August, 2015:
Hong Kong still plans e-cigarette ban despite new UK study claiming they’re 95% less harmful than tobacco
Emily Tsang emily.tsang@scmp.com
Vapours 95pc less harmful than tobacco, British report says, but health officials are unswayed
The local health authority is determined to press on with a ban on the sale of electronic cigarettes in the city despite a recent British study suggesting their vapours are around 95 per cent less harmful than tobacco, the South China Morning Post has learned.
The study by Public Health England, an agency of Britain’s Department of Health, concluded that most of the chemicals causing smoking-related diseases were absent in e-cigarettes and they should be promoted as a means to help smokers quit.
The findings contradict a 2014 report by the World Health Organisation recommending strict regulation of e-cigarettes and bans on their indoor use and sale to minors. According to the Food and Health Bureau, plans remain in place to proceed with a proposed ban on e-cigarette sales sometime this year. Health officials believe e-cigarette manufacturers target young people and market their products as trend-setting.
But Asian Vape Association, formed by five major e-cigarette companies in the city, heralded the British report as a major turning point and urged the government to consider regulating the ingredients of the vapour instead of banning their products outright. “The report proves that electronic cigarettes are indeed an effective tool for harm reduction,” said Nav Lalji, founder and chairman of the association. “We urge the Hong Kong government to advocate e-cigarettes as a safer alternative instead of completely banning them.”
According to a 2010 study, Hong Kong has one of the lowest smoking rates in the world – 11.1 per cent of people above the age of 15.
E-cigarettes can be sold legally in the city to anyone regardless of age if the product does not contain nicotine. Products containing more than 0.1 per cent of nicotine must be registered with the Department of Health.
Undersecretary for Food and Health Sophia Chan Siu-chee said many battery-powered vaporisers contained substances that were addictive and posed health hazards. She added that there was little evidence to show they helped reduce the consumption of tobacco.
The Jewish couple who fought Big Tobacco
http://www.jpost.com/Diaspora/The-Jewish-couple-who-fought-Big-Tobacco-412749
By LAURA KELLY
US husband-and-wife legal team Stanley and Susan Rosenblatt never doubted they could achieve the impossible.
Stanley and Susan Rosenblatt. They took on Big Tobacco in the courtroom and won.. (photo credit:LAURA KELLY)
On July 14, 2000, after nearly a decade of legal proceedings – including two years of courtroom litigation – a Florida jury awarded the plaintiffs in a class-action lawsuit against Big Tobacco a staggering $145 billion in punitive damages, the highest verdict in history.
While that figure was immediately appealed and would later be set aside, and while class members seeking compensation would be instructed to file separate lawsuits, the verdict was nonetheless a breakthrough in holding Big Tobacco accountable for diseases developed and health risks acquired through smoking. Additionally, the jury found that the companies had committed fraud and had conspired to hide evidence that their products were dangerous.
These findings paved the way for how the world views smoking today – whether it’s the smoking bans on air – planes and in public spaces, accountability in advertising, or the research and medical breakthroughs spawned or funded through litigation.
But outside a Florida courthouse on a hot summer day, with news cameras crowding the steps, co-class counsel Stanley Rosenblatt extended his hand to his wife, his partner in the case. Just after their victory, Susan Rosenblatt wore a relieved and triumphant smile – and in her hand she carried a book of Psalms.
The Orthodox Jewish couple’s ninth and youngest child was only two years old when they filed Engle vs R.J. Reynolds, et al. on May 9, 1994. They admit that their work and the trial took a toll on their family, in addition to being physically and emotionally draining.
“The only thing that kept our sanity was Shabbos ,” Stanley says. “Friday night, Saturday, we were with the family. If not for that, we would have been [working] seven days.”
They have been described as the “mom and pop” law firm em – broiled in a “David vs Goliath” case. Fifteen years later, in the con – ference room of The Jerusalem Post , it’s clear that for Stanley, it was as simple as the pursuit of truth and justice.
“I just felt, when you saw these guys – these CEOs from Philip Morris and Reynolds and the tobacco companies – still saying, ‘It doesn’t cause cancer, it hasn’t been proven,’ and this kind of thing, I just wanted to get them,” he says.
One can imagine him standing in the courtroom, speaking clearly, succinctly, the sole litigator for thousands of plaintiffs, pitted against a defense team of some of the most accomplished lawyers in the US.
In Jerusalem, he leans forward in his chair. “I wanted to look these guys in the eye and have them tell me, ‘It’s a coincidence.’” As for Susan, she found herself be – coming more religiously observant and spiritual over the years they were em – broiled in the trial.
“We were up against an industry with essentially unlimited resources that boasted of their ability to wear their opponents down, financially and physically,” she says. “Winning was a miracle.”
Where Stanley is gruff, Susan is sweet; he speaks in short, straight-to-the- point sentences, while she elaborates with background and carefully chosen words. In their give-and-take, one can imagine that where she excels, he defers – and where he shines, she supports.
“We’re overachievers,” she offers casually as a catch-all for the couple’s achievements, individually or together. These include paving the way for the filing of thousands of individual law – suits against Big Tobacco, as well as the setup and funding of numerous centers of research into cancer and smoking- related diseases. Stanley is also an author of four books and was the host of two PBS shows, Within the Law and Israel Diary . In the latter, he interviewed such Israeli stalwarts as Shimon Peres, Ariel Sharon, Yitzhak Shamir, Yitzhak Rabin, Chaim Herzog and Abba Eban, among others.
‘It was a setup’ Susan grew up in Brooklyn, New York, and set out on her overachieving path early, graduating from high school at the age of 12. She went on to the University of Miami, where she earned her BA in economics, finishing at 17.
After university, she went to stay with her brother for a year in Califor – nia, where she alludes to having experienced a time of freedom and experimentation.
“I saw Janis Joplin,” she offers in summary.
She began work as a legal secretary and, in – trigued by the practice, set her sights on law school. She says her only hesitation came from her belief that she was too emotional to be a courtroom lawyer, but in the end, at the age of 21, she graduated cum laude from the University of Mi – ami Law School.
Stanley took a similar path, geograph – ically at least: He was born and raised in Brooklyn and then moved to Miami. He majored in political science as an undergrad at the University of Miami, graduating magnum cum laude, and also attended law school there.
Despite their similar trajectories, the two most likely would not have gotten together if it weren’t for an eager shad – chan (matchmaker).
Susan unexpectedly lost her father to an aortic aneurysm. She was a young lawyer at the time, and a colleague of hers came to the shiva to pay her respects. With the lawyer was the of smoking, but felt powerless to quit. He said he had tried to quit over 100 times; he would see patients and sneak out the back door to have a cigarette in the alley.
Similar to Rosier, this lawsuit also touched on a personal nerve. Dr. Engle was the couple’s pediatrician for eight of their nine children.
The Rosenblatts initially wanted to file a national class-action suit, but in the end resigned themselves to representing just residents of Florida – with a still-impressive 700,000 people on the case.
While Stanley prepped the witnesses and litigated in the courtroom, Susan compiled the research and arguments at the office. They worked like this constantly for months on end. Where Big Tobacco would bring – in Stanley’s words – a hotshot lawyer for two weeks to handle one witness, it was just Stan – ley and Susan handling 157 witnesses.
The two would sometimes meet their witnesses only the night before they were expected to take the stand.
“Just tell the truth, just tell your story,” Susan recalls saying during some of that crunch preparation.
When the work in the courtroom ended, the preparation for the next day began immediately at home. They were working around the clock.
“When lawyers would ask us, ‘You’ve been in trial eight, nine months, how do you do it?’ One day at a time, that’s the only way we survived,” Stanley says.
For the couple, already hard workers, the two-year Engle trial fully engrossed their lives. It was physically exhausting. Susan developed atrial fibrillation, a rapid and irregular heartbeat, and was prescribed medication for it. “That started because of the trial and the pres – sure, because you’re under constant pressure,” she says.
The lawyers had to rely on relatives to watch or entertain the children and missed out on many school activities. Susan admits that she did receive lectures from her children about how much they were working and how much they were missing out on, but having a big family was also a positive – the kids had each other.
The two bring up one particular in – stance in which they could see how the trial had a positive impact on the children and brought them together.
They were in the appeals process of Engle, in the Florida Supreme Court. While appeals are Susan’s specialty, the stress of arguing was too much for her to bear physically, and she prepped Stanley for the argument. But when a justice from the Supreme Court asked Stanley a technical question, “I had no idea what the hell the guy was talking about,” he says, “so I said, ‘I’m going to let my wife handle that.’” “Which is not a normal thing to say when you’re in front of the Supreme Court,” Susan adds.
At the time, four of the Rosenblatts’ children were in school in Israel, but they were watching the proceedings streamed online. Susan, despite her hesitation, stood up and began her argument, while across the ocean, her children cheered her on.
‘Just file a lawsuit, see where it goes’ Both Stanley and Susan hope that young lawyers are inspired to work in the public sector due to the successes of their own cases.
“So many law students are getting out of the big schools and want to work for Wall Street, and that’s a problem,” Stanley says. “Instead of going into the public sector and going against corporations that are abusing people, they are doing the opposite and they’re joining the corporations.”
While today corporations lobby Congress for legislation to protect them from verdicts like the Rosenblatts’ $145b., Susan says holding them accountable is “still doable.” She provides clear instructions: “Just file a lawsuit, see where it goes.”
Today, the Rosenblatts divide their time between Miami and Jerusalem, en – joying their nine children and 16 grand – children. Stanley serves as chairman, and Susan as one of seven trustees, of the Flight Attendant Medical Research Institute, established with a $300 mil – lion endowment from winning Broin.
“What we’ve done through the re – search organization,” Stanley says, is “to take basically bad money – profits made from addicting children, causing disease – and yet using that money for a good purpose. In terms of working for Wall Street and everything like that, the money’s good, but how many houses can you have? How many trips can you take, and how many expensive bottles of wine? It can’t match the satisfaction and gratification when you know you’re having a positive impact on people’s lives. Especially health, that’s the bottom line.”
He also has words of praise for the juries on their cases.
“After the two-year trial, getting the jury – who were exposed to all these tobacco lawyers, all the industry arguments – and to come back with the verdict of $145b., from the standpoint of a trial lawyer, that’s a great achievement,” he says. “You gotta compliment the jury, which basically sat there – there were some breaks, of course – but basically to sit there for two years, their lives on hold. So they also had to be public-spirited, and it was very much appreciated.
Vaping is safer than smoking, new study
http://www.digitaljournal.com/science/vaping-is-safer-than-smoking-new-study/article/441568
By Tim Sandle Aug 20, 2015 in Health
London – The e-cigarette versus traditional tobacco smoking has edged forward with a new study concluding e-cigarettes are safer than smoking tobacco products.
The new evidence in favor of vaping has been provided by Public Health England, which is an agency of the U.K. government. The health organization has come down on the side of electronic cigarettes as a mechanism for weaning people away from tobacco products, including conventional cigarettes.
An electronic cigarette, also known as an e-cigarette, personal vaporizer or PV, is an electronic inhaler that vaporizes a liquid solution into an aerosol mist, simulating the act of tobacco smoking.
Public Health England has stated that, based on the evidence accumulated to date, e-cigarettes are 95 percent less harmful than tobacco cigarettes. However, the report does not state e-cigarettes are harmless. A risk remains, albeit a much lower one than with any comparable tobacco based product, with their regular use. The health agency is particularly worried that e-cigarettes are perceived in the same way as traditional cigarettes, i.e. no safer.
Other key findings from the review are:
Nearly half the population (44.8 percent) do not realize e-cigarettes are much less harmful than smoking; and, there is no evidence so far that e-cigarettes are acting as a route into smoking for children or non-smokers.
The main findings are contained in a comprehensive 111-page document titled “E-cigarettes: an evidence update.”
The U.K. health body also proposes that e-cigarettes should become a licensed medicine (which means coming under the regulation of a medicines agency, such as MHRA in the U.K. or FDA in the U.S.). By being licensed, this would allow medical practitioners to prescribe e-cigarettes as an alternative to other anti-smoking products such as nicotine patches.
Interviewed by The Guardian, the U.K. government’s chief medical officer, Dame Sally Davies is quoted saying it is the government’s preference that one day only licensed e-cigarettes be permitted to be sold: “I want to see these products coming to the market as licensed medicines. This would provide assurance on the safety, quality and efficacy to consumers who want to use these products as quitting aids, especially in relation to the flavorings used, which is where we know least about any inhalation risks.”
Whether this means a preference for e-cigarettes made available through pharmacies only is unclear. One reason for seeking control is because, as a separate review notes: “Under the current regulatory system individual e-cigarette products vary considerably in quality and specification.”That is, some products work better than others and some may be safer than others.
This tallies with the evidence gathered to date. Public Health England recommends that e-cigarettes are only used as a transitional means to move away from tobacco products. People, it cautions, who do not currently smoke should not begin using e-cigarettes and e-cigarettes used by former tobacco smokers should not be used for prolonged periods of time.
These additional caveats are important for a U.S. study has found that many teenagers, including those who have never smoked traditional tobacco products, have begun experimenting with e-cigarettes.
In terms of extended use, some studies suggest e-cigarette vapor contains toxic chemicals that are damaging to the body, particularly the immune system (see: Public Library of Science One “Exposure to Electronic Cigarettes Impairs Pulmonary Anti-Bacterial and Anti-Viral Defenses in a Mouse Model.”) To add to this, care is needed about over-use leading to nicotine poisoning, especially with young people. This risk was recently highlighted in a study by the U.S. Centers for Disease Control and Prevention.
The Public Health England report has been generally welcomed by Electronic Cigarette Industry Trade Association (ECTIA), which is the trade association of e-cigarette manufacturers. In a statement, the manufacturers’ group writes: “We are pleased that the public health community have recognized that the impact of a 95 percent reduction in harm when smokers move to e-cigarettes could be revolutionary.”
The position taken by Public Health England differs to that adopted by the World Health Organization. As Digital Journal reported last year: “The World Health Organization has called on e-cigarettes to be banned from indoor public spaces. Furthermore, the United Nations Agency has said that the devices pose a risk to adolescents and the fetuses of pregnant women.”
The Public Health England review is most comprehensive published to date. While it doe snot close off the debate, it moves the discussion about the practical use and benefits of e-cigarettes to a new level.
Despite Evidence, FDA Targets E-Cigarettes With Proposed Regulations
Written by Raven Clabough
http://www.thenewamerican.com/usnews/health-care/item/21435-despite-evidence-fda-targets-e-cigarettes-with-proposed-regulations
Despite evidence that electronic cigarettes are both safer for users than tobacco and also help smokers kick the habit, the U.S. Food and Drug Administration has launched a campaign against them. According to FDA Commissioner Dr. Stephen Ostroff, the FDA is looking to enact a “deeming rule” that would expand the agency’s regulation of tobacco to include e-cigarettes, which do not use tobacco. Critics contend that such an illogical decision underscores that the FDA is at the behest of lobbyists that benefit financially from tobacco and nicotine addiction.
The U.S. Food and Drug Administration issued its proposal earlier this year for new rules on e-cigarettes, including reviewing new e-cig products before they are sold and outlawing sales of the e-cig devices to minors, as well as requiring health warning labels on the products. The public comment period for the proposed rulemaking ends on August 31.
The FDA has defended its proposal by asserting that e-cigarettes have not been properly studied, leaving consumers unaware of potential health effects related to their usage. (If only the government were so concerned about the lack of long-term studies on the genetically modified organisms it has approved for American consumption.)
The FDA’s stance on e-cigarettes got a boost of support from the Centers for Disease Control, which resorted to outright lies about e-cigarettes to convince users that they are no better than actual cigarettes. In May the CDC issued a statement, which read, “If you only cut down the number of cigarettes you smoke by adding another tobacco product, like e-cigarettes, you still face serious health risks. Smokers must quit smoking completely to fully protect their health — even a few cigarettes a day are dangerous.” (Emphasis added.) As previously mentioned, e-cigarettes are non-tobacco products.
Contrary to assertions by the CDC and the FDA, however, California Polytechnic State University professor of economics Michael Marlow asserts that e-cigarettes should be left alone, as they are valuable tools in helping smokers quit smoking. “If e-cigarettes help smokers reduce consumption of more harmful tobacco or maybe even allow them to quit cigarettes, even if e-cigarettes themselves are somewhat harmful, it still would be an overall reduction of harm,” Marlow states.
In fact, evidence shows that e-cigarettes have been the most successful tool to help smokers quit smoking. “E-cigarettes have become the greatest source of ‘creative destruction’ that we’ve seen against the tobacco industry,” Marlow claims, which may be the motivation behind the decision to regulate them. “Unfortunately, maybe it’s also a source of creative destruction for those who make a living out of tobacco control,” Marlow observed.
According to the Tobacco Control Journal, the nicotine replacement therapies that have been approved by the FDA, such as nicotine gum, have no better success rates than quitting cold turkey.
Some view the FDA’s proposed regulations against e-cigarettes as an attempt to keep competitive products off the market, as the pharmaceutical companies behind those nicotine replacement therapies benefit from smokers’ inability to quit.
Dr. Gilbert Ross, medical and executive director of the American Council on Science and Health, opines, “Some of the group’s advocating for this anti-science, anti-public health charade … are influenced by undisclosed but generous financial support from the pharmaceutical industry, which is devoted to keeping effective competition to its poorly performing nicotine replacement therapy patches, gums, and drugs off the market.”
The New York Times has reported that GlaxoSmithKline, which sells Nicorette gum, and Johnson & Johnson, which manufactures nicotine patches, have helped lead a “strong opposition” against e-cigarettes. What’s more, the Food and Drug Administration’s Center for Tobacco Products, which headed the regulation of e-cigarettes, is led by former lobbyist Mitch Zeller, whose consulting clients included GlaxoSmithKline.
The Washington Examiner writes on the power of pharmaceutical lobbying in Washington:
No industry spends more on lobbying in the U.S. than the drug industry, and drugmakers’ agendas are often bigger government. Without the efforts of the drug lobby, for instance, Obamacare probably would have died in the summer of 2009. President George W. Bush’s single biggest expansion of government was creating the Medicare prescription drug benefit — at the behest of the drugmakers.
“The alarmist concerns raised by the drug companies are understandable,” Dr. Ross told the Washington Examiner, “because they’re rent seeking [a term that refers to seeking profit through public policy].”
And while the drug companies profit off the sale of their ineffective smoking remedies, is it too cynical to note that the federal government makes a substantial amount of money off smokers’ inability to quit?
In 2008, the New York Times reported that the federal government collected nearly $7 billion annually in cigarette excise taxes. In 2010, the number was as high as $15.5 billion, wrote the Daily Caller.
The NY Times article went on to explain how else the federal government profits from cigarette smoking:
But taxes are not the only government revenue from cigarettes. Settlements in the late 1990s to end state lawsuits against tobacco companies mean that the cigarette industry is paying states nearly $250 billion over 25 years. Under the agreement, those payments to states will continue flowing even beyond 25 years as long as the tobacco industry is healthy. But the payments would phase out as cigarette company profits decline and would ultimately disappear if people stop smoking.
So the government has become a financial stakeholder in smoking, some would argue, even as public health officials warn people about its deadly consequences. Smoking declines as cigarette taxes increase, but a core group of smokers hang on to the habit.
Stephanie Saul, who wrote the Times article, was compelled to ask, “Would politicians shut down an industry that supplies so much money?”
In other words, who else stands to lose from the impact that e-cigarettes can have on the tobacco industry?
Meanwhile, on the other side of the Atlantic, health officials are touting the benefits of e-cigarettes. This week, Public Health England has announced that vaping is safer than smoking and could lead to the destruction of the traditional cigarette.
The Guardian reports, “The health body concluded that, on ‘the best estimate so far’, e-cigarettes are about 95% less harmful than tobacco cigarettes and could one day be dispensed as a licensed medicine in an alternative to anti-smoking products such as patches.”
A 111-page expert independent evidence review found “no evidence so far that e-cigarettes are acting as a route into smoking for children or non-smokers,” a finding that directly contradicts a study by the University of California that found that adolescents who used the devices were more likely to smoke cigarettes.
“My reading of the evidence is that smokers who switch to vaping remove almost all the risks smoking poses to their health,” said Professor Peter Hajek of Queen Mary University, who co-authored the report with Professor Ann McNeill of King’s College London.
Maybe the FDA has not yet gotten the memo.
Australian teens leading charge in eschewing drinking and smoking
Young people are waiting until nearly 16 to try their first cigarette and delaying first drink by nearly a year compared with 1998 figures, study shows
It was not until Fairfax Media reported the lawyer had appealed against the decision to Victoria’s Civil and Administrative Tribunal, that the council became aware the lawyer was an employee of the tobacco giant, Harper said.
“We had no idea that British American Tobacco was behind the request,” he said. “All we knew was it was an individual from a law firm who wanted the data. I’m disappointed that the tobacco company wasn’t upfront about its involvement.”
Harper said the council was concerned that, once made public, the data could be used by tobacco and alcohol companies to gain insight into the buying and drug consumption habits of young people, as well as the types of brands that appealed to them.
The data is used by the Cancer Council to help it understand where and how to direct publishing health messaging, as well as for scientific studies. When parents consented to their children completing the survey, the did so believing the data would be used only in the interest of public health, Harper said.
Fairfax Media also revealed that the same lawyer used the Freedom of Information Act to get information from surveys of adult smokers in that state, which included questions about their attitudes toward smoking.
“The Cancer Institute NSW was compelled to provide tobacco survey data requested under the NSW Government Information [Public access] Act,” its chief cancer officer, David Currow, told Fairfax.
A spokeswoman for British American Tobacco told Guardian Australia the Victorian data request “wasn’t about children”.
“This is about plain packaging,” she said. “We did not seek any personal data or information in respect of children. We’ve asked for figures via a normal freedom of information request because we want to find out if plain packaging, a measure introduced without evidence and that directly affects our industry, is having the impact the Australian government claims it is.”
The assistant health minister, Fiona Nash, said the government would not back away from plain packaging regardless of tactics by tobacco companies to discredit it.
“If tobacco companies are obtaining research on young people through state FOI legislation to increase their sales to children, then I am appalled,” she said.
In a world first, Australia passed plain packaging legislation in 2011, requiring all cigarette packaging to be stripped of advertising and branding, apart from the company name and health warnings. All tobacco now comes in olive green cardboard containers with graphic health messages.
In a series of papers published by the Cancer Council in the BMJ journal Tobacco Control in March, plain packaging was associated with an increase in the number of people thinking about quitting and trying to quit. The research also found children aged between 12 and 17 found standardised packaging less appealing.
An appeal date for the freedom of information request is yet to be set.
Cancer Council unaware tobacco giant behind FOI request on child smoking habits
http://www.theguardian.com/society/2015/aug/20/cancer-council-unaware-tobacco-giant-behind-foi-request-on-child-smoking-habits
British American Tobacco criticised in Australia for not being ‘upfront about its involvement’ in freedom of information request for survey data
Melissa Davey
Cancer Council Victoria says it had no idea a British American Tobacco worker was behind a freedom of information request for data on the tobacco use and buying habits of thousands of school children.
For the past 30 years, the council has surveyed children aged between 12 and 17 about their age, gender and location, access to money, alcohol and tobacco consumption and buying habits, and preferred brands.
The director of the Victorian Cancer Council, Todd Harper, said a lawyer had requested the survey data under the Freedom of Information Act, but the request was rejected because it was not in the public interest to release it.
Big tobacco firms come late to the vaping party
http://www.cityam.com/222696/big-tobacco-firms-come-late-vaping-party
by Aaron Payne
IMPERIAL Tobacco yesterday announced increased market share and revenue from its growth brands, with revenues steady across the business.
The firm’s report did not reveal what impact, if any, had been made by its $27bn (£17.5bn) purchase of e-cigarette brands from Reynolds American.
E-cigarettes made headlines yesterday as a government-commissioned report by Public Health England (PHE) declared e-cigarettes to be up to 95 per cent safer than traditional, or “combustible”, cigarettes.
Big tobacco manufacturers like Imperial are turning an increasing amount of attention to e-cigarettes.
As government regulation and taxation grow more aggressive in the face of campaigns for improved public health, the so-called vaping products offer a new market and the chance of serious growth.
But different approaches by governments are putting a veil of smoke in front of the real commercial prospects for e-cigarettes.
According to Shane MacGuill, senior tobacco analyst at Euromonitor, for big tobacco companies, “everything about this is uncertain”.
India is planning an outright ban on e-cigarettes, while in Europe, Portugal and Italy have introduced a tax on e-liquids which has hit sales.
But reports such as PHE’s could undermine calls for more taxation of e-cigarettes due to public health worries. At present, tobacco giants have a small share of the e-cigarette market, for two main reasons. First, big tobacco came to the e-cigarette market late, and second, they are yet to seriously develop and market the type of vaping products consumers prefer.
Rather than “closed-system” variants that retain the look of traditional cigarettes, vapers are far more likely to use the boxier, metallic “tank-system” products.
The closed-system type offers tobacco companies greater influence on consumers, as they will not be able to switch between different vapour brands as they do now.
Some analysts believe a forthcoming EU report into vaping could shift the market in favour of closed-system products, due in part to child safety requirements.
Expansion into the e-cigarette market is definitely a long game for tobacco manufacturers, as most revenue available to cigarette companies is still heavily biased towards traditional tobacco products.
John Fell, a former equity adviser on tobacco and beverages, said: “Unless the market was to double and double and double again very, very rapidly the revenue pool is just not going to be a big enough size to impact [tobacco manufacturers’] profitability in the next few years.
“It will take time, patience and investment. But that doesn’t mean it’s not critical for them to keep developing products and investing.”
Analysts are divided as to the regions that will become major targets for growth.
Some believe that it makes long-term sense for manufacturers to target e-cigarettes in developed countries where smoking is becoming “de-normalised”, while countries where health awareness is less prevalent will remain receptive to growth in traditional products.
Fell disagrees. “It’s naive to assume that smokers in development markets aren’t going to want a similar choice of experience [to those in developed countries],” he said.
While not commenting on the role e-cigarettes are playing for her company so far, Alison Cooper, chief executive of Imperial, said: “This has been another good quarter, building on the progress we made in the first half.
“We are on track to deliver against full year expectations and to create further sustainable value for our shareholders.”
Shares in Imperial closed 0.49 per cent down, at 3,224p.
State Senate panel approves package of six anti-tobacco bills
http://www.latimes.com/local/political/la-me-pc-california-senate-anti-tobacco-bills-20150819-story.html
Michael Robinson Chavez / Los Angeles Times
A Senate panel on Wednesday approved a package of six anti-tobacco bills, including measures raising the smoking age to 21 and barring the use of electronic cigarettes in public places such as restaurants where smoking is banned.
Both the age increase and e-cigarette bills had stalled in the Legislature, but were revived for a special session on healthcare and approved by a new Senate Committee on Public Health and Developmental Services. Republicans did not vote for any of the bills in the package.
Sen. Mark Leno (D-San Francisco) proposed the measure that would designate e-cigarettes or vaping devices as tobacco products subject to the same restrictions on public use as traditional, combustible cigarettes.
“The fastest growing market segment of this very quickly growing industry is made up of children of middle- and high-school ages,” Leno told the committee. “Students who have never smoked a traditional cigarette are using e-cigarettes.”
The bill also allows sting operations to catch retailers who sell vaping devices to minors and requires child-resistant packaging. “It will definitely protect the next generation,” he said.
The measure was opposed by the Smoke Free Alternative Trade Assn. as an attack on a product that it says has helped some smokers quite traditional cigarettes.
The bill would “stymie a growing industry,” said the association’s Michael Mullins.
The measure does not itself contain a tax, but Kari Hess, co-owner of Nor Cal Vape in Redding, said the legislation will lead to taxing the industry.
“This bill will make vapor products cost prohibitive and I may be forced to close my doors,” Hess told the panel.
The bill raising the age to legally buy cigarettes from 18 to 21 was introduced by Sen. Ed Hernandez (D-West Covina), who said it will significantly reduce the number of young people who take up smoking and result in significantly lower health costs.
“It should not be so easy for our children to get ahold of this deadly drug,” Hernandez told the panel.
Opponents, including Pete Conaty, a lobbyist for veterans groups, argued that if residents are old enough to join the military and fight in wars at 18, they ought to be able to decide whether to smoke.
Other bills approved by the committee and sent to a Senate finance panel for consideration would:
Require all schools, including a growing number of charter schools, to be designated as smoke free.
Close loopholes in smoke-free workplace laws, extending them to hotel lobbies, small businesses, break rooms and warehouses.
Allow county voters to tax tobacco distributors.
The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines
http://jama.jamanetwork.com/article.aspx?articleid=2430590
Jing Luo, MD1; Aaron S. Kesselheim, MD, JD, MPH1
1Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
JAMA. Published online August 20, 2015. doi:10.1001/jama.2015.10872
After a difficult legislative battle, President Obama signed into law Trade Promotion Authority on June 29, 2015. The legislation allows for an up-or-down vote with no amendments in Congress for international trade agreements such as the Trans-Pacific Partnership (TPP) Agreement. The TPP Agreement includes 12 Asia-Pacific countries (United States, Canada, Mexico, Peru, Chile, Japan, Vietnam, Malaysia, Singapore, Brunei, Australia, and New Zealand) with a collective trading power amounting to 40% of the global gross domestic product. The TPP Agreement is still being negotiated; recently, in a meeting of trade ministers in Maui, Hawaii, negotiators failed to finalize the text of the Agreement due in large part to disagreement regarding intellectual property protections for pharmaceutical products.1
Intellectual property rights, including patents, are central to the business model of brand-name pharmaceutical manufacturers. Manufacturers can charge high prices during patent-protected periods without fear of competition, earning profits that are intended to provide incentives for investment in drug innovation. However, low-income patients frequently lack access to expensive drugs, and excessive spending on pharmaceuticals can strain government budgets, leading to reductions in other health services. In addition to addressing barriers to trade, the TPP will affect the pharmaceutical market in member countries due to its intellectual property provisions.
It is critical to ensure that patents protect only innovative pharmaceutical products and for governments to balance grants of market exclusivity with other competing interests, such as the widespread availability and affordability of certain drugs. In the United States, for example, patents are supposed to be issued only to novel products that are an innovative step beyond what already exists, and patents along with a variety of regulatory and other exclusivities permit conventional drugs to receive an average time of about 13 years of market exclusivity before competing generic versions are approved.2
The 1994 Trade Related Aspects of Intellectual Property (TRIPS) Agreement, which countries must agree to as a criterion for membership into the World Trade Organization, standardized basic intellectual property protections for pharmaceutical products around the world. Before TRIPS many lower-income countries had chosen not to grant patents for pharmaceutical products, emphasizing low-cost access over contributing to incentivizing innovation; however, the TRIPS Agreement required all signatory countries to change their policies and grant pharmaceutical patents.
In the years since, countries have implemented this requirement in different ways. Indian law, for example, required new forms of existing drugs to show significant improvements in efficacy before they can be granted a patent. This controversial provision was recently upheld in an Indian Supreme Court decision related to a new formulation of imatinib (Gleevec), a tyrosine-kinase inhibitor used to treat chronic myelogenous leukemia.3 In that decision, the Indian Supreme Court stated that the beta crystalline form of imatinib was not patentable in part because it was too similar to an older formulation discovered prior to India’s enforcement of patents for pharmaceutical products under TRIPS.
The TPP may end such flexible approaches to granting patents and add a number of new requirements related to intellectual property in addition to the TRIPS measures. Even though the exact details of the TPP are not known, negotiating drafts have been leaked, with the most recent intellectual property chapter dating from May 11, 2015.4 This chapter includes 8 sections covering a wide range of topics including patents, trademarks, copyright, industrial designs, and geographical indications.
In the case of pharmaceuticals, the text of the draft seeks to bring international intellectual property law into closer alignment with current US standards regarding the scope of what may be patented. For example, US negotiators favor allowing patents to cover inventions in all fields of technology (including inventions derived from plants and microorganisms), despite legal systems in other countries that include a more limited scope of patentable subject matter.
The TPP also could allow new uses of a known product to be granted additional monopoly protection. This may reduce TPP countries’ abilities to create patent laws that seek, as India’s does, to ensure that only truly innovative and clinically important pharmaceutical products are patentable. Seeking patents for the new methods of using existing drugs is a common tactic that pharmaceutical manufacturers in the United States use to delay the generic competition. For example, Eli Lilly sued Canada for $500 million dollars over its decision to invalidate 2 pharmaceutical use patents: the use of olanzapine (Zyprexa) in schizophrenia and atomoxetine (Strattera) in attention-deficit/hyperactivity disorder.5 Both drugs were previously patented in Canada for other uses, and a generic manufacturer (Novopharm) successfully challenged the validity of these patents by showing that there was insufficient evidence to support the claims at the time of filing. In the case of olanzapine, Lilly attempted to secure additional monopoly protection by restating the claims from an earlier patent while simultaneously failing to demonstrate substantial advantage over other antipsychotics for this new use, which is the current standard required under Canadian law. Under the TPP, a multinational pharmaceutical company could use the investor-state dispute settlement mechanism to challenge domestic laws like the one in Canada, which are intended to promote timely availability of generic drugs.6
The TPP also contains provisions that could make it more difficult to successfully challenge patents after they have been issued by shifting the burden of proof onto the challengers. This would ensure that potential generic market entrants must expend substantial resources to clear the numerous interrelated patents that innovator companies obtain on their products, increasing the cost and time of generic entry. The TPP draft could also impose substantial civil and criminal penalties on potential generic manufacturers found to have infringed patents, increasing the business risk for these companies. Moreover, language requiring the seizure and destruction of in-transit goods for “confusingly similar” products may expand the geographic scope of the TPP to affect countries not part of the direct agreement, such as India or Brazil, which may find it more complicated to ship generic medicines that are legal under their patent regimes through TPP member states.
In addition to forcing TPP member states to adopt patent laws that closely align with that of the United States, the TPP could also require member states to adopt the US Food and Drug Administration’s approach to preventing generic manufacturers from reaching the market for a minimum of 5 to 7 years after the approval of a new small-molecule drug, 3 years for new indications, and 12 years after approval of a new biologic drug.7 Nine TPP countries provide no guaranteed exclusivity periods for safety and efficacy data associated with biologic drugs because the complex manufacturing processes required to create these medicines naturally makes for fewer follow-on biologic competitors and fewer cost reductions arising from that competition. Notably, in the United States, the Federal Trade Commission similarly recommended no guaranteed exclusivity periods for biologics, and the Obama administration has repeatedly proposed to reduce the period of biologic exclusivity from 12 to 7 years for these same reasons. The TPP may reduce the flexibility of US policymakers to change the period of guaranteed biologic data exclusivity in the future, maintaining high biologic drug prices.
Thus, in its current form, the TPP could lower the bar for the patenting of pharmaceutical innovations and make it substantially more difficult for generic manufacturers to enter the market in TPP member countries. In addition, legal generic products could become seized during international transit. The overall effect of the TPP could be to extend the effective patent life of drugs and to decrease the availability of generic drugs or biosimilar medicines available to patients around the world.
Some economists have suggested that the intellectual property chapter of the TPP should be abandoned, because it could result in higher drug prices for patients.8 By contrast, industry representatives suggest that strong intellectual property protections are necessary for costly research and development, although this assertion has been disputed.9
It is likely that a balance between these competing objectives has not been struck by the TPP agreement in its most current form. The recent breakdown in negotiations suggest that some countries are taking a hard-liner on pharmaceutical-related provisions, so there remains hope that an agreement could be negotiated. If the United States continues down the path exposed in the leaked draft and expects other TPP countries to accept new standards for pharmaceutical intellectual property protections, it should also allow concessions that would encourage low-cost and high-quality generic drugs competition once market exclusivity ends. For example, data exclusivity for medicines should not be redundant or geographically transportable, meaning that if a 5-year exclusivity period has already expired in the United States, no additional exclusivity would be granted by regulatory authorities in other TPP member countries. In addition, meaningful technology transfer could be incorporated to promote local pharmaceutical manufacturing capacity. An innovative financing instrument, such as a nominal levy on top of existing tariffs for nonpharmaceutical trade (eg, goods and services), could also be created to help less-wealthy, signatory countries procure medicines that will inevitably be made more expensive by the agreement.