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reviews of data on individual medicines or classes of medicines where, “when you add together the published and unpublished evidence, you get a very different picture of the quality and effectiveness of those drugs”.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.
I live on the outskirts of, and commute daily into our great capital city. Yet, since being promised a measles outbreak in London by numerous medical experts over the last few months I have been disappointed in the lack of cases this year…I jest obviously but still I feel rather cheated. The assertion from the medical establishment, politicians and the media that measles is this huge killing machine that “spreads like wildfire” is clearly a myth.
Geographically speaking, the UK is tiny, so London is virtually next door to Wales, the North West and North West of England where other ‘large’ measles outbreaks have occurred recently. Thus, we would expect this monster virus to have travelled to London within days of the welsh outbreak and set up camp in those parts of the capital where MMR uptake is lowest (around 50% in some cases). So where is this monster measles virus? Well in fact according to the Health Protection Agency there were 67 laboratory confirmed cases between January & March 2013 – just over 20 cases in a population of around 8 million people! Where are all the medical experts now? Are they too embarassed to come forward and admit this virus does not “spread like wildfire” as was spouted over and over again. Even the Health Protection Agency say (with respect to measles) “The geographical pattern does not suggest widespread circulation across the country.”
Furthermore, WDDTY found around a third of those people in Wales who contracted measles had already been vaccinated against the disease. They go on to say that similar surveys of vaccinated children in the US found 98% of them contracted measles. So measles where art thou?
After casting doubt on the measles component here and in previous posts, lets quickly move on to one of its bed-fellows – mumps. Now mumps doesn’t fare much better than measles.
In 2006, the United States had the largest mumps outbreak in two decades. A total of 6584 cases were reported, with an estimated incidence of 2.2 cases per 100,000 persons. In patients for whom vaccination status was known, 63% had received two doses of the mumps vaccine. The same mumps strain that caused a recent outbreak in the United Kingdom caused the 2006 outbreak.N Engl J Med 2008; 358:1580-1589
Why with doubts over the effectiveness of this combined MMR vaccine do governments, health authorities and doctors still persist in insisting this and other dubious vaccines are essential? Possibly something to do with the massive big pharma lobbyists that practically live with ministers? Gosh what a cynic I am…
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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The latest measles outbreak in Swansea is obviously concerning as any childhood illness is. But what I find more concerning is the move to demonize those parents who have decided not to vaccinate their child/children. As the numbers of infected people increases there ARE more scare tactics being spouted by health officials, politicians and the media.
Since the outbreak in Swansea there have been numerous radio phone-in shows, news reports and tv shows coming from a pro-vaccination angle where so-called medical experts repeat the mantra that measles “is a killer” and how people in poor countries queue for hours for vaccinations (Dr Rosemary Leonard who’s never off the radio/tv). Dr Leonard didn’t add that clean water, good nutrition and good sanitation would as we know clear up at lot of these diseases without vaccinations.
Coupled with this callers, some of whom are parents, rang up to radio shows only to abuse the non-vaccinated saying that we are putting everyone at risk, blah, blah. Even when on one radio show a parent phoned in saying his child had developed autism immediately after receiving the MMR jab, the presenter still questioned that fact that his other child had not had the MMR, and could possibly be a danger to other children! Duh!
Presenters of these radio shows rarely allow the counter view I’ve noticed. Is it because they are scared the other side of the story will come out? They are not shackled by anyone. So why not have an open & honest debate instead of saying in effect: Andrew Wakefield has long been discredited so just get on with getting the MMR. To be honest my views on this having nothing now to do with Wakefield. I have seen too much evidence (although un-linked officially in the UK) of children becoming sick after receiving the MMR vaccination. I would highly recommend visiting http://www.childhealthsafety.wordpress.com/ for in-depth coverage of MMR and other vaccinations.
But haven’t we been here before with Swine Flu a couple of years ago? Do you remember the insane assertion by Sir Liam Donaldson (the then Chief Medical Officer) that there would be 60,000 dead in the UK due to the Swine Flu outbreak and that vulnerable people need to have the Tamiflu vaccination. And what happened? Yup – nothing!
This is what is now happening with this current measles outbreak. People are being scared into getting the MMR not only in Swansea but across the country. Currently, there is a national push to target those children who have not received both doses of the MMR with “one-to-one” meetings with the doctor. More sinister are the calls for compulsory vaccinations. At the moment thank goodness, the majority of doctors are against this, but, if measles cases increase, especially in London which they are predicted to do, then I can envisage more and more health workers calling for compulsory vaccinations.
One thing the ‘experts’ keep on coming back to is herd immunity. We need (apparently) 98% coverage of MMR to prevent measles epidemics. Quick question: Macedonia had a 98% coverage of measles vaccination but also had a massive outbreak in 2011. Hmmm. Why is this? Furthermore, this killer disease apparently according to the Health Protection Agency claimed very few lives every year if any over the last 25 years.
Wow what a couple of weeks it has been for the ‘food’ industry. Processed food such as cheap beef burgers and beef lasagne ready meals being found to contain up to 100% horsemeat. I’ve listened to a lot of news reports and consumers views overthe same period and most of the talk has been “horsemeat – would you eat it” where consumers would either say “not bovvered” or “eeeeeewwwwwww that’s disgusting!”.
Little coverage has actually been given over to shining a great big intense light onto the murky world that is the ‘food’ industry. Owen Paterson has indicated that there may be widespread criminal corruption involving foreign gangs pressurising suppliers into signing off horsemeat as beef. Yes, up to now it has been easy to dismiss this scandal on foreigners, but now it transpires that a slaughterhouse and meat company in the UK have come under scrutiny for alleged horsemeat mislabelling.
It’s all very complex and confusing with supermarkets blaming suppliers who in turn point the finger at their own suppliers. For example, Tesco dropped their supplier Silvercrest Foods over the scandal. ABP who own Silvercrest blamed McAdam Foods who in turn blamed their Irish suppliers. WTF!!!
With all this complexity and throw into the mix the period of austerity we are experiencing it seems crystal clear that corners have been cut. And guess who is on the end of this – yes the good old consumer (again).
More worrying is an investigation by the Ulster Society for the Protection of Animals (USPCA)who believe the dangerous drug phenylbutazone or ‘bute’ has entered the human food chain. Bute is a painkiller given to horses but is reported to cause cancer in humans and is not permitted in any quantity whatsoever.
The USPCA report that around 70,000 (many in poor condition) horses were corralled in Northern Ireland, shipped to England (under false passports and chips) for slaughter before sending on to Europe. Once in Europe the meat went predominantly to Belgium & France, but it has been suggested that the meat was processed into cheap ‘beef’ goods and shipped back to the UK! YUM!
Testing, as I write (14th Feb), has been carried out for bute in horses slaughtered in the UK. Nearly 4% had traces of the drug in them. Of course the amounts were small and not a cause for concern, ahem…
I guess the clue is in the two words ‘food industry’. Something as important to our health as the food we put into our mouths I think should not be an industrial process. We seem to have lost our connection with the food we eat and where it comes from and only interested in how much it costs, the cheaper the better. Well now the chickens (and horses) are coming home to roost!
To end on a positive note I like Toby Hemenway’s ideas on sourcing food where the last place you should be going for food is the supermarket!
1. your garden/growing your own
2. community gardens
3. farmers market
4. independent groceries
5. chain supermarkets
p.s. for a good overview to date of this scandal go to BBC Radio 4 Food programme
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
Today Andy Burnham MP critisized levels of sugar in children’s cereals where some brands including favourites such as Kellogg’s Frosties, Sugar Puffs and Coco Pops have up to near 40% sugar content. I would like to say thank you to Mr Burnham MP for re-igniting this debate, however, I hope if he ever becomes Health Minister again I hope he sticks to his beliefs and not cave in under pressure from the food industry lobbyists.
Read Daily Telegraph article here.
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.
A doctor who is also a Conservative MP (Phillip Lee) has been calling for obese people to contribute to their medical bills if they need treatment that is related to their condition, e.g. Type 2 Diabetes. Sounds good in theory because as we all know obese people are all just greedy gluttons who can’t help but stuff armfuls of food down their necks…Yes there are people who make the wrong food choices but Dr Lee has not looked under the surface for possible causes of this obesity epidemic. There are reasons as to why a person is obese but I guess it is easier to blame them than look elsewhere – maybe the food industry that effectively lobbies government. Perhaps Dr Lee you should be looking at what crap gets put in our food these days – I’m particularly talking about hidden sugars/fructose (those low fat options for example). There is good evidence that junk food is addictive in the same way as cigarettes and alcohol and the western diet makes you eat more. We are also now seeing obese 6 month old babies. It seems that there is something awry when a baby who isn’t even eating food yet is becoming obese…they can’t be blamed for their obesity can they! I guess Dr Lee would charge for treatment of these babies if they were obese! Ridiculous!
I know we should all be home cooking with fresh ingredients preferably with organic, free range foods, etc. But this option can be far more expensive (particularly if you live in the US) than buying ready made meals for example. Indeed in poor neighbourhoods it’s hard if not impossible to find fresh ingredients at all. This is made especially more difficult if people are trying to survive in this economic climate with pay freezes for those lucky enough to be working and reductions/freezes on welfare payments…
So please please please stop the demonisation of obese people!