An Oxford professor is to lead an extensive review into the side effects of the cholesterol-lowering drugs statins.Sir Rory Collins, co-director of the University’s Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), and his Oxford colleagues will re-examine the medical records of tens of thousands of patients included in previous studies into the widely prescribed drug.The new review will assess the prevalence of various reported side effects, such as muscular pain, diabetes, and memory loss.The editor of the British Medical Journal (BMJ) Dr. Fiona Godlee commented, “This is of real concern. We wrongly assumed all the details of possible side effects had been thoroughly assessed before new guidance made tens of thousands of people eligible for this drug. We now know this is not the case and would urge that any re-analysis be done in the most transparent way.”Last July, the National Institute for Health and Care Excellence (NICE) published new guidelines on statins, with doctors instructed to prescribe statins to patients deemed to be at a ten per cent risk of a heart attack in the next decade, if lifestyle changes are unsuccessful at bringing down the risk.Prior to the release of the latest guidance, NICE had recommended that statins should only be prescribed to individuals with a 20 per cent risk of heart attack in the next ten years.The new instructions, based on what NICE described as the “best and most complete review of evidence in this field”, mean that up to 40 per cent of the adult population are eligible to be prescribed statins.Conservative MP Dr. Sarah Wollaston, chairwoman of the House of Commons’ Health Select Committee, said, “I’m concerned there may be side effects that have not been reported. Drug manufacturers should release all their trial data on statins so they are available for scrutiny.”Oxford’s Visiting Professor of Public Health Epidemiology Dr. Klim McPherson commented, “We know these drugs have side effects but we do not know if these have been assessed properly by the drug companies who carried out the trials.“It is outrageous. Why do they not make their data available for scrutiny? Taking these drugs should be a matter of individual patient preference with patients fully aware of their risks, which at the moment is not the case.”Statins are a group of drugs that lower blood cholesterol levels by limiting the build-up of fatty deposits in the arteries, which can cause cardiovascular conditions.Cardiovascular disease (CVD) is the biggest killer in England and Wales, constituting nearly a third of deaths each year and having cost the NHS an estimated £7.88bn in 2010.NICE has argued that if all eligible patients were offered statins, as many as 28,000 heart attacks and 16,000 strokes could be prevented each year.Nonetheless, this has been met with fears of the influence of pharmaceutical companies and unnecessary ‘medicalisation’.
Bradford bakery firm Happy Bread has been found guilty of driving qualifications fraud.Coultons Bread, which trades as Happy Bread, has been stripped of its licence to run three of its 60-strong fleet of vehicles, after some its drivers at the Bradford depot obtained qualifications fraudulently, without being properly trained.Kevin Rooney, the Traffic Commissioner for the north east, said it was “unacceptable for a company to put profit before legal requirements”.But Coultons Bread director Howard Hunter told British Baker: “I think they’re making an example of us to be honest, as its the first case of its kind. This is all the result of an individual whistle blower, an ex-employee who left us with grievances.”Obviously it should never have happened in the first place, and I should have personally checked more thoroughly that all was right and in place with the licences. But the company hasn’t been fined, I haven’t been fined and we are not in a criminal position.”Following a public inquiry, Rooney said Happy Bread failed to ensure that drivers were legally able to meet a deadline to be qualified with a Certificate of Professional Competence (CPC).“Having effectively run out of time, the local management team took the decision to put in place arrangements, such that driver qualification cards were issued to the drivers fraudulently, without the drivers having undertaken the relevant training,” said Rooney.Under new EU regulations, professional HGV drivers must complete a mandatory 35 hours of training before being issued with driver CPC qualification cards.The Driver and Vehicle Standards Agency (DVSA) examiners found three CPC trainers in Greater Manchester, working for another operator, ABF Grain Products Ltd, trading as Allied Bakeries, had made false statements in order to obtain CPC qualifications for the drivers employed by Coultons Bread.One of the CPC trainers admitted that he had signed 12 certificates to say drivers had undertaken the relevant training, even though he knew they had not done so.Investigations revealed Happy Bread was aware that the qualifications had been fraudulently obtained. The drivers also admitted to knowing that they had not completed the required training.The company have until 8 July to reapply for the qualifications in question.In 2012, Liverpool-based plant bakery firm Coulton’s Quayside relaunched the Happy Bread range of products.