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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U.S. backs Israeli response to Gaza attacks

Israeli soldiers ride on top of an armored personnel carrier close to the Israel-Gaza border, in southern Israel. …The White House on Thursday threw its full support behind Israel's military response to a barrage of rockets fired by the Islamist Palestinian movement Hamas that rules the Gaza Strip. Deputy National Security Adviser for Strategic Communications Ben Rhodes said it would be "up to the Israeli government" whether to follow up punishing airstrikes with a ground assault.


"Our view is that the Israelis have the right of self-defense when their citizens are faced with the threat of indiscriminate rocket fire from within Gaza," Rhodes told reporters on a conference call.


Asked whether the Obama administration would have any issues with an Israeli ground assault, Rhodes replied that "ultimately, it's up to the Israeli government to make determinations about how they're going to carry out their military objectives."


The Associated Press has reported that Hamas fired more than 200 rockets on Thursday, killing three people, and that Israel seemed to be gearing up for a ground invasion of Gaza. The escalating conflict amounted to President Barack Obama's first major foreign policy test since winning re-election Nov. 6. Rhodes said American officials were in close consultation with their Israeli counterparts "to have an understanding of their plans going forward." The Obama administration has been in discussions with Turkey, Egypt and "some of our European partners," he said, thought to have sway over Hamas in order to get them to urge the militant organization to halt its rocket attacks.


"At the United Nations, where this is being discussed, we've sought to keep the focus where it should be—which is on Hamas's rocket fire as the precipitating cause here," Rhodes explained.


"What we've also said is that the best course of action would be for there to be a general de-escalation of the violence, but that the onus is on Hamas—and those with influence over Hamas—to help bring about that de-escalation, so that we don't see a widening conflict," he told reporters. "So we certainly want to see a de-escalation, we certainly want to see a broader conflict avoided."


The official noted that the White House has urged Israel to take "all steps ... to avoid civilian casualties." He added, "And we deeply regret the loss of life on the Israeli and Palestinian side."


Israeli Ambassador to the United States Michael Oren briefed key senators on the operation. The lawmakers—Democrats and Republicans—released a joint statement expressing "solidarity" with Israel while warning that "escalation will only lead to further suffering on both sides."


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Egypt recalls envoy to Israel after Gaza strike
















CAIRO (AP) — Egypt has recalled its ambassador to Israel after an Israeli airstrike killed the military commander of Gaza‘s ruling Hamas.


In a statement read on state TV late Wednesday, spokesman Yasser Ali said that President Mohammed Morsi recalled the ambassador and asked the Arab League‘s Secretary General to convene an emergency ministerial meeting in the wake of the Gaza violence.













Morsi also called for an immediate cease fire between Israel and Hamas, an offshoot of Morsi’s Muslim Brotherhood. Israel says it struck in response to rocket attacks from Gaza.


Hours earlier, Morsi’s Muslim Brotherhood group denounced the Israeli airstrike as a “crime that requires a quick Arab and international response to stem these massacres.”


Relations between Israel and Egypt have deteriorated since longtime President Hosni Mubarak was ousted last year.


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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


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Clinton-Lewinsky 'spinners' resurface

WASHINGTON (Reuters) - It's a case of déjà vu in D.C.: some of the same high-profile, high-priced handlers who played supporting roles in the scandal over President Bill Clinton's affair with intern Monica Lewinsky have re-emerged in the sex scandal that has toppled one U.S. national security chief and threatens another.


It is unclear what will be the roles of the expensive legal and crisis-management talent drawn into the uproar over the relationships between former CIA director David Petraeus and Marine General John Allen and two female acquaintances. Neither Republicans nor Democrats in Congress appear to have an appetite for another year-long Monica-style media spectacle.


The latest scandal began with an FBI investigation into cyber-harassment, and indications so far are that ultimately the inquiry will produce no criminal charges.


Nonetheless, both women at the center of attention - Petraeus biographer and former mistress Paula Broadwell and Tampa socialite Jill Kelley, the woman to whom Broadwell is alleged to have sent suspected harassing emails - have turned for advice to veteran Washington lawyers and spin doctors with connections to the Lewinsky brouhaha.


On Monday, a source close to the Kelley family said that two Washington-based players in the Lewinsky scandal, trial lawyer Abbe Lowell and public relations adviser Judy Smith, were working for Kelley.


A day later, a Washington law firm which represented Lewinsky herself confirmed that one of its partners, Robert F. Muse, was representing Broadwell. The three advisors either were unavailable for comment or declined to comment.


It is not known whether Petraeus or Allen, who is the top U.S. military commander in Afghanistan, have retained attorneys.

 

A complaint by Kelley to the FBI about the harassing emails sparked an investigation that implicated Petraeus in a career-ending affair with Broadwell.


It also embroiled Kelley herself in the uproar over her still-murky relationship with Allen.


Kelley's lawyer, Lowell, who an insider said she had known for years, served as pro-Clinton Democratic Party chief counsel on a House impeachment inquiry. Recently he won a partial acquittal and partial mistrial for John Edwards, a former Democratic U.S. senator and vice presidential candidate who had been indicted for misusing undeclared campaign funds to support his mistress.


During the Clinton sex scandal, Smith, a one-time press aide to President George H.W. Bush, served as Lewinsky's spokeswoman. Smith also represented NFL quarterback Michael Vick, who was charged and convicted in a dogfighting cruelty case.


Smith also is a model for the main character in the ABC-TV drama "Scandal," a prime-time series in which ace spin-doctor Olivia Pope, along with a team of spies and ex-convicts, not only manages to sort out or cover up sex and spy scandals but also carries on a secret affair with a fictional U.S. president.


Muse's senior partner, Jacob Stein, and another prominent criminal lawyer from a different firm, Plato Cacheris, represented Lewinsky personally in a criminal investigation of Clinton by special prosecutor Kenneth Starr and a congressional inquiry which led to Clinton's impeachment by the House of Representatives but subsequent acquittal by the Senate. Muse himself did not represent Lewinsky, according to Cacheris.


Starr and a substantial special prosecution team pursued Clinton during the Lewinsky scandal. Starr turned his evidence over to the Republican-controlled House, which in a nationally televised broadcast impeached Clinton for high crimes and misdemeanors.


But Republicans could not muster the two-thirds majority in the Senate needed to remove Clinton from office. Republicans later were punished at the polls for what many of them conceded was a perceived overzealousness in pursuing Clinton.


CONGRESS WARY OF SPECTACLE


Lewinsky's lawyers were critical in helping her negotiate a legal thicket that included dealing with Starr's criminal investigators and the impeachment inquiry launched by Congress; she testified in both investigations. Lewinsky was also besieged for months by the media; eventually her team arranged decorous interviews with U.S. and British television networks.


Mindful of how the Lewinsky scandal played out, officials familiar with the views of both senior Democrats and Republicans in Congress say that congressional leaders are keen to avoid turning the scandal into a public extravaganza, even though there remain many unanswered questions.


If there are no public congressional hearings or a criminal prosecution, it is unclear what Broadwell's and Kelley's legal and public relations teams would do, apart from trying to manage news coverage and the hordes of paparazzi and TV cameramen now outside their clients' homes.


Lewinsky's lawyer, Cacheris, told Reuters that from what he could see, at this point Broadwell and Kelley do not know if there will be any charges against them. "These people are getting lawyers to ensure there is no criminal case," he added.


But Eric Dezenhall, a Washington crisis management expert, said some clients did not understand that there was a limit to how much even the most skilled lawyer and public relations specialist could do.


"You have to be very selective in the cases you take because you're going to end up with some very disgruntled clients," Dezenhall said.


(Editing by Warren Strobel and Paul Simao)

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General investigated for emails to Petraeus friend
















PERTH, Australia (AP) — In a new twist to the Gen. David Petraeus sex scandal, the Pentagon said Tuesday that the top American commander in Afghanistan, Gen. John Allen, is under investigation for alleged “inappropriate communications” with a woman who is said to have received threatening emails from Paula Broadwell, the woman with whom Petraeus had an extramarital affair.


Defense Secretary Leon Panetta said in a written statement issued to reporters aboard his aircraft, en route from Honolulu to Perth, Australia, that the FBI referred the matter to the Pentagon on Sunday.













Panetta said that he ordered a Pentagon investigation of Allen on Monday.


A senior defense official traveling with Panetta said Allen’s communications were with Jill Kelley, who has been described as an unpaid social liaison at MacDill Air Force Base, Fla., which is headquarters to the U.S. Central Command. She is not a U.S. government employee.


Kelley is said to have received threatening emails from Broadwell, who is Petraeus’ biographer and who had an extramarital affair with Petraeus that reportedly began after he became CIA director in September 2011.


Petraeus resigned as CIA director on Friday.


Allen, a four-star Marine general, succeeded Petraeus as the top American commander in Afghanistan in July 2011.


The senior official, who discussed the matter only on condition of anonymity because it is under investigation, said Panetta believed it was prudent to launch a Pentagon investigation, although the official would not explain the nature of Allen’s problematic communications.


The official said 20,000 to 30,000 pages of emails and other documents from Allen’s communications with Kelley between 2010 and 2012 are under review. He would not say whether they involved sexual matters or whether they are thought to include unauthorized disclosures of classified information. He said he did not know whether Petraeus is mentioned in the emails.


“Gen. Allen disputes that he has engaged in any wrongdoing in this matter,” the official said. He said Allen currently is in Washington.


Panetta said that while the matter is being investigated by the Defense Department Inspector General, Allen will remain in his post as commander of the International Security Assistance Force, based in Kabul. He praised Allen as having been instrumental in making progress in the war.


The FBI’s decision to refer the Allen matter to the Pentagon rather than keep it itself, combined with Panetta’s decision to allow Allen to continue as Afghanistan commander without a suspension, suggested strongly that officials viewed whatever happened as a possible infraction of military rules rather than a violation of federal criminal law.


Allen was Deputy Commander of Central Command, based in Tampa, prior to taking over in Afghanistan. He also is a veteran of the Iraq war.


In the meantime, Panetta said, Allen’s nomination to be the next commander of U.S. European Command and the commander of NATO forces in Europe has been put on hold “until the relevant facts are determined.” He had been expected to take that new post in early 2013, if confirmed by the Senate, as had been widely expected.


Panetta said President Barack Obama was consulted and agreed that Allen’s nomination should be put on hold. Allen was to testify at his confirmation hearing before the Senate Armed Services Committee on Thursday. Panetta said he asked committee leaders to delay that hearing.


NATO officials had no comment about the delay in Allen’s appointment.


“We have seen Secretary Panetta‘s statement,” NATO spokeswoman Carmen Romero said in Brussels. “It is a U.S. investigation.”


Panetta also said he wants the Senate Armed Services Committee to act promptly on Obama’s nomination of Gen. Joseph Dunford to succeed Allen as commander in Afghanistan. That nomination was made several weeks ago. Dunford’s hearing is also scheduled for Thursday.


___


Associated Press writer Slobodan Lekic in Kabul, Afghanistan, contributed to this report.


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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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