In article
..net,
William Wagner wrote:
In article , Charlie wrote:
On Fri, 22 Jun 2007 12:57:17 -0400, William Wagner
wrote:
Gives new meaning to grow our own.
Bill who shakes his head when Food laws exist.
http://preview.tinyurl.com/2vmowr
PS Soylent Green
from: http://www.straightgoods.ca/ViewFeature7.cfm?REF=328
Imposters shock oil conference
"Yes Men" propose burning humanity as "vivoleum" fuel in case of
climate calamity.
Charlie
Life imitates art comes to mind.
Ok Ok I'm going to grow horse corn but just leave me and my Dad alone.
We have so many impurities that the distilling process would not be
economical.
Ah a real strawberry
Juice and smell
Smooth yet rough
Taste that speaks of summer.
Bill
Sail On Sail On Beach Boys
Bill
Stolen from those folks over in SMC.
......................
Oxymoron department: Wall Street Journal -- "Phillip Morris Gears Up For
FDA Regulation: Using Science, It Tries To Prove Its Products Can Be
Lower-Risk"
*More options Jun 21, 3:14*pm
RICHMOND, Va. -- At a research park that's home to several biotech
companies, a $350 million facility under construction will soon house
hundreds of researchers. But instead of testing lifesaving medicines,
these scientists will be focused on a product that kills an estimated
438,000 Americans a year.
The facility, due to open in August, is owned by Philip Morris USA,
the nation's biggest tobacco company. The Altria Group Inc. unit is
preparing for a tectonic change -- regulation of tobacco by the Food
and Drug Administration. With Democrats in charge of Congress, the
long-debated step appears more likely than ever. A Senate bill is
expected to clear a key committee next month, and companion
legislation has been introduced in the House.
Both bills would give the FDA broad sway over tobacco products,
including the power to set product standards, which could include
limiting certain ingredients in cigarettes. Tobacco makers, whose
products have been largely unregulated, would have to turn over to the
agency extensive information about their products.
The bills also dangle a potentially lucrative opportunity. They say
that if a new kind of cigarette can be scientifically proven to
"significantly reduce harm" to smokers -- and its availability would
also benefit the health of "the population as a whole" -- the
cigarette's marketing claims may win approval from the FDA.
The legislation, which is backed by longtime tobacco-industry critics
Rep. Henry Waxman of California and Sen. Edward Kennedy of
Massachusetts, has won wide support from public-health advocates. But
many advocates warn that the FDA needs to be very careful about
allowing any health-related marketing. "We must be extremely wary of
claims made by manufacturers," says Kenneth Warner, dean of the
University of Michigan School of Public Health. Dr. Warner serves on a
Pfizer Inc. advisory board that examines tobacco policy issues, and
turns the honorarium over to his university. Pfizer makes the smoking-
cessation drug Chantix.
Philip Morris, which is working on a slew of new products it hopes
might qualify for FDA-approved health claims, acknowledges it must
transform itself into a credible player in the expected scientific
debates at the FDA. So the company is trying to emulate an industry
already under the agency's purview -- the drug companies.
The company has a number of highly engineered products in the works,
all of which are designed to possibly reduce tobacco's dangers. Among
them: Marlboro Ultra Smooth, a cigarette with a high-technology carbon
filter; Accord, which uses a holder to primarily heat, rather than
burn, tobacco; and snus, a line of "spit-free" smokeless tobacco
products. So far, the products aren't selling well in test markets,
Philip Morris confirms, possibly because they aren't being pitched as
having any health advantages. Philip Morris hasn't announced when, or
if, any of them might be sold nationally.
Analysts say the effort is consuming about half of the estimated $200
million Philip Morris spends on research and development each year.
Philip Morris scientists are conducting human studies, presenting
results at research conferences and publishing findings in scientific
journals such as the Journal of Clinical Pharmacology.
To staff its 450,000-square-foot research center, its biggest
investment in two decades, Philip Morris is trying to recruit dozens
of physicians, biochemists, and other scientists. And in the same way
that pharmaceutical companies pay top researchers to lead drug studies
and speak about their findings to regulators and other scientists, the
tobacco maker is trying to forge relationships with outside experts
who might support Philip Morris's research efforts.
The company faces immense technical hurdles in its quest to develop an
FDA-approved lower-risk cigarette. Scientists say there aren't proven
measures that would allow Philip Morris to verify that any new kind of
tobacco product is less likely to cause cancer or heart disease.
Cigarette smoke contains thousands of different components, many of
which are known to be toxic. And testing a cigarette is far different
from testing a cholesterol drug.
A big problem for Philip Morris may be its reputation. For many years,
tobacco companies denied the health risks of their products, quietly
funding research that ran counter to scientific opinion. They peddled
"light" cigarettes with implied health benefits when, under real-world
conditions, the products were generally no safer than standard smokes.
As a result, Philip Morris faces many deeply suspicious public-health
experts. Many of them believe its efforts are at best, empty public-
relations gestures and at worst, manipulative.
"The industry has no credibility with the scientific community and the
FDA," says David Kessler, a former FDA commissioner whose efforts in
the 1990s to regulate tobacco were struck down by the Supreme Court.
If there are to be reduced-risk tobacco standards, he says, "the
opinion leaders that are going to develop the science are not going to
be the tobacco industry." Dr. Kessler says he has made tobacco-policy
speeches in the past and accepted honoraria from pharmaceutical
companies that make smoking-cessation products.
While they have been reaching out to outside scientists and medical
researchers who can review their own reduced-harm product research,
Philip Morris's rivals haven't done as much to ready themselves for
regulation. In the eyes of some Wall Street analysts, Philip Morris's
efforts are a gamble. Not only might the bills fail to become law, but
it might be decades before cigarette makers are able to amass enough
scientific data for reduced-risk products to pass muster with the FDA.
Philip Morris is "making a sizeable and substantial investment,
particularly versus the outlay of their peers," says David Adelman,
Morgan Stanley's tobacco analyst. The risk, he adds, is that the
company's newfangled products flop, and "the time, energy and
resources have been wasted."
Philip Morris says it has no choice but to pursue its high-risk
strategy. Last year, it sold an estimated 183.4 billion cigarettes --
roughly one of every two smoked in America. But per-capita adult
cigarette consumption plummeted 19% between 2001 and 2006, according
to the U.S. Department of Agriculture. "We're doing this because we
think it's in the interest of our business," says John R. Nelson,
president of operations and technology at Philip Morris USA.
The company began beefing up its research operations around 2000. At
first, the work was mostly done through outside contractors. "It was
an infrastructure that we had never done, and really didn't exist" at
Philip Morris, says Jane Y. Lewis, vice president of product
assessment at Philip Morris USA.
One challenge for the company was designing the human studies it would
need to satisfy health agencies. Since it would be unethical to force
cigarettes on study participants who elect to quit, Philip Morris
officials say they pay people fully for their time, even if
participants decide to stop smoking halfway through a trial. Because
certain results can be blurred by the food subjects eat, company
researchers have also begun studies in which smokers stay in a
facility for a period of time. That way, Philip Morris researchers can
control and monitor subjects' diets.
Another reason to have smokers stay at a facility -- the new research
center will have roughly 30 beds, so smokers can spend the night -- is
that Philip Morris researchers are able to control the number of
cigarettes subjects smoke in a day, Ms. Lewis says. Still, she notes,
"we don't control how they smoke." The way smokers puff, or even how
they hold a cigarette, can affect how much nicotine and other toxins
they consume.
For one prototype of Accord, which uses a battery-operated holder to
heat the tobacco, the company ran short-term studies in humans
beginning in 2001. It also followed consumers for as long as a year.
In 2002, Philip Morris started an ambitious, yearlong examination of
American smokers, the Total Exposure Study, to help answer questions
about the effects of cigarettes. The study eventually involved 4,662
people at about 40 sites across the U.S. Scientists gathered data
about more than a dozen measures that might reveal the impact of
exposure to cigarette smoke.
Smokers had their blood checked for the presence of carbon monoxide
and markers that signal heart risk, such as cholesterol and a protein
that is a sign of inflammation. Urine was tested for an array of
chemicals that might be signs of cancer-causing substances.
These data could eventually serve as a baseline, giving a picture of
what measures best highlight the differences between a smoker's body
and a nonsmoker's body, company officials say.
Many public-health researchers, while conceding that the research
could prove useful, say they're wary of furthering Philip Morris's
agenda. They also fear the peddling of a "safer" cigarette could
discourage smokers from quitting, ultimately the safest option.
Tobacco companies "have a long and successful track record of
subverting people in public health," says David Burns, a professor at
the University of California, San Diego, who has testified against
tobacco companies in court and says he refused an invitation from
Philip Morris to apply for research grants. "We have to be very
careful that we maintain both objectivity and independence."
Philip Morris's Mr. Nelson says the company is committed to trying to
work with researchers who have opposed it. "Some of our critics have a
lot of constructive things to say, some are a little shrill, but we
listen, and we talk," he says.
One of the company's efforts -- hiring the Life Sciences Research
Office in Bethesda, Md. -- has already sparked controversy. A
nonprofit founded to conduct research for the Army, it has done work
under contract for the FDA, as well as such projects as weighing the
evidence of walnuts' health benefits for a group of walnut growers.
In 2004, Life Sciences began a Philip Morris project that focused on
reviewing research from tobacco companies and others related to
potential reduced-risk products, with the goal of figuring out what
evidence was needed to prove reduced-risk claims. The nonprofit says
it reached out to about 1,000 scientists and organizations, seeking
recommendations on what questions to address and who might serve on
panels that would conduct the review. It also invited scientists to
submit research and participate in meetings.
Some tobacco-industry opponents informally boycotted the process,
declining invitations to join the Philip Morris-funded scientific
panel or speak to the group. "I'm not going to lend my name to the
perception and credibility of the company," says Mitch Zeller, an FDA
official under Dr. Kessler who says he declined to participate in the
nonprofit's work. Mr. Zeller consults for drug maker GlaxoSmithKline
PLC on its smoking-cessation products.
Some "of these folks just don't want to participate in company-funded
projects," says Philip Morris's Mr. Nelson, adding the organization's
work was transparent and independent.
Life Sciences' findings, issued in April, appear to be a win for
Philip Morris. The organization's main outside panel concluded that
it's possible to generate data to "assess differences in risks of
adverse health effects" between tobacco products. It endorsed the idea
of reduced-risk claims, arguing that information about potentially
safer products is being withheld from the public. The choice may be
whether "some good is better than none at all," the report says.
The conclusion clashes with views of a number of public-health
researchers, who say the science isn't developed enough to justify
reduced-risk claims for tobacco products.
Earlier this month, two University of California-San Francisco
researchers published a paper in Tobacco Control, an antitobacco
journal, accusing Life Sciences of downplaying or concealing its "true
level of involvement" with the tobacco giant. It warned that Life
Sciences may not be fully independent, saying that some members of the
nonprofit's outside panels have had financial relationships with
tobacco companies.
"Anytime you come out with a conclusion that someone doesn't agree
with, the whole process is called into question," says Michael Falk,
Life Sciences' executive director. Dr. Falk says the nonprofit's
process was transparent, and that it didn't find professional or
scientific conflicts of interest among the people it allowed on the
tobacco review panels. A spokesman for Philip Morris said it is still
reviewing the results of Life Sciences' report.
With its new research center a few weeks away from completion, Philip
Morris is trying to persuade scientists with a range of backgrounds,
including pharmacologists and neurologists, to join the staff of a
tobacco company. Mr. Nelson says the facilities will have labs and
offices for at least 300 scientists and engineers. "We're still
looking around to hire people," he notes.
In August, the company launched a careers Web site intended to attract
potential applicants. The site has a link to an artist's rendering of
the completed center, alongside photos and testimonials from current
employees.
On the Web site, physician Barbara Zedler says that "to work on
projects that may potentially reduce the health risks associated with
smoking is both challenging and exciting," and the company is "eager
for us to succeed." She conducts studies of Philip Morris products on
smokers. Another testimonial, from "Kimberly," a molecular biologist,
says "going to work for a tobacco company was a total leap for me."
But, the text says, she believes her work "has the potential to
positively impact public health."
Write to Anna Wilde Mathews at and Vanessa
O'Connell at
* * *
Tobacco Control 2007;16:157-164; doi:10.1136/tc.2006.017186
Old ways, new means: tobacco industry funding of academic and private
sector scientists since the Master Settlement Agreement
Suzaynn F Schick and Stanton A Glantz
Center for Tobacco Control Research and Education, University of
California San Francisco, San Francisco, California, USA
ABSTRACT
When, as a condition of the Master Settlement Agreement (MSA) in 1998,
US tobacco companies disbanded the Council for Tobacco Research and
the Center for Indoor Air Research, they lost a vital connection to
scientists in academia and the private sector. The aim of this paper
was to investigate two new research projects funded by US tobacco
companies by analysis of internal tobacco industry documents now
available at the University of California San Francisco (San
Francisco, California, USA) Legacy tobacco documents library, other
websites and the open scientific literature. Since the MSA, individual
US tobacco companies have replaced their industry-wide collaborative
granting organisations with new, individual research programmes.
Philip Morris has funded a directed research project through the non-
profit Life Sciences Research Office, and British American Tobacco and
its US subsidiary Brown and Williamson have funded the non-profit
Institute for Science and Health. Both of these organisations have
downplayed or concealed their true level of involvement with the
tobacco industry. Both organisations have key members with significant
and long-standing financial relationships with the tobacco industry.
Regulatory officials and policy makers need to be aware that the
studies these groups publish may not be as independent as they seem.
* * *
Presentations Philip Morris made to Life Sciences Research Office in
2005 as it was preparing for a project to measure risk reduction.
Includes details on the company's Total Exposure Study of risks to
adult U.S. smokers.
http://www.lsro.org/rrrvw/meetings/c...entations.html
--
S Jersey USA Zone 5 Shade
http://www.ocutech.com/ High tech Vison aid
This article is posted under fair use rules in accordance with
Title 17 U.S.C. Section 107, and is strictly for the educational
and informative purposes. This material is distributed without profit.