Cigarette Type
Even One THC Hit Carries Risk for Inducing Psychosis
Meta-Analysis: Even One THC Hit Carries Risk for Inducing Psychosis
— Evidence suggested adding CBD does not ameliorate these effects
https://www.medpagetoday.com/psychiatry/generalpsychiatry/85472?xid=nl_mpt_morningbreak2020-03-18&eun=g220600d0r
The psychoactive components of cannabis were linked to new-onset psychotic symptoms even at low doses, according to a systematic review and meta-analysis.
Across nine studies involving 196 healthy young adults, tetrahydrocannabinol (THC) was associated with significantly increased total symptom severity on the Brief Psychiatric Rating Scale compared with placebo (standardized mean change 1.10, 95% CI 0.92-1.28, P<0.0001) even at low doses, ranging from 1.25 mg to 10 mg, reported Oliver Howes, MD, PhD, of King’s College London, and colleagues.
Also, just one of four studies in which cannabidiol (CBD) was administered concurrently with THC found CBD administration reduced these symptoms, they wrote in the Lancet Psychiatry.
“Our findings highlight the risk of psychiatric symptoms after even a single dose of some THC-containing cannabis products,” Howes told MedPage Today in an email.
These findings add to the “growing scientific consensus” in support of the psychosis-cannabis link, an association that appears to be bidirectional, wrote Carsten Hjorthøj, PhD, and Christine Merrild Posselt, PhD, both of the University of Copenhagen in Denmark, in an accompanying commentary.
“In some people, cannabis leads to incident psychosis, whereas in other people, psychosis leads to incident cannabis use,” they wrote.
Hjorthøj and Posselt cautioned against extrapolating these findings to assume “single doses of THC will eventually lead to schizophrenia,” but also emphasized that “caution should not be thrown to the wind.”
For example, CBD in particular has been touted as a potential “wonder drug” with antipsychotic, anxiety-reducing effects, but the findings here suggest the usefulness of CBD and other cannabis extracts “might be somewhat exaggerated compared with what we can expect in clinical practice,” they continued.
This meta-analysis involved double-blind, placebo-controlled studies of healthy participants administered IV, oral, or inhaled THC with or without CBD. Individuals were generally in their mid-20s and predominantly male.
Of the 15 studies included, 13 were considered to have a “low” risk of bias and two studies had a “moderate” risk, as measured through the Newcastle Ottawa Scale. The authors calculated the SMR scores for “positive (including delusions and hallucinations), negative (such as blunted affect and amotivation), and general (including depression and anxiety) symptoms,” they explained.
Compared with placebo, THC was associated with significantly increased positive symptom severity scores in 14 studies (SMC 0.91, 95% CI 0.68-1.14, P<0.0001), negative symptom severity scores in 12 studies (SMC 0.78, 95% CI 0.59-0.97, P<0.0001), and general symptoms in eight studies (SMC 1.01, 95% CI 0.77-1.25, P<0.0001), researchers reported.
THC was also associated with increased total symptom severity versus placebo regardless of whether it was administered intravenously or inhaled (P=0.37), and regardless of whether participants were frequent or current cannabis users (P=0.73, P=0.95, respectively), the authors noted.
However, intravenous THC was associated with slightly “more pronounced” increased symptoms than inhalation, although this may be confounded by dose, they added.
The induction of psychotic symptoms was also lower in people with higher versus lower tobacco use, suggesting tobacco use may be a “protective factor,” the authors noted, although they cautioned against using tobacco to “counter” THC effects.
Howes told MedPage Today that “[another] possibility suggested by other evidence is that tobacco reduces the levels of the protein in the brain that THC binds to so it has less effect. This needs testing, and it is important that people don’t think tobacco will protect against the effects of THC containing cannabis.”
Many of the meta-regression analyses used involved fewer than 10 studies and were underpowered to detect small or moderate effects, which is a limitation, the authors noted. More participants were male than female, so the generalizability of these findings is also limited, they added. Researchers were additionally unable to differentiate the effects of THC on specific symptoms, like hallucinations or delusions.
Inside the Philip Morris campaign to ‘normalize’ a tobacco device
https://www.reuters.com/article/us-philipmorris-international-iqos-insig/inside-the-philip-morris-campaign-to-normalize-a-tobacco-device-idUSKBN20F1Q7
(Reuters) – At Germany’s Bambi Awards for the media industry in November, celebrities posed for red-carpet photos against a backdrop of established luxury brands. Alongside the likes of Mercedes-Benz and Swiss watchmaker Chopard was a newer name: IQOS, a “reduced risk” heated-tobacco device sold by cigarette maker Philip Morris International Inc.
Across Europe, Asia and South America, the tobacco firm has affixed the IQOS brand to music festivals and art exhibits. The company also markets through IQOS lounges at mountainside resorts in the Pyrenees and in fashionable neighborhoods of Rome. Throughout Europe, it has partnered with “IQOS friendly” bars and restaurants – closed to cigarettes but open to IQOS.
Such promotions are part of a wide-ranging “normalization” strategy by Philip Morris (PM.N) to scrub its image as a purveyor of cancer-causing cigarettes and present its new smoking alternatives as youthful, upscale lifestyle products, according to a ten-month study by tobacco researchers at Stanford University, who shared it exclusively with Reuters before its release on Friday. The marketing strategy mimics that of tobacco companies in the mid-20th century, when they started associating cigarettes with Hollywood and high society.
“Philip Morris, as a company name, is somewhat of a pariah,” said Robert Jackler, a professor who led the study and heads Stanford’s Research into the Impact of Tobacco Advertising. “IQOS is an attempt to sanitize their product line.”
The Stanford researchers said their study was spurred in part by a May 2019 Reuters investigation that found Philip Morris had used young online personalities, including a 21-year-old woman in Russia, to promote IQOS. The company’s internal marketing standards prohibit it from using youth-oriented celebrities or “models who are or appear to be under the age of 25.” The Reuters report prompted the company to acknowledge it had violated its own policy and to suspend its use of social media influencers.
The Stanford study found that, although the company suspended its “most visible” social-media influencer programs, IQOS marketing continues to stray substantially from its corporate standards on youth-oriented marketing.
“Its use of youth-oriented social media channels, trendy pop music festivals and celebrity influencers are mis-aligned with their commitment to exclusive ‘adult smoker’ targeting,” the Stanford report concluded.
Philip Morris declined to answer detailed questions from Reuters on its IQOS marketing strategy and the Stanford findings, saying it did not have access to the full report. “However, we doubt that there is anything PMI could say or do that Dr. Jackler, and others who criticize our scientific commitment and smoke-free vision, would ever find satisfactory.”
The IQOS device is central to the firm’s efforts to overhaul its image through such initiatives as its “unsmoke” campaign, which promotes such “smoke-free” alternatives as a way to accelerate the shift away from cigarettes. The device heats up but does not burn packages of ground-up tobacco, which resemble small cigarettes, to create a nicotine-filled aerosol that is similar to that produced by e-cigarettes, which heat flavored liquid nicotine.
At this year’s Davos World Economic Forum in Switzerland – a gathering of some of the world’s richest people – Philip Morris set up an “Unsmoke your mind” lounge, where panelists argued against regulations preventing “truth in marketing” by tobacco firms looking to promote smoking alternatives.
IQOS is sold in about 50 countries, including the United States through a partnership with U.S. Marlboro maker Altria Group Inc. The two companies pledged to regulators that they would market the device only to adult smokers, showing sample advertisements of adults conservatively dressed in business attire.
But in other markets across the world, the Stanford study said, Philip Morris uses “coaches” and “ambassadors” to market IQOS. In Romania and Russia, employment agencies recruit attractive women as young as 19 to market IQOS, according to job postings mentioned in the Stanford report and reviewed by Reuters.
Instagram postings for Be Like Me, a Romanian marketing agency, show young women posing with the IQOS device in recent months, often wearing robe-like uniforms in malls. The Instagram account for RBT Group, a staffing agency in Russia that markets IQOS, similarly shows photos of attractive young women in front of IQOS signs or posing with other “coaches.”
Be Like Me and RBT Group could not be reached for comment.
Other Instagram accounts with the “IQOS” name, including one called “iqostyle.arm,” based in Armenia, continue to show young women posing with the IQOS in what appear to be professional photographs. One photo on that account from last July – two months after Philip Morris said it had suspended all influencer marketing – showed Nika Shuvalova, a 22-year-old Ukrainian model, posing in a swimsuit on a boat with an IQOS.
Shuvalova could not be reached for comment.
A message sent to the “iqostyle.arm” Instagram account was returned by someone calling themselves Tiko, who said the IQOS postings were a “hobby” and that he had not been paid by Philip Morris.
BIG BET ON IQOS AND ‘NORMALIZATION’
The stakes for Philip Morris are huge: The company invested $6 billion in developing “smoke-free” products such as IQOS in hopes of staving off a trend of declining global cigarette sales. In 2018, company CEO Andre Calantzopoulos told shareholders that it hoped to receive about 40% of its revenue – nearly $20 billion – from “reduced risk” products by 2025.
Internal Philip Morris documents underscore the importance of its larger strategy: “Make ‘normalization’ a PMI priority and imbed this mindset into the organization,” read an internal company document from 2014, reviewed by Reuters as part of a 2017 investigation. The document also cited “the threats posed by PMI/industry de-normalization” – such as lobbying bans and exclusions from international treaties and trade agreements – “and the need to reverse this trend to drive future growth.”
The Stanford researchers pointed to wide-ranging company efforts to associate IQOS with fashion, art and popular culture in a way that cigarette brands such as Marlboro have been unable to do, given changing social attitudes and laws around the world that prohibit such advertising and promotions.
IQOS has been present at events such as Germany’s Bambi Awards – which honor stars in TV and film, sports, art and music – as well as that country’s Playboy Playmate of the Year Awards.
Philip Morris worked with British sculptor Alex Chinneck on a dramatic installation at the 2019 Milan Design Week. The work depicted the facade of an old, two-story building being unzipped like a pair of jeans – meant to signify the IQOS “notion of opening the future,” the sculptor said in an interview with FAD magazine. A representative of Chinneck confirmed the partnership.
The company also worked with distinguished industrial designer Karim Rashid to create an installation at the previous year’s Milan Design Week. In an interview with website fashionrepublik.com, Rashid described his installation, showing two faces meeting one another, as similar to the IQOS, which he called “an intimate device that speaks to forward-thinking and original expression.” A representative of Rashid said he was unavailable for an interview on Thursday.
GETTING TOBACCO BACK INTO RESTAURANTS, BARS
The company has also sought to distinguish IQOS from smoking through partnerships with restaurants, bars and salons who designate themselves as “IQOS friendly” spaces, where cigarettes are banned but the IQOS device is allowed. The Stanford researchers found evidence of hundreds of “IQOS friendly” establishments in places such as the Czech Republic, Ukraine, Romania and Japan.
Philip Morris did not respond to questions about its business relationships with the establishments that promote the device and display its branding.
The Stanford researchers and other experts say such policies undermine public smoking laws and encourage dual use of cigarettes and alternative devices. Many users will continue smoking outdoors, but turn to e-cigarettes or IQOS where they are permitted indoors. Such switching can “deepen nicotine addiction and make cessation less probable,” the Stanford report said.
The brand also had a presence at a Tel Aviv University student music festival last year – where the minimum age for entrance was 16, and where a video showed young IQOS staff at a pop-up booth.
At a launch party for IQOS in Albania last year, a performer in an elaborate white sequined dress did an interpretive dance on stage with an IQOS, while another performer attached to wires performed acrobatic moves in the air while playing a violin.
“They’re trying very hard to resurrect the glory era of smoking, where it was glamorous and sophisticated and stylish,” Jackler said. “It’s about associating it with all the good things in life.”
Philip Morris suspends social media campaign after Reuters exposes young ‘influencers’
https://www.reuters.com/article/us-philipmorris-ecigs-instagram-exclusiv/exclusive-philip-morris-suspends-social-media-campaign-after-reuters-exposes-young-influencers-idUSKCN1SH02K
(Reuters) – Cigarette maker Philip Morris International Inc has suspended a global social media marketing campaign in response to Reuters inquiries into the company’s use of young online personalities to sell its new “heated tobacco” device, including a 21-year-old woman in Russia.
https://www.reuters.com/video/?videoId=RCV006PLP&jwsource=cl
The company’s internal “marketing standards” prohibit it from promoting tobacco products with youth-oriented celebrities or “models who are or appear to be under the age of 25.”
The company told Reuters of the decision late Friday, saying it had launched an internal investigation into marketing posts and photographs that Reuters sent to the company for comment earlier this week.
They included a paid post plugging the tobacco product by social media “influencer” Alina Tapilina in Moscow – who listed her age as 21 on Instagram – alongside often seductive photos of herself drinking wine, swimming and posing with little clothing in luxurious settings.
“We have taken the decision to suspend all of our product-related digital influencer actions globally,” the company told Reuters. “Whilst the influencer in question is a legal age adult smoker, she is under 25 and our guidance called for influencers to be 25+ years of age. This was a clear breach of that guidance.”
“No laws were broken,” the company told Reuters. “However, we set high standards for ourselves and these facts do not excuse our failure to meet those standards in this instance.”
The company added: “We were deeply disappointed to discover this breach and are grateful that it was brought to our attention.”
The U.S. Food and Drug Administration (FDA) last month decided it would allow sales of the IQOS device in the United States after a two-year review process in which Philip Morris repeatedly assured the regulator that it would warn young people away from the product.
The FDA declined to comment Friday evening on Philip Morris’s decision to suspend the marketing campaign. The agency earlier said it would “keep a close watch on … how the company is marketing its products.”
While most of the social media influencers hired by Philip Morris overseas did not list their ages on Instagram, a Reuters review of the firm’s social media marketing of IQOS in Japan, Italy, Switzerland, Russia and Romania shows that Tapilina’s online persona was typical of what the company called its social media “ambassadors” for the device – rail-thin young women who revel in the high life.
The company did not directly respond to additional questions Friday night regarding the intended audience for its digital influencer campaigns.
Many of the messages contained the hashtag “#IQOSambassador,” tying them into a network of social media influencers that the international tobacco giant has relied on to brand the IQOS as a safer alternative to cigarettes and a sexy fashion accessory.
“I finally have the new IQOS 3, and I can confidently say yes to change … the level of harmful substances is on average about 90 percent lower than in smoke,” Tapilina wrote in an April post. “You haven’t yet switched to IQOS?”
One Romanian IQOS marketer is 25 years old, according to a separate actress biography, but did not list her age on Instagram. Tapilina and nine other IQOS marketers did not respond to requests for comment.
Philip Morris, in its statement to Reuters, said its suspension of the social marketing campaign is “concrete proof” of its “conviction to achieve a smoke-free world through socially responsible practices.”
Matthew Myers, president of The Campaign for Tobacco-Free Kids, had a different take upon hearing of the suspension Friday night. The advocacy group collected some of the IQOS marketing images reviewed by Reuters.
Philip Morris, he said, “is changing their behavior only when caught red-handed.”
The company, Myers said, has historically been “the single most successful across the globe in making cigarettes fashionable to young people.”
HAPPY VALENTINES DAY!
Over the past year, Philip Morris has increasingly publicized its “mission” to prevent young people from using tobacco products. Last month, it issued a release calling on “all tobacco and e-cigarette companies to do their part to guard against youth nicotine use.”
“Let me be clear: We at Philip Morris International do not, and will not, market or sell our products to youth,” CEO André Calantzopoulos said during a speech in Boston earlier this month. “For Philip Morris International, age matters.”
When Philip Morris submitted marketing plans with an FDA application for IQOS in 2017, its sample advertisements featured models appearing at least a decade older and wearing modest, professional clothes.
That application, which is still pending before the FDA, seeks approval to market the IQOS as less harmful than smoking and outlines company plans to ensure it doesn’t market the device to “non-intended audiences.” The device heats up but does not burn packages of ground-up tobacco, which resemble small cigarettes, to create a nicotine-filled aerosol.
In Japan, the intended audience for IQOS marketing includes the Instagram followers of Ayame Tachibana, a 27-year-old DJ and model. In one post, she shows off a Valentine’s Day message for the IQOS device, lovingly scrawled with multicolored pens.
“Happy Valentine IQOS. Love you sooo much!” reads the Instagram post from February.
Alina Eremia, a Romanian actress and singer, holds a gold-colored IQOS in front of a Christmas tree.
“My list of resolutions contains 95% fewer moments without a smile,” says Eremia, who is 25 according to her actress biography on multiple movie and celebrity information websites.
Philip Morris says the IQOS – an acronym for “I quit ordinary smoking” – contains up to 95 percent fewer toxic compounds than cigarettes.
Vlad Parvulescu, a manager for Eremia, confirmed she had been hired to promote IQOS and said she had been contacted by a Romanian public relations agency. He did not respond to additional questions about the financial arrangement.
Marketing deals between companies and social media influencers vary widely, according to industry experts. But typically a company will work through third-party public relations or advertising firms that have relationships with online personalities. Compensation typically ranges from $20 to $25,000 or more for each post.
Corporations have become increasingly sophisticated in how they approach their social media campaigns in the past two years, said Joe Gagliese, co-founder of Viral Nation, a marketing and talent agency that works with influencers.
He once had to explain the basic concept of an “influencer” in pitch meetings. Now, companies approach him with “tailor-made decision briefs saying, ‘this is exactly what we want.’”
Reuters reviewed dozens of social media posts featuring the IQOS device. Many included hashtags such as #IQOSAmbassador, #paidad, and #notriskfree, indicating that they are IQOS marketing posts.
Many of the Instagram influencers featuring the products had tens of thousands of followers, and a few had more than a million.
VIRAL CAMPAIGNS, BLURRED LINES
Devices such as IQOS and Juul hold potential as a way for cigarette smokers to transition to less harmful nicotine products, but some public health advocates worry the sleek new devices are addicting young people who would have never smoked cigarettes. Among traditional cigarette smokers, 90 percent start smoking before the age of 18, according to federal data.
Philip Morris said there have been “no reports” of “worrisome levels” of unintended use of IQOS.
As part of the FDA review process, Philip Morris pledged to market only to adult cigarette smokers once it begins selling IQOS this summer through a partnership with Altria Group Inc, which sells Marlboro cigarettes in the U.S. IQOS delivers about the same level of nicotine as a traditional cigarette.
Altria did not respond to requests for comment.
Social media marketing has become a flashpoint in the debate over regulation of tobacco products, particularly the newest generation of products such as the wildly popular Juul e-cigarettes.
Some of Juul’s early social media and YouTube marketing included images of attractive young people, particularly at a 2015 product launch party. Twitter images from that time on Juul’s official account featured sensual images of a young woman breathing out Juul vapor in a group, next to the slogan, “Share a #Juulmoment.”
Those early campaigns sparked an explosion of video and photo posts from young people showing themselves using the product at school or with friends, often under the hashtags #doit4juul or #juullife. Juul Labs Inc has since said it stopped using social media influencers and requires anyone in its ads to be a former cigarette smoker older than 35.
Juul Labs Inc said in a statement it recognizes that “some of our earliest marketing initiatives did not fully reflect the goal of our company,” which it describes as helping cigarette smokers transition to its products.
“As a young company, we learned from our experiences and instituted changes to help ensure that we are only reaching current adult smokers,” the company said.
CONDITIONAL APPROVAL
U.S. laws governing tobacco advertising – which is banned on radio and television – were drawn up long before social media and digital advertising became a dominant force in consumer marketing.
Although no current state or federal law restricts tobacco advertising on the Internet – including for e-cigarettes and devices such as IQOS – the FDA can use its authority over new devices to assert sweeping control over a company’s marketing.
As a condition for allowing the device to be sold, the FDA is requiring Philip Morris to provide detailed analyses of the age ranges of consumers it reaches through digital advertising. Philip Morris is also required to submit any new advertising campaigns, including digital and social media efforts, to the FDA at least 30 days before it plans to launch them.
Any paid influencers promoting the product also must disclose “any relationships between you and entities that create labeling for, advertise, market, and/or promote the products, on your behalf, or at your direction.”
Those rules aim to restrict youth access to tobacco marketing, the FDA said in a statement, “especially in shared digital properties such as social media sites.”
‘Heat-not-burn’ cigarettes still damage lungs
https://www.reuters.com/article/us-health-iqos/heat-not-burn-cigarettes-still-damage-lungs-idUSKCN1M12CB
(Reuters Health) – A new type of “heat-not-burn” cigarette may lead to just as much lung damage as traditional cigarettes, a recent study suggests.
So-called “heat-not-burn” devices are designed to heat disposable tobacco sticks and give users the taste of tobacco without the smoke or ash.
For the study, researchers analyzed data submitted by Philip Morris International to the U.S. Food and Drug Administration when the company was trying to win regulatory approval to market its I-Quit-Ordinary Smoking (IQOS) product as a safer alternative to traditional cigarettes.
The FDA has yet to weigh in on whether Philip Morris can sell its IQOS device as a lower-risk cigarette alternative. But an expert scientific panel convened by the FDA recommended against such a move earlier this year, and the new study offers fresh evidence of health risks associated with IQOS.
When smokers switched from traditional cigarettes to “heat-not-burn” devices, researchers didn’t find any evidence of improvements in lung function or reductions in inflammation that can signal tobacco-related blood vessel damage.
“Even if a patient could switch completely from regular cigarettes to heat-not-burn products, Philip Morris International’s own data shows that there will continue to be significant health risks associated with these products,” said lead study author Dr. Farzad Moazed of the University of California, San Francisco.
“Although quitting smoking is challenging, there are many other options for smoking cessation that are more effective and safer than the use of these products,” Moazed said by email.
There is evidence that IQOS may reduce exposure to certain harmful chemicals, Moazed said, a point Philip Morris emphasized in a statement released after the FDA advisory panel decision. (bit.ly/2O0S42z)
Philip Morris also disputed the study authors’ conclusions.
“The totality of evidence available on IQOS supports that it is likely to present less risk of harm compared to continued smoking,” Philip Morris said in an emailed statement to Reuters Health. “This includes a significant reduction in inflammatory response and favorable changes in lung function.” (bit.ly/2QPuiVF)
“Heated tobacco products, also known as heat-not-burn products, generate a nicotine aerosol by heating sticks made up of tobacco and other chemicals without lighting them on fire,” Moazed said. “While this reduces the amount of some of the harmful chemicals associated with smoking, it increases the levels of other chemicals, and the evidence to date shows that these products continue to result in harm.”
While there’s limited data on the safety of IQOS relative to traditional cigarettes, and no long-term studies, the available evidence suggests that the devices are just as harmful to the lungs and immune system as traditional cigarettes, Moazed’s team concludes in Tobacco Control.
It’s also unclear from research to date whether IQOS might help smokers quit, a factor that might influence how scientists think about the safety of these devices and other tobacco products sold as alternatives to traditional cigarettes.
The human studies Philip Morris submitted to the FDA excluded people who were “dual users” of both traditional cigarettes and IQOS devices, the study authors note.
Any safety advantage relative to traditional cigarettes might be diminished if people continue to smoke traditional cigarettes once they start using IQOS devices, said Bonnie Halpern-Felsher, a tobacco prevention researcher at Stanford University School of Medicine in Palo Alto, California, who wasn’t involved in the study.
“We have no studies outside of Philip Morris on whether these IQOS will actually help people quit or on their relative safety,” Halpern-Felsher added. “People are unlikely to understand what “switching completely” means and that therefore they are likely to be misled,” by any safety claims that are contingent on smoking cessation.
SOURCE: bit.ly/2NVTxXY Tobacco Control, online August 27, 2018.