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Hundreds of thousands of people dying each year due to unsuitable medical products, says WHO

Olivier Rey / Red Dirt Report
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NORMAN, Okla. –The World Health Organization (WHO) recently published two reports highlighting the worldwide expansion of falsified medical products.

An estimated 10 percent of medical products in developing countries is substandard or falsified.

“Substandard and falsified medicines particularly affect the most vulnerable communities,” says Dr. Tedros Adhanom Ghebreyesus, the WHO Director-General. “Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die.  This is unacceptable.  Countries have agreed on measures at the global level – it is time to translate them into tangible action.”

From July 2013 to June 2017, WHO Global Surveillance and Monitoring System has received over 1,500 reported cases of substandard or falsified products. The reports came mainly from sub-Saharan Africa (42 percent), the American continent (21 percent) and Europe (21 percent).

But the reports pointed out that due to the lack of collected data, some regions such as South-East Asia, are underrepresented in the statistics. To help countries detect and respond to this issue, WHO has trained 550 regulators from around the world.

“As more people are trained, more cases are reported to WHO,” said Dr. Suzanne Hill, the director of Department of Essential Medicines and Health Products at WHO during a phone conference.

WHO’s reports show that cases of substandard or falsified products affect every type of medical products including vaccines, common antibiotics, antimalarials, cancer medicines and other lifesaving medical products. Falsified medical products affect also both generic and innovator products.

Although the causes are numerous, WHO identified three main factors to the emergence of falsified medical products; constrained access, poor government and weak technical capacity.

 “When these three issues conspire together, substandard and falsified medical products reach the market,” said Dr. Michael Deats, an expert on medicine safety and vigilance at WHO. 

Internet and globalization, a dangerous cocktail

According to WHO’s reports, globalization makes the task of regulating medical products more and more difficult. The phenomenon is amplified by online sales, making it easy for pharmaceutical companies to bypass the regulatory authorities. A scenario that is often observed in developed countries, like the U.S.

“The bottom line is that this is a global problem,” says Dr. Simão. “Countries need to assess the extent of the problem at home and cooperate regionally and globally to prevent the traffic of these products and improve detection and response.”

Wasting money and life

In addition, WHO conducted a second study in collaboration with the University of Edinburgh and the London School of Hygiene and Tropical Medicine that estimated a 10.5 percent failure rate in all medical products used in developing countries.

The study was based on over 100 scientific publications on medicine quality surveys done in 88 developing countries involving 48,000 samples of medicines. But according to WHO, the amount of data wasn’t enough, therefore the results should be considered as estimates.

And based on the 10 percent of substandard and falsified medicines the University of Edinburgh estimates that up to 169,000 children per year may be dying from pneumonia due to substandard and falsified antibiotics. The London School of Hygiene and Tropical Medicine found similar results: up to 158,000 deaths per year from malaria due to unsuitable medicines in sub-Saharan countries.

The total worldwide cost based on 10 percent of substandard and falsified medicines is estimated at $30 billion a year.

Numerous solutions but not funding needed

WHO Global Surveillance and Monitoring System proposed several recommendations and action plans to reduce the sale of substandard and falsified medical products. WHO’s tools aims to increase prevention, detection and response to help governments to face this issue. However, a specific budget has been allocated, leaving developing countries, that already have limited financial resources, to finance it by themselves.

No data available in the U.S.

WHO’s studies focus almost entirely on developing countries due to the lack of data provided by developed countries where stringent regulations and laws deter the sale of substandard or falsified products. 

Asked if Oklahoma has any record of such issues, Maggie Pool, the Assistant Director of Clinical Services at the University of Oklahoma, wrote, “I am not aware of any issues with substandard or falsified medical products here or anywhere in Oklahoma."


Click here to read WHO’s reports.

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Olivier Rey

Olivier has traveled in 20 countries on six continents before landing in Norman. Native French...

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