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By Emily P. Walker, Special toTHE CHRONICLE OF HEALTHCARE MARKETING
ANEW US FDA USER-FEE PROGRAM
will require g eneric dr ugmakers topay annual fees to increase inspec-
tions of foreign manufacturing plants.
The proposed deal, first re ported by
theNew York Times, will see generic drug-
makers paying the FDA US$299 million a
year to suppor t inspections of foreign
plants, to be conducted ev ery two years.
(All figures are cited in US dollars.)
The agency has been in neg otiations
with the generic drug industry since early
this year to establish a user -fee prog ram
similar to the ones that exist for brand-
name drugs and for medical devices.About 80 per cent of all ingredients
in drugs sold in the US are manufactured
abroad, according to the FDA.
INDUSTRY TURNED ON ITS EAR
Historically, the g eneric dr ug industr y,
which makes about two-thirds of all pre-
scription medications used in the US , has
resisted pa ying user -fees. Decades ag o,
generic drug companies were largely mom
and pop shops.
But the industr y w as tur ned on its
head in the mid-1980s with the passage of
the Hatch-Waxman law that establishedan appro val pathw ay for g eneric dr ugs.
The generic drug industry ballooned from
MMXI,Allrightsreserved.
ChronicleI/RLtd.
Publicatio
nsMailAgreementNo.
40016917
M a r k e t i n g
Target likelyadopters ofnew therapies
n If no progress madewith one doctor, odds
are rep should move
on to other physicians
By Louise Gagnon,of THE CHRONICLE OF HEALTHCARE MARKETING
IN A CHANGING LANDSCAPE, SALES rep-
resentatives need to more effecti vely
target physicians who are likely to be
adopters of new therapies , according to
a panel at the conference R edefining
Pharma Marketing in Toronto.
Mark Beaudet, co-founder and
veepee of sales and marketing atPaladin Labs Inc ., said his company
decided to tak e a closer look at the
impact that the company s sales force
was ha ving on business and assess if
the sales re presentatives w ere actually
producing any effect on the regular pre-
scription of medications.
They sur veyed 6,000 ph ysicians
and examined their prescribing patterns
from the launch of a drug to up to 12
months after the launch.
We found that 75 per cent of physi-
cians wrote their f irst prescription with-
out ever being called on by a sales repre-
sentative, said Beaudet. This called into
question how we do our business.Theres a belief that you will g et
more share amongst doctors y ou call
O v e r s i g h t
In the US, generics will pay new fees toincrease inspections of foreign plantsn Up to 80% of ingredients in drugs sold in US manufactured abroad, FDA says
Turn to Target, page 11Turn to Generics, page 8
ANNUAL SPECIAL REPORT ON HEALTHCARE AGENCIES: Find a way to adapt to changing times, or disappear 4
MY TURN: A Toronto pediatrician says our healthcare system is failing our children 14
E-MARKETING IN 2011: Definitely not in the infancy stage anymore, analysts agree 7
$7.95 September 30, 2011 Covering Canadian and Global Pharmaceutical Economics www.pharmacongress.info
Build your brand with breakthrough thinking from Canadas Health & Lifestyle Agency. Call Kevin Brady at 416-960-3830.
Toronto Montreal www.andersonddb.com
Aerius sponsors
allergy clinics onQuebec streets
Mobile clinicsoffered allergistconsultations toshoppers in Laval and St-
Bruno, Que., from Aug.
4th to 21st. Interested
passers-by were given an
opportnity to meet an
allergist on site, and to
receive information and
product samples. The pro-
gram was sponsored by
Merck Canada..
Inside this issue:Your Autumn 2011 edition of
Drug Rep Chroniclefeaturing reports on
the future of thepharmaceutical representative
-
8/3/2019 The Chronicle of Healthcare Marketing ~ 08-11
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CELLS
The basic structural unitof all life was discoveredby examining a sectionof cork with a crudemicroscope. Englishscientist Robert Hookenamed the small chamberscells in 1655.
VITAMINS
An 18th century naval surgeon discovered thatlimes cured scurvy, a disease that killed moreBritish sailors than wars.
PENICILLIN
1928, a simpletwist of fate led Sir
Alexander Flemingto observe mould ina Petri dish that waskilling staphylococci,and we had the firstantibiotic.
ANTISEPTICS
Carbolic acid had been around for years, but in1869 Joseph Lister dipped his surgical instruments
in it and reduced deaths by half.
GENETICS
In 1865, anAugustinian monkdiscovered thatphysical traits arepassed from parentto offspringthrough simple
experiments withpea plants.
CAUSEOF MALARIA
It was killing millions,but in 1897 a British doctor
in India came across howit spreads by finding malaria
parasites while dissecting a mosquito.
TO P T E N S I M P L E M E D I C A L
D ISCOVER I ES THAT CHANGED
T H E WO RL D.MORPHINE
The first recordedmedical use ofopium was 200BC. In 1803, aGerman pharmacistisolated morphine
and gave theworld of medicineits most significantpain and anxietyreliever.
IMMUNIZATION
1880, Pasteur discovered by a simple accident thatanthrax bacteria cultivated at high heat lost it svirulence after a few generations.Later, animals inoculated withthese enfeebled bacteriashowed resistance to thedisease.
ASPIRIN
The ancient Greeks knew about it, so did NorthAmerican Indians: willow. Rich in salicin, a pain
and fever reliever, it was synthesized as ASAin 1897.
ANATOMY
A simple leap from dissecting apes tohuman cadavers led a Flemish physician
to the first true look at the structure of thehuman body in 1543.
SCIENCEPHOTOL
IBRARY
4th in series
A SIMPLE AD YOU MAY HAVE MISSED.Firs t appeared in The Chronic le of Heal thcare Marketing December, 2007.
-
8/3/2019 The Chronicle of Healthcare Marketing ~ 08-11
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Some things only become obvious in
the rear-view mirror, and for MERCKs
one-time kingpin Ray Gilmartin, the
big revelations about capitalism didnt reveal themselves until after
his retirement. Now that hes finally got some spare t ime for con-
templation, Gils reached the conclusion that larg e corporations
have been placing way too much emphasis on maximizing share-
holder value and not enough on generating value for society.
Moreover, he says, writing in his blog on the Harvard Business Review
web site, It seems as though CEOs are recognized and rewarded
handsomely for downsizing and outsourcing, acquiring or merging,
and making the quarterall justified by the responsibility to maxi-
mize shareholder value. Any of these actions can be necessar y in
certain circumstances; most of us have taken one or another. My
concern is that these a ctions have become the standard by which
CEOs are expected to manage.
TEVAs $6.8 billion takeover ofCephalon may have hit a snag, after
allegations by U.S. officials that Ceph engaged in off-label promotion
of bendamustine (Treanda.) Cephalon is no stranger to the courts,
having coughed up US$425 million to settle previous c harges of off-
label marketing in 2008. A spokesman for Teva declined to comment
on the matter. n Not playing favorites, stateside G-men also tight-
ened the dragnet around MERCK, investigating the companys pro-
motion of oncology Rx temozolomide (Temodar) and interferonformulations PegIntron and Intron A, both he patitis C Txs. The
brands were acquired by Merck in their 2009 acquisition of
Schering-Plough.
Its no secret that Big Pharmas growth is occurring in the devel-
oping markets, but a new report from Ernst & Young illustrates
the extent of the trend. The study says the contribution of emerg-
ing markets to the growth of global pharma market increased five-
fold, between 2003 and last year, to 40 per cent from 8 per
cent. India and China will both crac k the worlds 10
leading Rx markets by 2015, the researchers say, with
Brazil, Russia, Venezuela, Turkey and Korea also grow-
ing quickly. n CARDINAL HEALTH, the Rx whole-
saler, says it will shop for further acquisitions in
China, following last years $60 million purchase ofZuellig Pharm China.
Stateside drugmakers are still t wo years away
from new requirements that will pub-
licly disclose all honoraria, gifts and
speakers payments to physicians, but
early information is already finding its
way to the Internet. The website
http://projects.propublica. -
org/doc dollars/ now maintains an open database of payments to
MDs by 12 Rx- and device-makers, along with this invitation to
patients: Is this your doctor? Wed like to hear from you.
Information ranges from the picayune (Dr. Syed Ali Abutalib of
Zion, Illinois was treated to $268 worth of dinners byPFIZERlast
year) to the somewhat eyebrow-raising news that a half-dozen docs
at Chicagos Rush University Medical Center each collected more
than $100,000 in Big Phar ma munificence. Hospital officials tell the
Chicago Tribunetheir policies toward physician acceptance of speak-
ing fees will change as a result of the information becoming public.
If you were going to appoint a new hire to the office of Chief
Strategy Officer, he might earn the nickname Mr. Do, after the
popular 80s video game where a joystick-propelled can-do figure
manoeuvred his way through a maze. However, MERCKs new CSO,
who arrives on the job Oct. 3, is con veniently already named Cuong
Viet Do, which will make his success in the position a cer tainty. He
held previous poitions with Lenovo Group and the McKinsey consul-
tancy. He replaces Mervyn Turner, a 26-year Merck hand who just
retired.
Canadas federal government, and provincial solons in BritishColumbia are attempting two new tactics aimed at encouraging smok-
ing cessation. B.C. plans to offer a carrot, providing free nicotine-
replacement Txs, while Ottawa will provide the stick, in the form of
gruesome images that will depict the effects of cigarette smoking.
The new labelling will require that 75 per cent of cigarette packages
display a warning, some of which will feature a disturbing near-death
photo of anti-smoking advocate Barb Tarbox. Ms. Tarbox died of
lung Ca at age 42. The new packages are coming to a convenience
store near you by Q1 of next year.
New drugs are less risky than older products? Thats what many
seem to believe, based on a recent study of 3,000 adults just pub-
lished in Archives of Internal Medicine. Said Dr. Michael Steinman
of San Francisco, author of a commentary in the journal:
One of the reasons doctors tend to prescribe newer, expen-sive drugs is theres a widespread percep-
tion that newer is better. Thats some-
times true, but many times its not true.
So much of what doctors learn about
new drugs is somehow affected by drug
company marketing.
The Chronicle of Healthcare Marketing September 30, 2011 3
Active immunizing agent 08-16Recombinant human papillo-
mavirus type 16, type 18 L1
protein (Cervarix,GlaxoSmithKline Inc.)
Comments: Product mono-graph revised, 20 G/0.5ML
Type I and II alpha-reductaseinhibitor and alpha-adreno-receptor antagonist 08-15
Tamsulosin hydrochloride 0.4
MG/CAP/Dutasteride 0.5
MG/CAP (Jalyn, GlaxoSmith-Kline) Comments: oral cap
Hypothyroidism therapy 08-12Liothyronine sodium (Cytomel,
Pfizer Canada Inc.)
Comments: 5 G/TAB, 25
G/TAB
Antibiotic 08-12
Penicillin G benzathine (Bicillin
L-A, Pfizer Canada Inc.)Comments: 1200000
UNIT/2ML
Antiviral agent 08-11
Ribavirin, boceprevir, peginter-
feron alfa-2B (Victrelis Triple,Merck Canada Inc.)
Comments: ribavirin 200
MG/CAP, boceprevir 200
MG/CAP, peginterferon alfa-2B 80
G/0.5ML; ribavirin 200
MG/CAP, boceprevir 200
MG/CAP, peginterferon alfa-2B
100 G/0.5ML; ribavirin 200MG/CAP, boceprevir 200
MG/CAP, peginterferon alfa-2B
120 G/0.5ML; ribavirin 200
MG/CAP, boceprevir 200
MG/CAP, peginterferon alfa-2B
150 G/0.5ML
Healthcare, Inc.
Turn to NOCs page 12
N O C s o f N o t e :
August 31, 2011
Significant TTP approvals
of Rxs for human use
O u t t h e r eWhats happening in drug marketing
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The impacts of these events on phar-
mas and their suppliers w ere widespread,
and contin ue toda yMerck recently
announced it would furlough 13,000 glob-
al employees between now and 2015and
healthcare communications ag encies w ere
not spared.
Its been c hallenging o ver the last
decade, admits K evin Brady, head hon-
cho at Anderson DDB, Toronto. The lat-
ter part of 2008 and then 2009 were a lot
rougher on companies , cer tainly ours ,
with both category and pharmaceutical
industry issues plus t he l arger economic
issues.There w as a r obust p harmaceutical
marketing communications community at
one point and there still is , sa ys Aldo
Cundari, main man at Cundari
Commun ica ti ons, T oron to, whi c h
includes AstraZeneca and the Canadian
Breast Cancer F oundation among its
clients.
But I would say our [healthcare] busi-
ness shrank by 70 per cent over the last five
years.
Healthcare comm unications ag encies
have reacted to the industry turbulence in a
number of ways.
Cundaris response was to substantial-
ly change Cundari Health from a complete
separate entity within Cundari
Communications to an offering of the
same exper tise and ser vices within the
company.INNOVATION EQUALS SURVIVAL
We were quite lucky. We didnt have to lay
anybody off, he reports, but were able to
transfer them into phar ma-related and
other business areas. And I know for a fact
that theres a number of agencies in the city
that used to have robust pharma practices
that have done practically he same thing I
did.
Innovation, Cundari adds, is the key to
business survival and success . It doesn t
matter what I do to grind it out, if Im not
an innovative shop I wont survive.
Mario Daigle, prexy at kbs+p Canada,
Montreal, says the firm followed the M&A
lead of some global pharmas when the for-
mer A llard-Johnson s hop j oined f orces
with a U.S. agency to establish kbs+p andand linking the new fir m with the MDC
Partners network of agencies.
Allard Johnson had begun to diversify
into non-pharmaceutical services about 10
years ag o, according to Daigle , and this
revision has enabled the agency to weather
downsizing from its phar ma clients, who
he says also benefited from the diversifica-
tion.
It allowed those who w ant to reac h
consumers directly to tak e adv antage of
the new expertise we gained with diversifi-
cation, he says. His firm has also enlarged
its client list to other industries and gov-
ernment agencies and one client (Church
& Dwight) with OTC products.We also in vested substantial
resources in digital and social media. Right
now our staff in these areas is about 25 per
cent larger.
Like other healthcare communications
agency execs, Daigle has found that despite
the escalation to digital and social media,
not all pharma clients have made the deci-
sion to switc h their promotion effor ts to
these channels.
There are a lot of legal constraints,
Daigle said in an inter view, and it s very
important in the phar-
maceutical industry to
maintain control in a
highly regulated en vi-
ronment.
There has beena shak eout in the
entire industr y, star t-
ing with the phar ma
companies, and ha v-
ing impacts on suppli-
ers like the communi-
cations ag encies first,
and below the agen-
cies, the suppliers that
supply us, says Mark
McElwain, Daigle s
colleague at the fir ms
Toronto office where
he i s vee-pee of t he
Wellness division.
McElwain sees acloudy future for bou-
tique ag encies if they
do not adapt to the
current situation,
stumble in their
growth, or come up
short of the necessary
staff and services pharma clients demand.
4 September 30, 2011 The Chronicle of Healthcare Marketing
The Chronicle of Healthcare Marketing
This SPECIAL REPORT was compiled
byIan J.S. Moore, a frequent contribu-tor to THE CHRONICLE OF HEALTHCAREMARKETING
Special Report
Few would be sur prised if Canadian phar mas were toapply that well-worn Latin phrase Annus horribilis tomany of the industrys recent difficult years, years thatincluded widely publicized recalls of major brandproducts, corporate extinction via merger and acquisi-
tion, loss of exclusivity for major bloc kbuster medications and
the cost containment efforts of various governments.
Healthcare agencies
in2011
Daigle
McElwain
Cran
Turn to Healthcare, page 5
Challenging times, sure, but for some agencies the last few yearsChallenging times, sure, but for some agencies the last few yearshave provided an opportunity to reinvent their suites of serviceshave provided an opportunity to reinvent their suites of services
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In effect, ag encies m ust no w be
prepared to produce and execute a
campaign within weeks, instead of
what used to be acce ptable in the
good old da ys, a deadline ofmonths.
You need to be an ag ency
that is more di versified in what it
offers, McElw ain sa ys. Y ou
need to be an agency that has a
pharmaceutical di vision that
works alongside OTC products ,
alongside food products and
a longside consumer pac kage
goods so each can draw on a stu-
dio and creati ve staff that k eeps
the creative juices flowing.
The creati ve product in
pharma adv ertising has been
improving, and it is more likely to
continue to impro ve in a di versi-
fied ag ency than it is in a bou-
tique.
Canadian pharmas may be liv-
ing through turbulent da ys, but
there is some good news for some
other firms w orking in the phar-
maceutical industr y, according to
James Cran, co-founder and prexy
of Antibody Healthcare
Communications, T oronto and
Montreal.
SLIMMED DOWN PHARMA NEEDS
PARTNERS, NOT SUPPLIERS
The industry is g oing through a
rough time, Cran says, but it hasb e n e f i t e d
A n t i b o d y ,
m a i n l y
because the
s a m e
r e s o u r c e s
may no
longer b e
there no w
for the phar-
mas product
management
team, so they
have to lean
on p artners
like us ev enmore so.
A l ot
of t hings
that used to
be handled
internally are
now b eing
handled b y
our company
and other
[communica-
t ions ag en-
cies]. We
become an extension of the mar-
keting de partments, and become
more involved with the client as a
partner than as a supplier.
One effect of patent cliff
plunges, Cran has noted, is that
pharmas seem to be giving priority
to their smaller brands, allotting
these products larg er promotion
budgets to generate higher sales in
an effort to recoup the sales v ol-
ume brought about b y loss of
exclusivity.
The response to the disap-
pearance of the bloc kbuster era
from Paul Hickey, prexy of
BrandHealth in P eterbor-ough,
Ont., was to focus his firms
efforts on smaller mark et-share
brands.
Were b igger a nd s tronger
than we were a y ear ago, he s ays
of t he r esul t o f t he d ecision .
Weve tended to grow organically
within the clients that we have. We
continue to add people , w e now
have 30 full-time employees, buttheyre w orking on smaller
accounts.
BrandHealth does not under-
take inde pendent projects or
accept one-off assignments, and
if there is a trend among its A OR
clients, it is to explore digital
options in their cor porate and
brand promotions.
GOING MORE DIGITAL
A lot of our A OR clients are
using iPads for selling, and w ere
Bergeron
montralterry oshea
514 315 2705 | [email protected]
torontomark mcelwain
416 323 2052 | [email protected]
kbsp.ca
explore incessantly
improve mercilessly
The Chronicle of Healthcare Marketing September 30, 2011 5
MacLeod
Hickey
Turn to Healthcare page 6
Healthcare agencies: Survival underscores need for innovationcontinued from page 4
A lot of things that used to be handled internallyare now being handled by our company and
other [communications agencies]. We become an
extension of the marketing depart-ments, and become more involved with the
client as a partner than as a supplier.James Cran,
Antibody
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6 September 30, 2011 The Chronicle of Healthcare Marketing
spending a lot more w ork on
training apps for iPads, Hickey
reports, and cer tainly a lot less
on traditional printed pieces ,
although that medium still plays a
role today.
PHARMA MARKETINGS FUTURE
REMAINS A CHALLENGE
With c lients s till e xpecting t he
same quantities and quality of
services and personnel they
received when blockbuster
agents dominated their product
lists, H ickey a grees w ith o ther
observers and par ticipants that
the biz w orld is a more difficult
environment today.
You need to be w orking
for the business units within
companies that are in launc h or
growth mode , Hic key advised
in an e-mail.
And y ou need sev eral of
these solid perfor ming brands,
probably more that you ever did
before, to continue growing and
to be solid and stable enough to
a ttr ac t a nd r e ta in t he b e st
account and creative talent, he
continued.
Paul Bergeron, executive
vee-pee at LXB Marketing in
Montreal, says that he has also
seen significant c hanges during
the past few years in how things
are done.
More programs, more mea-
surements, a di versified targ et
audience, and, of course , more
and more digital, Bergeron sum-
marizes.
The future will be a c hal-
lenge, for both clients and ag en-
cies, Berg eron believes. Gaining
market access will be a major
concern, and the current trend to
specialized products with the
majority of scripts being written
by specialists can be expected to
accelerate.
Bergerons b elief a re c on-
firmed in recent IMS Brog an
market survey results and a bleak
forecast for the industr y for the
next few years.
Theres n ot r eally m uch
getting away from the f act that
for the next three to four years
in Canada, especially if youre in
branded primar y care , it s not
going to be a lot of fun, Paul
Crotty, f ormer g ee-em a t I MS
Brogan told attendees at one of
the company s Phar ma-Focus
meetings for clients held late last
year.
Youre g oing to ha ve to
hold on and tough it out.
And that approac h, appar-
ently, appears to be precisely the
approach that healthcare com-
munications agency execs intend
to practice.
A shakeout isnt a protract-
ed decline, McElwain observes
from the kbs+p offices in
Toronto. As the populationages and science adv ances, peo-
ple a re g oing t o n eed b e tter
treatment in a whole v ariety of
categories and are g oing to be
willing to pay.
We are actually seeing, now,
that model of companies with
deep specialties in par ticular dis-
ease categ ories doing pretty w ell
at it.
OFFERS PHARMA GREAT
OPPORTUNITY TO MARKET
Liz MacLeod, biz director at
DraftFCB Healthcare , T oronto,
believes the l ean years p redictedin the IMS Brogan forecast will
offer phar mas another g reat
option.
It presents them with an
opportunity to really embrace
marketing, and because we have a
consumer-rooted agency, it gi ves
an opportunity to lev erage some
of the g reat stuff weve done in
packaged goods and try to put
that thinking into phar m, she
daid.
The dr ug companies g o
through some rough times , but
they s till h ave t o g et t he w ork
done, Antibody s Cran offeredduring his w orking v acation in
northern Ontario. And they rely
on their ag ency partners because
they dont ha ve the head count
internally.
From a m ulti-national per-
spective you just have to be more
linked in, says Anderson DDBs
Brady.
You have to be able to do
global programs, so you can ser-
vice a clients global needs as well
as its domestic needs.
There will be more nic he
opportunities in the biotec h sec-tor, cer tainly an ex citing area
from a comm unications [agency]
standpoint and from the prod-
ucts standpoint, Anderson
DDBs Brady noted.
The question is , will the
clients in vest as m uch as they
did previously to bring them to
market?
Healthcare agencies developing strategies to remain close to pharmacontinued from page 5
Waking up matters.
Being ableto breathe matters.
Your packaging doesnt matter.
The efcacy o your brand doesnt matter.Unless it connects with something
that matters to her.
Our job is to come up with the 6.5 seconds that matter most.
And use them to strengthen the relationship between
HCPs, patients and your brand.
To learn how to make 6.5 seconds work
for your brand, call 416.545.5748
or email [email protected]
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MM&M 2010 Agency o the Year
-
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The Chronicle of Healthcare Marketing September 30, 2011 7
By Ian J.S. Moore,of THE CHRONICLE OF HEALTHCARE
MARKETING
ASEISMIC SHIFT IS UNDERWAY
in phar maceutical and
healthcare comm unica-
tions as more and more Canadian
physicians and other healthcare
professionals put aside their
d e s k t o p s ,
laptops and
notebooks
in fa vor of
s m a r t
p h o n e s ,
iPads and
o t h e r
mobile digi-
tal devices.
A n d
while the
trend ma y
not be as
pronounced
in Canada as
it is in the
USwhere
73 per cent
of MDs are
said to pre-
fer e-detail-
ing and on-
line semi-
nars to face-to-face p ro-
motions
there is no
doubt the
switch to digital mobility is speed-
ing forward across medicine.
The indication from ph ysi-
cians is that their use of smart
phones and iP ads is displacing
their use of laptops and desk-
tops, re ports Lily Holm yard,
partner at Essential R esearch
Inc., T oronto, whic h recently
announced the results of a recent
survey of MD uses of digital
technology (Essential Ph ysicianV.3.0).
The mobile devices gi ve
them ultimate f lexibil ity in
accessing information and appli-
cations they can use at the precise
moments they need them in their
clinical practice: at P atient Point-
of-Care, both during and
between patient visits.
ONLY 17% USE iPADS
The survey found o wnership of
smart phones among primar y
care physicians has increased to
61 per cent from 55 per cent in
the past year; 65 per cent of
physicians say their use of smart
phones is increasing, and 86 per
cent report they use the devices
for professional purposes.
Physicians using iP ads are a
small group of only 17 per cent
of ph ysicians toda y, Holm yard
disclosed, but that n umber is
expected t o g row l arger. We
expect that iP ad adoption will
follow a similar adoption path as
smart phones.
[Digital mobility] is defi-nitely not in the infancy stag e,
anymore, ag rees Sean Ma yers,
director, business interacti ve at
Grip Limited, T oronto. Its an
emerging trend in ter ms of in-
patient consultation betw een
doctor and patient, par t of the
norm when
you g o t o
your ph ysi-
cian.
More
often than
not at least
one o f
those tw owill ha ve a
m o b i l e
d e v i c e ,
whether its
a smar t
phone or a
t a b l e t ,
which they
will utilize
as a refer-
ence tool.
Digital
m o b i l i t y
hasnt yet
reached the
s t a g e
w h e r e
p a t i e n t s
can foreg o
a visit to
the doctors office and simply dig-
itally comm unicate their symp-
toms and expect a diagnosis and
treatment regimen, also deli vered
digitally, in return, Mayers says. .
The in-patient visit has not
changed. You still require a phys-
ical presence.
Many patients, if not most,
now use their computers or digi-
tal devices to Google their possi-ble ailments , then c heekily pre-
sent their physician with a list of
possible diagnoses and therapies
for discussion.
But Iv e found that many
doctors will no w utilize their
smart phone or tablet device to
do their o wn reference and
search as they re with the
patient, Mayers reports. Thats
becoming more of the norm.
APPS POPULAR WITH DOCTORS
But digital comm unications do
not extend to follo w-up
exchanges of patients re porting
poor response to original medica-tions and the ph ysician digitally
sending a new , revised script to
the phar macy, according to
Grace deBrabandere, Grips asso-
ciate partner, business.
I dont think it s g one that
far yet. W ere not hearing any-
thing about that kind of commu-
nicating. But more and more doc-
tors are using their mobiles to
download cer tain applications
check on suc h things as dr uginteractions.
I get the feeling its growing
exponentially because they re
learning from each other, and its
a bit viral in that way.
Pharmas, she adds , are now
looking at digital mobiles to
deliver their product mono-
graphs.
But, Mayers notes, the world
of mobile is more than apps .
Because eac h app m ust be
designed specifically for
Blackberry, iPhone, or Android, a
single, optimized, mobile web site
that can be accessed b y anymobile device may be the prefer-
able, more economic option.
Its much more cost effec-
tive for phar mas to utilize a
mobile web site.
Theres no magic or m ys-
tery behind mobile . Its simply a
new c hannel to g et the same
information y ou can already g et
via nor mal w eb sites on y our
computer. T he adv antage with
mobile is the por tability.
DEVICES ALWAYS ON
Leerom Segal, prexy and CEO of
Klick Communications, Toronto,isnt surprised that digital mobili-
ty is the newest strong channel in
healthcare communications, one
thats bound to be even stronger.
People recognize that b y
2013over the next two years
more than half of the web traffic
will be mobile. And if you follow
the money, the digital budgets are
increasing and the propor tion
allocated to mobile is being dras-
tically increased.
Its ironic that all these dig-
ital conferences are done face-to-
face, Seg al remarks about the
many g atherings organizedaround digital themes , including
two sc heduled for T oronto this
fall.
But behind the need to bet-
ter understand social [media],
mobile is probably the second
most impor tant thing for ev ery
pharmaceutical marketer to
understand.
For the first time, he adds,
digital mobility gi ves mark eters
the oppor tunity of mo ving
beyond just marketing to provide
tangible utilities lik e apps for
both patients and healthcare pro-
fessionals.
MORE OPPORTUNITIES TO COME
These devices are alw ays on,
theyre alw ays visible , they re
increasingly smar t and ev ery
device tends to be a little more
web-friendly, more connected
and better integrated, so the
opportunity to deliver better util-
ities is just drastically increased,
he says.
Despite this potential, Seg alsays not a ll mark eters ha ve
explo it ed the oppor tuni ties
offered b y digital mobility , but
they should.
The more c hronic and
higher consideration the disease
state, the bigger a portion of the
budget that should be allocated
to digital. T hats really the onlyway to eng age in a meaningful
way, and these are patients who
obviously want that.
Pharmas appear to have
boosted their investments in dig-
LegalThis is the second in a series of columns by
Eileen McMahon, Partner and Co-Chair of
the Intellectual Property and Food and Drug
Regulatory Practice at Torys LLP. Eileen is a
practising lawyer and patent agent, who, in
this column, responds to questions posed by
readers. If you have a question that you
would like Eileen to answer, please submit
them to [email protected]
My company markets medical devices in the United States
and Canada. I have heard that a recently released report
criticized the way that medical devices are reviewed and
approved in the United States. Will this report change the
U.S. approval process? Does this report have any implica-
tions for Canada?
The report focused on the 510(k) process, under which compa-
nies that wish to sell medical devices in the United States areallowed to show that their devices are safe and effecti ve by com-
paring them to devices already marketed in the United States
(known as predicate devices). The report found that the 510(k)
process is deeply flawed and does not ensure that devices are safe
and effective, and made available to patients in a timely manner.
Nonetheless, it is unlikely that the 510(k) process will be scrapped.
The FDA swiftly rejected the re ports conclusions.
Furthermore, the report has no impact on Canadas process
for approving medical devices, which is governed by Canadas
Medical Devices Regulations. Certain corporations and industry
organizations have criticized the Canadian review process for
being even more f lawed than the U.S. process, noting that devices
approved years ago by regulatory agencies in Europe, Australia
and the United States are still undergoing review by Health
Canada. In many cases, review times in Canada take two to threetimes longer than Health Canadas stated targ ets.
The lawyers at my company seem to need to have a say (or
control of) almost everything we do in marketingwhat we say
in social media, the funding we want to give to research, the
pitch we make to physicians, and even the way we use our
brand. Its a bit tiresome. Why do our lawyers need to do this?
Well, there are several reasons. First, your in-house lawyers want
to ensure that your company is complying with applicable laws:
laws that set out what you may and may not say when you market
your product; privacy laws that govern the information you collect
from patients and physicians and the way you can use that infor-
mation; and laws regarding misleading advertising that govern
how aggressively you can pitch your product. In addition to all
these laws, there can be pressure from y our U.S. head office to
ensure that your marketing practices and codes of conduct inCanada conform to those in the United States (where stiff penal-
ties are imposed for violating laws in these areas). And if funds
flow from a company to g overnment officials, the U.S. foreign
corrupt practices legislation can rear its head in Canada. So ,
although your in-house lawyers involvement can be tiresome, they
are doing their job to k eep your company out of trouble.
The answers provided in this column ar e based on limited information and do
not constitute legal advice or the opinions or position of Torys LLP.
Turn to E-marketing, page 8
Holmyard
Mayers
deBrabandere
or what?
D i g i t a l a g e
E-marketing: Not in the infancy stage anymoren By 2013, half of all web traffic is expected to be mobile, and a large proportion will be doctors and patients
Segal
Hislop
Follett
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8/3/2019 The Chronicle of Healthcare Marketing ~ 08-11
8/16
8 September 30, 2011 The Chronicle of Healthcare Marketing
a $1 billion industr y pre-Hatc h-
Waxman to the $63 billion indus-
try it is today.
Before g eneric dr ug user
fees are enacted, the US
Congress must approve the deal.The pro vision will lik ely be
included in a massi ve bill, whic h
must be passed before the end of
2012, that would also reauthorize
user fees and funding for name-
brand drugs and devices.
The cur rent deal stemmed
from neg otiations betw een the
FDA, the Generic Phar maceuti-
cal Association (GPhA), the
European Fine Chemicals
Group, and the Bulk
Pharmaceuticals T ask F orce
(BPTF). All of these groups have
pushed for increased inspectionof dr ug ing redients man ufac-
tured at foreign facilities.
MORE INSPECTORS COMING
A 2010 re port from the
Government Accountability
Office (GA O) found that the
FDA inspects only about 11 per
cent of forei gn man ufacturing
plants that export to the US. At
its cur rent pace , it w ould tak e
nine to 13 years to inspect ev ery
foreign facility that exports to the
US.
The issue of unsafe ingredi-ents being shipped to the US was
brought to the public s attention
in 2008 when tainted he parin,
manufactured in and shipped
from China, caused the deaths of
as many as 81 people and injured
scores of others.
About 100 different coun-
tries ship dr ugs or dr ug ingredi-
ents to the US , according to the
GAO.
Before the FD A approves a
new g eneric dr ug, an inspector
must sign off that the facility is
safe. The user-fee deal will lik elylead to the hiring of more inspec-
tors, whic h could cut do wn on
the average 31 months needed to
approve a new generic drug.
Copyright Med Page Today, LLC. All
rights reserved. Reprinted with per mis-
sion. www.medpagetoday.com
continued from page1
Generics will pay FDA for inspections of foreign plants
AWARD CRITERIANominees are healthcare marketing professionals who, consistently through their careers in Canada, in
the pharmaceutical, biotechnology, medical device/supply industries, or organizations which supply thoseindustries (such as communications, educational services, advertising and marketing services) have:
made a lasting impact on others; or
served as a source of inspiration; or
have demonstrated extraordinary dedication and commitment to the humane principles
inherent in our profession
DEADLINE FOR NOMINATIONS : Oct. 31, 2011
Your nomination must include:(1) Nominees name and contact information;
(2) Your name and your contact information;
(3) A brief rationale of 100 to 250 words supporting the
nomination.
Mail to: The Chronicle of Healthcare Marketing, 555 Burnhamthorpe
Road, Suite 306, Toronto, Ont. M9C 2Y3 Canada.
Or fax to: 416.352.6199 (Toronto), 514.221.3085 (Montreal), or
800.865.1632
Or E-mail to: [email protected]
PLEASE KEEP IN MIND.....The Canadian Healthcare Marketing Hall of Fame program is a voluntary
effort established to recognize the acheivements of our colleagues. Since
the founding of the program in 2002, 73 honored Members have been
inducted, from among many hundreds of deserving nominees. The Hall of
Fame selections committee evaluates nominations based on the number of
nominations received for a particular nominee, the rationale for the
nomination, the length of industry service by the nominee, and the number
of times that a nominee has been proposed since the inception of the
program. Announcement of 2012 Inductees will be made in December
2011. We welcome your questions and comments concerning this program.
ACHIEVEMENT AWARDS
Presented to individuals who
have dedicated over 10 years of
their careers to our industry, who
have accumulated a body of
achievements
MERIT AWARDS
Presented to individuals whose
specific activities deserve
recognition, either for having led
or championed a noteworthy
project or effort, or having acted
as mentors
PHIL DIAMOND AWARD
Presented to an individual whose
record of service to the
community is exemplary and
deserving of industry-wide
recognition
2012 Call for NominationsCanadian Healthcare Marketing
Hall of FameCreated to honor healthcare marketers who have
contributed to our avocation and are an inspiration to others
CATEGORIES OF AWARD
2011 Canadian HealthcareMarketing Hall of Fame Inductees
Lorenzo BiondiLorenzo Biondi James CranJames Cran
Steve GreenSteve Green Morris GoodmanMorris Goodman
Regina KulikowskiRegina Kulikowski Dan LegerDan Leger
Stuart MaddinStuart Maddin Lorne MarkowitzLorne Markowitz
ital mobility units because theyincrease the potential v alue of
each sales re ps MD office visit,
according to Graham Hislop ,
managing director at GHI
Technologies, Mississauga, Ont.,
a tec hnical ser vices company
supplying life-sciences customer
relationship management (CRM)
software and other mobility-dri-
ven services.
Youre seeing more and
more org anizations g oing to the
mobility piece because of the
many things they can do with it,
he says.
Sales reps can put an iPad orany type of tablet into a briefcase
and off they g o, fully equipped
and armed with the data they need
for an effective sales call.
The [digital mobility] cus-
tomersboth patients and
healthcare professionalsare in
many ways are kind of voting with
their fingers in terms of how and
where they w ant to access co n-
tent, according to Neil F ollett,
founder and CEO of Brightworks
Interactive, Toronto.
This is not a scenario any-
body i s g ett ing a head o f t he
trend, but a scenario where weretrying to catch up and understand
what is really a seismic shift in the
way people access content and
information, Follett said.
MAPS AND APPS
Follett estimates that while trac k-
ing records sho w that one per
cent of browser traffic was via a
mobile device 18 months ago, the
percentage is now is as high as 10
per cent. T hree years ag o, the
smartphone was used for e-mail,
two years ag o it w as used for e-
mail and some apps, but today the
access point ma y be e-mail, surf-ing the w eb, maps , apps , social
networking, travel check-ins, Four
Square, and other uses, he says.
Thats not something mar-
keters ha ve done , he notes .
Thats something the devices have
done. Chec king a w eb page on a
phone two generations of phones
ago was a terrible experience.
Checking it on m y iPhone
now is a radically different expe-
rience, one that could be quite
convenient if the site is designed
for a mobile device.
Follett uses the c hicken or
egg analogy to gauge the value ofcontent and the con venience of
mobility.
Both the c hicken and the
egg are being held in our hands ,
in the form of these unbelievably
powerful devices, he said, and
only now are we figuring out how
we can c hannel the oppor tuni-
ties.
E-marketing:Not in infancy stage
anymore, market
observers reportcontinued from page 7
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8/3/2019 The Chronicle of Healthcare Marketing ~ 08-11
9/16
By Andrew Senior, Special to THECHRONICLE OF HEALTHCARE MARKETING
ONE OF THE GREAT INNO-
VAtions in pharmaceutical
marketing came with the
advent of smart cards from STI.
When smart cards first appeared
they represented a new way of
sampling which delivered a com-
petitive advantage to innovative
companies.
STI and smart cards have
come a long w ay since their
inception as the company has
developed more po werful appli-
cations for the tec hnology than
just sampling. Smart cards have
been used for clinical trials, brand
retention after patent expir y,
patient assistance and bridging
campaigns, and the data g enerat-
ed has been utilized for more
effective sales and mark eting
efforts. W hile the utility ev olved
so did the product mix, with STI
now offering customizable on-
line offerings such as do wnload-
able eCards and P atient
eServices.
EXTEND SALES FORCE EFFORTS
The development of STIs eCard
offerings pro vide ph ysicians,
patients, and ev en phar macists
cards at their fing ertips without
the need to ha ve a supply of
physical cards on hand. T his
approach can g reatly enhance
and extend sales force effor ts
while ensuring that the highest
users of smar t cards nev er run
out.The eCards are a vailable in
three versions to meet a brand s
needs and budget.
1. eCardbranded do wnload-
able eCard
2. eCard Micrositedownload-able eCard plus three to four
additional pages of branded con-
tent
3. eCard Custom w ebsitefully
customized website.
eCARD CAN BE INTEGRATED
INTO AVAILABLE SYSTEMS
STIs solutions pro vide options
for e ffective o n-line p resence
with an eCard, including: adding
it to an existing cor porate or
brand site; integ rating it into a
system that already has physician
presence ( such as a n EMR s ys-
tem or i MD); accessing it v ia a
standalone web address or URL;or even having it identified b y a
therapeutically relevant blog.
The utility of the eCards is
s imilar to the original smar t
cards with implementation avail-
able for programs like alternative
A r e v i e w o f i n n o v a t i o n s i n p h a r m a c e u t i c a l m a r k e t i n g
Downloadable solutions expand utility of ecardsn System said to provide improved ability to measure and report activation and redemption activities
2011 IMS Health Incorporated or its affiliates. All rights reserved.
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Environmental challenges in Canada require a closer look at your business unitsperformance relative to the Canadian and global markets. Executive Monitor armsyou with the information to excel in this increasingly competitive landscape.
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IMS EXECUTIVE MONITOR
KEEPING YOU AT THE PULSE
OF YOUR BUSINESSIN CANADA AND AROUND THE WORLD
September 30, 2011 9
Turn to Ecards, page 10
E-cards canprovide
physicians,
patients,
and even
pharmacists
with cards
at their
fingertips,eliminating the
need to have a
supply of
physical cards
on hand.
THE CHRONICLE OF HEALTHCARE MARKETINGpresents another instalmentin a new feature series intended to critically assess new tools, technologies, and tac-tics available to the pharma marketer from a range of Canadian and inter nation-
al suppliers. In this issue, Andrew Senior looks at marketing tools.
Innovation ReviewsThe Chronicle of Healthcare Marketing
-
8/3/2019 The Chronicle of Healthcare Marketing ~ 08-11
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10 September 30, 2011 The Chronicle of Healthcare Marketing
eCard utilityenhanced by greater
ability to measure and
report activities
sampling, bridging to co verage,
compassionate use , patient assis-
tance, and loss of exclusivity. The
advantage is a simplified, more
extensive distribution netw ork
and greater ability to measure and
report activation and redemption
activities.
The Patient eServices solution
is useful for dr ugs that require a
higher level of scrutiny or involve
more complex treatments suc h as
biologic therapies or controlled
substances.
For one client, the P atient
eService Solution w as implement-
ed as a qualifier for patients in
need of compassionate product
access and reimbursement sup-
port. The patients entered data
about themselves and their finan-
cial s ituation and the P atient
eServices prog ram ev aluated and
determined the appropriate level
of suppor t for whic h they quali-
fied.
MIGHT HELP OPTIMIZE STRATEGY
FOR DRUG MARKETERS
For an injectable dr ug, P atient
eServices served as the medical
directive which gave authority to a
nurse to proceed with patient
training and the initial injection. In
the past this would have required a
signed for m or letter from the
physician, no w it s a few mouse
clicks to provide consent and acti-
vate an e-card whic h begins the
process of getting a patient started
on therapy.
As with all smar t card pro-
grams, re porting helps the mar-
keter optimize strateg y. With
eCards, the re porting includes
valuable and traditional online
coupon metrics suc h as redemp-
tion rates. STIs ability to provide a
real time snapshot of eCard adop-
tion also helps mark eters adapt
and re-tool sales or promotional
focus on the fly.
We now li ve in a self-ser vice
online w orld and an effect i ve
eCard strategy has the potential to
extend the reac h of a smar t card
strategy, and P atient eSer vices
offers an effective way to individu-
alize patient benefits.
For a mark eter looking to
enhance efficiencies and g ain a
competitive advantage, it could bewell worth your time to speak with
STI about their customizable solu-
tions.
For more information contact
Simon R oberts, director of mar-
keting and business dev elopment,
STI, at 902-442-9303, or b y email
The pitynot
getsgets
continued from page 9
Roche Canada to create globaldevelopment site
A $190 million investment byRoche over five years, in partnership with theOntario Ministry of Economic Development and
Trade, is expected to creata 200 jobs in Mississaug a,
Ont. The new Pharmaceutical Development site, oneof six in the world, will manage operations for all
stages of global clinical trial research. Pictured (l-r)
are: Sandra Pupatello, Ontario Minister of Economic
Development & Trade, Bob Delaney, MPP,
Mississauga-Streetsville, Ronnie Miller, Roche Prexy
& CEO, and Audrey Haukioja, Global Head, Product
Development Operations.
-
8/3/2019 The Chronicle of Healthcare Marketing ~ 08-11
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The Chronicle of Healthcare Marketing September 30 ,2011 11
on vs. doctors you dont, he said.
Is there evidence of that?
The answer appears to be no,
based on Paladin Labs own expe-
rience and
other data,s a i d
B e a u d e t .
There is no
d o s e -
r e s p o n s e
relationship
between fre-
quency o f
sales visits and frequency of p re-
scriptions, he said, adding the
finding s uggests r epetition o f
message does not appear to pro-
duce a beha vioural c hange and
that post-launc h promotional
a c t i v i t i e s
diminish ineffec t ive -
ness m ore
quickly than
thought.
T h e
f i n d i n g
prompted
the compa-
ny to adopt a new approac h in
their sales effor ts, categ orizing
physicians as users , niche users,
and advocates, among other cate-
gories, and asking ph ysicians
questions to evaluate where they
are in ter ms of stag es of adop-
tion of a product. T here is thenthe oppor tunity to mo ve the
physician from a nic he user to
expanded use of a medication.
Were telling our representa-
tives that if they are not making
progress, there is no point in
going back [to that physician], he
said. They have reached the end
of the selling process, and should
move to the next best opportuni-
ty in their [geographic] area.
Given that mor e an d more
products coming to market are pre-
scribed by specialists, pharmaceuti-
cal marketers need to tailor contin-
uing medical ed ucation to thosephysicians and to incorporate tech-
nology to more regularly communi-
cate with these physicians.
We need to engage physi-
cians more often, said Darryl Vaz,
Managing Director , Meducom
Health Inc., a medical communica-
tions agency based in Guelph, Ont.
We are trying to engage these
audiences betw een the time w e
hold advisory board meetings.
Were dev eloping a secure
portal and providing information
to them through that portal, said
Vaz. We can ask them a question
that we forgot to ask them at anadvisory board meeting or ask
them about infor mation or
research data that came out at a
medical conference and ho w it
affects us.
General practitioners need to
be involved in the equation as well,
even if there is a trend to new
products being prescribed b y spe-
cialists, according to Vaz, suggest-
ing that train-the-trainer sessions
may assist in producing g eneral
practitioners who are familiar with
specialty products and who edu-
cate their patients about the v alue
of the specialty products. In addi-tion, they can then refer those
patients to specialists.
GADGETS CANT SELL DRUGS
Vaz cited data from the Boston
Consulting Group whic h found
that the majority of patients
express non-adherence to medica-
tion for intentional reasons , citing
they dont want side effects from
medication, don t believ e they
need medication, or don t believe
the medication will work.
To address non-adherence
to medication, particularly among
patients who ha ve rare condi-tions, phar maceutical mark eters
need to adopt tec hnology initia-
t ives suc h as patient por tals
where patients can discuss their
condition with other patients and
are given access to specialists.
Technology c an b e w on-
drous, but it will not sell the drug
for the phar maceutical mark eter
when it comes to the interaction
between t he s ales r epresentative
and the physician.
Dont take a detail aid and
put that on your tablet technolo-
gy, said Vaz. No tablet technol-
ogy will sell your drug for you.The technology facilitates a
discussion between the sales rep
and the physician, said Vaz.
Art Tramonte, director , mar-
keting at A potex Inc., ec hoed the
view that sales r epresentatives can-
not merely have a transactional rela-
tionship with the customer, which,
for Apotex, is the pharmacist.
Firms like Apotex Inc . have
become tec hnologically inno va-
tive, dev eloping prog rams lik e
iPharmacist mobile, which allows
pharmacists to access reference
materials on their mobile device ,
supporting the enhanced scopeof practice of pharmacists.
Pharmacists who decide to
subscribe to the service are pro-
vided training on how to use the
program. T he tec hnology also
allows phar macists to identify
patients who are candidates for
medication review counselling,
according to Tramonte.
Target likely adopters of new therapies, Paladin exec recommendscontinued from page 1
Beaudet Vaz
is,every message
throughthrough
get through
Context is everything: meaning that effective communicating isnt merely amatter of what you say; its where you choose to express the thought. The print and
electronic publications of Chronicle Companies offer precision targeting, immediacy,
and are geared to elicit direct response. Which, in turn, offers you the assurance that
your vital marketing message will get through to its intended audience.
Find out more, by visiting www.chronicle.ca.E-mail: [email protected],
or call us anytime toll-free at 866-63-CHRON (24766)
-
8/3/2019 The Chronicle of Healthcare Marketing ~ 08-11
12/16
Estrogen 08-11
Estrone (Estragyn Vaginal
Cream, Triton Pharma)Comments: Revisions to the
Indications and Clinical Use
and the Dosage andAdministration Sections of the
Product Monograph, 1 MG/G
Gonadotropin 08-10
Choriogonadotropin alfa(Ovidrel, EMD Serono, a divi-
sion of EMD Inc. Canada)
Comments: 250 G/CART
Tumour necrosis factor alpha
inhibitor 08-05Golimumab (Simponi singleuse autoinjector, Janssen Inc.)
Comments: 50 MG/0.5ML
Biological response modifier 08-05
Infliximab (Remicade, JanssenInc.) Comments: 100
MG/VIAL
Antileukemic agent 08-05
Cytarabine (Cytosar, Pfizer
Canada Inc.)
Comments: Updateto the Product
Monograph to
Include 500mg/Vial, 1 g/Vial
and 2 g/Vial with
Reactivated DrugIdentification
Numbers; 500 MG/VIAL, 1G/VIAL, 2 G/VIAL
Selective immunomodulatingagent 08-05
Ustekinumab (Stelara, Janssen
Inc.) Comments: 45MG/0.5ML, 90 MG/0.5ML
Angiotensin II AT1 receptorblocker / calcium channelblocker 08-03
Amlodipine besylate, telmisartan
(Twynsta, Boehringer Ingelheim
Canada Ltd. Ltee) Comments:
Amlodipine besylate 5 MG/TAB,
telmisartan 40 MG/TAB;
Amlodipine besylate 10 MG/TAB,
telmisartan 40 MG/TAB;
Amlodipine besylate 5 MG/TAB,
telmisartan 80 MG/TAB;
Amlodipine besylate 10 MG/TAB,
telmisartan 80 MG/TAB
Neuromuscular paralytic
agent 08-02
Clostridium botulinum neuro-
toxin type A (150 KD), free
from complexing proteins
(Xeomin, Merz Pharmaceuticals
GMBH) Comments:Addition
of new manufacturing facility,
addition of a dosage form or
change in the formulation, 50
UNIT/VIAL, 100
UNIT/VIAL
Hematopoietic growth factor07-29
Sargramostim (Leukine,
Genzyme Canada Inc.)
Comments: 250 G/ML, 500
G/ML
Growth hormone receptorantagonist 07-29
Pegvisomant (Somavert, PfizerCanada Inc.) Comments: New
manufacturing facility; 10
MG/VIAL, 15 MG/VIAL, 20
MG/VIAL
Antineoplastic 07-28
Busulfan (Bosulfex, Otsuka
Pharmaceutical Co. Ltd.)
Comments: Updates to the
Indications, Drug-Drug
Interactions, Adverse Reactions,
Clinical Trials and Bibliography
sections of the Product
Monograph; 6 MG/ML
Human gonadotropin 07-29
Follitropin beta (Pureg on,
Merck Canada Inc.)
Comments: New manufactur-ing facility, 833 UNIT/ML
Oral antihyperglycemic agent:DPP-4 inhibitor: Incretinenhancer 07-28
Linagliptin (Trajenta, Boehringer
Ingelheim Canada Ltd. Ltee.)
Comments: 5 MG/TAB
Interleukin receptor inhibitor07-27
Tocilizumab (Actemra,
Hoffmann La Roche Limited)
Comments: New manufactur-
ing process, 80 MG/4ML, 200
MG/10ML, 400 MG/20ML
Biological response modifier07-27
Adalimumab (Humira, AbbottLaboratories Limited)
Comments: Update to Product
Monograph, 40 MG/0.8ML
Bone metabolism regulator 07-27
Risedronate sodium (Actonel
DR, Warner Chilcott Canada
Co.) Comments: New dosage
form: Delayed-release tablet,
35 MG/TAB
Androgen biosynthesisinhibitor 07-27
Abiraterone acetate (Zytiga,
Janssen Inc.) Comments: 250
MG/TAB
Anti-neovascularisation agent07-25
Ranibizumab (Lucentis,Novartis Pharmaceuticals
Canada Inc.) Comments: New
Indication: Lucentis
(ranibizumab) is indicated for
the treatment of visual impair-
ment due to macular edema
secondary to retinal vein occlu-
sion (RVO), 10 MG/ML
Vasopressin V2-receptorantagonist 07-25
Tolvaptan (Samsca, Otsuka
Pharmaceutical Co. Ltd.)
Comments: 15 MG/TAB, 30
MG/TAB, 60 MG/TAB
Protein-tyrosine kinaseinhibitor 07-19
Dasatinib (Sprycel, BristolMyers Squibb Canada)
Comments: New indication:
For the treatment of adults
with newly diagnosed
Philadelphia Chromosome
Positive (Ph+) Chronic
Myeloid Leukemia (CML) in
chronic phase, 20 MG/TAB,
50 MG/TAB, 70 MG/TAB, 80
MG/TAB, 100 MG/TAB, 140
MG/TAB
N O C s o f N o t e :
August 31, 2011
Significant TPP approvals of Rxs for human use
continued from page 3
12 September 30, 2011 The Chronicle of Healthcare Marketing
p.r.n. Publishing Inc.1-877-744-4PRNwww.prnonline.ca
the ultimate
resource d irectory
for Canadas
pharma industry
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At SickKids, many parents fail to bring their c hildren
for follo w-up appointments at da y-time clinics because
they work irregular hours or jeopardize their jobs if they
have to take time off.
Meanwhile, i n t he e vening, l arge n umbers o f p arents
camp o ut overnight i n t he emergency d epartment. T heyvebrought their children in f or medical attention, but b ecause
they cant afford cars or taxis, theyre waiting for the 6 a.m. start
of the subway to carry them many miles back to their homes.
The health and well-being of Canadian children grow-
ing up in po verty has to become a priority and healthcare
has to move back out into the community.
We cant turn bac k the clock, but it is time to reintro-
duce some of the common-sense prev entive health pro-
grams that used to be standard in many Canadian schools
dentists to screen for c hildren with dental problems , vision
screening and regular nurse visits in public schools.
Of course, restoring these health initiatives cant rem-
edy poor li ving conditions or close the income g ap, but
here are some examples of what can be done.
A joint public/pri vate initiative at inner city T oronto
schools, where poverty rates are high, pro vided vision tests
to 16,000 children last year. About 2,000 were found to need
glasses, which were provided at no charge. Hearing tests are
also being introduced in sc hools through this program.
IGNORING CHILDREN GROWING UP IN POVERTY
At least two Toronto public schools have set up their own
medical clinic, staffed by a nurse practitioner, so that chil-
dren can be seen onsite . T his spares parents , many of
whom are new to Canada and face language and financial
barriers, a confusing and often long trip to the hospital. At
other schools, visiting n urses work in coordination with
local health services.
To be fair , v arious lev els of g overnment across
Canada have been taking some important steps to improve
the lives of children, and there are some inspiring stories
out there.But disturbing questions ling er. Why, when Canadian
The Chronicle of Healthcare Marketing September 30, 2011 13
CIPHER PHARMACEUTICALS
of Mississauga, Ont. inked a
Canadian distribution and
supply pact with Medical Futures for pain Tx tramadol
(Durela.) The Rx was okayed by Health Canada in
August. Med Futures Medical Futures says it will launch
the product in Q1 next year, with a field force of 22.
Says Cipher prexy Larry Andrews: This agreement, cou-pled with our [...] agreement with Vertical
Pharmaceuticals for the US market, will provide another
valuable royalty revenue stream.
EISAI CANADA of Mississauga, Ont. got a green light
from Health Canada for epilepsy Rx rufinamide
(Banzel), for the adjunctive Tx of seizures associated
with Lennox-Gastaut syndrome (LGS) in adults and
children four years of age and older. Says Eisai Canada
prexy Takihiro Hirasawa: The Canadian approval of
Banzel supports the Eisai human health care mission to
bring medicines to the people who need them the
most.
ROCHE CANADAwill invest more than $190
million during the next five years expanding its
Rx development site in Mississauga, Ont.
The centre, one of six Roche global sites,
will manage operations for all stages of
global clinical trial research. Says prexy
Ronnie Miller: We have built a respected
clinical expertise within the Roche global network, and
this new capability will firmly establish Roche Canada,
and the province of Ontario, as a global hub for life sci-
ences and biophar maceuticals. Above all, we are excited
about the promise this holds for patients in Canada andaround the world. The centre is expected to add 200
jobs.
VALEANT PHARMACEUTICALS of Mississauga, Ont.
and Paladin Labs of Montreal are duking it out over
which company will acquire Afexa Life Sciences, the
Edmonton-based maker of OTC Tx Cold-FX. At press
time, Val was offering 85 cents per share , topping Pals
81 cent bid. Val previously pitched a 71 cent offer. Pals
interim boss Mark Beaudet tells the National Postnews-
paper: The Valeant bid provides neither the value nor
the choice of Paladins enhanced offer. Counters Val
kingpin Michael Pearson: While we normally dont
participate in an auction process, given that our
existing offer has the full suppor t of the Board
and Management of Afexa, we felt it was appro-
priate to continue to respond quic kly to Paladins
hostile overtures. n Earlier this summer, Pal
paid $20.4 million to acquire LABOPHARM, the
struggling Laval, Que. maker of a qd stramadol
formulation.
U p h e r eWhats happening in the world of drug marketing
Health systemfailing our childrencontinued from page 14
researchers ha ve been so instr umental in dev eloping the
scientific evidence of the impor tance of early c hildhood
development, have we not developed comprehensive initia-
tives to improve the well-being of our children?
Why do w e continue to ignore the major problems
faced by children growing up in poverty?
Dr. Elizabeth Lee Ford-Jones is a pediatrician specializing in social pediatrics, a P roject
Investigator at SickK ids, and P rofessor in the Department of P aediatrics at the University of
Toronto. She is an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan
online resource designed to help journalists covering health policy issues in Canada. This column
represent the opinions of Dr. Lee Ford-Jones and not necessarily the official positions of either TheHospital for Sick Children or the University of Toronto.
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14 September 30, 2011 The Chronicle of Healthcare Marketing
Jack Layton
JACK LAYTON, THE RECENTLY DECEASED LEADER OF
the official Canadian opposition par ty, nev er pre-
tended to be a friend to the m ultinational phar ma-
ceutical industry. He was ardently committed to the prin-
ciples of democratic socialism. Those two designations
non-friend to phar ma, and dedicated socialistdo not
always need to go hand-in-hand, but in Mr . Laytons case,they did.
Through his time in charge of the federal New
Democratic Party, his top-lev el obser vations and policy
statements regarding Big Phar ma were de pendably unin-
formed, and reliably calculated to anno y captains-of-
industry. Correspondingly, those of us employed b y this
publication deri ved m uch enjo yment from moc king his
partys antediluvian views on healthcare . W e found it
especially comical when he proposed establishing, at tax-
payer expense, a new state-owned drug discovery compa-
ny that would bequeath its inno vative therapies to all the
deserving people of the world. Never mind that the last
occasion when Mr . Layton ran any sor t of commercial
enterprise was most likely a Gazetteroute in Hudson, back
in his c hildhood. After all, all y ou need to do to create athriving drug company is go hire some bureaucrats; noth-
ing to it.
That aside, you generally knew where you stood with
Mr. Layton, which is an extreme rarity in the present-day
political sphere. Canadian politicians are kno wn to pa y
lip-service to the principles of free enter prise, to the
need for researc h, and to the impor tance of the private
sector. And, then, when the c hips are do wn, or when
they think no one is watching, they will surely find a way
to abandon the previous high-minded doctrine , and slip
the spoils to their friends . (Are your ears burning, Allan
Rock?)
The for mer Liberal P arty head, Mic hael Ignatieff ,seemed poised to contin ue this leadership tradition of
speaking one w ay and acting another , and it ma y be said
that Mr. Layton delivered an invaluable service to the
nation by eliminating Mr. Ignatieff s political future , dur-
ing the course of a televised election debate earlier this
year.
Pointing out that Mr . Ignatieff had the w orst atten-
dance record in the House of Commons of any member
of Parliament, Mr. Layton did not disguise the joy he took
in lambasting his opponent. Y ou know, he said, most
Canadians, if they dont show up for work, they dont get a
promotion. You missed 70 per cent of the v otes. Mr .
Ignatieffs response w as to mime the mannerisms of a
punctured balloon, right do wn to his final disappearance
behind the furniture, for which Canadians will always oweMr. Layton a debt of gratitude.
Voters subsequent response to this exchange was to
elevate the New Democratic Party from f ringe status, to
that of parliamentary opposition. This stunning outcome
had little to do with the quality of the NDPs
policies, philosophies, or personnelall are
l ameand ev er yth ing to do wit h Mr .
Laytons ostensible attribute of genuineness.
It will not dishonor his memory to point out that he was
not entirely what he seemed. It is never an easy trick, to
convincingly fake authenticity. But, for those who would
seek public office, duplicity is as much a requirement as a
snazzy necktie, and Mr. Layton cer tainly lived up to that
standard.
Indeed, when the subject turns to the politics of
healthcare, we far prefer Mr. Laytons brand of manipu-
lative, self-ser ving nai vety, if thats what it w as, to thecrazed bombast of the U.S. politicians now vying for the
Republican party nomination for the presidency . There,
one candidate , Dr . R on P aul of T exas, w as recently
asked apropos of his opposition to government-mandat-
ed health coverage, whether he agrees that the wealthiest
nation in the world should simply let its ailing and unin-
sured citizens die without intervention. Dr. Paul, a physi-
cian who seems to have permanently misfiled his copy of
the Hippocratic Oath, did not directly answ er the ques-
tionbut his audience did, noisily , with cries of Yes!
and Let them die! This exchange contributed one more
moment of disg race to a shameful period in American
society, and provided an opportunity for Canadians to
silently acknowledge our countr ys continuing values of
fundamental decency and ci vility.As a senior Canadian politician, Mr . Layton offered
the pharmaceutical industry absolutely nothing with which
to agree, but he conducted himself with acce ptable deco-
rum and the slightest trace of humor, and we sort-of did-
nt mind him, in spite of everything.
We sor t-of didn t mind him, anyw ay. There is an
epitaph that few other contemporar y political figures will
ever earn, or deserve, more than Jack Layton
How our health system is failing our childrenBy Dr. Elizabeth Lee Ford-Jones, Special to THE CHRONICLE OF HEALTHCARE MARKETING
In the last quarter century theres been an explosion in our understanding of child development.Unfortunately, all that new knowledge hasnt translated into improved child health. The fact is, far too many
of our children are not doing wellnot at all well. I never dreamed that after 35 years in medicine I would
now find so many children in worse shape than when I star ted.
Three years ag o, I was asked to set up a Social P aediatrics program at T he Hospital for Sic k Children
(SickKids) in Toronto. Social pediatrics recognizes that po verty places c hildren at high risk for cur rent and
future health problems.
A TRANSFORMATIVE EXPERIENCE?
And so we send our medical residents out on public transit to make home visits and provide care at local clinics
in parts of the cityboth suburban and downtownwhere parents struggle and children are disadvantaged.
The experience is transfor mative. One y oung doctor had to examine a sic k child in a dim apar tment
because the electricity had been cut off . She said shed never ag ain do an assessment or write a prescription
without wondering if paying for the antibiotic might mean no food on the table .
Because we recognize the problems that some parents face , we ha ve a free leg al clinic at Sic kKids. For
more than two years, lawyers who offer their exper tise to the Family Legal Health Program have been helping
parents with a wide range of issuesfrom family and immigration law, to housing and employment problems.Canadian scientists have played and continue to play a leading role in researc h into early brain dev elop-
ment, the inter play between genetics and the en vironment, and the long-ter m health consequences of early
childhood experiences.
But in all the ex citement of these findings, I believe many of us have lost sight of whats happening to
the children in our comm unities. We havent acted on what w e know. Perhaps most disturbingly , the g ap
between rich and poor is g rowing in Canada and one child in 10 is living in poverty.
In my role at SickKids, Ive been on home visits to apartment towers where, quite frankly, I have to ask how we
can expect parents to raise healthy children in the face of next-door drug dealers, constant police sirens, and bed bugs.
Certainly weve made progress in some areas. If children have access to medical care, they no longer have
to be hospitalized for croup or other v accine-preventable diseases.
But our children have new health problems and Canadian children rank embarrassingly poorly in interna-
tional comparisons for many key indexes.
Recent United Nations reports place Canada 22nd among 31 Organisation for Economic Cooperation
and Development (OECD) countries for infant mor tality rates, and right next to the bottom of the heap of
OECD countries for our high rates of childhood obesity. This is especially disturbing because c hildren who
are overweight or obese face increased health risks including diabetes and h ypertension.Those UN reports rank the situation of all Canadian children; its obvious that children living in poverty
face additional obstacles. Parents may have difficulty affording healthy foods or organized recreational activi-
ties for their children; many face challenges paying for the medicine and equipment to keep conditions such as
diabetes or asthma under control.
Poor housing exacerbates asthma and parents who are financially strapped often can only afford to gi ve
their kids symptom relievers for asthma, and these are not medications whic h should be used regularly. Their
children often end up in the emergency ward.
Attention disorders among children are rising at a disturbing rate and far too many children are simply not
getting enough sleep for healthy child development.
Published seven times annually by theproprietor, Chronicle InformationResources Ltd., from offices at 555Burnhamthorpe Rd., Suite 306, Tor -onto, Ont. M9C 2Y3 Canada. Tele -
phone: 416.916.2476; Fax 416.352.6199. E-mail: health@chroni cle.org
Contents Chronicle Information Resources Ltd., 2011, exceptwhere noted. All rights reserved worldwide. The Publisher prohibitsreproduction in any form, including print, broadcast, and electronic,without written permission. Printed in Canada.
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ISSN 1209-0654
September 30, 2011 www.pharmacongress.info
EDITORIAL DIRECTOR
R. Allan RyanSENIORASSOCIATE EDITOR
Lynn BradshawASSISTANT EDITOR
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SALES & MARKETING
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Turn to Health system, page 13
My Turn
THE CHRONICLE OF HEALTHCARE MARKETINGwelcomes contributions from
readers. In particular, wed like to know whats going on at your company, or organi-
zation, and you are especially welcome to keep us informed about new develop-
ments, new appointments, and new practices at your shop.
If y oure submitting an article, opinion piece, press release, or letter to the edi-
tor for consideration, please bear in mind that w e select material for publication
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Our policies are: All material submitted to T HE CHRONICLE becomes the prop-erty of Chronicle Information Resources Ltd., and is subject to the companys usual
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What Lies Ahead: Original articles of approximately 500 to 700 words dealing with trends
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Please refer inquiries to: Editor, The Chronicle of Healthcare Marketing,
555 Burnhamthorpe Rd., Suite 306, Toronto, Ont. M9C 2Y3 Canada.
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