Dear Linda Herman and the Parkinsn list:

I not only read the HealthScout article, but read the original article in
the JAMA.  I agree that the researchers are reputable, and the journal is
too.  However, that does not make the science good, no the lay media report
accurate.  Nowhere in the article or abstract does it say or claim that they
"debunked" the idea that the drugs cause sleep attacks.  They only say that
sleep attacks are rare, and that using some of their scales, a bigger
problems, excessive sleepiness, could be detected.

Linda, since you did refer to the abstract, please do read it carefully.

Also, please read the article, not the Health Scout Report, and pay
attention to
the findings in the article, not only the abstract.

I will repost this, which I posted before, concerning the JAMA article:


 The article referred to in that news release which Mario offered for
 discussion does NOT debunk the connection between medications and sudden
 sleep attacks (SSA).  The full article is available on-line, free of
charge,
 at:

 http://jama.ama-assn.org/issues/v287n4/rfull/joc10367.html

 If I may quote from the article itself:

""" Falling asleep at the wheel is typically preceded by a warning of
sleepiness
 rather than occurring suddenly and unpredictably. Patients should be warned
 about the nature of excessive daytime sleepiness. They should be educated
to
 recognize the warning symptoms and the associated risks of these episodes
 occurring while driving, and about the importance of never driving when
 sleepy. Finally, patients should be asked regularly during follow-up visits
 about symptoms that suggest daytime sleepiness39 or sudden onset of sleep.
 EPISODES SUGGESTING SUDDEN "SLEEP ATTACKS" WERE VERY UNCOMMON IN OUR STUDY.
 AT PRESENT IT SEEMS THAT THE BEST PREDICTOR OF FUTURE SLEEP ATTACKS AT THE
 WHEEL IS AN INITIAL SLEEP ATTACK AT THE WHEEL

 Conclusions  ***Excessive daytime sleepiness is common*** even in patients
 with PD who are independent and do not have dementia. ***SUDDEN-ONSET SLEEP
 WITHOUT WARNING IS INFREQUENT.*** The Epworth score has adequate
sensitivity
 for predicting prior episodes of falling asleep while driving and its
 specificity can be increased by use of the Inappropriate Sleep Composite
 Score. ***It is unknown if routinely performing these assessments could be
 more effective in predicting future risk for these rare sleep attacks.***
 PATIENTS SHOULD BE WARNED NOT TO DRIVE IF THEY DOZE IN UNUSUAL
 CIRCUMSTANCES."

 The article DOES NOT say that there is no connection between the sudden
 sleep attacks and the drugs.

 The article does say that PWP seem to have excessive daytime sleepiness to
a
 greater extent than non-PWP people, and suggests that excessive daytime
 sleepiness could be a risk while driving, even more so than the sudden
sleep
 attacks.  This is not because the sudden sleep attacks do not happen, but
 because they are infrequent, and are much less frequent than excessive
 daytime sleepiness and drowsiness.  Even in non-PWP people, excessive
 daytime sleepiness causes many accidents, and if excessive daytime
 sleepiness occurs, extra caution is necessary.

 Indeed, the following figures from the study are sobering:

 1) 420 of the 638 patients studied were driving

 2) Of those 420, 78 (19%) had experienced dozing while driving or being
 stopped in traffic. 49 (12%) experienced dozing while actually in movement.

 Another important issue emphasized in the article:

 """The fact that most individuals were taking multiple drugs reduced our
 power to separate clearly the effects of individual medications."""

 If you look carefully, however, one can see the following

 1) There were 152 patients treated with levodopa ALONE amongst the drivers,
 and only 5 of those (3.3%) dozed off while driving.

 2) Of those 420, 268 were either on no drug or combination (which may have
 included levodopa).  According to Table 3, 235 were on dopamine agonists
 (alone, or in combination)  Of these, 42 (17.8%) dozed of while driving and
 were on agonist alone or a combination of levodopa with agonist.

 It seems that the data overwhelmingly support the notion that the risk of
 falling asleep at the wheel is much greater if you are taking agonist,
alone
 or in combination, than with levodopa alone, whether you have sudden sleep
 attack or just doze off.

 It is sad to see that in this case, it is the media who distorted this
 report.

 Jorge A Romero, MD


----- Original Message -----
From: "Linda J Herman" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Monday, February 04, 2002 5:45 AM
Subject: Dopamine agonists and sleep attacks : article in JAMA


> Jorge and others,
>
> If you look again closely at the HealthScout homepage you will see the
> "Advertisment" tag refers to the banner directly underneath it -- not to
> the report itself.
> HealthScout is a health news portal - one of  many that collects news
> from many different sources, some reliable, others not so - then
> repackages it for the consumer. Their web sites are a mix of news
> reports, links to valuable information sources and also to "sponsors" and
> advertisements - and it's difficult to tell what's what.
>
> When in doubt - go to the original source -- if you are able to find it
> and it's freely available on the Web.
> In this case the full article is on the JAMA website www.jama.com  (as of
> 6 AM today)
> The abstract is below. This study was conducted by highly regarded PD
> researchers and published by JAMA, a peer reviewed medical journal
> originally.
>
> Also note at the end of most reputable medical journal articles is a
> funding statement - who supported the research and how the funder was
> involved. Drug companies often do sponsor such research, but there are
> controls over their involvement as in this study. (see below)  Also
> included are the affiliations and sponoring institution of the
> investigators - another way to evaluate the study.
> It's getting more and more difficult on the Web to separate the medical
> facts from the media hype and from the advertising. Our best weapon is to
>  Know your source.
> Linda
> -------------------------
> FROM Journal of the American Medical Association Online :
> Excessive Daytime Sleepiness and Sudden-Onset Sleep in Parkinson Disease
>
>
> A Survey by the Canadian Movement Disorders Group
>
>   Douglas E. Hobson, MD, FRCPC; Anthony E. Lang, MD, FRCPC; W. R. Wayne
> Martin, MD, FRCPC; Ajmal Razmy, BSc; Jean Rivest, MD, FRCPC; Jonathan
> Fleming, MD, FRCPC
>
> Excessive Daytime Sleepiness and Sudden-Onset Sleep in Parkinson Disease
>
>
> A Survey by the Canadian Movement Disorders Group
>
>   Douglas E. Hobson, MD, FRCPC; Anthony E. Lang, MD, FRCPC; W. R. Wayne
> Martin, MD, FRCPC; Ajmal Razmy, BSc; Jean Rivest, MD, FRCPC; Jonathan
> Fleming, MD, FRCPC
>
>
> Context  Somnolence is a recognized adverse effect of dopamine agonists.
> Two new dopamine agonists, pramipexole and ropinirole, have been reported
> to cause sudden-onset sleep spells in patients with Parkinson disease
> (PD) while they were driving. The frequency of these spells and whether
> driving should be restricted has yet to be established.
>
> Objective  To determine the frequency of and predictors for sudden-onset
> sleep and, particularly, episodes of falling asleep while driving among
> patients with PD.
>
> Design, Setting, and Participants  Prospective survey conducted between
> January and April 2000 in 18 clinics directed by members of the Canadian
> Movement Disorders Group; 638 consecutive highly functional PD patients
> without dementia were enrolled, of whom 420 were currently drivers.
>
> Main Outcome Measures  Excessive daytime sleepiness and sudden-onset
> sleep as assessed by the Epworth Sleepiness Scale and the Inappropriate
> Sleep Composite Score. The latter score, designed for this study,
> addressed falling asleep in unusual circumstances. The 2 scales were
> combined in 3 separate formats: dozing off, sudden unexpected sleep, and
> sudden blank spells.
>
> Results  Excessive daytime sleepiness was present overall in 327 (51%) of
> the 638 patients and in 213 (51%) of the 420 drivers. Patients taking a
> variety of different dopamine agonists had no differences in Epworth
> sleepiness scores, in the composite score, or in the risk of falling
> asleep while driving. Sixteen patients (3.8%) had experienced at least 1
> episode of sudden onset of sleep while driving (after the diagnosis of
> PD); in 3 (0.7%), it occurred without warning. The 2 risk factors
> associated with falling asleep at the wheel were the Epworth Sleepiness
> Scale score (odds ratio [OR], 1.14; 95% confidence interval [CI],
> 1.06-1.24) and the Inappropriate Sleep Composite Score (OR, 2.54; 95% CI,
> 1.76-3.66). A standard Epworth Sleepiness Scale score of 7 or higher
> predicted 75% of episodes of sleep behind the wheel at a specificity of
> 50% (exclusion of the question related to driving provided 70%
> sensitivity and 52% specificity), whereas a score of 1 on the
> Inappropriate Sleep Composite Score generated a sensitivity of 52% and
> specificity of 82%.
>
> Conclusions  Excessive daytime sleepiness is common even in patients with
> PD who are independent and do not have dementia. Sudden-onset sleep
> without warning is infrequent. The Epworth score has adequate sensitivity
> for predicting prior episodes of falling asleep while driving and its
> specificity can be increased by use of the Inappropriate Sleep Composite
> Score. It is unknown if routinely performing these assessments could be
> more effective in predicting future risk for these rare sleep attacks.
> Patients should be warned not to drive if they doze in unusual
> circumstances.
>
> JAMA. 2002;287:455-463
>
>
> ...."Funding/Support: Boehringer-Ingelheim (Canada) Ltd provided an
> unrestricted educational grant for the conduct of this study.
>
> Role of the Sponsor: Support for this survey was provided through
> Boehringer-Ingelheim (Canada) Ltd. This sponsor was approached by one of
> the authors (A. E. L.) to provide an unrestricted grant to carry out the
> study. The sponsor assisted in the logistics of developing the study
> (conference calls between investigators), development of the
> questionnaire forms, teaching sessions for the study centers (by the
> authors), and provision of funding (on a per subject basis) to the sites.
> Data were submitted by the sites to an independent third party where they
> were keyed into the database and checked. The third party communicated
> directly with the investigators (not the sponsor) about the data. The
> sponsor did not have access to the data and did not assist in data
> analysis."
>
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