april2008

In October 2006, Dr. Claudia Henschke of Weill Cornell Medical College jolted the cancer world with a study saying that 80 per cent of lung cancer deaths could be prevented through widespread use of CT scans.

Small print at the end of the study, published in The New England Journal of Medicine, noted that it had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. A review of tax records by The New York Times shows that the foundation was underwritten almost entirely by US$3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands.

The foundation got four grants from the Vector Group, Liggett’s parent, from 2000 to 2003.
Dr. Jeffrey M. Drazen, editor in chief of the medical journal, said he was surprised. “In the seven years that I’ve been here, we have never knowingly published anything supported by” a cigarette maker, Dr. Drazen said.

An increasing number of universities do not accept grants from cigarette makers, and a growing awareness of the influence that companies can have over research outcomes, even when donations are at arm’s length, has led nearly all medical journals and associations to demand that researchers accurately disclose financing sources.

Dr. Henschke was the foundation president, and her longtime collaborator, Dr. David Yankelevitz, was its secretary-treasurer. Dr. Antonio Gotto, dean of Weill Cornell, and Arthur J. Mahon, vice chairman of the college board of overseers, were directors.

FOUNDATION ORGANIZED QUICKLY
Vector issued a press release on Dec. 4, 2000, saying that it intended to give US$2.4 million to Weill Cornell to finance Dr. Henschke’s research. Articles in Business Week and USA Today mentioned the gift. No mention was made of the foundation, begun so hastily that its 2000 tax return stated “not yet organized.”

Paul Caminiti, a Vector spokesman, confirmed that the company donated US$3.6 million to the foundation over three years. The company “had no control or influence over the research,” he said.

Prominent cancer researchers and journal editors, told of the foundation by the Times, said they were stunned to learn of Dr. Henschke’s association with Liggett. Cigarette makers are so reviled among cancer advocates and researchers that any association with the industry can taint researchers and bar their work from being published.

“If you’re using blood money, you need to tell people you’re using blood money,” said Dr. Otis Brawley, chief medical officer of the American Cancer Society. The society gave Dr. Henschke more than US$100,000 in grants from 2004 to 2007, money it would not have provided had it known of Liggett’s grants, Dr. Brawley said.

In an e-mail message, Drs. Henschke and Yankelevitz wrote, “It seems clear that you are trying to suggest that Cornell was trying to conceal this gift, which is entirely false.”
“The gift was announced publicly, the advocacy and public health community knew about it, it is quite easy to look it up on the Internet, its board has independent Cornell faculty on it, and it was fully disclosed to grant funding organizations,” they wrote, adding that the Vector grant represented a small part of the study’s overall cost. The foundation no longer accepts grants from tobacco companies, they wrote.

In the Vector press release, Dr. Henschke was quoted as saying that, thanks to the Vector grants, “we have raised the initial funding needed to support this important research and data collection on the effectiveness of spiral CT screening.”

Dr. Gotto said in an interview that Dr. Henschke, Dr. Yankelevitz, and another colleague set up the foundation initially without the university’s approval, which he said faculty members are allowed to do. He and Mr. Mahon joined the board some weeks or months after its creation to ensure that the Vector grants were handled correctly, he said.
“If we had been approached, we would not have set up the foundation,” Dr. Gotto said. “We would have accepted the gift directly. We think we behaved honorably. There was no attempt to set up a foundation to hide tobacco money.”

Days earlier, Andrew Ben Ami, assistant secretary of the foundation, said in an interview he would not disclose the source of the charity’s financing at the request of the university.
In another interview before Dr. Gotto agreed to speak, Mr. Mahon, another foundation director, said he did not know the source of the funds.

Dr. Robert C. Young, chancellor of the Fox Chase Cancer Center in Philadelphia and chairman of the Board of Scientific Advisors of the National Cancer Institute, said he had never heard of the Vector grants. “As someone who really hung around the inner sanctum of cancer research, I have never heard anybody—anybody—ever say anything about this,” Dr. Young said.

Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and the author of a book about conflicts of interest, said he believed that Weill Cornell had created the foundation to hide its receipt of money from a cigarette company. “You have to ask yourself the question, ‘Why did the tobacco company want to support her research?’ ” Dr. Kassirer said. “They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that’s outrageous.”

EARLY DETECTION UNDERCUT BY SOURCE OF FUNDING
Dr. Henschke’s work, while controversial among cancer researchers, has been embraced by many lung-cancer advocacy organizations, which have pushed for legislation in California, New York, and Massachusetts to create trust funds to pay for lung cancer screening—often with language tailored to benefit Dr. Henschke’s group.

In New York, a bill would create a US$10 million fund “to carry out lung cancer early detection research using computer tomography (CT) scanning” at a place “that was established by the multi-institutional, multi-disciplinary research program that began at 22 sites in the state in the year 1991,” a description that could only fit Dr. Henschke’s group.
But the disclosure that Dr. Henschke’s work was in part underwritten by grants from a cigarette maker will undercut those efforts, prominent cancer researchers said.
“She’s the biggest advocate for widespread spiral CT screening,” said Dr. Paul Bunn, a lung cancer expert and executive director of the International Association for the Study of Lung Cancer. “And now her research is tainted.”

Corporate financing can have subtle effects on research and lead to unconscious bias. Studies have shown that sponsored research tends to reach conclusions that favor the sponsor, which is why disclosure is encouraged. The tobacco industry has a long history of underwriting research—sometimes through independent-sounding foundations—to make cigarettes seem less dangerous.

Since 1999, Dr. Henschke has asserted that annual CT scans of smokers and former smokers would detect lung cancer when tumors are small enough to be cured, preventing as many as 80 per cent of the 160,000 deaths a year from lung cancer, by far the biggest cause of cancer deaths in the United States.

Her 2006 study said that, after screening 31,567 people from seven countries, CT scans uncovered 484 lung cancers, 412 of them at a very early stage. Three years later, most of those patients were still alive, and she projected that 80 per cent would be alive after 10 years and assumed that they would have died without the screens.

Critics question both her survival projections and her assumption that all would have died without screening. Indeed, most in the cancer establishment say that Dr. Henschke has yet to prove her case. CT scans have radiation risks and sometimes detect cancers that would not have progressed, leading to risky procedures like biopsies and lung surgery when not needed.

To settle the dispute, the US National Cancer Institute started in 2002 the US$200 million National Lung Screening Trial comparing death rates among 55,000 people randomly assigned to have CT scans or chest X-rays. Results are not expected until 2010. Dr. Henschke has asserted that allowing hundreds of thousands of people to die in the meantime is unethical.

PROBLEMS FOR UNIVERSITY
The Cancer Letter, a newsletter, recently reported that Drs. Henschke and Yankelevitz had failed to disclose in articles and educational lectures a patent and 10 pending patents related to CT screening and follow-up. General Electric, a maker of CT scanners, licensed the issued patent beginning in 2001.

Jonathan Weil, a Weill Cornell spokesman, said Dr. Henschke did not disclose the patents in some articles and lectures because she did not deem them relevant.

In late March, the Journal of the American Medical Association published corrections about unreported financial disclosures from Drs. Henschke and Yankelevitz. The patent and pending patents reported by The Cancer Letter “are relevant to these publications,” an editors’ note stated. Editors at the journal were not aware of Dr. Henschke’s association with Liggett, said Dr. Catherine D. DeAngelis, the journal’s editor in chief.

“I would never publish a paper dealing with lung cancer from a person who had taken money from a tobacco company,” Dr. DeAngelis said.

Universities are responsible for policing conflicts of interest and, in many cases, the required disclosures of their faculty. But Weill Cornell shared in the proceeds of Dr. Henschke’s patent and pending patents, and university officials were on the foundation board.

“We have a very strict oversight policy” for conflicts of interest, Dr. Gotto of Weill Cornell said. He dismissed any suggestion that the university could not police and benefit from faculty members’ financial deals.

But Dr. Kassirer said, “The problem is that universities, because they’re so conflicted themselves, ignore the conflicts of interest of their faculty.”

FOUNDATIONS SCRUTINIZED
Legislation being considered in US Congress would require drug and device makers to post registries of payments to doctors.

An increasing number of doctors and institutions are setting up foundations to accept money from companies without having to disclose its source, said Dr. Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education.

“This is the third time in the past few weeks that one of these has been identified to us,” said Dr. Kopelow, whose organization is investigating how widespread the practice is.

Laurie Fenton Ambrose, president and chief executive of the Lung Cancer Alliance, a nonprofit patient advocacy group, said she still trusted Dr. Henschke and still believed in widespread CT scanning to prevent lung cancer deaths.

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From The New York Times, March 26, 2008. Copyright 2008 The New York Times. All rights reserved. Used by permission and protected by the copyright laws of the United States. The printing, copying, redistribution, or retransmission of the material without express written permission is prohibited.

Direct-to-consumer

DTC ads do shape patient, physician interactions

Survey reports that prescription drug ads are changing dynamics of medical care

By Peggy Peck
Special to The Chronicle
of Healthcare Marketing

Direct-to-consumer advertising of prescription drugs has had a major impact on how patients deal with their doctors, confirmed a nationally representative survey of American adults.

The survey found that 91 per cent of the patients said they have heard or seen the ads, and 32 per cent said they discussed the advertised drugs with their doctors.

And physicians apparently listened to what patients were saying, the survey found. Forty-four per cent of those who talked to their doctors about an advertised drug were given a prescription for that drug, and 54 per cent said their doctor gave them another prescription. The net result: 82 per cent of patients said they received a prescription when they brought up a drug ad.

The survey, which was conducted by the Harvard School of Public Health, Kaiser Family Foundation, and USA Today, also found that 80 per cent of Americans think prescription drugs cost too much and 16 per cent said paying for prescription drugs was a serious problem.

Not surprisingly, 52 per cent of those who said they had difficulty paying for prescription drugs, or sometimes didn’t fill prescriptions because of the cost, or cut pills in half to stretch out supplies, said they didn’t have prescription drug insurance coverage. Likewise 54 per cent of low-income people and 59 per cent of people who said they took at least four prescription drugs regularly had the same complaint.

PHARMA PROFITS HIGH ON LIST
The nationally representative telephone survey was conducted between Jan. 3 and Jan. 23 among 1,695 adults ages 18 and older, and has a margin of sampling error of plus or minus three percentage points.

Seven in every 10 adults surveyed said pharmaceutical companies were “too concerned about making profits and not concerned enough about helping people,” according to a press release issued by the Harvard School of Public Health and the Kaiser Family Foundation.

Other findings:
• Nearly 60 per cent said insurers should only pay for new drugs that are safe and more effective than existing ones;
• 78 per cent said they thought drugs sold in the US were safe—although only about 25 per cent said they were very confident that drugs were safe;
• 47 per cent said US FDA regulations were adequate to ensure safety, but 44 per cent said there should be more regulation, and 8 per cent said there should be less regulation;
• About half of Americans said the pharmaceutical industry had the right level of input into the drug approval process, and close to 40 per cent said industry had too much influence on the process; and
• 52 per cent said government moved too slowly on drug approvals.

Overall, the public has mixed opinions of pharmaceutical companies, with 47 per cent viewing the industry favorably and 44 per cent unfavorably. Drug companies are viewed slightly more favorably than health insurers (40 per cent favorable), but significantly less than doctors (81 per cent favorable).

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Shoring up research

The Pfizer-FRSQ Innovation Fund started out with a bang: A $10 million endowment from Pfizer Canada to support research projects in human health. The initiative was launched by Paul Lévesque, prexy and CEO, Pfizer Canada, Raymond Bachand, of Quebec’s Department of Economic Development, Innovation, and Alain Beaudet, CEO, Fonds de la recherche en santé du Québec (FRSQ).

__________________________________________________________________________________

(CNW Group/Fonds de la recherche en santé du Québec)

Healthcare, Inc.

Up Here:What's happening in drug marketing

It began with a Toronto GP’s effort to find a treatment for his own Parkinsonian symptoms, and ended in April with a $255 million buyout by a little-known company based in India. DRAXIS HEALTH, founded by the late physician-entrepreneur-media personality Dr. Morton Shulman, received an offer from Jubilant Organosys, which likes Draxis’s CMO capabilities and radiopharmaceuticals unit. Jubilant helmer Shyam Bhartia says he’s “committed to grow Draxis by supporting management and employees through new product launches, entry into new markets, and expansion of customer base.” However, investors weren’t all that jubilant about the selling price, which is 9 per cent below what analysts were expecting. The Indian business media, on the other hand, thought the price may have been too rich. However, the deal thrilled the writers of this publication, who get to point out how similar the Indian company’s name is to “Jubilation T. Cornpone,” the show-stopping tune from the 1956 Broadway sensation “L’il Abner.”

On the heels of the likely takeover of one Canadian healthcare bulwark (see previous item), a stateside investor made advances on Toronto-based MDS, the health-services conglomerate. The Ottawa Citizen newspaper reports Obrem Capital of New York has acquired 5.1 per cent of MDS, and may push the company to sell or divest some of its business units, including its troubled contract research arm.

The usefulness of injectable botulinum toxin (BOTOX, Allergan) continues to expand in unlikely areas. A Montreal Children’s Hospital otolaryngologist says he successsfully treated a rare neonatal disorder, CHARGE syndrome, with Botox. Dr. Sam Daniel says he used Botox to successfully control the salivary glands of a 10-week-old infant. Dr. Daniel tells Canadian Press the Rx is an alternative to tracheotomy. The patient is now three years old, and in good health.

QLT caught a break from the stateside FDA on the labelling of its topical acne Tx dapsone (Aczone). The beleagured Vancouver drugmaker received regulatory okay to drop two required screening requirements from the indication. The company has been trying to find a buyer for the product, as it divests Txs outside its core ophthalmic and dermatologic areas.

The Canadian Supreme Court upheld NOVOPHARM's challenge to patents on olanzapine, allowing a knock-off version of Eli Lilly’s anti-psychotic Zyprexa. A US court threw out a similar suit by Ivax in 2005; however, a Canadian judge ruled that verdict had no bearing on the local case. Both Ivax and Novopharm are units of Teva, the Israeli generics outfit. Lilly Canada’s top lawyer tells Bloomberg news he plans to “take every possible step to enforce our Zyprexa patent in Canada.”

RANBAXY LABORATORIES may initiate a Supreme Court appeal to a Canadian federal court decision upholding Pfizer’s patent on atorvastatin (Lipitor). The recent verdict overturns a previous lower court ruling, and prevents introduction of a knock-off version of Lipitor until 2010. Pfizer vee-pee Peter Richardson said the verdict “provides the incentive for research-driven pharmaceutical companies to make the significant high-risk investments necessary to develop new life-saving medicines.”

PALADIN LABS of Montreal filed an NDS with Health Canada for Seasonique. an extended-cycle oral contraceptive in-licensed from Barr Pharmaceuticals. The Rx is designed to reduce the number of withdrawal bleeding periods to four periods annually from 13. Says Pal prexy Jonathan Ross Goodman: “Seasonique is an excellent strategic fit to our strong women’s health franchise.”

Drugbiz CEO faces criminal charges over Actimmune marketing

There’s a thin line between exuberence and fraud, as Dr. W. Scott Harkonen discovered in mid-March. The former CEO of drugmaker Intermune, who now runs biotechie CoMentis, was indicted in a California court on felony charges involving the marketing of Interferon gamma-1b (Actimmune) as pulmonary fibrosis Tx. That’s an off-label use, and an investigating grand jury thinks Dr. Harkonen may have been a bit fanciful in issuing press releases that claimed Actimmune showed efficacy in treating the disease. He’s charged with wire fraud, and faces a $500,000 fine and 23 years in a place like the one Johnny Cash sang about.

NOCs of Note: April 2008

Significant TPP approvals of Rxs for human use

Antineoplastic agent 03-13
Pemetrexed (supplied as pemetrexed disodium) (Alimta, Eli Lilly Canada Inc.) Comments: New strength: 100 mg pemetrexed per vial; PWSO(100mg/vial)IV

Antibiotic03-19
Retapamulin (Altargo, GlaxoSmithKline Inc.) Comments: ONT(1%)TOP

Anticoagulant03-20
Warfarin sodium (Coumadin, Bristol-Myers Squibb Canada) Comments: Changes to the product monograph; TAB(1.02mg)ORL

Multikinase inhibitor - antineoplastic agent 03-03
ISSUED UNDER THE NOC-C POLICY Sorafenib (supplied as sorafenib tosylate) (Nexavar, Bayer Inc.) Comments: Revisions to the warnings and precautions, adverse reactions, dosage and administration, action and clinical pharmacology sections of the product monograph; TAB(200mg)ORL

H+, K+-ATPase inhibitor03-11
Pantoprazole (supplied as pantoprazole sodium) (Pantoprazole Sodium for Injection, Sandoz Canada Inc.) Comments:PWSO(40mg/vial)IV

Corticosteroid03-13
Fluocinolone acetonide (Retisert, Bausch & Lomb, Inc.) Comments: IMP(0.59mg)IVL

Antiviral agent 03-07
Valganciclovir (supplied as valganciclovir hydrochloride) (Valcyte, Hoffmann-La Roche Limited) Comments: New dosage form; PWSO(50mg/ml)ORL

Endothelin receptor antagonist03-20
Ambrisentan (Volibris, GlaxoSmithKline Inc.) Comments:TAB(5mg, 10mg)ORL

Enzyme replacement therapy02-29
Agalsidase beta (Fabrazyme, Genzyme Canada Inc.) Comments: Revised product monograph; PWSO(5mg/vial, 35mg/vial)IV

Active immunizing agent03-13
Hepatitis A vaccine, inactivated (Havrix 1440 and Havrix 720 Jr, GlaxoSmithKline Inc.) Comments: New formulation; SUS(1440unit/ml, 720unit/0.5ml)IM

Active immunizing agent04-08
Tick-borne encephalitis vaccine, inactivated (FSME-IMMUN, Baxter Corporation) Comments: Changes to the manufacturing facility; SUS(2.4mcg/0.5ml)IM

Active immunizing agent03-28
Recombinant human papillomavirus type 6 L1 protein, recombinant human papillomavirus type 11 L1 protein, recombinant human papillomavirus type 16 L1 protein, recombinant human papillomavirus type 18 L1 protein (Gardasil, Merck Frosst Canada Ltd., Merck Frosst Canada Ltée) Comments: Product monograph revised; SUS(20mcg/0.5ml, 40mcg/0.5ml, 40mcg/0.5ml, 20mcg/0.5ml)IM

Antidepressant03-06
Citalopram supplied as citalopram hydrobromide (Mint-Citalopram, Mint Pharmaceuticals Inc.) Comments: New manufacturer and product name; TAB(20mg, 40mg)ORL

Coagulation factor04-04
Antihemophilic Factor (Recombinant) (Helixate FS, Bayer HealthCare LLC) Comments: New 2000 IU presentation; PWSO(2000unit/vial)IV

Active immunizing agent04-11
Rabies vaccine inactivated (RabAvert, Novartis Vaccines and Diagnostics GmbH & Co. KG) Comments: Changes in manufacturing process; PWSO(2.5 unit/dose)IM

Erythropoiesis stimulating agent03-31
Methoxy polyethylene glycol-epoetin beta (Mircera, Hoffmann-La Roche Limited) Comments: Single-dose vials: SOL(50mcg/ml, 100mcg/ml, 200mcg/ml, 300mcg/ml, 400mcg/ml, 600mcg/ml, 1000mcg/ml)IV, SC; Single-dose pre-filled syringes: SOL(50mcg/0.3ml, 75mcg/0.3ml, 100mcg/0.3ml, 150mcg/0.3ml, 200mcg/0.3ml, 250mcg/0.3ml, 400mcg/0.6ml, 600mcg/0.6ml)IV, SC

Replacement therapy for immunodeficiencies03-31
Immune globulin (human) (Gammagard Liquid, Baxter Corporation) Comments: Alternate manufacturing area; SOL(1g/10ml, 2.5g/25ml, 5g/50ml, 10g/100ml, 20g/200ml)IV

Antineoplastic04-03
ISSUED UNDER THE NOC/C POLICY Panitumumab (Vectibix, Amgen Canada Incorporated) Comments:SOL(100mg/5ml, 200mg/10ml, 400mg/20ml)IV

Special Report

Detailing in 2008

Pharma sales forces are declining quickly. IMS figures show that the total field sales force (including managers) in the Canadian pharma industry slid by 10.3 per cent from 2003 to 2006. During the National Pharmaceutical Congress II, held last November in Toronto, figures presented by Mark Beaudet, vee-pee of marketing and sales at Paladin Labs, Montreal, put the overall drop in the industry’s sales forces at a considerably steeper 17 per cent.

With the abatement of pharma M&A activity, industry observers rule that out as a primary reason for the reduction, and point to several other factors that are not only changing the numbers, but also revising how detailing is undertaken in 2008.

Mark Lalande, general manager of the Council for Continuing Pharmaceutical Education in Montreal, attributes this attrition in sales staff numbers mainly to the extraordinary length of time between submissions for new drugs and NOC approvals, at the same time as more and more products are losing their patent protection.

Even an NOC, Lalande notes, does not guarantee a listing on provincial government formularies. The detour here is the Common Drug Review, established as a federal government initiative in 2002 to make formulary reimbursement recommendations to the provinces after Health Canada has issued an NOC.

“This is turning into a political nightmare,” Lalande laments. “Occasionally, CDR will question whether a drug should be approved or not. It’s losing focus. Originally, it was supposed to replace the provinces’ individual drug review committees, but in reality they can ignore CDR’s recommendations.
“Ultimately, just one more layer of bureaucracy was added to delay the approval process.”

TOO MANY PRODUCT SAMPLES?
Merril Mascarhenhas, prexy of Arcus Group, a research and strategy consulting firm located in Toronto, believes three factors have influenced the current decline in pharma sales staff numbers: stiffer resistance to sales calls by doctors, inadequate staff training, and too many product samples.

“There’s a lot of fatigue in the MD community [about too many reps] and the approach reps take toward physicians makes the problem worse,” he says. “Rampant sampling erodes the value of the product proposition and is replaced, literally, by a free product to keep doctors happy.”

But whatever the total pharma sales force number may be today, Mascarhenhas believes it is still too high.
“It’s a lot higher than it should be,” he claims, noting that average one- or two-minute visits by thousands of industry reps are not likely to have any significant sales impact. Pharmas have done nothing substantial to address this deficiency, he charges.

“In a recent study we found that only seven per cent of rep visits last more than two minutes; 43 per cent don’t even get past the receptionist.”

Like many others, Mascarhenhas repeats the HR gospel that to be effective and productive a sales rep must have excellent product knowledge. He says practice management know-how is another line that most good reps would likely have on their resume.

“A good understanding of how the practice works, the profitability around the operation, and the nuances of managing patient care, anything that adds value to the physician-patient interaction” are concepts that a good rep will know and understand, he says.

However, he does admit that at this time there is a significant lack of expertise in these areas.
Ultimately, Mascarhenhas says, detailing must evolve from a relationship based on transactions to one based on knowledge.

DRUG COVERAGE PROGRAMS REDUCED
Robert Tomas, helmer at Impres Pharma Inc., a contract sales firm in London, Ont., agrees with Lalande that the delay in NOC approvals accounts for a good deal of the trend toward sales staff cutbacks, but also identifies the reduction in coverage by public drug plans, principally provincial government programs, as also having a significant influence.

“Private [plans] have made changes, too, but their customers are more value oriented,” Tomas says, “but for government it is more a question of budget rather than value.”

New drugs specifically are often immediately put in the prescription penalty box because they are either rejected for formulary listing or burdened with multiple usage and system restrictions that discourage physicians from prescribing them.

For Steve Gregory, prexy of Pharmahorizons, Toronto, the reductions began when pharmas realized returns on investments in sales activities were marginal at best—at about the same time Rx&D regulations surrounding promotional efforts were tightened.

“There’s less that the reps can do,” Gregory notes, “so you need fewer of them.”

In 2008, Gregory says, the focus for pharmas is special training for their reps, specifically in disease management and evidence-based medicine.

“Today, when the rep gets time with the doc, the nature of the conversation is more scientific and more about benefits for the physician. The biggest challenge the pharma companies face, in my view, is developing representatives who are a medical liaison source, and who can engage the physician in decent conversations.

“And the people who will help [pharmas] do that are the sales managers,” Gregory says. “The sales management role is pivotal.”

Gregory also expects co-detailing, or co-marketing, to become more prevalent, as pharmas combine their field forces or enlist contract sales organizations to try to keep communications channels with their customers open while cost pressures rise.

THIRD-PARTY PAYERS BECOMING AN INFLUENTIAL FACTOR Government restrictions on formulary listings and the influence of third party payers may be important factors in the reduction of sales staff, but a change in customer influence also has a heavy impact, according to Joe Knott, CEO of Panagaea Group, Toronto.

“We now have pharmacists prescribing, we have nurses prescribing,” he notes. “The prescribing influence is shifting from the traditional physician to new audiences.”

(In April, 2007, pharmacists in Alberta were given the authority to change the duration and dose of original prescriptions; later in November, 42 pharmacists were able to “product select” prescriptions. In Quebec, Bill 130 will offer pharmacists similar powers, but implementation of this legislation is proceeding more slowly). The Ontario government’s payment of $50 for counselling individuals on three chronic medications could be the start of a product selection triage.

“New laws in Saskatchewan, Nova Scotia, and Quebec cover not just pharmacists, but include other segments of [the healthcare profession] such as nurses,” Knott says.

To deal with these legislative changes, Knott suggests pharmas will have to refine their particular approaches to various market segments.

“The real winners will be the companies that fine tune, instead of tearing apart their promotional resources,” he predicts.

TRACKING APPROVAL TIMES
Complaints about the time it takes various Health Canada directorates to award a therapy market access are common and sometimes frequent, but the time it takes to review new drug submissions (NDS), supplemental new drug submissions (S/NDS), and clinical trial application in recent years is actually just sprint time compared to the marathon-like time periods that were commonplace just 20 years ago.

According to Rx&D, in 1988 the mean number of days between an NDS and receipt of Notice of Compliance (NOC) listing totalled 1,024 days. The delays reached a peak of 1,163 days in 1991 and a trough of 549 days in 1997.

In 2006, according to the results of a survey of member Rx&D pharmas, the Therapeutic Products Directorate’s (TPD) average time for NDS and S/NDS approvals was “close to the target of 355 days,” and two-thirds of submissions were reviewed within the target time of 355 days.

That same year, the Biologics and Genetic Therapies Directorate (BGTD) also lowered the average time it took to approve NDS and S/NDS documentation, but still trailed the TPD in the timeliness of reviews. Both directorates were also able to process the majority of Clinical Trial Applications within the target processing window of 30 days.

However, both agencies were a little slower than the US FDA in 2006, according to Rx&D. The average time for a Health Canada approval of the same drug was 319 days compared to 248 in the US; for the same biologic the respective numbers were 558 and 293.

A comparison between the results in Canada and the European Union also showed similar differences in favor of the EU.
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This SPECIAL REPORT was compiled by Ian J.S. Moore, a frequent contributor to THE CHRONICLE OF HEALTHCARE MARKETING

PMCQ 50th Anniversary

Into the pharma marketing Way-Back Machine

Once again, The Chronicle examines the unofficial archives of the Pharmaceutical Marketing Club of Quebec

BART TURNER makes no effort to conceal his rapturous admiration of the sports jacket worn by the speaker at a 1983 meeting (right), none other than pop star Andy Kim. Okay, it’s not Andy Kim. It’s Montreal Gazette writer Clair Balfour, who would address the PMCQ on the timely subject, “The Role of a Newspaper Ombudsman as Business Migrates from Quebec.” There’s nothing to indicate whether Mr. Balfour would be invited back to speak again a couple of months hence, when business began its predictable migration back to Quebec.

TODAY he moves in rarefied international circles as co-chair of Stiefel Labs, but when Richard J. MacKay was president of the company’s Canadian affiliate, one of his concerns was encouraging the effectiveness of the local industry’s lobbying effort to the federal government. He speaks on the subject at a 1982 dinner meeting. The bottle-like objects seen at the bottom of the photo are believed to be somehow connected to an after-dinner ring-toss competition.

Canadian Healthcare Marketing Hall of Fame

IMS Health Team Awards presented to Novo Nordisk, Paladin's Plan B at annual Hall of Fame ceremony

Novo Nordisk's educational initiatives regarding diabetes, Paladin's Plan B named top examples of Big Pharma's ability to develop innovative therapies and marketing strategies that recognize the importance of community education

In recognition of demonstrated excellence in pharmaceutical marketing, Novo Nordisk and Paladin Labs became the latest recipients of IMS Health Canada Team Awards, presented during the 6th annual Canadian Healthcare Marketing Hall of Fame induction ceremonies in Toronto.

The awards were hosted by Bruce Good, president of IMS Health Canada.

“These two companies have distinguished themselves in a very challenging environment,” Good said. “Education and innovation were key this year.”

The ceremony was introduced by Leo Rautins (right), the noted professional basketball figure.
The award recipients were selected by a panel consisting of representatives from advertising agencies, pharmaceutical marketing organizations, and industry publications. The selection committee based its decision regarding the 2007 honorees by considering overall awareness of the campaign, public and/or community education, and ground-breaking innovation.

Diabetes Awareness
Novo Nordisk Canada

Novo Nordisk Canada was selected in recognition of the company’s efforts to increase awareness of diabetes among Canadians and around the world by working with patient groups, associations, and leaders in diabetes. The company was also honored for its educational and philanthropic efforts with particular regard to its work at Banting House in Toronto, an historic site that celebrates the history of diabetes innovation in Canada and the life and career of Sir Frederick Banting, the co-discoverer of insulin.

Novo Nordisk is also involved in diabetes prevention activities. The company has partnered with the Ontario Physical Health and Education Association (OPHEA) to deliver an innovative school-based program to Grade 5 school children. The program is designed to enlighten the children regarding the benefits of physical activity and healthy eating as part of a long-term foundation for their health.

The company was also a key supporter and catalyst for the new UN resolution on diabetes, which has dedicated Nov. 14, Banting’s birthday, as World Diabetes Day. This is the first time the UN has recognized a chronic disease as a major threat to global health.

On the first World Diabetes Day last November, Novo Nordisk worked with the Canadian Diabetes Association, the Juvenile Diabetes Research Foundation, and other stakeholders around the world to demonstrate the UN has recognized that access to diabetes care is a human right that cannot be ignored.
Novo Nordisk also sponsored a Changing Diabetes bus that helped deliver the message regarding diabetes prevention across Canada and around the world.

“With appropriate awareness, education, and innovation, diabetes is preventable, and secondary prevention efforts can also make a difference in reducing problems such as amputation, cardiovascular disease, and blindness,” said Novo Nordisk president Vince Lamanna, who accepted the award on behalf of the company and its employees.

“I believe that our success is founded on a sustainable approach to business that balances responsibility to society with financial success,” said Lamanna “This balance of commercial and social focus is, I believe, the reason we are being honored with this team award today.”

Plan B
Paladin Labs

Paladin Labs was selected for recognizing consumer needs in niche therapeutic areas. According to Mark Beaudet, co-founder and vice-president of the Montreal company, the Plan B (levonorgestrel) team worked hard to come up with fundamental consumer insights about peoples’ perceptions regarding risky behavior and unprotected sex. The team took the information, developed a strategy, and came up with a creative execution.

“The team put together a recommendation that was financially viable,” said Beaudet. “They suffered the slings and arrows of management but persisted with their conviction and were able to win the day.” Two members of the team, Farrukh Rehan and Sabine Chauvet, attended the ceremony.
“I’m gratified that this is a team award, which recognizes the hard work, creativity, and passion of our team,” said Beaudet. “Candor and conviction and courage are qualities you want in the people in your organization.

“We work in a sales and marketing environment that’s often tough, and we get a lot of grief,” said Beaudet. “It’s nice to be recognized by a group outside the company for what we do, and we appreciate that.”
He likened the success of marketing programs to a batter in baseball, where if a batter strikes out eight of 10 times he would be relegated to the minor leagues, but if he strikes out six of 10 times, he would likely be admitted to the Hall of Fame.

During his acceptance of the award on behalf of the Plan B team, Beaudet thanked the Paladin managment committee (“We would be nothing without the steady stream of products”), and gave special thanks to co-founder and CEO Jonathan Ross Goodman.

“We’re fortunate to work in the environment he creates. When making recommendations, there is no idea that is too crazy to be accepted—some might be too expensive, but not too crazy. Jonathan creates a tremendously fascinating environment.

“It’s a great environment at Paladin, and I'm very proud of the team.”

The provinces

What should provinces pay for pharmaceuticals?

Critics say BC's new pharma panel, seen as stacked with drug company personnel, could result in higher prices

By Andrew MacLeod
Special to The Chronicle
of Healthcare Marketing

BC Health Minister George Abbott’s November appointment of a new pharmaceutical task force stacked with people connected to the industry is taking fire from critics.

Former MP and head of the Federation of Retired Union Members, Joy Langan, calls it “shocking and unbelievable.” NDP health critic Adrian Dix says the panel’s composition is “extraordinary and bizarre.” Health researcher and writer Alan Cassels says, “People in my world are sort of bewildered by the whole task force.”

Five of the nine people on the panel have clear connections to the pharmaceutical industry, including Russell Williams, the Ottawa-based head of the drug industry lobby group Canada’s Research-Based Pharmaceutical Companies (Rx&D).

Before Abbott appointed Williams to the panel, he was already registered as an active lobbyist.
Williams’ entry in the province’s lobbyist registry fails to provide the details of when he was lobbying or with whom he’s been talking, something an Information and Privacy Commissioner’s office representative says they’ll be contacting him about. The subjects, however, include national pharmaceutical policy, drug safety and effectiveness, and drug access and pricing. All are topics Abbott’s new task force is supposed to address as well.

So, what does Williams want to tell British Columbians about our drug policies? A media handler in his Ottawa office took the question and said he would try to set up an interview for Dec. 10, but in the end Williams wasn’t available.

Critics of Abbott’s new panel say nobody is likely to represent the interests of patients or the public. NDP healthcare critic Adrian Dix was among those advocating having someone like Alan Cassels added to the panel.

Cassels, who is a drug policy researcher affiliated with the School of Health Information Sciences at the University of Victoria and is critical of the panel’s pro-drug firm slant, considers Williams in particular an odd choice. “He represents the association that sued the government twice and lost over reference pricing,” he says. “These are known foes of the government.”

BC has been doing some things right to contain the amount the province spends on drugs, Cassels says. But every dollar the government saves is one the drug industry doesn’t earn.

With talk of setting up a national drug plan growing, he says, industry players may want to quash the BC example.

The province’s press release identified areas the panel would look at including the Common Drug Review, the Therapeutic Initiative, and how it is decided which drugs PharmaCare covers. All are areas the industry doesn’t like, Cassels says, and would not want to see replicated or strengthened in a national plan.
Since Cassels won’t be on the panel, The Tyee asked him to walk us through those areas and give his perspective on why the industry might want to get rid of them.

COMMON DRUG REVIEW
The Common Drug Review is a federal group founded in recent years to provide advice to the provinces on which new drugs their public plans should cover.

“They determine how does the drug fit among all the other drugs that are out there,” says Cassels. “The Common Drug Review is probably enemy number one. It’s questioning the value of their products.”
If a new drug does the same thing as an older drug, but it’s twice as expensive, the review would tell provinces paying for it that it is not a good use of public dollars. “That just drives the pharmaceutical companies fricking nuts. They just hate it.”

Less than 10 per cent of new drugs represent medical breakthroughs, he says, so the vast majority of new products should not and do not gain endorsement during the review process. The beautiful thing about it, he says, is the decisions, based on “the rules of evidence,” are made at a distance from the politicians and the lobbyists.

The review has given several drugs the thumbs down. “I would say they’re one of the best things to ensure we’re getting value out of our drug budgets.”

As it happens, BC was a strong proponent for setting up the Common Drug Review. “Why are they bringing up a task force to question the very existence of it? It strikes me as bizarre,” Cassels says.

THERAPEUTIC INITIATIVE
The Therapeutics Initiative, based at the University of British Columbia, has a similar mandate to the Common Drug Review. “The Therapeutics Initiative looks at the evidence,” says Cassels who does not currently work for the initiative, but has in the past. “They do extensive reviews of the evidence on new drugs then make recommendations to the government and physicians... They don’t make policy decisions. They offer opinions about the quality of the evidence.”

Those opinions carry weight with the people who make the decisions on what gets covered, he says. “The government does rely heavily on the Therapeutics Initiative because they are the body of expertise.”
The agency has had a number of successes at raising early alarms, says Cassels.

The best example is Vioxx, an arthritis drug that Merck & Co. pulled from the market after it became apparent it increased the risk of heart attacks and strokes. While the drug was prescribed widely, it was used less often in BC than anywhere else in Canada.

“The warnings really came from the Therapeutics Initiative,” says Cassels. The initiative warned there were many unknowns about the drug and there was a large potential for adverse affects. “Nobody else in the country was doing this. We prevented a lot of unnecessary deaths.” He estimates at least 600 deaths were avoided in BC thanks to the initiative’s caution on Vioxx.

The recommendation on Vioxx also saved the government about $500 million, says Cassels. That’s good news if you are responsible for controlling public spending, but not so good if you are in the business of selling drugs. “Those are lost profits to companies. They will do whatever they can to stop that from happening.”

No wonder, says Cassels, Abbott’s new corporate-heavy PharmaCare panel wants to look at the Therapeutics Initiative. “They’ve always been hated by the drug companies,” he says. “The reason the pharmaceutical industry hates them is they demand value from drugs. They encourage the government not to be spending on drugs with no additional value.”

REFERENCE PRICING
Another area where the panel will likely want changes is the government’s policy of reference pricing, where PharmaCare pays for the cheapest drug that works.

The policy is used in just five classes of drugs, representing about 30 of the 5,000 medications on the market in the province. When a doctor sees a patient, says Cassels, “He’s limited to prescribing the cheapest and oldest medicine first.”

That older medicine in many cases will work just as well as the newest version of a drug, but at a fraction of the cost. If a patient tries the older drug and it doesn’t work, the doctor can fill out a form asking for “special authority” to prescribe a newer one. Some 98 per cent of those applications are approved, says Cassels.

Panel vice-chair George Morfitt led a 2002 review that found the program works well and saves the government about $12 million a year. Researchers at Harvard University and McMaster University have studied the policy and found it does not affect the health results for patients.

While reference pricing might be good for patients and the government that pays the bills, it does restrict drug companies’ ability to charge top prices for new treatments that are no better than old drugs.

The threat to BC’s PharmaCare program comes at a time when pressure is mounting for a national drug plan. It is something the provinces and the federal government have been talking about in recent years and public meetings on the topic were held in Vancouver and Victoria early in December.

“It was always intended when medicare was set up in the ‘60s there’d be a national drug plan, but it’s never seen the light of day,” says Cassels. There’s political support for the idea, but with Canadians spending some $21 billion a year on drugs, it’s hard for politicians to commit to covering the bill. He says, “They get sticker shock big time.”

That’s where BC may have much to share with the rest of the country, Cassels says, and why the drug companies are keen to rewrite the province’s policies. “A national PharmaCare program would only really be feasible with a strict approach to cost effectiveness. Otherwise it will never be affordable.”

An interesting question for the panel to look at, he suggests, is how much money the Therapeutics Initiative, reference pricing, and the Common Drug Review save the provincial government. “If that research got out to the rest of the country, every province in the country would be replicating the Therapeutics Initiative,” he predicts.

But with Williams and others with drug industry connections dominating the panel, those questions, says Cassels, are unlikely to be on the agenda.

__________________________________________________________________________________

Andrew MacLeod is legislative bureau chief in Victoria for thetyee.ca, a daily online source of BC news.

Creativity equals efficiency

COMMENTARY by Gord Schwab

Scenario 1:

Your company is about to make a multi-million dollar investment in new, state-of-the-art equipment upon which the success of a major product will partially depend. The equipment costs are competitive, so management decides it’s a wise investment.

Soon after, your Facilities Manager discovers something extraordinary. For a modest additional or reallocated investment of your total equipment budget, you could double or triple the efficiency.

Scenario 2:

Your company is about to make a multi-million dollar investment in a new, state-of-the-art marketing campaign upon which the success of a major product will partially depend. The advertising agency costs are competitive, so management decides it’s a wise investment.

Soon after, your Marketing Manager discovers something extraordinary. For a modest additional or reallocated investment of your total advertising budget, you could double or triple the efficiency.
In both of these situations the choice would appear to be relatively easy: Spend a little money, get a big potential return. Yet, freeing up resources for the development of an original marketing campaign can be difficult—despite the facts supported by research. It’s been shown that effective marketing campaigns can generate two or three times the brand awareness/intention to prescribe for half the media and/or sales force investment. There are also many excellent examples of parity brands that have reached dominance primarily through marketing success.

So, why the reluctance to invest? The reasons are many and here are a few of the more common ones:

1. We can use the global campaign for ‘free’. Rarely is this the case. Sometimes the global or US agency will charge ‘usage fees’ for each additional country. Other times, because of different regulatory environments, the main global concept (or the clinical data used to support it) are not approvable here. Worse yet, mandated global campaigns are often tested in major markets—but not Canada. Whether they will match the ideal Canadian strategy and be successful sometimes remains unanswered, until it is too late.

2. Straightforward ideas are easier to sell internally. Oftentimes, it is easy to fall back on ideas that are similar to what has been done in the past. Trouble is, traditional promotional concepts can be overwhelmed by ‘real world’ clutter, whereas original concepts can really break through. Strong ideas require decision makers to take calculated risks that are often rewarded many times over.

3. Doctors don’t react to ‘creative’ advertising. Like all targets, healthcare professionals respond to relevant product benefits communicated in a unique way. Obviously, a product with true superiority stands out on its own, but most successful marketing-driven campaigns need an exclusive, usually visual idea to set them apart.

4. Original photography is expensive, stock photography is cheap. Although some ‘royalty-free’ stock images are now less expensive, using quality ‘rights-managed’ stock photography can be pricey because of ongoing fees. This is especially true if you want to obtain exclusive rights for a year or two, or are using the same rights-managed image on multiple communications. It’s important to also factor into your budget the time required to look through hundreds (or thousands) of photographs to find the right one.

Next to all these ongoing charges, good quality original photography can become quite a bargain. Also, many stock images tend to be beautifully produced ‘non-ideas’ that can be very difficult for doctors to differentiate from your competitors’ images.

Last, but not least, strong ideas are frequently ‘executionally dependent’. That means great production values are necessary to get the most communication value out of the concept. That’s the magic a great photographer, illustrator, or production house adds to the equation and it cannot be underestimated.

5. Outstanding communication ideas are hard to come by. Yes they are, but that doesn’t mean the perfect one for your product isn’t waiting to be discovered. It’s a simple equation: Talent x Time x A Little Luck.

What can you do to help ensure success? Get the most experienced, successful talent your agency has to offer, give them a tightly focused brief and allow them the time to explore a range of strategic, executional, and media ideas. A long-term, brand-building campaign idea should be forthcoming (not to mention that big promotion you’ve been waiting for).

__________________________________________________________________________________

Gord Schwab is Partner and Creative Director of a new advertising agency, Gibson, Schwab & Boyd Communications. Previously, as partner at Schwab & Piquette, he wrote the launch materials for megabrands Pantoloc, Avandia, Aranesp and the DTC campaigns for Twinrix. He can be reached at (905) 713-3615 or gord@gsandb.com

Web advertising

Interactivity playing larger role in marketing plans

Digital media, CHE/CME can bring exposure to brand, offer physicians flexibility in their personal schedules

By Louise Gagnon
Special to The Chronicle
of Healthcare Marketing

In 2008, a desire for flexibility in personal schedules and making information available on demand to users is driving the expansion of web-based marketing to physicians, allied healthcare providers, and patients.

Attendance at the “rubber chicken” dinners that demands physicians block off a weeknight evening to hear from a leading expert about a new therapeutic indication or product is being supplanted by web casts where physicians hear from a key opinion leader from the comfort of their home. In the not so distant future, pharma firms will likely look to social media networks on the Internet to promote communication amongst healthcare providers and patients.

It is not only big pharma that is infusing dollars into interactive media budgets. Car manufacturer Chrysler announced in April that it plans to make its biggest digital outlay to date of total dollars and percentage of the media buy to launch the 2009 Dodge Journey crossover. Huge market forces like Pepsi are advertising new products exclusively on the web and digitally.

“Interactivity is playing a bigger role in advertising plans,” notes James Cran, prexy of Antibody Healthcare Communications, a five-year-old pharma advertising agency with operations in Toronto and Montreal. “There isn’t one client, from big to small, that doesn’t have some electronic media component to their plans.”

About one-third of the budget of a healthcare clients’ overall marketing plan is now devoted to electronic/multimedia content, says Cran. For its part, Antibody organized more than 50 web casts in 2006.

Cran says in an era of 24-7 connectivity—when many professionals are striving for a healthy work-life balance—it is more appealing for physicians to sit in the family den and log onto a web cast. Previously, they had to dash from their offices to attend a cocktail reception at 5:30 pm followed by a dinner symposium that took up the better of their evening.

"It kills their night to make sure they are there in person,” explains Cran. “Participating in an interactive session requires an hour of their time after dinner where they can unwind with a cup of coffee and it doesn’t detract from their family life."

Physicians’ virtual participation in dinner symposia has an authentic feel: other participants hear the sounds of a dog barking or a child playing in the background. The “lunch and learn” has also been shaped into an interactive session where physicians can engage in discussion about a new therapeutic product or indication without leaving their practice in the middle of the day.

INTERACTIONS DWINDLING
Part of the push to interactivity is to maintain a pharmaceutical firm’s reach to physicians at a time when the number of sales representatives on the ground has dwindled. In some instances, a firm may be promoting a brand and have minimal field support behind that brand, so investing in digital media can bring necessary exposure to that brand.

Practically, the organization of live continuing medical education/continuing health education (CME/CHE) events can be expensive, and using technology is a more affordable route that can fetch a vast number of impressions. It is also much cheaper to produce interactive content that is easily reproducible and can be stored on a CD or DVD.

“Spending $100,000 can go a long way to effectively reach your audience when you don’t have 20 reps in the field to do it for you,” adds Cran. “It won’t replace the one-on-one interaction with the rep. It’s always a complement to that.”

Terry Cully, managing director of Ogilvy Healthworld, notes that since physicians are dispersed across large geographic areas in some parts of Canada, offering products like e-detailing eliminates the need for reps to travel long distances to meet with physicians. “Physicians that are geographically isolated are bigger users of e-detailing because they are not called on by sales representatives as much as those [physicians] in more urban settings,” says Cully.

Conversely, events such as web casts and webinars afford physicians in remote regions the chance to participate in educational events and hear from a key opinion leader in a therapeutic area. “Marketers find digital marketing offers multiple channels, and they can see which channel is most appropriate for which audience,” says Cully.

HELPS DEVELOP ADHERENCE PROGRAMS
With the shift to multidisciplinary care and the involvement of more allied health professionals in therapy, marketers have to consider getting the attention of those professionals through e-channels, according to Ian Ross, prexy of Merge Rx in Toronto. “It used to be the sole point of influence was your physician, and that has changed,” says Ross. “The brand manager now has multiple stakeholders that they have to reach out to in order to influence.”

Moreover healthcare agencies recognize that in the era of the Internet patients can access reams of health information online. For an agency like Antibody, patient use of the Internet and e-mail is an opportunity to develop electronic adherence programs. “Adherence programs promote interaction with the patient,” explains Cran. “We time the communication with them to act as reminders to adhere to therapy and ensure compliance.”

The multimedia presentation is one step in the interaction process with medical professionals, and marketers are wise to leverage digital media as a foundation for more informed in-person interaction, observes Joseph Puopolo, director of marketing at Toronto-based Merge Rx.

“You can have face-to-face interaction that adds value for the healthcare provider,” says Puopolo. “You don’t want the doctors to go away for six to eight months without any follow-up.”

But the one-on-one visit is not an opportunity for a sales representative to dazzle a physician with technology, since the emphasis on the bells and whistles of tablet technology may detract from the marketing message, notes James Gill, past partner, prexy, and COO of Toronto’s Klick Communications Inc., who’s now client relationship executive, e-Solutions, at Merge Rx.

“The rep may then lose control of the discussion and the focus becomes the technology,” says Gill. He notes stricter regulations endorsed by Rx&D may make some gestures on the part of a sales representative inappropriate. Employing digital media as a platform to communicate health information avoids the semblance of gift-giving or financial support.

“If a sales representative offers to drive a doctor from Mississauga to Oakville to attend a CME event, it may be seen as giving a gift to that doctor,” explains Gill.

Gill and Puopolo are contemplating the opportunities that lie ahead with Web 2.0 and social networking sites, where users are the drivers of the content.

Gill notes that social media represents the next frontier in healthcare marketing and holds the potential for advertisers to connect with segments of their customer groups and tailor health information to healthcare providers based on their profile, which could include level of knowledge and/or disease awareness, years of practice, gender, geographic location, and where they are in terms of their experience with the brand.

“We can’t take a one-size-fits-all approach,” Gill told The Chronicle of Healthcare Marketing. “The days of the Model-T in only black are dead. We want to tailor the message to healthcare participants.”

Online communities can serve as a forum where the message to healthcare participants is tailored to their need, and the communities can be as open or closed as the participants would like. Concerns regarding confidentiality would be addressed through the security of the technical network.

PATIENTS RECEIVE PEER SUPPORT
“We would take appropriate steps to ensure that we adhering to privacy regulations,” explains Gill, noting data that are supplied can be managed to protect individual identities. “It would depend on what information you want to have shared. The site can be as secure or open as you would like it to be.”

Particularly for patients with chronic conditions, the exchange of communication and information with healthcare providers or with other patients is invaluable: patients are getting additional information from healthcare providers and are more likely to adhere to their therapy, and in sharing information with other patients, they are receiving peer support.

Chris Lemme, prexy of healthcare agency Euro RSCG Life in Toronto, also sees the integration of social media into marketing plans as another effective avenue to reach healthcare providers. One of the challenges may be in ensuring that marketers can relay key messages and sidestep pitfalls such as extensive discussion of adverse events.

“In terms of what people are saying to each other in online chats, you have to consider how you will manage that,” says Lemme, whose company doubled their interactive business in 2007 and is opening an office in Montreal this year.

Out There: What's happening in the world of drug marketing

It’s splitsville for TAP PHARMACEUTICALS, the stateside joint venture between Abbott and Japan’s Takeda. Ab will retain prostate Ca Rx leuprolide (Lupron), while Takeda takes blockbuster GI Rx lansoprazole (Prevacid) and cash. Takeda’s Seizo Masuda tells Reuters news agency: “We may pay Abbott up to $1.5 billion although the actual amount will depend on Prevacid 2008 sales and the progress of products in the pipeline.” That’s far from being Tapped out.

TEVA, parent of Toronto-based Novopharm, paid US$360 million at the end of March for publicly traded Bentley Pharmaceuticals, which markets generics in the EU. Bentley, which is divesting its Rx delivery system separately, has a strong presence in Spain, described by Teva kingpin Shlomo Yanai as a “fast-growing... generic pharmaceutical market.”

CHURCH & DWIGHT, the consumer products outfit, paid $380 million for the brands of Del Pharmaceuticals, which include oral analgesic Orajel. Del, which rang up $100 million in total revenues last year, was acquired by Coty, the beauty products marketer, late in 2007.

With the challenges to the drugbiz mounting, Big Pharma is looking to diversify, and no company more so than novartis. The Swiss purveyor of branded and generic Rxs (along with nutritionals and ophthalmic Txs) anted up $39 billion as part of a staged acquisition of eye-care colossus Alcon. Explains Nov helmer Daniel Vasella: “We were never a pharma pure play. And it’s getting harder to find good opportunities for acquisitions in pharmaceuticals.” Vasella tells the New York Times: “The margins are higher than our pharma business and are obviously very attractive.” The seller was the majority owner of Alcon, namely Nestlé, the Swiss confectionary concern. The deal raises questions about Nestlé’s committment to its other Rx investments, notably the dermatology operation, Galderma. However, NOVARTIS says it’s not interested in other acquisitions, at least for the moment.

KING PHARMACEUTICALS received a bad-boy letter from the US FDA, which doesn’t care for the recent promotion for King’s analgesic morphine (Avinza). According to the G-men, “The combination of such broad and unsubstantiated efficacy claims about the benefits of Avinza and the omission of the serious, potentially fatal risks associated with its use, as well as its potential for abuse, is especially egregious and alarming in its potential impact on the public health.” King bought the controlled-substance Tx last year from Ligand Pharmaceuticals.

Opinion & Commentary

Sale of Draxis Health to foreign company signals the end of an era

Another homegrown Canadian specialty pharma company was acquired recently by offshore interests, and, ho-hum, it’s hard to find anyone who cares. Takeovers of domestic drugmakers have accelerated during the last several years, from Shire buying BioChem, to Teva’s purchase of Novopharm, to numerous other transactions which have become frequent and commonplace. This trend, both within the drug business and also in other corporate sectors, is commonly referred to as the “hollowing-out” of Canada’s head offices.

And yet, it remains surprising that little attention has been paid by the media or within the pharma industry to the pending sale of Draxis Health to Jubilant Organosys of Mumbai, India.

Certainly, Draxis, in its latest incarnation as a contract manufacturing organization that also sells some branded radiopharmaceuticals, may have simply ceased to be interesting. Having pared back its earlier ambitions, the company became too small, too niche, and frankly too boring to capture the limelight.

It was not always so.

Some observers may not realize that Draxis had an exciting prior life. Indeed, this may seem as unexpected as discovering that Clements, that milquetoast in accounting, was once a full-patch member of the Black Diamond Riders motorcycle club, way back in the seventies, or that Delores-the-cafeteria-lady toured as a backup singer for Byron Lee and the Dragonaires. Such things happen, and tend to be hidden in the back pages.

Draxis Health used to be known as Deprenyl Research. And Deprenyl, it can’t be over-emphasized, was a drug company unlike any other.

We hear a lot these days about how the pharmaceutical industry needs to become more patient-centric. Well, Deprenyl represented the rare example of a patient who, upon finding that existing therapies failed to meet his needs, empowered himself by going out and starting his own successful drug company. How often does that happen?

The patient was Morton Shulman, and, granted, he had a few characteristics that might predispose someone toward success in the drug business. He was a practicing physician, to start. He had a winning track-record as an investor, and wrote several internationally best-selling books on the subject, including one called “Anyone Can Make a Million.” (In those pre-inflation days of the mid-1960s, that quaint figure represented actual wealth, not a high school teacher’s pension annuity, or a month’s pay for the CEO of a struggling enterprise.) A fictionalized series about his career as Toronto’s chief coroner was broadcast on the CBC, and later inspired the American TV series “Quincy.” He was politically active, and served as a high-profile Ontario MPP. And he was a familiar media figure, having been for five years the bombastic host of a controversial weekly TV show in Toronto, as well as a local newspaper columnist.

Shulman was diagnosed, at age 58, with the onset of Parkinsonian symptoms. A colleague at Toronto Western Hospital, Dr. Tony Lang, mentioned that he’d heard good things about a CNS agent available only in the Eastern Bloc, through the state-owned Hungarian drug-works. During the Cold War, decades before globalization meant much, this must have seemed a fairly preposterous suggestion, but Shulman corresponded with Jozsef Knoll, the Budapest pharmacologist who first used a compound known as l-deprenyl to treat Parkinson’s. Following one tradition of clinical experimentation, Shulman self-medicated, and concluded the Hungarians were on to something. He acquired Canadian licensing and distribution rights to the drug, which was a simple process since it would never have occurred to anyone else that the rights might be worth anything.

He would later claim that his next thought was to promote the product to physicians, but this would seem to be drastically out of character. The urge to promote was inevitably his first thought, and it was often his second and third thoughts, as well. This instinct would eventually emerge as a hindrance, about which, more later.

As he related the story at an OPMA meeting in the late 1980s, he one day called the advertising desk of the Medical Post, and explained that he wanted to place an ad for some sort of Hungarian brain drug he hoped to distribute. The ad clerk, surprisingly diligent, asked Shulman for the DIN number for the product. Shulman’s reply was, “What’s a DIN number?”

This tale, which is supposed to illustrate how much of a naïf Deprenyl’s founder was in 1987 when he established his company, seems just a tad implausible, but it also conveys a sense of the difficulties faced by the well-intentioned patient who suddenly wishes to become a pharmaceutical tycoon. After initial reluctance, Health Canada approved l-deprenyl (Eldepryl), which had accumulated impressive European safety and efficacy data. The FDA followed, in April 1989.

Shulman’s tendencies continued to run against the grain. As his company grew, rather than locating his operation near the Pill Hills of either Mississauga or Montreal’s west island, he leased offices over Pollack’s Hardware Store on Roncesvalles Avenue, a block away from his medical practice. If he claimed to know nothing about the drug business (“What’s an NOC? What’s IMS data? What’s a KOL?”), his record as a canny investor and image as a colorful character were both useful, first for attracting notice, and then especially for taking the company public. Which, of course, was his next move. Fish swim; birds fly; promoters promote.

Deprenyl Research began to branch out, acquiring a one-sixth ownership stake in the nascent Medicis Pharmaceuticals (which was quickly sold, and would today be worth hundreds of millions) and several photodynamic therapies that didn’t quite revolutionize medicine. There was also a veterinary division of the company, Deprenyl Animal Health, the US operations, Deprenyl USA, an orthopod spin-off, and on, and on. Those who say you’re supposed to under-promise and over-deliver never had to live for a second inside Morton Shulman’s head.

Giddy from widespread interest in l-deprenyl in the medical and financial communities, and by relentless media attention, the doctor’s self-restraint seemed to evaporate. The local press was accustomed to Shulman, and may have assumed that the public took whatever he said with a grain of salt. The international media, alas, was another matter.

Shulman never actively discouraged the off-label use of l-deprenyl for sexual dysfunction and other age-related disorders, but he probably went too far in hyping Alzene, an unapproved Tx for Alzheimer’s derived from alpha-linolenic and linoleic acids. In 1992, the Wall Street Journal detailed a list of Deprenyl Research’s questionable marketing practices, highlighting Shulman’s cross-border promotion of Alzene to US neurologists. (To further confuse matters, the Alzene brand is used for the anti-allergy Rx cetirizine in some countries.)

Displaying the sort of brash charm that served him well in Canada, Shulman, according to the Journal article, “blithely offered to give a reporter’s family shares of a [...] Deprenyl Research subsidiary.” The reporter declined, and the Deprenyl chairman came away looking rather seedy to Wall Street. Far from entering the armamentarium of memory therapies, Alzene is today itself a memory.

Shulman next embarked on a Quixotic campaign seemingly aimed against his own company, intended to improve Jozsef Knoll’s royalty deal. He concurrently entered into many public feuds, including one with Ontario MPP Jim Wilson, who complained in Parliament about “bold-faced attempts to muzzle me simply because I asked a question in this Legislature concerning [Shulman’s] business practices.” Viewed one way, the antics were endlessly entertaining—except to Deprenyl shareholders, a group that realized the basic incentive behind stock-ownership is return on investment, not amusement from the public ravings of the board chairman.

So Deprenyl’s founder was given the heave-ho by his directors, and replaced as chair by a former Deputy Minister of Health for the Province of Ontario. The company’s name was changed, and a revised course was charted. Draxis Health relocated to Mississauga’s Pill Hill, consolidated its animal health division, removed Shulman’s portrait from the lobby, hired some fresh faces for regulatory affairs and investor relations, bought the old Burroughs-Wellcome plant on the T-Can in Kirkland, entered into promising in-licensing arrangements with outfits such as Ireland’s Elan Pharmaceuticals. Shulman stomped off to relative obscurity, emerging briefly to hustle via a startup entity a purported erectile dysfunction cure developed by a Toronto urologist. He died in 2000, at age 75. At the time, an admirer told a Toronto newspaper, “Everything Morty did was on the edge.” Truly, an epitaph one might interpret several different ways.

Draxis continued to follow a sober, responsible, conservative business plan, in the process becoming so dull as to appear pulse-less to Bay Street analysts. The Elan deal didn’t pan out. For pretty much its entire existence, investors placed a top value of around five bucks a share for Draxis until the fellows from Mumbai just stepped in with their offer of six smackers, which sounded fine to the directors.

Deprenyl USA, known as DUSA, continues as a separate publicly traded enterprise based near Boston and led by Morton Shulman’s son, Geoff, a dermatologist. DUSA shares peaked at nearly $35 a share in 2000, and today fetch around two dollars: or, in keeping with the company’s acronym, one deuce-a.

Such is the path we’ve all travelled since the inception of Deprenyl Research, which leads us here into the 21st century. Just yesterday, you could launch your drug company over a downtown hardware store, next door to a fruit stand. Tomorrow, the new owners arrive for meetings following a 12-hour flight. Yesterday, one motivated person could beat the drum for an unapproved pharmaceutical product, proclaiming pretty much whatever popped into his head, and nonetheless still see it become a standard treatment, all without the benefit of an office building filled with MBA grads. Let’s agree that things have changed since then.

It turns out that Shulman and his creation, Deprenyl Research, have built several models for the pharma industry in the new millennium, of both the good and bad variety. For the good: Deprenyl was above all nimble and entrepreneurial, in advance of the current notion that perhaps you can run a branded drug company and out-source many traditionally integrated functions. Also for the good: Deprenyl was created to fulfill patients’ immediate needs, a responsiveness and focus to which we all aspire. And for the bad: Shulman’s promotional excesses may have been a crude early precursor to the modern industry’s addiction to marketplace ballyhoo, and the numerous difficulties this has engendered.

It has been noted previously in these columns that the antecedents of the modern pharmaceutical business were creators, not managers. In the last century, companies bore the names of individuals: John Wyeth & Bro., Charles E. Frosst & Co., Henry K. Wampole & Co. Ltd., Frank W. Horner Ltd., J.F. Hartz Co. Ltd. Sometimes the names live on, more often not.

Draxis may prosper under its new ownership, and it’s entirely possible that one day “Jubilant Organosys” will sound less peculiar to the Canadian ear. As for Morton Shulman, no one is proposing to erect a bronze statue of him depicted carrying a medical bag down Roncesvalles Avenue, but, hey, that’s Toronto for you.

Still, some recognition is due. Perhaps if you happen to find yourself in the neighborhood seeking a Thai dinner or a lug wrench one evening, it would be permissible to nod your head once briefly, both to acknowledge an improbable achievement in pharmaceutical marketing, and to greet the Deprenyl founder’s unquiet ghost.

My Turn

Do your pharmaceutical reps know who they're selling to?

By Alan G. Bayham, RPh,
Special to THE CHRONICLE
of HEALTHCARE MARKETING

THIS HAPPENS OVER AND OVER AGAIN.

The pharmaceutical sales representative delivers an outstanding presentation to the prospect. She not only knew all the facts about her product, but also about all of her competitors. Her vocal skills were impeccable, and she portrayed professionalism and confidence. Her close was strong and affirmative.

But her prospect—a very prominent physician—said he would “consider” using her product if it became “appropriate.” He may as well have said, “No.”

What went wrong?

What did the sales rep do wrong?

While it is true that everyone is different and unique, it’s also true that people tend to fall into four basic behavioral types when it comes to buying a service or product. The success (or failure) of the sales call is dependent upon the sales representative being able to distinguish the correct behavioral type of the prospect, the sales message, and also the appropriate communication style. For example, a sales representative cannot sell the same way to Donald Trump as he can to Richard Simmons, and visa versa. The product is the same in both sales calls, but in order to close the sale effectively, the approach and the message would (or should) be different for each of the four categories.

THE DONALD TRUMP—THE DIRECT TYPE
This buyer is usually a Type A personality—think, “Donald Trump.” They are usually in a hurry and tend to be very direct in their conversation. Direct Type Buyers are often blunt and even interrupt the sales representative constantly. They state their opinions as fact. They are impatient and demanding, wanting to get to “the bottom line” quickly.

While you want to be direct and specific, provide alternatives so that the Direct Type Buyer can make the decision to buy. Let this buyer speak and you listen. Do not go into all the details or try to control the situation. Ensure he/she “wins.” You must act quickly, because this buyer type decides fast. Whatever happens, don’t take issues personally.

THE RICHARD SIMMONS—THE INTERPERSONAL BUYER
This buyer is very friendly and excitable, often animated—think “Richard Simmons.” They cannot focus on details and jump from subject to subject. Because they don’t always have the ability to listen for long periods, they may ask the same question several times. Interpersonal Buyers are more interested in forming a relationship than they are in buying.

Schedule time for chatting and let this buyer speak, giving recognition as appropriate. Talk about people and feelings. As you converse with this buyer type, move closer and maintain a positive atmosphere. You want to show how your product will help to achieve popularity and recognition. Focus on the people aspects. Do not fail to socialize. Also, do not set hard restrictions, unless absolutely necessary.

THE AUNT BEE—THE SAFETY OR STATUS QUO TYPE
These buyers usually appear calm and do not get easily excited, imagine speaking with “Aunt Bee” from the old Andy Griffith show. They listen carefully and ask specific questions. Completely new ideas/things make these buyers uncomfortable.

It is key to slow down your presentation and build trust. Provide the necessary information that this buyer needs logically, and secure commitment piece by piece. Ask specific questions to find out true needs, and then provide support. It is also advantageous to provide precedents or examples of previous success to reduce uncertainty. Be sincere and do not dominate.

THE ALBERT EINSTEIN—THE CONTEMPLATIVE BUYER
These buyers are usually very quiet. They focus on details and ask questions. The “Albert Einstein” characters of the world study specifications and other information carefully. In fact, they may have even done some research on your product or service prior to your sales call.

When selling to this type, patiently provide facts and plenty of detailed information. Go slowly and do not invade his or her private space. Avoid talking about personal issues or small talk. Listen carefully, and then answer questions calmly and carefully. Be thorough; remember to include all relevant information, utilizing written supporting documentation. Find out what the key issues are and focus on them. Don’t move too fast, move too close, or lose patience in providing all the requested information. Also, don’t expect decisions right away.

In order to be successful, pharmaceutical sales representatives must tailor their approaches and messages very differently to each Buyer Behavioral Type. Let’s examine the differences.

As the numbers suggest, sales representatives who try to use the same “canned” message will be effective only 25 per cent of the time because the approach and message will be effective only for the buyer behavior type it was designed for. The ability to recognize the various behavior types and adapt the sales call appropriately takes training and practice.

Also, just as buyers fall into one of each of these buying types, so do sellers. More times than not, sales representatives will have to learn (and train) themselves on how to adapt their own behavioral type to the specific prospect they are calling on.

Success in the sales arena will increase exponentially by training sales representatives on how to properly identify the behavioral type of their prospect, and how to adapt the sale approach and message appropriately.

__________________________________________________________________________________

Alan G. Bayham, RPh, President of the Rx Training Institute, has decades of experience in pharmaceutical and medical equipment sales and has served as a regional field trainer for a Fortune 500 pharmaceutical company. In addition, he has a decade of experience as the pharmacy director for managed care organizations in the United States and Puerto Rico. He can be reached at 504-259-8682 or abayham@RxTrainingInstitute.com

Table of Contents

Lung cancer study funding scrutinized

Cigarette manufacturer behind foundation that sponsored lung cancer study

DTC ads do shape patient, physician interactions

Survey reports that prescription drug ads are changing dynamics of medical care

Up Here:What's happening in drug marketing

Drugbiz CEO faces criminal charges over Actimmune marketing

NOCs of Note: April 2008

Significant TPP approvals of Rxs for human use

Detailing in 2008

Into the pharma marketing Way-Back Machine

Once again, The Chronicle examines the unofficial archives of the Pharmaceutical Marketing Club of Quebec

IMS Health Team Awards presented to Novo Nordisk, Paladin's Plan B at annual Hall of Fame ceremony

Novo Nordisk's educational initiatives regarding diabetes, Paladin's Plan B named top examples of Big Pharma's ability to develop innovative therapies and marketing strategies that recognize the importance of community education

What should provinces pay for pharmaceuticals?

Critics say BC's new pharma panel, seen as stacked with drug company personnel, could result in higher prices

Creativity equals efficiency

Interactivity playing larger role in marketing plans

Digital media, CHE/CME can bring exposure to brand, offer physicians flexibility in their personal schedules

Out There: What's happening in the world of drug marketing

Sale of Draxis Health to foreign company signals the end of an era

Do your pharmaceutical reps know who they're selling to?