Why are drugs illegal?

‘To enable Harry Anslinger to keep his army of drug enforcers [the Untouchables], he created a new drug threat, cannabis, which he called marijuana to make it sound more Mexican.’ Photograph: Tomas Rodriguez/Corbis

 David Nutt in The Guardian


This is, of course, a flawed question but one that illustrates a major paradox in the UK and international laws on drugs. Some drugs – such as alcohol, caffeine and nicotine – are legal, whereas others – such as cannabis, cocaine and opium – are not. This has not always been the case.

In the 19th century extracts of these three now-illegal drugs were legal in the UK, and were sold in pharmacies and even corner shops. Queen Victoria’s physician was a great proponent of the value of tincture of cannabis and the monarch is reputed to have used it to counteract the pain of menstrual periods and childbirth. Now it is denied to people with severe enduring spasticity and pain from neurological disorders and cancer. Why?

Activists to get high together in protest against psychoactive substances ban



The truth is unpalatable and goes back to the period of alcohol prohibition in the US in the 1920s. This was introduced as a harm-reduction measure because alcohol was seen (correctly) as a drug that seriously damaged families and children. But public demand for alcohol in the US did not abate and this fuelled a massive rise in bootleg alcohol and underground bars (known as speakeasys) that encouraged the rise of the mafia and other crime syndicates.

To combat this, the US government set up a special army of enforcers, under the command of Harry Anslinger, which became known as “the untouchables”. This army of enforcers was widely celebrated by the newspapers and the acclaim propelled Anslinger to national prominence. However, when public disquiet at the crime and social damage caused by alcohol prohibition led to its repeal, Anslinger saw his position as being in danger.

To enable him to keep his army of drug enforcers, he created a new drug threat: cannabis, which he called marijuana to make it sound more Mexican. Working with a newspaper magnate, William Randolph Hearst, he created hysteria around the impact of cannabis on American youth and proclaimed an invasion of marijuana-smoking Mexican men assaulting white women. The ensuing public anxiety led to the drug being banned. The US then imposed its anti-cannabis stance on other western countries and this was finally imposed on the rest of the world through the first UN convention on narcotic drugs in 1961.

 

Mexican soldiers burning marijuana, cocaine, heroin and other drugs in Ciudad Juarez, Chihuahua. Photograph: AFP/Getty

This process of vilifying drugs by engendering a fear of the “other people” who use them became a recurring theme in drug policy. Black Americans were stigmatised on account of heroin use in the 1950s. In the 1960s hippies and psychedelics were targeted because they opposed the Vietnam war. In the 1970s it was again inner-city black Americans who used crack cocaine who received the brunt of opprobrium, so much so that the penalties for crack possession were 100 times higher than those for powder cocaine, despite almost equivalent pharmacology. Then came “crystal” (methamphetamine) and the targeting of “poor whites”.

The UK has followed US trends over cannabis, heroin and psychedelics, and led the world in the vilification of MDMA (ecstasy). In the UK a hate campaign against young people behaving differently was instigated by the rightwing press. As with past campaigns, they hid their prejudice under the smokescreen of false health concerns. It was very effective and resulted in both MDMA and raves being banned. This occurred despite the police being largely comfortable with MDMA users since they were friendly – a stark contrast to those at alcohol-fuelled events.


Since the demise of ecstasy we have seen the rise and fall of several alternative legal highs, most notably mephedrone. This was banned following a relentless media campaign, despite no evidence of deaths and with little attempt to properly estimate its harm. Subsequently we have discovered that it saved more lives than it took because so many people switched from cocaine and amphetamine to mephedrone that deaths from these more toxic stimulants decreased by up to 40%. Since mephedrone was banned in 2010, cocaine deaths have risen again and are now above their pre-mephedrone levels.

As young people seek to find legal ways to enjoy altered consciousness without exposing themselves to the addictiveness and toxicity of alcohol or the danger of getting a criminal record, so the newspapers seek to get these ways banned too. Politicians collude as they are subservient to those newspapers that hate youth and they know that the drug-using population is much less likely to vote than the drug-fearing elderly. We have moved to a surreal new world in which the government, through the new psychoactive substances bill, has decided to put an end to the sale of any drug with psychoactive properties, known or yet to be discovered.

This ban is predicated on more media hysteria about legal highs such as nitrous oxide and the “head shops” that sell them. Lies about the number of legal high deaths abound, with Mike Penning, minister for policing and justice, quoting 129 last year in the bill’s second reading. The true figure is about five, as the “head shops” generally now sell safe mild stimulants because they don’t want their regular customers to die.

‘Queen Victoria’s physician was a great proponent of the value of tincture of cannabis, and she is reputed to have used it to counteract the pain of menstrual periods and childbirth.’ Photograph: Alamy

The attack on nitrous oxide is even more peculiar as this gas has been used for pain control for women in childbirth and surgical pain treatments for more than 100 years with minimal evidence of harm. But when a couple of premiership footballers are filmed inhaling a nitrous oxide balloon, then it becomes a public health hazard. In typical fashion the press renamed it “hippy crack” to scare people – what could me more frightening to elderly readers than an invasion of hippies on crack? In truth, the effect of nitrous oxide is nothing like crack and no self-respecting hippy would ever use it. Still, it seems likely it will be banned along with every other mind-altering substance that is not exempted.

The psychoactive substances bill is the most oppressive law in terms of controlling moral behaviour since the Act of Supremacy in 1558 that banned the practice of the Catholic faith. Both are based on a moral superiority that specifies the state will decide on acceptable actions and beliefs even if they don’t affect other people. Worse, it won’t work – evidence from other countries such as Poland and Ireland that have tried such blanket bans shows an increase in deaths as people go back to older illegal drugs such as cocaine and heroin.

Moreover, it may seriously impede research in brain disorders, one of the few scientific areas in which the UK is still world-leading. But hey, who cares about the consequences of laws, so long as the police and the press are appeased?

So the short answer to the question “why are (some) drugs illegal?” is simple. It’s because the editors of powerful newspapers want it that way. They see getting drugs banned as a tangible measure of success, a badge of honour. And behind them the alcohol industry continues secretly to express its opposition to anything that might challenge its monopoly of recreational drug sales. But that’s another story.

What the Tamiflu saga tells us about drug trials and big pharma

We now know the government's Tamiflu stockpile wouldn't have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there's a lot we don't know about other medicines we take

• 
• • Ben Goldacre
  • The Guardian, Thursday 10 April 2014

Tamiflu capsules. Photograph: Per Lindgren/REX

Today we found out that Tamiflu doesn't work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn't in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.

 The UK government spent £0.5bn stockpiling Tamiflu. Photograph: Hanodut/EPA

Cochrane had summarised the data from all the trials, explained Hayashi, but its positive conclusion was driven by data from just one of the papers it cited: an industry-funded summary of 10 previous trials, led by an author called Kaiser. From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry. That's not reliable enough.

This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from. Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 review. He realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed.

First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: they should contact Roche. Here theproblems began. Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tricky: Cochrane reviews are built around showing their working, but Roche's proposed contract would require them to keep the information behind their reasoning secret from readers. More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions. Roche's demand, worryingly, is not unusual. At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary. He never received a reply.

Then, in October 2009, the company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere. Roche had given this other group the study reports, so Cochrane couldn't have them. This was a non-sequitur: there is no reason why many groups should not all work on the same question. In fact, since replication is the cornerstone of good science, this would be actively desirable.

Then, one week later, unannounced, Roche sent seven documents, each around a dozen pages long. These contained excerpts of internal company documents on each of the clinical trials in the Kaiser meta-analysis. It was a start, but nothing like the information Cochrane needed to assess the benefits, or the rate of adverse events, or fully to understand the design of the trials.

 Packets of Tamiflu in a drawer at a German pharmacy. Photograph: Wolfgang Rattay/Reuters

At the same time, it was rapidly becoming clear that there were odd inconsistencies in the information on this drug. Crucially, different organisations around the world had drawn vastly different conclusions about its effectiveness. The US Food and Drug Administration (FDA) said it gave no benefits on complications such as pneumonia, while the US Centers for Disease Control and Prevention said it did. The Japanese regulator made no claim for complications, but the European Medicines Agency (EMA) said there was a benefit. There are only two explanations for this, and both can only be resolved by full transparency. Either these organisations saw different data, in which case we need to build a collective list, add up all the trials, and work out the effects of the drug overall. Or this is a close call, and there is reasonable disagreement on how to interpret the trials, in which case we need full access to their methods and results, for an informed public debate in the medical academic community.

This is particularly important, since there can often be shortcomings in the design of a clinical trial, which mean it is no longer a fair test of which treatment is best. We now know this was the case in many of the Tamiflu trials, where, for example, participants were sometimes very unrepresentative of real-world patients. Similarly, in trials described as "double blinded" – where neither doctor nor patient should be able to tell whether they're getting a placebo or the real drug – the active and placebo pills were different colours. Even more oddly, in almost all Tamiflu trials, it seems a diagnosis of pneumonia was measured by patients' self-reporting: many researchers would have expected a clear diagnostic algorithm, perhaps a chest x-ray, at least.

Since the Cochrane team were still being denied the information needed to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make full study reports available. For four years, they then failed to do so.

During this period, the global medical academic community began to realise that the brief, published academic papers on trials – which we have relied on for many years – can be incomplete, and even misleading. Much more detail is available in a clinical study report (CSR), the intermediate document that stands between the raw data and a journal article: the precise plan for analysing the data statistically, detailed descriptions of adverse events, and so on.

By 2009, Roche had shared just small portions of the CSRs, but even this was enough to see there were problems. For example, looking at the two papers out of 10 in the Kaiser review that were published, one said: "There were no drug-related serious adverse events", and the other doesn't mention adverse events. But in the CSR documents shared on these same two studies, 10 serious adverse events were listed, of which three are classified as being possibly related to Tamiflu.

 Roche HQ in Basel, Switzerland. Photograph: Bloomberg/Bloomberg via Getty Images

By setting out all the known trials side by side, the researchers were able to identify peculiar discrepancies: for example, the largest "phase three" trial – one of the large trials that are done to get a drug on to the market – was never published, and is rarely mentioned in regulatory documents.

The chase continued, and it exemplifies the attitude of industry towards transparency. In June 2010, Roche told Cochrane it was sorry, but it had thought they already had what they wanted. In July, it announced that it was worried about patient confidentiality. By now, Roche had been refusing to publish the study reports for a year. Suddenly, it began to raise odd personal concerns. It claimed that some Cochrane researchers had made untrue statements about the drug, and about the company, but refused to say who, or what, or where. "Certain members of Cochrane Group," it said, "are unlikely to approach the review with the independence that is both necessary and justified." This is hard to credit, but even if true, it should be irrelevant: bad science is often published, and is shot down in public, in academic journals, by people with good arguments. This is how science works. No company or researcher should be allowed to choose who has access to trial data. Still Roche refused to hand over the study reports.

Then Roche complained that the Cochrane reviewers had begun to copy in journalists, including me, on their emails when responding to Roche staff. At the same time, the company was raising the broken arguments that are eerily familiar to anyone who has followed the campaign for greater trials transparency. Key among these was one that cuts to the core of the culture war between evidence-based medicine, and the older "eminence-based medicine" that we are supposed to have left behind. It is simply not the job of academics to make these decisions about benefit and risk, said Roche, it is the job of regulators.

This argument fails on two fronts. First, as with many other drugs, it now seems that not even the regulators had seen all the information on all the trials. But more than that, regulators miss things. Many of the most notable problems with medicines over the past few years – with the arthritis drug Vioxx; with the diabetes drug rosiglitazone, marketed as Avandia; and with the evidence base for Tamiflu – weren't spotted primarily by regulators, but rather by independent doctors and academics. Regulators don't miss things because they are corrupt, or incompetent. They miss things because detecting signals of risk and benefit in reviews of clinical trials is a difficult business and so, like all difficult questions in science, it benefits from having many eyes on the problem.

While the battle for access to Tamiflu trials has gone on, the world of medicine has begun to shift, albeit at a painful pace, with the European Ombudsman and several British select committees joining the push for transparency. The AllTrials campaign, which I co-founded last year, now has the support of almost all medical and academic professional bodies in the UK, and many more worldwide, as well as more than 100 patient groups, and the drug company GSK. We have seen new codes of conduct, and European legislation, proposing improvements in access: all riddled with loopholes, but improvements nonetheless. Crucially, withholding data has become a headline issue, and much less defensible.

Last year, in the context of this wider shift, under ceaseless questions from Cochrane and the British Medical Journal, after half a decade, Roche finally gave Cochrane the information it needed.

So does Tamiflu work? From the Cochrane analysis – fully public – Tamiflu does not reduce the number of hospitalisations. There wasn't enough data to see if it reduces the number of deaths. It does reduce the number of self-reported, unverified cases of pneumonia, but when you look at the five trials with a detailed diagnostic form for pneumonia, there is no significant benefit. It might help prevent flu symptoms, but not asymptomatic spread, and the evidence here is mixed. It will take a few hours off the duration of your flu symptoms. But all this comes at a significant cost of side-effects. Since percentages are hard to visualise, we can make those numbers more tangible by taking the figures from the Cochrane review, and applying them. For example, if a million people take Tamiflu in a pandemic, 45,000 will experience vomiting, 31,000 will experience headache and 11,000 will have psychiatric side-effects. Remember, though, that those figures all assume we are only giving Tamiflu to a million people: if things kick off, we have stockpiled enough for 80% of the population. That's quite a lot of vomit.

Roche has issued a press release saying it contests these conclusions, but giving no reasons: so now we can finally let science begin. It can shoot down the details of the Cochrane review – I hope it will – and we will edge towards the truth. This is what science looks like. Roche also denies being dragged to transparency, and says it simply didn't know how to respond to Cochrane. This, again, speaks to the pace of change. I have no idea why it was withholding information: but I rather suspect it was simply because that's what people have always done, and sharing it was a hassle, requiring new norms to be developed. That's reassuring and depressing at the same time.

Should we have spent half a billion on this drug? That's a tricky question. If you picture yourself in a bunker, watching a catastrophic pandemic unfold, confronting the end of human civilisation, you could probably persuade yourself that Tamiflu might be worth buying anyway, even knowing the risks and benefits. But that final clause is the key. We often choose to use treatments in medicine, knowing that they have limited benefit, and significant side-effects: but we make an informed decision, balancing the risks and benefits for ourselves.

And in any case, that £500m is the tip of the iceberg. Tamiflu is a side show, the one place where a single team of dogged academics said "enough" and the company caved in. But the results of clinical trials are still being routinely and legally withheld on the medicines we use today and nothing about a final answer on Tamiflu will help plug this gaping hole.

 Star anise provides the principal component of Tamiflu. Photograph: Adrian Bradshaw/EPA

More importantly, for all that there is progress, so far we have only sentiment, and half measures. None of the changes to European legislation or codes of conduct get us access to the information we need, because they all refer only to new trials, so they share a loophole that excludes – remarkably – all the trials on all the medicines we use today, and will continue to use for decades. To take one concrete and topical example: they wouldn't have made a blind bit of difference on Tamiflu. We have seen voluntary pledges for greater transparency from many individual companies – Johnson & Johnson, Roche,GSK, now Roche, and more – which are welcome, but similar promises have been given before, and then reversed a few years later.

This is a pivotal moment in the history of medicine. Trials transparency is finally on the agenda, and this may be our only opportunity to fix it in a decade. We cannot make informed decisions about which treatment is best while information about clinical trials is routinely and legally withheld from doctors, researchers, and patients. Anyone who stands in the way of transparency is exposing patients to avoidable harm. We need regulators, legislators, and professional bodies to demand full transparency. We need clear audit on what information is missing, and who is withholding it.

Finally, more than anything – because culture shift will be as powerful as legislation – we need to do something even more difficult. We need to praise, encourage, and support the companies and individuals who are beginning to do the right thing. This now includes Roche. And so, paradoxically, after everything you have read above, with the outrage fresh in your mind, on the day when it feels harder than any other, I hope you will join me in saying: Bravo, Roche. Now let's do better.

India's activist role in breaking the pharmaceutical patent monopolies

Ritu Kumar in The Indian Express 4 March 2014

Recently, there were rumours that the United States Trade Representative (USTR) was getting ready to announce “trade enforcement actions” or sanctions against India over its intellectual property rights regime. The Obama administration has been under pressure from the US Chamber of Commerce and lobby groups, like the Pharmaceutical Research and Manufacturers of America, to take a tough stance against Indian rulings that have vetoed several multinational pharmaceutical company patents.

The lobbyists are pushing for India to be classified as a “priority foreign country”, a label associated with the worst offenders of patent law. The row blew over, but not before the USTR had filed a case at the World Trade Organisation (WTO) against India’s domestic content requirements for its solar programme.

In the last few years, the Indian government and judiciary have taken up major cases on patent protection for life-saving cancer drugs. Novartis’s drug Glivec was denied patent protection by the Supreme Court and India granted a compulsory licence to Bayer’s drug Nexavar, which treats kidney and liver cancer.

Compulsory licences are a provision in international patent norms, including the WTO’s TRIPS agreement, under which a government permits someone else to manufacture the patented product without the consent of the patent owner, usually to lower prices of life-saving drugs and increase access to them.

This is not the first time that India has taken a strong stance in the pharmaceutical patent wars. In 2001, Indian generic manufacturers played a crucial role in slashing prices of anti-retroviral (ARV) drugs used against HIV, bringing down the cost of the drugs per patient per year from around $15,000 to about $300. Today, the cost of ARV drugs is as low as $60 per patient per year. This remarkable achievement was only possible because at the time, India was not party to WTO agreements on patent protection.

Indian generic manufacturers were able to disregard patents, and ended up supplying over 80 per cent of all ARV drugs purchased in the world. India was recognised as playing a leading role in providing quality healthcare to people in developing countries.

It is evident that India’s role in the pharmaceutical patent wars has great implications for poor people’s access to healthcare, not just at home but around the world. Emerging economies like Brazil and South Africa follow the Indian model when they modify their intellectual property laws in order to bar awards to frivolous and obvious patents, and to allow pre-and post-grant challenges. For instance, Brazil’s proposed changes to its patent policy quote provisions in India’s Patents (Amendment) Act, 2005. Doctors Without Borders, meanwhile, has publicly encouraged South Africa to borrow from India when drafting its new patent policy.

With markets in the developed world becoming saturated, multinational drug companies are increasingly looking to emerging economies with large populations for sales expansion and growth. However, their model of intellectual property protection as an incentive for innovation is running into obstacles in low- and middle-income countries. Supporters of the pharmaceutical industry believe that without patent protections, there will be no breakthrough innovations and no new life-saving technologies.

They argue that the high costs of research and development for new drugs can only be compensated by patent monopolies that allow expensive drug prices. Yet, developing economies are keen on providing affordable healthcare products for their citizens. The developed world itself is beset with unsustainable rising healthcare costs and is looking for cost-effective innovation. A reassessment of patent monopolies, especially in the case of life-saving products, is essential if healthcare access is to be broadened beyond wealthy patients.

Some new models of incentivising medical research are being proposed. Since large funds are required for the development of new medical technologies, scholars have proposed the creation of attractive prizes, along the lines of the XPrize, which was instituted to encourage space exploration by giving successful teams up to $10 million in awards. The idea behind prizes is that the winning team receives a large one-time payment, but it cannot patent the solution, which ensures that the technology remains in the public domain.

Other models of funding innovation have already seen success in the marketplace, such as the public-private partnership that created a new rotavirus vaccine. This vaccine, called Rotavac, is now sold in India and other developing countries by Bharat Biotech, at profit, for about $1 per dose.

Millions of patients are suffering from many other poorly managed or untreatable diseases, such as diabetes or dengue fever. They would greatly benefit if companies were incentivised to create therapies at affordable prices that were widely accessible. India must not slow the pace of developing new therapies, nor shy away from the difficult work of making healthcare available to all. The rest of the world is watching.

Lottery of NHS drugs punishes the dying

Thousands of patients denied life-extending treatments approved by health watchdog

Despite certain drugs approved by the NHS rationing body, at least 14,000 patients a year are not receiving them Photo: ALAMY

By Laura Donnelly, Health Correspondent

7:42PM GMT 21 Jan 2014

154 Comments

Thousands of patients suffering from cancer and other serious illnesses are being denied the drugs they need from the NHS, according to a report.

Even though the treatments have been approved by the health service rationing body, at least 14,000 patients a year are not receiving them.

As many as one in three of those suffering from some types of cancer are going without medication that could extend their lives, the figures show.

Experts said the report, from the Health and Social Care Information Centre, a government quango that provides NHS statistics and analysis of trends in health and social care, exposed an “endemic and disastrous postcode lottery” of care within the health service.

Charities said the findings were “alarming” and meant patients were being condemned to an early death because local NHS bodies were failing to fund drugs even though they had been proven to work. 

When the National Institute for Health and Care Excellence (Nice) was created by the last Labour government, officials promised to end the variation in medical treatment across the country and ensure that if a drug was found to be effective, patients should not have to fight to get it.

However, the findings show that thousands of patients suffering from cancer, motor neurone disease and an eye condition which is the most common cause of blindness, are not being given the best medication.

The research examined 10 common treatments which have been backed by Nice, meaning they should be given to all patients who require them.

It found that in three of the groups, there was a gulf between the number of patients who should have been given the drugs and the numbers who were actually prescribed them.

The worst findings were for kidney cancer, which affects more than 8,000 patients a year, and for a form of motor neurone disease which affects almost 3,000 people.

One in three patients who could have benefited from sunitinib (which has the brand name Sutent) and pazopanib (brand name Votrient), life-extending drugs for kidney cancer, or from riluzole (brand name Rilutek), the only treatment for motor neurone disease, did not receive them.

More than 12,000 patients were denied injections for wet age-related macular degeneration (AMD), the most common cause of vision loss and blindness.

Nice makes rulings on whether drugs are effective and good value, but has been criticised for refusing to support drugs in the face of evidence that they can extend lives by months or even years, and for delaying decisions.

But the findings suggest that even when Nice says NHS bodies must fund the drugs, thousands of patients are still denied medication.

Charities said too many terminally-ill patients ended up fighting bureaucratic procedures in an attempt to secure NHS funding for treatment.

In other cases, they were never told about drugs such as Sutent, which can double life expectancy with kidney cancer to 28 months, and was approved by Nice more than four years ago.

Andrew Wilson, the chief executive of the Rarer Cancers Foundation, said patients were suffering from “an endemic postcode lottery in access to Nice-approved medicines”.

“It is extremely worrying that the NHS does not seem to be making available cancer treatments to all patients who could benefit, even when the drug is approved by Nice,” he said.

Nick Turkentine, the chief operating officer of the James Whale Fund for Kidney Cancer, said the failure to follow national guidance was “a disaster” for patients with aggressive cancers. He said: “Sutent was one of the first drugs to be approved for kidney cancer — it is really disastrous that patients are still having to battle for a drug which we know can give several extra years of life.”

Duleep Allirajah, the head of policy at Macmillan Cancer Support, said: “Patients do not choose which cancer they get. Every patient deserves equal access to treatment no matter who they are, where they are from, or which cancer they have.”

A spokesman for Nice said the organisation hoped the report would help ensure that guidance was followed more widely, and that local NHS groups needed to be able to justify variations from it.

A spokesman for the Department of Health said: “Patients have a right to drugs and treatments that have been approved by Nice and we expect the NHS to provide them if they are needed.

“That is why the chief executive of the NHS has written to the local NHS requiring them to publish which NHS organisations are funding and using drugs and treatments approved by Nice, and which are not.”

Drugs whose use was lower than expected:

• Riluzole (Rilutek) - the only treatment for motor neurone disease - 35 per cent of patients who would have been expected to receive the drugs did not.

• Sunitnib (Sutent) and pazopanib (Votrient) for kidney cancer - 32 per cent of patients who would have been expected to receive the drugs did not.

• Ranibizumab (Lucentis) - the most effective treatment for wet age-related macular degeneration, which can cause blindness - 5 per cent of patients who would have been expected to receive the drugs did not.

Heroic Uruguay deserves a Nobel peace prize for legalising cannabis

The war on the war on drugs is the only war that matters. Uruguay's stance puts the UN and the US to shame

• 
• • Simon Jenkins
  • The Guardian, Thursday 12 December 2013 20.35 GMT

'Uruguay will legalise not only cannabis consumption but, crucially, its production and sale.' Illustration by Satoshi Kambayashi

I used to think the United Nations was a harmless talking shop, with tax-free jobs for otherwise unemployed bureaucrats. I now realise it is a force for evil. Its response to a truly significant attempt to combat a global menace – Uruguay's new drug regime – has been to declare that it "violates international law".

To see the tide turn on drugs is like trying to detect a glacier move. But moving it is. Wednesday's statute was introduced by the Uruguayan president, José Mujica, "to free future generations from this plague". The plague was not drugs as such but the "war" on them, which leaves the world's youth at the mercy of criminal traffickers and random imprisonment. Mujica declares himself a reluctant legaliser but one determined "to take users away from clandestine business. We don't defend marijuana or any other addiction, but worse than any drug is trafficking."

Uruguay will legalise not only cannabis consumption but, crucially, its production and sale. Users must be over 18 and registered Uruguayans. While small quantities can be grown privately, firms will produce cannabis under state licence and prices will be set to undercut traffickers. The country does not have a problem on the scale of Colombia or Mexico – just 10% of adults admit to using cannabis – and stresses that the measure is experimental.

This measured approach is still way in advance even of American states such as Colorado and Washington, which have legalised recreational as well as medical cannabis consumption, but not production. While the Uruguayan law does not cover other drugs, by depriving traffickers of an estimated 90% of their market, the hope is both to undermine the bulk of the criminal market and to diminish the gateway effect of traffickers pushing harder drugs.

Mujica's courage should not be underrated. His is a gently old-fashioned country, and two-thirds of those polled oppose the move, though this is up from 3% a decade ago. In addition some pro-legalisation lobbies object to his de facto nationalisation. An open question is whether a state cartel will be as effective as a regulated free market. But the drugs chief, Julio Calzada, is blunt: "For 50 years, we have tried to tackle the drug problem with only one tool – penalisation – and that has failed. As a result, we now have more consumers, bigger criminal organisations, money laundering, arms trafficking and collateral damage."

The response of the UN's International Narcotics Control Board has been to incant futile bromides. The move, says its chief Raymond Yans, would "endanger young people and contribute to the earlier onset of addiction". It would also be in breach of a "universally agreed and internationally endorsed treaty". Yet the UN admits that half a century of attempted suppression has led to 162m cannabis users worldwide, or 4% of the total adult population .

The 78-year-old Mujica notes the irony that many of his South American contemporaries agree with him, but only after leaving office. They include Brazil's Fernando Cardoso, Mexico's Ernesto Zedillo and Colombia's César Gaviria, all of whom have now called for the decriminalisation of the drug market so that they can begin to regulate a trade whose feuding operators are killing thousands of people each year. Thevalue of the drugs trade is second only to the trade in arms. Yet the US resists decriminalisation so it can continue to fight cocaine and opium production in Latin America and Afghanistan, to avoid confronting the real enemy: a domestic consumption that is out of control.

For all this, the futility of suppression is leading to laws crumbling across the west.Twenty US states have legalised medical cannabis. California this year narrowly rejected taxing consumption (turning down an estimated $1.3bn in annual revenue) and may yet relent. Drug use is accepted across most of Latin America and, de facto, Europe. Even in Britain, where possession can be punished by five years in prison, just 0.2% of cases prosecuted result in such a sentence. The most intensive drug users are said to be in the state's own jails. The law has effectively collapsed.

The difficulty now is to resolve the inconsistency of enforcers "turning a blind eye" to consumption while leaving supply (and thus marketing) untaxed and unregulated in the hands of drug traffickers. This is little short of a state subsidy to organised crime. Indulgence may save the police and the courts from the cost of enforcement, but it leaves every high street open to massive cross-jeopardy, from cannabis to hard drug use.

Ending this inconsistency requires action from legislators. Yet they remain seized by a lethal mix of taboo, tribalism and fear of the media. British policy on all intoxicants and narcotics (from booze to benzodiazepines) is chaotic and dangerous. The government on Thursday admitted its inability to control "legal highs", new ones being invented every week. It is running round back-street laboratories waving bans and arrest warrants like the Keystone Cops.

The catastrophe of death and anarchy that failed drug suppression has brought to Mexico and to other narco-states makes the west's obsessive war on terror seem like a footling sideshow. The road out of this darkness is now being charted not in the old world but in the new, whose heroic legislators deserve to be awarded a Nobel peace prize. It is they who have taken on the challenge of fighting the one world war that really matters – the war on the war on drugs. It is significant that the bravest countries are also the smallest. Thank heavens for small states.

Reclassifying ketamine is more fiddling while the crack pipe burns

Why can't we have an honest conversation about drugs?

 

• 
• • Suzanne Moore
  • The Guardian, Wednesday 11 December 2013 20.00 GMT

Why can't we talk about our history of intoxication? Photograph: guardian.co.uk

Tis the season to be off your head, legally and in a ladylike manner. At the moment there is a lot of focus on the harm that us people (ie, women) do to ourselves with our: "Yay, it's wine o'clock." Or, as the Sun explains: "So many mums open the wine once the kids are in bed. The cork rarely goes back in the bottle."

One might ask why women's lives are so stressful that self-medication is needed, and why alcohol is such an astonishingly cheap way to get wasted. Legally.

I stress legal because the news that government advisers want ketamine reclassified from a class C to B drug is more fiddling while the crack pipe burns. The drug wasn't banned until 2006, but someone who gets caught with it will now face up to five years in prison instead of two. A heavy price, one feels, for the person who wants to anaesthetise themselves of an evening. Send them to prison where drugs are the currency? It's almost as if government advisers don't live in the real world.

Sure, the long-term effects of ketamine (bladder damage) are not nice and I have never doubted that it is dangerous. When I was 16, two boys I knew broke into a veterinary surgery and injected it. The dose was for horses, not humans. They both died stupid, stupid deaths.

Reclassifying it might mean a few students may now think twice. But those who will be thinking really hard are the manufacturers who will design a legal substance that guarantees the effects of ketamine and can be sold online. For this is how prohibition works hand in hand with capitalism and organised crime. Recently, we have all experienced contact highs – cooking up meth (Breaking Bad), cheering on Nigella (coke), Paul Flowers (a vile cocktail of everything and ill- considered banking). We watch Russell Brand's abstinence monologues that do indeed break the barriers of space and time.

There is no joined-up drugs policy. It is rare that I say a good word about George Osborne but, as I have said in the past, I don't care if he took cocaine. Because I don't. And to be fair to Nick Clegg – maybe I really am out of my mind – he admits that in the war on drugs, drugs won, acknowledging that many senior police officers want decriminalisation. Addiction, Clegg declared recently, is a health issue, not a criminal justice one.

Facts remain a dangerous substance in this debate, as Professor David Nutt knows. In 2009, he said that illegal drugs should be classified according to the harm, both social and individual, they cause. Alcohol would certainly have a high classification. Booze and tobacco, he said, were more harmful than LSD, cannabis and ecstasy. So he had to be got rid of, as few politicians ever seem to be able to expand their minds enough to consider actual evidenced-based policy-making.

Decriminalising certain drugs would inevitably mean misuse. But the unsayable thing is that many of us use drugs, legal and illegal, at certain stages in our lives. And enjoy them.

Instead, however, we hand over the trade to organised crime, which is why Mexico is in the state it is now, upping its poppy production massively. We have spent 10 years trying to bomb or bribe away the only cash crop the Afghans can grow (the opium poppy). What do we want them to sell? Cabbages? This year is a record one for the crop, produced mainly in Helmand, so that has really worked.

You may be the sort of person who does not want to drink or take drugs. You may not wish to expand your mind, or lose it. You may not want to connect the handing-out of mood-altering SSRIs (selective serotonin reuptake inhibitors) with kids smoking skunk and mums' little wine clubs. You may think it's no longer cool to neck any pills other than statins. You may want to move to Uruguay, which has just legalised marijuana, though I can't think of anything worse than being in Montevideo with a load of gap yahs. It's not my drug of choice, as I like things that make you want to talk.

I would like the real drug conversation, not the gurning, coked-up, aren't-we-amazing one. Not the one where Tulisa is a threat to civilisation. Why can't we talk about our history of intoxication, personal and political? Those who make the laws that would make me a criminal are not coherent in their logic. They are cowards, afraid of a media that is neither clean nor sober. Drugs, legal and illegal, are a fact of life. Even life-enhancing. There will be casualties of drugs but there are casualties of not facing reality. Both need to be managed. Honestly, I really cannot snort another line of this hypocrisy.

How I bought drugs from 'dark net' – it's just like Amazon run by cartels

Last week the FBI arrested Dread Pirate Roberts, founder of Silk Road, a site on the 'dark net' where visitors could buy drugs at the click of a mouse. Though Dread – aka Ross Ulbricht – earned millions, was he really driven by America's anti-state libertarian philosophy?

• 
• • Carole Cadwalladr
  • The Observer, Sunday 6 October 2013

The FBI alleges Ross Ulbricht ran the vast underground drug marketplace Silk Road for more than two years. Photograph: theguardian.com

Dear FBI agents, my name is Carole Cadwalladr and in February this year I was asked to investigate the so-called "dark net" for a feature in this newspaper. I downloaded Tor on to my computer, the anonymous browser developed by the US navy, Googled "Silk Roaddrugs" and then cut and pasted this link http://silkroadvb5piz3r.onion/ into the address field.

And bingo! There it was: Silk Road, the site, which until the FBI closed it down on Thursday and arrested a 29-year-old American in San Francisco, was the web's most notorious marketplace.

The "dark net" or the "deep web", the hidden part of the internet invisible to Google, might sound like a murky, inaccessible underworld but the reality is that it's right there, a click away, at the end of your mouse. It took me about 10 minutes of Googling and downloading to find and access the site on that February morning, and yet arriving at the home page of Silk Road was like stumbling into a parallel universe, a universe where eBay had been taken over by international drug cartels and Amazon offers a choice of books, DVDS and hallucinogens.

Drugs are just another market, and on Silk Road it was a market laid bare, differentiated by price, quality, point of origin, supposed effects and lavish user reviews. There were categories for "cannabis", "dissociatives", "ecstasy", "opioids", "prescription", "psychedelics", "stimulants" and, my favourite, "precursors". (If you've watched Breaking Bad, you'll know that's the stuff you need to make certain drugs and which Walt has to hold up trains and rob factories to find. Or, had he known about Silk Road, clicked a link on his browser.)

And, just like eBay, there were star ratings for sellers, detailed feedback, customer service assurances, an escrow system and a busy forum in which users posted helpful tips. I looked on the UK cannabis forum, which had 30,000 postings, and a vendor called JesusOfRave was recommended. He had 100% feedback, promised "stealth" packaging and boasted excellent customer reviews: "The level of customer care you go to often makes me forget that this is an illegal drug market," said one.

JesusOfRave boasted on his profile: "Working with UK distributors, importers and producers to source quality, we run a tight ship and aim to get your order out same or next day. This tight ship also refers to our attitude to your and our privacy. We have been doing this for a long time … been playing with encryption since 0BC and rebelling against the State for just as long."

And so, federal agents, though I'm sure you know this already, not least because the Guardian revealed on Friday that the National Security Agency (NSA) and GCHQ have successfully cracked Tor on occasion, I ordered "1g of Manali Charras [cannabis] (free UK delivery)", costing 1.16 bitcoins (the cryptocurrency then worth around £15). I used a false name with my own address, and two days later an envelope arrived at my door with an address in Bethnal Green Road, east London, on the return label and a small vacuum-packed package inside: a small lump of dope.

It's still sitting in its original envelope in the drawer of my desk. I got a bit stumped with my dark net story, put it on hold and became more interested in the wonderful world of cryptocurrencies as the value of bitcoins soared over the next few months (the 1.5 bitcoins I'd bought for £20 were worth £300 at one point this spring).

Just under a month ago I was intrigued to see that Forbes magazine had managed to get an interview with "Dread Pirate Roberts", the site's administrator. And then, last week, came the news that Dread Pirate Roberts was 29-year-old Ross Ulbricht, a University of Texas physics graduate who, according to the FBI's documents, had not just run the site – which it alleges earned him $80m in commission – but had hired a contract killer for $80,000 to rub out an employee who had tried to blackmail him.

If that sounds far-fetched, papers filed last Thursday show that he tried to take a contract on a second person. The documents showed that the FBI had access to Silk Road's servers from July, and that the contract killer Ulbricht had thought he'd hired was a federal agent. It's an astonishing, preposterous end to what was an astonishing, preposterous site, though the papers show that while the crime might have been hi-tech, cracking it was a matter of old-fashioned, painstaking detective work.

Except, of course, that it's not the end of it. There are two other similar websites already up and running – Sheep and Black Market Reloaded – which have both seen a dramatic uplift in users in the last few days, and others will surely follow. Because what Silk Road did for drugs was what eBay did for secondhand goods, and Airbnb has done for accommodation: it created a viable trust system that benefited both buyers and sellers.

Nicholas Christin, a professor at Carnegie Mellon University in Pittsburgh, Pennsylvania, who conducted six months of research into the site, said that what surprised him most was how "normal" it was. "To me, the most surprising thing was how normal, when you set aside the goods being sold, the whole market appears to be," he said. And, while many people would be alarmed at the prospect of their teenagers buying drugs online, Silk Road was a whole lot more professional, regulated and controlled than buying drugs offline.

What's apparent from Dread Pirate Roberts's interview with Forbes and comments he made on the site's forum is that the motivation behind the site does not seem to have been making money (though clearly it did: an estimated $1.2bn), or a belief that drugs hold the key to some sort of mystical self-fulfillment, but that the state has no right to interfere in the lives of individuals. One of the details that enabled the FBI to track Ulbricht was the fact that he "favourited" several clips from the Ludwig von Mises Institute, a libertarian Alabama-based thinktank devoted to furthering what is known as the Austrian school of economics. Years later, Dread Pirate Roberts would cite the same theory on Silk Road's forum.

"What we're doing isn't about scoring drugs or 'sticking it to the man'," said Dread Pirate Roberts in the Forbes interview. "It's about standing up for our rights as human beings and refusing to submit when we've done no wrong."

And it's this that is possibly the most interesting aspect of the story. Because, while Edward Snowden's and the Guardian's revelations about the NSA have shown how all-encompassing the state's surveillance has become, a counterculture movement of digital activists espousing the importance of freedom, individualism and the right to a private life beyond the state's control is also rapidly gaining traction.

It's the philosophy behind innovations as diverse as the 3D printed gun and sites as mainstream as PayPal, and its proponents are young, computer-savvy idealists with the digital skills to invent new ways of circumventing the encroaching power of the state.

Ulbricht certainly doesn't seem to have been living the life you imagine of a criminal overlord. He lived in a shared apartment. If he had millions stashed away somewhere, he certainly doesn't seem to have been spending it on high-performance cars and penthouses.

His LinkedIn page, while possibly not the best arena for self-expression for a man being hunted by the FBI, demonstrates that his beliefs are grounded in libertarian ideology: "I want to use economic theory as a means to abolish the use of coercion and aggression amongst mankind," he wrote. "The most widespread and systemic use of force is amongst institutions and governments … the best way to change a government is to change the minds of the governed … to that end, I am creating an economic simulation to give people a firsthand experience of what it would be like to live in a world without the systemic use of force."

Silk Road, it turns out, might have been that world. Anybody who has seen All the President's Men knows that, when it comes to criminality, the answer has always been to "follow the money". But in the age of bitcoin, that's of a different order of difficulty. Silk Road is just one website; bitcoin is potentially the foundation for a whole new economic order.