Marijuana shoppers flock to Colorado for first legal recreational sales

'This is going to be a turning point in the drug war,' says one customer at a cannabis dispensary, 'a beginning of the peace'

• Rory Carroll in Denver
• theguardian.com, Wednesday 1 January 2014 20.23 GMT

Sean Azzariti, an Iraq war veteran, makes the first legal recreational marijuana purchase in Colorado from Betty Aldworth. Photograph: Theo Stroomer/Getty

The debut of the world's first legal recreational marijuana got off to a smooth and celebratory start with stores across Colorado selling joints, buds and other pot-infused products to customers from across the United States.

Throngs lined up from before dawn on Wednesday to be among the first to buy legal recreational marijuana at about three-dozen licensed stores, with cheers erupting when doors opened at 8am local time.

“It's a historical event. Everyone should be here,” said Darren Austin, 44, who drove from Georgia and joined a festive crowd gathered in falling snow outside Denver's 3-D Cannabis store. “This is going to be a turning point in the drug war. A beginning of the peace.”

His son Tyler, 21, held a sign saying “It's about time”. Like his father, he painted his face green. “I'm going to move to Colorado. Seriously,” said Darren.

Behind them waited Savannah Edwards, 21, a substitute teacher who drove overnight from Lubbock, Texas. “I'm here not so much for the marijuana as the history.” Just as people reminisced about Woodstock, she would be telling this story half a century from now, she said. “I've never been to a dispensary before. I don't even know what I'll buy.”

Colorado became the first jurisdiction in the world – beating Washington state and Uruguay by several months – to legalise recreational cannabis sales. Voters approved the measure in a ballot initiative in the November 2012 general election – a landmark challenge to decades of “drug war” dogma which could herald a shift as radical as the end of alcohol prohibition in 1933.

JD Leadam, 24, a bioplastics producer from Los Angeles, flew in just for the day. “This is the first time in the whole of the world that the process is completely legal. It's something that I can tell my kids about.”

After Washington, Alaska may follow suit later this year, with activists then targeting Arizona, California, Nevada and Maine, said Mason Tvert, director of communications for the Marijuana Policy Project. “Making marijuana legal for adults is not an experiment. Prohibition was the experiment and the results were abysmal,” he told a press conference.

Activists, customers and media gathered at the 3D Cannabis store for the first ceremonial sale. "It's 8am. I'm going to do it," said Toni Fox, the owner.

Tyler Austin, 21, who travelled from Georgia, held a sign saying 'It's about time'. 'I'm going to move to Colorado,' he said. Photograph: Ed Endicott/Demotix/Corbis

The first customer was Sean Azzariti, an Iraq war veteran who featured in pro-legalisation campaign ads. He bought an eighth of an ounce of an Indica strain called Bubba Kush and some marijuana-infused truffles. Total price, $59.74, including 21.22% sales tax.

State regulations insist every marijuana plant must be tracked from seed to sale but about 400,000 of the 2m tags sent in the post did not reach all stores in time. Authorities allowed licensed stores to sell regardless. The Denver Post called the glitch disappointing.

The three dozen stores that sold recreational pot on Wednesday will multiply in coming weeks. Regulators have issued 348 recreational pot licences: 136 for retail stores, 178 for cultivation, 31 for infused edibles and other spin-off products, and three for testing.

Cynthia Johnston, 69, bought two pre-rolled joints ($10 each) and an eighth of an ounce of Sour Diesel. “I've been working towards this moment since 1979,” she grinned. “Now, where can I smoke?”

Not in public spaces and not, according to notices which sprouted overnight, in many hotels. Pot must be consumed in private and cannot be transported over state lines, putting some restraints on the expected pot tourism boom.

Fears of joint-toking throngs in the street did not materialise by midday. Police said crowds were orderly and respectful. Denver City councilman Albus Brooks hailed their diversity and peacefulness.

As the first customers left the stores clutching their purchases jokes rippled across Twitter. “Curious if there has been a spike in Funyuns, Doritos and Taco Bell sales across Colorado today?” asked one.

The drugs do work, but they can't cure unhappiness

Antidepressants are sometimes prescribed when they aren't needed, but never to use them is to miss an opportunity

• Tim Cantopher
• theguardian.com, Wednesday 20 November 2013 16.20 GMT

Antidepressants buy you time to sort out the issues that caused the depression in the first place. Photograph: Cultura/Rex Features

I can't stand zealots. Unfortunately, the literature on antidepressants is full of them. I'm not impressed by the protagonists in the polarised argument over the efficacy or otherwise of these drugs, whose positions are firmly held and loudly proclaimed. Many researchers appear to have written the conclusion of their study before the protocol.

At the one pole are the pharmaceutical industry and academic psychopharmacologists. I'll call them the pros. They urge us to practise only evidence-based medicine, by which they mean following rigid protocols based on treatments that have achieved positive results either in double-blind placebo-controlled drug trials, or meta-analyses (a method for grouping together results from several trials). Most of these studies focus on antidepressants because their effects are easy to measure.

The pros despise any practice not based on this narrow definition of evidence. One of them once told me: "Employing clinical experience to decide how to treat patients means continuing to make the same mistakes and never learning from them." So much for the lessons I've learned from treating about 3,000 people with this illness.

At the other pole are a group of naysayers who assert that antidepressants don't work any better than placebo. I'll call them the cons. They use the available statistics in the way best suited to their argument and are equally dismissive of any contrary view.

It's part of our culture to take up polarised positions. Our political and legal systems are based on this premise and our media rely on it. The middle ground isn't interesting and is rarely aired. It is this environment in which the pros and cons dominate the literature on antidepressants. Meanwhile, sufferers from the depressive illness don't know which way to turn.

The root of the problem is that good research is difficult and limited. Research is good at showing big effects in large groups of people. It's not so good at showing more subtle, or difficult to define, effects in subgroups of people. The results of your study will depend on whom you study, what you measure, what you define as an effect and what you do with your data.

The cons say that the pros have suppressed some findings that didn't suit them. If you compare two identical groups 20 times, you will find an apparently significant difference between them once. Test your ineffective antidepressant 20 times and you'll be able to publish a positive result, so long as you suppress the other 19. We clinicians knew this was happening years ago. One particular antidepressant was known by everyone to lack efficacy, yet the studies appeared to show that it worked as well as all the rest. Something was wrong with the published research and it seems we may now know what it was. Recent research seems to under-report some side-effects and withdrawal effects of antidepressants.

The cons are equally selective. They point to meta-analyses showing that antidepressants don't out-perform placebo sufficiently to reach this arbitrary level of significance. They conclude that antidepressants don't work. This is the oldest misuse of statistics in the book. An insignificant difference doesn't mean that you've proven no difference; it just means that you haven't proved that there is one.

Another issue is failing to exclude the outlier. As I've already pointed out, one expects occasional misleading results from research. A meta-analysis should deal with this problem by excluding from the analysis any study with results wildly different from all the others. The pros say that this hasn't always happened in the cons' analyses, potentially producing misleadingly negative results.

So research is failing us in this field. Unfashionable though this is in the environment currently existing in medicine, it means we clinicians need to use our experience, powers of observation and common sense, bearing in mind the experience of other clinicians.

We need to take note of the available research, while also taking a critical view of it. Here is the upshot, accepted by most of us on the ground: antidepressants usually work, but only for real clinical depression, the type involving a chemical disturbance in the brain, with a full range of characteristic physical symptoms. They don't work for unhappiness, grief or chemically induced depression and if you take them irregularly or for too short a period, the depression comes back.

Prescription numbers are rising mainly because doctors are getting better at identifying depression, though antidepressants are sometimes prescribed when they aren't needed and won't work. Except for people suffering from recurrent depression they are only first aid, buying you time to sort out the issues that caused the depression in the first place, but never to use them is to miss an opportunity to provide relief from this horrible illness.

Dr Tim Cantopher, consultant psychiatrist, Priory Hospitals Group, author of Depressive Illness – the Curse of the Strong (Sheldon)

Questions about India’s drug industry

NARAYAN LAKSHMAN in the hindu

 

Change that supports measures such as surprise checks on manufacturing facilities, and greater transparency in and policing of drug approval processes and clinical trials is a must. Photo: M. A. Sriram

 

Unless a deeper, institutional change is ushered in to break the nexus between drug companies and the regulatory regime, Indians consuming drugs may be exposing themselves to serious risks

Even before I walked into the Mayflower Hotel in the heart of Washington on a crisp autumn afternoon to meet Dinesh Thakur, whistle-blower and former director of India-based pharmaceutical giant Ranbaxy, I had a hunch that this conversation would spark some troubling questions on India’s malfunctioning drug industry.

On May 13, 2013, Ranbaxy pleaded guilty to seven felonies relating to drug manufacturing fraud and agreed to cough up $500 million to settle the case brought by the U.S. Department of Justice (DoJ) after eight years of investigation. The vast evidence in the case, some of it supplied by Mr. Thakur and marshalled by the U.S. Food and Drug Administration (FDA), included inspection reports compiled after multiple FDA visits to Ranbaxy plants in India — in Paonta Sahib, Himachal Pradesh, and Dewas, Madhya Pradesh.

Ranbaxy makes a long list of generic medications — 200 different “molecules”, according to its website — everything from anti-retroviral drugs to treat HIV-AIDS to commonly used antibiotics such as Amoxicillin and Cephalexin (Mox and Sporidex in India). It makes generic combinations of Paracetamol and Ibuprofen, and sells numerous over-the-counter products, such as pain relief gel Volini and cosmetic product Revital in India.

While it is apparent that Indians consume Ranbaxy drugs at a prolific rate — accounting for approximately Rs.2,600 crore, or 18 per cent of the company’s global revenue for 2012 — what is less clear is why the Indian government has not launched a vigorous investigation into the current Good Manufacturing Practices (cGMP) violations that the U.S. authorities found at multiple Ranbaxy facilities.

Go-slow approach

The Drug Controller General of India (DCGI), G.N. Singh, said in June: “When the issue has been flagged, as a regulator it is our duty to see that whatever medicines have been produced here are of assured quality.” But he did not specify the date by which a “review” of Ranbaxy’s past drug applications would be completed, leave alone committing himself to holding surprise visits to facilities aimed at investigating manufacturing standards.

This go-slow approach is all the more baffling given that, despite assurances by Ranbaxy after its admission of guilt in May that all of its other facilities adhered to the required process quality standards, a third plant, this time in Mohali, Punjab, was slapped with an import alert by the U.S. in September.

If any doubt remains about the seriousness of the claims made by the FDA so far, it is worth taking a quick look at the dossier of evidence submitted by the DoJ in the case against Ranbaxy.

Settlement documents make it clear that Ranbaxy admitted that had the seven felony charges brought by the DoJ gone to trial, the government “would have proven … beyond a reasonable doubt” that the company in 2006 had “knowingly made materially false, fictitious and fraudulent statements,” with regard to the stability testing of drugs, and in 2003, it “with intent to defraud and mislead,” failed to submit timely field reports to the FDA.

FDA investigation

According to the FDA’s investigation, Ranbaxy acknowledged violations of cGMP regulations with regard to a U.S.-distributed drug, Sotret, even as far back as 2003. That was at a time when the billionaire brothers Malvinder and Shivinder Singh owned the company. The Singh brothers sold Ranbaxy to Japanese Daiichi-Sankyo in 2008 and walked away with a cool $4.6 billion.

Nevertheless, the Sotret episode marked the beginning of a series of FDA investigations of Ranbaxy facilities in India, particularly of the two that focussed on production for U.S. markets: Paonta Sahib and Dewas, where Ranbaxy manufactured Sotret and two other popular drugs, Gabapentin and Ciprofloxacin.

Inspecting Paonta Sahib in February 2006, the FDA found no fewer than eight deviations from cGMPs. These included failure to include a complete record of all drug testing data as required by FDA guidelines, and failure to establish an adequate testing programme for the stability characteristics of drugs — essential to determine drug storage conditions and expiration dates.

Dewas was also investigated the same month and the FDA found not only a similar unavailability of quality-control data but also a “failure to extend investigations into any unexplained discrepancy,” such as testing deviations noted for specific drug batches.

Quality issues

Additional inspections of the Dewas facility in 2008 unearthed a range of quality problems. For example, there were no separately defined areas for the production and packaging of penicillin that could prevent microbiological contamination of this drug from exposure to other drugs in the vicinity. Again, quality control test failures of certain drugs were not thoroughly investigated.

These early hints ought to have set alarm bells ringing at FDA headquarters: prescribed procedures were not being followed; the required data documenting these procedures were not being compiled; and where deviations were noted, they were not being investigated. They did not appear to raise the red flag — or at least not enough of them.

Thus, in November 2011, the FDA did not see it fit to hold Ranbaxy back from selling generic Lipitor, the popular cholesterol-reducer. Blessed with a six-month exclusivity grant, the company went on to rake in $600 million in sales revenue. Only when “fate” appeared to intervene and glass particles were discovered in samples of the drug did Ranbaxy issue a massive recall notice.

Yet, if the FDA only scratched the surface of drug quality problems at three Ranbaxy facilities, then there is an enormous question mark over the extent to which other Ranbaxy facilities beyond the ken of U.S. authorities are similarly involved — a matter of great importance to the 150-odd countries in which Ranbaxy sells its products, including India.

Poor enforcement in India

In this context, the Indian drug control authorities must share some of the blame for not coming down harder on fraud. The institutional reasons for poor enforcement in India are well known. In the context of drug regulation, the point was made most poignantly by the department-related Rajya Sabha Standing Committee on Health and Family Welfare in its 59th report, on the functioning of the Central Drugs Standard Control Organization (CDSCO).

In 2012, the Standing Committee lambasted the “collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts,” citing in one case the spurious nature of the approvals process for new drug applications made by pharmaceutical companies.

While there is much more that the DCGI and CDSCO could do, it would be unfair to say they haven’t been jolted into action by l’affaire Ranbaxy, and then again by the FDA issuing import alerts against another Indian generics company, Wockhardt.

Earlier this month, the DCGI reportedly ordered a third pharmaceutical major, Sun Pharmaceutical, to suspend clinical research activities and new drug filings and applications at its Mumbai-based bio-analytic laboratory, “after discovering that Sun didn’t have the requisite approval from the Central government for operating the laboratory.”

However, until a deeper, institutional change takes place to break the nexus between drug companies and India’s regulatory regime — a change that incorporates everything from surprise checks on manufacturing facilities to greater transparency in, and policing of, drug approvals processes and clinical trials — there is a strong likelihood that Indian consumers of drugs made by these companies have poison coursing through their veins.

Alcohol without the hangover? It's closer than you think

Science now allows us to develop a safer way to get drunk. But before we can sober up in minutes, the drinks industry needs to embrace this healthier approach

• 
• • David Nutt
  • theguardian.com, Monday 11 November 2013 19.04 GMT

'If alcohol was discovered today it could never be sold as it is far too toxic to be allowed under current food regulations'. Photograph: Action Press/Rex Features

Imagine enjoying a seasonal drink at a Christmas party without the risk of a hangover the next day, or being able then to take an antidote that would allow you to drive home safely. It sounds like science fiction but these ambitions are well within the grasp of modern neuroscience.

Alcohol is both one of the oldest and most dangerous drugs, responsible for about 2.5 million deaths worldwide, which is more than malaria or Aids. The reasons for this are well known: alcohol is toxic to all body systems, and particularly the liver, heart and brain. It makes users uninhibited, leading to a vast amount of violence and is also quite likely to cause dependence, so about 10% of users get locked into addiction. If alcohol was discovered today it could never be sold as it is far too toxic to be allowed under current food regulations, let alone pharmaceutical safety thresholds. In this health-conscious age, it is odd that these aspects of alcohol are rarely discussed.

The only proven way to reduce alcohol harms is to limit consumption through increased pricing and limiting availability. Most governments have shied away from this because of pubic opinion and fears of lost tax income – the notable exception being Scotland with its minimum pricing strategy. An alternative strategy that offers greater health benefits would be to make a safer version of alcohol.

We know that the main target for alcohol in the brain is the neurotransmitter system gamma aminobutyric acid (Gaba), which keeps the brain calm. Alcohol therefore relaxes users through mimicking and increasing the Gaba function. But we also know that there are a range of Gaba subsystems that can be targeted by selective drugs. So in theory we can make an alcohol surrogate that makes people feel relaxed and sociable and remove the unwanted effects, such as aggression and addictiveness.

I have identified five such compounds and now need to test them to see if people find the effects as pleasurable as alcohol. The challenge is to prepare the new drink in a fashion that makes it as tasty and appealing. This is likely to be in the form of a cocktail, so I foresee plenty of different flavours. The other great advantage of this scientific approach to intoxication is that if we target compounds that affect the Gaba system, then it is possible to produce other drugs that could be sold alongside the alcohol substitute as an antidote.

I have sampled both new forms. After exploring one possible compound I was quite relaxed and sleepily inebriated for an hour or so, then within minutes of taking the antidote I was up giving a lecture with no impairment whatsoever.

All that is needed now is funding to test and put them on the market. A few contacts within the alcohol industry suggest they are interested but do not need to engage until this new invention becomes a threat to their sales. This is a similar situation to that of the tobacco companies when e-cigarettes were being developed. They stood back at first but now own many of the companies making the safer alternatives to cigarettes. Likewise, without investing in a new approach to alcohol, we shall not realise the enormous health potential of a safer alternative.

The gambling machines helping drug dealers 'turn dirty money clean'

Dealers talk to the Guardian about laundering drug money through fixed odds betting terminals in bookies across Britain

• 
• • Randeep Ramesh, social affairs editor
  • theguardian.com, Friday 8 November 2013 18.03 GMT

The Gambling Commission admitted in September what has long been privately acknowledged: FOBTs present a 'high inherent money laundering risk'. Photograph: Alamy

Dressed in a grey hoodie and jeans, James, 24, looks like just another lost soul in the high street, shuttling between the six betting shops in an east coast seaside town. It's a weekday morning and if you catch up with him inside a bookmaker, you'll find him peering intently into the green glowing screen of an electronic gambling machine – feeding in £200, "a score at a time".

But this is not a young gambler blowing his meagre wages. James is a drug dealer and his interest in the bookmakers – and the fixed-odds betting terminals (FOBTs) in each shop – is all about laundering money. "That's what turns dirty money clean," he says. Dealers feed their drug money through the machines, losing a little and then cashing out with the vast majority of their stake, James says. They can then collect a printed ticket showing they have gambled that day – meaning that if stopped by police, they can answer questions about why an apparently unemployed young man carries hundreds of pounds in rolled-up cash.

The FOBTs are probably the single most profitable pieces of property in the town centre's shabby pedestrian precinct. Each machine, according to industry figures, grosses about £900 a week. The 24 FOBTs within a few minutes' walk are worth an estimated £1m a year in profits to the betting industry.

The terminals arrived in Britain in 2001 and were lightly regulated from the outset. Punters in bookmakers found that they could bet £100 every 20 seconds on roulette. The temptation of high-speed, high-stake casino games in the high street proved irresistible: there are now 33,345 FOBTs in the UK.

However, several high-profile cases have exposed a seamier side to the rise of the machines. Earlier this month the Gambling Commission, the industry regulator, finedCoral bookmakers £90,000 in profits it made from one drug dealer who had laundered almost £1m in its shops. Last month the industry regulator also publicly admitted what has long been privately acknowledged: FOBTs present a "high inherent money-laundering risk". In a letter to the industry trade association, the commission warned about "a retail betting model that includes high volumes of cash transactions, particularly where this includes low individual spend and a high level of anonymity... especially where that model also offers (FOBTs)."

What the machines provide is the chance for criminals to convert quickly large sums of money from the real world into virtual cash that can later be converted back into the real thing. There is little official research into the scale and extent of such operations. The 2005 Gambling Act, which regulates the terminals, says one of its primary objectives is "preventing gambling from being a source of crime or disorder, being associated with crime or disorder or being used to support crime".

However, it has long been obvious to the public that criminals can convert their loot into a clean win on an electronic roulette table. Surveys for the commission show that 40% of the public regularly identify gambling with criminal activity. The industry regulator found one in 14 respondents associated money laundering with gambling.

The Guardian persuaded a number of drug dealers to talk about their criminal pursuits. What was remarkable was that they saw FOBTs as both a nuisance and necessary, trapping "weaker" people into addiction while allowing the "strong" to prosper. All exchanged tips with fellow dealers on the best ways to launder money; all were surprisingly frank about their methods.

James's strategy is simple: £20 on black, £20 on red and £2 on zero. A press of a button and the wheel spins before the ball lands on red. That's a loss of £2. The money placed on the zero is the only risk James is taking with his cash. If the ball does land on zero, he wins £72.

With no horses to run or dealer to shuffle and just the 20-second spin of an electronic roulette wheel to wait for, it takes a little over a minute for this drug dealer to cash out. James says he knows that unless he gambles at least 40% of the float money he has put in the machine, an alert will pop up on the staff computer warning them of suspicious activity. So he methodically places the same bet to make sure that he has wagered enough.

To ensure that his winnings are not an unlikely round number, he loses some more money on the one-armed bandit. Leaving the tea brought over by the shop manager to go cold, James wanders over to the counter to collect his winnings in the form of a receipt – transforming the money he made from cocaine into apparent gambling winnings. He has lost a little more than £10. "You have to make it realistic," he says. "Bookies get nervous if you come in and just lose the same amount every day. So I vary it a little."

Drug dealers say the reason fixed-odds betting terminals are used is precisely because they are so lightly policed. James is careful not to visit the same shops in a pattern. Handily there are 15 betting shops in the town within walking distance of the main bus routes that snake through the suburbs and along the Thames estuary. "Smart dealers don't drive around here. You are more likely to be stopped by police driving around late at night doing deliveries than if you are taking a bus somewhere into town."

Then there are favoured bookies. Ladbrokes, says James, is useful because you can transfer winnings in the shop to an online gaming account. In William Hill's you can ask for your winnings to be credited directly to your debit card, with the cash landing up in your bank the same day. "Look at my account and I am a very successful punter," he says.

The economics of drug dealing make it cost-effective to pay 5% to 10% to betting shops to launder the illicit profits. James claims to have "about 100K" in his bank account. He sells about 56g (2oz) of ordinary cocaine a week and another 28g of a purer, more expensive version. "Normal customers like teachers, doctors they get the ordinary stuff. The cleaner gear is for the City boys."

 Selling cocaine in 0.8g wraps, James, a dealer, says he turns over about £5,500 of drugs – of which half is profit. Photograph: Andy Rain/EPA

James left school at 16 and worked in shops and restaurants before ending up in the City of London. "That's where I saw people using coke and I was asked if I could get some. I knew some people and I did. Never looked back. How long would it have taken to save £100,000 if I just continued doing admin in a bank?"

Selling cocaine in 0.8g wraps, in a week James turns over about £5,500 of drugs, of which half is profit. "I buy it on tick so you end up carrying a lot of money around. The trade is run by Albanians around here, so it's best to have cash ready if you need to pay it back in a hurry."

Almost all his money is laundered via FOBTs. James calculates he is worth £15,000 a year to the betting industry. "Valued customer," he grins. "I'd say there were about half a dozen of us [dealers] around here using machines. We swap tips – where to go, least crowded, staff not bothered, that sort of thing. You don't want to be recognised too many times."

In opening up to the Guardian, James says there is a risk that bookmakers in the coastal town will tighten up on who enters and who leaves. "Sure, they could stop us, but in the end they want the money.We can hang back for a bit and go somewhere else. Pretty soon they will relax and welcome us all back."

Bookmakers essentially regulate themselves: deciding whether to bar problem gamblers, call the police over violent behaviour or report crime. As the machines contributed £1.4bn to its bottom line last year, there have been suspicions that the industry has played down the shadier side of the terminals.

Adrian Parkinson, a former regional machines manager at the Tote, now with theCampaign for Fairer Gambling, said: "Money laundering on FOBTs has been a problem since their introduction. Whether it's cleaning notes from the proceeds of crime or drug dealers legitimising profits, it is well known in the industry that it goes on.

"I raised the issue some years ago at the Tote after being swamped with incidents of money laundering following a series of armed robberies but it's still going on."

Even worse, Parkinson says, the technology is outpacing the law. He says by the end of the year, customers in Coral will be able to transfer any FOBT winnings to their online account. "The staff won't be able to intervene, whatever their suspicions. The industry is riding rough shod over the licensing objectives. Keeping crime out of gambling has to take precedent over profit."

The Association of British Bookmakers said the industry complied fully with the law. William Hill said it had "robust systems" to meet its regulatory obligations. In a statement, Ladbrokes said: "Any criminals attempting to launder large sums are placing themselves at high risk of detection as they will be on CCTV and staff are trained to spot suspicious behaviour. Given most stakes in shops are small, any large transactions are easily recognisable. Any attempt to transfer money to online accounts will require identity verification at account opening or first transactions which in conjunction with CCTV would be an excellent source of evidence for the police."

The media have helped to cement the place of gambling in the national psyche. Advertising during televised football matches exhorts audiences to have a flutter. Electronic gambling has found a younger audience through online role-playing games such as World of Warcraft, in which players have been able to set up virtual casinos. This year the United Nations Office on Drugs and Crime warned that such games were being used by organised crime to launder cash.

Also helping to rehabilitate gambling is a new range of interactive TV programming. Late-night shows such as ITV's Jackpot247 – in which television viewers place bets online or over the phone, playing along to a live presenter-hosted roulette show – repolish gambling's image by treating electronic betting as a form of mainstream entertainment.

This shift in the marketing of electronic gambling has taken place as suspicions emerge that the industry has been targeting poor people. Last December, in a paper for the Journal of Gambling Studies, Heather Wardle, a former project director of the British Gambling Prevalence Survey, warned that gambling machines were more likely to be found in areas of high socioeconomic deprivation. Earlier this year, the Guardian revealed that in the 50 parliamentary constituencies with the highest numbers of unemployed people, punters visited 1,251 betting shops and wagered an astonishing £5.6bn through 4,454 fixed-odds betting terminals.

 Salford has 72 people chasing each vacancy. It was the only part of Greater Manchester which last year recorded a rise in numbers on jobseeker's allowance. Photograph: Christopher Thomond for the Guardian

The presence of these machines appears to have a distorting effect on these moribund local economies. In a pub near Salford's Duchy estate, close to where rioting took place in 2011, two young men nursed pints of soft drink and explained how a vortex of soft drug sales, payday lenders and betting shops kept the local economy afloat. Salford has 72 people chasing each vacancy. It was the only part of Greater Manchester which last year recorded a rise in numbers on jobseeker's allowance (JSA).

Unemployed Jake, 28, sells marijuana on the local streets and smokes some of the profit. He recoups any losses by gambling and taking out loans at payday lenders. He points out the brown shopping arcade in Salford lined with bookmakers and loan companies. "It's the only thriving industry around here," he says.

"There are six bookmakers, one more is on its way, and five loan shops. Even if you are on JSA you can borrow money from Speedy Cash. It's the main business around here.Take dole, turn it into weed, sell them, take your profits and put them into the machines. If you win, you are quids in. If you lose, you get cash from the money shops to cover your losses. Back to dole and buying drugs. There's nothing else around here to do."

The drug dealer admits that he is "a bit" addicted to gambling, comparing the thrill of betting on the electronic spin of a roulette wheel to the rapid highs and lows of drugs. "You get a buzz. Which is why you might lose £16 or £1,600 and not notice until it's too late. I've done both."

The spread of betting shops in this part of the north-west is astonishing. Manchester city centre has 26. A few miles away in deprived Cheetham Hill, dubbed the "Bronx of Britain" for gang violence, there are four bookies in the high street, with another scheduled.Such bunching could be linked to the fact that bookmakers are limited to four machines a shop. As the machines are hugely lucrative the betting industry has bypassed the restriction by opening branches in high streets – "clustering" in poorer areas.

A betting shop manager in Greater Manchester, who agreed to be interviewed anonymously, said the FOBTs in Cheetham Hill easily earned £10,000 a week, four times the over-the-counter trade, and that local mobsters gambled heavily. "We get punters who lose big time on the FOBTs, punch them, chuck them to the ground. Smash them. We tell staff to play it cool. Don't call police. We don't want to arouse suspicions. It's madness. We employ young mothers in those shops.

"You have people laundering money every day with cash from robberies and drugs. Do you know that dyed notes from bank robberies can be submitted to the Bank of England and the company gets reimbursed? Staff know what pays their wages. They stay quiet."

LSD may not be bad for you, says study

Tony Paterson in The Independent 5 Sep 2013

The late acid guru Dr Timothy Leary would doubtless have claimed to have known it all along, but after conducting an exhaustive study on tens of thousands of Americans, a team of Norwegian scientists has concluded that LSD may actually be good for you.

Researchers Pal-Orjan Johansen and Teri Krebs from Norway’s University of Science and Technology in Trondheim examined American drug-use surveys carried out between 2001 and 2004 on over 130,000 US citizens, of which 22,000 had used a psychedelic drug such as LSD at least once in their lives.

The results may not amount to an appeal to “turn on, tune in and drop out”, but they appear to overturn the opinion long-held in parts of the medical establishment that LSD and other “mind-enhancing” drugs automatically result in debilitating flashbacks, uncontrollable paranoia attacks and a desire to leap off buildings.

In the science journal PLOS One, Mr Johansen and Mrs Krebs wrote: “There were no significant associations between lifetime use of any psychedelics, or use of LSD in the past year, and an increased rate of mental health problems. Rather, in several cases psychedelic use was associated with a lower rate of mental health problems.”

In an interview with Norway’s English-language news website, The Local, Mr Johansen said that expert studies which attempt to discover whether psychedelic drugs such as LSD, mescaline and the “magic mushroom” drug psilocybin are harmful had not demonstrated that they caused chronic health problems.

“Everything has some risk; psychedelics can elicit temporary feelings of anxiety and confusion, but accidents leading to serious injury are extremely rare,” Mrs Krebs told the website. “Over the past 50 years, tens of millions of people have used psychedelics and there is just not much evidence of long-term problems,” she added.

The scientists claimed the notion that LSD and other psychedelic substances damaged mental health stemmed from a small number of case reports on patients who were already suffering from some form of mental illness.

They added that both psychedelic drug use and the onset of mental illness tended to occur in late adolescence, which in the past had led researchers to wrongly attribute mental problems to LSD.

“Both mental illness and psychedelic drug use are prevalent in the population, which likely leads to many chance associations,” Mr Johansen said.

Both scientists concluded in a report published last year in the British Journal of Psychopharmacology that a single dose of LSD was a highly effective treatment for alcoholism. They recommended that the drug be used more often to help patients with a drink problem and argued that it was probably just as effective as current medications used to treat alcohol addiction.

Dr Leary – a champion of LSD who was simultaneously a cult figure for the late 1960s Hippie movement and branded the “most dangerous man in America” by President Nixon – came to similar conclusions in the 1950s while researching the drug at Harvard. He died in 1995.

The Trondheim researchers said their conclusions about LSD and alcoholism were based on surveys carried out in the 1950s, 1960s and 1970s. They said they had come across a total of six studies which met contemporary scientific standards. They established that 59 per cent of patients who had been given a dose of LSD had either stopped drinking completely or were drinking less than they were before taking the drug.

Strange trip: The acid story

 

1943 World’s first “acid trip” taken by Swiss chemist Dr Albert Hofmann who stumbled on LSD almost by accident while trying to discover beneficial properties of the ergot fungus, commonly found on rye plants, for the Sandoz chemical company. Hoffman’s first trip lasted two hours. His second last six hours and he reported experiencing “Alice in Wonderland” (pictured) fantasies.

 

1950s-1960s Harvard University psychology lecturer Dr Timothy Leary (above) carries out research on psylocybin from “magic mushrooms”. His findings are labelled subversive and he is expelled from Harvard. Branded “the most dangerous man in America” by Richard Nixon, Leary praises LSD (“turn on, tune in, drop out”) and becomes a founding father of the hippie movement. (Picture credit: Getty Images)

 

1960s-1970s By the late Sixties LSD, along with marijuana, has become a popular recreational drug for the anti-Vietnam war, counter-culture and flower power movements. LSD is referenced in songs such as “Lucy in the Sky with Diamonds” by the Beatles and “Purple Haze” by Jimi Hendrix (above, credit: Getty).

 

1980s-present LSD experiences something of a revival in the Rave scene where it continues to be taken along with Ecstasy and a battery of newer but still illegal mind-altering substances. 

DRUG PRICE REGULATION - Another bitter pill for patients

SAKTHIVEL SELVARAJ

  

 

The current market prices are essentially over and above the actual cost of production — a difference that could run from 100 per cent to 5,600 per cent, depending upon various therapeutic categories

In a liberalised market economy, do we need price controls on drugs? Policymakers and the pharmaceutical industry do not think so. They believe that price controls are an inefficient tool that distorts resource allocation, squeezes revenue, reduces profit, and breeds corruption. However, the evidence around the world runs counter to this view. Every country imposes price controls on medicines, including the most liberalised market economies. Although the design and pattern of price controls may vary, they are an important public policy tool to make drugs affordable. Medicine price controls are critical because unlike other commodities, consumers (patients) do not exercise ‘choice’ in the market when buying drugs, but are guided by the doctors or dispensers, whose primary objective may not be guided by the factor of affordability for patients.

The origin of a comprehensive and well-designed drug price control system in India dates back to 1978, when 350 life-saving and essential drugs were brought under regulation. However, in 1986 and in 1995, the number of medicines under the Drug (Prices Control) Order (DPCO) dwindled to 186 and 76 respectively. As a result, the percentage of medicines in the market under price control declined from over 90 per cent in 1978 to nearly 10 per cent now. Currently, a free market scenario prevails in the pharma sector, and the new drug price policy only legitimizes this trend.

In 2002, a price control order sought to reduce price control by half, but after civil society took up the issue, the High Court in Karnataka struck it down. Since then the Supreme Court has directed the Government of India to bring all essential drugs under price control.

The drug price control mechanism until now is based on cost-plus based (CPB) pricing. Under this arrangement, as per DPCO 1995, a 100 per cent mark-up is allowed over and above the ex-factory price, to allow for post-manufacturing expenses including packaging cost, margins of wholesalers, retailers and so on. In bringing in all 348 life-saving and essential medicines under ‘price control’, the new drug price order of 2013, adopting sleight of hand, takes away the advantage available to the patient because it moves away from CPB to MBP (Market-Based Pricing). Under the MBP, prices of essential medicines would be determined based on average price of various brands of a medicine with one (or more) per cent market share. Thereafter, a 16 per cent margin would be added as retailer’s margin. Thus the ceiling price of drugs will now be based on prevailing market prices of various brands of a drug rather than the actual cost.

The current market prices are essentially a premium price paid over and above the actual cost of production — a difference that could run from 100 per cent to 5,600 per cent depending upon various therapeutic categories. It is strange logic that the government appears to have bought into, one that was sold solidly by the pharma companies. The drug market in India is very complex and unique. We have a scenario where, often the market leader who sets the price is also the brand leader. In several other competitive markets, market leader prices are much lower than the brand leader. Take Glibenclamide, one of the key medicines in diabetes treatment. Sanofi Aventis, which sells the medicines, is not only a market leader in terms of market share but its price is also the highest in the market, despite the presence of a dozen producers. Atorvastatin (10 mg, 10 tablets), a critical drug used in the treatment of high cholesterol, for prevention of heart attacks and strokes, is manufactured and marketed in India by over 50-plus producers. However, Ranbaxy clearly has an edge over the others and its prices are the highest. Therefore, any ceiling price based on a formula derived from market prices will tend to move towards the higher range, instead of bringing it down.

The new pricing formula will be several per cent more than the old cost-plus based pricing methods. For instance, Atorvastatin (10 tablets of 10mg) will be fixed at Rs 65.30 according to the new DPCO 2013 formula, while the same would have been sold for Rs. 5.60 if CPB method were to be used. In fact, the Tamil Nadu Medical Services Corporation currently buys it directly from the manufacturer at a cost of Rs. 2.10, for the same strength and dosages. The premium on cost of production and the ultimate prices paid by the patients are, evidently, several hundred or even thousand per cent higher. This is nothing but profiteering in the name of curing patients.

FIXED DOSE COMBINATIONS LEFT OUT

Moreover, the DPCO 2013 has left out Fixed Dose Combinations (FDCs) of drugs involving one or more essential drugs. By simply combining one essential medicine with another non-essential drug, a manufacturer can wriggle out of the ceiling price. Nearly half of most therapeutic categories of medicines in India now consist of FDCs, and this trend has intensified in recent years, especially in drugs used in chronic conditions. India is also the capital of many ‘me-too’ drugs, where several versions of a similar chemical substance are produced with therapeutically equivalent effect. By not bringing similar therapeutic drugs under price ceiling, a wide open escape route has been provided to the pharma manufacturer. Drug producers often find it easy to convince the medical community to move towards a particular brand and to a specific therapeutic product. In view of restrictive and narrowed definition and interpretation of the Essential Drug List and its dosages and strengths, the new DPCO 2013 is expected to cover only 18 per cent of the overall oral solid market.

The aam admi has been yet again administered a bitter pill, while the pharma companies are pleased. The government would claim to have fulfilled its commitment given to the court, of bringing all essential drugs under ‘price control’.

Cancer medication as low as Rs 1,000/month on way

Malathy Iyer, TNN

MUMBAI: It's widely known that a month's dose of cancer drugs can cost lakhs, but what isn't common knowledge is that Tata Memorial Hospital's doctors are working on alternatives that could cost less than Rs 1,000 a month.

Dubbed the metronomic treatment protocol, it comprises daily consumption of a combination of low-dose medicines that are cheap because they have been around for decades. "There is no need to worry about patents or recovery of billions spent on research,'' said Dr Shripad Banavali, head of the medical oncology department of Tata Memorial Hospital, Parel, who has been working on the low-dose-low-cost therapies.

His colleague, Dr Surendra Shastri sums up the mood well: "The metronomics experiment is path-breaking in terms of providing good quality and affordable cancer care for a majority of the over 10 lakh cancer cases diagnosed in India each year.'' These findings could revolutionize cancer care in most developing countries, he said.

The catch is, however, that this branch is still in research stage. The conventional cancer treatment comprising chemotherapy is given at "maximum tolerated doses" which are tested and have reams of research to back it. As against this, in metronomic therapies, the drugs are given at very low doses. "But side-effects are fewer and patients have a good quality of life,'' said Dr Banavali.

The word metronomics is borrowed from music; musicians use the metronome to mark time and hence rhythm. Patients are asked to take these medicines for a period of 21 days or more before taking a break of a week; such a cycle continues for months.

Dr Banavali's work has been published in the May issue of the medical journal Lancet Oncology. Thousands of patients have been on metronomic treatment in Tata Memorial Hospital as well as its rural centre, with a sizeable number managing to control the growth of cancer. "In India, the main challenge in cancer is not just finding cures, but to develop affordable treatments'' he said.

In fact, the metronomic work arose out of such cost concerns over a decade back. The Tata doctors found that many patients were lost to treatment because they were overwhelmed by the cost of medicines. "Moreover, many patients came so late for treatment that we had to turn them away without any medicines,'' said Dr Banavali. Instead of turning away such patients, the Tata team decided to adopt the metronomic treatment as palliative treatment that was being tested out in various parts of the world. "We gave them drugs that would help in pain or at least ensure that their case doesn't worsen," he adds.

But the results surprised them. In a large group of children with blood cancers called acute myeloid leukemia (AML), they found that metronomic maintenance treatment had helped increased survival rate to 67%. The group then started its own innovation, going ahead of the rest of the world. "The West used the same set of medicines for all forms of cancer, but we introduced personalised medicines for various types of cancers,'' said Dr Banavali.

The Lancet paper, titled 'Has the time come for metronomics in low-income and middle-income countries', mentions combination of drugs used for four cancers (see box). The Tata doctors feel that these drugs may work as well for newly developed tumours. "While the developed world is going after 'drug discoveries', that is discovering new drugs which are very costly for our patients, we are going after 'drug repositioning', that is using time-tested drugs for the treatment of cancer," said Dr Banavali. For example they are using drugs likemetformin (an anti-diabetic drug), sodium valproate (an anti-seizure drug) and propranolol (an anti-hypertensive drug) in the treatment of cancer.

The Lancet paper said, "The combination of metronomic chemotherapy and drug repositioning might provide a way to overcome some of the major constraints associated with cancer treatment in developing countries and might represent a promising alternative strategy for patients with cancer living in low- and middle-income countries.''

Metronomics chemotherapy works at three levels. It attacks tumours while working on the "micro-environment", like the blood vessels, around the tumour. Thirdly, it works on the immuno-modulating system of the body. "Unless the metronomic dose works on all these three fields, it may not work,'' said the doctor.

Survivor of twin blows, counselor for others

On the occasion of Cancer Survivors Day on June 2, members of Ugam, an NGO, will put up a skit at Tata Memorial Hospital to underline the problems of parents whose children suffer from cancer. Comprising childhood cancer survivors, Ugam members counsel cancer patients undergoing treatment at Tata Memorial Hospital. One of its founder members, Shalaka Mane (29), who lost her right eye to cancer, will be there too. She feels people discriminate against cancer patients. "I feel there is a need to increase awareness about the treatment of cancer in society and the government, and enable these families to get financial help," she says. Diagnosed with blood cancer when she was eight years old, she barely got back to being at the top of her class when she was found to have brain cancer. "I was in Class XII and planning to take up medicine, but it wasn't to be,'' she says. The second cancer was so virulent that she lost her eye. But she emerged victorious a second time and completed her masters. She now teaches at Kalvidhai Mission High School, Andheri, which she attended as a student. "My principal and teachers never discriminated against me because of my illness. I enjoy my job," she adds.

'Cancer can't affect my future'

Artist Sachin Chandorkar is a poster boy of sorts at the Tata Memorial Hospital, Parel. At 28, he has won several awards (one from chief minister Prithviraj Chavan last month) for his murals and sculptures. But the Tata connection comes from his victory over cancer when he was five years of age. He was suffering from Hodgkin's Lymphoma. "I remember feeling irritated due to the itch on my head. When I would stratch my head, tufts of hair would come into my hands. I would then start crying," says Chandorkar, who studied at the JJ School of Arts. He usually doesn't talk about his battle with the Big C. "When my mother and sisters sometimes talk about it, I ask them to stop. I have decided that cancer is a part of my past and cannot affect my future,'' he adds.