Prof. Sheizaf Rafaeli

University of Haifa

 Digital Culture/Clutter 

 

This talk outlines the disruptions, both positive and negative, that are brought about by our immersion in the digital. The scope and depth of aspects of impacted individual and collective activities, range from our privacy to our education, and from our livelihood to our security. One can form dystopian or utopian views of the direction in which we are marching. This talk aims to inform the discussion.

 

Written by  Read 17833492 times Last modified on Friday, 27 December 2019 00:25
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    By Toni Clarke

    WASHINGTON, Jan 22 (Reuters) - In a decision expected to test the Trump administration's approach to tobacco regulation,
    U.S. health advisers will vote this week on whether to allow Philip Morris International Inc to sell its novel iQOS
    tobacco device and claim it is less harmful than cigarettes.


    The sleekly packaged little tube would not look out of place in an Apple store.
    It is designed to heat tobacco but not burn it. Most of
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    The advisers to the Food and Drug Administration will discuss the product on Wednesday and
    Thursday and recommend whether it should be cleared. The FDA is not obliged to follow the recommendations of its outside advisers
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    disease. National smoking rates have declined to near
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    But in July, newly appointed FDA Commissioner Scott Gottlieb proposed reducing
    nicotine levels in cigarettes to "non-addictive" levels while increasing development of
    lower-risk alternatives. The policy assumes that some percentage of the population will be unable or unwilling
    to give up nicotine.

    To make the new strategy succeed, the agency needs a stable
    of vetted, reduced-risk alternatives to cigarettes on the market.

    Philip Morris is one of the few companies that can finance such a long and expensive development process.

    It has spent close to $3 billion on reduced-risk
    products.

    "If this application fails, it will be clear that this is an expensive, wasteful, regulatory dead end," said Clive Bates, a tobacco expert who runs
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    Bates and others argue that if Philip Morris cannot win FDA
    clearance for a modified-risk product, no one will be able to.



    Other companies have submitted modified-risk
    products for FDA review. 22nd Century Group Inc, which
    genetically engineers tobacco plants to have lower nicotine levels, seeks clearance
    for its "Brand A" very low nicotine cigarettes. R.J. Reynolds Tobacco Co, owned by British American Tobacco
    Plc , is seeking clearance for six snus products - a
    moist smokeless tobacco pouch placed under the lip
    - under the Camel brand. (For a graphic on market share of
    smokeless tobacco and vapor products, see: website

    THE CLAIM

    IQOS is used by nearly 4 million people in 30 markets outside the United States.
    It consists of a small pen-like holder containing a heated
    tobacco stick, and a charger. It looks similar to an e-cigarette, but uses real tobacco rather than nicotine-laced liquid.


    Philip Morris says that iQOS contains up to 95 percent fewer harmful or potentially harmful chemicals than the cigarette smoke produced from burning
    tobacco. If approved, the product would be marketed by U.S.

    partner Altria Group Inc.

    The hurdles for success are high.

    To sell a new tobacco product, a company must demonstrate
    that it significantly reduces the risk of disease and does not encourage more
    smoking or delay quitting.

    To date, the FDA has determined that only eight products meet that standard, all of them snus
    smokeless tobacco pouches made by Swedish Match AB. The agency has
    granted no company the right to specifically claim that their product is less risky than cigarettes.


    Tobacco control activists say companies like Philip Morris cannot be trusted to make reduced-risk
    claims. They point to the industry's previous promotion of "light" and "low-tar"
    cigarettes as safer alternatives despite evidence showing they were not.


    Others argue that things have changed. Since 2009, the tobacco industry has had to answer to the FDA under federal law.
    New technology, including e-cigarettes and heat-not-burn products,
    may help smokers quit or shift those who cannot quit onto a less harmful substitute, they say.



    "Many of my friends in the tobacco control movement are still fighting the tobacco wars of the 1980s," said Scott Ballin, an independent
    health policy consultant and long-time anti-tobacco activist.
    "We are beyond that now."

    The FDA's Gottlieb favors an approach to treating addiction that makes available less harmful versions of addictive
    substances, including nicotine and opioids. These products, he argues,
    can help minimize damage to those unable to quit.

    Mitch Zeller, head of the FDA's tobacco division, refers frequently to a "continuum of risk" for nicotine products,
    with nicotine gums and lozenges on one end
    and cigarettes on the other. The FDA would like to shift smokers unable to quit nicotine from high-risk to low-risk products.


    "What we have developed is an offering on the continuum of risk," said
    Ruth Dempsey, Philip Morris' director of scientific engagement.
    "We believe it is better than cigarettes."

    (Reporting by Toni Clarke; Editing by Michele Gershberg and
    Matthew Lewis)

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    Andone, Dakin; Silverman, Hollie (December 25, 2020).

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