HOW TO STOP STATINS IN THE BEST POSSIBLE SCIENTIFIC PATIENT ORIENTED WAY
Dear Professor Chalmers,
You wrote in your BMJ rapid-response dated 18-6-2014 about your complaints on muscle pain in your right upper arm and that you asked yourself: could these pains be caused by an adverse reaction on statin treatment? Should statin treatment be stopped? You would welcome information on possible unwanted effects of statin medication and proposed a randomized, placebo controlled withdrawal/discontinuation trial as the best available scientific efficient research strategy to obtain such information.
Of course, I fully agree with you: the strategy you propose would provide scientific evidence that could help you and other doctors to make better clinical decisions. However, a drawback is that it would not contribute much to a solution for the problems you have at this moment: should I stop taking statins or not?
On 9-6-2014 I posted on BMJ-online doc2doc a rapid response (see below) in which I warned for possible adverse effects of statins and for the idea that statins have reliably been tested on their value for prevention of heart disease. I wrote: “ Statins are said to inhibit HMG-CoA-reduction and to inhibit sterol biosynthesis. Statins lower cholesterol and are widely prescribed and prevent heart disease. However, up to now there are no reliable scientific clinical trials that tested the hypothesis and reported that statins can safely and effectively be used for prevention of heart disease. As long as that is the case statins treatment can best be regarded as unscientific unproven alternative medicines for prevention of heart disease”. Now, 7-7-2014, my ideas about how to present my warning rapid response has changed and I entitle it:
STATINS ARE ALTERNATIVE CHELATION THERAPY
But first I have to explain why I think that statins can best be classified as chelating agents. Chelating agents are chemical compounds that trap, bind or remove heavy metals from enzymes. My idea is that statins inhibit HMG-CoA-reduction by chelation of metals from the enzyme. I warn that chelating agents are known for their adverse reactions and that myopathy and muscle pains are known harms of statin treatment. My hypothesis is that muscle pains in persons like you who are treated with simvastatin are caused by an adverse effect of the chelating agent simvastatin.
SECRETS IN HEALTHCARE
I am afraid that secrecy on the chelating effect of statins and other enzyme-inhibitors is damaging rational critical thinking in evidence-based medicine. I feel a commitment to transparency and open data and I warn for secrecy. Conflicts of interest may lead to keeping certain data secret. I think that knowledge that statins are chelating agents has been kept secret. This secret role of chelation is not specific for statins. On the contrary, metformin (drug for Diabetes type 2) and tamiflu (antiviral drug) are comparable enzyme inhibitors and up to now the secret that these drugs can for be classified as alternative chelation therapeutics has not yet been discovered completely.
Underreporting is a major problem in medicine. “Underreporting research is scientific misconduct” were your words Prof. Chalmers in an article in the JAMA 20 years ago.
Underreporting on adverse effects of statins may have led to harm to patients with heart disease: estimates of benefits and safety of treatment may have been exaggerated and this may have inhibited efforts to discover more effective and safe treatments.
Underreporting on adverse effects of chelating agents has led to harm to patients with various diseases.
- Underreporting EDTA-chelation for cardio-vascular diseases. The quality of reporting was poor; several fatalities were reported; non-fatal adverse effects were numerous.
- Underreporting adverse effects of penicillamine chelation therapy. Since its introduction in 1956 this unscientific, not-very effective and very unsafe therapy became worldwide known as treatment of choice for treatment of patients with Wilson’s copper disease. Estimates of benefits and safety had been exaggerated extremely and were not at all evidence based. This tragic underreporting of adverse effects of penicillamine inhibited the development of effective and safe oral zinc therapy that the Dutch neurologist Schouwink had developed and defended for his thesis in Amsterdam in 1961.
- Underreporting of the effectiveness of zinc therapy for Wilson’s disease. Schouwink had performed a comparative clinical trial comparing effectiveness of penicillamine versus oral zinc therapy. It is interesting to report here that Schouwink performed his study as a sort of ‘ N-of-1 clinical trial ‘ in 2 single patients. His attempts to publish his discovery in a worldwide international journal were unsuccessful. The manuscript did not pass the peer-review and was rejected for publishing. This underreporting of zinc therapy is shameful severe scientific misconduct and has led to many unneeded harms, unneeded dismay, unneeded deaths and unneeded liver transplantation.
N-of-1 RCT (Randomized Clinical Trial)
Dear Professor Chalmers, at first sight I fully agreed with you that your proposal to set up a placebo controlled withdrawal/discontinuation trial for identifying side effects attributable to statins would be the best available scientific research strategy.
However, at second sight and on some more reflection I think that your strategy could win by being transformed in a placebo controlled withdrawal/discontinuation clinical trial in a single patient (N-of-1 RCT). It should not be difficult to change the protocol from RCT to N-of-1 RTC and neither difficult to find patients to participate in such a clinical trial. In my opinion you would develop in this way the best available scientific strategy to stop taking statins and to help doctors to make better clinical decisions.
I look forward hearing your response to this suggestion,