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Ex-FDA Commissioner faces RICO charges, helped form e-cig regulations

May 19th, 2016
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Current FDA head Califf also has ties with Johnson & Johnson, corruption may be inevitable.

http://us.blastingnews.com/opinion/2016/05/ex-fda-commissioner-faces-rico-charges-helped-form-e-cig-regulations-00921737.html

You wouldn’t think of “corruption” in any form when you think of the Food and Drug Administration (FDA). Certainly, you wouldn’t think of conspiracy and intent to conceal detrimental information to the public. Certainly, you’d be wrong. Those employed by the government have the responsibility and duty to “protect” the public. They are supposed to be in the care and custody of information and decisions that may endanger or save lives via regulations. They’re not doing a very good job of it.

Racketeering and corrupt organizations

Margaret Hamburg, former FDA Commissioner (May 2009 to March 2015) is facing charges under the “Racketeer Influenced and Corrupt Organizations” (RICO) act for concealing deadly consequences of the drug Levaquin made by Johnson & Johnson. Along with her abuse of power, her husband Peter Brown was a hedge-fund manager at Renaissance Technologies and is also facing RICO charges along with drug giant, Johnson & Johnson. According to the Alliance for Human Research Protection (AHRP) report, Brown’s reported income was “$10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012″ due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.”

Corruption by design or default

While Hamburg was acting Commissioner, she was instrumental in forming e-cigarette regulations before she left the FDA. Her replacement, Dr. Robert Califf also has financial ties to pharmaceutical giants AstraZeneca, Johnson & Johnson, GlaxoSmithKline and more. While he was the director of the Duke Translational Medicine Institute (DTMI) he received a consulting payment from Johnson & Johnson of $87,500. Taking over where Hamburg left off, Califf released the FDA e-cigarette regulations, and litigation is already pending on the rule. Regulations, by design or default, may be heavily strewn with conflict of interest. With the makers of nicotine reduction therapies and drugs like Johnson & Johnson having an FDA Commissioner and former commissioners ear, corruption may be inevitable.

Are decisions based on health?

Senator Ron Johnson (R-Wis.) wants answers from the FDA about regulations. In a letter, the chairman of the Senate Homeland Security and Governmental Affairs Committee asked Commissioner Califf a few specific questions. Burdensome expenses related to the application and approval costs and public health were of importance in his letter. As he stated, “the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences.” Another observation made by Senator Johnson stated:

“The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.”

Then Senator Johnson asked, in part:

“How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health”?

The Committee on Homeland Security and Governmental Affairs is authorized to investigate “the efficiency and economy of operations of all branches of the Government.”

Senator Johnson stated he wanted all material “no later than 5:00 p.m. on May 31, 2016.”

Australia versus Philip Morris. How we took on big tobacco and won

May 17th, 2016
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http://www.smh.com.au/federal-politics/political-news/australia-versus-philip-morris-how-we-took-on-big-tobacco-and-won-20160517-gowwva.html

Previously sealed documents reveal the tobacco giant Philip Morris lost its case against Australia over plain packaging because the international tribunal considered it an “abuse of rights”.

Philip Morris sued Australia under the provisions of an obscure Hong Kong Australia investment treaty in 2012 after British American Tobacco and Japan Tobacco lost a challenge to the plain packaging legislation in the High Court.

As had its competitors in the failed High Court challenge, the manufacturer of Marlboro and Longbeach cigarettes argued Australia had confiscated its trade marks, turning from “a manufacturer of branded products to a manufacturer of commoditised products”.

Philip Morris wanted the tribunal to order Australia to withdraw the law or to award damages of at least $US4.2 billion plus compound interest at the Australian bank cash management rate dating back to the to the law’s introduction.

Its use of an outside tribunal rather than an Australian court to sue the government was unusual, in that it was making use of a provision available to foreign companies under trade agreements but denied to Australian companies.

The government spent more than $50 million defending the case, assembling a team including two Queens Counsels and two Senior Counsels and ferrying to Singapore witnesses including the former treasurer Wayne Swan and former judge Roger Gyles QC.

The 186-page judgement, unsealed on Tuesday, shows the tribunal rejected the claim at the first hurdle, finding Philip Morris had moved its Australian and Asian headquarters to Hong Kong for the express purpose of making the claim.

“The tribunal cannot but conclude that the initiation of this arbitration constitutes an abuse of rights, as the corporate restructuring by which the claimant acquired the Australian subsidiaries occurred at a time when there was a reasonable prospect that the dispute would materialise and as it was carried out for the principal, if not sole, purpose of gaining treaty protection,” the judgement finds.

A spokesman for assistant health minister Fiona Nash said she welcomed the decision which validated the government’s decision to take on Philip Morris.

Originally rare, the use of so-called investor-state dispute settlement provisions in international treaties has ballooned in the past decade. Australia’s Productivity Commission counted 42 in 2014.

Productivity Commission count of iinvestor-state dispute settlement cases

Productivity Commission count of iinvestor-state dispute settlement cases

Investor-state dispute settlement provisions have been included in Australia’s recently-signed treaties with Korea and China and the 12-nation Trans-Pacific Partnership which has been signed but not yet ratified by the Australian parliament.

La Trobe University public health academic Deborah Gleeson said the victory would add to momentum for the spread of plain packaging legislation around the world, but she said it didn’t mean that investor-state dispute settlement provisions weren’t a threat to public health.

“If we ratify the Trans-Pacific Partnership transnational corporations based in the United States will gain an avenue to sue Australia. There’s an exclusion for tobacco control measures, but no solid exclusion for other health measures.”

Australia continues to face challenges to its plain packaging laws in the World Trade Organisation from tobacco-growing nations including Cuba, the Dominican Republic, Honduras and Indonesia. The Ukraine withdrew its challenge last year.

Tribunal Publishes Redacted Version of Award on Jurisdiction and Admissibility

May 16th, 2016
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Tobacco Firms Lose Packet Legal Challenge

May 11th, 2016
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The European Court of Justice dismisses the final legal challenge to EU rules which aim to stop youngsters from starting smoking.

http://news.sky.com/story/tobacco-firms-lose-packet-legal-challenge-10268916

Europe’s highest court has rejected a legal challenge by tobacco firms against standardised packaging rules for cigarettes.

The ruling, at the European Court of Justice, essentially dismissed complaints that changes to EU laws went beyond what was necessary on health grounds.

It also paves the way for member states to impose further requirements such as plain packaging measures proposed in the UK, France and Ireland.

In addition, the ruling removes legal barriers to the banning of menthol cigarettes from 2020 and also electronic cigarette advertising.

The updated Tobacco Products Directive will take effect on 20 May though cigarette retailers will have a year to sell off their remaining stocks before the standardised packaging rules take effect.

They are designed to make the cartons less attractive to youngsters – with health warnings more prominent and covering 65% of a packet.

The EU hopes the move will cut smoking numbers by 2.4 million and prevent 700,000 premature deaths.

A separate legal challenge by tobacco firms against UK Government plans to remove all branding from cigarette packs is due to be heard on 18 May at the High Court and could be subject to appeal.

The packaging case against the EU was brought to by Philip Morris International, the maker of Marlboro, and the firm behind Rothmans and Benson & Hedges, British American Tobacco.

They argued that the bloc was abusing its authority.

But the ruling said: “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”.

The Directive was due to be introduced in 2014 but was held up in the courts.

Deborah Arnott, chief executive of the anti-smoking charity Ash, welcomed the ruling.

She said: “We (now) await the UK court judgement, which is expected shortly, but we are optimistic that the court will confirm that the introduction of standardised packaging in the UK is lawful.

“From 20 May, all packs manufactured for sale in the UK will have to be plain, standardised, in the same drab green colour with the product name on the pack in a standard font”.

A spokesman for British American Tobacco said: “The reality is that many elements of the directive are disproportionate, distort competition and fail to respect the autonomy of member states.”

Governments urged to hold tobacco companies accountable

May 10th, 2016
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https://www.ghanabusinessnews.com/2016/05/10/governments-urged-to-hold-tobacco-companies-accountable/

The Vision for Alternative Development (VALD), a non-governmental organisation, has joined advocates from Africa, the United Kingdom and Latin America to call on governments to hold the British American Tobacco (BAT) accountable.

The advocates claim that the BAT had made profit from generations of addiction to tobacco around the world and, therefore, their governments should demand accountability from the tobacco industry.

The call comes as BAT convenes its annual general meeting in London.

Mr Labram Musah, the Programmes Director of VALD, in a statement copied to the Ghana News Agency, said at least it was undoubtedly clear that delays in adopting Tobacco Control laws was largely due to industry interference in public health policies.

The VALD called on Ghana Government and the world over to stand firm and resolute in the midst of tobacco industry interference and formulate lifesaving legislation that would protect present and future generations from the devastating effects of tobacco use and tobacco smoke.

“While BAT’s executives toast to deadly profits and generations of addiction, people and governments around the world are organising to hold them accountable for their abuses,” Mr John Stewart, the Deputy Director at the Corporate Accountability International, has said.

European Court judgement clears way for plain packaging of tobacco in Ireland

May 4th, 2016
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Big Tobacco arguments rejected by CJEU

https://www.cancer.ie/about-us/news/european-court-judgement-clears-way-plain-packaging-tobacco-ireland#sthash.TTszgZlV.dpbs

The Irish Cancer Society has today welcomed a Court of Justice of the European Union (CJEU) judgement that has stopped attempts by the tobacco industry to block the introduction of plain packaging of tobacco in Ireland in 2016.

The CJEU judgement upholds the rights of EU member states to introduce standardised packaging of tobacco products, where it is justified on grounds of public health.

The Court considered that that prohibition protects consumers “against the risks associated with tobacco use”.

The Irish Cancer Society says that this is a defeat for the tobacco industry who knows plain packaging works.

Donal Buggy, Head of Services and Advocacy at the Irish Cancer Society said: “Plain packaging of tobacco will save lives. The rejection of the tobacco industry’s case against the tobacco products directive (TPD) highlights the fatuous nature of their arguments and their fear that plain packaging will eat into profits.”

“Big tobacco knows that plain packaging, as a health measure, works, and are doing everything to prevent its introduction because they need to recruit 50 new smokers every day in Ireland to replace those dying and quitting.”

The CJEU found that the standardisation of labelling and packaging is a ‘proportionate’ measure and that EU legislature allowing for its introduction from May 20 is “appropriate and necessary”. The judgement clears the way for the introduction of plain packaging here in Ireland this summer.

Mr. Buggy said: “Today’s ruling represents the overcoming of another legal hurdle to the introduction of plain packaging in Ireland. What remains to be done now is the passing of minor technical amendments to legislation here so that plain packaging can be introduced in the very near future.”

The formation of a Government will, according to Mr. Buggy, “hopefully see the speedy progression of this legislation through the Oireachtas very shortly”.

The Irish Cancer Society warned however, that this will not be the last legal challenge to plain packaging either in Ireland or at EU level.

Mr. Buggy said: “The tobacco industry has deep pockets and will continue to fight these life-saving measures. Australia, the first country to introduce the measure, is still battling spurious cases from the industry four years on.”

Figures from the Australian Government show that since the introduction of plain packaging the number of people smoking has dropped to historically low numbers. Daily smoking rates have fallen from 15.1% in 2010 to 12.8% in 2013 – compared to 19% in Ireland. And among 12-17 year olds, only 5% smoke in comparison to 8% here.

“The louder Big Tobacco shout about this, the more we know it works.”

Mr. Buggy commended the efforts of the European Commission and Irish Government in “remaining steadfast in the face of enormous and costly legal pressure by the industry”.

“5,870 people die from tobacco related disease every year. The challenge now is to commit to public health, to commit to plain packaging and to reject the actions of a tobacco industry in crisis.”

Mr. Buggy said: “This is another big step towards achieving the goal of a tobacco-free Ireland by 2025”.

The Department of Health have committed to a Tobacco Free Ireland by 2025 – which means an overall smoking rate of less than 5%.

Today’s CJEU judgement also dismissed actions against the prohibition of menthol cigarettes and special rules concerning warnings, content and advertising of e-cigarettes.

– See more at: https://www.cancer.ie/about-us/news/european-court-judgement-clears-way-plain-packaging-tobacco-ireland#sthash.TTszgZlV.dpuf

PROCEDURAL ORDER NO. 17

May 2nd, 2016
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Regarding Redaction of Confidential Information in the Award on Jurisdiction and Admissibility

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How might Big Tobacco react to a rise in cigarette excise?

Apr 20th, 2016
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http://theconversation.com/how-might-big-tobacco-react-to-a-rise-in-cigarette-excise-57895

There now appears to be bipartisan recognition in Australia of the political stench of cigarettes. Labor governments have taken a dim view of smoking for at least a decade, but now even the Liberal Party is joining the attack.

As the campaign donations from the tobacco industry dry up, the Turnbull government has set its sights on a product that, thanks to its unfortunate tendency to kill off its natural constituency, makes for an obvious target. The government is expected to announce a rise in tobacco excise in the coming federal budget.

The current taxation debate is just a small part of a much wider effort to curb smoking rates. And with every successful legislative change in Australia, other nations are increasingly emboldened to take on an industry once considered too politically powerful and dangerous.

Australia’s plain-packaging laws are already viewed as a model for Ireland, the UK and France. Its taxes – among the highest in the world – have routinely been shown to cut smoking rates to historic lows. Its citizens now overwhelmingly accept bans on passive smoking.

Still, Big Tobacco will never give up its fight against regulation and taxes. It knows that for every day it delays change, it saves millions in profits. As such, it relies on tactics of deceit, delay and frustration, which it has developed and refined over half a century.

But it also knows that it can’t make its argument directly. Instead, it relies on rhetorically gifted proxies. To that end, Big Tobacco has collaborated with a global web of friendly lobby groups, researchers and free-market think-tanks, such as the Institute of Public Affairs (IPA). Each proxy is expected to push an agenda, such as suggesting that research on tobacco smoke is “junk science” and critics of tobacco are “biased”.

Once the research has been completed, there are always media outlets willing to dutifully repeat the industry’s claims, which are used to build a narrative of the “nanny” state repeatedly kicking the mature and informed smoker.

Capitalism and freedom – for smokers

In the West, the freedom-of-choice argument has been at the heart of most of Big Tobacco’s campaigns since the 1970s. It’s a powerful idea, but it deliberately ignores the issue of child and passive smoking.

As such, Big Tobacco primarily relies on the argument that the state is trampling on personal liberty. When plain-packaging laws were being debated in Australia in 2010 – the first such laws in the world – the industry and its allies leapt into action.

The resultant advertising campaign was designed to portray the government and anti-smoking campaigners as part of a “nanny state” that was determined to tell adults how to live their lives.

An anti-plain-packaging advertisement.

(Stuck in) Nineteen Eighty-Four

The liberty argument may be a legitimate point of debate. But Big Tobacco also contended that plain-packaging laws would fail to deter people from smoking.

The IPA pointed out the tremendous monetary value of packaging, and Australia’s vulnerability to legal challenges that would cost billions of taxpayer dollars.

But, later, a senior IPA member released a study that showed spending on tobacco products had – controlling for other factors – increased following the plain-packaging laws’ passage.

Writers in the Murdoch press reported both stories, unaware of their contradictory nature.

Media Watch on how the plain-packaging studies were reported.

(Big Tobacco’s) crime and punishment

Another line of attack suggests that high taxes on cigarettes cause crime.

In 2015, the tobacco industry commissioned KPMG to study the effects of cigarette taxes on smuggling and black market sales. Unsurprisingly, the report said exactly what the tobacco industry wanted it to – going so far as to suggest that one in seven cigarettes smoked in Australia were smuggled.

As with all industry-funded “research”, government critics were keen to regurgitate the findings.

This is a distraction tactic. It is true that very high taxes, or a prohibition, will create a black market. It is also beside the point of plain packaging – which is to reduce smoking, while allowing for some free choice, provided it is informed and adult. Such laws have proved successful to that end.

The tobacco industry, insisting that we look anywhere but at them, wants to repaint a health issue as a law-enforcement one.

However, the tobacco industry is deeply hypocritical on smuggling. It systematically floods key foreign markets with its product, in turn facilitating smuggling in Western markets. The tactic allows it to claim plain-packaging laws and taxes cause the same crime it creates.

The heart of darkness

Big Tobacco fights in this way because of what it stands to lose.

So, the industry of death continues to exact its toll. It knew that people died from smoking and passive inhalation decades before it conceded the point. It knew of children taking up smoking – it even helped them do so. It complains of smuggling while being the biggest source of the problem.

Big Tobacco does these things because it is afraid. Imagine the profits lost should other countries adopt similar messages. Tens of billions every year are at stake.

In the tobacco wars, the strategic importance of Australia is critical. Big Tobacco will go to extraordinary lengths to ensure moves to quell smoking fail.

Liability: untapped potential in the Framework Convention on Tobacco Control

Apr 11th, 2016
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http://blogs.bmj.com/tc/2016/04/11/liability-untapped-potential-in-the-framework-convention-on-tobacco-control/?q=w_tc_blog_sidetab

The history of the Framework Convention on Tobacco Control (FCTC) is filled with one unprecedented victory after another (see page 21). The next milestone for the treaty can—and should— tap the potential of Article 19 to hold the industry liable. Though the implementation of measures in line with Articles 5.3 and 13 has dramatically shifted the way the tobacco industry can operate globally, Article 19 has similar—if not greater—potential to curb the operations of the industry, and therefore the tobacco epidemic. As we look to the next Conference of the Parties (COP) in November, Parties should be looking to make sure that Article 19 achieves its potential.

For many who participated in the drafting of the FCTC, Article 5.3 (protecting public health policies from the tobacco industry) and Article 13 (banning tobacco advertising, promotion and sponsorship) seemed too visionary. Many thought these articles would be politically and technically impossible to implement. But a decade later, Parties are prioritizing these articles— and the effects are startling. Today, tobacco industry marketing is being rolled back across the globe. And dozens of countries have barred the industry from the policymaking table, creating space for effective policies to take hold.

But still the industry continues to be enormously profitable, with the top six corporations raking in $44 billion of profits in 2013. This, in part, because it breaks national laws and is not held accountable for what its products cost society. Governments pay billions of dollars in healthcare costs due to the tobacco epidemic. And evidence continues to mount of the tobacco industry’s illegal activities, which it currently appears to engage in with relative impunity—from illicit trade to widespread and systematic bribery.

To take the next big step in reducing the industry-driven tobacco epidemic, we must be able to hold the industry civilly and criminally liable. We must appreciate the visionary potential in Article 19. And we must take bold, courageous action to realize the world that Article 19 can make possible.

A vast ocean of possibility

Successful civil liability litigation in the U.S. and Canada has proven this tactic has great, global potential. It can provide an avenue for governments to hold the industry accountable for breaking laws, whether it be illegal marketing practices or illicit trade. Financially, it can shift the cost of the tobacco epidemic to the industry, where it belongs, raise the price of tobacco products (which reduces consumption), and provide funds for tobacco control campaigns. And finally, civil liability suits can expose internal industry documents, which provide invaluable insight into the industry’s tactics and help pave the way for even more effective legislation and litigation.

Holding the tobacco industry criminally liable, on the other hand, is admittedly venturing into less tested waters. But the ocean of possibility is vast.

Research on criminal liability provides cause for hope. A successful criminal prosecution would dramatically change the landscape for the tobacco industry. Tobacco executives could face potential prison time for violating tobacco control laws or for misleading people about the lethality of their products. The negative publicity generated with such charges would go far in denormalizing the tobacco industry and would chill the recruitment of talent.

Moral and financial imperative

To be sure, successful implementation of liability measures will prove to be challenging. And it will look different in each country given the range of legal systems across Parties. But the moral and financial imperatives are clear. Parties in the Global South, such as those recently targeted by British American Tobacco’s bribery, are now calling for tools to advance Article 19. These are some of the same Parties who championed Articles 5.3 and 13 during the FCTC negotiations.

We can and must follow these Parties’ visionary lead once again. During COP7, Parties should adopt strong guiding principles to advance implementation of Article 19. These include principles for developing and reforming legislation, and best practices for litigating in civil and criminal liability regimes in both civil and common law jurisdictions and systems.

Without a doubt, litigating against the tobacco industry is costly and intimidating. But many governments are already locked in defensive legal battles with the industry as it turns to litigation more and more to undermine strong tobacco control policies around the world. If governments are going to be in court with the industry, they should be doing it on their terms, proactively holding the industry liable for its myriad of abuses. And to do so, they need tools and guidance for implementation of Article 19 from the treaty, the Secretariat, and the COP. We have the ability to bring the untapped potential of Article 19 into fruition and to rein in the tobacco industry as we have never seen before. We have no time to lose. We must act, as a global community, now.

Chris Bostic is Deputy Director for Policy at Action on Smoking and Health (Twitter: @AshOrg). Richard Daynard is University Distinguished Professor of Law at Northeastern University and President of the Public Health Advocacy Institute . Tamar Lawrence-Samuel is Associate Research Director at Corporate Accountability International. (Twitter: @StopCorpAbuse)

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Official Note Verbale issued on TI Interference & ITIC

Mar 14th, 2016
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http://tobaccowatch.seatca.org/index.php/2016/03/15/official-note-verbale-issued-on-ti-interference-itic/

Has the International Tax and Investment Center (ITIC) been talking to your government? What recommendations has it been proposing? The FCTC Convention Secretariat (FCS) has issued a Note Verbale warning Parties about the ITIC and its activities, and to reject the tobacco industry’s interference in addressing tobacco smuggling problem.

The FCS has warned governments that the ITIC, which has 4 transnational tobacco companies on its Board, has been working to further the interest of the tobacco industry. The ITIC has been organising regional and global meetings where the meetings feature discussions on tobacco taxation and promote tax policies favouring the industry rather than the recommendations of the FCTC especially Article 6 and its Guidelines.

The ITIC will be holding its next annual Asia-Pacific Tax Forum in Jakarta, on 23-25 May 2016. It has routinely invited government officials, especially from customs departments, to attend its meetings. On its website and publications, the ITIC promotes photos of its own executives posing with officials from Asia to illustrate its close association with Asian governments.

Smuggling of tobacco is a problem is faced by many countries in the region. Big Tobacco (PMI, BAT, JTI and IB [Imperial Brands]) has blamed substantial excise tax increases and high tobacco taxes as the problem. Additionally, the industry promotes its own ‘Codentify’ system to solve the smuggling problem.

The FCS’s Note Verbale advices governments not to accept ‘Çodentify’ to address the illicit trade in tobacco products. The Note Verbale reminds Parties to “reject partnerships and non-binding or non-enforceable agreements with the tobacco industry”.

In addition, Article 8.12 of the Protocol on Elimination of Illicit Trade in Tobacco Products, explicitly states that a Party’s obligations shall not be performed by, or delegated to, the tobacco industry. An expert paper, The Tobacco Industry and the Illicit Trade in Tobacco Products provides further information on the tobacco industry’s behaviour in addressing tobacco smuggling.

For information on TI denormalization, check out SEATCA’s Tobacco Industry Watch website.

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