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Monday, January 17, 2011

Congress affirms that regulations account for over 80% of drug development time

As a consequence of the increasing development times, new drugs often enter the marketplace with only a few years of patent life remaining. Consequently, manufacturers had to charge excessive prices for new drugs in order to make up their increasing research and development costs. To counter this trend, Congress passed the Waxman-Hatch Patent Restoration Act in 1984 to extend pharmaceutical patent life. Companies could recover up to half of the time lost to regulatory requirements, as long as their total patent life at time of marketing didn’t exceed 14 years. (Patents generally expire 17 years from the time of issuance or 20 years from date of patent filing, whichever is later.)

The Act estimated the “regulatory review time” as the number of years of clinical testing and FDA evaluation. When the Act was passed, the regulatory review time accounted for about 84% of drug development time. About two-thirds of the regulatory review time could be directly attributed to the 1962 amendments.

As a research scientist in drug discovery and development at the Upjohn Co., between 1976 and 1995, I was quite aware of the impact of increasing regulatory demands on drug development time. My colleagues and I joked that we spent so much time fulfilling the regulations that we had no time to discover new drugs to treat disease! However, as we’ll soon see, it’s no laughing matter: it’s a matter of life and death!

In 1992, the Prescription Drug User Fee Act was passed. This Act allowed pharmaceutical firms to pay “user fees” of hundreds of thousands of dollars to the FDA. The agency would then hire new examiners to expedite their review of the company’s new drug application. This process shaved about a year from the drug development process. As you can see from Figure 2, had this legislation not been passed, drug development times in the 1990s would have more than 15 years-greater than three times the average development time prior to amendment passage!

SOURCE




Hot flushes during menopause 'halves chances' of breast cancer

A dark cloud with a silver lining, apparently. The research methodolgy was a bit weak but the findings seem reasonable

Women who suffer hot flushes during the menopause may be half as likely to get breast cancer. Those whose lives are blighted by the symptoms of the ‘change’ seem to have significant protection against the disease later in life, say scientists.

The results of a study show the worse the hot flushes are, the lower a woman’s risk of developing the most common forms of breast cancer. It suggests the same hormone deficiency which causes severe menopausal symptoms also lowers the chances of developing a tumour.

It is estimated that women who suffer several hot flushes a day during the menopause have up to 40 per cent less oestradiol – a form of the hormone oestrogen. Oestrogen is known to play a central role in the development of some types of breast cancer.

The findings, by researchers from the University of Washington and the Fred Hutchinson Cancer Research Centre, both in Seattle, will bring some comfort to thousands of women who struggle to cope with the effects of the menopause.

It occurs when the ovaries stop producing oestrogen and progesterone, another female sex hormone, usually when a woman is in her early fifties. The most common symptoms are hot flushes and sweating attacks, affecting three in four women. Lasting three to six minutes at a time, these can happen dozens of times throughout the day.

At night, some women sweat so heavily they have to get up to change the sheets. Depression, mood swings, tiredness and headaches are also common symptoms.

The researchers, whose work was published in the journal Cancer Epidemiology Biomarkers and Prevention, recruited just over 1,000 women aged 55 to 74 who had been diagnosed with breast cancer.

Each volunteer was asked how badly they were affected by symptoms during the menopause and the results were compared with a similar sized group of cancer-free women.

Those who endured severe hot flushes, night sweats, depression and insomnia were up to 50 per cent less likely to go on to develop either an invasive lobular carcinoma or an invasive ductal carcinoma, the two most common forms of breast cancer.

In a report on their findings the researchers said: ‘This is the first study to report that women who experience menopausal symptoms have substantially reduced risk of breast cancer and that the severity of hot flushes is also inversely associated with risk. ‘A plausible explanation is that menopausal symptoms are a marker for hormonal changes relevant to the development of breast cancer.’

Every year, around 38,000 women in Britain are diagnosed with breast cancer, the equivalent of more than 100 a day. A woman has a one in nine chance of developing the disease at some point in her life.

A spokesman for Cancer Research UK said: ‘We already know hormones are linked to breast cancer risk. ‘Women who start their periods later, have more children, breastfeed, or have an early menopause have a lower risk. While it’s too soon to add menopausal symptoms to that list, more research will certainly help further our understanding of this area.’

SOURCE

Sunday, January 16, 2011

Beauty and brains DO go together! Study claims good-looking men and women have higher IQs

Another of the many positive correlates of IQ

Handsome men and women often appear to be blessed with lucky lives. Now research has shown they are cleverer than most people as well. Studies in Britain and America have found they have IQs 14 points above average. The findings dispel the myth of the dumb blondes or good-looking men not being very bright.

It appears that those already physically blessed attract partners who are not just good looking but brainy too, according to research by the London School of Economics. The children of these couples will tend to inherit both qualities, building a genetic link over successive generations between them.

LSE researcher Satoshi Kanazawa told the Sunday Times: ''Physical attractiveness is significantly positively associated with general intelligence, both with and without controls for social class, body size and health. 'The association between attractiveness and general intelligence is also stronger among men than among women.'

In other research on social standing, he found that middle-class girls tended to have higher IQs than their working- class counterparts.

Among the millions of examples of beauty and brains, there's supermodel Lily Cole who went to Cambridge University, actress Kate Beckinsale, an Oxford graduate, and physicist Brian Cox, one-time keyboard player with D:ream.

In Britain, the study found that men who are physically attractive had IQs an average 13.6 points above the norm while women were about 11.4 points higher.

Kanazawa's findings were based on the National Child Development Study which followed 17,419 people since their birth in a single week in March, 1958. Throughout their childhood up to early adulthood, they were given a series of tests for academic progress, intelligence and marked on appearance.

The American research was taken from the National Longitudinal Study of Adolescent Health which involved a similar study of 35,000 young Americans.

Kanazawa, whose paper was published in the academic journal Intelligence, said: 'Our contention that beautiful people are more intelligent is purely scientific. It is not a prescription for how to treat or judge others.'

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Brazilian mothers benefit from vitamin pills

Brazil is a poor country. The pills may have helped make up for nutritional deficiencies

A capsule containing a cocktail of ­essential oils and vitamins could make PMS less painful for millions of women – not to mention the men in their lives. In tests, the natural supplement cut monthly symptoms by up to two-thirds, with minimal side-effects.

It is thought the pills, which contain a mixture of healthy fats and vitamin E, make the body less sensitive to a hormone blamed for much of the misery of pre-menstrual syndrome.

In a study, 120 women were asked to rate the severity of the bloating, tiredness and aches and pains that often beset them in the days leading to menstruation.

Eighty were then prescribed pills containing varying doses of a trio of polyunsaturated fatty acids and vitamin E, which is found in nuts, seeds and green vegetables. Forty women were given packs of dummy pills.

All were told to take two capsules before bedtime each night leading up to their period and asked to rate their symptoms after three months and again at six months.

Those taking the essential oils experienced a clear easing of symptoms after three months. By six months the effects were dramatic, especially among those taking the highest doses.

In some of these cases the severity of ­symptoms fell by more than two-thirds, the journal Reproductive Health reports. Side-effects were rare, with one woman experiencing stomach ache and another’s period starting later than usual.

The researchers, from the Federal University of Pernambuco, in Brazil, believe the contents of the capsules make the body less sensitive to prolactin, a hormone blamed for fluid retention and breast tenderness.

Reacting to the study, Nick Panay, a consultant gynaecologist, questioned whether the capsules would relieve psychological symptoms such as mood swings or low self-esteem. But he added: ‘It sounds encouraging and it is good to see that people are doing proper trials.’

SOURCE
F.D.A. Plans New Limits on Painkillers

I think that the medicine that people are allowed to use should be a matter solely between the patient and his doctor -- so I oppose bans on the whole.

Nonetheless there is something to be said for the actions mentioned below. There seems to be something of a fad for medical practitioners to recommend paracetamol-based pain relievers -- with the general impression being that it is "safe".

It is anything but. Nothing is completely safe but the side-effects of aspirin are rarely catastrophic -- unlike paracetamol (acetaminophen).

Banning paracetamol in prescription drugs but not in over-the-counter drugs is of course ludicrous -- the sort of thing one expects from a bureaucracy -- but as a signal to slow down the paracetamol bandwagon it should be useful nonetheless


The government announced Thursday that it would sharply restrict some of the nation’s most popular prescription painkillers, saying they cause many patients to poison themselves with overdoses of the drug acetaminophen.

The decision by the Food and Drug Administration fell short of the ban on pills like Percocet and Vicodin recommended by an advisory panel in 2009. Instead, manufacturers of these drugs, which combine narcotics with acetaminophen, have three years to reformulate them or stop making them altogether.

Under the new limit, the pills may contain no more than 325 milligrams of acetaminophen — less than half the amount found in many of them now.

The action does not apply to over-the-counter pills like Extra Strength Tylenol, which also have more than 325 milligrams of acetaminophen and which the advisory panel also recommended banning. But more actions could be ahead, officials said.

The F.D.A. will require more explicit warning labels on the prescription medicines about the risk of overdosing with acetaminophen. “F.D.A. is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Dr. Sandra Kweder, deputy director of the agency’s new drug office.

Acetaminophen, which relieves pain and fever and is also known as paracetamol and APAP, is one of the world’s most popular medicines. In 2005, Americans bought 28 billion doses of remedies that contained it. And drugs that combine acetaminophen with opioids like codeine, oxycodone and hydrocodone are prescribed more than 200 million times each year.

The problem, the drug agency said, is that many patients, unaware of the pills’ acetaminophen content, also take over-the-counter painkillers like Tylenol, exposing themselves to side effects that can be life-threatening.

Even recommended doses of acetaminophen can cause liver damage in some people. More than 400 people die and 42,000 are hospitalized every year in the United States from overdoses. Often the overdose results when a patient takes one acetaminophen-based medicine for back pain, another for migraines, and perhaps a third for cough and cold symptoms.

Federal drug regulators have tried for decades to cut down on acetaminophen’s toll, but little changed until June 2009, when the F.D.A.’s panel of experts voted by a bare majority to call for a ban on drugs that combine acetaminophen with narcotics.

Dr. Kweder said Thursday that a ban would have meant “disruption for patients in pain” and that the 325-milligram limit would not weaken the medicines’ painkilling power. “We don’t believe we’re making these products less effective,” she said. “The amount of acetaminophen in these products has gradually crept up over the years.”

Dr. John Markman, director of the Neuromedicine Pain Management Center at the University of Rochester Medical Center, applauded the decision and said an outright ban would have led patients to take other, equally risky drug combinations. Now the F.D.A. will be able to study whether this more moderate step prevents drug-induced liver injuries.

But Dr. William M. Lee, a professor of internal medicine at Southwestern Medical School in Dallas, said he hoped the F.D.A. would eventually ban the combined pain medicines like Percocet and Vicodin because patients in chronic pain end up taking more and more of the pills as they gain tolerance of the opioid component, not realizing that the resulting higher doses of acetaminophen are dangerous.

Half of all acetaminophen overdoses are in patients taking prescription medicines, and many over-the-counter medicines will soon contain more acetaminophen than prescription pills.

The agency has delayed action against the over-the-counter remedies, which would require a far more time-consuming and burdensome regulatory process than the one for prescription pills. “We have not made a decision about what action or actions to take with regard to over-the-counter products,” Dr. Kweder told a news conference. “We’re continuing to consider our options along that line.”

While waiting for the F.D.A. to decide whether and how to act, drug manufacturers “can voluntarily choose not to make the extra strength” formulations, Dr. Kweder said.

But Marc Boston, a spokesman for Johnson & Johnson, said Extra Strength Tylenol and other high-dose formulations provided “many consumers with a safer alternative to other pain medicines.”

Dr. Sidney Wolfe, director of Public Citizen’s health research group, said the government’s inaction against high-dose, over-the-counter pills was inexcusable. “It’s been a year and a half since the advisory meeting,” he said. “What are they doing?”

Abbott Laboratories manufacturers Vicodin with doses of acetaminophen at 500, 650 and 750 milligrams — all of them over the new limit. “Abbott is evaluating the F.D.A.’s guidance and will determine how best to comply,” said Elizabeth Hoff, a company spokeswoman.

SOURCE




A strong handshake predicts a healthy old age?

It appears to among Japanese Hawaiians anyway. That strength and health should go together is not inherently a surprise, however and the odds ratio was rather higher than what we see in most epidemiological studies

Midlife Hand Grip Strength as a Predictor of Old Age Disability

By Taina Rantanen et al.

Abstract

Context: Poor muscle strength, functional limitations, and disability often coexist, but whether muscle strength during midlife predicts old age functional ability is not known.

Objective: To determine whether hand grip strength measured during midlife predicts old age functional limitations and disability in initially healthy men.

Design and Setting: A 25-year prospective cohort study, the Honolulu Heart Program, which began in 1965 among Japanese-American men living on Oahu, Hawaii.

Participants: A total of 6089 45- to 68-year-old men who were healthy at baseline and whose maximal hand grip strength was measured from 1965 through 1970. Altogether, 2259 men died over the follow-up period and 3218 survivors participated in the disability assessment in 1991 through 1993.

Main Outcome Measures: Functional limitations including slow customary walking speed (≤0.4 m/s) and inability to rise from a seated position without using the arms, and multiple self-reported upper extremity, mobility, and self-care disability outcomes.

Results: After adjustment for multiple potential confounders, risk of functional limitations and disability 25 years later increased as baseline hand grip strength, divided into tertiles, declined. The odds ratio (OR) of walking speed of 0.4 m/s or slower was 2.87 (95% confidence interval [CI], 1.76-4.67) in those in the lowest third and 1.79 (95% CI, 1.14-2.81) in the middle third of grip strength vs those in the highest third. The risk of self-care disability was more than 2 times greater in the lowest vs the highest grip strength tertile. Adding chronic conditions identified at follow-up to the models predicting disability reduced the ORs related to grip strength only minimally.

Conclusions: Among healthy 45- to 68-year-old men, hand grip strength was highly predictive of functional limitations and disability 25 years later. Good muscle strength in midlife may protect people from old age disability by providing a greater safety margin above the threshold of disability.

SOURCE

Saturday, January 15, 2011

Exercise may not outweigh health effects of "couch potato" recreation

A slightly more sophisticated repeat of some boring old epidemiological rubbish. It probably just shows that people who are not very well or not very vigorous do not exercise much. I suppose it's some comfort that they realized that but controlling for it needs almost Godlike knowledge. Epidemiology just does not enable causative inferences. You need double-blind studies

Spending too much leisure time in front of a TV or computer screen appears to dramatically increase the risk for heart disease and premature death from any cause, perhaps regardless of how much exercise one gets, according to a new study.

The analysis found that people who spend more than four hours daily on screenbased entertainment like TV, computer or videogames are more than twice as likely to have a "major cardiac event" involving hospitalization, death or both compared to people who spend less than two hours on such activities.

The research is published in the Jan. 18 issue of the Journal of the American College of Cardiology. Billed as the first study to examine the association between screen time and nonfatal as well as fatal cardiovascular events, it also suggests metabolic factors and inflammation may partly explain the link between prolonged sitting and the risks to heart health.

"People who spend excessive amounts of time in front of a screen primarily watching TV are more likely to die of any cause and suffer heartrelated problems," said Emmanuel Stamatakis of University College London, who led the research. "Our analysis suggests that two or more hours of screen time each day may place someone at greater risk for a cardiac event."

Compared with those spending less than two hours a day on screenbased entertainment, the study found a 48 percent increased risk of allcause mortality in those spending four or more hours a day and a roughly 125 percent increase in risk of cardiovascular events in those spending two or more hours a day. These associations were independent of traditional risk factors such as smoking, hypertension, excess weight, social class, as well as exercise.

The findings have prompted authors to advocate for public health guidelines that expressly address "recreational sitting" especially as a majority of working age adults spend long periods inactive while commuting or slouched over a desk or computer.

"It is all a matter of habit. Many of us have learned to go back home, turn the TV set on and sit down for several hours it's convenient and easy to do. But doing so is bad for the heart and our health in general," said Stamatakis. "And according to what we know so far, these health risks may not be mitigated by exercise."

Stamatakis said the next step will be to try to uncover what prolonged sitting does to the human body in the short and longterm, whether and how exercise can mitigate these consequences, and how to alter lifestyles to reduce sitting and increase movement and exercise.

The study included 4,512 adults who were respondents of the 2003 Scottish Health Survey, a representative, household-based survey, researchers said. A total of 325 all-cause deaths and 215 cardiac events occurred during an average of 4.3 years of follow up.

Measurement of "screen time" included selfreported TV and DVD watching, videogaming, as well as leisure-time computer use.

The authors also said they took steps to rule out the possibility that ill people spend more time in front of the screen as opposed to the other way around. The authors excluded those who reported a previous cardiovascular event and those who died during the first two years of follow up just in case their underlying disease might have forced them to stay indoors and watch TV more often. Stamatakis and his team also adjusted analyses for [some] indicators of poor health, such as diabetes and hypertension.

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NJ: Appeal lost in Denny’s sodium case

A state appeals court has shot down an appeal by a Tinton Falls man who tried suing Denny's restaurant chain over its sodium content.

Nick DeBenedetto, 49, filed a lawsuit claiming the chain wasn't upfront about the high-sodium content of its food. The appeals court upheld a lower court's dismissal of the case.

The three-judge appeals panel found that DeBenedetto couldn't prove Denny's had a defective or dangerous product, or that he was harmed.

DeBenedetto says he was being treated for hypertension and ate at Denny's about 10 times in the year before he filed the lawsuit.

New Jersey Press Media reports that a health, nutrition and food-safety advocacy group represented him in court.

SOURCE

Thursday, January 13, 2011

U-turn on when to stop breast-feeding

Mothers are being warned that breastfeeding exclusively for six months may not be best for their babies and could put them at risk of allergies, food aversion and even obesity.

New research, which contradicts nearly a decade of official advice, says babies can be safely given solid foods at least eight weeks earlier in life.

British researchers have questioned guidelines issued in 2001 by the World Health Organisation – and supported by the Department of Health in 2003 – which told women to breastfeed for the first six months before giving solid foods to babies. Based on WHO ‘global recommendations’, the aim was to help children worldwide avoid allergies and gastroenteritis.

But experts led by a paediatrician from University College London’s Institute of Child Health now claim the policy may actually have increased the risk of babies suffering allergies and iron deficiency. In addition, it could deter children from eating foods with bitter tastes that are good for them, fuelling the rise in obesity.

The new study in the British Medical Journal has sparked controversy, with the Royal College of Midwives claiming it can only benefit the baby food industry. But other breastfeeding specialists welcomed the ‘common sense’ findings that many mothers instinctively follow despite feeling guilty about ignoring official advice.

The Department of Health last night stuck by the old guidelines, but admitted it has asked a panel of scientists to consider all the evidence and report back this year.

The new study says that when the WHO edict came out in 2001, many Western countries, including two out of three European nations, and the U.S. chose to ignore it. But in 2003, Britain agreed to comply with the recommendation, which sprang from a review of 16 studies. They included seven from developing countries and the remainder from developed countries which were of ‘variable quality’. The conclusion was that babies given breast milk alone for six months had fewer infections.

But another review of 33 studies carried out at the same time found ‘no compelling evidence’ against introducing solids at four to six months, known as weaning. There is growing evidence that breastfeeding alone for six months does not give babies all the nutrition they need, with some becoming iron deficient. Babies fed on formula milk get extra iron, but they too are exposed to other drawbacks of late introduction of solid foods.

The new study says Swedish research links problems with tolerating gluten to a delay in eating it until six months – with the ideal wait being four to six months.

Professor Mary Fewtrell, who led the research team, said: ‘Perhaps the Department of Health might conclude similarly were it to commission an objective, independent review of the evidence.’

Clare Byam-Cook, an independent breastfeeding counsellor and former midwife, said: ‘The findings are long overdue because there is no evidence to show harm from introducing solids at three months or if the baby is over 12 pounds in weight.’

But Janet Fyle, policy adviser at the Royal College of Midwives, said changing official advice would be a retrograde step that ‘plays into the hands of the baby food industry’. She said there was ‘irrefutable evidence’ that breast milk confers many health benefits on babies that last a lifetime.

A spokesman for the Department of Health said: ‘Mothers who wish to introduce solids before six months should always talk to health professionals first.’

SOURCE





Magic bean? Soya could help to fight two cancers

The first study was too small to get excited about and the second was epidemiological specualtion

Soya could boost the battle against prostate and breast cancer, scientists believe. The potential health benefits of the bean have been highlighted in two ­separate studies.

In one, researchers from Northwestern University, ­Chicago, found that one pill a day of genistein, a natural ­isoflavone chemical in soya, seemed to slow or stop the spread of prostate cancer.

Although it was tested on a small group of only 38 men, scientists say the results could lead to the first non-toxic treatment that prevents cancer cell movement.

Professor Raymond Bergan said: ‘The first step is to see if the drug has the effect that you want on the cells and the prostate, and the answer is yes, it does. ‘If this drug can effectively stop prostate cancer from ­moving in the body, theoretically a similar therapy could have the same effect on the cells of other cancers. 'This could be the first therapy for any cancer that is non-toxic and targets and inhibits cancer cell movement.'

In the second study, of almost 1,300 women, researchers from the University at Buffalo, New York, showed isoflavones from soya can reduce the risk of developing breast cancer. Researcher Anne Weaver found those with the highest isoflavone intake had a 30 per cent lower risk of an invasive breast tumour and a 60 per cent lower risk of a low-grade tumour.

Ms Weaver and colleagues evaluated 683 women with breast cancer and compared them with 611 healthy women. She said: 'Like most dietary studies, these findings are not definitive and need to be considered in the context of further follow-up and confirmation. 'Still, we definitely saw a reduction that deserves further investigation.'

SOURCE

Wednesday, January 12, 2011

Feds propose decrease of fluoride in water

The addition of fluoride to drinking water has been considered one of the great public health advancements of the 20th century. But with fluoride now in nearly every over-the-counter product related to oral hygiene, the US Department of Health and Human Services is now calling for a reduction in fluoride levels in drinking water. The reason? We're now getting too much fluoride, and that's leading to splotches on the teeth of children and other possible health problems.

The splotches, known as fluorosis, appear to be common among adolescents, and the condition has increased among them since the 1980s. Approximately 40 percent of children between the ages of 12 and 15 have it. Fluorosis, which causes slight pitting in the teeth, is a cosmetic condition that's usually only noticed by dentists. But the feds aren't calling for reduction in fluoride levels solely because of splotchy teeth.

Two new reviews of fluoride by the EPA yesterday link high intakes of fluoride over time to brittle bones, fractures and bone abnormalities. the new proposal from HHS calls for fluroide levels to be at 0.7 parts per million. Currently it can be anywhere from 0.7 to 1.2 parts per million, depending on climate. Maybe for those who still consider fluoridation of water a Communist plot, it will also lead to a return of their essence.

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How high-pitched music could cure tinnitus by 're-booting' the brain

Colour me skeptical. I think the problem is entirely located in the inner ear

Scientists may have developed a cure for tinnitus, the persistent ringing in the ears that blights the lives of hundreds of thousands of Britons. In tests, researchers were able to stop the irritating noises by stimulating a nerve in the neck while playing a high-pitched tone into the ears.

The technique – which ‘reboots’ the brain – has been successfully tested on rats. Clinical trials on humans are due to start in the next few months.

Around one in ten adults in the UK suffers from permanent tinnitus and around 600,000 have it badly enough to affect their quality of life. It can affect one or both ears and is usually described as a ringing noise, although it can also take the form of high pitched whines, rattling, low beeps or a rushing sound.

Tinnitus is often triggered by exposure to loud noise, which destroys cells in the inner ear that transmit sound signals to the brain.

Scientists believe the brain tries to compensate for the missing signals, leading to phantom sounds. Other causes of tinnitus include injury and normal ageing.

The American researchers carried out experiments on tinnitus-affected rats designed to trigger changes in the ‘auditory cortex’ – the part of the brain that responds to sound.

By electrically stimulating the vagus nerve – a large nerve running from the head and neck to the abdomen – with a small electrode at the same time as playing a high-pitched sound, they banished tinnitus from the rats.

Treated rats showed responses that indicated the ringing in their ears had stopped, the journal Nature reported yesterday. Animals that did not receive the therapy continued to display signs of tinnitus.

Study leader Dr Michael Kilgard, from the University of Texas at Dallas, said: ‘The key is that, unlike previous treatments, we’re not masking tinnitus, we’re not hiding the tinnitus.

We are retuning the brain from a state where it generates tinnitus to a state that does not generate tinnitus. We are eliminating the source of the tinnitus.’

When the vagus nerve is stimulated it releases chemicals that can alter brain circuitry. Patients taking part in the human trial in Europe will undergo vagus nerve stimulation paired with sounds at daily treatment sessions over several weeks.

The stimulation will be delivered by a wireless electrode surgically attached to the left vagus nerve. The device was developed by MicroTransponder, a U.S. biotech firm.

SOURCE
Ibuprofen (Nurofen) as dangerous as banned Vioxx -- i.e. only in rare cases

The search for a safe painkiller is a chase after a chimera

Large regular doses of ibuprofen and similar painkillers could treble the risk of strokes and increase the likelihood of heart attacks, researchers are warning.

Scientists have found high doses of ibuprofen may carry a similar health risk to painkillers that were withdrawn from the market several years ago on safety grounds.

Up to eight million Britons are prescribed so-called anti-inflammatory drugs every year, usually to combat arthritis or back pain.

Doctors stress that the stroke and heart risks only exist for those taking high doses of ibuprofen over long periods – and there is no danger in the odd pill for a headache, for example.

Researchers from the University of Bern in Switzerland looked at more than 31 clinical trials involving 116,429 patients.

They had each taken one of seven commonly-used painkillers, The study, published in the British Medical Journal, found that those who had taken ibuprofen over a long period of time were almost three times as likely to suffer a stroke.

The painkiller was also shown to raise significantly the risk of heart attacks and deaths caused by heart disease.
Nurofen has ibuprofen as its active ingredient: 'Only take when genuinely necessary' say doctors

Nurofen has ibuprofen as its active ingredient: 'Only take when genuinely necessary' say doctors

Another commonly prescribed pill, diclofenac, which is also sold under the trade name Rhumalgan, was shown to almost treble the risk of strokes and increase the likelihood of heart disease related death by four times.

The study also suggested that ibuprofen carried a similar risk of stroke and death from heart disease to rofecoxib, also known as Vioxx, which was withdrawn from the market in 2004 over safety concerns.

Professor Peter Jüni, of the University of Bern, said: ‘We looked at patients taking these drugs three to four times a day.

‘They were mainly being treated for osteoarthritis with a few who had rheumatoid arthritis. A lot of them are elderly who are already have lots of risk factors and these will then be duplicated with these painkillers.

‘In terms of stroke, ibuprofen doesn’t look very good. If I was in chronic pain I would not take it as the risks are just too high. I would look at the different options.’

But researchers say those at risk would have to be taking three or four pills a day – a dose of up to 2,000mg – for several months or even years.

Professor Simon Maxwell, chairman of the British Pharmacological Society’s Prescribing Committee, said the finding should be taken in context.

He added: ‘Most users of these drugs will only take them for a relatively brief duration to treat short-lasting episodes of pain and are at minimal risk.’

SOURCE




Doubts about a "miracle" molecule creeping in

About time the resveratrol craze died down

The pharmaceutical company Sirtris announced last month that it had halted the last of its clinical trials of resveratrol, the minor ingredient of red wine that some researchers see as a drug that can extend life.

The decision signifies an apparent divergence of views on the merits of resveratrol between the current head of the company, which was bought by GlaxoSmithKline in 2008 for $720 million, and its founders.

George Vlasuk, Sirtris’s chief executive, said in an interview last week that SRT501, Sirtris’s formulation of resveratrol, “was not an important part of the acquisition of Sirtris by GSK.” Resveratrol has several features that make it unsuitable as a drug, he said. These include the fact that it is hard to maintain a consistent level of resveratrol in the bloodstream and that it seems to have different effects at different doses.

Resveratrol is thought to work in humans by activating a protein called SIRT1, but at some doses it actually inhibits SIRT1, Dr. Vlasuk said.

In addition, from a commercial point of view, resveratrol is a natural substance and not patentable.

Glaxo’s purchase of Sirtris, Dr. Vlasuk said, was more because the company afforded an entry into a new research field, and had developed several small, synthetic, patentable chemicals that mimic resveratrol in activating SIRT1. SIRT1 is thought to extend life in mice fed low-calorie diets, and researchers hope it may do the same in people by enhancing tissue maintenance and postponing the usual diseases of age.

Sirtris has completed three clinical trials with its synthetic resveratrol-mimicking drugs and will announce the results next year. These drugs work fairly specifically on SIRT1, unlike resveratrol, which also affects many other processes in the cell. “We have much more confidence that we are targeting SIRT1 and that it’s an important target. Resveratrol is not that important any more,” Dr. Vlasuk said.

But the co-founders of Sirtris, David Sinclair and Christoph Westphal, retain their confidence in resveratrol. Dr. Sinclair, a researcher at the Harvard Medical School, has long taken resveratrol. Referring to the unpublished results of a new trial with rhesus monkeys, he said that resveratrol “was and remains an excellent proof-of-concept molecule.”

Dr. Westphal said he believed there is accumulating evidence that resveratrol and Sirtris’s resveratrol-mimicking chemicals activate SIRT1, and that sirtuin-activating drugs have beneficial effects in animal and human studies.

Based on preliminary data about the synthetic drugs tested by Sirtris, “I’m as optimistic about the science and the potential of sirtuin activators as I’ve ever been,” Dr. Sinclair said. Sirtuin is the name of a family of proteins of which SIRT1 is the most important. Humans have seven sirtuins, all with different roles.

The rhesus monkey trial has been conducted by Rafael de Cabo, a researcher at the National Institute on Aging. It is similar to a study on mice in which he and Dr. Sinclair showed resveratrol extended the life of obese mice fed on a high-fat diet, but not of normal mice. Even the normal mice, however, showed some improvement on measures of heart function and bone loss. Dr. de Cabo said he could not discuss the results of the study until it is published. It looked at various markers of disease but did not try to assess resveratrol’s effect on longevity, given that rhesus monkeys live 40 years and it takes a long time assess any effect on life span.

“Resveratrol is a complex molecule in that it has many targets, and it behaves differently depending on the tissue and the metabolic status of the organism,” Dr. de Cabo said. That may make it too complex for a pharmaceutical company, which must prove to the Food and Drug Administration that a new drug works by a defined mechanism on a specific target. But resveratrol remains of great interest to researchers. “What is the actual use for humans still needs to be discovered,” he said.

Dr. de Cabo said he does not take resveratrol. “I don’t think it’s a reasonable thing for people to start consuming these compounds without more information,” he said.

SOURCE

Monday, January 10, 2011

Futile fight against fat

On New Year’s Day, as the Victorian and Northern Territory governments followed NSW, WA and the ACT by implementing laws preventing cigarettes from being put on display to the public, the Australian Medical Association (AMA) called for a $25 million TV and newspaper advertising campaign showing “damaged vital organs or people drinking liquefied body fat” to shock Australians into giving up junk food and sugary soft drinks.

The good doctors based their call upon a belief that the fear-based advertising campaigns used by the TAC (in Victoria) and Quit have been effective in changing behaviour around driving and smoking. The mistake that they are making is that there is much more to the change of behaviour in relation to driving and smoking than the shock advertisements that have formed part of these long social marketing campaigns.

The advertisements that the AMA are suggesting are based on similar advertisements launched by the New York Health Department in October, 2010, highlighting how much sugar is in a bottle of soft drink. A video that was released as part of the "Pouring on the Pounds" campaign aimed to “educate New Yorkers about the potentially serious health effects of consuming sugary drinks.”

One of the videos in the campaign showed a man drinking fat poured from a soft drink can with the tag saying, “drinking one can of soda a day, can make you 10 pounds fatter a year,” while another showed a man consuming sixteen packets of sugar to demonstrate the amount of sugar in an average-sized soft drink.

And at the far end of the obesity shock spectrum, a viral execution called “Break the Habit” developed as a community service by The Precinct Studio in October, 2010, featured a mother preparing to inject her son with heroin before the scene changed to show him eating a hamburger. The end tag read, “You wouldn’t inject your children with junk, so why are you feeding it to them?”

At face value, and amongst those who think that consumers are rational, thoughtful creatures that just need to be reminded of their vices to persuade them to change their behaviour, this seems like a reasonable approach.

Frighten the masses. Give 'em the facts. Change their behaviour.

But shock advertising, on its own, is unlikely to have the desired effect of getting people to stop eating junk food and eating more healthily. Research in marketing and consumer behaviour suggests that some forms of shock advertising can have the opposite effect of increasing attitudinal loyalty to the brand or the product category, particularly amongst regular users. One explanation is related to the need for the ego to protect itself against any attacks on previous decision-making, thus avoiding or combating feelings of guilt. Advocacy groups need to recognise that shock for its own sake does not change behaviour. An emotional creative execution is useful, because it helps the brain to form memory connections when our emotions are heightened, but we need to be careful not to activate the “reject” or flight response.

In a paper published in April 2010 in the Journal of Marketing Research, Nidhi Agrawal and Adam Duhachek found ads that were designed to trigger guilt amongst the target market actually triggered a defensive processing mechanism. This mechanism, they argued, was explained by the notion that people tend to think things will go much better for them than for the average person. In other words, we think our own personal greatness buffers us from all potential negative consequence, whether it’s driving, smoking, or eating junk food

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Futile fight against alcohol

This wasn't just a meal deal. This was a Marks & Spencer meal deal - without alcohol. Yet when the High Street giant trialled the new version of its hugely popular Dine In For Two for œ10 offer with better quality food, but without the usual bottle of wine thrown in, it seems customers were just not interested. Instead of snapping up the deals as usual, the normally loyal shoppers took their business elsewhere, and some even spoke up about their outrage.

Now the trial has come to an end, and Marks and Spencer has no plans to repeat it - promising that the 'Dine In' offer will continue, but with a bottle of wine option included as standard.

The experiment, which was carried out in a handful of stores over the New Year, came after a series of attacks on shops for encouraging heavy drinking by offering cheap alcohol. But middle class Britons have evidently shown that they remain a pushover for bargain booze, in spite of the warnings of experts.

The Dine In For Two offer was launched in 2008 as growing recession made many consumers think twice about eating out in restaurants. In response, Marks and Spencer began offering couples a choice of ready meals for two and a side dish, along with a dessert and bottle of wine, all for œ10.

Although customers are offered a soft drink as an alternative to the wine, campaigners against alcohol abuse raised questions - and over the New Year, the trial alternative without any alcohol was tested. The new version offered upgraded gourmet ready meals - rather than the standard ready meals usually offered, as well as the usual side dish and dessert. But without the customary bottle of wine.

According to the industry magazine The Grocer, feedback on the re-jigged deal on the internet consumer forum Money Saving Expert was overwhelmingly negative. Shoppers, it appeared, feared that the popular promotion was set to change for good - and deprive them of their bottle of wine. One shopper said: 'I saw the poster in-store and thought I had misread it when I could not see the wine listed. 'Such a shame. I regularly bought the Dine In meal but it doesn't seem like such a good deal now.'

Another shopper wrote: 'Haha, this won't wash with me. No wine, no deal. Think again M&S!" A third added: 'I definitely won't be buying again. Without the wine there is no way I'd bother.'

Marks & Spencer Food business development head Jill Bruce told The Grocer the usual offer had been tinkered with as a 'test'. 'We were keen to see if Dine In could work during the festive holiday peak and if the meal offered at this time should be more special,' she said. 'To test this out, a small number of stores ran some different menus.'

She said that they had trialled more premium food options without wine as M&S had received feedback from some customers that they would prefer to choose their own wine. However she insisted: 'We have no plans to change what is a very successful promotion and will have another Dine In event in-store from January 13 with the usual combination of main, side, dessert and wine or a soft drink.'

The Dine In deal has been credited with turning round the fortunes of M&S food, and has been copied by leading High Street rivals including Waitrose and Sainsbury's.

But there have been criticisms. Last October the British Liver Trust claimed such deals should carry health warnings, as they encouraged heavy drinking among middle-aged professionals - yet were promoted in sections of stores away from the alcohol department. The charity made its claim as official statistics showed 22 per cent of the middle classes drink at least five days a week - compared to just 11 per cent of manual workers.

British Liver Trust spokeswoman Sarah Matthews said: 'These meal deals are prominently advertised and make regular drinking at that level seem like a perfectly acceptable everyday habit. They are totally wrong.' 'If a couple share a bottle of wine every night, the woman would be more than double her limit by the end of the week and the man would also be way over.'

And in September, a Scottish National Party member of the Scottish Parliament proposed making it illegal to artificially discount alcohol by combining it with food items. 'I do not believe alcohol should be used as a promotional device at all,' he said.

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Australian consumer group slams "nutrient" drinks

CHOICE is stepping up the campaign against vitamin water drinks, describing them as "expensive lolly waters" with hyperventilated health claims". Some contain a third of a woman's recommended daily sugar intake in one 500ml bottle.

The consumer advocate CHOICE first complained to the Australian Competition and Consumer Commission (ACCC) in 2008 that Coca Cola Amatil's Glaceau Vitamin Water made a mockery of food labeling laws, but the complaint was rejected. Since that time the market has been flooded with similar products such as Nutrient Water and Smart Water.

CHOICE spokeswoman Ingrid Just said Nutrient Water claimed its Cranberry Grapefruit Multi-Vitamin Water drink offered the same benefits as eight hours sleep, a bowl of steamed greens and pre-dawn power walks.

She said it was time to "get tough on potentially misleading promotions and labelling", such as 'nature approved ingredients' and 'natural flavours', "which mean nothing". "This type of labelling creates the impression that the drinks can be used as a safety net for a poor lifestyle when grabbing an apple and a glass of water will provide you with far more nutrients for a fraction of the cost," she said.

A spokesman for the ACCC would "neither confirm nor deny whether any investigations are underway". However recent actions include labeling changes for Sanitarium breakfast cereals and National Foods juices.

The ACCC was concerned that Berri Australian Fresh "Daily Juice" packaging suggested that it only contained juice that was recently squeezed, when in fact the products within this range may contain either fresh juice or a blend of fresh juice and aseptically stored juice. Sanitarium packaging suggested certain breakfast cereals contained more fruit than was actually the case.

CHOICE has called for the ACCC to take another look at the way vitamin waters are marketed. "These drinks are leading consumers up an imaginary garden path to health and vitality," Ms Just said. "Treat them like any other sugary or artificial drink; enjoy occasionally, not as a means to any kind of wellbeing whatever the label or pretty pictures might suggest."

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Prozac 'gives movement back to stroke victims left paralysed'

Taking the antidepressant Prozac may help restore movement in stroke victims and reduce paralysis, according to the largest study of its kind. The drug may aid recovery after a stroke whether patients are depressed or not, researchers found.

They said the beneficial effect of selective serotonin re-uptake inhibitors (SSRIs), the class of drug that includes Prozac, is independent of the effect on depression, a common response to having a stroke. The pills boost serotonin levels and other compounds in the central nervous system which, it is thought, improves nerve growth.

The study investigated the use of SSRIs in stroke after mounting evidence from smaller trials that they improve motor and cognitive functions.

At around £5 for a month's supply, Prozac's cheapness could lead to its widepread use in this area, the researchers added. The team from the University Hospital of Toulouse looked at 118 patients five to ten days after a stroke. Half were given 20mg of Prozac, while the others got a dummy pill. All patients, who had moderate to severe movement problems, also received physiotherapy.

Greater improvements in motor function were found after three months in patients on Prozac, with a 50 per cent increase in scores used to measure recovery, said a report published online in The Lancet Neurology. Importantly, this gain was significant for both the upper and lower limbs, as paralysis and weakness on one side of the body are the most common disabilities left after a stroke. Depression was significantly less common in patients on Prozac, suggesting it could prevent the condition if given early after a stroke, said lead researcher Professor Francois Chollet. He added: `The positive effect of the drug on motor function of recovering patients suggests that the action of SSRIs provides a new pathway that could be explored further in the treatment of acute ischaemic stroke.'

In the same journal, Robert Robinson and Harold Adams from the University of Iowa said the findings raised the question of whether `most patients with motor impairments after stroke should be treated with SSRIs'. But they added that more studies were needed.

Around 150,000 people a year in the UK have a stroke, of whom a third are left with a disability such as paralysis down one side of their body.

SOURCE