Academic Drug Detailing: an Evidence-Based Alternative

NEWS Academic drug detailing: an evidence-based alternative

t’s a little known service to physicians offered in 5 provinces. One, I though, recently axed its program, while another may soon follow suit. It could be called a distant and poor cousin of pharmaceutical detailing because it too hopes to influence physician prescribing patterns. But there’s no commercial interest in academic detailing. Its aim is to visit doctors or oth- erwise disseminate evidence-based information about specific drugs, or classes of drugs, after conducting im- partial, independent reviews of their ef- ficacy. The long-term goal is simply to Comstock promote optimal prescribing. Publicly funded efforts to promote optimal prescribing, such as academic detailing programs, Is there a need for such a creature? have modest budgets and staffing compared with pharmaceutical industry efforts. As one of just a handful of academic detailers in the country providing independent, analytic advice about pharma- est. According to an August 2006 study gies in Health, was created in 2004 to ceuticals to doctors, Dr. Michael Allen of academic detailing conducted by the promote optimal prescribing. Modelled wryly notes it’s axiomatic for Canadian University of Victoria’s Drug Policy Fu- on the Australian National Prescribing physicians to believe they aren’t in any tures team and entitled Show me the Ev- Service, it received $19.5 million over 5 way influenced by the subtle pitches of idence, Canada’s 5 provincial programs years to conduct 3 to 4 drug studies per pharmaceutical detailers. “But they had a combined work force of 10.2 posi- year for use by policy-makers, provincial think that their colleagues are,” the di- tions. The study concluded such pro- drug plans, prescribers and patients. Its rector of the Dalhousie Academic De- grams are invaluable, even though their first major study, on proton pump in- tailing Service adds. budgets range between $75 000 and hibitors, is slated for release this spring. The scale of those divergent forms $500 000 per year. The best funded, in Ontario’s Institute for Clinical Eval- of detailing, however, are hardly com- Alberta, was recently discontinued, uative Sciences has occasionally re- parable. The pharmaceutical industry while the most modestly funded, in viewed classes of drugs, but spokesper- spends an estimated $500 million an- Manitoba, awaits word on renewal. son Julie Dowdie says the non-profit nually meeting with doctors and clini- Modest fund also typifies other pub- organization’s mission isn’t to directly cal pharmacists to promote the use of licly funded initiatives aimed at provid- promote better prescribing so much as their medications and boost sales. In- ing evidence-based drug information, to research effectiveness and efficiency dustry watchers say such outlays for pro- such as University of British Columbia’s within the broader health care system. motion, and the number of detailers Therapeutics Initiative and Health In short, the magnitude of publicly working doctor’s offices, continues to Canada’s Canadian Optimal Medication funded initiatives to promote evidence- rise. According to the Hay Group, a Prescribing and Utilization Service based drug choices, compared with the global human resource consultancy, (COMPUS). pharmaceutical industry’s effort to influ- there are 5500 to 6000 pharmaceutical The Therapeutics Initiative, which ence sales, is nothing short of what Allen sales representatives in the country. The conducts comprehensive systematic re- calls “a case of David and Goliath.” IMS Health Group says there are views of drugs or classes of drugs and Academic detailing’s goal is to famil- roughly 5700 people employed as repre- mails the information out to the iarize physicians with such concepts as sentatives or managers of those repre- province’s doctors and pharmacists, re- relative risk reduction and uncertainties sentatives — about 1 pharmaceutical ceives $1.5 million per year from the BC surrounding data about specific drugs, sales rep for every 11 doctors. and federal governments. Allen says. Essentially, it promotes “crit- By contrast, public efforts to promote COMPUS, an off-shoot of the Cana- ical thinking. Because of the evidence- optimal prescribing are altogether mod- dian Agency for Drugs and Technolo- based approach we use and the informa-

tion we present, they are now more criti- through a provincial survey of doctors. Program Director Loren Regier says the cal of the information they get from Dalhousie disseminates its findings 10-year-old, $315 000 per year initiative other sources and that includes pharma- through office visits with physicians but also conducts sessions at medical confer- ceutical reps.” its 4 counterparts in other provinces ences, issues newsletters and email up- The Dalhousie program, which be- employ a range of methods. dates through the Saskatchewan Medical gan in 2001, has annually received be- Saskatchewan’s RxFiles Academic De- Association, and electronically compiles tween $200 000 and $300 000 to conduct tailing Program visits roughly two-thirds a compendium of its drug comparison 1 or 2 reviews per year on topics chosen of the province’s physicians annually, but charts, which it publishes periodically as a book that is distributed to every doctor in the province. The next edition, slated for release “This is the kind of information we need” this month, will cover over 55 therapeutic areas. “We’re getting to be pretty here’s no doubt in the mind of clinical pharmacist Dr. Aaron Tejani, comprehensive on the core areas.” the co-ordinator of clinical research and drug information for The discontinued 7-year-old Alberta T British Columbia’s Fraser Health Authority (FHA), that academic Drug Utilization Program (ADUP), by detailing has a indispensable role to play in the daily decisions that physi- contrast, relied primarily on written re- cians and pharmacists make. ports to disseminate findings. Two Tejani, whose duties include serving as pointman for the FHA’s 12 acute years ago it began meeting with physi- care hospitals in meetings with pharmaceutical reps, says that becomes ap- cians face-to-face, says Program Ad- parent many days that he meets pharmaceutical detailers. Last summer, for ministrator Don Phillipon, a professor example, Tejani met with a Pfizer Inc. representative who pitched the use of of strategic management and health acetylcholinesterase inhibitor donepezil (sold as Aricept for the treatment of policy at the University of Alberta. The Alzheimer’s disease) to treat mild cognitive impairment (MCI), an off-label in- $500 000 per year program provided dication. visits to physicians in 2 (Calgary and Tejani promptly hauled out a Therapeutic Letter , an academic detailing David Thompson) of Alberta’s 9 health publication produced by the University of British Columbia’s Department of regions, reaching about 100 physicians. Pharmacology and Therapeutics (April-August 2005;56). It indicated: that When it was axed, Calgary authorities an unpublished clinical trial of the drug involving patients with MCI demon- were so disappointed they found a way strated no benefit in terms of preventing or delaying progression toward to resuscitate it within city boundaries. Alzheimer’s disease; that several trials had suggested just 16% of people with Phillipon can’t comprehend why MCI go on to develop Alzheimer’s; and that there wasn’t a known correlation ADUP was scuttled. “It’s hilarious…. I between the 2 disease states. teach a course comparing health sys- “A 16% conversion rate is relatively small, so treating all people with MCI tems, and pharmacy is one of the areas would be, in my mind, dangerous, especially when you have trials showing we comment on because this is the area some of these drugs cause harm,” Tejani says. of the Canadian health system that’s Pfizer spokesperson Christine Antoniou says the promotion of off-label use most disorganized when you compare of drugs “is not standard practice and our representatives receive a lot of train- it to other countries with universal ing and regular reminders that off-label promotion is not at all something that health systems. And here was an initia- we want to do. We hope it’s an isolated incident and we’re looking into it.” tive that was really looking at utiliza- Tejani says off-label promotion is common and described a number of tion issues and it was discontinued.” similar pitches, including ones for off-label use of Recombinant Factor 7 for Alberta Health and Wellness Com- stroke patients, and moxifloxacin eyedrops for people undergoing cataract munications Director Michael Shields surgery. Pharmacy representatives have even urged FHA staff to lobby regula- says ADUP’s limited scale proved its tors to approve a drug for off-label indications, Tejani adds. undoing. “The program, while provid- In 2005, the FHA invited drug company representatives to a forum, where ing evidence of effectiveness in chang- expectations regarding the accuracy and quality of clinical evidence presented ing prescriber behaviour, was not by drug detailers were spelled out. “We told them: ‘This is what we feel is ap- viewed as cost-effective if scaled to the propriate, and this is where we think you will be crossing the line.’” entire prescriber community. There are Tejani says such incidents demonstrate the value of optimal prescribing ini- over 7100 prescribers registered in Al- tiatives like therapeutics letters or academic detailing visits. “It [does away] berta, ADUP reached only 250 physi- with clinical opinion and bias. Instead, it simply states what we know and what cians in 2 areas in the province.” we don’t know about the evidence… [and] this is the kind of fact-based infor- Prescription Information Services in mation clinicians and patients need to make informed decisions.” — Wayne Manitoba faces a similar fate. Executive Kondro, CMAJ Director Shawn Bugden says future funding for the $300 000, 4-year initiative is in DOI:10.1503/cmaj.070071 abeyance, despite its self-evident value. “It means that a physician can sit down

CMAJ • February 13, 2007 • 176(4) | 430 News

for 10 to 15 minutes, or as long as they Scotia uses 2 pharmacists and a nurse as are safe. If they fail, the chemicals will want, get the distillation, ask the ques- detailers), others found it “invaluable.” face stringent controls or be banned. tions that they want and have someone be The primary knock has been cost, While the plan has been endorsed able to provide them with answers to the Allen says. “But if you think education by several high profile environmental clinical problems that they’re running is expensive, try ignorance. You don’t groups including Pollution Probe and across in their practice, in a relatively have to save many prescriptions to Environmental Defence, it has been short amount of time, from someone cover the costs of academic detailing.” met with skepticism by some scientists whose job isn’t to sell them a product.” — Wayne Kondro, CMAJ and medical doctors. Along with the BC Community Drug Scientists for a Healthy Environ- Utilization Program, the 4 aforemen- DOI:10.1503/cmaj.070072 ment has garnered nearly 800 signa- tioned programs have also attempted to tures from scientists in a letter that crit- jointly produce reviews under the rubric icizes the Tory’s new strategy of an informal umbrella called the Cana- “I suspect it’s an inadequate plan,” dian Academic Detailing Collaboration. Canada’s new toxic hit list says Dr. David Schindler the Killam They cooperated on a review of statins for Memorial professor of ecology at the cardiovascular disease, and ultimately called “inadequate” University of Alberta and the driving hope COMPUS will aid their cause by force behind Scientists for a Healthy producing reviews they can disseminate s it a toxic hit list or toxic miss list? Environment. “I think the expense of within their respective provincial borders. That’s the question many in the doing a thorough review and evaluation In turn, Vice President Barb Shea I medical and scientific community of these things is beyond the budgets says embryonic COMPUS itself hopes to are asking about the federal govern- that we see in these departments these eventually build a publicly accessible ment’s new Chemicals Management days, and I think the onus if not for do- electronic database collating all evi- Plan — a multi-million dollar program ing them, then funding them, should dence-based reviews, including those that imposes strict new regulations on be thrust back on industry.” undertaken by academic detailers; as about 4000 “legacy chemicals” used in The group’s letter criticizes the gov- well as undertake research and then cre- industrial and consumer products. ernment for not moving fast enough ate a pair of databases about the relative The so-called “toxic hit list,” un- and for not using the “precautionary merits of evidence-based interventions veiled by Prime Minister Stephen principle” when dealing with the chemi- like academic detailing, therapeutics Harper on Dec. 7, targets substances cal industry. Also called “reverse onus,” letters and e-detailing. “One [database] such as benzene, sulfuric acid and the principle would shift the responsi- would be about what works with health Bisphenol A that were grandfathered bility to industry to prove its products professionals. And the second is what onto the market in 1994 when tougher are safe. Under the current system, it’s works with consumers and patients.” new environmental rules took effect. up to the government to prove that sub- Therapeutics Initiative Program Coor- Phase 1 of the 4-year $300-million plan stances are dangerous. Schindler says he dinator Ciprian Jauca says therapeutic will begin in February when Environ- believes such a legislative shift is crucial, newsletters have already proven their ef- ment Canada launches a review of 200 especially when you consider the severe fectiveness. Under UBC’s program, es- chemicals, which it categorizes as budget cuts the department has faced tablished in 1994, findings are essentially “high-priority” and a potential risk to over the past 30 years. disseminated as a randomized control human health. Once every 3 months “I just don’t think those depart- trial, with the letters being mailed out to the department will release the names ments have the capacity anymore,” he doctors. of chemicals in small groups, after says. “Of these thousands of chemicals Prescribing profiles are subsequently which industry will have to provide in- there might be 4 or 5 people in Envi- examined. “Thus far, we’ve found that formation that proves the substances ronment Canada who are knowledge- you can’t see an impact of any one letter able enough to wade through them.” by itself. There were trends but none of George Enei, Environment Canada’s it was statistically significant,” Jauca point man on legacy chemicals, says says. “But when you combined the ef- that there is currently no plan to adopt fects of the letters over time, there are reverse onus. Rather, his department highly statistically significant effects in has moved towards a “shared” responsi- terms of actually prescribing changing bility between government and industry. in the expected direction.” “Historically, when you take a look Allen says Nova Scotia recently sur- at the legacy substances it’s always veyed its doctors to ascertain the effective- been on the shoulders of the govern- ness of academic detailing as a continu- Comstock ment to collect the data, analyze the ing medical education (CME) tool. While data and make a decision. Now what Critics say the government ought to some physicians found office visits in- adopt the precautionary principle when we’re saying is ‘no, we’re not going to convenient and weren’t thrilled by having dealing with toxic substances. take that full responsibility. We want CME provided by non-physicians (Nova others to do some of that work for us,”

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