the chronicle of healthcare marketing ~ 08-11

8/3/2019 The Chronicle of Healthcare Marketing ~ 08-11

1/16

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-

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Merck Canada..

Inside this issue:Your Autumn 2011 edition of

Drug Rep Chroniclefeaturing reports on

the future of thepharmaceutical representative


2/16

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.


3/16

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, peginterferon alfa-2B

100 G/0.5ML; ribavirin 200MG/CAP, boceprevir 200


120 G/0.5ML; ribavirin 200



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

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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


5/16

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


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


6/16


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]

STRATEGIC PLANNING ADVERTISING DIGITAL DTC MARKETING SALES SUPPORT AND COLLATERAL PATIENT SUPPORT

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7/16


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


8/16


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


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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Consistent and seamless updates every month (global data quarterly)

SIMPLE, DIRECT AND RELEVANT INFORMATION

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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


10/16


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

at: [email protected]

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.


11/16

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)


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;






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


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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


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.


14/16


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.

Subscriptions: $59.95 per year in Canada, $74.95 per year in all other

countries. Combined rate including Chronicle MONDAY and ChronicleMIDWEEKnewsletters: $240 per year in Canada, $360 per year in all othercountries. Single copies: $7.95 per issue (plus 13% HST).

Canada Post Canadian Publicat ions Mail Sales Product Agreement Number40016917. Please forward all correspondence on circulation matters to:Circulation M anager, The C hronicle o f H ealthcare M arketing, 5 55Burnhamthorpe Rd., Suite 306, Toronto, Ont. M9C 2Y3 Canada. E-mail:[email protected]

ISSN 1209-0654

September 30, 2011 www.pharmacongress.info

EDITORIAL DIRECTOR

R. Allan RyanSENIORASSOCIATE EDITOR

Lynn BradshawASSISTANT EDITOR

Josh Long

SALES & MARKETING

Henry RobertsPRODUCTION & CIRCULATION

Cathy DusomeCOMPTROLLER

Rose Arciero

PUBLISHER

Mitchell Shannon

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

from a large volume of submitted material, and that we may not be able to publish

your submission in a specific issue (or at all) due to space constraints and other con-

siderations.

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

editorial procedures; We will not consider for publication any material that has been

simultaneously sent to other publications; Only original material or infor mation will

be considered; Payment at our established freelance rates will be offered upon publi-

cation for feature articles and for the following departments:

What Lies Ahead: Original articles of approximately 500 to 700 words dealing with trends

that shape the healthcare industry;and

My Turn: Opinion pieces of approximately 500 to 700 words, offering original commentary on

issues facing the healthcare industry.

Please refer inquiries to: Editor, The Chronicle of Healthcare Marketing,

555 Burnhamthorpe Rd., Suite 306, Toronto, Ont. M9C 2Y3 Canada.

Fax 416.352.6199, E-mail: [email protected]


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