The Threat of Fake Medications

From The Atlantic.

In 2016, an estimated 595,690 patients passed away from cancer. That same year, there were over 15.5 million Americans with a history of this terrible illness for whom it was not fatal. This is because the slivers of hope around cancer treatment have only grown larger over the years, with new, innovative medicines and treatments more available than ever before.

Between 2011 and 2016, 70 new cancer treatments were launched globally.

But not every medicine sold is legitimate.

There are those who would take advantage of the undeniable gravity of a cancer diagnosis. A statement released earlier this year by the U.S. Food & Drug Administration warned of this threat. “A cancer diagnosis often provokes a sense of desperation. Unfortunately, rogue operations exploiting those fears peddle untested and potentially dangerous products, particularly on the internet,” write Donald Ashley, director of the agency’s Office of Compliance at the Center for Drug Evaluation and Research, and Douglas Stearn, director of the agency’s Office of Enforcement and Import Operations in the Office of Regulatory Affairs.

Rogue operations are also participating in the market for counterfeit medicine, manufacturing medications for cancer and other illnesses.

In 2017, international authorities seized 25 million counterfeit medicines—in just one week.

If a medicine’s origin is unknown, it could be dangerous.

Counterfeit medicine can look identical to legitimate medicine from an approved manufacturer and pharmacy, and the packaging can, too. In the internet age, it’s also available at the touch of a button online.

It’s logical that people seek out medications online, as they do for many other products. Buying online tends to be quick and convenient, and also grants anonymity to those who might feel­ uncomfortable discussing their personal health.

Some estimates say that 10 percent of pharmaceuticals in the global supply chain are counterfeit.

In 2017, 95.8 percent of the online pharmacies–more than 11,000–reviewed by the National Association of Boards of Pharmacy were out of compliance and listed as not recommended.

The internet has made counterfeit drug retail easy and lucrative.

It is up to governments, pharmaceutical companies, care providers, and patients to all remain vigilant and engaged in ensuring that medicines are legitimate. Otherwise, there’s an ever-growing possibility that medicines will be counterfeit—and could fail to treat consumers or even actively harm them. Though exact statistics are hard to calculate, it is estimated that between 100,000 and one million consumers die every year as a result of counterfeit medicine.

Research has found that if there is no physical address listed for an online pharmacy, there is a 50 percent chance the drugs are counterfeit.

But the same risks are present in developed countries, particularly among older patients who may not want to travel to brick-and-mortar pharmacies. Online pharmacies are hard to regulate and verify, and there’s no telling where the drugs are sourced.

In 2016, authorities from 44 countries seized more than 6.6 million doses of counterfeit versions of Pfizer medicines. Studies show that over 50 percent of online pharmacies offered foreign or non FDA-approved medicines. Counterfeit medicines and their factories are not regulated or inspected.

In some cases, a counterfeit drug simply doesn’t contain the active ingredient that would make it effective. But other versions offer much worse; inspectors and authorities have seized counterfeit medicines that contained:

  • Toxic pesticides
  • Highway paint
  • Rat poison
  • Heavy metals
  • Floorwax
  • Chalk
  • And worse.

What do we need to watch for? There are some telltale signs.

Significantly lower costs for medicines are often a telltale sign of a counterfeit, experts warn. A legitimate online pharmacy must also require a prescription, provide a phone number and address based in the customer’s country, and display a Verified Internet Pharmacy Practice Sites seal.

Other key things to look for include confirmation that the website’s URL ends with “.pharmacy” and that the website is on the FDA’s list of approved, verified online pharmacies. The website should also provide contact and background information for a licensed, human pharmacist associated with the practice.

Pharmaceutical companies have a part to play, too. They have their own investigative teams that not only track down counterfeit drug manufacturers and distributors, but also work closely with federal law enforcement to produce and implement new policies and regulations. New technologies can also help them closely track their product, as well as make sure that the only drugs being distributed are those made by trusted manufacturers.

When it comes to medicine, vigilance is warranted from all players, sellers and buyers alike. Convenience isn’t always worth the risk.

March 2017.


Tens of thousands dying from $30 billion fake drugs trade, WHO says

By Ben Hirschler, Reuters.
One in 10 drugs sold in developing countries is fake or substandard, leading to tens of thousands of deaths, many of them of African children given ineffective treatments for pneumonia and malaria, health officials said on Tuesday.


In a major review of the problem, the World Health Organization (WHO) said that bogus drugs are a growing threat as increased pharmaceutical trade, including Internet sales, open the door to sometimes toxic products.

Some pharmacists in Africa, for example, say that they are compelled to buy from the cheapest but not necessarily the safest suppliers to compete with illegal street traders.

Fake drugs could contain incorrect doses, wrong ingredients or no active ingredients at all. At the same time, a worrying number of authorized medicines fail to meet quality standards because of improper storage and other issues.

The scale of the problem is hard to quantify precisely, but a WHO pooled analysis of 100 studies from 2007 to 2016, covering more than 48,000 samples, showed 10.5 percent of drugs in low and middle-income countries to be fake or substandard.

With pharmaceutical sales in such countries running at nearly $300 billion a year, this implies that trade in fake medicines is a $30 billion business.

The human toll is enormous, according to a team from the University of Edinburgh, which was commissioned by the WHO to study the impact of fake drugs.

They calculated that up to 72,000 deaths from childhood pneumonia could be attributed to the use of antibiotics with reduced activity, increasing to 169,000 deaths if drugs had no activity.

Poor-quality drugs also add to the danger of antibiotic resistance, threatening to undermine the power of life-saving medicines in future.

Another group from the London School of Hygiene and Tropical Medicine estimated that 116,000 additional deaths from malaria could be caused each year by bad antimalarials in sub-Saharan Africa.

“Substandard and falsified medicines particularly affect the most vulnerable communities,” said WHO Director-General Tedros Adhanom Ghebreyesus. “This is unacceptable.”


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