End war on drugs, says police chief

28 September 2013 Last updated at 19:54 ET

Syringe and heroin powderMike Barton compared current drugs policy to the alcohol prohibition era in America

Class A drugs should be decriminalised and drug addicts “treated and cared for not criminalised”, according to a senior UK police officer.

Writing in the Observer, Chief Constable Mike Barton of Durham Police said prohibition had put billions of pounds into the hands of criminals.

He said a controlled environment would be a more successful way of tackling the issue.

Mr Barton suggested this could be done through the NHS.

‘Route of supply’

The chief constable said he believed decriminalisation of Class A drugs would take away the income of dealers and destroy their power.

He said: “If an addict were able to access drugs via the NHS or something similar, then they would not have to go out and buy illegal drugs.

“Buying or being treated with, say, diamorphine is cheap. It’s cheap to produce it therapeutically.

“Not all crime gangs raise income through selling drugs, but most of them do in my experience. So offering an alternative route of supply to users cuts their income stream off.

“What I am saying is that drugs should be controlled. They should not, of course, be freely available.”

Mr Barton compared drugs prohibition to the ban on alcohol in the US in the 1920s which fuelled organised crime.

He said some young people saw drug dealers as glamorous gangsters and envied their wealth.

The officer said drug addicts must be treated and cared for and encouraged to break the cycle of addiction – they did not need to be criminalised.

Groups on radar

He said: “I think addiction to anything – drugs, alcohol, gambling, etc – is not a good thing, but outright prohibition hands revenue streams to villains.

“Since 1971 [the Misuse of Drugs Act] prohibition has put billions into the hands of villains who sell adulterated drugs on the streets.

“If you started to give a heroin addict the drug therapeutically, then we would not have the scourge of hepatitis C and Aids spreading among needle users, for instance. I am calling for a controlled environment, not a free-for-all.”

He said if the “war on drugs” meant trying to reduce illicit supply then it had failed.

There were 43 organised crime groups on their radar in the Durham Constabulary area alone, he added.

Mr Barton is among a small number of top police officers in the UK who have called for a major review of drugs policy.

Danny Kuschlick, of campaign group Transform Drug Policy Foundation, said: “We are delighted to see a serving chief constable who is willing to stand up and tell the truth – prohibition doesn’t work.”


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Flu vaccine offered to toddlers

28 September 2013 Last updated at 19:45 ET

Girl being given flu vaccine nasallyThe Scottish government’s senior medical officer said the nasal spray was more effective in children

The flu vaccine is for the first time being offered to every child in Scotland, in the form of a nasal spray.

Previously, only children in “at risk” groups were offered the protection.

The country’s largest ever immunisation programme was launched by First Minister Alex Salmond, who received the vaccine in a surgery in Aberdeenshire.

He said that as an asthmatic, he gets the injection every year and urged other eligible Scots to get protected before the winter.

A fifth of the Scottish population will be offered a free flu vaccine, including people aged over 65 and those with conditions that put them at greater risk.

For the first time, all two and three-year-olds – about 120,000 children – and about 100,000 primary school pupils will be offered the vaccine. It will take the form of a nasal spray rather than an injection.

Scotland’s senior medical officer said the spray, which is being phased in this autumn and rolled out over the next two years, was more effective in children than injections, as well as simpler to administer.

The roll-out will see about one million children aged between two and 17 have the chance to be immunised towards the end of 2015.

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What is flu?

How an influenza virus particle might look

  • Flu is a respiratory illness linked to infection by the influenza virus.
  • Symptoms usually include headache, fever, cough, sore throat, aching muscles and joints.
  • Influenza occurs most often in winter and usually peaks between December and March.
  • The virus was first identified in 1933.
  • There are two main types that cause infection: influenza A and influenza B
  • New strains of the virus are constantly emerging, which is why the flu vaccine should be given each year.

Speaking after receiving his own vaccine, Mr Salmond said it was better to be safe than sorry.

“As an asthmatic, I get my flu vaccination every year to make sure I’m protected and ready for the winter and I’m delighted to launch this national campaign,” he said.

“It is hugely successful and the existing programme has seen 2,000 fewer hospitalisations and 25,000 fewer GP consultations.

“For the first time this winter we are taking extra precautions to protect families by making sure children are also offered this vital vaccine.”

Senior medical officer Dr Nicola Steedman said every year she sees examples of how devastating flu can be.

She added: “For those with existing health conditions such as asthma, diabetes, heart or liver problems, flu can result in serious complications.

“Furthermore, those who are pregnant or over 65 are also at increased risk of flu and its complications and should be vaccinated to help protect against flu, even if they currently feel healthy and fit.

“Flu can also be very serious for children, particularly the youngest ones who have little or no immunity to the infection, which is why we are rolling out the new childhood flu immunisation programme.”


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U.S. House passes bill to regulate drug compounding

WASHINGTON | Sat Sep 28, 2013 3:26pm EDT

WASHINGTON (Reuters) – The U.S. House of Representatives on Saturday passed legislation that would give the Food and Drug Administration more authority to regulate companies that compound sterile drugs and ship them across state lines.

The bill, called the Drug Quality and Security Act, now goes to the Senate for a vote. House and Senate committees agreed on the legislation on Wednesday.

Introduced after a deadly outbreak of fungal meningitis killed more than 50 people last year, the act would also create a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medication into the drug supply.

The fungal meningitis outbreak was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Massachusetts.

Complaints from companies that felt previously proposed laws would cost too much to implement helped derail earlier attempts to create such national standards to track and trace drugs.


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Race to get Obamacare online sites running goes to the wire

Get Covered America buttons are seen during a training session in Chicago, Illinois September 7, 2013 before volunteers canvas a Chicago neighborhood to talk with residents about the Affordable Care Act - also known as Obamacare. Picture taken September 7, 2013. REUTERS/John Gress

Get Covered America buttons are seen during a training session in Chicago, Illinois September 7, 2013 before volunteers canvas a Chicago neighborhood to talk with residents about the Affordable Care Act – also known as Obamacare. Picture taken September 7, 2013.

Credit: Reuters/John Gress

By Sharon Begley

NEW YORK | Sat Sep 28, 2013 11:52am EDT

NEW YORK (Reuters) – Just days before the launch of the new U.S. state health insurance exchanges that are the centerpiece of the Affordable Care Act, a nationwide push is still under way to test and patch the technology behind the online sites.

Officials working on the sites have acknowledged that information technology (IT) failures will prevent many of them from functioning fully for weeks, and perhaps longer. That will slow the government’s drive to enroll millions of uninsured Americans under President Barack Obama’s healthcare reform law starting Tuesday.

From a political standpoint, a successful opening day will shape perceptions of Obama’s signature policy initiative. But the system’s functioning is to a large extent beyond the control of politicians and policy experts, and instead sits in the hands of the battalions of coders working for IT sub-contractors.

Six months ago, people involved in setting up the exchanges were more hopeful that everything would be ready on time, said Cristine Vogel, an associate director at Navigant Consulting.

“I don’t think there were enough hours in the day, or enough people with the skills,” she said. “When we look back, I think we’ll see that we missed an opportunity to share technology.”

Opponents of the healthcare reform known as Obamacare say the computer problems bolster their view that the 2010 law is a “train wreck” and should be delayed or repealed. The Obama administration insists the exchanges will be open for business on October 1, even if some uninsured Americans may not be able to buy coverage right away. More importantly, they say, the new health plans will begin to provide health coverage on January 1, as planned.

“So long as the website is accessible and the plans and the plan information are displayed properly so a consumer can shop for coverage and compare the plans, they will claim victory,” said Chris C1ondeluci, an employee benefits attorney at Venable LLP and a former staffer at the Senate Finance Committee who helped draft the Affordable Care Act.

FIRST-DAY CRASH?

This week, the Obama administration said its Spanish-language website would not be ready in time, and that it would be weeks before small businesses and their employees could sign up online for coverage on exchanges operated by the federal government.

The exchanges in Colorado and the District of Columbia, meanwhile, cannot calculate the amount of federal subsidies customers qualify for.

In New York, the exchange is not able to transfer data to some insurers instantaneously, as planned, one carrier told Reuters. Instead, the data will be sent in batches once a day or so. The glitch will not affect customers, but it raises questions that New York might have other IT problems.

Oregon had sufficient qualms about its online insurance marketplace that no one can enroll unless they use a trained, certified agent or other “community partner.”

As late as this week, Oregon also had trouble correctly displaying information about insurance plans on a test site. The problem could mislead customers about deductibles, prices and other details if it occurs on the live site Tuesday.

In Ohio, Lieutenant Governor Mary Taylor, a fierce opponent of the healthcare law, said in a radio interview this week that her state’s online exchange, which is being run by the federal government, could well crash on its first day.

In testing, she said, some plans filed by insurers “sat in a queue for the federal government for a week, so my concern is something similar is going to happen on October 1 because of the amount of (online) traffic.”

WORKAROUNDS OFFERED, TAKE TIME

In most cases, exchanges will offer workarounds that will take time to execute. In Washington, D.C., off-line contractors will calculate federal subsidies and inform applicants what they qualify for in November, by which time the online calculator might be working.

In Colorado, until at least November, customers will have to call phone service centers, where representatives will manually take them through the calculations to determine what subsidies they qualify for.

Even before the exchanges open, the finger-pointing has begun, with states blaming contractors for glitches and contractors blaming states or other contractors.

The system to calculate federal subsidies for the D.C. exchange was built by Curam Software, which IBM acquired in 2011. In tests of complex family situations, the software was getting subsidies wrong 15 percent of the time, said exchange spokesman Richard Sorian.

In a statement, IBM spokesman Mitchell Derman said the city “decided that a phased-in approach best meets the needs of its citizens.” He pointed out that Curam also built the eligibility software in Maryland and Minnesota, “two states that plan to have full functionality on October 1.”

In other words, a company that achieved its goal on time in two states fell short in a third. The reasons, said outside experts, include relationships among contractors and the specifics of existing computer systems in a state.

In Washington, Infosys, the giant Bangalore, India,-based technology company, is the system integrator – the contractor that takes software from sub-contractors like Curam and puts it all together. The fact that Curam’s calculation software is working on other exchanges suggests the glitch may not lie in its integration with the D.C. exchange’s other IT.

“A software package like Curam’s is put into the system by the system implementer, not the software provider,” said an IT expert not involved in the D.C. exchange. A spokesman for Infosys was not able to comment on its D.C. work.

MEDICAID SYSTEMS POSE HUGE HURDLE

One of the most difficult IT jobs has been to integrate each health insurance exchange with its state Medicaid system. These legacy systems are typically decades old. In Massachusetts, for instance, the system runs on the COBOL programming language, which is to today’s languages like a rotary phone is to an iPhone-5.

“These legacy systems are old and difficult to configure and re-configure,” said Tom Dehner, managing principal at Health Management Associates, a healthcare consultant, in Boston and former director of Massachusetts Medicaid.

“To change how eligibility is calculated,” as federal law now requires, he said, “you need to modify your Medicaid system, and that’s not something you can do by buying software off the shelf.”

The difficulty of interfacing with Medicaid will keep Colorado’s exchange from calculating subsidies online.

To determine eligibility for federal subsidies, explained Nathan Wilkes, a member of the board of Connect for Health Colorado, the system “first goes through Medicaid determination. That means connecting to a legacy system,” he said.

“Six or nine months ago we got an early warning that the way we wanted to integrate these systems wouldn’t work, and then time got away from us.”

Colorado’s exchange tested 100,000 scenarios to see how its software calculated subsidies, and got error after error.

“It’s an IT nightmare,” Wilkes said.

(Additional reporting by Lewis Krauskopf and Caroline Humer; Editing by Michele Gershberg and Doina Chiacu)

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Cancer drugs fund ‘to be extended’

27 September 2013 Last updated at 20:08 ET

Patient receiving chemotherapyThe £650m fund has paid for treatment for over 28,000 patients

A £200m-a-year fund for life-enhancing cancer drugs is to continue until 2016, the prime minister has announced.

The Cancer Drugs Fund was set up in 2011 to help patients in England access certain drugs before they get approval for widespread NHS use.

The scheme was due to end next year, but David Cameron has pledged £400m to keep it running.

Cancer charities have welcomed the move, but Labour accused the prime minister of “letting down” patients.

The aim of the fund was to make it easier for medics to prescribe treatments even if they have not yet been approved by the National Institute for Health and Care Excellence (Nice).

The scheme was set to run until 2014 and campaigners raised concerns about where patients would turn for help when the funding ceased.

Andrew Wilson, chief executive of the Rarer Cancers Foundation, welcomed the announcement.

He said: “The Cancer Drugs Fund has made a huge difference to cancer patients in England, significantly improving the quality of treatment available to people with advanced forms of cancer.

“It has also addressed some of the historic inequities that have existed for people with rarer cancers, ensuring that access to treatment is not denied simply because you are unlucky enough to have a rare form of cancer.

“This is a compassionate, common sense announcement which will be warmly welcomed by many thousands of cancer patients.”

Continue reading the main story

image of Nick Triggle Analysis Nick Triggle Health correspondent


An extension of the Cancer Drugs Fund in England means a radical overhaul in the NHS drugs pricing system is now unlikely.

Next year was meant to mark the start of value-based pricing, a system proposed by former Health Secretary Andrew Lansley to promote a closer link between the price the NHS pays and the value a medicine offers.

It could have led to higher price thresholds for medicines for diseases with a greater burden of illness or in areas where there is un-met need, or if it could be demonstrated that there would be wider benefits, such as getting people back to work.

Some of these elements are to be incorporated into the work of the drugs advisory body the National Institute of Health and Care Excellence from January.

But this announcement effectively signals a light-touch version of what was first envisaged.

So far more than 34,000 patients have benefited from the fund and the charity estimates that 16,500 extra patients will benefit each year as a result of the extension.

Mr Cameron said: “When I became prime minister three years ago many patients with rare cancers were being denied life-saving treatments.

“That is why we created the Cancer Drugs Fund, it is why we are extending it, and it is why we are partnering with Cancer Research UK to conduct new research into the effectiveness of cancer drugs.

“It is only because we have protected health spending that we can afford these life saving treatments.”

Dr Andrew Protheroe, consultant in medical oncology at The Churchill Hospital in Oxford, also backed the extension of the scheme.

He said: “The more treatment options that are available to me, the better job I feel I can do for my patients.

“There is nothing more frustrating than knowing there is an effective, licensed, evidence-based treatment available which I am not allowed to use.

“It is like trying to do your job with one hand tied behind your back.

“Before the Cancer Drugs Fund, doctors were not able to use a whole range of drugs which were part of standard practice in other countries.

“This fantastic announcement means we won’t have to go back to those days.”

But shadow health minister Liz Kendall said the government was “letting down cancer patients”.

She highlighted the fact that expert cancer networks – set up to improve access to high quality services – were scrapped during the reorganisation of the NHS earlier this year.

She added: “David Cameron should also stand up to the tobacco lobby rather than caving in to them over standardised cigarette packaging, which experts say would be a powerful weapon in the long-term fight against cancer.”

Alongside plans to extend the fund, Mr Cameron also announced that Genomics England – a government-owned organisation tasked with mapping the DNA of 100,000 patients with cancer and rare diseases – will begin a partnership with Cancer Research UK.


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Failing GP surgeries 'face closure'

28 September 2013 Last updated at 09:26 ET

Doctor in consulting roomGPs will face tougher scrutiny under a new system being introduced by the CQC

Failing GP surgeries in England have been warned they face closure by the NHS’s first chief inspector of GPs.

Prof Steve Field, who starts his role on Tuesday, also wants local doctors to offer services seven days a week.

However, the Royal College of GPs says the profession is already at “breaking point” and longer working hours could put quality of care at risk.

Health Secretary Jeremy Hunt has reiterated his calls for GPs to improve their care for the elderly.

Prof Field was appointed by the Care Quality Commission last month to oversee the quality of care provided by GP surgeries across England.

Speaking to the Guardian, the former chair of the Royal College of GPs indicated his willingness to improve standards in poorly performing surgeries by using sanctions, such as fines and the suspension of licences.

He said: “I will not hesitate at all to order the closure of GP practices that we find to be unsafe, or providing poor access, or which do not care for patients properly or treat them with dignity.

“While we’ve got some of the best general practice in the world, it’s let down by a small percentage of practices which aren’t providing appropriate access or quality of care,” he added.

‘Breaking point’

Dr Clare Gerada, chair of the Royal College of GPs, said doctors would be prepared to take on more work but not at the risk of patient care.

She said: “The concept of widespread weekend access is laudable but quality of care must never be sacrificed for access and GPs are already working 11 hour days, with some making up to 60 patient contacts in a single day.

“No doctor in the NHS should be expected to work weekends on top of this without a break. It is not safe or sustainable, for patients or GPs.”

Dr Gerada also said GPs should be fairly remunerated for their work.

She added: “GPs currently make 90% of patient contacts within the NHS – for only 9% of the budget.

“We are keen to do more but the profession is now at breaking point and we do not have the capacity to take on any more work, without the extra funding and resources to back it up.

“We are calling on the government for an emergency package of additional investment for general practice to protect GP services and protect the care we deliver to our patients.”

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Failing GP surgeries ‘face closure’

28 September 2013 Last updated at 09:26 ET

Doctor in consulting roomGPs will face tougher scrutiny under a new system being introduced by the CQC

Failing GP surgeries in England have been warned they face closure by the NHS’s first chief inspector of GPs.

Prof Steve Field, who starts his role on Tuesday, also wants local doctors to offer services seven days a week.

However, the Royal College of GPs says the profession is already at “breaking point” and longer working hours could put quality of care at risk.

Health Secretary Jeremy Hunt has reiterated his calls for GPs to improve their care for the elderly.

Prof Field was appointed by the Care Quality Commission last month to oversee the quality of care provided by GP surgeries across England.

Speaking to the Guardian, the former chair of the Royal College of GPs indicated his willingness to improve standards in poorly performing surgeries by using sanctions, such as fines and the suspension of licences.

He said: “I will not hesitate at all to order the closure of GP practices that we find to be unsafe, or providing poor access, or which do not care for patients properly or treat them with dignity.

“While we’ve got some of the best general practice in the world, it’s let down by a small percentage of practices which aren’t providing appropriate access or quality of care,” he added.

‘Breaking point’

Dr Clare Gerada, chair of the Royal College of GPs, said doctors would be prepared to take on more work but not at the risk of patient care.

She said: “The concept of widespread weekend access is laudable but quality of care must never be sacrificed for access and GPs are already working 11 hour days, with some making up to 60 patient contacts in a single day.

“No doctor in the NHS should be expected to work weekends on top of this without a break. It is not safe or sustainable, for patients or GPs.”

Dr Gerada also said GPs should be fairly remunerated for their work.

She added: “GPs currently make 90% of patient contacts within the NHS – for only 9% of the budget.

“We are keen to do more but the profession is now at breaking point and we do not have the capacity to take on any more work, without the extra funding and resources to back it up.

“We are calling on the government for an emergency package of additional investment for general practice to protect GP services and protect the care we deliver to our patients.”


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Thrombectomy Outcomes Poor in Elderly

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Meeting Coverage

Published: Sep 28, 2013

By John Gever, Deputy Managing Editor, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Action Points

  • This study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.
  • Only about one-quarter of stroke patients 80 and older who underwent endovascular treatment after thrombolysis had good functional recovery.
  • Point out that the study suggests that thrombectomy in elderly patients should be reserved only for those with the most favorable risk factors at time of treatment, such as a low burden of comorbities.

VIENNA — Only about one-quarter of stroke patients 80 and older who underwent endovascular treatment after thrombolysis had good functional recovery, according to a single-center study reported here.

Among 28 such patients treated at an academic center in Salzburg, Austria, 24% had modified Rankin scores of 2 or less when evaluated 3 months after treatment — even though the thrombectomy was technically successful in re-establishing blood flow in 68% of patients, reported Erasmia Broussalis, MD, of Christian Doppler Clinic at Paracelsus Medical University in Salzburg.

In patients younger than 60 treated at the clinic, successful recanalization was achieved at essentially the same rate (71%) but 66% of patients had modified Rankin scores of 2 or less after 3 months, she told attendees at the World Congress of Neurology.

When the analysis was restricted only to patients with successful recanalization, 31% of the elderly patients had good 3-month outcomes, compared with 71% of the patients younger than 60 (P=0.004), Broussalis said.

She suggested that, based on these results, thrombectomy in elderly patients should be reserved only for those with the most favorable risk factors at time of treatment, such as a low burden of comorbidities. At the same time, though, she emphasized that age alone should not be an absolute contraindication to thrombectomy.

Initial treatment in ischemic stroke patients reaching a hospital in a timely way is thrombolysis, but it does not always succeed in clearing the occlusion, Broussalis noted. In such patients, “thrombectomy provides an effective treatment option for flow restoration,” she said.

Previous research has established that older age is a predictor of poor outcomes, but no particular age level has been established as a cutoff, and the extent to which the age risk applies to patients achieving recanalization has been unclear. Broussalis noted that many trials of endovascular treatments have excluded patients 80 and older.

In the current study, 166 consecutive stroke patients treated with thrombolysis followed by thrombectomy from December 2009 to February 2013 were enrolled. The Trevo device was used for the endovascular treatment. Recanalization was defined as grades of 2b or 3 in the TICI system, determined from CT and/or MRI vascular scans.

Patients were stratified for analysis into age groups of under 60, 60 to 79, and 80 and older. Median NIH Stroke Scale scores in the three groups were the same at 18. Other factors were also similar, including time from symptom onset to admission, door to needle time, location of occlusion, and procedure time.

Periprocedural complications were similar as well, except that vessel perforations were more common in the elderly group (11% versus none in the under-60 and 2% of the 60 to 79 group (P=0.06).

But outcome differed considerably among the three groups, most markedly between the oldest and youngest patients.

Although median NIH stroke scores were the same at admission, they were much lower in the under-60 group at discharge (median 10) whereas they only declined slightly in the 80-and-older group (median 16, P=0.06).

Mortality was also much greater in the older patients: 36% versus 14% in the 60 to 79 group (P=0.01) and 8% in those younger than 60 (P=0.001 versus the oldest group).

The pattern for mortality remained the same when only patients with successful recanalization were included: 19% in the oldest group, 0% in those 60 to 79 (P=0.04), and 3% in those younger than 60 (P=0.004).

Broussalis said several factors probably contributed to the poorer outcomes in the older patients. These included more comorbidities at admission, a higher rate of complications post stroke, reduced “neuronal reserve,” and less social support.

Although the analysis did not attempt to correlate these factors with outcomes, she recommended that they be taken into account when considering older patients for thrombectomy after failed thrombolysis.

The study had no external funding.

Broussalis reported no potential conflicts of interest.


Primary source: World Congress of Neurology
Source reference: Broussalis E, et al “Is there an evidence to perform thrombectomy in patients over 80 years old?” WCN 2013; Abstract 2650.

John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!

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Fewer Cardiac Deaths When Insulin Started

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Meeting Coverage

Published: Sep 27, 2013

By Todd Neale, Senior Staff Writer, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • In patients with established type 2 diabetes, starting insulin therapy was associated with a small reduction in the risk of cardiovascular death.
  • Note that in a cumulative dose exposure analysis, only premixed human insulin was associated with a reduced risk of fatal MI and only basal human insulin was associated with a reduced risk of fatal stroke.

BARCELONA — In patients with established type 2 diabetes, starting insulin therapy was associated with a small reduction in the risk of cardiovascular death, an observational study showed.

Each additional year of exposure to insulin therapy was associated with a significant 4% to 7% relative reduction in the risk of dying from cardiovascular disease over about 5 years of follow-up, depending on the type of insulin, according to Sorin Ioacara, MD, PhD, of the “I. Pavel” Diabetes Outpatient Clinic in Bucharest, Romania.

Much of the benefit was related to a reduction in the risk of fatal myocardial infarction, he reported at the European Association for the Study of Diabetes meeting here.

“These data support the concept of macrovascular benefit for basal analog [insulin] use in type 2 diabetes,” he said, acknowledging that the magnitude of the reductions was small. But, he said, if those risk reductions are multiplied over several years, “you have significance. Not only statistical significance, but clinical [significance].”

Ewan Pearson, PhD, MBBChir, of the University of Dundee in Scotland, was more skeptical of the results.

“I think the effects were so tiny that I don’t believe there’s any actual cardiovascular benefit in terms of any of the insulins versus any of the other treatments,” he said.

Although previous evidence regarding the cardiovascular effects of insulin therapy have been mixed — with some studies showing a benefit and some showing harm — Pearson pointed out that the 12,000-patient ORIGIN trial comparing insulin glargine to standard care in patients with early type 2 diabetes showed a neutral result in terms of cardiovascular outcome.

When asked about the discrepancy between that trial and the current results, Ioacara suggested that it was related to differences in the stage of disease. The ORIGIN trial involved patients early in the course of type 2 diabetes and the current analysis involved patients who had progressed to the point of needing to start insulin therapy after years of taking oral diabetes medications.

The study included 4,990 patients ages 40 to 80 (mean 62) living in Bucharest who were taking an oral diabetes medication for at least 6 months and who starting taking insulin at some point from 2001 through 2008. Those who were taking insulin at the initial screening visit were not included in the analysis.

All patients were followed through the end of 2011; the average follow-up was 4.7 years.

During that time, 887 patients died — 59% from cardiovascular disease, 18% from cancer, 9% from disorders of the digestive system, 4% from respiratory disease, 2% from renal disease, and 8% from “other” causes.

Exposure to all types of insulin was associated with slightly, but significantly, reduced risks of cardiovascular mortality in a cumulative time exposure analysis (with hazard ratios for every additional year of insulin exposure, not considering dose):

  • Basal human insulin (HR 0.93, 95% CI 0.89-0.96)
  • Premixed analog insulin (HR 0.95, 95% CI 0.93-0.96)
  • Premixed human insulin (HR 0.96, 95% CI 0.95-0.97)
  • Glargine (HR 0.96, 95% CI 0.94-0.98)

The findings were similar when fatal MI was used as the endpoint, but less consistent when fatal stroke was used.

For comparison, there were also reduced risks of cardiovascular mortality associated with increasing exposure to the insulin sensitizers metformin (HR 0.98, 95% CI 0.95-0.99) and pioglitazone (HR 0.94, 95% CI 0.88-0.99).

In a cumulative dose exposure analysis, only premixed human insulin was associated with a reduced risk of fatal MI and only basal human insulin was associated with a reduced risk of fatal stroke. No harm was evident with any insulin type.

Ioacara did not report any conflicts of interest.


Primary source: European Association for the Study of Diabetes
Source reference: Ioacara S, et al “Cardiovascular mortality in type 2 diabetes patients with incident exposure to long-acting insulin analogs” EASD 2013; Abstract 199.

Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University.

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Moving Forward on Arkansas’ Innovative Plan to Provide Health Coverage to 200,000 Arkansans

By Cindy Mann CMS Deputy Administrator and Director, Center for Medicaid and CHIP Services

Today, the Centers for Medicare & Medicaid Services announced the approval of the Arkansas Medicaid 1115 Demonstration to expand Medicaid coverage to over 200,000 people that do not have access to health coverage.  This demonstration is part of the state’s larger initiative to create affordable, quality coverage options for all its residents. This coverage is possible thanks to the Affordable Care Act.

Over the last few months, CMS has worked closely with Arkansas on the Arkansas Health Care Independence Program, or as they call it in Arkansas, the Private Option and has benefited from public comments from a diverse group of stakeholders. Under the Private Option demonstration, the state will use premium assistance to provide adults who make $15,280 or less with coverage provided by Qualified Health Plans operating in the Health Insurance Marketplace. As a result, most of the newly eligible adults in Medicaid will receive almost all of their Medicaid benefits and cost-sharing coverage through the same plans that are serving Arkansans who enroll through the federally facilitated Marketplace. Under this and all premium assistance approaches, individuals in the demonstration retain all the rights, responsibilities, and protections as other Medicaid beneficiaries, including cost-sharing protections.

Outreach, the application process, and plan choice will be the same regardless of whether an Arkansas resident is enrolled in Medicaid or has a premium tax credit through the Marketplace. Arkansas is leading the state’s outreach effort for the Marketplace.  It is training “Health Insurance Guides” to help individuals in all 75 counties understand their options.  It has been running advertising on 28 television stations, 24 regional radio stations, 118 community radio stations, and in 120 community newspapers.  In addition, ads have been placed on 227 billboards, 100 gas pumps, two Central Arkansas Transit buses, and direct mail will be sent to 254,000 households and 172,000 small businesses.  The marketing tag line of “Get In” has switched to “Get Informed” and will be shift to “Get Enrolled” beginning October 1, 2013. Open enrollment for the new Medicaid demonstration as well as the Marketplace will begin on October 1, 2013 with eligibility effective January 1, 2014.

The Administration remains committed to working with states on the flexibility and resources they need to build new systems for health coverage.  Premium assistance is one option, and we will continue to work with states on solutions that work best to meet shared goals.  We encourage states to come to us with their delivery system ideas, and look forward to continuing to work with states on these and other innovative approaches to provide affordable coverage to all Americans.


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