Adverse Drug Reactions - Previous posts part 3

Found the following on the WDDTY website - the figures relate to the USA but for rough UK numbers divide by six - wouldn't you rather look after your health with vitamins, herbs and minerals?

Drug Reactions: Deaths and serious problems triple in 8 years
13 September 2007
The annual rates of serious adverse reactions and deaths from a prescribed drug have almost tripled since 1998.Just 51 drugs – including painkillers and immune system-modifying agents – were responsible for the vast majority of reactions, new figures reveal.In 2005 – the most recent year when figures have been made available - 15,107 people in America died as the result of taking a prescription drug, while 89,842 people suffered a serious adverse reaction, which resulted in disability, hospital care or a birth defect.These reactions – all reported to America’s drug regulator, the Food and Drug Administration – represent an increase of 2.7 times on figures produced in 1998.Overall, the FDA received reports of 467,809 deaths and serious adverse reactions between 1998 and 2005.(Source: Archives of Internal Medicine, 2007; 167: 1752-9).

Previous Post Part 2

Hmmmm........ woke up today to hear the radio full of 'anti-oxidants are bad for you' and the papers full of it as well. Can't help thinking that too many people are taking responsibility for their own health and this worries the multinational drug companies i.e. if you look after yourself you will need less drugs - less drugs sold means less profits so: lets publish a flawed report (see below) frighten the masses and as your food is so processed and polluted and there is no chance you can get all the nutrition you need from food alone then in time you will become sick and need expensive drugs to make you well again........ or am I just seeing another conspiracy?
Anyway the best ripost to all this nonsense can be found in Patrick Holfords latest news letter which I hav e reproduced below complete with all his links and references.
And my final word. How many people have actually died from antioxidant overdose? think we might be talking about the figure ZERO again. Now read my previous post on adverse drug reactions to prescribed drugs - didn't that item on the radio......

Here's Patrick's newsletter...


Headlines in today's papers such as 'Vitamin Pills "Increase Risk of Early Death"' claim that anti-oxidants are not good for you and could even do you harm. But, don't believe everything you read!
What's this review about?
This is the fourth time Bjekalovic and his group have reviewed the effects on selected studies on antioxidants. Anyone following the science of antioxidants over the past 20 years will be aware of a vast number of studies reporting positive results. So, how do you end up with a headline that implies antioxidants increase mortality?
In this review, which is a rehash of their paper published last year in the Journal of American Medical Association (JAMA), they first excluded over 400 trials, that had no deaths. They then decided which trials they liked (low risk bias) and did not like (high risk bias), a factor that has received criticism in mainstream medical journals.
What the experts say
One of the world's leading experts in this field, Dr Balz Frei said "This is a flawed analysis of flawed data, and it does little to help us understand the real health effects of antioxidants, whether beneficial or otherwise," (1)
Dr Bernadine Healey, former director of the National Institute of Health said, "Blenderizing these diverse trials into one giant 232,606-patient-strong study to come up with a seductively simple proclamation is just silly. When the researchers tallied up the mortality from the 68 trials, there was no difference based on vitamin intake. The headlines that these supplements significantly increase the risk of death by 5 percent overall came only when the researchers pulled out the 47 trials they deemed to have been the best executed. Actually, in the 21 randomized trials they peeled off, mortality was decreased by 9 percent among those taking the vitamins." (2)
How did they come up with the reported results?
Not surprisingly, the selection process in today's review excluded many of the most positive studies. For example, quoting the review itself, 'In secondary prevention trials (meaning people with disease) with high-bias risk, mortality was significantly reduced by supplements.' In those they called 'low-bias risk' there was no significant change in mortality.
To report an even more negative result, which is what newspapers often home in on, they also excluded all trials on selenium, which actually reduced mortality the most of all the antioxidants considered.
Beta-carotene
As an example, let's look at beta-carotene, which is given the worst rating. The review states 'Beta-carotene used singly or in combination with other antioxidants had no significant effect on mortality when including all 24 trials' BUT 'After exclusion of high-bias risk and selenium trials, however, beta-carotene singly or combined significantly increased mortality in 12 trials.'
Antioxidants and cancer
Even if we were to accept the exclusion of the so-called high-bias risk trials let's look more closely at the apparently negative studies. A graph of all these trials shows five that skew the results towards a negative (p.167). I thought I'd look closer at these trials. The first was by Dr Correa from the pathology department at the Louisiana State University Health Sciences Centre, and showed a clear protective effective of antioxidant supplements against gastrointestinal cancer. (3)
I decided to contact Dr Correa and he was "amazed", he said, because his research, "far from being negative, had shown clear benefit from taking vitamins". Correa told us there was no way the study could show anything about mortality. "Our study was designed for evaluation of the progress of pre-cancerous lesions", he said. "It did not intend, and did not have the power, to study mortality and has no value to examine mortality of cancer."
Vitamin E and statins
The next, called the DATOR trial, gave people with high cholesterol, high dose vitamin E (750iu) and statins. (4) As nutritionists we caution against this because statins stop you making CoQ10 which results in vitamin E becoming a potentially harmful oxidant. That's exactly what this trial reported, "These results indicate that the antioxidant effect of Vitamin E is attenuated (reduced) when given in conjunction with this statin." So these negative effects of vitamin E might actually be because it's taken with a drug that makes it harmful! Given that the majority of the trials included in this review were on sick people, presumably taking medication, this kind of confounding variable really should be taken into account. It is not.
Selenium's protective effects
The next trial, published on the Mayo Clinic's journal, that skewed the results to a negative reported a positive outcome. (5) It investigated the effect of selenium of oesophageal cancer. It found that 'among subjects with mild esophageal squamous dysplasia (early stage) at baseline, selenomethionine did have a protective effect.' For those with more advanced cancer it did not.
In January this year the authors published a paper 'Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis.'(6) Their conclusion was that 'beta carotene supplementation appeared to increase cancer incidence and cancer mortality among smokers, whereas vitamin E supplementation had no effect. Selenium supplementation might have anticarcinogenic effects in men and thus requires further research.'
So, what does all this mean?
Well, if you look at all the studies reviewed, strictly for reducing mortality, not for other benefits, Bjekalovic concludes 'Beta-carotene, vitamin A and vitamin C, used singly or in combination with other antioxidants had no significant effect' although a number of vitamin C studies did report reduced mortality. 'Selenium used singly or in combination with other antioxidants significantly decreased mortality.' (7). Beta-carotene, as we know, is best not taken singly by smokers. Vitamin E in high dose, as we know, should not be taken by those on statins without additional CoQ10. Selenium and vitamin C are most likely to be beneficial.
So, should we throw away our antioxidants?
Certainly not. Personally, I haven't recommended isolated antioxidant supplementation for 20 years and doubt they would produce much effect in sick people with advanced disease states, except for vitamin C at high doses - a subject not examined in this review. Antioxidants are team players. I take a combination of vitamin E, CoQ10, vitamin C, glutathione, anthocyanidins, resveratrol, beta-carotene, alpha lipoic acid and selenium. There's good reason to do so if you look at what's known about their effects in reducing markers of ageing. But these are as well as eating loads of fruit and veg, nuts and seeds.
Wishing you the best of health, and don't forget - if you want to stay ahead of the pack on health and nutrition news then join my 100%health Club.
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References
1. http://oregonstate.edu/dept/ncs/newsarch/2007/Feb07/vitaminstudy.html
2. http://health.usnews.com/usnews/health/articles/070304/12healy_print.htm
3. P Correa et al, 'Chemoprevention of gastric dysplasia: Randomized trial of antioxidant supplements and anti-Helicobacter pylori therapy', Journal of the National Cancer Institute (2000), vol 92, pp1881-8.
4. Manuel-Y-Keenoy B et al Impact of Vitamin E supplementation on lipoprotein peroxidation and composition in Type 1 diabetic patients treated with Atorvastatin. Atherosclerosis. 2004 Aug;175(2):369-76]
5. Bardia et al Randomized, placebo-controlled, esophageal squamous cell cancer chemoprevention trial of selenomethionine and celecoxib.Gastroenterology. 2005 Sep;129(3):863-73
6. Bardia A et al Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis. Mayo Clin Proc. 2008 Jan;83(1):23-34.
7. Bjelakovic et al, Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases (Review), Cochrane Library, Issue 2, 2008

Still think the Multinational drug companies are on your side?

It struck me recently that there seems to be a lot of articles in the press attacking complementary therapies, especially homeopathy. And then I read that the BBC had removed information about complementary therapies from its website - so what's going on? Are the multinational drug companies worried about something?

Last year I remember an article about someone self-medicating chinese herbal medicine which resulted in kidney failure: naturally there was a big hoo ha in the press. But consider this; apart from the case above how many people died last year from; reiki, hypnotherapy, acupuncure, homeopathy or any holistic therapy you might care to mention? 500? 100? 50? keeping going down and stop when you get to a big fat zero. Can you imagine the fuss if just one person had died, it doesn't bare thinking about.

Now, if you are in North Bucks and want to win a free session (offer ends April 30th 2008) of Reiki, Hypnotherapy or eft what's your educated guess for how many people, on average, die each year due to adverse reactions to prescribed or over the counter medication?
10? more...........100 no keep going............. 1000, that's a lot isn't it but keep going some more....... 2500, still better keep going. The figure that will win you the treatment is a round figure, higher than 4000 but less than 6000.

If you really want to blow your mind then have a read of the following article, printed in the Guardian recently on how much the NHS has to spend because of adverse drug reaction: give me a good herbalist and a dose of reiki anyday...........

The NHS is spending nearly £2bn a year treating patients who have had an adverse reaction to drugs prescribed for them by doctors, according to new figures from the centre-left thinktank Compass.
The amount of money spent on hospital care for those given the wrong medicine or who have reacted badly to a drug could pay for 10,000 new midwives or easily cover the estimated cost of combating MRSA infections, says Compass.
The health minister Dawn Primarolo confirmed to the organisation that 6.5% of hospital admissions are a result of an adverse reaction. Total admissions in 2006 were 16 million, which means that 1,040,000 patients were there as a result of the drugs they were prescribed.
Compass bases its calculation on an average stay of eight days in hospital at a cost of £228 a day. That puts the annual NHS bill at £1,896,960,000 just for those admitted with ill-effects. It does not include those patients who had a bad reaction to their medicines while they were in hospital. If that cost were added in, the bill would top £2bn.
The new figures, which are substantially higher than any previous estimates, have been compiled as part of an investigation into the pharmaceutical industry, its relationship to public health and regulation. "It is increasingly apparent that the lack of effective regulation is costing the taxpayer, and in some cases is causing unnecessary suffering," said Zoe Gannon, who is leading the Compass investigation.
Scandals such as that over the arthritis painkiller Vioxx, which caused heart attacks, and the antidepressant Seroxat, which was found to increase the risk of suicidal thinking in young people, suggest that industry could do more, she said.
"The industry knew about these adverse drug reactions and chose not to accept the responsibility because its ultimate goal is to make a profit," she said. "From our perspective this £1.9bn figure is not completely reducible - we are going to have to accept some adverse drug reactions - but the sheer size of this figure is enormous. It is all about getting a balance between risk and benefit and we feel that the balance is wrong."
Drug companies have huge profit margins, she said - in excess of 14.3% against a business average of 4.6%. Yet the number of genuinely innovative medicines - as opposed to copies of those already on the market - is decreasing.
"The pharmaceutical industry has the upper hand in terms of research and development investment and is always promising the latest miracle drug but too often failing to deliver,"she added.
"Now is the time for a debate about costs and policies about which drugs the healthcare service can afford as people are paying infinitely higher prices - the drugs bill to the NHS now stands at £11bn - for increasingly marginal rewards and higher risk from adverse drug reactions."
Compass's investigation will question whether it is appropriate for the Department of Health to take the lead in relations with the pharmaceutical industry. It will also be calling for a review of progress since the 2005 report of the health select committee. Compass aims to publish its own report in the autumn.