PHA-Exchange> Safeguard Interests of Clinical Trial Subjects

[kireenmm]

 Dear Friends,
CAP (Consumers Association of Penang) believes that tighter measures are needed to protect those who participate in clinical trials. Below we share some of the points that we have used in a letter to the press. We would welcome feedback on the situation in your country and/or the action that is being taken.

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SAFEGUARD INTERESTS OF CLINICAL TRIAL SUBJECTS
It was recently reported in the local press that a world premier pharmaceutical company specializing in diabetic healthcare is collaborating with a university here for a long-term clinical trial center. In this report, the medical director of the company was quoted as saying that they were expanding at a tremendous speed and it was rather difficult to get good people and good levels of collaboration with institutions involved in clinical trials.

While on one hand it can be noted that there are increased efforts by international pharmaceutical companies to gain access to clinical trial centers in the Asian region, CAP is extremely concerned that not enough is being done to serve the interests of those taking part in clinical trials. 

International events have highlighted the need to take precautions. The John Hopkins Bayview Medical Center in the US is world-renowned and regularly solicits volunteers for its numerous research studies. In one of its recent studies, a 24 year old volunteer lapsed into a coma and subsequently died after taking just one dose of an asthma drug. The researchers had failed to warn her that the drug carried serious medical risks.

Investigators thereafter found numerous safety problems and authorities have suspended almost all of the university's studies involving human subjects. Specifically, it was found that the John Hopkin's institutional review boards had failed to adequately inform patients of dangers. 

Participants in cancer clinical trials at John Hopkins were also found to have signed consent forms that lacked information on the toxicity of the drug and the treatment itself. An internal investigation later determined that several risk statements had been omitted.  

At the University of Pennsylvania two years ago, an 18 year old man died while taking part in a gene therapy study at the University of Pennsylvania, causing a temporary halt to some trials there. 

Last year, federal regulators in the US had to shut down all government-funded human medical experiments at the University of Oklahoma Health Sciences Center in Tulsa following evidence that researchers went against rules established to protect patients. They then tried to cover up their lapses by withholding information from university overseers and patients.

Earlier this year, the Nigerian government withdrew the trading licence of a well-known multinational drug company after the Washington Post reported that the company had used Nigerians as guinea pigs to test a new drug.  There is currently a lawsuit filed in the US against this company. In a Washington Post report, it was stated that the experiment appeared to have been carried out in a hurried fashion and without following procedures that would have been compulsory under US law. 

These overseas experiences have raised queries on how multinational drug companies test drugs without following safety rules. There have been calls on the international community to ensure that participants in clinical trials receive protection. 

Presently, there is a clinical trial code that serves as a guideline for conducting trials. However, it has been noted that there are no concrete laws to back up these guidelines. In the wake of all the untoward international incidents, it would be more appropriate for laws to be established to protect clinical trial subjects. Among other things, these laws could ensure that:

  a.. trial subjects are fully aware of the objectives, expected outcomes and implications before they give consent to take part in any trial
  b.. trials do not proceed without prior review and approval by relevant authorities
  c.. adverse events and adverse drug reactions are appropriately handled and documented
  d.. in the event of any research related injuries, there will be avenues to claim for compensation  
Even with the best institutions equipped with the latest technology and facilities, the factors of human weakness and human error still exist. It is hoped that necessary action will be taken to institute safeguards.  



Kireen

on behalf of:

S.M. MOHAMED IDRIS

President,

Consumers Association of Penang,

228, Jalan Macalister,

10400 Penang,

Malaysia 

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