XTEND-15sec-NEWSt
2nd July 2003
Please click on the summary link of interest:
Antioxidants found to reduce risks of cancer by 30% plus...n1
An eight year study conducted in France with 13,000 healthy subjects found a 30% reduction in cancers with the group taking antioxidant supplements compared to a group which was given a placebo. The researchers claim that the study, called SU.VI.MAX, is the first randomized trial to show that an adequate intake of vitamins and minerals from fruit and vegetables can reduce the risk of cancer. For the full article please click here.
Warren Matthews comments: This is good news but is not a surprise as it has been clearly established that antioxidants play a major role in reducing cancer risks…in spite of various interested parties in recent years trying to downplay the effectiveness of them, and indeed discredit them. However, what is odd about the publicity given to this study is that the researchers downplay the role of the antioxidant supplements even though they admit that is what they used to get the results, because it was the only way they could control the study. They suggest that you would get even better results if you got your antioxidants from fruit and vegetables! Interesting…does this mean that during the eight years that both groups did not eat their fruit and veges?? I wonder if someone is whispering in their ear to downplay the role that the supplements had in the results???
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Cigarette smoke may sap blood levels of folate...n2
The US Center for Disease Control and Prevention this month published in Nicotine & Tobacco Research a study about the effects of cigarette smoke on levels of folate in the blood for both smokers and non smokerS exposed to secondhand smoke. After blood testing of 15,500 adults they concluded that smokers averaged 20% lower levels of folate and non smokers exposed to second hand smoke were also subject to lower folate levels.
Folate or folic acid is an important B vitamin and adequate levels are believed to be essential to prevent possible birth defect and to give some degree of protection against cancers.
Warren Matthews comments: Just another reason to give up smoking or at least cut it back, or if you can't do either of these things try to avoid having your friends and family who don't smoke inhale your 'surplus' smoke.
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Paxil under investigation in the UK... n3
Paxil a popular anti-depressant pill known as Seroxat in the UK is expected to be subject this week to scrutiny by clinical auditors from Britain's Medicine Control Agency. The reason for the interest is that there are concerns that the manufacturer Glaxo-SmithKline a major pharmaceutical group may have suppressed a series of negative studies on Paxil. Some responsible party has delivered to the Medicines and Healthcare Products Regulatory Agency (MHRA) copies of nine studies of Paxil that confirm the antidepressant can lead to suicidal tendencies and other medical damage when administered to people under the age of 18.
To read an article about this by Alex Brummer, City Editor, Daily Mail please click here.
Warren Matthews comments: Anti depressants are responsible for a lot of bad things…and it is not limited to just young folk. Shame when companies put profits in front of the wellbeing of their customers.
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6/25/03 - Eating sufficient fruit and vegetables to maintain antioxidant vitamin and mineral levels could reduce the risk of cancer and mortality in men, report researchers from the French health and medical institute Inserm. (Full Article)An eight-year study found a 30 per cent reduction in cancers and 37 per cent reduction in mortality among men who received a daily antioxidant supplement compared to placebo. The researchers claim that the study, called SU.VI.MAX, is the first randomised trial to show that an adequate intake of vitamins and minerals from fruit and vegetables can reduce the risk of cancer.
The double-blind, placebo-controlled study tested the impact of a daily dose of antioxidants on 13000 healthy subjects. The dose included 6mg of beta-carotene, 120mg of vitamin C, 30mg of vitamin E, 100ug of selenium and 20mg of zinc. The 7886 women, aged 35 to 60 years old, and 5141 men, from 45 to 60 years old, were divided into two groups and followed up over an average of 7.5 years.
There was no difference between the two groups concerning heart disease, supporting other studies testing the effects of antioxidants on cardiovascular health, but cancer risk was reduced by 31 per cent among men. This included most cancers, especially digestive, respiratory and skin cancers.
The absence of such effects in women was not due to the different cancers they developed but rather their better state of health at baseline, explained the Inserm researchers at a press conference this week.
Again, while risk of death was 37 per cent lower among men receiving the supplements, the same effect was not seen in women.
The researchers also found a higher risk of cancer and heart disease among men with the lowest levels of beta-carotene. The lower the level of the nutrient, the higher the risk of disease.
The team stressed however that the findings should support a nutritious diet with regular consumption of fruit and vegetables rather than supplements. Use of antioxidant supplements was necessary to be able to compare to placebo, but they claim that this effect applies equally to nutrients found readily in plant foods. The results back nutrition advice to consume at least five portions of fruit and vegetables daily rather than relying on supplements, claim the researchers.
They add that the observed effect is likely weaker than would be seen from fruit and vegetables, which have additional nutrients not included in the supplement used in the study. Further, they pointed to fears that people taking supplements may eat less fruit and vegetables, calorie sources which often lead to reduction in consumption of fatty and sugary products.
The findings will be published in Inserm's Formation Santé publication.
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Glaxo faces storm over Seroxat (Full Article)f2
Alex Brummer, City Editor, Daily Mail
9 June 2003
CLINICAL auditors from Britain's medicines control agency are expected to descend on Glaxo-SmithKline this week amid concerns that the pharmaceuticals group may have suppressed a series of negative studies on its key antidepressant drug Seroxat, known as Paxil in the US.
In a highly unusual move, a team from the Good Clinical Practice unit of the Medicines and Healthcare Products Regulatory Agency (MHRA) will demand access to all of GSK's files and studies on Seroxat.
The decision to take this dramatic step was taken following the delivery to the MHRA of nine studies of Seroxat that confirm the antidepressant can lead to suicidal tendencies and other medical damage when administered to people under the age of 18. There has been extensive media coverage of the potential harmful effects on young people of Seroxat, one of GSK's leading compounds. But until now the company has declined to acknowledge any serious problems.
This week, however, it will be asked by the MHRA to contact general practitioners, letting them know of the potential dangers to people under 18.
Sources at GSK confirmed that an amendment to the instructions carried with Seroxat was under discussion with the authorities and an announcement would be made shortly. There was no knowledge of the impending clinical audit.
Disclosure of the regulatory concerns about Seroxat, which contributes £1.5bn-£2bn of annual turnover to GSK, is likely to lead to nervous selling on the stock market when it opens for business today. Glaxo shares have recovered to 1258p this year after falling below £10 in 2002.
Concerns that clinical practices may have slipped at Britain's flagship pharmaceuticals group will put additional pressure on the company's chief executive Jean-Pierre Garnier, who is already under fire over his possible £22m severance package.
A senior source at the MHRA told the Daily Mail that the decision to conduct an audit at GSK was 'very, very unusual'. 'Normally we have a good relationship with these guys and work closely together,' the source said.
If it were found that critical studies had not been available to regulators then GSK could eventually face criminal charges under the Medicines Act.
Previous Good Clinical Practice audits have been carried out at second-line pharmaceutical groups where research practices are sometimes less rigorous.
Members of the Committee on the Safety of Medicines, the licensing arm of the MHRA, were disturbed when they saw the parallel Seroxat and placebo studies recently submitted by GSK. They revealed a predilection to suicide, aggressive behaviour and other psychosis in Seroxat users under 18, which were not present in the placebo studies.
The belief is that a deep volume of research work showing 'contraindications in children' could not have been carried out overnight and the appropriate regulatory authorities should have been alerted much earlier - so appropriate amendments could be made.
The big worry for GSK now is that the disclosure of the disquiet at the MHRA and its offshoots could attract the attention of the Food & Drugs Administration in the US, which works closely with the British regulators.
That could seriously damage GSK's reputation in the US, where it does much of its business and where Garnier has his headquarters.
A spokesman for GSK said: 'We can confirm we are in discussion with the MHRA regarding proposed updates of the product characteristics of Seroxat. However, it is not appropriate to discuss this dialogue further until the outcome of this review.
'Seroxat is an important medication for treatment of anxiety and depression, and has been for more than 10 years. It has benefited the lives of millions of people suffering with these serious conditions.'
A decision on the safety of Seroxat/Paxil, and other widely prescribed anti-depressants like Eli Lilly & Co's Prozac, will be announced tomorrow, according to the UK Medicines Control Agency. 'We will be making an announcement about Seroxat tomorrow but we're not saying anything in advance,' spokeswoman Alison Langley said.
Glaxo refused to comment on whether a clinical audit was being carried out, but confirmed it is in talks with the MHRA. 'We can confirm we are in discussion with the MHRA regarding proposed updates of the product characteristics of Seroxat,' Glaxo's Martin Sutton said.
SEROXAT is one of the biggest selling antidepressants in the world. It treats depression, panic, obsessive compulsive disorder, post-traumatic stress disorder, social anxiety disorder and general anxiety disorder. Last year 400,000 people were prescribed the treatment, also known as the 'anti-shyness pill', in Britain alone.
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