Friday, February 17, 2012

News and Events - 12 Feb 2012




NHS Choices
09.02.2012 14:32:00

“Parents who frequently move house put children’s health at risk,” according to the Daily Mail. The newspaper said that research found moving several times can affect children’s health and psychological state, and also increases the likelihood that a child may use illegal drugs.

This Scottish research, which looked at potential links between moving house in childhood and adult health, produced far more mixed results than the Mail implied. However, the press release accompanying the research did not always clearly reflect the findings of the study, which found very few significant links between moving frequently and poor health.

In fact, once the researchers accounted for factors such as social deprivation and moving schools, moving house was only significantly linked to a higher chance of using drugs in later life. Adults who had moved frequently showed no greater risk of being overweight, having high blood pressure, long-term illness, psychological distress, drinking or smoking later in life.

While researchers say the risk of having certain measures of poor health was “elevated” in people who moved house more frequently as a child, the increase in risk was not statistically significant, which means it could have happened by chance.

 

Where did the story come from?

The study was carried out by researchers from the Medical Research Council, the University of Stirling, Queen’s University and Scotland’s Chief Scientist Office. It was funded by the Chief Scientist Office of the Scottish Government Health Directorate. The study was published in the  peer-reviewed Journal of Epidemiology and Community Health.

The study’s findings were overstated by the Daily Mail. The newspaper reported that there were “negative health effects” from frequent moves, whereas the study found that frequent moving was only significantly linked to an increased chance of drug use. This finding on drug use was independent of other variables.

Moving during childhood was not significantly associated with adult measures of physical health, such as weight and blood pressure. The Mail only touched on these elements towards the end of its report.

It’s worth noting that in the press release that accompanied publication of the study, only the penultimate paragraph stated that only illegal drug use was independently associated with frequent moves.

 

What kind of research was this?

This research was part of a large  cohort study from the west of Scotland, which has taken place over 20 years. It compared the health of people who had been “residentially stable” during childhood with those who had moved house, using a range of health measures.

The authors say previous research suggests that frequent childhood moves may be associated with poorer health outcomes and behaviour in adolescence. The researchers say their present study brings together a wider range of health outcomes than has previously been considered, and also looked at the extent to which associations between childhood mobility and health in adolescence last into adulthood.

 

What did the research involve?

The study was based on a cohort of 1,515 participants who were 15 when it started in 1987 and who were followed up for 20 years. Data from this cohort were collected at five points in time, the final time when the participants were 36. The final sample analysed in the study was 850 participants, so 665 original participants (44% were not included in the final analysis because they had left the study.

Researchers collected their data through face-to-face interviews conducted by nurses. A parental questionnaire was completed at the start of the study.

The researchers got information about moving house from the number of addresses people had lived at between birth and 18 (they excluded recent moves out of the family home .  They collected information on a range of health measures including:

  • Physical health measures - these were all taken by nurses and included body mass index, waist-to-hip ratio, lung function and blood pressure.
  • Overall health - people were asked to report whether they had limiting long-term illness (answering yes or no and to give their own assessment of their general health, as rated on a four-point scale.
  • Psychological distress - this was assessed using a standard 12-item questionnaire (with a cut-off score of 3 points taken to indicate psychological distress . Whether people had thought about suicide was also examined, with people asked at certain points whether they had thought about taking a drug overdose or deliberate self-injury. The third measure of psychological distress was anxiety, as measured on a standard scale.
  • Health behaviours - the behaviours examined were heavy drinking (defined as exceeding maximum weekly safe limits , illegal drug use and smoking.

Importantly, the researchers also looked at participants’ family and household circumstances based on information provided by the children’s parents at the start. They also looked at other factors such as social deprivation (calculated by postcode and using recognised deprivation categories , housing status (home-owner or not , social class, family structure (intact or not and number of siblings. Also included were data on school mobility, derived from the number of primary and secondary schools attended. The researchers also looked at participants’ social class, education and marital status in adulthood.

The researchers then analysed the relationship between number of house moves in childhood and health at the ages of 18 and 36. They adjusted their findings for possible confounders, such as social class, deprivation and family circumstances.

 

What were the basic results?

The researchers found that approximately one in five people did not move address throughout childhood. Three in ten moved once or twice, and a further one in five had moved at least three times. They also found that children in single-parent households and those with two or three siblings were significantly more likely to have moved home (while those with at least four siblings were more likely to have stayed put .

After they adjusted their findings for both socioeconomic circumstances and the number of school moves, the researchers found that, when the participants were 18:

  • People who had moved at least three times were significantly more likely to have used illegal drugs than those who had never moved ( odds ratio [OR] 2.44, 95%  confidence interval [CI] 1.45 to 4.10 .
  • Those who moved at least once had a significantly higher chance of scoring 3 or more (indicating distress on the questionnaire for psychological distress than those who had not moved at all (OR 1.62, 95% CI 1.11 to 2.35 .
  • The risk of several outcomes (having a long-term illness, having suicidal thoughts for those who had moved at least once, and heavy drinking and smoking for those who had moved at least three times were “elevated” compared to those who had not moved at all, but the increased risks were not significant.
  • There was no association between childhood mobility and physical health measures such as blood pressure and weight.

When the participants were aged 36, the researchers found that:

  • Frequent moving in childhood was independently associated with illegal drug use (OR 1.92, 95% CI 1.00 to 3.69 .
  • The odds of poor health across other measures remained “elevated” but not statistically significant.
  • There was no association between moving address during childhood and physical health measures such as blood pressure and weight.

 

How did the researchers interpret the results?

The researchers concluded that increased residential mobility in childhood is associated with an elevated risk of poor health in adulthood, across a range of measures. This is explained in part, they say, by both social and economic circumstances and the frequency of school moves.

The relationship between childhood residential mobility and poorer health appeared to be stronger in adolescence than adulthood, possibly because people’s own socioeconomic circumstances lessened the effects over time.

 

Conclusion

This study looked at the effect of multiple address moves during childhood on people’s physical and psychological health at the ages of 18 and 36.

The way the authors interpreted the results of their study is confusing. They say that a higher risk of poor health outcomes is associated with frequent moves of home in childhood. However, the only significantly higher risk, once the results were adjusted for various confounders, was illegal drug use. This is important because it means that the other increases in risk identified are more likely to have occurred by chance.

The study examined an important issue, and one strength is the length of time of it covered. Another is its detailed collection of data, which might help explain why frequent moves of house could have an association with poorer health outcomes. For example, this could be because of frequent school moves, family break-up and deprivation.

However, the study has a number of limitations. Its high drop-out rate (around 43% raises the question of reliability and it is possible that those who dropped out or were lost to follow-up also had the most mobile childhoods. The study’s reliance on the parents to report outcomes, such as overall health, is another limitation as their reports may be subjective or difficult to appraise.

Families move home for a range of different reasons, including improved schooling and employment opportunities, change in financial circumstances or family break-up, and the study did not assess the reasons for the family moves. It seems obvious that children are more likely to be negatively affected when disruption or financial problems cause a family to move, rather than when the motive is to seek better schools or a better job.

The way children’s wellbeing is affected by frequent moving is an important issue, but it is also a complex one which needs to be examined further.

Links To The Headlines

Parents who frequently move house 'put children's health at risk'. Daily Mail, February 9 2012

Links To Science

Brown D, Benzeval M, Gayle V et al. Childhood residential mobility and health in late adolescence and adulthood: findings from the West of Scotland Twenty-07 Study. Journal of Epidemiology and Community Health, 6 February 2012 (published online first




10.02.2012 19:39:00

A research study into the drug benfluorex (marketed as Mediator , which was withdrawn from the French market in 2009 because of side effects, shows that its use in France during 1976-2009 was probably responsible for around 1300 deaths and 3100 hospital admissions.

The study, published in
Pharmacoepidemiology and Drug Safety
, was carried out by Agnes Fournier and Mahmoud Zureik, two epidemiologists from the Institut National de la Sante et de la Recherche Medical (Inserm (2012, doi:
10.1002/pds.3213 .

They warn that these figures may be underestimates. Patients who took the appetite-suppressant drug experienced valvular insufficiency.

“We have worked with available data from hospitals activity monitoring and from Social Security reimbursements,” Dr Zureik explains. “The population we have studied consisted of 303?336 patients who had taken 78 million boxes of Mediator.” About 5 million people took the drug in the 33 years it was on the market.

The results are published at a difficult time for its manufacturer Servier, because the founder of the company Jacques Servier and his collaborators are due to appear in court in Nanterre, from 14 May to 6 July, to face charges of deception.

Monsieur Servier, and several other executives from his firm, are accused of knowingly hiding the side effects of benfluorex, a fenfluramine derivative drug marketed as an adjunct in the treatment of hyperlipidaemia.

This is only one of two legal cases facing the company. In the second case, which is underway in Paris, the company faces charges of “deception” and “unintentional injuries and manslaughter.”

Lawyers representing the victims of the drug say that it will cover the whole period during which benfluorex was on the market, and not just the past 10 years of its use. Servier’s lawyer has repeatedly asked for the two proceedings to be merged into one, but France’s highest court, the Court of Cassation, rejected this demand. A merger would postpone the trial for several years.

An earlier study of the drug showed that the relative risk of hospitalisation for valvular insufficiency in 2007-8 was 3.1 (95% confidence interval 2.4 to 4.0 among individuals with at least one prescription for benfluorex, compared with those without any prescription for it in 2006 (
Pharmacoepidemiol Drug Saf
2010;19:1256-62, doi:
10.1002/pds.2044 .

From another large scale study done in the US general population (
Lancet
2006; 368:1005-101, doi:
10.1016/S0140-6736(06 69208-8 , Fournier and Zureik conclude that “43% of individuals diagnosed through a clinically indicated echocardiography with a severe to moderate valvular heart disease will die prematurely because of that disease.” This enabled them to calculate that “1320 deaths due to valvular insufficiency are attributable to the use of benfluorex in France during the period 1976-2009.”

These figures may underestimate the number of deaths as well as the “real mortality risk ratio among benfluorex users ever hospitalised for valvular insufficiency,” say the two authors.

Notes

Cite this as:
BMJ
2012;344:e996

via
bmj.com

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10.02.2012 6:55:00

An ongoing legal case between GlaxoSmithKline and courts in Argentina has drawn attention to possible procedural problems in trials done in developing nations. Natalia Fuertes reports.
After GlaxoSmithKline (GSK was fined US$92 000 by Argentinian courts for administrative irregularities in a vaccine trial, observers have questioned whether trials are done under the same strict principles all over the world.
On Dec 28, 2011, Marcelo Aguinsky, a judge in the province of Mendoza, found GSK guilty of irregularities in obtaining informed consent in a trial assessing the efficacy and safety of Synflorix—a vaccine against Streptococcus pneumoniae and acute otitis media caused by non-typeable Haemophilus influenzae. Aguinsky fined the drug company and the two main investigators, Miguel Tregnaghi and Hector Abate, a total of AR$1 million. GSK is currently appealing the decision. “GSK conducts clinical trials to the same high standards, irrespective of where in the world they are run”, the company said in a statement.
The COMPAS trial was done between 2007 and 2008 in rural areas of three provinces in the east and north of Argentina—Mendoza, Santiago del Estero, and San Juan. It involved around 400 health professionals and was originally intended to recruit 17 000 children.
Problems in the GSK trial first came to light in 2007, when paediatrician Ana Marchese reported possible irregularities to FeSProSa (Syndicate Federation of Argentinian Health Professionals after speaking to the trial participants' families. FeSProSa investigated the accusations and filed a report to the National Administration of Drugs, Food and Medical Technology (ANMAT in December, 2007, declaring problems surrounding informed consent. GSK stated that it was the company that had identified the irregularities through self-monitoring and reported them straight to ANMAT.
ANMAT undertook an inspection of the procedures and consent forms and found that in some of them, there was reason to believe that the parents of the participants did not fully understand what they were signing and the witnesses were not impartial. Due to these irregularities, the recruitment process was stopped in August, 2008. Roberto Lede, director of Planning and Institutional Relationships of ANMAT, states that “the intervention of the ANMAT was very opportune. The recruitment was stopped in the way it was being carried out and resumed with intensive control. It should be noted that the irregularities only affected less than 1% of the subjects.”
14 infants who were taking part in the COMPAS trial died during it. However, because they were in the placebo group, GSK and ANMAT agreed that the trial could continue. COMPAS ended successfully in 2008, with only 18% fewer subjects than originally intended, and Synflorix was approved by ANMAT.
However, as the problem regarding invalidity of some of the consent forms remained, ANMAT issued a fine to GSK and the local doctors in charge. While GSK are appealing the fine in Mendoza, in Santiago del Estero, their appeal to the Supreme Court was successful, and the ruling was dismissed. In San Juan, the local courts have yet to rule.
The ruling of the Argentinian courts marks a pivotal moment in the regulations of trials by local authorities. Luis Petri, a member of the Lower House in Mendoza presented a bill in early January, 2012, to ban clinical trials in the province. “Children of Mendoza must not be used as guinea pigs by pharmaceutical companies to try their drugs or vaccines, regardless of the consent of their parents”, he stated. The bill is still under consideration.
In 2007, about 200 trials were done in Argentina, but not all of them were officially registered. After the irregularities in the COMPAS trial were disclosed, the government decided to create a National Register of Trials. In November, 2008, ANMAT ordered drug companies throughout the country to include a warning sign in red capital letters on every consent form, clearly stating the experimental nature of the trial. However, ANMAT's Lede said that “there was no need to introduce any modifications to the law; the problem was not the law but the compliance with it”.
Brian Angus, director of the Wellcome Trust UK Centre for Clinical Tropical Medicine in Oxford, UK, states that “protection of volunteers for clinical trials is crucial. Especially overseas, where people sometimes do not have the level of education to understand the implications of a clinical trial, there is even greater need for the doctors to act in the patient's best interests. It is ultimately the doctor's responsibility. What would you do if somebody agrees to be part of a clinical trial but you do not think they really understand what it means? The answer is clear, you do not recruit them.”
GSK's fine is the largest Argentina has issued against a drug company. And while the case has led to legal changes in the country, it has also drawn attention to the need to improve ethical and procedural standards of trials done in developing regions of the world.

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10.02.2012 22:55:15

A federal jury finds that Sigma International General Medical Apparatus did not infringe on CareFusion's infusion pump technology patents.

CareFusion logo

Sigma logo

A federal jury this week decided against CareFusion (NYSE:
CFN in a patent lawsuit filed against Sigma International General Medical Apparatus over drug pump technology.

CareFusion had accused Sigma, in a lawsuit filed in February 2010, of patent infringement with the Spectrum intravenous infusion pumps, a claim that jurors rejected.



read more

http://www.massdevice.com/news/federal-jury-decides-against-carefusion-pain-pump-patent-lawsuit#comments



11.02.2012 19:46:29
The perception of people who become addicted to illegal or legal forms of drugs as people who have chosen to become addicted, are weak, or who have chosen addiction as a lifestyle may be incorrect. Addiction to drugs may be a predisposition based upon a number of different factors, some of which a person is unable to control, and some of which they are not.



10.02.2012 18:26:47

Controversial plans to build a US-style mega farm pose serious health risks to those living and working nearby, campaigners say

Controversial plans to build a US-style mega pig-farm in South Derbyshire close to a prison and residential housing pose serious health risks to those living and working there and could breach their legal rights to protection of their private and family life, the local council is being warned.

In the light of fresh legal advice, the organic farmers' group, the Soil Association and Friends of the Earth have joined forces with local group Foston Community Forum and
Pig Business, film-makers and campaigners, to urge Derbyshire county council to refuse planning permission for the proposed development at Foston.

Their challenge – the first against the scheme under the Human Rights Act – is
set out in a joint letter to the county council, stating that "planning authorities … have an obligation under the Human Rights Act 1998 to consider the effects of their decision on the human rights of affected third parties. The right to private and family life prevents not just physical incursions into the home or residence, but also interference from things such as noise, smell, emissions."

It goes on to say that the prison staff cannot avoid working close to the proposed development unless they resign from the jobs. The inmates of Foston Hall prison are not living in the area by choice, and clearly do not have the option of moving away if the development goes ahead. They will not be able to escape the risk to their health posed by the development, and the letter warns that allowing the pig factory to go ahead could also breach the inmates' right to be protected from inhumane treatment.

Midland Pig Producers (MPP has applied for permission to build the farm – which could house up to 25,000 animals – on a greenfield site west of the historic village of Foston and adjoining a women's closed prison which houses up to 290 prisoners. If approved, it would become the third largest factory farm in the UK, sending more than 1,000 pigs to slaughter every week.

The legal letter also cites new research which shows that intensive pig factories of this kind can adversely affect the health of nearby residents. This has been confirmed by the government's
Health Protection Agency (HPA , which says that those living within 150 metres of intensive pig farms "could be exposed to mutli-drug resistant organisms". The proposed development will be built within 150m of HMP Foston Hall - as well as within 75m of the nearest properties being planned for workers at the development site.

In November last year the project
was dealt a major blow when Derbyshire district council refused to back it. The final decision – already delayed – will be taken at county council level although no date has yet been set for a meeting.

After an application for a mega-dairy in Lincolnshire by Nocton Dairies,
which was later shelved, Foston has become the focus of a fierce fight over opposing visions for British farming. The Soil Association's concerns have been mainly about disease, antibiotic resistance and animal welfare in large pig herds.

But at an early stage the Foston battle took an unprecented twist involving libel law, when the Soil Assocation
received a threatening letter from solicitors Carter-Ruck - acting for MPP – saying its objection was defamatory and should be withdrawn.

Peter Melchett, policy director of the Soil Association, said: "The objections to the pig factory at Foston are mounting all the time, because of the growing weight of new scientific evidence of real risks to the health of local people, and to the staff and inmates of the prison right next door to the proposed site. Now it seems that the legal rights of local people may also be infringed by the proposed development."

Victoria Martindale, representative of the Foston community forum, said: "As a medical professional I am concerned about the health risks that this proposal will bring to local residents. Those living in the closest vicinity to the proposed site include the most susceptible and at risk groups such as children, the elderly and individuals already with known respiratory and other diseases. It is not fair to expect the residents of Foston to go about their everyday lives while being forced to continuously breathe in air that will put their and their families' health at risk."

A Derbyshire county council spokesperson said: "We have had thousands of views during the consultation and have had to look at and consider them. Following this, we have sent out for additional information from some agencies and are awaiting that. When this comes in we shall have to consider this and ensure we have all the information we need before compiling the report for the committee to consider."

MPP was contacted by the Guardian but has not issued a response to the letter.



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11.02.2012 23:01:05
Guatemalan President Otto Perez Molina says he will propose legalizing drugs in Central America in an upcoming meeting with the region's leaders.



11.02.2012 23:18:52



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10.02.2012 0:24:53

Police say they have arrested a major player in a smuggling syndicate which imported $25 million worth of illegal drugs hidden inside juice cartons from Iran.




2012-02-10 10:43:39
A Canadian study in this week’s issue of the British Medical Journal highlights the dangers of driving under the influence of pot, which nearly doubles the risk of a serious or fatal car crash, writes Sharon Kirkey for the
Vancouver Sun. Using cannabis within three hours of driving causes accidents at nearly twice the rate as those who are not under the influence of drugs or alcohol claims the paper’s authors, from Dalhousie University. Lead author Mark Asbridge, an associate professor in the department of community health and epidemiology at Dalhousie told Kirkey: “Surveys of young drivers have also shown rates of driving under the influence of cannabis have surpassed rates of drinking and driving in some jurisdictions.” “Not only is cannabis relatively easy to obtain, many young people really don’t believe cannabis impairs.” Previous studies into cannabis and automobile accidents have had mixed results. Some showed an increased risk of an automobile collision after using marijuana, others have found either no association whatsoever, or even a lower risk. For this study, researchers reviewed nine studies with a total sample of 49,411 subjects from Australia, New Zealand, the US, France and the Netherlands to determine the driving risks. The studies tested for tetrahydrocannabinol (THC , the active chemical in cannabis, by analyzing blood samples or using direct reports of cannabis use from those involved. Most studies used any amount greater than zero as the cut-off for a positive test result. Duncan Vernon, a road safety manager at the Royal Society for the Prevention of Accidents (RoSPA , told
BBC News that previous studies in controlled lab conditions had shown that cannabis does impair a driver’s ability drive safely and responsibly. “This new research strengthens the evidence that driving under the influence of cannabis increases the likelihood of being seriously injured or killed in a collision,” Vernon explained. “This adds to the argument that a system needs to be put in place to monitor the number of serious and fatal accidents where impairment from illegal drugs was a contributory factor, so that appropriate action can be taken to prevent them.” The study concluded with the suggestion that the consumption of cannabis indeed impairs safe motoring ability and increases the chance of collisions. --- On the Net:



11.02.2012 4:29:13

Prosecutors object to Utah drug doctor’s freedom during appeal



By Melinda Rogers



The Salt Lake Tribune

Published Feb 10, 2012 07:29PM MDT
The U.S. Attorney’s Office has asked the 10th Circuit Court of Appeals in Denver to overturn a ruling by a federal judge allowing a Brigham City doctor convicted of illegally distributing painkillers to stay out of prison through an appeals process. U.S. District Judge Dee Benson last month denied a request to allow Dewey C. MacKay, 64, to stay out of prison while his attorneys appeal his guilty verdict and 20-year prison sentence. But the judge also granted a request from MacKay’s attorney, Pe...
Copyright 2012 The Salt Lake Tribune. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.



11.02.2012 0:03:00


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JEFFREY BROWN: President Obama backtracked some today on a birth control insurance mandate. His new plan sought to satisfy critics of the plan, while maintaining support from women's health advocates.

The president entered the White House Briefing Room bent on calming a political storm.

PRESIDENT BARACK OBAMA: Religious liberty will be protected, and a law that requires free preventive care will not discriminate against women.

JEFFREY BROWN: Just three weeks ago, the administration announced that religiously affiliated schools, hospitals and other institutions had to cover birth control free of cost. Roman Catholic officials, in particular, charged the mandate would force them to violate their own teachings.

Today, the president said the revised plan would address that objection.

BARACK OBAMA: Under the rule women will still have access to free, preventive care that includes contraceptive services no matter where they work. So that core principle remains.

But if a woman's employer is a charity or a hospital that has a religious objection to providing contraceptive services as part of their health plan, the insurance company -- not the hospital, not the charity -- will be required to reach out and offer the woman contraceptive care free of charge without co-pays and without hassles.

JEFFREY BROWN: The president of the Catholic Health Association, representing Catholic hospitals, welcomed the decision.

Sister Carol Keehan said in a statement, "The framework developed has responded to the issues we identified that needed to be fixed."

The head of the U.S. Conference of Catholic Bishops was more restrained. Archbishop of New York Timothy Dolan said, "Today's decision to revise how individuals obtain services that are morally objectionable to religious entities and people of faith is a first step in the right direction."

Groups that supported the birth control mandate, from Planned Parenthood to the National Organization for Women, backed the compromise.

Louise Melling is deputy legal director for the American Civil Liberties Union.

LOUISE MELLING, American Civil Liberties Union: We were pleased that, today, the Obama administration made perfectly clear its longstanding commitment to contraceptive coverage, that it made clear, again, and reaffirmed its commitment to ensure that women across the country, no matter where they work, will be able to have coverage for contraception.

JEFFREY BROWN: For their part, Republican presidential candidates kept up their criticism of the original mandate.

Former House Speaker Newt Gingrich spoke at a gathering of conservative activists in Washington.

NEWT GINGRICH (R : Our core document says we are endowed by our creator with certain unalienable rights. And Barack Obama seeks to cut across those.

And I, frankly, don't care what deal he tries to cut, this is a man who is deeply committed -- if he wins reelection, he will wage war on the Catholic Church the morning after he's reelected. We cannot trust him, we should -- we know who he really is, and we should make sure the country knows who he really is.

(APPLAUSE

JEFFREY BROWN: At that same conference, former Pennsylvania Sen. Rick Santorum accused the administration of overreach. He spoke shortly before the president's remarks.

RICK SANTORUM (R : This is the kind of coercion that we can expect. It's not about contraception. It's about economic liberty. It's about freedom of speech. It's about freedom of religion. It's about government control of your lives. And it's got to stop.

(CHEERING AND APPLAUSE

JEFFREY BROWN: Mitt Romney didn't directly respond to the Obama announcement, but he vowed that his would be a pro-life presidency.

MITT ROMNEY (R : And I will reverse every single Obama regulation that attacks our religious liberty and threatens innocent life in this country.

JEFFREY BROWN: The president today suggested the political uproar should die down now that the policy has changed.

BARACK OBAMA: I understand some folks in Washington may want to treat this as another political wedge issue, but it shouldn't be. I certainly never saw it that way.

This is an issue where people of good will on both sides of the debate have been sorting through some very complicated questions to find a solution that works for everyone. With today's announcement, we've done that.

JEFFREY BROWN: With the president hoping to put the birth control furor behind him, aides will be watching to see if Republicans in Congress push ahead with emergency legislation on the issue.

RAY SUAREZ: This afternoon, I spoke about the president's decision with Kathleen Sebelius, the secretary of health and human services. She spoke from the front lawn of the White House, where construction has been under way for more than a year, work that resumed during our interview.

Secretary Sebelius, welcome back to the NewsHour.

HEALTH AND HUMAN SERVICES SECRETARY KATHLEEN SEBELIUS: Thank you. Nice to be with you, Ray.

RAY SUAREZ: Could the administration have avoided a damaging fight over contraception coverage by announcing this policy in the first place?

KATHLEEN SEBELIUS: Well, I think what people missed is that the announcement that I made two weeks ago suggested that we were moving ahead with the exemption that had been originally drafted, but, also, we would spend time reaching out to stakeholders, to religious employers who objected to offering this coverage, and we would spend a year finding arrangements that both respected their religious liberty, but made sure at the end of the day that women employees of these institutions, whether she was a university professor or a nurse or a janitor, could make their own determination about very important preventive health care.

RAY SUAREZ: Did you have any idea what was coming? Were you warned by administration colleagues about possible backlash?

KATHLEEN SEBELIUS: Well, there were certainly people who felt we should broaden the exemption greatly.

I think the president from the outset determined that he was not willing to have millions of American women bear the financial burden of their employer deciding they should not access contraception, a drug that is the most frequently used prescription drug of women 14 to 40, and that often has a serious financial cost, up to $600 if a woman is paying out of pocket for it.

So, on one hand, we wanted to make sure that the preventive health benefits, no co-pays, no co-insurance applied to the whole range of IOM recommendations, so keep the exemption narrow, for churches and church affiliates, but also use the time to look at the 28 states which have mandatory contraceptive coverage, see what arrangements were satisfactory to the various Catholic institutions who right now offer that coverage, universities and hospitals, and deem that to be effective going forward.

When the firestorm broke out, the president basically said, we have got to speed up this process. Let's find a solution respecting religious liberty and guaranteeing that millions of women in America, and really all women in America now, have insurance policies that will have a range of health services needed by them and their families without co-pays and co-insurance to make sure they can access them.

RAY SUAREZ: So, you mentioned the administration spoke to religious institutions beforehand. Have you spoken to them about this latest adjustment, this latest change of policy?

It's reported that President Obama has already spoken to Archbishop Timothy Dolan of New York, one of the senior leaders of the Catholic Church.

KATHLEEN SEBELIUS: Well, I don't -- I know he has reached out to Archbishop Dolan. I know he has spoken to Sister Carol Keehan from the Catholic Health Association, who has issued a statement very supportive of this rule that we're going to publish in the federal register today.

I know he has spoken to Cecile Richards from Planned Parenthood, who was also very supportive of the rules we put out today. We are going to be -- again, as we develop the specifics around this regulation, work with insurance companies, work with institutions.

But I think this does exactly what the president asked us to do, which is make sure that millions of women, regardless of who their employer is, can make their own health decisions, have access to this full range of very important preventive health services, as recommended by the Institute of Medicine, and at the same time respect the religious liberty of their employers who may object to either paying for or directly offering this coverage.

RAY SUAREZ: Secretary, can we talk about mechanics? If you've just taken a new job at a religiously based hospital or university, your employee paperwork is silent on reproductive health care, what happens next?

KATHLEEN SEBELIUS: Well, typically, if you are a new employee and in an insured plan, the insurance company or the variety of insurance companies are the ones who actually publish the benefit package.

So, in this case, again, the insurance company would be reaching out to employees, making it clear that it is their choice whether to access contraceptive benefits. And what we know, Ray, is that actually this is a no-cost benefit, that the National Business Council on Health, that our actuaries, a variety of people in group plans say having contraception as part of a group insurance plan actually lowers the overall cost, doesn't increase it, because, on balance, preventive services around family planning, avoiding what may be unhealthy pregnancies, avoiding the health consequences of that actually is a cost reducer.

So we have a situation where the insurance companies directly offer this benefit to the women employees, and the religious employer doesn't pay for it, doesn't refer to it, and doesn't have to offer it.

RAY SUAREZ: You say money from the religious institutions doesn't pay for this, but isn't money fungible?

If a Catholic nonprofit is paying for your insurance coverage, isn't it paying for contraception if you are getting the coverage through that same insurer?

KATHLEEN SEBELIUS: Well, again, Ray, in this case, actuaries have looked at this benefit.

The federal employees health plan, when contraception was added to federal employees' benefit, which is the largest employee group in the country, costed this as no cost, free, no cost, because adding contraception and having some employees take advantage of that coverage lowers the overall cost of the health plan.

So we have that in place around the country. We have actuaries that have inserted that, and so we're not -- this isn't a shell game of passing the costs along. This is a real no-cost option that is, according to the National Business Council on Health, could reduce an insurance plan by about 15 percent. We're not counting on that.

But I think we can say very safely that this doesn't add to the cost of either the employer's plan -- and we know that women, if they have to purchase this coverage outside of a health plan, could spend up to $600, which is a substantial financial barrier to access a very important health benefit and a benefit used by 99 percent of women across this country at some point in their lives.

RAY SUAREZ: Well, you've transferred the administrative burden to insurance companies. Are insurers ready to pay? Have they signed on?

KATHLEEN SEBELIUS: We will be doing just that.

But as part of the Affordable Care Act, our department will define the rules under which we offer these benefits. And we're confident that this works and that insurers are prepared to step up and do this. Again, this is in place in many states in the country right now, where there is an insurance company providing benefits to employees, and the employer not directly offering those benefits.

RAY SUAREZ: Health and Human Services Secretary Kathleen Sebelius, Madam Secretary, thanks for joining us.

KATHLEEN SEBELIUS: Great to be with you, Ray.




10.02.2012 18:16:00
The U.S Food and Drug Administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements. (MB

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