FDA's Deborah Autor to join drugmaker Mylan

Tue Apr 30, 2013 3:55pm EDT

(Reuters) – Generic drugmaker Mylan Inc said on Tuesday it has hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.

John M. Taylor, III, Counselor to the Commissioner, will take Autor’s place in an acting capacity as the agency looks for a replacement, FDA Commissioner Margaret Hamburg said in an email to staff.

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FDA’s Deborah Autor to join drugmaker Mylan

Tue Apr 30, 2013 3:55pm EDT

(Reuters) – Generic drugmaker Mylan Inc said on Tuesday it has hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.

John M. Taylor, III, Counselor to the Commissioner, will take Autor’s place in an acting capacity as the agency looks for a replacement, FDA Commissioner Margaret Hamburg said in an email to staff.


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Antibiotic-resistant ground turkey found in 21 states: report

By Carey Gillam

KANSAS CITY | Tue Apr 30, 2013 4:20pm EDT

KANSAS CITY (Reuters) – Dangerous antibiotic-resistant bacteria has been found in ground turkey on U.S. grocery shelves across a variety of brands and stores located in 21 states, according to a report by a consumer watchdog organization.

Of the 257 samples of ground turkey tested, more than half were found to be positive for fecal bacteria and overall, 90 percent were contaminated with one or more types of disease-causing organisms, many of which proved resistant to one or more common antibiotics, Consumer Reports found.

The non-profit, independent product-testing organization said in the June issue of its magazine that the sampling marked the first time it had conducted a laboratory analysis of ground turkey, a popular consumer alternative to hamburger. It was alarmed by the results.

“Some bacteria that end up on ground turkey, including E. coli and staph aureus, can cause not only food poisoning but also urinary, bloodstream, and other infections,” said a Consumer Reports statement on its findings.

The group said it samples ground turkey from 27 different brands including major and store brands.

Turkeys, like other livestock in the United States, are commonly given repeated low doses of antibiotics in an effort to keep the animals healthy and help promote growth. But there has been growing concern that widespread use of antibiotics in animals that are not sick is speeding the development of antibiotic resistance.

The National Turkey Federation said the findings were sensationalized on a sampling that was “extremely small,” and said that blaming use of antibiotics in animals was “misleading.”

“There is more than one way they (harmful bacteria) can wind up on food animals,” said National Turkey Federation vice president Lisa Picard. “In fact, it’s so common in the environment, studies have shown that generic E.coli and MRSA (Methicillin-resistant Staphylococcus aureus) can even be found on about 20 percent of computer keyboards.”

The U.S. Food and Drug Administration also found widespread contamination, discovering antibiotic resistant E coli, salmonella and other harmful bacteria in turkey, ground beef, pork chops and chicken in sampling done in 2011.

The food safety regulator says resistance of bacteria to antibiotics is “a major public health threat,” and last year issued voluntary guidelines for animal health and animal agriculture industries aimed at limiting the antibiotic use in livestock. The agency has rebuffed efforts to mandate reduced usage, however.

U.S. Rep. Louise Slaughter, a New York Democrat, last month reintroduced legislation that would ban non-therapeutic uses of eight types of antibiotics in food animal production.

The Centers for Disease Control and Prevention also has issued a warning about antibiotic resistance infections, saying they are becoming increasingly difficult to treat and more infected people are likely to die.

“Humans don’t consume antibiotics every day to prevent disease and neither should healthy animals,” said Dr. Urvashi Rangan, Director of the Food Safety and Sustainability Group at Consumer Reports. “Prudent use of antibiotics should be required to stem the public health crisis generated from the reduced effectiveness of antibiotics.”

(Reporting By Carey Gillam; Editing by Leslie Gevirtz)

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How much do financial interests sway researchers?

By Genevra Pittman

NEW YORK | Tue Apr 30, 2013 3:40pm EDT

NEW YORK (Reuters Health) – Funding from drug companies and other potential conflicts of interest did not influence the conclusions reached by researchers testing new cancer treatments over the past few years, according to a new analysis.

But Dr. Aaron Kesselheim, who has looked into that issue at the Harvard School of Public Health, pointed out that other studies have shown the opposite.

“One study put against the mass of data suggesting the funding of the study does relate to the outcomes I don’t think changes anything necessarily,” Kesselheim, who wasn’t involved in the new research, told Reuters Health.

The new report, which assessed publications in major cancer journals between 2008 and 2011, found the authors of more than two-thirds of the 150 trials had at least one conflict of interest.

However, only a given trial’s results – and not who funded it – influenced their conclusions, the study team wrote Monday in the Journal of Clinical Oncology.

One past study suggested transparency rules at medical journals were all over the map – and some didn’t have clear policies about reporting conflicts of interest at all (see Reuters Health story of June 22, 2011 here: reut.rs/n7NxRy ).

Many journals have firmed up their policies in recent years, which the new findings suggest may be having a positive effect, Kesselheim said.

“I would agree with the authors that based on their study, the financial disclosure information that authors are now required to provide for most credible medical journals does impact their writing (and) how they present data,” said Dr. David Johnson, head of internal medicine at the University of Texas Southwestern School of Medicine in Dallas.

“All transparency can be beneficial,” he added.

Industry affiliations may still affect what authors highlight or downplay about their findings, he pointed out, as well as whether certain trial data are published at all.

Dr. Rachel Riechelmann from the Instituto do Cancer do Estado in Sao Paulo, Brazil and her colleagues analyzed 150 trials and linked editorials on experimental treatments for a range of cancers.

Overall, just over half of those trials were funded by industry and 69 percent had a conflict of interest listed for at least one researcher.

Close to 55 percent of the trials found the experimental therapy worked. In their discussion of the findings, authors were “positive” or “highly positive” about the treatment in question for 51 to 53 percent of trials, regardless of whether they had reported a conflict of interest, Riechelmann and hear team wrote.

Unlike in some previous analyses, they said, the new data suggest conflicts of both researchers and editorial writers “did not influence their interpretation of trial results.”

BE CAUTIOUS

Johnson, who wrote a commentary published with the report, said doctors should still be cautious about new research and closely evaluate how studies were conducted – whether or not they were funded by a drug company.

“I think we should always maintain a level of healthy skepticism when new reports emerge about a new therapy,” he told Reuters Health.

Johnson said doctors and researchers should wait for second and third studies backing up the first before moving forward with a new treatment – and then “remain vigilant” for any worrisome findings that may come later.

SOURCE: bit.ly/ZU7Yeu Journal of Clinical Oncology, online April 29, 2013.

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Shingles jab for people in their 70s

29 April 2013 Last updated at 20:31 ET

By Michelle Roberts Health editor, BBC News online

Shingles rashThe rash can be extremely painful and blister

People in their 70s in England, Scotland and Northern Ireland will be offered a vaccine against shingles from this September.

Experts have been recommending routine immunisation for some years.

The government-led programme will target 70, 78 and 79-year-olds in the first instance and should prevent tens of thousands of shingles cases a year.

Elderly people are at greatest risk and vaccination should prevent nearly half of cases in the over 70s.

The Welsh government is debating introducing a similar programme

Catch-up campaign

It is estimated that, in England alone, around 800,000 people will be eligible for the vaccine in the first year.

Continue reading the main story

WHO IS ELIGIBLE FOR THE VACCINE?

  • From September 2013, year one of the catch-up campaign, people aged 70 and 79 in England, Scotland and Northern Ireland
  • In years two, three, four and five onwards more of the 70-79 age group will be offered the vaccine until, ultimately, only people aged 70 need to be targeted

Targeting of people aged 70-79 will be staggered in the next few years that follow until the age group is fully covered.

Thereafter, the jab should only need to be offered to people as they reach their 70th birthday.

Shingles is caused by the same virus as chickenpox, herpes varicella zoster.

The illness affects the nerves and the skin causing a painful rash.

In severe cases it can cause complications such as hearing loss or brain swelling.

Flare up

Shingles happens when an old chickenpox infection is reactivated.

The virus can remain inactive in the nervous system for decades, with the body’s immune system keeping it in check, but later in life it can flare up again and emerge this time as shingles.

If you have not had chickenpox before, you can catch it from someone with shingles, but it is not possible to catch shingles itself from someone with the condition.

A Department of Health spokesman said: “Shingles can be a nasty disease for older people and can lead to long-term health problems for around 14,000 people each year.

“This new vaccine can prevent some of the most serious cases, giving people the chance to live without the discomfort and pain that shingles causes.”


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Europe's regulator digs in for drug data fight

By Ben Hirschler

LONDON | Tue Apr 30, 2013 8:36am EDT

LONDON (Reuters) – Europe’s medicines regulator has been stopped from releasing clinical trial data about drugs made by AbbVie and Intermune, following a court ruling favoring the two U.S. companies.

The European Medicines Agency said on Tuesday it intended to appeal the interim decision by the European Union’s general court.

The court action, which prevents the European Medicines Agency (EMA) from releasing documents until a final ruling is given, highlights the battle between campaigners for more transparency and companies who fear it will harm their business.

The London-based watchdog has been on a collision course with some drugmakers since deciding it would lift the lid on previously secret clinical trial data that is submitted by companies as part of the application process for new drugs.

Since November 2010, the EMA has released 1.6 million pages of detailed clinical trial information – an approach it says reflects growing public demands for more openness to ensure that drugmakers cannot conceal adverse drug effects.

Its policy was challenged, however, by both AbbVie and Intermune, which sought an injunction in cases relating to requests for the release of data about their drugs.

In the case of AbbVie, information had been sought about its rheumatoid arthritis drug Humira, the world’s top-selling medicine. One of those seeking the data was UCB, a rival Belgian drug company.

The Intermune case related to information that was sought by academic researchers.

An AbbVie spokeswoman said the U.S. company supported transparency of clinical research for the benefit of patients, but was concerned that commercially confidential information contained in EMA filings could be used by other companies to compete against its product.

In a move that has alarmed a number of pharmaceutical companies, the EMA plans to step up transparency further from next year by establishing a systematic process for the release of full clinical trial data.

(Editing by Keith Weir)

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Europe’s regulator digs in for drug data fight

By Ben Hirschler

LONDON | Tue Apr 30, 2013 8:36am EDT

LONDON (Reuters) – Europe’s medicines regulator has been stopped from releasing clinical trial data about drugs made by AbbVie and Intermune, following a court ruling favoring the two U.S. companies.

The European Medicines Agency said on Tuesday it intended to appeal the interim decision by the European Union’s general court.

The court action, which prevents the European Medicines Agency (EMA) from releasing documents until a final ruling is given, highlights the battle between campaigners for more transparency and companies who fear it will harm their business.

The London-based watchdog has been on a collision course with some drugmakers since deciding it would lift the lid on previously secret clinical trial data that is submitted by companies as part of the application process for new drugs.

Since November 2010, the EMA has released 1.6 million pages of detailed clinical trial information – an approach it says reflects growing public demands for more openness to ensure that drugmakers cannot conceal adverse drug effects.

Its policy was challenged, however, by both AbbVie and Intermune, which sought an injunction in cases relating to requests for the release of data about their drugs.

In the case of AbbVie, information had been sought about its rheumatoid arthritis drug Humira, the world’s top-selling medicine. One of those seeking the data was UCB, a rival Belgian drug company.

The Intermune case related to information that was sought by academic researchers.

An AbbVie spokeswoman said the U.S. company supported transparency of clinical research for the benefit of patients, but was concerned that commercially confidential information contained in EMA filings could be used by other companies to compete against its product.

In a move that has alarmed a number of pharmaceutical companies, the EMA plans to step up transparency further from next year by establishing a systematic process for the release of full clinical trial data.

(Editing by Keith Weir)

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Do school programs keep kids from smoking?

By Andrew M. Seaman

NEW YORK | Tue Apr 30, 2013 2:43pm EDT

NEW YORK (Reuters Health) – Certain school-based programs that aim to keep kids from smoking cigarettes seem to work, according to a fresh look at some past research.

After examining over a hundred “gold standard” studies, researchers found that school-based programs that teach children life skills and self esteem were linked to a significant reduction in the number who started using tobacco down the road.

“There was a significant effect for more than one year,” said Julie McLellan, one of the study’s authors from the University of Oxford in the UK.

McLellan and her colleagues published their findings in The Cochrane Library, which is a publication of the Cochrane Collaboration, an international organization that evaluates medical research.

They write that the review was needed because many U.S. schools include tobacco education in their lessons although few have been tested.

A survey from 2000 found between 50 and 70 percent of U.S. middle and high school students had been taught about the short-term consequences of tobacco use.

“It’s important because there are no other reviews that have gone and looked into the world literature on school-based smoking prevention programs,” McLellan said.

For the new review, the researchers searched several academic databases for studies that assigned students, classes or schools randomly to either have a prevention program, or not have one.

The children had to be between 5 and 18 years old, and had to be tracked by the researchers for at least six months.

While the researchers found 134 studies, they focused on 49 that tracked about 142,000 students who never smoked before the programs began.

Some programs consisted of lessons that gave students information on smoking, and others taught students life skills, such as problem solving and decision making.

Overall, the programs that taught students life skills and those that also showed them how to overcome social influences were linked to a reduction in the number of smokers after at least a year.

McLellan gave the example that they would expect about 30 percent of any population to smoke. The program would be linked to a three percentage point decrease, which would bring the number of smokers to 27 percent of the group.

MORE RESEARCH NEEDED

But McLellan said more research is needed on those social support programs, which made up only a few of the 49 studies, and whether prevention programs lead to cost savings.

Andy Johnson, who has studied school-based prevention programs but was not involved with the new research, told Reuters Health that the new findings point to areas for future research.

“It does say there is a productive science here of how to prevent cigarette smoking and probably other substances as well. We have to pursue that science,” said Johnson, dean of the School of Community and Global Health at Claremont Graduate University in California.

SOURCE: bit.ly/15Xk8HX The Cochrane Library, online April 30, 2013.

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ECG Alarm Alerts Docs to Silent Killer

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By Chris Kaiser, Cardiology Editor, MedPage Today

Published: April 30, 2013

Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania

Action Points

  • Note that this single-center study demonstrated that prolonged QT intervals on ECGs were associated with all-cause mortality in hospitalized patients.
  • Be aware that only patients who had been ordered an ECG as part of clinical care could be included, potentially biasing the results.

An institution-wide, computer-based alert system for irregular heart rhythms identified and characterized patients at risk of death, researchers found.

Patients identified by the alert system with a greater than 500 ms corrected interval between the Q and T waves of their ECG cycle had a significantly higher risk of death compared with a QTc interval less than 500 ms (19% versus 5%), reported Michael J. Ackerman, MD, PhD, and colleagues from the Mayo Clinic in Rochester, Minn.

A pro-QTc (c=corrected) risk score for mortality, which takes into account clinical diagnoses, lab abnormalities, and medications known to influence the QT interval, among other risk factors, was an independent predictor of death (HR 1.18, 95% CI 1.05 to 1.32, P=0.006), according to the study published in the latest edition of the Mayo Clinic Proceedings.

In comparison, the hazard ratio for the risk associated with an additional year of age was 1.02 (95% CI 1.01 to 1.03, P=0.004).

A number of QT-prolonging diagnoses and conditions were included in the pro-QTc risk score. For each diagnosis or condition, patients received a score of 1. Those with a score of 4 or greater had significantly higher mortality than did patients with a pro-QTc score less than 4 (log-rank P<0.001).

A total of 99% of the study population had a pro-QT score of 1 or greater. The mean pro-QT score was 3.1 (ranging from 0 to 9).

Medications and electrolyte abnormalities were the primary drivers of increased pro-QTc scores. The higher the score, the greater the risk of death.

Antidepressants were the most common QT-prolonging medication among the study population, followed by antiarrhythmics and antibiotics/antifungals. The authors described a “QT perfect storm” that included the potentially lethal combination of antidepressants with QT-prolonging antibiotics on top of concomitant electrolyte abnormalities. They emphasized the importance of being aware of such clinical scenarios.

QT-prolonging medications can be changed and other QT-prolonging stressors can be reduced when physician awareness is raised, the researchers said.

Since 2005, the FDA has required drugs to be evaluated in a Thorough QT (TQT) study to determine their effect on the QT interval. In fact, the most common reason for a drug to be withdrawn from the market is because of their QT-prolongation properties.

However, more than 100 drugs now on the market are known to cause QT prolongation or at least have the potential to cause the syndrome — and they cross all healthcare disciplines. “Yet, the average healthcare professional’s awareness of QTc as a predictor of death is lagging,” Ackerman and colleagues wrote.

When the American Heart Association and the American College of Cardiology called attention to the need to identify patients who are vulnerable to QT prolongation early in their hospital experience, the Mayo researchers decided to develop and implement the QT alert system.

The electronic alert goes to the ordering physicians, and they are encouraged to visit the website AskMayoExpert “to inform and guide them regarding the potential significance of this electrocardiographic (ECG) finding.”

For the study, researchers reviewed slightly more than 81,000 ECGs from 52,579 unique patients who were treated at the Mayo Clinic between November 2010 and June 2011.

Of these patients, 1,145 (2%) had one or more ECGs that received a QT alert (which was seen by at least one of 654 different physicians), and 470 (41%) of these alerts had an “electrocardiographically isolated QTc of 500 ms or greater.” The latter became the study population.

In the study population, a cardiovascular diagnosis (46%) led the list of most common reasons for hospital admission, followed by infectious and gastrointestinal diseases (13% each).

The study population was significantly younger (mean age 55 versus 61), but the prolonged QTc put them at significantly greater risk of death (log-rank P<0.001).

Of the 87 patients in the study population who died, researchers obtained the death diagnosis for 77 of them. Malignancy topped the list of most frequent diagnosis (26%), followed by cardiovascular death (21%), and infectious disease/sepsis (20%).

Those who died of a malignancy were taking more QT-prolonging medications than those who died of other causes. But researchers noted that they cannot prove causation.

Regarding the cardiovascular deaths, seven occurred suddenly, eight died from progressive heart failure, two from amyloidosis, and one was unspecified.

The study confirms QT as a “potent risk predictor of mortality” and shows that an electronic alert system holds promise for bringing more awareness of QT prolongation on an institution-wide scale.

The study’s retrospective design is one of the limitations, as was the lack of specific data for each condition, researchers said.

Funding for the study came from various sources including the Frederick W. Smith family, the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program, the South-Eastern Norway Regional Health Authority, and the Center for Heart Failure Research in Oslo, Norway.

Ackerman reported relationships with Transgenomic, Boston Scientific, Medtronic, and St Jude Medical. Transgenomic and Mayo Clinic Health Solutions have a partnership that includes several licensing agreements that pay royalties and are related to the study topic.

From the American Heart Association:

  • ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death – Full Text

Primary source: Mayo Clinic Proceedings
Source reference:
Haugaa KH, et al “Institution-wide QT alert system identifies patients with a high risk of mortality” Mayo Clin Proc 2013; 88(4): 315-325.

Related Article(s):

  • Long QT Syndrome Diagnosis Aided by Standing ECG
  • FDA Warns Against High-Dose Citalopram
  • Energy Drinks May Put Heart at Risk
  • FDA Adds Cardiac Warning to Saquinavir Label

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