The latest on this are the following two letters.....
Jaro
^^^^^^^^^^^^^^^^^^
Angiogene trial executed correctly
[The Gazette, 23 Feb. 2003]
The Feb. 15 article "Radioactive heat" raised concerns about the level of radioactivity experienced by cardiology patients who had participated in Angiogene Inc.'s Phase I clinical trial with the Oliglow-Infiltrator. Unfortunately, this artide reflects an erroneous conclusion made by Dr. Christian Janicki of the McGill University Health Centre about the estimated radiation dose to vital organs, which was, in fact, only a small fraction of the dose he suggested.
Not only did Health Canada carefully review Angiogene's dosage level and trial procedures before allowing us to proceed with the trial, we also had the approval of the ethics review board at the Centre hospitalier de 1'universite de Montreal and the support of a scientific advisory board of world-renowned specialists. In accordance with requirements by Health Canada, Angiogene also communicated any risks associated with the clinical trial to the six patients involved. From an ethical and legal point of view, the company acted correctly.
François Bergeron
President, CEO Angiogene Inc.
Publicize results of radiation study
[The Gazette, 23 Feb. 2003]
In its letter to The Gazette published today, Angiogene Inc. claims that the Feb. 15 article "Radioactive heat" "reflects an erroneous conclusion" made by me "about the estimated radiation dose to vital organs." This strong assertion deserves an appropriate response.
The estimates referred to in The Gazette and that have sparked concerns about the safety of the procedure are based on animal data for the same molecule used by Angiogene that were published in a peer-reviewed medical journal by an independent investigator in 1994.
The estimates reflected in The Gazette article are obtained using standard and validated techniques used routinely by trained physicists working in the field of radiation dosimetry.
The dose calculations that I made, based on the 1994 study, are standard calculations and cannot be in error. I fully stand by them. Any discrepancies can only originate from differences in Agiogene's animal studies and the 1994 independent study. It should be noted that Angiogene has declined thus far to make public any results from its Oliglow-Infiltrator experiments.
Any further debate must await publication of these results.
Christian Janicki
Medical physicist
McGill University Health Centre
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-----Original Message-----
From: Franta, Jaroslav [mailto:frantaj@aecl.ca]
Sent: Sunday February 16, 2003 2:25 PM
To: multiple (E-mail)
Subject: " Radioactive heat "
Curious controversy.....
Jaro
Angiogene has sparked concerns about the safety of its human testing of a method to keep coronary arteries clear. Was the exposure too large?
Radioactive heat
DON MACDONALD THE GAZETTE [ 15 Feb. 2003, BUSINESS SECTION ]
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