Talk:Enzyme potentiated desensitization

Aperson
Aperson - most of your edits are most welcome, particularly changing the refs (I'm new to this game), but the fact was that EPD was only allowed by the FDA to be imported into the USA because of an investigative study authorised by the FDA. When the FDA revoked approval for it then EPD could no longer be imported. The reasons given by the FDA were that each EPD treatment used a number of mixed allergens for each medicine, and the FDA's reading of its own rules was that this was not permitted. There is no pending investigative study by the FDA. My understanding is that they will only let EPD back into the USA if it gets a marketing license, and that this would have to be for each allergen separately, which would cost a fortune (tens of millions of dollars) and never be affordable. So I will change that bit of your edit. Technopete 10:41, 17 September 2006 (UTC)

Changed to footnotes as suggested by Jfdwolff Technopete 22:31, 15 September 2006 (UTC)

Could the author please use Footnotes to string references to the claims made in this article? JFW | T@lk  11:00, 14 September 2006 (UTC)

The last few edits make some interesting points. Spurred on by them I have added the reason cited by the FDA for revoking approval for the USA institutional review board. I have added a link to the results of a proof of concept experiment for treatment of EPD for rheumatoid arthritis. The graph shows a very statistically significant improvement, so I have added the adjective "encouraging". Apparently the reduction in symptoms shown by the graph is as good as it gets in virtually any clinical trial (though this experiment is not a clinical trial of course). The Epidyme web site says that they are planning to research EPD treatment of other autoimmune diseases as well as rheumatoid arthritis, though that is only a statement of intent, of course, not a guarantee they will have the money or the plan will not change.

EPD does not seem to have an absolutely clear cut theory yet - it just appears to work. T regulatory cells appear to be a relatively new entrant to the scene. One would expect there to be a better theoretical underpinning before clinical trials would be allowed to start for treatment of any autoimmune diseases.

Clearly all EPD treatment is carried out by EPD exponents, so we ought really to take their word for it when they tell us what the treatment regime is.

Will continue to improve the rest of the article after some sleep.

Technopete 23:54, 5 May 2007 (UTC)

On the "Experimental evidence" paragraph. I have removed the reference claimed to support the statement that most doctors and allergists consider EPD to be experimental and ineffective, as it is just a reference in another journal to the BMJ article with a reference later in the paragraph and the BMJ article is professionally written and does not make any claims as to what most doctors and allergists believe about EPD. However, experimental is a good descriptive term as EPD has only a manufacturing license, not a marketing license. I have also added the quantitative evidence with references for the total number of patients completing the trials in the 9 successful trials and retained the starting numbers for the one unsuccessful trial. Also added some documented speculation from the Epidyme web site by the inventor of EPD on why the latter trial failed.

On the comparison with conventional immunotherapy I have re-organised this material under a separate heading to clarify the structure for the reader, and amalgamated the two statements into one.

The statistic of 1 in a million adverse reactions is interesting. It needs a reference, and clarification of whether this is one in a million people dying as a result of injections, or one in a million injections causing a death (in which case it is not quite so reassuring). The text as written is just sufficiently ambigous as to need this clarification IMHO. Technopete 12:02, 6 May 2007 (UTC)

The US FDA reference does not appear to be relevant to safety. It cites violations of the FDA rules and the fact that EPD is not licensed. Even if the FDA had evidence that EPD were both safe and efficacious, the violations of the FDA rules reference would still stand and they would still ban EPD from the US. Hence I have moved the FDA reference to the section dealing with FDA refusal at the top of the article. Technopete 11:05, 29 July 2007 (UTC)

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