The Chronicle of Healthcare Marketing - June 2010

By Todd Neale, Special toTHE CHRONICLE OF HEALTHCARE MARKETING

EXPERTS ADVISING THE WORLD

Health Organization on pandemicinfluenza and writing some of its

guidance did not disclose their financialties to the pharmaceutical industry,according to an investigative report in theBritish Medical Journal.

Some of the paid relationshipsinvolved companies that made antiviralsand vaccines and were positioned to ben-efit financially from preparations for a flu

pandemic, reported Deborah Cohen, fea-tures editor of BMJ, and Philip Carter, ajournalist with the Bureau of InvestigativeJournalism in London.

NEW EVIDENCE, NEW QUESTIONSThe conflicts of interest were never pub-licly disclosed by WHO, according to thereport, which was featured under theheadline, “Did the drug industry influenceWHO’s decisions about the swine flu pan-demic?”

The investigation “has uncoveredevidence that raises troubling questions

about how WHO managed conflicts ofinterest among the scientists who advisedits pandemic planning, and about thetransparency of the science underlying itsadvice to governments,” Cohen andCarter wrote.

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Healthcaretrends holdimportantlessons forBig Pharman Analyst recommendstaking a longer view ofindustry’s role inhealthcare, beyondproduction of drugsBy Ian J.S. Mooreof THE CHRONICLE OF HEALTHCARE MARKETING

MAJOR REFORMS ARE UNDERWAY

in the country’s healthcare sys-tem and Canadian pharmas

should start planning now on how toanticipate and respond to these some-times earth-shaking periods, IMSHealth Canada has told its clients.

“Make no mistake about it. It willbe an active period,” John Pye, the edi-tor of the company’s Health Editiontold the recent Pharma Focus 2014meetings IMS held for its clients inToronto and Montreal.

“There is a definite need for allplayers in healthcare—including thepharmaceutical industry—to be pre-pared for it. You will need to take alonger view of your role in healthcarebeyond just producing good drugs.”

In the current environment of

C o n f l i c t s o f i n t e r e s t

Investigation raises questions aboutWHO’s handling of flu pandemicn Influenza experts did not disclose financial ties to pharma, charge BMJ critics

Turn to Longer view, page 14Turn to WHO, page 8

PATIENT-CENTRED MARKETING: Uptick in PAAB reviews confirms emphasis on reaching patients • 4

PPUULLLL--OOUUTT SSUUPPPPLLEEMMEENNTT:: Drug Rep Chronicle for the evolving field force

REGULATORY: Subsequent entry biologics a challenge in Canadian market • 9

• June 30, 2010 • • www.pharmacongress.info

W a l k t o f i g h t a r t h r i t i s

The Arthritis Society’s The Arthritis Society’s first national Walk to Fight Arthritisinvolved 3,500 participants in 16 Canadian cities who raised $900,000.Among the participants was the former leader of the Toronto MapleLeaf dressing room Wendel Clark (far right), who joined the walk tosupport his mother-in-law and other friends and former teammateswith the disease. (CNW Group/McNeil Consumer Healthcare)

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Strategy • Creative • Rep Tactics • CME • Patient Adherence Programs • DTC • James Cran 416 926 2126 or 514 989 3157 • www.antibodycommunications.com

17th in series

PACLITAXEL

Is an anti-cancer treatment derived from the Pacifi c

Yew tree.

DOPAMINE

A dopamine agent used for Parkinson’s

treatment is derived from the Mucuna pruriens species.

QUININE

Comes from the bark of the cinchona tree and is a potent anti-malarial fever reducer.

COCAINE

It comes from the coca plant, and is still used today in surgeries.

ALCOHOL

Derived from fermented grain, fruit, or vegetables, it’s used widely in medicine as an antiseptic and analgesic.

MARIJUANA

THC from the cannabis/marijuana plant is a psychoactive drug used today to alleviate pain and stimulate the appetite of chemotherapy patients.

ASPIRIN

Salicylic acid was fi rst discovered in white willow bark.

ALOEThe aloe vera plant contains a

powerful antibacterial agent.

CAFFEINE

Found in coffee beans (and tea), it is the world’s most widely used stimulant.

OPIUM

Found in seeds of the poppy plant, its derivatives gave medicine its most effective pain killer.

TOP TEN SIMPLE DRUGS FROM NATURE

THAT CHANGED THE WORLD.


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Launch Phase

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Mature Phase

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Adherence and Retention Slower Erosion

BIOVAIL, Canada’s largest independentintegrated drugmaker, will merge withVALEANT PHARMACEUTICALS in a$3.2 billion deal that will see the com-bined companies headquartered in Mississauga, Ont. The merged outfitwill be called Valeant Pharmaceuticals International, and will focus onCNS and skin Txs, and generics in markets outside the USA. Valeant,once known as ICN Pharmaceuticals, currently maintains Canadianoffices in Montreal. The outfit, which will have combined annualturnover of $1.7 billion, will be helmed by Val supremo J. MichaelPearson. Biovail CEO Bill Wells will serve as non-executive chairman.The company will trade on the Toronto and New York stock exchanges.

Health Canada give thumbs up to NOVARTIS’ quadrivalent meningococ-cal conjugate vaccine for active immunization of adolescents and adults(ages 11 to 55 years) to prevent invasive meningococcal disease caused byseveral Neisseria meningitidis serogroups. Marketed as Menveo, the com-pany says it will seek approval of the vaccine for children aged two to 10.The company says meningococcal disease causes approximately 50,000deaths globally each year. n In other developments, Ottawa ordered aboxed warning to smoking cessation Rx varenicline (Champix, PFIZER),advising of potential neuropsychiatric side effects.

ASTELLAS PHARMA CANADA tapped Michael Tremblay as prexy.Outgoing helmer Fumiaki Sakurai will assume a new role at the compa-ny’s HQ in Japan. Says Seigo Kashii, CEO of Astellas Pharma US:“[Mike’s] demonstrated leadership and excellent track record will proveinvaluable to Astellas as he drives the implementation of our strategicplan for growing our business in Canada.” Tremblay has been withAstellas for 10 years, and has been sales and marketing vee-pee since2007.

Member companies in the brand-name drug industrygroup, CANADA’S RESEARCH-BASED PHARMA CEUT ICALCOMPANIES (Rx&D), last year invested $1.1 billion inresearch here, according to the lobby’s prexy. However,Russell Williams cautions: “Since 1993, Rx&D membercompanies’ total investment in R&D in Canada has aver-aged over 10 per cent of sales. The commitment made in1987 was based on a favorable environment ofaccess and reimbursement. That envi-ronment has significantly deterioratedand the commitment may no longerbe sustainable unless Canada becomes

more internationally competitive.... Weneed a strategy to compete globally andcapture a greater share of investment.”Williams’ comments were followed by a

press release from the Canadian Generic Pharmaceutical Association,which claimed R&D spending in Canada by Big Pharma dropped to itslowest level in 20 years. The clonemeisters cited statistics from the annu-al report of the Patented Medicine Prices Review Board.

Communications MECA of Montreal and Toronto-based Pal ette PublicRelations joined forces to create energi PR, a privately held, Canadianentity specializing in public relations, social media/digital and corporatecommunications, according to energi PR’s three founding partners,Esther Buchsbaum, Carol Levine and Martin Waxman. Clients of thenew firm include P&G BEAUTY brands, ASTELLAS PHARMA CANADAand FORD CANADA.

BAYER and TEVA CANADA inked a pact for Bayer’s antihypertensive Rxnifedipine (Adalat XL), where Teva will become the product’s sole dis-tributor in Canada. Says Bayer’s Doug Grant: “In the new multisource environment, we want to make sure patients have consistent access tobrand name medication at a competitive market price. We have a richpipeline of cardiovascular products and remain committed to the car-diovascular health of Canadians.”

Drug insurance plans should take a fresh look at their maximum reim-bursement prices, because Canadian generic drug prices are too high.That suggestion was contained in a discussion paper just issued by theHEALTH COUNCIL OF CANADA, which also proposed that “the use ofalternative and competing distribution channels could be encouraged.”Says the council’s CEO John G. Abbott: “Canadians pay some of thehighest prices in the world for generic drugs. [This] should help policymakers and people across the country move forward to curtail the costof generic drugs for both public and private plans while maintaining

access and quality of service.”

A study just released by the INSTITUTE FOR CLINICAL EVALUATIVESCIENCES predicts that 1.9 million new cases of diabetes will devel-

op in Canada by 2017. According to principalinvestigator Doug Manuel: “Calculating howmany people can be expected to develop dia-betes will help us refine our picture of the dia-betes ‘epidemic’ and determine the best pre-

vention strategy.”

The Chronicle of Healthcare Marketing June 30, 2010 · 3

Lower gastrointestinal anti-inflammatory 05-26

Mesalazine (5-AminosalicylicAcid, Sanis Health Inc.)Comments: New manufacturerand product name;ECT(400mg)ORL

Tricyclic antidepressant 04-29Trimipramine (supplied asTrimipramine Maleate) (AA-Trimip, AA Pharma Inc.)Comments: New manufacturerand product name; TAB(12.5mg,25mg, 50mg, 100mg)ORL;CAP(75mg)ORL

Antiepileptic / Migraine pro-phylaxis 05-26

Topiramate (Accel-TopiramateTablets, Accel Pharma Inc.)Comments: New manufacturerand product name; TAB(25mg,100mg, 200mg)ORL

Bone metabolism regulator 05-27Alendronic Acid (supplied asAlendronate Sodium)(Alendronate-FC, MeliaPharmInc.) Comments: Manufacturerand product name change;TAB(70mg)ORL

Antineoplastic agent 05-11Pemetrexed (supplied asPemetrexed Disodium) (Alimta,

Turn to NOCs page 16

N O C s o f N o t e : June 2010

Significant TTP approvals

of Rxs for human use

U p h e r eWhat’s happening in drug marketing


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The evidence is in the Markham, Ont.office of the Pharmaceutical AdvertisingAdvisory Board, which reports patient-directed material accounts for 20 per centof the volume submitted for review so farthis year, a bump up from the estimated 10per cent previously.

Pharmas, healthcare units, and othergroups are using a variety of forms andmedia to reach their target audiences,although there is no reliable data to showthat one approach or medium is superiorto others.

“We are moving from a ‘push’ basedmessage to a more word-of- mouth mes-sage to create a community on-line,” saysLindsay Peterson, vee-pee in the Torontooffice of PR firm, energiPR (formerlyCommunications Meca).

That approach was behind Meca’srecent campaign to have people with over-

active bladders contribute to creating amap of available bathrooms on the routebetween Vancouver and Whistler duringthe Winter Olympics.

Peterson agrees there is no convincingdata to show that one approach is superiorover others, but the anonymity, safety, andwelcoming environment offered by theInternet and social media create a level ofcredibility that provides a significant advan-tage over traditional print and electronicoutlets, especially with healthcare topics.

APPROACHES WILL DIFFER“The influence lies with the person, thepatient,” Peterson maintains, “and their abil-ity to share their views in a compelling way,in real time, in a peer-to-peer environment.

“At the end of the day, content—yourmessaging—is still key. And it’s reallyimportant to be as innovative and out-of-the-box as possible.”

The approach a marketer takes dependsupon the products offered and to whom theoffer is made, according to ClaudioBattaglin, manager of e-marketing at Bayer

Inc., which promotes its products to health-care pros (HCPs) and consumers through avariety of media andchannels.

“Promoting tohealthcare profes-sionals is still ourbread and butter, andwe do that with everysingle one of ourproducts,” Battaglinreports. “We go withconsumers only withthose types of prod-ucts where there is acertain consumerinvolvement for somereason or other.”

A woman usingoral contraceptives,Battaglin notes, ismore likely to beproactive about learn-ing about her OCbrand, its composi-tion, mode of action,and side effects pro-file. Another individ-ual, coming to gripswith an illness such asbronchitis, is less likely to take much, if anytime learning about the properties of theantibiotic the pharmacist dispensed.

“The majority of time the programsuse the traditional means of communicat-ing with consumers or patients, as well themore innovative, non-traditional ways.

With our Yaz oral contraceptives, forexample, if users registered online they

could get daily textmessages on their cellphones so they couldremember to taketheir pill at a specifictime during the day,”Battaglin said.

Peterson’s andBattaglin’s confidencein the power of theInternet and digitalmedia is not mis-placed, according toStatistics Canadawhich recentlyreported that last yearmore than 80 per centof Canadians aged 16and older used theInternet for personalreasons. And 70 percent of those whoaccessed various sitesfrom their homessearched for healthinformation.

The report con-firms the results of

an earlier survey released last year byEssential Research, Toronto.

“The majority of Canadian on-linehealth consumers and patients act on theinformation found on the Internet,

4 · June 30, 2010 The Chronicle of Healthcare MarketingThe Chronicle of Healthcare Marketing

This SPECIAL REPORT was compiledby Ian J.S. Moore, a frequent contribu-tor to THE CHRONICLE OF HEALTHCAREMARKETING

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PHARMAS MAY STILL BE CUTTING STAFF (PFIZERannounced last month that the company would bedistributing another 9,000 pink slips worldwide),journal advertising may still be in a death spiral(down by more than another 15 per cent in the US

between 2008 and 2009, according to IMS), but the most sig-nificant trend in the world of Canadian healthcare promotion isthe swing toward more patient-centric marketing.

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whether it’s scheduling anappointment with a doctor orstopping or taking a prescriptionmedication,” says partner LilyHolmyard.

Info from the ‘net will alsoprompt patients to prompt theirphysicians to change their medica-tion(s), and to start taking alternatemedications, Holmyard adds, andonly 18 per cent of the peopleinterviewed for the survey saidthey did nothing with the informa-tion they found on the Internet.

Web sites and social media,however, were not the primarysources of health info for therespondents. Pharmacists (80 percent) and physicians (70 per cent)were consulted most frequently,followed by general health websites (39 per cent).

MIX AND MATCHDespite its apparent power, not allcompanies rely on web sites andsocial media. Afexa Life SciencesInc., Calgary, makers of the natur-al product COLD-FX, has used asmorgasbord of public relations,television, print, social media, andcombinations of each to boost itsales to a cumulative total in early2010 of $250-million from a baseof $1.5-million in 2003

“We do a lot of the tradition-al type of marketing,” vee-pee ofmarketing Steve Wallace explains,“but we do a lot more PR andnon-traditional activity and thecommitment behind the digitalspace is to provide consumerswith the information they’re look-

ing for.”T h a t

i n f oincludes thelocal inci-dence of“cold andf l u ”throughoutthe year onthe compa-ny’s website, anddirect e-mails whenthe inci-d e n c ereaches epi-demic pre-alert oralert status.

A f e x aturned tosocial medialate last yearw h e nCOLD-FXbecame the

“official cold and flu remedy ofthe 2010 Olympics” using a viralvideo users of Facebook andTwitter could customize andupload to promote themselves as“Athlete of the Year.”

“We didn’t push the prod-uct,” said Justin Jones, director ofdigital strategy. “We also started

creating a whole range of tools, inline with our self-care philosophy,where people could assess theirown levels of immune health.”

The result of this multi-pronged campaign was a 50 percent increase in COLD-FX salesin Q1 of the current financial year.

EMPHASIS IS SHIFTINGThe emphasis in marketing todayhas shifted from physician topatient, according to Brian Good, aformer pharma guy who wentfrom bag carrier at one pharma

through the ranks to national salesdirector for another, and who isnow vee-pee at InformationDisplay Systems in Oakville, Ont.

“When I first started wealways tried on the pharma-sci-ence side to convince physiciansto ask patients the right ques-tions,” he recalls. “That’s goneaway. Now we’re concentratingon the patient asking the physi-cian the right questions.

“When you do that, you get tothe right solution much quicker.”


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Patients act on information they collect from the Internet, survey shows

Turn to PAAB page 6

IMS Payer Solutions

Raise Your Game with Payer Insights from IMSAs third-party coverage continues to grow within the marketplace, the stakes are higher than ever before,

which calls for taking a hard look at how you are playing your game, to change what needs changing and

change it quick!

Obtaining market access in an era of cost management means broadening the customer definition. And

more than ever, this means including private payers. If you compete in a market with a new product

launch, uneven formulary acceptance, formulary listing changes, or an LOE, knowledge of which payers are

driving the market changes everything.

WITH IMS PAYER SOLUTIONS, YOU’LL HAVE THE PRECISION NEEDED TO ACCURATELY IDENTIFY SOURCES

OF PRIVATELY AND PUBLICLY-PAID PRESCRIPTIONS WITH EASE.

Contact our consulting team at 514-428-6000 or 905-816-5000 or visit imshealthcanada.com

© 2010 IMS Health Canada Incorporated or its affiliates. All rights reserved.

“Now we’re concentrating on the patient askingthe physician the right

questions”—Brian Good


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6 ·June 30, 2010 The Chronicle of Healthcare Marketing

Like Afexa, Good’s agency is notwelded to any medium, but offers clients anumber of strategies and tactics, includingbrochure display systems, narrow-cast tele-vision network for MD offices, and morerecently, a wellness portal.

A PART OF PROVIDING EDUCATIONSome healthcare centers of excellence havetaken a more innovative approach andadopted the SmartPayment card system ofpharmacy reimbursement developed bySTI, Halifax, reports gee-em Bill Adams.

The system is used in smoking cessa-tion programs at the Vancouver CoastalHealth Authority, the Horizons HealthNetwork in New Brunswick, and theUniversity of Ottawa Heart Institute.

“Our system has been used in a varietyof clinical trials to help in smoking cessationclinical studies, and one of the clinical inves-tigators involved in this study had experi-enced our technology first-hand and thoughtit would be good for an extensive program.

“The program will touch a significantnumber of Canadians,” according to Adams,“and will provide excellent education andsupport for their smoking cessation efforts,using our technology to access some of thevaluable treatments that are available.”

STI Technologies, he adds, has similarprograms with pharmas working with advo-cacy groups in other areas, such as adher-ence to fasting glucose goals in diabetes.

Don Swainson, managing partner atCameron Stewart Life Sciences, Toronto,wouldn’t be surprised to see retail pharma-cy chains launch their own patient-centricprograms in coming months. The catalystfor this development was the Ontario gov-ernment’s recent decision to eliminate pro-fessional allowances, the fees generic com-panies paid to retail pharmacies.

“The pressure on pharmacies is a bignew event,” Swainson says. “I know first-hand from dealing with the pharmacy chainsthat they’re all looking at [patient-centricprograms]. Even the independents are look-ing at ways to keep the patients they’ve got.”

Swainson also expects pharmacy chainswill soon make the case to pharmas that theirdispensaries are the ideal choices as reliable,direct routes for patient-centric programs.

“The trend to more patient-centric mar-keting will continue,” he predicts. “We do alot of work with companies and more andmore they’re starting to think of putting upa patient website and identifying it directly ontheir packaging to try and get people to learnabout the medications they’re taking.

“It’s really more strategies to try andkeep patients, not necessarily to get them.”

The final words on the current trendto patient-centric marketing belong toPAAB Commissioner, Ray Chepesiuk.

“We are reviewing more projects thisyear than previous years. I remind mar-keters that existing rules related to adver-tising do come into play for this type ofpromotion and the PAAB, having exten-sive experience in this area, can help youstay on the right side of the regs.

“Please consult PAAB code section6.4.”

continued from page 5

1 Eva Road, Suite 210, Toronto, Ontario M9C 4Z5Tel 416-626-2200 Toll Free 1-877-370-3303 Fax 416-626-8810

www.thehealthinitiative.com

Rosemarie Patodia,BScPhm, CGPEditorial Director

Nadine Melemis, President, The Health Initiative Inc., is pleasedto announce the appointment of Rosemarie Patodia asEditorial Director.

Rosemarie is a pharmacist with extensive experience incommunity pharmacy with a major Canadian pharmacy chain,and has worked in both hospital pharmacy and long-termcare. Throughout her career in pharmacy, Rosemarie hasdeveloped and facilitated numerous continuing education andprofessional development programs for pharmacists and otherhealth professionals, and has built patient care programs tosupport enhanced pharmacist services. She brings her strongclinical pharmacy, management and communication skills tothis role.

Rosemarie is a graduate of the University of Toronto and has held a certification in geriatric pharmacy (CGP) for over10 years.

The Health Initiative Inc. is a full-service health carecommunications agency with over 20 years of experience inhealth care professional and patient education.

Sandra Carey,BScPharmDirector, Program Development

Nadine Melemis, President, The Health Initiative Inc., is pleasedto announce the appointment of Sandra Carey as Director ofProgram Development.

Sandra has 20 years of experience as a practising pharmacist.Over the past 10 years she has lectured at the university andcollege level and developed and facilitated continuingeducation and professional development programs for healthcare professionals. She has worked in management andleadership positions that have given her extensive knowledgeof government relations and regulatory affairs, and has beenan active participant in complex health care model changeinitiatives. Sandra brings strong skills in communication,leadership and management to this role.

Sandra is a graduate of Memorial University of Newfoundlandand Labrador.

The Health Initiative Inc. is a full-service health carecommunications agency with over 20 years of experience inhealth care professional and patient education.

1 Eva Road, Suite 210, Toronto, Ontario M9C 4Z5Tel 416-626-2200 Toll Free 1-877-370-3303 Fax 416-626-8810

www.thehealthinitiative.com

Last year, I posted a provocative question on several LinkedIngroups that stimulated much discussion: “Why is medical mar-keting still focused on the doctor when the patient is the newconsumer? Ask the patient not the doctor.” Patient-centredmarket research is focused on asking patients (consumers andcaregivers) about their information, social, and emotional sup-port needs as a way to connect with their lived experiences.Establishing a patient connection is essential for creatingauthentic patient-centred resources, including social mediatools, to help patients make informed choices.

The first place to start connecting with the patient mar-ket is right at the click of a mouse: “listen” to e-patients whoare online talking about their diseases and your brands.Augment social media audits with primary research (see Figure1) to embellish key findings and elicit insights from a more tar-geted, Canadian audience.

INSIGHTS INTO THE PATIENT MARKETHere’s what you need to know about many patients, the 3 Cs:

Confused: Patients are confused; they are bombarded witha morass of information and misinformation.

Connected: Patients want to be connected with otherpatients, doctors (as partners in care) and new, cutting-edgeinformation, particularly about new products/treatments.

Control: Patients want to be in control of their diseasejourney. They regard knowledge and planning as “power.”

PATIENTS ARE PEOPLE, NOT STATISTICSListen and connect to patients through patient-centred marketresearch. The figure provides examples of qualitative researchmethods to include in your toolkit, from traditional focus groupsto more innovative online methods that capture geographicallydispersed populations (i.e., “research without borders”).

Use methods that best address your research objectives andappeal to your target market. For example, mobile research isideal forteens/youngadults (18 to29 years),r e a l - t i m e ,and compli-ance-relatedr e s e a r c h .Online meth-ods (focusgroups, jour-naling) ort e l e p h o n ei n t e r v i ewsare ideal forpatients who are not mobile due to their disease or treatmentstage. For patients who prefer to express themselves visually,photography or videography provide creative ways to story livedexperiences. For those seeking camaraderie, meetups and twee-tups represent a new way to convene offline clubs of peoplesharing common interests. Twitter parties (moderated virtualconversations) are popular among moms.

PATIENTS HAVE PERSPECTIVESPatients—not pharma—are the users of patient websites.Pharmas should engage patients in the development and testing

of patient websites with static (information) and dynamic (socialconnectivity) features. Focus groups with patients/consumersand caregivers provide invaluable insights into technology plat-forms, information content, format/structure, features, design,and support tools. Usability testing involving triads and/or one-on-one cognitive interviewing (i.e., users are observed andrecorded as they interact physically and verbally with the web-site), provides invaluable insights into functionality, layout (‘lookand feel’), navigation pathways, and ease of navigation.

CREATING AUTHENTIC PATIENT-CENTRED SOCIAL MEDIA• Partner with patient associations to add credibility to your site.• Engage and leverage patient opinion leaders (POLs) and bloggers to build patient communities.• Add ratings and reviews to the site to build trust and show authenticity.• Give patients what they want:

Interactive (Q/A, discussion forums)Experiential (stories, testimonials)Practical (toolkits, question checklists)Personalized (customizable disease management plans)Relevant (lifestyle focus)Cutting edge (fresh, new information)Audio/visual (simulations, videos, podcasts)Mobile technologies (wireless, applications)

• Lose control (uncensored discussions, user-generated content)

COMMUNITY OUTREACH MANAGEMENT AND MODERATIONRecently, breast cancer survivor Ann Adams posted her baldheaded photo on Sanofi-Aventis’ Facebook page with an accom-panying message: “Good morning Sanofi, I had your drugTaxotere and as you can see from my photo this is what my scalplooks like four years later. Do you have any comments to make?”Rather than acknowledge and respond to the post, theFacebook group administrator blocked her from the site. Thesame photo subsequently appeared on other Facebook groupsand social media sites. Ironically, the Facebook site is called“VOICES.” Ann’s voice was not heard and she was dismissed.Clearly, this was a missed opportunity for Sanofi-Aventis to posi-tion itself as a caring, responsive company that listens topatient voices and acknowledges their pain.Recommendation:• Include a site moderator and establish the following prior

to leaping into social media:• Terms of use policy that specifies to what extent user

generated content (messages, pictures, videos) ispermissible and what topics (e.g., brand-relateddiscussions) are acceptable or unacceptable.

• Corporate policies/procedures for engaging with e-patients and managing online conversations (pre-screen comments before posting, post-screen after posting, no screening at all).

• Protocol for moderating and responding to user generatedcontent that is insulting or inappropriate, or inadvertentlyaddresses drug safety concerns, off-label use, misinfor-mation and customer services questions and concerns.

Kim Bercovitz, PhD, is a medical sociologist and president of TheResearch Doctor Inc. (www.theresearchdoctor.com), a boutique com-pany specializing in patient-centred market research, social mediamonitoring, and moderation.

Figure: Research methods toolkit

PAAB reviewingmore patient-targeted projects

De-Mystifying the Patient and E-Patient MarketBy Dr. Kim Bercovitz, Special to THE CHRONICLE OF HEALTHCARE MARKETING


Trap Editor


When patients win,everybody wins.

Congratulations BMS/sanofi -aventis Canada on winning ”Best Disease State Program”

Awarded at the annual Strategic Patient Adherence Awards by the Center for Business Intelligence.

Your partners at:


Trap Editor


8 · June 30, 2010 The Chronicle of Healthcare Marketing

Although they said that“experts need to work withindustry to develop the best pos-sible drugs for illnesses,” theyargued that “questions remainabout what level of involvementexperts with industry ties shouldhave in the formulation of publichealth policy.”

The US Department ofHealth and Human Servicescame to WHO’s defense, issuingthe following statement:

“The WHO handled the

outbreak in a very measured andappropriate manner. Their deci-sions were driven by the existingand evolving conditions at thetime and what the best scientificinformation was telling us. It’svery easy to look back through a20-20 lens and essentially be anarmchair quarterback.”

Addressing the possibility ofindustry influence on WHO’sdecisions, the HHS spokesmansaid, “The WHO based its deci-sions on strong public healthconsiderations, and I don’t think

there was any indication from ourperspective that their decisionswere influenced by industry inany way.”

The H1N1 pandemic, whichmarked its one year anniversaryon June 11, “could, of course,have been far worse,” Cohen andCarter wrote. “Planning for theworst while hoping for the bestremains a sensible approach. Butour investigation has revealeddamaging issues. If these are notaddressed, H1N1 may yet claimits biggest victim—the credibilityof the WHO and the trust in theglobal public health system.”

SECOND REPORT ADDS TOGROWING CONTROVERSYA report from the Council ofEurope Parliamentary Assemblypublished on the same day theBMJ report was released calledinto question WHO’s handling ofthe H1N1 pandemic. Thatinquiry was led by Paul Flynn, aBritish member of parliament.

A provisional version of thereport stated, “The ParliamentaryAssembly is alarmed about theway in which the H1N1 influenzapandemic has been handled, notonly by the World HealthOrganization (WHO), but also bythe competent health authoritiesat the level of the EuropeanUnion and at the national level.”

“It is particularly troubled bysome of the consequences ofdecisions taken and advice givenleading to distortion of prioritiesof public health services acrossEurope, waste of large sums ofpublic money, and also unjusti-fied scares and fears about healthrisks faced by the European pub-lic at large,” it stated.

The report also addressedthe transparency issues raised byCohen and Carter, “which havegenerated concerns about thepossible influence of the phar-maceutical industry on some ofthe major decisions relating tothe pandemic.”

EXPERTS DISPUTE CHARGESExperts contacted about the BMJreport disputed the insinuationthat researchers’ financial ties toindustry influenced WHO’s deci-sion-making surrounding pan-demic influenza in general andthe H1N1 pandemic specifically.

“I do find these investiga-tions troubling, when the onlyway WHO could be exonerated isif there had been tens of millionsdead,” said John Barry, a distin-guished scholar at TulaneUniversity and author of TheGreat Influenza. “And then we’dhave investigations about howineffective they were.”

“While I agree WHO shouldhave disclosed any relationshipbetween advisers and industry,”he continued, “based on whatWHO actually did, I find it

ºº

continued from page 1

WHO experts did not disclose financial connections to pharma

“[The parliamentary assembly] is

particularly troubled by some of the

consequences of decisions taken and

advice given leading to distor-tion of priorities of public

health services across Europe”

Turn to WHO page 15


Trap Editor



By Ian J.S. Mooreof THE CHRONICLE OF HEALTHCAREMARKETING

INTRODUCING SUBSEQUENT

entry biologics (SEBs) to theCanadian market may be a

tempting notion for some phar-mas. However tempting, though,significant questions should sur-round any decision to enter theNorth American segment of thisglobal market even though ittotalled $38.5-billion last year andis expected to chalk up world-wide sales of $55.5-billion by2016.

“The big question is ‘Is thisinvestment going to be worthit?’” lawyer Nathaniel Lipkus, ofGilbert’s LLP, Toronto, told the4th annual drug pricing and reim-bursement conference organizedby the Canadian Institute.

Lipkus, a specialist in gov-ernment relations and intellectualproperty litigation for patentholders and challengers, saidsome current Canadian regula-tions such as the formal recogni-tion of SEBs as a distinct class ofdrugs and allowing those filingNDS documents to rely on a for-eign reference product, facilitatethe entry of SEBs.

“This is a very unique provi-sion undertaken by Canada,”Lipkus said. “It says ‘Your prod-uct doesn’t actually have to beapproved here. You can use a[reference] product from else-where, and that’s good enoughfor us.’

“That’s a recognition thatcompanies are not going to bedesigning their development pro-grams from Canada, obviouslysomething that generic compa-nies were looking for.”

CERTAIN PATENTS ALLOWEDSEB sponsors (manufacturers)can also be granted additionalindications without having tounderwrite further clinical trials,but only an innovator canreceive data exclusivity for eightyears.

There are, however, someroadblocks on the route to anNOC. SEBs are considered asnew products for all purposesexcept the approval process anddeclarations of similarity or inter-changeability are not available.PM(NOC) regulations also applyto SEBs.

The result, Lipkus said, isthat a system designed for smallmolecules that only allows certainkinds of patents—not processpatents—has been applied tobiologics, and there is no indica-tion regulators intend to makechanges.

“You can expect more litiga-tion, more work for lawyers. It’sone that hasn’t played out yet, butcertainly will play out for prod-

ucts that have patents listed onthe patent register.”

Another unresolved issue isthe place of SEBs in Canadianreimbursement schemes. Whatimpact will current federal legisla-tion and regulation have on theprovincial substitution policiesthat are designed around smallmolecules? Will anticipatedchanges to the federal Food andDrugs Act affect market access

for SEBs?“Right now, we have

provinces that say generics are apercentage of the referenceproduct price on a formulary andbiologics are almost never on theformulary,” Lipkus noted.“They’re either limited use at bestor some part of a special accessprogram.”

The recent reformsannounced in Ontario will also

raise more questions. Will thereforms change the formularystatus of biologics? Will theother provinces act together toharmonize their pricing poli-cies?

REGULATORY OBSTACLESSPECIFIC TO CANADASome obstacles to SEB marketentry, such as similarity to the ref-erence product and proven prod-uct safety, are found in target

markets everywhere, Lipkus said,but some regulatory obstacles arespecific to Canada: patent link-age, interchangeability and inno-vator marketing.

“We are literally the onlycountry in the world that doesnot have patent linkage for sub-sequent entry biologics,” he said.“You’re now asking companiesto invest 30 times as much as

M a r k e t i n g t h e r a p e u t i c s

Subsequent entry biologics a challenge in Canadan Reforms in Ontario raise more questions, such as possibility of provinces harmonizing pricing policies

Turn to Bio-Similars page 12

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Trap Editor


By Dr. Kim BercovitzSpecial to THE CHRONICLE OF HEALTHCARE MARKETING

The Ontario PharmaceuticalMarketing Association socialmedia-related breakfast ses-

sion meeting was among the bestattended OPMA events of theyear, and featured interestingspeakers who discussed digitalsolutions and online marketing in

the pharmaceutical industry. NeilFollett, managing director ofBrightworks Interactive Marketing,introduced the seven talkingpoints, and Claudio Battaglin, man-ager of E-Marketing at BayerHealthcare, and Laurie DeMille,marketing manager, digital solu-tions at GlaxoSmithKline, offeredtheir insights.

“Digital” is not a tactic, any

more than “paper” is a tactic.You cannot “just digitize.” Digitalcan be implemented in a multi-tude of ways and should not bethought of as a mere extensionof a print strategy. As Follettremarked, “When is the last timeyou completed a brand plan andassigned the leftovers to ‘paper’?”

You need a clear marriagebetween the goals.

Digital strategies should employthe same mindset as marketing101 since there must be overlapbetween your goals and those ofyour target audience. Identifyyour mutual interests and devel-op your digital strategy accord-ingly.

Tactics must service the needwhile respecting the audience.Neither the pharma company or

the agency are the target audi-ence. Put yourselves in the shoesof your audience and ask the fol-lowing questions:

• Who is going to accessyour content? (your target audi-ence);

• How would they like toaccess it? (mobile device, online,branded context, extension ofexisting program); and

• Where are they accessing itfrom? (i.e., mobile device, or ipadvs. home computer involves tech-nology implications such as con-nection speeds, browsers, etc.).

Spend wisely.Companies tend to spend toomuch money implementing theirweb strategy. Programs don’tneed to be too broad or compli-cated, time-consuming, or expen-sive.

One way to manageresources is to create your digitalprogram in phases as a way tospread out the risk and spending.Roll out your promotional strate-gy slowly, attract some traffic, testthe waters, adapt and add compo-nents as you go along.

Architecture can make all thedifference.It can be challenging for users tonavigate a website. Help moveusers along the path by prioritiz-ing site architecture (structure)over design. Think throughwhich buttons you would like theusers to click on first and whichprominent components youwould like seen.

If you build they won’t come.Almost no one will type in yourURL except you and your agency.Figure out a strategy to directtraffic flow to your site.Continually monitor how usersinteract with online content andnavigate the site.


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Turn to OPMA page 13


Trap Editor



Trap Editor


they did for small molecules andyet deal with the same incum-bencies.

“So, the question is ‘Ifyou’re breaking new barriers,what does that market looklike?’”

Another major questionhovers about the issue of dataprotection, he added. Today, pro-tection in Canada lasts for eightyears, but in Europe it is for 10and in the US,. 12 years. Will pro-tection be extended here, asEurope and lobbyists are insist-ing?

“At this point it is too earlyto say,” Lipkus said, “but it mat-ters. It matters enough that it’sthe number one issue for bios inthe United States.”

PAYERS ALWAYS LOOKING FORSOME KIND OF COST SAVINGSThree marketing strategies areavailable for SEB companies inCanada, Lipkus reported: Biobetter (high price, heavy market-ing), bio-similar (medium price,medium marketing) and bio-generic (low price, low market-ing).

“I think what market strate-gy dominates matters,” Lipkussaid, “because it will shape policy,and it will shape the pricingresponse the companies want toget. It’s something to watch outfor.”

So far, none of theprovinces have indicated theyplan to look for cost savings withSEBs, he noted, but they do haveoptions, whether through classi-fying SEBs as preferred drugs orperhaps even imposing a maxi-mal allowance cost in the thera-peutic area.

“The world is their oyster.But is the political will there, orwill it be something they don’twant to deal with and let the mar-ket take care of itself ?”


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Merck will invest $17.3 million over five years to enableToronto’s University Health Network (UHN) through Princess MargaretHospital and its research arm, the Ontario Cancer Institute, to join leading can-cer research institutions around the world as a centre of excellence for clinicaltrials of new drugs for cancers. From left to right: Dr. Christopher Paige, vicepresident, research, University Health Network; Dr. Malcolm Moore, head ofthe department of medical oncology and hematology and the Robert andMaggie Bras and Family New Drug Development Program; Dr. Ben Neel,director of the Ontario Cancer Institute and the Campbell Family CancerResearch Institute; Honourable John Milloy, Ontario’s Minster of Research andInnovation; Carlos Dourado, president of Merck; Dr. Eric Rubin, vice presi-dent, clinical research, oncology, Merck Research Laboratories.

Bio-similars:Will Canadianprovinces act toharmonize their pricing policies?—continued from page 9


Trap Editor


Don’t even think about socialmedia.Social media is a tactic that comeslater in the digital planningprocess. Instead of asking whattools your company should use,ask why and for what target marketthey be used.

Public sites such asFacebook may not be appropriatefor sensitive therapeutic areassuch as acne or erectile dysfunc-tion. Alternatively, Facebook canbe a preferred tool among userswho prefer simple sites with usergenerated content.

Pharma opportunities,challenges moving forwardPharma marketers “don’t knowwhat they don’t know” especiallywith a continually changingonline marketplace, Battaglinnoted. Some agencies looking fornew opportunities try to be a“jack of all trades and a master atnone.” He added that one of thechallenges pharma faces is find-ing the right vendor/agency part-ner (with experience in digital,pharma ,and the Canadian mar-ket) to learn together in thisevolving digital space.

There is no formal digitalprocess yet, DeMille said. Thekey is to listen and understandcustomers’ needs first. Digital isappropriate for some brands butnot others, she said. When thereis money left over in the budget,digital is added to the marketingmix, but when there are budgetcuts, digital is often the first togo. It’s a good idea to convinceprocurement to expand suppli-er/vendor services to ensurethat digital specialists are onboard.

Digital can be phased inslowly—one brand at a time—toget some “quick wins” started,DeMille said. This, addedBattaglin, enables pharma to“blaze the path” and integrate keylearning across other brands andprograms. You can integrate digi-tal into current brand strategies(e.g., buy ad space online and off-line). The challenges for pharmais to be “on the pulse” of a fast-paced field with a continuallyevolving menu of online tactics.

Kim Bercovitz, PhD is a med-ical sociologist and president ofThe Research Doctor Inc.(www.theresearchdoctor.com),a boutiquecompany spe-cializing inpat ient-cen-tred marketr e s e a r c h ,social mediamonitoring and moderation.


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OPMA speakerstake a turn at tryingto figure out onlinemarketing strategies—continued from page 10


Trap Editor



economic and financial belt tight-ening, value for money is the keyfactor. Pharmas will have todemonstrate this concept in theirproduct and services offerings asnever before.

“Hospitals are in for the bighurt in the restructuring process,”Pye predicted. “It is going to be avery difficult environment to dobusiness with these customers.Hospital managers will be lookingfor help to deal with expenditures,and drugs, particularly cancer

therapies, are in the top part ofthe list.”

Opportunities will alsoemerge during the healthcarerestructuring process and phar-mas should look for them on amarket by market basis. Chronicdisease prevention and healthyliving are but two of these oppor-tune markets envisioned by IMS.

APPROACHES TO CONSIDER“These programs are the first tofall when budgets have to be cut,as we have already seen,” Pye

said. “Supporting such programswould make sense for you, andwill win you a lot of points aswell.”

Pharmas, he added, will alsohave to pay attention to itsbiggest client segment, Canadianphysicians. A large number willretire from practice within thenext five years, and their youngerreplacements, an IT savvy group,are expected to be working short-er hours.

“They will be under greaterscrutiny to make responsible use

of healthcare resources throughperformance contracts,” Pyesaid. “You will have to make sureyour value for money proposi-tion is linked to these perfor-mance contracts they will be try-ing to meet.”

In the short term, Pye said,service delivery issues areinevitable as the provinces grap-ple with their deficits. Ontario,for example, intends to restricthospital budget increases to 1.5per cent, down from the previous2.1 per cent.

“This is going to be a diffi-cult course for governments tonavigate, considering that half ofthem are up for re-election nextyear,” Pye said.

“The push-back from voters,unhappy with healthcare servicesin their communities, may testtheir resolve.”

In the short to mediumterm, he predicted, the debate onhow, or if, the healthcare systemcan be sustained will also heat up.Quebec recently announced avariety of measures to raise newhealthcare revenues, and thesehave set the stage for argumentsand proposals about the parame-ters of service delivery and fund-ing structures.

“It only takes one provinceto push the envelope for theCanada Health Act for others tofollow, and Quebec is better posi-tioned than any of them to dothis,” Pye said.

Looking toward a longertime line, Pye foresees the privatesector offering more deliveryoptions as the public servicebecomes less and less able “to beall things to all people” andCanadians increase theirdemands for access to qualityhealthcare and the latest thera-pies.

Propelling the current andanticipated changes in the health-care system are the fiscal chal-lenges that lay ahead for the fed-eral and provincial governments,he said.

ANNUAL INCREASES WILL BELOWER THAN ANTICIPATEDThe recent recession squeezedCanada’s GDP by 3.6 per cent,and the federal governmentexpects to record deficits everyfiscal year from now to 2014-15.According to reports, it intendsto manage these deficits mainlythrough reductions in programbudgets and healthcare will notbe spared.

“The provinces have hadtheir own economic stimulusprograms,” Pye noted, “and againthis will produce a sea of red inkin the next five years. Again it is acocktail of falling tax revenuesand loose spending.”

Healthcare expenditures thisyear will swallow 40 per cent ofOntario budget dollars and 45per cent of Quebec’s budget.According to information fromthe Canadian Institute for HealthInformation, the provinces hadoriginally been expected to boosttheir health spending overall by7.2 per cent.

“The future outlook forhealth spending is a lot more fru-gal,” Pye reported. Severalprovinces (BC, Saskatchewan,Ontario, and Quebec) have indi-cated their increases in the nexttwo fiscal years will be in thethree per cent range.

Longer view may help pharma cope with changes in healthcare policycontinued from page 1


Trap Editor



WHO experts did not disclose financial connections to pharmaabsurd to accuse them of havingbeen influenced by the drugindustry. Antivirals, though hard-ly a magic bullet, are the onlydrug option. And a recommenda-tion to stockpile them was theonly option.”

PREPARATIONS JUSTIFIEDAddressing concerns that thepandemic was declared to profitpharmaceutical companies, Barrysaid that “if anything, WHO wasslow to make that call. And if youknow anything about the historyof the influenza virus, again ithad no option. 1918 saw a verymild spring wave, quite compara-ble to what we experienced in2009. It turned virulent monthslater.”

Dr. John Treanor, a vaccineexpert at the University ofRochester Medical Center, inRochester, NY, agreed thatWHO’s preparations were justi-fied.

“I think even the authors [ofthe BMJ report] would have toagree that there really was nochoice here but to prepare for apandemic,” he said. “If there hadbeen a severe pandemic and therehad been no preparations, theoutcome (and the outcry) wouldhave been far worse.”

Although some of theWHO’s advisers received com-pensation from manufacturers ofthe same antivirals and vaccinesrecommended for use during theH1N1 pandemic, Treanor notedthat there are few options avail-able for combating influenza.

“You can tweak the plans—how much antivirals, what kinds,where is the vaccine comingfrom, who should be vaccinatedfirst, should you close schools,etc.—but the basic elements aregoing to be the same,” he said.“So I don’t see the argument hereas whether WHO made the rightrecommendation at the time,regardless of who was advisingthem—they clearly did.”

One researcher, Dr. HenryMiller, criticized WHO for mis-takes made, including the declara-tion of a pandemic for H1N1influenza in the first place.However, “the stockpiling ofanti-flu medicines and the pro-duction of vaccine weren’tamong them,” said Miller, abiotechnology expert at StanfordUniversity’s Hoover Institution.

“Much of the criticism ofWHO as having been undulyinfluenced by industry seems tobe coming from anti-industryNGOs [nongovernmental orga-nizations],” Miller said.

PLANNING BEGAN IN 1999Cohen and Carter detailedWHO’s pandemic influenzapreparation starting in 1999,when a preparedness plan wasdrafted by six researchers in col-

laboration with theEuropean ScientificWorking Group onInfluenza (ESWI).Over the next decade,according to theirinvestigation, WHOfailed to discloseindustry ties amongresearchers advisingthe organization.

The documentdrafted in 1999 didnot include informa-tion on conflicts of

interest. Cohen and Carter point-ed out that ESWI is fundedentirely by Roche, which makesoseltamivir (Tamiflu), and thattwo of the authors of the docu-ment had participated in Roche-sponsored events in the previousyear. Both were also involved in arandomized controlled trial ofoseltamivir supported by thecompany.

Copyright 2010 MedPage Today LLC. -All rights reserved. Reprinted with permission. www.medpagetoday.com

continued from page 8“If there hadbeen a severepandemic andno prepara-

tions, the out-cry would have

been farfarworseworse”


Trap Editor


Eli Lilly Canada Inc.) Comments: New indication:Maintenance treatment of locally advanced or metastatic non-squamous non-small cell lung cancer, in good performancestatus patients without disease progression immediately fol-lowing four cycles of first-line platinum doublet chemothera-py, excluding pemetrexed; PWSO(100mg/vial, 500mg/vial)IV

Smoking-cessation aid 05-28Varenicline (supplied as Varenicline Tartrate) (Champix,Pfizer Canada Inc.) Comments: Safety updates to theProduct Monograph; KIT, TAB(0.5mg / 1mg)ORL

Antibiotic 05-28Clindamycin (supplied as Clindamycin Phosphate) /Octinoxate / Avobenzone (Clindasol, GlaxoSmithKlineInc.) Comments: Manufacturer name change;CRM(1%/7.5%/2%)TOP

Topical antibiotic 05-20Clindamycin (supplied as Clindamycin Phosphate)(Clindets, GlaxoSmithKline Inc.) Comments:Manufacturer name change; PAD(1%)TOP

Topical acne therapy 05-07Clindamycin (supplied as Clindamycin Phosphate) /Benzoyl Peroxide) (Clindoxyl Gel, GlaxoSmithKline Inc.)

Comments:Manufacturer namechange; GEL(10mg/g /50mg/g)TOP

Lipid metabolismregulator 04-29Rosuvastatin (supplied asRosuvastatin Calcium)

(AstraZeneca Canada Inc.) Comments: New indication: usein pediatric patients 10-17 years old with heterozygous famil-ial hypercholesterolemia; TAB(5mg, 10mg, 20mg, 40mg)ORL

Active immunizing agent 05-21Pertussis Toxoid, Filamentous Haemagglutinin, FimbriaeType 2 and 3 (FIM), Pertactin, Tetanus Toxoid, DiphtheriaToxoid, Inactivated Poliomyelitis Vaccine (V.C.O.) Type 1Mahoney, Inactivated Poliomyelitis Vaccine (D.C.O.) Type 2M.E.F. 1, Inactivated Poliomyelitis Vaccine (V.C.O.) Type 3Saukett (Adacel-Polio, Sanofi Pasteur Ltd.) Comments:SUS(2.5mcg/0.5ml, 5mcg/0.5ml, 5mcg/0.5ml, 3mcg/0.5ml,5LF/0.5ml, 2LF/0.5ml, 40unit/0.5ml, 8unit/0.5ml,32unit/0.5ml)IM

Corticosteroid 05-27Amcinonide (Cyclocort, GlaxoSmithKline Inc.)Comments: Manufacturer name change; CRM(0.1%)TOP;LOT(0.1%)TOP; ONT(0.1%)TOP

Hormonal contraceptive 05-07Norelgestromin / Ethinyl Estradiol (Evra, Janssen-OrthoIncorporated) Comments: Changes to the adhesive com-ponent of the patch and the drug product specification;ERP(6mg / 0.6mg)TRD

Oral antihyperglycemic agent / DPP- 4 inhibitor /Incretin enhancer 05-14

Sitagliptin (supplied as Sitagliptin Phosphate Monohydrate)(Januvia, Merck Frosst Canada Ltd / Merck Frosst CanadaLtée) Comments: New indication: Januvia is indicated in com-bination with metformin and a sulfonylurea in adult patientswith type 2 diabetes mellitus to improve glycemic control whendiet and exercise, and dual therapy with these agents, do notprovide adequate glycemic control; TAB(100mg)ORL

Human immunodeficiency virus (HIV) proteaseinhibitor 06-04

Lopinavir / Ritonavir (Kaletra, Abbott Laboratories,Limited) Comments: New dosing administration: oncedaily dosing in antiretroviral treatment-experiencedpatients; TAB(100mg/25mg, 200mg/50mg)ORL;SOL(80mg/ml / 20mg/ml)ORL

Eyelash growth enhancer 05-05Bimatoprost (Latisse, Allergan Inc.) Comments:SOL(0.03%)TOP

Antibiotic 05-27Minocycline (supplied as Minocycline Hydrochloride)(Minocin, GlaxoSmithKline Inc.) Comments:Manufacturer name change; CAP(50mg, 100mg)ORL

Progestogen 05-11Levonorgestrel (Mirena, Bayer Inc.) Comments: New indi-cation: treatment of idiopathic menorrhagia followingappropriate diagnostic investigation in women acceptingthe contraceptive effect of Mirena; INSER(52mg/unit)IU

Angiotensin converting enzyme inhibitor 04-27Lisinopril (Prinivil, Merck Frosst Canada Ltd. / MerckFrosst Canada Ltée) Comments: Revisions to the ProductMonograph: use in hypertensive pediatric patients;TAB(5mg, 10mg, 20mg)ORL

Renin inhibitor 05-25Aliskiren (supplied as Aliskiren Fumarate) (Rasilez, NovartisPharmaceuticals Canada Inc.) Comments: Update packagelabels to approved indication; TAB(150mg, 300mg)ORL

Anti-vertigo agent 05-28Betahistine Hydrochloride (Serc, Abbott Products Inc.)Comments: Manufacturer name change; TAB(16mg,24mg)ORL

Coagulant 06-04Antihemophilic Factor (Recombinant) (Advate, BaxterHealthcare Corporation) Comments: New manufacturingfacility; PWSO(250unit/vial, 500unit/vial, 1000unit/vial,1500unit/vial, 2000unit/vial, 3000unit/vial)IV

Antiarrhythmic agent 06-01Amiodarone Hydrochloride (Teva-Amiodarone,Amiodarone for Injection, Teva Canada Limited)Comments: Teva-Amiodarone: Manufacturer and productname change; TAB(200mg)ORL; Amiodarone for Injection:Manufacturer name change; SOL(50mg/ml)IV

Elevated intraocular pressure therapy / ProstaglandinF2alpha analogue 06-04

Travoprost (Travatan Z, Alcon Canada Inc.) Comments:Removal of preservative formulation from the Canadianmarket; SOL(0.04%)OPH

Antiviral agent 05-19Valganciclovir (supplied as Valganciclovir Hydrochloride)(Valcyte, Hoffmann-La Roche Limited) Comments:Extension of treatment duration for the prevention ofCMV disease and addition of Pediatric, Pharmacokineticdata; PWSO(50mg/ml)ORL; TAB(450mg)ORL

Antineoplastic agent 05-27Pazopanib (supplied as Pazopanib Hydrochloride)(Votrient, GlaxoSmithKline Inc.) Comments: TAB(200mg,400mg)ORL

Antineoplastic agent 05-13Trabectedin (Yondelis, Janssen-Ortho Incorporated)Comments: PWSO(0.25mg/vial, 1mg/vial)IV

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been a bunch of losers, too—and never forget, the advent of a

good journal will soak up more of the worthwhile papers, lifting up the ever-expanding poolof mediocre stuff (and worse) by capillary action. You have to fill those pages somehow!

If this problem is driven largely by academia, that’s where the solution will have tocome from, too. The authors suggest several fixes: (1) limit job applications and tenurereviews to the top five or six papers that a person has to offer. (2) Prorate publicationrecords by the quality of the journals that the papers appeared in. (3) Adopt length restric-tions in printed journals, with the rest of the information to be had digitally.

I don’t think that those are bad ideas at all—but the problem is, they’re already more orless in effect. People should already know which journals are the better ones, and look askanceat a publication record full of barking, arf-ing papers from the dog pound. Already, the bestpapers on a person’s list count the most. And as for the size of printed journals, well. . .thereare some journals that I read all the time whose printed versions I haven’t seen in years.

CONTRIBUTING TO CAREER MEDIOCRITYNo, these ideas are worthy, but they don’t get to the real problem. It’s not like all the crap-py papers are coming from younger faculty who are bucking for tenure, you know. Plentymore are emitted by well-entrenched groups who just generate things that no one ever real-ly wants to read. I think we’ve made it too possible for people to have whole scientificcareers of complete mediocrity. I mean, what do you do, as a chemist, when you see anoth-er paper where someone found a reagent to dehydrate a primary amide to a nitrile? Did youread it? Of course not. Will you ever come back to it and use it? Not too likely, consider-ing that there are 860 reagents that will already do that for you. We get complaints all thetime about me-too drugs, but the me-too reaction problem is a real beast.

Now, I realize that by using the word “mediocrity” I’m in danger of confusing theissue. The abilities of scientists are distributed across a wide range—I doubt if it’s a truenormal distribution, but there are certainly people who are better and worse at this job. ButI’m complaining on the absolute scale, rather than the relative scale. I know that there’salways going to be a middle mass of scientific papers, from a middle mass of scientists: Ijust wish that the whole literature was of higher quality overall. A chunk of what now goesinto the mid-tier journals should really be filling up the bottom-tier ones, and most of thestuff that goes into those shouldn’t be getting done in the first place.

I suppose what bothers me is the number of people who aren’t working up to theirpotential (although I don’t always have the best position to argue that from myself!) Toomany academic groups seem to me to work on problems that are beneath them. I knowthat limits in money and facilities keep some people from working on interesting things, butthat’s rare, compared to the number who’d just plain rather do something more predictable.And write predictable papers about it. Which no one reads.

Derek Lowe writes for In the Pipeline, a pharma-related blog available atCorante.com. Reprinted with permission of the author.


BIG PHARMA’s proportion of sales fromnewer Rxs has dropped, and the industrycontinues to rely on a rapidly aging suiteof products, according to a new report.Data from the 2010 Pharmaceutical R&DFactbook shows that the top three drugsfor a drugmaker contributes, on average,44 per cent of the company’s total sales.Says Hans Poulsen, head of consulting atCMR International, which issued the find-ings: “The latest data shows that poor pro-ductivity in 2009 continued to be [exacer-bated] by the low success rate for drugs inlate stage development and a decline insales from new drugs launched within thelast five years.”

ALLERGAN, BIOGEN IDEC, CELGENE,GENZYME and GILEAD SCIENCES arethought to be among the candidates onthe shopping list of Sanofi-Aventis, as thecompany seeks a US-based acquisition,reports Bloomberg news service. HOSP -IRA, the hospital supply outfit, and nutri-tionals maker MEAD JOHNSON are con-sidered outside shots, according to specu-lation. Sanofi, which has bulked up with$17 billion worth of acquisitions in thepast two years, is believed to be seeking astateside company valued at around $20billion. An observer tells Bloomberg:“Sanofi have made it very clear they gen-erate lots of cash and part of their way ofmitigating the patent cliff is rein-vesting capital.” Sanofi has beenrumored to be in merger talkswith Bristol-Myers Squibb onseveral occasions, but BMSdoesn’t appear to figure in thecurrent rumors.

Policy makers are vehemently opposed todrug marketers offering free meals, travel,and gifts to doctors, but apparently noone’s ever thought of asking the doctorshow they feel about things. Well, accord-ing to a study of 590 physicians just pub-lished in the Archives of Surgery, 72 per centof physicians say they like the marketingtrinkets and dinners, while only half thatpercentage claim they are influenced towrite prescriptions by the offerings.However, when asked if their colleaguesmight be influenced, 52 per cent said,“Sure they would.”

PIERRE FABRE GROUP, the second largestindependent French pharmaceutical com-pany, tapped Olivier Bohuon as CEO, effec-tive Sept. 1. Bohuon is an old Abbott hand,who served as prexy of the pharma divi-sion. He will replace Jean-Pierre Garnier.

Waste not, want not, said BenjaminFranklin, but the U.S. DEPARTMENT OFHEALTH AND HUMAN SERVICES has itsown ideas. The agency says 40 million doesof swine flu vaccine, representing 25 percent of a production run, has expired andwill be incinerated. Value of the inventory:$260 million. The agency says it may chuckanother 30 million doses later this year,which would mean 43 per cent of thenation’s stockpile will have been trashed.Says Bill Hall, spokesman for the agency:

“Although there were many dosesof vaccine that went unused, it wasmuch more appropriate to have

been prepared for the worst casescenario than to have had too few

doses.” (See article, page 1)

D o w n t h e r eWhat’s happening in the world of drug marketing

Worthless papers still getting published—continued from page 18


Trap Editor



Sorry, but we happen to be fresh out of drugs today

DEPENDABILITY IS WHAT CANADIANS LOOK FOR

from our institutions. And, come what may, thepublic utilities suppliers live up to expectations by

reliably cranking out your electricity, pumping your tap-water, collecting your recyclables, and processing yoursewage. Similarly, Tim Horton’s, rightly regarded as thegreatest of all Canadian bulwarks, achieved its exalted sta-tus in part because it never exhausts its inventory of dou-ble-doubles while you’re making your way to the counter.Following those principles, it should never have to occurto patients that Canadian drugstores might run out ofdrugs. Except that it has. Because, amazingly, they have.

The great drug shortage of 2010, documentedrecently on the front pages of newspapers from Sask -atchewan to Newfoundland, arrives at an especially sus-picious time. For more than a decade, patients havehearing suggestions that Ottawa’s price controls onbranded pharmaceuticals, in a globally driven market-place, might one day suppress needed local supplies ofnewly introduced products, including difficult-to-manu-facture biologicals.

However, this current situation seems to have

nothing to do with new branded drugs. According toreports, the shelves seem to be increasingly bare ofmainstay generic therapies. The Star-Phoenix newspaperof Sask atoon reports community pharmacies on anaverage business day are short of up to 40 prescriptiondrugs. Says one local druggist: “I’ve been a pharmacistfor 17 years and I’ve never seen anything like thisbefore. And I’ve never seen it be such a mystery, suchas why this shortage is happening. Even our provincialregistrar, our top boss, said that he doesn’t know why.”

The scarcity has challenged the ingenuity of phar-macists. Pill-counters have been forced to brush up ontheir long-dormant compounding skills. According tothe Telegram of St. John’s, pharmacists in Newfound -land are reformulating children’s liquid versions ofRxs, to compensate for the inavailability of adult-strength tablets.

The shortage, while officially inexplicable, seems tohave been on the horizon at least since this January,when Apotex announced without explanation that itwould discontinue Apo-Levocarb CR, its version ofanti-Parkinsonian Tx Sinemet CR (Bristol-MyersSquibb.) The company, known for its exceptionallyloquacious founder and management, lately has beenclose-lipped on supply matters, and the Canadian Gen -eric Pharma ceutical Association, which previously has

been able to explain just about anything, isuncharacteristically at a loss for words.However, the CGPA’s Julie Tam did seem toinfer that changing economics might play arole. Ont ario recently enacted Bill 16,reducing formulary pricing for generics,effectively slicing the price it pays by up tohalf. Other provinces appear poised to fol-low. Ms. Tam, acknowledging that marginshave been tightened, tells the Telegram:“Depending on the drug, you don’t alwayshave the luxury of making lots of extrabatches.”

Some anxious commentators have rushed to con-clude that generics manufacturers may be dialing downsupplies as a means of protesting Ontario’s actions.While this publication has found fault, on occasion,with certain practices of the generics industry, we flat-ly reject the idea that the current drug shortages arepart of a design intended to punish politicians byalarming the public.

It is more plausible to blame Barack Obama. By enacting expanded health coverage in the US,

President Obama has broadened the stateside market forgeneric drugs. Resultantly, Canadian generic manufactur-ers have sought FDA certification to produce medicinefor export to the US, which first requires a stringentreview by inspectors of operating and quality assuranceprocedures. The process, according to some accounts,may be responsible for slowing or disrupting domesticsupply lines in Canada. It’s one theory that, in the absenseof other explanations, has some resonance.

Regardless of the cause, the shortages must beviewed with grave concern. A recent article in the jour-nal Neurology (2009; 73:213-217) entitled “Causes andcosts of a generic drug shortage” examined the conse-quences of the inavailability in the US of ParkinsonianTx selegiline (a compound for which, coincidentally,five out of six scrips are filled by Apotex.) The article’sauthors provide a prescient comment: “Generic drugshortages carry economic and health implications.Given ongoing consolidation in the generics drugindustry, these shortages may become more commonand may require heightened regulatory scrutiny of thegeneric drug industry.”

For Ottawa, this should be a simple puzzle to solve.The way to ensure a dependable and affordable arma-mentarium of generic drugs is to encourage a greaterdegree of competition in the sector—which can be quick-ly achieved by opening up our market to reputable foreignsuppliers. Honorable Leona Aglukkaq? Where do youstand on this issue?

All those worthless papersBy Derek Lowe, Special to THE CHRONICLE OF HEALTHCARE MARKETING

THAT’S WHAT THIS ARTICLE AT THE CHRONICLE OF HIGHER EDUCATION COULD BE CALLED. INSTEAD IT’Sheadlined “We Must Stop the Avalanche of Low-Quality Research”. Which still gets the point across.Here you have it:

While brilliant and progressive research continues apace here and there, the amount of redundant, incon-sequential, and outright poor research has swelled in recent decades, filling countless pages in journals andmonographs. Consider this tally from Science two decades ago: Only 45 per cent of the articles published in the4,500 top scientific journals were cited within the first five years after publication. In recent years, the figureseems to have dropped further. In a 2009 article in Online Information Review, Péter Jacsó found that 40.6per cent of the articles published in the top science and social-science journals (the figures do not include thehumanities) were cited in the period 2002 to 2006.

As a result, instead of contributing to knowledge in various disciplines, the increasing number of low-cited publications only adds to the bulk of words and numbers to be reviewed. Even if read, many articles thatare not cited by anyone would seem to contain little useful information.

WHY DO ALL THESE PAPERS GET WRITTEN?If anything, this underestimates things. Right next to the never-cited papers are the grievously undercited ones,most of whose referrals come courtesy of later papers published by the same damn lab. One rung further outof the pit are a few mutual admiration societies, where a few people cite each other, but no one else cares verymuch. And then, finally, you reach a level that has some apparent scientific oxygen in it.

The authors of this article are mostly concerned about the effect this has on academia, since all thesepapers have to be reviewed by somebody. Meanwhile, libraries find themselves straining to subscribe to all thejournals, and working scientists find the literature harder and harder to effectively cover. So why do all thesepapers get written? One hardly has to ask:

The surest guarantee of integrity, peer review, falls under a debilitating crush of findings, for peer review canhandle only so much material without breaking down. More isn’t better. At some point, quality gives way to quantity.

Academic publication has passed that point in most, if not all, disciplines—in some fields by a long shot.For example, Physica A publishes some 3,000 pages each year. Why? Senior physics professors have well-financed labs with five to 10 PhD-student researchers. Since the latter increasingly need more publications tocompete for academic jobs, the number of published pages keeps climbing.

We can also lay off some blame onto the scientific publishers, who have responded to market conditions bystarting new journals as quickly as they can manage to launch them. And while there have been good quality jour-nals launched in the past few years, there have

THE CHRONICLE OF HEALTHCARE MARKETING welcomes contributions fromreaders. In particular, we’d like to know what’s 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 you’re submitting an article, opinion piece, press release, or letter to the edi-tor for consideration, please bear in mind that we select material for publicationfrom a large volume of submitted material, and that we may not be able to publishyour submission in a specific issue (or at all) due to space constraints and other con-siderations.

Our policies are: All material submitted to THE CHRONICLE becomes the prop-erty of Chronicle Information Resources Ltd., and is subject to the company’s usualeditorial procedures; We will not consider for publication any material that has beensimultaneously sent to other publications; Only original material or information willbe 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; andMy 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]

Published seven times annually by theproprietor, Chronicle Infor mationResources Ltd., from offices at 555Burnhamthorpe Rd., Suite 306, Tor -onto, Ont. M9C 2Y3 Canada. Tele -

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Contents © Chronicle Information Resources Ltd., 2010, 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 othercountries. Combined rate including Chronicle MONDAY and ChronicleMIDWEEK newsletters: $240 per year in Canada, $360 per year in all othercountries. Single copies: $7.95 per issue (plus 5% GST).

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ISSN 1209-0654

June 30, 2010 • Published with Chronicle MONDAY and Chronicle MIDWEEK

EDITORIAL DIRECTOR

R. Allan RyanSENIOR ASSOCIATE EDITOR

Lynn BradshawASSISTANT EDITOR

Josh Long

SALES & MARKETING

Henry RobertsPRODUCTION & CIRCULATION

Cathy DusomeCOMPTROLLER

Rose Arciero

PUBLISHER

Mitchell Shannon

Turn to Worthless papers, page 17


Trap Editor


* SRx is a prescription captured at all retail pharmacies and reported within 24 hours. PIPEDA and CAI compliant.

SmartTechnology programs offer an accurate, relevant and timely measure of new patient starts.

Once a SmartTechnology

product is redeemed at

any retail pharmacy,

it becomes a legal

prescription (SRx*).

This SRx data is reported by thepharmacy to STI in Real-Time, and then

provided within 24 hours

to a customer.

Every SmartTechnology program

includes specific redemption

information by pharmacy and

territory along with important

patient age/gender demographic

information.

All SmartTechnologyprograms supply anearlier and more relevant indicator of actual sales (SRx is non-projected).

Sales Representative physician distributions

can be captured within CRM systems.

Once each distribution is linked to an

SRx redemption, it identifies high and

low prescribing physicians in Real-Time.

Ultimately, SmartTechnology programs allow business decisions to be made sooner at an individual physician level,more quickly driving top line sales for your brand.

V i s i t S R X r e a l t i m e R O I . c a o r c a l l 9 0 2 . 4 5 0 . 5 5 0 0

Alternative sampling and pharmacy co-pay

assist solutions...tracking actual patients


Trap Editor



Trap Editor


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