Mass prescription of statins based on junk science?

The Health section of this morning’s Sunday Express in the UK carries an article with the headline: ‘We are very worried’ Former Royal doctor demands statins inquiry.

Statin drugs are prescribed to around 12 million people in the UK to lower cholesterol, according to doctors’ guidelines issued by NICE and reinforced by the NHS with targets for prescribing statins to older patients. Statin drugs are supposed to prevent heart disease but, as we highlighted in our film You must be nuts! – the business of dementia, they have many side effects, including possibly dementia.

However, as Dr Stephanie Seneff revealed in the interview above, she was unable to publish her 2009 analysis that statins could cause Alzheimer’s until all references to statins had been deleted from her paper. It would seem likely that she is not the only researcher to have found negative effects of statins which have remained unpublished.

Sir Richard Thompson, former president of the Royal College of Physicians and personal doctor to the Queen for 21 years, has called for an inquiry to scrutinise the data on which this mass prescription is based. His comments follow the publication of the paper Beyond Confusion and Controversy, Can We Evaluate the Real Efficacy and Safety of Cholesterol-Lowering with Statins? by Dr Michel de Lorgeril and Dr Mikael Rabaeus in the Journal of Controversies in Biomedical Research.

The paper begins by drawing attention to the “increasing signs of altered validity of numerous company-sponsored trials”. As an example, it cites the neuraminidase inhibitors for treating influenza.

“The 5-year battle needed to access the raw trial data led to a reversed picture of the drugs: benefits had been overestimated and harms under-reported in the company-sponsored trial reports. Ultimately, the benefit/harm balance was not in favor of the drugs; this is a critical issue for physicians, in particular when they are in charge of fragile patients. One probable cause of the failure is that none of the trials was independent of the drug’s manufacturers. Several experts conclude that the “Tamiflu story” may suggest that the entire ecosystem of drug evaluation and regulation could be flawed.”

The paper concludes that “contrary to what has been claimed for decades, statins do not have a significant effect in primary and secondary prevention of cardiovascular disease.” It also recommends that “medical doctors should not prescribe statins in diabetics and in patients with metabolic syndromes.”

In essence, the paper points out that the main studies on which the enthusiasm for statins has been based would have been disqualified under the 2005/2006 EC regulations in the conduct and publication of randomised controlled trials. Even so, it suggests that “investigators and industrials can still succeed in finding a way around them.”

“This has led to the dogmas about statin efficacy and safety, based on unrealistic clinical reports and flawed meta-analyses, resulting in biased recommendations about statin use and ultimately extravagant situations and claims.”

After the failure of the UK Parliament’s Commons Health Select Committee to even reply to Obhi’s call for a formal investigation into this area (let alone taking any action), we hope that Sir Richard Thompson’s call will lead to a change in the current policy of prescribing drugs based on dogma, rather than science.

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