Screening might avert many lung cancer deaths: study

Cigarette butts in an ashtray in Los Angeles, California, May 31, 2012. REUTERS/Jonathan Alcorn

Cigarette butts in an ashtray in Los Angeles, California, May 31, 2012.

Credit: Reuters/Jonathan Alcorn

By Kathryn Doyle

NEW YORK | Wed Feb 27, 2013 4:02pm EST

NEW YORK (Reuters Health) – A calculation based on results from a large lung cancer screening trial projects that 12,000 deaths a year among the highest-risk smokers and ex-smokers in the U.S. could be avoided with a national screening program.

The National Lung Screening Trial, published in 2010, found 20 percent fewer deaths from lung cancer in a group of people at highest risk for the disease when they were screened annually with CT scans, a form of high-resolution X-ray that can spot suspicious lung nodules.

Based on the 8.6 million Americans who would fall into that high-risk category because of a decades-long history of smoking, researchers at the American Cancer Society say in a new study that 12,000 fewer people a year would die of lung cancer if national screening were put in place.

“This is the first paper that attempts to assess the impact of screening on lung cancer cases nationally,” one of the authors, Ahmedin Jemal, told Reuters Health. “Twelve thousand is a lot of cases,” he said.

In the National Lung Screening Trial, current or former smokers between the ages of 55 and 74 who had accumulated 30 “pack-years” of smoking – for example by smoking 20 cigarettes a day for 30 years, or 40 cigarettes a day for 15 years – were considered to be at the highest risk for lung cancer.

The 20 percent reduction in deaths among people in that category in the trial was “a singular, enormous accomplishment” said Larry Kessler, of the University of Washington in Seattle, who studies the diagnostic value of screening technologies.

“That was a pivotal event that should have woken people up,” said Kessler, who also wrote an editorial accompanying the new study in the journal Cancer.

To put a number on the potential benefits demonstrated in the NLST, the American Cancer Society researchers used U.S. census and health survey data to calculate the number of Americans at highest risk for lung cancer.

About 60,000 of those people die from lung cancer every year, according to their estimates, which could be reduced to 48,000 if every one of those people had a CT scan to identify early-stage nodules that could be removed surgically.

A national screening program would represent a breakthrough in the battle against lung cancer, which kills about 160,000 people in the U.S. every year, the researchers argue. Other major killers like breast cancer and colon cancer can be screened for with mammograms and colonoscopies, but lung cancers are too often caught too late for life-saving treatment, they point out.

Although the prospect of reducing deaths by 20 percent sounds significant, there’s a reason screening hasn’t been adopted since the NLST results came out two years ago, cautions Paul Pinsky, of the Division of Cancer Prevention at the National Institutes of Health in Bethesda, Maryland.

“You could do a quick back of the envelope calculation and come up with something pretty close to this,” said Pinsky, who was not involved in the new study. “At most it’s a rough ballpark of the potential effect if CT screening were introduced in a mass way.”

The numbers probably wouldn’t translate to a real world situation, however, because not every eligible smoker or ex-smoker will want to be screened, and if they did, there wouldn’t be enough imaging centers with the expertise to handle the testing, Pinsky said.

And even in a best-case scenario, questions about national lung cancer screening remain, according to Kessler.

“There are two pieces missing,” Kessler said. “Screening costs money, and someone’s got to pay. And it also comes with risks.”

When not covered by insurance, a CT scan can cost between $500 and $1500. If the Unites States Preventative Services Task Force (USPSTF), a government-backed advisory group, decides to recommend lung cancer screening for people at high risk, then the Affordable Care Act dictates it must be covered by Medicare, Kessler notes. Then insurance companies may follow suit, as they often take their cues from Medicare.

Even if the screening were made more affordable, Kessler said, it would still be unrealistic for 100 percent of eligible people to be screened, especially because smokers tend to be more reluctant to go in for tests.

Moreover, screening comes with risks that haven’t yet been assessed, he added. Lung CT scans are prone to false positives – they identify suspicious nodules that turn out to be harmless or a benign form of cancer. But, as in all screening, false positives can cause patients real anxiety and lead to further painful, invasive and expensive testing. (See Reuters Health story of May 21, 2012 here: reut.rs/JLpCvs).

False positives can also lead to unnecessary surgery, which is especially dangerous, Kessler said. “With surgery, you have to be careful in the lung arena. You can’t cut out every lung nodule, like you can take out any colon polyp.”

While screening risks and benefits are being assessed, the focus should remain on helping people to quit smoking as the best way to prevent lung cancer deaths, Kessler said.

“Screening is important, but it’s not really a substitute for smoking cessation,” Jemal agreed.

SOURCE: bit.ly/We6kFg Cancer, online February 25, 2013.

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Analysis: Emerging deadly virus demands swift sleuth work

A electron microscope image of a coronavirus is seen in this undated picture provided by the Health Protection Agency in London February 19, 2013. REUTERS/Health Protection Agency/Handout

1 of 2. A electron microscope image of a coronavirus is seen in this undated picture provided by the Health Protection Agency in London February 19, 2013.

Credit: Reuters/Health Protection Agency/Handout

By Kate Kelland, Health and Science Correspondent

LONDON | Wed Feb 27, 2013 8:34am EST

LONDON (Reuters) – The emergence of a deadly virus previously unseen in humans that has already killed half those known to be infected requires speedy scientific detective work to figure out its potential.

Experts in virology and infectious diseases say that while they already have unprecedented detail about the genetics and capabilities of the novel coronavirus, or NCoV, what worries them more is what they don’t know.

The virus, which belongs to the same family as viruses that cause the common cold and the one that caused Severe Acute Respiratory Syndrome (SARS), emerged in the Middle East last year and has so far killed seven of the 13 people it is known to have infected worldwide.

Of those, six have been in Saudi Arabia, two in Jordan, and others in Britain and Germany linked to travel in the Middle East or to family clusters.

“What we know really concerns me, but what we don’t know really scares me,” said Michael Osterholm, director of the U.S.-based Center for Infectious Disease Research and Policy and a professor at the University of Minnesota.

Less than a week after identifying NCoV in September last year in a Qatari patient at a London hospital, scientists at Britain’s Health Protection Agency had sequenced part of its genome and mapped out a so-called “phylogenetic tree” – a kind of family tree – of its links.

Swiftly conducted scientific studies by teams in Switzerland, Germany and elsewhere have found that NCoV is well adapted to infecting humans and may be treatable medicines similar to the ones used for SARS, which emerged in China in 2002 and killed a tenth of the 8,000 people it infected.

“Partly because of the way the field has developed post-SARS, we’ve been able to get onto this virus very early,” said Mike Skinner, an expert on coronaviruses from Imperial College London. “We know what it looks like, we know what family it’s from and we have its complete gene sequence.”

Yet there are many unanswered questions.

SPOTLIGHT ON SAUDI ARABIA, JORDAN

“At the moment we just don’t know whether the virus might actually be quite widespread and it’s just a tiny proportion of people who get really sick, or whether it’s a brand new virus carrying a much greater virulence potential,” said Wendy Barclay, a flu virologist, also at Imperial College London.

To have any success in answering those questions, scientists and health officials in affected countries such as Saudi Arabia and Jordan need to conduct swift and robust epidemiological studies to find out whether the virus is circulating more widely in people but causing milder symptoms.

This would help establish whether the 13 cases seen so far are the most severe and represent “the tip the iceberg”, said Volker Thiel of the Institute of Immunobiology at Kantonal Hospital in Switzerland, who published research this month showing NCoV grows efficiently in human cells.

Scientists and health officials in the Middle East and Arab Peninsular also need to collaborate with colleagues in Europe, where some NCoV cases have been treated and where samples have gone to specialist labs, to try to pin down the virus’ source.

“ONE BIG VIROLOGICAL BLENDER”

Initial scientific analysis by laboratory scientists at Britain’s Health Protection Agency (HPA) – which helped identify the virus in a Qatari patient in September last year – found that NCoV’s closest relatives are most probably bat viruses.

It is not unusual for viruses to jump from animals to humans and mutate in the process – high profile examples include the human immunodeficiency virus (HIV) that causes AIDS and the H1N1 swine flu which caused a pandemic in 2009 and 2010.

Yet further work by a research team at the Robert Koch Institute at Germany’s University of Bonn now suggests it may have come through an intermediary – possibly goats.

In a detailed case study of a patient from Qatar who was infected with NCoV and treated in Germany, researchers said the man reported owning a camel and a goat farm on which several goats had been ill with fevers before he himself got sick.

Osterholm noted this, saying he would “feel more comfortable if we could trace back all the cases to an animal source”.

If so, it would mean the infections are just occasional cross-overs from animals, he said – a little like the sporadic cases of bird flu that continue to pop up – and would suggest the virus has not yet established a reservoir in humans.

Yet recent evidence from a cluster of cases in a family in Britain strongly suggests NCoV can be passed from one person to another and may not always come from an animal source.

An infection in a British man who had recently travelled to Saudi Arabia and Pakistan, reported on February 11, was swiftly followed by two more British cases in the same family in people who had no recent travel history in the Middle East.

The World Health Organization says the new cases show the virus is “persistent” and HPA scientists said the cluster provided “strong evidence” that NCoV, which like other coronaviruses probably spreads in airborne droplets, can pass from one human to another “in at least some circumstances”.

Despite this, Ian Jones, a professor of virology at Britain’s University of Reading, said he believes “the most likely outcome for the current infections is a dead end” – with the virus petering out and becoming extinct.

Others say they fear that is unlikely.

“There’s nothing in the virology that tells us this thing is going to stop being transmitted,” said Osterholm. “Today the world is one big virological blender. And if it’s sustaining itself (in humans) in the Middle East then it will show up around the rest of the world. It’s just a matter of time.”

(Editing by Anna Willard)

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Drug Has Mixed Results in Diastolic HF

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By Todd Neale, Senior Staff Writer, MedPage Today

Published: February 26, 2013

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

Action Points

  • This randomized, controlled trial demonstrated echocardiographic, but not clinical improvements in patients with diastolic dysfunction who received spironolactone.
  • Not that the study was underpowered to detect mortality differences.

In patients with heart failure with preserved ejection fraction, spironolactone improved left ventricular diastolic function but did not affect clinical status, the Aldo-DHF trial showed.

One of the two primary endpoints — an echocardiographic measure of diastolic function (E/e’) — showed a significant improvement with spironolactone versus placebo through 1 year of treatment (P<0.001), according to Burkert Pieske, MD, of the Medical University of Graz in Austria, and colleagues.

However, there was no difference between the groups on the other primary endpoint, maximal exercise capacity on cardiopulmonary exercise testing (peak VO2) at 1 year (P=0.81), the researchers reported in the Feb 27. issue of the Journal of the American Medical Association. The findings were reported last year at the European Society of Cardiology meeting.

In addition, spironolactone did not have any effect on heart failure symptoms, quality of life, depressive symptoms, or hospitalizations, and slightly reduced the average 6-minute walking distance (517 versus 536 meters, P=0.02).

“Whether the improved left ventricular function observed in the Aldo-DHF trial is of clinical significance requires further investigation in larger populations,” Pieske and colleagues wrote.

Heart failure with preserved ejection fraction, or diastolic heart failure, accounts for more than half of all heart failure causes, but there are no proven therapies.

“This is the first trial to show … that therapy with a drug for diastolic heart failure results in improvement in diastolic abnormalities of the left ventricle,” Jeffrey Teuteberg, MD, medical director of the UPMC Artificial Heart Program in Pittsburgh, said in an interview. “Unfortunately, it didn’t show improvements in quality of life or exercise capacity, so I think this lays the groundwork to some degree [for] further trials for diastolic heart failure.”

In the Aldo-DHF trial, which took place at 10 sites in Germany and Austria between 2007 and 2012, the authors evaluated aldosterone receptor blocker therapy with spironolactone in 422 ambulatory patients ages 50 and older (mean age 67) who had the following:

  • Chronic New York Heart Association class II or III heart failure (86% had class II symptoms)
  • A left ventricular ejection fraction of at least 50%
  • Echocardiographic evidence of diastolic dysfunction or atrial fibrillation at presentation
  • A peak VO2 no greater than 25 mL/min/kg

On a background of standard risk factor control, the patients were randomized to spironolactone 25 mg/day or placebo. The study lasted 12 months.

The improvement seen on the coprimary endpoint of E/e’ with spironolactone became apparent as early as 6 months and was sustained through 1 year. There was no difference between the groups in peak VO2 at any time point.

Aside from the measure of diastolic function, there were some other indicators of benefit, including a reduction in the left ventricular mass index by 6 g/m2 (P=0.009) and significantly lower levels of N-terminal pro-brain-type natriuretic peptide (median 152 versus 165 ng/L, P=0.03). Also, left ventricular ejection fraction at the end of the study was slightly higher in the spironolactone group (67.2% versus 65.9%, P=0.04).

But those changes were not associated with an improvement in the clinical status of the patients.

“Our study population may have been too young or too healthy, or the treatment period may have been too short, for observing a translation of improved diastolic function into a clinical benefit,” Pieske and colleagues wrote.

In terms of safety, spironolactone increased serum potassium levels by 0.2 mmol/L (P<0.001) and decreased estimated glomerular filtration rate by 5 mL/min/1.73 m2 (P<0.001). There was no difference between the groups in the rate of serious hyperkalemia, but the proportion of patients who had worsening renal function was greater in the spironolactone group (36% versus 21%, P<0.001).

The researchers acknowledged that the study may have been limited by the inclusion of stable patients with moderate heart failure; thus, the findings may not apply to a sicker population. In addition, the study was not powered to evaluate differences in heart failure hospitalizations or mortality.

In an accompanying editorial, John Cleland, MD, PhD, and Pierpaolo Pellicori, MD, of the University of Hull in Kingston-upon-Hull in England, questioned whether the patients in the trial actually had heart failure, noting that various indicators were better in the current trial than in other studies of diastolic heart failure.

“In Aldo-DHF, cardiac dysfunction may not have been severe enough to account for impaired exercise capacity, which could account for the lack of effect of spironolactone,” they wrote.

“Ultimately, the Aldo-DHF trial provides valuable new information but is not particularly reassuring in terms of either the efficacy or safety of mineralocorticoid antagonists for patients with [heart failure with preserved ejection fraction],” they wrote. “A large trial, TOPCAT, is expected to report the effects of spironolactone on morbidity and mortality in a similar population but with more advanced disease.”

The study was supported by the German-Austrian Heart Failure Study Group and the German Competence Network of Heart Failure. Aldo-DHF was funded by the Federal Ministry of Education and Research. The University of Göttingen was the formal sponsor.

Pieske reported receiving speaker honoraria from Bayer Healthcare, Boehringer Ingelheim, Servier, Medtronic, Bristol-Myers Squibb (BMS), and Menarini and serving as a consultant and/or steering committee member for Bayer Healthcare, Menarini, and Novartis. He participated in research cooperations (institutional) with Bayer Healthcare and Medtronic. His co-authors reported relationships with Berlin Chemie, Novartis, Pfizer, Servier, Bayer, Gilead, CVRx, Relypsa, Sanofi, AstraZeneca, Boehringer Ingelheim, Boston Scientific, Johnson & Johnson, Medtronic, Verlag Hans Huber, Deutscher Ärzteverlag, KKH-Allianz, Merck Sharpe & Dohme, BMS, sanofi-aventis, Health Insurance Company, BMW, Impulse Dynamics, and Robert Bosch Health Care.

The editorialists reported that they had no conflicts of interest.

Primary source: Journal of the American Medical Association
Source reference:
Edelmann F, et al “Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: the Aldo-DHF randomized controlled trial” JAMA 2013; 781-791.

Additional source: Journal of the American Medical Association
Source reference:
Cleland J, Pellicori P “Defining diastolic heart failure and identifying effective therapies” JAMA 2013; 309: 825-826.

Related Article(s):

  • ESC: Drug Shows Some Benefit for Diastolic HF

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Ban smoking in cars, says minister

26 February 2013 Last updated at 10:49 ET

Man smoking in carHealth campaigners have been calling for a ban on smoking in cars

Smoking should be banned in cars carrying children, says England’s public health minister.

Anna Soubry said her personal view was that it was justified on “child welfare” grounds.

The move has been called for by several health groups, although so far the government has resisted.

The prime minister has said while he supports the smoking ban in pubs and clubs, he is “more nervous” about legislating what happens in cars.

At the Local Government Association’s annual public health conference, Ms Soubry said: “I would ban smoking in cars where children are present.

“I would do that for the protection of children. I believe in protecting children. I would see it as a child welfare issue.

“I think it is something we should at least consider as government.”

Ms Soubry, who is a former smoker herself, made it clear to the audience she was expressing her own views.

While the government is not considering a ban currently, it has run marketing campaigns aimed at encouraging people not to smoke in the presence of their children at home or in cars.

A survey by the Department of Health last year found that more than one in five smokers lit up in front of their children in the home or in cars.

Children are particularly vulnerable to secondhand smoke due to their higher breathing rate, less well-developed airways, lungs and immune system.

Those exposed are more at risk of respiratory illnesses, asthma, meningitis and even cot death.

Research shows that 300,000 children in the UK visit the GP each year due to second-hand smoke with 9,500 visiting hospital.


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Dementia in care homes 'more common'

25 February 2013 Last updated at 19:28 ET

By Nick Triggle Health correspondent, BBC News

Holding handsThe number of people with dementia is on the rise

More than 320,000 of the 400,000 people living in care homes in England, Wales and Northern Ireland now have dementia or severe memory problems, the Alzheimer’s Society charity estimates.

It said the figure was almost 30% higher than previous estimates because of the rise in the ageing population and improvements in data collection.

Of 2,000 adults surveyed, 70% said they would be scared about going to a home.

Another two-thirds felt the sector was not doing enough to tackle abuse.

And just 41% of 1,100 family members and carers surveyed thought their loved ones’ quality of life was good

Continue reading the main story

What is dementia?

  • Dementia is an umbrella term describing a serious deterioration in mental functions, such as memory, language, orientation and judgement.
  • There are many types, but Alzheimer’s disease, which accounts for two-thirds of cases, is the most well-known.

Alzheimer’s Society chief executive Jeremy Hughes said: “Society has such low expectation of care homes that people are settling for average.

“Throughout our lives we demand the best for ourselves and our children. Why do we expect less for our parents?

“We need government and care homes to work together to lift up expectations so people know they have the right to demand the best.”

David Rogers, of the Local Government Association, which represents councils, said: “This report shows the lack of confidence in a care system which is buckling under the weight of rapidly growing demand and years of underfunding.

“Local authorities want to offer a service which goes beyond a basic level of care but this is becoming increasingly difficult as our population ages, costs climb and the already significant funding shortfall becomes even more severe.”

Visit the Source Site

Dementia in care homes ‘more common’

25 February 2013 Last updated at 19:28 ET

By Nick Triggle Health correspondent, BBC News

Holding handsThe number of people with dementia is on the rise

More than 320,000 of the 400,000 people living in care homes in England, Wales and Northern Ireland now have dementia or severe memory problems, the Alzheimer’s Society charity estimates.

It said the figure was almost 30% higher than previous estimates because of the rise in the ageing population and improvements in data collection.

Of 2,000 adults surveyed, 70% said they would be scared about going to a home.

Another two-thirds felt the sector was not doing enough to tackle abuse.

And just 41% of 1,100 family members and carers surveyed thought their loved ones’ quality of life was good

Continue reading the main story

What is dementia?

  • Dementia is an umbrella term describing a serious deterioration in mental functions, such as memory, language, orientation and judgement.
  • There are many types, but Alzheimer’s disease, which accounts for two-thirds of cases, is the most well-known.

Alzheimer’s Society chief executive Jeremy Hughes said: “Society has such low expectation of care homes that people are settling for average.

“Throughout our lives we demand the best for ourselves and our children. Why do we expect less for our parents?

“We need government and care homes to work together to lift up expectations so people know they have the right to demand the best.”

David Rogers, of the Local Government Association, which represents councils, said: “This report shows the lack of confidence in a care system which is buckling under the weight of rapidly growing demand and years of underfunding.

“Local authorities want to offer a service which goes beyond a basic level of care but this is becoming increasingly difficult as our population ages, costs climb and the already significant funding shortfall becomes even more severe.”


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FDA halts trials of Amgen drug in children, cites death

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The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason Reed

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009.

Credit: Reuters/Jason Reed

Tue Feb 26, 2013 12:31pm EST

(Reuters) – The U.S. Food and Drug Administration said on Tuesday it has stopped all pediatric clinical trials of Amgen Inc’s Sensipar after the reported death of a 14-year-old patient taking part in a study of the drug used to lower calcium levels in the blood.

The agency said it was collecting information on the circumstances of the teenager’s death. It said it does not know if the Amgen drug, used to lower dangerously high calcium levels in the blood, had any role in the death.

“This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete,” the FDA said in a statement posted on its website.

Sensipar is approved to treat adults 18 and over. The trials were being conducted to determine the safety and efficacy of the drug in younger patients.

Drugmakers also often conduct pediatric trials because they are rewarded with an additional six months of patent protection for testing medicines in children.

(Reporting by Bill Berkrot; Editing by David Gregorio)

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We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/

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Switzerland's Roche pledges to open up access to drug data

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The logo of the Swiss drugmaker Roche is seen on a factory in Burgdorf near Bern November 17, 2010. REUTERS/Pascal Lauener

The logo of the Swiss drugmaker Roche is seen on a factory in Burgdorf near Bern November 17, 2010.

Credit: Reuters/Pascal Lauener

Tue Feb 26, 2013 12:48pm EST

* Says will give third-party researchers access to trial data

* Follows GSK decision to publish reports and data

* Drugmakers under pressure to increase transparency

ZURICH (Reuters) – Swiss drugmaker Roche Holding has agreed to expand access to its clinical trial data as the pharmaceutical industry faces calls for greater transparency on scientific data.

The company’s move follows a decision this month by British rival GlaxoSmithKline to publish detailed clinical study reports as well as the results of all drug trials.

Roche has also come under pressure from critics, including non-profit organization The Cochrane Collaboration, to hand over data on its blockbuster flu drug Tamiflu amid claims from researchers that there is little evidence it works.

The drugmaker said on Tuesday that it would work with an independent body to evaluate and approve requests to access anonymized patient data and would support the release of full clinical study reports (CSR) via regulatory authorities.

“We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine,” Daniel O’Day, head of Roche’s pharmaceuticals unit, said.

O’Day said that the new process for accessing trial data would ensure patient confidentiality while avoiding the risk of publishing misleading results.

CSRs are formal study reports that provide more detail on the design, methods and results of clinical trials and form the basis of submissions to regulators such as the U.S. Food and Drug Administration and the European Medicines Agency.

Last year Europe’s medicines regulator agreed to open its data vaults to systematic scrutiny, allowing independent researchers to trawl through millions of pages of clinical trial information.

Roche also said it would make arrangements to make public three Roche-sponsored Tamiflu trials that are not currently available.

The company has been embroiled in a bitter row over the trial data, and in an attempt to appease critics it said in November that it would set up a multi-party advisory board to review all the Tamiflu data.

It said that it has agreed to allow a board of experts from academia and private institutions to decide what analyses are useful in assessing Tamiflu’s public health role and all requested Tamiflu trial data will then be handed over.

(Reporting by Caroline Copley; Editing by David Goodman)

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Switzerland’s Roche pledges to open up access to drug data

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The logo of the Swiss drugmaker Roche is seen on a factory in Burgdorf near Bern November 17, 2010. REUTERS/Pascal Lauener

The logo of the Swiss drugmaker Roche is seen on a factory in Burgdorf near Bern November 17, 2010.

Credit: Reuters/Pascal Lauener

Tue Feb 26, 2013 12:48pm EST

* Says will give third-party researchers access to trial data

* Follows GSK decision to publish reports and data

* Drugmakers under pressure to increase transparency

ZURICH (Reuters) – Swiss drugmaker Roche Holding has agreed to expand access to its clinical trial data as the pharmaceutical industry faces calls for greater transparency on scientific data.

The company’s move follows a decision this month by British rival GlaxoSmithKline to publish detailed clinical study reports as well as the results of all drug trials.

Roche has also come under pressure from critics, including non-profit organization The Cochrane Collaboration, to hand over data on its blockbuster flu drug Tamiflu amid claims from researchers that there is little evidence it works.

The drugmaker said on Tuesday that it would work with an independent body to evaluate and approve requests to access anonymized patient data and would support the release of full clinical study reports (CSR) via regulatory authorities.

“We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine,” Daniel O’Day, head of Roche’s pharmaceuticals unit, said.

O’Day said that the new process for accessing trial data would ensure patient confidentiality while avoiding the risk of publishing misleading results.

CSRs are formal study reports that provide more detail on the design, methods and results of clinical trials and form the basis of submissions to regulators such as the U.S. Food and Drug Administration and the European Medicines Agency.

Last year Europe’s medicines regulator agreed to open its data vaults to systematic scrutiny, allowing independent researchers to trawl through millions of pages of clinical trial information.

Roche also said it would make arrangements to make public three Roche-sponsored Tamiflu trials that are not currently available.

The company has been embroiled in a bitter row over the trial data, and in an attempt to appease critics it said in November that it would set up a multi-party advisory board to review all the Tamiflu data.

It said that it has agreed to allow a board of experts from academia and private institutions to decide what analyses are useful in assessing Tamiflu’s public health role and all requested Tamiflu trial data will then be handed over.

(Reporting by Caroline Copley; Editing by David Goodman)

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USPSTF: Vitamin D and Calcium Don’t Stop Fractures

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37535

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By Charles Bankhead, Staff Writer, MedPage Today

Published: February 25, 2013

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Action Points

  • Current evidence does not support supplementation with daily vitamin D or calcium to reduce the risk of fractures in adults, according to the United States Preventive Services Task Force.
  • Note that supplementation at or below 400 IU of vitamin D3 and 1,000 mg of calcium conveys a slightly increased risk for renal stones.

Current evidence does not support supplementation with daily vitamin D or calcium to reduce the risk of fractures in adults, the United States Preventive Services Task Force (USPSTF) concluded.

In particular, the combination of 400 IU of vitamin D and 1,000 mg of calcium has no effect on fracture risk in community-based postmenopausal women, and evidence is insufficient to support higher doses of the supplements in this segment of the population for fracture prevention, a USPSTF panel stated in recommendations published online in Annals of Internal Medicine.

While supplementation with less than 400 IU of vitamin D and less than 1,000 mg of calcium does increase the risk of kidney stones, the “USPSTF assessed the magnitude of this harm as small,” pointed out chair Virginia Moyer, MD, and co-authors.

“Except for postmenopausal women, there is inadequate evidence to estimate the benefits of vitamin D or calcium supplementation to prevent fractures in noninstitutionalized adults,” they wrote. “Due to the lack of effect on fracture incidence and the increased incidence of nephrolithiasis in the intervention group of the Women’s Health Initiative (WHI) trial, the USPSTF concluded with moderate certainty that daily supplementation with 400 IU of vitamin D3 and 1000 mg of calcium has no net benefit for the primary prevention of fractures in noninstitutionalized postmenopausal women.”

“Although women enrolled in WHI were predominately white, the lower risk for fractures in nonwhite women makes it very unlikely that a benefit would exist in this population,” they added.

The panel emphasized that the recommendations apply only to community-dwelling adults with no history of fractures, and that includes adults, ages 65 and older, who are at increased risk for falls. Moreover, the recommendation against supplementation with vitamin D and calcium does not apply to adults with osteoporosis or vitamin D deficiency.

The USPSTF cited a need for more research to assess the potential benefits and harms of supplementation of higher doses of vitamin D and calcium. The panel also noted a need for research into the impact of supplementation in early adulthood on fracture risk later in life, and for studies of supplementation in diverse populations, beyond the traditional focus on white women, who have the greatest risk of osteoporotic fractures.

The task force developed the recommendations after commissioning two systematic evidence reviews and a meta-analysis on vitamin D supplementation, with or without calcium, to assess the effects of supplementation on bone health outcomes in community-dwelling adults. They also looked at the association of vitamin D and calcium levels with bone health outcomes and the adverse effects of supplementation.

The recommendation consists of “terse statements unlikely to settle the debates,” according to the authors of an accompanying editorial. Nonetheless, the USPSTF arrived at an “unambiguous conclusion,” and the recommendation regarding postmenopausal women is equally unambiguous: “Do not supplement.”

“While we wait for the results of further research, the USPSTF’s cautious, evidence-based advice should encourage clinicians to think carefully before advising calcium and vitamin D supplementation for healthy individuals,” said Marion Nestle, PhD, of New York University in New York City, and Malden Nesheim, PhD, of Cornell University in Ithaca, N.Y.

Nutrition authority Walter Willett, MD, had little to quibble about within the narrow focus of the USPSTF recommendation. However, clinicians and patients are likely to be confused by the absence of guidance regarding the potential value of higher doses of vitamin D and calcium, the large population of institutionalized individuals, and other factors that predispose adults to a risk of fracture.

“We need to look at the evidence for calcium and vitamin D separately,” Willett, chair of nutrition at Harvard School of Public Health in Boston, told MedPage Today. “The evidence is quite different for these two essential nutrients.”

A substantial body of evidence suggests that calcium intake, whether by supplementation or food sources, does not reduce the risk of fracture. The optimal dose has yet to be determined, but the World Health Organization recommendation of 500 mg daily probably makes more sense than the 1,200 mg dose commonly recommended in the U.S.

With respect to vitamin D, Willett agreed with the USPSTF that more research is needed to determine the appropriate dose. Available evidence suggests that 1000 to 2000 IU daily is appropriate for most people who get inadequate amounts of vitamin D through the most common natural source, sunlight.

Members of the USPSTF panel reported no conflicts of interest.

Nestle disclosure a royalty intersted related to a book, and Nesheim disclosed a relationship with Steven Barclay Agency.

Willett reported no conflicts of interest.

Primary source: Annals of Internal Medicine
Source reference:
Moyer VA, et al “Vitamin D and calcium supplementation to prevent fractures in adults: US Preventive Services Task Force recommendation statement” Ann Intern Med 2013.

Additional source: Annals of Internal Medicine
Source reference:
Nestle M, Nesheim MC “To supplement or not to supplement: The US Preventive Services Task Force recommendations on calcium and vitamin D” Ann Intern Med 2013.

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