The development of new drugs, and especially new vaccines, is very much in the public eye at the moment. This development is hugely costly not least because most potential products have to be rejected during development as not sufficiently safe and/or effective – this means the successful products have to carry the costs of all the failures as well as their own. It also means that once a product has made it through to official approval and general use there is inevitably huge reluctance to find fault with it as long-term problems emerge – very few drugs and vaccines are withdrawn at this stage. This makes it particularly important that any one of us who experiences a problem with a drug or vaccine reports it so the side-effect/bad reaction/failure can become part of official statistics about the product.
The phases of drug development are…
- Discovery and development when bio-scientists look for likely candidates based on knowledge of human biology
- Preclinical (lab-based) research
- Clinical research (what we think of as ‘drug trials’ where efficacy, dosage, safety etc are assessed)
- Official review and approval for specific uses by the relevant national authority (e.g. FDA in the US; MHRA in the UK; HPRA in Ireland)
- Post-marketing surveillance and monitoring (‘pharmacovigilance’)
Those of us outside the industry can contribute to drug and vaccine safety and efficacy by taking part in clinical trials, if the opportunity arises, if we have a particular health problem or are prepared to act as healthy ‘control’ patients. However, ALL of us who receive any medication or vaccination can contribute to ongoing monitoring by reporting any negative effect. In the UK this is done via the Yellow Card system (there is a great article about the Yellow Card system on the website of Independent Living here). In the US, the FDA monitors adverse events that may occur related to receiving a vaccine through its Vaccine Adverse Event Reporting System.
How many times have you, or someone you know, grumbled that a flu jab has given you a fever and a day or more off work? Or an asthma attack? Or that an antibiotic has had strange side effects, such as loss of hearing? Or that a statin has left you constantly weak and exhausted? But have you recorded the problem so that anybody who could take this into account knows? Just as we should exercise our right to vote, we need to exercise our right to speak out about the ill effects of health products – and the Yellow Card system applies not just to drugs and vaccines but medical devices (e.g. implants) and equipment (e.g. hearing aids which are often overly complicated for those to whom they are sold) too. With the roll-out of a number of brand new vaccines developed at unprecedented speed we must not be complacent or keep problems to ourselves – it is time to exercise our pharmaco-vigilance!