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Thursday, September 21, 2023
PENANG, Malaysia, Feb 1 2007 (IPS) - Eyeing the expanding market for clinical research in the region, Malaysia is trying to position itself as an ideal place for pharmaceutical majors to conduct clinical trials. But critics worry about weak safeguards and poor enforceability of existing regulations.
Indeed, the local population’s lack of sophistication about clinical trials appears to be one of the selling points.
In a brochure that encourages foreign biotechnology players to conduct clinical trials here, ‘investPenang’, the Penang state government’s marketing arm, not only touts Malaysia’s ‘‘ethnically heterogeneous” population, but actually brags that ‘’Malaysians are still drug naïve”.
Since 2000, the number of Phase III clinical trials in Malaysia has more than doubled to reach around 50 in 2005. This is based on the number of applications received by the National Pharmaceutical Control Bureau for clinical trial import licences of unregistered products and excludes bio-equivalence studies.
This number could soar further if Malaysia signs a Free Trade Agreement with the United States for which negotiations are ongoing. A senior official from the U.S. Patent and Trademark Office reportedly pointed out last month that Jordan has conducted or is in the process of carrying out 35 clinical trials after it signed an FTA with the U.S.in 2000, compared to only one before that year.
Contract research organisations (CROs)in Singapore, Malaysia and Thailand are already eyeing market opportunities estimated to be worth 140 million US dollars in 2007.
Info Kinetics bills itself as a one-stop CRO that handles clinical trials and bio-availability and bio-equivalence studies. Through a strategic alliance with Gleneagles Clinical Research Centre, which belongs to the largest network of private hospitals in the region, it has access to 100 hospital sites for conducting clinical trials in South-east Asia and beyond.
Info Kinetics carries out a range of clinical trials, including providing Viagra to children aged 1 – 16 suffering from pulmonary arterial hypertension (high pressure in the blood vessels to the lungs), a life-threatening condition. Viagra is said to lower blood pressure throughout the body including that in the lungs.
About a dozen children are believed to be involved in the ongoing trials, which are randomised and double-blind placebo controlled, according to the firm’s website. A source familiar with the trials revealed that the side effects of Viagra on the subjects include bluish vision similar ‘‘to the effect of (seeing through) a blue filter”, depending on the dosage given.
When IPS contacted Gleneagles paediatrician Dr Sim Joo Seng, who is involved in the clinical trials, he declined to comment, saying he needed written authorisation from the ‘‘ethics committee” and permission from the sponsor before he could speak to the media about the trials.
The ethics committee he was referring to is probably the ‘‘Joint Penang Independent Ethics Committee”, a 14-member committee under the joint authority of the Penang Medical College and Gleneagles. This committee carries out ethical reviews of clinical trials conducted at the privately owned Gleneagles Medical Centre, Penang and the Penang Medical College, which is partly owned by the state-run Penang Development Corporation.
Whether it is really independent is debatable. Among the sponsors listed on the Info Kinetics website are big pharmaceutical firms such as Pfizer, Bristol-Myers Squibb, GlaxoSmithKline and Malaysia’s Pharmaniaga.
When contacted, Associate Corporate Affairs Manager for Pfizer Malaysia Chin Yoon Ann was unable to confirm if such clinical trials on children were being carried out, saying that she had to ‘‘check first”. Another Pfizer spokeswoman, when contacted over the telephone, wanted e-mailed verification of identity before she would respond to questions about the firm’s involvement in clinical trials.
It is not just the private sector that is involved in clinical trials. The Clinical Research Centre of the health ministry, based in Kuala Lumpur, serves ‘‘clients from pharmaceutical, biotechnology and medical device industries, both public and private health care providers and medical research organisations”. The Centre makes use of the health ministry’s network of hospitals (‘‘those with experienced and GCP certified investigators”) as investigative sites for clinical trials.
The Centre’s head, in a presentation at the BioMalaysia 2006 conference in Kuala Lumpur in December, noted that in Malaysia there are ‘‘no specific legal provisions addressing the conduct of Clinical Trial(s); only administrative provisions through Malaysia GCP (Good Clinical Practice) Guidelines”.
These guidelines, among other things, state that in obtaining informed consent from subjects, investigators ‘‘should adhere to the GCP and in the ethical principles that have their origin in the Declaration of Helsinki”. All serious adverse events should be reported within two working days to the sponsor.
The guidelines add that those conducting the trials must also comply with the applicable regulatory requirements on the reporting of such reactions to the authorities and to the independent review board/independent ethics committee.
On the other hand, the National Pharmaceutical Control Bureau’s website, provides the regulatory guidelines for the reporting of adverse drug reactions during clinical trials. All fatal and life-threatening, unexpected adverse drug reactions should be reported within seven days while other serious, unexpected reactions that are not fatal or life-threatening must be reported within 15 days.
The problem is that all these official guidelines are not binding and enforcement is lax, observed Dr T. Jayabalan, an advisor on health care issues for the Consumers Association of Penang, who has written on the ethics of large pharmaceutical firms conducting clinical trials in developing countries. ‘‘They are merely good practices to follow,” he told IPS. ‘‘There is tremendous under-reporting of adverse drug reactions in the private sector. That is well known.”
He said the procedures are cumbersome and bureaucratic, and ‘‘very few would want to go through the hassle of reporting”. In an article for Resurgence, a magazine published by the Penang-based Third World Network, Jayabalan noted that pharmaceutical firms can save 30 percent on the cost of conducting clinical trials in Asia compared to in the West. ”Relaxed or non-existent regulatory mechanisms also play a significant part in the choice of drug trial destinations.”
Jayabalan added that the trend of outsourcing clinical trials to developing countries has raised concerns about large biotechnology and drug companies ‘‘exploiting the healthy who are strapped for cash and the sick who seek cheap or free remedies.”
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