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Clinical trial results are being routinely withheld from doctors, undermining their ability to make informed decisions about how to treat patients, an influential parliamentary committee has claimed.
MPs have expressed “extreme concern” that drug manufacturers appear to only publish around 50% of completed trial results and warned that the practice has “ramifications for the whole of medicine”.
Their conclusions have emerged in a public accounts committee report which examined the Department of Health’s decision to spend £424m on stockpiling the flu drug Tamiflu, before writing off £74m because of poor record keeping.
The MPs found that experts failed to agree on how well Tamiflu works, but discussions were hampered because important information was held back.
Richard Bacon, a senior member of the committee, said the practice of holding back results was undermining the ability of doctors, researchers and patients to make informed decisions about treatments. “Regulators and the industry have made proposals to open up access, but these do not cover the issue of access to the results of trials in the past which bear on the efficacy and safety of medicines in use today,” he said. “Research suggests that the probability of completed trials being published is roughly 50%. And trials which gave a favourable verdict are about twice as likely to be published as trials giving unfavourable results.
“This is of extreme concern to this committee. The department [of health] and Medicines and Healthcare products Regulatory Agency [MHRA] must make sure, prospectively and retrospectively, that clinical trials are registered and the full methods and results of all trials are available for independent wider scrutiny by doctors and researchers.”
The committee noted that an NHS National Institute for Health Research review in 2010 estimated that the chance of completed trials being published is roughly half. Trials with positive results were about twice as likely to be published as trials with negative results.
Dr Fiona Godlee, editor-in-chief of the British Medical Journal, told the MPs that the pharmaceutical industry published more positive results than negative ones from their trials. She noted that the journal had published very clear summaries of systematic reviews of data on individual medicines or classes of medicines where, “when you add together the published and unpublished evidence, you get a very different picture of the quality and effectiveness of those drugs”.
A review by the non-profit Cochrane Collaboration into 20 existing studies into Tamiflu found it “did not reduce influenza-related lower respiratory tract complications” but did induce nausea.
It is now receiving full clinical study reports from manufacturer Roche, which are being used to complete a further review of the effectiveness of Tamiflu. The results of that should be used by government, the MHRA and the National Institute for Health and Care Excellence to review the drug’s use, MPs said.
They also called on ministers to take action so that full trial results are available to doctors and researchers for all treatments currently being prescribed and carry out regular audits of how much information is being made available.
Bacon added: “There is still a lack of consensus over how well the antiviral medicine Tamiflu, stockpiled for use in an influenza pandemic, actually works. The lack of transparency of clinical trial information on this drug to the wider research community is preventing proper discussion of this issue among professionals. We are disturbed by claims that regulators do not have access to all the available information.
“The case for stockpiling antiviral medicines at the current level is based on judgment rather than on evidence of their effectiveness during an influenza pandemic. Before spending money in future to maintain the stockpile, the department needs to review what level of coverage is appropriate. It should look at the level of stockpiling in other countries, bearing in mind that the patent for the medicine runs out in 2016.”
An MHRA spokesman said the body would work with partners in the UK and in the EU to ensure greater transparency in the dissemination of clinical trials information.
2013 MEASLES NEWS: The UK’s Fake Welsh Measles Epidemic – Only 8 Cases Confirmed For March – 302 Wrongly Diagnosed and “Notified” By Docs
Thanks to eagle-eyed Child Health Safety we can see the truth behind the measles media hysteria. I wonder if any of those rabid pro-vaccine folk will comment on this? I very much doubt it…
[ED: CHECK OUTUPDATE MEASLES UK 2013 – Health Officials in Tail-Spin Over Vastly Hyped Claims of Welsh Measles Epidemic – BBC Removes False Claims from Website – ADDED 12 May 2013 @ 0400 UTC/00:00 EST/05:00 GMT]
[ED: CHECK OUT COMMENTS AT END FOR LATEST FIGURES FOR APRIL AND DISCUSSION – ADDED 4 May 2013 @ 10:30 UTC/05:30 EST/11:30 GMT]
UPDATE 13/5/13 – April figures:
We stated on May 3, when this article was posted
.. if the figures for April are wildly different, you will know for sure someone is not telling it as it is.”
We were 100% right.
Public Health Wales own figures of confirmed measles cases to the end of March 2013 were 8 for the whole of Wales:
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Exactly what we/the planet needs – a move away from nutrient-deficient annual crops to more sustainable, more nutritious perennial systems.
Conventional wisdom has it that the path to alleviating global hunger and poverty requires farming in the developing world to become more like agriculture in the U.S. But with American farmers now dealing with ever-more-frequent natural disasters and crippling drought, maybe it’s time they learned from their counterparts in the Global South, who have been facing similar ecological challenges for at least a decade now.
That’s what Danielle Nierenberg realized after spending three years traveling the developing world, meeting with farmers from Bolivia to Botswana to find out how they’re adapting to the changing climate’s effect on their livelihoods. Providing farmers around the world with a way to interact and share their ideas in a wiki-style format — an “innovation database,” Nierenberg calls it — will be a major component of Food Tank, the new food-focused think tank Nierenberg started with fellow activist Ellen Gustafson.
While Nierenberg has done…
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Glucose appears to temper brain activity in regions that regulate appetite and reward — but fructose does not, researchers found.
In a brain imaging study, participants who had a drink sweetened with glucose had significant reductions in cerebral blood flow in the hypothalamus, while those who drank a fructose-sweetened drink saw a slight increase in activity (P=0.01), Robert Sherwin, MD, of Yale University, and colleagues reported in the Jan. 2 issue of the Journal of the American Medical Association.
Glucose also reduced activation in the insula and striatum, other brain regions that regulate appetite, motivation, and reward processing, while fructose did not, the researchers wrote.
In an accompanying editorial, Jonathan Purnell, MD, and Damien Fair, PhD, of Oregon Health & Science University in Portland, said the findings “support the conceptual framework that when the human brain is exposed to fructose, neurobiological pathways involved in appetite regulation are modulated, thereby promoting increased food intake.”
As the obesity epidemic has grown, so too has consumption of fructose in the American diet, the researchers explained in their article. Fructose is found in both sucrose, or table sugar, and in high-fructose corn syrup, another common sweetener. It is valued because it’s sweeter than glucose.
But studies show fructose may have different metabolic effects than glucose. For instance, fructose only weakly stimulates secretion of insulin, a hormone that can increase satiety, and attenuates levels of the satiety hormone glucagon-like peptide-1 (GLP-1) — so researchers are concerned that it could possibly increase food-seeking behavior and intake.
To assess those effects, Sherwin and colleagues conducted functional MRIs (fMRIs) in 20 normal-weight, healthy adults who were given 75 grams of either glucose or fructose in a cherry-flavored drink, and then crossed over to a drink with the other sweetener.
Participants rated their feelings of hunger, satiety, and fullness before and after the scan, and the researchers took blood to assess circulating hormone levels.
Overall, the researchers found that glucose significantly reduced cerebral blood flow in the hypothalamus, while fructose did not.
Specifically, blood flow fell 5.45 mL/g per minute from baseline with glucose, compared with an increase of 2.84 mL/g per minute with fructose, for a mean difference of 8.3 ml/g per minute, they reported (P=0.01).
They also found that glucose reduced cerebral blood flow in the thalamus, insula, anterior cingulate, and striatum — “regions that act in concert to ‘read’ the metabolic state of an individual and drive motivation and reward” — compared with baseline (P<0.05).
In contrast, fructose reduced blood flow in the hippocampus, posterior cingulate cortex, fusiform, and visual cortex — but also in the thalamus (P<0.05).
In terms of connectivity between brain regions, glucose upped the links between the hypothalamus and the thalamus and striatum, while fructose only increased connectivity between the hypothalamus and thalamus, but not the striatum — the latter of which also de-activates once a person is sated, the researchers said.
“These findings suggest that ingestion of glucose, but not fructose, initiates a coordinated response between the homeostatic-striatal network that regulates feeding behavior,” they wrote.
They also found that glucose, but not fructose, had effects on circulating “hunger” hormone levels. Glucose elevated levels of insulin and GLP-1 compared with fructose (P<0.001 and P=0.01, respectively).
Leptin and ghrelin levels, however, weren’t significantly different between the two sugars, the researchers found.
The differences in brain effects between glucose and fructose also appeared to coordinate with ratings of hunger, since there was a significant difference from baseline in terms of fullness and satiety when participants drank glucose, but not fructose (P=0.005 and P=0.03, respectively).
Sherwin and colleagues cautioned that the study was limited because fMRI doesn’t provide a direct measure of neuronal activity, and thus any clinical implications can’t yet be determined.
Editorialists Purnell and Fair noted that while some researchers and clinicians warn that the total amount of calories is more important than the type of food when it comes to losing weight, the “reality … is that hunger and fullness are major determinants of how much humans eat, just as thirst determines how much humans drink. These sensations cannot simply be willed away or ignored.”
“The remedy remains eating less,” they wrote, “but the means involve reducing the food element, if possible.”
By Kristina Fiore, Staff Writer, MedPage Today
9-year-old Emma Whitehead was in her second relapse of acute lymphoblastic—or lymphocytic—leukemia, commonly called (ALL), when doctors prescribed something unexpected, a disabled form of the HIV virus. Emma was chosen to receive the CT019 therapy, an experimental treatment that involves doctors reprogramming a person’s T-cells (white blood cells that help fight disease in the immune system) to search out and kill cancer cells. The disabled form of HIV helps fight the cancer because the virus is adept at carrying genetic material into T-cells so they’re able to kill off cancer cells. Those genetically altered T-cells go to work attacking cells in the body that play a role in the development of leukemia. To read the rest of the article, click here.
YOu couldn’t make it up could you? It transpires that the Pan-American arm of the WHO has been asking the food industry for its advise it tackling obesity…well seems there won’t be any attempt to regulate fizzy drinks then. Coca-Cola, Nestle and Unilever have also bribed sorry donated large amounts of cash to the organisation. Apparently this is a “new ay of doing business”. I suggest this is one of the oldest ways of doing business, i.e. bribe the regulator!
I had two ailments recently for which I would normally saunter off to the doctor and promptly receive (I would imagine) a prescription for antibiotics to cure me. But NO! I held out and saw both off with grit, determination and a dose of self-medication…
The first is a recurring sore gum which seems to rear it’s ugly head when I’m feeling a bit run-down. It’s actually I think an infection (fungal?) of some sort as my bottom left gum and cheek were sore and red and coated with a whitish film that looked fungal to me. The cheek also felt rough when felt with my tongue.
Due to my natural phobia towards doctors (over-prescribing, sheep mentality) and dentists (just scary) I decided that I would try and fight it off by myself. With a combination of crushed garlic (ouch!!!) pressed on the gum/cheek daily, garlic tablets, swills of salt water and also taking of Pine Needle Oil (for apparently reducing inflammation and killing bacteria – I found out about this from my wife’s family who are Vietnamese).
I also remembered about bicarbonate of soda being an anti-fungal agent so I washed my mouth with this twice-daily – I basically threw any anti-microbial thing I had in the kitchen/medicine chest at it! It finally subsided after around 3/4 weeks. Hooray!
The euphoria was short-lived as the second ailment which occurred two weeks later (about 5/6 weeks ago now) and stayed for a month was (I guess) a chest infection that came from nowhere. Symptoms – coughing up lots of thick green phlegm everyday (sorry for the graphic description!). Again I treated this by myself with garlic tablets and pine needle oil tablets. It went on as I say for about a month and although I did feel like going to the doctor on a few occasions (particularly when my wife was nagging me) I resisted and again it went by itself.
The only other thing I did was to eat a healthy diet and get lots of rest which is easier said than done with a full-time job and 3 kids under 10 years of age…
Yes, a dose (or two in my case) of antibiotics would have undoubtedly got rid of these infections quickly but stepping back figuring out what is wrong and trying to treat yourself initially I think is the best way forward. Yes of course if things hadn’t got better I would have gone to the doctor (I’m not a masochist!) to seek help but if we did a bit more of listening to our bodies, supporting the immune system with natural products rather than run to the doctor we would all be better off (including financially…)
Just out today – the UK has finally gone mad and will offer all children between the ages of 2 and 17 a flu vaccine – http://www.bbc.co.uk/news/health-18969338
According to the World Health Organisation (WHO) the greatest people at risk are the under-2’s and over 65’s so it beats me as to why 2-17 year olds are being targeted…The article actually says: “Children usually get a mild and sometimes unpleasant illness from seasonal flu. They rarely suffer complications. Youngsters who do are usually in the at-risk groups already offered a flu vaccine”. So if there is little problem why introduce it!? I guess AstraZeneca who manufactures the vaccine is rubbing its hands with glee…
The BBC article states “The UK is thought to be the first country in the world to offer free flu immunisation to all children” Are they serious? Where do you think the money will come from to pay for these jabs? Or have AstraZeneca become a charity overnight. The answer lies two paragraphs above this quote : “Nine million children will be eligible for the nasal flu vaccine and the price tag could be more than £100m a year“. So there you go £100m of tax payers money will be paid to AstraZeneca – great!