Thursday, March 17, 2011

Divided Opinion

Mobile phones slaughter brain cells. Drugs and booze are bad for you. Crash helmets are good. Right? Well no, perhaps not. Researchers have discovered that what's bad for us, in certain conditions, might actually be good for us, writes Eimear Vize.

Contradictions abound in the tangle of ever-expanding clinical research; the undergrowth is thick with new truths that regularly spring up to replace conventional wisdom. Some of these conflicting facts suggest that what is bad for you is actually good and vice versa. Certainty is turned on its head, forcing us to question long-held beliefs.

Almost two decades ago, Dr Serge Renaud’s “French paradox” stunned the world with revelations that moderate and daily consumption of red wine is good for the heart, even tempering the adverse effects of eating inexcusable amounts of heart-stopping, artery-clogging saturated fats and smoking Gauloises cigarettes.

The French scientist went on to unveil another startling discovery in 1998: two to three glasses of wine a day reduces death rates from all ailments by up to 30%. In the Epidemiology article, Renaud also reported a 35% reduction from cardiovascular disease, and an 18-24% reduction from cancer.

Today, some of the latest research to challenge established opinions involves compounds considered so dangerous to public health they are illegal in most countries.

Agony and Ecstasy
A growing body of researchers are investigating the benefits of psychedelics and marijuana, used in proper settings, to treat conditions for which conventional medicines provide limited relief, such as post-traumatic stress disorder (PTSD), pain, drug dependence, anxiety and depression associated with end-of-life issues.

In July last year, the Journal of Psychopharmacology reported the results of the world’s first randomised, controlled trial of the class A drug Ecstasy. The study’s authors, led by Dr Michael Mithoefer, a South Carolina psychiatrist, gave Ecstasy or a placebo to patients with PTSD, whose condition had not been alleviated by any standard combination of psychotherapy and antidepressants. The new paper showed that Ecstasy is not only safe when administered in controlled settings but also remarkably effective in treating PTSD in conjunction with psychotherapy.

Participants treated with a combination of Ecstasy and psychotherapy saw clinically and statistically significant improvements in their PTSD – over 80% of the trial group no longer met the diagnostic criteria for PTSD following the trial, compared to only 25% of the placebo group. In addition, all three subjects who reported being unable to work due to PTSD were able to return to work following treatment with Ecstasy.

The investigators have now received the go-ahead from the US Food and Drug Administration (FDA) for a protocol for a three-arm, dose-response design that they expect will result in successful blinding. This new study is for US veterans with war-related PTSD, mostly from Iraq and Afghanistan and a few from Vietnam.

In vino sanitas?
Although excessive alcohol intake affects every body system, causing a wide range of health problems, drinking in moderation may actually prove beneficial – although, perhaps not to the extent claimed by some wine producers who began lobbying for the right to label their products ‘health foods’ following Renaud’s “French paradox” revelations.
Recently, several studies have added further value to indulging in the occasional tipple. Research published in the journal Rheumatology in November 2010 found that drinking alcohol could not only reduce the severity of rheumatoid arthritis (RA) but may also cut the risk of developing the disease, confirming the results of previous studies in this area.
The first author of the study, Dr James Maxwell, a consultant rheumatologist and honorary senior clinical lecturer at the University of Sheffield, said: “We found that patients who had drunk alcohol most frequently had symptoms that were less severe than those who had never drunk alcohol or only drunk it infrequently. X-rays showed there was less damage to joints, blood tests showed lower levels of inflammation, and there was less joint pain, swelling and disability. This is the first time that a dose dependent inverse association between frequency of alcohol consumption and severity of RA has been shown in humans.”
Dr Maxwell and his colleagues also found that non-drinkers were four times more likely to develop RA than people who drank alcohol on more than 10 days a month. Evidence that alcohol suppresses the activity of the immune system, influencing the pathways by which RA develops, may explain this phenomenon.
Meanwhile, recent claims that beer can help prevent osteoporosis are being credited to the brew’s significant source of dietary silicon, a key ingredient for increasing bone mineral density.
A study published in February last year in the Journal of the Science of Food and Agriculture, reported for the first time on the factors in brewing that influence silicon levels in beer. The authors explained that beers containing plenty of malted barley and hops could promote better bone health thanks to their rich dietary silicon content.
Memory loss may be an unpleasant side effect of excessive drinking, but in moderation alcohol consumption may actually prevent the onset of Alzheimer’s disease, especially if you avoid tobacco. That’s according to a study in the May 2010 edition of the Journal of Alzheimer’s Disease, which found that that effect was strongest in women.

Going to pot
The virtues of marijuana in helping post-traumatic stress disorder patients were extolled recently by Israeli scientists from the Learning and Memory Lab in the University of Haifa’s Department of Psychology.

Published in the prestigious Journal of Neuroscience, the results of this study show that cannabinoids can play an important role in stress-related disorders. “The results of our research should encourage psychiatric investigation into the use of cannabinoids in post-traumatic stress patients,” the authors suggested.

Research has also confirmed that cannabis is a viable treatment option for some patients with spasticity related to multiple sclerosis (MS). A systematic review, published in the open access journal BMC Neurology in December 2009, found that five out of six randomised controlled trials reported a reduction in spasticity and an improvement in mobility. “The therapeutic potential of cannabinoids in MS is comprehensive and should be given considerable attention,” urged the authors from the Global Neuroscience Initiative Foundation, Los Angeles.

While some investigations indicate that using cannabis increases the risk of psychotic symptoms or disorders – for example a meta-analysis reported in the Lancet in 2007 showed a 40% risk increase in people who had ever used cannabis – the evidence for the relationship between cannabis and schizophrenia or psychosis remains controversial.

Scientists from four universities in the UK found it would be necessary to stop 2,800 heavy cannabis users in young men and over 5,000 heavy cannabis users in young women to prevent a single case of schizophrenia. Among light cannabis users, those numbers rise to over 10,000 young men and nearly 30,000 young women to prevent one case of schizophrenia. Their study was published in Addiction in October 2009.

Crash helmet dummies?
Wearing a crash helmet is essential to a motorcyclist’s safety, but could it actually be harming their health and affecting their riding?

That is what academics from the two Bath universities in the UK are investigating in a new year-long research project, which concludes in February 2011. 

“The noise inside the helmet at the legal speed of 70mph is higher than the legal limit for noise at work – more than enough to cause serious hearing damage,” said Dr Michael Carley, from the Department of Mechanical Engineering at the University of Bath. “The issue isn’t noisy engines or loud exhausts as you may think. The noise is simply from the airflow over the helmet. Earplugs won’t help much either as the noise is transferred into the inner ear from the rider’s bones. This has been known for 20 years yet little research has been done on the noise and its effects.”

The other lead researcher, Dr Nigel Holt from the Department of Psychology at Bath Spa University, added: “This isn’t about putting people off riding or wearing helmets; it’s about finding ways to reduce this damage so that riders can have a better riding experience.”

Tobacco's protective properties 
 One substance that gets a lot of bad press for its harmful effect on the body is tobacco. Smoking is known to cause cancer, cardiovascular disease, emphysema and other chronic lung diseases. However, new evidence shows that tobacco could actually protect against Parkinson’s disease.


Researcher Maurizio Facheris
In May 2010, a team from the Mayo Clinic in Minnesota presented their research findings that a particular variant of the gene CYP2A6 (which encodes the enzyme responsible for metabolising nicotine), when combined with smoking, considerably reduces the risk of contracting Parkinson’s disease.

It remains to be clarified whether the protection against the disease is provided by the particular gene variant or by the presence of cotinine, the substance into which nicotine is transformed through the action of the gene. “If this second hypothesis is confirmed, producing a cotinine-based drug would be a means to reduce exposure to the disease,” explained team member Dr Maurizio Facheris. The study was the first study of its kind to be presented at the annual convention of the American Academy of Neurology, and was selected as among the top 5% of over 2,000 articles received.

In the not-too-distant future, perhaps the tobacco plant may become as well known for keeping us healthy as it is for causing illness. In June last year, a scientist at the Hebrew University of Jerusalem succeeded in producing a replica of human collagen from tobacco plants – an achievement with tremendous commercial implications for use in a variety of human medical procedures, including in surgical implants and many wound-healing devices in regenerative medicine.

And, in March 2010, UK scientists announced the development of a genetically modified strain of tobacco that helps temper the damaging effects of toxic pond scum, scientifically known as microcystin-LR, which makes water unsafe for drinking, swimming, or fishing. This plant could serve as a major tool for helping keep water sources safe to use, especially in developing nations.

Puncturing the theory
Qi or energy. Sounds harmless enough. But wait, researchers are now arguing that this ancient healing practice has resulted in the emergence of a new clinical syndrome in the 21st century – acupuncture mycobacteriosis.

Professor Patrick Woo and colleagues from the University of Hong Kong describe the number of reported cases of acupuncture-transmitted diseases as “the tip of the iceberg”. Writing in the BMJ in March 2010 they called for funding to introduce proper infection control guidelines to tackle this growing problem.

While most patients recover from infections, says Prof Woo, 5-10% of the reported pyogenic bacterial infections end up with serious problems including joint destruction, multi-organ failure, flesh-eating disease and paralysis.

The 'Devil's Brew'
Multitudes of people worldwide begin each day with a cup of steaming hot coffee. Although it is sometimes referred to as ‘the devil’s brew’, coffee contains several nutrients, including calcium, as well as hundreds of potentially biologically active compounds, such as polyphenols, that may promote health.

Scientists are now reporting new evidence that drinking coffee may help prevent diabetes and that caffeine may be the ingredient largely responsible for this effect. Their findings appeared in the Journal of Agricultural and Food Chemistry in June last year.

In addition, two articles published in the April 2010 issue of the American Journal of Clinical Nutrition report results of two studies that support the potential health benefits of coffee.

The studies by Kempf and Sartorelli, respectively, revealed that coffee consumption may have beneficial effects on subclinical inflammation and HDL cholesterol, and also that caffeine intake is associated with a statistically significantly lower risk of diabetes.

D for Damage
Vitamin D is quickly becoming the ‘go-to’ remedy for treating a wide range of illnesses, from osteoporosis to atherosclerosis. However, new evidence from a US study suggests that supplementing vitamin D in those with low levels may have different effects based on patient race and, in black individuals, the supplement could actually do harm.

The study, which appeared in the Journal of Clinical Endocrinology and Metabolism in March last year, is the first to show a positive relationship between calcified plaque in large arteries, a measure of atherosclerosis, and circulating vitamin D levels in black patients.

“In black patients, lower levels of vitamin D may not signify deficiency to the same extent as in whites,” said the study’s lead investigator, Dr Barry Freedman, chief of the section on nephrology at the Wake Forest University School of Medicine in North Carolina. “We should use caution when supplementing vitamin D in black patients while we investigate if we are actually worsening calcium deposition in the arteries with treatment.”

Brain waves
There has been much controversy about whether electromagnetic waves from mobile phones cause brain cancer. Some researchers argue that the risk of glioma (40% of all brain tumours) doubles after 10 or more years of mobile phone use. However, others contend that since the overall lifetime risk of developing a brain tumour of any type is less than 1%, any doubling of this risk would still be very low.

And now the millions of people who spend hours every day on their mobile phones may have a new excuse for yakking. A surprising new study in mice provides the first evidence that long-term exposure to electromagnetic waves associated with mobile phone use may actually protect against, and even reverse, Alzheimer’s disease.

The study, led by University of South Florida (USF) researchers at the Florida Alzheimer’s Disease Research Center (ADRC), was published in January last year in the Journal of Alzheimer’s Disease.

“It surprised us to find that cell phone exposure, begun in early adulthood, protects the memory of mice otherwise destined to develop Alzheimer’s symptoms,” said lead author Gary Arendash, PhD, USF Research Professor. “It was even more astonishing that the electromagnetic waves generated by cell phones actually reversed memory impairment in old Alzheimer’s mice.”

“Our study provides evidence that long-term cell phone use is not harmful to brain,” another author remarked. “To the contrary, the electromagnetic waves emitted by cell phones could actually improve normal memory and be an effective therapy against memory impairment”

A little of what you like
Though often tagged with a disclaimer, studies that tell us to eat, drink, inhale and generally indulge in ‘bad stuff’ are music to our ears, particular after a holiday season of requisite guzzle and gorge. Perhaps the compulsory January detox can be abandoned after all? Certainly, the impulse is to plough ahead and enjoy these bad-for-you remedies, in moderation of course, at least until the next study inevitably overturns the research.



Tuesday, February 1, 2011

Female Genital Mutilation in Ireland

The young migrant woman sitting across from her doctor has suffered one of the most horrific tortures imaginable. Her smile and relaxed conversation belie her daily discomfort, the agony of her monthly cycle and the enduring nightmare of the day she was held down while a woman cut way her clitoris and part of her labia and then stitched her closed. She was six years old.
Now, in her new home in Ireland, her doctor and others close to her may never know of this most intimate violation, which could seriously compromise her health, both physically and psychologically.
There are thousands of similar stories from women and girls residing in Ireland who have undergone Female Genital Mutilation (FGM). New figures released to Scope show that their numbers are increasing, from 2,585 in 2006 to more than 3,170 last year. This escalation has led to urgent calls for legislation to protect children in practicing communities in Ireland and for more awareness among health care personnel, particularly in the obstetrical field.
FGM involves removal of either a part or the whole of the female external genital organ for cultural, traditional or any other non-medical reasons. This is global phenomenon that has claimed its casualties mostly from Africa and countries of the Middle East.
Also referred to as female genital cutting or female circumcision, this brutal procedure is most commonly performed between the ages of four and eight, although it can take place at any age from infancy to adolescence, usually without benefit of anaesthesia, surgical implements or sterile surroundings.
Infection rates are high, and other immediate complications include post-operative shock and bleeding. Some girls do not survive but those who do will live with the emotional and physical damage, including chronic infections of the bladder and vagina, dysmenorrhoea, childbirth obstruction and obstetric fistula.
AkiDwA, the African and Migrant Women’s Network in Ireland, hopes to mark it’s tenth anniversary this year with the introduction of new legislation offering explicit legal protection against FGM in Ireland, while also making it a criminal offence to take a child out of Ireland to have this barbaric procedure performed in their family’s native country.
According to the Department of Justice, Equality and Law Reform, the Non-Fatal Offences Against the Person Act 1997 criminalises the practice of FGM in Ireland. However, many are concerned that this legislation is not sufficient to protect the 11,500 women and girls residing in Ireland from communities that widely practice FGM.
The Department of Health is planning to bring newly drafted legislation specifically banning FGM to the Dail in the New Year. Scope was told that the new Bill will make illegal the sending or taking of these children to another country for FGM, a scenario not covered by the 1997 Act, which may also be flawed in terms of outlawing possible cases of FGM in Ireland.
For example, it is not clear whether a defense of consent could be pleaded in a case of FGM under the 1997 Act. Adolescent girls and women very often agree to undergo FGM because they fear the non-acceptance of their communities, families and peers. Or, in the case of a minor, that her parents had given consent on her behalf.
A spokesperson for the Department of Health stresses that Minister Mary Harney is committed to publishing the new FGM legislation. But with the country facing into a general election and the economy in disarray, genuine concerns abound that the promised new laws may be lost in the ensuing political quagmire.
Alwiye Xuseyn
“This legislation is very important to our work,” says Alwiye Xuseyn, Migrant Women's Health Officer, AkiDwA. “We are putting all our eggs in one basket, and that basket is this new legislation. It will support our work with health care professionals and the practicing community to protect children and women at risk.
“There are a lot of women from practicing communities living in Ireland and we need to educate them and their community that genital mutilation is not what we should want for our daughters.
“To do this we need to get the help of health professionals and educators in Ireland. We need to have this legislation to show them that it is a real problem in Ireland, that our Government recognises the real risk to our children; that they must help.”
Dr Andrea Nugent, a consultant obstetrician and gynaecologist at Dublin’s Coombe Hospital and former course director of the MSc in women’s health at the RCSI, agrees that having legislation would bring this harrowing issue to the forefront.
“Right now FGM it is very much an undercover topic. It is an issue that most of us are unfamiliar with in Ireland. Often our patients will never disclose that they have had this procedure done, for fear of being harshly judged, or maybe it is a cause of embarrassment, or perhaps they don’t even know that they are any different from other women because they were mutilated as such a young age
“We have to protect women and girls of practicing communities in Ireland from being taken back to their country of origin to have this harmful procedure done to them, or even to have it done within the bounds of Ireland.”
Dr Nugent is not aware of any cases of FGM
Comfort Momoh
Dr Comfort Momoh, an international expert on FGM, who established the African Well Woman’s Clinic at Guy's & St Thomas's Hospital in London, says she sees over 400 women and girls every year at her clinic with FGM related problems such as flash backs, memories, recurrent urinary infection and difficulties during pregnancy and childbirth. 
“Obviously in summer we get really anxious,” she adds “All activists and professionals working around FGM get anxious because this is the time that families take their children back home. This is the time when all the professionals need to be really alert.”
“My fear is that what is happening in the UK will eventually happen over here,” cautions Dr Nugent. “Right now in Ireland there is nothing to stop a parent taking their young daughter back to their native country to have this done. There is no specific legislation to stop them arranging these “cutting parties” in Ireland. I think if and when that penny drops and people realise there are legal loopholes that could allow them to escape prosecution; it could become very dangerous for the girls in Ireland. The new legislation must be introduced without further delay.”
While this new law is important, several groups including AkiDwA, the Women’s Health Council and the Children’s Rights Alliance in Ireland believe it must be presented as a protective measure which should be promoted through a delicate balance of law enforcement, public education, and dialogue in order to protect children and future generations of women.
AkiDwA sees the medical profession as having a key role in this effort, both as change agents in attempting to convert advocates of FGM, but also as doctors capable of responding effectively to the consequences of FGM in women presenting to their services.
However, interviews and workshops run by AkiDwA revealed that these women felt unable to articulate the significant and enduring health impacts of FGM to service providers they encountered.
To address this, AkiDwA commenced an FGM health project in 2008 examining the very specific and urgent health-care needs of women who have undergone FGM and who now reside in Ireland. It soon became apparent that there were few resources on this issue for Irish health-care professionals.
This led to a successful collaboration between the Dr Nugent, her RCSI MSc Women's Health students and AkiDwA, to compile the first ever Irish handbook on FGM entitled “Female Genital Mutilation: Information for Health-Care Professionals Working in Ireland”.
This “tool-kit” was launched in January 2009 and almost 2,000 copies of the handbook have been distributed in Ireland and internationally. AkiDwA has just received funding for a second print run.
Dr Nugent explains: “On the masters course we have a broad mixture of students who are GPs, gynaecologists obstetricians and midwives. They each approached the subject of FGM from different angles and brought a real multidisciplinary aspect to the document.
“FGM is not well known in Ireland. In fact, about 75 % of the course students had never heard of it, or had heard of it in passing but didn’t fully understand the repercussions for the woman or for their medical practice.
“We wanted to make the kit very streamlined so that if you had a patient in front of you, you could access it online and it would address the very immediate issues and then give you the reference for future referral should you need it.”
The resource pack also contains a pronunciation guide and terms in the specific languages of countries where FGM is practiced; a break-down of gynaecological, obstetric, psychological and health issues; a map of FGM prevalence across Africa, and a removable image sheet designed to be used with a patient to illustrate FGM typologies.
To date, over 560 health-care professionals have attended FGM training organised by AkiDwA, including classes held in the Dublin maternity hospitals.
Dr Andrea Nugent
“It is so important to understand the intricacies of dealing with this problem,” says Dr Nugent. “A doctor needs to be able to approach it delicately and in an appropriate manner. If you believe that your patient may have been subjected to FGM it is a good idea to ask. Most people don’t have a problem if you introduce the subject by saying: ‘I understand in your country the rates of female circumcision are high, has that happened to you or do you know?’ There will be times that the patient does not know this has happened to them.
“It’s also important that when you have girls from these practicing communities who come home from their holidays and are having pelvic or genital pain, to ask if anything like this has happened to them.”
Service providers, encountering the topic of FGM for the first time, may have quite an initial emotional reaction towards FGM.
“We can be shocked by a lot of things that we come across day by day in the medical profession but it is very important not show that disapproval or judgement in your expression or in your attitude.   This type of behaviour will only push the patient away. They need to feel like there are open lines of discussion available for them to discuss their problem,” Dr Nugent advises.
The health problems a girl can experience are largely dependent on the severity of the procedure: girls and women who undergo more extensive ‘cutting’ in type II and type III (the latter includes infibulation), are likely to experience more severe health complications, but health consequences for type I have also been widely reported.
When infibulation (Type III) is performed, the opening left in the genital area is too small for the head of a baby to pass through. Failure to reopen this area can lead to death or brain damage of the baby, and death of the mother.
A study published in 2006 by the World Health Organization (WHO) found that women who have who have been subjected to Type III FGM have on average 30% more cesarean sections and there is a 70% increase in suffering postpartum haemorrhage.
Researchers also found there was an increased need to resuscitate babies whose mother had had FGM (66% higher in women with FGM III). The death rate among babies during and immediately after birth is also much higher for those born to mothers with FGM: 15% higher in those with FGM I; 32% higher in those with FGM II, and 55% higher in those with FGM III).
“It is quite common for women with FGM not to access antenatal services in a timely fashion, or to go through their pregnancy without a vaginal exam. It would not be uncommon that the obstetric or midwifery staff would not know that a woman has had this procedure until time of delivery. There is anecdotal evidence of this even in Irish hospitals. It is not frequent, but it has happened”, says Dr Nugent.
In these cases experienced surgeons should be consulted according to the injury so that the patient can be opened for delivery. Medical representatives bodies in Ireland, the UK and abroad stipulate that the woman must not be reinfibulated.
AkiDwA has plans to develop a multi-disciplinary network of counsellors and doctors who are appropriately trained to help women with FGM. At present, there is an informal arrangement with the Rotunda Hospital, where they have referred women with FGM to be defibulated, either prior to delivery or as a life choice.
“Communities that practise FGM often believe they are doing the best for their daughters. There are often pressures from home within some practicing communities that could facilitate its continuation in Ireland,” cautions Dr Nugent. “We need to develop sensitive and effective intervention strategies to support parents to abandon the practice. That’s why I’m really proud of the work that AkiDwA has done to increase awareness of a very difficult subject, and I do believe that awareness around FGM is increasing in Ireland. We may yet see a formal training course on FGM in our medical schools in the future.
“As with most things, only when we end the negativity of silence around a difficult subject,  can positive changes come about.”

(Author's note: since this article was published in early January, the now former Minister for Health Mary Harney presented the Criminal Justice (Female Genital Mutilation) Bill 2011 to Seanad Éireann on Tuesday 18 January. This is a very welcome initial stage towards new legislation.  But there is still a long way to go before the Bill can be enacted into law (four more stages in the Seanad and then four additional stages in the Dail). Hopefully the new Government will deal with this important legislation expediently.


Why is FGM practiced?
 
The origin of FGM are largely unknown, but the practice predates contemporary world religions. Among communities that practise FGM, the procedure is a highly valued ritual, whose purpose is to mark the transition from childhood to womanhood.
The function of this practice, whether mild or severe, is ultimately to reduce a woman's sexual desire, and so ensure her virginity until marriage.
The more extensive procedure, involving stitching of the vagina, has the same aim, but reducing the size of the vagina is also intended to increase the husband's enjoyment of the sexual act.
Certain communities carry out FGM for religious reasons, believing that their faith requires it; this is particularly true of Muslims who adhere to the practice. Other communities consider female genitalia to be ugly, offensive or dirty, and thus the removal of the external genitalia makes a woman more hygienic and aesthetically pleasing.
Some even subscribe to the absurd notion that the clitoris contains powers strong enough to cause harm to a man’s penis or to damage a baby during childbirth.
This cruel practice persists today - even in African countries where recent legislation has made it illegal - primarily because of the strongly held belief that a girl is not marriageable if she has not undergone FGM, which has serious impacts on her future financial and social status.


WHO FGM Classification:


Type I
Partial or total removal of the clitoris and/or the prepuce (clitoridectomy).
Type II
Partial or total removal of the clitoris and the labia minora, with or without excision of the labia majora (excision).
Type III
Narrowing of the vaginal orifice with creation of a covering seal by cutting and appositioning the labia minora and/or the labia majora, with or without excision of the clitoris (infibulation).
Type IV
All other harmful procedures to the female genitalia for non‑medical purposes, e.g. pricking, piercing, incising, scraping and cauterisation.


Prevalence

The World Health Organization estimates that between 100 and 140 million women worldwide have undergone female genital mutilation (FGM), and three million girls are at risk of FGM in Africa annually. This equates to 6,000 women and girls undergoing FGM daily in the world.
The European Parliament estimates 500,000 girls and women living in Europe are suffering lifelong consequences of FGM.
A 2007 study by the UK organisation FORWARD estimated that nearly 66,000 women with FGM were residing in England and Wales in 2001. The study speculated that this number would likely increase in the years thereafter. The study also found that nearly 21,000 girls in England and Wales aged eight and younger were at risk of FGM, and 11,000 of this cohort were likely to have already undergone some type of FGM.


Poor level of FGM awareness among doctors

A groundbreaking study in Spain identified a poor level of awareness among primary health care professionals in respect of female genital mutilation (FGM). Less than 40% correctly identify the typologies and less than 30% know in which countries it is practiced - in spite of the fact that 82% of them attend to a sub-Saharan African population, especially Senegal and Gambia, where this practice is performed on 20% and 80% of the female population, respectively. What is more, 18% of doctors showed no interest.
This project, carried out by the Interdisciplinary Group for the Prevention and Study of Detrimental Traditional Practices from the Autonomous University of Barcelona (AUB), shows that the cases of FGM detected in primary health care during a three-year period have tripled, while awareness by health care professionals has not increased proportionally.

International Day of Zero Tolerance

The United Nations has designated 8 February as the "International Day of Zero Tolerance of Female Genital Mutilation".
Increasingly, the international community is identifying FGM as a harmful traditional practice and a violation of the fundamental human rights of girls and women. Global efforts to bring an end to the custom of female genital cutting are on the rise, with many nations putting in place legislation against the practice, and a number of international organisations making the elimination of FGM a priority.
END FGM is a European campaign, led by Amnesty International Ireland, working in partnership with a number of organisations in EU member states.
By lobbying EU institutions, the campaign is committed to ensuring that Europe adopts a definitive strategy to end FGM and provide protection to women and girls who flee their countries for fear of being mutilated.

Monday, January 31, 2011

A prescription for prayer?

Is prayer an effective and important element in a person’s healing process? Can the prayers of a priest in an American diocese or a rabbi at Jerusalem’s Western Wall really influence the health of a cancer patient in a Dublin hospital?

A new international study of healing prayer, which suggests that prayer for another person's healing just might help, has re-opened the debate on the hotly contested question: can prayer heal?

Investigators in the latest US-led study say a crucial difference between their research and previous studies in this area is its key focus on proximity – the person praying is physically near the person being prayed for. This, they claim, could make all the difference.

The new research, titled "Study of the Therapeutic Effects of Proximal Intercessory Prayer (STEPP) on Auditory and Visual Impairments in Rural Mozambique," measured surprising improvements in vision and hearing after Proximal Intercessory Prayer (PIP) was administered.

"We found a statistically significant effect of PIP for the population of both those with auditory and visual impairments," says study lead author Dr Candy Gunther Brown, an associate professor in the Department of Religious Studies at Indiana University in Bloomington. "We didn't generally find that people who were totally deaf or blind to start with ended up with 20/20 vision and perfect hearing, but those with moderate to severe impairments when tested before the intervention, had a much, much improved threshold."

Scientific research on intercessory prayer has in recent decades generated a firestorm of controversy, with critics charging that attempts to study the efficacy of prayer are inherently unscientific and should be abandoned because the mechanisms are poorly understood and too complex to measure. Not surprisingly, several research efforts have produced contradictory findings.

The title of the current study makes reference to the widely discussed 2006 "STEP" (study of the therapeutic effects of intercessory prayer) research, led by the renowned Dr Herbert Benson of Harvard Medical School, which evaluated the impact of such prayer on patients recovering from coronary artery bypass graft surgery. It concluded that prayer itself had no effect, but certainty of receiving prayer adversely affected health.

However, Dr Gunther Brown points out that the STEP study, like most previous research on the healing power of prayer, focused on distant intercessory prayer (DIP) rather than proximal prayer.

"If empirical research continues to indicate that PIP may be therapeutically beneficial, then - whether or not the mechanisms are adequately understood - there are ethical and non-partisan public policy reasons to encourage further related research," she urges. "It is a primary privilege and responsibility of medical science to pursue a better understanding of therapeutic inventions that may advance global health, especially in contexts where conventional medical treatments are inadequate or unavailable.”

Dr Candy Gunther Brown
Dr Gunther Brown’s research is published in the September 2010 issue of the Southern Medical Journal. She and her colleagues studied the activities of the healing groups Iris Ministries and Global Awakening in Mozambique and Brazil because of their reputation as hotspots of specialised prayer for those with hearing and vision impairments.

The researchers used an audiometer and vision charts to evaluate 14 rural Mozambican subjects who reported impaired hearing, and 11 who reported impaired vision, both before and after the subjects received PIP. The study focused on hearing and vision because it is possible to measure them with an audiometer and vision charts, allowing a more direct measure of improvement than simply asking people whether they feel better.

Subjects exhibited improved hearing and vision that was statistically significant after PIP was administered. Two subjects with impaired hearing reduced the threshold at which they could detect sound by 50 decibels. Three subjects had their tested vision improve from 20/400 or worse to 20/80 or better.

Dr Gunther Brown recounts that one subject, an elderly Mozambican woman named Maryam, could not see two fingers held up just one foot in front of her when she arrived for a Pentecostal prayer intervention in her village. Nor could she see the eye chart from a similarly close distance.

But after a healer at the evangelical meeting laid hands on her and prayed for less than a minute, Maryam was able to not only see the five fingers held up in front of her but could count them as well. The eye chart also came into view, with Maryam able to read down to the 20/125 line.

Supplemental digital content for the published study reports on a follow-up study with similar findings conducted by the same researchers in urban Brazil.

While Dr Gunther Brown doesn’t discount that some of the results may stem from a placebo effect, the magnitude of measured effects exceeds that reported in previous suggestion and hypnosis studies.


She has observed that many people who turn to divine healing also try "holistic" approaches such as chiropractic, acupuncture, yoga, homeopathy, and Reiki. "When people are sick," she remarks, "many look for healing wherever they can find it. They really don't care about philosophical or theological consistency."

Irish bio-ethicist Dr Donal O'Mathuna has explored this issue in great detail, conducting a thorough review of research into the healing power of prayer for a book he co-authored on “Alternative Medicine” for the Christian Medical Association in the US.

Although one might not immediately associate prayer with the myriad of complementary medical therapies available, Dr O’Mathuna says it is one of the most frequently reported alternative treatments used.

Several prominent surveys, led by Professor of Medicine David Eisenburg, Harvard Medical School, which examined trends in alternative medicine use in the US, repeatedly found that prayer was by far the most commonly reported alternative therapy, as defined by the researchers.

“Yet they would then leave that out of their overall conclusion because, if they incorporated that statistic, they would effectively be saying that about 85 percent of Americans use alternative medicine,” says Dr O'Mathuna, who is Senior Lecturer in Ethics, Decision-Making & Evidence in the School of Nursing, Dublin City University.

“I think the recent interest in the healing power of prayer has arisen in part because when you define alternative medicine as broadly as is has been defined, prayer falls into that definition. But the traditional secular or non-religious approach to medicine, as it has become, would prefer not to deal with the issue of spiritual and sacred prayer.

“Medicine is very scientific and prayer for healing is both very difficult to define and very difficult to measure, and yet it is so important with the general public. More important with the patients than perhaps secular medicine wants to acknowledge or is aware of.”

Dr Donal O'Mathuna
Dr O'Mathuna points out that research on prayer is not a recent phenomenon. In 1872, Carlow native John Tyndall, a professor in London, proposed having all Christians pray for patients in a particular hospital for a number of years. Tyndall was sceptical of prayer's efficacy and anticipated no differences in health outcomes.

Although his proposed experiment was never carried out, it created much controversy, raising methodological, theological and ethical concerns that still apply today. One response published by Sir Francis Galton, a cousin of Charles Darwin, boldly observed that royalty and clergy, for whom a long life is frequently prayed for, had shorter life expectancies than other gentry or professionals.

During the course of researching his book, Dr O'Mathuna identified approximately 30 scientific studies on prayer for healing conducted over the last couple of decades. But he remarks that, on closer examination, from a methodological perspective, many of these suffer from some clear limitations.

Dr Benson’s STEP study, along with a number of other research endeavours in this area, examined the efficacy of different prayer approaches from various religious traditions by combining the different types together.

“To me, this is a really weak way to design scientific research; it’s like trying to study the effectiveness of a drug but doctors can administer it in which ever way they feel like, and at what ever dose they want.

“Other researchers have taken a different approach and used a particular prayer from a particular religious tradition. For example, the first most significant study was a high-quality, randomised controlled trial published in 1988 by Dr Randolph Byrd, who used only born again Christians practicing daily devotional prayer and actively involved in Christian fellowship. He evaluated the effects of distant intercessory prayer in about 400 coronary care unit patients.

“But Byrd had 27 or so different outcomes that they measured to see whether or not there was a difference between the intercessory prayer group or a control group. This is another methodological minefield because the more measures you use, the greater the possibility that, just by pure chance, you find significant differences between the groups.

“Byrd found in some of the results that there was a significant difference but in the majority of measurements there wasn’t a difference. Of course, when the study was picked up, the press tended to focus on those significant improvements but left out the fact that there were many results that didn’t find any difference.

“From a methodological point of view, you would want to have one or two specific primary outcomes and they should be the focus as to whether there is a significant difference.”

Of those prayer studies that adopted this approach, Dr O'Mathuna’s says that only one showed dramatic improvements in the prayed for group, compared to the control group. The controversial findings, published in the September 2001 issue of the Journal of Reproductive Medicine, revealed that a group of women who had people praying for them had a 50 percent pregnancy rate compared to a 26 percent rate in the group of women who did not have people praying for them. None of the women undergoing the IVF procedures knew about the praying.

However, this hopelessly flawed Columbia University “miracle” study has since been discredited. Critics of the study question its methodology - involving several "tiers" of people, some praying for the study subjects and others praying that the prayers would be effective - as well as the fact that no informed consent was obtained.

Since its publication, the lead author, Dr Rogerio Lobo, has withdrawn his name from the paper, ostensibly because of his limited relationship to the study. Furthermore, co-author Daniel Wirth, a lawyer who designed and allegedly conducted the study, was sentenced in November 2004 to five years in prison after pleading guilty to conspiracy to commit mail and bank fraud. FBI papers filed during the case also show that Wirth has used a series of false identities over the years. And in February 2007, the third author, Dr Kwang Cha was charged with plagiarism of a study he published in 2005.

“Although there is nothing conclusive to show that the results of this study are fraudulent, there are huge question marks over its methodology and the credibility of the authors,” Dr O'Mathuna offers.

Commenting on the new STEPP research, examining proximal intercessory prayer, he highlights the absence of a control group as an obvious disadvantage. “That’s going to suffer from the limitations of any before and after study. They may show real differences in a person’s life but they’re not going to be able to show what the causes of those differences were.”

However, he adds: “To me [the STEPP] study confirms the importance that medicine is a relational professional. Of course the doctor or surgeon’s skill is very important, but for medicine to really heal people you need to have the whole relational, personal aspect taken care of. Whether it’s the surgeon or the nurse at the bedside, family members or community to take care of those needs, all of that is what these types of studies are confirming.

“From a Christian perspective, clinical trials cannot control for the intervention of God to heal patients in one study group or the other. Also the Bible teaches that God may answer prayers, not by granting a healing but by giving the patient greater strength and greater faith.

“Perhaps, if prayer research could measure the outcomes of people's ability to deal with illness and tragedy, we could expect significantly positive results.



The people behind the studies of prayer and healing



Dr Wendy Cadge
A novel social history of intercessory prayer studies has suggested that these clinical investigations actually say more about the scientists conducting the studies than about the power of prayer to heal.

Collectively, this 2009 analysis of four decades of prayer studies provides a fascinating snapshot of changing religious demographics, evolving ideas about the relationship between religion and medical science, and the development of the clinical trial as the gold standard of biomedical research.

"I do not know why physicians and scientists conducted these studies," said the research author and Brandeis University sociologist Wendy Cadge, an expert on the intersection of religion and medicine in contemporary American society, "but personal religious beliefs appear to have played a role, along with curiosity."

The earliest studies undertaken in the sixties were based exclusively on Protestant prayers, while more recent studies, reflecting growing social awareness of other religions, combine Christian, Jewish, Buddhist and other prayers, Dr Cadge observed.

"With double blind clinical trials, scientists tried their best to study something that may be beyond their best tools," she said, "and reflects more about them and their assumptions than about whether prayer 'works.'"

Reflecting a recent shift toward de-legitimising studies of intercessory prayer, recent commentators in the medical literature concluded: "We do not need science to validate our spiritual beliefs, as we would never use faith to validate our scientific data."



The healing power of prayer


Unlike medical practitioners in the East, many physicians in the West argue that the healing power of science is far superior to, and often incompatible with, the healing power of prayer. This is not the view of Dr Larry Dossey, one of the world's foremost authorities on the synergy of physical health and spiritual awareness, and former chief of staff of Medical City Dallas Hospital.

Dr Dossey has penned several books on the health benefits of prayer and spirituality. His 1993 New York Times Bestseller, Healing Words, details the enormous body of data showing, he claims, that the act of prayer can greatly affect the practice of medicine. Prayer can help with high blood pressure, asthma, heart attacks, headaches, and anxiety, he writes. Moreover, it could alter enzyme activity, blood cell growth, and the germination of seeds.

In his 1999 book, Reinventing Medicine, Dr Dossey presents a compelling argument for merging awareness of consciousness into the practice of modern medicine.

He contends that we are entering an era of the "non-local mind" - that consciousness can accomplish healing outside the confines of one's brain and body, influencing distant events, people and circumstances. He does not discount the efficacy of medical intervention so much as he anticipates an enlightened model of partnership between patient and healer.

Popular spirituality author and medical doctor Deepak Chopra maintains that prayer experiments are supporting what he's been saying all along: There are healing forces in nature that science is only beginning to understand.

He remarks: "At the moment, I would agree that some of these studies are tentative, that we should be cautious in the way we interpret the results. But the studies are encouraging enough that we should pursue them, because if we don't, we may have missed one of the most amazing phenomena in nature."




Wednesday, January 26, 2011

Building bridges for tomorrow’s medicine


More than 16,000 new cases of cancer are diagnosed in Ireland each year. Despite aggressive treatment, for some of these patients, current cancer therapies will not enough to save their lives. But there is hope on the horizon. Buzzwords like “translational research”, “personalised medicine” and “smart drugs” now form part of a more optimistic lexicon describing new potential for effective, targeted approaches to cancer therapy.
Translational medical science is an exciting and rapidly evolving domain, and no where more so than in cancer research, which is now reaping the benefits of the translational approach to research. The primary goal of “translational” research is to integrate discoveries in the laboratory with clinical trials and observational studies in hospital and outpatient settings - taking pioneering developments more rapidly from the “bench-to-bedside”.

A team approach
A central strength is that translational research has fostered extensive cooperation between basic researchers, clinical investigators and the pharmaceutical industry. In cancer medicine, this broad-based partnership is generating many new and innovative, targeted treatments that work more effectively and with less toxicity.
This emerging field presents a promising future for cancer medicine, not only in terms of discovering potential cures, but also developing new diagnostic and prognostic tools as well as less toxic therapies that could add decades to a cancer patient’s life.
All Irish universities now have state of the art biosciences and translational research centres which integrate with the clinical research centres in Irish hospitals. For example, Molecular Medicine Ireland links five medical schools and their associated academic hospitals in a partnership that translates “eureka’ events in the lab into improved diagnostics and therapies for patients.

ICORG
A driving force behind many of the Irish translational cancer research endeavours is ICORG - the All-Ireland Co-operation Oncology Research Group. ICORG is a national network of over 400 clinical and laboratory-based cancer researchers which has built up an enviable international research reputation over the last 13 years, securing affiliations with some of world’s leading cancer research centres and companies in the US and Europe engaged in clinical and translational cancer research.
In so doing, ICORG has also secured very early access for Irish cancer patients to the latest and most novel therapeutics available anywhere in the world.
For instance, ICORG is playing a pivotal role in the development and evaluation of a new test which may permit the individualisation of treatment of early stage (Node negative, estrogen receptor positive) breast cancer. This TAILORx trial has recently completed a global enrolment of over 11,000 breast cancer patients with the largest single recruitment site being in Ireland.
The study is evaluating the ability of a revolutionary new 21 gene test, called Oncotype Dx, to predict and distinguish patients who are likely to need more aggressive therapy from those who’s cancer is unlikely to spread and can therefore be saved the toxicity and side effects of this form of treatment.
Due to the huge clinical and patient interest in this molecular-based diagnostic tool and the diagnostic value of the test, a leading Irish insurance company announced late last year that it would cover the €3,180 test cost in all of its health insurance plans.

At the interface of basic and clinical research
Dr Robert O’Connor
“There’s no question that translational medicine is really the only way forward now in identifying better treatments and diagnostic tools for cancer, and our clinicians and scientists in Ireland are very active in this field,” confirms Dr Robert O’Connor, who is Biological Science lecturer and a Senior Programme Leader in Translational Cancer Pharmacology, at the National Institute for Cellular Biotechnology in Dublin City University (DCU).
“Translational research is at the interface of clinical and laboratory science. It focuses on developing new and safer medicines and diagnostic tools. We know clinically and scientifically that cancer is a very complex set of diseases. It’s not a specific disease; each cancer is individual to each patient. While some breast cancers, for example, respond very well to treatment in some women, other breast cancers don’t, even if the cancer is at the same stage and looks identical in other ways.
“This is where translational medicine is helping us to better individualise treatment, it’s helping to identify the molecular characteristics that give us the most information about that form of cancer, what is likely to happen to it and what treatments will be most effective.”
This is a two-way process with scientists and clinicians using advanced laboratory techniques to gather basic information on the important fundamental mechanisms underlying cancer and governing growth; progression and treatment response using cultured cell models, clinical samples from patients, and observing differences between normal and disease states, expression of disease biomarkers and response to therapy.
Such work is only meaningful when conducted in partnership with specialist clinical resources, which treat patients in a carefully controlled manner using international standards of treatment and research to collect clinical, diagnostic information and provide high quality patient samples.
One of the labs at the National Institute for Cellular Biotechnology, DCU
This direct collaboration between clinical staff and lab researchers promotes the discovery of disease biomarkers and drug targets that is resulting in more rational drug design, and more effective and safe treatments that can be quickly and efficiently introduced into medical practice via clinical trials.
“It’s taking laboratory research directly to patients. Where putative markers have been identified, you then want to see if it is a valid marker in ‘real’ cancer because, as scientists, we can develop a nice hypothesis in the lab but cancer, in reality, is a lot more complex in the patient,” says Dr O’Connor.
This approach to coordinated translational research has led Irish researchers identifying important new diagnostic markers such as the proteins urokinase plasminogen activator and plasminogen activator inhibitor 1, whose significance in breast cancer treatment was first identified by Professor Joe Duffy, St Vincent’s University Hospital Dublin.

Focusing on emerging anti-cancer drugs
“Until about ten years ago any investigation of a new drug would have gone through a standard development process. A new drug for breast cancer would have gone into a clinical trial of breast cancer patients; the trial would run its course over months or years and after an evaluation was conducted, the researchers would report on the response rate in the whole patient population.
“Nowadays, translational medicine is allowing us to take a closer look at the individual tumours within those breast cancer patients. We can look at additional information to see if there is more we can learn about the treatment, for example, can we identify markers that will tell us which patient will respond or which patients will not? And can we find markers that will tell us early on that the patient has responded to treatment?
“This is very important because many of our tools in clinical cancer research only give information on treatment response several months after treatment begins. This is extremely valuable time as, in some advanced malignancies, it is all too common for the first type of treatment given to have limited effect and therefore patients may be exposed to side effects and toxicity while the agent itself is not helping shrink their tumour and this may only become evident months later. Translational research is providing tools that indicate upfront which patients should or should not receive particular treatments and more rapidly identifying those responding to treatment - and should therefore continue - from those nor responding and should therefore move to another treatment option.
“So translational medicine tries to identify new targets for treatment, new markers that will indicate whether treatment is working or not, and new ways of conducting trials,” he explains.

Biological markers
Biomarkers are molecular characteristics of precancerous or cancerous cells that can aid in predicting cancer development, behaviour, and prognosis. Biomarkers can be grouped into three major categories: diagnostic, prognostic, and predictive.
Diagnostic markers aid in diagnosing disease, such as measurement of the rate of change of PSA levels in prostate cancer or CA-125 in ovarian cancer. Prognostic markers, such as hormone receptors, angiogenic markers, growth factor receptors and proliferation markers, provide information about the likely clinical course of a disease. Predictive markers can help anticipate the course of a disease and how a patient may respond to particular types of therapy. Together with diagnostic and prognostic markers, predictive markers can help physicians formulate a more individualised treatment plan.
“Our clinical trials are moving now away from being focused purely on the anatomical type of cancer that a patient has, whether its breast or brain cancer, for example, to examining the cancer’s molecular characterisation,” says Dr O’Connor.
“It is an evolving area. In a lot of cases now we are starting to get a handle on some of those indicators. We are making discoveries now that may provide us with the tools in the not-too-distant-future to molecularly characterise a person’s cancer and identify the best possible treatment for that particular patient.”
An illustrative case is the identification in 1987 of the human epidermal growth factor receptor 2 (HER2) gene, which is present in about 20% of cases of invasive breast cancer.
Interestingly, the team which identified this protein is led by Professor Denis Slamon, at the UCLA Department of Medicine, who has since been collaborating closely with a number of Irish cancer research institutions to further research on breast cancer.
HER2 is part of a family of genes that play roles in regulating cell growth. Women whose breast cancer had more copies of the HER2 gene spread the fastest and had a worse prognosis.
“When it was originally discovered HER2 was a negative prognostic marker. If your breast cancer demonstrated the over expression of this marker there was a likely to be a poor outcome due to rapid growth of that tumour. But using translational research methods, treatments were developed specifically to target and inhibit the HER2 protein,” Dr O’Connor says. “In some cases it appears that this has given rise to cure, but in the majority of cases what it means is that patients can be given a much less toxic treatment over a long duration that will basically manage and control their breast cancer much more effectively.”
In another exciting development, progress has been made in a treating a particular subtype of lung cancer. In approximately 3 to 5% of Non Small Cell Lung Cancers NSCLC - the most common form of lung cancer - a gene called ALK-1 is found to have fused with another (EML4) and the product drives the growth of this tumour.
In these patients, a recent study found that 90% responded to treatment with a new ALK-targeting drug called Crizotinib. This response is all the more noteworthy as NSCLC generally responds very poorly to standard forms of treatment.
This initial success with Crizotinib is a good illustration of the ultimate goal for translational research; to marry the identification of specific tests, which characterise individual cancers with the novel agents and therapeutic strategies that will achieve high efficacy with minimal toxicity in that specific molecular form of cancer.

Building bridges to the medicine of tomorrow
Examples of other such successes are emerging with increasing regularity in other forms of cancer. This revolution in biotechnology and interdisciplinary collaboration has become critically important in adding to the armamentarium of anti-cancer therapies. Its potential is reflected in the fact that most of the clinical trials in Ireland run by ICORG have a translational component.
National Institute for Cellular Biotechnology, DCU
“Advances in this field can be a frustratingly slow sometimes for patients, their families and researchers. But conducing this research to the highest possible standards is essential, and this takes time,” Dr O’Connor notes. “In the lab we can get results relatively quickly, but clinical research often takes quite a bit longer, because of the complexities of cancer in patients and the vital safeguards that must be employed. It is very satisfying, however, for any researcher to see a hypothesis that developed in the lab, be taken to patients in Irish hospitals in a clinical trial and for any positive result to be found.
“On the negative side, very few people actually understand what translational medicine is and its unique importance in this field. It is only in the last two years that we have started to see funding agencies begin to specifically support this kind of research. The funding environment and the support structures in the hospitals and industry are also still in their infancy.”
Yet, translational research in recent years has yielded not only significant advances in cancer therapeutics but also improvements in the ability of doctors to predict the clinical course of a patient's disease based on individual tumour characteristics.
This collaboration of scientists and doctors, companies and patients, is vital in translating laboratory findings into clinically applicable therapies.
“Translational medicine is always a team approach; it’s never one individual,” stresses Dr O’Connor. “You can have a charismatic leader or advocate, vital for maintaining the momentum but in reality it’s always a team approach. Having good integration between the research nurses, the medical staff, the scientists, the regulatory authorities and pharmaceutical companies, that’s where we are really making advances in Ireland. We’re coming together as a group, a co-operative, and that allows us to do things in an exciting way that we just couldn’t do on our own.”

USEFUL Web links:

All Ireland Cooperative Research Group

The National Institute for Cellular Biotechnology
www.nicb.ie

Molecular Medicine Ireland

Translational research pioneer Professor Dennis Slamon

Further information on Crizotinib

HRB-SFI Translational Research Awards

Oncotype Dx breast cancer test
http://www.genomichealth.com/OncotypeDX/Index.aspx