In addition to requiring authors to register their clinical trials in a publicly accessible database, Addiction now requires authors to report and justify any discrepancies between the trial protocol and the study itself in the methods section of the submitted paper. A full list of registers can be found via the WHO International Clinical Trials Registry Platform (ICTRP).
We welcome suggestions and contributions from our readers. Send your material to John Witton, News and Notes Editor, Addiction, National Addiction Centre PO48, 4 Windsor Walk, London SE5 8AF. Fax +44 (0)20 7848 5966;
Wayne Hall writes: In April this year the Marron Institute at New York University hosted a 2 day Cannabis Science and Policy Summit. Mark Kleiman, who convened the summit, said that his intention was to “pry cannabis policy from the culture wars,” dispel the false policy polarisation between prohibition and legalisation to ensure that legalisation and prohibition were not seen as exhausting the cannabis policy space.
In the opening plenary, Jon Caulkins from Carnegie Melon University argued that cannabis should be regulated as a dependence producing, performance degrading, temptation good by using taxation and regulation to minimise the amount of heavy cannabis use (which accounted for most consumption) and the harms arising from it.
In the remainder of the meeting a series of parallel sessions covered topics as varied as the effects of cannabis on the brain; the impacts of medical marijuana and recreational cannabis legalisation on cannabis and other drug use (especially the opioids); emerging new medical and recreational cannabis products, such as edibles and extracts with a THC content up to 40%; and the implications of US cannabis policies for the international drug control treaties.
The old tension between supporters of cannabis legalisation and prohibition was replaced by another tension familiar to those in the alcohol policy field, namely, a split between public health advocates who advocated regulations and taxation policies to reduce heavy use and harms and representatives of the emerging legal cannabis industry who argued that restrictions on potency would limit consumer choice; that restrictive regulations, higher taxes and testing would limit their success in replacing the cannabis black market. The cannabis industry’s answers were always better consumer education and self-regulation.
The main take home messages for me were confirmation of an impression formed at a distance that it is much too early to judge how legal cannabis markets will be regulated, how soon they will increased availability and lower prices, and how these changes will affect rates of cannabis use and cannabis-related harm. There were some indications that liberal medical marijuana laws have reduced prices and increased the frequency of regular use among current users but it will take longer still to detect any increases in new users.
A major surprise was the increased use in legalisation states of high potency cannabis products, especially edibles and concentrates with up to 40% THC. Public health attendees raised concerns about increased risks of dependence, psychosis and other acute adverse effects. The industry was more concerned about pesticide contamination because pesticide levels (which are a minor issue for herbal cannabis products) increase along with the THC content in these concentrated products.
There are plans for similar summits in future to monitor the effects of cannabis legalisation. It will be interesting to see how many more will include representatives of cannabis industry and the public health community on the organising committee and among the speakers.
A report from the Royal College of Physicians (RCP), Nicotine without Smoke: Tobacco Harm Reduction, examines “the science, public policy, regulation and ethics surrounding e-cigarettes and other non-tobacco sources of nicotine.” The report concludes that e-cigarettes “represent an important means to reduce the harm to individuals and society from tobacco use” and that they should continue to receive government support and be promoted as a harm reduction strategy for tobacco.
The United Nations adopted a new framework that puts “people at the centre of global policies on drug control” at the UN General Assembly Special Session on the World Drug Problem (UNGASS) in April. “Putting people first means balanced approaches that are based on health and human rights, and promote the safety and security of all our societies. Putting people first means looking to the future, and recognizing that drug policies must most of all protect the potential of young people and foster their healthy styles of life and safe development,” said the Executive Director of the United Nations Office on Drugs and Crime, Yury Fedotov. The framework had been drafted in March by the Commission on Narcotic Drugs in Vienna and was adopted on the special session's opening day. The document, Our Joint Commitment to Effectively Addressing and Countering the World Drug Problem, reaffirmed a commitment to "promote a society free of drug abuse," and recognized the three UN drug control treaties as "the cornerstone of the international drug control system." Margaret Chan from the World Health Organization told the meeting that “In the view of WHO, drug policies that focus almost exclusively on use of the criminal justice system need to be broadened by embracing a public health approach. A public health approach starts with the science and the evidence.” Advocates of a change of international drug policy away from a prohibitionist approach were disappointed by the outcome of the meeting. In The Guardian, former president of Switzerland and critic of current drug policy Ruth Dreifuss said, “the world community is not ready, is not willing, to have the change of politic that is absolutely necessary.”
Reuters reports that India’s Supreme Court has ruled that the Indian tobacco industry must adhere to government rules requiring health warnings covering 85% of the cigarette pack surface. The court also rejected the tobacco’s industry’s petition to stay the introduction of the new tobacco control rules. The Supreme Court judges said that the tobacco industry "should not violate any rule prevailing as of today." The cases had been filed by bidi manufacturers and the Tobacco Institute of India (TII), which represents large tobacco firms.
The European Union’s Court of Justice has rejected a legal challenge by tobacco companies against the European Union’s 2014 Tobacco Products Directive (TPD). The court ruled in May that standardisation of packaging, the future EU-wide prohibition on menthol cigarettes and the special rules for electronic cigarettes are lawful. The TPD will take effect on 20 May and will ban menthol cigarettes by 2020, standardise packs and impose rules on e-cigarettes, such as limits on nicotine strength, tank size and advertising. Wholesalers and retailers will be given a year to sell stocks manufactured before that date. In its decision the court said that “The court finds that, in providing that each unit packet and the outside packaging must carry health warnings … the EU legislature did not go beyond the limits of what is appropriate and necessary.”
On 1 April Brazil launched the first of five planned regional centres that will collect and share information about tobacco industry strategies to undermine tobacco control. The observatory will house an online database that will be available to governments, civil society stakeholders, academic researchers and the public. The centre is a partnership of the Government of Brazil and the International Union against Tuberculosis and Lung Disease, a member of the Framework Convention Alliance (FCA). The observatory is part of a project to create industry monitoring centres in the five BRICS countries (Brazil, Russia, India, China and South Africa), and was initiated by the Secretariat of the WHO Framework Convention on Tobacco Control (FCTC).
ABC News reports that the Access to Medicinal Cannabis Bill was passed by parliament in Victoria in April. Victoria is the first state in Australia to legalise the use of medicinal cannabis. The Government is establishing the Office of Medicinal Cannabis to oversee manufacturing and all clinical aspects of the medicinal cannabis framework. Children with severe epilepsy will be the first to have access to the drug in 2017. "We're starting with these children with severe epilepsy, whose lives have been shown to improve so significantly, because we know these children often don't make it until [sic] adulthood," Victoria's Health Minister Jill Hennessy said. "I just think that in this day and age, it's unfair and unacceptable to ask a parent to make a decision between obeying the law and acting in the best interests of their child," she added. Access to medicinal cannabis will eventually be made available to people in palliative care and with HIV.
The Supreme Court of Canada has ruled that a federal law introduced by the former governing Conservative Party was unconstitutional. The law had made a one-year minimum sentence mandatory for a drug crime when the offender has a similar charge on his or her record. The court said the law constituted “cruel and unusual punishment,” a violation of section 12 of the Charter of Rights and Freedoms. Chief Justice Beverley McLachlin wrote on behalf of the court majority, “At one end of the range of conduct caught by the mandatory minimum sentence provision stands a professional drug dealer who engages in the business of dangerous drugs for profit, who is in possession of a large amount of drugs, and who has been convicted many times for similar offenses. At the other end of the range stands the addict who is charged for sharing a small amount of drugs with a friend or spouse, and finds herself sentenced to a year in prison because of a single conviction for sharing marijuana in a social occasion nine years before. Most Canadians would be shocked to find that such a person could be sent to prison for one year."
The Los Angeles Times reports that California governor Jerry Brown signed five anti-tobacco bills in May, including one that raises the legal age to purchase cigarettes from 18 to 21 and another that regulates e-cigarettes the same as tobacco products. Under the bills, California follows Hawaii to become the second state in the US to raise the smoking age. The five bills signed by the governor went into effect on June 9. Governor Brown vetoed one anti-tobacco bill that would have allowed counties and cities to ask voters to approve local tobacco taxes. In vetoing the bill Governor Brown wrote, “Although California has one of the lowest cigarette tax rates in the nation, I am reluctant to approve this measure in view of all the taxes being proposed for the 2016 ballot.” There are several tax initiatives proposed for California’s November ballot, including one to increase the tax on a pack of cigarettes from 87 cents to $2.
The Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2014 came into effect in India on April 1, following the Indian health ministry’s notification on September 24, 2015 of its plan to implement the rules. The new rules stipulate that tobacco products should have pictorial health warnings covering 85% of the packaging space. In March a parliamentary committee had recommended that the warnings should be just 50% on both sides of the principal display area “as it will be too harsh and result in the flooding of illicit cigarettes in the country.” Immediately following the introduction of the new rules the major Indian tobacco and bidi companies decided to shut all their factories and stop production, citing an “ambiguity” in the new policy. In response a senior health ministry official said: “We want to clarify that there is no ambiguity. This is a bogey raised by the tobacco industry. The case is crystal clear. We had issued the notification in September last year. If they had found an ambiguity, why did they send their letter in March, 2016?”
Data from the Coroners Court of Victoria (Australia) have shown that overdose deaths in the state have increased by nearly 23 per cent since 2010, with 420 overdose deaths recorded for 2015. In 2015 almost twice as many overdose deaths involved legal prescription medication, compared with illicit drugs. The data were released with coronial findings into the death of Frank Edward Frood, a 47-year-old man who died from bronchopneumonia "in a background of methadone and benzodiazepine use." The coroner wrote that the death "reinforces the immediate need for a real-time prescription monitoring system to assist doctors in their clinical decision-making around drug prescribing... to tackle the ever-increasing toll of pharmaceutical drug related deaths in the state." The Age reports that the Victorian Alcohol and Drug Association executive officer Sam Biondo said there had been calls for prescription monitoring going back 20 years: "If you add up this sort of death level and multiply it over 20 years, how many thousands of people have died deaths that were preventable and who is responsible for that?" A health ministry spokesperson said that the Victorian government has committed $300,000 to start work on a prescription monitoring system.
The Texas Tribune reports that the Texas Supreme Court has overruled a lower court decision and determined that state regulators could impose a special tax on cigarette makers that were not part of a multibillion-dollar settlement reached with the major tobacco companies in the late 1990s. A 2013 state law placed a 55-cent-per-pack fee on cigarettes not manufactured by the major tobacco companies that settled lawsuits filed by Texas and other states over allegations of deceptive advertising and marketing to children. The tax had been imposed to recover smoking-related health care costs from all manufacturers and to remove a marketing advantage that allowed smaller tobacco companies to sell cheaper products, making them more attractive to younger people. The tax also was intended to protect state funding as the market share continued to fall for the six large tobacco companies that pay Texas about $500 million per year under the settlement. State Attorney General Ken Paxton welcomed the ruling and said: “Tobacco producers who have not taken responsibility for the ill-health effects of their products must not enjoy a competitive advantage over producers who do.”
Following a review by Canada’s Federal Health Department, naloxone is now available in Canada without a prescription. In announcing the review, Health Canada said: "The large increase in opioid overdose episodes has prompted the provinces to design programs to provide greater access to naloxone at the site of the overdose, either through first responders or ‘take-home programs’. These programs are hindered by the prescription status of naloxone. The provinces and territories have collectively asked Health Canada to re-evaluate the status of naloxone." From March naloxone is exempt from prescription status for the emergency use of naloxone outside hospital settings for opioid overdose. The exemption became effective immediately, without the usual six-month delayed implementation period.
The California legislature passed six anti-tobacco bills in March that included a bill to raise the tobacco smoking age from 18 to 21. California would become the second US state after Hawaii to adopt the higher age limit statewide. Governor Jerry Brown must sign the legislation before it can become law. Speaking to KPBS, Assemblyman Jim Wood said: “We are not criminalizing smoking in California. We are just making it harder for young people to buy cigarettes.” Another bill in the package would also restrict electronic cigarettes by classifying them as tobacco products. “With California having such a huge population, it’s going to be very impactful nationwide,” said Cathy Callaway, associate director of state and local campaigns for the American Cancer Society.
The New York Times reports that the US Supreme Court declined to hear a lawsuit challenging Colorado’s legalization of recreational cannabis. Nebraska and Oklahoma, two states neighbouring Colorado, had argued that cannabis grown and processed in Colorado was being trafficked into their states and was causing crime and other problems. The states asked the Supreme Court justices to allow them to file a lawsuit directly in the Supreme Court. The US Constitution gives the court such “original jurisdiction” to hear disputes between states, but this process is only rarely used. Oklahoma and Nebraska’s lawsuit had no data to support it and in urging the justices to reject the lawsuit the US Solicitor General Donald B. Verrilli wrote: “Nebraska and Oklahoma essentially contend that Colorado’s authorization of licensed intrastate marijuana production and distribution increases the likelihood that third parties will commit criminal offenses in Nebraska and Oklahoma by bringing marijuana purchased from licensed entities in Colorado into those states. But they do not allege that Colorado has directed or authorized any individual to transport marijuana into their territories in violation of their laws.”
The second EU Drug Markets Report estimates that the EU retail drug market is worth at least 24 billion euros a year. While the cannabis market is the largest at 38% of the total, the report says that there are recent signs of an increasing availability of heroin in Europe. In 2015, 100 new psychoactive substances were detected for the first time, bringing the total number of new substances monitored in Europe to more than 560. The report suggests that: “It is unlikely that any regulatory system can be designed to sufficiently limit the stream of new substances being manufactured without resorting to a ban on a huge range of chemicals.”
In March U.S. Health and Human Services (HHS) Secretary Sylvia M. Burwell announced a targeted initiative aimed at reducing prescription opioid- and heroin- related overdose, death and dependence. The HHS plans to develop bipartisan work across the federal government and through strategic partnerships with states and private industry. To support this initiative, the Centers for Disease Control and Prevention (CDC) have issued the Guideline for Prescribing Opioids for Chronic Pain. The guideline provides recommendations for managing chronic pain in primary care settings and information about the benefits and risks of opioid use for patients and doctors. The guidance can help doctors to determine if and when to start opioids to treat chronic pain, and provides information on medication selection, dosage, and duration of treatment.
The British government’s blanket ban on “legal highs” due to come into effect on 6 April was postponed. The announcement followed claims that the current definition of a psychoactive substance in the Psychoactive Substances Act is not enforceable by the police. The same difficulty has hindered prosecutions in Ireland, which introduced similar legislation in 2010. “We need to ensure the readiness of all the activity necessary to enable the smooth implementation of the legislation across the UK and to support law enforcement in their ability to drive forward the legislation on commencement,” a government spokesperson said. The legislation aims to ban any substance intended for human consumption that is capable of producing a psychoactive effect. Exemptions from the act include alcohol, nicotine and caffeine. Alkyl nitrites, poppers, were excluded from the act at a very late stage following advice from the Advisory Council on the Misuse of Drugs that alkyl nitrites are not psychoactive in the context of the act and were also not seen to be capable of “having harmful effects sufficient to constitute a social problem.”
A report from the European Monitoring Centre on Drugs and Drug Abuse (EMCDDA) draws on an EMCDDA study that examined internet drug markets and the contributions of a wide range of experts attending an EMCDDA meeting on the topic in 2015. The report describes how internet markets work, the technology that enables them to work, and how these markets work in relation to the more traditional drug markets. Academics, journalists, law enforcement practitioners, treatment service workers and drug users all contributed to the report, which provides an up-to-date conspectus of practical experience and research. The report also covers the sale of psychoactive medicines via online pharmacies and/or other virtual platforms and explores their potential role as a source for the illicit drug market. A final chapter observes that the size and scale of online markets is unclear but experienced drug users report choosing to use online drug markets for their easy accessibility, availability of their drugs of choice and good quality of products. The report suggests that the next generation of darknet markets are likely to be decentralised, peer-to-peer networks. Judith Aldridge, one of the report’s co-authors, said “Despite the growth and popularity of these markets, they tend to be short-lived, and their success substantially hampered by the growth of mistrust amongst market participants due to scams and, to a more limited extent, law enforcement activities.”
The Centre for the Integrated Management of Addiction in Dakar (CEPIAD) opened in Senegal in December 2014. The centre is the first publicly supported opioid substitution treatment (OST) to open in West Africa and received support from the World Health Organization and the United Nations Office on Drugs and Crime. The centre also offers a needle exchange programme, skills training, anti-retroviral therapy and counselling as well as a pilot methadone service. While there are similar services in Sub-Saharan Africa, based in Kenya, Tanzania and Mauritius, other countries such as Burkina Faso and South Africa only have private OST services.
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27 - 29 May 2016, Leiden, The Netherlands.
29 - 31 May 2016, Toronto, Ontario, Canada.
30 May - 3 June 2016, Stockholm, Sweden.
30 - 31 May 2016, Budapest, Hungary.
5 - 7 June 2016, Boston, Massachusetts, USA.
10 - 13 June 2016, Palm Springs, California, USA.
11 - 16 June 2016, Palm Springs, California, USA.
17 June 2016, Oxford, UK.
23 - 24 June 2016, Pittsburgh, Pennsylvania. USA.
25 - 29 June 2016, New Orleans, Louisiana, USA.
10 - 14 July 2016, Bath, UK.
17 - 22 July 2016, Durban, South Africa.
18 - 19 July 2016, Chicago, Illinois, USA.
25 - 27 July 2016, Windsor, UK.
4 - 7 August 2016, Denver Colorado, USA.
18 - 21 August 2016, Denver, Colorado, USA.
20 - 23 August 2016, Seattle, Washington, USA.
7 - 9 September 2016, Oslo, Norway.
17 - 20 September 2016, Vienna, Austria.
21 - 22 September 2016, Abuja, Nigeria.
22 - 24 September 2016, Toronto, Ontario, Canada.
22 - 23 September 2016, Lausanne, Switzerland.
25 - 27 September 2016, Bethesda, Maryland, USA.
29 September - 1 October 2016, Gold Coast, Australia.
2 - 4 October 2016, Venice Italy.
5 - 8 October 2016, Las Vegas, Nevada, USA.
7 - 11 October 2016, Minneapolis, Minnesota, USA.
12 - 14 October 2016, Seattle, Washington, USA.
16 - 19 October 2015, Gramado, Brazil.
20 - 22 October 2016, Montreal, Quebec, Canada.
29 October - 2 November 2016, Baltimore, Maryland, USA.
29 October - 2 November 2016, Denver, Colorado, USA.
30 October - 2 November 2016, Sydney, Australia.
3 - 5 November 2016, Washington, DC, USA.
9 - 12 November 2016, Vienna, Austria.
10 - 11 November 2016, York, UK.
11 - 15 November 2016, Boston, Massachusetts, USA.
12 November 2016, Bern, Switzerland.
12 - 16 November 2016, San Diego, California, USA.
16 - 18 November 2016, Adelaide, Australia.
8 - 11 December 2016, Bonita Springs, Florida, USA.
7 - 11 March 2017, Florence, Italy.
15 - 18 March 2017, Washington DC, USA.
24 - 26 October 2017, Lisbon, Portugal.