Science Policy For All

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Science Policy Around the Web – December 1, 2017

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By: Kelly Tomins, BSc

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source: pixabay

Fake Drugs

Health agency reveals scourge of fake drugs in developing world

The World Health Organization (WHO) released two concerning reports detailing the prevalence and impact of substandard and falsified medical products in low and middle income countries. Although globalization has led to the increase in e-commerce of medicine, making life-saving treatments available to a broader population, it also created a wider and more accessible market to dispense fake and harmful medicines for profit. Despite this, there was a lack of a systematic method of tracking falsified medicines on a global scale. Thus, the WHO created the Global Surveillance and Monitoring System for substandard and falsified medical products (GSMS). With this program, medicine regulatory authorities can enter information about fraudulent drug incidences into a centralized database, making it easier to understand global trends and to possibly identify the source of harmful products. The WHO also conducted an extensive literature search of nine years’ worth of medicine quality studies to assess rates of fake medicines.

Their dual analysis showed that falsified medicines are heavily prevalent, particularly in low-and -middle income countries. They estimate that an incredulous 10.5% of medicines in these countries are falsified or substandard, representing $30 billion in wasted resources. Low income countries are the most vulnerable to this type of exploitation, given their higher incidence of infectious disease and their likelihood of purchasing cheaper alternatives to more reliable and tested medicines. In addition, these countries are more likely to lack the regulatory framework and technical capabilities to ensure safe dispensing of medicines. However, reports of fake drugs were not limited to developing countries. The Americas and Europe each accounted for 21% of the reported cases, highlighting how this is a global phenomenon.

Antimalarials and antibiotics are the two products most commonly reported as substandard or falsified, with 19.6% and 16.9% of the total reports respectively. These findings are especially concerning given a recent finding that the number of malaria infections increased the past year, despite a steady global decrease from 2000-2015. In addition, the number of deaths from the disease have not decreased for the first time in 15 years. By providing an insufficient dose to eradicate the malaria parasite from the body, the use of substandard or falsified antimalarials can foster the emergence of drug-resistant strains of malaria, like those recently found in several Asian countries. Overall, the WHO estimates that falsified products may be responsible for 5% of total deaths from malaria in sub-Saharan Africa.

Despite the clear need for action to ensure drug safety around the world, there are an abundance of challenges to making this possible. The supply chain of drug manufacturing, from the chemical synthesis of the drug, to the creation of packaging and the shipping and dissemination, can span multiple countries with extremely variable regulatory procedures and oversights. The need for strengthened international framework and oversight is necessary to ensure patients receive the drugs they think they are getting and preventing hundreds of thousands of deaths each year.

(Barbara Casassus, Nature)

Biotechnology

AI-controlled brain implants for mood disorders tested in people

Mood disorders have been traditionally difficult to treat due to the often-unpredictable onset of symptoms and the high variability of drug responses in patients.  Lithium, a popular drug used to treat bipolar disorder, for example, can cause negative side effects such as fatigue and poor concentration, making it more likely for patients to elect to stop treatment. New treatments developed by the Chang lab at Massachusetts General Hospital and Omid Sani of UCSF hope to provide real-time personalized treatments for patients suffering from mood disorders, such as depression and PTSD. The treatment utilizes a brain implant that can monitor neural activity, detect abnormalities, and then provide electrical pulses to a specific region of the brain when needed. These electrical pulses, known as Deep Brain Stimulation (DSB), have already been used to treat other disorders such as Parkinson’s disease. Other groups have tried to use DSB in the past to treat depression, but patients showed no significant improvement. In those studies, however, the pulses were given constantly to a single portion of the brain. What is unique about this treatment is that the pulses are only given when necessary, or when the implant receives signals that the brain is producing abnormal neural activity. The researchers have also found ways to map various emotions and behaviors to specific locations in the brain. They hope to utilize that information in order to more finely tune a person’s behaviors. In addition, the algorithms created by the labs to detect changes in the brain can be modified for each patient, providing an alternative to the one-size-fits all pharmacological approaches currently used.

Despite the promising and appealing aspects of this personalized treatment, it also raises several ethical issues regarding privacy and autonomy. First off, with such detailed maps of neural activities, the patient’s mind is practically an open book to their doctor. They have little agency of what emotions they would want to share or, more importantly, hide. Also, the patient may feel a lack of autonomy over their treatment, as the implant itself decides when the patient is displaying an unwanted mood or behavior. The algorithms could also potentially change the patient’s personality for worse by limiting the spectrum or intensity of emotions that a patient can feel. Any type of manipulation of brain activity could be viewed as worrisome from an ethical standpoint, and although promising, this proposed treatment should undergo intense scrutiny in order to maintain autonomy for the patients.

(Sara Reardon, Nature)

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Written by sciencepolicyforall

December 1, 2017 at 4:03 pm

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