A major tightening of the law governing the oversight of drugs companies will be announced today when the government says GlaxoSmithKline delayed informing the authorities that a controversial drug increased the likelihood of suicide among teenagers.
The health minister Dawn Primarolo will tell MPs that new legislation will be introduced by the end of the year to ensure drugs companies pass on results of clinical trials as soon as the alarm is raised about one of their medicines.
The government is to intervene after a four-year investigation by the drug regulatory body into the way GSK withheld the full results of their trials of the antidepressant Seroxat on children.
The trial data, which was finally handed to the Medicines and Healthcare Regulatory Authority (MHRA) in May 2003, identified two problems of which the company had been aware as early as 1998:
- A higher risk of suicidal behaviour among under 18s using Seroxat rather than a placebo.
- Seroxat was ineffective in dealing with depressive illness among under 18s.
Primarolo will announce that GSK should have told the MHRA earlier than it did about the results. But GSK will not face criminal prosecutions, she will say, because the legislation in this area is insufficiently clear on whether and when drugs companies should inform the regulator.
The minister will announce that new legislation will be introduced by the end of the year placing a greater obligation on companies to disclose results of trials.
The MHRA’s investigation asked whether GSK had informed the regulatory body in reasonable time. It shows that the drug company had the information about the potentially suicidal effects of Seroxat and concludes that GSK should have informed the MHRA earlier. However, it finds that the company acted within the letter of the law by withholding data that would have shown up a problem. The failure to take stronger action against GSK will anger the many critics of the regulatory body, who say it is not up to the job of policing the pharmaceutical industry.
Patients and some doctors have been urging a tough line against GSK ever since the MHRA suddenly announced, in June 2003, that doctors must not give Seroxat to children and under 18s.
The agency said it was acting within two weeks of being given the full set of data from trials of Seroxat in children. The statistics contained in those results showed that the drug was no better than a placebo in alleviating depression in children and that those on the drug were more likely to develop suicidal tendencies than those on placebo. In one of the trials, 6.5% of those taking Seroxat became suicidal compared with 1.1% in the placebo group.
A leaked internal document from GSK, dated to 1998, said the company would have to “effectively manage the dissemination of these data in order to minimise any potential negative impact”.
In the United States, GSK was sued by the New York state attorney general, Eliot Spitzer, and settled for $2.5m (£1.25m) and an agreement to publish all its trial results - negative or positive - on a publicly available database.
Critics have called for big changes to the MHRA. In its report into the influence of the pharmaceutical industry, the Commons’ health select committee expressed concern that the MHRA did not get all the information it needed from manufacturers before it licensed drugs. It called for a new regime of random audits of the raw trial data collected by companies and for more staff to be employed.
GSK has always completely rejected allegations that it improperly withheld data on the drug. It said Seroxat had never been approved by EU or US regulators as a medicine for those under 18, and that the company had therefore never marketed the drug for that age section.
Scientists Issue Heart Warning on Fat Content of Doner Kebabs
16 May 2008 Author: Bilig In: Medicine
Crunchy salad, toasted pitta bread and a dash of chilli sauce have helped aficionados kid themselves and their taste buds that a doner kebab is one of the healthier takeaway options.
But scientists have found that the food contains up to the equivalent of a wine glass of cooking oil. One of the kebabs tested contained 140g of fat, twice the maximum daily allowance for women. Another contained 111g. Nutritionists said eating two a week could cause a heart attack within 10 years.
The least fatty takeaway food was found to be Chinese char sui or barbequed pork, but shish kebab also scored low in fat.
The best in terms of low salt content was fish and chips.
Denise Thomas, head of nutrition and dietetics at Portsmouth Hospitals Trust, said that 111g of fat in a kebab was 1,000 calories, the equivalent of a wine glass of cooking oil. “The majority of that fat is saturated, so it’s going to raise your cholesterol and give you thickening of your arteries,” she said. “If you were eating that meal twice a week on top of your ordinary diet, it’s a ticking time bomb of coronary heart disease.”
The effect of eating doner kebabs was dependent on the rest of a person’s diet. “If you eat lots of fruit and vegetables the rest of the time, it’s not going to be a problem. But if you’re eating pie and chips and fried breakfasts as well, you’re heading towards a heart attack within 10 years.”
Relatad Link: Killer Kebab
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Of all the controversies surrounding cancer, the role of Vitamin D is one of the most contentious. It has been known for years that this essential nutrient is produced in the body when it is exposed to sunlight. It can also come from our diets, but most people do not eat enough fish to make the amount we need for healthy bones.
The public health messages about avoiding too much sunlight have been criticised in the past few years by those who believe we have to expose ourselves a bit in order to make Vitamin D. Some doctors believe the medical community has been unwilling to accept evidence that the vitamin can play a significant role in protecting against bowel cancer and other diseases, and that the ’safe sun’ messages have been overplayed. According to Professor Lesley Rhodes, whose work in Manchester is funded by Cancer Research UK, people may not need too much sunlight to make the nutrient. ‘Sunlight is important, but after a while our ability to make Vitamin D is switched off. We think that it may be just ten to 15 minutes you need to get the full benefits of the sun, before you start to burn.’
A daily dose of aspirin reduces a woman’s chance of developing a particular type of breast cancer by 16%, according to a study of more than 126,000 women.
The latest research backs up a review of 21 studies which found that anti-inflammatory drugs such as aspirin reduce breast cancer risk by up to 20%. About 45,000 women a year in the UK are diagnosed with breast cancer.
In the new study, Dr Gretchen Gierach and colleagues at the US National Institutes of Health in Rockville, Maryland, studied 126,124 women aged between 51 and 72. When the study started, none of the volunteers had breast cancer. During follow-ups between 1995 and 2003, 4,501 of the women developed breast cancer. The team found that women who took aspirin daily were 16% less likely to develop so-called oestrogen receptor positive breast cancer. Around three-quarters of breast cancers are oestrogen receptor positive.
Contrary to previous research, the study did not find a reduction in breast cancer risk overall in the group of women who used aspirin regularly, and did not find that other nonsteroidal anti-inflammatory drugs (NSAIDs) reduced breast cancer risk.
Aspirin is thought to influence cancers by blocking the action of an enzyme called cyclooxygenase. This in turn lowers the amount of oestrogen in the body. The results are reported in the journal Breast Cancer Research.
Liz Baker, science information officer at Cancer Research UK, said anyone considering taking aspirin regularly should consult their doctor first. “Weighing up the risks and benefits, it’s too soon to recommend aspirin as a way of reducing the risk of cancer.”
In a separate study, researchers have found that having a child appears to give mothers some protection against breast cancer.
Dr VK Gadi, at the University of Washington in Seattle, and colleagues found that stem cells left behind in the mother by the foetus appear to make her less likely to develop breast cancer.
The study is reported in New Scientist magazine.
At a magnitude of 7.9, the earthquake that rocked China’s Sichuan province is now estimated to be the country’s deadliest in recent history. Fatalities have tallied over 15,000 in an industrial city that was reduced to a living situation most closely resembling a refugee camp. As national guards continue rescue efforts in rain drenched rubble, the potential for after-shocks has driven most families from their homes. Access to any type of building or upright structure still standing is prohibited by Chinese officials. Without shelter, citizens unable to evacuate the area sleep in plastic bags to keep dry.
Despite the Chinese governments efforts, the rain-drenched hillsides remain unstable and prone to landslide. International sympathy has started to come in from the United States, international relief organizations and even from the Dalai Lama who offered his prayers to the victims.
