Women should not be prescribed statins as they fail to provide any overall health benefit

This article was published in the British Medical Journal 2007 May 12; 334(7601): 983 Study title and author:

Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No

Malcolm Kendrick, general practitioner

24 Prestwick Close, Tytherington, Macclesfield, Cheshire SK10 2TH

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1867901/?tool=pubmed

Dr. Kendrick believes there is little or no evidence of health benefits for women taking statins.

 

He makes the following observations:

(a) To date, none of the large trials of secondary prevention with statins has shown a reduction in overall mortality in women.

(b) The primary prevention trials have shown neither an overall mortality benefit, nor even a reduction in cardiovascular end points in women.

(c) Women should not be prescribed statins. Not only do statins fail to provide any overall health benefit in women, they represent a massive financial drain on health services. This money could be diverted to treatments of proved value.

(d) Statins carry a substantial burden of side effects.

(e) Mass medicalisation is a dangerous road with many psychological and societal consequences.

(f) In the Scandinavian simvastatin survival study three more women died taking statins than the women who took the placebo.

(g) In the studies of primary prevention neither total mortality nor serious adverse events have been reduced.

(h) A meta-analysis published in the Lancet found that statins even failed to reduce coronary heart disease events in women.

(i) Another meta-analysis of statins in primary prevention suggested that overall mortality may actually be increased by 1% over 10 years (in both men and women).

(j) Data from 124,814 women in 19 studies and trials found that cholesterol levels had no impact on total death rates and heart disease.

(k) Studies have suggested that side effects from statins may be much more common than is recognised.

(l) One study found that 80% of athletes could not tolerate statins.

(m) Research by Golomb and McGraw found that doctors often dismiss most (probable) statin related events. Patients who met the criteria for definite or probable adverse events reported that their doctors tended to dismiss symptoms, deny specific statins adverse events, and failed to appreciate the effect of the adverse reaction on their quality of life.

(n) More evidence comes from the US Food and Drug Administration adverse event reporting system. Between November 1997 and May 2004 simvastatin was reported as a direct cause of 49,350 adverse events and 416 deaths.Adverse events are greatly under-reported, so the actual figures are likely to be much higher.

(o) Of further concern, as statins are increasingly prescribed to younger women, is the potential for birth defects, with severe neurological abnormalities reported. Spending millions on a treatment that has no proved benefit and may cause serious harm goes against the rationale of evidence based prescribing.

 

Women should not be prescribed statins as they fail to provide any overall health benefit.

UK doctors virtually compelled to prescribe statins against their better judgement

This post includes a letter published in the British Medical Journal 2003 October 18; 327(7420): 933

Study title and author:
Might money spent on statins be better spent?
Arnold J Jenkins, general practitioner principal
Colne Road Surgery, Burnley BB10 1LG ; Email: AJ_Jenkins@compuserve.com

The following letter was sent to the British Medical Journal from Arnold J Jenkins, a general practitioner in the UK

Access at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC218861/?tool=pubmed

Editor—As Abbasi argues in his Editor's choice, the benefits of publishing negative findings should be obvious.
 
As a general practitioner I wonder how many million pounds sterling the NHS could save if the Medical Research Council, the British Heart Foundation, and the Lancet shared this view. An example is in the prescribing of statins. They are a major cost in my practice, as I am sure they are to many practitioners.
 

Books:

Even in general practice I recognised the Scandinavian simvastatin survival study as a seminal paper on the benefits of statins, and as we used to be taught to evaluate evidence (as opposed to stick to protocols) I read it. I was surprised to learn that more women died in the treated group than in the control group. On discussion with cardiology colleagues I was assured that as the numbers were small it was a statistical anomaly, resolvable by larger studies.

 
Imagine my delight when I heard of the large heart protection study showing clear benefits in the use of statins for women. On reading this study I was therefore disappointed to find the total mortality data for women missing. I now understand that the total mortality benefit for women did not reach significance and therefore was not published (Louise Bowman, personal communication, 2002).
 
I do not understand why the censors of this paper do not realise two things.
 
Firstly, any meta analyses based on this study are likely to be skewed.
 
Secondly, in such long term studies total mortality, not improvement in the condition, should be the gold standard for evaluation (euthanasia, for example, provides 100% cure of headache but should be ruled out on the mortality data).
 
I have yet to find a paper showing a significant reduction in mortality in women for groups treated with statins. It therefore seems that any benefit, if found, will be minimal. Yet we are almost compelled by protocols such as the national service framework for coronary heart disease and local prescribing incentives to prescribe for this subgroup. Also the supporting documentation to the new general medical services contract indicates that such statin prescribing may become a quality indicator.
 
I wonder whether the money could be better spent or if we should abandon the little evidence based medicine we currently have?
 
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Lipitor (a statin), the cholesterol-lowering drug, has become the bestselling pharmaceutical in history. Here's how Pfizer did it

This post features an article published in Forbes magazine January 6th 2003 and a recipe for lemon and garlic scallops.

Pfizer's sales campaign in doctors' offices has been very aggressive

Books:

Every year, drug companies spend billions of dollars teaching their sales reps how to 'persuade' doctors to prescribe their particular products.

Pfizer have 13,000 salespeople. The trainees go through weeks of simulated sales calls in a mock physician's office, built like a movie set on one of Pfizer's upstate New York campuses. On the simulation stage, former sales reps play harried and irritable doctors. Trainees are timed and judged on their ability to deliver a pitch for a Pfizer drug.

This begs the question: Should patients be given particular drugs based on how good the sales reps are at their job?

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Recipe of the day

Lemon and Garlic Scallops
 
Serves 6
 
Ingredients:

Food Mall: Scallops

•3 tbsp garlic, minced;

•2 tbsp lemon juice;

•3/4 cup butter (or Ghee);
•2 pounds large scallops;
•Salt and pepper to taste.

Technique:
1.Heat a pan over a medium heat and melt the butter or ghee. Add the minced garlic for a minute, until fragrant;

2.Add the scallops and cook for a few minutes on the first side so they are about halfway cooked. Turn the scallops and finish cooking until they are firm and opaque.

3.Put the scallops aside to a plate and add the lemon juice to the hot butter and garlic in the pan. Season to taste;

4.Serve the scallops on a bed of steamed or roasted vegetables with the lemon and garlic butter sauce on top. Spinach and asparagus go very well with scallops. Additionally, sprinkle some fresh parsley or chives on top if available.

Doctor's low awareness of statin side effects

This post includes a summary of a study published in the American Journal of Cardiovascular Drugs: 1 November 2008 - Volume 8 - Issue 6 - pp 373-418

Study title and authors:
Statin Adverse Effects: A Review of the Literature and Evidence for a Mitochondrial Mechanism
Golomb, Beatrice A; Evans, Marcella A

Books:

Dr Beatrice Golomb reviewed the scientific literature regarding the adverse effects caused by statin drugs.

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/19159124

Dr Golomb found:
(a) Muscle adverse events were the most reported problem both in the literature and by patients.
(b) In meta-analyses of randomized controlled trials, muscle adverse events are more frequent with statins than with placebo.
(c) A number of manifestations of muscle adverse eventss have been reported, with rhabdomyolysis the most feared.
(d) Adverse events are dose dependent, and risk is amplified by drug interactions that functionally increase statin potency.
(e) An array of additional risk factors for statin AEs are those that amplify (or reflect) mitochondrial or metabolic vulnerability, such as metabolic syndrome factors, thyroid disease, and genetic mutations linked to mitochondrial dysfunction.
(f) Converging evidence supports a mitochondrial foundation for muscle adverse events associated with statins, and both theoretical and empirical considerations suggest that mitochondrial dysfunction may also underlie many nonmuscle statin adverse events.
(g) Evidence from randomized controlled trials and studies of other designs indicates existence of additional statin-associated adverse events, such as cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction.
(h) Physician awareness of statin advers events is reportedly low even for the adverse events most widely reported by patients.
(i) Awareness and vigilance for adverse events should be maintained to enable informed treatment decisions, treatment modification if appropriate, improved quality of patient care, and reduced patient morbidity.

The paper outlines the unhealthy adverse effects of statins and that doctors have a low awareness of the problems.

 
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Do doctors report statin side-effects?

This post contains a summary of a study published in Drug Safety 2007; 30 (8): 669-675

Study title and authors:
Physician Response to Patient Reports of Adverse Drug Effects
Implications For Patient-Targeted Adverse Effect Surveillance
Beatrice A. Golomb,1,2 John J. McGraw,1,3 Marcella A. Evans1 and Joel E. Dimsdale4

1 Department of Medicine, University of California, San Diego, California, USA                 Books:

2 Department of Family & Preventive Medicine, University of California, San Diego, California, USA

3 Department of Anthropology, University of California, San Diego, California, USA

4 Department of Psychiatry, University of California, San Diego, California, USA

This paper can be accessed at: http://www.pharmalot.com/wp-content/uploads/2007/08/drug-safety-2007-physician-response.pdf

This study was a patient targeted survey and sought to assess patients experience of how physicians responded when patients presented with possible statin adverse drug reactions. The study included 650 adult patients taking statins with self-reported adverse drug reactions. The paper focused on patients' experience of the doctor-patient interaction and the physicians' response when patients report statin adverse drug reactions.

The study found:
(a) 87% of patients spoke to their physician about the possible connection between statin use and their symptom.
(b) Patients reported that they and not the doctor most commonly initiated the discussion regarding the possible connection of drug to symptom (98% vs 2% cognition survey, 96% vs 4% neuropathy survey, 86% vs 14% muscle survey).
(c) Physicians were 147% more likely to dismiss than affirm the possibility of a connection between statins and cognition symptoms.
(d) Physicians were 88% more likely to dismiss than affirm the possibility of a connection between statins and neuropathy symptoms.
(e) Physicians were 62% more likely to dismiss than affirm the possibility of a connection between statins and muscle symptoms.
(f) Rejection of a possible connection was reported to occur even for symptoms with strong literature support for a drug connection, and even in patients for whom the symptom met presumptive literature-based criteria for probable or definite drug-adverse effect causality.
(g) Here are some physicians responses to patients concern about the possible connection between statin use and their symptoms grouped into seven categories: (i) "Attributed to age", (ii) "dismissed importance of symptoms", (iii) "dismissed existence of symptom", (iv) "dismissed relation to statins", (v) "dismissed relation to statins, muscle-specific", (vi) "dismissed relation to statins, cognition-specific", (vii) "disbelief that statins cause adverse drug reactions in general".
(h) The comments below are attributed to physicians:
(i) Attributed to age: "Just normal aging process". "Can expect some problems at your age". "Well, you're no youngster". "You're just getting old".
(ii) Dismissed importance of symptoms: "Doctor said would have to live with side effects and did not seem to care". "Ignorned complaints about side effects". "Doctor shrugged and said some people just live with it, then laughed". "Did not seem to be concerned with side effects". "Didn't take seriously". "Made me feel I was alone in my inability to take statins because of 'minor discomfort'".
(iii) Dismissed existence of symptom: "Acted as if it was in imagination". "Doctor suggested it was imagination". "Don't think doctor believed me". "Told me I just didn't like taking pills". "Nothing wrong with me". "It's all in my head". "She 'pooh-poohed' me and said keep taking Lipitor".
(iv) Dismissed relation to statins: "Almost impossible". "Cannot be statins". "Not possible". "Denied possibility". "Can't be". "Said this has nothing to do with the Pravachol". Said that's not a side effect of this drug". "They (doctors) were very skeptical even though I presente Pfizer's own report on side effects". "Statins could not be cause of symptoms". "Neither doctor (internest, neurologist) believed me - my pharmacist suggested Lipitor as a cause". "My chiropractor suggested it may be the Lipitor - my MD didn't think so".
(v) Dismissed relation to statins, muscle-specific: "Didn't think Lipitor caused muscle weakness because there was no pain". "Wouldn't consider Lipitor the cause of body aches". "Doctor didn't think cramps were caused by statins". "Doctor felt that there was no connection between pain and the statin drugs".
(vi) Dismissed relation to statins, cognition-specific: "Statins do not cause memory loss and may, in fact, help it". "No research linking statins to memory problems". "Doctor said statins would improve (not worsen) memory". "Memory and peripheral neuropathy are not acknowledged side effects of statins". "I was the first to tell hom (doctor) about this significant side effect (memory problems, coordinating thoughts/complex tasks) and since then he has had other patients with similar problems".
(vii) Disbelief that statins cause adverse drug reactions in general: "Doctor said there were no side effects". "Doctor had heard of no difficulties". "Said Lipitor has mimimum to no adverse drug reactions". "Can't be the statins, thinks it is a miracle drug". "Said that only 1% of patients have side effects".

The data shows that doctors may fail to even contemplate a possible statin adverse reaction which contributes towards low reporting rates of statin adverse reactions. Since low reporting rates are considered to contribute to delays in identification of adverse drug reactions, findings from the study suggest that additional adverse statin reaction cases may be identified by targeting patients as reporters, potentially speeding the recognition of statin adverse drug reactions.

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