Updated 8:07 p.m. | For years, many health care experts, medical professionals and politicians have been touting the benefits of electronic health records (EHRs . They say EHRs will not only improve quality and efficiency but also reduce costs by tens of billions of dollars annually to a system that too often orders unnecessary or duplicate tests and procedures.
But
a new study out Monday in Health Affairs challenges that premise and says that doctors may actually order more testing in some cases -- potentially adding to costs.
The findings come as the Obama administration has included new assistance to speed along the adoption of EHRs, which are a part of the Affordable Care Act reforms. And incentive payments were made available to hospitals and health professionals as part of the stimulus law.
The study, which was done by Cambridge Health Alliance's Danny McCormick and David Bor and CUNY School of Public Health's Stephanie Woolhandler and David Himmelstein, found that office-based doctors were more likely to order an imaging test if they had access to EHRs. The authors studied records of more than 28,700 patient visits to nearly 1,200 doctors. Physicians who could look at EHRs ordered imaging 18 percent of the time, compared to about 13 percent of the time with doctors who couldn't use EHRs.
We spoke with McCormick, the lead author of the study. An edited conversation is below.
Q: What were the most important findings of this study?
McCormick: I think the most important finding is that in contrast to what has sort of become common wisdom, which is that health IT is likely to decrease overall health care costs through the reduction in test ordering, we find in outpatient practice across the county in a nationally representative sample, there was no decrease in outpatient practices that have the capacity to view prior imaging studies or laboratory studies. And in fact, it appears that capacity actually drove up test ordering both for imaging and for laboratory studies.
Q: For years people in health policy have stated that EHRs would not only decrease testing but would save the country money on health care. Why do you think you found opposite results?
McCormick: I think that those conclusions or that idea was based on a few small studies that were done at cutting-edge hospitals years ago that in fact showed that when you have highly skilled health IT departments developing customized health IT systems for their own purposes -- understanding the needs of their institutions and carefully tailoring the health IT systems to their needs -- that you actually could decrease both redundant test ordering and unnecessary test ordering. Unfortunately, that really is the only data that exists on the question. No one has actually looked into actual practice -- whether those same findings were generalizable. This study finds that in fact it drives up costs.
We speculate that there are a couple of things: the two main mechanisms that people point to for decreasing lab testing and image testing ordering. One is that if computers could talk with each other in an effective way, you could decrease test ordering. If you could see a test that was done yesterday at another hospital, for example, you wouldn't necessarily have to order it again today. So sort of redundant test ordering.
The second is that computers could be devised so that they can help doctors make better decisions about who actually needs a radiology test, for example, in a particular situation. I think what we're seeing is that both of those conditions don't really exist in current-day outpatient medical practices in the U.S. That is, we don't have good interoperability -- the ability for computers to communicate -- and we may not have adequate decision aids that help doctors make those better decisions about who actually needs a test. Even though in idealized settings, that may work, in practice -- where health IT systems are often selected with billing features as the predominant criteria -- it may just be that the decisions aids are not adequate. They don't work well enough in general practice to decrease test ordering.
Q: What more do we understand about the reasons for this?
McCormick: We weren't able to study the motivation of physicians in this study. What may be happening is that if you make something easier to do, people will do it more often. What we think may be happening is that if physicians have the electronic ability to view test results and imagining results, it may lower the barrier to ordering a test because you know you can retrieve the test results the next day at your computer screen with certainty and without hassle. In contrast, physicians who don't have that ability often face the onerous task of chasing down the laboratory imaging tests that they order.
Frequently, it's not uncommon that if you don't have computerized way of doing the images, you may have to call a radiology facility the next day and try and track that result down. And they fax it over on paper that you can't really read because there are lines all over it -- that kind of thing. And you may have another call back to the facility or you may have to put somebody in your office on the case to retrieve those results. We think that it might make it slightly easier in borderline cases.
We don't think this phenomenon would influence decisions where clearly a patient needed an MRI or clearly they didn't. It's really in those gray-zone patients, where there's a moment of contemplating whether to get a test or an imaging study.
Q: What will the impact of this study have on those doctors who are wondering whether they should go to the effort to computerize patients medical records?
McCormick: I think it's important to point out that the conclusions of this study really aren't about the value of health IT overall. We really address one dimension of the purported benefits of health IT, and that's costs. It doesn't address quality or efficiency at all. There may be a lot of reasons from a quality point of view or an efficiency point of view that people would want to get health IT. And in fact, if you asked me as a doctor if I would give up my fairly sophisticated health information technology system, which I use every day and was just on a second ago, I would say no. I see the value of it.
However, what this study addresses is the cost piece. With regard to cost, it also doesn't say that in no system at no time with no amount of effort, a system couldn't be devised that would lower imaging (ordering . What it does say is that in current practice in the U.S. -- a sort of national snapshot based on more than 28,000 visits -- it does not seem to decrease test ordering or cost.
I think that the biggest implication is the national health policy implication. A lot of the discussion that led up to passage of the HITECH Act, the historic federal investment in health information technology that was passed in 2009, was predicated on the assumption that there would be substantial cost savings to the U.S. health care system. I think these results have most implications for people making those claims and should raise the question about whether that's actually correct and whether future investments in health IT are appropriately framed. That is to say, do they take into consideration the lack of evidence that costs savings will be realized? That may or may not influence whether the federal government makes investments in health IT. Again, it may be appropriate because of improvements in quality.
Q: What do you think this study says about the role IT may play in saving money on overall health care? Does it have the potential to throw cold water on this whole move to get the entire country on board with IT?
McCormick: I think it has implications on several levels, and I think the biggest one is the one I mentioned, which is the U.S. health care system costs. I think it's become common wisdom that health IT will substantially decrease those costs. I think that the study raises a substantial concern that may not come to pass. I think that if we figure that out, we can better align future federal investments in health IT or in other things with our national health priorities. And presumably they include coming up with a way of saving costs. If this may not be it, than it means that we need to consider alternatives that may be more affective.
I think there are some implications, to go backward, for health IT developers and for physicians. I think that those implications are that we need to make sure that health IT systems that are being developed actually perform well and are driving by clinical needs as opposed to billing needs or both.
And then physicians also will need help in selecting among the wide range of products that are out there, and (they will need help implementing (the systems . Most physicians now in practice are incredibly busy taking care of patients and have not been trained to implement health IT -- how to gear their practice, how to fit it into health IT systems in such a way that they're efficient, effective and decrease test orders. So there are lots of different steps I think that will need to be focused on, but I think what the study is saying is that, as currently implemented, it doesn't appear to be working to produce lower costs.
We also asked for a short response from Dr. David Blumenthal, who was the national coordinator for health information technology at the Department of Health and Human Services for the Obama administration from 2009-2011.
Blumenthal: This is one of many, many studies, and the studies are overwhelmingly supportive of cost-reductions by using electronic health records. Anytime you see anything that is complicated like this (the implementation of EHR throughout the system , some studies will be positive, some will be negative.
But if you look at the total review of literature that was done a year ago, it puts it into context: 92 percent of studies were positive. I expect that if you study something 100 times, there's going to be some variation.
Second, this is really not a study of costs. This is a study of test orders. It studies results, and it's a viewing of those results, not EHR overall. EHRs have many other aspects that are not included here. It doesn't look at EHR and total health costs. It only looks at particular tests. It's possible that the increased cost from imaging may reduce costs in other ways. Ordering a particular test that's being observed may or may not increase costs. You can't really infer any major conclusions about costs from this study. And the study doesn't look at the benefits for quality of care at all. It's possible the use of tests by some of the doctors could have avoided other costs. This study has no way of assessing the overall implications of the behavior that it's finding.
The effectiveness of knee replacement surgery was in the news today, when the BBC and Independent reported that more evidence was needed on the long-term safety of knee implants.
The news, which follows recent reports on the safety of PIP breast implants and certain metal hip implants, is based on a report on knee replacement surgery published in The Lancet medical journal. It argued that although knee replacement surgery is highly successful as a treatment for osteoarthritis, there is a need for more long-term monitoring of surgery outcomes and steps to ensure that patients selected for surgery are suitable.
In addition, the report’s authors say that new implant designs are continually being introduced, often with little or no evidence of their effectiveness, and that more long-term monitoring of their safety and effectiveness is needed.
Although some online news sources have suggested that the review article found knee replacement to be dangerous, this is misleading. The report says that knee replacement is generally successful but that more needs to be done to assess which patients will benefit, to collect data on outcomes and to carefully monitor the introduction of new implant designs.
Why are knee replacements performed?
Knee replacements are usually carried out when the knee has been damaged by arthritis. In most cases, surgery is for osteoarthritis, the most common form of this disease, although it is also used for other forms. In osteoarthritis, the parts of the knee that slide over each other as you move become damaged, through either gradual wear or an injury. Only a small number of people with arthritis in the knees are given knee replacement surgery. It is usually considered if someone is in persistent, disabling pain and if non-surgical treatments, such as physiotherapy, have not helped.
During the operation, the surfaces of the knee joint that have been damaged by arthritis are removed and replaced by new parts, made of metal and plastic. In effect, this artificial hinge replicates the natural range of movements of the knee. Patients can have either a total knee replacement (TKR , in which all the surfaces are replaced, or a partial knee replacement, in which only part of the knee is replaced. A TKR is the most common form of the operation.
How many people in the UK have an implant?
Knee replacement surgery is an increasingly common procedure and the number of operations is rising annually. Over 70,000 knee replacement operations are carried out each year, about four out of five of them in women. In the UK, rates of knee replacement operations in women increased from 43 per 100,000 person years in 1991 to 137 per 100,000 person years in 2006.
The average age for having this surgery is 70 years old but, according to the new report, knee replacement is increasingly being considered for patients younger than 55. The authors say that the reason for this trend is unclear. For example, it could be due to increased patient expectation or more osteoarthritis among young people because of the increasing incidence of obesity.
Are knee replacements effective?
Knee replacement surgery is generally considered to be a highly successful operation. It improves pain, mobility and quality of life in many people with advanced arthritis of the knee joint. The charity Arthritis Research says that about four out of five people who’ve had the operation say they are happy with their new knees. However, some people are disappointed with the outcome of their surgery or are unsure whether there has been an improvement.
This is why it’s important to ensure that patients considered for the operation are those who would derive the most benefit. The National Institute for Health and Clinical Excellence (NICE says that although joint replacement operations can provide very good pain relief for many people with osteoarthritis, in a substantial number of cases the outcome is not good enough. “It would be very useful to have pre-operative tools to help choose the people who would derive most benefit,” NICE commented.
The new review article argues that there’s an urgent need for improved decision making to assess whether a patient should undergo the procedure. Evidence-based information should be given to patients about factors that are known to influence the outcome of their surgery.
The article also says that long-term monitoring of outcomes is needed, through national joint-replacement registries and electronic patient records reporting the rates of revision surgery and other outcomes.
Are knee replacements safe?
All major operations carry some immediate risks, including blood clots and infection. In the longer term, knee replacement surgery can lead to complications. These include the knee giving way (instability or continuing to hurt, numbness around the joint, problems with bending and the need for a second operation to correct or remove part of the implant, known as revision surgery. The need for revision surgery is often the result of the new joint becoming loose. Other common reasons include infection, pain and stiffness.
Some internet news reports implied that the review has judged knee replacements to be unsafe. However, the article primarily discussed the decision-making processes behind knee replacement surgery and the need to gather evidence on the best practice for knee replacement and on the effectiveness of new implant designs. It did not suggest that knee replacement is unsafe or that it should be stopped, although it did argue for improved collection of safety data.
What does the report say about implant design?
The report says that orthopaedic manufacturers are continually introducing new designs for implants and that doctors expect that these new implants will improve outcomes. However, there is evidence to suggest “this belief is incorrect”. The new implants are often introduced with little or no evidence of their effectiveness, the report adds.
Limited release of new implant designs as part of well-conducted large-scale randomised controlled trials is essential, the authors argue. In addition, national joint registries should monitor the outcomes of new implant designs.
How are knee replacements tracked?
The report says that national joint replacement registries, such as the UK’s National Joint Registry (NJR , are one of the best and most important sources of data on knee replacement surgery. These registries collect data on measures such as revision surgery, as well as patient-reported outcomes.
According to the report, improved long-term monitoring of outcomes using both national registries and electronic patient records should be undertaken. This is so that both patients and surgeons have good-quality evidence to assess different implants and techniques and to improve decision making.
The Medicines and Healthcare products Regulatory Agency has reportedly said that since April 2003, all knee joint replacement operations in England and Wales have been recorded by the NJR.
Who should I speak to if I'm worried about my implant?
If your implant is causing problems or you are anxious about it, ask your GP to refer you to your surgeon.
Links To The Headlines
Total knee replacement implants evidence is 'lacking'. BBC News, March 6 2012
New safety concerns over knee replacements. The Independent, March 6 2012
Links To Science
Carr AJ, Robertsson O, Graves S et al. Knee replacement. The Lancet, 6 March 2012 (early online publication
A pill costing ?1.40 a day “could save the lives of thousands of heart disease patients”, according to the Daily Mail.
Several other newspapers have reported on the drug ivabradine, known by the brand name Procoralan, as European drug regulators have today approved it for the treatment of chronic heart failure. In heart failure, the heart is unable to pump sufficient blood to the limbs and organs, causing a range of unpleasant symptoms such as weakness and breathlessness.
The drug is already used to treat some patients with a form of heart-related chest pain called angina. After an examination of evidence by the European Medicines Agency (EMA , ivabradine has also been granted a “marketing licence” for the treatment of chronic heart failure. This will allow ivabradine’s manufacturer to make the medicine available to patients and healthcare professionals in all EU countries. However, before it is available on the NHS, its treatment effects and cost effectiveness will need to be assessed by the National Institute for Health and Clinical Excellence (NICE .
Despite all the positive news coverage, prescribers will need to consider both the effectiveness and cost of ivabradine compared to other treatments for heart failure. It’s possible that other drugs could perform as well or better for less cost.
What is ivabradine used for?
Despite what some news reports suggest, ivabradine is not a new drug. It is already used to treat the symptoms of long-term stable angina. It is not the first choice for treating stable angina, and NICE guidelines recommend that it is only prescribed to people who cannot take beta-blockers or calcium channel blockers, which are generally preferred to treat angina.
The drug has made the papers because it has now been granted a licence for the treatment of some types of chronic heart failure. Although it has previously been approved for treating stable angina, drugs must be licensed for each of their specific uses. In August 2010, Behind the Headlines reported on a randomised controlled trial that looked at ivabradine for heart failure.
What is heart failure?
Contrary to what the term implies, heart failure does not mean that somebody’s heart has stopped beating or misses beats. Instead, it refers to a chronic condition where the heart can no longer pump sufficient blood around the body.
During each heartbeat, blood enters the heart and is pumped out towards the organs and limbs. In heart failure, the heart cannot cope with pumping the normal amount of blood in each heartbeat. This can be due to the lower chambers of the heart (the ventricles not contracting properly so that blood is not completely pumped out of the heart (systolic heart failure or because the ventricles do not fill up with enough blood between each heartbeat (diastolic heart failure . It can be a combination of the two. It may affect the left or right side of the heart, or both sides. It can cause a range of symptoms, including breathlessness, tiredness, weakness, dizziness, nausea, swollen ankles and legs, enlargement of the liver, constipation and loss of appetite.
Risk factors or causes of heart failure include:
- ischaemic heart disease (coronary heart disease
- diseases of the heart muscle or heart valves
- abnormal heart rhythms
- high blood pressure (hypertension
Around 68,000 new cases of heart failure are diagnosed in the UK each year.
How does ivabradine work?
Ivabradine slows the heat rate. This may have a protective effect on the heart, and allow the heart to pump more efficiently at a slower rate.
Is it suitable for everyone?
The European Medicines Agency (EMA , which is responsible for issuing the authorisation, says that ivabradine is medically suitable for people with:
- long-term heart failure with symptoms (a severity of symptoms called NYHA II to IV
- the form of the illness involving systolic dysfunction (where blood is not completely pumped out of the heart
- a regular rhythm and a heart rate of 75 beats a minute or more
The EMA says that when treating heart failure, ivabradine can be given either in combination with standard therapies, including beta-blockers, or on its own when beta-blocker therapy is not suitable or not tolerated.
The EMA also states that ivabradine should not be used for patients who have:
- unstable or acute heart failure, also known as “new onset” heart failure
- a heart rate imposed exclusively by a pacemaker
Ivabradine is also unsuitable for people who:
- react to any of the components of the tablets
- have a heart rate below 60 beats a minute before treatment
- have very low blood pressure
- have various types of heart disorder (cardiogenic shock, a history of acute heart attack, rhythm disorders or unstable or acute heart failure or have unstable angina or a pacemaker
- have liver problems
- are taking certain other drugs
- are pregnant or breastfeeding
Are there any side effects?
The most common side effect of ivabradine is a temporary brightness in the field of vision. Other common side effects (affecting 1 in 100 people or more include:
- blurred vision
- headaches
- changes in electrical activity of the heart
- heart or circulation problems
- dizziness, tiredness, weakness, lowered blood pressure, general feeling of being unwell, fainting or brief losses of consciousness
Is ivabradine available now?
Ivabradine is available now for the treatment of long-term stable angina, having been approved for this use several years ago. It is in the news because it has now been granted “marketing authorisation” by the EMA as a treatment for heart failure. This allows the manufacturer of ivabradine to make the medicine available to patients and healthcare professionals in all EU countries. However, before it is available on the NHS, it will need to be approved by NICE.
What kind of things will NICE have to consider?
NICE will consider the cost effectiveness of ivabradine treatment (how its medical effectiveness relates to the cost of the drug . It should not be assumed that ivabradine will become the standard treatment for heart failure. Other drugs may be more effective or less likely to cause side effects, and therefore better options.
While several newspapers have reported that the drug is cheap at just ?1.40 a day, this is higher than many beta-blocker drugs currently in use, which may cost just a few pounds a month. If these existing drugs can provide similar or better results to ivabradine for a lower price, then it is likely they will remain the default option for prescribers.
Links To The Headlines
The ?1.40 heart pill lifesaver: 10,000 patients a year could be saved by newly-licensed drug. Daily Mail, March 6 2012
Ivabradine, the lifesaving ?1.40 heart pill, gets European approval. The Daily Telegraph, March 6 2012
Wonder drug hope: ?10-a-week treatment cuts risk of heart failure by 39%. Daily Mirror, March 6 2012
Heart drug approved by European regulators. The Guardian, March 6 2012
"That's not even a quarter of their profits," said Copeland, a law professor at
Pennsylvania State University. "I was up in arms."
Government officials say they are, too, and they've talked about incorporating some of Copeland's ideas.
"That's a question we've been struggling with for the last couple of years," said Gregory Demske, assistant inspector general for legal affairs at Health and Human Services. "We recognize there's a problem."
If a company is excluded from doing business with the government, then medications that only those companies produce will not be available to beneficiaries. But, Copeland said, the fees associated with corporate integrity agreements haven't been enough to keep companies from bilking the government again.
"It's still in the company's interest to promote off-label marketing because they're still going to make more in profits than they lose in fines," she said.
HHS officials are talking with those at the
Justice Department and Food and Drug Administration to fix the problem, Demske said.
Most of the cases come from off-label marketing of prescription medications. For example, Pfizer was accused of marketing Bextra, a painkiller, for uses other than what the
FDA had approved. Such uses constitute fraud because they take government money for purposes the FDA has not approved.
Instead of excluding an entire company from doing business with the government, Copeland said, the drug being marketed off-label could be excluded.
HHS officials considered that, Demske said, but they needed to ensure that beneficiaries could get their medications. The agency is considering taking away a company's patent rights as part of a settlement with the government.
That, he said, would allow other companies to make and sell the drugs to the government. Such a deal could be negotiated with companies as part of a fraud settlement and would not require congressional approval.
"We could require other things if the defendant will agree to it," he said. "If not, there might not be a settlement."
And if there's no settlement, there may be an exclusion.
Copeland suggested requiring companies to conduct clinical trials for the off-label uses they were accused of, requiring that they license a product to other manufacturers and holding high-level individuals criminally liable. Demske said that investigators began going after individuals in companies in 2010 and that they have focused resources on that idea.
Pfizer,
Bristol-Myers Squibb and
Abbott Laboratories did not respond to questions from USA TODAY.
"Imposing such a severe penatly on a person who had no knowledge of the wrongdoing at issue is manifestly unfair and unjust," said
Matthew Bennett, senior vice president of the Pharmaceutical Research and Manufacturers of America.
The Supreme Court ruled in the 1970s that the government may go after officials who should have knowledge that fraudulent behavior is happening under their management. However, the law applies only to individuals holding a position at a company.
"If they leave, we can't reach them," Demske said. "The law is written in present tense."
The government has to send a note notifying the person that it is considering excluding them, which leaves the person plenty of time to leave the company.
"They would be free to work elsewhere," Demske said.
A bill to address the problem passed the House last year but hit the Senate too late in the session to make it to a vote. A new bill, HR 675, has been introduced.
Officials with the Centers for Medicare and Medicaid Services are looking for answers, said Ted Doolittle, deputy director of CMS' Center for Program Integrity. Instead of excluding a company, the CMS can revoke payment, which the government plans to do more aggressively, he said.
Last month, 78 home health care agencies in Texas were suspended in connection with a fraud case, and Doolittle said the CMS will not pay them for services until they are cleared of wrongdoing. First, he said, the CMS had to make sure beneficiaries would be able to get the services they need if those centers were out of business.
Congress members have suggested mandatory exclusions for crimes, but Copeland said the cases often don't reach that point because the parties settle before a proclamation and because the government has to worry about patient access.
If the government targeted individuals more aggressively, that could send a powerful message to drug companies, said Stan Twardy, leader of law firm Day Pitney's health care compliance group.
"Something called a jail is going to send a lot stronger signal than a fine," he said. "The regulations can change, but individuals and companies will take advantage of any loopholes they may find. It's part of that game of maximizing profits."
Under a system of agreements and fines, he said, the corporate culture will remain the same.
Copeland said she doesn't think that's enough.
"If you go after the sales manager because the sales manager could have prevented the fraud, it doesn't change the corporate culture," she said. "The more prescriptions, the more money you make, so the incentive remains."
Patrick Burns, spokesman for the non-profit Taxpayers Against Fraud, said although there may be differences of opinion, there is a greater sense or urgency about fighting the problem.
"We're all thinking the same thing," Burns said of investigators and Congress members. "The good news is they're pushing to actually do it."
Scotland’s premature birth rate has fallen by 10% since the public smoking ban came into force in 2006, BBC News has today reported.
The news is based on the results of a large Scottish study that looked at trends in numbers of premature births and small babies born between 1996 and 2009, and how these related to the introduction of the smoking ban in March 2006. The researchers found that there was a decline in the number of premature births in the three months before the introduction, but since then there has been a slight fluctuation and numbers have begun to rise again overall. Conversely, the number of babies born small for the length of time they were in the womb declined around 2006, and has generally continued to fall.
Smoking is a known risk factor for premature birth and babies born small for the length of time they were in the womb (gestational age , and this research provides valuable clues to the potential impact of the smoking ban. However, the study only found trends, which means it cannot prove the legislation caused the drop in rates seen. It is possible that other factors may be responsible, such as general improvements in antenatal care.
Both smoking in pregnancy and passive smoking are associated with a higher risk of premature birth, babies born small and other pregnancy complications.
Where did the story come from?
The study was carried out by researchers from University of Glasgow and Western General Hospital, Edinburgh. It was funded by Scotland’s Chief Scientist Office. The study was published in the peer-reviewed medical journal PLoS Medicine.
It was reported accurately by the BBC, which pointed out that other factors might have influenced the results.
What kind of research was this?
This time-trend study looked at the numbers of babies born prematurely or small for gestational age in Scotland before and after the introduction of the smoking ban in March 2006. It looked at data on babies born to nearly 717,000 pregnant women between 1996 and 2009.
The researchers examined both trends in data and the possible impact of the legislation in Scotland. However, while this type of study can identify trends, it cannot confirm the various factors that caused the trends. It examined how trends related to both “active” and “passive” smoking’, also known as first-hand and second-hand smoking respectively.
Both active and passive smoking during pregnancy are known to increase the risk of various complications. The researchers say the legislation, the Smoking, Health and Social Care (Scotland Bill, has been very successful in reducing exposure to environmental tobacco smoke (ETS in public places. It has also been associated with greater voluntary restrictions on smoking in the home. They say there was an increase in attempts to quit among current smokers three months before the legislation was introduced, and a reduction in the amount smoked by those who continued to smoke.
What did the research involve?
The researchers gathered data from a national administrative database on pregnancy, which collects information on all women discharged from Scottish maternity hospitals and records many factors, including pregnancy complications and smoking status. Data on smoking status were based on women’s self-reported smoking habits, which were reported as “current”, “never” and “former” smokers. The researchers obtained data on all singleton, live-born babies delivered at 24 to 44 weeks of pregnancy between January 1996 and December 2009. They used postcodes as an indicator of the women’s socioeconomic status.
From this data, they collected information on the rates of two complications of pregnancy - babies born small for gestational age and premature delivery. Babies were classed as small for gestational age if their birth weight was within the lowest 10% of babies of the same sex born at the same point in pregnancy. Premature delivery was defined as delivery before 37 weeks of pregnancy, and was categorised as:
- mild - between 34 and 37 weeks
- moderate - between 32 and 34 weeks
- extreme - earlier than 32 weeks
The researchers also looked at other outcomes, such as spontaneous premature delivery (as opposed to overall premature deliveries which would include those that were planned, for example premature induced labour or caesarean due to complications with the mother or baby .
Researchers looked at the trends in these outcomes before and after the introduction of smoking legislation. They were particularly interested in two time points: the date when the legislation was implemented (March 26 2006 , and three months before (January 1 2006 . The latter date, they explain, allows for the possibility of people making changes to smoking behaviour in anticipation of the legislation and was chosen because it coincided with a New Year peak in attempts to quit smoking found in a previous study.
In their analysis, the researchers adjusted their results to account for other factors that may affect these pregnancy outcomes, including maternal age, sex of the infant and socioeconomic factors.
What were the basic results?
The researchers included 716,941 women who fulfilled all their criteria and for whom they had information on smoking status. They found that the number of current smokers fell from 25.4% before legislation to 18.8% after legislation. From looking at the trends in numbers of babies born prematurely or small for gestational age, they noticed that, of the two dates, January 1 2006 (three months before the smoking ban seemed to have a greater influence on the fall.
The graph depicting the trend in premature births between 1996 and 2009 shows a general fluctuation in rates. Around January 2006, there is an apparent decline in rates, but over the following three years, there has been continued fluctuation and numbers have begun to rise again. For the number of babies born small for gestational age, there was a similar decline around 2006. However, the trend, though still fluctuating, seems to have continued downwards since then, rather than rising as it did with premature births.
The researchers report that, after January 1 2006:
- The number of babies born small for gestational age fell by 4.52% (95% confidence interval [CI] -8.28 to -0.60 .
- The number of babies born prematurely fell by 11.72% (95% CI -15.87 to -7.35 .
- The number of babies born after spontaneous premature labour fell by 11.35% (95% CI -17.20 to -5.09 .
These significant reductions were found among all women, including those who still smoked and those who had never smoked.
How did the researchers interpret the results?
The researchers say that three months before the introduction of the new legislation, the numbers of premature deliveries and babies born small for gestational age fell significantly, although they point out that rates of premature births have since begun to rise again. They say this is consistent with a previous study which showed that smokers anticipated legislation, resulting in a significant peak in prescriptions for nicotine replacement therapy in January 2006.
Conclusion
Overall, this analysis of the relationship between pregnancies and the smoking ban in Scotland provides a valuable insight into the possible results of anti-smoking legislation. In particular, the decline in rates of premature births and babies born small for gestational age around January 2006 is interesting. As smoking is a known risk factor for these outcomes, the trend could be the result of higher quit rates, both among pregnant women or the public in general, in anticipation of the new law.
However, the trend analysis performed in this study cannot prove there is a definite relationship between the two, but only that there are associations. It is possible that other factors are involved, such as general improvements in antenatal care and management of pregnant women who are at risk of these complications. Furthermore, there has been continuing fluctuation in numbers of babies born prematurely or small for gestational age since the smoking ban in 2006. The subsequent general increase in premature births makes it even harder to draw any conclusions about the reasons behind this trend.
A further limitation of the study was that women’s smoking status was based on them reporting whether or not they smoked. As the authors point out, there is evidence that pregnant women underestimate how much they smoke and it is possible they felt under pressure to conceal their smoking following the new law. However, this would not affect the overall results of the study, which related to all deliveries irrespective of smoking status.
The study cannot prove that smoking legislation – or anticipation of it – reduced the risk of pregnancy complications. Nevertheless, smoke-free legislation is now recognised as having health benefits and it is plausible that improved pregnancy outcomes are one of them.
Links To The Headlines
Fewer premature births after smoking ban in Scotland. BBC News, March 7 2012
Links To Science
Mackay DF, Nelson SM, Haw SJ, Pell JP. Impact of Scotland's Smoke-Free Legislation on Pregnancy Complications: Retrospective Cohort Study. PLoS Medicine 9(3 : e1001175.
The initiative, with the support of the UN, hopes to help people envisage a sustainable future using low-carbon resources
Arnold Schwarzenegger and Europe's climate chief, Connie Hedegaard, are spearheading a new push to help people envisage a sustainable future using low-carbon resources.
The Sustainia initiative,
launched on Wednesday with the support of the United Nations global compact, aims to take dozens of new and developing technologies from renewable energy to hydrogen-powered buses, and use designers to create visual representations and recreations that will allow people to imagine what a more environmentally friendly world would be like.
This is needed in order to allay people's fears that opting for more environmentally sustainable practices may lead to a lower quality of life, according to the founders.
"We've done this because it is hard for people to understand what a sustainable future could look like," Hedegaard told the Guardian. "Many people do not want to give up what they know because they fear that if we get away from business as usual, we will go to a grey and uninteresting life. But we can show that doesn't have to be – we can create cities where there is cleaner air, where people have better transport and nice houses to live in. Showing that vision is very important."
The initiative is aimed at the Rio+20 conference this June, where governments, businesses and civil society will discuss ways to encourage environmental sustainability. The theme of the Rio+20 conference is "the future we want", and Sustainia is meant to allow people to envisage what such a future would look like.
As well as creating a virtual model of a future sustainable world, and publishing a book laying out what that world will look like, the organisers of Sustainia will set up an award they are billing as a "Nobel prize for sustainable development". It will reward technological breakthroughs and designs that tackle environmental problems.
Schwarzenegger said: "Being a champion in body building, in movies and in politics where I was able to lead California to renewable energy, energy efficiency, green jobs … I believe it is important to demonstrate that sustainability is the better choice for all of us. For communities around the world and for the individual, the Sustainia award offers a multitude of benefits in terms of better health, more liveable regions and cities and increased productivity. But we need to actually see it to understand it. And this is what we will make possible."
The head of the Intergovernmental Panel on Climate Change, Rajendra Pachauri, and Gro Harlem Brundtland, the former politician, many regard as the founder of environmental sustainability thinking, after she coined the definition of sustainability at the first Rio conference 20 years ago, are also taking part in Sustainia.
Businesses are also involved, including Microsoft, General Electric, Philips and TetraPak.
Georg Kell, executive director of the UN Global Compact, said: "Sustainia is a clear articulation of the future we want" and aligns well with the message the UN wants to convey in Rio and beyond: we can build a desirable, sustainable future. Sustainia is a fresh and much-needed approach to communicating sustainability, engaging key stakeholders, and inspiring tangible action."
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Farming has the worst death rate of any sector, yet the coalition is planning a bonfire of the rules that protect workers
Twelve agricultural workers living in a caravan with no water, sanitation, lighting, heating or cooking facilities. Thirty workers living in a two-bedroom house that was structurally dangerous, threatened by men wielding baseball bats if they complained. A worker who lost a leg when the illegal minivan transporting him was involved in an accident.
A bonded worker doing 12 hours hard labour six days a week from 3.30am milking cows and breaking rocks on a dairy farm. These are
a tiny number of the cases of extreme exploitation found by the Gangmasters Licensing Authority (GLA during its recent inspections. Last year it uncovered 845 cases of workers being exploited in the food processing and farming business in the UK. More than 90% of its operations, which are driven by intelligence it receives, identified serious cases of abuse.
Yet the government has deemed all this activity "a burden on business", so much tedious red tape around a beleaguered industry that should be swept aside in favour of a more "voluntary" and "light-touch" approach to enforcement.
On coming into office it set up a farming regulation taskforce as part of its "
red tape challenge", a Tory pledge to revisit all regulation to see whether it is really necessary and to free business where possible of its shackles. The taskforce made 220 recommendations of ways to ease the burden on farmers, and
the government has just published its response to those.
Its answer to the vast majority of the recommendations is an enthusiastic yes, with no pause even to consult further as would be usual.
The recommendations include the idea of inspecting "good" farmers less often, and looking at alternatives to the mandatory licencing of gangmasters including voluntary registration.
The taskforce
was drawn almost entirely from the farming industry or people with vested interests in it and chaired by Richard Macdonald, the recently retired director general of the National Farmers Union. There was no one on it representing workers, or the wider environment. No one to remind them as they considered their bonfire of rules designed to protect the rural environment and the safety of those working in it that
this sector has the worst workplace death and injury rates of any, including those often considered more dangerous: mining and construction.
But inviting industry in to rewrite the policy rules is a pattern with this government: the secretary of state for health, Andrew Lansley, has the food and alcohol industry coming up with voluntary measures to tackle the public health crises of obesity and binge drinking; the Treasury has the tax directors of major corporations on its working groups drawing up new rules on easing the burden of taxation on multinationals.
The farming industry has been greatly displeased by the GLA's activities in exposing abuses in the dairy industry. It is currently prosecuting 19 dairy farmers who include some of the largest and most high-profile in the country for using an unlicensed gangmaster to supply them with skilled migrant dairy men (18 of the defendants have pleaded not guilty, the other has entered no plea .
Many in the industry have accused the GLA of being overzealous and argued a warning would have done, as though the law need not apply to them. It is an open secret that some have lobbied ministers against the authority, which has already endured the punishment of a 25% cut in funding over the lifetime of this parliament.
But before the government rushes to undermine the GLA and its powers any further, it would do well to remember that much of the anger against immigration that has boiled up in its rural and blue-collar working heartlands has been fuelled by dismay at the crime that has been so clearly and visibly associated with gangmaster employment of migrants.
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@commentisfree
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Created: 3/6/2012 10:05:00 AM
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New York Times, Attorney General Lanny A. Breuer said “Taking advantage of his special access as a chemist at the F.D.A., Mr. Liang used sensitive inside information to reap illegal profits in the pharmaceutical securities market. “For years, he exploited his position in the agency to make easy money on the stock market. But today’s sentence shows that easy money has consequences. Investors engage in insider trading at their peril.” According to court documents, Mr. Liang told the judge, "I'm terribly sorry for what I've done.” --- On the Net:
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Created: 3/6/2012 8:05:00 AM
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Created: 3/2/2012 2:06:00 PM
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District Judge Richard Leon found that the attempt by the U.S. Food and Drug Administration (FDA to force cigarette makers to display graphic pictures of blackened lungs, rotten teeth and sickly patients on their products was unconstitutional. Carefully pointing out that the burden of proof lay on the side of the federal regulatory body, Leon stated that: “The government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech.” Leon also noted that the proposed warning labels, which aim to deter tobacco use, were exaggeratedly large. He also pointed out that the government already has a variety of more effective and targeted weapons for reducing smoking in its arsenal such as cigarette taxes and labels that contain factual medical information rather than macabre images. The Obama administration announced Monday that it would challenge the court’s decision, filing an appeal Monday with the U.S. Court of Appeals for the District of Columbia Circuit. According to legislation passed in 2009, the FDA is charged with the task of making sure that cigarette packaging is equipped with color warning labels in addition to the well-known written warnings from the Surgeon General. The label must cover 50 percent of both the front and back of the cigarette pack as well as 20 percent of advertisements in magazines. A handful of major tobacco companies challenged the law, which was scheduled to go into effect in September of this year. Tobacco giants R.J. Reynolds, Lorillard Inc., Liggett Group LLC and Commonwealth Brands have alleged that the legislation would essentially force them to advertise against the purchase of their own entirely legal products. --- On the Net:
This achievement shows that where there is a will, it is possible to truly transform the lives of hundreds of millions of people for the better. Now we must tackle sanitation
More than 3,000 children die daily from diarrhoeal diseases, and 88% of these deaths are due to poor drinking water, lack of sanitation and poor hygiene. So the news from the World Health Organisation and Unicef joint monitoring programme that
the world has met the drinking water target of the millennium development goals is very welcome.
Since 1990 over 2 billion more people in the world have received access to drinking water. And this progress has not been driven by just big middle-income countries – smaller, less well-endowed countries have also shown the way.
Even in sub-Saharan Africa, where progress towards achieving the target is off-track, 273 million additional people gained access to drinking water since 1990. So, we should raise our hats to the governments, organisations, communities and individuals who put great effort and resources into making this happen. They show that where there is a will, it is possible to truly transform the lives of hundreds of millions of people for the better.
However 783 million people still do not have access to drinking water, this most basic human right. That is more than one in 10 people in the world. It is perhaps particularly depressing when one considers who these people are, where they live, and the impact this has on their lives. In addition, the other part of the same millennium development goal target – relating to access to adequate sanitation – is still off track.
Nowhere are the inequities of this world clearer than in access to drinking water and basic sanitation. Unicef is convinced that focusing on the poorest and hardest to reach is the fairest and most cost-effective way to use the donations we receive. It is the only way we will achieve the vision of the
Millennium Declaration, reinforced by the UN general assembly's recent recognition of drinking water and sanitation as basic human rights.
The majority of people without access to drinking water – 479 million – live in countries that are not among the poorest. The country with the largest number of people without access to improved water – 119 million – is China, the world's second largest economy, according to most estimates. The next highest number – 97 million – live in India, another burgeoning and vibrant economy, followed by 66 million people in Nigeria.
This still leaves another 304 million people in the so-called least developed countries (LDCs , which need significant assistance to confront this huge challenge.
But one of the most inspiring findings from this report is that several smaller and poorer countries have made significant contributions to global progress. This tells us that results can be truly transformational given the right conditions, the right kind of external assistance, and allocating resources to the right kinds of things.
Take Malawi, for instance, an LDC. Since 1995, this small country provided more than 7.2 million of its people – almost half its current population – with access to drinking water. Burkina Faso and the Gambia, also both LDCs, have achieved similar feats. This shows we need to redouble our efforts to ensure the poorest countries have the technical guidance and information necessary to set the right conditions for achieving results, and to allocate resources accordingly.
In April, Unicef and the World Bank are convening a meeting of finance ministers from developing countries and ministers of development co-operation from donor countries on behalf of the
Sanitation and Water for All partnership to prioritise drinking water and sanitation. This is a huge opportunity for many more countries to move from stagnation or incremental progress to transformational change in less than a generation. It can be done.
Three thousand children dying each day is 3,000 too many. No child should be excluded from global progress.
• Sanjay Wijesekera is chief of water, sanitation and hygiene for Unicef, New York
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A Gold Coast consultant psychiatrist will explore the link between heart disease and depression.
Dr Chris Stapelberg, from Griffith University’s School of Applied Psychology, said up to 20 per cent of people who suffer heart attacks also later suffer from depression.
Dr Stapelberg hopes his research will lead to a breakthrough in understanding both conditions and how they interact.
“If you've had a heart attack, your risk of developing depression is about four times higher than it is for the general population,” he said.
“If you've suffered from depression, your risk of developing heart disease is at least doubled.”
Cardiovascular disease is the largest cause of death in Australia, with Australian Bureau of Statistics figures showing it accounted for 16 per cent of deaths in 2009.
The study comes as the World Health Organisation predicts heart disease and depression will be the two most devastating diseases in the world by 2020.
Dr Stapelberg said depression was the leading cause of non-fatal disability in Australia, costing more than $600 million a year.
“There are many physiological as well as psychological mechanisms linking the mind and heart,” he said.
Dr Stapelberg is seeking 120 people to be involved in his year-long clinical trial, including people in good health, those who have had either depression or a heart attack or both conditions.
He said he hoped the research could lead to a greater detection of depression.
“It would also send a powerful message to people who have heart attacks about looking after their mental health too,” he said.
The research, which will be run from the Lakeside Rooms practice in Robina, Queensland, will examine changes in mood and heart function.
. A pill made from a woman's placenta and taken by that woman to treat certain postpartum conditions.
—"
More Mothers Using Placenta Pill To Combat Postpartum Depression," CBS Miami, March 1, 2012
—"
Would you take a pill made out of your own placenta? Midwife sells babies' afterbirth back to new mothers," Daily Mail, January 24, 2012
—Steve Friess, "
Ingesting the placenta: Is it healthy for new moms?," USA Today, June 19, 2007
The more general sense of the phrase placenta pill — a pill made from a human placenta — is quite a bit older:
—James Kell, "Hot and cold in every room," The Guardian, April 30, 1988
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Pubs, hairdressers and shops are among the public places that will screen harrowing images of abuse against women
Regulars at The Head of Steam on Huddersfield station can expect a change from their usual viewing this week as televised sport in the pub gives way to a series of harrowing films about domestic violence.
Seven short films, called Lives, by Yorkshire artist Beverley Addy will be played in pubs, hairdressers, shops and other public places across the town in a launch coinciding with
International Women's Day on 8 March.
Addy says the project was born out of her own experience of an abusive relationship and a desire to "hold a mirror up to society" and get people talking about an issue that is still taboo.
For the films she ran a series of workshops with women who had used domestic violence services and asked them: "What sights and sounds make your hair stand on end?"
"They said 'hot things', so in one of the abstract films I use a pulsing electric cooker ring and an iron. And I weave in other images that kept cropping up, like falling down stairs and the sound of doors slamming," explains Addy.
There are three text-only films using animated words, and two narratives, one based on a woman's description of how she rode her bike along a canal towpath to try to get away from the horrible thoughts in her head.
Just one of the Arts Council-funded films features the victim herself: a woman who describes how, when she was pregnant, her partner pushed her down the stairs and she miscarried.
Addy says: "Sometimes the emotional abuse was as damaging as the violence. At the mundane end it's men saying they don't like what you're wearing. But that's not about the clothes, it's about pulling the rug from under you and controlling you.
"It's hard for people to talk about all this. The women described how, slowly slowly, their confidence was ground down and they felt smaller and smaller."
At the film's preview at the Lawrence Batley theatre in Huddersfield last week one woman wrote in the comments' book: "It reminded me of my life and my childhood." Another noted: "That film with the doors slamming – I was back there."
Addy says: "I apologise to anybody who is upset because they've been through it. Material like this is not often seen by the general public, but art should not exist in a bubble.
"It's not a public information film, but maybe it might make a man in a pub reflect on his behaviour. Or a woman in a hairdresser watching while she waits for her colour to take might think, 'Oh my God, I don't want to be like that.'
"If it saves someone wasting five or 10 years of their life being somebody they really don't want to be, that would be great."
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Category: Health News
Created: 3/3/2012 11:01:00 AM
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Created: 3/5/2012 10:05:00 AM
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Category: Health News
Created: 3/5/2012 6:06:00 PM
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Category: Health News
Created: 3/2/2012 4:06:00 PM
Last Editorial Review: 3/5/2012
WASHINGTON – The nation's largest drugmakers have paid at least $8 billion in fines for repeatedly defrauding Medicare and Medicaid over the past decade, but they remain in business with the federal government because they are often the sole suppliers of critical products, records show.
"We're seeing some of the big companies a second and third time," said Gregory Demske, assistant inspector general for legal affairs for Health and Human Services. "The corporate integrity agreement is not sufficient to deter further misconduct."
In addition, the cases are labor- and cost-intensive as the companies fight often for years to avoid an exclusion, Demske said.
To try to change that trend, the government announced in 2010 that, rather than exclude an entire company, investigators would go after individuals within a company. Demske said his organization, the Justice Department and the Food and Drug Administration have come up with some ideas to use within the scope of the rules — such as taking away a company's patent rights as a condition of a settlement. That could begin with cases being investigated now, he said.
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