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Incorporating continuing education into single-drug REMS: Exploring the challenges and opportunities


The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18 titled, “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

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Image Source: © Joshua Lott / Reuters
       




drug

Detoxifying Colombia’s drug policy

Colombia’s counternarcotics policy choices have profound impact on consolidating peace in the wake of the 2016 peace deal with the Revolutionary Armed Forces of Colombia — People’s Army (Fuerzas Armadas Revolucionarias de Colombia — Ejército del Pueblo, FARC) and on the building of an effective state. Strategies of forced or voluntary eradication of coca crops…

       




drug

What coronavirus means for online fraud, forced sex, drug smuggling, and wildlife trafficking

Possibly emerging as a result of wildlife trafficking and the consumption of wild animal meat, COVID-19 is influencing crime and illicit economies around the world. Some of the immediate effects are likely to be ephemeral; others will take longer to emerge but are likely to be lasting. How is the COVID-19 outbreak affecting criminal groups,…

       




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Drugs and drones: The crime empire strikes back


Editors’ Note: Organized crime actors have increasingly adopted advanced technologies, with law enforcement agencies adapting accordingly. However, the use of ever fancier-technology is only a part of the story. The future lies as much behind as ahead, writes Vanda Felbab-Brown, with criminal groups now using primitive technologies and methods to counter the advanced technologies used by law enforcement. This post was originally published by the Remote Control Project, a project hosted by the Oxford Research Group.

The history of drug trafficking and crime more broadly is a history of adaptation on the part of criminal groups in response to advances in methods and technology on the part of law enforcement agencies, and vice versa. Sometimes, technology trumps crime: The spread of anti-theft devices in cars radically reduced car theft. The adoption of citadels (essentially saferooms) aboard ships, combined with intense naval patrolling, radically reduced the incidence of piracy off Somalia. Often, however, certainly in the case of many transactional crimes such as drug trafficking, law enforcement efforts have tended to weed out the least competent traffickers, and to leave behind the toughest, meanest, leanest, and most adaptable organized crime groups. Increasingly, organized crime actors have adopted advanced technologies, such as semi-submersible and fully-submersible vehicles to carry drugs and other contraband, and cybercrime and virtual currencies for money-laundering. Adaptations in the technology of smuggling by criminal groups in turn lead to further evolution and improvement of methods by law enforcement agencies. However, the use of ever fancier-technology is only a part of the story. The future lies as much behind as ahead (to paraphrase J.P. Wodehouse), with the asymmetric use of primitive technologies and methods by criminal groups to counter the advanced technologies used by law enforcement.

The seduction of SIGINT and HVT

The improvements in signal intelligence (SIGINT) and big-data mining over the past two decades have dramatically increased tactical intelligence flows to law enforcement agencies and military actors, creating a more transparent anti-crime, anti-terrorism, and counterinsurgency battlefield than before. The bonanza of communications intercepts of targeted criminals and militants that SIGINT has come to provide over the past decades in Colombia, Mexico, Iraq, Pakistan, Afghanistan, and other parts of the world has also strongly privileged high-value targeting (HVT) and decapitation policies-i.e., principally targeting the presumed leaders of criminal and militant organizations.

The proliferation of SIGINT and advances in big-data trawling, combined with some highly visible successes of HVT, has come with significant downsides. First, high-value targeting has proven effective only under certain circumstances. In many contexts, such as in Mexico, HVT has been counterproductive, fragmenting criminal groups without reducing their proclivity to violence; in fact, exacerbating violence in the market. Other interdiction patterns and postures, such as middle-level targeting and focused-deterrence, would be more effective policy choices. 

A large part of the problem is that the seductive bonanza of signal intelligence has lead to counterproductive discounting of the need to:

  1. develop a strategic understanding of criminal groups’ decisionmaking—knowledge crucial for anticipating the responses of targeted non-state actors to law enforcement actions; Mexico provides a disturbing example;
  2. cultivate intelligence human intelligence assets, sorely lacking in Somalia, for example;
  3. obtain a broad and comprehensive understanding of the motivations and interests of local populations that interact with criminal and insurgent groups, notably deficient in Iraq, Afghanistan, and Pakistan; and 
  4. establish good relationships with local populations to advance anti-crime and counterinsurgency policies, such as in Colombia where drug eradication policy antagonized local populations from national government and strengthened the bonds between them and rebel groups. 

In other words, the tactical tool, technology—in the form of signal intelligence and big-data mining—has trumped strategic analysis. The correction needed is to bring back strategic intelligence analysis to drive interdiction targeting patterns, instead of letting the seduction of signal data drive intelligence analysis and targeting action. The political effects, anticipated responses by criminal and militant groups, and other outcomes of targeting patterns need be incorporated into the strategic analysis. Questions to be assessed need to include: Can interdiction hope to incapacitate—arrest and kill—all of the enemy or should it seek to shape the enemy? What kind of criminals and militants, such as how fractured or unified, how radicalized or restrained in their ambitions, and how closely aligned with local populations against the state, does interdiction want to produce? 

Dogs fights or drone fights: Remote lethal action by criminals

Criminal groups have used technology not merely to foil law enforcement actions, but also to fight each other and dominate the criminal markets and control local populations. In response to the so-called Pacification (UPP) policy in Rio de Janeiro through which the Rio government has sought to wrestle control over slums from violent criminal gangs, the Comando Vermelho (one of such gangs), for example, claimed to deploy remote-sensor cameras in the Complexo do Alemão slum to identify police collaborators, defined as those who went into newly-established police stations. Whether this specific threat was credible or not, the UPP police units have struggled to establish a good working relationship with the locals in Alemão.

The new radical remote-warfare development on the horizon is for criminal groups to start using drones and other remote platforms not merely to smuggle and distribute contraband, as they are starting to do already, but to deliver lethal action against their enemies—whether government officials, law enforcement forces, or rival crime groups. Eventually, both law enforcement and rival groups will develop defenses against such remote lethal action, perhaps also employing remote platforms: drones to attack the drones. Even so, the proliferation of lethal remote warfare capabilities among criminal groups will undermine deterrence, including deterrence among criminal groups themselves over the division of the criminal market and its turfs. Remotely delivered hits will complicate the attribution problem— i.e., who authorized the lethal action—and hence the certainty of sufficiently painful retaliation against the source and thus a stable equilibrium. More than before, criminal groups will be tempted to instigate wars over the criminal market with the hope that they will emerge as the most powerful criminal actors and able to exercise even greater power over the criminal market—the way the Sinaloa Cartel has attempted to do in Mexico even without the use of fancy technology. Stabilizing a highly violent and contested—dysfunctional—criminal market will become all the more difficult the more remote lethal platforms have proliferated among criminal groups.

Back to the past: The Ewoks of crime and anti-crime

In addition to adopting ever-advancing technologies, criminal and militant groups also adapt to the technological superiority of law enforcement-military actors by the very opposite tactic—resorting asymmetrically to highly primitive deception and smuggling measures. Thus, both militant and criminal groups have adapted to signal intelligence not just by using better encryption, but also by not using cell phones and electronic communications at all, relying on personal couriers, for example, or by flooding the e-waves with a lot of white noise. Similarly, in addition to loading drugs on drones, airplanes, and submersibles, drug trafficking groups are going back to very old-methods such as smuggling by boats, including through the Gulf of Mexico, by human couriers, or through tunnels. 

Conversely, society sometimes adapts to the presence of criminal groups and intense, particularly highly violent, criminality by adopting its own back-to-the-past response—i.e., by standing up militias (which in a developed state should have been supplanted by state law enforcement forces). The rise of anti-crime militias in Mexico, in places such as Michoacán and Guerrero, provides a vivid and rich example of such populist responses and the profound collapse of official law enforcement. The inability of law enforcement there to stop violent criminality—and in fact, the inadvertent exacerbation of violence by criminal groups as a result of HVT—and the distrust of citizens toward highly corrupt law enforcement agencies and state administrations led to the emergence of citizens’ anti-crime militias. The militias originally sought to fight extortion, robberies, theft, kidnapping, and homicides by criminal groups and provide public safety to communities. Rapidly, however, most of the militias resorted to the very same criminal behavior they purported to fight—including extortion, kidnapping, robberies, and homicides. The militias were also appropriated by criminal groups themselves: the criminal groups stood up their own militias claiming to fight crime, where in fact, they were merely fighting the rival criminals. Just as when external or internal military forces resort to using extralegal militias, citizens’ militias fundamentally weaken the rule of law and the authority and legitimacy of the state. They may be the ewoks’ response to the crime empire, but they represent a dangerous and slippery slope to greater breakdown of order.

In short, technology, including remote warfare, and innovations in smuggling and enforcement methods are malleable and can be appropriated by both criminal and militant groups as well as law enforcement actors. Often, however, such adoption and adaptation produces outcomes that neither criminal groups nor law enforcement actors have anticipated and can fully control. The criminal landscape and military battlefields will resemble the Star Wars moon of Endor: drone and remote platforms battling it out with sticks, stones, and ropes.

Publication: Oxford Research Group
      
 
 




drug

What coronavirus means for online fraud, forced sex, drug smuggling, and wildlife trafficking

Possibly emerging as a result of wildlife trafficking and the consumption of wild animal meat, COVID-19 is influencing crime and illicit economies around the world. Some of the immediate effects are likely to be ephemeral; others will take longer to emerge but are likely to be lasting. How is the COVID-19 outbreak affecting criminal groups,…

       




drug

The State of Drug Safety Surveillance in the U.S.: Much Improved, More to Come


When a new drug is approved in the United States, it is virtually impossible to know all of the risks that a population may encounter when using that product. Even though the U.S. Food and Drug Administration (FDA) requires drug manufacturers to meet rigorous standards demonstrating the drug’s safety and effectiveness for its intended use, once approved, drugs can be used by many more patients than were studied in clinical trials. This may include patients with unique clinical conditions, differing health status, ethnicity, age, or other characteristics which were not well-represented before the drug’s approval. Further, the drugs themselves can be used in different ways and in different settings than were studied. Until recently, FDA did not have the necessary tools and data access to rapidly and consistently track the risks of serious side effects of regulated drugs after approval. Recognizing this challenge, FDA has developed a pilot system to make the best use of available electronic health data using a new data and research network capable of evaluating the safety of medical products in the U.S. 

Authorized by the Food and Drug Administration Amendments Act (FDAAA) of 2007, this pilot is known as Mini-Sentinel, and is part of FDA’s larger Sentinel Initiative. Sentinel was envisioned as a national electronic system to track the safety of regulated medical products, through the use of existing health insurance claims and electronic clinical data that are generated as part of routine care. In the four years since its inception, Mini-Sentinel has made tremendous progress toward developing this system. Mini-Sentinel is comprised of insurance claims and clinical data from 18 participating data-partners, including some of the largest private health plans in the United States. In order to best protect patient privacy, the data from each partner is maintained behind each individual health plan fire-wall. This “distributed data” approach allows a single coordinating center to distribute FDA safety questions in the form of “queries,” to each of the participating data partners to be run against their own data. Aggregated summary results are then sent back to the coordinating center for final analysis. This process allows FDA to access data that can help in addressing safety questions in near real-time.  

Through Mini-Sentinel, FDA has the capability to better understand the safety outcomes using electronic health care data of approximately 169 million covered lives. This accumulation of data represents the capture of 382 million person-years of observation time and billions of prescription dispensings.[1] Examples of the types of safety questions that have already been addressed by Mini-Sentinel include the following:

  • Safety concerns with drugs used to treat high blood pressure and the incidence of angioedema;
  • Safety concerns with a new diabetes treatment and the incidence of heart attacks; and
  • Impact of FDA regulatory actions (i.e. drug label changes) intended to mitigate serious risks of drugs.

The Mini-Sentinel pilot has demonstrated substantial progress and has proven to be a very useful tool for FDA, largely due to the strong partnerships developed between FDA, collaborating academic institutions, and private health plans. However, in order to ensure continued progress and long-term sustainability, it will be critical for progress to continue in several key areas. 

First, continued methods development and data understanding will be necessary to ensure FDA has access to the most innovative tools. The field of pharmacoepidemiology and drug safety surveillance is still young and the continued development of better study designs and analytic tools to quantify risks of serious adverse events, while accounting for many confounding factors that are inherent on observational data, will be critical. Further, as health reforms impact that way health care is delivered and financed (e.g., development of accountable care organizations and increased use of bundled payments), the electronic health data will change. It will be important to focus efforts on understanding how these changes will impact data used for safety evaluations. 

Second, it is clear that Sentinel’s contributions may extend well beyond FDA’s medical product assessments. The tools and infrastructure that have been developed by FDA over the last four years could be used as a platform to establish a national resource for a more evidence-based learning health care system. This system will enable a better understanding of not only the risks, but also benefits and best uses, of drugs in the post-market settings. 

FDA has initiated steps to ensure the long-term sustainability and impact of Sentinel infrastructure and tools. Within the next few years, FDA has proposed that Sentinel be transitioned into three main components: the Sentinel Operations Center, the Nation Resource Data Infrastructure, and the Methodological Resource for Medical Product Surveillance using Electronic Healthcare Databases. FDA has indicated that while the Sentinel Operations Center will continue to serve as FDA’s portal to the distributed database, the Nation Resource Data Infrastructure could potentially be used by other groups to support broader evidence generation. Potential groups with interest in improving our understanding of the impact of medical products and who could benefit from this framework include the National Institutes of Health, the Regan-Udall Foundation, the Patient Centered Outcomes Research Institute, and other possible stakeholder groups, such as the private industry. 

Collectively, these components will ensure that FDA continues to have the tools to engage in medical product surveillance, while ensuring the long-term sustainability of the system. In just four years, the Sentinel Initiative has laid the groundwork to transform how FDA, and the nation, benefits from electronic health care data. This network continues to foster a community of stakeholders committed the evidence generation, which will ultimately contribute to a learning health care system.

New Advances in Medical Records Reflects the Realities of the U.S. Healthcare System

For more information on these issues, including discussion by leaders from Sentinel stakeholders, please visit the Sentinel Initiative Public Workshop event page. There you will find archived video, presentations, and further reading.



[1] http://mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx

Video

Authors

      
 
 




drug

Louisiana’s prescription drug experiment: A model for the nation?

The high cost of prescription drugs has become an increasingly pressing concern for policymakers, insurers, and families. New drugs—like those now available for hepatitis C— offer tremendous medical benefits, but at a cost that puts them out of reach for many patients. In an effort to address the affordability dilemma, the Louisiana Department of Health…

       




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Organic gardening helps inmates kick drug addiction

Physically and mentally, growing plants without chemicals has a transformative effect.




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Irish drugstore is built to Passivhaus standard

Passivhaus or Passive House does not mean they are just houses.




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Are Drugs Destroying the Amazon?

When I wrote about the cocaine industry destroying rainforests, many commenters argued that really it is the prohibition of drugs—not the drugs themselves—that create these negative consequences. That debate will most likely get stirred up




drug

Mussels test positive for opioids and chemo drugs

Over the course of three months, previously clean mussels picked up a slew of contaminants from the waters of Puget Sound.




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No more dental fillings? Drug found to stimulate tooth regrowth

Researchers have found that an Alzheimer's drug triggers dentine regrowth, eliminating need for fillings.




drug

The very surprising way common insomnia drugs can be fatal

The FDA has announced new (and stronger) warning requirements for certain prescription insomnia medications. Here's why.




drug

From World's Drug Capital to Green Oasis: The Incredible Story of Medellin, Colombia

Medellin, Colombia: This city's name used to strike fear in peoples' hearts. In the 80s and early 90s, it was known as the drug capital of the world and the most violent city on the planet.But Medellin has come a tremendous distance in less than a decad




drug

From World's Drug Capital to Green Oasis: The Incredible Story of Medellin, Colombia (Slideshow)

Medellin, Colombia: This city's name used to strike fear in peoples' hearts. In the 80s and early 90s, it was known as the drug capital of the world and the most violent city on the planet.




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NEW DATA EVALUATING THE BOSTON SCIENTIFIC ELUVIA™ DRUG-ELUTING VASCULAR STENT SYSTEM DEMONSTRATE 94.4 PERCENT PRIMARY PATENCY RATE AT NINE MONTHS - Hear from Professor Stefan Müller-Hülsbeck, M.D., PhD, MAJESTIC trial principal investigator

Hear from Professor Stefan Müller-Hülsbeck, M.D., PhD, MAJESTIC trial principal investigator





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Pfizer to outsource some drug production, focus on coronavirus vaccine

Pfizer said on Friday it is in talks to shift more of its medicine production to outside contractors as it prepares for large-scale production of an experimental vaccine to prevent Covid-19, should it prove safe and effective.




drug

JPMorgan health-care expert: Mergers, drug pricing and 2019 outlook will be leading topics at conference

Jim Cramer gets a preview of J.P. Morgan's upcoming health-care conference with the firm's top health-care analyst, Lisa Gill.




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Drug name...or Star Wars planet?

Prescription drugs have weird names. But so do planets in the Star Wars universe. We asked CNBC staffers whether they could tell the difference.




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Repurposing existing drugs to treat coronavirus will likely be quicker than a vaccine, scientists claim

A team of international experts said that while there was no "magic bullet" for treating Covid-19, successfully identifying a drug that could treat the virus was likely to take less time than rolling out a vaccine.




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Scientific American: As Trump Touts Dangerous Cures, Here's What We Know About COVID-19 Drug Tests

President Trump dangerously suggested injecting disinfectants could help patients sick with the coronavirus, then said he was being "sarcastic." But his remarks led to a spike in calls to helplines about taking disinfectants. We look at "What We Know About the Most Touted Drugs Tested for COVID-19" with Tanya Lewis, associate editor for health and medicine at Scientific American.




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Profiting from the Pandemic: Will Pharmaceutical Giants Use Patents to Limit Access to COVID Drugs?

As the number of confirmed COVID-19 cases worldwide approaches 4 million and the pandemic could be with us for months or years, we look at who can access drugs like remdesivir, being developed by pharmaceutical giant Gilead, which has the patent for the drug and is poised to make massive profits. We look at how much drugs like remdesivir will cost, and who can access them, with writer Achal Prabhala, coordinator of the AccessIBSA project, which campaigns for access to medicines in India, Brazil and South Africa.




drug

Three Ways to Make Coronavirus Drugs in a Hurry

With no time to make treatments from scratch, researchers search for existing compounds that deflect harm

-- Read more on ScientificAmerican.com




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Shortcuts in COVID-19 Drug Research Could Do Long-Term Harm, Bioethicists Worry

Compassionate use of experimental medicine needs to coexist with scientific rigor to help patients, researchers write in the journal Science

-- Read more on ScientificAmerican.com






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Gangs take bigger risks to smuggle drugs into lockdown Britain

Consignments are being moved in bulk across borders as Covid-19 cuts off normal routes, say police

Organised crime groups are taking increasingly audacious risks as they attempt to smuggle large quantities of drugs into lockdown Britain, senior police figures say.

Analysing the latest operations of transnational criminal networks, the National Crime Agency’s head of drug threat said that police were making more significant seizures during the pandemic than normal.

Continue reading...




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Pet food can contain drug-resistant bacteria that may pass to humans

Some dogs and cats may be passing gut microbes to their owners that withstand last-resort antibiotics, which can be needed to fight off pneumonia from a coronavirus infection




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Red light could be used to precisely target rheumatoid arthritis drugs

People with rheumatoid arthritis often take medicines that can have damaging side-effects, but a system that uses red light to deliver drugs exactly where they are needed could help




drug

2.9 kg of ephedrine drug seized from a courier hub in Navi Mumbai

On the basis of the specific input, the NCB Mumbai unit seized 2.9 kg white crystalline powder suspected to be ephedrine, from a courier hub in Navi Mumbai on March 2, 2019. The two parcels which contained ephedrine concealed in them were booked by a lady who was arrested on last Saturday in connection with a seizure of 280 gm of amphetamine.

The said consignments were destined for New Zealand and Zambia. Further investigations are under process to identify the source of the seized drugs.

Ephedrine is a controlled substance in India which has legitimate industrial usage, however, it can also be used in the illicit drug market for the manufacturing an illicit drug.

Dealing in drugs may attract punishment of rigorous imprisonment up to 20 years and a financial penalty of up to Rs. 2 lakhs and even can even lead, to being awarded a death penalty.

Catch up on all the latest Crime, National, International and Hatke news here. Also download the new mid-day Android and iOS apps to get latest updates





drug

Unproven herbal remedy against COVID-19 could fuel drug-resistant malaria, scientists warn

Several African leaders have expressed an interest in a plant-based tonic developed in Madagascar




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War against drug addicts! Naigaon Kolis start campaign to uproot menace

Members of koli society in Naigaon are fed up with the influx of drug addicts in their area. Triggered after the alleged suicide of a young junkie from their society a few days ago, they have decided to catch the menace in their nets, so to speak.

They have started rounding up druggies in the area and, one by one, taking them to be admonished in front of their parents, in a bid to make the elders aware what their kids are up to and work towards putting a stop to it.

Around 400 men and women from Amol Nagar, Parera Nagar, Vijaya Park, Mariyam Nagar, Koliwada and Kuchuda have started patrolling the area at night and have, so far, caught 15-odd drug addicts red-handed. The youths, after being taken to their families, were warned that they would be taken to the police if they were caught again.

Fighting the good fight
A social worker from the area, Ashish Vertak, said, "The population of Naigaon has increased in the past few years and is set to rise further with hundreds of complexes and colonies under construction. While this has brought a lot of people from other parts of the city to stay here, their bad habits have followed too.

"We have seen people sitting by the seashore drinking and getting high at night; many of them are youths from our society. We are simple fisherfolk and don't want such nuisance in our area. Hence, we decided to fight the root of the disease and started communicating with others from the society."


Hundreds of residents have started patrolling the area at night. Pics/Hanif Patel

The residents have created a WhatsApp group and also formed a sangathan, named Naigaon Koli Vyasanmukti Thalaval. The latter's founder members are Yogesh Bhayandarkar, Mahindra Bhayandarkar, Nivrutti Ghusekar, Satish Koli, Pravin Vartak, Sai Bokale, Nandakumar Vaity, Hemant Holekar, Hemant Masnekar, Sada Godavarikar, and Vijay Vaity.

Saving the children
Mayur Bhayandarkar,
sangathan member
'Over the past several years, we have seen more and more youths getting addicted to drugs. Through this campaign, we are trying to save our children and make
them aware how narcotics will destroy their lives. If we don't do this, who will? All we want is for them to come out of this rut'

Satish Koli,
founder member of sangathan
'After seeing teenagers fall prey to the habit, we decided to fight to remove this disease from the root. We held discussions with other locals and started this campaign. We are now planning to meet police officers and request them to take strict action against those involved in selling drugs and destroying the future of our children'

Catch up on all the latest Mumbai news, crime news, current affairs, and also a complete guide on Mumbai from food to things to do and events across the city here. Also download the new mid-day Android and iOS apps to get latest updates





drug

Mumbai Crime: Police arrests main accused in 20 kg drug seizure case

The Amboli police on Tuesday arrested the main accused in the 20 kg ephedrine seizure case. On New Year's Eve, the Amboli police seized 20 kg ephedrine worth Rs 3 crore from Jogeshwari. Two people were arrested earlier. Now, Amboli police have also nabbed the main accused in the case.

The accused has been identified as Shankar Narsaiyya Madderla (49), who is the owner of Venus chemical and drugs Pvt Ltd, based in Karnataka. He was arrested from Hyderabad by the team lead by PI Daya Nayak. Before this, in 2013, the accused was arrested for possessing 250 kg ephedrine which was seized by the Narcotics Control Bureau.

On New Year Eve, the Amboli Police busted a drug haul which was supposed to be supplied at high profile parties across the city. Around 20 kg ephedrine worth more than 3 crores has been seized and the two suppliers were arrested on the same day.

Both of them had previous records of supplying drugs for high profile parties. One of them was a class 4 custom officer who was fired in 2013 after he was found smuggling drugs. Cops believed that this is a gang which mostly operates for big events, especially New Year.

The accused, who were arrested earlier, have been identified as Mohammed Ismail Gulamhusaind, 45, who hails from Hyderabad and Dayanand Manik Muddanar, 32, who was a resident of Vasai. 

An officer from Amboli Police said, "The accused arrested from Hyderabad has supplied drugs to the accused who have already been arrested earlier. We are probing as to where the drugs were supposed to be delivered. The accused has been arrested under various sections of the NDPS Act."

Catch up on all the latest Crime, National, International and Hatke news here. Also download the new mid-day Android and iOS apps to get latest updates





drug

Silicon Valley trend of using drugs in mini doses daily is catching up in India

Over a phone call from Kolkata, Vikram Rajan*, an audio engineer and guitarist formerly based out of Mumbai, wants us to listen to a track that he has composed. It's available on Soundcloud and, as we stream it, we more or less agree that its flavour of electronica-jazz could accompany a languorous Sunday evening. "For a long time, I had been unable to come up with something good. And, then, I composed this around March while I was microdosing and sometimes, megadosing on acid," says Rajan.

The 33-year-old is referring to a way-of-life that's effectively snapping the ties between drug abuse and the creative arts. This is a lifestyle experiment that some of the brightest techies in Silicon Valley are engaging in, and has got psychiatrists and anti-drug crusaders distraught. "From a 100 mics paper, I take about 20 mics, twice a week, giving the doses a 2-3 days gap. The effects of acid last for about six hours for me," says Rajan, who started experimenting with drugs as a teenager.


After a litany of prescriptions failed to control her mood swings and depression, Ayelet Waldman found relief in LSD. The former federal public defender authored A Really Good Day: How Microdosing Made a Mega Difference in My Mood, My Marriage, and My Life, in 2016. She wrote: "(It) made room in my mind not necessarily for joy, but for insight. It allowed me a little space to consider how to act in accordance with my values, not just react to external stimuli. This, not the razzle-dazzle of pleasure, was its gift." Pic/Getty Images

In need of a quick glossary before we proceed? Acid is officially called Lysergic Acid Diethylamide (LSD), a psychedelic drug banned in India, the possession of which can lead to imprisonment from one to 20 years under the Narcotic Drugs and Psychotropic Substances Act. LSD is often illegally sold in the form of stamps, with the hallucinogen embedded on blotter paper. Mics is micrograms, that's one-millionth of a gram. A microdose is when you have about one-tenth of a recreational 'party' dose, which starts at about 200 mics.

"With microdosing, you are not tripping — this is not a trip. The euphoria isn't there. It's not about feeling good, it's about calmness," continues Rajan. Microdosing first hit headlines after Steve Jobs' passed away in 2011, when a number of inspiring tales on how LSD became the new go-to substance for enhanced performance by tech employees hit the net. Espresso became passé. 'Flow states' were the new yoga. While Jobs did more than just microdose (he was known to have gone all the way), Silicon Valley techies are reportedly doing acid in quantities such that their effects are 'sub-perceptual', where you won't "see stuff" but you harness its "positive" effects.


A dropper with CBD cannabis oil, used for medicinal purposes. Initial research in the area has shown that patients can reap the benefits without its full-blown 'high' effects

Paul Austin, founder of The Third Wave, where you will find a manifesto on microdosing, defines it as, "the act of integrating sub-perceptual doses of psychedelics, such as LSD or Psilocybin Mushrooms, into your weekly routine for higher levels of creativity, more energy, increased focus, and improved relational skills." The Third Wave, according to Austin, follows the first two waves, in which psychedelics were used indigenously for thousands of years, and then, in the 60s and 70s, when they were a part of American counterculture. Austin writes that The Third Wave is upon us, "brought about by recent developments in cannabis legalisation and psychedelic research — and it will change the way mainstream culture perceives psychedelic use."

Classically acid, now weed
For Rajan, however, it wasn't sub-perceptual Silicon Valley that got him to ration his 100 mics stamps, each of which costs about R2,000. It was simply a matter of demand and supply. Mumbai had better stuff than Kolkata, and more availability. Microdosing has classically been associated with LSD, but now has been extended to cannabis as well. Austin's website has guided instructions for microdosing on nine drugs, including cannabis and ayahuasca. Mumbai-based communications officer Varna Kumar*, 25, smokes a mandatory post-work joint every night in order to cope with anxiety and panic attacks. "I feel I have worked enough through the day, without much time to understand what I am going through. At night, when I am by myself, I smoke a small joint to achieve REM sleep," she says. The joint, a mix of two strains, sativa and indica, help her body relax. It makes her anxiety seem defeatable, is how she describes it. Her counsellor, who also smokes up, has not advocated this as a coping mechanism. "It's different from when I am smoking up recreationally during the weekend or when I am away on a vacation. I will do three to four joints when I have nothing to take care of," she says.

Rajan doesn't buy it. He offers an example that may be best contemplated upon or contested by those who have done both LSD and cannabis. "With weed, you are either stoned, or you are not. You will need to smoke up as soon as the high wears off. When you get stoned, your mind becomes passive. But, microdosing on LSD allows you to be calm enough to multitask, allowing a lot of information to be funnelled into your brain easily. You are alert, you are awake," he says, adding, "What is LSD all about? When you start tripping, you see a shift in perspective." You need not agree with Rajan, as he himself says, "We are all chemical reactions", with each of us reacting differently to drugs.

Covert, not convenient
Microdosing will often be compared to that hard-earned and well-deserved one drink after work hours. It's nothing like that, microdosers will tell you, and so will psychiatrists and rehab therapists. For one, microdosing has none of the ease of getting a drink at your favourite pub. You will be persecuted in your search for your creative spell or a calmer mind. Next, it's not even like getting a drug prescription that your GP advises you to have for the course of a fortnight. Kumar and Rajan know it all too well. Microdosing means self-experimentation, knowing when you are crossing the threshold into recreational high dosages. Cannabis, for instance, is best microdosed through edibles, like space brownies, which are available legally in some parts of the world. It's probably the reason why microdosing is yet to take on Silicon Valley proportions in India. "Here, we don't often get to know what strain of cannabis we are using, or where it is sourced from," says Kumar. Saying "this stuff is craazzyy" is, therefore, not enough if you want to microdose. "If you are living with family, it's hard to make edibles. All this means that the convenience factor associated with a drink is not the same with this covert process," she adds.

The idea of the junkie, with matted hair and piercings, is a stereotype that microdosing is replacing. It's no longer cool to be a junkie, especially in the vegan-conscious, gluten-free, aerial yoga health lifestyle that we are seeing around us. Microdosing may be the most metrosexual among the various kinds of drug use, and it carries the allure of high-performance and alleviation of mental health issues, with published studies to back these up. But doctors and psychiatrists are warning us about the glamourisation of microdosing, even as research to mainstream it for mental health is going on. Psychiatrist Dr Samir Parikh says, "Microdosing encourages the thought process that you need a drug for enhanced performance or better creativity or to calm your nerves. This will mean that students microdose before exams, athletes before a run, couples before a wedding, and the next thing you know, because someone has to attend a birthday bash. There is no end to important situations in life. We are making people believe that a student could have scored an additional five marks in an exam had she just microdosed. Can you imagine the perils of this philosophy?" he says. He backs this up with the number of risks associated with prolonged drug abuse, such as a permanent change in brain circuitry, cerebrovascular diseases, and panic attacks.

Then there are those who will argue that moderation as 'one-drink-a-day' is more addictive than the weekend drunken revelry. Is addiction, even in microdoses, still addiction, where the brain searches for rewards compulsively? Kumar disagrees. "Microdosing is the difference between dependence and addiction. For example, I am dependent on a cab to take me to the station. Can I get through my day without it? Can I walk to the station? Yes, I can. That's what microdosing is. I can get through my day without a joint, but a joint just makes it a little easier," she says.Psychiatrist Dr Yusuf Merchant, who runs a rehabilitation centre at Kalyan, says microdoses pose the risk of turning into overdoses. "With any drug, the body learns to metabolise it faster. Which means, that the quantity for a microdose will keep increasing and your hold on reality will keep getting more tangential."

Rajan himself admits to a 'bad trip'. LSD users will tell you that recreational doses are best done in settings that you feel comfortable in, to enjoy, or cope, with the hallucinations. With microdosing, you are headed into your office or your studio to function better. Rajan had once taken more than a microdose, leading him to have a panic attack, the kind where he couldn't even see his hands. The golden rule, he says, is that if you don't go on a full trip, you will never know what a microdose is.

That ailing pain
The push for microdosing is coming from a quarter where its future seems to be most secured — pain management. Mumbai-based homemaker Susheela Kamath*, 48, was diagnosed with stage II breast cancer a couple of years ago, and having undergone nearly a year's worth of chemotherapy and radiation, the accompanying pain and nausea, were all too real. Her daughter provided her with high-grade hash oil. The dealer provided her with a tiny spoon, the kind that you are handed inflight to stir your coffee with. "I had to initially understand, through a lot of trial and error, by gauging my mother's mood, on what a microdose for her would be. Hash oil is very potent," says the daughter.

A little drop of it on her toast every day, helped Kamath cope with pain. "From the third day to the tenth day after chemotherapy, my mother would have about three to four spoons a day, and, on other days, just half a spoon," says the daughter. Coping with the pain meant she could do more during her day, and also have an appetite. Now, months after she has wound up chemotherapy and radiation, she has bid adieu to the prescription drugs that came along with it, and the hash oil as well, without yearning for that high. Unfortunately, unlike medical grade marijuana that is available in some countries, and still not permitted in India, the daughter did not know if the oil had cannabidiol (CBD), which gives marijuana its medical properties, or tetrahydrocannabinol (THC) which gives you the "high".

Dr Kailash Kothari, interventional spine and pain management specialist at Fortis Hospital, Mulund, says that there is not enough evidence to either prove or disprove that microdosing on cannabis can help with pain management, the way opioids, such as morphine, act on the nervous system. "Do cannabinoids work like tranquilisers or do they have long-term effect? There is not enough research as of now," he says, adding, "Getting dependent on these takes a lot of time and not something that can happen in about 15 days of use." In the meanwhile, you can enjoy a night of quiet or a better track on Soundcloud by rationing your stash. But, is it short-term solace or long-term abuse?

*All names have been changed on request to protect identity





drug

'Hepatitis C drugs may help fight virus'

Several drugs approved for the treatment of hepatitis C viral infection have been identified as potential candidates against COVID-19 caused by the SARS-CoV-2 coronavirus, according to a study based on extensive calculations using supercomputer simulations.

Researchers from Johannes Gutenberg University Mainz (JGU) in Germany simulated the way that about 42,000 different substances listed in open databases bind to certain proteins of SARS-CoV-2, and thereby inhibit the penetration of the virus into the human body or its multiplication. Using the powerful MOGON II supercomputer operated by JGU and the Helmholtz Institute Mainz, the researchers made more than 30 billion single calculations within two months.

They found that compounds from the four hepatitis C drugs simeprevir, paritaprevir, grazoprevir, and velpatasvir have a high affinity to bind SARS-CoV-2 very strongly and may therefore be able to prevent infection. "This computer simulation method is known as molecular docking and it has been recognised and used for years. It is much faster and less expensive than lab experiments," said Professor Thomas Efferth from JGU, lead author of the study published in the Bulletin of the World Health Organization. "As far as we know, we were the first to have used molecular docking with SARS-CoV-2. And it is fantastic news that we have found a number of approved hepatitis C drugs as promising candidates for treatment," Efferth said.

The results are also supported by the fact that both SARS-CoV-2 and the hepatitis C virus are a virus of the same type, a so-called single-stranded RNA virus, explained Efferth. According to the researchers, a natural substance from the Japanese honeysuckle (Lonicera japonica), which has been used in Asia against various other diseases for some time now, might be another strong candidate against SARS-CoV-2. "Our research results now need to be checked in laboratory experiments and clinical studies," said Efferth. Molecular docking had already been used successfully in the search for active substances against the coronaviruses MERS-CoV and SARS-CoV, he added.

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