud charges The United States has asked Britain to extradite the arrested son of Kyrgyzstan's fugitive ex-president on fraud charges, the American embassy in Bishkek said on Saturday. The request looked likely to be granted, since the United States and Britain have an extradition agreement. The Kyrgyz president's office said Maxim Bakiyev, son of the former president Kurmanbek Bakiyev, had been arrested in London on Friday at the request of Kyrgyzstan and the United States. British police said Bakiyev, 34, was detained by extradition officers on the request of US authorities, who want to question him for alleged involvement in fraud, after he voluntarily went to an appointment at a central London police station. "The United States has requested the extradition of Mr Bakiyev from the United Kingdom to face trial in US federal court on serious charges of conspiracy to commit securities fraud and obstruction of justice," the US embassy in the Kyrgyz capital Bishkek said in a statement. "If convicted, Mr Bakiyev could face a lengthy prison sentence." The Kyrgyz president's office said on Friday that given the absence of an extradition deal between Bishkek and London, Britain was considering the option of sending Bakiyev to face justice in the United States. Kurmanbek Bakiyev was given shelter by Belarus after crowds of protesters seized his government headquarters in an April 2010 revolt in which around 90 people were killed when security forces opened fire on opposition supporters. Kyrgyzstan, a mainly Muslim former Soviet republic of 5.5 million people that hosts both US and Russian military air bases, has struggled to build Central Asia's first parliamentary democracy since Bakiyev's fall. "The UK staunchly supports the efforts of the leadership and people of Kyrgyzstan over the last two years to set Kyrgyzstan firmly on a path to a more democratic, stable and prosperous future," the British Embassy said in a statement. "We are conscious that, as part of those efforts, the leadership and people of Kyrgyzstan are keen to ensure that those accused of past abuses of power are brought before the courts to answer allegations against them." Belarus, which is run by the authoritarian President Alexander Lukashenko, has repeatedly rejected Kyrgyzstan's requests to extradite Bakiyez Sr, who is accused of "mass killings" of protesters during the coup. Maxim Bakiyev, who under his father headed an investment agency, has been accused by Kyrgyz authorities of involvement in large-scale frauds that stripped the impoverished country's coffers of millions of dollars. Kyrgyzstan's ties with Belarus have soured after Minsk also declined to extradite the ex-president's younger brother, Zhanybek, who headed his personal security guard and is also accused of committing mass killings. Two presidents, including Bakiyev, have been toppled in Kyrgyzstan since 2005. Some 500 people were killed in inter-ethnic violence in southern Kyrgyzstan in June 2010.
  | | | | | | | | | | | | | | | | | | | | | | | | | Meetings in Havana paved the way for negotiations that open in Oslo on Wednesday on ending long-running civil war The ailing former Cuban leader Fidel Castro, together with Venezuela's recently re-elected leader Hugo Chávez, played a critical role in bringing the Colombian government and the deadly Farc guerrilla group together for peace talks that could end one of Latin America's longest-running civil wars, the Observer has learned. According to sources closely involved in the peace process, which sees historic talks opening in Oslo on Wednesday, the key breakthrough after almost four years of back-channel talks between the two sides came during a visit earlier this year by Colombia's president, Juan Manuel Santos, to Cuba, where he met both Castro and Chávez, who was in Cuba being treated for cancer. That meeting was the first of many in Havana between the two sides, facilitated primarily by Cuba and Norway with the backing of Venezuela, which saw agreement on the detailed agenda for the first round of talks this week. "Officially President Santos went to Cuba to discuss the Americas summit," said a source intimately involved in the peace negotiations. "But the purpose of that trip was to discuss the peace initiative." The meetings earlier this year followed the decision last year by Santos to take the step of recognising that an "armed conflict" existed in his country, an initiative encouraged by Chávez since 2008. Those contacts also came in the same period that Farc announced it was ending kidnapping, one of five preconditions for talks that had been set down by Santos as a gesture of goodwill. Farc and the government have been at war since 1964, with the group more recently accused of having taken a directing role in coca production in areas it controls, an issue that will be on the agenda for the talks. But in what is being billed as the best chance to bring about a negotiated end to the long-running conflict, the Colombian government delegation will sit down with Farc leaders whose Interpol arrest warrants have been suspended to allow them to travel to Oslo without fear of arrest. The government delegation, for the first time ever, will include retired generals with the trust of the country's military and representatives of Colombia's business elite, whose presence, it is hoped, will help sell any peace deal that emerges to those hostile to the process. After the failure of the last round of peace negotiations, which foundered 12 years ago, top of the agenda will be the issues of land reform – Farc's key demand – political participation, the disarmament of the guerrilla group and the issue of paramilitaries who have in the past sought to torpedo any deal. The disclosure of the key role of Cuba in organising support for the peace process marked the culmination of a long period of back-channel talks first initiated by Santos's predecessor as president, Alvaro Uribe, under whom Santos served as minister of defence. During those four years contacts continued despite the death during an army operation of Farc's leader, Alfonso Cano, last year. Others credited with having created the conditions for the talks in Norway are unnamed former participants in the Northern Ireland peace process. The talks are due to begin amid warnings from both sides, as well as observers, that a serious threat exists from those on both sides of Colombia's political divide who might attempt to use violence to derail the process. The attempt to reach a negotiated peace settlement foundered over a decade ago as both sides accused the other of stalling and rebuilding their forces, a period, observers say, that saw a doubling of anti-Farc paramilitaries. A senior Colombian government source, who briefed the Observer on condition of anonymity, described the chances for talks as the best ever, adding that the Santos government had already enacted a new law for land reform and victim restitution. "President Santos is a pragmatist. He has already presented to congress a framework for an agreement. Colombia was already moving into a post-conflict phase, in some respects, even as the conflict continues. It is the right moment. Farc have a historic opportunity – probably the last – to find a solution to this conflict with dignity. To go into history and say they fought for social justice. To say they fought for land reform. "We want to see 'Timochenko' [Rodrigo Londoño Echeverri, who took over command of Farc after Cano's death in 2011] in Colombia's congress just as we have seen Gerry Adams in the Northern Ireland assembly." The sense of a guarded new optimism is shared by outside observers, including Marc Chernick, a US academic who has followed the history of Colombian peace negotiations and written The Farc at the Negotiating Table. Speaking from Colombia on Friday, Chernick said: "I've observed all the previous negotiations and I have been optimistic before, but this time I believe there is a real seriousness on both sides that has not been shown before. "In the past Farc has always asked for a demilitarised zone as a precondition and this time it has not pressed for that. Four years ago it started to release prisoners, first civilians then military, and then renounced kidnapping. "Clearly they want to talk. And they stayed at the table for the pre-negotiations even though three senior leaders were killed, including Alfonso Cano. "Santos is clear, too. He was former minister of defence under President Uribe. They pushed the war as hard as they could and killed leaders. Now he has recognised that it will go on indefinitely. So Santos has come to the conclusion that only a negotiated solution is possible." Chernick – like the senior government source – warned of the risk of violence during the peace talks from those, particularly on the right, opposed to peace with Farc, not least, he says, from paramilitaries who, although officially "disbanded", are still active and supported by elite sectors of society. "What is different this time," added Chernick, "is that both sides have signed up to the idea that the intended end of the peace talks is the end of the conflict."
 | | | | | | | | | | | | | | | | | | | | | | | | | A day after the US announces budget shortfall of more than $1tn, treasury secretary talks of need for balanced fiscal plan Despite making progress on getting its fiscal house in order, the United States still has much work to do, treasury secretary Timothy Geithner told fellow financial leaders Saturday. The comment came just hours after the US government announced that the budget deficit had topped $1tn for a fourth straight year, despite a modest improvement thanks to stronger economic growth. "It is important that we in the US enact a balanced framework to bring down our fiscal deficit and debt over several years, while continuing to provide support for jobs and growth in the short term," Geithner told a meeting of the International Monetary and Financial Committee during the annual meeting of the IMF and World Bank, which is being held in Tokyo. The Treasury Department said Friday that the deficit for the 2012 budget year totaled $1.1tn, though a 6.4% increase in tax revenues thanks to stronger growth had helped contain the deficit. The risk of the US running into a "fiscal cliff" of tax increases and deep spending cuts next year, unless the Obama administration and Congress resolve a deadlock over the budget, has overshadowed the gathering of top financial officials. Such a prospect would deal a heavy blow to the economy, eroding progress made since the 2008 global crisis. The overwhelming emphasis of the Tokyo gathering has been on coddling fragile growth around the globe. At Saturday's meeting of the IMFC, which advises the IMF and monitors the world financial system, officials from developing and emerging economies urged the US and European nations to prevent malaise in their regions from slowing global growth. "Advanced countries should rethink their macroeconomic strategies and avoid simultaneous fiscal contractions and the consequent overburdening of monetary policies," Guido Mantega, Brazil's finance minister, told the committee. "In many advanced economies, fiscal and structural policies are severely hampered by political paralysis." He urged that spending be focused on areas that can have a maximum impact and on social safety nets to protect the poor. Mantega and other finance ministers expressed concern over monetary easing in the US and other countries that is meant to encourage more bank lending: some worry could destabilize markets while failing to stave off recession. During the meetings in Japan, IMF managing director Christine Lagarde has been urging countries to not sacrifice growth for the sake of austerity, saying they should temper spending cuts to help create jobs and support future growth. Greece, Spain and other European countries laboring under massive debts have slashed spending and raised taxes, seeking to restore confidence in their public finances and qualify for emergency financing. The economies of financially healthier European countries, such as Germany and Finland, face a potential blow to growth if those troubled economies fail to get their financial houses in order. The IMF has scaled back its global growth forecast for 2012 to 3.3% from 3.5%, and has warned that even its dimmer outlook might prove too optimistic if Europe and the United States fail to resolve their crises.
  | | | | | | | | | | | | | | | | | | | | | | | | | Turkey's prime minister, Recep Tayyip Erdogan, says current system is unfair and fails to reflect will of most countries The Turkish prime minister has criticised the UN security council for failing to reach an agreement on how to respond to the bloody conflict in Syria. Recep Tayyip Erdogan told an international conference that the world had been witnessing a humanitarian tragedy in the 19 months since the uprising against Bashar al-Assad's regime began. He also called for reform of the council, which he described as an unequal and unfair system that failed to reflect the will of most countries. "If we leave the issue to the vote of one or two members of the permanent five at the United Nations security council, then the aftermath of Syria will be very hazardous and humanity will write it down in history with unforgettable remarks," Erdogan said. "It's high time to consider a structural change for international institutions, especially for the UN security council." Erdogan did not mention specific countries, but his comments were seen as referring to Russia and China, permanent members of the council, which have so far torpedoed resolutions that sought to put pressure on Damascus to end the conflict and agree a political transition. The violence in Syria has increased tensions between Damascus and Ankara, which were once allies. On Wednesday, Turkey intercepted a Syrian passenger plane en route from Moscow to Damascus and said it had seized military equipment. Syria said Turkey's operation was air piracy that lacked evidence, and Russia said the cargo contained radar parts that complied with international law. Last week five Turkish civilians were killed by a Syrian mortar in the border town of Akcakale. Turkey then authorised its troops to launch operations and strikes against Syrian targets. The UN security council said the incident showed the "grave impact" of the Syrian crisis on regional peace and stability. Erdogan, however, believes that the council is not doing enough to find a solution. Turkey's foreign minister, Ahmet Davutoglu, met Arab and European leaders on Saturday, including Lakhdar Brahimi, the UN-Arab League envoy for Syria, to discuss the escalating tensions. According to AFP, the German foreign minister, Guido Westerwelle, who was also due to have talks with Davutoglu, said: "It is important that no one pours oil on the fire. We are counting on moderation and de-escalation." The Syrian Observatory for Human Rights estimates that more 31,000 people have been in killed in Syria in a little over a year and half, and commentators say the ongoing tensions between the Syrian government and Turkey constitute a direct threat to international peace and security, as laid down in the UN charter.
 | | | | | | | | | | | | | | | | | | | | | | | | | State agencies face questions over enforcement of existing regulations covering compounding pharmacies Authorities in Massachusetts have been accused of failing to properly enforce regulations aimed at protecting patients from contaminated drugs, after the death toll from an outbreak of meningitis linked to a medicine made in the state rose to 14. The specialised compounding pharmacy at the centre of the escalating health scandal is being investigated for breaches of state and federal laws. A patient from Minnesota, one of almost 14,000 patients at risk of contracting the disease after being injected with the potentially tainted steroid produced by New England Compounding Center, has filed what is expected to be the first of many lawsuits against the company. Now state agencies are facing questions over their enforcement of existing regulations. On Friday, a congressional committee called on the state's pharmacy regulator to provide information about its oversight of the company. Massachusetts is one of just 17 states with regulations designed to protect patients from the sort of health scare which has now spread to 11 states. Two former compounding pharmacists who now work in the quality control industry told the Guardian that the risk to patients would have been minimal had the regulations, known as USP 797, been enforced. "It's abysmal that the local authorities are calling for greater oversight" said Eric Kastango, a committee member of US Pharmacopeia (USP), the industry body behind regulations governing compounding sterile drugs. "If someone just enforced Massachusetts law, these cases could have been avoided. They failed in their responsibility for enforcing what they already had." The scale of the outbreak makes it by far the worst of a series of fatal infections and overdoses connected to specialised "compounding" pharmacies. Each case has prompted calls for federal oversight of the drug-producers, which are not subject to the same controls as mass manufacturers but whose regulation falls between the state board of pharmacy, the state department of health and the Food and Drug Administration, which regulates the pharmaceutical industry. Kastango questioned how closely the state board of pharmacy had inspected NECC's books and said that the regulations adopted by the state to protect patients, if properly applied, should have avoided contamination. "If they had complied with USP 797 they would have avoided contamination. They would have found the source of it and remediated it. In my heart of hearts, I believe that." He said a company complying with the regulations would have more effectively "tested and they would have been monitoring their environment. They would have been cleaning the facilities. They would have been able to detect deviation in the process and they would have picked this up." The process to make the steroid was "extremely complex", requiring two major compounding procedures, one of which involves taking the solution and pumping it into vials without contamination. It would have been considered "high risk", he said. Kastango, a consultant in quality control who has 30 years experience in compounding, said that a recent, as yet unpublished analysis by the USP has found that in almost all of the recent cases where there have been health scares linked to compounding pharmacies, a breach of regulation USP 797 had been involved. The analysis included the infections from Avastin, which affected 16 people in Tennessee and Florida, leaving some of them blind, that was linked to a compounding company in Hollywood last year. "There is a need for states to enforce the UPS and to hold people to account to existing regulation and to ensure that people who are doing this know what they are doing" Kastango said. There have been 200 adverse events involving 71 compounded products since 1990, some of them with "devastating repercussions", according to the FDA. Three patients died of infections from drugs used in open-heart surgery in 2006 and two patients were blinded at a Veterans Affairs hospital in Washington due to a compound product that was used in cataract surgery in 2005. Last year, contaminated nutritional supplements from an Alabama company killed nine patients and injured 10 others. Kate Douglas, a former director of a compounding pharmacy who is now president of Performance Strategies LLC, which consults sterile compounding pharmacies on safety issues, said not enough was being done by state boards to enforce regulations and called for more funding for states to ensure compliance. "I can walk into a pharmacy and tell you within an hour whether they are following USP 797," she said. "But they need to find a way to get them inspected and hold them accountable. It's a challenge for state board of pharmacies. They need to make sure they are knowledgeable about 797 and maybe more funds are needed for states to do that." She added: "If you are a nurse or physician, you are held accountable to state regulations and you have to do the right thing and sometimes doing the right thing takes time. We can only reduce the risk of contamination, it can never drop to zero but if you follow the standards of practice you won't be killing people." The Massachusetts office of health and human services said it had taken "swift action" against the NECC, but pointed to loopholes in regulatory requirements which left them powerless. The state department of public health called on Congress to act to address the need for new laws. On Thursday, it accused the company of violating one state law which requires compounding pharmacies to only produce drugs to specified patients with a prescription. In a joint press briefing with the FDA and the Centers of Disease Control and Prevention, Madeleine Biondolillo, the department's director of heathcare and safety, said: "So, you know, NECC under Massachusetts board of pharmacy licensing regulations was licensed to deliver compounded products in response to individual patient specific prescriptions. "And it looks through the investigation as though they have violated that aspect of the state licensing regulation despite their assertion that they were operating under the regulations." In a statement to the Guardian, the department said: "The FDA and the Massachusetts Board of Pharmacy have conducted joint reviews of NECC for more than a decade. These collaborative investigations are essential to maximizing regulatory oversight, and ensuring public safety. "We've taken swift action to date, including securing the surrender of the company's license, obtaining a recall of all of its products and promptly notifying all providers and patients. We are jointly examining all root causes of these events with the FDA, and we are committed to ensuring that all responsible parties are held accountable. "We urge Congress to act quickly to address the need for new laws on the federal level to fill in the regulatory gaps, so that there is clear authority over regulating these practices." Federal and state regulators have also come under scrutiny for allowing a previously unknown pharmaceuticals sector known as compounding to grow at such a pace without much federal oversight. The industry has grown so large that some of the companies operate more like drug manufacturers than pharmacies, critics say. In 1997, the FDA got Congress to pass a law giving it more power to regulate compounding pharmacies. But in 2002, the US Supreme Court struck down its no-advertising provisions on First Amendment grounds, leaving the rest of the law in limbo.
  | | | | | | | | | | | | | | | | | | | | | | | | | Spokesman says 'we will send pictures of dead French hostages' after UN backs African-led force in north of country Islamists in Mali threatened Saturday to "open the doors of hell" for French citizens, in a statement following the adoption by the UN Security Council of a plan to oust al-Qaida linked militants from occupied territory. The UN resolution, proposed by France and approved Friday, expressed alarm over the infiltration by "al-Qaida in the Islamic Maghreb (AQIM), affiliated groups and other extremist groups," and condemned "the abuses of human rights committed in the north of Mali by armed rebels, terrorist and other extremist groups". The Islamists' renewed threats against French hostages held in the country and expatriates comes ahead of a summit of French-speaking nations in Congo, where President François Hollande is expected to urge the rapid deployment of an African-led force to rout the Islamists. "If he continues to throw oil on the fire, we will send him the pictures of dead French hostages in the coming days," said Oumar Ould Hamaha, a spokesman for Islamist group MUJWA, in an apparent reference to four French nationals who were seized in neighboring northern Niger in 2010. "He will not be able to count the bodies of French expatriates across West Africa and elsewhere." MUJWA is among the Islamist groups that have controlled the northern two-thirds of Mali since fighters swept the territory in April, following a coup in the capital Bamako. The UN's assistant secretary-general for human rights, Ivan Simonovic, returned from Mali to tell reporters this week that al-Qaida-affiliated Islamic militias have imposed a harsh version of Shariah law on the north. "The population is suffering," he said, adding that he had received testimony that forced marriage, forced prostitution and rape are widespread and that women are being sold as "wives" for less than $1,000 in northern Mali. Separately, Simonovic said: "It is frightening to hear that lists are being compiled of women who are either pregnant or have children and are not married. We don't know what will happen to them." AQIM had abolished taxes in the north and were using extortion, ransom payments and funds from drug transshipping to establish their rule, he said. Children are being recruited to build bombs and to serve as soldiers, with payments made to their families of $600 on enlistment and $400 a month afterward, in a territory in which half the population live son less than $1.25 a day, Simonovic said. Executions of captured soldiers and cases of rape had become "more systemic," he said. More than 1.5 million Malians have had to flee their homes, with some 40,000 displaced people in the regional city of Mopti. More than 100,000 refugees have registered in Mauritania, over 100,000 in Burkina Faso, 40,000 in Niger and 30,000 in Algeria. The UN resolution gives Secretary-General Ban Ki-moon 45 days to help Mali, the West Africans and the African Union develop plans to recover the occupied territory. It invokes Chapter Seven of the UN Charter, which opens the door to military intervention and enforcement of the council's decisions. It also calls for help from the European Union to help train and assist the Malian army to retake the north. Another resolution authorizing deployment and backing of the African peacekeeping force would have to come later, after Ban sends specific recommendations to the Security Council. The main thrust of the plan is likely to be hammered out at a 19 October meeting in Bamako, Mali, of representatives of the United Nations, t he Economic Community of West African States (ECOWAS), the AU, the European Union and neighboring countries. ECOWAS and Mali's transitional government asked the Security Council in September to authorize a military intervention to oust the al-Qaida linked Islamists. But the council said it wanted the West African group to prepare a "feasible" plan with "detailed options" for a force, and to coordinate with other African nations and the European Union. French president Hollande said Thursday that any military intervention must be carried out only by Africans. He emphasized France's willingness to provide material and training, but said: "There will be no [French] troops on the ground." Mali's democratically elected leader was ousted in a military coup in March. The junta accused him of failing to quell a rebellion in the north, which began in January. After the coup, Tuareg rebels took advantage of the power vacuum and within weeks took control of the north, aided by an Islamist faction. But the Islamists quickly ousted the Tuaregs and took control of half the country. Friday's resolution urges the transitional authorities and Malian secular rebel groups such as the Tauregs to cut off their ties to al-Qaida and negotiate as soon as possible "in order to seek a sustainable political solution" to the crisis.
  | | | | | | | | | | | | | | | | | | | | | | | | | Timothy Kurek, a graduate of the evangelical Liberty University, decided to 'walk in the shoes' of a gay man and emerged with his faith strengthened Timothy Kurek grew up hating homosexuality. As a conservative Christian deep in America's Bible belt, he had been taught that being gay was an abomination before God. He went to his right-wing church, saw himself as a soldier for Christ and attended Liberty University, the "evangelical West Point". But when a Christian friend in a karaoke bar told him how her family had kicked her out when she revealed she was a lesbian, Kurek began to question profoundly his beliefs and religious teaching. Amazingly, the 26-year-old decided to "walk in the shoes" of a gay man in America by pretending to be homosexual. For an entire year Kurek lived "under cover" as a homosexual in his home town of Nashville. He told his family he was gay, as well as his friends and his church. Only two pals and an aunt – used to keep an eye on how his mother coped with the news – knew his secret. One friend, a gay man called Shawn – whom Kurek describes as a "big black burly teddy bear" – pretended to be his boyfriend. Kurek got a job in a gay cafe, hung out in a gay bar and joined a gay softball league, all the while maintaining his inner identity as a straight Christian. The result was a remarkable book called The Cross in the Closet, which follows on the tradition of other works such as Black Like Me, by a white man in the 1960s deep south passing as a black American, and 2006's Self-Made Man, by Norah Vincent, who details her time spent in disguise living as a man. "In order to walk in their shoes, I had to have the experience of being gay. I had to come out to my friends and family and the world as a gay man," he told the Observer. Kurek's account of his year being gay is an emotional, honest and at times hilarious account of a journey that begins with him as a strait-laced yet questioning conservative, and ends up with him reaffirming his faith while also embracing the cause of gay equality. Along the way he sheds many friends, especially from Liberty, who wrote emails to him after he came out asking that he repent of his sins and warning that he faced damnation. He does not regret their loss. "I now have lots of new gay friends," Kurek said. But it was not a straightforward journey. Early on Kurek decided to try to acclimatise to Nashville's gay scene by visiting a gay nightclub. Entering alone, he soon found himself dragged on to the dance floor by a shirtless muscular man covered in baby oil and glitter. As the pair danced to Beyoncé, the man pretended to ride Kurek like a horse to the disco music and called him a "bucking bronco". It was all a bit too much, too soon. "I want to vomit. I need a cigarette. I feel like beating the hell out of him," Kurek writes. But soon things started going better. In order to avoid unwanted sexual passes from men, Kurek recruited Shawn to act as a faithful boyfriend and he rapidly became part of the Nashville gay scene. He explored gay culture and found it to be as diverse and interesting as any other slice of American life. In one gay bar, Kurek was stunned to discover gay Christians earnestly discussing their belief in creationism. "I found gay Christians more devout than me!" Kurek says. He became active in a gay rights group and wound up joining a protest outside the Vatican's embassy to the United Nations in New York. However, there was a cost to the experiment. In order to gauge his mother's true reaction to the news that her son was gay, Kurek read her private journal. In it he found that she had written: "I'd rather have found out from a doctor that I had terminal cancer than I have a gay son." But Kurek's journey also became her own. Eventually she too was won over and changed her views. "My mom went from being a very conservative Christian to being an ally to the gay community. I am very proud of her," he said. Kurek also experienced firsthand being called abusive names. Though he himself had once called gay protesters at Liberty "fags", he found himself on the other side of the fence of insults. During a softball practice session in Nashville, a man walking his dogs called Kurek and his team-mates "faggots". Kurek had to be restrained from confronting the man and then broke down in tears at the shock. "When I was first called that for real, I lost it. I saw red. I felt so violated by that word," he said. Finally Kurek's journey ended when he revealed his secret life and "came out" again, but this time as a straight Christian. However, he says that one of the most surprising elements of his journey was that it renewed his religious faith rather than undermined it. "Being gay for a year saved my faith," he said. Kurek also said that he felt his experience not only should show conservative Christians that gay people need equal rights and can be devout too, but that it can also reveal another side of evangelicals to the gay community. "The vast majority of conservative Christians are not hateful bigots at all. It is just a vocal minority that gets noticed and attracts all the attention," he said.
 | | | | | | | | | | | | | | | | | | | | | | | | | Ayman al-Zawahiri praises those who took part in deadly violence triggered by the film The Innocence of Muslims The leader of al-Qaida has called for holy war against the United States and Israel over an anti-Islamic video which triggered mayhem in the Muslim world. Ayman al-Zawahiri praised as demonstrators who breached the US embassy in Cairo and the attackers who stormed the US consulate in Benghazi last month in violence linked to the film as "honest and zealous". The Benghazi attack on 11 September, in which the US ambassador to Libya, Chris Stevens, and three others were killed, is now believed to have been carried out by al-Qaida-linked militants. The trailer for the film produced by Nakoula Basseley Nakoula, a California-based Egyptian-American angry at the treatment of Christians in his homeland, triggered mayhem across the Muslim world after it was uploaded to YouTube, with at least 17 people killed in violent protests. In an audio message released by al-Qaida's media arm As-Sahab and posted on militant websites on Saturday, al-Zawahiri claimed Washington had allowed the film's production under the pretext of freedom of expression, "but this freedom did not prevent them from torturing Muslim prisoners". Nakoula, 55, had been previously convicted of bank fraud before he embarked on making a film under the assumed name of Sam Bacile. The Innocence of Muslims depicts the prophet Muhammad in an extremely negative light, which inflamed many Muslims around the world and gave others the pretext for violence. There are unconfirmed reports the film was screened once earlier this year to a largely empty cinema in Hollywood. Not in question is the fact that in July a 13-minute video in English purporting to be a trailer for a full-length film was posted on YouTube under the pseudonym Sam Bacile. It was subsequently promoted by a Washington DC-based radical Coptic activist, Morris Sadik, and the Qur'an-burning Florida pastor Terry Jones. An Arabic-language version was posted on YouTube on 4 September. Five days later it was denounced by media and Muslim clerics in Egypt, prompting the assaults on US diplomatic missions.
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