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Counterfeit pharmaceuticals – the cost can be deadly

BY VICTOR BARRETT

Monday, September 03, 2018

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Counterfeit pharmaceuticals are among the products with the greatest potential for harming Jamaicans if not contained from an early stage. The production of pharmaceuticals for the Jamaican market is heavily regulated to ensure product compliance with the highest quality and safety standards.

All drugs must undergo clinical trials before being marketed to test their efficiency, verify their quality and exclude the potential existence of side effects on patients. These institutional and technical measures are meant to work as a safety valve to guarantee the quality of all medications.

Unfortunately, these regulations and requirements are not observed by the manufacturers of counterfeit products. Instead, they use substandard products and hazardous chemicals. The end result from using counterfeit medicine ranges from ineffective therapeutic results to severe health problems or death.

Before interrogating the various dimensions of the problem, it is imperative to define the term “counterfeit drug”. According to the 1992 World Health Organization (WHO) definition, a counterfeit drug is a pharmaceutical product “which is deliberately and fraudulently mislabelled with respect to identity and/or source”. The WHO further clarifies that this definition applies to both branded and unbranded medicines, the so-called generics, and it includes products “with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging”. This definition stresses the adulteration, inappropriateness, illegality and by extension, the dangers of these products.

Scope of the Problem

The WHO estimates that in Europe and in the United States, as well as other developed countries, less than one per cent of the medications sold are counterfeits. However, in developing countries the issue is on a completely different level. According to experts, up to 10 per cent of the medicines available there are counterfeit. The problem is highly dependent on how tight legal controls are.

Often when we think about counterfeit products the first things that come to mind include fake Gucci handbags, fake Nike shoes, fake Rolex watches, among other things, but the real money is in plagiarising pills. The pharma criminals counterfeit medicines ranging from Lipitor tablets to imitation Viagra and Cialis capsules, to name a few.

Counterfeit pharmaceuticals are a €188-billion (US$200 billion) annual business, in Europe, making them the largest segment of the €1.6 trillion in fraudulent goods sold worldwide every year. Even in the most secure markets in the world, there are concerns. In 2015, authorities in Germany confiscated four million counterfeit tablets and in developing regions, such as Africa, the proportion of fake pharmaceuticals can rise to 70 per cent.

National Security Threat

The counterfeiting and pirating of goods may seem to be a victimless crime, where no one is harmed by imitation goods sold at much lower prices than brand-name products. However, the world of counterfeiting and piracy stretches to nearly every product on the market and has often led to considerable harm, including death, to consumers.

The consequences are well-known, as the United States Department of Homeland Security states, “counterfeit and pirated goods pose a serious threat to America's economic vitality, the health and safety of American consumers, and our critical infrastructure and national security”. Piracy and counterfeiting are not victimless crimes; they cost US businesses more than US$200 billion annually and account for the loss of more than 750,000 jobs. This is also a worldwide problem and all the sentiments are applicable to our beloved country Jamaica.

Who Is Affected by Counterfeit Drugs?

Everything that is profitable will be forged. This can affect either medications protected by patents or so-called generics. Expensive, prescription drugs such as those used in AIDS or cancer therapy are especially lucrative for dubious businesses. Antibiotic treatments are the most commonly counterfeited drugs worldwide. Moreover, there is a growing trend in so-called “lifestyle” medications. At the top of the list stand drugs against erectile dysfunction — Viagra and Cialis. Therefore, theoretically, every patient is at risk, even though there might be differences at a national level.

Counterfeit pharmaceuticals exact a devastating human toll. Some one million people die annually after taking fake drugs, according to WHO estimates. Some are killed outright by counterfeits containing toxic ingredients such as rat poison or floor wax. In one well-publicised case from 2008, adulterated heparin from China killed hundreds in the US and elsewhere.

Even when fake drugs don't kill people, they can cause serious harm. Some 25 per cent of physicians who responded to a survey conducted in the United Kingdom in 2009 said they have treated patients suffering adverse effects from a drug purchased on the Internet, a primary conduit for counterfeit drugs in developed countries.

The counterfeit pharmaceuticals, many of which contain few or no active ingredients, cause patients to suffer and sometimes die from preventable or curable illnesses. Malaria researchers estimate that 450,000 people die of the disease every year after taking ineffective counterfeit pills. Therefore when one looks at the effects worldwide it presents a scary reality to humanity.

Pharmaceutical companies follow the legal requirements to ensure patients get safe medicine. In many countries, the risk of being effectively punished for producing fake medicines is very low. Therefore, it is understandable that counterfeiting medication seems more lucrative than selling illegal drugs. However, there are also comparable structures of organised crime in the field of counterfeiting.

Public Health Concern

Counterfeit drugs are a public health issue worldwide and Jamaica is not excluded. The problem has been growing rapidly with the supplies coming from all over the world.

A case in point is that of a patient who was treated with injections for anaemia, after a liver transplant. After eight weeks of injections, the patient was still not responding to treatment. The treating physicians discovered that the medicine the patient used was counterfeit. In such cases, the consequences of counterfeits can be serious.

Another particularly serious case involved counterfeit versions of bevacizumab (Avastin), a cancer-fighting medication. Avastin's manufacturer, Roche, notified physicians in February 2012 of a counterfeit version of bevacizumab that contained salt and starch, but not the active component of the drug.

Another example of the dangers of counterfeit medications in the United States is the 2008 counterfeit case of the blood thinner heparin. In this case, the active ingredient was replaced with a cheaper substance that caused patients to have adverse reactions and resulted in a nationwide recall of heparin. The medication, whose counterfeit active ingredient came from China (a major source of counterfeiting), was suspected to be the cause of as many as 81 deaths. The implications for patients are clear: counterfeits can kill. The US company that sold heparin was subject to 740 lawsuits and eventually sold the division that produced the medicine.

Conclusion

There is no such thing as a “good quality” counterfeit drug. Developing countries are the worst affected because regulatory structure is weaker. Counterfeiting is not just a “brand” issue: ie, generics are more extensively counterfeited — especially in poor regions.

Fake and poor quality drugs can lead to serious and even deadly consequences for the people who buy them, who are often poor and lack access to safe and affordable medicine. “What happens when you have to buy twice the dose? What happens when your child dies because he didn't take the right treatment course? What happens when you get severe, complicated malaria because the first course of treatment you got was substandard or falsified?” These are pertinent questions to be asked.

Preventing counterfeit medicines from entering most countries is especially difficult, in part because nearly 40 per cent of drugs are made overseas and approximately 80 per cent of the active medicinal components of drugs are imported. Because many of these medicines are expensive, buyers are attracted by lower prices.

The rise of Internet pharmacies makes regulation of drug safety more difficult. Detecting counterfeits is often difficult, because many of these goods pass through a long and complicated distribution network, thereby creating opportunities for counterfeits to enter the legitimate supply chain.

No type of medicine, from expensive and ground-breaking treatments to everyday antibiotics or birth control, is immune. These medicines might have the wrong amount of the active ingredient (or none of it at all), or contain a different drug or other materials such as chalk or cornstarch. They can also be contaminated by bacteria or unknown impurities. Sometimes, a product isn't up to snuff because it wasn't manufactured or stored correctly. But often, they are intended to trick people.

While it's difficult to detect with the naked eye, it is best to to buy medicines from reputable pharmacies and consult your physician if in doubt. Please don't discount your health. Those who trade in counterfeit pharmaceuticals must be punished severely and as Gene Green once said, “Punishment for putting patients at risk ought to reflect the gravity of manufacturing, distributing or selling counterfeit medications.”

— Victor Barrett is an assistant superintendent of police, and attorney-at-law. He is assigned to the Counter Terrorism and Organised Crime Branch's Intellectual Property Unit

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