The Fake Drug Problem

 

By Gesa Junge, PhD

Tablets, injections, and drops are convenient ways to administer life-saving medicine – but there is no way to tell what’s in them just by looking, and that makes drugs relatively easy to counterfeit. Counterfeit drugs are medicines that contain the wrong amount or type of active ingredient (the vast majority of cases), are sold in fraudulent packaging, or are contaminated with harmful substances. A very important distinction here: counterfeit drugs do not equal generic drugs. Generic drugs contain the same type and dose of active ingredient as a branded product and have undergone clinical trials, and they, too, can be counterfeited. In fact, counterfeiting can affect any drug, and although the main targets, particularly in Europe and North America, have historically been “lifestyle drugs” such as Viagra and weight loss products, fake versions of cancer drugs, antidepressants, anti-Malaria drugs and even medical devices are increasingly reported.

The consequences of counterfeit medicines can be fatal, for example, due to toxic contaminants in medicines, or inactive drugs used to treat life-threatening conditions. According to a BBC article, over 100,000 people die each year due to ineffective malaria medicines, and overall, Interpol puts the number of deaths due to counterfeit pharmaceuticals at up to a million per year. There are also other public health implications: Antibiotics in too low doses may not help a patient fight an infection, but they can be sufficient to induce resistance in bacteria, and counterfeit painkillers containing fentanyl, a powerful opioid, are a major contributor to the opioid crisis, according to the DEA.

It seems nearly impossible to accurately quantify the global market for counterfeit pharmaceuticals, but it may be as much as $200bn, or possibly over $400bn. The profit margin of fake drugs is huge because the expensive part of a drug is the active ingredient, which can relatively easily be replaced with cheap, innate material. These inactive pills can then be sold at a fraction of the price of the real drug while still making a profit. According to a 2011 report by the Stimson Center, the large profit margin combined with comparatively low penalties for manufacturing and selling counterfeit pharmaceuticals make counterfeiting drugs a popular revenue stream for organized crime, including global terrorist organizations.

Even though the incidence of drug counterfeiting is very hard to estimate, it is certainly a global problem. It is most prevalent in developing countries, where 10-30% of all medication sold may be fake, and less so in industrialized countries (below 1%), according to the CDC. In the summer of 2015, Interpol launched a coordinated campaign in 115 countries during which millions of counterfeit medicines with an estimated value of $81 million were seized, including everything from eye drops and tanning lotion to antidepressants and fertility drugs. The operation also shut down over 2400 websites and 550 adverts for illegal online pharmacies in an effort to combat online sales of illegal drugs.

There are several methods to help protect the integrity of pharmaceuticals, including tamper-evident packaging (e.g. blister packs) which can show customers if the packaging has been opened. However, the bigger problem lies in counterfeit pharmaceuticals making their way into the supply chain of drug companies. Tracking technology in the form of barcodes or RFID chips can establish a data trail that allows companies to follow each lot from manufacturer to pharmacy shelf, and as of 2013, tracking of pharmaceuticals throughout the supply chain is required as per the Drug Quality and Security Act. But this still does not necessarily let a customer know if the tablets they bought are fake or not.

Ingredients in a tablet or solution can fairly easily be identified by chromatography or spectroscopy. However, these methods require highly specialized, expensive equipment that most drug companies and research institutions have access to, but are not widely available in many parts of the world. To address this problem, researchers at the University Of Notre Dame have developed a very cool, low-tech method to quickly test drugs for their ingredients: A tablet is scratched across the paper, and the paper is then dipped in water. Various chemicals coated on the paper react with ingredients in the drug to form colors, resulting in a “color bar code” that can then be compared to known samples of filler materials commonly used in counterfeit drugs, as well as active pharmaceutical ingredients.

Recently, there have also been policy efforts to address the problem. The European Commission released their Falsified Medicines Directive in 2011 which established counterfeit medicines as a public health threat and called for stricter penalties for producing and selling counterfeit medicines. The directive also established a common logo to be displayed on websites, allowing customers to verify they are buying through a legitimate site. In the US, VIPPS accredits legitimate online pharmacies, and in May of this year, a bill calling for stricter penalties on the distribution and import of counterfeit medicine was introduced in Congress. In addition, there have also been various public awareness campaigns, for example, last year’s MHRA #FakeMeds campaign in the UK,  which was specifically focussed on diet pills sold online, and the FDA’s “BeSafeRx” programme, which offers resources to safely buying drugs online.

In spite of all the efforts to raise awareness and address the problem of fake drugs, a major complication remains: Generic drugs, as well as branded drugs, are often produced overseas and many are sold online, which saves cost and can bring the price of medication down, making it affordable to many people. The key will be to strike the balance between restricting access of counterfeiters to the supply chain while not restricting access to affordable, quality medication for patients who need them.

Ebola – Closer than You Think

 

Ebola, the hemorrhagic fever is closer than you think, but there is no reason to panic…yet!

By Jesica Levingston Mac leod, PhD

In case you did not hear about it, the Center of Disease Control (CDC) reported an outbreak of a “more virulent” Ebola virus infections in Guinea, spreading now to Sierra Leone . Ebola virus is the etiological agent of severe hemorrhagic fever. The symptoms? Fever, rash, severe abdominal pain, vomiting, and bleeding, both internally and externally. The fatality rate? Around 90%. Even worse, these outbreaks are occurring with increasing frequency. Some explanations for this are the increased contact between humans and the natural reservoir of the viruses (fruit bats), and fluctuations in viral load and prevalence in this reservoir. The transmission of the virus mostly occurs by contact with infected blood, secretions or organs of either bats, nonhuman primates or humans. This is why you should not eat bats or monkeys if you visit any of the affected areas, or hang around any cemeteries. Not surprisingly, Ebola was named as the most frightening disease in the world. It was documented for the first time in 1976 in the Republic of Congo; one of the sources came from the Ebola River.

 

In 2012 an outbreak in Uganda found us in a similar medical emptiness: the research of two of the vaccines that were “apparently” going great had been canceled by the department of defense, due to funding constraints.  Therefore, so far we do not have any vaccine or effective treatment available.

 

Albeit a DNA based vaccine was described in 2003 to fully protected macaques against the fatal virus, it did not continue to further clinical trials.  It was not until 10 years later that a group in the US National Institutes of Health published research about a vaccine consisting of a recombinant vesicular stomatitis virus expressing the ebola glycoprotein which protects macaques from Ebola virus infections, although this method is not licensed for human use.

 

But, why does the US department of defense care about an African virus? The answer is pretty obvious: it can be used as a bio hazard weapon. On the other hand, no leading pharmaceutical is going to invest in a “very expensive and time consuming” vaccine development to be used in countries that can not afford even a basic level of health care. Some compounds are showing a promising antiviral effect in vitro and/or an inhibition of a variety of viral proteins activities. Sadly, all of them are in an early stage of drug development.

 

Before freaking out, the best “cure” and prevention method against this scaring virus is knowledge, so check out the updates in the CDC website.

Want to stay on top of ebola outbreak and possible treatment? Create your feed with these keywords, it’s free.