Goals and achievements
Cancer survivor and six-time Tour de France champion Lance Armstrong will be part of a 20-strong team riding across America this autumn as part of a commitment to support clinical trials and cancer research - the Tour of Hope*.
Various reports have shown that the search for a cancer cure is being held up because less than 5% of eligible adults participate in research studies. The goal of the Tour of Hope is to dispel the myths about clinical trials, and urge people to become more educated about their vital importance.
But, even with full participation in clinical trials, the results can still cause companies headaches. Following the withdrawal of Baycol three years ago and the completion of a comprehensive three-year group restructuring, it was good to see Werner Wenning, board chairman of Bayer, expressing optimism for his company in the drug field.
However, in recent weeks other companies have not been so fortunate. Shire Pharmaceuticals' ADHD drug, Adderall XR, was taken off the Canadian market, by Health Canada, and AstraZeneca has been faced with a petition to remove Crestor (rosuvastatin calcium) from the market.
Admittedly, the FDA rejected the petition, saying the product's use is based on a thorough analysis of clinical trial safety data and post-marketing data, but it must be of concern to the drug industry that a product that has been studied in 50,000 patients - more than any other marketed statin - and has treated more than 1,500 patients for at least two years, can so easily be called into question.
While the effectiveness of clinical trials is apparent - as evidenced recently by AZ and GSK, both of whom saw negative results from a trial: the former with its last-hope cancer drug Iressa, and GSK, which recently halted clinical trials on multiple sclerosis drugs after a patient died from a rare infection of the central nervous system - is there another way of developing drugs?
Given that individuals react differently to the active ingredients, it is timely to consider the FDA's new guidelines that will, hopefully, speed up the development of personalised medicines, and individual therapies: 'The FDA's efforts will bring us one step closer to "personalising" medical treatment,' explained Janet Woodcock, acting deputy commissioner for operations, FDA.
The new technology should allow medicines to be uniquely crafted to maximise their therapeutic benefits and, hence, minimise their potential risks for each patient. Could this initiative be the clinical trials panacea our industry needs?
*The Tour of Hope Cycle starts in San Diego on 29 September and concludes in Washington, DC on 8 October.