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To: Dan O who wrote (3094)4/3/1999 2:03:00 PM
From: Andrew Abraham  Read Replies (1) | Respond to of 4122
 
Dan O posted:

Please compare the following two quotes - the first from Dick denying that he and his company ever improperly promoted the Lintroscan and the second from the FDA auditor saying that they did:

Grable: "The FDA action taken in Wisconsin concerning the LINTRO-SCAN resulted because of the irresponsible action of the individual who owned the LINTRO-SCAN and personally chose to promote it improperly. The individual promoted the LINTRO-SCAN as a REPLACEMENT FOR MAMMOGRAPHY, A CLAIM NEVER MADE BY ME OR ANYONE DIRECTLY ASSOCIATED WITH THE COMPANY. Mrs. Grable nor I had any control over the device nor how it was promoted or used after it was
sold. The posting presents this fact in a totally different manner." Richard Grable email previously posted on this board (capital emphasis mine).


Also compare Richard Grable's statement with this section of FDA investigator Leon Law's report: (http://www.aaskolnick.com/imds/fda4.jpg)

"Attached to CDRH Assignment #4811 was an advertisement which was promoting their [the Grables] Lintro-scan as equal to or better than mammagraphy [sic] for the early detection of breast cancer. I showed the copy of the advertisement printed in November/December, 1985, Journal of Medical Imagery and Therapy. Mr. Grable provided me with a publication of their magazine and I made a copy of the cover page, advertisement article and the back cover page (Exhibit #3). Mr. Grable stated that a copy of this advertisement was shipped with only one device. Mr. Grable stated that the advertisement is no longer being shipped with the devices.

"Mr. Grable state that he provides his customers with a folder of advertising literature for his Lintro-Scans. Mr. Grable stated that the literature is provided sometimes before and after a device has been shipped. Mr. Grable stated that the literature is also passed out at trade shows by his salesmen and by himself. There are four different pieces of literature in the folder. Some make claims that the Lintro-Scan is an effective way for early detection of breast cancer through non-invasive transillumination."

(Bold letter emphasis mine.)



To: Dan O who wrote (3094)4/11/1999 6:44:00 PM
From: Dan O  Read Replies (1) | Respond to of 4122
 
Please compare the following two quotes - the first from Dick denying that he and his company ever improperly promoted the Lintroscan and the second from the FDA auditor saying that they did:

Grable: "The FDA action taken in Wisconsin concerning the LINTRO-SCAN resulted because of the irresponsible action of the individual who owned the LINTRO-SCAN and personally chose to promote it improperly. The individual promoted the LINTRO-SCAN as a REPLACEMENT FOR MAMMOGRAPHY, A CLAIM NEVER MADE BY ME OR ANYONE DIRECTLY ASSOCIATED WITH THE COMPANY. Mrs. Grable nor I had any control over the device nor how it was promoted or used after it was
sold. The posting presents this fact in a totally different manner." Richard Grable email previously posted on this board (capital emphasis mine).

FDA: "Ms. Grable stated that the "Rose" brochure was revised sometime in 1988. As previously discussed LILI was incorporated in Florida on or about February 1988. Ms. Grable stated that she personally changed the wording. During the inspection, Richard J. Grable stated that Linda B. Grable had changed the wording, on her own initiative. The new wording reads in part, "***the Lintro-Scan examination is recommended INSTEAD OF MAMMOGRAPHY particularly for:***women with very dense breasts where mammography may not provide a good image, ***Pregnant women.***" (etc.)." FDA report Sept 6-21, page 10 (capital emphasis mine).

So, call me short, long or indifferent. Here I have two quotes - one from an FDA report and one from Richard Grable. They APPEAR to be saying oppositte things. I'm willing to entertain contrary evidence, but I've seen none. If you think I am misrepresenting something, go to Skolnicks site and read for yourself. You can see Dicks email back in Aug of 1998 posted on AOL by DrJMF1 and posted on SI on 8/26/98, post 1630, I believe.