An antidepressant drug that has been prescribed for 13 years in the UK has been castigated as "useless and potentially harmful" in a recent study published in the British Medical Journal. This has shaken confidence in the reporting of drug trials and the licensing of drugs that are used by the NHS and private doctors alike.
The BMJ is calling for changes to the European laws that govern clinical trials in order to restore confidence in the drug industry.
German Study finds Reboxetine "Useless and Potentially Harmful"
The German Institute for Quality and Efficiency in Health have revealed the results of their study of a drug known as reboxetine and sold under the names of Edronax, Norebox, Prolift, Solvex, Davedax or Vestra for the last 13 years to the National Health Service. Their results have may have shaken the confidence of consumers on the veracity of clinical trials.
An independent body of scientists, they decided to scrutinize the manufacturer's research data on reboxetine because of doubts that were raised about its effectiveness coupled with the fact that the US Food and Drug Administration (a body charged with safeguarding the American public from harmful drugs) refused to grant the drug a licence in 2001.
Was there Bias in the Reboxetine Data Published by Pfizer?
The German Institute for Quality and Efficiency in Health have accused Pfizer of "only publishing positive results for the drug." Eight of 13 significant trials had never been made available, which represents 74 per cent of the studied population.
Should European Law be Changed to Ensure Better Reporting of Drug Trails?
Beate Wieseler, Deputy Head of the institute's drug assessment department and his colleagues are calling for changes to be made to European law to prevent future data bias in drug licensing. He feels that it should be mandatory for all of the results of a trial to be published, even when the results have been poor.
British Medical Journal Backs Reform in the Drug Licensing Laws
Dr. Fiona Godlee, editor of the British Medical Journal, is quoted by The Guardian newspaper as saying that the medical evidence for the safety and effectiveness of Edronax was distorted by missing clinical trial data. She and her colleague Dr. Elizabeth Loder call for urgent action to restore trust in existing evidence.
"Full information about previously conducted clinical trials involving drugs, devices and other treatments is vital to clinical decision making," they urge. "It is time to demonstrate a shared commitment to set the record straight."
References:
The Therapist (Journal of the BACP) November, 2010
The Guardian, Wednesday 13th October 2010
