20 November 2017

"Big Brother" in a pill

The US has approved a drug with a sensor inside for the first time

Angelina Krechetova, Forbes, 14.11.2017

The development will allow patients and their attending physicians to monitor their medication intake. The consequences of refusing to take them or not following the instructions of specialists claim the lives of 125,000 Americans annually

The U.S. Food and Drug Administration (FDA) for the first time approved the drug Abilify MyCite, which includes a "digital system for tracking drug intake." The sensor built into the tablet will allow you to record when the patient took it and whether he took it at all.


"The product is approved for the treatment of schizophrenia, acute manic and mixed episodes associated with grade I bipolar disorder, as well as as an accompaniment to the treatment of depression in adults," the FDA said. The data is transmitted from an internal sensor "embedded" in the medicine to a wearable patch, which then sends the received information to a special application installed on the patient's smartphone. Now he can track the progress of treatment, as well as open access to this information to his doctor and family members. The patient can also close access to this information at any time.

The drug was created jointly by the manufacturer of the drug Abilify (used for bipolar disorders, schizophrenia and depression) Otsuka and the California-based Proteus Corporation, which took over the development of the sensor. We are talking about a drug with an active substance – aripiprazole (a drug of the class of atypical antipsychotics), approved by the FDA relatively recently in 2002.

A sensor consisting of copper, magnesium and silicon (according to the developer, these are elements that are safe for humans, which are also contained in food) generates a signal when interacting with gastric juice. The signal is picked up by a device that is worn on the left side of the chest and changes weekly. Up to this point, it was not possible to integrate the sensor into the tablet, and such a device could simply be inserted into a single capsule along with the drug, The New York Times points out. The publication notes that Proteus has spent years creating a sensor capable of solving this problem, and has attracted about $400 million from investors, including Novartis pharmaceutical corporation and Medtronic, a manufacturer of medical equipment. Otsuka has already patented the novelty and reserved the exclusive rights to use the drug with the Proteus sensor (the drug itself can be used by other manufacturers). First, Abilify MyCite will receive a limited number of patients according to quotas. In 2018, the tablets are planned to be put on sale. It is not yet known how much they will cost. 

A serious problem for patients

American Forbes, citing experts, clarifies that now about half of patients in the United States do not take their medications in accordance with prescriptions, and there are many reasons for this: someone forgets about taking them, someone wants to avoid side effects, and others do not know how to take certain medications correctly. According to a study published in The Journal of the American Medical Association in 2015, from 1999-2000 to 2011-2012, the percentage of adults taking five or more prescription drugs increased from 8.2% to 15%. It is quite difficult to remember when and how each of them should be taken. In April 2017, Business Insider reported that non-compliance with the medication regime poses a serious threat to the health of citizens: every year, the consequences of refusing to take medications or non-compliance with doctor's orders claim about 125,000 lives in the United States and cost the American medical community $ 100-289 billion a year. In most cases, the costs arise due to the fact that patients become even more ill and require additional treatment or hospitalization.

Director of the "Scientific and Practical Center of Medical Radiology DZM", President of the European Society of Medical Imaging Informatics, Professor Sergey Morozov agrees that the problem of "low patient compliance", that is, non-compliance with the prescribed treatment regime, really exists. "A tablet with a sensor allows you to increase compliance with the treatment regimen and, accordingly, increase the effectiveness of treatment," the Forbes interlocutor is sure. At the same time, for pharmaceutical companies, according to him, this is a great opportunity to clarify data on the effectiveness of medicines and potentially show more successful results in clinical trials.

The New York Times points out that despite the voluntary consent to the transfer of information, which the patient can refuse at any time, the technology can still raise doubts about confidentiality, as well as ethical questions about pressure on patients. "Will this lead to the fact that patients will have fewer relapses, fewer hospitalizations, they will be able to improve their professional and social life? There is some irony in the fact that pills are given to people with mental disorders who may have delusional ideas (that they are being watched). It's like a biometric "Big Brother," Jeffrey Lieberman, head of the department of psychiatry at Columbia University, says in an interview with the newspaper.

Prospects for a new drug

Nevertheless, the novelty, according to journalists, can be welcomed by elderly people who find it difficult to remember when and what medications to take, as well as patients who require a long course of treatment under the supervision of specialists, for example, tuberculosis. The technology could potentially be used to monitor patients' use of opioid drugs (whether they exceed the dosage prescribed by a doctor), which are taken in the United States after surgery. Denis Kurek, CEO of Future Biotech, is confident that this is another step towards digital medicine.

"The article is about a pill for diseases whose manifestations can be dangerous for other members of society, so it is important to know how often the drug is taken, not only to the patient himself, but also to the doctor," he notes in an interview with Forbes. According to the CEO of Future Biotech, the development can help patients in taking courses of prescribed medications until the end, and "not until the symptoms disappear due to stimulation by a doctor." The information obtained through sensors, in his opinion, in the future can be used not only by a doctor, but also, for example, "for targeted advertising."

Alexey Remez, founder and CEO of UNIM, agrees that the event is a "significant milestone" in the pharmaceutical industry. He emphasizes that the problem of accounting for the intake of pharmaceuticals is quite significant. "Large vendors in the medical equipment market create both individual and hospital accounting systems, since the control of the correctness and regularity of taking pharmaceuticals directly affects the effectiveness of treatment," he explains. At the same time, the FDA approval of the first drug capable of signaling the fact of admission creates a full control cycle. In the future, this information, according to the Forbes interlocutor, can be used in synergy with both individual and hospital systems. "Such developments have been conducted for a long time, the precedent of FDA approval suggests that this will soon become a widespread practice. The only factor hindering the expansion of the market for such drugs may be their rise in price compared to classic tablets," he concludes.

Geneticist, CEO of Genotek Valery Ilyinsky believes that in the long term, this approach may become a trend for all drugs, the reception of which is critically important for maintaining the health of patients. "In the treatment of schizophrenia, bipolar disorder and other mental illnesses, an independent monitoring tool for taking the drug (after the patient's consent) will allow the doctor to assess the real response to therapy, excluding the possible influence of the patient's behavior (avoidance of taking the drug, violation of the timing of taking or dosage)," he is sure. In the future, a similar approach can be applied to almost any drug, but this approach will be most relevant for drugs whose intake may be disrupted due to the characteristics of the patient's behavior (mental illness, neurodegenerative diseases and some others), the Forbes interlocutor argues.

Similar developments in Russia

The New York Times clarifies that companies around the world are developing digital medical devices, including sensors with visual recognition technologies that can confirm whether a patient has put a specific pill on his tongue and swallowed it. Not all of them require regulatory approval from regulators, and some are already being used or tested, for example, on patients with heart disease, diabetes and stroke survivors.

Evgenia Konovalova, the founder and CEO of Science Guide, admits in an interview with Forbes that there are no drugs that would work in conjunction with wearable devices or mobile applications in Russia yet. At the same time, here, according to her, there are much more serious developments on tracking medication intake, but "we do not know how to package them in a similar way (as in American companies) yet." Other experts interviewed by Forbes agree with Konovalova. "There have been such developments in Russia, for example, in nanotechnology for the treatment of oncological diseases. For example, we have several companies in the south of Moscow that develop such drugs, I have personally seen them. There, such a label is obtained by analyzing the interaction of antigen-antibody, or there is some kind of marker that fixes when the drug passes through the blood-brain barrier (the physiological barrier between the circulatory system and the central nervous system). That is, if we talk about targets and markers – such systems have existed for a long time, the question is in connection with a wearable device," she explains.

Investment analyst of the FRII Yakov Kop noted that there is one company in the fund's portfolio that solves this problem – an inhaler and a cloud system from a Novosibirsk company Personal Medicine & Health Management (PM&HM), in the development of which FRII will invest almost 200 million rubles.

"The inhaler has a built-in fingerprint sensor, monitoring the delivery of the dose of the drug. The appearance of such a pill, which is written in the news, is an important event for medicine, we are aware of several developments in Europe and America, but there is no information publicly about such technologies and tablets in Russia," he admits. The interlocutor of Forbes believes that the event is quite significant from a regulatory point of view, as it potentially changes the approach to controlling medication intake. "Indeed, insurance companies will be interested in changing payments depending on the accuracy and accuracy of taking medications. In the future, the technology can also improve the quality of treatment," the Cop concludes.

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