Ausa 3
Ausa 3
Ausa 3
A few years ago, I filed an action (pro se) under the FCA (U.S.A., Davidson, ex rel versus Davita Inc, et al). This
action was dismissed without prejudice to refiling. I, subsequently, asked you to forward the matter to the Criminal
Division of DOJ.
May I ask, in confidence, what if any investigation may be underway ? Please recall that I was the ORIGINAL
SOURCE in your interview of me at your office in Houston, TX of the allegation of a certain "surgical clip" on a chest
radiographs which was represented as being the chest radiograph of six different research subjects at Albany
Medical Center in Albany, NY.
I believe that FDA, SEPRACOR, Albany Medical College, and possibly PPD Inc (in the "conduct" of the illegal
enterprise), WILLFULLY hid from the public their actual knowledge of the fabricated chest X-rays, so as to avoid a
criminal prosecution for Thomas B. Edwards, M.D., thereby allowing Xopenex, Singulair, Accolate, and Foradil
to gain EXPEDITED market approvals under the PDUFA.
Edwards was directly involved in AT LEAST two studies for Merck's MK-0476 (Montelukast), AT LEAST one study
for Novartis's formoterol (foradil), AT LEAST two studies for Zeneca's Accolate, and AT LEAST one study for
Sepracor's Xopenex. The only reason I can think of that Edwards was not convicted for criminal fraud, was
his direct involvement in the aforementioned studies. Why did FDA apparently let the sponsor gain control over
the fabricated chest X-rays ??? It doesn't pass the "smell
test". To me, at least, it wreaks of probable criminal obstruction of justice. In my non-attorney opinion, there is
ample probable cause for a criminal indictment. Why was there no mention made of the "surgical clip" in the Albany
NY FDA EIR of Thomas B. Edwards, M.D. ???
Grossman was directly involved in PROBABLY (at least) twice as many studies (compared to Edwards) in support
of New Drug Applications in both Albany, NY and Tucson, AZ. The only reason I can think of that Grossman was not
convicted for criminal fraud, was his direct involvement in the aforementioned studies. Why did FDA do essentially
NOTHING after the Tucson AZ EIR reports of April and May 1999 were published ???
Might the United States be interested NOW, in intervening, if I refile under the FCA, possibly naming PPD Inc, Davita
Inc, Albany Medical College, Thomas B. Edwards, M.D., Jay Grossman, M.D., Merck, Novartis, Zeneca, Sepracor,
and others, for the submission of false claims to Medicare/Medicaid/Tricare for reimbursement of fraudulently
"researched" and fraudulently "approved" Singulair, Ketek, Serevent, Symbicort, Advair, Flovent, Pulmicort, Zyflo,
Foradil, Accolate, and Xopenex ?
The FDA's [current] interest in suicide comes after a 15-year-old in Queensbury, N.Y., hanged himself after starting
the drug [Singulair]. There are NOW faces (dead victims) of the crimes I have been alleging for almost a decade.
Why won't DOJ enforce the law ??? There should have been criminal indictments long ago !!! How many more
have to DIE ??? I disclosed the unblinding of studies, the alleged death(s), and the surgical clip to the Assistant U.S.
Attorney (Houston, TX) about two years ago.
Sincerely,
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