Alzheimer's Society replies to Iain Chalmers

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