¿Las demandas por los efectos adversos de Neurontin aumentan el gasto en salud?

NUEVA YORK (Reuters Health) – En el 2004, el laboratorio

Pfizer aceptó declararse culpable y pagar más de 430 millones de

dólares por la acusación de haber comercializado el

antiepiléptico Neurontin ilegalmente para usos no aprobados.

Ahora, un estudio publicado en Journal of Clinical Psychiatry

cuestiona si el juicio terminó aumentando el gasto en otros

antiepilépticos en lugar de reducir los usos sin aprobación.

Los médicos pueden recetar fármacos con usos no autorizados

por las autoridades regulatorias de Estados Unidos, pero la

industria tiene prohibido comercializarlos con esos fines.

“En los últimos años hubo juicios importantes para penalizar

a las empresas farmacéuticas por la promoción ilegal de usos no

aprobados”, dijo Meredith Chace, investigadora especializada en

políticas farmacéuticas de la Facultad de Medicina de Harvard,

Boston. “Sospechábamos que eso podía tener consecuencias no

intencionales.”

Con su equipo analizó información del período 2001-2005 de

los seguros de salud federales Medicare y Medicaid. Se

concentraron en el tratamiento del trastorno bipolar, uno de los

distintos usos sin aprobar de Neurontin (gabapentina).

Desde la primera noticia publicada sobre el juicio en marzo

del 2002, la participación de Neurontin en el mercado de los

antiepilépticos que se utilizan para tratar el trastorno bipolar

se redujo del 21 al 15 por ciento.

En tanto, se disparó o siguió creciendo ese uso sin

aprobación de otros cuatro fármacos (uno de ellos aprobado más

adelante). Hasta el gasto en Neurontin aumentó, a pesar de que

se redujo su indicación.

“Desafortunadamente, el estudio sugiere que los médicos

siguieron indicando medicamentos sin efectividad probada para el

tratamiento del trastorno bipolar”, dijo el doctor Daniel

Carlat, psiquiatra y director del Proyecto Pew de Indicaciones

Médicas, que promueve políticas para limitar las relaciones

entre los médicos y la industria que afecten la atención de los

pacientes.

¿NO TAN DAÑINO COMO SE ESPERABA?

El nuevo estudio detalla que en el 2000, dos años antes de

que se conocieran las noticias sobre el juicio, las ventas de

Neurontin eran de casi 1.000 millones de dólares, principalmente

por sus usos no autorizados. Chace opinó que la cobertura

negativa de los medios influyó en parte en la caída de las

ventas de Neurontin y que es posible que el fabricante

aumentara los precios para anticiparse.

El equipo estima que el gasto gubernamental en

antiepilépticos para el tratamiento del trastorno bipolar

aumentó en más de 200 millones de dólares después del juicio,

sin incluir los potenciales cambios de indicaciones del mismo

producto para otras enfermedades, como la migraña, el síndrome

de piernas inquietas y distintos trastornos asociados con el

dolor.

“Las consecuencias no esperadas incluyen la sustitución de

otros productos similares y un aumento del gasto general”, dijo

Chace a Reuters Health.

Agregó que los ensayos clínicos habían demostrado que

Neurontin no es efectivo para el tratamiento del trastorno

bipolar, aunque con algunas excepciones.

Una limitación del estudio es no haber incluido información

sobre la inversión de la industria en la comercialización de sus

productos. Además, el cargo de Carlat está parcialmente

financiado con un subsidio que surgió del arreglo comercial de

la demanda contra Pfizer.

“Se desconoce si el juicio fue la causa del aumento de la

indicación de antiepilépticos y, por lo tanto, del gasto en

salud -dijo Carlat por e-mail-. El estudio no controló los

efectos de otros factores en las decisiones médicas, como la

estrategia de comercialización de otros productores de

antiepilépticos y la información científica de la efectividad de

otros fármacos.”

El doctor Randall S. Stafford, que no participó del estudio,

opinó sobre la posibilidad de que el juicio “no haya dañado a

Pfizer tanto como se esperaba”. Dijo por e-mail que “se estaba

venciendo la patente de Neurontin y el juicio sólo aceleró el

cambio deseado al uso sin aprobar de Lyrica”, un antiepiléptico

(pregabalina) que aún conserva su patente y fue motivo de otro

juicio similar contra Pfizer, que aceptó un convenio por 2.300

millones de dólares en el 2009.

Pfizer no realizó comentarios sobre resultados asociados “con

un acuerdo de hace una década”.

Chace consideró que las autoridades deberían trabajar con las

asociaciones médicas para informar a los profesionales sobre

estas crisis para que actúen adecuadamente.

FUENTE: Journal of Clinical Psychiatry, online 16 de octubre

del 2012

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Disney buys firm behind Star Wars

30 October 2012 Last updated at 17:25 ET

Disney is buying Lucasfilm, the company behind the Star Wars films, from its chairman and founder George Lucas for $ 4.05bn (£2.5bn).

Mr Lucas said: “It’s now time for me to pass Star Wars on to a new generation of film-makers.”

In a statement announcing the purchase, Disney said it planned to release a new Star Wars film, episode seven, in 2015.

That will be followed by episodes eight and nine and then one new movie every two or three years, the company said.

The last Star Wars film was 2005′s Revenge of the Sith, and Disney said it believed there was “substantial pent-up demand”.

Disney will pay about half in cash and half in stock, issuing 40 million Disney shares in the transaction.

The deal follows Disney’s acquisitions of Pixar studios for $ 7.4bn in 2006 and Marvel comics for $ 4.2bn in 2009.

“Our valuation of Lucasfilm is roughly comparable to the value we placed on Marvel when we announced that acquisition in 2009,” Disney said, adding that the valuation was almost entirely driven by the Star Wars franchise.

Transition

George Lucas launched Lucasfilm in 1971 and the first Star Wars film was released in 1977.

“For the past 35 years, one of my greatest pleasures has been to see Star Wars passed from one generation to the next,” Mr Lucas said.

“I’ve always believed that Star Wars could live beyond me, and I thought it was important to set up the transition during my lifetime.”

Mr Lucas will continue as a creative consultant.

Kathleen Kennedy, currently co-chairman of Lucasfilm, will become president of the firm and will be the executive producer on the new Star Wars films.

Lucasfilm is also the production company behind the Indiana Jones franchise, and fantasy films Willow and Labyrinth.

Michael Corty, analyst at Morning Star, said Disney’s deal was clearly part of a pattern in buying new franchises.

“Pixar was the first big one, then Marvel, and now this one here,” he said.

“Because Lucas is private, I would assume most investors would be surprised.”

BBC News – Business

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Apple software, retail chiefs out in sweeping overhaul

SAN FRANCISCO (Reuters) – Apple Inc Chief Executive Tim Cook on Monday replaced the heads of its software and retail units in the company’s most sweeping executive shake-up in a decade following embarrassing problems with its new mapping program and unpopular store-related decisions.

Software chief Scott Forstall, who oversaw the launch of the flawed mapping software and much criticized Siri voice-enabled assistant, will leave Apple next year and serve as an advisor to Cook in the meantime.

Forstall, seen as a polarizing figure inside Apple, had been billed as one of the future candidates to take the top job at Apple. He was the executive behind the panned Apple Maps app that the company announced with much fanfare in summer.

The moves, which come a little more than a year into Cook’s tenure as CEO, were described by Apple as a way to increase “collaboration” across its hardware, software and services business.

“These changes show that Tim Cook is stamping his authority on the business,” Ben Wood, analyst with CCS Insight, said. “Perhaps disappointed with the Maps issues, Forstall became the scapegoat.”

Critics of the maps debacle, which led Cook to apologize to customers, had been calling for Forstall’s head. “Does Apple have a Scott Forstall problem?” Fortune editor Philip Elmer Dewitt wrote on Sept 29.

The moves hand over substantially more responsibility to Cue, the head of Internet Software and Services who helped create the iTunes music store and App Store. The 23-year Apple veteran already is in charge of Cloud services and will take on Apple Maps and Siri.

Apple said a search is underway for a new retail chief to replace John Browett and that the retail team would report directly to Cook. Browett had riled up the retail store staff when he decided to reduce the number of retail employees.

Browett took over as head of Apple’s retail stores earlier this year, replacing Ron Johnson, who went on to become the CEO of JC Penney.

Last week Apple delivered a second straight quarter of disappointing financial results, and iPad sales fell short of Wall Street’s targets, marring its record of consistently blowing past investors’ expectations.

(Reporting by Alexei Oreskovic; Editing by Richard Chang)

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Taylor Swift to co-host Grammy nominations in Nashville

LOS ANGELES (Reuters) – Country-pop star Taylor Swift will co-host the Grammy nominations live on television from Nashville, the capital of country music, the Recording Academy said on Monday.

Swift, 22, who has won six Grammy awards, will join rapper-actor LL Cool J to announce nominees in some of the major categories during a one-hour live telecast on December 5, featuring performances from country artist Luke Bryan and pop-rockers Maroon 5.

The singer is currently on a touring blitz to promote her latest album, “Red”, and has become an awards show favorite, most recently premiering her new single at the MTV Video Music Awards in September.

Swift’s addition to the roster is part of the Grammy organization’s celebration of country music this year, moving the nominations concert from Los Angeles to Nashville, home to the Grand Ole Opry and dozens of recording studios that have spawned artists such as Swift, Carrie Underwood and Lady Antebellum.

Organizers began televising the nominations in a live show five years ago in a bid to boost TV viewership for the annual Grammy Awards ceremony in Los Angeles in February. This year, 39.9 million viewers tuned in to see British singer Adele sweep the awards with six major wins.

(Reporting by Piya Sinha-Roy; Editing by Jill Serjeant and Dale Hudson)

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Hurricane Sandy: Tips to Make Tap Water Safe for Drinking

Oct 29, 2012 7:10pm

If water supply becomes contaminated, you can either boil water for one minute or make water safe with bleach.

Here is how:

If tap water is clear:

1. Add eight drops of household unscented liquid bleach to one gallon of water.

2. Mix well and wait 30 minutes or more before drinking.

If tap water is cloudy:

1. Add 16 drops of unscented household liquid bleach to one gallon of water.

2. Mix well and wait 30 minutes or more before drinking.

In addition:

• Never mix bleach with ammonia or other cleaners.


• Open windows and doors to get fresh air when you use bleach.

For more information, go to the Centers for Disease Control and Prevention website.

SHOWS: World News

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Pole gets 30 years for killing 6 on Channel Island

LONDON (AP) — A Polish builder who killed six people, including his wife and children, on the British Channel Island of Jersey has been sentenced to 30 years in prison.

Damian Rzeszowski, 31, carried out the knife attack in August 2011 at his home. He was said to have become depressed after his wife admitted to an affair.

Rzeszowski was convicted of six counts of manslaughter but cleared of murder. On Monday, Judge Michael Birt sentenced him to 30 years in jail for each victim, but the sentences are to run concurrently.

Rzeszowski’s victims were his wife Izabela Rzeszowska, 30; 5-year-old daughter, Kinga; 2-year-old son, Kacper; father-in-law, Marek Gartska, 56; his wife’s friend Marta De La Haye, 34; and her 5-year-old daughter, Julia.

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Citigroup is fined $2 million over Facebook IPO

NEW YORK (AP) — Citigroup has paid a $ 2 million fine and fired a junior analyst after the employee leaked confidential information about Facebook‘s initial public offering to a popular tech blog.

The charges were brought by the top securities regulator in Massachusetts, who has a history of aggressive enforcement actions against banks. The regulator, Secretary of the Commonwealth William Galvin, announced the charges Friday. Citi agreed to the settlement and admitted to the events detailed in the consent order.

Citi was part of the team of banks that helped underwrite the deal that made Facebook a public company in May. When a bank helps underwrite such a deal, it has information about a company that the broader investing public does not have. The bankers who underwrite the deal are not supposed to act on that information or share it with any favored clients, because it would give them an unfair advantage over the public.

Galvin’s office noted in the order that securities laws required that members of Facebook’s underwriting syndicate “refrain from disseminating written research or other written content about Facebook until 40 days after the IPO.”

The arrangements can also bring accusations of conflicts of interest; banks not only help companies go public or do other deals, they also have units that provide research on the companies. The research is supposed to be impartial, but the banks have a stake in how a company does if it is helping it with underwriting.

According to Galvin’s office, a junior analyst in Citigroup’s San Francisco office was assigned to help research Facebook. On May 2, the junior analyst sent an email to two employees at the technology website TechCrunch.com, with proprietary information about Citigroup’s research on Facebook.

“I am ramping up coverage on FB and thought you guys might like to see how the street is thinking about it (and our estimates),” the junior analyst wrote to two TechCrunch writers. “…This, of course is confidential.”

One of the TechCrunch employees wrote back: “There’s no way I can publish this doc from an anonymous source, right?”

A minute later, the junior analyst replied: “My boss would eat me alive.”

The analyst and the TechCrunch employees were friends, according to Galvin’s office. The junior analyst and one of the employees had gone to Stanford together. According to Galvin’s office, “they keep in touch using social media and all live in the Bay Area.”

Citigroup fired the junior analyst in late September, after Galvin’s office subpoenaed the bank. A subpoena is a request for information and does not necessarily imply wrongdoing.

The bank told Galvin’s office that the junior analyst acted alone. In addition to agreeing to the $ 2 million fine, Citi also agreed to review its policies for overseeing analysts’ communications, and to strengthen compliance training for the analysts.

“We are pleased to have this matter resolved,” Citigroup spokeswoman Sophia Stewart said. “We take our internal policies and procedures very seriously and have taken the appropriate actions.”

Galvin has a long history of suing top players in the banking industry. He was involved in a landmark settlement in 2003 that accused major banks, including Citi’s Salomon Smith Barney unit, of publishing fraudulent research reports about the companies it was working for, and allowing investment bankers working for the companies to influence the opinions of the research analysts covering them.

In the consent order issued Friday, Galvin said the penalty “should serve as a warning to the industry as a whole.”

This is the first penalty that Galvin’s office has issued over the Facebook public offering. A spokesman declined to say if there could be more.

Separately, Galvin’s consent order also implicates the junior analyst’s boss, a senior analyst, for other conduct.

The consent order didn’t name the senior analyst but gives enough information to identify him as Mark Mahaney, Citi’s well-known and influential managing director of Internet research, a frequent commentator to journalists and a person who boosted Citigroup’s research profile.

The consent order does not implicate Mahaney in the Facebook misconduct. But it does say that separately, he sent emails with his private, unpublished opinion about YouTube’s financial results to a reporter at a French business magazine, Capital.

Later, when a communications employee told him he’d need to get approval to talk to the Capital reporter, Mahaney said that he wouldn’t respond to the reporter’s questions even though he already had.

Later, he wrote to the communications employee, “This could get me in trouble. Shoot.”

Citigroup confirmed that Mahaney is no longer at the bank. A source familiar with the matter, who wasn’t allowed to speak on the record about personnel matters, said Mahaney had been fired because he misled the bank about his communications with the French magazine.

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Reports: UK rocker arrested as part of Savile case

LONDON (AP) — Police investigating child sex abuse allegations against the late BBC television host Jimmy Savile arrested former glam rock star and convicted sex offender Gary Glitter on Sunday, British media reported, raising further questions about whether Savile was at the center of a broader pedophile ring.

Police would not directly identify the suspect arrested Sunday, but media including the BBC and Press Association reported he was the 68-year-old Glitter.

The musician, whose real name is Paul Gadd, made it big with the crowd-pleasing hit “Rock & Roll (Part 2),” a mostly instrumental anthem that has been a staple at American sporting events, thanks to its catchy “hey” chorus. But he fell into disgrace after being convicted on child abuse charges in Vietnam.

Sunday’s arrest was the first in a widening scandal over Savile’s alleged sex crimes, which started garnering attention earlier this month when a television documentary showed several women claiming that Savile abused them when they were teenagers. Hundreds of potential victims have since come forward to report similar claims to police against Savile, a much-loved children’s TV presenter and disc jockey who died at the age of 84 last year.

Most have alleged abuse by Savile, but some said they were abused by Savile and others. Most claimed they were assaulted in their early teens.

The scandal has raised questions about whether the BBC, the publicly funded and trusted broadcaster, had ignored crimes it suspected over several decades. Its executives have apologized and vowed to uncover the true scale of the alleged abuse.

“The BBC’s reputation is on the line,” Chris Patten, the chairman of the BBC Trust, wrote in The Mail on Sunday newspaper. “The BBC risks squandering public trust because one of its stars over three decades was apparently a sexual criminal … and because others — BBC employees and hangers-on — may also have been involved.”

On Sunday, the BBC and Sky News showed footage of Glitter, who wore a hat, a dark coat and sunglasses, being taken from his home by officers and driven away.

Police would not directly identify the suspect, but when asked about Glitter a spokesman said the force arrested a man in his 60s early Sunday morning in London on suspicion of sexual offenses in connection with the Savile probe. He was released later Sunday and was due to return to a London police station in December for further questioning, police said. British police do not generally identify suspects under arrest by name until they are charged.

Glitter, known for his shiny jumpsuits and bouffant wigs, was jailed in Britain in 1999 for possessing child pornography, and convicted in 2006 in Vietnam of committing “obscene acts with children” — offenses involving girls aged 10 and 11. He was deported back to Britain in 2008.

In 2006, the NFL advised its football teams not to use the Glitter version of “Rock and Roll (Part 2)” at games.

One witness recently told a BBC-TV show that she once saw Glitter having sex with a schoolgirl in Savile’s dressing room at the broadcaster’s TV center in the 1970s. Glitter has denied the allegations.

Police have said that though the majority of cases it is investigating relate to Savile alone, some involve the entertainer and other unidentified suspects. In addition, some potential victims who reported abuse by Savile also told police about separate allegations against unidentified men that did not involve the BBC host.

The scandal has horrified Britain with revelations that Savile, the longtime host of the popular BBC shows “Top of the Pops” and “Jim will Fix It,” allegedly cajoled and coerced vulnerable teens into having sex with him in his car, his camper van, and even in dingy dressing rooms on BBC premises. Police describe him as one of the worst sex offenders in recent history.

The BBC has set up an independent inquiry into the corporation’s culture and practices in the years Savile worked there. It also launched a separate inquiry into why its managers shelved an investigation into the allegations.

But the scandal continues to put the broadcaster under pressure, and it seems likely that more people — either outside or inside the corporation — could be implicated.

“It could be the beginning of other high-profile arrests,” Roy Greenslade, a journalism professor at London’s City University, said in an interview with The Associated Press on Sunday.

Max Clifford, a prominent public relations guru, claimed that dozens of celebrities from the 1960s and 1970s have approached him to express fear that they could be drawn into to the scandal and criticized for their hedonistic behavior in the past.

Greenslade said that while Glitter’s arrest must be a huge concern to the BBC, it is too early to say that the broadcaster’s reputation is in crisis.

“If any BBC employee is shown to be involved, then there would be a nosedive in public trust,” he said. “But nothing at the moment has been proven.”

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Massachusetts closes third pharmacy since meningitis outbreak

BOSTON (Reuters) – Massachusetts regulators shut down a pharmacy on Sunday after a surprise inspection raised concerns about the sterility of its drugs, in the third such closure since a deadly meningitis outbreak caused by contaminated drugs from another pharmacy in the state.

The latest pharmacy to be closed, Infusion Resource, is not affiliated with New England Compounding Center, the company linked to the outbreak, officials said.

Infusion Resource in Waltham was closed after inspectors last week found “significant issues” and “expressed concerns for the sterility of products,” said Madeleine Biondolillo, director of the state’s Bureau of Healthcare Safety and Quality.

No contaminated drugs were found at Infusion Resource, but 40 patients and their doctors were asked to return any medications they received from the company, she said.

Massachusetts regulators have come under fire after contaminated drugs from NECC, based in Framingham, were cited as the cause of the outbreak which has so far killed 25 people and sickened another 337 in 18 states.

The state is conducting inspections of all compounding pharmacies which handle sterile medications in the wake of the deadly national meningitis outbreak.

The two pharmacies shut down earlier were NECC itself, which was closed on October 3, and a sister company of NECC, called Ameridose, that closed voluntarily for inspections on October 19.

Bernard Lambrese, CEO of Infusion Resource, said in a statement he wanted to reassure “patients and the general public of the safety, purity and efficacy” of solutions produced at his company’s Waltham pharmacy. “Patient safety is something we take very seriously,” he said.

Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, told reporters the ongoing state-wide inspections are part of “a series of aggressive and necessary actions to protect public safety and enhance oversight of this industry” following the national meningitis outbreak.

The U.S. Food and Drug Administration said on Friday it found “greenish black foreign matter” and other contaminants in an injectable steroid produced by NECC. It also found that vials from the same bin of the steroid contained what appeared to be a “white filamentous material,” according to the report released by the FDA following inspections of the facility in October.

(Editing by Alex Dobuzinskis and Christopher Wilson)

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Economy ‘shows signs of optimism’

28 October 2012 Last updated at 12:22 ET

There is “reason for some optimism” for the UK economy, the Bank of England’s deputy governor Charlie Bean has said.

He cautioned against “getting over-excited” after new GDP data showed the recession was over – pointing out the Olympics had given a one-off boost.

But Mr Bean said there were “signs of progress” from the eurozone and banking crises and inflation should be lower.

Labour said families were still being squeezed but ministers reject claims austerity policies were hitting growth.

Last week’s official gross domestic product figures, which measure the value of everything produced in the country, showed the economy grew by 1.0% in the three months from July to September.

It had been in recession for the previous nine months and has still not recovered the levels of output seen before the financial crisis in 2008.

‘The right path’

Speaking on the Murnaghan show on Sky News, Mr Bean said: “The big picture here is of an economy that has been bumping along the bottom for two years.

Continue reading the main story

The statistics are one thing, how people feel is another”

End Quote Chuka Umunna Shadow business secretary

“We do think there is reason for some optimism going forward. Some of the headwinds we have been struggling against in the past couple of years will be abating somewhat.

“Most particularly, we have seen a big squeeze on households’ real spending power… Going forward, that squeeze should not be so intense.”

Labour’s shadow business secretary Chuka Umunna told the programme families and businesses were still struggling.

Official GDP figures showed the UK economy had contracted by 6.4% between the start of 2008 and the middle of 2009, and had since recovered about half of that lost output. The level of output in the third quarter of 2012 was almost exactly the same as it had been in the third quarter of 2011.

“It is good news that, with the help of the Olympics and after the longest double-dip recession since the Second World War, we saw a positive number last week,” Mr Umunna said.

“But I think the statistics are one thing, how people feel is another… All we saw last week was essentially things going back to the position we were in last year.”

Interviewed on the BBC’s Sunday Politics, Chief Secretary to the Treasury Danny Alexander accepted the impact of the eurozone crisis and commodity price rises meant “growth has been much slower than we would have liked over the last two to three years”.

But he added: “We knew when we came into office that they were going to be difficult but I don’t think that means that the path we chose was wrong…

“If we hadn’t gone for the austerity programme that we did – the deficit reduction, the spending reductions and so on – then our economy would have been in a much worse position.”

BBC News – Business

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