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reviews of data on individual medicines or classes of medicines where, “when you add together the published and unpublished evidence, you get a very different picture of the quality and effectiveness of those drugs”.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…
This morning I heard an interesting discussion between Dr Ben Goldacre (an epidemiologist) and Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry on Radio 4 where Dr Goldacre asserts that big Pharma regularly with-hold negative clinical trial data and thereby mislead doctors and patients who subsequently take these medicines without knowing ALL of the potential risks. In addition, the regulatory bodies fail to force these companies to publish ALL of the data.
Here the discussion here (available only till 2nd October) around 2hrs 35mins into the programme. Also check out an informative (and funny) presentation by Dr Goldacre at TED below. The bit about big Pharma misleading doctors is at 7mins 40secs (but watch the whole thing)
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!
Well it’s good for Big Pharma and their shareholders anyway. Why do I say that? Well just look at the recent $5.3bn acquisition of Amylin Pharmaceuticals Inc. by Bristol-Myers Squibb and AstraZeneca. Amylin produce diabetes drugs Byetta and Bydureon. It is estimated that they will need to make $2bn in peak sales to justify the transaction. Byetta made $518m in sales last year and Bydureon $7m in the first quarter of the year being only approved for sale in January. So looking at the figures they are going to have to do some hard selling to get their money back! Indeed Bristol executives said that while Amylin’s sales force had targeted endocrinologists, the combined sales forces of the three companies would be able to widen their presence to cover primary care physicians.
One endocrinologist I’ve mentioned in previous posts is Dr Robert Lustig who has stated that the lack of fibre in our modern diet combined with too much sugar (and high-fructose corn syrup) is the cause of obesity and diabetes. He believes you can cure type 2 diabetes in a week with a high-fibre diet. But do you think Big Pharma actually cares about this endocrinologists opinion. Hell no. At the end of the day these companies are raking in the profits as more and more people become ill through their poor diet. It’s the same for the food industry. It’s been shown that their lobbying of governments and other agencies forces them to water-down or even shelve reports that would hurt their business. Have a look at these articles where the sugar industry threatened the WHO (World Health Organisation) over a report they drafted recommending reducing a persons sugar intake:
And guess what happened? Yup the WHO recommendations were dropped – check out the video 9 mins in:
Also check out YouTube for all the episodes of The Men Who Made Us Fat – not on BBC iplayer anymore.
Just came across this obesity graphic on Reuters showing the most obese nations. Fine. Underneath this map however is a projection of obesity-related drug sales where the top three drugs Lorcaserin (Arena Phamaceuticals), Qnexa (Vivus Inc) & Contrave (Orexigen Therapeutics) will earn their respective drug companies $755m, $689m & $443m. These drugs, as these companies know full well, ain’t going to help these people, only going to boost their profits. The real solution as highlighted in tonights BBC programme – The Men Who Made Us Fat is the rise of high fructose corn syrup in most processed foods…
Unfortunately, as is well known the food industry has huge power here and in the US so governments are too scared to do anything about it…indeed in the programme it mentioned the industry warning the WHO not to publish a damming report on sugar consumption, which it apparently shelved after being ‘leant on’. Same old. Same old….
Sounds great doesn’t it? No more chemo or other poisons in the war against one of the western worlds biggest killers cancer. Now, this idea/theory has been around for a few years though I must admit I’ve only come across it recently as I have been looking around for possible alternatives to the mainstream treatment of cancers. Why? Well, lets face it we seem to be losing the battle with cancer. Over the past 2/3 years I’ve personally known three people who have died after having cancer – the last one was a recent friend of the family who passed away less than a week ago at the time of writing this. All three were in their mid/late fortiies. That is what I find truly scary – not even reaching 50 years old. All were fit and active people were not overweight or smoked…Each cancer was different – one had skin cancer initially, one bone cancer and the most recent one had stomach cancer initially. In all three cases the given chemotherapy and in at lastt one case the medics were trying out ‘novel’ treatments on him which obviously failed.
Some people do beat their cancer and go on to live happy healthy lives, though in a lot of cases the cancer is the victor – According to the World Health Organisation (WHO) cancer killed nearly 8 million people worldwide with almost half a million deaths occuring in the richest country of the world – the U.S.A. Now, I’m not saying not to use ‘conventional’ treatments were appropriate but I feel that the medical establishment needs to look into alternative treatments as well which leads me back to baking soda or more accurately bicarbonate of soda. Now I’m not medically trained but commonsense tells me that if something isn’t working we should look to do something else.
One doctor has an alternative theory regarding cancer and he goes by the name of Dr Tullio Simoncini. What intrigued me about this doctor is that he is a medical doctor and furthermore an oncologist, i.e. a cancer doctor so he should know what he is talking about. Dr Simoncini believes that cancer is caused by a common fungus (Candida albicans) which is in all our bodies but is usually gets kept in check by our immune system. When our immune systems are low the Candida can take advantage and cause cancer. This is not as controversial as it sounds ass Candida is found at the centre of the cancer it’s just that current mainstream thinking believes that the Candida does not cause cancer but moves in afterwards. What was predictable was Dr Simoncini’s treatment in the media and medical establishment for voicing his theory (and practice). Indeed he was struck off as a doctor in Italy because his treatments do not conform to mainstream practice (even if it cures the patient it seems!). This intrigues me even more when the mainstream lashes out – to me it smells of fear that he may be on to something (a bit like the treatment of Dr Andrew Wakefield and MMR – another story!). Futhermore, Dr Simoncini was banned from talking in the UK (Totnes, Devon) after a local politician (also a doctor) objected. She said “There are, very rightly, safeguards in place to protect people against adverts for remedies which really have no basis in evidence” Hmmmm… rather like a lot of conventional cancer treatments then…! If it’s such quackery then then mainstream medical establishment haven’t got anything to worry about have they? Anyway make your own mind up. Go to Dr Simoncini’s website and/or find him on You Tube:
Just reading a recent news release from the Health Protection Agency (HPA) regarding a measles “outbreak” on Merseyside. As usual the same old scare tactics are being used to get kids immunised with the MMR (measles/mumps/rubella) vaccine.
Measles on Merseyside – latest
26 March 2012
A measles outbreak on Merseyside is now the largest in the North West since MMR vaccine was introduced in 1988. To date there have been 113 laboratory confirmed cases and a further 43 probable cases are under review.
Twenty-eight people needed hospital inpatient treatment and three of these, two adults and a child, were extremely ill but have thankfully recovered and been allowed to return to their homes.
A feature of the outbreak is that approximately 29 of the confirmed cases are in teenagers (over the age of 15) and young adults who were not vaccinated as children. There are also 27 cases in children under the age of 13 months who were too young to be vaccinated.
The majority of the remaining cases (31) are in unvaccinated children aged between 13 months and five years. (For the sake of completeness, there have been nine cases in children aged 5-9 years and five cases in children aged 10-14).
Dr. Roberto Vivancos, a specialist with the HPA’s Cheshire and Merseyside Health Protection Unit, said: “Measles is highly infectious and anyone who has not previously been vaccinated is at risk when it gets into a community, as it has done here.
“In this outbreak we have seen measles spreading amongst unvaccinated children, teenagers and young adults and affecting infants and toddlers who are too young to be vaccinated. Our advice to teenagers and young adults is to arrange vaccination now. Speak to your family doctor. It’s not too late. Our advice to parents is, arrange to have your children vaccinated regardless of their ages. If you are not sure if they have been immunised in the past, check with your family doctor.”
It goes on to say about it being a serious disease, blah blah blah…
So from this blurb you would have the impression that you are far more likely to get measles if you haven’t had th vaccine…
Cast your mind not so far back to 2011 when it was reported that a massive measles outbreak occurred in Europe with France in particular being hit hard with over 7,000 cases bring reported between January to April 2011. However, looking at the World Health Organisations (WHO) own figures France had a 90% vaccine uptake of a “measles-containing” vaccine in 2010. So, this beggars the question if 90% of the french population were immunised in 2010 why did that country have a massive outbreak at the beginning of 2011? The total reported cases for 2011 was 15213. Do you know how many deaths there were from all of these 15213 cases? 6! Yes a mighty 0.04% people who contracted measles died. Similarly in The former Yugoslav Republic of Macedonia which had the highest incidence of measles per million population the vaccine uptake has been very high according to WHO figures (98% in 2010).
Surely if a country has virtually 100% vaccination rates for measles and has a massive outbreak of this disease then shouldn’t this raise serious questions regarding the vaccine? This doesn’t get reported. Why? We should all be asking the health authorities and the media this very question.
We have 3 kids, their ages being 8, 6 & 18 months. Now as good citizens of the world, my wife and I let the medics give our eldest child all of the vaccines that they could and we happily filled up her little jab book to completion. Following her jabs she was frequently sick, nothing life threatening you understand but frequent fevers, constant colds and bouts of eczema. Even now she seems to catch every bug going around.
My 6 year old received a mix bag, i.e. got some jabs but not others as we started to question the numerous vaccines and boosters to keep at bay all of the nasty diseases out there. What we did notice, however, is that he has had less illness than my eldest. And guess what? Our youngest has yet to be injected and in her short life of 18 months has been the healthiest of the three. Coincidence?
Now, I am very open minded kinda guy and want to do right by my kids, but I am slowly coming to the conclusion in in my cynical old (ish!) age that vaccines are a great money spinner for the big pharmaceutical companies who, at the end of the day only have £££’s in their sights and if some people become sick or even die from having jabs then that’s just life…your loved one had a “rare complication” or it was just a coincidence they keeled over literally hours after receiving a vaccine…
There are, as you can imagine lots of videos on YouTube about vaccines (for & against), but this one caught my eye recently:
So I now question the need to give so many if any at all vaccinations to very young children. My wife and I still debate our decisions and we still get jab junk mail from the GP but we are trying to resist and do what we think is right by our kids.