Biomedical Engineering Reference
In-Depth Information
concluded that the lesions in the lung are most likely caused by
M. pulmonis, which may have been incorrectly interpreted as lympho-
mas by the Ramazzini Foundation (Schoeb et al., 2009).
Correct diagnosis is also a question. In the Ramazzini Foundation
study of aspartame, 75 slides from the study were reviewed by a
National Toxicity Program pathology working group (PWG) (NTP,
2004). On the basis of this review, it appears that the Ramazzini
Foundation “appeared to apply a more severe classification to lesions
than the NTP PWG.” For example, the NTP PWG confirmed the
diagnoses of only two out of six ear duct carcinoma reported by
Ramazzini Foundation in this limited review. Over classification by
Ramazzini Foundation of tumors in the mammary gland, pelvic and oral
cavities were also suggested in the aspartame study by the NTP (2004).
The Ramazzini Foundation also reported a treatment related increase in
total tumors. An over classification by Ramazzini Foundation would
also affect the total number of tumor-bearing animals.
In a later partial review of the Ramazzini Foundation, methanol study
by a team of NTP pathologists was not sufficient to support or refute the
conclusions of Ramazzini Foundation (NTP, 2010). The NTP patholo-
gists reviewed histological sections of the lung, spleen, lymph nodes,
thymus, ear canal, Zymbal's gland, and cranium from the 100 high dose
and 100 control males in the Ramazzini Foundation methanol study. In
the lung, the NTP pathologist reported a higher incidence of lung
inflammation and a lower frequency of leukemia or lymphomas than
was reported by the Ramazzini Foundation. NTP pathologists reported
inflammation in the nose of most animals as well as inflammation in the
inner ear, but reported half the incidence of squamous cell carcinomas
in the ear that were reported by the Ramazzini Foundation. The NTP
pathologists also reported fewer osteosarcomas in the cranium than did
the Ramazzini Foundation in this comparison. They also reported fewer
leukemia or lymphomas overall than did the Ramazzini Foundation.
The NTP pathologists noted no significant differences, when the results
were compared to the Ramazzini Foundation report, in liver, spleen,
thymus, or Zymbal's gland tumors.
In 2011, a detailed pathology review (pathology data review, quality
assurance, and PWG) of five Ramazzini studies was conducted at the
