Adverse drug reactions

France is the number one European consumer of phytosanitary (3rd worldwide) and the largest European consumer of medicine (the average consumption of a French citizen is 50 packets of prescription drugs per year).

A worrying logic
The FDA, which regulates medicines in the US, says that an undesirable side-effect is rare if it affects 1 in 20 000 people. This risk percentage is sufficient for a drug to be removed from the market.
A surprising fact is that the majority of medicines authorised by the FDA have only been tested on 1 500 volunteers when it should  be at least 100 000! It is only after a products launch that side effects are discovered.

The French have a reputation of being hypochondriacs and many don’t trust doctors that only prescribe a single drug at a time. They are reassured by multiple prescriptions as they are unaware that the likelihood of side effects increases with the quantity of drugs taken simultaneously.

A recent study of Americans aged 57 to 85 years old found that 30% of this age group take at least 5 types of medication at any one time. This increases to 37% when focused on the 75 to 85 age bracket.1 This doesn’t even take into account non-prescription drugs and dietary supplements.

Self-medication

According to the AFIPA, 7/10 French people self-medicate. The main reasons are aches and pains, fevers, headaches, colds, coughs and sore throats.

This number increases with digestive problems, skin disorders, and oral hygiene issues. Food supplements are active substances which interact with drugs. A good portion of these ‘comfort problems’ could be avoided by natural means (i.e rehydrating during or after consumption of alcohol and diarrhoea and constipation by changing diet).

The First Guinea Pigs: Human Beings

All medicines have been developed then tested on animals. As no species can serve as a biological model for another (see: Scientific Reasons) it is self-evident that a substance declared safe and effective in animals can have a completely random effect on man.
The first human trials are carried out on volunteers in clinical trials (CTs) which aim to roughly find the side-effects and set the recommended dose for the drug.

Some undesirable side-effects come to light in the long term due to a combination of medicines or an error in the dosage.

Half of the medicines that get to the market are definitely removed or called back to change the labelling.2

Adverse Drug Reactions (ADRs)

It is impossible to know the true number of deaths due to side effects as they aren’t always diagnosed (i.e myocardial infarction (heart attack), cerebro-vascular adverse events (strokes), suicides, etc.).
The World Health Organisation has set up a pharmacovigilance system (around 130 countries strong) but doesn’t publish statistics in the public domain. We have to extrapolate from available studies to gain an insight.
According to an American meta-analysis of 39 studies, in 1994, 2 216 000 ADR victims were hospitalised and 106 000 died.3
The researchers determined that in 1994 ADR deaths were the 4th largest cause of death in the US after heart disease, cancer and stroke. An unofficial figure for 2010, based on 0.04% of the US population, gave an estimated figure of 123 500 deaths per year. This figure only takes into account hospital admissions and not all the undiagnosed deaths, administrative errors, overdoses or failed treatments.

Pharmaceutical Disasters

Numerous pharmaceutical disasters demonstrate the inability to correctly predict ADRs using animal models.
Here are a few of the many examples:

Thalidomide is a drug that was prescribed to pregnant women at the end of the 1950s and the early 1960s. Thousands of children were born with sever deformities, such as stunted limbs, due to this drug.

Vioxx is a non-steroid anti-inflammatory, primarily used as a painkiller for arthritis sufferers. Tests on animals, especially dogs, showed it would be very good for the heart. In reality it was the complete opposite in humans. Thousands of people died due to cardiovascular problems.

Toxidermias are skin and mucosa problems due to the ingestion or injection of a medicine. They represent between 10% and 25% of ADR-related hospitalisations. They range from skin irritations to emergency hospitalisations for the worst cases. Lyell syndrome & Stevens-Johnson syndrome are among the most deadly forms as dermatological lesions can be accompanied by internal lesions leaving serious physical and psychological repercussions.

Bromfenac (Duract ©) is a non-steroid anti-inflammatory which was banned after it’s launch. It is part of the rare side-effect medications as it was discovered to be toxic in 1/20 000 people. The number of victim organisations are a testament to pharmaceutical accidents.
Unfortunately these organisations haven’t all linked animal testing to side-effects in humans. However, a large number of organisations, with members from medical and scientific professions, have understood this and are fight against animal testing. (Nurses Movement for Responsible Medicine, Safer Medicines, Doctors and Lawyers for Responsible Medicine, Association for the Abolition of Animal Experiments, etc.).

 

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This Work, Adverse drug reactions [translated by Juan Dates], by Coalition Anti Vivisection France is licensed under a Creative Commons Attribution-ShareAlike license.