It's hard to know these days which way the proverbial worm is turning when it comes to shifts in drug policy. Election years tend to do that. Despite an historical turn of events in Central America which saw Presidents of drug trafficking nations come together to call for world wide decriminalization of drugs, in an effort to end the violence and corruption of the drug trade, the US continues to demur, absurdly claiming that the "War on Drugs" has been a success. Even stranger is Canada's recent announcement that they plan to follow the US model of a "tough on crime" approach to drug policy, which threatens to swell their correctional system in the same ways as in the US. Still, good news abounds with recent studies showing that LSD can cure alcoholism, psychedelics can cure PTSD, and cannabis smoking is not nearly as harmful as the prohibition governments claim. ~ CS
Google+ Presents:
It's Time To End The War On Drugs
To liberalise or prohibit, that is the question. And to answer it the masters of live debate have joined forces with the masters of web technology to create a never-seen-before combination of Oxford debating and Silicon Valley prowess.
Prohibitionists argue that legalising anything increases its consumption. The world has enough of a problem with legal drugs like alcohol and tobacco, so why add to the problem by legalising cannabis, cocaine and heroin?
The liberalisers say prohibition doesn’t work. By declaring certain drugs illegal we haven’t reduced consumption or solved any problem. Instead we’ve created an epidemic of crime, illness, failed states and money laundering.
Julian Assange and Richard Branson; Russell Brand and Misha Glenny; Geoffrey Robertson and Eliot Spitzer. Experts, orators and celebrities who’ve made this their cause – come and see them lock horns in a new Intelligence?/Google+ debate format. Some of our speakers will be on stage in London, others beamed in from Mexico City or Sao Paulo or New Orleans, all thanks to the “Hangout” tool on Google+.
The web will have its say, and so can you at the event in London. Be part of the buzz of the audience, be part of an event beamed across the web to millions. Come and witness the future of the global mind-clash at the first of our Versus debates, live at Kings Place
Source:
Intelligence 2 from Google +
North America
America's plague of incarceration
The message is (or should be deeply disturbing. Shouldn't the USA be ashamed at having the world's largest prison system and highest incarceration rate (754 per 100 000 people ? The richest country in the world has so many of its citizens in prison that it can't afford to house them with even basic minimum medical care (more than half of all prisoners have mental health or drug problems . Prison overcrowding itself has become so terrible in California, that in May, 2011, the US Supreme Court affirmed a lower court order that California release some 46 000 prisoners because of the inhuman conditions under which they were being held. In the Court's words, “A prison that deprives prisoners of basic sustenance, including adequate medical care, is incompatible with the concept of human dignity and has no place in a civilised society.”
Source:
"
A Plague of Prisons: The Epidemiology of Mass Incarceration in America,"
The Lancet.
International Women's Day: U.S. Must Address Impact of Mass Incarceration on Women.
More women are ending up behind bars than ever. Between 1980 and 1989, the number of women in U.S. prisons tripled. And the number of women in prison has continued to rise since. In the last 10 years, the number of women under jurisdiction of state or federal authorities
increased 21 percent to almost 113,000. During the same time period, the increase in the number of men in prison was 6 percentage points lower, at about 15 percent. The increase in women in the federal population was even larger- over 41 percent from 2000 to 2010.
Most women are incarcerated for nonviolent offenses. Over one-fourth are in prison for a drug offense, while 29.6 percent were convicted of a property crime. Addiction plays a large part in a number of women's property crimes, and a lack of available or appropriate treatment only serves to drive their contact with the justice system.
Source:
Justice Policy Institute
From Cell to Screen: The Story of Mumia Abu-Jamal -- Part I
Stephen Vittoria is that rare commodity in Hollywood today: a filmmaker with a conscience. To be more precise, a filmmaker with a strong political conscience. After making two feature films,>Black and White& Hollywood Boulevard (1996 , as well as three feature documentaries:Save Your Life -- The Life and Holistic Times of Dr. Richard Schulze (1998 ,;Keeper of the Flame (2005 and the award-winning art house hit One Bright Shining Moment: The Forgotten Summer of George McGovern (2005 , a portrait of the South Dakota senator who tried to unseat Richard Nixon from the White House in 1972.
For his latest exploration into America's socio-political landscape, Vittoria joins forces with radio producer Noelle Hanrahan to bring Long Distance Revolutionary, the story of Mumia Abu-Jamal, to the screen. Born Wesley Cook in Philadelphia, Abu-Jamal made his name as a tireless writer and journalist during the racially-charged 1970s that often portrayed the City of Brotherly Love as anything but. With his intense coverage of the MOVE organization, a black empowerment group whose ongoing battle with the police and city hall came to a fiery end in 1985, Abu-Jamal become a constant thorn in the side of the city's powerful establishment. Things came to a sudden head for Abu-Jamal himself on the evening of December 9, 1981 when he was accused of murdering a Philadelphia police officer. He received a death sentence the following year, and has been on Pennsylvania's death row until early this year, when his death sentence was commuted to a life sentence in December, 2011.
Abu-Jamal's case remains one of the most controversial and heatedly debated in American legal history, with participants on both sides either protesting his innocence in the murder of Officer Daniel Faulkner or his absolute guilt with equal passion and more often, great vehemence.
Source:
Huffington Post
What’s In a Name? A Lot, When the Name is “Felon”
At a
recent conference of journalists at John Jay College, I raised an issue I have about language in the media: the frequent use of the word “felon” to describe a person who has been convicted of a crime.
“Felon” is an ugly label that confirms the debased status that accompanies conviction. It identifies a person as belonging to a class outside many protections of the law, someone who can be freely discriminated against, someone who exists at the margins of society.
In short, a “felon” is a legal outlaw and social outcast.
Source:
The Crime Report
Addiction: Medical Disease or Moral Defect?
Scientific theories that addiction hijacks the brain have just increased the stigma that they were meant to stop. At least in the moralistic bad old days, addicts were still viewed as having free will. Here's an alternative to both of these no-win approaches.
Source:
The Fix
Scientists Explore Hallucinogen Treatments for PTSD, Sex Abuse Victims
Mind-altering compounds, such as LSD and psilocybin, stirred controversy in the 1960s. As the counter-culture’s psychedelic drugs of choice, the widespread use - and abuse - of hallucinogens prompted tougher anti-drug laws.
Asthma inhalers may be linked to birth defects, the Daily Mail has today reported. The newspaper said that new research has linked steroid asthma pumps "to a slightly increased risk of hormonal and metabolic disorders in babies"
The research was from a Danish study that looked at whether the risk of developing a variety of early childhood diseases was linked to their pregnant mother’s use of glucocorticoid steroid inhalers - a standard preventative treatment for asthma.
The national study looked at over 65,000 Danish women who gave birth between 1996 and 2002, 6.3% of whom had asthma, and followed the children to an average of six years. The researchers looked at a wide range of disease types but found the use of inhalers was only linked to an increased risk of developing an endocrine (hormonal or metabolic disorder during early childhood.
Further research into the long-term effects of inhaled corticosteroids is warranted, and additional research to confirm the finding of this research is needed. In the meantime, recommendations on the use of steroid inhalers are unlikely to change. Pregnant women prescribed inhaled steroids should continue to take these medications as advised as the benefits of using this medication are likely to outweigh the risks, especially in women who have severe asthma.
Where did the story come from?
The study was carried out by researchers from the University of Basel, Ruhr-University Bochum and other medical and research institutions throughout Europe and the US. The research was funded by the Danish National Research Foundation, the Swiss National Science Foundation, the German National Academic Foundation and Research Foundation of the University of Basel.
The study was published in the peer-reviewed American Journal of Respiratory and Critical Care Medicine.
This study was not widely reported in the media; however, the Daily Mail did focus on it in a story about prescription drugs and risk of birth defects. The story mentioned a range of different types of prescription drugs that could be linked to birth defects, although it mainly discussed a possible link between asthma inhalers and birth defects. While the story did mention that the research found only a slightly increased risk in one category of diseases, it did not report that this study found no significant increased risk for most diseases.
Throughout its article the Mail referred to a ‘major inquiry’ and an ‘investigation’ into the use of a variety of medications during pregnancy. The research in question is the EUROmediCAT study, a large ongoing project to look at the use of medication during pregnancy. The way the project was described might lead readers to assume it is some sort of emergency investigation or was set up as the result of a specific health scare. However, it is an ongoing scientific study and does not suggest any kind of health scare or emergency at present.
This Behind the Headlines article focuses on the study looking at inhalers and potential birth defects, rather than the EUROmediCAT study.
What kind of research was this?
This was a national cohort study that aimed to assess the association of women using glucocorticoid inhalers for asthma during pregnancy and their child’s risk of developing several types of disease during the first several years of life.
Previous research into the safety of inhaled glucocorticoids has suggested that they are safe to use during pregnancy, and are not associated with increased risk of birth defects. This research has provided the basis for many policies recommending the continued use of inhalers for the treatment of asthma during pregnancy. The researchers say, however, that these studies only examined the short-term risks, and that research should assess the children for longer to determine if there are any longer-term associations with a wider variety of diseases.
A prospective cohort study is an appropriate design for assessing associations such as long-term outcomes of medicine use, as it collects information on a range of factors before any outcomes develop, and then goes on to see how they might account for any relationship that develops.
What did the research involve?
This study analysed data from the Danish National Birth Cohort, which included births between 1996 and 2003. Women were invited to participate during their first antenatal visit, at around 6 to 12 weeks of pregnancy. Approximately 60% of the invited women decided to participate. Interviews during and after pregnancy were conducted, and researchers assessed the development of disease during early childhood by examining medical registries.
For this substudy looking specifically at the use of certain asthma medications, the researchers extracted data from the Danish National Birth Cohort on women with asthma who gave birth to a single baby (women carry twins or other multiples were not included in the analysis .
Women were considered as having asthma if the condition occurred at any time during the current pregnancy. Researchers recorded information on the type of asthma treatment at several times during the study - at weeks 12 and 30 of pregnancy and at six months after birth.
Researchers also collected information on the child relating to diagnoses in a number of disease types based on the International Classification of Diseases, version 10. They used a statistical technique called regression analysis to assess the association between use of inhaled corticosteroids and the development of these disease types during early childhood:
- infections and parasitic diseases
- neoplasms (cancers
- diseases of the blood or immune system
- endocrine or metabolic disorders
- mental disorders
- diseases of the nervous system
- diseases of the eye
- diseases of the ear
- diseases of the circulatory system
- diseases of the respiratory system
- diseases of the digestive system
- diseases of the skin
- diseases of the musculoskeletal system
- diseases of the genitourinary system
- any disease
During these analyses the researchers included several measures that have been shown to impact on early childhood health, including socioeconomic status, mother’s occupation, the number of previous pregnancies, child sex, and the use of any non-steroid inhalers during the pregnancy. This allowed them to assess the influence any of these factors might have on the relationship between maternal inhaler use and the risk of early childhood diseases.
What were the basic results?
There were 65,085 mother-child pairs enrolled in the original Danish National Birth Cohort. Of these, 4,083 (6.3% had asthma during pregnancy and were included in the current analysis. Of women with asthma, 1,231 (30% used steroid-inhalers during pregnancy, the most common of which was budesonide. The median (average child age at the end of the study was 6.1 years (range 3.6 to 8.9 years .
In all, 2,443 children developed a disease during early childhood. When the researchers compared the risk of developing diseases between the children of women who used inhaled corticosteroids compared to the children of women who did not, they found there was no significant difference in risk for the following categories:
- infections and parasitic diseases
- neoplasms
- diseases of the blood or immune system
- mental disorders
- diseases of the nervous system
- diseases of the eye
- diseases of the ear
- diseases of the circulatory system
- diseases of the respiratory system
- diseases of the digestive system
- diseases of the skin
- diseases of the musculoskeletal system
- diseases of the genitourinary system
- any disease
A total of 93 children (2.28% of the asthma cohort developed an endocrine or metabolic disorder during early childhood. The endocrine system is made up of various glands that release hormones into the blood. The metabolism is the system the body uses to turn food into energy.
The researchers calculated that children of women who used inhaled glucocorticoids during pregnancy had 62% increased risk of developing an endocrine or metabolic disorder, compared to children of women who did not use the inhalers (hazard ratio 1.62, 95% confidence interval 1.03 to 2.54, p=0.036 .
How did the researchers interpret the results?
The researchers concluded that use of glucocorticoids during pregnancy was not associated with an increased risk of the child developing most diseases during early childhood compared to the children of mothers with asthma who did not use the treatment. The only disease category in which use of inhalers was associated with an increased risk was endocrine and metabolic disorders.
Conclusion
This large cohort study suggests that the use of inhaled glucocorticoids for the treatment of asthma during pregnancy does not increase the risk of developing most types of disease during early childhood. As the researchers say, this data is ‘mostly reassuring’ and supports the use of these inhalers during pregnancy.
The study did find an increased risk of developing endocrine or metabolic disorders in children of mothers with asthma who used steroid inhalers during pregnancy. However, it is important to remember that the increased risk is relative to children of women with asthma who did not use inhaled steroids, and that only 93 children developed an endocrine or metabolic disorder of the 4,083 whose mothers who had asthma during pregnancy.
The study does not give absolute numbers of children with these conditions whose mothers did and did not use steroid inhalers, but the absolute risk for both groups is likely to be quite low.
The researchers say that their results regarding this increased relative risk for endocrine and metabolic diseases should be investigated further. They point to several limitations of their study, including the fact that they relied upon a clinical diagnosis of a disorder and did not consider other potentially more sensitive measures. In addition, the researchers did not have information on diagnoses made by the childrens’ GPs, and therefore may have missed out on a diagnosis of less severe disease.
They also say that some disease categories had very small number of diagnoses (such as cancers and blood and immune system diseases , which may have resulted in an imprecise estimation of the hazard ratios.
An editorial accompanying this study suggested that the results be interpreted with caution, given some of the study limitations, such as the fact that the analysis did not control for asthma severity or patients’ use of other treatments alongside their inhalers. They say that it is unclear whether the findings are the result of women using inhaled steroids for the management of more severe asthma.
Pregnant women who have been prescribed inhaled steroids for asthma should continue to take these medications as advised, as well-controlled asthma is important for the health of both the mother and the baby.
Women who have any concerns about the medical management of their asthma during their pregnancy should speak with their doctor.
Analysis by Bazian
Links To The Headlines
Are asthma inhalers linked to birth defects? Thousands of pregnant women at centre of inquiry into health problems in babies. Daily Mail, March 12 2012
Links To Science
Tegethoff M, Greene N, Olsen J et al. Inhaled Glucocorticoids during Pregnancy and Offspring Pediatric Diseases A National Cohort Study. American Journal of Respiratory and Critical Care Medicine. March 1 2012, vol. 185 no. 5 557-563
Related editorial
George J, Abramson MJ, and Walker SP. Asthma in Pregnancy: Are Inhaled Corticosteroids Safe?. American Journal of Respiratory and Critical Care Medicine. 2012; 185: 476-478.
One Pennsylvania doctor in 2008 wrote 1,913 prescriptions for the antipsychotic drug Risperdal - a bit more than 5.2 per day in that leap year, counting weekends and holidays - costing Medicaid $341,273.71.
The top 10 prescribers in Pennsylvania's system that year wrote 9,557 Risperdal scripts costing Medicaid $1.76 million, according to figures provided by a state official to U.S. Sen. Charles Grassley (R., Iowa , who has pushed for disclosure of such information and the relationship between doctors and pharmaceutical companies.
The numbers raised questions for Grassley, and Pennsylvania officials sent letters to scores of doctors emphasizing the need for safety in prescribing antipsychotic drugs. Twelve were suspended, dropped from Medicaid, or are under investigation, according to a copy of a letter to Grassley released Tuesday by the state welfare department.
The numbers also play a role in the U.S. Department of Justice's efforts to fight health care fraud. In the case of Risperdal, the Justice Department is negotiating with Johnson & Johnson, whose Janssen subsidiary makes the drug, to address allegations that the company illegally promoted it to doctors and through Medicaid programs.
Medicaid is the taxpayer-funded insurance plan for poor Americans and is administered by the federal and state governments.
J&J previously disclosed that it set aside money to settle criminal and civil charges in the Risperdal litigation, though it had not specified the amount.
Reports over the weekend from the Wall Street Journal and Bloomberg News said the Justice Department had demanded a payment of about $1.8 billion, an increase from the $1 billion figure reportedly negotiated by the U.S. Attorney's Office in Philadelphia in December.
Spokesmen for J&J, the Justice Department, and the U.S. Attorney's Office declined to comment.
The $1.8 billion figure would be the largest settlement for a case involving a single drug, but some of the other big settlements also involved antipsychotic drugs.
"Both Sen. Grassley and the Department of Justice are making great headway in the battle against Medicaid fraud," said Allen Jones, the former investigator for Pennsylvania's Office of Inspector General whose findings were ignored by state officials in 2004.
Jones was fired by state officials when he took the information to the New York Times, but his whistle-blower lawsuit resulted in J&J's paying $158 million to settle charges that it illegally marketed Risperdal through the Texas Medicaid system. Jones will get a portion of that settlement. He now works as an adviser to attorneys in related litigation.
Eli Lilly & Co. paid $1.7 billion to settle charges of illegal marketing of its antipsychotic drug Zyprexa. Pfizer Inc. paid $2.3 billion to settle charges of illegal marketing of several drugs, notably Bextra, but also its antipsychotic Geodon. Late in 2011, GlaxoSmithKline P.L.C. said it had reached a deal to pay $3 billion to settle charges related to several drugs, including Avandia, but the Justice Department has declined to comment on that one as well.
Jones provided The Inquirer with state figures sent to Grassley's office in 2010 by Michael Nardone, then an official with the Pennsylvania Medical Assistance Program.
New Jersey never responded to Grassley's 2010 request for information nor a follow-up letter dated Jan. 24. State officials could not be reached for comment Tuesday. Delaware Medicaid officials responded to Grassley in 2010 and again in February.
J&J's Risperdal lost patent protection at the end of 2007, so the 2008 figures were the beginning of the decline in costs as generic versions were used more often.
As a comparison, AstraZeneca P.L.C.'s antipsychotic, Seroquel, is just now losing patent protection on most versions.
In 2008, the top 10 prescribers in Pennsylvania wrote 18,705 prescriptions for Seroquel, costing Medicaid $3.67 million. State officials provided The Inquirer with the most recent response to Grassley. That letter says the top 10 prescribers wrote 17,692 scripts for Seroquel, costing Medicaid $5.73 million.
In 2010, AstraZeneca paid $520 million to settle charge of illegal marketing of Seroquel.
"I liken the DOJ effort to a storm surge building for a long time," Jones said, crediting Grassley and a few others in Congress for helping to push the issue. "They have a clear eye on the dirty ways of fraudulent marketing and are systematically exposing it. It is changing the way antipsychotic drugs are marketed in America."
Contact David Sell at 215-854-4506 or dsell@phillynews.com.
A major new study of pain relief during labour was widely reported in the papers today, with the Daily Express claiming that drugs work better than drug-free alternatives such as massage, and the Daily Mail reporting that painkillers are more effective than hypnosis or electronic pain-relief machines.
In fact, these headlines were misleading and oversimplified the results of this large review, which looked at all high-quality research on pain management during labour. It found there is generally better evidence available for the effectiveness of drugs to relieve labour pains (including epidurals , and less robust evidence for non–drug approaches such as hypnosis.
However, saying there is less evidence on certain methods is not the same as saying these methods ‘do not work as well’. As the authors make clear, it means that, to date, there have been few good quality studies confirming how effective they may or may not be.
The review also points out that most drug-based approaches can have side effects. Epidurals, for example, increase the risk of further interventions such as forceps. It is also noteworthy that one of the interventions for which there is little evidence is the use of intramuscular painkillers such as pethidine, which is commonly used in many obstetric units.
This review provides good insight into what options women might prefer during birth, which can be discussed and noted when making a birth plan.
Where did the review come from?
The review was undertaken by researchers from the Cochrane Collaboration, a respected international research group that carries out independent reviews of the evidence on healthcare treatments. The rigorous methods these reviews employ mean that they are among the best evidence sources for evaluating medical procedures.
In this particular review the researchers drew together the results of a number of previous systematic reviews on the subject of pain relief during labour. They then used well-established methods to identify relevant research and to assess its quality. In total, they brought together 15 previous Cochrane reviews on the subject and three non-Cochrane reviews, and used them to assess a range of pain relief options.
Why was this review needed?
The type and intensity of pain that women experience during labour can vary greatly. It can be affected by many physiological and psychosocial factors, including fear and anxiety, prior experience and the degree of emotional support they receive. Most women require some form of pain relief.
While there are several drug and non-drug options available, the reviewers point out there has not yet been a single evidence source pulling together all the evidence from good trials on pain management in labour. The new overview aims to provide a summary of all the good quality evidence, both for medical professionals and pregnant women.
What pain relief methods did it look at?
The review covered a number of pain relief methods including:
- epidurals: is an injection of anaesthetic drugs in between the spinal bones but outside the spinal cord, and can be delivered either through single injections or fed as needed through a fine tube left in the lower back
- Combined spinal epidurals (CSE : as per a regular epidural a CSE is a low dose injection of fast-acting pain relief (a mini-spinal , but an epidural tube is also placed so that further drugs can be given as the effects of the mini-spinal wear off. The aim of CSEs is to provide faster pain relief than epidurals alone.
- inhaled analgesia: known as Entonox or ‘gas and air’
- injected or intramuscular opioid painkillers (such as pethidine
- non-opioid painkillers: such as paracetamol, ibuprofen and so on.
- local anaesthetic nerve blocks
- sterile water injections: injected into the skin over the base of the spine
- immersion in water: when a woman uses a special pool during labour
- relaxation methods: such as breathing and yoga
- acupuncture
- massage
- hypnosis
- biofeedback: where the woman receives signals as to her pulse, heart rate etc.
- aromatherapy: the use of essential oils
- Transcutaneous electrical nerve stimulation (TENS : a mild electric current is passed through the skin to reduce nerve pain signals
What did the reviewers find?
The reviewers divided the different pain relief methods into different categories, according to how much good quality evidence had been carried out on each of them. The three categories were
- what works
- what may work
- insufficient evidence to make a judgement
What works?
The reviewers found that there is good evidence for both forms of epidurals, and that CSEs gave faster pain relief than standard epidurals alone. There was more limited evidence for gas-based pain relief (inhaled analgesia methods during labour, although the research still supported their use.
Both epidurals and inhaled analgesia can have adverse effects. The review found that inhaled analgesia is associated with nausea and vomiting, while epidurals increased the number of vaginal births needing a forceps or ‘ventouse intervention’, a technique using a suction cup to help deliver the baby. Epidurals also increased the risk of low blood pressure for the mother, as well as other side effects such as being unable to pass urine and having difficulty moving one’s legs.
What may work?
The review found there is some evidence to suggest that immersion in water, relaxation, acupuncture, massage, local anaesthetic nerve blocks and non-opioid drugs (for example, paracetamol and NSAIDs may help to manage labour pains, with few adverse effects.
Women reported satisfaction with the pain relief they gained from all these interventions, apart from massage.
Relaxation and acupuncture reduced the need for forceps and ventouse interventions, and acupuncture reduced the number of caesarean sections. However, the researchers point out the evidence for each of these methods was mainly limited to a few individual trials (rather than systematic reviews .
Where is more evidence needed?
The researchers found ‘insufficient evidence to make a judgement’ on the effectiveness of:
- hypnosis
- biofeedback
- sterile water injections
- aromatherapy
- TENs
- injected or intramuscular opioids
What happens now?
The reviewers say that the trials they looked at showed ‘considerable variation’ in how outcomes such as pain intensity were measured and that some important outcomes were never included. For example, no studies examined a woman’s sense of control during labour, the effect of pain relief on the ability to breastfeed and on mother-baby bonding, despite surveys showing that these factors are important to women.
Designing future trials that include these factors is essential, the researchers argue. In addition, further good quality research on the effectiveness of non-drug interventions during labour is needed.
The authors say that during pregnancy women should be told about the benefits and the potential adverse effects of all available pain relief methods, both for them and their babies. They should feel free to choose whatever pain management they think would help them most.
What kind of pain relief should I choose?
The choice of pain relief during labour will be an individual one, and clearly there are benefits and drawbacks to each that must be considered. However, this review provided a good overview of the various types of pain relief available during labour, and how much evidence there is supporting their use.
Women do not have to make this choice alone, as they can get medical advice from their doctor or midwife on what may suit them best. Women can do this when creating a birth plan setting out other options such as where they will give birth.
Importantly, women who choose non-drug pain management should feel free to move on to a drug-based intervention if needed, and might benefit from planning a back-up pain relief option if their initial choice is not effective during the birth.
Links To The Headlines
Painkillers ‘best in labour’. Daily Express, March 14 2012
Painful reading for fans of natural birth. The Daily Telegraph, March 14 2012 [Print only]
Links To Science
Jones L, Othman M, Dowswell T et al. Pain management for women in labour: an overview of systematic reviews (Review (PDF, 1.41MB . The Cochrane Library 2012 Issue 3
HEALTH SERVICES/OUTCOMES RESEARCH
POSITIONS AND RESPONSIBILITIES: The Department of Pharmaceutical Systems and Policy at the West Virginia University (WVU School of Pharmacy seeks applications for an Assistant Professor to join our health services/outcomes research team. This 12-month tenure track position is available immediately. Primary responsibilities include graduate and professional program teaching, graduate student mentoring, and developing an independently funded research program in health services and outcomes research. Salary and start-up packages are competitive.
QUALIFICATIONS: Ph.D. or equivalent degree with a strong research focus in patient-reported outcomes (e.g., Health Related Quality of Life, patient satisfaction , or chronic disease epidemiology. Candidates should have a promise for excellence in research and teaching in relevant areas, as well as peer-reviewed publications. Experience and participation in funded research is an advantage and excellent communication skills are important. Candidates should interact effectively with collaborators from diverse disciplines and be eligible for appointment to the graduate faculty in order to teach and mentor graduate students engaged in health services and outcomes research.
APPLICATION: Interested persons should submit an application consisting of a letter of interest, curriculum vitae, and contact information for three professional references to: Usha Sambamoorthi, Ph.D., West Virginia University School of Pharmacy, PO Box 9510, Morgantown, WV 26506 or by e-mail to usambamoorthi@hsc.wvu.edu with a copy to acframe@hsc.wvu.edu. Applications will be considered as they are received and will be accepted until position is filled.
SCHOOL AND COMMUNITY: The School of Pharmacy has a nationally recognized Ph.D. graduate program in health outcomes research with 15 Ph.D. students, the majority of whom are supported by external research funding. It offers exciting opportunities through the Rational Drug Therapy Program which is supported by West Virginia state agencies, the AHRQ funded West Virginia Collaborative Health Outcomes Research of Therapies and Services (CoHORTS center, and the newly established Wigner Institute for Advanced Pharmacy Practice Education and Research. Established partnerships with the state Medicaid program and the state health insurance program, managed care organizations, several pharmaceutical companies, and the nearby National Institute of Occupational Safety and Health (N.I.O.S.H. and Mylan Pharmaceuticals offer potential opportunities for collaborative research. In addition, a newly launched School of Public Health and research faculty and graduate programs in business, communication, education, psychology, public administration, and sociology provide opportunities for multidisciplinary collaboration and research.
The School of Pharmacy is situated within a large state-assisted academic health sciences center which includes a 460-bed teaching hospital, a psychiatric hospital, rehabilitation hospital, and regional cancer center. West Virginia University (a Doctoral Research-Intensive University is the state's land-grant university with an enrollment of 29,000 students. WVU is located in Morgantown, a scenic rural area that has been featured in numerous publications for its high quality of life, cultural amenities, outdoor recreation, and is within easy driving distance to Pittsburgh, PA, and Washington, DC.
West Virginia University is an Equal Opportunity/Affirmative Action Employer. Women and minorities are encouraged to apply. The WVU Health Sciences Center is a smoke free campus. West Virginia University is the recipient of an NSF ADVANCE award for gender equity.
Apply Here
The government in India has granted the rights to an indigenous pharmaceutical group to manufacture a generic version of the cancer treatment drug Nexavar.
For the first time, an Indian drugs firm has been approved to produce a medication under licence when the original's still patent-covered.
As a result of the agreement, the firm - Natco Pharma - is obliged to forward six per cent in royalties back to Bayer, which presently markets Nexavar alongside Onyx Pharmaceuticals.
Bayer, meanwhile - according to reports - isn't best pleased with the Indian government's move. "We are disappointed about this decision", company representative Sabrina Cusimano stated in comments made to the Associated Press. "We will see if we can further defend our intellectual property rights in India".
Nexavar Cancer Drug
Nexavar is the market name for sorafenib, an orally-taken medication now approved to treat two types of cancer - advanced hepatocellular carcinoma (liver cancer and advanced renal cell carcinoma (kidney cancer .
The kidney cancer approval came first, in 2005, when the US FDA declared its satisfaction with the product. It did the same for the drug as a liver cancer treatment two years later and, with clinical trials now in progress, thyroid cancer could be the next condition added to this approved treatment list.
Controversially, the drug's not available as a UK liver cancer treatment, after being rejected - on grounds of cost - by the National Institute for Health and Clinical Excellence in November 2009.
Natco Generic Nexavar Approval
The Natco generic Nexavar approval decision will see the production of drug copies priced at the equivalent of £112 for a box of 120: less than £1.00 each. This is dramatically cheaper than the original drug, with the same quantity presently priced at over 30 times that cost.
The Indian pharmaceutical firm believes that the drug's availability is key to the treatment of close to 9,000 cancer patients in India.
"This is a victory for Indian patients and for India's generic manufacturers, which are under attack", Natco Pharma's General Manager, Madineedi Adinarayana, stated according to the BBC, adding: "many more such cases will follow."
Many researchers debate whether it is safe for women to take antidepressants during pregnancy. However, according to the Mayo Clinic, the risk of a child being affected by antidepressant use during pregnancy is fairly low.
Despite this argument, some antidepressant manufacturers have been taken to court by women claiming that taking antidepressants during pregnancy caused their children to be born with birth defects.
Three women who took the antidepressant medication Lexapro® while pregnant filed a lawsuit against Forest Laboratories on February 16, 2012, in the St. Louis Circuit Court in Missouri.
The lawsuits allege that Forest Laboratories knew and withheld information regarding possible birth defects caused by Lexapro. The plaintiffs claim they would not have taken the medication if they’d known about the potential birth defects.
As a result of the complications caused by Lexapro, one plaintiff’s daughter was born with spina bifida, another plaintiff’s daughter was born with club foot, and the last plaintiff’s daughter was born with cleft lip and cleft palate.
Lexapro is included in a class of antidepressants widely used throughout the United States known as selective serotonin reuptake inhibitors (SSRIs . Other SSRIs includes Zoloft®, Paxil®, Prozac®, and Celexa®.
Sources:
- Mayo Clinic Staff. (2012, January 10 Antidepressants: Safe during pregnancy? Mayo Clinic. Retrieved from
http://www.mayoclinic.com/health/antidepressants/DN00007 - A.D.A.M. Medical Encyclopedia. (2010, September 4 Postpartum depression: Depression - postpartum; Postnatal depression. PubMed Health. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004481/
Botox injections may help women with urinary incontinence, The Daily Telegraph has today reported. The newspaper said that injecting the muscle-freezing toxin into the wall of the bladder can have a long-lasting impact on overactive bladder syndrome, a major cause of incontinence.
The newspaper’s story is based on a UK medical trial that investigated whether the paralysing properties of botox were effective at reducing the symptoms such as frequently using the toilet, feeling an urgent need to urinate, and leakage in patients with overactive bladder syndrome.
The trial featured 240 women who had not responded to medical treatments for overactive balder syndrome. The researchers found that women who received the botox injection experienced these symptoms significantly less frequently than women who received a dummy injection of saltwater. However, women given botox were more likely to get urinary tract infections.
The results of the study indicate that botox may be effective in treating a common and upsetting health condition. However, if it does get adopted into use in this way there are several other treatment options (including lifestyle measures, bladder training exercises and medication that would be considered first. Botox may be considered as an option only if these treatments fail, and the benefits would have to be considered in relation to its potential harms.
Where did the story come from?
The study was carried out by researchers from the University of Leicester and was funded by the Moulton Charitable Trust and the women’s health charity Wellbeing of Women.
The study was published in the peer-reviewed medical journal European Urology.
The Telegraph covered this study appropriately, covering the study size and design, as well as the treatment benefits and harms.
What kind of research was this?
While it is hard to gauge the true scale of the problem, research suggests that around 13% of women in the UK may have some form of urinary incontinence. Although many conditions and factors can cause urinary incontinence, one major cause is overactive bladder syndrome. The condition is marked by uncontrolled contraction of the bladder that results in an urgent need to pass urine. While this can lead women to need the toilet frequently, some also experience a form of leakage called urge incontinence.
An overactive bladder can be a cause of urge incontinence, which is when urine leaks at the same time or just after you feel an intense urge to pass urine. Urge incontinence differs from stress incontinence, where the pelvic floor muscles are too weak to prevent urination. This causes urine to leak when your bladder is placed under pressure from actions such as coughing or laughing.
This was a placebo-controlled randomised controlled trial that examined the effectiveness and safety of using botulinum toxin (botox as a treatment for overactive bladder syndrome. A randomised controlled trial is the best way to measure the effectiveness of a treatment, as the randomisation process helps to ensure that any patient characteristics that may influence the outcome have an equal chance of appearing in either treatment group. This allows researchers to be confident that any observed effect is due to the treatment under study.
What did the research involve?
The researchers enrolled 240 women with bladder muscle overactivity, or overactive bladder syndrome, that had not responded to previous treatment. The women were randomly allocated injections of either Botulinum toxin A (botox or placebo (saltwater into the wall of the bladder. Women with another common type of incontinence, stress incontinence, were not included in the study.
The participants kept a diary over three days, recording the number of times they:
- emptied their bladder
- felt an urgent need to empty their bladder
- experienced an unintentional passing of urine (or leakage
The women also completed a questionnaire that assessed their quality of life, as overactive bladder syndrome often has a significant negative impact on patient quality of life.
The researchers conducted follow-up sessions with the women on average at six weeks, three months and six months after treatment. They assessed differences in the frequency of the above three symptoms between the two treatment groups. They also compared quality of life scores, treatment complications and time until troubling symptoms returned between the two groups.
The researchers used appropriate statistical methods to assess differences in frequency of symptoms between the two groups.
What were the basic results?
There were 122 women allocated to the botox treatment group and 118 women allocated to the placebo group.
The researchers compared the outcomes in the botox and placebo groups at the six-month follow-up. They found that in any 24-hour period women in the botox group:
- emptied their bladders less often: 8.33 times versus 9.67 times, a difference of 1.34 (95% confidence interval [CI] 1.00 to 2.33, p=0.0001
- experienced fewer leakage episodes: 1.67 versus 6.00, a difference of 4.33 episodes (95% CI 3.33 to 5.67, p
<0.0001 - experienced fewer episodes of urgency to urinate: 3.83 versus 6.33, a difference of 2.50 episodes (95% CI 1.33 to 3.33, p
<0.0001
Almost a one-third of women in the botox group (31.3% developed bladder control (or continence following their treatment, compared to 12.0% in the placebo group (Odds Ratio [OR] 3.12, 95% CI 1.49 to 6.52, p=0.002 .
However, urinary tract infection was reported at least once during six months by a one-third of women in the botox treatment group, compared to 10% in the placebo group (OR 3.68, 95% CI 1.72 to 8.25, p=0.0003 .
Those given botox also reported greater difficulty emptying their bladders, which required self-catheterisation to remove their urine: 16% of the botox group compared to 4% of the placebo group (OR 4.87, 95% CI 1.52 to 20.33, p=0.003 .
How did the researchers interpret the results?
The researchers concluded that injections of botulinum toxin A into the bladder wall is an effective and safe treatment for overactive bladder syndrome in women who have not responded to previous treatment.
Conclusion
Urinary incontinence can be a distressing and problematic condition, and although we cannot be sure of the number of people affected, research suggests it is surprisingly common.
While there is a range of potential treatments and ways to manage urinary incontinence (including medication, bladder training, lifestyle changes and surgery not all people respond to them, and they can have problems. This randomised controlled trial provided good evidence that botox injections may be a useful treatment option for women with incontinence due to overactive bladder syndrome that has proven difficult to treat with other methods.
The researchers say that the relief of symptoms reported by the participants was considerably better than those who used oral anticholinergic drugs. These drugs act on the nerve supply to the bladder and are the standard medical treatment used for this condition. They add that other randomised controlled trials have reported similar effects.
The researchers say that since they designed their trial, other studies have published results that support using a lower recommended dose of botox for this type of treatment. Therefore, it is unclear if the same results would be found at this reduced dose. They also say that their study recruited participants with severe cases of overactive bladder syndrome, and that it is unclear if the treatment would be as effective in less severe cases.
It is important to note that the study participants did not have stress incontinence, which is a common cause of urinary incontinence. Therefore, the results of this study cannot be generalised to all women with symptoms of overactive bladder or incontinence, but can only be applied to those with diagnosed overactive bladder syndrome (or detrusor overactivity .
Botox is not routinely used by the NHS in this way, but if it were then it would probably be considered as an option only among women who have required specialist referral for their condition. This would be given after they had tried other treatment options first, which may include lifestyle measures and bladder training exercises in addition to oral medications. If these treatments fail, the benefits of botox would have to be considered in relation to its potential harms.
Links To The Headlines
Botox 'stops the call of the bathroom'. The Daily Telegraph, March 12 2012
Links To Science
Tincello DG, Kenyon S, Abrams KR et al. Botulinum Toxin A Versus Placebo for Refractory Detrusor Overactivity in Women: A Randomised Blinded Placebo-Controlled Trial of 240 Women (the RELAX Study . European Eurology, Published online 5 January 2012
The first Pradaxa lawsuit was filed against drug manufacturer Boehringer Ingelheim last week on behalf of Bertha Bivens, who claims her mother died after suffering a gastrointestinal bleed that Pradaxa allegedly caused. Since the first lawsuit was reported, at least five more have been filed.
Pradaxa (dabigatran is a blood thinning medication first approved in 2008 by the European Commission for treatment of post-knee surgery and atrial fibrillation. Two years later in October, the U.S. Food and Drug Administration approved Pradaxa for treatment of atrial fibrillation, a condition in which a dysfunctional heartbeat leads to blood clot formulation. These blood clots may cause serious and even deadly conditions if left untreated. For example, a blood clot can cause a stroke if it travels to the brain or a pulmonary embolism if it travels to the lungs.
Shortly after FDA approval, a flood of complaints was filed linking Pradaxa to a number of adverse side effects including gastrointestinal bleeding, internal bleeding, brain hemorrhaging, heart attack, and death. The FDA has not issued a recall, but it has begun to investigate the reported internal bleeding occurrences.
Some researchers pose the argument that Pradaxa’s side effects may be reversible if it contained a reversing agent present such as the one in Warfarin, a traditional and competing blood thinner. Other researchers believe that the reported adverse side effects are caused by healthcare professionals’ improper dosing.
Pradaxa is included in a class of drugs called direct thrombin inhibitors that work by preventing the functionality of the enzyme that causes blood cells to form clots.
In the case Bivens vs. Ingelheim , Bivens alleges that her mother was prescribed Pradaxa in January of 2011 and died from gastrointestinal bleeding three months later. As of November 2011, more than 260 deaths linked to Pradaxa were reported. The majority of these are associated with intense bleeding events.
Antibiotics are not usually recommended for treating E. coli infections; however one of these drugs showed promising results when given to victims of last year's massive European outbreak linked to sprouts.
Azithromycin, administered to patients to prevent the spread of meningitis, was associated with a shorter duration of shedding of the E. coli O104:H4 bacteria in stool specimens according to a study published in the March 14 issue of JAMA (Journal of the American Medical Association .
Patients who received azithromycin were also less likely to carry the bacteria long-term. Out of a group of 65 patients treated at the University Hospital Schleswig-Holstein in Lubeck, Germany, 22 were given the drug and 43 received no antibiotic treatment. Patients who received the drug (both in-patients and out-patients were treated approximately 12 days after they started showing symptoms of infection.
After 21 days, only 31.8 percent of the treated group were still carriers of the bacteria, whereas 83.7 percent of those not treated continued to be Shiga toxin-producing E. coli (STEC carriers.
Long-term carriage was measured starting at day 28. At this time, 4.5 percent of those treated carried the bacteria. That percentage was 81.4 among those not treated with azithromycin. At day 35, none of the treated patients was still an STEC carrier. However 8 days later, at day 43, 57.7 percent of the control group was still carrying the bug.
Long-term carriage of STEC can be dangerous both to those exposed to the patient, who is infectious, and to the individual himself.
"Long-term carriers of entheropathogenic bacteria represent a chronic risk of human-to-human transmission and, therefore their individual social and working life is legally restricted by the German health authorities, posing a high psychological and socioeconomic burden," says the report, according to Science Daily.
These patients also risk persistent diarrheal symptoms, according to the authors.
The jury is still out on whether or not azithromycin can be used to treat STEC patients, in addition to reducing the endurance of the disease. A major concern in STEC treatment is preventing the onset of hemolytic uremic syndrome, or HUS, a potentially life-threatening complication that affects the kidneys.
"Clinicians should not consider these data as an endorsement of the safety or efficacy of using azithromycin to treat diarrhea caused by Shiga toxin-producing E. coli, because the subjects in this study were treated late in illness well after the outcome of greatest concern, i.e., HUS, had already ensued," warns Dr. Phillip Tarr, Co-Leader of the Pathobiology Research Unit and Director of the Division of Gastroenterology and Nutrition at the Washington University School of Medicine's Department of Pediatrics.
While the study was "very well done," he says, "its applicability is limited to the carriage state, after the most severe phase of illness has passed," he noted in an emailed statement to Food Safety News.
It is possible, however, that future research on the drug may reveal an ability to combat STEC symptoms.
Azithromycin could be "a safe therapeutic option for the treatment of [Shiga toxin-producing enterohemorrhagic E. coli] diarrhea to avoid development of HUS," said Dr. Johannes Knobloch of the University of Luebeck when presenting the preliminary results of this study at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC in Chicago last September.
However, a prospective trial would need to be conducted to test this potential, he noted.
The European outbreak, which began in May of 2011 and was eventually linked to sprouts grown from fenugreek seeds, sickened 3,816 people in that country alone and over 4,000 people total. Of all victims, 852 developed HUS and 50 died from both HUS and non-HUS infections.
Controversy continues to swell around the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, better known as DSM-5. A new study suggests the 900-page bible of mental health, scheduled for publication in May 2013, is ripe with financial conflicts of interest.
The manual, published by the American Psychiatric Association, details the diagnostic criteria and recommended treatments -- many of which are pharmacological -- for each and every psychiatric disorder. After the 1994 release of DSM-4, the APA instituted a policy requiring expert advisors to disclose drug industry ties. But the move toward transparency did little to cut down on conflicts, with nearly 70 percent of DSM-5 task force members reporting financial relationships with pharmaceutical companies -- up from 57 percent for DSM-4.
"Organizations like the APA have embraced transparency too quickly as the solution," said Lisa Cosgrove, associate professor of clinical psychology at the University of Massachusetts-Boston and lead author of the study published today in the journal PLoS Medicine. "Our data show that transparency has not changed the dynamic."
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