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Rapid Responses: Rapid Responses published:
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The Alzheimer's Society and public trust
- Iain Chalmers (20 September 2007)
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Why I am no longer a member of the Alzheimer Society
- Linda Furlini (26 September 2007)
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Alzheimer Society of Canada responds to Linda Furlini ‘Why I am no longer a member of the Alzheimer Society’
- Scott Dudgeon (3 October 2007)
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Iain Chalmers, Editor, James Lind Library Summertown Pavilion, Middle Way, Oxford OX2 7LG
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The BMJ has decided to publish only one of the responses to my Personal View about the Alzheimer’s Society’s alliance with drug manufacturers to attack judgements reached by the National Institute for Health and Clinical Excellence (NICE) (1). In the light of the published response from the chief executive of the Society I need to reiterate the words posted on the Society’s website after the legal judgement exonerating NICE in respect of five of the six charges brought against it. I was prompted to submit my article to the BMJ by the following statement on the home page on 25 August 2007: "NICE failed to listen to the views of thousands of carers who told them drug treatments make a huge difference to their lives. It is deeply disturbing that a public body, required to use rigorous standards of evidence based decision making, can simply guess at vital data. This is simply unacceptable . . . To retain its authority as a public body it must command the confidence of the public. The result of this case must call into question whether NICE has lost that confidence." I think these statements are outrageous. On what evidence can the Society claim that NICE “failed to listen to the views of thousands of carers”? How can it claim that NICE “simply guess[es] at vital data”? And on what extraordinary logic does the Society conclude that the court’s exoneration of NICE on five of the six charges brought against it by the Society and drug firms “must call into question whether NICE has lost [public] confidence?” As illustrated by other responses to my article, the Society needs to take more seriously the possibility that its alliance with drug manufacturers may have eroded confidence in its own ability to represent, independently of commercial interests, the interests of people with Alzheimer’s disease and those that care for them . For example, one of the other responses to my article (3) stated: “The Alzheimer's Society has funded some excellent research on health of carers of people with dementia, and much else. For this reason I was very happy to subscribe to a direct debit donation to the Society. As a health economist, I am committed to fair and open allocation of health care resources for the people of the UK, so that each pound spent by the government gains as much benefit as it can for people in need. “I have had a growing unhappiness about the way that the Alheimer's society has 'marketed' the drug, and has raised unrealisable hopes and expectations among many I know for its value to potential users and to society. “I have now decided to withdraw my donation as long as the charity's funds are being used to assist sales of a drug of very marginal effectiveness. The fact that the company manufacturing the drug has not paid for this campaign seems to imply that donors to the Society are happy to promote the drug. I am not. If successful, this campaign could very well (unintentionally of course) result in poorer social services, which are currently struggling to provide the very help that is so lacking at present for people with dementia. “I might take a different view if the Alzheimers Society were campaigning for a lower price for this drug, which is apparently helpful to some for a while.” As someone who is at above average risk of developing Alzheimer’s disease myself I am reassured to learn that the Society is already doing some of the things that I believe it should be doing. But it is not yet doing so with the transparency to which it claims to be committed. This is important because of increasing concern over the lack of transparency about the extent to which patients’ groups are being funded by industry (4). The Society should be taking advantage of the opportunity to reassure the public by trumpeting the fact that only 0.5 per cent of its money comes from pharmaceutical companies. The Society’s website provides an opportunity for it to draw attention to the steps that it is taking to address the challenges I posed to it. I shall hope that transparency there - drawing attention to the evidence supporting its assertions - will help to restore my former substantial respect for the Society. References 1. Chalmers I. The Alzheimer’s Society, drug firms, and public trust. BMJ 2007;335:400. 2. Hunt N. Alzheimer’s Society replies to Iain Chalmers. BMJ 2007;335:541. 3. Mugford M. Alzheimer’s Society and drug promotion. http://www.bmj.com/cgi/eletters/335/7616/400 4. Herxheimer A. Relationships between the pharmaceutical industry and patients' organisations. BMJ 2003; 326: 1208- 1210; doi:10.1136/bmj.326.7400.1208. Competing interests: I am a member of the NICE research and development advisory committee and provided written evidence challenging the charge that NICE's assessment and consideration of the AD2000 study (of donezepil in Alzheimer's disease) was irrational. |
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Linda Furlini, Research Ethics Officer McGill University Health Center, 687 Pine Ave. West, Montreal, Quebec. H3A 1A1
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As a past caregiver, past executive board member of the Alzheimer Society of Canada, professional, researcher - primarily focused on caregivers of persons with Alzheimer’s Disease - and at risk of developing Alzheimer’s disease myself, I have similar concerns as those expressed by Sir Iain Chalmers in his article (August 25, 2007) “The Alzheimer Society, drug firms, and public trust.” I also agree with Mr. Neil Hunt’s claim (September 19, 2007) that “Early intervention is the key to putting people in control of their condition and enables them to access the information and support they need.” However, factors such as “control” and “information and support,” as a general rule, are not attained by drug therapy but rather by psychosocial means. Caregivers are most often the only ever present witnesses to the ravages of a disease whose variable and unpredictable symptoms affect behavior and personality to such a degree that they destroy the essence of their loved ones. No known drug changes this facet of the disease. To claim otherwise, in the face of caregivers’ experiences, is but an indication of overt partiality to the drug industry. It is also disheartening that Mr. Hunt takes credit for the single charge ruled in the Alzheimer’s Society’s favor by Mrs. Justice Dobbs, but completely ignores the other five charges that went against it. For, I would have expected that he would focus the Society’s attention on them and attempt to reach some positive conclusion on their ramifications. Sir Iain Chalmer’s charge of an alliance between the Alzheimer’s Society and the pharmaceutical industry is strongly supported by my own personal experience and research results, and documented in many other studies about patient advocacy groups (Ball, Tisocki & Herxheimer, 2006, Batt, 2005, Lemmens, 2004). I believe, therefore, that the Alzheimer Society should, at the very least, ardently pursue the development of clear conflict of interest and disclosure guidelines, which are publicly accessible, for its board members, staff, affiliates and consultants as well as establish an appropriate monitoring mechanism. I enclose the letter I sent to Sir Iain Chalmers in response to his article (August 25, 2007)that, in essence, reflects my experience-based conclusions from a Canadian perspective. If the Alzheimer Society had demonstrated the same zeal and energy in advocating for better information, support and resources for persons with dementia and their caregivers, and driven the desperate need for advancement in research on the disease as they had for questionable drug treatments, I may have still been a member of and an advocate for this agency. (The text of this letter has been edited on legal advice.) Dear Dr. Chalmers, When I read your article, published in BMJ (August 25, 2007), I was so relieved to finally find a reasonable voice emerge in the debate about dementia drugs and the Alzheimer Society. You brought up many excellent points and I would like to respond and add to them. First, let me begin by telling you a bit about myself. Both my parents were simultaneously affected by Alzheimer’s disease at age 60, starting about 1979. I was 23 years of age at the time and there was no known family history of the disease. I had no medical background and knew little about it. My father’s illness lasted approximately 10 years and my mother’s 20 years. She died in 2000. Since 1992, I have been involved with caregivers through volunteer, professional and academic activities. Notably, I served the Canadian Alzheimer Society at the local, provincial and national level for 10 years. From 1996-1999 I was President of the Federation of Quebec Alzheimer Societies, a body overseeing 21 local Quebec provincial societies, and served on the Executive Committee of Alzheimer Canada. I returned to academe later in life and in 2005 completed my doctoral studies. My thesis was entitled, “Living with chronic dementia from the caregiver perspective: A case for educational support.” It was a multidisciplinary study that looked at how caregivers perceive the caregiving process and the support they needed. Through qualitative research, I was able to highlight the lack of caregivers’ voices in research about them and critically examined the information they receive, if any, about the disease and medications to treat it (in clinical practice and research) (Furlini, 2005). My post doctoral work involved exploring attitudes about mental incapacity and ongoing participation in a large longitudinal population-based study on older Canadians. My comments about your article are couched within the context of my many experiences, interactions with caregivers and research on Alzheimer’s disease. Like so many others, I learned about Alzheimer’s disease through trial and error by taking care of my parents. Initially, I approached the Alzheimer Society in the early 1980’s for information about desperately needed support and resources. Little did I know at the time how my involvement with this organization would turn out to be one of my greatest educational experiences. Regrettably, I was to learn much about the pharmaceutical industry and their cozy relationships with the Alzheimer Society, and other agencies. Therefore, I share your lack of respect for and confidence in this organization. I will add my comments to each of the points you raised. 1. “it should declare clearly on its website the sources and amounts of support it receives for its work” I believe that all donations, including special funds, should be made transparent by the Alzheimer Society. It should also make transparent any donations made in kind. To distribute the money collected from the research fund, the Alzheimer Society asked researchers to sit on a peer review panel that evaluated proposals that were submitted. I noted that some of the reviewers on this panel had direct or indirect ties and financial interests connected to the drug manufacturers. The Alzheimer Society should make transparent which reviewers are chosen to sit on evaluation panels, their affiliations to and financial interests connected to the drug manufacturers. They should also make transparent affiliations and financial interests of the medical advisors that serve the Alzheimer Society. Through the ten years I was involved with the Alzheimer Society, I observed that communication experts also served as board members. These same board members, I later learned, were, at the same time, writing communications for the Alzheimer Society about dementia drugs as volunteers while working as paid consultants for the dementia drug manufacturers. Board members’ work affiliations and financial interests should be made transparent. 2. “the society should make clear what alternative distribution of limited resources it regards as more appropriate--and why” As President of the Federation of Quebec Alzheimer Societies, I took part in creating a strategic plan with 21 regional societies. One of the items of the original strategic plan was to lobby the Ministry of Health for desperately needed resources. At the time the Aricept had just been approved for use by Health Canada for those in the early stages of Alzheimer’s disease and immediately, the drug manufacturers began pressuring the Quebec Ministry of Health to have Aricept placed on the Quebec Provincial Drug Formulary. If it were to be accepted, those taking the drug would have it paid for by the provincial public drug insurance plan. The pressure put on the Federation by different factions orchestrated by the drug manufacturer was so great that I saw the entire strategic plan high-jacked and replaced by a new and sole agenda point: to have the Federation lobby for the approval of the drug approved on the provincial drug formulary. In the end, caregivers and their sick loved ones had a drug of questionable worth approved for partial payment while they languished in an isolated long standing sea of despair without adequate or suitable resources. The Alzheimer Society continues to place disproportionate emphasis on dementia drugs and too little importance on caregivers’ needs for support and resources. The Alzheimer Society must ensure that the needs of people with the disease and their caregivers are evaluated appropriately, represented and promoted effectively. 3. “it should campaign for treatments for dementia to be evaluated using outcomes that are meaningful to patients and caregivers, and challenge the licensing and use in the NHS of any new drugs that fail to conform to these expectations” There is much that I would like to say about drug treatments than feasible in the context of this letter. However, the Alzheimer Society is one stakeholder that affects whether evaluated outcomes are meaningful to patients and caregivers. I will try to limit my comments to a few points regarding this stakeholder. Evaluating outcomes of drug treatments for persons with chronic dementia, such as Alzheimer’s disease, is very difficult, if not impossible, because the disease is variable and unpredictable. This and other manifestations of the disease, such as its protracted progression and personality changes, are rarely acknowledged by the Alzheimer Society, but very meaningful for caregivers who struggle to cope. The Alzheimer Society must be more vigilant in bringing to light how caregivers experience the manifestations of the disease and how they relate to drug treatment outcomes, rather than selectively using caregivers’ testimonies to promote drug manufacturers’ agendas. The Alzheimer Society rarely brings up contentious and ethical issues, such as competency assessments that are used to determine eligibility to participate in clinical trials. Mysteriously, I had a document placed upon my desk some time ago. It was a competency assessment guide for eligibility to participate in a drug manufacturers’ clinical trial conducted in a hospital. The contents of this guide concerned me greatly. For each of the 8 questions asked in this very limited assessment, assessors were instructed to give participants at least 3 opportunities to respond correctly to the questions asked. Assessors were also instructed to repeat the questions until a correct answer was provided. Each time that the question was repeated, it was more simply worded and contained less information. The first time each of the 8 questions was raised, an open ended question was asked. If an incorrect answer was given, the question was changed to two closed and very leading answer options. Persons with Alzheimer’s disease are vulnerable to the power of suggestion. Conducting this type of competency assessment is ethically abhorrent and makes a mockery of the outcome measures. The Alzheimer Society should advocate that ethical issues to protect persons with Alzheimer’s disease in clinical trials receive attention. I am concerned that if subjects’ eligibility to participate in clinical trials is evaluated in such a fashion, then I also seriously question how drug treatments evaluations are undertaken altogether. Are tests to gauge drug efficacy designed similarly to the competency assessment guide just described? If so, subtle and insidious deficits and changes that accompany persons with Alzheimer’s disease are hardly expected to be detected, making the drugs appear more effective than they really are. I suspect that current treatment outcome evaluations are not meaningful to patients and their caregivers, not only, as you state because outcome measures are difficult to interpret, but also because test designs and their implementation are flawed, making the outcome measures all too often irrelevant and equally deceptive and worthless. By gathering anecdotal evidence from the many caregivers I interviewed during the years, I noted that, generally, caregivers reported dementia drugs had little or no benefit, but for some under their care produced adverse effects including severe psychiatric symptoms that are hardly ever mentioned, notwithstanding that they are psychotropic drugs. Few studies have explored how caregivers view current medications. Some studies I have reviewed, interviewed caregivers early in the disease process and indeed some caregivers have stated that the drugs were effective to varying degrees. However, if caregivers are interviewed at the onset of the disease, they usually know little about the disease’s nature, including the unpredictability and variability of the disease’s manifestations and its progression and prognosis. In contrast, I have interviewed caregivers, many years into the disease process, who stated that, in retrospect, the drugs had little or no perceived benefit. I also suspect that when physicians stop prescribing the medication, some caregivers are reluctant to do so or object because they have expectations that the drug provides benefits based on poor information and false hope. During my tenure with the Alzheimer Society, I witnessed how drug manufacturers find ways and means to recruit vulnerable caregivers early in the disease process into lobby groups which they then fund surreptitiously. Inevitably, these caregivers receive free drugs from these manufacturers for their ill loved ones. The Alzheimer Society’s role should be pivotal in scrutinizing how drug treatments are evaluated in clinical trials and/or practice, and caregivers’ evaluations of them. In my doctoral research (Furlini, 2005), I examined at length a consent form regarding participation in a clinical trial which compared two existing dementia drugs. The manufacturer of one of these drugs sponsored the clinical trial. My review revealed that the consent form lacked important and independent information about these two drugs, such as their potential for adverse effects. In a similar vein, drug advertisements on dementia drugs contain claims that are misleading and often erroneous. Although drug advertising is illegal in Canada, Canadians are able to view them on U.S. channels because they watch American networks. Direct-to- consumer advertising on drugs is legal in the United States. The claims and images posted on these advertisements play to caregivers’ fears. Physicians also are affected by advertisements that appear in professional journals and through drug manufacturers’ representatives. Through the years, I have collected numerous advertisements placed in professional journals and ordinary magazines and seen the claims made about dementia drugs change over time, depending upon what will sell best in any given political and research climate. The time is overdue for the Alzheimer Society to promote the development of independent information on dementia drugs, rather that acting as a disguised drug manufacturer mouthpiece. Little is done to limit or counteract the misleading and erroneous claims that drug manufacturers make about medications and the Alzheimer Society is remiss in not attending to them. 4. “it should insist that all data from clinical trials be published and that anonymised data for individual patients are made available, so that researchers can try to identify which patients are most likely to be helped by treatments and which patients are unlikely to benefit or may be harmed I agree with your point entirely and merely wish to underline the word “all.” I could write much more about these issues but, most importantly, I wanted to underline the great significance of your article and the great value of the issues that you raised. Moreover, I admire your courage to write it. . I have just finished a post doctoral appointment and have subsequently accepted a position in a somewhat different direction. However, as you can imagine, I continue to follow issues relating to Alzheimer’s disease intensely. Sincerely, Linda Furlini, PhD. References Ball, D., Tisocki, K. & Herxheimer, A. (2006). “Advertising and disclosure of funding on patient organization websites: A cross-sectional survey,” BMC Public Health. 2006; 6: 201. Published online 2006 August 3. doi: 10.1186/1471-2458-6-201 Batt, S. (2005). Marching to different drummers: Health advocacy groups in Canada and funding from the funding from the pharmaceutical industry. Retrieved from the Women and Health Protection website: http://www.whp-apsf.ca/pdf/corpFunding.pdf Furlini, L. (2005). Furlini, L. (2005). Living with chronic dementia from the caregiver perspective: A case for educational support. Unpublished doctoral thesis, McGill University, Montréal, Québec, Canada. Lemmens, T. (2004). Leopards in the temple: Restoring scientific integrity to the commercialized research scene. The Journal of Law, Medicine & Ethics, 32, 641-57. Competing interests: None declared |
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Scott Dudgeon, Chief Executive Officer Alzheimer Society of Canada, 20 Eglinton Ave West, Suite 1200, Toronto, ON M4R 1K8
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As the CEO of the Alzheimer Society of Canada, I am disturbed that the British Medical Journal would seek to add additional confusion to an already inflamed issue by giving voice to Dr. Linda Furlini, who seeks to call into question the integrity of the Alzheimer’s Society of the UK by recounting her experience with the Alzheimer Society of Canada, a different and completely independent organization on the other side of the Atlantic. Still, in response to what can only be viewed as a direct attack on the Alzheimer Society in Canada, I feel it necessary to correct Dr. Furlini’s claim that the we are more interested in supporting the agendas of pharmaceutical companies than we are in helping improve the lives of Canadians touched by dementia. Let me start by saying that the majority of funds raised by Alzheimer Societies across Canada, including the one Dr. Furlini led in Quebec, are directed to help provide information and support to those directly affected by dementia. The Alzheimer Society is, and will continue to be, completely dedicated in its mission to provide help for today to the almost half a million Canadians living with dementia. We do this through extensive education and informational programs, innovative services such as Safely Home™ - Alzheimer Wandering Registry, and through hundreds of caregiver and early stage support groups. Through its research program, the Alzheimer Society of Canada also supports critically needed research both into the basic biomedical search for a cure, as well as research into the social/psychological aspects of Alzheimer's disease. The latter, which focuses on improving the quality of life of both those with the disease and their caregivers, is a unique program, and one we are very proud of. The Alzheimer Society is not in the business of evaluating the effectiveness of different therapies, but instead advocates that all treatment options deemed safe and effective by Health Canada be available and accessible to all those who might benefit from them. In supporting activities that enhance the quality of life of people with Alzheimer’s disease and of their caregivers, the Alzheimer Society of Canada shares a common cause with our counterparts around the world, including the Alzheimer’s Society in the UK. As the national voice for Canadians affected by dementia, the Alzheimer Society is also a strong advocate for change within our provincial and federal governments. It is our belief that the Government of Canada must act now and sponsor the development of a Canadian Dementia Management Strategy. The strategy will draw upon the collaborative efforts of policymakers, health-care system managers, clinicians, researchers and health-care providers. It will encompass those aspects that most directly impact the lives of those touched by Alzheimer's or a related dementia, including research, prevention, diagnosis, improved care, care for the caregivers and improved treatment. Our advocacy efforts can be viewed on our website at www.alzheimer.ca. As to the question of where our funding comes from, the majority is donated to the Society by individuals from across the country. While the Alzheimer Society does receive donations in the form of unrestricted educational grants from pharmaceutical companies, we also receive funding from many other major corporations in every sector of the economy – from banks to restaurant chains. These funds allow the Society to independently develop and support our critical programs and services. Our financial statements can be viewed on our website at www.alzheimer.ca. Finally, to suggest that the Alzheimer Society is simply a “disguised drug manufacturer mouthpiece” is an extreme injustice to the thousands of dedicated staff, volunteers and donors across the country who work very hard to understand and meet the needs of people whose families have been affected by dementia, and to the researchers attempting to prevent or ameliorate it. Scott Dudgeon, Chief Executive Officer, Alzheimer Society of Canada Competing interests: None declared |
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