April 2005
The Chronicle of Healthcare Marketing
April 30, 2005
Covering Canadian and Global Pharmaceutical Economics
www.pharmaweenie.com
Table of Contents
PMPRB puts pricing rules, guidelines under review
Up Here: What's happening in drug marketing
A case in point: The HRT conundrum
10 minutes with... Hans Mader, prexy of Procyon Biopharma
Where is the drug industry's own Super Bowl?
Marketers tinker with DTC format, following COX-2 withdrawals
Out There: What's happening in t he world of drug marketing
Shooting the messenger: Perhaps not the smartest reaction
Pharmaceutical industry, heal thyself
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What makes a drug too risky?
Positive effects of treatment can outweigh potential risks for patients, and doctors
By Ron Winslow
Special to THE CHRONICLE OF
HEALTHCARE MARKETING
Few people are caught more tightly in the vortex of the controversy swirling over drug safety than Debby Demaree and her family.
Her three teenage children take Adderall, the attention-deficit drug Canadian regulators banned from the market. Her son also takes Accutane, an effective acne medication that infamously causes birth defects. A decade ago, at age seven, one of her daughters took the antidepressant Prozac, whose rivals have recently been implicated for increasing suicide risk. Meantime, her husband was taking Vioxx for intermittent back pain last fall when Merck yanked that pill from the market over heart concerns. Now he’s taking Celebrex, which has since come under a similar cloud of its own.
Ms. Demaree, who with her husband runs a commercial real-estate company in Bethesda, Md., is troubled by the possible hazards these drugs pose, but that’s not what she’s really worried about. For her family, “the side effects of not have those drugs,” she says, “are much more serious than the risks of taking the medications.”
The flood of reports in recent months over the risks associated with a variety of widely used medicines has spotlighted the issue of drug safety with as much intensity as at any time since furor over birth defects and the morning sickness pill thalidomide. That episode in the ’60s sparked an overhaul of drug evaluation and gave rise to the modern Food and Drug Administration in the US.
Ms. Demaree’s concerns underscore the challenge that regulators, drug companies, and doctors alike face as they confront troubling evidence of potentially serious risks of medicines that have provided benefits to millions of patients.
NOT BEING TREATED POSES RISKS
Statistically, only a relatively small number of patients taking the medicines at the heart of the current fray over the safety of painkillers are at risk. Canadian regulators, for instance, ordered the new, once-daily version of Adderall withdrawn based on 20 sudden heart-related deaths. Merck pulled Vioxx after a study found an extra 7.5 heart attacks and strokes per thousand patients on the drug for at least 18 months compared with a placebo. GlaxoSmithKline PLC’s antidepressant Paxil raised concern based in part on an analysis of nine studies showing a 3.4 per cent of patients had side effects “possibly related to suicidal behavior” compared with 1.1 per cent on placebo.
Despite the small numbers, medical science can’t definitively rule anybody in or out of danger.
At the same time, there are risks for not being treated. Many experts credit a rise in use of Paxil, Prozac, and other antidepressants known as SSRIs for a 25 per cent reduction in teenage suicides in the past 10 years, to about eight per 100,000 teenagers per year. Failure in school and criminal behavior are among possible outcomes for kids whose attention disorders go untreated while switching pain relievers can also mean trading a risk of heart problems for one of gastro-intestinal troubles that can be just as serious.
“It’s not all about safety,” says J. P. Garnier, Glaxo’s chairman and chief executive officer. “It’s about the millions of people who benefit [from a drug]. When you pull a drug off the market, there are millions of people who will suffer as a consequence.”
At the US FDA, there isn’t a single threshold of risk that automatically leads to a drug withdrawal. Factors such as how convincing the risk is, whether alternative treatments are available, and the nature of the illness are among variables that can determine whether the agency thinks action is necessary.
“We tolerate gross toxicities for cancer and AIDS drugs that we wouldn’t tolerate for an antihistamine,” says Robert Temple, director of the office of medical policy in the FDA’s drug center. “Some very severe risks can be tolerated if the need [for the treatment] is great enough. In the case of Adderall, the FDA hasn’t found sufficient risk to take action.”
The Bush administration took steps to beef up the agency’s capacity to monitor safety of drugs already on the market by announcing plans to set up an independent Drug Safety Oversight Board. It will gather post-marketing data on risks and benefits of drugs and provide updates to doctors and patients.
At the heart of the conundrum is how people perceive medical risk. Research shows that many people accept significant risks in cases of known hazards where they feel they have personal control, such as driving 80 miles per hour, smoking cigarettes, or riding a motorcycle without a helmet.
But when it comes to drug risks, consumer knowledge and control are often wanting. Direct-to-consumer marketing campaigns help create a distorted view that drugs are essentially risk-free, many experts say. “You see enough ads showing a ‘before’ picture of someone who is markedly physically impaired and an ‘after’ picture when they’re out playing golf or doing gymnastics, that gives you visual reinforcement,” says Carolyn Clancy, director of the federal Agency for Healthcare Research and Quality. Compounding the problem is a paucity of data from rigorous clinical trials to provide doctors and patients alike with objective long-term data on the performance of many pills in America’s medicine cabinet.
The notion that drugs are perfectly safe “is Wonderland,” says Glaxo’s Mr. Garnier. “Drugs have side effects. If you know about it up front, it can be managed.” The problem, he says, is that “people don’t like to discover things later.”
Merck’s decision to withdraw Vioxx, one of a class of arthritis painkillers called COX-2 inhibitors, from the market late last September set off a cascade of events that has culminated in the advisory panel hearing. It has since enveloped Celebrex and Bextra, COX-2 drugs marketed by Pfizer Inc., and the whole class of older pills known as non-steroidal anti-inflammatory drugs, or NSAIDs, that includes ASA and well-known over-the-counter brands such as Aleve and Advil that have been staples of medicine cabinets for years.
The COX-2 medicines, which were introduced in the late 1990s, aren’t, on average, any more effective that the older, cheaper NSAIDs, but as once- or twice-a-day dosing, they are easier to use than the four-times daily NSAIDs, as the older drugs are known. And they were intended to reduce incidence of stomach bleeding that is a common side effect of NSAIDs. Indeed, studies indicate that gastrointestinal bleeding from taking the NSAIDs leads to more than 15,000 deaths and more than 100,000 hospital admissions a year in the US.
Whether the remaining COX-2 pills actually cause less stomach bleeding is controversial, and a question the FDA panel is expected to consider. But both Vioxx, which accounted for US$2.5 billion in annual sales before it was withdrawn, and Celebrex, a US$3 billion-a-year pill, quickly became huge sellers when they hit the market, thanks largely to aggressive direct-to-consumer advertising. That enormous success many have been Vioxx’s undoing and threatens Celebrex as well.
“What blew up in the faces of these COX-2 inhibitors is that the companies oversold the drugs,” says Ira S. Nash, associate director of the cardiovascular institute at Mount Sinai Medical Center, New York. The result was many people took a COX-2 who didn’t need it, some of whom turned out to have heightened risk for heart complications.
“It leads to a situation where the side effects seem to outshine the benefits for a [narrower] population of patients,” Dr. Nash says. “These drugs may well have had a much more established place if their use was limited to people for whom the risk-benefit ratio was more favorable.”
HEIGHTENED WARNINGS ON WAY
The fate of other drugs caught in a risk-benefit downdraft after they reached the market offers some insight into options the US FDA has in handling the COX-2s and other pills. Baycol, a cholesterol drug known as a statin marketed by Bayer AG was withdrawn in 2001 after it was linked to a very rare but potentially fatal muscle-wasting condition called rhabdomyolosis. Other statins provided a similar benefit to patients, but with significantly less risk of the side effect. “If you have a drug that is clearly more toxic than other members of its class and offers no advantage, that drug is going to disappear,” the FDA’s Dr. Temple says.
Drugs such as the nonsedating antihistamine Seldane and the diabetes treatment Rezulin were permitted to remain on the market with heightened warnings despite troublesome risks until safer alternatives with similar benefits became available, he adds.
But Lotrenox, Glaxo’s remedy for irritable bowel syndrome that was pulled in 2000 based on reports of potentially fatal bowel obstruction and intestinal injuries, was allowed back on the market two years later with strict limitations. Patients who had benefited from the drug suffered severe relapses when it wasn’t any longer available and couldn’t find suitable alternatives.
The breast cancer drug Herceptin offers a future model for managing important risks of a beneficial drug. The medicine, marketed by Genentech, extended survival in advanced breast cancer patients by seven months in clinical studies, but it works only in patients with tumors with certain biological traits that are detected with a diagnostic test. The drug also comes with a significant risk of heart failure. Using the diagnostic to determine who is likely to respond to the drug also rules out exposing people who won’t benefit to the heart failure risk.
“We don’t always insist on that direct therapy to people most likely to respond,” Dr. Temple says, “but with ongoing genetic advances that are expected to foster more personalized treatment, we’re likely to see more of that.”
The COX-2 controversy is fraught with conflicting and hard-to-interpret data that challenged the FDA panel being asked to advise the agency on what course to take with the medicines and other pain relievers. Mount Sinai’s Dr. Nash is hopeful that the debate will provoke more conversations between doctors and patients that would blunt the impact of marketing campaigns and instead lead to a better match of benefit and risk.
“Maybe it does make sense to take some risk of heart attack if you prevent a lot of deaths from GI bleeding,” he says. But “what you’d like to believe is that a physician would say, ‘this is somebody at high risk for GI complications and low risk for heart problems—maybe a COX-2 makes sense.’” But for a person with low risk of ulcers, a conventional NSAID may be the route. “Those kinds of decisions get lost in the hype,” he says.
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Copyright The Wall Street Journal, 2005. Reprinted with permission.
PMPRB puts pricing rules, guidelines under review
Agency wants pharma to provide notification prior to price increases
By Ian J.S. Moore
for THE CHRONICLE OF
HEALTHCARE MARKETING
Pharmaceutical manufacturers of patented medicines in Canada can expect to see significant changes this year in the way their price increases are regulated by the Patented Medicines Prices Review Board (PMPRB) if several of its proposals currently under consideration are adopted.
The PMPRB is reviewing price increases announced by patented drug manufacturers last year and wants to change the regulations to oblige manufacturers to notify the PMPRB before they raise their prices. The PMPRB also wants to review, and perhaps eliminate, the regulation that automatically allows price increases to match the full rise in the Consumer Price Index.
Advance notice of these potential changes was given by PMPRB chairman Dr. Robert G. Elgie during the 12th annual Pharmac 2004 conference in Toronto. He noted that manufacturers of approximately 35 per cent of the patented medicines in Canada under the agency’s jurisdiction announced price increases last year.
“We will ensure [2004 price increases] comply with the guidelines,” he said, “and consistent with the Patent Act we will be prepared to ensure that price increases are not excessive in any market in Canada, and not just on the basis of a national average.”
The 2004 price increases, he pointed out, had exposed potential weakness in the Patent Act legislation.
WANTS TO BE ADVISED OF PRICE INCREASES
“If the board is only able to review price increases after the fact, can consumers be confident that they are protected from excessive pricing? Can drug plans make their difficult decision about listing and reimbursing drugs if they do not know if the prices they are asked to pay are consistent with federal law?” Dr. Elgie asked rhetorically.
Manufacturers currently provide advance notice of price increases to their customers, and there is no apparent reason why they could not advise the PMPRB at the same time. “This change in process would allow the board to determine if the proposed price conforms with the guidelines beforehand, providing protection to consumers and providing greater certainty to manufacturers.”
The board, Dr. Elgie maintained, should have the power to block price increases that are not justified by the Patent Act legislation, “and not have to wait until the damage has been done.”
Currently, manufacturers are required to inform the board after they raise prices and these increases can be made on the basis of a national average.
In his Pharmac address, the PMPRB board chairman said current guidelines that automatically allow price increases to match increases in the CPI should be reviewed because they place additional pressure on prices in today’s marketplace and threaten to upset the international price parity the board has achieved and maintained in the past decade.
“It may be that some price increases are appropriate, but if so, the public should be satisfied that is the case,” he said. “I am proposing that this review of the CPI Guidelines become a matter of high priority for the board, and that we issue a paper for discussion purposes.”
Noting that prices had remained stable for a decade in Canada and in the six European countries the PMPRB tracks for comparison purposes, the board chairman wondered if the recent pattern of selective increases would disrupt therapeutic class comparisons of prices and if price increases now were a strategy to allow for higher prices for new drugs yet to be approved.
“By asking these questions, I do not want to be an alarmist, but I do want to raise an alarm. There is a risk that the publicity about drug price increases will become a self-fulfilling prophecy.
“We could wait to see if that happens and try to deal with it then, or we can begin to act now to ensure we do not experience excessive price increases that would disrupt the delicate balance in drug pricing that Canada has achieved.”
NO DUAL PRICING
Dr. Elgie said the PMPRB was also concerned about another issue: adherence to a Voluntary Compliance Undertaking. Last year a pharmaceutical firm agreed to lower the price of one of its products by a substantial amount (to $125 from $295 per vial) to bring it within the international price range, but the company had yet to lower the published price.
This created a situation where the company let its customers know it would not charge any customer in Canada more than $125 per vial, but any potential customer looking for price information would find the older, more expensive cost in published price lists.
“This situation raises potential questions about compliance with the Voluntary Compliance Undertaking and the enforcement and integrity of the PMPRB’s policies,” Dr. Elgie said.
“We are conducting a preliminary review to identify what action, if any, may be appropriate to address this attempt at dual pricing.”
The PMPRB reviews prices twice each year. The final filing date for patented drug companies for 2004 was Jan. 31, 2005, and the review of last year’s price increases is underway.
“The board has prepared, in one case, a discussion paper [on price increases] and in the other case a document that lists its proposal [for advance notice of price increases] and put that to consultation,” PMPRB board secretary Sylvie Dupont told The Chronicle of Healthcare Marketing. This information can be reviewed online at www.pmprb-pepmb.gc.ca.
California governator Arnold Schwarzenegger makes his mark on a vehicle participating in a drive around the world to raise funds for Parkinson’s disease research. Last fall, the citizens of the Golden State voted to commit US$3 billion to stem cell research, bucking a national trend against such studies set by the Bush administration. __________________________________________________________________________________
(PR Newswire Photo Service)
What's happening in drug marketing
ORYX PHARMACEUTICALS of Mississauga, Ont. got thumbs-up from Health Canada for prescription extended-release niacin (Niaspan) as Tx for dyslipidemia. The product is in-licensed from Kos Pharmaceuticals. Oryx prexy Douglas Reynolds calls the approval “a significant milestone for Oryx.”
ASTELLAS arrived in April--it’s the new entity formed from the merger of Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical. Worldwide HQ of the company, which ranks among the 20 largest global drugmakers, is in Tokyo. Astellas’ core Tx areas are: immunology, anti-infectives, dermatology, urology, and CV. Hiromu Ozaki, president of the company’s Markham, Ont.-based Canadian unit, says he “looks forward to benefiting from an enriched pipeline as well as all of the synergies that will result when resources are maximized to their fullest potential.”
COLOMBIAN REGULATORS okayed miltefosine (Impavido, Aeterna Zentaris) for cutaneous manifestations of leishmaniasis. The company, based in Quebec City, said the approval was the first for the skin variation of the disease.
SATIVEX (tetrahydrocannabinol-cannabidiol, GW Pharmaceuticals, Bayer), the first cannabis-derived Rx, was okayed by Health Canada as Tx for neuropathic pain in MS patients. The action represents an unusual case of Ottawa green-lighting a compound not approved in the EU or US. Says Toronto neurologist Dr. Allan Gordon: “The approval of Sativex reflects the urgent need for additional treatment options in the field of neuropathic pain in MS.”
ISOTECHNIKA, the Edmonton Rx developers, said Canadian phase III psoriasis trials for its lead immunosuppressive drug, ISA247, show promising results. The trial, known as SPIRIT, is being conducted at 32 sites, and the company claims it’s the largest of its kind in Canada for an oral antipsoriatic. Says investigator Dr. Darryl Toth of Probity Medical Research in Waterloo, Ont.: “Based on my clinical observations to date, the data suggests that ISA247 is an efficacious treatment with a promising safety profile.”
NOCs of Note: April 2005
Significant TPP approvals of Rxs for human use
Antidiabetic agent, insulin, resistance reducing agent03-30
Rosiglitazone (as rosiglitazone maleate) (Avandia, GlaxoSmithKline Inc.) Product monograph update: a) newly reported clinical data from double blind randomized trials, open-label extension studies to monotherapy, combination with metformin and combination with sulfionylureas; b) Comments: storage conditions updated to reflect a completed freeze thaw study; TAB(1mg, 2mg, 4mg, 8mg)ORL
Type I and II 5 alpha-reductase inhibitor03-31
Dutasteride (Avodart, GlaxoSmithKline Inc.) Comments: Update to the product monograph with inclusion of four year safety data; CAP(0.5mg)ORL
Antineoplastic, antibiotic03-30
Bleomycin for Injection, USP, Bleomycin (supplied as bleomycin sulfate) Pharmaceutical Partners of Canada Inc. Comments: PWSO(15unit/vial)IAR/IM/IPL/SC/IV
Nodular/inflammatory and conglobate acne therapy03-31
Isotretinoin (Clarus, Prempharm Inc.) Comments:CAP(10mg, 40mg) ORL
Antidepressant, antiobsessional, antipanic, anxiolytic agent, social phobia (social anxiety disorder), posttraumatic stress disorder therapy03-10
Paroxetine supplied as paroxetine hydrochloride (Co Paroxetine, Cobalt Pharmaceuticals Inc.) Comments:TAB(10mg, 20mg, 30mg)ORL
Lipid metabolism regulator03-04
Rosuvastatin supplied as rosuvastatin calcium (Crestor, AstraZeneca Canada Inc.) Comments: Addition of 5 mg dosage and updated safety information; TAB(5mg, 10mg, 20mg, 40mg)ORL
Acne therapy03-31
Cyproterone acetate, ethinyl estradiol (Diane-35, Berlex Canada Inc.) Comments: Update to the product monograph to reflect the most current safety information, as per new medical data and an April 10, 2003 Dear Care Professional Letter and Safety Advisory; TAB(2mg, 35mcg)ORL
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis; antitumor agent04-01
Letrozole (Femara ISSUED UNDER THE NOC/C POLICY, Novartis Pharmaceuticals Canada Inc.) Comments: New indication: for the extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy; TAB(2.5mg)ORL
Antineoplastic03-10
Fludarabine phosphate supplied as fludarabine phosphate sodium (Beneflur, Berlex Canada Inc.) Comments: Additional product name; PWSO(50mg/vial)IV
Oral antidiabetic agent03-02
Repaglinide (GlucoNorm, Novo Nordisk Canada Inc.) Comments: New indication: use of repaglinide in combination with rosiglitazone; TAB(0.5mg, 1mg, 2mg)ORL
Anticoagulant, antithrombotic03-15
Enoxaparin sodium (Lovenox, Lovenox HP, Aventis Pharma Inc.) Comments: Revisions to the product monograph related to dosage adjustment for patients with severe renal impairment; [Lovenox: SOL(300mg/3ml, 30mg/0.3ml, 100mg/ml)SC], [Lovenox HP: SOL(150mg/ml)SC]
Antimalarial agent03-10
Atovaquone and proguanil hydrochloride (Malarone Pediatric, GlaxoSmithKline Inc.) Comments: New strength for pediatric use; TAB(62.5mg, 25mg)ORL
Lipid metabolism regulator03-10
Nicotinic acid (Niaspan, Oryx Pharmaceuticals Inc., a Subsidiary of Filiale d’Arrow Pharmaceuticals Inc.) Comments: SRT(500mg, 750mg, 1000mg)ORL
Selective serotonin reuptake inhibitor04-15
Paroxetine (as paroxetine hydrochloride) (Paxil CR, GlaxoSmithKline Inc.) Comments: New strength – 37.5mg; SRT(37.5mg)ORL
Cholinesterase inhibitor04-08
Galantamine (as galantamine hydrobromide) (Reminyl ER, Janssen-Ortho Inc.) Comments: New dosage form - extended release capsules; SRC(8mg, 16mg, 24mg)ORL
Antipsychotic agent03-31
Risperidone (Risperdal, Risperdal M-Tab, Janssen-Ortho Inc.) Comments: New indication as monotherapy for the management of acute episodes associated with Bipolar 1 disorder; RISPERDAL:TAB(0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg)ORL, SOL(1mg/ml)ORL; RISPERDAL M-TAB: TAB(0.5mg, 1mg, 2mg)ORL
Cannabinoid analgesic 04-15
Delta-9-tetrahydrocannabinol (from Tetranabinex - Cannabis sativa L. extract), cannabidiol (from Nabidiolex - Cannabis sativa L. extract) (Sativex ISSUED UNDER THE NOC/C POLICY, G W Pharma Limited) Comments:SPR(27mg/ml, 25mg/ml)BUC
Inhalation anesthetic03-15
Sevoflurane (Sevoflurane, Baxter Corporation) Comments: LIQ(99.97%)INH
Lipid metabolism regulator03-10
Simvastatin (Taro-Simvastatin, Taro Pharmaceuticals Inc.) Comments: New manufacturer and product name; TAB(5mg, 10mg, 20mg, 40mg, 80mg)ORL
Anti-epileptic agent04-07
Topiramate (Topamax, Janssen-Ortho Inc.) Comments: New indication as monotherapy for the management of patients (adults and children six years and older) with newly diagnosed epilepsy; CAP(15mg, 25mg, 50mg)ORL; TAB(25mg, 50mg, 100mg, 200mg, 300mg, 400mg)ORL
Vitamin D analog03-31
Paricalcitol (Zemplar, Abbott Laboratories Limited) Comments: SOL(5mcg/ml)IV
Antiretroviral agent03-31
Abacavir sulfate (Ziagen, GlaxoSmithKline Inc.) Comments: New dosage regimen - once daily; SOL(20mg/ml)ORL, TAB(300mg)ORL
Specific antibody for digoxin04-18
Digoxin Immune Fab (Ovine) (Digibind, GlaxoSmithKline Inc.) Comments: New manufacturing site; PWSO(38mg/vial)IV
Nodular/inflammatory and conglobate acne therapy03-31
Isotretinoin (Clarus, Prempharm Inc.) Comments: CAP(10mg, 40mg) ORL
Active immunizing agent03-29
Vibrio cholerae Inaba 6973 E1 Tor biotype, formalin inactivated; vibrio cholerae Inaba 48 Classical biotype, heat inactivated; vibrio cholerae Ogawa 50 Classical biotype, formalin inactivated; vibrio cholerae Ogawa 50 Classical biotype, heat inactivated; recombinant cholera toxin B subunit (rCTB) (Dukoral, SBL Vaccin AB) Comments: Changes to manufacturing facility; SUS(250million/dose, 250million/dose, 250million/dose, 250million/dose, 1mg/dose)ORL
Benzodiazepine antagonist03-30
Flumazenil Injection (Flumazenil, Pharmaceutical Partners of Canada Inc.) Comments:SOL(0.1mg/ml)IV
Science and the sales pitch
The traditional sales call has always been a key ingredient in the pharmaceutical marketing mix, but tighter regulations and changing demographics suggest that the traditional sales call could soon be toast. Some pharma companies, struggling to find the winning recipe for sales force success, have turned to state-of-the art technologies to increase sales effectiveness, while placing greater emphasis on science-based training for pharmaceutical reps. But will the science—or the sales pitch—be the order of the day?
Several pressure points affect the traditional relationship-building model today, says Marc Lalande, gee-em of the Council for Continuing Pharmaceutical Education (CCPE). With twice as many pharma reps today as there were in 1993, Lalande maintains, “We’ve reached a saturation level.”
Sales forces have more limited access to physicians, many of whom have busier practices due to higher demand from an aging population, and the number of female doctors has risen dramatically, leading to a need for different strategies. The male vs. female demographics that suggest 50 per cent of practicing physicians will be women in the next eight to 10 years, has created an entirely different sales model for pharma companies, says Lalande. Sales managers will be forced to find ways to reach these elusive female practitioners who frequently opt for part-time practices and are more involved with family commitments.
It seems female practitioners are also fussier about the kinds of events they’ll attend. “If you’re thinking of inviting a female physician to a dinner or breakfast meeting, forget it,” says Lalande. Large meetings where there is a blended group of male and female participants are also less popular with female physicians than situations offering smaller group interaction, he adds.
But one of the challenges to the relationship-building process between pharma reps and physicians is the recently revised Rx&D code of ethics, which seriously limits hospitality, and underlines the need for new sales competencies. “Now sales reps may have 30 seconds to two minutes to deliver a message or try to build a relationship,” clearly not enough time to do either effectively, Lalande adds.
MANAGING THE CUSTOMER RELATIONSHIP
Steve Gregory, prexy of IsaiX Technologies Inc. of Montreal, points out that “the mantra” of sales consultants has always been target, reach, and frequency. “This is all the same old jargon… but that’s not the only battle,” he says. The challenge is not only getting in front of the right people, with innovative strategies like CHE, but to “leverage” these impacts through effective customer relationship management.
Scott Lambert, director of sales at Fournier Pharma Inc. says that for his biz, customer relationship management (CRM) is “huge.” His company currently has a task force made up of reps and managers to determine what they need from the CRM platform in order to make it more effective.
But most companies aren’t leveraging CRM as well as they should, says Gregory. “That’s a massive challenge and it outstrips sales because it now involves medical affairs and CHE departments. We watch customers spend millions on CRM applications but the quality of the data entered by the other departments is negligible.” Consultants are advising the industry to analyse and target the right physicians, “but if the quality of information being put in is corrupt, CRM is just a targeting tool. And I would say in pharma right now, its primary use has been to track target reach and frequency.”
Marketing gurus caution that reach and frequency is a primary care model that may not apply to specialty care where there are fewer physicians to call on. Specialty care does not have the same level of marketing and prescribing data and research as primary care, says one industry source. In specialty areas, market segmentation is becoming the order of the day. Marketers need to understand that doctors prescribe drug therapies for a variety of different reasons, including effectiveness, safety, reimbursement, relationships with the rep, or a combination of those factors. Market segmentation helps to target the right doctor with the right message.
Used properly, the new analytics play an important role in specialty areas like oncology where there are multiple contacts with a customer for different reasons, says Dayle Acorn, director of sales, oncology at Hoffmann-La Roche in Mississauga, Ont. “To me the importance of CRM is being able to fundamentally collect and share that information in order to really understand the value of that physician to the company.” But CRM is “like a house, you’ve got to know what the plans are, what you’re building before you start.”
For Acorn, one-on-one contact is paramount. Unlike the primary care area, it’s not uncommon for an oncology rep to spend 30 minutes to an hour with a doctor due to the level of complexity of the subject matter. During that time there is “lots of in-depth discussion, teasing apart where the product would fit.” From the marketing perspective, the mix may include an advertising campaign, mail campaign, CHE, and strategy building around the key message, but “a big piece of that vehicle is field force face-to-face with doctors,” Acorn says.
The one opportunity that the field force provides is the ability to have that message “flexed,” says Acorn. “If a doctor looks at an ad, it’s just whatever interpretation they have. A rep goes in and they communicate that message, they now can interact with that physician, so depending on the level of acceptance of the message in the ad, you can now build a case and reinforce that because of the personal interaction.”
MORE SCIENCE IS KEY
However, one of the keys to accessing specialists, and frequently GP/FPs as well, is increasingly the science, says Lambert, who adds: “We’ve become much more reliant on studies and clinical data.” Lambert explains that with safety issues arising with drugs such as Vioxx and Baycol, doctors—and government—are demanding more hard data. As a result, “our specialist sales force has to be much more focused on the science—not only for our products but for the competition.” Scientific savvy not only maximizes the time that a doctor spends with a rep, but “If reps are more knowledgeable, have better scientific data to provide, then the doctors will be more apt to spend more time with them.” Lambert notes, however, that when a field force becomes too focused on the science, clinical trials, etc. then there is the risk that “they are no longer selling for the company.”
Still, science-based learning is now top of mind for company-based training programs that are now being supplemented with hefty science texts, and an increased focus on clinical studies and evidence-based medicine. The morphing healthcare model has also prompted the educational and accrediting bodies like the CCPE to introduce more science-based courses into their curriculum. With a vision toward the future, CCPE has also recently benchmarked and introduced a “practical tool” to guide pharma sales reps in their development efforts.
The “Seven Skills of a Highly Successful Rep” program identifies the technical competencies required for top performance in the sales representative role across the pharma industry in Canada, as defined and validated by a select group of 27 representatives from 15 companies. “It is designed to complement the current competency model and organization developmental process that the employer currently has in place,” Lalande told The Chronicle of Healthcare Marketing. “The focus of this program is very different from anything CCPE has developed in the past.”
Most would agree that high-calibre reps are a valuable, if expensive, commodity. Retaining top talent is another issue, industry observers add, but the prudent, long-term strategy is hire, motivate, and compensate.
In the future, field force viability may be increasingly dictated by the lifecycle of products, particularly new products coming to market. Reps still play a crucial role in educating physicians about new therapies for groups of patients who might normally not get help, says Acorn. “The rep is a communication vehicle for appropriate prescribing and utilization of new products to help patients. That’s a core reason you have a field force. That doesn’t go away. We all have new products we need to promote, we all have messaging we have to get out there. The question is how [to do that with] the black eye the industry has now. We have to get back to that.”
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THIS SPECIAL REPORT was compiled by Suzi Martin-Cusimano, a frequent contributor to THE CHRONICLE OF HEALTHCARE MARKETING
A case in point: The HRT conundrum
The results of the Women’s Health Initiative (WHI) study released in 2002—which concluded the risks of hormone replacement therapy (HRT) outweighed any benefits proferred by the therapy—sliced US$850 million off the category the following year, as concerned women consulted with their doctors. The widely-publicized study results indicated that while HRT did reduce the risk of bone fractures and colon cancer, it also appeared to increase the risk of heart disease, stroke, breast cancer, and the development of blood clots.
Three years later, however, these conclusions are being questioned. According to a report from the Datamonitor organization, some key confounding issues identified by post-study analyses include the fact that two-thirds of the study participants were over the age of 60 years and so not newly menopausal, and the majority had a body-mass index of 28.5, which might have contributed to the cardiovascular findings. A high BMI is also considered a risk factor for certain cancers.
“Key opinion leaders believe that HRT still plays an important role in the treatment of symptomatic patients,” says a Datamonitor press release, that goes on to blame the media for misinterpretation and miscommunication of the trial results leading to what they call a “culture of fear among patients”.
“Many opinion leaders believe that hormone therapy is still the only proven, effective treatment for menopause symptom management, and has an important role for many women suffering significant or bothersome symptoms.”
Atlana's prexy John Suk holds aloft the Oakville (Ont.) Business Excellence in Manufacturing and Distribution award, recently presented to the company. Altana bested such organizations as Ford of Canada and Xerox to take the award. Since its inception in 1997, Altana Pharma (formerly known as Byk), has grown to over 200 employees.
10 minutes with...Hans Mader, prexy of Procyon Biopharma
Headquartered on the second floor of an office building along the Trans-Canada Highway in Dorval, Que., Procyon Biopharma is a publicly traded biotech outfit that is concentrating its research efforts on finding new therapies for HIV/AIDS and cancer. The company’s principal compounds are PPL-100, a new protease inhibitor and PCK3145, a synthetic peptide for the treatment of metastatic hormone-refractory prostate cancer. Chronicle correspondent Ian J.S. Moore reached prexy Hans Mader at his office.
What’s the quick history of Procyon?
Procyon was a London, Ont.-based company initially, [incorporated in 1986] by Dr. Chandra Panchal of the University of Western Ontario. They were looking for a president, someone who had business acumen and not just a science backround, so when I left Novartis back in ’99 we came to an agreement. I would be president and CEO and bring the company to Montreal because Quebec was about the only place you could get some money at that time.
We have our labs at the Biotechnology Research Institute here in Montreal, which is part of the National Research Council in Ottawa. BRI is like a giant incubator; about a dozen biotech companies have their labs there.
You were previously president of a major pharma. Tell us about that.
I was with Sandoz in Europe and I spent 12-and-1/2 years in the US at Sandoz as vice-president of marketing. Then I spent several years in Canada, and ended up as president of Sandoz and Novartis in Canada during the merger for two years. Then I left.
What distinguishes your product PPL-100 from the more than half-dozen other protease inhibitors listed in the Compendium of Pharmaceuticals and Specialties?
Its effect on resistant HIV strains. The AIDS virus mutates all the time, producing resistant strains to available medications. It’s the biggest problem today, because people are already infected with resistant strains. We have shown PPL-100 is the most potent agent to kill those resistant strains today.
We also have a back-up to PPL-100 called PL-337, and a new group of anti-AIDS drugs, intergrase inhibitors, which prevent the virus from entering the cell.
Assuming the tests and trials are positive, is it Procyon’s intention to develop and market PPL-100 alone, or are you looking to join forces with a major pharma?
Our business model is usually to bring the products from a pre-clinical stage, ideally with some in vivo pre-clinical data so that we have proof of concept. This is usually about 18 months before we get to the Investigational New Drug submission stage, which means investigations with humans, doing the toxicology studies, making sure the patents are all clean, and then on to Phase I and Phase II.
Once you have shown the toxicity is acceptable, once you have shown your efficacy data in a large enough number of cohorts of patients, once you have done your patents properly and you have done your up-scaling for development and for manufacturing, then we tend to license it out to a pharma company, who can do Phase III.
Phase III gets quite expensive, with lots of patients and long trials. Big Pharma can do it quicker and better than we can. We’ll take up front payments, milestones, and future royalties.
Have you established any alliances or licensing agreements with other pharmas in the past?
We have, but not in therapeutics. PPL-100 and PCK3145 will be the first major ones that will go next year, I would say. But we have a couple of diagnostic tests for prostate cancer, instead of PSA, which is not very specific. We just made a deal with MediCorp, a company here in Montreal who are distributing this test as a research test.
We also have a deal with a company in Toronto, IMI International Medical Innovation, Inc. for a colon cancer identification test that’s not invasive. They’re developing that one as well and should put it on the market next year.
How competitive is the biopharma industry in Canada?
It is very competitive. We have good research in Canada, but the problem is that we’re all grossly underfunded. Most of us are small and undervalued, de facto. If you look at the US the companies tend to be bigger, have more cash, and higher valuations.
The trick in Canada, really, for survival in biotech is to consolidate. We are too many and too small. Get them together with the right technologies so you have synergies to produce higher valuations and you’ll have a better chance to compete against the Americans for cash.
The big problem in biotechnology now is access to cash, venture capital, and biotech funds.
How is this “coming together” going to happen? Mergers and acquisitions?
Yes. Some of them have already happened. PPL-100, for example, did not come from us. We acquired a biotech company two years ago called Pharmacorp, which was early stage, had no money any more, and they needed help. We brought them aboard, we merged them into [Procyon], and now the product is ready to go to market.
You mentioned Quebec government incentives as a reason for moving the company to Montreal. How important are these incentives to the industry?
That was the former government, unfortunately. The current government has cut back. They’re reduced the amount of tax credits, eliminated the Quebec Stock Savings Plan, so there’s less cash and the Societe Generale de Financement has basically stopped investing in biotech. And loans from Investment Quebec have been frozen or eliminated.
It’s like a Siberian wind. It’s a philosophic issue. They appear to believe the government should not intervene in private business, even if it’s small, core competency biotech. It’s too bad.
Where is the drug industry's own Super Bowl?
There is a legendary story in consumer advertising concerning one commercial that literally changed the face of television advertising in the US.
It was 1984 and Apple was about to launch the original Macintosh computer. A commercial was developed by Chiat/Day that was so revolutionary in its concept and production values that it is still widely considered one of the greatest commercials ever created. A teaser, it was directed by Ridley Scott (who has also helmed the filmic productions “Alien” and “Gladiator”), and ran during the 1984 Super Bowl telecast.
The results were spectacular. Not only did the spot generate millions of dollars in pre-release sales for the first Macintosh, but the story didn’t end there. Many large blue-chip organizations took note. It quickly became a matter of US corporate pride to create the most ingenious advertising concepts for subsequent Super Bowl telecasts. Suddenly, creative departments were challenged to out-do one another. A vast wasteland of me-too concepts was, over the next few annual telecasts, replaced by original, inspiring, sales-generating ideas. To this day, the 1984 commercial is seen as one of the key catalysts that improved the overall creativity of American consumer advertising.
Has all this ingenuity paid off? Well, certainly the audience is paying attention.
Last year, 92 per cent of those who expected to watch the Super Bowl said they like the ads and half (51 per cent) said they like them a lot. Only 6 per cent didn’t like them, according to a Harris Poll.i Twenty-seven per cent of Americans surveyed admitted they paid more attention to the Super Bowl commercials than the game.ii
So how is this relevant to healthcare marketing?
It shows that strong creative competition is good for the industry. Great ideas from one company can stimulate both agencies and clients to improve their marketing and cut through the clutter.
In our industry, every agency (and most clients) know of marketing campaigns that have spurred product sales far higher than their clinical profile deserved. It could be a 3rd or 4th place me-too entry, which appears out of nowhere to capture high market share, or the leading product where the positioning and creative concept has been so strong, ‘new and improved’ competitors couldn’t gain a foothold.
Yes, the healthcare industry is full of creative restrictions, but that’s just an excuse. Many Canadian healthcare agencies and clients are winning key international awards, and at the same time they are gaining acclaim from their superiors at both their Canadian and corporate head offices.
This raises an interesting question. Why doesn’t the healthcare industry in Canada reward brilliant marketing campaigns as a way of motivating the entire industry to new strategic and creative heights? Are great ideas truly worth recognizing or is it true that all it takes is a bigger sales force and some additional marketing muscle to win the day?
Not only should our industry celebrate outstanding ideas but we also need to expose the next generation of marketing professionals to a broader range of high-quality Canadian work. They need to see (and be rewarded for) great locally developed ideas and the success it generates for their companies and their careers. In addition, it would serve to build an effective group of Canadian-based marketers and advertising professionals who know a good idea when they see one.
Some might say this sort of awards show self-congratulation is self-serving. Yet doesn’t every company reward its top performers? Shouldn’t every industry recognize those who are brave enough to challenge the status quo and push the industry to a new level? By congratulating a few, perhaps we can inspire many.
It is in the best interest of all our industry associations to support the best work possible. Agencies, clients, and publishers alike have a vested interest in developing the strongest ideas possible. Now the question for all of us is how to get together and create an awards competition worthy of our Canadian-based industry.
Our industry would be better because of it.
.i The Harris Poll: http://www.harrisinteractive.com/harris_poll/index.asp?PID=435
ii http://www.mediapost.com/dtls_dsp_news.cfm?newsID=236337
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Gord Schwab is CEO, Creative Director of Ogilvy Healthworld-Toronto. He wrote the launch campaigns for Pantoloc, Avandia, the new PAAB campaign to physicians, and the award-winning Twinrix DTC and Rebif campaigns. He can be reached at (416) 920-5045
Marketers tinker with DTC format, following COX-2 withdrawals
Some drugmakers switch to print from broadcast, others try to introduce more serious TV content
TAP Pharmaceuticals, a joint venture of Abbott and Takeda, voluntarily yanked its stateside TV campaign for GI Tx lansoprazole (Prevacid). The company planned to invest Cdn$123 million in US media buys this year.
A spokesman for the company said they'll divert the spend to consumer print vehicles: “Print advertising allows consumers to take their time reviewing important risk-benefit information. Additionally, it gives us ample space to include that information.”
The implosion of the widely promoted COX-2 Rx category has prompted US marketers to re-think their DTC advertising strategies. Stateside spending by Big Pharma on DTC has risen to Cdn$4.9 billion annually, with much of the promotion depicting non-clinical images likely calculated to establish a mood.
That’s all going to change, reports the New York Post, which cites what it calls the “prominent example” of Ortho’s US campaign for the norelgestromin-estradiol transdermal system (Ortho-Evra.)
The revised Evra spots now feature a doctor sternly lecturing a patient about the risk of stroke if she happens to smoke while on an Evra regimen. The newspaper says audiences have grown cynical of DTC ads.
Pfizer’s new stateside DTC ad for antidepressant sertraline (Zoloft) features a novel spokesman: Dr. Jennifer Melfi, psychiatrist to the guilt-ridden mobster Tony Soprano on the hit TV drama, “The Sopranos.” Actually, the individual featured in the Zoloft spots is not Dr. Melfi, but Lorraine Bracco, the actress who portrays the doctor.
It seems Bracco had a year-long depressive episode, which qualifies her to ask viewers: “Why live with depression when maybe you can live without it?”
The ad prompts its audience to a web site, www.depressionhelp.com, which provides further details of Bracco’s illness. Zoloft is not mentioned in the commercial.
Out There: What's happening in the world of drug marketing
ASTRAZENECA won stateside approval for IV infusion or injection formulation of esomeprazole (Nexium) for short-term Tx of GERD patients with a history of erosive esophagitis, who are unable to take capsules.
PENWEST PHARMACEUTICALS of Connecticut outlicensed beta blocker PW2101, a candidate for antihypertensive and angina Tx, to privately held Prism Pharmaceuticals. Prism will be responsible for the commercialization and marketing of PW2101 stateside and in Canada. Says Penwest prexy Robert Hennessey: “This agreement represents a significant step for Penwest in the development of this product, the first that we have fully developed and submitted to the FDA on our own.”
In March, the government of INDIA began a process of ending laws that, in essence, allow the country’s generic drugmakers to copy patented medicines without paying royalties to the drug’s patent owner. As a member of the World Trade Organization, India is required to uphold intellectual property rights. Under revised legislation, the country’s clonemeisters will now make licensing payments to the developer of a copied Rx. India, which is emerging as a significant player in the global pharma business, supplies an estimated 40 per cent of the world’s generics.
JOHNSON & JOHNSON’s acquisition frenzy continued when the company paid Cdn$305 million for privately held Peninsula Pharmaceuticals of California, which is noodling out next-generation antibiotics, including doripenem, currently in Phase III trials. The deal does not include rights to a tweaked version of cephalo-sporin, which Pen plans to divest into a spin-off company named Cerexa. Cerexa will remain independent of J&J.
ELI LILLY inked a brilliant R&D pact with an illuminating partner: General Electric. The companies joined forces to noodle out a unique Tx for Alzheimer’s disease, marking the first time GE has aligned with a drugmaker. Says Scott Donnelly, who heads research for the conglomerate: “We are confident that this collaboration will result in a definitive molecular diagnostic for this disease that has been long overdue in the medical community.”
OSI PHARMACEUTICALS of New York bought out its minority partners in Prosidion, a two-year-old UK developer of obesity and diabetes Txs. Prosidion will continue to operate as an independent subsidiary of OSI. The company’s lead Rx candidate is PSN9301, purchased a year ago from a German biotechie. Says OSI’s Dr. Colin Goddard: “The transaction is a vote of confidence in our rapidly evolving diabetes and obesity programs and represents a firm commitment by the OSI board and management team to maximizing the value we believe to be inherent in these R&D programs.”
Japanese drugmaker MITSUBISHI PHARMA and California genomics outfit Perlegen Sciences inked a buddy pact to commercialize antidiabetic Tx candidate MCC-555, a peroxisome proliferator-activated receptor agonist. Says Mitsu’s mister big, Takeshi Komine: “Mitsubishi has made ‘tailored medicine’ an integral part of its strategy, and we are excited to partner with Perlegen.”
Shooting the messenger: Perhaps not the smartest reaction
Jamie Reidy is a drug rep with a sideline unusual to his profession. He writes books. Perhaps he is not the first of his occupation to perform such a feat, but he provides a welcome balance to the contingent of his colleagues who believe books were invented to prop up the short leg of their pool table.
Given such potential uniqueness, you might guess that any pharma company would be proud to employ such a rara avis as a bag-carrier/author.
Nope. Far from encouraging Mr. Reidy to continue his wordsmithing, his employer, Eli Lilly, was inspired to do a little writing of a different type. Lilly’s HR office wrote Mr. Reidy’s social security number on a pink slip, and instructed him to visit the state unemployment office. We can imagine the book might engender a fair number of scathing literary reviews, but none would contain a phrase quite as hurtful as “You’re fired.”
Lilly says the book violated the company’s policies and sets a poor example for co-workers. That may well be. Judging from the volume’s title, “Hard Sell: The Evolution of a Viagra Salesman,” it is possible that Reidy may be more intent on vulgarizing his chosen profession, rather than proffering an uplifting philosophical discourse, along the lines of Plato’s Dialogues.
Let’s go out on a limb and assume that the author’s work may have a deleterious effect on his colleagues. Under those circumstances, was the company therefore correct to terminate Mr. Reidy’s employment?
A couple of generations ago, two flight attendants named Trudy Baker and Rachel Jones scandalized their employers and their industry by writing a ribald and silly bestseller entitled “Coffee, Tea or Me? The Uninhibited Memoirs of Two Airline Stewardesses.” The book misrepresented the behavior and professionalism of worldwide airline employees, as well as trivializing gender issues in an entirely unacceptable way.
As a direct result of the book’s publication, aviation regulators were incensed, the public boycotted airports, and the air transportation industry ceased to exist around 1966. No, wait. That’s not what happened. Actually, everyone had a good laugh, and accepted that airline workers are human, the seriousness of their jobs notwithstanding. And then the book was quickly forgotten, which is what happens to mediocre books.
However, we must note that there would be no public curiosity whatsoever concerning any particular pharmaceutical product, or its sales agents, were it not for drugmakers in the US market spending US$3 billion each year on consumer advertising. It is more than unrealistic to think that Big Pharma can turn drug brands into household words… and then continue to exclusively control or effectively lead the discussion surrounding those brands.
What is called for is Openness and Transparency, comrades: Openness and Transparency. Repudiating an employee who wrote a book, even a potentially dubious book, strikes us as an out-of-touch retrograde response, in this age of information accessability.
This theory will be further put to the test when Michael Moore, the maverick documentary filmmaker, releases his forthcoming movie, which is reputed to concern the pharma sector and its marketing practices. We understand that some companies have taken caution to ensure that their employees avoid the inquiring lenses of Mr. Moore and his camera-wielding accomplices.
Anyone who witnessed Mr. Moore’s previous cinema achievements will comprehend the inclination to be wary: He specializes in big-screen depictions of corporate spokespeople being made to look like idiots. This is as unfair on Mr. Moore’s part as it is entertaining, and we would surely not volunteer to be first-in-line before his camera.
However, even when confronted with a filmmaker intent on mischief-making, most contemporary institutions have come to realize the wisdom inherent in the following credo: Openness and Transparency are good; avoidance and denial are bad.
These days, everyone knows that.
Don’t they?
Pharmaceutical industry, heal thyself
By David Handelsman
for THE CHRONICLE OF
HEALTHCARE MARKETING
No one would argue that the reputation of the pharmaceutical industry has recently taken a public beating. In fact, filmmaker Michael Moore, famous for movies that have taken to task gun lobbyists and the Bush administration, is now setting his sights on the pharmaceutical and healthcare industries. Unfortunately, Moore isn’t alone in his scrutiny of pharmaceuticals. Ever-spiralling drug prices and the recalls and recent warnings about popular prescription medications have caused doctors, patients, investors, and government regulators to seriously examine an industry once revered for its stellar reputation and contributions to society.
While unnerving to the industry, the public’s disdain is just a serious side effect of a more formidable challenge. In addition to drug safety concerns and soaring costs, the inability of pharmaceutical companies to meet the challenges of trickling product pipelines and lengthy times-to-market also are fueling the negative public perception.
Long before high-profile drug recalls were making headlines, pharmaceutical companies were trying to identify and address drug safety issues before they become a threat to the general population. But actual and threatened recalls are now forcing them to re-evaluate the systems and processes they have in place to detect potential adverse affects as early as possible in the drug development process.
One of the major roadblocks, however, is an insufficient system for sharing clinical trial data throughout the organization. Because of the global structure of many pharmaceutical companies, clinical trials for the same drug may be conducted in multiple locations. This means that enormous amounts of data regarding drug safety are being collected throughout the organization, quite often in disparate systems. Because the data is scattered, pharmaceutical executives lack a clear view of all safety-related criteria. As a result, it is difficult to have adequate information early enough in the process to make accurate decisions regarding the potential safety of a particular drug.
What drug companies need is an integrated system for managing, analysing, reporting, and reviewing data from multiple, disparate sources across trials, development phases, and therapeutic areas. With this type of drug development system in place, scientists and researchers throughout the organization would have a complete view of all the necessary research data in order to assess and identify any safety issues that may be of concern. However, even then, identifying drug safety issues prior to approval can be like looking for grains of salt on a sandy beach.
Sophisticated data mining applications can only find these grains of salt when they exist, and patient populations in clinical trials represent a very small section of the “beach.” Post-marketing safety data—whether collected through the clinical trials process or via government databases—often provides the only robust data pool for finding subtle safety issues.
802 MILLION REASONS TO INNOVATE
In addition to earlier identification of possible adverse effects, an integrated system enables pharmaceutical organizations to determine the viability of prospective drugs earlier in the process as well. And the sooner a drug’s failure can be determined, the more money pharmaceutical companies can save and ultimately redirect to more promising programs. This leads us to another big challenge: soaring drug development costs.
In 2004, biotechnology and pharmaceutical companies spent a whopping US$38.8 billion in R&D—up from $34.5 billion in 2003, according to the Pharmaceutical Research and Manufacturers of America (PhRMA). Unfortunately, this increase in spending has not been matched by an increase in the number of new drug applications (NDA) being submitted to the FDA for approval. In fact, that number has fallen by almost 50 per cent since the mid-1990s.
The reduced flow of product pipelines from a torrent to a trickle is one of the primary reasons for the decrease in new drug applications.
The blockbuster drugs on which the industry has staked its reputation are becoming increasingly more difficult—and more costly—to identify. According to the Tufts Center for the Study for Drug Development, a new prescription drug costs, on average, US$802 million and takes up to 15 years to develop and to win FDA approval. Pharmaceutical companies are searching for ways to tackle that challenge.
According to a recent article in Computer Business Review, bioinformatics—a combination of IT and biology—is one of those ways. The article states that “bioinformatics directly contributes to bottom line growth by expediting the manufacture of drugs and lowering costs throughout the discovery, development and post-marketing cycle.”
THE CASE FOR IN-LICENSING
Collaboration with biotechnology companies and other pharmaceutical organizations is another avenue pharmaceuticals are taking to enhance the development pipeline while containing costs. An August 2004 McKinsey Quarterly article stated that “licensed compounds cost an average of US$5 million to $9 million less to acquire at the preclinical stage than internal candidates cost to develop, are twice as successful in clinical trials, and achieve similar commercial results.”
Both of these approaches, along with the traditional internal product development process, are sure to create more opportunities and potential profits, but they will also create more data and more data integration issues.
This reiterates the importance of having an integrated system where scientists and researchers can easily access data—whether from an internal or third-party source—and then explore and analyse that data so that trends can be easily identified and key “go/no go” decisions can be made with confidence as early as possible.
Even if pharmaceutical companies are successful at expediting the time required for development, they still must factor in a complex FDA approval process—one that has the potential to become even more difficult and highly regulated due to the public’s growing concern over drug safety.
Drug development systems that manage research content must be designed specifically to meet sound business practices as well as government regulations, such as CFR 21 Part 11. With a system in place to store research data in a controlled, validated environment in compliance with regulatory requirements and guidelines, pharmaceutical companies can manage their research intelligently and streamline the submission preparation process while feeling confident about the pending results.
Drug safety and escalating development costs are only two of the obstacles facing pharmaceutical companies today. But it’s clear that they have a common underlying thread: the need for a drug development system that supports complete data integration through a controlled, centralized information repository. By giving scientists and researchers access to a comprehensive view of the data, they can spot trends both positive and negative earlier and avoid wasting valuable time and resources while protecting the health and well-being of patients. That alone will go a long way toward restoring the public’s faith in this still highly valued industry.
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David Handelsman is a clinical research and development strategist at SAS Institute Inc. in Cary, NC. The column is reprinted from the company’s Health and Life Sciences e-newsletter, with permission. We invite your comments on this article