Every Friday for the past two months, Peter Krykant has parked his white van on Parnie Street in central Glasgow, Scotland, around the corner from a games shop and several art galleries, and waited for people to come by and inject illegal drugs.

Inside the van are two seats and two tables, each with a stainless steel tray and hypodermic needles as well as several biohazard trash cans. The van is also equipped with naloxone, the medication used to reverse an opioid overdose, and a defibrillator. (There are COVID-19 safety precautions, too: hand sanitizer and a box of masks.)

Krykant usually opens the van by 10 a.m., and on this particular day three people were already waiting to get inside. This was something of a surprise, since Scottish police had charged him with obstruction the week before when he refused to open the vehicle to officers, knowing several people were inside taking drugs. He wasn’t sure anyone would come back after that scare.

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Scotland is in the midst of its worst drug crisis on record and one of the worst in the world. The country has tallied five straight years of record-setting drug-related deaths and now holds a per capita death rate three times higher than anywhere else in Europe.

Overdoses are more common in Scotland, by some measures, than even the United States. In 2018, Scotland had nearly 20 drug-related deaths per 100,000 people, compared with 18 deaths in the United States and around five in Ireland, Finland and Sweden.

Krykant is adamant that drug consumption rooms will help slow the rate of overdose deaths in Scotland by allowing drug users to inject under supervision and with naloxone on hand.

Krykant chats easily with several men waiting to be let inside. He asks them what type of drug they’ll be injecting, writes it down and then opens the sliding back door.

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In addition to Krykant, at least one other trained volunteer is on duty; they take turns watching for police and checking on the people inside.

Krykant, a former addict himself, said he had “learned very quickly that harm reduction is the most fundamental thing.”

“People don’t get any more opportunities after they’re dead,” he said.

Drug consumption rooms are facilities that legally allow people to take illicit drugs under the supervision of trained professionals in a sterile environment and with clean equipment. They have been shown to reduce overdose deaths and blood-borne viruses like HIV, decrease public injecting and more quickly connect people to treatment services.

“In all recorded injections that have taken place in these spaces across the world, there has not been one recorded death,” said Andrew McAuley, a public health professor at Glasgow Caledonian University.

The first legal facility opened in Switzerland in the mid-1980s, and over the last three decades they have been established across Europe, Canada and Australia — around 200 in all.

Despite their effectiveness and Scotland’s increasingly dire drug problem, they remain illegal throughout Britain.

The Scottish government has expressed its support, but Westminster has not budged. “We have no plans to introduce drug consumption rooms, and anyone running them would be committing a range of offenses,” a spokesperson for the British Home Office said in a statement.

But Krykant thinks blaming Westminster is an easy out.

“All we’ve been hearing is that it’s the U.K. government’s fault,” he said. “We could have drug consumption rooms in Scotland right now if there was political will.”

With Scotland in control of its own health care and policing — a system known as devolution — Krykant and other drug policy advocates argue that the Lord Advocate, Scotland’s chief public prosecutor, could provide legal cover in the form of a “letter of comfort” stating that drug consumption rooms could operate without fear of criminal prosecution. (The Lord Advocate provided similar guidance this spring for naloxone.)

But he has so far declined to do this, saying the facilities require a legal solution that addresses civil liability and the full range of exemptions from criminal law.

To date, police have not shut down the van, nor have they made any arrests. In a statement, they seemed to suggest they would leave well enough alone — for now, at least.

“The establishment of any form of safe consumption location contravenes the U.K. Misuse of Drugs Act 1971,” an assistant chief constable of Police Scotland, Gary Ritchie, said in a statement. “Any attempt to circumvent the law, as it stands, by providing an unregulated and unlicensed facility may expose already vulnerable people to more risk and harm.”

For Krykant, the goal of the van is to challenge drug policy more than to curb Scotland’s soaring drug deaths.

“We may keep people alive, but this has always been about a push for an official establishment,” he said. “We can’t provide a service for hundreds of people from the back of one transit van.”

Krykant grew up in Falkirk, about 20 miles from Glasgow, and said he was taking drugs on a daily basis by the time he was 11 years old. By 17, he was injecting heroin, and a few years later found himself in Birmingham, England, living on the street and begging for money to fuel his drug habit.

He was eventually approached by an outreach team in Birmingham and offered a chance to enter a residential treatment program. “I grabbed my bag and enough drugs to take on the train and got myself there,” he said.

After that, he moved to Brighton in southern England and completed another program, and has been clean now for two decades. He returned to Falkirk in 2013 with his family and started working in drug recovery services.

In February, he attended a conference sponsored by the Scottish government and heard about the promise of drug consumption rooms. He was intrigued. A few weeks later he traveled to Copenhagen and met with the people who opened Denmark’s first mobile site in 2011. Less than a year later, the Danish Parliament legalized supervised injection facilities.

“I took my inspiration from what happened there,” he said. “They quickly got the legal framework and now have the world’s largest safe-consumption facility.”

He traveled back to Scotland and decided to do the same.

He invested 500 pounds, or about $650, of his own money and crowdfunded the remaining 2,400 pounds to purchase the well-traveled van and outfit it with the necessary equipment. On Aug. 31 — International Overdose Awareness Day — he drove it to Parnie Street for the first time.

Krykant chose the van’s parking spot carefully. Within a 30-second walk is an alleyway where drug users publicly inject. It is filled with discarded needles, slivers of foil and small spoons.

James Muir, 34, said that when the van was not there, he usually injected in alleys like the one nearby or in parking lots around Glasgow. He said he had been to the van about three or four times now, adding, “I think it’s really good.”

Asked if he was worried about the possibility of police showing up and arresting him over drug possession, “the guy reassured me he locks the van,” Muir said, referring to Krykant. “I trust him.”

Every Friday for the past two months, Peter Krykant has parked his white van on Parnie Street in central Glasgow, Scotland, around the corner from a games shop and several art galleries, and waited for people to come by and inject illegal drugs.

Every Friday for the past two months, Peter Krykant has parked his white van on Parnie Street in central Glasgow, Scotland, around the corner from a games shop and several art galleries, and waited for people to come by and inject illegal drugs. Inside the van are two seats and two tables, each with a stainless steel tray and hypodermic needles as well as several biohazard trash cans. The van is also equipped with naloxone, the medication used to reverse an opioid overdose, and a defibrillator. (There are COVID-19 safety precautions, too: hand sanitizer and a box of masks.) Krykant usually opens the van by 10 a.m., and on this particular day three people were already waiting to get inside. This was something of a surprise, since Scottish police had charged him with obstruction the week before when he refused to open the vehicle to officers, knowing several people were inside taking drugs. He wasn’t sure anyone would come back after that scare. Also read| Britain hopes for 'normal Christmas' as coronavirus cases surge in Europe Scotland is in the midst of its worst drug crisis on record and one of the worst in the world. The country has tallied five straight years of record-setting drug-related deaths and now holds a per capita death rate three times higher than anywhere else in Europe. Overdoses are more common in Scotland, by some measures, than even the United States. In 2018, Scotland had nearly 20 drug-related deaths per 100,000 people, compared with 18 deaths in the United States and around five in Ireland, Finland and Sweden. Krykant is adamant that drug consumption rooms will help slow the rate of overdose deaths in Scotland by allowing drug users to inject under supervision and with naloxone on hand. Krykant chats easily with several men waiting to be let inside. He asks them what type of drug they’ll be injecting, writes it down and then opens the sliding back door. Also read| UK to unveil 'largest military investment' in three decades In addition to Krykant, at least one other trained volunteer is on duty; they take turns watching for police and checking on the people inside. Krykant, a former addict himself, said he had “learned very quickly that harm reduction is the most fundamental thing.” “People don’t get any more opportunities after they’re dead,” he said. Drug consumption rooms are facilities that legally allow people to take illicit drugs under the supervision of trained professionals in a sterile environment and with clean equipment. They have been shown to reduce overdose deaths and blood-borne viruses like HIV, decrease public injecting and more quickly connect people to treatment services. “In all recorded injections that have taken place in these spaces across the world, there has not been one recorded death,” said Andrew McAuley, a public health professor at Glasgow Caledonian University. The first legal facility opened in Switzerland in the mid-1980s, and over the last three decades they have been established across Europe, Canada and Australia — around 200 in all. Despite their effectiveness and Scotland’s increasingly dire drug problem, they remain illegal throughout Britain. The Scottish government has expressed its support, but Westminster has not budged. “We have no plans to introduce drug consumption rooms, and anyone running them would be committing a range of offenses,” a spokesperson for the British Home Office said in a statement. But Krykant thinks blaming Westminster is an easy out. “All we’ve been hearing is that it’s the U.K. government’s fault,” he said. “We could have drug consumption rooms in Scotland right now if there was political will.” With Scotland in control of its own health care and policing — a system known as devolution — Krykant and other drug policy advocates argue that the Lord Advocate, Scotland’s chief public prosecutor, could provide legal cover in the form of a “letter of comfort” stating that drug consumption rooms could operate without fear of criminal prosecution. (The Lord Advocate provided similar guidance this spring for naloxone.) But he has so far declined to do this, saying the facilities require a legal solution that addresses civil liability and the full range of exemptions from criminal law. To date, police have not shut down the van, nor have they made any arrests. In a statement, they seemed to suggest they would leave well enough alone — for now, at least. “The establishment of any form of safe consumption location contravenes the U.K. Misuse of Drugs Act 1971,” an assistant chief constable of Police Scotland, Gary Ritchie, said in a statement. “Any attempt to circumvent the law, as it stands, by providing an unregulated and unlicensed facility may expose already vulnerable people to more risk and harm.” For Krykant, the goal of the van is to challenge drug policy more than to curb Scotland’s soaring drug deaths. “We may keep people alive, but this has always been about a push for an official establishment,” he said. “We can’t provide a service for hundreds of people from the back of one transit van.” Krykant grew up in Falkirk, about 20 miles from Glasgow, and said he was taking drugs on a daily basis by the time he was 11 years old. By 17, he was injecting heroin, and a few years later found himself in Birmingham, England, living on the street and begging for money to fuel his drug habit. He was eventually approached by an outreach team in Birmingham and offered a chance to enter a residential treatment program. “I grabbed my bag and enough drugs to take on the train and got myself there,” he said. After that, he moved to Brighton in southern England and completed another program, and has been clean now for two decades. He returned to Falkirk in 2013 with his family and started working in drug recovery services. In February, he attended a conference sponsored by the Scottish government and heard about the promise of drug consumption rooms. He was intrigued. A few weeks later he traveled to Copenhagen and met with the people who opened Denmark’s first mobile site in 2011. Less than a year later, the Danish Parliament legalized supervised injection facilities. “I took my inspiration from what happened there,” he said. “They quickly got the legal framework and now have the world’s largest safe-consumption facility.” He traveled back to Scotland and decided to do the same. He invested 500 pounds, or about $650, of his own money and crowdfunded the remaining 2,400 pounds to purchase the well-traveled van and outfit it with the necessary equipment. On Aug. 31 — International Overdose Awareness Day — he drove it to Parnie Street for the first time. Krykant chose the van’s parking spot carefully. Within a 30-second walk is an alleyway where drug users publicly inject. It is filled with discarded needles, slivers of foil and small spoons. James Muir, 34, said that when the van was not there, he usually injected in alleys like the one nearby or in parking lots around Glasgow. He said he had been to the van about three or four times now, adding, “I think it’s really good.” Asked if he was worried about the possibility of police showing up and arresting him over drug possession, “the guy reassured me he locks the van,” Muir said, referring to Krykant. “I trust him.”

How a man with a van is challenging UK drug policy

The UK&#39;s healthcare regulator has decided to suspended marketing approval for a widely used antibiotic that had won clearance based on clinical trials conducted by India&#39;s Quest Life Sciences, due to concerns over the integrity of trial data. 
 
The Medicines and Healthcare products Regulatory Agency (MHRA) might also deny other pending drug approval requests that rely on studies conducted by Quest, the UK agency said in a letter dated June 22. 
 
The MHRA&#39;s decision bars the sale of a generic version of erythromycin that is being sold in the UK by Dawa Ltd, a Kenyan drugmaker, an MHRA spokesman said.&nbsp; 
 
The MHRA said it is in contact with the involved parties, who have the right to appeal and submit new data to prove that the drugs in question meet the required standards.&nbsp; 
 
The agency added that it does not believe there to be any risk to public health and that its decision to suspend marketing approval is purely a precautionary measure. 
 
Quest&#39;s President Yati Chugh said the company plans to appeal the suspension as he believes the agency relied on a two-year-old study and the following inspection report to reach its decision, and that it did not review the company&#39;s latest quality management systems. 
 
He said Quest had significantly improved its quality systems since 2014, and would ask the MHRA to re-inspect its site, as MHRA&#39;s move means four other drugs Quest performed trials on that are awaiting approval with the UK regulator will not be approved until the agency clears its facility. 
 
These drugs include the antibiotics doxycycline and cephalexin, and the diabetes drug metformin, on which Quest had conducted trials on behalf of UK drugmaker Strandhaven and India&#39;s Kopran, said Chugh.&nbsp; 
 
Strandhaven, Kopran and Dawa did not respond to requests for comment on the matter. 
 
Latest setback 
 
The MHRA&#39;s move is the latest blow to India&#39;s drug industry, whose reputation has been tainted in recent years as foreign regulators have criticised manufacturing standards and questioned the reliability of clinical data produced by some of the sector&#39;s biggest names. 
 
Chennai-based Quest is a contract research firm that conducts clinical trials on generic drugs on behalf of local, as well as multinational drugmakers. Drugmakers in turn use clinical data produced by companies like Quest to seek approval to sell their drugs in various countries.&nbsp; 
 
Data from Quest has been used to support drug approvals in the United States, Europe, Australia and elsewhere, according to its website.&nbsp; 
 
The MHRA said that during an inspection of Quest&#39;s facility in February, it found several issues with data integrity in a clinical trial Quest had conducted, including discrepancies in Quest&#39;s patient records and instances where electrocardiogram (ECG) data of patients had been deleted or manipulated. 
 
The World Health Organisation told Quest in July last year about similar ECG data manipulation issues in another drug study.&nbsp; 
 
The MHRA said it believed its findings meant that the safety or wellbeing of patients had been jeopardised in the trial. 
 
&quot;The MHRA inspectors identified a large number of issues which indicated that there were very serious concerns with many aspects of the company&#39;s quality system,&quot; the MHRA spokesman said, adding the problems cast &quot;serious doubt on the integrity of any data produced&quot;. 
 
Similar issues around data at Quest&#39;s larger rival GVK Biosciences led to a recall of about 700 drugs across Europe last year. 
 
(Reuters)

Medicines and Healthcare products Regulatory Agency might also deny other drug approval requests, causing a blow to India's drug industry

The UK's healthcare regulator has decided to suspended marketing approval for a widely used antibiotic that had won clearance based on clinical trials conducted by India's Quest Life Sciences, due to concerns over the integrity of trial data. The Medicines and Healthcare products Regulatory Agency (MHRA) might also deny other pending drug approval requests that rely on studies conducted by Quest, the UK agency said in a letter dated June 22. The MHRA's decision bars the sale of a generic version of erythromycin that is being sold in the UK by Dawa Ltd, a Kenyan drugmaker, an MHRA spokesman said. The MHRA said it is in contact with the involved parties, who have the right to appeal and submit new data to prove that the drugs in question meet the required standards. The agency added that it does not believe there to be any risk to public health and that its decision to suspend marketing approval is purely a precautionary measure. Quest's President Yati Chugh said the company plans to appeal the suspension as he believes the agency relied on a two-year-old study and the following inspection report to reach its decision, and that it did not review the company's latest quality management systems. He said Quest had significantly improved its quality systems since 2014, and would ask the MHRA to re-inspect its site, as MHRA's move means four other drugs Quest performed trials on that are awaiting approval with the UK regulator will not be approved until the agency clears its facility. These drugs include the antibiotics doxycycline and cephalexin, and the diabetes drug metformin, on which Quest had conducted trials on behalf of UK drugmaker Strandhaven and India's Kopran, said Chugh. Strandhaven, Kopran and Dawa did not respond to requests for comment on the matter. Latest setback The MHRA's move is the latest blow to India's drug industry, whose reputation has been tainted in recent years as foreign regulators have criticised manufacturing standards and questioned the reliability of clinical data produced by some of the sector's biggest names. Chennai-based Quest is a contract research firm that conducts clinical trials on generic drugs on behalf of local, as well as multinational drugmakers. Drugmakers in turn use clinical data produced by companies like Quest to seek approval to sell their drugs in various countries. Data from Quest has been used to support drug approvals in the United States, Europe, Australia and elsewhere, according to its website. The MHRA said that during an inspection of Quest's facility in February, it found several issues with data integrity in a clinical trial Quest had conducted, including discrepancies in Quest's patient records and instances where electrocardiogram (ECG) data of patients had been deleted or manipulated. The World Health Organisation told Quest in July last year about similar ECG data manipulation issues in another drug study. The MHRA said it believed its findings meant that the safety or wellbeing of patients had been jeopardised in the trial. "The MHRA inspectors identified a large number of issues which indicated that there were very serious concerns with many aspects of the company's quality system," the MHRA spokesman said, adding the problems cast "serious doubt on the integrity of any data produced". Similar issues around data at Quest's larger rival GVK Biosciences led to a recall of about 700 drugs across Europe last year. (Reuters)

UK drugs regulator to halt antibiotic cleared by Indian clinical trials firm

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How a man with a van is challenging UK drug policy

UK drugs regulator to halt antibiotic cleared by Indian clinical trials firm