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TOBACCO OUTLET BUSINESS
JULY/AUGUST 2012
The Wrong Side
of History—Part 2
PUBLISHER’S LETTER
BY ed o’connor
In the January/February issue of the
TOB
publisher’s letter we
spoke to the absurdity of the FDA’s position concerning their
apparent opposition to so-called “harm reduction” products.
Using the FDA characterization “Modified Risk Tobacco
Products” (MRTP), their oppositiondirected towardelectronic
cigarettes, but encompassed all “tobacco” harm reduction
candidates. FDA’s position contravenes what leading public
health tobacco experts conclude. Paraphrasing Dr. Joel
Nitzken, President of the American Association of Health
Care Physicians, at the 2011 Tobacco Merchants Association
(TMA) meeting, “Smoking carrots would likely have the same
deleterious effect on health as smoking tobacco.” It’s not
the tobacco, it’s the smoke, which the FDA either won’t or
can’t acknowledge as the primary health culprit. The agency
is steadfast on their qualification protocols, running the risk
that they will likely find themselves “on the wrong side of
history,” all the while compromising agency credibility on
issues they have been charged to oversee and resolve.
The best evidence of the FDA’s utter disdain for tobacco
and the health benefits offered by MRTP products is
demonstrated in the qualification parameters required to
secure FDA approval as a tobacco product offering reduced
smoking hazards. Dr. Michael Siegel of Boston University’s
Public Health Department spoke to the myths related to FDA
MRTP qualification at the TMA’s annual conference in May.
Here’s an example of what he presented: “Myth 1: MRTP
provision, as implemented by the FDA guidance, will serve
primarily to prevent false claims by tobacco companies
about the hazards of their products.” Dr. Siegel’s response to
this alleged myth: “The MRTP provisions serve primarily to
prevent MRTPs from reaching the market.” Again, Dr. Siegel:
• “MRTP provisions are not necessary to prevent false
claims by tobacco companies about the hazards of their
products.”
• “MRTP provisions put a nearly insurmountable barrier
in front of the introduction and successful marketing of truly
modified risk products.”
“The irony…It’s business as usual for the most harmful of
the range of tobacco products on the market” while nearly
impossible standards prevent the introduction of “what
might be much safer products.” What’s wrong with this
picture?
FDA intransigence on MRTP calls the “why” into question.
Is it a desire to punish an industry for past “sins?” Is it their
goal to fulfill an attack-dog role? Is it a personal vendetta
by senior FDA officials toward the industry? Is it a catch-22
deriving from the language of the tobacco bill itself? Is it all
or none of these? It is certain that the FDA’s MRTP method of
operation is not in the larger interests of public health.
Was the FDA motivated to fulfill its responsibility as
a
, not
the
, guardian of the public’s health and if the motivation for
the position it has taken on MRTP is truly not motivated by
a clandestine mind-set, it would act on the preponderance
of the evidence by setting aside the requirement for rigid
scientific scrutiny, for which there is neither a cost effective
methodology nor certain outcome even if there were.
Recall, if you will, the Kobayashi-Maru Test in the fictional
Star Trek
universe, an unsolvable Gordian knot administered
to all Starfleet command candidates as a test of character.
James T. Kirk, aka Captain Kirk, received a commendation for
being the only candidate to ever resolve the unsolvable. He
changed the conditions of the test by rewiring the computer.
Given the MRTP dilemma, resolution of our industry’s
Gordian knot requires open, good faith dialogue between
our industry and the FDA. Given FDA pronouncements to
date, I, for one, regrettably have my doubts that this can
occur. I am certain, however, the lessons gleaned from
the Kobayashi-Maru demand that in the interests of public
health, we change the conditions of the test.