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June 3rd, 2015:

Obeying Court Order, FDA Revamps Tobacco Panel

Four members ousted from agency’s tobacco advisory committee.

by Shannon Firth

WASHINGTON — Four members of its Tobacco Products Scientific Advisory Committee (TPSAC) were dismissed or have resigned, the FDA said, following a federal court decision last year that they were too cozy with anti-tobacco interests.

Three new members have already been chosen for the committee, according to an FDA press statement.

The shake-up follows a July 2014 ruling by U.S. District Judge Richard Leon, who ordered the agency to overhaul the committee, as well as prohibiting use of its 2011 report that found menthol as a cigarette additive is harmful.

Leon’s decision came in a lawsuit filed in 2011 by tobacco manufacturer Lorillard. The firm argued, and Leon agreed, that some members of the committee had unacceptable conflicts of interest because of their relationships with companies that make tobacco-cessation products and/or were working with litigants in anti-tobacco lawsuits.

Leon ruled that the members’ conflicts “irrevocably tainted [the committee’s] very composition and its work product.”

The four departing members are: Chairman Jonathan Samet, MD, MS, director of the University of Southern California Institute for Global Health; or Medical Sciences; Joanna Cohen, PhD, professor at John Hopkins School of Public Health; and Suchitra Krishnan-Sarin, PhD, associate professor of psychiatry at the Yale School of Medicine.

“This is a loss for the FDA and for public health. Under other circumstances, there would be strong reasons for the agency to consider a waiver or authorization that would allow these individuals to continue their valuable service. However, in light of Judge Leon’s ruling, we do not believe we are able to exercise our discretion to consider this option at this time,” wrote Mitch Zeller, JD, director of the Center for Tobacco Products.

Any candidate for an FDA advisory committee must relay his or her financial holdings, employment, and research grants and contracts, for the agency to assess potential conflicts of interest. “All original and current TPSAC members successfully met the FDA’s rigorous requirements upon selection,” wrote Zeller. “However, Judge Leon’s ruling further expands the FDA’s [conflict of interest] criteria.”

The new court ruling mandated “rescreening” four members of the committee who failed to meet Judge Leon’s criteria. Afterwards these four members either resigned or were terminated.

Their replacements so far include Pebbles Fagan, PhD, MPH, associate professor at the University of Hawaii Cancer Center; Gary Giovino, PhD, professor and chair of the department of community health and health behavior at the University of Buffalo; and Thomas Novotny, MD, MPH, professor and associate director for border and global health at San Diego State University Graduate School of Public Health.

Rosamond Rhodes, PhD, professor of medical education and director of bioethics education at the Icahn School of Medicine at Mount Sinai, in New York City, said that conflicts of interests have been demonstrated in multiple studies and are common in research fields.

“In medical centers, in places that have allowed drug representatives to provide pizza lunches or give out pens, the prescribing patterns are very different from institutions that don’t allow it,” Rhodes said.

And the psychological effects are “invisible” to the person who’s experiencing them.

But the people with expertise tend to be people with conflicts of interests, she said.

“The danger moving forward is if you keep making the conflicts of interest standards higher, you keep decreasing the pool of expertise that’s available to serve on these important committees. So you’re risking the scientific rigor on the one hand. On the other hand you’re risking biased judgment,” Rhodes said.

“The leadership of FDA tends to be, in my limited experience, very in tune to what the expertise needs are. So I’d be worried that perhaps this change has gone too far.”

Leon is the same judge who, in 2012, threw out an FDA requirement that cigarette packaging include graphic images of diseased lungs and other adverse impacts of smoking, and who prevented the FDA in 2009 from banning imports of e-cigarette devices as unapproved drug-delivery devices.

Wales passes smoking ban in cars

Smoking in a car where children are present will be made illegal in Wales after Assembly Members passed landmark legislation.

The new law will come into effect in less than four months’ time and could see those breaking it hit with a £50 fine or even a court appearance.

AMs ratified the Welsh Government policy this evening by a majority of 46 to 1 at a key vote in the Senedd.

Critics say the move is too heavy-handed and fear it could pave the way for banning smokers from lighting up in their own home.

But Health Minister Mark Drakeford said there was compelling evidence against the dangers of second hand smoke and the new law would help protect children’s health.

He said: “Some people believe that opening the window of a car will help disperse smoke but in reality it simply blows back in. It causes a real and substantial threat to children’s health.

“Children cannot escape from the toxic chemicals contained in second-hand smoke when travelling in cars. They often don’t have a choice over whether or not they travel in cars and may not feel able to ask an adult to stop smoking.

“As with the existing smoke-free regulations, success will not be based on the number of enforcement actions that are taken but by how behaviour, attitudes and health outcomes change over time.”

Legislation banning smoking in enclosed public places was introduced in Wales in 2007. However, while the law covered public and work vehicles it did not extend to private vehicles.

The new regulations will make it an offence to smoke in an enclosed private vehicle when more than one person is present, at least one of whom is under the age of 18, and for a driver to fail to prevent smoking in such circumstances.

The Labour-controlled Welsh Government believes legislation is necessary after its public health campaign Fresh Start Wales failed to produce the results officials had hoped for.

A spokesman said: “Results of research carried out during the campaign show the number of children exposed to second-hand smoke in cars decreased; but regrettably they also show there remains a cohort of adults who continue to smoke in vehicles when children are present with 17% of children from poorer families more likely to report that smoking was allowed in their car compared to 7% of those from more affluent families.”

Several health and children’s groups welcomed the new law.

Dr Mair Parry, Officer for Wales at the Royal College of Paediatrics and Child Health, said: “This is an historic vote and a victory for child health. There is growing medical evidence of the damage cigarette smoke can do to children – including asthma, chest infections, ear problems and cot death – and frighteningly smoke in cars can be up to 11 times more concentrated than in a smoky bar.”

The British Lung Foundation also described the move as “a tremendous victory” for the “thousands of children being exposed to second-hand smoke every week”.

However, while the overwhelming majority of AMs voted in favour of the legislation there was concern in the Siambr among some opposition AMs.

Welsh Liberal Democrat leader Kirsty Williams said the issue of “banning behaviour” was a complex one.

“At what point do we say that people cannot smoke in front of children within their own home?”, she added.

And party colleague Peter Black said he would not be voting in favour of the law.

Pro-smoking group Forest branded the new law as “heavy handed”.

A spokesman said: “The overwhelming majority of smokers know that smoking in cars is inconsiderate and don’t do it.

“Education has to be better than legislation but the government prefers gesture politics and the big stick.”

The ban will come into effect on October 1 – the same day similar measures are being implemented in England.

Joseph Carter, head of the British Lung Foundation in Wales, said: “Today’s vote marks a monumental triumph for children’s health in Wales. After years of campaigning on this issue, we are glad that common sense has prevailed and that, as of October 2015, children in Wales will no longer be subjected to toxic smoke in the small confines of a car.

“With almost half a million children being exposed to second-hand smoke in the family car every week in the UK, it is right that Wales is joining England in supporting such a ground-breaking public health measure. We now look to our neighbours in Scotland and Northern Ireland to offer their children this same protection.”

Fix fundamental TPP flaws to fit 21st century

SCARSDALE, NEW YORK – The Trans-Pacific Partnership negotiations have been hijacked by lobbyists from America’s biggest manufacturing and agribusiness corporations, Silicon Valley high-tech firms and Wall Street’s “too-big-to-fail” banks.

Under the TPP, Wall Street will be able to circumvent the U.S. government regulations that discourage the fraudulent financial games that bankrupted more than 15 million Americans in 2008. The TPP will let large pharmaceutical firms and Silicon Valley IT firms prolong their patent monopoly profits. Manufacturing firms will more freely send their jobs abroad. Large agribusiness will fatten its profits and small family farmers in the U.S. and abroad will suffer.

In 1993, under the North American Free Trade Agreement (NAFTA), a precursor to the TPP, American supermarket chains rushed into Mexico and pulled in the produce of American big agribusiness. Mexico’s small farmers lost their domestic markets to American supermarkets’ imports of American agribusiness produce. Displaced Mexican peasants became undocumented migrant workers in the United States. U.S. manufacturing firms moved over 1 million jobs to Mexico, widening the income gaps between the top 1 percent and the rest of American households.

The Trade Adjustment Assistance (TAA) that was touted as a boon to American workers’ job retraining turned out to be a meager “burial insurance” for the abandoned workers. There were no new jobs available for the retrained workers. The “job protection rules” of the TPP are no better.

The TPP will have an international tribunal of private attorneys outside any sovereign nation’s legal system. This tribunal will compensate multinational firms for “unjust expropriation” of their foreign assets and profits deemed lost due to a sovereign host nation’s laws. Philip Morris is already claiming that Uruguay’s anti-smoking regulations have diminished its profits.

Under the TPP, global corporations will challenge any host government’s regulations and laws protecting consumers from unsafe products or unhealthy foods, investors from fraudulent securities or predatory lending, or the environment from toxic emissions.

The TPP promoters are using an obsolete 19th-century trade theory concocted by David Ricardo. He was a wealthy merchant in the British parliament and represented the rising industrialist class against the traditional landed gentry. Britain protected English wheat from cheaper French grains. The landed gentry wanted to continue the protectionism, but the industrialists wished to keep their wage payments low by importing cheaper French wheat.

To show the benefits of “free trade,” Ricardo argued, with an unrealistic numerical example, that even if Britain could produce both cotton and wine more cheaply than Portugal, both nations would benefit economically if Britain specialized in cotton and Portugal in wine and exchanged mutually their production surplus.

Immediately, an astute opponent replied, “Ricardo’s theory is relevant perhaps only to the man who was suddenly planted on a different planet where no ignorance, no restriction of trade, no taxes, no idle workers and no individual rivalry existed.”

In the 21st century, the three ingredients of a nation’s economic growth — namely capital, technology and information — travel around the globe at the speed of light. Wall Street’s financial economy is increasingly separated from the real economy and is destroying manufacturing jobs. Tax cuts to the wealthy and big business simply fuel their financial games. Import tariffs are already low. The international flows of manufacturing are determined by technological innovation, quality of labor, taxation systems, fluctuating rates of currencies, the natural environment, management attitude toward labor, labor laws and industrial policies, and quality of social infrastructure.

President Barack Obama says the TPP would help export U.S. cars to Japan. However, Japanese drivers are not buying American cars because of high tariffs or import quotas. Rather, they’re seen as too big for narrow Japanese roads and their quality and dealer services are considered inferior.

On the other hand, Obama’s rescue of Detroit was a resounding success only because Ford, GM and Chrysler emulated Toyota’s manufacturing skill and customer service. American import quotas on Japanese automobiles persuaded Japanese auto and parts manufacturers to make their products in the U.S. and train American labor to become just as productive and quality conscious as their Japanese counterparts. Japanese auto plants in America are exporting their products to Asia. Selective “protectionism” is necessary to protect labor, technological innovation and manufacturing skill of a nation’s strategic industry.

The emerging TPP is fundamentally flawed because its U.S. negotiation processes have excluded labor, environmentalist and citizens’ groups, and because its primary framework is the destructive private tribunal.

Furthermore, its hidden agenda is to contain China, the second largest economy of the world. But without China’s membership in the TPP, the trade and navigation route from the South China Sea to Northeast Asia — Japan, Taiwan and South Korea — will be exposed to China’s “saber-rattling.”

As shown by U.S.-China cooperation over global warming problems, the TPP must be built on the tripartite cooperation of the U.S., China and Japan. This framework would finally help Prime Minister Shinzo Abe acknowledge Imperial Japan’s wartime atrocities and reset its relations with China and South Korea. Then, the new TPP should be crafted to help the U.S. rebuild its manufacturing skill, employment and social infrastructure, and to help Japan modernize its agricultural sector.

California Senate votes to raise smoking age to 21 from 18

(Reuters) – The California Senate voted on Tuesday to raise the legal smoking age in the most populous U.S. state to 21 from 18, the bill’ author said,

If it becomes law, the bill, which must still be approved by the state Assembly, would make California one of the first states to approve a higher smoking age.

The California Senate voted 26-8 in favor of the measure, the office of bill author Senator Ed Hernandez, a Democrat, said in a statement.

“We will not sit on the sidelines while big tobacco markets to our kids and gets another generation of young people hooked on a product that will ultimately kill them,” Hernandez said in a statement. “Tobacco companies know that people are more likely to become addicted to smoking if they start at a young age.”

A representative for Philip Morris USA, the tobacco company division of Altria Group Inc, could not be reached for comment.

Hawaii lawmakers approved a measure in April to raise the smoking age to 21, and that is awaiting the state governor’s signature. No other state has a smoking age that high, but a few including Alabama and Utah set it at 19.

(Reporting by Alex Dobuzinskis and Cynthia Johnston; Editing by Sandra Maler)