Hello Ernie:
You wrote:
>>> Ernie Peters <[log in to unmask]>
07/25/97 03:56pm >>>
>>Hello Stephan,
>>.....It would give me no satisfaction at all to argue the
>>Parkinsons Disease Research Group (PDRG) report as
>>being the true story. I would like to learn that there is
>>indeed a flaw in this research and my hopes are that this
>>will be the case. . . . .I believe that, in the interests of
>>those trying to make difficult decisions, it should be
>>pointed out that they should at least be aware of the
>>adverse report of the PDRG printed in the BMJ of Dec
>>1995. They could then read it and/or discuss it with their
>>Neuro and make up their own minds. . . . . .
>>Your reply to me made a number of points which, if taken
>>at face value, would indeed cast great doubt on the PDRG
>>research. In the interests of getting the full picture on this,
>>could you perhaps just clarify or comment on the
>>following:
"Many responses to the results pointed out
flaws in the methodology"
>>Who made these responses? Were they medically
qualified, or researchers? Are they on record and do you
have an example?
"...not the least of which was accuracy of clinical
diagnosis protocols."
>>The criticism that I read was that detailed causes of death
>>were not recorded in each case. Well, I agree this was a
>>failing because detailing accurately the cause of death
>>could have more accurately pinpointed a specific medical
>>problem. However, the clinical diagnosis of death is not
>>so hard and if you take two randomized groups, each on
>>different medication, and one group has a 60% higher
>>mortality rate at the end of 5-6 years, then suspicion has
>>to fall on the medication, would you not agree? These
>>results were independent of sex or age by the way. Also,
>>you will have no doubt read that the PDRG report
>>criticized the Birkmeyer et al studies in turn as having
>>"several major deficiencies, including a retrospective, non
>>randomised design".
"The data was reanalyzed and the conclusion was
that the study could not support the finding of
increased mortality in the use of selegiline and
Levodopa medication."
>>Who reanalyzed the data? I contacted the Parkinsons
>>Society today and they confirmed that they have not yet
>>finished reanalyzing their data. So, who concluded that
>>the study could not support the finding of increased
>>mortality?
"Subsequent studies have published findings that
there has been no increase in mortality in patients
using selegiline and Levodopa."
>>I must admit I have not seen any studies on the subject
>>since the DEC 95 report. Can you let me have any details
>>as to which body conducted and published them? I would
>>be very interested.
>>I am not taking sides one way or the other, I simply >>say
we have two conflicting reports and we should not yet
>>dismiss EITHER of them as wrong. . . . .
>>. . . all our drugs carry some increased risk with which we
>>have to live. People are not exactly dropping dead in the
>>streets from Eldepryl poisoning. The research simply
>>gives us information which we can use to make informed
>>judgements.
>>Ernie. 54/3.8
Ernie, I'll begin with a disclaimer: much of my information
comes from sketchy notes and recollections I have of several
1996 lectures/presentations, and my informal discussions
afterwards with researchers.
The responses to the original 1995 PDRG/UK study were
received by the British Medical Journal in the forms of letters
to the journal. These correspondents pointed out -
1. Although the study suggested the increased mortality in
the levodopa-selegiline group could be due to cardiovascular
causes: both groups reported the same number of deaths
due to cardiovascular causes.
2. The reported major cause of death in the
levodopa-selegiline group was listed as "PD." That raised
the issue of the clinical diagnosis, since PD is very rarely the
listed cause of death.
3. Many patients who dropped out of the study were included
in the analyzed data.
4. There was no protocol in the study for a group taking
selegiline only.
At a symposium on PD in September 1996 in Wash., D.C.,
Dr. Warren Olanow, M.D., Chairman of the Neurology Dept.
at Mt. Sinai School of Medicine (NY) reported on the results
of a reanalysis of the PDRG/UK data. They did not find an
increase in mortality in the levodopa-selegiline group. Dr.
Olanow stated that selegiline has a levodopa-sparing effect
and may slow the progression of PD. However, he considers
its antiparkinsonian effects as minimal.
Also, at the end of 1996, the DATATOP Steering Committee
(of which Dr. Olanow is a member) reported that the study
did not observe abnormal mortality attributable to selegiline.
The researchers report that they have continued to observe
500 test subjects for about 5 years and that data is being
collected and analyzed.
At the end of 1996, Dr. R. Pahwa, M.D., Assistant Professor
of Neurology, at the Univ. of Kansas Med. Cntr., while
conducting a clinical trial on pramipexole, mentioned that the
reanalysis of the DATATOP results [not yet published]
showed: no increase in mortality in the levodopa-selegiline
study group.
Ernie, my friend, I hope this information sheds some light on
the subject and adds to our understanding of the disease and
its treatment.
Stephan 53/7
