Too much informationBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5153 (Published 13 August 2014) Cite this as: BMJ 2014;349:g5153
All rapid responses
The editorial has nicely brought out the issue of information overload and its implications on the patients. Several patient’s characteristics play a role in their behaviour towards intake of medications. The behaviour may vary from lack of patient enthusiasm in taking medicine to that of extreme interest in taking medicines. Literacy, awareness about the medicines, previous experience, perceptions, myths, misconceptions, opinion from fellow patients, besides economic status (affordability), accessibility to health services etc. have a role in shaping the behaviour. Generally, the acceptability of medication is related to the information or awareness about the medicine. Doctors play a major role in the decision about a particular medicine. For newer medicines on the other hand, the patients do have certain anxiety about effect and adverse reactions, if any. Awareness about the adverse effects might bring about a negative attitude on the part of the patient which might lead to stoppage of the medication. As has been pointed out in the present article, information overload might have a contrarian role in the intake of medicines by the patients. However, it is also necessary that appropriate information should be provided to the patients so that they can decide about the medicines.
Many side effects of medicines are generally overlapping. The serious side effects, if any, are few and these may warrant stoppage of the medication. Knowledge about these serious side effects should be given to the patients so that they can report of any such effects immediately to the physician. In a situation where ignorant, illiterate patients are there, it may not be acceptable to them if they are given the information about serious side effects. They generally leave it to the attending physicians to decide about the medicines. In such circumstances, physicians need to have adequate, evidence based information about the medicines before taking decisions. Only one or two small trial reports should not be the basis for prescribing the medicines. Information, as required adequate, should be at the discretion of the physician, who can, in turn educate the patients considering the socio-economic, educational level of the patients.
Competing interests: No competing interests
I agree with Editor in Chief Fiona Godlee that information about drug side effects should not be hiddem.1
It is ridiculous that Tan et el want common (warning) symptoms removed from data sheets for common drugs including oral contraceptives (OCs).2 As far as I know there have been no randomised double blind control trials of OCs for obvious reasons and HRT trials have been terminated prematurely because of increases in cancers and vascular diseases.
Recording full patient histories before, during and after drug use, along with relevant biochemical and pathological investigations, reveals many preventable or treatable reasons for symptoms and increases in serious illnesses. The commonest reasons for common symptoms are common social poisons especially taking hormones, smoking or drinking alcohol and using drugs.
Progestogen dominant oral contraceptives, including 6 different norgestrel dose combinations, increased the incidence of headaches and migraines from 17% (including 7% with migraine) among 500 women before OC use to up to 60% in the first year of use. The first year discontinuation rate matched the headache incidence and the number of endometrial biopsies with over-developed arterioles.3 Headaches also related to low zinc and magnesium levels.4 Depression, tiredness and loss of libido match low oestrogen levels and raised monoamine oxidase activity.5 Tiredness also related to distended venous sinusoids and weight gain increased with progestogenic potency.
In 1978 the number of migraines reduced 10 fold when progestogens and/or oestrogens, ergot mediations and smoking were discontinued by migraine clinic patients.6 An exclusion and reintroduction diet, with avoidance of diagnosed masked food allergens, resulted in 85% of 60 patients having no more headaches or hypertension. Medications were reduced from 115 tablets per month to an average of 0.5 tablet.7
In the decades since then this method has been effective for numerous patients. In fact, avoiding drug medications and excluding food and chemical precipitants is a corner stone of Ecological Medicine and was first described by Hippocrates.
1 Godlee F. Too much information. BMJ 2014;349:g5153.
2 Tan K, Petrie KJ, Faasse K, Bolland MJ, Grey A. Unhelpful information about adverse drug reactions. BMJ 2014;349:g5019.
3 Grant ECG. Relation between headaches from oral contraceptives and development of endometrial arterioles. BMJ 1968;3:402-5.
4 Grant ECG, Pryce Davies J. Effect of oral contraceptives on depressive mood changes and on endometrial monoamine oxidase and phosphatases. BMJ 1968;3:777-80.
5 Grant ECG. The pill, hormone replacement therapy, vascular and mood over-reactivity, and mineral imbalance. J Nutr Environ Med 1998;8:105-116.
6 Grant ECG. Food allergies and migraine. Lancet 1979;1:966-69.
7 Grant ECG. Oral contraceptives, smoking, migraine and food allergies. Lancet 1978;2:581-2
Competing interests: No competing interests
Having worked in drug safety from 1986 until 2003 in various capacities in several pharmaceutical companies I am familiar with the problems which this piece discusses. It is, apart from one egregious error, a good exposition of the problem. The egregious error referred to is the definition given of 'Adverse Effect.' The definition given is that of 'Adverse Event,' an easy mistake which I and no doubt countless others have made. The term 'Adverse Effect' is a synonym for 'Side Effect' and 'Adverse Drug Reaction.' The key distinction between these and an Adverse Event is that an Adverse Event is some occurrence which is reported in a patient exposed to a drug, but for which no causal relationship to the drug is proposed. I shrink from pedantry, but I fear this is more than a pedantic point.
I would also like to draw attention to the reasons, as I have observed them, for the confusing state of affairs in which drug safety data find themselves. The problem seems to me to be a fundamental lack of trust, no doubt well founded in many cases, between pharmaceutical companies, drug regulatory agencies, the medical profession, and the drug consuming public at large. For simple commercial reason it is in the short term interest of the drug manufacturers and sellers to minimise and obscure the harmful effects of their products and to exaggerate their benefits. For the regulators the motives are reversed, while for the rest of us, medical and lay users, we would like to have a precise and accurate statement of both efficacy and safety. This latter state of affairs does not obtain,
Following various disasters, the Sulfanilimide affair in the USA, (http://www.fda.gov/aboutfda/whatwedo/history/productregulation/sulfanila...) and the thalidomide business in Europe (http://pediatrics.aappublications.org/content/30/4/654.abstract) governments were obliged to respond by the establishment of regulatory bodies to supervise and control the actions of pharmaceutical manufacturers and marketers. A statutory obligation to declare or 'label' known side effects of marketed drugs is now in force in all significant world markets.
Once an effect is 'labelled' i.e. printed in the information which accompanies the product, then the duties on the market authorisation holder to notify reported suspected reactions become much less onerous. No doubt the industry resisted this requirement initially, but has come to accept and comply with it. To begin with, drug safety labelling was brief and largely germane, but latterly we have come to the state of affairs described in this article. It might seem disingenuous to suggest that this acceptance is related to the fact that the labelling serves to obscure rather than elucidate drug perils, but this is at least a possibility.
I well remember when I first went in to General Practice in 1976 that I often responded to enquiries from patients about side effects by refusing to tell them of any, while urging them to tell me of anything which they thought might be drug related. I was aware of the nocebo effect then, although I don't think the term had been coined. Nowadays it is difficult for doctors, let alone non-medical patients, to discern any signal of truth among the noise of spurious reports on drug labels. Working in malign concert with the unintentional effects of regulation is the duel between the lawyers employed by drug companies and those of aggrieved consumers of their products. In this arena it serves the interests of companies to declare effects labelled at an early point as this blunts the case against them where patients seek redress.
Sadly I have no solution to this problem, save for truthful and honest dealing on all sides. A solution to many of the world's problems, but regrettably only evident in Swift's fantasy of the Houyhnhnms (http://en.wikipedia.org/wiki/Houyhnhnm). We are still living in the land of the Yahoos.
Competing interests: A very small holding of shares in Glaxo SmithKline.