ACCORDING to a research conducted on 90 drugs approved by US regulators between 1998 and 2000, the results of more than half of all clinical trials which demonstrate the safety and effectiveness of new drugs are not published within five years of the drugs in the market.
The researchers, who traced the publication or otherwise of 909 separate clinical trials in scientific literature, wrote that the failure of drug companies to publish evidences relating to new medicines amounted to "scientific misconduct," harming public good and preventing informed decisions by doctors and patients on the safe use of new medicines.
However, to most people in many lands, the United States is a nation that stands at the apex of consumer safety and effective drug market regulation in comparison with other nations throughout the world. But the contrary reality by these research findings may hold critical lessons for Nigeria and other countries with strong dependence and increased public confidence in foreign medical supplies for the day to day management of domestic healthcare problems.
For instance, when a call was made in April 2012 by NAFDAC that a 200 billion naira Pharmaceutical Intervention Fund be established in Nigeria, the idea was viewed by many people as financially expensive. According to official statements, the proposed Fund would be used in
financing loans to local pharmaceutical firms in order to enhance their capacity for more production or possible expansion. Yet, the idea received some resentment from a section of the Nigerian masses.
But this critical report by American researchers may become a strong reason for most of them to now reconsider their respective positions on the matter, particularly as the nations on which Nigeria depends for health safety are being linked with consumer risks and other regulatory challenges.
On July 26, 2000, the Journal of the American Medical Association (Vol. 284, No. 4) reported that, every day, 290 people are killed by prescription drugs approved by the United States Food and Drug Administration, FDA. The report was authored by Dr. Barbara Starfield (MD, MPH) of the Johns Hopkins School of Hygiene and Public Health, who also placed the annual figure for deaths from the adverse effects of FDA-approved prescription medications at 106, 000 people.
With this manner of scary statistics from reputable medical sources, the regulation of consumer imports in Nigeria deserves to be treated as an urgent matter of national security. In order to achieve this, there must be a clearly laid_out plan to increase local production of pharmaceutical goods and enhance proportional reduction in the amount of imported medical supplies.
Already, there are favourable conditions for achieving this, but the Nigerian government seems to be going slow in this direction. Recently, the World Health Organization, WHO, certified Pan African Foundation, PAF, as a potential beneficiary of the NAFDAC-proposed Fund. PAF is a Nigerian disposable syringe manufacturing company based in Port Harcourt, and was one among 11 other companies selected by NAFDAC for the WHO prequalification exercise. The company won a place alongside more others in South Africa, Uganda and Morocco, thus completing a list of seven companies endorsed by experts from US and the European Union.
In technical terms, a pre_qualification by WHO gives pharmaceutical companies the franchise of marketing their products worldwide. If PAF succeeds to function this way, it will not only strengthen the nation's arm of consumer safety but also boost its revenue base.
However, without a swift reaction to the NAFDAC-proposed Fund, Nigeria may only be sitting on her prospects in the sustainable management of its healthcare sector.
Mr. Ikyaa, a commentator on national issues, wrote from Abuja.