UK Government's NHS Reforms - Anyone Understand Them? Professor Asks

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Main Category: Public Health
Article Date: 18 Jan 2012 - 10:00 PST

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Even though Professor Martin McKee, from the London School of Hygiene and Tropical Medicine, has 25 years of experience in researching health systems, including writing more than 30 books and 500 academic papers, he states in a personal view published on bmj.com today that he still does not understand the government's plan for the NHS, saying: "I have tried very hard, as have some of my cleverer colleagues, but no matter how hard we try, we always end up concluding that the bill means something quite different from what the secretary of state says it does."

According to McKee, even Malcolm Grant, the incoming chairman of the National Commissioning Board, has expressed that the bill is "completely unintelligible."

Professor McKee teaches a course on health systems every year, knowing that his students will also expect him to explain the changes proposed by the Department of Health in England this year. He writes:

"If I am to do so, I need to understand them first.
Here lies the problem."

He states that his first problem lies in understanding what the changes are trying to solve. Whilst the government claims that a reform is needed due to the NHS's poor performance in international terms, the evidence it has produced has been completely discredited. For example, in regard to mortality rates caused by heart attacks, independent studies have demonstrated that the UK is now improving at a more rapid rate than nearly any other country. In addition, the Organization for Economic Co-operation and Development (OECD) has claimed that the UK would have performed even better if it had not continually reorganized the NHS.

McKee writes that his second problem lies in trying to understand what is being proposed:

"The prime minister has reassured us that he will not privatize the NHS. Yet the management of one hospital has just been handed over to what is essentially a private equity consortium."

McKee also tries to figure out the secretary of state's role. Whilst he reads that the secretary of state will no longer have a direct role in the management of the NHS, he sees "ever more examples, from waiting times to refusals to treatments, where he is actively intervening."

His third problem lies in understanding why so much is happening now. Whilst the president in the United States is unable to do anything without the approval of Congress, in the UK, the Health and Social Care Bill is already being implemented, although it has not passed as legislation.

In a concluding statement, McKee writes:

"I realize that my bewilderment may simply be a consequence of my own failure to understand the insights that have been granted to wiser and more learned individuals than myself ... But I'm also hoping that someone, somewhere, among the BMJ's extensive and erudite readership, will be able to help me."

Written by: Petra Rattue

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No Safe Level Of Alcohol During Pregnancy

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Academic Journal
Main Category: Pregnancy / Obstetrics
Also Included In: Alcohol / Addiction / Illegal Drugs;  Pediatrics / Children's Health;  Women's Health / Gynecology
Article Date: 18 Jan 2012 - 2:00 PST

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The authors of a study published online on Tuesday that was designed to overcome the difficulties of obtaining accurate and reliable data in Fetal Alcohol Syndrome research, say their findings reinforce the warning that there is no safe level of alcohol consumption during pregnancy.

The lead author of the study is Haruna Sawada Feldman, a post-doctoral student in the University of California, San Diego pediatrics department, where senior author Christina Chambers, is a professor. The study is published in the journal Alcoholism: Clinical and Experimental Research.

Fetal Alcohol Syndrome (FAS) is a spectrum of growth, mental and physical abnormalities that can occur in babies whose mothers drink alcohol during pregnancy.

Physical features of serious FAS include smooth philtrum (no groove between nose and upper lip), thin vermillion border (thin upper lip), short palpebral fissures (abnormally small-set eyes), microcephaly (small head circumference), and growth deficiencies in weight and height.

Feldman said in a statement that they designed the study to overcome two key problems in Fetal Alcohol Syndrome research.

One is that FAS research often relies on what the mothers say about their alcohol consumption. Sourcing data in this way raises questions about inaccuracy due to recall bias and social stigma.

Feldman says they overcame this by collecting data during pregnancy when women were unaware of their pregnancy outcome.

"The data were also collected by trained counseling specialists who had built a rapport with the woman and guaranteed confidentiality while collecting sensitive information," said Feldman.

An added bonus of getting the data in this way was that it included specific details about the stage of pregnancy, dose and pattern of alcohol consumption.

The other difficulty with FAS research is spotting the symptoms in newborns. This requires a careful examination of specific physical features:

"These alcohol-related features are often subtle, and a non-expert examiner may miss or misclassify features, and/or can be biased by subjectivity, especially if he/she suspects or knows about prenatal alcohol exposure (PAE)," said Feldman.

To overcome this second challenge, the study used an expert in dysmorphology, someone trained to look for physical abnormalities, including very subtle ones.

And the expert was exposure blinded, that is they did not know which of the babies they were examining were suspected of having FAS, and further potential bias was reduced because the exams were done in the context of a larger piece of research that was looking at over 70 different variables, of which effects of alcohol was only one.

The data for the study came from 992 women and their single babies in California gathered between 1978 and 2005. It included patterns of drinking and timing of alcohol exposure in relation to selected FAS features.

Patterns of drinking were assessed in terms of drinks per day, number of binge episodes and maximum number of drinks.

Timing of exposure was evaluated for zero to six weeks after conception, six to 12 weeks after conception, and during the first, second, and third trimesters.

The results showed that: Higher prenatal alcohol exposure in every alcohol consumption pattern was significantly linked to an increased risk of the baby being born with reduced birth weight or length, having a smooth philtrum, thin vermillion border or microcephaly.
The most significant links were during the second half of the first trimester.
During this period of gestation, for every increase of one alcoholic drink in the average daily consumption, there was a 25% increase in risk for smooth philtrum, 22% increase in risk for thin vermillion border, 12% for microcephaly, 16% for reduced birth weight, and 18% for reduced birth length.The authors note that the links "were linear, and there was no evidence of a threshold."

"Women should continue to be advised to abstain from alcohol consumption from conception throughout pregnancy," they add.

Feldman said the fact they found no links during the first half of the first trimester between alcohol consumption and FAS signs should not be taken to mean it is safe to drink alcohol during this stage of pregnancy.

Their study only took into account live births and so did not include women who may have miscarried or had stillbirths.

"It is important to know that alcohol-exposed infants who would have exhibited alcohol-related minor malformations might also be more likely to be lost to miscarriage following exposure during the first six-week window," warned Feldman.

"Clinicians should continue to follow the recommendations to encourage women who are planning a pregnancy or have the potential to become pregnant to avoid alcohol, and to advise women who become pregnant to stop alcohol consumption," said Feldman.

"These new findings can also help clinicians quantify the importance of discontinuing alcohol as early as possible."

Written by Catharine Paddock PhD
Copyright: Medical News Today
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Visit our pregnancy / obstetrics section for the latest news on this subject. "Prenatal Alcohol Exposure Patterns and Alcohol-Related Birth Defects and Growth Deficiencies: A Prospective Study Alcoholism: Clinical and Experimental Research"; Haruna Sawada Feldman, Kenneth Lyons Jones, Suzanne Lindsay, Donald Slymen, Hillary Klonoff-Cohen, Kelly Kao, Smriti Rao and Christina Chambers; Alcoholism: Clinical and Experimental Research, first published online 17 January 2012; DOI: 10.1111/j.1530-0277.2011.01664.x; Link to Abstract.
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Blood Clots After Hip Or Knee Replacement - Study Looks At Prevalence

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Main Category: Bones / Orthopedics
Also Included In: Blood / Hematology
Article Date: 18 Jan 2012 - 15:00 PST

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According to a study in the January 18 issue of JAMA, approximately 1 in every 100 patients undergoing knee replacement surgery, and 1 in every 200 patients undergoing hip replacement surgery who use current preventive medications for venous thromboembolism (VTE; a blood clot that develops within a vein that might become serious), will develop VTE before being discharged from hospital.

In acute care hospitals, a crucial safety issue is postoperative VTE, which includes pulmonary embolism and deep vein thrombosis (DVT). The researchers write:

"Without prophylaxis, VTE (both symptomatic and asymptomatic) is the most frequent surgical adverse event after infections. Large numbers of patients world-wide undergo hip and knee replacement [arthroplasty] procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process. Also, symptomatic VTE after total or partial knee arthroplasty (TPKA) and after total or partial hip arthroplasty (TPHA) are proposed patient safety indicators, but data are lacking."

In order to establish a contemporary literature-based estimate of symptomatic VTE event rates before patients undergoing TPHA or TPKA, who received VTE prophylaxis were discharged from hospital, Jean-Marie Januel, R.N., M.P.H., of the Lausanne University Hospital, Switzerland, and colleagues reviewed 47 relevant investigations (6 observational, and 41 randomized human trials).

The studies included a total of 44,844 patients (21,369 undergoing TPHA and 23,475 undergoing TPKA). 20 studies included patients undergoing knee arthroplasty, 21 included patients undergoing hip arthroplasty, and 6 studies included both.

The pooled incidence rates for patients undergoing total or partial knee arthroplasty were: 1.09% for symptomatic postoperative VTE0.27% for pulmonary embolismand 0.63% for DVTFor those undergoing total or partial hip arthroplasty the pooled incidence rates were: 0.53% for symptomatic postoperative VTE0.14% for pulmonary embolismand 0.26% for DVTThe researchers write: "In patients undergoing TPKA, the pooled incidence rates of symptomatic postoperative VTE were significantly heterogeneous [dissimilar]; the pooled incidence rates of symptomatic postoperative DVT and pulmonary embolism indicated less heterogeneity. For patients undergoing TPHA, similar heterogeneity was observed for the pooled incidence rates of symptomatic postoperative VTE and DVT.

These pooled rate estimates indicate that, under contemporary prophylactic regimens, approximately 1 in every 100 patients undergoing TPKA, and 1 in every 200 patients undergoing TPHA, will experience a VTE event before hospital discharge.

These estimates are of value to individual patients and clinicians in the consideration of risks and benefits of TPKA and TPHA, as well as to individuals and organizations seeking to evaluate institutional VTE event rates against contemporary benchmarks. Our above-mentioned rate estimates provide these contemporary benchmarks."

In an associated report, John A. Heit, M.D., of the Mayo Clinic, Rochester, Minn., comments about the accuracy of the estimates in this investigation:

"Of the patients included in their meta-analysis, more than 80 percent were enrolled in randomized clinical trials. The generalizability of the estimated in-hospital VTE rates to all patients undergoing TPHR and TPKR is uncertain.

Because the authors did not have individual patient-level data on the dates of surgery, postoperative VTE events, and death or other loss to follow-up, their VTE rates are not adjusted for differing periods of observation.

Since clinical trials typically mandate some form of leg vein imaging between postoperative days 7 and 10 and patients with identified asymptomatic DVT were usually treated, the study by Januel et al likely underestimated the true rate of symptomatic VTE for the reported mean durations of follow-up (13 days). However, because the current duration of hospitalization for TPHR and TPKR is only 3 to 4 days, the current rates of symptomatic VTE prior to hospital discharge likely are lower than those reported by Januel et al."

Written By Grace Rattue
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Obesity In Children - Virtually Unchanged In U.S.

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Main Category: Obesity / Weight Loss / Fitness
Also Included In: Pediatrics / Children's Health
Article Date: 18 Jan 2012 - 15:00 PST

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Two investigations being published by JAMA reveal that the prevalence of obesity in the United States has not changed considerably. Approximately 1 in 3 adults and 1 in 6 children and adolescents are obese according to data from 2009-2010. The data also revealed that the prevalence of obesity in certain demographics has increased.

In order to determine obesity rates in the U.S., Katherine M. Flegal, Ph.D., Cynthia L. Ogden, Ph.D., M.R.P., and colleagues with the Centers for Disease Control and Prevention, Hyattsville, Md., examined data from the 2009-2010 National Health and Nutrition Examination Survey (NHANES). Rates of obesity among adults were compared with data from 1999-2008. Obesity was defined as a body mass index (BMI) of 30 or greater. The Survey includes the heights and weights of 22,847 adult individuals from a nationally representative sample of the U.S. population in 1999-2008, and 5,926 adult individuals in 2009-2010.

After adjusting for age, the average BMI was 28.7 for men and women in 2009-2010. Overall, the age-adjusted obesity prevalence was 35.7%. The prevalence of obesity among men was 35.5%, while the prevalence of obesity within race/ethnicity groups ranges from 38.8% among non-Hispanic black men to 36.2% among non-Hispanic white men. The researchers found that between 1999-2000 to 2009-2010 there was a considerable increase in obesity for men.

The prevalence of obesity among women was 35.8%, while the prevalence within race/ethnicity groups ranged from 58.5% among non-Hispanic black women to 32.2% among non-Hispanic white women. Overall, the team found no significant increase in the prevalence of obesity among women over the period from 1999 through 2010, although they discovered that for non-Hispanic black women and Mexican American women increases were statistically considerable. For both genders, 2009 to 2010 did not differ considerably from the past 6 years (2003-2008).

Overall, the age-adjusted prevalence of overweight and obesity combined (BMI 25+) was 68.8%, 63.7% among women, and 73.9% among men.The researchers explain:

"Obesity prevalence shows little change over the past 12 years, although the data are consistent with the possibility of slight increases."

In order to determine the prevalence of obesity among children and teens in the U.S. (birth to 19 years of age), the researchers examined NHANES data from 2009-2010, which included a representative sample (n=4,111 [1,376 non-Hispanic white, 792 non-Hispanic black, and 1,660 Hispanic]) with measured heights and weights. Among the measures examined were the prevalence of high weight-for-recumbent length (95th percentile or greater on the growth charts) among children from birth to 2 years old, as well as obesity (BMI 95th percentile or greater of the BMI-for-age growth charts) among those aged 2 to 19 years old. In addition, there were examinations of obesity trends by gender and race/ethnicity, as well as BMI within gender-specific age groups every two years from 1999 to 2010.

The team discovered that 16.9% of the children and adolescents examined aged 2 to 19 years were obese in 2009-2010, and 31.8% were overweight or obese. The prevalence of obesity among females was considerably lower (15.0%) than among males (18.6%). Between 2007-2008 and 2009-2010, the researchers found no difference in obesity prevalence among both genders, although it increased significantly between 1999-2000 and 2009-2010 in male children and teens but not females.

The researchers explain:

"Significant differences in obesity prevalence by race/ethnicity were found. In 2009-2010, 21.2 percent of Hispanic children and adolescent and 24.3 percent on non-Hispanic black children and adolescent were obese compared with 14.0 percent of non-Hispanic white children and adolescents."

In 2009-2010, the team found that the prevalence of high weight-for-recumbent length among children from birth to 2 years was 9.7%, and did not change between 1999-2000 and 2009-2010. When the researchers examined these two time periods together they discovered that Mexican Americans are considerably more likely to have high weight-for-recumbent length than non-Hispanic whites.

Furthermore, they discovered that among males aged 12 to 19 there was a considerable increase in BMI, but not among females or any other age group. The researchers explain: "Many efforts both at the national level and at state and local levels focus on reducing childhood obesity. Yet results from NHANES indicate that the prevalence of childhood obesity in the United States remains unchanged at approximately 17 percent; although increases in obesity prevalence may be occurring among males."

Written By Grace Rattue
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New Drug For Advanced Colorectal Cancer Shows Promise In Trial

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Main Category: Colorectal Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 18 Jan 2012 - 3:00 PST

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An experimental drug for advanced colorectal cancer that available treatments have failed to halt, has shown promise in a clinical trial, says Bayer HealthCare, the company that makes it. The results of the phase III trial show that compared to placebo, regorafenib slowed tumor growth and extended survival.

In a statement released yesterday, Bayer announced that the Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial "met its primary endpoint, showing statistically significant improvement in overall survival ... in patients with metastatic colorectal cancer (mCRC) whose disease had progressed after approved standard therapies".

The statement goes on to add that the trial also shows that regorafenib showed statistically significant improvement in progression-free survival and improvement in disease control rate in the patients who received the drug compared to those who received placebo.

The trial results show that more of the side effects commonly or occasionally seen with chemotherapy occurred with the drug than with placebo, including fatigue, hand-foot skin reaction, diarrhea, anorexia, high blood pressure, oral mucositis (inflammation of the lining of the mouth) and rash/skin peeling.

The trial was "unblinded" late in 2011 after an independent data monitoring committee said the drug was showing significant improvement in overall survival and patients receiving placebo should be offered the option to take it.

It was conducted in North America, Europe, China, Japan and Australia and enrolled 760 patients.

Bayer said they will be seeking Food and Drug Administration (FDA) approval for regorafenib within the next 12 months. If approved, it will be the first new treatment for colorectal cancer in over five years.

Dr Axel Grothey, MD, Professor of Oncology at the Mayo Clinic is a co-principal investigator on the trial.

He is presenting the trial results at the 2012 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI), in San Francisco later this week.

The oral abstract presentation (LBA number 385) is set to take place at 14:30 h PT on 21 January in the Level 3 Ballroom, Moscone Center West.

Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in the US, in both men and women.

About half of patients diagnosed with the disease have the advanced form (metastases, usually to the liver), either at the time of diagnosis or due to recurrent disease.

Written by Catharine Paddock PhD
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Malignant Melanoma Recurrence - How To Avoid It After Targeted Treatment

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Main Category: Melanoma / Skin Cancer
Also Included In: Cancer / Oncology
Article Date: 18 Jan 2012 - 15:00 PST

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According to a study published in the New England Journal of Medicine, researchers at The Institute of Cancer Research (ICR) have demonstrated how to prevent new cancers that can occur when malignant melanoma patients are treated with drugs known as BRAF inhibitors.

In the past, doctors have observed that between 15 and 30% of patients who were treated with BRAF inhibitors, including the FDA-approved drug vemurafenib (Zelboraf), developed another type of skin cancer known as cutaneous squamous cell carcinoma, which required surgical removal.

Professor Richard Marais from the ICR, and his worldwide collaborators, assessed squamous cell carcinoma tissue, which had been obtained from 21 malignant melanoma patients who were treated with vemurafenib in a clinical trial. They tested the DNA of the new tumors for the presence of known cancer-causing mutations including KRAS, HRAS, NRAS, TP53 and CDKN2A and discovered that 60% of the samples contained either KRAS or HRAS mutations.

They observed that further testing showed that the BRAF inhibitors do not directly trigger squamous cell carcinomas, but speed up the development of existing cancerous changes to the skin that were not yet showing symptoms. Significantly, they observed in mice that another type of drug, a MEK inhibitor, was able to inhibit the development of these second tumors even when BRAF drugs were present.

Professor Marais, who is co-senior author of the study, explains: "Around half of all patients with malignant melanoma have a mutation in their BRAF gene, and can be treated with BRAF-inhibiting drugs. However, between 15 and 30 per cent of the treated patients develop other skin tumors. By determining the mechanism by which these develop, we have been able to devise a strategy to prevent the second tumors without blocking the beneficial effects of the BRAF drugs. This may allow many more patients to benefit from these important drugs."

Dr Antoni Ribas, a professor of hematology and oncology, who is also a researcher with UCLA's Jonsson Comprehensive Cancer Center, commented: "This is one of the very few times that we understand molecularly why a side effect to cancer treatment is happening. The side effect in this case is caused by how the drug works in a different cellular setting. In one case it inhibits cancer growth, and in another it makes the malignant cells grow."

Cancer Research UK's senior science information manager, Dr Julie Sharp, concludes: "This research reveals a possible new approach to avoid the second cancers that affect some malignant melanoma patients taking BRAF inhibitors. The next stage will be to explore these results in more patients in clinical trials to see if this drug combination could treat the original cancer while preventing new cancers from forming."

Written by: Petra Rattue

Copyright: Medical News Today
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Caffeine Therapy Does Not Help Preterm Babies Long Term

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Main Category: Pediatrics / Children's Health
Article Date: 18 Jan 2012 - 16:00 PST

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According to an investigation published in the January 18 issue of JAMA, caffeine therapy, which has been demonstrated to lower the rate of cognitive delay and cerebral palsy at 18 months, did not considerably improve the rate of survival without disability at 5 years of age among very low birth weight infants with apnea.

In infants born very prematurely with apnea, who are at increased risk of disability with apnea or death, caffeine therapy is the recommended treatment. "However, outcomes up to 2 years after very preterm birth may not accurately predict function later in childhood", the researchers explain.

In order to find out if the benefits of neonatal caffeine therapy last or if the treatment has newly apparent risks at early school age, Barbara Schmidt, M.D., M.Sc., of McMaster University, Hamilton, Canada, and the University of Pennsylvania, Philadelphia, and colleagues carried out an investigation.

The 5-year follow-up study from 2005 to 2011 consisted of 2,006 participants in 31 of 35 teaching hospitals in Canada, Europe, Israel, and Australia. 96.3% (1,932 participants) had been enrolled in the randomized, placebo-controlled Caffeine for Apnea of Prematurity trial between 1999 and 2004.

A total of 84.9% (1,640 children) born weighing 500 to 1250 g (17.6 to 44.1 ounces) had sufficient data for the primary outcome at 5 years. The researchers defined the primary outcome as the combined survival or death to 5 years, with 1 or more cognitive impairment, behavior problems, deafness, blindness, poor general health or motor impairment. 176 (21.1%) of the 833 children who received caffeine treatment survived or died with at least 1 impairment, in comparison with 200 of the 807 children (24.8%) who received placebo. The researchers explain:

"The rates of motor impairment, cognitive impairment, behavior problems, poor general health, blindness, and deafness were not significantly different between the 2 groups. Only 2 children in each of the 2 groups died between 18 months and 5 years."

In a secondary examination, the researchers discovered evidence of an improvement in gross motor function connected with caffeine therapy. In both groups, the incidence of cognitive impairment was lower at 5 years than at 18 months (4.9% compared with 5.1%).

According to the researchers concerns have been raised that treating infants with caffeine therapy may cause harm in the long-term. "The absence of any adverse effects in children who were randomly assigned to neonatal caffeine therapy on the incidence of behavior problems or on any other outcomes is reassuring."

They conclude:

"In summary, this 5-year follow-up study of participant in the international Caffeine for Apnea of Prematurity trial showed that the benefits of neonatal caffeine therapy on the rate of survival without disability at 18 months were attenuated during child development. The rate of cognitive impairment were much lower at 5 years than at 18 months, suggesting that cognitive delay during the second year of life may not be a lasting outcome after very preterm birth."

In an associated report, Nathalie L. Maitre, M.D., Ph.D., and Ann R, Stark, M.D., of the Vanderbilt University School of Medicine and Monroe Carell Jr. Children's Hospital, Nashville, Tenn., comments on the findings of this investigation.

"As the Caffeine for Apnea of Prematurity trial demonstrates, long-term follow-up is essential for reaching accurate conclusions about the efficacy of new therapies in preterm infants. This trial also highlights how fortunate preterm patients have been in the routine use of caffeine, a drug previously untested in newborns. All along, neonatologists were using the first safe neuroprotective agent in this vulnerable population."

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