I attended a hearing on Pharmocovigilance in January, where experts from Europe presented worrying trends on ADRs (Adverse Drug Reactions).
Licenses awarded are increasing yet many drugs may not even be as good as existing products on the market (perhaps cheaper). The death rate from ADRs is also increasing and is the 5th leading cause of death in Europe at the moment. Examples given were HRT and breast cancer (55,000 cases just in the UK.) And VIOXX, an anti-inflammatory which caused 100,000 + deaths world wide due to stroke. It was later found that Merck with-held information from the original trials.
New legislation hopefully will be approved which will promote patient reporting throughout Europe. It is only when a drug is used by patients on other medications and over time that full ADRs can be monitored, yet many counties in Europe do not even allow patients to report side effects without it being approved by their GP…
I traveled with Helen Kimball-Brooke of the EFVV (European Forum Vaccine Vigilance) and our question was
“(We) represent a group called the European Forum for Vaccine Vigilance which over a six-year period, conducted a survey, mainly through direct patient reporting, of the adverse effects of vaccination in six European countries. The sample numbered approximately 1000. Very few of these events had been officially reported to the health authorities. In fact, the concerns of these patients, many of them with very serious conditions, were dismissed as unrelated to vaccination, the link even ridiculed. Vaccines are not subjected to safety trials such as the gold standard randomised double-blind placebo procedure where the placebo is benign. Furthermore, the reporting of side effects by the medical profession is restricted by the acceptance of vaccines as “established medicines” which are assumed to be safe; as such, a medical professional is only required to report SERIOUS side effects which occur within a maximum of a few weeks, despite the fact that vaccines may present long-term biological and genetic risk. We therefore feel that vaccines must be treated differently and that a separate, independent body must be set up to deal solely with vaccination. We would like to know your thoughts on this European study and this proposal.”