Are statins safe for everyone? research data compared to patient experience

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?

http://www.telegraph.co.uk/health/healthnews/9269027/All-over-50s-should-be-taking-statins.html

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?
They include

o Memory loss

o Bleeding strokes (burst blood vessel in brain)

o Muscle weakness and worse (rhabdomyolysis)

o Kidney failure

o Liver conditions

o Depression

o Diabetes

o Sleep problems

o Stomach problems

o Headaches

Take a careful look at the data provided by Pfizer before you decide to take a statin

http://www.medicines.org.uk/EMC/medicine/1424/SPC/Lipitor+10mg%2c+20mg%2c+40mg%2c+80mg+Tablets

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.

Government enquiry into benzodiazepine addiction highlights a need for withdrawal services.

A Press Release from Jim Dobbin MP Chair of the All Party Parliamentary Group on Involuntary Tranquilliser Addiction discusses the need for research into and introduction of effective withdrawal services. We mentioned this in our post on 27th June 2009.


"Sky News and the Times are reporting today that Michael Jackson's death has been ruled to be a homicide and that the drugs found in his body included the anaesthetic Propofol but also the benzodiazepine tranquillisers Ativan (Lorazepam),Valium and Midazolam.

I would like to comment on the dangers of the benzodiazepine tranquillisers involved. In 2004 the Canadian Ativan data sheet contained the warning that "Use of benzodiazepines,including lorazepam may lead to potentially fatal respiratory depression." It also contained a seven day addiction warning and suicide warning ,for lorazepam.

Phil Woolas M.P. wrote to Sir Alastair Breckenbridge, Chair of the U.K. drug licensing authority the MHRA,in 2004 asking for similar warnings to be introduced into the U.K. product information.The warnings were never introduced and in fact no product information sheet for lorazepam tablets was published at all in the U.K. in 2009, despite the increased number of licenses issued.

Tranquilliser related deaths in the U.K. are running at some 300 per year,in some years they have exceeded the total number of deaths for all class A drugs added together ,according to Home Office figures.In answer to a Parliamentary question the Department of Health reported that in 2008 over 17 million tranquilliser prescriptions were issued in the U.K.,an increase on 2007. My question is how many people have died a Michael Jackson type death in the U.K.,and elsewhere, but with no homicide investigation or any other kind of investigation.

Tranquillisers are highly addictive yet the Department of Health provides no withdrawal treatment at all except for one worker in Belfast and two in Oldham. The All Party Parliamentary Group on Involuntary Tranquilliser Addiction (APPGITA) is campaigning for the introduction of specialized tranquilliser withdrawal services by the Department of Health.We are also campaigning for medical research into the damage caused by tranquillisers,a review of the benzodiazepine product licenses ,which were issued with no assessment of safety or efficacy and a no-fault drug compensation scheme for patients who suffer drug injuries.

Jim Dobbin M.P."

In light of these recommendations, we should be aware of two interesting studies which involved Professor Heather Ashton (who spoke at APRIL’s 2008 conference) and discussed two effective approaches that also save money.

The cost-effectiveness of two brief interventions for helping people to withdraw from long-term benzodiazepine use are addressed in the following two papers by Nick Heather and colleagues in 2004 and Christine Godfrey and coworkers in 2008. These interventions consisted of a letter that was sent to patients advising a gradual withdrawal as well as a brief GP consultation.

The earlier paper reports that both interventions are effective in leading to a reduced intake of benzodiazepines.

http://www.benzo.org.uk/amisc/rndoi.pdf


The later study found that of the two interventions, overall the letter was the most cost-effective. The authors estimate that the savings for that particular authority in Newcastle and North Tyneside would be a minimum of £4.9 million.

http://www.benzo.org.uk/amisc/rndce.pdf


It would be interesting to make an estimate of financial savings and reduction in human suffering and iatrogenic illness, that could be made nationally using these interventions.

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