Drug charges dropped against Jon Bon Jovi’s daughter
















(Reuters) – Drug charges against the daughter of rock star Jon Bon Jovi were dropped on Thursday, a day after she suffered a suspected heroin overdose, officials in New York said.


Oneida County District Attorney Scott D. McNamara said in a statement that Stephanie Bongiovi could not be charged because New York law prohibits the prosecution of people who had overdosed and were in possession of small amounts of drugs.













Bongiovi, 19, was found unresponsive in a dormitory room at Hamilton College in Clinton, New York, early on Wednesday and was later booked on misdemeanor charges of possession of a controlled substance (heroin), marijuana possession and criminal use of drug paraphernalia, which were found in the room.


A message left with the singer’s representative was not immediately returned.


Heroin and marijuana charges against fellow student Ian S. Grant, 21, in connection with Bongiovi’s case were also dropped as a witness or victim to a drug or alcohol overdose cannot be prosecuted in New York.


Bongiovi is the oldest of four children of Bon Jovi and wife Dorothea Hurley.


(Reporting By Eric Kelsey, editing by Jill Serjeant and Andre Grenon)


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People overestimate benefits of prevention
















NEW YORK (Reuters Health) – Patients asked to estimate how many lives would be saved through cancer screening or how many hip fractures can be prevented with bone-building medication mostly overestimate the benefits of these preventive measures, according to a survey of New Zealanders.


Annette O’Connor of the University of Ottawa, who studies how patients weigh risk and make decisions, said she would expect that people would overvalue any given prevention effort.













“Most people would overestimate because they’re told about their benefits, but with no numbers…so why would you think that it’s going to be really low?” said O’Connor, who was not involved in the new study.


Doctors, nurses and others who communicate health information often don’t detail how much a given test or drug can help, but only say that people ought to have it, O’Connor told Reuters Health.


“I think it’s led to more people taking part in screening or availing themselves of preventive medication than would have been the case if they were presented the information in more meaningful terms,” said Dr. Ben Hudson, the new study’s lead author and a professor at the University of Otago in Christchurch, New Zealand.


“I would also be concerned that it’s led to people having over-heightened expectations of what these things can achieve, and that may lead to disappointment when the inevitable breast cancer happens despite screening,” he added.


Hudson said that in talking with his patients about screening, he found they were surprised by how small the benefits were.


To get a broader sense of patients’ expectations for preventive measures, Hudson and his colleagues asked 354 people about the benefits of breast cancer screening with mammography, bowel cancer screening with stool testing, taking antihypertension medication and taking bone-strengthening medication.


Specifically, participants were asked to imagine scenarios in which 5,000 people between ages 50 and 70 undergo one of these preventive interventions for 10 years, then asked how many “events” the participants thought would be avoided as a result of the measure.


For three of the four interventions in the survey, the event to be avoided was death and in the case of bone drugs, it was hip fracture.


For breast cancer screening, only seven percent of the participants answered in the correct range of one to five lives being saved with screening, whereas 90 percent overestimated how many lives would be saved. Fully a third thought that 1,000 deaths would be averted.


The numbers were similar for bowel cancer screening, which is thought to save five to 10 lives for every 5,000 people tested, Hudson’s group reports in the Annals of Family Medicine.


Eighty-two percent of participants overestimated the number of fractures prevented by bone-strengthening medication, which in reality is about 50 for every 5,000 patients given the drug.


And 69 percent of participants reported that 500 or more lives would be saved if 5,000 people took blood pressure medication, when the correct range should have been 50 to 100.


“It’s probably unreasonable to expect people to make an accurate guess at the absolute number (of lives saved or fractures prevented), but what we found was a consistent trend toward higher levels,” Hudson told Reuters Health.


“I don’t think most patients are likely to have access to good numerical data presented in a simple and informative way. I think that’s part of the problem here,” he said.


The U.S. Preventive Services Task Force (USPSTF) issues screening recommendations and other guidelines for disease prevention, which doctors, nurses and public health groups often consult when counseling patients.


A survey of U.S. physicians found that most of them don’t fully grasp what the numbers mean when it comes to cancer screening (see Reuters Health story of March 5, 2012).


O’Connor said that when health care professionals repeat these guidelines to patients, they often don’t include the numbers when talking about benefits or they only refer to something called the “relative risk.”


The relative risk describes the change in a person’s chances of developing a disease, but it does not give any sense of how much risk that person had to begin with.


For example, a “50 percent reduction in risk” may be less significant than it sounds if a person’s absolute risk for a condition – how likely they are to develop it at some point in life – was originally five percent, and drops to 2.5 percent.


“Professionals and people who provide health information need to know absolute benefits,” O’Connor said.


The relative risk of dying from breast cancer is 17 percent lower among a population of women aged 50 to 69 who get screened, compared to women who do not get screened, for instance.


But in absolute terms, that means that instead of 23 in 100,000 women dying of breast cancer, screening would reduce that number to 19 in 100,000 women.


Hudson said that one of the potential problems that can arise when people overvalue a test is that if recommendations are scaled back because of insufficient benefits, people get upset.


In 2009, for instance, the USPSTF changed its guidelines for regular mammograms from beginning at age 40 to beginning at 50, because the number of lives saved through screening during that extra decade of life was too small compared to the potential harms from the screening itself and follow-up procedures.


A survey of women at the time found that most of them considered the new guidelines to be “unsafe,” at least in part because they feared that insurers would no longer cover screening for women in their 40s who wanted it.


“The other thing that happens when you have an established screening program for which people have heightened expectations, it becomes very politically difficult to make any changes insofar as recommending reduced access, even when the evidence is pretty convincing that the outcomes are better,” said Hudson.


Hudson advocated for better informing patients of the benefits and harms of any preventive intervention.


“I have a feeling this would all be easier if we could present (patients) with this information, trust them with their decisions and support them in doing so,” he said.


SOURCE: http://bit.ly/XINd5u Annals of Family Medicine, November/December 2012.


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Obama: Wealthy must pay more tax



















President Obama said his approach was that ”the wealthiest Americans pay a little bit more”



US President Obama has reiterated his call for high earners in the US to pay more in taxes, in his first news conference since winning re-election.


He called for quick legislation to rule out tax rises on the first $ 250,000 (£158,000) of income, but refused to extend cuts for the wealthiest 2%.


“We should not hold the middle class hostage while we debate tax cuts for the wealthy,” Mr Obama said.


The US faces an end-of-year “fiscal cliff” of spending cuts and tax rises.


The fiscal cliff would see the George W Bush-era tax cuts expire in combination with automatic, across-the-board reductions to military and domestic spending.


Loophole offer


Some $ 607bn (£380bn) of savings and tax rises are planned, including reductions in the defence budget, the end of an employee tax holiday, changes to Medicare allowances and higher personal taxes.


The lower paid are set to lose some child and income credits, but Mr Obama has made fewer references to other portions of the stimulus deal set to expire beyond the tax cuts.


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The fiscal cliff is due to take effect because Congress failed to reach a deal on deficit reduction after a stand-off over the US debt ceiling in mid-2011.


Congressional Republicans have said since last week’s US elections that they are open to raising revenue through tax reform and closure of loopholes, but oppose tax rises on the wealthy.


Glenn Hubbard, an economic adviser to Republican Mitt Romney’s failed presidential bid, writing in the Financial Times, called on fellow Republicans to accept the need for the rich to pay more tax, albeit through closing loopholes such as tax deductions.


Other Republicans favour ending the right of Americans to deduct mortgage interest payments from their taxable income – something analysts say is likely to hurt the middle classes far more than top earners.


During his news conference on Wednesday, Mr Obama was dismissive of a loophole-only reform, telling reporters that “the math tends not to work” in helping to cut the deficit.


“It really is arithmetic, not calculus,” he said.


The president has long opposed extending the Bush-era tax cuts for earnings above $ 250,000 a year, but gave into Republican demands in 2010 when the cuts were last up for renewal.


On Wednesday, Mr Obama said that would not happen this time.


“A modest tax increase on the wealthy is not going to break their backs,” he said. “They’ll still be wealthy.”


But the president said he was confident that the White House and Congress could reach a deal before 1 January to avoid the “fiscal cliff”, as the US economy could not afford it coming to pass.


He suggested the immediate extension of all the expiring tax cuts except the top rate, followed by a more comprehensive reform of the tax code as well as some of the US’ largest benefits programmes, including Social Security in 2013.


In doing so, he distanced himself from some in his own party who want the combined tax rises and cuts to happen, in order to give Mr Obama a better negotiating position.


‘Great distance’


On Tuesday, US Treasury Secretary Timothy Geithner warned against extending all of the tax breaks that are due to expire in January as a way of giving Washington more time to broker a deal on the deficit.


Mr Geithner claimed doing this would create more uncertainty in the financial markets.


House Speaker John Boehner has scheduled a response to Mr Obama on Wednesday, as the White House planned to meet with congressional leaders on Friday, when both sides are expected to designate aides in search of a compromise.


Mr Obama met on Tuesday with allies from labour and liberal groups, and also invited a group of chief executives to the White House.


Earlier, Democratic Senator Dick Durbin of Illinois said that “many Republicans believe now is the time to sit down and talk more revenue”, saying up to 20 Republican senators are willing to work towards accommodation.


But Sen Durbin said “there is a great distance” between Republicans in the House and Senate.


“Basically it comes down to the question of whether Speaker Boehner is willing to look for a bipartisan solution.”


BBC News – Business



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Steve Wozniak, Danny Trejo to appear in 8-bit video game
















LOS ANGELES (TheWrap.com) – When it comes to the iPhone, Steve Jobs created it, but Steve Wozniak got game.


The Apple co-founder will appear as a playable character in an upcoming iOS video game “Danny Trejo‘s Vengeance: Woz with a Coz.”













The game, slated to be released around November 22, puts Wozniak alongside “Machete” star Trejo in an 8-bit mobile game, fighting a city full of enemies with an assortment of weapons.


The plot is simple: “Woz” is forced to save his wife, J-Woz, after she is kidnapped by street thugs. Teaming up with Vengence, Woz tears up Fusion City in his quest to rescue her.


“Featuring an over-the-top, old school inspired action combined with a retro 8-bit and exciting gritty art style, players will enjoy Woz’s brain power, translator apps, Danny Trejo’s machetes, guns and other crazy upgrades,” a Facebook fan page devoted to the game says.


Other playable characters will include musician Baby Bash and MMA World Champion “Suga” Rashad Evans.


Gaming News Headlines – Yahoo! News



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NBC names new top producer for ‘Today’
















NEW YORK (AP) — NBC News is staying in-house in its effort to turn around the “Today” show.


The network on Wednesday appointed a 23-year veteran of the morning news show as its new executive producer. Don Nash began working for “Today” as a production assistant in NBC’s Burbank office in 1989 and will now run the four-hour broadcast.













Nash was most recently senior broadcast producer in the show’s control room. He replaces Jim Bell, who shifted to NBC Sports to run its Olympics broadcasts.


After nearly two decades of dominance, “Today” has slipped behind ABC’s “Good Morning America” in the ratings.


NBC also added another layer of management for the show, appointing Alexandra Wallace as the network’s executive in charge of the program.


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New gene triples risk for Alzheimer’s disease
















Scientists have identified a new gene variant that seems to strongly raise the risk for Alzheimer’s disease, giving a fresh target for research into treatments for the mind-robbing disorder.


The problem gene is not common — less than 1 percent of people are thought to have it — but it roughly triples the chances of developing Alzheimer’s compared to people with the normal version of the gene. It also seems to harm memory and thinking in older people without dementia.













The main reason scientists are excited by the discovery is what this gene does, and how that might reveal what causes Alzheimer’s and ways to prevent it. The gene helps the immune system control inflammation in the brain and clear junk such as the sticky deposits that are the hallmark of the disease. Mutations in the gene may impair these tasks, so treatments to restore the gene’s function and quell inflammation may help.


“It points us to potential therapeutics in a more precise way than we’ve seen in the past,” said Dr. William Thies, chief medical and scientific officer of the Alzheimer’s Association, which had no role in the research. Years down the road, this discovery will likely be seen as very important, he predicted.


It is described in a study by an international group published online Wednesday by the New England Journal of Medicine.


About 35 million people worldwide have dementia, and Alzheimer’s is the most common type. In the U.S., about 5 million have Alzheimer’s. Medicines such as Aricept and Namenda just temporarily ease symptoms. There is no known cure.


Until now, only one gene — ApoE — has been found to have a big impact on Alzheimer’s risk. About 17 percent of the population has at least one copy of the problem version of this gene but nearly half of all people with Alzheimer’s do. Other genes that have been tied to the disease raise risk only a little, or cause the less common type of Alzheimer’s that develops earlier in life, before age 60.


The new gene, TREM2, already has been tied to a couple other forms of dementia. Researchers led by deCODE Genetics Inc. of Iceland honed in on a version of it they identified through mapping the entire genetic code of more than 2,200 Icelanders.


Further tests on 3,550 Alzheimer’s patients and more than 110,000 people without dementia in several countries, including the United States, found that the gene variant was more common in Alzheimer’s patients.


“It’s a very strong effect,” raising the risk of Alzheimer’s by three to four times — about the same amount as the problem version of the ApoE gene does, said Dr. Allan Levey, director of an Alzheimer’s program at Emory University, one of the academic centers participating in the research.


Researchers also tested more than 1,200 people over age 85 who did not have Alzheimer’s disease and found that those with the variant TREM2 gene had lower mental function scores than those without it. This adds evidence the gene variant is important in cognition, even short of causing Alzheimer’s.


“It’s another piece in the puzzle. It suggests the immune system is important in Alzheimer’s disease,” said Andrew Singleton, a geneticist with the National Institute on Aging, which helped pay for the study.


One prominent scientist not involved in the study — Dr. Rudolph Tanzi, a Harvard Medical School geneticist and director of an Alzheimer’s research program at Massachusetts General Hospital — called the work exciting, but added a caveat.


“I would like to see more evidence that this is Alzheimer’s” rather than one of the other dementias already tied to the gene, Tanzi said. Autopsy or brain imaging tests can show whether the cases attributed to the gene variant are truly Alzheimer’s or misdiagnosed, he said.


___


Online:


Medical journal: http://www.nejm.org


Alzheimer’s info: http://www.alzheimers.gov


Alzheimer’s Association: http://www.alz.org


___


Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP


Health News Headlines – Yahoo! News



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Cisco sees slower growth in second quarter
















(Reuters) – Cisco Systems Inc reported first quarter results that beat estimates but expects flat earnings and slower revenue growth for the current quarter.


“We are modeling Europe to get worse before it gets better,” Chief Executive John Chambers said on Tuesday, echoing his comments from the company’s fourth-quarter earnings call in August.













However, he added that “we see signs of improvement in the U.S. in enterprise, service provider and commercial.”


Still, Chamber said, it was too early to speak of a trend “though we are continuing to see what we like.”


Cisco said it expects earnings per share, excluding items, of 47 cents to 48 cents in its fiscal second quarter, which runs until the end of January. A year earlier it reported EPS of 47 cents.


It also said it sees revenue growth in a range of 3.5 percent to 5.5 percent, compared with 11.6 percent growth in the second quarter of 2012.


Chambers said he would give a long-term outlook at the company’s financial analyst day next month.


In its first quarter, which ran until the end of October, Cisco surprised analysts with a solid beat, due to cost cuts and the company’s broad product range.


First-quarter net income, excluding items, rose 10.6 percent to $ 2.6 billion, or 48 cents per share, compared with analysts’ average estimate of 46 cents a share as compiled by Thomson Reuters I/B/E/S.


Revenue rose 6 percent from the year-ago quarter to $ 11.9 billion, compared with a Street view of $ 11.77 billion.


Cisco’s shares rose 6.7 percent to $ 17.98 in after-hours trading.


Analysts applauded the company’s cost discipline and welcomed solid results in a tough environment.


“Given concern about enterprise spending, the company seems to be bucking the trends,” said Bill Kreher, senior technology analyst at Edward Jones.


“The bar was low but the company did exceed those expectations. The company appears to be using strong cost discipline in meeting their numbers.”


Mizuho Securities analyst Joanna Makris said “at first blush these are good numbers in a bad macro (environment).”


“It’s largely due to a product mix – a larger shift to routing – and cost cutting,” adding that “this is better than expected. We have been thinking they would squeak by on the top line.”


(Reporting by Nicola Leske; additional reporting by Liana Baker and Jennifer Saba; Editing by Phil Berlowitz)


Business News Headlines – Yahoo! News



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RIM sees BB10 devices in stores soon after launch
















WATERLOO, Ontario (Reuters) – Research In Motion is confident its new BlackBerry 10 devices will be 100 percent ready for the January 30 launch and available in stores “not too long after” that, Chief Operating Officer Kristian Tear said on Tuesday.


“We’re working hard right now to make sure all the bits and pieces and all the details are in place for the date, when the devices will be available for consumers and enterprises,” Tear told Reuters in an interview.













RIM, which virtually invented the concept of mobile email with its first line of BlackBerry devices more than a decade ago, was roundly criticized for the botched 2011 launch of its PlayBook tablet computer, which RIM had hoped would compete with Apple’s blockbuster iPad.


The PlayBook looked pretty and had top-of-the-line hardware. But its software was far from complete at the launch and needed multiple updates.


The device also lacked the library of apps available on the iPad and on devices that run on Google Inc’s competing Android operating system.


RIM says its the new devices will be faster and smoother than its existing phones and have a large catalog of applications that are crucial to the success of any smartphone.


The company hopes the new devices will allow it to claw back some of the market share it has lost to Android and Apple phones.


Tear said RIM has used input from current BlackBerry users to influence the design of the new devices, The new phones both build on the strengths of RIM’s existing operating system and improve on its weak points, he said.


RIM last month began carrier testing on the new devices, with an initial rollout to more than 50 carriers. Tear, who joined RIM a few months ago from Sony Mobile Communications, said RIM was expanding that to a wider group of carriers across the globe.


“We submitted to 50 carriers to begin with, and obviously that number is increasing as we move forward,” he said. “Our ambition is to make this a global launch, everything will not happen at the same time, but it will be a global launch.”


RIM has said it initially plans to roll out a high-end touchscreen version of the device. Phones with the mini QWERTY keyboards that many long-time BlackBerry users adore will come a few weeks later, while lower-end versions of both devices will be launched later in the year.


The company has yet to say exactly when the devices will be available in stores worldwide or how much they will cost.


“We have to agree with carriers as well on what they want to announce when, so it’s not absolutely to our own discretion,” Tear said.


COST CUTTING


RIM, whose share price has fallen more than 90 percent from a 2008 peak around $ 148, is part way through a major restructuring, as it seeks to trim costs in the run-up to the launch of the new devices.


The company, which has also said it is examining its strategic options, is lowering operating costs by about $ 1 billion and cutting about 5,000 jobs, or about 30 percent of its workforce, by the time its fiscal year ends in early March.


“We are on track to deliver on that,” said Tear. “It is an ongoing process, when it comes to efficiencies and costs.”


RIM’s Chief Legal Officer Steve Zipperstein said the company is pushing ahead with its strategic review.


“The process is ongoing and it continues to be a focus on RIM’s senior management, but we have nothing to report at this moment,” said Zipperstein.


RIM shares, which have risen slightly over the last couple of months in the run-up to the launch of BB10 devices, closed 4.7 percent lower at $ 8.40 on Nasdaq. RIM’s Toronto-listed shares fell by a similar margin to C$ 8.40.


(Reporting by Euan Rocha; Editing by Janet Guttsman, Leslie Adler and Tim Dobbyn)


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Twilight cast bids farewell at final premiere
















LOS ANGELES (Reuters) – Thousands of screaming fans lined the black carpet late on Monday for the final “Twilight” film premiere as the cast of “Breaking Dawn – Part 2″ bid farewell to the franchise and its loyal followers.


Robert Pattinson, Kristen Stewart, Taylor Lautner and other cast members greeted fans known as “Twi-hards,” many of whom had camped out for days in downtown Los Angeles to catch a glimpse of their favorite actors and see the film before it is released in theaters on Friday.













Breaking Dawn – Part 2 will see the love story of human Bella Swan (Stewart), vampire Edward Cullen (Pattinson) and werewolf Jacob Black (Lautner) come to a tantalizing end, when Bella and Edward are forced to protect their child from an ancient vampire coven.


Stewart, who was finally able to embrace her wild side by playing Bella as a vampire, hoped people would enjoy the ultimate transformation of her character in the film.


“Bella has worked pretty hard to get to the point where they can have it all, and it’s fun to be there. She’s always been human, but now that she’s not, you’re just in full blown vampire land and it feels funny in a great way,” Stewart told Reuters.


More than 2,200 fans from all over the world came to camp out on a concrete plaza in downtown Los Angeles last week, where Twilight movie studio Summit laid out activities and marathon screenings of the previous movies.


All of the film’s main actors spent time signing autographs and posing for photographs with the loyal fans who had camped out in chilly November weather over five days.


Pattinson, who plays vampire Edward Cullen, said he hoped the fans would like the franchise’s swan song.


“I hope they feel it kind of respects them, because I think in a lot of ways that’s what we were thinking when we were making it,” the actor said.


Lautner, who plays werewolf Jacob, said he’d be sad to say goodbye to the films and his character and hoped fans would be happy with the conclusion of the final film.


“I’m feeling fantastic, sad, emotional, there’s a lot of things going on inside of me right now but I’m just trying to soak up every moment because this means the world to me,” Lautner said.


The three lead stars were joined by fellow cast members including Nikki Reed, Ashley Greene, Kellan Lutz, Jackson Rathbone, Michael Sheen and Dakota Fanning, as well as director Bill Condon and author Stephenie Meyer, whose Twilight novels kicked off the franchise and phenomenon.


Meyer said she would miss watching the three lead cast members evolve as actors and characters in the films.


“It’s really been great to watch them grow up, particularly Kristen because her character gets to evolve so much in this film, and to watch her be all powerful and really get to where the character was always meant to go, to be the fiercest of the fierce, was really rewarding for me,” the author said.


(Reporting By Piya Sinha-Roy, editing by Paul Casciato)


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Report: FDA wanted to close Mass pharmacy in 2003
















WASHINGTON (AP) — Nearly a decade ago, federal health inspectors wanted to shut down the pharmacy linked to a recent deadly meningitis outbreak until it cleaned up its operations, according to congressional investigators.


About 440 people have been sickened by contaminated steroid shots distributed by New England Compounding Center, and more than 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention. That has put the Framingham, Mass.-based pharmacy at the center of congressional scrutiny and calls for greater regulation of compounding pharmacies, which make individualized medications for patients and have long operated in a legal gray area between state and federal laws.













The House Energy and Commerce Committee released a detailed history of NECC‘s regulatory troubles on Monday, ahead of a meeting Wednesday meeting to examine how the outbreak could have been prevented. The 25-page report summarizes and quotes from FDA and state inspection memos, though the committee declined to release the original documents.


The report shows that after several problematic incidents, Food and Drug Administration officials in 2003 suggested that the compounding pharmacy be “prohibited from manufacturing” until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.


The congressional report also shows that in 2003 the FDA considered the company a pharmacy. That’s significant because in recent weeks public health officials have charged that NECC was operating more as a manufacturer than a pharmacy, shipping thousands of doses of drugs to all 50 states instead of small batches of drugs to individual patients. Manufacturers are regulated by the FDA and are subject to stricter quality standards than pharmacies.


The report offers the most detailed account yet of the numerous regulatory complaints against the pharmacy, which nearly date back to its founding in 1998. Less than a year later, the company was cited by the state pharmacy board for providing doctors with blank prescription pads with NECC’s information. Such promotional items are illegal in Massachusetts and the pharmacy’s owner and director, Barry Cadden, received an informal reprimand, according to documents summarized by the committee.


Cadden was subject to several other complaints involving unprofessional conduct in coming years, but first came to the FDA’s attention in 2002. Here are some key events from the report highlighting the company’s early troubles with state and federal authorities:


__ In March of 2002 the FDA began investigating reports that five patients had become dizzy and short of breath after receiving NECC’s compounded betamethasone repository injection, a steroid used to treat joint pain and arthritis that’s different from the one linked to the current meningitis outbreak.


FDA inspectors visited NECC on April 9 and said Cadden was initially cooperative in turning over records about production of the drug. But during a second day of inspections, Cadden told officials “that he was no longer willing to provide us with any additional records,” according to an FDA report cited by congressional investigators. The inspectors ultimately issued a report citing NECC for poor sterility and record-keeping practices but said that “this FDA investigation could not proceed to any definitive resolution,” because of “problems/barriers that were encountered throughout the inspection.”


__ In October of 2002, the FDA received new reports that two patients at a Rochester, N.Y., hospital came down with symptoms of bacterial meningitis after receiving a different NECC injection. The steroid, methylprednisolone acetate, is the same injectable linked to the current outbreak and is typically is used to treat back pain. Both patients were treated with antibiotics and eventually recovered, according to FDA documents cited by the committee.


When officials from the FDA and Massachusetts Board of Pharmacy visited NECC later in the month, Cadden said vials of the steroid returned by the hospital had tested negative for bacterial contamination. But when FDA scientists tested samples of the drug collected in New York they found bacterial contamination in four out of 14 vials sampled. It is not entirely clear whether FDA tested the same lot shipped to the Rochester hospital.


__ At a February 2003 meeting between state and federal officials, FDA staff emphasized “the potential for serious public consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.” The agency issued a list of problems uncovered in its inspection to NECC, including a failure to verify if sterile drugs met safety standards.


But the agency decided to let Massachusetts officials take the lead in regulating the company, since pharmacies are typically regulated at the state level. It was decided that “the state would be in a better position to gain compliance or take regulatory action against NECC as necessary,” according to a summary of the meeting quoted by investigators.


The FDA recommended the state subject NECC to a consent agreement, which would require the company to pass certain quality tests to continue operating. But congressional investigators say Massachusetts Board of Pharmacy did not take any action until “well over a year later.”


__ In October 2004, the board sent a proposed consent agreement to Cadden, which would have included a formal reprimand and a three-year probationary period for the company’s registration. The case ended without disciplinary action in 2006, when NECC agreed to a less severe consent decree with the state.


Massachusetts officials indicated Tuesday they are still investigating why NECC escaped the more severe penalty.


“I will not be satisfied until we know the full story behind this decision,” the state’s interim health commissioner Lauren Smith said in a transcript of her prepared testimony released a day ahead of delivery. Smith is one of several witnesses scheduled to testify Wednesday, including FDA Commissioner Margaret Hamburg.


The committee will also hear from the widow of 78-year-old Eddie C. Lovelace, a longtime circuit court judge in southern Kentucky. Autopsy results confirmed Lovelace received fungus-contaminated steroid injections that led to his death Sept. 17.


Joyce Lovelace will urge lawmakers to work together on legislation to stop future outbreaks caused by compounded drugs, according to a draft of her testimony.


“We now know that New England Compounding Pharmacy, Inc. killed Eddie. I have lost my soulmate and life’s partner with whom I worked side by side, day after day for more than fifty years,” Lovelace states.


Barry Cadden is also scheduled to appear at the hearing, after lawmakers issued a subpoena to compel him to attend.


The NECC has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license. The pharmacy has recalled all the products it makes, including 17,700 single-dose vials of a steroid that tested positive for the fungus tied to the outbreak.


Health News Headlines – Yahoo! News



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