Research data as compared to patient experience in the case of Statins
The ludicrous headline in the Telegraph and the article repeating the view that Statins are good following dubious based research has attracted over 700 comments from the public. This shows that people are not fooled by trial data funded by the industry and professors looking for funding for their university.
When pharmaceutical drugs are licensed for use by the general population, one would think that evidence of the safety of these drugs would have been established.
The manufacturers look specifically for the action of a drug but not for the harms in the clinical trials, so often harms are not recorded. Patients who drop out of trials due to adverse drug reactions may not be listed. Withdrawal effects are not followed up. Raw data is not seen by the licensing authority, only summaries of trial data produced by companies that rely on the good favour or the pharmaceutical company for their livelihood.
Less than 10% of serious adverse drug reactions (ADRs) are reported and some health professionals think the figure is more like 1%
Emergency hospital admissions due to ADRs have increased by 76.8% over 10years and deaths by 10% (official statistics) http://jrsm.rsmjournals.com/content/103/6/239.full
So where does that leave the patients?
We are bombarded with Disease awareness campaigns telling us that if a diagnostic test result is below or above a certain number we are at risk –
We have to ask the question
Are we put at more risk by the treatment than the test number prediction.?
Why does a headline such as today’s in The Telegraph, quote such nonsense as Statins should be prescribed to everyone over the age of 50?
I had a conversation with a renowned consultant urologist this morning about the claims by Professor Colin Baigent that Statins should be prescribed to more people, the consultant was as horrified as I was. He said "statins are not safe for everyone. What about the Asian community who are at greater risk from statins." He mentioned the harm to liver and kidney, the increase in alzheimers?
A Professor of Clinical Pharmacology said to me:
“Would you take a lifestyle drug now to prevent something that may never happen in the future, that could make you ill now”
Questions to ask before you take Professor Baigen’s comment seriously.
Will he benefit by obtaining funding for his research. Who provides the funding for the research?
What are the details of the 27 random trials that the study took the data from?
o Were the 27 random trials all independent of pharmaceutical company funding?
o Did the random trials include people from the Asian and other populations known to be at increased risk of adverse drug reactions (ADRs) from statins
o How many women were included in the random trials (as it is know that statins were originally licensed following clinical trials mainly on men)
o Were the people on dummy pills (placebo) free of previous history of heart conditions.
The statement in the report “for every 1000 people in the low risk group treated with statins for five years there would be 11 fewer major hear attacks or strokes - A benefit that greatly exceeds any known hazards of statin therapy” needs teasing apart.
For example official statistics claim less than 10% of serious ADR are reported.
Read the forums with memory loss linked to statin use. These are not in the official statistics.
How many people are receiving steroid injections for muscle pain without being told to stop the statins or being given a CK test as recommended by the manufacturers.
What are the ‘know hazards of statin therapy?
o Memory loss
o Bleeding strokes (burst blood vessel in brain)
o Muscle weakness and worse (rhabdomyolysis)
o Kidney failure
o Liver conditions
o Sleep problems
o Stomach problems
Take a careful look at the data provided by Pfizer before you decide to take a statin
Official pharmaceutical company data sheet – summary of product characteristics (SPC) – for Lipitor and the same for all statins states: The patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue on this diet during treatment with Lipitor.
Data sheet states under 4.4 Special warnings and precautions for use:
- Liver function tests should be performed before the initiation of treatment and periodically thereafter
- Lipitor should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.