Patients who volunteer for studies that help drug companies to develop new products are often misled into taking part, say research ethicists in the latest edition of the British Medical Journal.
The ethicists have called on drug companies to immediately end what they say is a "cynical use of these studies for marketing purposes".
When developing new drugs, most pharmaceutical companies carry out open label extension studies (OLES) which enable them to collect data after clinical trials have been carried out but before the drug receives final approval.
Many of the patients who volunteer to take part in these studies have previously been involved in clinical trials of the product and are often recruited on the basis that they are helping scientific research.
But researchers investigating OLES estimate that less than four per cent of these studies were published in scientific journals and found that many of the trials they looked at were of dubious scientific integrity.
One of the problems cited by Dr Gordon Taylor from the University of Bath and co-author Professor Paul Wainwright from Kingston University was that patients volunteering for the trials tend to be a self-selecting group with those unlikely to benefit from the new group dropping out following clinical trials.
This means that the sample of people on the study is not fully representative and provides biased estimates of safety and tolerability which drug companies can sometimes use in their marketing promotions.
The researchers say that the cynical use of these studies for marketing purposes only should cease immediately.
They also question the ethics of recruiting patients who were involved in 'blind' trials of a new drug - where they don't know if they are receiving the drug or a placebo - as they may decide to take part in the study because the new drug, or placebo, made them feel better without ever really knowing which they received.
As many of these studies are carried out whilst clinical trials are still ongoing, it is not always clear that the new drug is actually an improvement on existing treatments that are available. Some patients may be involved in OLES for as much as two years - or even longer in some cases - having only been involved in clinical trials for a few weeks.
"Dressing up marketing exercises in the regalia of research lends them a spurious authority, allowing participants and clinicians to believe they are contributing something worthwhile to science, rather than simply boosting the market share for the relevant pharmaceutical company," said Dr Taylor who is a Council Member of the Association of Research Ethics Committees.
"Open label extension studies are used to gather information about the safety and tolerability of the new drug in the long term and through day to day use, but less than four per cent of these trials are ever published.
"We are not suggesting that all studies are necessarily unscientific or unethical, but it is our experience that a considerable number of studies raise significant concerns.
"These studies appear to be particularly prone to the pressures of marketing of good research methodology and research ethics.
"Although these studies provide the drug company with valuable marketing information, such as increasing the number of people taking the drug before general release and creating a market for it, the value of these studies to science is highly questionable."
Where OLES can be useful, they argue, is in giving patients access to beneficial drugs when no suitable alternative is available. However, they say that this 'compassionate prescribing' of new drugs should not be facilitated through research studies.
The researchers are now calling for sweeping changes to the ethical review of OLES.
"Some of the problems with these studies could be resolved by letting patients know whether they have been receiving the new drug or a placebo in phase three of the clinical trial," said Dr Taylor who works in the University's Research and Development Support Unit in the School for Health.
"This will make sure that they can make a decision on whether to continue in the open label extension study based on their experiences from the trial.
"If these studies are to go ahead under the name of research, then there should be a much more rigorous application of scientific principles in their design and implementation that will allow for variations in samples and other areas.
"Compassionate use of new drugs should not be undertaken through research studies and another licensing method should be sought instead. The cynical use of these studies for marketing purposes only should cease immediately."
The researchers were given exclusive access to the confidential records of the Multi-centre Research Ethics Committee for Wales and discussed their conclusions with members of the Committee, on which they have both sat.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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