The FDA has announced its first ever approval of a pill with an embedded sensor that digitally tracks if patients have ingested it, ushering the US into a new era of smart pharmaceuticals – and medical surveillance.
The treatment, called Abilify MyCite, is essentially a clever delivery system for the antipsychotic aripiprazole, used to treat schizophrenia and bipolar disorder. And now, for the first time, doctors prescribing the drug will know first-hand if their patients are actually taking it.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” says the FDA’s director of psychiatric drugs evaluation, Mitchell Mathis.
“The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”
Abilify MyCite’s tracking system is centred around a tiny ingestible sensor about the size of a grain of sand, called an Ingestible Event Marker (IEM), made from safe levels of copper, magnesium and silicon.
Once the pill and the IEM inside it are swallowed, stomach acid activates the sensor, sending an electrical signal to a wearable patch worn on the patient’s chest. The patch records the date and time the pill was ingested, and relays this information to a smartphone app.
Users of the app – including the patient, but also any authorised doctors or family members – can then check in on the patient’s ingestion data, keeping direct tabs on the timely swallowing of oral medication in private like never before.
In other words, that old hide-the-pill-under-your-tongue trick will not work here.
The smart pill’s manufacturers – Otsuka (which makes Abilify) and Proteus (the IEM developer) – bill their innovation as “the first digital medicine system”, which they say will make it easier for caregivers to objectively monitor patients’ adherence to medication regimens.
While there’s no research as yet to indicate the ingestion tracking system actually improves patients’ compliance in taking their meds, the companies are hopeful that it might do just that – which, in the case of schizophrenia, could potentially help mitigate the symptoms of the 1.1 percent of Americans with the illness.
But some experts are concerned about the psychological ramifications of a drug that essentially acts as a tattletale if you don’t take it the right way, especially considering the target market for aripiprazole.
“Many [schizophrenia] patients don’t take meds because they don’t like side effects, or don’t think they have an illness, or because they become paranoid about the doctor or the doctor’s intentions,” psychiatrist Paul Appelbaum from Columbia University told The New York Times.
“A system that will monitor their behaviour and send signals out of their body and notify their doctor? You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia.”
Those concerns were shared by fellow Columbia University psychiatrist Jeffrey Lieberman, who likened Abilify MyCite to “a biomedical Big Brother”, noting the “irony in it being given to people with mental disorders than can include delusions”.
Yet, the ultimate impact of an embedded drug monitoring system like this goes well beyond the treatment of just schizophrenia and mental illness.
Non-adherence to recommended medication taking patterns in the US has been estimated to cost more than US$105 billion annually, so there are important economic factors behind the FDA’s approval.
But while Abilify MyCite may be the first of these kinds of drugs, it almost definitely won’t be the last, with reports the FDA is anticipating a coming wave of such self-monitoring medications.
If so, we could soon be looking at a new level of data-driven surveillance in the healthcare sector, bringing up all kinds of questions and concerns about ethics, privacy, personal rights, and whether this kind of ingestion tracking can truly be safeguarded in the interests of the patient.
“We’ve seen time and time again that stuff that’s being transmitted ends up in the hands of people it shouldn’t,” pharmaceutical policy researcher Walid Gellad from the University of Pittsburgh told NPR.
“There are real concerns about data security.”
Before we have all the answers to those questions, Abilify MyCite is expected to hit the market sometime next year, and for better or worse, the seeds of snitch medication will have been planted.
Government will soon issue Uniform Code for Medical Device Marketing Practices (UCMDMP) which may stipulate and prescribe limit to the incentives which can be provided to the doctors for recommending or using the medical device for the sake of patient safety and healthy competition.
The UCMDMP draft which is awaiting government approval was discussed with the industry recently under the chairmanship of Department of Pharmaceuticals (DoP) Secretary Jai Priye Prakash.
“UCMDMP draft which has recently been framed stipulates that there are certain limits which need to be prescribed on a voluntary basis to start with so that such inductive mechanisms to distort markets are eliminated or removed,” said a senior health ministry official.
UCMDMP has been drafted to ensure high ethical standards for the medical device industry much in the similar manner as has been done in the case of pharmaceutical industry by introducing Uniform Code for Pharma Marketing Practices (UCPMP) in 2011.
As per the UCPMP, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents i.e. distributors, wholesalers, retailers, etc. Gifts for the personal benefit of healthcare professionals and family members (both immediate and extended) (such as tickets to entertainment events) also are not to be offered or provided.
According to a senior health ministry official which drafted the UCMDMP, all such technologies which are closed systems like the Glucometer for which you have to buy the reagents of a particular brand can be given or considered as induced in turn incentive to the physician. If a company gifts the doctor a Glucometer, he will be forced to buy and then recommend the strips of the same Glucometer although the Glucometer was free. So in a way you are distorting the market.”
Another case in point is training the doctor on a machine which in a way is influencing the decision to buy the same machine after he comes back from the training which is again distorting the market. It is actually not training the physician on the machine but influencing his selection by training him on the machine, the official emphasized. .
The Medical Council of India (MCI) also prescribes the maximum number of incentives for a doctor. There are limits set in regulation which prohibit the manufacturer or trader to induce demand through incentivising the doctor but in case of medical devices the situation is very complex considering the cases mentioned above.
The UCPMP, a voluntary code was issued by the DoP in 2011 and its amended version came out in 2015. The marketing code lacks penal provisions to deter wrongdoers. Taking advantage of this, a number of companies have not adhered to the marketing code. In a bid to ensure industry’s cent percent compliance with UCPMP, the DoP had decided to make the marketing code mandatory with legal backing and penal provisions by introducing it under Essential Commodities (EC) Act.
The kind of blood you have could increase or decrease your risk of having a heart attack in response to high levels of air pollution, new research suggests.
A variant ABO gene – which can only be found in A, B, and AB blood types – has been linked with elevated risk of heart attack during periods of significant air pollution, whereas people with blood type O show lower risk.
“We wondered, if someone has a specific variation in this ABO gene, are they more or less likely to experience a heart attack in times of higher pollution?” says clinical epidemiologist Benjamin Horne from the Intermountain Medical Center Heart Institute in Salt Lake City, Utah.
Horne’s team analysed data from Intermountain Healthcare patients seen between 1993 and 2007, and identified a subset of patients that experienced an acute coronary syndrome (ACS) event corresponding with short-term exposure to high PM2.5 levels – a measure of concentration of fine, inhalable particles with a diameter of 2.5 micrometres and smaller.
When they cross-matched the data, they found that carriers of an ABO variant called rs687289 A allele had a marginally higher risk of heart trouble during high PM2.5 concentrations.
“The primary mutation we studied differentiates between O blood types and non-O, which includes positive and negative A, B, and AB blood types,” says Horne.
“The one that’s been found in genetic studies to be lower risk is O. The other three were higher risk.”
That said, everybody’s level of risk appears to rise when PM2.5 concentration rises above the threshold of 25 micrograms of fine particles per cubic metre of air – it’s just that the risk goes up more for people with non-O blood types.
“At levels higher than 25 micrograms per cubic metre of pollution, the increase in risk is linear, while below that level there’s little if any difference in risk.”
For each 10 additional micrograms of PM2.5 particles per cubic metre, risk for people with non-O blood types goes up by 25 percent, whereas for people with O blood it only goes up by 10 percent.
It’s not the only time recently that blood types have been linked with these kind of cardiac problems.
A study presented in April analysed more than 1.3 million people and also found that people with non-O blood types stood a higher risk of cardiovascular events including heart attacks and stroke, although it did not establish what causal mechanisms were behind the pattern.
In reference to the latest research, the team says the new findings aren’t anything to panic over, but are worth being aware of.
“In the information we provide to our patients about pollution, we try to stress that they can do something about it to reduce their risks,” Horne says.
“Stay indoors out of pollution. Exercise indoors. And make sure they’re compliant with taking their heart medication to reduce their risk.”
The findings were presented this week at the American Heart Association’s Scientific Sessions 2017 conference in Anaheim, California.
With just a few days left for pharmacovigilance (PV) system to become a mandatory in-house mechanism for all pharmaceutical manufacturing units, the Indian Pharmacopoeia Commission (IPC) has started training programs to the people in the industry on how to implement the system.
Like any other facility in a manufacturing unit, PV will also become a legal requirement of a company from January 2018.
In Tamil Nadu, the officers of the IPC from New Delhi, have given training to 120 industry people hailing from various districts in the state. Similar training was also provided to the manufacturers and other staff of the pharma companies in Pondicherry, where 80 people were benefited. In a two days program arranged by TN IPA along with IPC, total 200 industry personnel were able to clear their doubts on the new ADR reporting mechanism.
The officers said, from January 2018, every industrial unit must have the mechanism for reporting ADR of their products. The PV system, which is set up based on sub para (2) of Para 28 of Schedule M of Drugs and Cosmetics Act and Rules, reports of serious adverse drug reactions resulting from the use of a drug, along with comments and documents, should be henceforth reported to the concerned licensing authority or to the National Coordination Centre of the PvPI.
Dr. Rishi Kumar, senior pharmacovigilance associate at IPC, was the scientific officer delegated by the Commission to educate the industry people in Chennai and in Pondicherry. He said the ministry of health has amended Schedule Y of the Drugs & Cosmetics Rules 1945, in which pharmacovigilance is one of the legal obligations for the marketing authorization holders.
In his address, he said the PV system, set up by the industry, should consist of facilities for collection, processing and forwarding the reports to the licensing authority for information on adverse drug reactions emerging from the use of the drug manufactured or marketed by the applicant (industrial unit). Besides, the system should be managed by qualified and trained personnel, and the officer in charge of the collection and processing of data must be a medical officer or a pharmacist trained in ADR reporting.
The PV system will comply with the legal requirements for pharmacovigilance tasks and responsibilities. It will prevent harm from adverse reactions in humans arising out of the use of authorised medicinal products, promote the safe and effective use of medicinal products and contribute to the protection of patients and public health.
TN IPA president Dr. S Manivannan presided over the meeting held in Chennai. J Jayaseelan, chairman of TN IDMA, the former president of IDMA, SV Veeramani, M Rajaratinam and Revichandran were among others who spoke on the occasion.
Throughout our lifetimes, our cells divide to create new cells to keep the body running, ensuring a steady supply of biological building blocks. This process not only protects against illness, it could also help fight cancer cells, according to new research.
The latest study uses mass spectrometry to analyse the way this DNA replication is regulated to keep it running smoothly – scientists have been able to precisely map the flow of nucleotides, the basic units of DNA and RNA.
And the team from the University of Copenhagen in Denmark says that by tweaking the chemical signalling that’s going on inside these cells, we could potentially cause cancer cells to crash and burn by replicating too quickly without any brakes.
“We can see that these processes follow the same periodic rhythm,” says one of the researchers, Jiri Lukas.
“We found a mechanism that instantly slows down DNA-replication when RNR, the nucleotide factory, gets out of that rhythm, but well before the nucleotide supply becomes critically low.”
In other words, when the ribonucleotide reductase (RNR) enzyme isn’t producing enough nucleotide units, a message gets passed up the chain to slow down DNA replication too.
That’s vital as cells divide – if the DNA information isn’t exactly the same in both of the newly split cells, then our genetic code gets scrambled, which can lead to numerous diseases in the body.
A protein called PRDX2 was identified by the researchers as the chemical messenger involved, slowing down cell (and DNA) copying when there’s a bottleneck further up the chain. Eventually, nucleotide production can catch up again.
The end result is there are always enough nucleotides to ensure the DNA gets accurately copied. The overall process is well-known, but this is the first study to really examine how nucleotide production and cell division regulate their speed.
So how does all this apply to cancer? Well, cancer cells don’t happen to like speedy division and replication, and if we can switch off the chemical signalling that warns them about nucleotide slowdowns, they might produce enough errors to kill themselves off.
“We found that cancer cells copy their DNA rather slowly, because they have abnormal genomes and replicating DNA has to overcome many obstacles,” explains one of the team, Kumar Somyajit.
“When we remove their ability to copy their genomes slowly, the cancer cells die because they cannot cope with too many bumps on their DNA templates.”
It’s almost like putting the cancer cell production line into overdrive – at that speed the cancer cells, which are more complex than normal, can’t properly spread themselves.
Any kind of treatment based on these findings is still a long way off, but we now understand more about this most crucial of biological functions – and that’s going to help us both prevent disease and treat disease in the future.
The good news is it’s not the only line of attack we’ve got. A new type of cancer immunotherapy, where a person’s own cells are used to attack the disease, was approved by the FDA earlier this year.
Meanwhile, in September researchers working in the UK announced they had developed a new type of cancer cell suicide mechanism. It works in the lab, and the challenge now is to see if the same effects can be reproduced in humans.
All of which gives us hope that better and more effective cancer treatments are well on their way.
The research has been published in Science.