According to a report, a worldwide pandemic of fake drugs killing children around the world



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"We are talking about about 300,000 children – at least – who have died as a result of murders of drugs allegedly distributed by criminals," said Dr. Joel Breman, co-author of the report and scientific advisor emeritus at the Fogarty International Center of the National Institutes of Health of the United States.

The World Health Organization has defined three types of falsified and substandard medical products.

"Forged medical products" deliberately distort their identity, composition or source. "Substandard medical products" are regulated drugs that do not meet quality standards or specifications – for example, they contain fewer amounts than necessary of active pharmaceutical ingredients. "Unregistered or unlicensed medical products" are untested and unapproved drugs.

The number of falsified and substandard medical products is increasing, according to Breman and his co-authors of the report published Monday in the American Journal of Tropical Medicine and Hygiene. In 2008, for example, Pfizer Global Security, the team of the drug manufacturer working to fight against counterfeit medicines, 29 of its products in 75 countries have been identified as falsified. Only 10 years later, Pfizer discovered 95 fakes in 113 countries.

"Initially, we focused on poor countries because they have no control and a high disease burden," said Breman, also president-elect of the American Society of Tropical Medicine and Hygiene .

He said the "impact" of falsified and substandard medicines is estimated at 10% of all drugs, at a cost of up to $ 200 billion, in low- and middle-income countries.

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Antimalarials, which could be responsible for the deaths of more than 150,000 children each year, are one of the top two areas of concern in these countries, Breman said. Antimalarials and artemisinin combination (often called ACT) are the best solution for treating malaria.

The ACT-watch program, a division of Population Services International, a non-profit health organization, monitors these drugs in eight African countries. The program revealed that an entire quarter of ACTs available in the field were not assured in quality. (In fact, the program has identified 185 unsecured ACT manufacturers, compared to only 12 reputable companies producing these approved combination therapies.)

Antibiotics used to treat pneumonia in children are another source of concern in low- and middle-income countries. Every year, fake or substandard antibiotics cause as many deaths in children as fake antimalarials.

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Beyond children, a new category of falsified and substandard drugs is on the rise: treatments for chronic diseases such as hypertension. The Pharmaceutical Security Institute, a non-profit surveillance organization, estimates that these account for more than 50% of counterfeit medicines.

Some of the most common drugs, often on the Internet and sometimes linked to organized crime and terrorist groups, include drugs for heart disease, erectile dysfunction, cancer, and pain (prescription opioids).

Breman said he would not "glorify" the illicit facilities that produce fake medicines and opioids, especially under the name of "laboratory". "They are used with pests and outdated and obsolete equipment," he said, adding that the pills could be encrusted with fentanyl and other harmful substances.

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According to Breman and his co-authors, there were few online pharmacies in 2009, but seven years later, about 35,000 of these pharmacies were in operation around the world. Meanwhile, Internet access continues to grow in emerging economies, putting more people at risk.

Pharmaceutical companies are well aware of the problem. To test online resources, Pfizer Global Security made 250 purchases of its Xanax drug from internet providers and found that 96% of them were fakes. In some cases, even vaccines have been falsified, Breman said, citing the report.

Over the past decade, academics and non-profit organizations have raised public awareness of the issue, while the United Nations Office on Drugs and Crime, Interpol and WHO have together to address the problem of falsified and substandard medicines, he said.

"There seems to be a movement now and leadership has been slowly entrusted to the WHO," he said, adding that it was time to "put everything in place." to identify drugs, but also to ensure that all countries have legislation, that they have standards of acceptance, that they are monitored.

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An international treaty may be necessary, according to the report's authors. Technical problems must also be addressed: for example, it is necessary to identify "the best method of testing drugs at the patient's bedside," said Breman, explaining that there are high-powered analytical tests but that the laboratories where these analyzes are carried out are both remote and effective. expensive.

The distribution of fake medicines means that the specter of antimicrobial resistance is also emerging, he said. Mediocre medications promote and propagate resistance because of their inability to completely kill bacteria, as do drugs without an active ingredient, called "whites".

International efforts needed, says WHO

"Most of the cases we see are falsified – that means that someone decided to deliberately cheat you to fool you, that's the real thing when it's not the case" said Michael Deats, head of the medical products group Substandard and Falsified. "It's a criminal activity."

Deats, who did not participate in the new study, said falsified and substandard drugs were a "hot political issue" for years, but before 2012, "the protection of intellectual property rights by opposition to the protection of public health has been confused. "

Since then, however, WHO has come up with clearer definitions and has put in place "a work plan to prevent, detect and treat substandard and falsified medicines".

Today, with a clearer vision of the problem, a coherent policy and a coordinated approach endorsed by all Member States, the WHO has begun to progress, said Deats, "but there are still major challenges to relieve".

Low- and middle-income countries are particularly vulnerable due to porous borders and weak regulatory capacity. "In low- and middle-income countries, one in 10 medications have failed on average in quality tests," said Deats. A WHO Technology Working Group is studying wearable devices that would allow regulators and other actors in the field to conduct rudimentary product testing, but a technology that is as powerful as it is. is not a quick fix, he added.

Thanks to the Internet, high-income countries are not immune to this problem: unregistered online pharmacies and "smartphone apps that allow you to order non-prescription drugs and have them delivered by a doctor. motorcycle guy who shows up at your home. " Deats says.

The US Food and Drug Administration estimates that "about 80% of the drugs or component drugs available in the United States come from outside the United States," Deats said. "It's really important that we have secure supply chains.

"Investing in regulatory authorities is a key element of safeguarding supply chains", but a "strong political will to tackle this problem, not only in the United States, but in the world "is also necessary," he said.

"We have to collaborate," said Deats. Without partnerships between countries, besides public-private collaborations between countries and industry, "we will not be able to tackle this problem".

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