Doping at U.S. Tracks Affects Europe’s Taste for Horse Meat





PARIS — For decades, American horses, many of them retired or damaged racehorses, have been shipped to Canada and Mexico, where it is legal to slaughter horses, and then processed and sold for consumption in Europe and beyond.







Christinne Muschi for The New York Times

A slaughterhouse in Saint-André-Avellin, Quebec, where meat is processed for sale in Europe.






Lately, however, European food safety officials have notified Mexican and Canadian slaughterhouses of a growing concern: The meat of American racehorses may be too toxic to eat safely because the horses have been injected repeatedly with drugs.


Despite the fact that racehorses make up only a fraction of the trade in horse meat, the European officials have indicated that they may nonetheless require lifetime medication records for slaughter-bound horses from Canada and Mexico, and perhaps require them to be held on feedlots or some other holding area for six months before they are slaughtered.


In October, Stephan Giguere, the general manager of a major slaughterhouse in Quebec, said he turned away truckloads of horses coming from the United States because his clients were worried about potential drug issues. Mr. Giguere said he told his buyers to stay away from horses coming from American racetracks.


“We don’t want them,” he said. “It’s too risky.”


The action is just the latest indication of the troubled state of American racing and its problems with the doping of horses. Some prominent trainers have been disciplined for using legal and illegal drugs, and horses loaded with painkillers have been breaking down in arresting numbers. Congress has called for reform, and state regulators have begun imposing stricter rules.


But for pure emotional effect, the alarm raised in the international horse-meat marketplace packs a distinctive punch.


Some 138,000 horses were sent to Canada or Mexico in 2010 alone to be turned into meat for Europe and other parts of the world, according to a Government Accountability Office report. Organizations concerned about the welfare of retired racehorses have estimated that anywhere from 10 to 15 percent of the population sent for slaughter may have performed on racetracks in the United States.


“Racehorses are walking pharmacies,” said Dr. Nicholas Dodman, a veterinarian on the faculty of Tufts University and a co-author of a 2010 article that sought to raise concerns about the health risks posed by American racehorses. He said it was reckless to want any of the drugs routinely administered to horses “in your food chain.”


Horses being shipped to Mexico and Canada are by law required to have been free of certain drugs for six months before being slaughtered, and those involved in their shipping must have affidavits proving that. But European Commission officials say the affidavits are easily falsified. As a result, American racehorses often show up in Canada within weeks — sometimes days — of their leaving the racetrack and their steady diets of drugs.


In October, the European Commission’s Directorate General for Health and Consumers found serious problems while auditing the operations of equine slaughter facilities in Mexico, where 80 percent of the horses arrive from the United States. The commission’s report said Mexican officials were not allowed to question the “authenticity or reliability of the sworn statements” about the ostensibly drug-free horses, and thus had no way of verifying whether the horses were tainted by drugs.


“The systems in place for identification, the food-chain information and in particular the affidavits concerning the nontreatment for six months with certain medical substances, both for the horses imported from the U.S. as well as for the Mexican horses, are insufficient to guarantee that standards equivalent to those provided for by E.U. legislation are applied,” the report said.


The authorities in the United States and Canada acknowledge that oversight of the slaughter business is lax. On July 9, the United States Food and Drug Administration sent a warning letter to an Ohio feedlot operator who sells horses for slaughter. The operator, Ronald Andio, was reprimanded for selling a drug-tainted thoroughbred horse to a Canadian slaughterhouse.


The Canadian Food Inspection Agency had tested the carcass of the horse the previous August and found the anti-inflammatory drug phenylbutazone in the muscle and kidney tissues. It also discovered clenbuterol, a widely abused medication for breathing problems that can build muscle by mimicking anabolic steroids.


Because horses are not a traditional food source in the United States, the Food and Drug Administration does not require human food safety information as it considers what drugs can be used legally on horses. Patricia El-Hinnawy, a spokeswoman for the agency, said agency-approved drugs intended for use in horses carried the warning “Do not use in horses intended for human consumption.”


She also said the case against Mr. Andio remained open.


“On the warning letter, the case remains open and no further information can be provided at this time,” Ms. El-Hinnawy said.


Read More..

Doping at U.S. Tracks Affects Europe’s Taste for Horse Meat





PARIS — For decades, American horses, many of them retired or damaged racehorses, have been shipped to Canada and Mexico, where it is legal to slaughter horses, and then processed and sold for consumption in Europe and beyond.







Christinne Muschi for The New York Times

A slaughterhouse in Saint-André-Avellin, Quebec, where meat is processed for sale in Europe.






Lately, however, European food safety officials have notified Mexican and Canadian slaughterhouses of a growing concern: The meat of American racehorses may be too toxic to eat safely because the horses have been injected repeatedly with drugs.


Despite the fact that racehorses make up only a fraction of the trade in horse meat, the European officials have indicated that they may nonetheless require lifetime medication records for slaughter-bound horses from Canada and Mexico, and perhaps require them to be held on feedlots or some other holding area for six months before they are slaughtered.


In October, Stephan Giguere, the general manager of a major slaughterhouse in Quebec, said he turned away truckloads of horses coming from the United States because his clients were worried about potential drug issues. Mr. Giguere said he told his buyers to stay away from horses coming from American racetracks.


“We don’t want them,” he said. “It’s too risky.”


The action is just the latest indication of the troubled state of American racing and its problems with the doping of horses. Some prominent trainers have been disciplined for using legal and illegal drugs, and horses loaded with painkillers have been breaking down in arresting numbers. Congress has called for reform, and state regulators have begun imposing stricter rules.


But for pure emotional effect, the alarm raised in the international horse-meat marketplace packs a distinctive punch.


Some 138,000 horses were sent to Canada or Mexico in 2010 alone to be turned into meat for Europe and other parts of the world, according to a Government Accountability Office report. Organizations concerned about the welfare of retired racehorses have estimated that anywhere from 10 to 15 percent of the population sent for slaughter may have performed on racetracks in the United States.


“Racehorses are walking pharmacies,” said Dr. Nicholas Dodman, a veterinarian on the faculty of Tufts University and a co-author of a 2010 article that sought to raise concerns about the health risks posed by American racehorses. He said it was reckless to want any of the drugs routinely administered to horses “in your food chain.”


Horses being shipped to Mexico and Canada are by law required to have been free of certain drugs for six months before being slaughtered, and those involved in their shipping must have affidavits proving that. But European Commission officials say the affidavits are easily falsified. As a result, American racehorses often show up in Canada within weeks — sometimes days — of their leaving the racetrack and their steady diets of drugs.


In October, the European Commission’s Directorate General for Health and Consumers found serious problems while auditing the operations of equine slaughter facilities in Mexico, where 80 percent of the horses arrive from the United States. The commission’s report said Mexican officials were not allowed to question the “authenticity or reliability of the sworn statements” about the ostensibly drug-free horses, and thus had no way of verifying whether the horses were tainted by drugs.


“The systems in place for identification, the food-chain information and in particular the affidavits concerning the nontreatment for six months with certain medical substances, both for the horses imported from the U.S. as well as for the Mexican horses, are insufficient to guarantee that standards equivalent to those provided for by E.U. legislation are applied,” the report said.


The authorities in the United States and Canada acknowledge that oversight of the slaughter business is lax. On July 9, the United States Food and Drug Administration sent a warning letter to an Ohio feedlot operator who sells horses for slaughter. The operator, Ronald Andio, was reprimanded for selling a drug-tainted thoroughbred horse to a Canadian slaughterhouse.


The Canadian Food Inspection Agency had tested the carcass of the horse the previous August and found the anti-inflammatory drug phenylbutazone in the muscle and kidney tissues. It also discovered clenbuterol, a widely abused medication for breathing problems that can build muscle by mimicking anabolic steroids.


Because horses are not a traditional food source in the United States, the Food and Drug Administration does not require human food safety information as it considers what drugs can be used legally on horses. Patricia El-Hinnawy, a spokeswoman for the agency, said agency-approved drugs intended for use in horses carried the warning “Do not use in horses intended for human consumption.”


She also said the case against Mr. Andio remained open.


“On the warning letter, the case remains open and no further information can be provided at this time,” Ms. El-Hinnawy said.


Read More..

Thefts a Concern as Holiday Deliveries Increase


Librado Romero/The New York Times


A driver in Midtown Manhattan on Friday. U.P.S. expects to deliver more than 500 million packages this season, leaving some to fear a rise in thefts.







A pair of brown leather boots was snatched last week from a doorstep in the suburbs of Chicago. A computer disappeared from a front porch in Fort Worth last month, and an iPad case was stolen outside a Long Island home this week.




As the peak of the holiday gift-buying season approaches and more people are ordering online, here is the downside: Grinch-like bandits are swiping the deliveries from doorsteps when families are not home. Some thieves follow U.P.S. and FedEx trucks along their routes and nab the gifts, while others simply drive through residential neighborhoods looking for packages.


In River Forest, Ill., where the police arrested two young men last week, accusing them of stealing deliveries from homes, plainclothes police officers trail U.P.S. trucks to ferret out thieves who may be following them, Cmdr. Jim O’Shea said.


“This is common at this time of year,” Commander O’Shea said. “We’re trying to take a proactive approach to curtail this.”


So far this holiday season, Americans have spent $21.4 billion online, up 14 percent from last year, according to comScore, a research company. U.P.S. alone expects to deliver more than 500 million packages, and with many of them being left on doorsteps, there could be ample opportunity for thieves to strike.


The Better Business Bureau now recommends that customers be proactive, asking their shipping companies for tracking numbers and requiring signatures upon delivery. If they are not at home, customers should ask for their packages to be held at a lobby desk or at a local shipping center, advised Claire Rosenzweig, the president of the group’s New York chapter.


 


There are no national statistics on doorstep thefts, but reports of local episodes abound. In Burbank, Calif., with five reported incidents this year, compared with one last year, two teenagers were arrested last month after they were found trailing a U.P.S. truck. One young man was released, while the other person, Ararat Gevondyan, 19, was charged with receiving stolen property, with his bail set at $10,000.


“It’s a crime of opportunity,” Sgt. Darin Ryburn of the Burbank Police Department said. The burglars are “going through these packages for items that could be resold,” he said.


On Long Island, two young men were arrested this week, suspected of stealing headphones, an iPad case and two pairs of Skechers shoes from homes in the Bay Shore area.


A few of the thefts have been caught by home surveillance cameras set up to catch or deter vandals. A television station in Pasadena, Calif., showed a video of a woman taking a package from a doorstep. The homeowner said she never got the Paula Deen electric salt-and-pepper shaker her sister had sent her.


While it may seem extreme to install cameras to keep an eye on packages, this type of home surveillance has become more common in recent years, said Marc Horowitz, a spokesman for Brickhouse Security. The company’s sales for home security cameras have more than doubled in the past year, he said, as the cameras have become less expensive. A simple motion-activated porch camera costs about $100.


Some camera customers fear the culprit is closer to home, breaking that commandment of the cul-de-sac, Do Not Covet Thy Neighbor’s Flat-Screen TV.


Mr. Horowitz said he had heard reports from his sales representatives that some customers were buying cameras because they suspected neighbors of pilfering packages (or newspapers and plants).


U.P.S. started a program last year called U.P.S. My Choice, which allows a customer to receive an e-mail or text message before a package arrives and reroute it if no one is going to be home.


U.P.S. drivers are also trained to leave packages out of sight, said Natalie Godwin, a company spokeswoman. Ms. Godwin was with a driver in Atlanta on Tuesday when he decided not to leave a package on someone’s stoop because it was clearly an expensive computer monitor. He dropped it off nearby at the apartment complex’s office.


Drivers leave notes telling the tenants where to find packages, Ms. Godwin said. Often, she added, “They’ll use their own judgment.”


Read More..

Somber Chávez to Have Surgery and Names Successor





LA PAZ, Bolivia — President Hugo Chávez of Venezuela announced Saturday in Caracas that he would have to undergo another operation for cancer, and he designated his vice president, Nicolás Maduro, as his successor if he should prove unable to continue to lead the country.




Mr. Chávez, appearing somber and contemplative, made the announcement in a televised address from the presidential palace. Mr. Maduro sat to his left, and several other cabinet members were also present.


It was the first time that Mr. Chávez had said publicly whom he wanted as his successor. Mr. Chávez said that he would fly to Havana on Sunday for the operation. The announcement came just weeks after he was elected to a new six-year term, beginning in early January.


He said Saturday that tests immediately after his re-election found no cancer. But he said he later experienced swelling and pain. He went to Cuba on Nov. 27 for what the government said was hyperbaric treatment meant to aid in healing.


Exhaustive tests at the time found “some malignant cells,” Mr. Chávez said.


“With the favor of God, as on the previous occasions, we will be victorious,” he added.


But he acknowledged the possibility that he may not be able to continue as president or begin his new term. If he is unable to do so, the Constitution says that new elections would have to be called within 30 days.


In that case, he said, “my strong opinion, as clear as the full moon, irrevocable, absolute, total” is that “you should elect Nicolás Maduro” as the new president.


“I ask it from my heart,” he added.


Mr. Chávez said that he was in a significant amount of pain and that his doctors had urged him to have the operation no later than Friday, but he had insisted on postponing it so that he could return briefly from Cuba, where he had been undergoing medical treatment. He flew back to Caracas on Friday.


Mr. Chávez first received a cancer diagnosis in June 2011. He had surgery and chemotherapy, but in February he said the cancer had returned. He then had another operation, followed by radiation treatment.


He has refused to say what kind of cancer he has, or exactly where in his body it had appeared.


Mr. Maduro is a former bus driver and legislator who has served for years as Venezuela’s foreign minister.


Read More..

Art and Commerce Meet in Miami Beach


Katie Orlinsky for The New York Times


Visitors at the V.I.P. opening of Art Basel Miami Beach.







MIAMI — Mera Rubell was taking time out from greeting the hundreds of visitors at her family’s sprawling contemporary art center here to vent.




“It’s the height of arrogance to dismiss — — ,” she began.


Jason, her son, interrupted: “It’s arrogance. It’s a completely uninteresting story.”


For the moment her husband, Don, had given up on trying to get a word in.


The Rubells, deans of Miami’s bustling art scene, were pushing back against a chorus of complaints that has been growing louder in the weeks leading up to Art Basel Miami Beach, the annual art pilgrimage that began Wednesday and ends Sunday.


Prominent art writers and critics, including Sarah Thornton, Felix Salmon, Will Gompertz and Dave Hickey, have been attacking the art world, arguing that the staggering sums of money being spent on works are distorting judgments about art and undermining its long-term cultural significance.


“Money talks loudly and easily drowns out other meanings,” Ms. Thornton wrote in TAR magazine in a recent article, “Top 10 Reasons NOT to Write About the Art Market.”


In its special edition for the opening day of the fair, The Art Newspaper asked whether “the art world is facing a crisis of values” because of the “pernicious influence of the market on art.”


And in the eyes of many critics, Art Basel Miami Beach — or what Simon Doonan, writing in Slate last week, labeled a “promo-party cheese-fest” — has become a symbol of everything that’s wrong with the art market. The fair’s extraordinary success in just over a decade, and its celebration of wretched excess, have triggered a backlash.


But the Rubells, along with a growing number of other prominent collectors, art dealers and curators, are having none of it. The backlash against the backlash has begun.


“The market supports artists,” Jason Rubell said. Given the limited amount of government support for the arts, he added, “it’s an industry that without commerce doesn’t exist. What do people want — to go back to the recession?”


Ms. Rubell was annoyed that critics seemed to ignore the social, economic and cultural transformation of Miami that the fair and collectors like her have helped bring about. She noted that the Rubells’ 45,000-square-foot art center — where one huge gallery is now filled with works by Oscar Murillo, a 26-year-old Colombian immigrant who lived with and was supported by the Rubells while he created dozens of mural-sized canvases — used to be a Drug Enforcement Administration storage center.


Outside, in the center’s courtyard, visitors like Martha Stewart admired the French artist Bernar Venet’s collaboration with Bugatti, the superluxury sports car brand, on a one-of-a-kind Veyron Grand Sport Venet car (a price hasn’t been set, a Bugatti spokeswoman said, but will undoubtedly be in “the higher end of the millions”).


“I’m grateful to Bugatti, Perrier, Bank of America and other companies,” Ms. Rubell declared. “Their support helps facilitate quality programs and opens exhibits like this” — the Murillo show — “to the public.”


In Miami Beach, at the main fair, the consumer-oriented glitter abounds this week: coffee carts with $20-a-glass Ruinart Champagne; Davidoff cigar rollers; BMW’s artist-designed cars; and Takashi Murakami’s $70,000-and-up commissioned portraits. One could almost imagine that the Barbara Kruger work on display at L&M gallery — a super-sized sign reading “Greedy” on one line and an unprintable expletive on the next — had an invisible subtitle telling the wealthy V.I.P.’s who had come to shop, “I’m Talking to You — Yeah, You!”


Of course, rich patrons have always supported artists, Don Rubell pointed out, from the pharaohs to the Medicis. Today, multimillion-dollar sales represent only a silk-thin layer of a deeply varied and thriving art market. The art world, Mr. Rubell asserted, is “actually becoming more democratic.”


“There’s 20 ancillary fairs” in addition to the high-end main event of Art Basel, he said. “Whatever amount of money you have in your pocket, you can enter this magical world of art.”


The notion that the art market contains multitudes is one with which Marc Glimcher, part of the family dynasty that runs the Pace Gallery, said he agreed.


Read More..

Justices to Take Up Generic Drug Case





WASHINGTON — The Supreme Court said on Friday that it would decide whether a pharmaceutical company should be allowed to pay a competitor millions of dollars to keep a generic copy of a best-selling drug off the market.







Stephen Crowley/The New York Times

Ralph Neas, head of the Generic Pharmaceutical Association, said the case would alter the marketing of new generics.







The case could settle a decade-long battle between federal regulators, who say the deals violate antitrust law, and the pharmaceutical industry, which contends that they are really just settlements of disputes over patents that protect the billions of dollars they pour into research and development.


Three separate federal circuit courts of appeal have ruled over the last decade that the deals were allowable. But in July a federal appeals court in Philadelphia — which covers the territory where many big drug makers are based — said the arrangements were anticompetitive.


Both sides in the case supported the petition for the Supreme Court to decide the case, each arguing that the conflicting appeals court decisions would inject uncertainty into their operations.


By keeping lower-priced generic drugs off the market, drug companies are able to charge higher prices than they otherwise could. Last year, the Congressional Budget Office estimated that a Senate bill to outlaw those payments would lower drug costs in the United States by $11 billion and would save the federal government $4.8 billion over 10 years.


Senator Charles E. Grassley, an Iowa Republican who co-sponsored the Senate bill, which never came to the floor for a vote, praised the decision.


The Federal Trade Commission first filed the suit in question in 2009. Jon Leibowitz, chairman of the F.T.C., said, “These pay-for-delay deals are win-win for the drug companies, but big losers for U.S. consumers and taxpayers.”


Generic drug makers say that the payments preserve a system that has saved American consumers hundreds of billions of dollars.


“This case could determine how an entire industry does business because it would dramatically affect the economics of each decision to introduce a new generic drug,” Ralph G. Neas, president of the Generic Pharmaceutical Association, said in a statement. “The current industry paradigm of challenging patents on branded drugs in order to bring new generics to market as soon as possible has produced $1.06 trillion in savings over the past 10 years.”


The case will review a decision by the United States Court of Appeals for the 11th Circuit, based in Atlanta, which in the spring ruled in favor of the drug makers, Watson Pharmaceuticals and Solvay Pharmaceuticals. Watson had applied for federal approval to sell a generic version of AndroGel, a testosterone replacement drug made by Solvay.


While courts have long held that paying a competitor to stay off the market creates unfair competition, the pharmaceuticals case is different because it involves patents, whose essential purpose is to prevent competition.


When a generic manufacturer seeks approval to market a copy of a brand-name drug, it also often files a lawsuit challenging a patent that the drug’s originator says prevents competition.


Last year, for the third time since 2003, the 11th Circuit upheld the agreements as long as the allegedly anticompetitive behavior that results — in this case, keeping the generic drug off the market — is the same thing that would take place if the brand-name company’s patent were upheld.


Two other federal circuit courts, the Second Circuit and the Federal Circuit, have ruled similarly. But in July, the Third Circuit Court of Appeals said that those arrangements were anticompetitive on their face and violated antitrust law.


The agreements are also affected by a peculiar condition in the law that legalized generic competition for prescription drugs. That law, known as the Hatch-Waxman Act, gives a 180-day period of exclusivity to the first generic drug maker to file for approval of a generic copy and to file a lawsuit challenging the brand-name drug’s patent.


Brand-name drug companies have taken advantage of that law, finding that they can settle the patent suit by getting the generic company to agree to stay out of the market for a period of time. Because that generic company also has exclusivity rights, no other generic companies can enter the market.


Michael A. Carrier, a professor at Rutgers School of Law-Camden, said that while there were provisions in the law under which a generic company could forfeit that exclusivity, “they really are toothless in practice.”


One wild card could still prevent the Supreme Court from definitively settling the question. In granting the petition to hear the case, the Supreme Court said that Justice Samuel A. Alito Jr. recused himself, taking no part in the consideration or decision.


That opens the possibility that a 4-4 decision could result, upholding the lower court case that went against the F.T.C. and in favor of the drug makers. But it would leave the broader question for another day.


The case is Federal Trade Commission v. Watson Pharmaceuticals et al, No. 12-416.


Read More..

Justices to Take Up Generic Drug Case





WASHINGTON — The Supreme Court said on Friday that it would decide whether a pharmaceutical company should be allowed to pay a competitor millions of dollars to keep a generic copy of a best-selling drug off the market.







Stephen Crowley/The New York Times

Ralph Neas, head of the Generic Pharmaceutical Association, said the case would alter the marketing of new generics.







The case could settle a decade-long battle between federal regulators, who say the deals violate antitrust law, and the pharmaceutical industry, which contends that they are really just settlements of disputes over patents that protect the billions of dollars they pour into research and development.


Three separate federal circuit courts of appeal have ruled over the last decade that the deals were allowable. But in July a federal appeals court in Philadelphia — which covers the territory where many big drug makers are based — said the arrangements were anticompetitive.


Both sides in the case supported the petition for the Supreme Court to decide the case, each arguing that the conflicting appeals court decisions would inject uncertainty into their operations.


By keeping lower-priced generic drugs off the market, drug companies are able to charge higher prices than they otherwise could. Last year, the Congressional Budget Office estimated that a Senate bill to outlaw those payments would lower drug costs in the United States by $11 billion and would save the federal government $4.8 billion over 10 years.


Senator Charles E. Grassley, an Iowa Republican who co-sponsored the Senate bill, which never came to the floor for a vote, praised the decision.


The Federal Trade Commission first filed the suit in question in 2009. Jon Leibowitz, chairman of the F.T.C., said, “These pay-for-delay deals are win-win for the drug companies, but big losers for U.S. consumers and taxpayers.”


Generic drug makers say that the payments preserve a system that has saved American consumers hundreds of billions of dollars.


“This case could determine how an entire industry does business because it would dramatically affect the economics of each decision to introduce a new generic drug,” Ralph G. Neas, president of the Generic Pharmaceutical Association, said in a statement. “The current industry paradigm of challenging patents on branded drugs in order to bring new generics to market as soon as possible has produced $1.06 trillion in savings over the past 10 years.”


The case will review a decision by the United States Court of Appeals for the 11th Circuit, based in Atlanta, which in the spring ruled in favor of the drug makers, Watson Pharmaceuticals and Solvay Pharmaceuticals. Watson had applied for federal approval to sell a generic version of AndroGel, a testosterone replacement drug made by Solvay.


While courts have long held that paying a competitor to stay off the market creates unfair competition, the pharmaceuticals case is different because it involves patents, whose essential purpose is to prevent competition.


When a generic manufacturer seeks approval to market a copy of a brand-name drug, it also often files a lawsuit challenging a patent that the drug’s originator says prevents competition.


Last year, for the third time since 2003, the 11th Circuit upheld the agreements as long as the allegedly anticompetitive behavior that results — in this case, keeping the generic drug off the market — is the same thing that would take place if the brand-name company’s patent were upheld.


Two other federal circuit courts, the Second Circuit and the Federal Circuit, have ruled similarly. But in July, the Third Circuit Court of Appeals said that those arrangements were anticompetitive on their face and violated antitrust law.


The agreements are also affected by a peculiar condition in the law that legalized generic competition for prescription drugs. That law, known as the Hatch-Waxman Act, gives a 180-day period of exclusivity to the first generic drug maker to file for approval of a generic copy and to file a lawsuit challenging the brand-name drug’s patent.


Brand-name drug companies have taken advantage of that law, finding that they can settle the patent suit by getting the generic company to agree to stay out of the market for a period of time. Because that generic company also has exclusivity rights, no other generic companies can enter the market.


Michael A. Carrier, a professor at Rutgers School of Law-Camden, said that while there were provisions in the law under which a generic company could forfeit that exclusivity, “they really are toothless in practice.”


One wild card could still prevent the Supreme Court from definitively settling the question. In granting the petition to hear the case, the Supreme Court said that Justice Samuel A. Alito Jr. recused himself, taking no part in the consideration or decision.


That opens the possibility that a 4-4 decision could result, upholding the lower court case that went against the F.T.C. and in favor of the drug makers. But it would leave the broader question for another day.


The case is Federal Trade Commission v. Watson Pharmaceuticals et al, No. 12-416.


Read More..

In Private Manning Case, Jailers Become the Accused


Patrick Semansky/Associated Press


Pfc. Bradley Manning faces a potential life sentence if convicted of leaking documents.







FORT MEADE, Md. — In a half-empty courtroom here, with a crew of fervent supporters in attendance, Pfc. Bradley Manning and his lawyer have spent the last two weeks turning the tables on the government.




Private Manning faces a potential life sentence if convicted on charges that he gave WikiLeaks, the antisecrecy organization, hundreds of thousands of confidential military and diplomatic documents. But for now, he has been effectively putting on trial his former jailers at the Quantico, Va., Marine Corps base. His lawyer, David E. Coombs, has grilled one Quantico official after another, demanding to know why his client was kept in isolation and stripped of his clothing at night as part of suicide-prevention measures.


Mr. Coombs, a polite but relentless interrogator who stands a foot taller than his client, has laid bare deep disagreements inside the military: psychiatrists thought the special measures unnecessary, while jail commanders ignored their advice and kept the suicide restrictions in place. In a long day of testimony last week, Private Manning of the Army, vilified as a dangerous traitor by some members of Congress but lauded as a war-crimes whistle-blower on the political left, heartened his sympathizers with an eloquent and even humorous performance on the stand.


“He was engaged, chipper, optimistic,” said Bill Wagner, 74, a retired NASA solar physicist who is a courtroom regular, dressed in the black “Truth” T-shirt favored by Private Manning’s supporters.


Private Manning, who turns 25 on Dec. 17 and looks much younger, was quietly attentive during Friday’s court session, in a dress uniform, crew-cut blond hair and wire-rimmed glasses. If his face were not already familiar from television news, he might have been mistaken for a first-year law student assisting the defense team.


It seemed incongruous that he has essentially acknowledged responsibility for the largest leak of classified material in history. The material included a quarter-million State Department cables whose release may have chilled diplomats’ ability to do their work discreetly but also helped fuel the Arab Spring; video of American helicopter crews shooting people on the ground in Baghdad who they thought were enemy fighters but were actually Reuters journalists; field reports on the wars in Iraq and Afghanistan; and confidential assessments of the detainees locked up at Guantánamo Bay, Cuba.


As the military pursues the case against Private Manning, the Justice Department continues to explore the possibility of charging WikiLeaks’ founder, Julian Assange, or other activists with the group, possibly as conspirators in Private Manning’s alleged offense. Federal prosecutors in Alexandria, Va., are still assigned to that investigation, according to law enforcement officials, but it is not clear how active they have been lately in presenting evidence to a grand jury.


The current tone of the legal proceedings against Private Manning is most likely temporary. His lawyer is asking the judge overseeing the case to throw out the charges on the ground that his pretrial treatment was unlawful, but that outcome appears unlikely.


As a fallback, Mr. Coombs is hoping the court will at least give Private Manning extra credit against any ultimate sentence for the time he spent held under harsh conditions at Quantico and earlier in Kuwait, where he was kept in what he described as “an animal cage.” After the uproar about his treatment, including public criticism from the State Department’s top spokesman and the United Nations’ top torture expert, military officials moved Private Manning in April 2011 from Quantico to a new prison at Fort Leavenworth, Kan., where he has not faced the same restrictions on clothing, sleeping conditions and conversation with other inmates.


As if to underscore the gravity of his legal predicament, Private Manning offered last month to plead guilty to lesser charges that could send him to prison for 16 years. Prosecutors have not said whether they are interested in such a deal, which would mean they would have to give up seeking a life sentence for the most serious charges: aiding the enemy and violating the Espionage Act.


Friday’s court session was attended by a dozen Manning loyalists, including Thomas A. Drake, the former National Security Agency official who was accused of leaking documents and pleaded guilty to a minor charge last year. They heard the commander of the Quantico brig, or military jail, explain why she refused Private Manning’s request to be taken off “prevention of injury” status.


Scott Shane reported from Fort Meade, and Charlie Savage from Washington.



Read More..

The Human Price: Bangladesh Fire Exposes Safety Gap in Supply Chain





ASHULIA, Bangladesh — The fire alarm shattered the monotony of the Tazreen Fashions factory. Hundreds of seamstresses looked up from their machines, startled. On the third floor, Shima Akhter Pakhi had been stitching hoods onto fleece jackets. Now she ran to a staircase.




But two managers were blocking the way. Ignore the alarm, they ordered. It was just a test. Back to work. A few women laughed nervously. Ms. Pakhi and other workers returned to their sewing tables. She could stitch a hood to a jacket in about 90 seconds. She arranged the fabric under her machine. Ninety seconds. Again. Ninety more seconds. She sewed six pieces, maybe seven.


Then she looked up.


Smoke was filtering up through the three staircases. Screams rose from below. The two managers had vanished. Power suddenly went out throughout the eight-story building. There was nowhere to escape. The staircases led down into the fire. Iron grilles blocked the windows. A man cowering in a fifth-floor bathroom called his mother to tell her he was about to die.


“We all panicked,” Ms. Pakhi said. “It spread so quickly. And there was no electricity. It was totally dark.”


Tazreen Fashions Ltd. operated at the beginning of the global supply chain that delivers clothes made in Bangladesh to stores in Europe and the United States. By any measure, the factory was not a safe place to work. Fire safety preparations were woefully inadequate. The building itself was under construction — even as sewing work continued inside — and mounds of flammable yarn and fabric were illegally stored on the ground floor near electrical generators.


Yet Tazreen was making clothing destined for some of the world’s top retailers. On the third floor, where firefighters later recovered 69 bodies, Ms. Pakhi was stitching sweater jackets for C&A, a European chain. On the fifth floor, workers were making Faded Glory shorts for Walmart. Ten bodies were recovered there. On the sixth floor, a man named Hashinur Rahman put down his work making True Desire lingerie for Sears and eventually helped save scores of others. Inside one factory office, labor activists found order forms and drawings for a licensee of the United States Marine Corps that makes commercial apparel with the Marines’ logo.


In all, 112 workers were killed in a blaze last month that has exposed a glaring disconnect among global clothing brands, the monitoring system used to protect workers and the factories actually filling the orders. After the fire, Walmart, Sears and other retailers made the same startling admission: They say they did not know that Tazreen Fashions was making their clothing.


But who, then, is ultimately responsible when things go so wrong?


The global apparel industry aspires to operate with accountability that extends from distant factories to retail stores. Big brands demand that factories be inspected by accredited auditing firms so that the brands can control quality and understand how, where and by whom their goods are made. If a factory does not pass muster, it is not supposed to get orders from Western customers.


Tazreen Fashions was one of many clothing factories that exist on the margins of this system. Factory bosses had been faulted for violations during inspections conducted on behalf of Walmart and at the behest of the Business Social Compliance Initiative, a European organization.


Yet Tazreen Fashions received orders anyway, slipping through the gaps in the system by delivering the low costs and quick turnarounds that buyers — and consumers — demand. C&A, the European retailer, has confirmed ordering 220,000 sweaters from the factory. But much of the factory’s business came through opaque networks of subcontracts with suppliers or local buying houses. Labor activists, combing the site of the disaster, found labels, order forms, design drawings and articles of clothing from many global brands.


Walmart and Sears have since said they fired the suppliers that subcontracted work to Tazreen Fashions. Yet some critics have questioned how a company like Walmart, one of the two biggest buyers in Bangladesh and renowned for its sophisticated global supply system, could have been unaware of the connection.


Julfikar Ali Manik contributed reporting from Ashulia, and Steven Greenhouse from New York.



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Drug Makers Challenge Pill Disposal Law in California





Brand name drug makers and their generic counterparts rarely find themselves on the same side of an issue, but now they are making an exception. They have teamed up to fight a local law in California, the first in the nation, that makes them responsible for running — and paying for — a program that would allow consumers to turn in unused medicines for proper disposal.




Such so-called drug take-back programs are gaining in popularity because of a growing realization that those leftover pills in your medicine cabinet are a potential threat to public health and the environment.


Small children might accidentally swallow them and teenagers will experiment with them, advocates of the laws say. Prescription drug abusers can, and are, breaking into homes in search of them. Unused pills are sometimes flushed down the toilet, so pharmaceuticals are now polluting waterways and even drinking water. One study found the antidepressant Prozac in the brains of fish.


Most such take-back programs are run by local or other government agencies. But increasingly there are calls to make the pharmaceutical industry pay.


“We feel the industry that profits from the sales of these products should have the financial responsibility for proper management and disposal,” said Miriam Gordon, California director of Clean Water Action, an advocacy group.


In July, Alameda County, Calif., which includes Oakland and Berkeley, became the first locality to enact such a requirement. Drug companies have to submit plans for accomplishing it by July 1, 2013.


But the industry plans to file a lawsuit in United States District Court in Oakland on Friday, hoping to have the law struck down. The suit is being filed by the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents brand-name drug companies, the Generic Pharmaceutical Association and the Biotechnology Industry Organization.


James M. Spears, general counsel of PhRMA, said the Alameda ordinance violated the Constitution in that a local government was interfering with interstate commerce, a right reserved for Congress.


“They are telling a company in New Jersey that you have to come in and design and implement and pay for a municipal service in California,” he said in an interview.


“This program is one where the cost is shifted to companies and individuals who are not located in Alameda County and who won’t be served by it.”


Mr. Spears, who is known as Mit, said that the program would cost millions of dollars a year to run and that pharmaceutical companies were “not in the waste disposal business.” He said it would be best left to sanitation departments and law enforcement agencies, which must be involved if narcotics, like pain pills, were to be transported.


Nathan A. Miley, the president of the Alameda County Board of Supervisors and the champion of the legislation, said late Thursday, “It’s just unfortunate that PhRMA would fight this because it would be pennies for them.”


“We will win legally and will win in the court of public opinion as well,” Mr. Miley said.


The battle in Alameda could set the direction for other states and localities. Legislators in seven states have introduced bills to require drug companies to pay for take-back programs in the last few years, said Scott Cassel, founder and chief executive of the Product Stewardship Institute, a nonprofit group that advocates such programs. But none of the bills have passed.


Mr. Cassel said about 70 similar “extended producer responsibility” laws have been enacted in 32 states for other products, like electronic devices, mercury-containing thermometers, fluorescent lamps, paint and batteries. He said he was not aware that any had been struck down on constitutional grounds.


The pharmaceutical industry already pays for take-back programs in some other countries. The law in Alameda is modeled partly on the system in British Columbia and two other Canadian provinces. There, the industry formed the Post-Consumer Pharmaceutical Stewardship Association, which runs the programs.


Consumers can take unused drugs back to pharmacies, from which they are periodically collected. Drug companies pay for the program in proportion to their market share, said Ginette Vanasse, executive director of the association. The program for British Columbia, with a population over four million, costs about $500,000 a year, she said.


The extent of the problem of unused pills and how best to handle them are matters of debate.


The United States Geological Survey has found various drugs, including antidepressants, antibiotics, heart medicines and hormones, in waterways it has sampled. Sewage treatment plants and drinking water treatment plants are not meant to remove pharmaceuticals.


Still, it is not known what effect the chemicals might have. “It’s a hard-to-pin-down problem,” said Sonya Lunder, a senior analyst at the Environmental Working Group, an advocacy group. It is thought that trace amounts in drinking water are probably not harmful. But larger amounts found in wastewater could be having an impact on wildlife.


It is also unclear whether take-back programs will help. Experts generally agree that the bigger source of pollution is urine and feces containing the remnants of drugs that are ingested, not the unused pills flushed down the toilet.


PhRMA also argues that take-back programs will not help much with the problem of drug abuse either. Mr. Spears said that it was better to have consumers tie up unused pills in a plastic bag and throw them in the trash. That is more effective, he said, because people would not have to travel to a collection point. Such collection points could become targets for thieves and drug abusers.


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