Why can´t we get access to all data?

May 2014

Adverse effects from statin treatment are very rare. This is what Sir Rory Collins, Professor of Medicine and Epidemiology at Oxford told the media in a fierce comment to two papers published in British Medical Journal (BMJ) where the authors claimed that 18%-20% of patients on the cholesterol-lowering drugs suffered adverse events. According to Collins side effects occurr in less than 1 per cent of the participants. Muscle weakness, for instance occur in only one in 10,000 people, he said and he therefore insisted that BMJ should withdraw the papers.

According to the industry-sponsored trial reports muscle damage, the commonest side effect occur in less than 1 per cent, but to achieve that number muscle problems are only recorded if the patient´s CK is more than ten times higher than the upper normal level and at two occasions. (CK, or creatine kinase, is an enzyme that appears in the blood in larger amounts than normally when muscle cells are damaged). However, a study of statin-treated patients with muscle damage verified by a microscopic examination of the muscle tissue, have shown that CK is normal in such patients.

The question is also, what happens with the muscles after ten or twenty years of treatment in patients whose CK is “only” nine times higher than normally.

Independent researchers have found that muscle problems occur in more than 20 per cent of statin-treated patients. In a recent statin trial performed by independent researchers their conclusion was that women were disproportionately affected…4 in 10 treated women cited worsening in either energy or exertional fatigue. And muscular problems is not an innocent side effect, because the cheapest and most effective way to prevent a heart attack is regular exercise.

Hitherto 39 “Rapid Responses” (click on Responses) from patients, doctors and scientists have been published in BMJ about this issue. Read in particular Zoë Harcombe´s comments about Rory Collins financial ties and John Briffa´s comments about the many tricks the trial directors use to minimize the number of side effects. (Today, Jan. 17, 2016 there are 89 responses!)

An explanation of the large differences between the number of side effects recorded in the statin trials would be easy to find if it was possible to get full access to the trial data, but the drug companies do not allow that. This is a fact, but apparently many doctors, researchers and media people are not aware of that. If you are in doubt, read Malcolm Kendrick´s blog. He has got access to several emails exchanged between Marianne Demasi and Professor Colin Baigent from the Cholesterol Treatment Trialists Collaboration, an Oxford based group that hold all the data from the statin trials. In the first part of Malcolm’s blog you can also read summaries of all the complaints made against the two ABC programs.

That the drug companies withhold their data is scandalous, to put it mildly. Thousands of clinical trials have not reported their results; some have not even been registered. Recently a British organization named #AllTrials has been created. Their aim is to call on governments, regulators and research bodies to implement measures to achieve full information about all clinical trials. Take a look at their video and please sign their petition!

There are good news also. The General Practitioner’s section of the BMA has voted against the proposed NICE guidelines for primary prevention of CVD using statins, until all the data are revealed.