When is a drug deemed so 'successful' that it deserves to be pulled off a trial?
There doesn't seem to be a standard rule on this, although apparently independent monitoring boards can make the decision if they see fit. A drug could take up to 10, 15 years or more to complete all 3 phases of its clinical trial, but this time varies depending on factors such as the type of treatment and problems with the new drug. [1]
Is this the best way to ensure the safety and efficacy of patients, the two most important duties of the MHRA's expert advisory body, the Commission on Human Medicine? A member of the British Pharmacopoeia Commission, who prefers to remain anonymous,had this to say about the recent controversy surrounding Vioxx:
- 'The adverse reaction with Vioxx only became effective after 18 months and the risk was an increased cardiovascular event. Slightly. A slight but real risk, but this wasn’t showing up if a patient was taking it for 18 months. Ie. If a patient was only taking it for 12 months, it only became apparent after 18 months. There's a very fine balance, you have the experts, the scientific experts as employees of the MHRA and those employed on commissions to advise of the work of the MHRA – they only take decisions based on information they receive.'
So why not gather as much information as possible before making a decision that could harm patients? This may have made a difference during the clinical trials for the anti-cholesterol drug Crestor (Rosuvastatin). There have been calls to have it removed from the market due to safety concerns as it carries a higher risk of side effects compared to other statins. http://news.bbc.co.uk/1/hi/health/3838915.stm
But these negative reports have been buried under a barrage of good news. It has now emerged the statin drug trial was halted six months early after being hailed a success.
von Radovitz, J.Statin Drug Trial Halted Six Months Early After Success The Independent Accessed on December,1,2008
'The study was funded by the drug company Astra-Zeneca, the maker of the statin used in the trial, rosuvastatin, marketed under the name Crestor. Astra-Zeneca had no access to unblinded trial data and played no role in the study’s analysis or interpretation, according to Brigham and Women’s Hospital.' http://www.physorg.com/news145450584.html
