FDA Moves to Regulate Walnuts as a Drug

This is certainly heavy-handed. Negotiation about what health effects can be asserted on the label would have been more reasonable

Big Government no longer has to pass the laugh test before expanding its power, which means any bureaucracy can regulate most anything that catches its attention. For example, the FDA is now cracking down on the “drug” we know as walnuts:

Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply.

Diamond’s transgression was to make “financial investments to educate the public and supply them with walnuts,” as William Faloon of Life Extension magazine put it. On its website and packaging, the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer. These claims, Faloon notes, are well supported by scientific research: “Life Extension has published 57 articles that describe the health benefits of walnuts”; and “The US National Library of Medicine database contains no fewer than 35 peer-reviewed published papers supporting a claim that ingesting walnuts improves vascular health and may reduce heart attack risk.”

This evidence was apparently not good enough for the FDA, which told Diamond that its walnuts were “misbranded” because the “product bears health claims that are not authorized by the FDA.”

The FDA’s letter continues: “We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?

There are actually people who want to live in a country where officious petty tyrants regulate every aspect of our lives. But the rest of us are Americans.

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Australian Professor thinks he can create skin cancer vaccine

CANCER expert Prof Ian Frazer is on the verge of a major breakthrough in skin cancer - he hopes to develop a vaccine within a year.

The former Australian of the Year and creator of the world's first cervical cancer vaccine, Gardasil, has developed a world-first strategy to combat the insidious disease that affects two out of three Australians.

"In my lifetime we should be able to remove the threat of skin cancer from the next generation," the 57-year-old immunology professor said. "The smoking gun evidence is there is a virus or viruses that cause it."

Prof Frazer believes people can "catch" cancer from a virus. He proved his theory by identifying the human papilloma virus (HPV) as the cause of cervical cancer and then developing a vaccine against the virus to rid the female population of the cancer.

Now he is using a similar tactic to try to combat skin cancer, including malignant melanomas. "This group of cancers caused by virus infection present a great opportunity because the idea of vaccinating to prevent a cancer is enormously appealing," he said.

Prof Frazer said the problem was two-fold. "Genetics and variations in people's immune systems may expose some people to greater risk of skin cancer after sun exposure," he said. "If you take away the body's defence systems, skin cancer becomes more common."

His theory is that some viruses - particularly the wart virus or HPV - are embedded in the layers of the skin, which then pose a skin cancer risk for people with damaged immune systems.

"The technology now exists for me to test my theory," Prof Frazer said. "It is very powerful but also very expensive. "Using this tool, we will go hunting for the fingerprints of the virus or viruses present."

Prof Frazer's team will input all the sequenced genetic information on skin cancer - which will take six months - and then get an answer. "We will know if a virus causes skin cancer and what virus it is," he said.

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Obesity war failing

Heavy-handed tactics aimed at making families seek help for overweight children are a waste of time, an obesity expert declared last night.

David Haslam, a leading GP and chairman of the UK’s National Obesity Forum, says his fellow doctors can spot overweight children the minute they walk through the door. ‘The problem isn’t identifying these people, it’s getting them motivated to lose weight and reduce their risks of disease,’ he said.

His comments came in response to a study showing that most parents who receive letters about the health risks of their children being fat do very little about it.

Dr Haslam, who is a GP in Hertfordshire, said: ‘Sending letters to parents like this is a waste of time. It’s the duty of the healthcare professional, doctor or nurse, when they see a patient whose weight is putting their health at risk to seize the moment – children’s lives are at stake.’

The research comes as experts predict two out of three children could be obese by 2050 if current trends continue. More than one in five is obese at present – so fat it threatens their health.

In the study, researchers at Bristol University contacted 285 families with children aged between five and 16 who were obese. The data came from GP records which had noted the children’s Body Mass Index (BMI) – the measure of weight and height which determines obesity – in the last two years.

The families were all sent a letter telling them their child was significantly overweight and offering them the chance to see their GP about it.

Just 47 per cent of the parents consulted doctors and barely 15 per cent of those who took up the offer ended up with a record of their child’s weight in GP records, suggesting the issue had not been thoroughly investigated. Just 25 fat children ended up in specialist clinics, according to the report in the British Journal of General Practice.

Researcher Dr Jonathan Banks, from the university’s school of social and community medicine, said one in two parents had rejected the opportunity to discuss their child’s weight problems. He said ‘Previous research has found that parents of overweight children find it difficult to seek help from a health professional and that many do not recognise overweight or obesity in their children. ‘It might be expected that parents who were unsure about how to deal with their child’s weight would be prompted by the letter, but the very low take-up suggests resistance to addressing the issue.’

Co-researcher Professor Julian Shields, professor of paediatrics at the university who runs weight management clinics, said GPs also seemed reluctant to deal with an often embarrassing subject with their patients. He said ‘It’s still a taboo area but things have got to change, this is one of the most pressing problems for our children. ‘But it’s difficult for GPs to say to parents their child is fat and something needs to be done without sounding rude, indifferent or blunt’ he added.

A scheme to measure fat children at school, and send warning letters to parents, attracted much criticism when it was launched in 2006, not least because many parents refused to give consent for their children to be screened. Heavier children were more likely to opt out.

Dr Haslam, who is a GP in Hertfordshire, said the latest research showed that better ways were necessary to motivate children and adults with weight problems into shedding the pounds. He said ‘Sending letters to parents like this is a waste of time.

‘The problem is not lack of access to obese children and adults, it’s getting them engaged and motivated into losing weight and keeping it off in the long term. ‘It’s the duty of the healthcare professional, doctor or nurse, when they see a patient whose weight is putting their health at risk to seize the moment – children’s lives are at stake.

‘If a child comes into the surgery with a thorn in a finger, take out the thorn and then ask then what they’re doing about trying to lose weight and how can we help’ he added.

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Faith can be a great healer

I am an atheist but if I were a medical professional, I would never discourage religious devotion

With a ten per cent chance of survival, he needed a miracle - and that's exactly what God gave him. Jacob Berger, from Indiana, was diagnosed in 2002 with stage four cancer that was spreading from the upper part of his throat to his brain.

With the size of the tumour, doctors said the chances of him being alive in three or four years was ten per cent. He had already lost his younger sister to a rare form of cancer in 1991, then his mother to breast cancer in 2002. His dad died two years after his diagnosis in 2004.

But Jacob Berger is now cancer free after, he said, God spoke to him and told him to stop his treatment. He did, and he attributes that message to his life and says he is living proof that beating cancer sometimes takes more than medicine.

Not only that, but when he was undergoing aggressive chemotherapy and radiation to shrink his tumour, he became sterile. Or so he thought. He now has two children and another on the way.

Speaking to ABC, he said: 'I woke up in the middle of the night and felt like God told me to stop taking the treatments, and told me it was over now. 'I had confidence that my prayers were going to be answered, and that God was a healer and was going to take care of me.' He listened to the divine advice and when he went for his next MRI, he learned his cancer was gone.

After his cancer diagnosis and losing his father, Mr Berger turned his life around and devoted it to God, joining the Church of Rock.

He said: 'I had two choices - give in to this illness or fight the good fight of faith, and I chose to fight the good fight of faith.'

Although he believes divine intervention worked for him, he would never recommend that anyone stop their treatments. He told ABC: 'I've personally ministered to people with cancer and told them don't refuse what doctors are saying, don't just be ignorant and not go to the doctor. 'I tell them to let them confirm that God is moving in their life.'

Dr Renato LaRocca, Berger's doctor and director of the Kentuckiana Cancer Institute in Louisville, Kentucky, said the odds were against Mr Berger's surviving. He said that while his four treatments played a part in his recovery, he can't explain why Mr Berger is still cancer-free nine years later.

He said: 'Maybe his immune system woke up, maybe there was a lot of mental and spiritual depression, and once he got that focus, that's what helped, but I never underestimate the power of the mind.'

But Mr Berger is defiant. He said: 'It was absolutely a miracle. The bone that had eroded has been replaced by brand new bone and there is no scar tissue.'

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"Organic" wackos obstructing the battle to feed the world

Monsanto is the heroic Sherman tank leading the battle but it is widely hated by the food romantics. The recent worldwide hike in the price of corn has heavily impacted the poor of the world so the battle is an ongoing one. As analyses have repeatedly shown, the only difference between "organically" grown crops and GM crops is that the organic crops produce much less food per acre. The organic delusion is a murderous superstition but the delusion is strong. See below

More than 270,000 organic farmers are taking on corporate agriculture giant Monsanto in a lawsuit filed March 30. Led by the Organic Seed Growers and Trade Association, the family farmers are fighting for the right to keep a portion of the world food supply organic—and preemptively protecting themselves from accusations of stealing genetically modified seeds that drift on to their pristine crop fields.

Consumers are powerful. For more than a decade, a cultural shift has seen shoppers renounce the faster-fatter-bigger-cheaper mindset of factory farms, exposéd in the 2008 documentary Food, Inc. From heirloom tomatoes to heritage chickens, we want our food slow, sustainable, and local—healthy for the earth, healthy for animals, and healthy for our bodies.

But with patented seeds infiltrating the environment so fully, organic itself is at risk. Monsanto’s widely used Genuity® Roundup Ready® canola seed has already turned heirloom canola oil into an extinct species. The suing farmers are seeking to prevent similar contamination of organic corn, soybeans, and a host of other crops. What’s more, they’re seeking to prevent Monsanto from accusing them of unlawfully using the very seeds they’re trying to avoid.

“It seems quite perverse that an organic farmer contaminated by transgenic seed could be accused of patent infringement,” says Public Patent Foundation director Dan Ravicher in a Cornucopia Institutearticle about the farmers’ lawsuit (May 30, 2011), “but Monsanto has made such accusations before and is notorious for having sued hundreds of farmers for patent infringement.”

Even as the megacorporation enjoys soaring stock, the U.S. justice department continues to look into allegations of its fraudulent antitrust practices (The Street, June 29, 2011):

Monsanto, which has acquired more than 20 of the nation’s biggest seed producers and sellers over the last decade, has long pursued a strict policy with its customers, obligating them to buy its bioengineered seeds every year rather than use them in multiple planting seasons. Farmers who disobey are blacklisted forever.

It’s a wide net Monsanto has cast over the agricultural landscape. As Ravicher points out, “it’s actually in Monsanto’s financial interest to eliminate organic seed so that they can have a total monopoly over our food supply.” Imagine a world devoid of naturally vigorous traditional crops and controlled by a single business with a appetite for intellectual property. Did anyone else feel a cold wind pass through them? Now imagine a world where thousands of family farmers fight the good fight to continue giving consumers a choice in their food—and win.

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Thalidomide approved for use across the NHS half a century after it was banned

A victory for sanity after many years. It was always an interesting and useful molecule but its grievous side-effects in one particular application has until now largely stopped its use

Thalidomide has been approved for use on the NHS - half a century after it caused one of the biggest medical scandals in history. The National Institute for Clinical Excellence have recommended that the drug can be used to treat myeloma - a cancer which hits the bone marrow.

An estimated 10,000 children had defects at birth after pregnant women were prescribed the drug to prevent morning sickness.

After the government finally apologised last year, the drug is today again approved for use across the NHS, the Independent revealed.

Thalidomide was withdrawn from sale in 1961 after it was revealed that it was causing birth defects. It led to wholesale reforms in the drug licensing process, with much tighter regulations put in place.

A component of the drug prevents the growth of new blood vessels in developing embryos, stunting limb growth, researchers discovered.

The drug's UK manufacturer, Distillers Biochemicals, paid around £28million compensation in the 1970s following a legal battle by the families of those affected. Last year Health Minister Mike O'Brien said there were 466 thalidomiders - as victims of the drug are known - supported by the Thalidomide Trust.

As thalidomide makes its return half a century after it was banned, another drug, Velcade, has also been approved for use in treating myeloma. Drugs like thalidomide which are approved by Nice should be made available to patients across the UK.

Eric Low, Myeloma UK chief executive, said: 'It is vital that doctors have various effective treatment options in their toolbox to treat myeloma patients. 'Today’s recommendation confirms the significant role that both thalidomide and Velcade have to play as initial treatment options.'

Thalidomide has been used on the NHS in recent years to treat brain cancer in a limited number of cases, although it is the first time it's use has been formally recommended by Nice.

In the 1990s the drug began to make a return after [Israeli] research showed that it could be used to treat leprosy. There have been suggestions it could also be used to halt the development of prostate cancer.

Prescribing thalidomide is expected to cost £2,100 per treatment cycle and up to 2,000 patients each year could be given it now it has been recommended for use. Myeloma cannot be cured but drugs can be used to reduce the symptoms and stop the spread of cancerous cells.

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Are hot dogs as bad for you as cigarettes? They are judging by new warning signs



They're as American as apple pie - you'll find them at virtually every cook-out in the land and every sporting event. But now a medical group in Washington D.C. is taking aim at the gold old hot dog.

The Physicians Committee for Responsible Medicine has just unveiled a billboard in Indianapolis with a picture of hot dogs in a cigarette pack. The message reads: 'Warning: Hot dogs can wreck your health.'

The group is trying to create awareness of a link between hot dogs and colorectal cancer.

The [epidemiological] 2007 study they cite by the [sensation-mongering] World Cancer Research Fund found that one 50 gram serving of processed meat a day, about the same amount in one hot dog, increases the risk of colorectal cancer by about 21 per cent.

Hot dogs should come with a 'warning label that helps consumers understand the health risk,' Susan Levin, the committee’s nutrition education director told USA Today, similar to warning labels on cigarettes.

Not all health experts agree, naturally. 'It is not necessary to eliminate consumption of red or processed meat; rather the message is that these foods should not be the mainstay of your diet,' states the guidelines of the American Cancer Society.

But with some of America’s biggest racing events right down the street, the Physicians Committee decided to target Indianapolis Speedway, where NASCAR will hold its Brickyard 400 this weekend, NBC reports.

July is national hot dog month and considering more than 1.1 million hot dogs were sold during last year’s Indianapolis 500, they may have targeted the right audience.

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IVF children have bigger vocabulary than unplanned babies

For once we see some reasonable conclusions below. See para. 3 below

Children who were conceived through infertility treatment start school with speech skills up to eight months more advanced than those born after unplanned pregnancies, research suggests.

A study has found that pupils whose parents did not intend to have a baby lagged five months behind planned babies at age five, when their vocabulary was tested, and a further three to four months behind those born after IVF.

However experts say the findings are just down to the developmental gap between rich and poor in Britain. The differences in scores “almost entirely disappear” when family background is taken into account, since children born following assisted reproduction tend to have older, better educated and richer parents.

The paper, published online at BMJ.com on Wednesday, concludes: “Unadjusted analyses show that children born after unplanned pregnancy score poorly in cognitive tests compared with their planned counterparts, while children conceived after assisted reproduction do significantly better in tests of verbal ability.

“These differences are almost entirely explained by confounding by socioeconomic factors, providing further evidence of the influence of socioeconomic inequalities on the lives of children in the UK. To help children achieve their full potential, policy makers should continue to target social inequalities.”

Dorothy Bishop, Professor of Developmental Neuropsychology at the University of Oxford, said: “This study shows how important it is to take social factors into account when looking at child outcomes. Children from unplanned pregnancies have lower scores on cognitive tests than those from planned pregnancies, but they are also much more likely to come from single parent, low income households. Once this is taken into account, there is no impact of an unplanned pregnancy on children's development.”

In the report, Dr Claire Carson, a researcher at the University of Oxford’s National Perinatal Epidemiology Unit, analysed data on 12,136 children included in the Millennium Cohort Study.

Of those studied, 41 per cent were born following an unplanned pregnancy, with 15 per cent of their mothers admitting they felt unhappy or ambivalent about being pregnant.

A further 53 per cent of the pregnancies had been planned and led to conception within a year; 4 per cent of couples conceived after more than a year of trying; and 2.6 per cent had babies after ovulation-inducing drugs or assisted reproduction.

Using the standard British Ability Scales to test verbal ability at age five, the research found that the unplanned children had scores equivalent to a “developmental delay of more than five months” compared with planned ones.

In turn, the planned children lagged behind those born after IVF treatment by “three or four months”.

However these differences were explained by the “generally advantageous socioeconomic position” enjoyed by those born after fertility treatment, with their language skills also benefiting from having better educated parents.

Those born after unplanned pregnancies were more likely to have poor, young or less educated mothers, and to have less access to “books, puzzles, trips to library”.

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Bowel cancer rate doubles for British men

This is what is to be expected of an ageing population. Old people fall apart in all sorts of ways and there are now a lot more of them. The claims about red meat are just epidemiological garbage

Bowel cancer rates for men have doubled since the 1970s, it was revealed yesterday. More than one in 15 men are at risk of developing the disease compared with one in 29 in 1975. For women, the risk has risen by more than a quarter to one in 19, from one in 26 in the mid-1970s, according to figures released by Cancer Research UK.

Experts say a diet rich in red and processed meat and lacking in fruit and vegetables is partly to blame for the soaring levels.

Sara Hiom, director of health information at the charity, said: ‘An ageing population as well as changes in lifestyle have both led to more people developing cancer than a generation ago.

‘But even though the chances of getting the disease have increased in the population there are many ways that people can cut their own risk. ‘You can reduce your risk of bowel cancer by keeping a healthy weight, being physically active, eating a healthy diet that’s high in fibre and low in red and processed meat, cutting down on alcohol and not smoking.’

In 2008 there were 21,500 cases of bowel cancer diagnosed in men compared with 11,800 in 1975. For women the numbers have gone up from 13,500 in 1975 to 17,400 three years ago.

The figures, published in the British Journal of Cancer, represent the ‘lifetime risk’ of getting the disease, a new method of calculation taking into account people who get cancer more than once or die from other diseases.

Professor Peter Sasieni, the Cancer Research UK epidemiologist who produced the figures, said: ‘As people are living longer the numbers getting cancer have increased and the lifetime risk of developing bowel cancer has gone up. ‘For some cancers, including bowel, the risk of cancer in the next ten years will be much higher for people in their 50s and 60s.

‘But if someone reaches their late 70s and hasn’t yet developed the disease then their risk of getting it during the rest of their lifetime is lower than their risk at birth.’

Survival rates have improved, however, with 50 per cent of bowel cancer patients now living for at least ten years, double the number in the early 1970s due to earlier diagnosis and improvements in surgical techniques.

Scientists warned earlier this year that eating less red meat could prevent 17,000 cases of bowel cancer in the UK every year.

Mark Flannagan, chief executive of the charity Beating Bowel Cancer, urged people who are offered screening to accept the offer. ‘It could save your life,’ he said. ‘But we must look at the positives. In around half of cases bowel cancer can now be beaten.’

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A Second Avastin Opinion

Oncologists vs. the FDA on the breast cancer drug. Clinical experience has shown that it helps SOME women a great deal but for most it does nothing. Obama nominees work on the "all men are equal" theory so refuse to admit that some patients are different. Politics threatens to kill women. Not that killing people has ever bothered Leftists

The "humanitarians" urging the Food and Drug Administration to withdraw Avastin for women with terminal breast cancer claim there is no other choice: The evidence shows Avastin doesn't work, so too bad. But how to square that view with the highly respected medical group that —reading the same evidence— recommends preserving Avastin as a treatment option?

The National Comprehensive Cancer Network is a consortium of 21 leading U.S. oncology programs that issues practice guidelines on the basis of "sound, evaluative clinical information," according to its mission statement. Last week, the NCCN's breast cancer panel reaffirmed its position that Avastin is "an appropriate therapeutic option" for some patients in combination with chemotherapy. The vote was 24 in favor, with one abstention. No members were opposed.

The FDA's expert panels have now reviewed Avastin three times. All three have rejected it, though the first vote was overruled by the FDA leadership in 2008 to give the biologic drug provisional approval. Cancer division chief Richard Pazdur moved to revoke approval last year after a negative re-review of the evidence, and a final decision is now pending following an unprecedented appeal hearing last month by Avastin's maker, the Roche subsidiary Genentech.

Yet the NCCN has now reviewed Avastin for breast cancer four times since adding it to the compendium in 2005, and each time it has reaffirmed its support. One reason for the group's divergence with government is that it fields practicing oncologists from institutions like Dana-Farber/Brigham and Women's Cancer Center at Massachusetts General Hospital, the University of Texas's M.D. Anderson and Memorial Sloan-Kettering in New York. They understand the benefits that Avastin can provide to some (but not all) women in controlling their disease, and the NCCN's advice is appropriately qualified.

The FDA, by contrast, favors statistical purists who think in the abstractions of controlled trials, and its conflict-of-interest rules are meant to exclude doctors who have experience treating specific cancers in the real world. For the FDA, believe it or not, being an expert in breast cancer fatally compromises your objectivity in ruling on a breast cancer drug. The oncologists also don't carry Dr. Pazdur's political agenda to increase his agency's power over cancer drug approvals.

Genentech is merely asking for Avastin to remain available for metastatic breast cancer while it conducts an additional trial to add to the evidence about which patients Avastin does help. FDA Commissioner Margaret Hamburg hasn't said when she'll make a final decision. If you were a patient, would you rather trust a federal regulator or some of the best cancer doctors in the country?

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Charles? He’s just a snake-oil salesman: Professor attacks prince on ‘dodgy’ alternative remedies

Prince Charles has been branded a ‘snake-oil salesman’ by Britain’s first professor of complementary medicine for supporting ‘dodgy’ alternative therapies.

Professor Edzard Ernst claimed yesterday that the prince’s backing for ‘unproven and disproven’ remedies was an attempt to smuggle them into the NHS despite scientific evidence showing they could be dangerous.

Prof Ernst, who set up Exeter University’s Centre for Complementary Medicine in 1993, left his post last month after claiming that a row with a senior aide to the prince had led to the withdrawal of support from university managers and the drying up of research funds.

He has carried out a series of scientific investigations into complementary medicine such as homeopathy and herbal remedies over the past decade.

Yesterday Prof Ernst told a conference in London that he found evidence that around 20 therapies were useful for various conditions, ranging from Co-enzyme Q10 supplements for high blood pressure to St John’s wort herbal pills for depression.

But the evidence was lacking for alternative therapies such as chiropractic, detox, herbal slimming aids, cancer cures, and homeopathy – which has long been championed by the prince and other members of the Royal Family.

He said such remedies were being peddled by ‘snake-oil salesmen and pseudo science’ and were dangerous to the public, who might be put directly at risk or as a result of rejecting conventional medicine in favour of ‘dodgy’ remedies. Asked whether he classified the prince as a snake-oil salesman, Prof Ernst replied: ‘Yes.’

In a comment for the Journal of Internal Medicine, the professor, who has been nicknamed the Quackbuster for his efforts to root out alternative remedies for which he can find no evidence, criticised the concept of integrated, or integrative, medicine. This advocates treating the patient with conventional and complementary approaches and is backed by the prince.

Prof Ernst said it covered a ‘wide range of unproven and disproven’ therapies, and was ‘nothing other than a cloak of respectability disguising alternative medicine’. He wrote: ‘At best, integrative medicine is well meaning but naive, at worst it represents muddled or even fraudulent concepts with little potential to serve the needs of patients.’

He said he suspected that Prince Charles wanted to get the NHS to supply more alternative therapies despite the lack of scientific evidence for many of them. The prince’s complementary health charity, the Foundation for Integrated Health, closed last year amid a criminal investigation into fraud and money-laundering.

Prof Ernst has clashed with the prince before. He accused him of ‘exploiting a gullible public’ by putting his name to a detox treatment in his Duchy Originals brand. The £10 Duchy Herbals Detox Tincture relied on ‘superstition and quackery’ rather than science and the range should be re-named ‘Dodgy Originals’, he said.

Prof Ernst, 63, has also blamed a row with the prince’s office five years ago for forcing his early retirement from Exeter’s complementary medicines unit in June – two years early. He attacked a report advocating complementary medicine, commissioned by the prince, as ‘outrageous and deeply flawed’.

This prompted a formal complaint from Sir Michael Peat, the prince’s private secretary. Prof Ernst said he had been cleared after a long investigation but blamed lack of support from the university coupled with lack of research funding for a closure threat to the unit.

He claimed he had offered to go if it would save the unit, and his offer was accepted by Professor Steve Thornton, the new dean of the university’s Peninsula Medical School, who agreed to fund the appointment of a successor. A university spokesman said: ‘We are looking to replace Professor Ernst on his retirement with another specialist in complementary medicine. 'We will support that person to raise funds to enable research to continue, but have earmarked £234,000 to support the centre over the next 12 months.’

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Migraines, Michele Bachman, and me

by Jeff Jacoby

WHEN THE DAILY CALLER, a news site based in Washington, DC, reported last week that Michele Bachmann gets migraine headaches, it labored to give the impression that it was breaking an important story.

"Stress-related condition 'incapacitates' Bachmann; heavy pill use alleged," the foreboding headline read. (Cue the grim background music.) The article, by Jonathan Strong, depicted a woman who regularly crumples in the face of stress, reacting to the normal aggravations of political life -- a staffer's resignation, a missed flight -- with "medical episodes" that leave her "incapacitated" for days at a time. To cope, she "takes all sorts of pills. Prevention pills. Pills during the migraine. Pills after the migraine. . . . Pills wherever she goes." These "debilitating" migraines "occur once a week on average," and at least three times have landed Bachmann in the hospital. Her staff must "constantly" consult with doctors to "tweak" their boss's medication.

Bottom line? "Some close to Bachmann fear she won't be equal to the stress of the campaign" and some former aides "are terrified" by the thought of a migraine-prone President Bachmann.

All very melodramatic. But a few things were missing from Strong's account. Like the nature of all those "pills" that Bachmann supposedly takes -- addictive narcotics, or something more innocuous? And the identity of any of the unnamed "former aides" whose allegations the story recycles -- what candidates, if any, are they working for now? Missing too was any evidence that a migraine condition is incompatible with the pressures of the presidency or any other high-powered position.

That's because no such evidence exists.

The health of presidential candidates is of course a legitimate news topic. That's especially true since, to quote the historian Robert Dallek,"concealing one's true medical condition from the voting public is a time-honored tradition of the American presidency."

Gone are the days when a presidential candidate with severe medical problems could brazenly claim to be in excellent health and expect to get away with it. During and after the 1960 campaign, John F. Kennedy -- who suffered from Addison's disease, colitis, urinary tract infections, and the near-crippling pain of degenerative back problems -- took what Dallek called "an extraordinary variety of medications," including steroids, painkillers, antibiotics, and anti-spasmodics. Yet with the help of a friendly press, the Kennedy machine easily downplayed JFK's afflictions; The New York Times, quoting an article in a medical magazine, described him as being in "superb physical condition."

Neither Bachmann nor any other 2012 candidate would get that kind of pass today. By the same token, no candidate should be subjected to anonymous media rumormongering about her health or medical fitness.

Migraine headaches are a uniquely painful misery, as I can attest from long personal experience, but they are not stroke or heart disease or polio or Alzheimer's. At their worst, migraine attacks can involve hours of throbbing head pain, as well as blind spots and other visual abnormalities, intense nausea, chills, and tears streaming from one eye. "That no one dies of migraine," Joan Didion wrote in a famous essay, "seems, to someone deep into an attack, an ambiguous blessing." Such attacks terrified me when I was young; I vividly remember wondering, as an 11- or 12-year-old, if I was dying of brain cancer. Not until I was in college did I learn that my agonies had a name, and that I wasn't the only one to experience them.

More than 35 million Americans suffer from occasional or chronic migraine; many, Bachmann included, control their symptoms with medication. Far from popping "pills wherever she goes," however, she takes medicine only when she has an attack. According to Congress's attending physician, Dr. Brian Monahan, Bachmann's migraines "occur infrequently" and are helped by sumatriptan, a standard drug for relieving the dilation of blood vessels that causes migraine pain, and odansetron, an anti-nausea drug.

Could someone with a migraine condition be president of the United States? Ask Thomas Jefferson.

In my case, age, not medicine, seems to have been the best therapy; when my odometer passed 40, the migraine attacks started growing less severe. But even before then, migraine wasn't a paralyzing disability. The headaches hurt like hell, but they didn't keep me from getting an education or holding a job. I don't recommend giving a speech or going on TV while having a migraine, but I've managed to do both. I imagine Bachmann has too. Her migraines plainly haven't slowed her impressive rise in national politics, or kept her from setting the GOP primary field on fire. If she were "incapacitated" on a weekly basis, it's unlikely she'd have come so far, so fast.

So is it news that a would-be president once complained of migraine attacks that are "paroxysms of excruciating pain" -- headaches that "came on every day at sunrise and never left me till sunset"? No -- not unless it's news that Thomas Jefferson, who wrote those words, suffered migraines. Ulysses Grant did, too.

Could Michele Bachmann become the next US president? I have no idea. But this much I do know: She wouldn't be the first one to live with migraine headaches.

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Losing weight on the diet? It won't last

More evidence of the futility of the obesity "war". The war is about control, not health. Controlling people gets a Leftist's rocks off

Scientists have come to a depressing conclusion for dieters: once you are fat, chances are you will stay so. They have found that while diets may help in the short term, the vast majority of dieters just put the weight back on afterwards.

Once people start to pile on the pounds in middle age their weight tends to continue "relentlessly upwards", according to a long-term study of 25,000 men and women.

Rather than concentrate efforts on diets, health campaigners should focus their efforts on stopping people getting fat in the first place, concluded the team from the Government-funded Medical Research Council.

Their work found that, while 12 million try a diet every year, only 10 per cent manage to lose a significant amount of weight. Of those that do, most will put it back on within a year.

They followed the lives of 5,362 men and women born in 1946, and 20,000 more born in 1958, who are part of the MRC's ongoing National Survey of Health and Development.

Rebecca Hardy, from the MRC, told The Sunday Times: "Both groups began increasing in weight in the 1980s and since then people have been increasing in mass all through life.

"For men it goes up steadily through life. For women it starts slowly and accelerates in the mid-thirties. Once people become overweight they continue relentlessly upwards. They hardly ever go back down. "A few lose weight but very few get back to normal. The best policy is to prevent people becoming overweight."

However, the team also said that while diets might not make much of an impact on the weighing scales, they often helped make people healthier by getting them to eat better foods and take more exercise.

About six in 10 adult Britons are either overweight or obese, a figure which is steadily rising.

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Can silk cure thrush?

This seems a remarkably silly study. Silk underwear was impregnated with antifungals and the reduction in thrush was attributed to the silk rather than the antifungals!

Ever wondered why Marilyn Monroe – wearing nothing but Chanel No 5 – preferred to sleep on silk sheets? Or why the mother of singer/actress Jane Birkin advised her: “When you’ve got nothing left… get into silk underwear and start reading Proust.”

New research suggests the sensuous fabric isn’t just practical shorthand for allure and intimacy, it also appears to be associated with healing qualities that range from easing the symptoms of the menopause, to anti-ageing, and, most recently, relieving recurrent thrush.

The study, a double-blind clinical trial at the University of Bologna, Italy, concluded that a new range of silk underwear dramatically reduced the itching and redness that can accompany persistent and recurrent vaginal thrush. This fungal infection is common, affecting three in four women at some point in their lives, and for one in 20 it will recur more than four times a year.

Typical treatment in persistent cases is with fluconazole (Diflucan), an anti-fungal agent.

The Bologna team asked half the women in its trial to try DermaSilk Intimo briefs, made from a special silk fabric developed by the Italian firm Alpretec.

The remaining 50 per cent wore cotton; neither group, nor their doctors, were told which fabric was being investigated, and the treated silk actually felt more like a cotton-type fabric than chic lingerie. After six months, about 90 per cent of the group wearing silk found their symptoms reduced, and recurrence of the infection was halved.

So how exactly could silk help? Candida albicans, the yeast that causes thrush, thrives in warm, moist conditions. The briefs are made from fibroin, a medical-grade silk that absorbs excess moisture.

It is also impregnated with an antimicrobial agent that kills a wide range of bacteria and fungi on contact, including C. albicans, and never loses its full activity even with regular washing. It should be pointed out that Alpretec funded the research, but the briefs are part of a clothing range that is now available on NHS prescription.

SOURCE

Review of The Great Cholesterol Con by Dr Malcolm Kendrick (John Blake 270 pp)

A useful review by Dr. Alick Dowling, originally presented to the Bristol MedChi society in May ‘07

The Bristol MedChi Society’s programme this year featured “Doctors under Pressure”. Dr Kendrick’s book is relevant, because he is a maverick outsider, tilting at an established theory. “Doctors under Pressure” is also relevant to GPs, in thrall to a policy, imposed by the Department of Health’s setting targets: cholesterol levels to be measured and lowered by statins. It is the GPs and perhaps the advising cardiologists who will be blamed if it turns out that statins were not the best answer.

Readers of the book who start at the back – a surprising number do so – will be impressed by the final Postscript, moderate, full of common sense and in agreement with much of what the medical mainstream has been saying for years. Turn to the Introduction and readers will be faced with a critical view of the Diet-Heart/Cholesterol Hypothesis, presented with mordant humour not perhaps to everyone’s taste, but preferable to the paternalistic material that comes from the DoH.
An example:

“Frankly, the idea that an inanimate molecule can suck cholesterol out of a plaque is so laughable that I can’t begin to explain here how preposterous an idea it is. And moreover, I would challenge any scientist anywhere to explain exactly how it happens. A molecule that travels both ways through a concentration gradient? ‘Of course it does, now run away and play with your friends and leave the adults alone.’

When Dr Kendrick warns about unrecognised dangers of statins, his style changes.

“Taking a statin is now viewed, among doctors, as akin to taking a multivitamin or low-dose aspirin. If this book achieves nothing else but start a debate on this issue, then I will be perfectly content. Perhaps you think statins are harmless, so it doesn’t really matter all that much? Well if you are a foetus, statins are not harmless at all. But be afraid, be very afraid. In April 2004 an article appeared in the New England Journal of Medicine – ‘Central nervous system and limb anomalies in case reports of first trimester statin exposure. Though contraindicated in pregnancy they found 52 confirmed cases of birth defects, as high as anything found with thalidomide and with more serious defects. With statins now available over the counter in the UK there is an increasing danger that warnings about taking statins in pregnancy will go unheeded.”

How many of us know this? The current debate about side effects of statins since a recent article by Dr James Le Fanu is another reason to consider Dr Kendrick’s approach.

Sweeping it under the carpet is not an option when so many people have access to the Internet. His essay on the subject in Panic Nation (2005) demolishing the Great Cholesterol Myth has not been challenged, and now he develops the theme with detailed references starting with the emphasis that cholesterol is vital for our physiology. The case of cholesterol is controversial. Demonised as a cause of heart attacks, cholesterol is a vital component in our body, being a precursor of important enzymes. Its blood level is the cause of much anxiety, made worse by the assumption that its level in the bloodstream is related to the cholesterol in our diet.

Physiologists know this is not true. The cholesterol in our blood comes not from cholesterol in our diet but from what we each manufacture in our livers ourselves. Supporters of the Atkins Diet claim his high-fat diet does not raise cholesterol levels. This suggests natural levels are less susceptible to influence by diet or drugs than many believe.

Should we concern ourselves with the opinion of one doctor who has chosen to challenge the ‘consensus’ about the dangers of high cholesterol levels? Yes:

a) because the ‘consensus’ has often been wrong. Dr Kendrick gives examples:

“Another leech anybody, or perhaps a radical mastectomy, or a tonsillectomy, or a removal of toxic colon? What about that old chestnut ‘no bacteria can live in the human stomach? And ‘strict bed rest following a heart attack’ – how many millions did that kill?”

b) because Richard Feynman, Physicist said:

“Of all the many values of Science the greatest must be the freedom to doubt.”

The DoH, through public health campaigns, promotes false information demonising cholesterol as uniquely harmful. It is surprising that so many have accepted this view, including the absurdities of ‘good’ and ‘bad’ cholesterol. Edicts from the Department of Health pronouncing official policy, with targets set for GPs, do not inspire confidence. They come with the stamp of certitude, never a suggestion of possible error. The DoH discourages those who question its policies, yet certainties have recently been overturned, as in the case of the organism Helicobacter pylori causing peptic ulcer.

The U-turn regarding ‘Helicobacter pylori’ was not an isolated event. Previous reversals of treatment have been accepted by the DoH, usually ungraciously. We must follow Professor Feynman’s advice and we must doubt – even those of us with perhaps a natural reluctance to question advice from Government sources. We must also confront advice that conflicts with physiology or common sense, both of which apply to the edict that we should believe saturated fat and cholesterol intake affects blood levels.

Though dismissed by the establishment as a lone voice that can be ignored, there are many who support Dr Kendrick’s stance. Dr Richard Asher (1912-1969), a much admired medical educator wrote in 1968, when clofibrate was promoted to reduce cholesterol levels:

“Please do not write any more articles about cholesterol and coronary disease and the diet and drugs which are supposed to influence them. The facts about coronary disease are these: the less atheromatous your ancestors, the harder your tap water, and the more habitual exercise you take, the less likely you are to be troubled by it. Do stop bothering about whether your fats are saturated or unsaturated, help yourselves liberally to butter and stop propagating these erroneous legends.”

Richard Asher also said

“to name something by its supposed cause, whether or not that cause is the right one, is a very serious mistake. However sure of a cause clinicians may be, a diagnostic label must be descriptive and not causal.”

He deplored unconfirmed diagnoses being used, because this perpetuated error and delayed proper evaluation of the condition. A modern example is using the name: Diet-Heart cholesterol syndrome. Many years previously Asher had used cholesterol levels when assessing the dosage of thyroid for myxoedematous patients so he was familiar with their capricious levels. He never thought they had any relevance to heart disease.

The structure of Dr Kendrick’s book is impressive, though the list of Contents does not make this immediately clear – too many of the important sub-headings are buried in the text of the longer chapters. Chapter 1 is not contentious; a description of heart attacks follows mainstream thinking and research.

In Chapter 2 & 3 Dr Kendrick surveys cholesterol (‘good’ and ‘bad’), saturated fats and unsaturated, lipoproteins and triglycerides and disentangles the misnaming and complexities of these and much else.

Chapter 4, the shortest is about statins, prefaced by a quotation “One of the first duties of the physician is to educate the masses not to take medicine: Sir William Osler (1849-1919).

Chapter 5 describes the rise of the Cholesterol Hypothesis, and in Chapter 6 subtitled “Diet Has Nothing to do with Heart Disease” Dr Kendrick starts to dismantle the diet-heart hypothesis in 21 pages, finishing with a Postscript of favourite quotes.

Chapter 7 The longest: Though many researchers have given up on the idea of the diet part of the diet/heart hypothesis, Kendrick is more isolated in challenging the cholesterol part. He writes as a convert. He used to believe that raised cholesterol levels caused heart disease. However when he realized that raised cholesterol levels were not a risk factor for strokes he had to revise his opinions, and this chapter is the heart of the book. Some readers might find it hard going, but his enthusiasm and style make it worth persevering.

Chapter 8 is the last in this section, entitled Statins and Heart Disease, and involves Dr Kendrick in assessing the many studies that have been made on this controversial subject. He has learnt how to recognize the weasel words that conceal rather than reveal the truth. ‘Might indicate’ ‘could show’ etc. Statistical evidence is often hard to judge – most doctors have had no training in this and Kendrick’s advice is enlightening:

How to do Scientific Studies – for Five-Year-Olds.

Rule 1 If you have more than one uncontrolled variable in your study you can’t prove anything.

Rule 2 If you think you have proved something in a study with more than one uncontrolled variable, Rule 1 shall apply.

Chapters 9, 10 & 11 (63 pages) are in effect a 2nd book (two for the price of one!) and provide an alternative hypothesis for the question What Causes Heart Disease. Readers who are not particularly interested in the ins and outs of cholesterol might well start with this part of the book – perhaps having already read the postscript, but we should at least do Dr Kendrick the courtesy of reading his book when he has taken the trouble to provide so much supporting evidence for his contention.

There are of course criticisms to be made of such an ambitious venture. The number of acronyms can be bewildering– an alphabetical list of them could easily be provided and if these were indexed the lack of a general Index would be easier to bear. An expanded list of Contents would help readers who wanted to refer back or forward.

Most medical readers will learn something new from this wide enthusiastic survey of current treatment for heart disease.

Disclosure: I am grateful to Professor Stanley Feldman, Professor Vincent Marks and the 16 other contributors to the essays: “Unpicking the Myths we’re told about Food and Health” – the subtitle of Panic Nation published July 2005. Many subjects, including Dr Malcolm Kendrick’s essay The Great Cholesterol Myth, considered in Panic Nation provide scientific justification for assertions made earlier on common sense grounds in Enjoy Eating Less. It is a relief to find such a raft of expert opinion to sustain them.

Received direct from author




Seaweed 'is natural way to protect the heart' as algae helps bring down blood pressure

This is all theory. No clinical evidence is presented

It's hardly the most appetising vegetable side dish. But tucking into a clump of seaweed at dinner time could help stave off heart attacks, say researchers. They have discovered key ingredients in the plant that help lower blood pressure, similar to commonly prescribed drugs.

According to a major study, seaweed is a rich source of proteins known as bioactive peptides – which are also found in milk. These chemicals have a similar effect to ACE inhibitor drugs, which are widely prescribed to help lower blood pressure and prevent heart attacks and strokes.

Seaweed is rarely eaten in Britain but has been a staple of the Japanese diet for centuries. Popular varieties include Wakame, used in miso soup, Kombu, and Nori, which is dried and used to wrap sushi.

One of the few types eaten by Britons is the red seaweed called laver, which is used to make laver bread. But experts insist many of the clumps found on our beaches are, in fact, edible. Dr Maria Hayes, of the Teagasc Food Research Centre in Dublin, said seaweed - known as macroalgae - was an 'untapped source' of these healthy ingredients.

The research, published in the American Chemical Society's Journal of Agricultural and Food Chemistry, looked at evidence from 100 other studies. It called for more effort to exploit the bioactive compounds and 'their potential for use and delivery to consumers in food products'.

The report stated: 'The variety of macroalga species and the environments in which they are found and their ease of cultivation make macroalgae a relatively untapped source of new bioactive compounds, and more efforts are needed to fully exploit their potential for use and delivery to consumers in food products.'

Seaweed is very low in calories and some scientists claim it helps weight loss by preventing the absorption of fat. Japanese researchers recently found that rats fed a certain type of seaweed lost 10 per cent of their weight.

SOURCE

Affordable Healthy Food is in the Eye of the Bill-holder

This past Wednesday, Michelle Obama hosted a press conference where she detailed the latest progress on her Let’s Move campaign. It seems she has shifted her focus from exterminating characters marketing unhealthy foods, and decided instead to pretty much shove broccoli and Brussels sprouts into people’s faces.

She announced that corporate giants such as Walgreens and Walmart have joined her fight to provide healthy food to under-served, low-income areas. The pledges from these and other companies promise to create thousands of jobs and bring healthy, affordable food to almost five million people. (And who said world peace wasn’t possible?)

Walgreens pledged to created “food oasis” stores that would provide such amenities as ready-made meals and fresh, pre-cut fruit, promising to create more than 6,000 jobs. Walmart said that it would make an effort to make all its food a little healthier and improve more than 300 stores, estimated to create 40,000 jobs. And several other smaller stores signed up to do their part for the cause.

At first glance, this program seems harmless. A bunch of stores are promising to supply healthier, more affordable items to their consumers, what could possibly be bad about that?

Well, as with everything in life, all good things come at a cost. In this case, $35 million of the proposed budget for 2011 alone and $300 million for 2012, all coming from the already over-stretched taxpayer pockets, which seeing as Obama’s idea of stimulating the economy is taking from those who work and giving to those who don’t, will largely be paid by the upper 2 percent. A demographic that is very likely not to be counted among those who are “under-served.”

So to recap, Michele Obama plans to propose $335 million in spending, in the midst of the worst economic crisis in decades, in order to put more fruit on the shelves of the American people. It is understandable to want to try and discourage obesity by advocating for a healthier diet, but quite another to dedicate portions of the national budget to impose lifestyle choices on communities that may not even want it.

The First Lady said herself that it was up to the communities to decipher what their specific needs were, so what if some “at-risk, under-served” communities want to keep their McDonald’s and KFC and aren’t keen on having a Walgreens “food oasis,” but need the jobs it could [potentially] provide? The program lures American’s in with its promise of jobs (as good as tying steak to yourself and jumping in a shark tank) and then locking them into food choices that they might not otherwise make without them realizing what it all meant (this is the part where the shark tears you in half).

Never mind the fact that people have the ability to choose what they eat, and have been choosing what types of food to consume, despite the selection provided for them. Fresh fruit is already sold in a multitude of stores, from big-name supermarkets, to corner stores and even 7Eleven. So why do we need to build more places to buy these items when they are already readily available in locations typically situated in “under-served” areas?

It seems that what Ms. Obama really wants to do is to take her idea of how Americans should eat, and force it on those who are unable to refuse her. Lower income, under-served communities need jobs more than any other demographic in this country and Michele thinks that they also need better nutritional habits.

In order to do that, she is using her bully pulpit to partner the gigantic new healthy food-bearing stores with the promise of increased jobs for those in need. She could have offered them anything and as long as it came with jobs, the communities would be on board.

What our nation needs right now is to focus on our debt, which will only be further exacerbated by the enormous spending increases suggested by this program. People will eat fruit if they want to, or Big Mac’s if they want to and a shiny new store with a big electric sign advertising “Healthy Food Sold Here!” isn’t going to change their minds.

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The Pretense of Medical Knowledge

Like his mentor Ludwig von Mises, Friedrich Hayek spent his academic career trying to expose the central planner's pretense of economic knowledge. In doing so, Hayek referred to "the knowledge problem." In explaining it, he writes,

The peculiar character of the problem of a rational economic order is determined precisely by the fact that the knowledge of the circumstances of which we must use never exists in concentrated or integrated form but solely as the dispersed bits of incomplete and frequently contradictory knowledge which all the separate individuals possess.…

If we can agree that the economic problem of society is mainly one of rapid adaptation to changes in the particular circumstances of time and place, it would seem to follow that the ultimate decisions must be left to the people who are familiar with these circumstances, who know directly of the relevant changes and of the resources immediately available to meet them. We cannot expect that this problem will be solved by first communicating all this knowledge to a central board that, after integrating all knowledge, issues its orders. We must solve it by some form of decentralization.[1]

Hayek and Mises strongly believed in decentralization because they believed that certainty regarding how to solve economic problems was impossible to attain, and that the best answers could only be arrived at through the spontaneous and uncoordinated actions of millions of individuals interacting freely within the marketplace.

They believed that steering the economy through a centrally planned, one-size-fits-all approach could never account for the thousands of degrees of variation within different individuals' operative knowledge, personal preferences, access to resources, etc. For these reasons, Mises and Hayek feared the unintended consequences of government planning, and rightly pointed out that such planning would necessarily block innovation and inject systemic risk into the system by preventing the market from routinely ferreting out poor practices.

To be clear, Mises and Hayek did not believe that markets were incapable of error. In fact, they believed that market participants would continually make mistakes, but that these mistakes would be corrected more quickly in market conditions than under conditions where government made the rules and had a vested interest in ensuring a certain outcome. I strongly believe that the history of the last century vindicates these men and the Austrian School in general. However, the purpose of this paper is not to explain how government intervention in general and "the knowledge problem" in particular have been responsible for any particular economic problem (that is better left to others), but rather to explain how the knowledge problem has profound implications for my own profession.

One can broaden Hayek's economic knowledge problem to include the practice of medicine by changing only a few key words in the above passage from Individualism and Economic Order.

The peculiar character of the problem of a rational medical order is determined precisely by the fact that the knowledge of the circumstances of which patients and physicians must use never exists in concentrated or integrated form but solely as the dispersed bits of incomplete and frequently contradictory knowledge which all the separate patients and their physicians possess.…

If we can agree that the medical problem of society is mainly one of rapid adaptation to changes in the particular circumstances of time and place, it would seem to follow that the ultimate decisions must be left to the physicians and patients who are familiar with these circumstances, who know directly of the relevant changes and of the resources immediately available to meet them. We cannot expect that this problem will be solved by first communicating all this knowledge to a central board which, after integrating all knowledge, issues its orders. We must solve it by some form of decentralization.

The idea of decentralization, critical to Mises, Hayek, and the Austrian School in general, is diametrically opposed to the prevailing trend to centralize medical decision making. All those who follow this trend share one thing in common: a false sense of certainty that medical decisions, previously made between the individual patient and his physician, can be better guided by an enlightened set of standardized practices determined by groups of experts (i.e., the Independent Payment Advisory Board). In my opinion, those who believe that medical decision making should be centralized are as misguided as those who believe that the federal government, in concert with the central bank, has perfect knowledge of the policies required to grow the economy.

Ultimately, medicine is practiced, not in black and white, but in shades of gray. This is not to say that "the state of medicine is worse than that of total ignorance," as Thomas Jefferson opined in a 1799 letter written to William Green Munford. Quite the contrary; we have developed an impressive, albeit incomplete, understanding of the states of sickness and health all the way down to the molecular level. Even so, it is quite difficult, if not impossible, to say for sure how any individual patient will respond to a particular therapy or surgery, or what the prognosis in days, months, or years will be for any individual patient's disease course. But despite this, institutional experts, central planners in Washington, trial lawyers, and their expert witnesses abandon all humility and insist that if something is done a certain way then a certain medical outcome can be or would have been achieved.

Often such assertions are based on scientific studies, but at best these studies can only help us to make generalizations about populations of patients; they do not tell us about any individual patient in particular. For example, a study might measure the blood-pressure responses of a group of 500 patients receiving drug A and a group of 500 patients receiving a placebo. If those receiving drug A experienced a 10-point decline in their blood pressure compared to the placebo group, all I could tell the patient sitting in front of me is that "in a study that compared drug A to a placebo, the group that took drug A, on average, experienced a 10-point decline in their blood pressure." I can't say with any certainty that the patient in front of me will experience a 10-point decline; he may experience a 20-point decline or no decline at all. Furthermore, he may also have an adverse reaction to the drug that cancels out any potential benefit.

When deciding whether or not to suggest drug A to my patient, I must take into account many factors. For example, if drug A has a narrow therapeutic window and a dangerous side-effect profile, I may not recommend it if my patient is taking multiple other medications or if he often has trouble taking medications correctly. These issues could increase the patient's chance of experiencing serious or even life-threatening side effects, thereby ultimately limiting the drug's potential benefits.

I also need to consider the context of the patient's overall health status. For example, is it worth subjecting the patient to another medication in the context of his other issues? Do the benefits of lowering his blood pressure outweigh the risks of the therapy? How I answer these questions will depend on how I interpret the data from published studies. These are just a few of the many considerations that I, as the physician, need to bear in mind.

Then there are the patient's considerations. He may not desire to take more pills in the setting of an already-large medication burden — many patients feel that medications have insidious effects that make them feel fatigued or miserable even in the absence of a major complication. Alternatively, a patient may opt to try diet and exercise to lower blood pressure before starting a medication. These are just two of the many considerations the patient needs to make.

Now, to restate the point made by Hayek, my patient and I cannot expect that the decision whether or not to take drug A (or to undergo a certain diagnostic study or surgical procedure) will be solved by first communicating all the knowledge we have separately, in addition to that gained through our own physician-patient relationship, to a central board which, after integrating all knowledge, issues its orders. It seems absurd. Unfortunately, this is the direction medicine has been heading for decades now.

One (perhaps the most ill-conceived) manifestation of central planning and the arrogance of medical knowledge is the government's endorsement of "pay-for-performance" measures.

Meeting these measures often requires strict adherence to professional guidelines. And while I see no problem in voluntary organizations making guidelines to be used as general recommendations for their members to follow, I see a major problem when guidelines become dogma. When this occurs,

1). Patients are no longer viewed and treated like unique individuals; instead, they are treated like numbers on an actuarial table.

2). Physicians are no longer regarded by society (and themselves) as thoughtful and caring practitioners; instead, they are regarded as mindless automatons.

At worst, strict adherence to guidelines can subject the individual patient to significant harm. Take for example the real-life case of blood-pressure management in the outpatient setting. Several professional organizations and task forces advise trying to get patients to reach a low blood-pressure number (i.e., <130/80). Unfortunately, this recommendation is most likely an overreach — as many physicians have suspected all along. More recent data suggests that aggressive treatment may increase the risk of serious side effects without conferring a survival advantage.[2]

Leading thinking in the field now considers the question of how best to manage blood pressure as significantly more nuanced and subject to many individual factors.[3] Despite this, pay-for-performance measures still indiscriminately endorse the attainment of low blood-pressure targets. In this case, forced adherence to overly simplistic guidelines is likely subjecting many patients to the potential harm of overly aggressive blood-pressure treatment.[4]

In conclusion, the study of medicine is a science, and science helps us to understand ourselves and the world in which we live.

As to this, there is no doubt. However, while science provides many answers, it provokes at least as many new questions. For this reason, medicine has always been considered both a science and an art. The art involves applying medical science, which is often unsettled, always changing, and still rapidly advancing, to the cases of individual human beings, who are unique in an infinite number of ways.

For both the advancement of the field and the well-being of patients, we should hope this art is not co-opted by governing elites (including those with an MD or MPH after their name) who believe that practicing medicine is as easy as checking off boxes and interpreting numbers on a computer screen. Such a simplistic view is undoubtedly a fatal conceit.

SOURCE

An unprecedented 1 in 66 Americans is a diagnosed psychotic

In the usual Leftist way the story below blames drug companies for decisions made by doctors -- showing the usual Leftist contempt for everyone but themselves. The power of intellectual fashions is ignored.

In a related matter, my GP says that he often tries to talk parents out of a referral to a psychiatrist for their child -- telling them that their son is just a perfectly normal lively little boy. But the parents believe teachers who in turn want a more docile class and so insist on a referral

So blame lazy Leftist teachers for all the kids on Ritalin

In the matter below note that is often nursing home managers who demand antipsychotic medications as a "chemical cosh" for difficult inmates. It's their own self-intertest, not drug salesmen, who motivate their demands

For whatever reason, however, there is clearly a huge amount of overmedication

Outselling even common drugs to treat high blood pressure and acid reflux, antipsychotic medications are the single top-selling prescription drug in the United States.

Once reserved for hard-core, One Flew Over The Cuckoo's Nest type of mental illnesses to treat hallucinations, delusions or major thought disorders; today, the drugs are handed out to unruly kids and absent minded elderly.

A recent story in Al Jazeera by James Ridgeway of Mother Jones illuminates the efforts by major pharmaceutical companies to get doctors prescribing medicines like Zyprexa, Seroquel, and Abilify to patients for whom the drugs were never intended.

Focusing on psychiatrists because they rely on subjective diagnoses, the drug reps have been so successful that they've changed the criteria for mental illness and disability payments. Ridgeway quotes former New England Journal of Medicine editor Marcia Angell.

"[T]he tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007 - from one in 184 Americans to one in seventy-six. For children, the rise is even more startling - a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children."

Particularly vulnerable because medication decisions are often out of their hands the old and the young suffer most.

For kids: the number diagnosed with bi-polar disorder rose 40-fold between 1994 and 2003 and one in five comes away from a psychiatrist with a prescription for an antipsychotic.

Dosing the elderly at nursing homes has become so common that sales reps have coined the term "five at five" -- meaning 5 milligrams of Zyprexa at 5 pm to sedate difficult residents.

For all their nefarious wrangling, in 2009, Lily agreed to pay $1.4 billion, including a $515 million criminal fine. The largest ever in a health care case and the largest criminal fine on any corporation in the U.S. That year, Lilly sold $1.8 billion of Zyprexa alone.

SOURCE





More evidence that high IQ is just one aspect of general biological good functioning

Since the studies by Terman & Oden in the 1920s it has been known that, although not all high IQ people are healthy, most are. They have fewer health problems and live longer. And IQ is the main determinant of educational success, so the findings below are as expected. Kids born with indications of poor health have lower IQs so do less well at school

A health test given to babies minutes after they are born could reveal how well they will do in secondary school, it has been claimed. A study of 877,000 Swedish teenagers compared school exam results with their Apgar scores after birth.

The Apgar is a test which rates the newborn's health on a scale of one to ten and how much medical attention the child needs.

Researchers found a link between an Apgar score of below seven and lower intelligence in later life.

Dr. Andrea Stuart, an obstetrician at Central Hospital in Helsingborg, Sweden, told Msnbc: 'It is not the Apgar score in itself that leads to lower cognitive abilities. 'It is the reasons leading to a low Apgar score (including asphyxiation, preterm delivery, maternal drug use, infections) that might have an impact on future brain function.'

The study appears in next month's issue of the journal Obstetrics & Gynecology.

The Apgar test is given between one and five minutes after birth. It evaluates an infant's heart rate, breathing, muscle tone, skin colour and reflex irritability (sneezing or coughing) on a scale of one to ten. Scores of eight and above are considered to be signs of good health. The test was developed by Dr Virginia Apgar in 1952 and has been a simple and effective way of testing a baby's health since.

Researchers also made the point that only one in 44 newborns with a low Apgar score went on to need special education, so mothers of babies who had low scores did not have cause for concern.

Dr Richard Polin, director of neonatology at Columbia University Medical Center and a member of the American Academy of Pediatrics Committee on Fetus and Newborn, said: 'Most babies who have Apgar scores of seven or less do perfectly fine.'

SOURCE

Vegetarian diet 'helps protect against common bowel disorder'

More speculation. Vegetarians undoubtedly differ from normals in all sorts of ways. They probably take more care of their health generally, for instance. They may also do more exercise and are usually slimmer. So there is no knowing which factor led to the reduced bowel disorder observed

A vegetarian diet could help protect against a common bowel disorder, research has suggested. Vegetarians were found to be a third less likely to get diverticular disease, a condition thought to be caused by eating too little fibre. It causes cramps, bloating, wind, constipation and diarrhoea.

A study led by Dr Francesca Crowe from the Cancer Epidemiology Unit at Oxford University, published online by the British Medical Journal, looked at 47,033 British adults, of whom 15,459 were vegetarian.

After an average follow-up of 11.6 years, there were 812 cases of diverticular disease. Vegetarians in the group had a 30% lower risk of having the disease, compared to those who ate meat, fish or both.

The authors said the reason could be the consumption of meat altering the metabolism of bacteria in the colon, and therefore weakening the colon wall and increasing the risk of diverticular disease. They found nothing significant about the amount of meat eaten.

The potential protective benefits of vegetarianism could be obtained even in a short time, the study found.

There also seemed to be a link between eating more fibre and being at lower risk of the disease. Patients who consumed the most fibre, more than 25.5g per day for women and more than 26.1g for men, had a 42% lower risk than those who ate less than 14g per day.

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Why taller women are a third more likely to be diagnosed with cancer

This is one finding that is NOT due to social class, as upper class women tend to be taller. Anecdotes prove nothing but I cannot help mentioning that for a time in Britain, I went out with a woman who was 5'10" tall, which is tall for a woman. She traced her ancestry back 1,000 years. On the principle of parsimony, the explanation for the finding below is most likely to be the one I have highlighted in red

Taller women are more likely to get cancer, research reveals today. Their risk of developing some of the most common forms is up to a third greater.

Scientists believe being tall may increase the levels of certain hormones known to trigger tumours.

A study carried out at Oxford University found the risk of cancer increased by around 16 per cent with every four inches of height. The scientists studied the link between height and ten of the most common forms of cancer including breast, bowel, kidney, womb, ovarian and leukaemia by looking at the medical records of one million British women. They found those who were 5ft 9in tall were more than 33 per cent more likely to get cancer than those who were just 5ft.

Researchers say the link may explain why cancer rates have risen so much over the past few decades when our average height has also progressively increased. Over the course of the last century the height of adults in Europe has gone up by more than a third of an inch (1cm) every ten years. And figures show that cancer rates have increased by about 3 per cent every decade. The scientists suggest an increase in height can explain up to 15 per cent of the rise in cancer cases seen over the past century.

They believe one reason for the link is that tall girls tend to start puberty earlier and this is when their bodies begin producing large amounts of the hormone oestrogen, known to trigger the growth of tumours.

The scientists also point out taller people have more cells in their body so they have a higher chance that one will become cancerous.

Jane Green, from the Cancer Epidemiology Unit at the University of Oxford, said: ‘The fact the link between height and cancer risk seems to be common to many different types of cancer suggests there may be a basic common mechanism, perhaps acting early in peoples’ lives, when they are growing. ‘Of course people cannot change their height. And being taller has been linked to a lower risk of other conditions, such as heart disease.’

Sara Hiom, director of health information, at Cancer Research UK, said: ‘Tall people need not be alarmed. Most people are not a lot taller than average and their height will only have a small effect on their individual cancer risk. ‘This study confirms the link between height and cancer paving the way for studies to help us understand why this is so.’

This study only involved women so it is not clear whether tall men are at risk. But past research has linked height with increases in prostate and testicular cancer.

SOURCE

Passive smoking harms hearing of teenagers

I abhor smoking but the report below is sheer nonsense. Working class people are more likely to smoke and have more hearing loss. That is all that they have detected. Yet another crappy study dedicated to condemning sidestream smoke

Teenagers exposed to second-hand smoke are twice as likely to suffer hearing loss, according to research. The findings add to the catalogue of health problems already attributed to second-hand smoke, including increased risks of asthma, heart disease and lung cancer.

Teens exposed to second-hand smoke were more likely to have ‘sensorineural’ hearing loss, which is usually caused by problems with the cochlea, the snail-shaped hearing organ of the inner ear. Scientists think passive smoking affects the blood supply to the area.

The damage caused makes it harder for the person to understand speech and has been linked to poor academic performance and disruptive behaviour in school.

Study author Dr Michael Weitzman, from New York University’s school of medicine, said: ‘It’s the type of hearing loss that usually tends to occur as one gets older, or among children born with congenital deafness.’

Dr Weitzman studied more than 1,500 teenagers aged 12 to 19. They were given extensive hearing tests along with blood tests for the chemical cotinine, a substance produced when the body breaks down nicotine. Those teens exposed to second-hand smoke, as measured by cotinine in their blood, were more likely to have sensorineural hearing loss than those who were not passive smokers.

Results of the study, published in journal Archives of Otolaryngology, which deals with head and neck surgery, also showed that more than four out of five affected were not aware of it.

Study co-author Dr Anil Lalwani, from the department of paediatrics at NYU’s school of medicine, said: ‘More than half of all children in the U.S. are exposed to second-hand smoke, so our finding has huge public health implications.’ He added: ‘Milder hearing loss is not necessarily noticeable. Thus, simply asking someone whether they think they have hearing loss is insufficient.’

Dr Weitzman added: ‘The consequences of mild hearing loss are subtle yet serious. ‘Affected children can have difficulty understanding what is being said in the classroom and become distracted. As a result, they may be labelled as troublemakers or misdiagnosed with ADHD.’

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Cholesterol at danger level? Why your doctor could be wrong

By John Naish

Recently I broke a strict personal rule by undergoing a complete private health screening. I’d always rigorously avoided such things, but this was obligatory for work. The battery of tests did the exact thing that I feared. It revealed a potential health problem I had never previously known — nor worried — about. The results showed I have high total cholesterol. Mine is 6.6mmol/l — the target is 5.1.

But I won’t be rushing to my family doctor. That’s because as a health journalist, I’ve seen the way the ‘danger’ threshold for cholesterol has been revised steadily down. Twenty years ago, I would have been well inside the ‘healthy’ category (back then you had to be over 7.6 to be considered unhealthy).

But am I being wise to ignore this warning? A new book by an expert on medical screening strongly vindicates my position. As author Dr H. Gilbert Welch explains: ‘There are many conditions that you can now be labelled with simply because you are on the wrong side of a number, not because you have any symptoms.’

Take diabetes — earlier this month it was revealed the NHS is lowering the threshold for diagnosing type 2 diabetes. As a result, the number of cases could rise by 20 per cent — a massive number. That means thousands more people will be treated for the condition without necessarily having any symptoms.

This is just another example of what Dr Welch describes as an ‘epidemic’ of overdiagnosis. In other words, physical abnormalities that will most likely lie dormant for the rest of our lives are being detected and treated as if you are actually ill.

Dr Welch, who is professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice in Virginia in the U.S., points the finger at our overzealous use of screening — blood tests and scans — which has caused millions of people to believe they are mortally sick when, in fact, they are perfectly healthy.

Worse, it has led countless numbers to take drugs and undergo surgery completely unnecessarily. As a result, they have suffered everything from botched removals of breast lumps to, says Dr Welch, medication-related car crashes.

At the heart of the problem is a change in medical culture over the past three decades. In the past, people didn’t go to the doctor when they were well — they tended to wait until they developed symptoms. And doctors didn’t encourage the healthy to seek care.

But that has changed. ‘Early diagnosis is the goal. People seek care when they are well,’ says Dr Welch.

‘But a patient who has been overdiagnosed cannot benefit from treatment. There’s nothing to be fixed — he or she will neither develop symptoms nor die from their condition — so the treatment is not needed. 'An overdiagnosed patient can only be harmed. And almost all treatments have the potential to do some harm.’

On top of this, there are changes to the thresholds that doctors use to judge if a person is ill or not. Dr Welch points to the example of diabetes. ‘The old rule, from when I was in medical school 30 years ago, was that if you had a blood-sugar level over 140, you had diabetes. But in 1997 experts changed the international definition. 'Now, if you have a reading of more than 126 you have diabetes. That little change turned millions of people into patients.’

As treatment is expanded to people with progressively milder abnormalities such as slightly high blood sugar, their potential to benefit from treatment becomes progressively smaller. But the risk from dangerous side-effects remains much the same.

Another reason for our modern diagnosis epidemic is the fact that we can see more inside the human body — thanks to high-tech machinery such as MRI scanners and CT scanners. They enable doctors to spot things that might be troublesome — even if they aren’t causing trouble and may very well never do so.

When investigators in three separate studies systematically scanned large numbers of healthy people, they found that about 10 per cent have gallstones, even though they have never had symptoms of gall bladder disease. Around 40 per cent show damaged knee cartilage, even though they have never had knee pain. And more than 50 per cent of people who have never had back pain show bulges in the discs in their spine when scanned by MRI.

In another test, in the journal Radiology, when 1,000 people were given total-body CT scans in commercial clinics, even though they had no problem symptoms, 86 per cent had at least one abnormality detected.

So if you go into hospital for broad-scale scanning tests, doctors are almost bound to find something problematic that needs ‘treatment’, even if it wasn’t what they were originally looking for — and even if it is, in fact, never going to cause problems.

The same sort of problem can occur with public-health campaigns such as Britain’s breast-screening programme. The potential dangers of overdiagnosis have even led the president of the Royal College of GPs, Iona Heath, to decline invitations to attend screening sessions.

Advocates of such screening say it prevents diseases, prompts early detection and saves lives — along with millions of pounds of NHS money. But as Dr Heath explains, a study of research evidence by the respected Cochrane Reviews Library ‘suggests that for every 2,000 women invited to screening for ten years, one death from breast cancer will be avoided but that ten women will be overdiagnosed with breast cancer’.

She adds: ‘This overdiagnosis is estimated to result in six extra tumour removals and four extra mastectomies and in 200 women risking significant psychological harm relating to the anxiety triggered by the further investigation of mammographic abnormalities.’

And now we’re entering new realms of disease-seeking, with the advent of DNA testing. Already, numerous commercial enterprises have emerged that will take your DNA and your money, promising to unlock the secrets of your genes.

But while DNA tests can reveal that you have a raised risk of developing one illness and a lower risk of another, ‘for the vast majority of conditions these predictions are inaccurate to the point of being meaningless’, says Dr Welch.

This is because our genes are not our destiny. Factors such as nutrition and harmful exposure to toxins affect human characteristics, even before birth, as does physical and even intellectual activity in childhood. ‘Virtually all of us will have genetic “abnormalities” if we look for them. So the new world of personal genetic testing has the potential to make all of us sick and arguably poses the greatest threat of overdiagnosis of all.’

Dr Welch is careful to say his scepticism is about testing for problems in people who are, to all intents and purposes, entirely well and free from any symptoms. ‘I am not saying that if you have early signs of symptoms of cancer, you shouldn’t go to your doctor,’ he explains.

‘The question is whether your doctor should be screening for cancers when you are well. It can hurt you. It can lead to you being overdiagnosed and treated needlessly.’

As for me, I’m going to stick to my everyday lifestyle — a vegetarian who exercises a lot — rather than start popping pills.

SOURCE

Can a "healthy" lifestyle prevent Alzheimer's?

This is the usual nonsense. The researchers themselves found that education was a big factor and education is a social class component. All that they have shown is that Alzheimer's is one of the many ailments that are more frequent in lower class people. That such people have a disapproved-of lifestyle is incidental

Half of all Alzheimer’s disease cases could be prevented by lifestyle changes such as exercise, eating healthily and not smoking, claim researchers. They say hundreds of thousands of patients could potentially avoid the devastating illness by simply changing bad habits.

Around 820,000 people in Briton suffer from dementia, of whom half have Alzheimer’s, and this is expected to rise to a million within the next ten years.

For the first time, scientists have calculated the extent to which certain lifestyle traits – including lack of exercise, smoking and obesity – all contribute to the disease. Researchers found that in the Western world, an inactive ‘couch potato’ lifestyle was the most important possible cause. Smoking, obesity in middle-age, high blood pressure and diabetes all increased the risk. Together, the modifiable risk factors contributed to 50 per cent of Alzheimer’s cases worldwide.

The study, published in the journal Lancet Neurology, found that not going to secondary school also made developing the disease more likely.

The researchers did not explain why education was important in reducing the risk of dementia, but it backs up several major studies that have found that spending years at school and university appeared to protect against memory loss in old age.

Scientists speculate that intense studying may make the brain better equipped to cope with the symptoms.

The Alzheimer’s Society has predicted that by 2021 there will be more than a million Britons living with dementia and this will rise to 1.7million by 2050. The numbers are expected to soar as more people live until their 80s and 90s, when they are at highest risk.

But there is now growing evidence that the disease may be partly caused by unhealthy diets, smoking, high blood pressure and cholesterol as they cause damage to blood vessels in the brain, leading to death of brain cells.

The researchers want to carry out more work to find out how many people can prevent the disease by making small changes to their lifestyle.

Lead researcher Deborah Barnes, associate professor of psychiatry at the University of California in San Francisco, said certain causes would be more important in different countries.

In the U.S. and UK, for example, most people go to secondary school but many will lead sedentary ‘couch potato’ lifestyles – so a lack of exercise may be more important.

Dr Barnes, who presented the findings at the Alzheimer’s Association international conference in France, said: ‘In our study, what mattered most was how common the risk factors were in the population. For example, in the U.S., about one third of the population is sedentary, so a large number of Alzheimer’s cases are potentially attributable to physical inactivity.

‘Worldwide, low education was more important because literacy rates are lower or people are not educated beyond elementary school. ‘Smoking also contributed to a large percentage of cases.’

Rebecca Wood, chief executive of Alzheimer’s Research UK, said: ‘If further research can prove that the observed risks are causes, then simple changes like quitting smoking and taking regular exercise could have an enormous impact.’

SOURCE





An old scare: Do I pee too frequently?

This seems to be theory and anecdote-based. No evidence is quoted, even though the advice has been around for decades

Dashing to the toilet at every opportunity may be harming your bladder, say experts.

Are you in the habit of always popping to the loo right before you leave the house? Do you avail of every toilet you see when you're out and about – just in case? If so, you may be doing yourself more harm than good with this seemingly innocent habit.

"Some people go to the toilet frequently because they think 'I'd better go before I leave', which you should never do," says Dr Elizabeth Farrell, a gynecologist with the Jean Hailes Foundation for Women's Health. "Frequent trips to the toilet means your bladder never gets a chance to fill up. Then because it never reaches its full volume - it shrinks."

So how many times a day should the average person urinate? "The normal range is between four and six times a day, including up to two visits to the loo during the night," explains Dr Farrell. In other words, once every four hours is considered normal. "Certainly anything under two hours would be too frequent," she adds.

Of course, there are a few factors that influence the frequency of voiding. "It's very dependent on how much you drink and your bladder capacity," says Dr Cindy Pan. "Sometimes people over drink with water, giving themselves urgency of the bladder. Other things that can stimulate the bladder include caffeine, soft drinks and spicy foods." Being dehydrated or suffering from interstitial cystitis are triggers too, adds Dr Farrell.

Getting help and taking steps to rectify the issue is vital to avoid bladder problems later in life, says Dr Farrell. "It is a significant constraint and some women are socially isolated because of it," she explains. "I have patients who come in and say they know where every toilet in the city is, because they're afraid that if they can't find a loo they'll wet themselves."

If you do find yourself doing the dash a bit too often, see your GP to ensure there are no underlying issues. "A urine infection is an abnormal condition that can cause frequent urination, as can diabetes or a neurological problem like a spinal cord injury," says Dr Pan. "Most of the time it's not going to be anything like that, however. It's usually just a behavioral thing."

The good news is that you can learn to retrain your bladder. "The best thing to do is try to hold on a bit more and resist the urge to void all the time," says Dr Pan. She also suggests keeping a diary of your fluid intake and how often you're voiding so you can work with your GP to fix the problem.

Pelvic floor exercises are also a must, says Dr Farrell, particularly post-childbirth. "See a pelvic floor physiotherapist for tips and exercises," she advises.

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