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Hi Brian: I have been biting my tongue re commenting on the ropinorole study. I agree with you that this study is questionable at best. For one thing, the data presented in this study have ALREADY been used heavily by Smith-Kline Beecham in marketing. These data were printed and distributed in beautiful brochures BEFORE it ever went through the peer review process for publication. It is sad that an "ethical" pharmaceutical company would have to resort to this type of tactic in marketing. The marketing claim is that early treatment with agonist is better than early treatment with levodopa. They claim that the study supports this contention because the prevalence of dyskinesia in the group that was treated first with agonist was less. The study had only two groups of parkinsonian patients: those treated with ropinorole first, and those treated with levodopa first. In BOTH groups, the clinicans were allowed to use supplemental l-dopa as the time went by and the disease progressed. Of course, at the endpoint, the levodopa group (levodopa first plus levodopa) was using a lot more levodopa on the average than the ropinorole group (ropinorole first plus levodopa). What they fail to empahsize or mention is that a group in which therapy begins with levodopa and is later supplemented with ropinorole was not used (levodopa first plus ropinorole). Any careful scientist would cry foul at this experimental design, since what is being compared is not cleanly the effect of the initial drug, but more significantly the effect of gradually increasing doses of levodopa pursuing diminishing returns,w hich you well know is not productive. We all know that excess levodopa makes dyskinesia worse. The study did NOT prove that early treatment with ropinorole prevents the dyskinesias. The "standard" use of agonists has been to use levodopa first and supplement with agonist later. Is there any reason for this group to be excluded from the study? No. The only reason is that if this group is included the results would not be likely to be favorable towards early treatment with the agonist. Unfortunately, these scientific objections are rather sophisticated and most people do not have the background in scientific research or clinical trial design to pick up on this glaring ommission. This study, of course, complied with all of the requirements of the FDA. But the result is that they are selling you real estate in an island in the Pacific. Jorge the difference beteen early treatment an ----- Original Message ----- From: "Brian Collins" <[log in to unmask]> To: <[log in to unmask]> Sent: Thursday, May 25, 2000 8:07 PM Subject: Was this really necessary? > The conclusion of a 5 year Double-blind placebo controlled experiment > has resulted in a tentative conclusion that two plus two equals FOUR. > A spokesman for the Research team said 'The findings should provide a > new insight into the difficult subject of prescribing drugs for the > treatment of Parkinson's Disease' > > Procedures; The study was carried out using a team of volunteers > who were all Neurologists between the ages of 25 and 30 years. > Using a double-blind random selection technique they were grouped > in pairs and locked into cages, with two pairs in each cage. > > After five years, the subjects were released and counted. To > the amazement of the Research team, the average number of neurologists > in each cage was Four! ( Eight of the cages contained only three > neurologists, but this was anticipated in the study, knowing how anti- > social some neuros can be. An unexpected result was obtained wherein > six cages were found to contain 5 people in each cage. The spokesman > became rather agitated and refused to discuss this result. > > In summary, this new finding will have repercussions whenever > prescriptions are produced, and in future in the manufacture and > packaging of drugs, all of which can be approached confident in the > knowledge that Two plus Two Equals Four. (At a 95% confidence level) > > ---------------------------------------------------------- > > No, I haven't flipped just yet: This bit of whimsy was provoked by > the report concerning Ropinerol and Dyskinesia, which must come high > in the list of statements of the obvious. I wrote this e-mail 7 days > ago, when the Ropinerol report had just been published, but I labelled > it Humour because it was, the start at least. It sank without leaving > a ripple, so this time its serious. Am I the only one to find this > report,( and the similar one published some months ago on using > Ropinerol to treat early symptoms), a total waste of money? > Even more worrying is the fact that they nearly failed to prove > their point in this latest report, because of the way in which the > procedure was defined > > Surely any neurologist worth his salt could ,after about two minutes > of concentrated thought, make a confident and accurate prediction of > the result of this study. > > On the other hand, maybe they would not predict the outcome correctly: > I have my model to help me, and it has not let me down yet. This is a > classic case showing research groups, without a working model, being > forced effectively to poke the problem with a big stick, and see if > it gets bitten off! > > It is obvious that the Ropinerol people are going to work their way > through the age ranges , and the whole Parkinson's Circus ( Patients > included) Are going to congratulate them on a splendid piece of work. > I think it is a TOTAL WASTE OF MONEY. > > I just had a mischeivous thought: I don't see why the other Dopamine > Agonist manufacturers should not read the Ropinerol result across to > their drug, with no further testing...... Any comments? > -- > Brian Collins <[log in to unmask]> (60/39/34) >