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Therapeutic Controversies
EDITORIAL EDITORIAL
Therapeutic Controversies Timothy Rowe, MB BS, FRCSC, FRCOG Editor-in-Chief
everal years ago, a group of disgruntled physicians gathered in the house of a Vancouver consultant to discuss the future of health care in the province. They were disgruntled because the provincial government had announced plans to reorganize the delivery of health care, expanding the bureaucracy and focusing on the whims of consumer opinion instead of maximizing efficiency in the delivery of services. Coincidentally they had rolled back a fee increase for physicians, citing budget constraints.
S
A guest at the gathering was a physician–scientist who had recently been elected to the provincial legislature. His campaign had been supported by sectors of the Vancouver medical community with the understanding that his presence in the government of the day (or even the opposition) would benefit the medical community in general and his supporters in particular. But, of course, once the colleague became a member of the legislature, it became clear he would have little influence on the government’s intended reforms. He dutifully supported his party’s plans for cost-containment within all ministerial budgets, but especially that of the Ministry of Health. He did not dispute the Ministry of Health’s inferences that the pharmaceutical industry was an opportunistic, ethically challenged manipulator of medical misfortune. Or that misguided prescribing of expensive medications was a significant contributor to rising costs of health care, even if such prescribing might be reducing costs in other areas of care. These inferences were not, by and large, seen as factual by the disgruntled physicians. But they did see value in their colleague’s idea of trying to rationalize prescribing patterns, so that any rise in Pharmacare costs could not be laid at the feet of wasteful and unthinking prescribers. Directly or indirectly—it is still unclear which—arising from the gathering of disgruntled physicians, the idea of having a therapeutics review body that was independent of both government and the pharmaceutical industry developed. The Therapeutics Initiative was established in 1994 as J Obstet Gynaecol Can 2008;30(11):995–996
an organization associated with the Department of Pharmacology and Therapeutics and the Department of Family Practice at the University of British Columbia. Its purpose was to provide evidence-based information for physicians and pharmacists about current drug therapy; it also provided reviews, on request, for the provincial Pharmacare drug program. Unfortunately (and this is where the trouble began) it received its funding from the Ministry of Health—admittedly through a grant to the University, but it was nonetheless a government-funded organization. Initial perceptions of the organization’s activities were favourable. Having a counter-balance to briefings about new therapeutic products coming directly from the manufacturer seemed like a valuable thing. The very existence of such a body drew praise from the rest of Canada and beyond.1 But, as the reports from the organization began to accumulate, readers detected a prevailing tone of caution and disapproval directed at new products. Public criticism began to appear, in the form of published concerns from individual physicians about the lack of transparency in the Therapeutics Initiative’s decision-making process, about apparent selectivity in the information used to make judgements, and about the lack of clarity in the process of appealing decisions.2 A basic area of controversy was that the Therapeutics Initiative showed an overwhelming reliance on published evidence in reaching decisions about therapies, with little regard for the experience of individual clinicians working in the relevant area. The inevitable result was that clinicians increasingly felt that their patients were being denied reasonable access to new therapies, and specialists felt marginalized by the Therapeutics Initiative despite their relatively greater expertise in their area of clinical practice.2 Rightly or wrongly, the Therapeutics Initiative came to be seen over time as a means by which the government could control access to expensive new therapies without appearing to be discriminatory or cheap. In response to mounting criticisms, the provincial Minister of Health established a task force to determine how to optimize decision making for the listing of pharmaceuticals and therapeutic devices. This task force was also directed specifically to assess the effectiveness, transparency, and future NOVEMBER JOGC NOVEMBRE 2008 l
995
EDITORIAL
role of the Therapeutics Initiative. The report of the task force, published in April 2008,3 concluded that “[t]he Therapeutics Initiative is regarded by most . . . as narrow, insular and resistant to meaningful stakeholder engagement.” The task force recommended “the replacement of the Therapeutics Initiative with a new process that would provide for a much wider array of expertise to consider the therapeutic value and cost-effectiveness of new drug therapies.” Ouch. But then, of course, finger-pointing began. Several members of the task force had direct links to the pharmaceutical industry, prompting the provincial opposition health critic to conclude that “the pharmaceutical industry got what it wanted.”4 The chair of the Therapeutics Initiative called the task force’s report “contradictory,” and a previous associate of the organization called it “stupid.”4 The provincial Minister of Health accepted all of the task force’s recommendations, but deferred action pending a further report from the University of British Columbia. It seems likely that the Therapeutics Initiative will continue, but it will be transformed into an organization that consults much more widely than its predecessor in determining the suitability of new therapeutics for government approval and insurance coverage. This narrative is intended to illustrate that, despite our best intentions, we don’t deal well with medical controversy, and especially therapeutic controversy. Finding the best course of action regarding use of therapeutics can be very difficult. The long delay in Canada for approval of depot medroxyprogesterone acetate as a contraceptive option showed how far decisions can be drawn out while risk and benefit are debated.5 The SOGC Committee Opinion published in this issue of the Journal, “Missed Hormonal Contraceptives: New Recommendations” deals with yet another controversy, and the authors are forced to conclude that “on the basis of the available scientific evidence, it is difficult to make simple recommendations on the steps to take after CHCs are missed or used improperly.”6 Discouraging, yes; but at least they’re honest, and they do make practical recommendations! In general, our best tools for dealing with medical controversy are evidence-based medicine and systematic reviews,
996
l NOVEMBER JOGC NOVEMBRE 2008
although each of these has its flaws. The systematic reviews conducted by the Therapeutics Initiative, while arguably objective and based on reliable evidence, nevertheless appeared to use data selectively.7,8 The polarization of attitudes towards the value of the Therapeutics Initiative underlined the need for a better way to deal with therapeutic controversies. Bodies that are supported or funded by government or by industry will always be suspected of having bias. The only reasonable middle option, as I see it, is what we are fortunate to have in this country: physician- and practitionerbased review bodies, supported only by their professional associations, which produce systematic reviews in their area of expertise. The SOGC has now supported such clinical and therapeutic review bodies for over 15 years, and clinicians working in areas with therapeutic controversy continue to benefit from the unbiased advice of their peers. The continuing popularity and citation of SOGC Clinical Practice Guidelines attest to the value of this middle course. We should all be proud of these guidelines, and of the colleagues who give so much of their time to produce them. REFERENCES 1. Silversides A. Highly lauded drug assessment program under attack. CMAJ 2008;179:26–7. 2. Bebb R, Cameron C, Elwood K, Fleming J, Frohlich J, Fung A, et al. The drug review process in BC: a critique. BCMJ 2001;43:86–7. 3. Report of the Pharmaceutical Task Force. Available at: http://www.health.gov.bc.ca/library/publications/year/2008/ PharmaceuticalTaskForceReport.pdf. Accessed September 6, 2008. 4. Life saving drug watchdog may be scrapped. Available at: http://thetyee.ca/News/2008/05/23/DrugWatch. Accessed September 6, 2008. 5. Black A; Ad hoc DMPA Committee of the Society of Obstetricians and Gynaecologists of Canada. Canadian contraception consensus—update on depot medroxyprogesterone acetate. SOGC Clinical Practice Guideline No. 174, April 2006. J Obstet Gynaecol Can 2006:28:305–13. 6. Guilbert E, Black A, Dunn S. Missed hormonal contraceptives: new recommendations. SOGC Committee Opinion No.219, November 2008. J Obstet Gynaecol Can 2008;30:1050-1062. 7. Fishman MJ. TI: Selective data? BCMJ 2001:43:262. 8. Miller DB, Humphries KH. A new way to evaluate randomized controlled trials? New approach does more harm than good. BCMJ 2005;47:241–4.
Therapeutic Controversies Timothy Rowe, MB BS, FRCSC, FRCOG Editor-in-Chief
everal years ago, a group of disgruntled physicians gathered in the house of a Vancouver consultant to discuss the future of health care in the province. They were disgruntled because the provincial government had announced plans to reorganize the delivery of health care, expanding the bureaucracy and focusing on the whims of consumer opinion instead of maximizing efficiency in the delivery of services. Coincidentally they had rolled back a fee increase for physicians, citing budget constraints.
S
A guest at the gathering was a physician–scientist who had recently been elected to the provincial legislature. His campaign had been supported by sectors of the Vancouver medical community with the understanding that his presence in the government of the day (or even the opposition) would benefit the medical community in general and his supporters in particular. But, of course, once the colleague became a member of the legislature, it became clear he would have little influence on the government’s intended reforms. He dutifully supported his party’s plans for cost-containment within all ministerial budgets, but especially that of the Ministry of Health. He did not dispute the Ministry of Health’s inferences that the pharmaceutical industry was an opportunistic, ethically challenged manipulator of medical misfortune. Or that misguided prescribing of expensive medications was a significant contributor to rising costs of health care, even if such prescribing might be reducing costs in other areas of care. These inferences were not, by and large, seen as factual by the disgruntled physicians. But they did see value in their colleague’s idea of trying to rationalize prescribing patterns, so that any rise in Pharmacare costs could not be laid at the feet of wasteful and unthinking prescribers. Directly or indirectly—it is still unclear which—arising from the gathering of disgruntled physicians, the idea of having a therapeutics review body that was independent of both government and the pharmaceutical industry developed. The Therapeutics Initiative was established in 1994 as J Obstet Gynaecol Can 2008;30(11):995–996
an organization associated with the Department of Pharmacology and Therapeutics and the Department of Family Practice at the University of British Columbia. Its purpose was to provide evidence-based information for physicians and pharmacists about current drug therapy; it also provided reviews, on request, for the provincial Pharmacare drug program. Unfortunately (and this is where the trouble began) it received its funding from the Ministry of Health—admittedly through a grant to the University, but it was nonetheless a government-funded organization. Initial perceptions of the organization’s activities were favourable. Having a counter-balance to briefings about new therapeutic products coming directly from the manufacturer seemed like a valuable thing. The very existence of such a body drew praise from the rest of Canada and beyond.1 But, as the reports from the organization began to accumulate, readers detected a prevailing tone of caution and disapproval directed at new products. Public criticism began to appear, in the form of published concerns from individual physicians about the lack of transparency in the Therapeutics Initiative’s decision-making process, about apparent selectivity in the information used to make judgements, and about the lack of clarity in the process of appealing decisions.2 A basic area of controversy was that the Therapeutics Initiative showed an overwhelming reliance on published evidence in reaching decisions about therapies, with little regard for the experience of individual clinicians working in the relevant area. The inevitable result was that clinicians increasingly felt that their patients were being denied reasonable access to new therapies, and specialists felt marginalized by the Therapeutics Initiative despite their relatively greater expertise in their area of clinical practice.2 Rightly or wrongly, the Therapeutics Initiative came to be seen over time as a means by which the government could control access to expensive new therapies without appearing to be discriminatory or cheap. In response to mounting criticisms, the provincial Minister of Health established a task force to determine how to optimize decision making for the listing of pharmaceuticals and therapeutic devices. This task force was also directed specifically to assess the effectiveness, transparency, and future NOVEMBER JOGC NOVEMBRE 2008 l
995
EDITORIAL
role of the Therapeutics Initiative. The report of the task force, published in April 2008,3 concluded that “[t]he Therapeutics Initiative is regarded by most . . . as narrow, insular and resistant to meaningful stakeholder engagement.” The task force recommended “the replacement of the Therapeutics Initiative with a new process that would provide for a much wider array of expertise to consider the therapeutic value and cost-effectiveness of new drug therapies.” Ouch. But then, of course, finger-pointing began. Several members of the task force had direct links to the pharmaceutical industry, prompting the provincial opposition health critic to conclude that “the pharmaceutical industry got what it wanted.”4 The chair of the Therapeutics Initiative called the task force’s report “contradictory,” and a previous associate of the organization called it “stupid.”4 The provincial Minister of Health accepted all of the task force’s recommendations, but deferred action pending a further report from the University of British Columbia. It seems likely that the Therapeutics Initiative will continue, but it will be transformed into an organization that consults much more widely than its predecessor in determining the suitability of new therapeutics for government approval and insurance coverage. This narrative is intended to illustrate that, despite our best intentions, we don’t deal well with medical controversy, and especially therapeutic controversy. Finding the best course of action regarding use of therapeutics can be very difficult. The long delay in Canada for approval of depot medroxyprogesterone acetate as a contraceptive option showed how far decisions can be drawn out while risk and benefit are debated.5 The SOGC Committee Opinion published in this issue of the Journal, “Missed Hormonal Contraceptives: New Recommendations” deals with yet another controversy, and the authors are forced to conclude that “on the basis of the available scientific evidence, it is difficult to make simple recommendations on the steps to take after CHCs are missed or used improperly.”6 Discouraging, yes; but at least they’re honest, and they do make practical recommendations! In general, our best tools for dealing with medical controversy are evidence-based medicine and systematic reviews,
996
l NOVEMBER JOGC NOVEMBRE 2008
although each of these has its flaws. The systematic reviews conducted by the Therapeutics Initiative, while arguably objective and based on reliable evidence, nevertheless appeared to use data selectively.7,8 The polarization of attitudes towards the value of the Therapeutics Initiative underlined the need for a better way to deal with therapeutic controversies. Bodies that are supported or funded by government or by industry will always be suspected of having bias. The only reasonable middle option, as I see it, is what we are fortunate to have in this country: physician- and practitionerbased review bodies, supported only by their professional associations, which produce systematic reviews in their area of expertise. The SOGC has now supported such clinical and therapeutic review bodies for over 15 years, and clinicians working in areas with therapeutic controversy continue to benefit from the unbiased advice of their peers. The continuing popularity and citation of SOGC Clinical Practice Guidelines attest to the value of this middle course. We should all be proud of these guidelines, and of the colleagues who give so much of their time to produce them. REFERENCES 1. Silversides A. Highly lauded drug assessment program under attack. CMAJ 2008;179:26–7. 2. Bebb R, Cameron C, Elwood K, Fleming J, Frohlich J, Fung A, et al. The drug review process in BC: a critique. BCMJ 2001;43:86–7. 3. Report of the Pharmaceutical Task Force. Available at: http://www.health.gov.bc.ca/library/publications/year/2008/ PharmaceuticalTaskForceReport.pdf. Accessed September 6, 2008. 4. Life saving drug watchdog may be scrapped. Available at: http://thetyee.ca/News/2008/05/23/DrugWatch. Accessed September 6, 2008. 5. Black A; Ad hoc DMPA Committee of the Society of Obstetricians and Gynaecologists of Canada. Canadian contraception consensus—update on depot medroxyprogesterone acetate. SOGC Clinical Practice Guideline No. 174, April 2006. J Obstet Gynaecol Can 2006:28:305–13. 6. Guilbert E, Black A, Dunn S. Missed hormonal contraceptives: new recommendations. SOGC Committee Opinion No.219, November 2008. J Obstet Gynaecol Can 2008;30:1050-1062. 7. Fishman MJ. TI: Selective data? BCMJ 2001:43:262. 8. Miller DB, Humphries KH. A new way to evaluate randomized controlled trials? New approach does more harm than good. BCMJ 2005;47:241–4.