Wednesday, September 30, 2009

Margarine consumption is linked to lower IQs in children

Most amusing: A "healthy" choice turns out to be anything but. I wonder how the "health" establishment will handle that? Sadly, however, this is not as good an example of the limits of official wisdom as it looks.

The article is a much better example of how medical researchers tend to work in a sort of vacuum and ignore the big picture. It in fact reveals an extraordinary lack of insight into their own society by these eight New Zealand researchers. It was once illegal to buy margarine without a doctor's prescription in N.Z. They have a big dairy industry that they like to prop up. So, given the peculiarly strong emphasis on margarine as a therapeutic agent in New Zealand, it would seem highly likely that people who felt less healthy to start with tended most to buy it. And people with poor health have less healthy children -- and lower IQ is one correlate of poor health. The findings then tell us about who buys margarine rather than any effect that margarine has.

Trans fats indeed! What we see in the report is not the influence of trans fats but the influence of unwarranted assumptions and conventional thinking. It never ceases to amaze me that people who claim to be scientists seem to think they can just intuit the causal relationships in a dataset. They are witchdoctors, not scientists. Not one out of the eight of them said: "Hey! Wait a minute!"

The journal abstract is here. The title of the article is "Dietary patterns and intelligence in early and middle childhood" and the leading author is Reremoana F. Theodore. No corresponding author or email address is given, which is rather strange

It became popular as a healthier alternative to butter. But children who ate margarine every day had lower IQs than those who did not, a study has found. At the age of three-and-a-half, they scored three points lower on intelligence tests than other youngsters. Importantly, the link held even when parental occupation and other factors affecting wealth and class were taken into account, the study of children born in the mid-1990s showed.

By the age of seven, scores were six points lower – but only in children that had been underweight when born, suggesting that diet is particularly important for brain development in the more vulnerable. Writing in the journal Intelligence, the researchers from New Zealand’s Auckland University said it is unclear what lies behind the link.

However, trans fats may be to blame. The fats have been linked to memory problems in animal tests and may make it harder for the body to process healthier fats. In the mid-1990s, trans fats formed up to 17 per cent of the mix of some margarines. Today, however, levels are around 1 per cent – significantly lower than some butters. The discovery in recent years that the fats clog up the arteries, raising the risk of heart disease, has led to concerted efforts to cut levels in food. However, the high amounts in the past may have hampered the development of today’s adults.

The researchers, whose study showed that eating fish and cereal boosted intelligence, said: ‘We found a number of dietary factors to be significantly associated with intelligence measures. The association between margarine consumption and IQ scores was the most consistent and novel finding.’

The researchers said that more work was needed to confirm if trans fats, which are formed when vegetable oil is solidified, were at fault, or if something else was to blame. They said: ‘Children who ate margarine daily had IQ scores that were up to six points lower compared to children who did not. ‘The impact of regular margarine consumption on intelligence now warrants further investigation in order to replicate these findings and to identify possible mechanisms that may underlie this association.’

Sian Porter, of the British Dietetic Association, said that margarine is generally healthier than butter but the high fat content means that both should be used sparingly. A spokesman for the Food Standards Agency said that trans fat consumption in the UK is now below the recommended levels.


Fatties really are happier

I am a bit bemused by this study being done in Japan, though. I didn't think there were ANY fat Japanese outside the Sumo ring. Maybe that shows how much I know but I still suspect that "fat" in Japan would not be fat in (say) America. If the study is replicable in Western countries, however (and it probably is), this does suggest that the obesity "war" is in at least some cases an attack on happiness -- and that seems morally obnoxious. Once again we see public policy sold as being "for your own good" when it is not for your own good at all. Why are people not entitled to be fat and happy?

People who are "happy and fat" tend to respond less well to slimming programmes, said psychologists. The findings indicate that a little negativity might benefit slimmers by leading them to worry more about their health and appearance.

Researchers in Japan conducted psychological profiles of 101 obese men and women undergoing a programme of counselling, nutrition and exercise therapy. Patients were asked to fill in personality questionnaires before and after the six-month course.

The study found that optimism and self-orientation characteristics improved for most patients during the programme. Those who became more self aware through counselling were more likely to lose weight than those who did not. But the research also found that people with a happy-go-lucky bright outlook at the start of the therapy were less likely to succeed. These patients were described as having ''free child'' (FC) ego states marked by assertiveness and optimism. Successful weight loss was associated with a more responsible and cautious ''adult'' or ''A'' ego state.

The scientists wrote in the journal BioPsychoSocial Medicine: ''The positive aspects of the FC ego state involve controlling negative emotion and are related to the ability to look on the bright side and do things in one's own style, while the negative aspects are not caring about disease and giving in to temptation because of optimism, as well as instinctive and impulsive behaviours.

"Weight loss was observed for patients who had less of an FC ego state at the start of the programme and an increased A ego state during the six-month programme." Overall, patients lost an average of a stone [14lb] and their Body Mass Index - a measurement relating weight and height - fell by more than two points.


Tuesday, September 29, 2009

Let them drink water!

The food freaks want to wage war on the poor

Not long after the attack on Pearl Harbor, in the winter of 1942, physiologist A.J. Carlson made a radical suggestion: If the nation's largest citizens were charged a fee—say, $20 for each pound of overweight —we might feed the war effort overseas while working to subdue an "injurious luxury" at home.

Sixty-seven years later, the "fat tax" is back on the table. We're fighting another war—our second-most-expensive ever—and Congress seems on the verge of spending $1 trillion on health care. Once again, a bloated budget may fall on the backs of the bloated public. Some commentators, following Carlson, have lately called for a tax on fat people themselves (cf. the Huffington Post and the New York Times); others, like a team of academics writing in the current issue of the New England Journal of Medicine, propose a hefty surcharge on soft drinks instead.

The notion hasn't generated much enthusiasm in Congress, but fat taxes are spreading through state legislatures: Four-fifths of the union now takes a cut on the sales of junk food or soda. Pleas for a federal fat tax are getting louder, too. The New York Times recently endorsed a penny-per-ounce soda tax, and Michael Pollan has made a convincing argument for why the insurance industry may soon throw its weight behind the proposal. Even President Obama said he likes the idea in a recent interview with Men's Health. (For the record, Stephen Colbert is against the measure: "I do not obey big government; I obey my thirst.")

For all this, the public still has strong reservations about the fat tax. The state-level penalties now in place have turned out to be way too small to make anyone lose weight, and efforts to pass more heavy-handed laws have so far fallen short. But proponents say it's only a matter of time before taxing junk food feels as natural as taxing cigarettes. The latter has been a tremendous success, they argue, in bringing down rates of smoking and death from lung cancer. In theory, a steep tax on sweetened beverages could do the same for overeating and diabetes.

It may take more than an analogy with tobacco to convince voters. As my colleague William Saletan points out, the first step in policing eating habits is to redefine food as something else. If you want to tax the hell out of soda, you need to make people think that it's a drug, not a beverage—that downing a Coke is just like puffing on a cigarette. But is soda as bad as tobacco? Let's ask the neuropundits.

Junk food literally "alters the biological circuitry of our brains," writes David Kessler [The Kessler quack again!] in this summer's best-seller, The End of Overeating. In a previous book, Kessler detailed his role in prosecuting the war on smoking as the head of the FDA; now he's explaining what makes us fat with all the magisterial jargon of cognitive neuroscience. Eating a chocolate-covered pretzel, he says, activates the brain's pleasure system—the dopamine reward circuit, to be exact —and changes the "functional connectivity among important brain regions." Thus, certain foods—the ones concocted by industrial scientists and laden with salt, sugar, and fat —can circumvent our natural inclinations and trigger "action schemata" for mindless eating. Got that? Junk food is engineered to enslave us. Kessler even has a catchphrase to describe these nefarious snacks: They're hyperpalatable.

Try as we might, we're nearly powerless to resist these treats. That's because evolution has us programmed to experience two forms of hunger. The first kicks in when we're low on energy. As an adaptation, its purpose is simple enough —we eat to stay alive. The second, called hedonic hunger, applies even when we're full—it's the urge to eat for pleasure. When food is scarce, hedonic hunger comes in handy, so we can stock up on calories for the hard times ahead. But in a world of cheap food, the same impulse makes us fat.

That's the problem with junk food. Manufacturers have figured out how to prey on man's voluptuous nature. Like the cigarette companies, they lace their products with addictive chemicals and cajole us into wanting things we don't really need. Soda is like a designer drug, layered with seductive elements—sweetness for a burst of dopamine, bubbles to prick the trigeminal nerve.

It's hard to draw a line, though, between foods that are drugs and foods that are merely delicious. Soda and candy aren't the only stimuli that "rewire your brain," of course. Coffee does, too, and so do video games, Twitter, meditation, and just about anything else that might give you pleasure (or pain). That's what brains do —they learn, they rewire. To construe an earthly delight as hyperpalatable —as too good for our own good— we're lashing out at sensuality itself. "Do you design food specifically to be highly hedonic?" Kessler asks an industry consultant at one point in the book. What's the guy going to say? "No, we design food to be bland and nutritious. …"

It's ironic that so many advocates for healthy eating are also outspoken gourmands. Alice Waters, the proprietor of Chez Panisse, calls for a "delicious revolution" of low-fat, low-sugar lunch programs. It's a central dogma of the organic movement that you can be a foodie and a health nut at the same time—that what's real and natural tastes better, anyway. Never mind how much fat and sugar and salt you'll get from a Wabash Cannonball and a slice of pain au levain. Forget that cuisiniers have for centuries been catering to our hedonic hunger —our pleasure-seeking, caveman selves— with a repertoire of batters and sauces. Junk foods are hyperpalatable. Whole Foods is delicious. Doughnuts are a drug; brioche is a treat. Some tastes, it seems, are more equal than others.

A fat tax, then, discriminates among the varieties of gustatory experience. And its impact would fall most directly on the poor, nonwhite people who tend to be the most avid consumers of soft drinks and the most sensitive to price. Under an apartheid of pleasure, palatable drinks are penalized while delicious —or even hyperdelicious— products come at no extra charge. What about the folks who can't afford a $5 bottle of POM Wonderful? No big deal, say the academics writing in the New England Journal of Medicine; they can always drink from the faucet. Here's how the article puts it: "Sugar-sweetened beverages are not necessary for survival, and an alternative (i.e. water) is available at little or no cost." So much for Let them eat cake.

We've known for a long time that any sin tax is likely to be a burden on the poor, since they're most prone to unhealthy behavior. (James Madison fought the snuff tax on these grounds way back in 1794.) But you might just as well say that poor people have the most to gain from a sin tax for exactly the same reason. It's also possible that revenues from a fat tax would be spent on obesity prevention —or go back to the community in other ways. There's a knotty argument here about the vexing and reciprocal interactions among health, wealth, and obesity. (I'll try to untangle some of these in my next column.) It's not clear whether, and in what direction, a soda tax might redistribute wealth. Whatever you think of the economics, though, raising the price on soda —and offering water in its place— will redistribute pleasure.

I don't mean to imply that any such regulation is unjust. We have laws against plenty of chemicals and behaviors that are as delightful as they are destructive. These are, for the most part, sensible measures to protect our health. What's disturbing is the thought that the degree of government control should vary according to who's using which drug. In April, the Obama administration called for an end to a long-standing policy that gives dealers of powdered cocaine 100 times more leeway than dealers of crack when it comes to federal prison sentences. Let's not repeat this drug-war injustice in the war on obesity. We may be ready to say that foods are addictive. Are we ready to judge the nature of a delicious high?


Is the definition of autism too broad? NHS claims one in 100 adults is autistic in some form

One per cent of the adult population is suffering from a form of autism, research has revealed. The study – the first of its kind – found that autism and related conditions such as Asperger’s syndrome, are as common in adults as in children. The finding is important because it had been suggested that the measles, mumps and rubella combination jab fuelled a rise in cases of the disorder after its introduction in the early Nineties.

If this were the case, rates of autism would be higher in children and young adults than in older age groups. But with the rate similar across all age groups, it seems that any rise in cases of autism in children can be attributed to better diagnosis and greater awareness of the condition.

As with children, the disorder is much more often found in males than in females. The Department of Health-funded research also found rates to be higher among single people and among men who haven’t been to university.

But the findings are likely to be seized upon as evidence that the definition of autism is now too broad. In the 1990s there was a huge surge in the number of autism cases reported in children, after a wider diagnostic definition of the condition was introduced.

The study found no evidence that rates of autism are on the rise and failed to find a link between the mumps, measles and rubella (MMR) vaccine and the condition. If there was a link with MMR, people aged in their early 20s or younger would expect to have higher rates of autism because they have had the jab, the report said. However, Jackie Fletcher, from vaccination awareness group Jabs, said: 'We're concerned the Department of Health is extrapolating from surveys not designed to find vaccine damage to bolster the uptake of MMR.'

Although rates of autism in children have been widely researched, the latest study is the first to attempt to set a figure for adults. Little was known about how autism affected people over the course of a lifetime.

Autism spectrum

1) Classic autism: The most severe form. Problems relating to people. They can be hypersensitive to their environment and be upset by certain colours and shapes. Often cling to rituals.

2) Asperger's syndrome: Milder form. Can be socially awkward and lack empathy.

3) Nonspecific pervasive developmental disorder (PDD-NOS): Shows some but not all the symptoms of classic autism

4) Rett syndrome: Rare condition that usually affects girls and is marked by poor head growth. May have poor verbal skills and make repetitive movements.

5) Childhood disintegrative disorder: Develops in children who previously seemed perfectly normal. Can stop talking and socialising.

Researchers asked more than 7,000 men and women 20 questions designed to pick up traits linked to autism and related conditions. Topics covered included attention to detail, ability to handle social interactions and ability to read emotions. After several hundred were put through a second, more stringent, assessment, the researchers estimated 72 people of those tested had autism or a related condition. If the results were extrapolated across the population as a whole, an estimated 1 per cent of adults would fall into the category. Three studies of children in England have come up with a similar rate, although other research has theorised the number numbers could be as high as one in 60.

Tim Straughan, of the NHS Information Centre, which carried out the study, said: ‘While the sample size was small and any conclusions need to be tempered with caution, the report suggests, despite popular perceptions, rates of autism are not increasing.’

Worryingly, the study also found men and women with the condition are no more likely to use services for those with mental or emotional problems than other adults. Mark Lever, of the National Autistic Society, said services and support for adults with autism were ‘woefully inadequate’. He added: ‘Nearly two-thirds (63 per cent) of adults with autism told us they do not have enough support to meet their needs. ‘This study gives us further evidence to demand that more vital support is put in place.’


Monday, September 28, 2009

The myth of the smoking ban “miracle”

Restrictions on smoking around the world are claimed to have had a dramatic effect on heart attack rates. It's not true. See also some prior comments on this blog on 15th.

‘Heart attacks plummet after smoking ban’ declared The Sunday Times earlier this month, as it reported that England’s smoking ban has ‘caused a fall in heart attack rates of about 10 per cent’ (1). A few days later, The Scotsman upped the ante, informing its readers that ‘Smoking ban slashes heart attacks by up to a third across world’ (2).

Tales of heart attacks being ‘slashed’ by smoking bans have appeared with such regularity in recent years that it is easy to forget that there is a conspicuous lack of reliable evidence to support them. It is almost as if the sheer number of column inches is a substitute for proof.

The most recent reports are a case in point. Although The Sunday Times claimed a 10 per cent drop in heart attacks, nowhere in the 500 word article was a source mentioned and no one was quoted giving this figure. The ‘study’ the newspaper referred to does not exist, and the anti-smoking pressure group Action on Smoking and Health (ASH) – not renowned for downplaying the risks of passive smoking – went to the unusual lengths of posting a notice on its website the following day to point out that ‘the figures reported in The Sunday Times yesterday (and now circulating elsewhere) are not based on any research conducted to date’ (3).

Although the story quickly went around the globe, no one seems to know where the figure came from. It’s all rather strange. Basing journalism on anonymous sources is commonplace in the world of politics, but it is surely not necessary in the realms of science.

The second story – reported by a host of news organisations, including the BBC – also had no new data to report. Instead, it took its cue from an article in the journal Circulation which examined previous smoking ban/heart attack studies. If nothing else, the Circulation paper offers an opportunity to reflect on just how feeble the collected evidence is on this issue (4).

The first study to make the claim that smoking bans ‘slash’ heart attacks was met with howls of derision when it was published in the British Medical Journal in 2004 (5). Studying the modest population of Helena, Montana – where the number of monthly heart attacks seldom strayed into double digits – the study’s authors made the astounding claim that the town’s smoking ban had led to the rate of acute myocardial infarction (heart attacks) plummeting by 40 per cent.

Dubbed the ‘Helena miracle’ by a legion of sceptics, the 40 per cent finding was damned by its very enormity. Since the authors were adamant that the drop was due to secondhand smoke (rather than smokers quitting), the finding required the reader to believe that 40 per cent of heart attacks in pre-ban Helena had been solely caused by passive smoking in bars and restaurants. To understand quite how miraculous the Helena miracle was, one must bear in mind that around 10 to 15 per cent of coronary heart disease cases are attributed to active smoking. That passive smoking could be responsible for a further 40 per cent strains all credibility.

Despite the inherent implausibility of the hypothesis, further studies were swiftly commissioned. If smoking bans could be shown to immediately save lives, it would be a compelling reason to implement bans elsewhere and expand those already in place. And since all that was required to ‘prove’ the hypothesis was a rough correlation between a declining heart attack rate and the start of a smoking ban, the prospects were good. Heart attack rates had been falling for years in most countries and there were plenty of smoking bans to choose from. The law of averages dictated that another heart miracle would soon come to light.

Flawed though it may have been, the Helena research was followed by several studies that displayed such a cavalier approach to the scientific process that they bordered on the comical. Researchers in Bowling Green, Ohio, for example, saw a large rise in heart attacks during the first year of the smoking ban. Side-stepping this awkward fact, they simply redefined year two of the ban as the ‘real’ post-ban period and, since that year followed an abnormal peak, there was naturally a decline in the heart attack rate. As a consequence, the researchers could triumphantly declare that the smoking ban had led to a 47 per cent reduction in heart attacks (6).

In the Piedmont region of Italy, there was an inconvenient rise in heart attacks amongst those over the age of 60 after the ban, and so those people were simply ignored. In a study that was trailed by the BBC (‘Smoking ban reduces heart risk’), the researchers focused entirely on those under 60, thereby recording an 11 per cent drop in cases (7).

Studies such as these form the basis for the recent reports of smoking bans slashing heart attacks by ‘up to a third’. The Circulation paper gathers them together and concludes that, on average, smoking bans cause rates of acute myocardial infarction to fall by 17 per cent. It includes the studies from Ohio and Italy, as well as three studies that have never been published and have only been ‘reported at meetings’.

The paper does not, however, include a mammoth (published) study of the entire United States, which concluded: ‘In contrast with smaller regional studies, we find that workplace bans are not associated with statistically significant short-term declines in mortality or hospital admissions for myocardial infarction or other diseases.’ (8)

Nor does it include an (unpublished) paper which found no statistically significant fall in heart attacks amongst the entire populations of California, Florida, New York and Oregon (9).

Perhaps the most remarkable aspect of the ongoing heart-miracle farrago is the eagerness to focus on small studies when complete hospital data is so freely available. It is extraordinary that no BBC journalist, for example, has thought of taking a few minutes to see how many people were rushed to hospital with acute myocardial infarction before and after the smoking bans of England, Scotland and Wales. If they did so, they would see that smokefree legislation has had no tangible influence on heart attack rates at all.

The graphs below show the number of emergency admissions for acute myocardial infarction, with the arrow indicating the start of the smoking ban. What is abundantly clear in each case is that the number of heart attack admissions has been falling for some time. Far from causing further dramatic cuts in heart attack rates, the bans had no discernible effect.

Publicly accessible hospital admissions data is like kryptonite to those who are so eager to believe in miracles. In most epidemiological studies pertaining to secondhand smoke, the raw data is not published. Here, it is open to all and shows quite clearly that the long-term downward trend in heart attacks has not been affected in any way by the implementation of smoking bans. It provides such a simple and straightforward rebuttal to the heart attack ‘slashing’ hypothesis that one wonders what level of hubris drives those who still espouse it.

The three graphs above cover a population larger than the sample groups in all the studies reviewed in Circulation combined, but no matter how much empirical evidence exposes the fantasy of the Helena miracle, it may be too late for the anti-smoking lobby to back down on this issue. Too many reputations are at stake.

After five years of covering these stories so uncritically, the same may be true of the media. One can scarcely blame newspapers for covering stories that offer such dramatic conclusions as the heart miracles. The irony is that if they dug just a little deeper, they might find a more interesting, and more believable, tale of human folly.

SOURCE (See the original for graphics)

Smoking status doesn't predict cardiovascular death

This article forms an amusing footnote to the one above. It essentially explains WHY smoking bans don't reduce circulatory disease.

It is also an interesting example of how one must consider intervening variables before drawing causal inferences. Non-smokers live many years longer but that is not due to their non-smoking. Smokers have other health problems and it is the sum of those problems that lead to death. Another example of the poor having worse health, I think. The poor are much more likely to smoke

Could it be good news for smokers? Current and past-smokers with coronary artery disease, cerebrovascular disease, or peripheral artery disease have less than half the cardiovascular mortality than never-smokers, the initial findings from a new study suggest. But don't be so quick to tell your patients to light up: After accounting for potential confounders, the association was not statistically significant.

"The relationship between smoking habit and outcome in patients with established arterial disease remains controversial," Dr. M. Monreal, of Hospital Universitari Germans Trias i Pujol, Barcelona, Spain, and colleagues write in the September issue of the European Journal of Internal Medicine. "Some studies have found that smoking may be associated with a better outcome among patients with acute coronary disease," they note. "As for patients with cerebrovascular disease or peripheral artery disease, there is little information on the influence of smoking on outcome."

The researchers used data from FRENA, an ongoing, observational registry of consecutive outpatients with symptomatic coronary artery disease, cerebrovascular disease, or peripheral artery disease, to compare the incidence of cardiovascular death during follow-up of all enrolled patients according to their smoking status. A total of 2501 patients from 24 participating Spanish hospitals had been enrolled in FRENA as of May 2008. Of these, 439 (18%) were current smokers, 1086 (43%) were past-smokers, and 976 (39%) never smoked.

Compared to never-smokers, current and past-smokers were younger, more often male, and more likely to have chronic lung disease. Diabetes, hypertension, and heart failure were less common in current- and past-smokers. There were a total of 250 major cardiovascular events in 239 patients (9.6% of the original 2501) over a mean follow-up of 14 months. A total of 123 (4.9%) patients died (cardiovascular death, 68) during follow-up.

Significantly lower cardiovascular mortality was observed among current smokers and past-smokers compared to non-smokers (1.1 per 100 patient-years in current smokers, 1.9 in past-smokers, and 3.5 in non-smokers). Similar results were found when patients with coronary artery disease, cerebrovascular disease, or peripheral artery disease were considered separately.

The mean age at cardiovascular death was 82 years for never-smokers, 70 years for past-smokers, and 67 years for current smokers. The mean age for non-cardiovascular death was 79, 74, and 69 years, respectively. "On univariate analysis, age >70 years, body mass index >28, chronic lung disease, heart failure, diabetes, prior history of artery disease, non-smoking status, atrial fibrillation, renal insufficiency, and the use of some drugs were significantly associated with an increased cardiovascular mortality," Dr. Monreal and colleagues write. However, on multivariate analysis, none of the variables, including smoking status, were independent predictors of cardiovascular death.

Eur J Int Med 2009;20:522-526.


Sunday, September 27, 2009

Now breast milk is bad for you -- but only in Denmark

Since Denmark and Finland are both highly "correct" countries that are also very similar in most other ways, this is probably best seen as an artifact of poor sampling. The Finnish sample may have been more rural, for instance. And it certainly "explains" nothing. Correlation is not causation

A study in Denmark suggests hormone-disrupting environmental chemicals may explain why so many men in the country develop the disease. Danish men are up to four times more likely to have testicular cancer as men in neighbouring Finland. Denmark also suffers high rates of other male reproductive disorders, including poor semen quality and genital abnormalities. Some experts believe man-made pollutants that alter the effect of hormones in the developing foetus may be to blame.

Researchers measured levels of 121 chemicals in 68 samples of breast milk from women in Denmark and Finland. They found a dramatic difference between the two countries. Danish breast milk had significantly higher levels of some chemicals, including dioxins, polychlorinated biphenyls (PCBs) and pesticides, than Finnish breast milk. Chemicals in breast milk acted as a marker of exposure to the pollutants in the womb, said the scientists, whose findings are reported in the International Journal of Andrology. Previous research in animals and humans has suggested a connection between hormone-disrupting chemicals and testicular cancer.

Why women in Denmark should have more of the chemicals in their breast milk than their Finnish neighbours remains unclear. Study leader Professor Niels Skakkebaek, from the University Department of Growth and Reproduction in Copenhagen, said: "We were very surprised to find that some EDC (endocrine disrupting chemicals) levels, including some dioxins, PCBs and some pesticides, were significantly higher in Denmark than in Finland. "Our findings reinforce the view that environmental exposure to EDCs may explain some of the temporal and between-country differences in incidence of male reproductive disorders."

However he urged women to continue breast feeding which had "many beneficial effects for the child".

Rates of testicular cancer vary greatly around the world. In the UK, almost 2,000 men are diagnosed with the disease each year, while in the US the number is more than 8,000.


The FDA Rejects Another Good Cancer Drug

No wonder people are worried about bureaucrats controlling health care. They can do what they like -- and do. In this case the usual Leftist enmity to drug companies seems to have been at work. Margaret Hamburg, Obama's appointee as boss of the FDA, is of course a known Leftist. See here for one example of politics being behind bad FDA decisions.

But how would it be if your health insurer were equally arbitrary? What if a black official didn't like the fact that you are white, for instance? It's very hard to get official decisions overturned and you could well die in the meantime

As the debate about health-care reform has heated up, there's been a lot of talk about creating expert panels that give bureaucrats control over what treatments we can receive. Truth be told, these panels already exist. Earlier this month, the Food and Drug Administration (FDA) bureaucracy made a decision that will deny women a viable option for fighting ovarian cancer.

Ovarian cancer is a rare disease and is therefore not usually targeted by drug companies. The pharmaceutical industry tends to focus on cancers that strike a large number of people. Finding treatments for such cancers gives drug companies their best chance to earn enough profit to pay for the enormous cost of developing a new drug.

Thus it was remarkable that the Centocor Company even developed its chemotherapy agent Yondelis. The culmination of the company's efforts was an appearance July 15 before the FDA Oncology Drug Advisory Committee (ODAC), a panel of cancer experts that assists the FDA. But on the day of the meeting the FDA turned its back on 25 years of regulatory precedent and rejected a new cancer drug that by all known standards had passed muster for approval.

Centocor had all of its ducks in a row. For example, in 2006 approval standards for ovarian cancer drugs changed. So Centocor modified its process to meet the new standards. The FDA told the company that Yondelis would have to show a six-week improvement over the most effective therapy now being used to slow the progress of ovarian cancer. When its efficacy results came back, Yondelis showed a six-week improvement.

Instead of approving the drug, however, the FDA had second thoughts and decided the drug did not show enough efficacy to outweigh its toxicity levels. But those levels were not out of line with what other chemotherapies cause. Centocor recommended countering these toxicities by monitoring those who received the drug. Women who received the drug in the clinical trials reported feeling no worse on Yondelis than those who were on the less-effective control drug.

More importantly, these known lab toxicities were well characterized at a meeting in 2006 that the company had with the FDA. If the toxic effects were so important, why didn't the FDA tell Centocor it needed to show 12, 20 or whatever number of weeks that would pass muster? If the standards the FDA set up for this drug weren't enough to pass it, was it ethical to allow women to take this drug during its trials? The FDA needs to be held accountable if it failed to guide the company toward what it needed to do to gain approval.

One member of ODAC briefly challenged the FDA's role in choosing the parameters for this drug's success. But it's too much to expect the panel to be a counterweight to the FDA. The FDA's cancer director, Richard Pazdur, heavily influences the choice of ODAC members each year. This is a little like allowing a prosecutor to pick his friends for a jury. When the ODAC acts in lockstep with the FDA, it's reasonable to question the fairness of the system.

Those of us in the rare-cancer community were sickened by the fate of Yondelis. Women's gynecological cancer has always been an afterthought to drug developers. The more drugs we have to fight these diseases the better.

This episode shows that a healthy dose of reform is needed in two areas at the FDA Office of Oncology Products. The first reform is that the FDA should tell the sponsor exactly what is needed for approval. A concrete measure of efficacy should be added if doubts exist about toxicity.

The other area is reform of the manner by which the cancer panel is chosen by the FDA cancer director in the first place. Given the life and death importance of the issues, there should be a more independent process to assure that the "jury" has been selected fairly, so that, when needed, truth can be spoken to power. A truly independent and impartial ODAC, critiquing both the regulated and the regulators, is the best way to show that the FDA is secure in its science. That will help restore public trust in this important institution.


Saturday, September 26, 2009

Does morphine cause bowel cancer?

Blocking signal molecule can prevent growth of large intestine and colon cancer. This is of relevance to heroin addicts. Don't laugh, but heroin (diamorphine) was orginally devised as a non-addictive form of morphine -- and that was achieved to some extent. It is not strongly physically addictive. The addiction is mainly psychological. But most heroin users will die of other things before they get bowel cancer

By seeing what substances and molecules affect the development of our diseases, we can develop drugs that prevent or cure diseases. In her dissertation at Kalmar University in Sweden, Ann Novotny has found that the signal molecule acetylcholine (ACh) is important for the progress of cancer of the large intestine and colon, knowledge that is important to factor in when developing drugs that block the effects of Ach on tumor cells.

Cancer of the large intestine and colon is the third most common cancer form in the Western world. Survival over a five-year period in Sweden is roughly 56 percent, but depends on how far the cancer has spread when it is discovered. It is known that the cancer has developed ways to signal in order to be able grow and spread independently of the regulatory systems of normal cells. In order to increase the number of survivors, it is important to map this signaling so that new forms of treatment for the cancer can be devised.

Ann Novotny studied the signaling used by the cancer in a portion of large intestinal and colon cancer. She found that there are receptors for opioids, such as morphine, on tumor cells. If morphine is supplied to these cells the protein urokinase is released, which the cancer cells can use to enhance their capacity to spread.

She also studied the nerve signaling molecule acetylcholine (ACh) and discovered that the cancer cells both build up and degrade the molecule. The study shows that the molecule is constantly released from the tumor cells and binds to a special receptor on the same cells, which leads to increased cell production as well as increased production of urokinase, which enhances the ability of the cancer cells to spread. These receptors can also be activated by nicotine, but also by the peptide SLURP-1 (secreted mammalian Ly-6/urokinase plasminagen activator receptor-related protein-1).

The levels of several enzymes, receptors, and the peptide SLURP-1 differ in early and late cancer of the large intestine and in healthy and diseased colons. This knowledge should help us develop drugs that block the effects of acetylcholine on tumor cells, which should be able to keep this cancer from developing further.


Small AIDS breakthrough: vaccine combination cuts HIV incidence a little

But useless for two thirds of the at-risk population. Full details of the research have yet to be released but the statistical significance of the difference reported looks dubious to me -- and we don't know if the study was double blind, though I assume it was

The experimental drug cut the risk of becoming infected with HIV by more than 31 per cent in the world's largest Aids trial of more than 16,000 volunteers in Thailand, researchers have announced. It is the first time in human trials that a vaccine has stopped the virus, which infects 7,500 worldwide every day.

Dr. Anthony Fauci, director of the United States National Institute of Allergy and Infectious Diseases, warned the development was "not the end of the road," but said he was surprised and very pleased by the outcome. "It gives me cautious optimism about the possibility of improving this result" and developing a more effective Aids vaccine, he said. "This is something that we can do."

"Today marks a historic milestone," said Mitchell Warren, executive director of the Aids Vaccine Advocacy Coalition, an international group that has worked toward developing a vaccine. "It will take time and resources to fully analyse and understand the data, but there is little doubt that this finding will energise and redirect the Aids vaccine field.

Even a partially effective vaccine could have a big impact. In 2007, two million died of Aids according to the United Nations agency UNAIDS.

Colonel Jerome Kim, who helped lead the study for the U S Army, which was also involved in the trial, said: "It is the first evidence that we could have a safe and effective preventive vaccine."

The Thailand Ministry of Public Health conducted the study, which used strains of HIV common in Thailand. Scientists stressed it is not clear whether the vaccine would work against other strains in the United States, Africa or elsewhere. The study tested a two-vaccine combination in a "prime-boost" approach, where the first injection primes the immune system to attack HIV and the second strengthens the response.

The vaccines are ALVAC, from Sanofi Pasteur, the vaccine division of French drugmaker Sanofi-Aventis; and AIDSVAX, originally developed by VaxGen Inc. and now held by Global Solutions for Infectious Diseases, a non-profit founded by some former VaxGen employees. ALVAC uses canarypox, a bird virus altered so it can't cause human disease, to ferry synthetic versions of three HIV genes into the body. AIDSVAX contains a genetically engineered version of a protein on HIV's surface. The vaccines are not made from whole virus — dead or alive — and cannot cause HIV.

Neither vaccine in the study prevented HIV infection when tested individually in earlier trials, and dozens of scientists had called the new one futile when it began in 2003. "I really didn't have high hopes at all that we would see a positive result," Dr Fauci confessed. The study tested the combination in HIV-negative Thai men and women ages 18 to 30 at average risk of becoming infected. Half received four "priming" doses of ALVAC and two "boost" doses of AIDSVAX over six months. The others received dummy shots.

All were given condoms, counselling and treatment for any sexually transmitted infections, and were tested every six months for HIV. Any who became infected were given free treatment with antiviral medicines. Participants were followed for three years after vaccination ended.

The results were that new infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 per cent lower risk of infection for the vaccine group. The vaccine had no effect on levels of HIV in the blood of those who did become infected, providing "one of the most important and intriguing findings" of the trial, according to Dr Fauci, giving scientists important clues in identifying whether treatment drugs are actually make a difference by giving protection to the immune system. Full details of the $105 million study will be given at a vaccine conference in Paris in October.

This is the third big vaccine trial since 1983, when HIV was identified as the cause of Aids. In 2007, Merck & Co. stopped a study of its experimental vaccine after seeing it did not prevent HIV infection. Later analysis suggested the vaccine might even raise the risk of infection in certain men. The vaccine itself did not cause infection. In 2003, AIDSVAX failed in two large trials — the first late-stage tests of any Aids vaccine at the time.

It is unclear whether vaccine makers will seek to license the two-vaccine combination in Thailand. Before the trial began, the United States Food and Drug Administration said other studies would be needed before the vaccine could be considered for public use. Also unclear is whether Thai volunteers who received dummy shots will now be offered the vaccine. Researchers had said they would do so if the vaccine showed clear benefit — defined as reducing the risk of infection by at least 50 per cent.

The study was done in Thailand because US Army scientists did pivotal research in that country when the Aids epidemic emerged there, isolating virus strains and providing genetic information on them to vaccine makers. The Thai government also strongly supported the idea of doing the study.


Food crazies harassing businesses

Chicken, fake and real, looks to be a target of several consumer and nutrition groups. The Center for Science in the Public Interest is acting as co-counsel on a lawsuit filed Thursday by an Arizona woman accusing Quorn Foods Inc. of not disclosing on labels the fact that some people have serious allergic reactions to the main ingredient in its Quorn line of meat substitutes. Quorn is derived from a protein-rich fungus, which the company grows in large vats.

The fungus, Fusarium venenatum, was discovered growing in a field in Buckinghamshire, England, in the late 1960s and developed as a food product. "In the 1960s, people were concerned that we would run out of protein and started a search for new protein sources that could feed the world and discovered this fungus that grows naturally in soil. It makes a delicious and nutritious meat alternative. It has as much protein as eggs and as much fiber as broccoli on an ounce-per-ounce basis," said David Wilson, managing director of Quorn, which is a division of Marlow Foods, a British company.

He said the lawsuit was frivolous and unwarranted. "Quorn has been in the U.S. market since 2002 and has been enjoyed by millions of Americans. We have developed our labeling with the Food and Drug Administration, and it is accurate and fair," Wilson said.

But the center, a Washington-based nonprofit food safety and nutrition watchdog group and a vocal critic of restaurant chains that offer salt- and fat-laden foods, disagrees. It said that more than 1,000 people have reported suffering from nausea, vomiting and diarrhea after eating Quorn's products, which include Chik'n Nuggets, Chik'n Patties, Chik'n Tenders and various Chik'n cutlets.

According to the lawsuit, Kathy Cardinale, a 43-year-old advertising executive, ate Quorn's Chik'n Patties on three occasions in 2008 and became "violently ill" each time. The lawsuit, which seeks class-action status, was filed in Superior Court in Stamford, Conn. The British company has its U.S. offices in Westport, Conn.

Meanwhile, the vegan-oriented Physicians Committee for Responsible Medicine says it is readying a lawsuit against the giant KFC fast-food chain under California law for failing to warn consumers that the chain's new grilled chicken product contains a carcinogen. [Lots of things are carcinogenic if you consume enough of them. The toxicity is in the dose. And giving rats huge doses of stuff is a common but scientifically disreputable way of branding something as a carcinogen. The food freaks commonly use that tactic]

The anti-meat advocacy group said that it commissioned independent laboratory tests that show that KFC's grilled chicken contains PhIP, a chemical that it said can increase a person's risk of developing cancer even if consumed in small amounts.

Not disclosing the presence of the chemical violates California's public health law, known as Proposition 65, the group contends. It plans to file the lawsuit next week in San Francisco County Superior Court.

Earlier this year, the group sued hot dog makers, alleging that their products increase cancer risk and should carry a warning label similar to those on tobacco products.


Friday, September 25, 2009

Irresponsible prostate testing proposal ignores risk of harm to men

Testing saves less than one life in a thousand and has its own perils. The great majority of men who get chopped about as a result would have been OK if left alone

In 2003, Professor Alan Coates, then 58 and head of Cancer Council Australia, admitted he had not had, and wasn't planning to have, a test to see if he had prostate cancer. Wayne Swan, a prostate cancer survivor, called his statement "public policy vandalism".

Coates was not a lone heretic. While it would be rare to find a smoker working in cancer control, or any woman in the same field who had not had a Pap smear, many men who know much about the evidence on whether prostate testing saves lives have not been tested themselves. A study in 2002 of male GPs in Victoria aged over 48 found less than half had been tested; many physicians choose to remain ignorant about whether they have the disease. What do they know that the Urological Society of Australia and New Zealand does not?

The society has recommended 40 as the age for men to consider having their first prostate-specific antigen test, or PSA, and for those in the top half of PSA levels to be considered higher risk and "monitored closely". Those with lower levels could have less frequent testing.

Earlier this year, results from a European trial involving 160,000 men aged 55-69 were published in the New England Journal of Medicine. Only some were given PSA tests. It showed that if you screen 1000 men, you will find 82 cases, and if you follow these men for an average of nine years, there will be 2.94 deaths. In 1000 unscreened men over the same period, 48 cases of prostate cancer will come to light by men presenting symptoms to their doctor. There will be 3.65 deaths. The difference between the two means, in short, testing saves 0.71 deaths per 1000 men over nine years.

Prostate cancer is a disease from which you are more likely to die very late in life. For elderly men - those over 84 - the death rate is 767 per 100,000 men, while for those aged 40 to 44 it is 0.3. This means there will be one death per year from prostate cancer in every 330,000 men aged 40-44, an age group the Urological Society now believes should be tested. The odds of any one man this age dying from the disease are nearly twice as poor as winning first prize in a lottery with 200,000 tickets.

By doing a PSA test on all these men and applying the proposed threshold, hundreds of thousands of men will now be considered higher risk and monitored closely for prostate cancer.

Autopsy studies show you can find prostate cancer in up to one-third of men of this age if you look hard enough for it. By finding all these cancers there is the potential for harm on a massive scale, because there are real and frequent risks associated with treatments for prostate cancer.

Getting a test result is just the beginning. When cancer is suspected following a PSA test, we know in Australia it is aggressively treated in younger men. The European trial showed that to save just one life from screening, an additional 48 men would need to be treated, and it was using a much higher threshold than is now proposed here. In other words, to save one life, 48 men would be treated who would not have died from the disease.

They are treated because our science is not advanced enough to know which of 49 men's lives will be saved by having their prostates removed. And the treatment is far from benign. According to a review last year by the US Preventive Services Taskforce, one year after surgically removing the prostate gland, 20 to 70 per cent of men have reduced erectile function, and 15 to 50 per cent have persisting urinary problems.

There is no evidence from trials to support the proposed new strategy, nor has the Urological Society commented on its cost-effectiveness. What are the costs of close monitoring of half the nation's men aged in their 40s? What health-care services are going to be cut to cover the additional costs? Or must the health budget be increased?

To make such recommendations without considering the potential to do harm to men and to the health-care budget is irresponsible. Furthermore, urologists and the companies selling PSA tests stand to benefit from concern among men to be tested. In a recent letter to the Herald a man who had undergone prostate removal said he paid $15,000. These facts are almost always absent from the advice given to men by the few agencies which are aggressively promoting screening.


Quackery at the University of Toronto

Three weeks ago or so, I expressed dismay at what I perceived as an autism quackfest being held at the University of Toronto. Worse, that quackfest had been partially funded by a grant from a very prestigious children's charity, The SickKids Foundation, which in response to complaints about its sponsoring the autism quackfest known as AutismOne/Autism Canada 2009 Conference, wrote a limp and pusillanimous form e-mail that it sent to everyone who complained. It was truly disappointing to see that an organization that should be supporting science-based research into the treatment of children's cancer and other serious diseases that primarily affect children would be lending its money, name, and prestige to autism quackery, including anti-vaccine loons, homeopaths, and "energy medicine" practitioners.

One salutary effect of my posts was that the University of Toronto's Dalla Lana School of Public Health. which had been previously listed on the early advertisements as a co-sponsor of this event, apparently told AutismOne to stop using its name. Certainly, more recent iterations of the Autism Canada website and advertisements show no such affiliation anymore.

I still find it truly depressing that the SickKids Foundation sees nothing wrong with funding this nonsense, and I sincerely hope that this is an older brochure and that the Dalla Lana School of Public Health has made it very plain that it does not support autism quackery.

More here

‘Egg whisk’ pioneered by doctor helps pump blood during heart surgery

A miniature “egg whisk” that rotates faster than a high-speed food blender has been pioneered by a British doctor to help the heart to pump blood round the body during life-saving surgery. The ground-breaking procedure, which involves passing the fold-up whisk through the body to a site next to the heart, allows patients with weak hearts to have an artery unblocked without the risk of kidney failure or cardiac arrest.

More than 100,000 patients undergo artery-clearing angioplasty annually, but many remain at high risk of serious complications because of their problems pumping blood. But now Professor Martin Rothman, a cardiologist based at the London Chest Hospital, has completed the first human trials of the revolutionary whisk, which is inserted via a catheter through the groin shortly before the angioplasty takes place.

The procedure, which has not yet been licensed, has proved so successful in patients to date that it was broadcast live yesterday to a key conference in San Francisco attended by 10,000 cardiologists. The whisk, called the Reitan catheter pump, is inserted in a tube via the femoral artery and manoeuvred up to the aorta, where it folds out to form a plastic cage encasing two stainless steel propeller blades of about 8mm in length.

Once switched on — a wire running down the catheter allows it to be powered electrically — the device rotates at up to 12,000rpm, enhancing the pumping action of the heart by drawing blood down from the aorta to the arteries. This keeps vital organs, such as the kidneys, working as the patient undergoes angioplasty.

Professor Rothman told The Times that the device effectively “unloaded the heart”, reducing the risk of heart attack, kidney failure and cardiogenic shock — when reduced blood flow causes multi-organ malfunction. Once the angioplasty is completed, the Reitan catheter pump can be removed.

Professor Rothman said that with up to one in ten patients who need angioplasty being at risk of cardiac and renal failure, the device would bring benefits for thousands of patients every year and even appeared to improve severe kidney problems. He added: “This technology offers real opportunity for sick patients to undergo a very important procedure — patients who, were you to blow a balloon up in their arteries, would otherwise likely be pushed over the edge. “The pump is incredibly powerful — if you stuck it in a bucket of water it looks like the whole thing is boiling. It helps people with heart failure survive this procedure better and with less risk.”

Professor Rothman carried out the first trial after discovering the device, designed by √ėyvind Reitan, a Swedish cardiologist and engineer, a few years ago. To date, the British doctor, who works in Barts and the London NHS Trust, has carried out 17 procedures, with published data on the first ten. While a pump would cost about £1,000, and can be used for only one procedure, the savings of preventing a patient from ending up on kidney dialysis are substantial. Three days on dialysis would cost about £10,000.

For the surgery last night, Professor Rothman operated on a woman, 79, who had blockages in her right coronary artery and proximal left anterior descending artery. As a diabetic with high blood pressure and raised cholesterol, the woman had been refused angioplasty by other cardiologists. She is now back on the ward.

Describing the notion that it might reverse kidney failure as a “Star Trek moment”, Professor Rothman said that his team were examining evidence collated so far. One case involved a woman who was only able to pass 10ml or urine per hour in the two weeks before the operation because of poor kidney function, who passed ten times the amount with the device in place.

“It was a revelation to see that patients who had a chronic or long-term impairment of the kidney could actually have that state reversed using the pump,” he said. “That was amazing. We saw the data and it made a lot of us think again. You think most people who have chronic kidney failure have exactly that. You don’t expect them to impove their function and that’s what we have seen.”

Ellen Mason, a cardiac nurse with the British Heart Foundation, described the work as pioneering. She said: “It is great to see a British cardiologist leading the way in the field of international cardiology. “The application would be in people with cardiogenic shock which is usually fatal, or severe heart failure probably due to a heart attack. The hope is that they would be able to undergo urgent treatment for heart attack, when before it would have been too risky. “The data from these trials will determine whether this will become more widespread in the UK and the rest of the world.”

A representative for Barts and The London NHS Trust, which includes the London Chest Hospital, said that it fully supported Professor Rothman’s work. “The trust is committed to providing first class clinical care to all its patients. Our support of cutting-edge research work such as the Reitan Catheter Pump System, is just one example of our ongoing work to help patients to live better, fuller and longer lives.”


Thursday, September 24, 2009

British study finds no evidence of autism surge in children

Autism is as common among adults as it is among children, a study has found, dispelling fears of a link between the MMR vaccine and the condition. A study of rates of autism spectrum disorder among adults suggests that one in every 100 people over the age of 18 has the condition — broadly the same as that cited for children.

The data, collected by the NHS Information Centre, is the first to show how autism affects people over the course of a lifetime, concluding that it is similar across all ages.

People in more than 4,000 households in England were asked a series of questions aimed at assessing their psychiatric health. The results were used to identify adults with an autism spectrum disorder, including Asperger’s syndrome.

The centre said that the study found no evidence to support claims of a link between the MMR jab given to children and the development of autism: if the vaccine was to blame, autism rates among children should be higher because the MMR has been available only since the early 1990s.

The study — the Adult Psychiatric Morbidity Survey 2007 — was funded by the Department of Health. It found that rates of autism were higher among men (1.8 per cent) than among women (0.2 per cent). This reflects studies in children, which have shown higher rates among boys than girls.

The report also found higher rates of autism among single people, among men with no university degree and among men who rent their homes rather than those in other types of housing. [The poor have worse health: The old, old finding]

Tim Straughan, chief executive of the NHS Information Centre, said: “This landmark report is the first major study into the prevalence of autism spectrum disorders among adults to be carried out anywhere in the world. “The findings do not support suggestions of a link between the MMR vaccine and the development of this condition.” Mr Straughan said that while the sample size was small and any conclusions needed to be treated with caution, the report suggested that, despite popular perceptions, rates of autism were not increasing.

The MMR jab was first introduced in the UK in 1988. Concerns over the vaccine were sparked by a paper published in The Lancet in 1998 by Dr Andrew Wakefield. The research has since been discredited.

Mr Straughan said that the findings backed those from the National Audit Office (NAO) that more was required to support people with autism through adulthood. The NAO found there was very little recognition and service provision by local authorities or the NHS for adults with autism spectrum disorder.

The NHS Information Centre report found that people with autism do not access support services for mental or emotional problems in any greater numbers than the general population. “This does beg some questions about whether services, as currently configured, are meeting the needs of this group of people,” Mr Straughan said.

Mark Lever, chief executive of the National Autistic Society (NAS), said that his organisation had long campaigned about awareness of “woefully inadequate” services and support for adults with autism. “Nearly two-thirds of adults with autism told us they do not have enough support to meet their needs. “Many thousands feel isolated and ignored and are often completely dependent on their families. This study gives us further evidence to demand that more vital support is put in place.” Mr Lever said that the report was the first part of a much more detailed research project into the prevalence of autism in the UK. “While we welcome this initial report, it only underlines the scale of the task that lies ahead and the importance of the forthcoming adult autism strategy in tackling the devastating lack of support and services,” he said.


Bashed your head? You needed a stiff drink

Crazy as it sounds, alcohol may one day be given to people with brain injuries to help them recover. The idea has arisen from a study of 38,000 people with head injuries, which found that those with alcohol in their blood were more likely to survive. For every 100 people who died when stone-cold sober, only 88 died with ethanol – the kind of alcohol in drinks – in their veins. "The finding raises the intriguing possibility that administering ethanol to patients with brain injuries may improve outcome," conclude the investigators.

Lead researcher Ali Salim of the Cedars-Sinai Medical Center in Los Angeles said he hoped a trial could be mounted, but more information is needed first. "We need a better understanding of the exact mechanism, the appropriate dose and specific timing of treatment before we can embark on clinical trials," he told New Scientist.

Salim said that several previous studies have found similar beneficial effects – although others do not. Animal experiments, meanwhile, suggest that relatively low doses of alcohol protect the brain from injury, but high doses increase the risk of death. More research is also needed to establish how alcohol protects the brain, but Salim says it may work by blunting the amount of adrenalin reaching the brain, which reduces inflammation.

Despite alcohol's potential for helping patients survive brain injury, Salim stressed that it is to blame for half of all injury cases. "Alcohol is and will always continue to be bad, since it contributes to over 40 per cent of traffic-related fatalities," he says.

The study also found that drinkers suffered more complications and more severe injuries than non-drinkers, even though the overall survival rate was higher.

David Hovda, director of the Brain Injury Research Center at the University of California at Los Angeles, agreed that more research is needed before a clinical trial could take place. "One would have to know the therapeutic time window and, of course, the dose," he says. "But the mechanisms of action involving the neurobiology of traumatic brain injury have different timeframes and regional profiles which would make ethanol therapy difficult to manage correctly."

Hovda also points out that brain injuries can be very diverse, so ethanol might work for some but not others. "Severity and type really make a difference when deciding on therapeutic options," he says.

Journal reference: Archives of Surgery, vol 144, p 865


Wednesday, September 23, 2009

Lies and deceit below

The original journal article is here. The article below glides over the fact that the effect of HRT on incidence of cancer was NON-SIGNIFICANT statistically. And given the large numbers involved, the effect had to be pretty tiny in absolute terms for that to be so. The marginally significant difference in mortality among HRT users who DO get cancer is more a puzzle than a threat. In absolute terms, women on HRT are most UNLIKELY to die of lung cancer -- unless they smoke. Smoking is the real risk factor

The constant reliance on relative risk ratios is very annoying and uninformative. It may be good for getting journal articles published but it is useless to the average person trying to work out a reasonable policy for themselves. What they need to know is the ABSOLUTE risk -- and in all the reports about the evils of HRT it is negligible

If taking HRT raises your risk of some illness from 1 in 4000 to 1 in 3000, that gives a relative risk ratio big enough to generate a scary academic journal article but in absolute terms the risk is still negligible

Hormone replacement therapy, already linked to [minute] increases in breast cancer, heart disease and stroke, nearly doubles a woman's risk of dying from lung cancer, researchers reported Saturday in a finding that may be the final nail in the coffin for a therapy that is already in rapidly declining use. The findings "seriously question whether hormone-replacement therapy has any role in medicine today," wrote Dr. Apar Kishor Ganti of the University of Nebraska Medical Center in an editorial accompanying the online publication of the report in the medical journal Lancet.

The link to lung cancer "is yet another reason to not use hormone replacement therapy if it can be avoided," said Dr. Mark Faries, director of translational tumor immunology at the John Wayne Cancer Institute in Santa Monica, Calif., who was not involved in the research. "It raises the bar for deciding to do HRT."

The findings come from the Women's Health Initiative, a large study originally begun in 1991 to demonstrate, in part, that administration of a combination of estrogen and progestin could relieve debilitating symptoms of menopause and reduce the risk of heart attack and stroke. The hormone replacement arm, which enrolled more than 16,000 women, was halted prematurely after about 51/2 years when it was observed that the risks far outweighed any potential benefits.

The therapy not only did not protect against heart disease and stroke, but it yielded only questionable improvements in quality of life and produced a small but statistically significant increase in the risk of heart disease, stroke and breast cancer. Several subsequent reports have shown that the rate of breast cancer rose by at least 15 percent during the 1990s when HRT was blooming, then dropped sharply when many women abandoned the treatment after a 2002 report on the subject.

Treatment with estrogen has a deleterious effect on breast cancer patients because the hormone binds to estrogen receptors on tumor tissue, accelerating its growth. Recent laboratory studies have shown that lung tissue also has estrogen receptors and that the accelerated growth is even more dramatic in lung tumor cells, according to Dr. Richard J. Pietras, who directs the Stiles program on oncology at the University of California, Los Angeles' Jonsson Comprehensive Cancer Center. Among other effects, the hormone promotes the growth of blood vessels that nourish growing tumors.

"We've been suspecting for a long time that this is an area we need to investigate," Pietras said. The need is especially dramatic because the incidence of lung cancer in women has been growing and more women now die from it than from breast, ovarian and colon cancers combined. About 99,000 women are diagnosed with lung cancer each year, and 71,000 die from it.

The first results from the Women's Health Initiative suggested that the hormones might have an effect on lung cancer. To further explore a link, Dr. Rowan Chlebowski of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and his colleagues studied the women in the Women's Health Initiative for an additional 2 1/2 years.

At the end of the eight-year period, they found that 109 women who received the estrogen and progestin treatments had been diagnosed with lung cancer, compared with 85 in the group that received a placebo — a modest 23 percent increase in incidence.

The difference was more dramatic when they considered deaths. In the group receiving hormone therapy, 73 women died, compared with 40 in the placebo group, a 71 percent increase. The increase in lung cancer deaths accounted for half of the overall increase in deaths in the women receiving hormone therapy, Chlebowski said. The effect was most pronounced for so-called non-small-cell lung cancer, the most common form in women. There were 62 deaths from this type of tumor in women receiving hormones, compared with 31 deaths in the placebo group.

"The important thing is this is the identification of a new, lethal side effect of estrogen plus progestin use," he said. The findings "have special significance" for women who are now or have been heavy smokers, he said.

Women who were current smokers and who took hormone therapy had a 1 percent chance of dying from lung cancer in five years. Women who had smoked had about half that risk. "About half the post-menopausal women in the United States would fall into either category," he said.

The findings suggest that the hormones do not themselves cause lung cancer, but that they accelerate the growth of existing tumors, making them more aggressive and more likely to metastasize, Chlebowski said.

Lung cancer is "a very potent, brutal disease," said Dr. Glen Justice, director of the MemorialCare Cancer Center at Orange Coast Memorial Medical Center in Fountain Valley, Calif. "The real take-home message here is that you have got to have a very good reason for going on hormones because we now know that there are so many negative effects."


Eating junk food could fatten your tax bill

And a tax is likely to be counterproductive anyway

Alarmed by a tripling of obesity rates among U.S. children over the past 30 years—nearly one in five of today’s adolescents is claimed to be obese—the Institute of Medicine and the National Research Council issued a report just before Labor Day recommending a series of policy initiatives aimed at trimming the flab from America’s youth.

Saying the child obesity problem cannot be solved at the federal level, the two groups counsel state and local officials to impose their own soft drink taxes, tax “junk food,” limit access to television and video games in after-school programs, replace public school vending machines with water fountains, open school playgrounds to the general public, build more sidewalks and bicycle paths, make shopping at stores that sell fresh food more convenient for people living in low-income neighborhoods, and require restaurants to list calorie counts on their menus.

The report takes another step down the road to government control of lifestyle choices. The more successful the current administration is in displacing private health insurance with a taxpayer-financed public option, the more coercion to adopt healthy ways of living one can expect—stop smoking, exercise regularly and eat only the foods recommended by those who know what’s good for you.

A public health insurance program will deny coverage to no one and will charge everyone (probably within certain age groups) the same premium, including those with pre-existing conditions, such as diabetes or merely being overweight. Under the circumstances, there are only a few ways of keeping the program’s costs from careening completely out of control. Government can regulate the types of medical procedures for which health care providers can apply for reimbursement; limit the amounts of those reimbursements; and use selective taxes and other government powers to “encourage” individuals covered by the public option to avoid behaviors the so-called experts link to illness and injury.

With private health insurance, by contrast, insurers have incentives to charge premiums that reflect the actuarially determined probability that individual policyholders will submit claims. Smokers pay more for health and life insurance than nonsmokers, and overweight people, especially those with histories of adult-onset (Type 2) diabetes, high blood pressure or elevated cholesterol levels, pay more than those with a clean bill of health.

With risk-based insurance premiums, the consequences of smoking and overeating are not social costs, borne by everyone, but private costs borne largely by those who overindulge. Private health insurers do not charge higher premiums to people who enjoy soft drinks or junk food on occasion, but to those who regularly pig out and put on the pounds.

Selective excise taxes are blunt instruments for controlling behavior. Taxing soft drinks may cause people to drink less soda, but some will substitute other high-calorie drinks. Taxing Big Macs may reduce cash register sales, but some will simply eat more loaded pizza, or make cheeseburgers at home.

Maine already tried this. During the 10 years the so-called snack tax was in effect, the state’s adult obesity rate doubled, from 10 percent to 20 percent.

What Nobel laureate James Buchanan calls the “meddlesome preferences” of those who want you to behave as they do now threaten our personal freedoms. Lifestyle choices should not be ceded to government.


Tuesday, September 22, 2009

NYT love letter to FDA

New York Times reporter Gardiner Harris has a front page article in today’s paper on the head of the Food and Drug Administration’s Office of Oncology Drug Products, Richard Pazdur. As the article notes, Pazdur has come under severe criticism in recent years for obstructing the approval of numerous innovative cancer drugs. Some of this criticism is unfair, and Harris is clearly attempting to defend Pazdur and the FDA, while proving the critics wrong. After all, Pazdur has implemented reforms that permit the FDA to occasionally consider New Drug Applications for cancer drugs that are supported by fewer clinical trials, with fewer patients in those trials, and that measure progress toward a “surrogate end-point” such as tumor suppression instead of increased length of patient survival.

But that’s not the whole story. Steven Walker, a co-founder of the patient advocacy group Abigail Alliance, is rightly quoted saying “Patients are right to be angry and frustrated with Richard Pazdur. … He is a dinosaur.”

Indeed, in his zeal to defend Pazdur, Harris gets a few important facts wrong. For example, he writes that “Federal law requires that the agency demand two ‘well controlled’ trials before approving a drug; in cancer, the Food and Drug Administration is often satisfied with just one.” Wow, you might think, this Pazdur guy must really be special if he’s willing to disregard federal law in order to speed new drugs to market.

Except that federal law hasn’t required two Phase III trials in all cases since passage of the FDA Modernization Act (FDAMA) in 1997, which specifically permits FDA to approve a drug on the basis of a single Phase III trial if the Secretary of HHS (of which FDA is a part) determines the information sufficient to prove the drug is effective. Similarly, FDAMA specifically grants FDA permission to “fast track” the approval of important new drugs by considering surrogate end-points rather than increased length of survival. Pazdur’s contribution was not to come up with these great ideas, but merely to implement them at the request of Congress and President Clinton.

Pazdur looks even less good when you consider some of the products he’s accused of derailing, such as the prostate cancer drug Provenge, which I wrote about two years ago. Provenge works like a vaccine to help a patient’s immune system fight off prostate cancer, a disease with few other available treatments. The independent panel of scientific experts that advises the agency on new oncology drug approvals unanimously agreed that Provenge was safe, and voted 13 to 4 that it was effective enough for approval, but the agency demanded additional testing before it would approve the drug.

In one trial, 34 percent of patients receiving the drug were alive three years after treatment, compared to just 11 percent of patients receiving the placebo. But the median survival time for those taking Provenge was just 4½ months longer than for the placebo group. Still, Taxotere, the only currently approved alternative for advanced prostate cancer, extends survival for just half that time, while killing some 300 patients outright every year.

FDA’s main contention was that the clinical trial showing these benefits in Provenge was actually designed to find a different end-point. So, under Pazdur’s leadership, the FDA oncology drugs unit refused to approve Provenge despite pretty reliable evidence of its safety and efficacy. That story doesn’t make it into Gardiner Harris’s article, however, since it might weaken his case for Pazdur’s sainthood.

Harris does, however, trot out a patient advocate and an industry analyst to make the case that, even safe drugs with uncertain benefits shouldn’t be approved. “We want drugs that prolong survival, not drugs that just improve a test result,” said Frances Visco of the National Breast Cancer Coalition.

Naturally, we don’t want snake-oil salesmen touting non-existent benefits of sham treatments. But, why can’t we require full disclosure of the ambiguity, and let patients and their doctors choose? In far too many cases, waiting for absolute proof of some huge benefit serves only to keep promising new drugs off the market. It also means that dying patients are refused the only option that might prevent or delay their death.

Harris notes, as a humanizing aside, that Pazdur doesn’t eat meat “because he believes a vegetarian diet will help protect him from cancer, although the supporting evidence is as thin as vegetable broth.” That’s wonderful; a balanced vegetarian diet certainly can’t hurt, and there is some evidence suggesting that it may well help improve Pazdur’s health. But, if this dietary choice were subject to the same evidentiary standards that Pazdur places on new drugs, he wouldn’t have that choice.

What seems not to have occurred to Pazdur, Harris, and Pazdur’s other supporters is that, if a drug with uncertain effectiveness is approved, those who “want drugs that prolong survival, not drugs that just improve a test result,” don’t have to use it. They can hold out for a product with more certain benefits. But, when a drug with uncertain benefits is not approved, it means that everyone is denied the choice.


British chemical warfare centre helps with war on wrinkles

For almost a century Porton Down has been Britain’s nerve centre for chemical warfare. Now one of its discoveries has been sent into battle against crow’s feet and wrinkles. Cosmetic surgeons are switching to a Botox-type drug developed by the biological research laboratories in Wiltshire. They believe the treatment lasts longer than Botox and is both more effective and less painful.

The drug, Dysport, was developed in the 1970s by a civilian arm of Porton Down. It drew on second world war research into botulism, a condition caused by a bacterium that can lead to organ failure.

Treatment with Dysport, as with Botox, involves the injection of tiny amounts of botulinum toxin, which relaxes muscles by blocking the nerve impulses that cause contraction. This removes wrinkles and lines for several months.

One of the doctors switching to Dysport is Nick Lowe, a consultant dermatologist at the Cranley clinic in London, who counts Anne Robinson among his celebrity clients. He has conducted comparative studies on more than 100 patients and is now writing a scientific paper. He found that Dysport worked faster than Botox and the effects lasted longer. “It has been shown that with Dysport you get an ever so slightly greater spread — it has a wider effect than the same injection of Botox. I think that is one reason why it can give a slightly more natural look,” he said.

Nigel Horlock, a consultant plastic surgeon in Southampton, said: “I’ve had patients with Dysport who’ve said it works in three days and another patient who had it five months ago and it was still working.”

Dysport was developed to treat a range of illnesses including dystonia, which causes spasms. Its name is a contraction of dystonia and Porton Down. The cosmetic potential of the drug was recognised in America, and it was licensed for use in Britain this year.


Monday, September 21, 2009

HRT ‘increases risk of dying from lung cancer’

This is just another epidemiological correlation of unknown causation or implication. That it is a statistical freak is suggested by the fact that taking HRT did NOT increase the number who got lung cancer

Lung cancer is likely to be fatal in women who undergo HRT, according to new statistics. Women who take controversial hormone replacement therapy drugs to combat symptoms of the menopause could be more likely to die if they develop lung cancer. An eight-year study of 16,600 women found the disease was 71 per cent more likely to be fatal in women taking HRT compared with those taking a placebo pill. This was the case even though there was not a significant increase in the number of women taking HRT who developed lung cancer.

About 20 per cent of women take HRT drugs, which boost levels of the hormones oestrogen and progesterone and help combat hot flushes, insomnia and palpitations. However, there are already fears over their safety. Previous studies have linked the pills with some increase in the risk of developing breast and ovarian cancer, strokes and heart problems.

Leading cancer specialists said the latest study was ‘plausible’ because oestrogen could increase blood flow to tumours, so preventing cancer treatments from working as effectively.

The authors of the US study, which is being published in British medical journal The Lancet, said: ‘Findings should be incorporated into risk/benefit discussions with women considering combined hormone therapy, especially those with a high risk of lung cancer... such as current smokers or long-term past smokers.’

The risk of dying from lung cancer was greatest for women taking HRT aged 60 to 79. There was no increased mortality risk for women aged 50 to 59.

Dr Apar Kishor Ganti, of the University of Nebraska, said: ‘These results seriously question whether hormone-replacement therapy has any role in medicine today.’

But UK cancer specialist Professor Karol Sikora said: ‘It’s not conclusive. Women still need HRT and they like it because it makes them look and feel better. There isn’t currently an alternative, so they shouldn’t stop taking it and doctors shouldn’t stop giving it out.’


SF Mayor wants to charge stores that sell sodas

Calling soda the new tobacco, San Francisco Mayor Gavin Newsom will introduce legislation this fall that would charge a fee to retailers that sell sugary beverages. Newsom would need voter approval to tax individual cans of soda and sugary juice, but only needs approval from the Board of Supervisors to levy a fee on retailers. His legislation would charge grocery stores like Safeway and big-box stores, but would not affect restaurants that serve sodas.

Newsom wouldn't say how much the stores would have to pay or how the city would spend the fees. When he first floated the idea in 2007, he said the money would go to his Shape Up San Francisco exercise program and for media campaigns to discourage soda drinking.

The mayor said the city attorney's office has warned him the city would probably be sued over the matter, but he said it is worth the risk to try to curb a leading cause of obesity and diabetes. "We know we'll be sued," he said. "But I really believe this is important to do."

Newsom said he was particularly motivated to move forward with the legislation by Thursday's release of a UCLA study showing a link between soda and obesity in California. Researchers found that adults who drink at least one soft drink a day are 27 percent more likely to be obese than those who don't - and that soda consumption is fueling the state's $41 billion annual obesity problem. The study also found that 41 percent of children and 62 percent of teens drink at least one soda daily.

"Soda is cheap, sweet and irresistibly marketed to teens," said Susan Babey, the study's lead author. "Not enough teens know about the health and dietary risks of drinking huge quantities of what is essentially liquid sugar." San Francisco would be the first city in the country to levy a fee on soda if, as expected, it is approved by the board. A handful of states, including Arkansas and Missouri, tax sodas, and California has considered the idea in the past. A soda tax has also come up in the national debate about health care reform as one way to help pay to insure more people.

The American Beverage Association has consistently fought attempts to implement soda taxes, and on Thursday released a statement combatting UCLA's study. It read in part, "If our goal is to address obesity, then educating consumers about the importance of balancing calories consumed from all foods and beverages with the calories expended through physical activity is what matters - not demonizing any one particular food."

In San Francisco, a soda tax would be just the most recent example of a long line of legislation intended to improve residents' health - a pattern some residents have complained smacks of a nanny state. In recent years, city officials have banned the sale of cigarettes in pharmacies, added a fee to packs of cigarettes, required chain restaurants to display calories and fat content on menus, and created a program to recognize restaurants that don't serve trans fats.

Jim Lazarus, vice president of the San Francisco Chamber of Commerce, said the group opposes the soda tax. "Does this mean there's a fee on candy bars, on ice cream, on potato chips?" he asked. "Where do you draw the line?" He added that a small fee - likely to be passed on from the retailer to the consumer - wouldn't be enough to dramatically change people's habits, leading him to believe it's meant to be just another revenue source for the city.

Mitch Katz, director of the city's Department of Public Health, said a study conducted over the past nine months shows a clear link between soda consumption and an increased burden on the public health system. He did not have a total dollar figure. He said he considers a soda fee an incremental step, and that other sugary foods could someday have a surcharge as well. "It makes sense for the government to help people to make the right choices, and it makes sense to use dollars from charges on sweetened beverages on health programs," he said.


Sunday, September 20, 2009

Eighteen reasons why you should NOT vaccinate your children against the flu this season

Reasons 7, 8, 10 and 17 are wild-eyed rubbish but the rest is well-founded

This year it is more important that you protect your children and loved ones from the flu vaccines than influenza itself. Here are the reasons:

1. This flu is simply another flu. It is not unusually deadly. In fact, the H1N1 swine flu in circulation is less deadly than many other influenza outbreaks. The first 1000 confirmed swine flu cases in Japan and China produced zero deaths. The Centers for Disease Control alleges 36,000 Americans succumb to the flu each year, but so far, since March through August of 2009 (6 months), the swine flu has been attributed to ~500–600 deaths in the US. The swine flu of 2009 has already swept through the Southern Hemisphere’s flu season without alarm. Only exaggerated reports have been issued by the World Health Organization regarding hospitalizations required during the flu season in South American countries. Getting exposed to influenza and developing natural antibodies confers resistance for future flu outbreaks. Artificially boosting antibodies by exposure to flu viruses in vaccines is more problematic than natural exposure. Americans have been exposed to the H1N1 swine flu throughout the summer of 2009 with far fewer deaths and hospitalizations than commonly attributed to the seasonal flu.

2. Health authorities tacitly admit prior flu vaccination programs were of worthless value. This is the first time both season and pandemic flu vaccines will be administered. Both seasonal flu and swine flu vaccines will require two inoculations. This is because single inoculations have failed to produce sufficient antibodies. Very young children and older frail adults, the high-risk groups in the population, may not produce sufficient antibodies in response to the flu vaccine. This is an admission that prior flu vaccines were virtually useless. The same people who brought you the ineffective vaccines in past years are bringing you this year’s new vaccines. Can you trust them this time?

3. In addition to failure to produce sufficient antibodies, this swine flu vaccine is brought to you by the same people who haven’t been able to adequately produce a seasonal flu vaccine that matches the flu strain in circulation. In recent years flu vaccination has been totally worthless because the strains of the flu in circulation did not match the strain of the virus in the vaccines. Authorities claim the prevalent flu strain in circulation in mid-September ’09 is the H1N1 swine flu, which appears to be milder than past seasonal influenza in circulation. If this data is correct, why receive the season flu shot this year?

4. The vaccines will be produced by no less than four different manufacturers, possibly with different additives (called adjuvants) and manufacturing methods. The two flu inoculations may be derived from a multi-dose vial and in a crisis, and in short supply, it will be diluted to provide more doses and then adjuvants must be added to trigger a stronger immune response. Adjuvants are added to vaccines to boost production of antibodies but may trigger autoimmune reactions. Some adjuvants are mercury (thimerosal), aluminum and squalene. Would you permit your children to be injected with lead? Lead is very harmful to the brain. Then why would you sign a consent form for your kids to be injected with mercury, which is even more brain-toxic than lead? Injecting mercury may fry the brains of American kids.

5. This is the first year mock vaccines have been used to gain FDA approval. Mock vaccines are made to gain approval of the manufacturing method and then the prevalent virus strain in circulation is added just days before it is actually placed into use. Don’t subject your children to experimental vaccines. Yes, these vaccines have been tested on healthy kids and adults, but they are not the same vaccines your children will be given. Those children with asthma, allergies, type I diabetes, etc. are at greater risk for side effects. Children below the age of 2 years do not have a sufficient blood–brain barrier developed and are subject to chronic brain infections that emanate into symptoms that are called autism. Toddlers should not be subjected to injected viruses.

6. Over-vaccination is a common practice now in America. American children are subjected to 29 vaccines by the age of two. This means a little bit of disease is being injected into young children continually during their most formative years! Veterinarians have backed off of repeat vaccination in dogs because of observed side effects.

7. Health officials want to vaccinate women during pregnancy, subjecting the fetal brain to an intentional biological assault. A recent study showed exposure flu viruses among women during pregnancy provoke a similar gene expression pattern in the fetus as that seen in autistic children. This is a tacit admission that vaccines, which inject a little bit of influenza into humans, causes autism.

8. Modern medicine has no explanation for autism, despite its continued rise in prevalence. Yet autism is not reported among Amish children who go unvaccinated. Beware the falsehoods of modern medicine.

9. School kids are likely to receive nasally-administered vaccines (Flu-Mist) that require no needle injection. But this form of live vaccine produces viral shedding which will surely be transmitted to family members. What a way to start an epidemic!

10. This triple reassortment virus appears to be man made. The H1N1 swine flu virus of 2009 coincidentally appeared in Mexico on the same week that President Nicolas Sarkozy of France visited Mexican president Felipe Calderon, to announce that France intends to build a multi-million dollar vaccine plant in Mexico. An article written by Ron Maloney of the Seguin, Texas Gazette-Enterprise newspaper announces a "rehearsal for a pandemic disaster" scheduled for May 2, 2009. The article says: "Guadalupe County emergency management and their counterparts around the country are preparing for just such a scenario…" This means county health authorities across the U.S. had been preparing a rehearsal for mass vaccinations prior to the announced outbreak in Mexico. Virologists admit this part swine flu/part avian flu/part human flu virus must have taken time to develop. But it somehow wasn’t detected by hundreds of flu monitoring stations across the globe. On April 24, 2009 Dr. John Carlo, Dallas County Medical Director, alludes that the H1N1 strain of the Swine flu as possibly being engineered in a laboratory. He says: "This strain of swine influenza that’s been cultured in a laboratory is something that’s not been seen anywhere actually in the United States and the world, so this is actually a new strain of influenza that’s been identified." (Globe & Mail, Canada)

11. Recall the swine flu scare of 1976. In a politically charged atmosphere where Gerald Ford was seeking election to the Presidency, the swine flu suddenly appeared at a military base. Vaccine was produced and millions of Americans were vaccinated. But the vaccine was worse than the disease, causing hundreds of cases of Guillain Barre syndrome and a few deaths. In a replay of the past, the White House is directly involved in promoting the H1N1 2009 swine flu vaccine. The federal government will use federal funds to pay off schools to administer vaccines, promote vaccination via highway billboards and TV advertisements, and conduct military-style mass inoculations in such rapid fashion that if side effects occur, it will be too late. The masses will have been vaccinated already. Over $9 billion has been allotted by the federal government to develop and deliver an unproven and experimental flu vaccine. Don’t be a guinea pig for the government.

12. Researchers are warning that over-use of the flu vaccine and anti-flu drugs like Tamiflu and Relenza can apply genetic pressure on flu viruses and then they are more likely to mutate into a more deadly strain. US health authorities want 70% of the public to be vaccinated against the flu this ’09 season, which is more than double the vaccination percentage of any prior flu season. This would certainly apply greater genetic pressure for the flu to mutate into a more virulent strain.

13. Most seasonal influenza A (H1N1) virus strains tested from the United States and other countries are now resistant to Tamiflu (oseltamivir). Tamiflu has become a nearly worthless drug against seasonal flu. According to data provided by the Centers for Disease Control, among 1148 seasonal flu samples tested, 1143 (99.6%) were resistant to Tamiflu!

14. As the flu season progresses the federal government may coerce or mandate Americans to undergo vaccination. France has already ordered enough vaccine to inoculate their entire population and has announced that vaccination will be mandatory. The US appears to be waiting to announce mandatory vaccination at a later date when it can scare the public into consenting to the vaccine. The federal government is reported to be hiring people to visit homes of unvaccinated children. This sounds like the Biblical account of Pharaoh attempting to eradicate all the young Israelite baby boys. Must we hide our babies now?

15. Public health authorities have cried wolf every flu season to get the public to line up for flu shots. Health authorities repeatedly publish the bogus 36,000 annual flu-related deaths figure to scare the public into getting flu shots. But that figure is based on the combined deaths from pneumonia in the elderly and the flu. Maybe just 5000–6000 or so flu-related deaths occur annually, mostly among individuals with compromised immune systems, the hospitalized, individuals with autoimmune disease or other health problems. As stated above, the swine flu in full force has only resulted in ~500–600 deaths in the first six months in circulation and it is far more dreaded by public health authorities than the seasonal flu. The Centers for Disease Control issues a purchase order for flu vaccines and then serves as the public relations agency to get the public to pay for the vaccines. Out of a population of 325 million Americans, only 100 million doses of flu vaccine have been administered each year and no epidemic has erupted among the unvaccinated.

16. The news media is irresponsible in stirring up unfounded fear over this coming flu season. Just exactly how ethical is it for newspapers to publish reports that a person has died of the swine flu when supposedly thousands die of the flu annually? In the past the news media hasn’t chosen to publicize each and every flu-related death, but this time it has chosen to frighten the public. Why? Examine the chart below. The chart shows that the late flu season of 2009 peaked in week 23 (early June) and has dissipated considerably.

While every childhood flu-related death should be considered tragic, and the number of flu-related pediatric deaths in 2009 is greater than prior flu seasons as a percentage, in real numbers it is not a significant increase. See chart below:

According to data provided by the Centers for Disease Control, for week 34 ending August 29, 2009, there were 236 hospitalizations and 37 deaths related to the flu. That would represent just 5 hospitalizations and less than one death per State, which is "below the epidemic threshold."

17. Public health officials are irresponsible in their omission of any ways to strengthen immunity against the flu. No options outside of problematic vaccines and anti-flu drugs are offered, despite the fact there is strong evidence that vitamins C and D activate the immune system and the trace mineral selenium prevents the worst form of the disease where the lungs fill up with fluid and literally drown a flu-infected person. The only plausible explanation as to why the flu season typically peaks in winter months is a deficiency of sunlight-produced vitamin D. Protect your family. Arm your immune system with vitamins and trace minerals.

18. Will we ever learn if the flu vaccine this year is deadly in itself? In 1993 the federal government hid a deadly flu vaccine that killed thousands of nursing home patients. It was the first year that flu shots were paid for by Medicare. The vaccine-related mortality was so large that this set back the life expectancy of Americans for the first time since the 1918 Spanish flu! Mortality reports take a year or two to tabulate and the federal government may choose not to reveal the true mortality rate and whether it was related to the flu or the vaccines. You say this couldn’t happen? It did in 1993!

SOURCE. (See the original for graphics)

Burger, ice cream fat 'sends signals to brain'

This is just a study of rats having bad things done to them but the conclusion is mundanre anyway: We eat more when we have food we like. Not exactly earth-shattering

A BIG hamburger on the way home from the pub on Friday night can still be making you hungry at work on Monday. A US study has found that fat from certain foods such as ice-cream and burgers heads to the brain, so that tub of ice cream really can control your brain and say "eat me." Once there, the fat molecules trigger the brain to send messages to the body's cells, warning them to ignore the appetite-suppressing signals from leptin and insulin, hormones involved in weight regulation - for up to three days.

"Normally, our body is primed to say when we've had enough, but that doesn't always happen when we're eating something good," said researcher Deborah Clegg. "What we've shown in this study is that someone's entire brain chemistry can change in a very short period of time. Our findings suggest that when you eat something high in fat, your brain gets "hit" with the fatty acids, and you become resistant to insulin and leptin. "Since you're not being told by the brain to stop eating, you overeat."

The researchers also found that one particular type of fat - palmitic acid which is found in beef, butter, cheese and milk, - is particularly effective at instigating this mechanism.

The study was performed on rats and mice but the scientists say their results, published in The Journal of Clinical Investigation, reinforced common dietary recommendations to limit saturated fat intake as "it causes you to eat more."

The study was conducted by exposing rats and mice to fat in different ways - by injecting various types of fat directly into the brain, infusing fat through the carotid artery or feeding the animals through a stomach tube three times a day.

The animals received the same amount of calories and fat and only the type of fat differed. The types included palmitic acid, monounsaturated fatty acid and unsaturated oleic acid which is found in olive and grapeseed oils. "The action was very specific to palmitic acid, which is very high in foods that are rich in saturated-fat," said Ms Clegg.