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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