Appendix — Ames v. Washington State Health Department Medical Quality Health Assurance Commission
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Supreme Court Us.
N° ———F-734 DEC 17 2009
OFFICE OF THE CLERK
Su The
Supreme Court of the United States
GEOFFREY S. AMES, M.D.,
Petitioner,
VS.
WASHINGTON STATE HEALTH DEPARTMENT
MEDICAL QUALITY HEALTH ASSURANCE COMMN.,
Respondent.
On Petition For Writ Of Certiorari To The
Supreme Court Of The State Of Washington
S
APPENDIX, PART TWO
PETITION FOR A WRIT OF CERTIORARI
WILLIAM R. BISHIN
Counsel of Record
WILLIAM R. BISHIN P.S.
1404 Kast Lynn
Seattle, WA 98112
(206) 323-7175
TABLE OF APPENDIX CONTENTS
Page
APPENDIX
Part 1
Opinion of the Supreme Court of Washington ... App. 1
Order Granting Petition for Review................. App. 12
Clerk’s Letter Reporting Denial of Objections ....App. 13
Opinion of the Court of Appeals, State of
Pe snes scussicnnsnncéaciounsspesemmnmesennelaaaeanee App. 15
Court of Appeals Order Denying Motion for
PRD OOT II ose sss ccrnccsneecncitieieuntiabnananne App. 31
Letter Opinion, Superior Court, Benton County,
Pro ossicsiniepcniinesssscctinisvanamaeea App. 33
Findings of Fact, Conclusions of Law and Final
Order, Medical Quality Assurance Commis-
SNOT, THOR oesinicnconvccncnsecsoccnscoevstneseneen App. 42
SUMAMEATY OF TVIGOTIOD 20000. cccccceccerscesconsesecersess App. 43
BRI iaccvitesvcixercntarsnacsinncesscsningencnaiee App. 44
FI GE I sideeseinicccinsictarsseetectacneeneae App. 48
COOMCENIOIS OF ANY occ ssnsessscncocrssvescsconssessssasnvil App. 57
III snisvossh'exasusansnsendemetecedasisauchanmuaneiend aaa App. 59
Order Denying Reconsideration, Supreme Court
OE FR Riiivrdticinrenincccmnunannuanee App. 65
Statement of Charges, Medical Quality Assur-
IG CII oaccicesnctecctncssastasscarissesinserene App. 66
ll
TABLE OF CONTENTS — Continued
Page
First Amended Statement of Charges .............. App. 70
Answer to First Amended Statement of
Neon iecscseesessnsecsnasevesssseeooses esse App. 77
Reply Memorandum (Excerpt), Department of
i lecsicssescescerocescnesecsvecsessesessees App. 84
Order Quashing Depositions.................:csssceeeees App. 88
Motion to Dismiss Statement of Charges......... App. 90
Order Denying Motion to Dismiss .................... App. 97
Department’s Amended Prehearing State-
rsd ciccnceucenesesesssseneveceecessocccoose App. 99
Prehearing Order No. 8 re Objections to
Neen. cannacctesveresccevescess App. 103
Opening Statement of Mr. Armstrong............. App. 107
Examination of Geoffrey S. Ames, M.D. (First)
i cinccscncasesscsesonssosseusecenscocess App. 114
Department’s Exhibit 3, p. 3 (Medical Records)
ee cidactbscscesseccsusserssessesceeesescesece App. 146
Department’s Exhibit 3, p. 2 (Medical Records)
i eiastisdesseccsrensescosereseccessecersoes App. 148
Examination of Patient One (Excerpts).......... App. 149
Examination of Richard A. Sherman
a cissstnsscressnsecscvovessceccecsssssesess App. 169
iii
TABLE OF CONTENTS -— Continued
Page
Part 2
Examination of Neil Ogden (Excerpts)............. App. 201
Examination of David Martin, M.D. (Excerpts) ... App. 223
Examination of Patient Two (Ex*erpts) ........... App. 246
Examination of James Clark ................sececeseeees App. 260
Examination of Geoffrey S. Ames, M.D. (Second)
CED vsnewsictvncasssscenspanetnieamaneeamescnmntens App. 304
Objections, Arguments, Rulings and Colloquies
at Hearing (Excerpts from Hearing Tran-
GOT es ciscitissncetessnssicecrecsendsansecsuuisevcemeneone ae
Petition for Review (Superior Court, Benton
CN SE sesh cbscaticcemtintessscerntnencpene App. 379
Petition for Review (Supreme Court of Wash-
SS CI hic ctctscrasinteacsescrcnasissensioncounes App. 390
Petitioner’s Motion for Reconsideration (Ex-
cerpts) (Supreme Court of Washington)...... App. 397
Opening Brief of Petitioner (Court of Appeals)
(Excerpts) Footnote 1G..........ccccscccscsscssseseesees App. 407
Respondent’s Answer to Petition for Discre-
Ce TD htiiiicidiiecreneane App. 413
Revised Code of Washington 18.130.180(1), (4),
(7), (16) (Uniform Disciplinary Act)............. App. 415
Washington Administrative Code
Pe ee i iceakccatisctinsnticeccicnecoune App. 416
Te ish kiciecdnticteceatenesees App. 417
PR a cienriessnsnasxcvinsainasencesansaneane App. 418
iv
TABLE OF CONTENTS — Continued
Page
Revised Code of Washington Ch. 34.05
(Administrative Procedure Act) (Excerpts)
I ian cictnrcetissachisinteavtontarnseeaccnnce App. 419
RCW 34.05.461 (Excerpts).............ccccceeseseeee App. 419
BE Fees MED viiiccie cncacisenscavancviccsaascosnsonss App. 421
Petitioner’s Opening Brief, Superior Court,
Benton County (Excerpts) .................csceceeees App. 422
App. 199
[2243] STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
In the Matter of the License
to Practice as a Physician
and Surgeon of:
GEOFFREY S. AMES, M.D.,
License No. MD 00026961,
Respondent.
Docket No.
02-06-A-1012MD
)
TRANSCRIPT OF PROCEEDINGS
DAY 2
(Filed Oct. 15, 2004)
APPEARANCES
HEALTH LAW JUDGE:
ARTHUR E. DeBUSSCHERE
FOR THE RESPONDENT:
WILLIAM R. BISHIN
Attorney at Law
701 Fifth Avenue, Suite 4040
Seattle, Washington 98104
FOR THE DEPARTMENT OF HEALTH:
KEITH D. ARMSTRONG
Assistant Attorney General
1125 Washington St. S.E.
Olympia, Washington 985694
COMMISSION MEMBERS PRESENT
SUNANDA UBEROI, M.D. JANICE PAXTON, PA-C
CABELL TENNIS, J.D.
Public Member
App. 200
Renton, Washington ROBERT H. LEWIS
January 13, 2004 & ASSOCIATES
Certified Court Reporters
Reported B :
nae wy Lodell 5113 Pacific Highway East,
Fife, Washington 98424-2639
LODELDW5SSNS 253.952.2030 — 1.877.952.2030
Fax: 253.927.2520
[2244] INDEX
WITNESSES:
PATIENT 1:
EES a ve ne 4
PEAS TANTS 7
REE SEE le ree ae ee 20
REIS NLS Se CORR Re EO Te 22
iit ea vsin cake cae avaasclcunsansenacentaceeuneunedin 30
ss ee upassnducioebnel 31
RICHARD A. SHERMAN:
SELLE TOTAAL TT RT 41
rcs ids saksatbasavancioasacsisavsoesesdccunall 83
IIIc. snocsn isin vintineunnbucabicvcbbavandemsaniocuauaes 103
in iad is wa eikeak shivaneianeaunousandentenan 104
i a Laces 107
I 2c Sac suukeuaues oacaraveeecnoncatal 110
NEIL OGDEN
EI TTL AIT TS RENATO TS 146
nos cassia cidelas uanslusts saghunadaenoieccedaaseniniellel 157
I seu eneademneeseeeeuaeie 173
ESE er Ne re a aN EMO TEL EN 177
ona ai acalsleglealameemamandanemnaitule 178
Be ET isi ciccalateidionstrindicentedsnenlapeninonadensaaaponaeaidnmads 180
I nn ceca cencaneakerancaencpnamenaiaciuonaneen 181
oii anc ots sasateseclaigilsnscbanuennepineiaeeaaaaae 185
I a 189
Ee MINIT ccsincsscsschivcnsndsiescaiiebannasenaesaccudacanses 190
Ey HIE cc iniiiin) sc osisncdicaciatelniinliatndunsidlinianibebtomiuecdian 191
* + * +
[2386] Ms. Paxton. They are hearing this case. I’m
presiding over the hearing. There is a court reporter
recording this proceeding. Mr. Keith Armstrong is the
assistant attorney general, and he’s representing the
Department of Health. Mr. William Bishin, Attorney
at Law, is here, representing Dr. Ames, who is
present.
You’ve been designated to testify as a witness, I
will ask the court reporter to swear you in at this
time.
NEIL OGDEN,
having been first duly sworn by the Notary, testified
as follows:
App. 202
JUDGE DeBUSSCHERE: One requirement
that I ask of you, Mr. Ogden — this is Health Law
Judge Art DeBusschere — is that you are testifying as
a fact witness. And I'd ask that — Of course, I
understand you are employed with the FDA. And if
you have documents there when you testify, if you are
referring a document, we’d ask that you identify that
document prior to your testimony, okay?
THE WITNESS: Yes.
JUDGE DeBUSSCHERE: Do you under-
stand that requirement?
THE WITNESS: Ido.
JUDGE DeBUSSCHERE: Can you hear me
okay?
[2387] THE WITNESS: Yes.
JUDGE DeBUSSCHERE: I ask, if you can
speak up just a little bit, too, so we can hear you. We
have you on a speaker phone.
THE WITNESS: Yes, I’m on a speaker-
phone as well, because with me is Mr. Carl Turner,
who is an attorney for the Commissioner’s Office.
JUDGE DeBUSSCHERE: Will he be there,
is he there to listen or is he going to be advising you
while you testify?
MR. TURNER: I’m primarily here to listen,
Your Honor.
App. 203
JUDGE DeBUSSCHERE: All right. Well,
Mr. Turner, if you do say something, I would ask that
you alert us what you are doing, okay?
MR. TURNER: I will.
JUDGE DeBUSSCHERE: Thank you.
Mr. Armstrong — Let’s see. One other thing. Mr.
Ogden, I understand you have to leave at 5:30 your
time; is that correct?
THE WITNESS: Yes, it is.
JUDGE DeBUSSCHERE: What time do
you have there?
THE WITNESS: 4:25.
JUDGE DeBUSSCHERE: You are at 4:25?
[2388] THE WITNESS: Approximately.
JUDGE DeBUSSCHERE: So it looks like
you have about an hour and five minutes available to
testify?
THE WITNESS: That would be correct.
JUDGE DeBUSSCHERE: Because of that,
I’m going to limit the parties to how much time they
have. So I will give Mr. Armstrong 20 minutes for
direct; Mr. Bishin, 20 minutes for cross. Then, the
panel members may want to ask you some questions,
and I give them 20 minutes to ask you questions as
well.
So go ahead, Mr. Armstrong.
App. 204
MR. BISHIN: Just one moment. I want to
make sure it’s clear on the record that I object to this
procedure, insofar as my right to cross-examine, my
client’s right to cross-examine has been curtailed.
JUDGE DeBUSSCHERE: Yes. Your objec-
tion is on the record. Thank you.
Go ahead, Mr. Armstrong.
DIRECT EXAMINATION
BY MR. ARMSTRONG:
Q Good afternoon, Mr. Ogden. Can you hear me
okay?
A Uh, fairly well.
Q I'll try to speak up.
* * * *K
[2399] cross-examination. Mr. Bishin?
CROSS-EXAMINATION
BY MR. BISHIN:
Q Mr. Ogden, good afternoon.
A Good afternoon.
Q First of all, Mr. Ogden, you don’t have any
personal knowledge of the LISTEN device that was
purchased by Dr. Jeffrey Ames, do you?
A That's correct.
App. 205
Q You don’t know what labeling that device had
on it; isn’t that correct?
A That’s correct.
Q And you don’t know the specifications that it
has; isn’t that correct?
A That’s correct.
Q Now, let’s go talk about the Digital Con-
ductance Meter for a Moment. You just testified
unequivocally that if there were changes made to the
LISTEN device, it would require another premarket
notification and clearance, or did I misunderstand
what you testified to?
A That’s correct.
Q You are saying that any changes to a device
that has been cleared requires a new clearance?
MR. ARMSTRONG: Asked and answered,
[2400] objection.
JUDGE DeBUSSCHERE: Overruled.
A No, that’s not what I’m saying. You could
make minor changes to a device by changing the
screws on the box, change some resistors, perhaps, in
their circuits to make it perform in the same manner
but more efficiently, and still not require a new
premarket notification.
App. 206
Typically, the trigger for acquiring a new pre-
market notification is you’ve changed the perform-
ance of the device in such a way that it now is outside
the performance range that was cleared.
Q (By Mr. Bishin) Wait a minute. Now, Mr.
Ogden, that isn’t what the FDA says in its published
documents, is it?
MR. ARMSTRONG: Objection. Your Honor,
he is asking the witness for a legal conclusion, and
you've already ruled that’s not going to be allowed in
this case.
JUDGE DeBUSSCHERE: Overruled.
Q (By Mr. Bishin) That’s not what the FDA says
in its published documents, is it?
MR. ARMSTRONG: Objection, again, Your
Honor.
JUDGE DeBUSSCHERE: Overruled.
MR. ARMSTRONG: Which document that
he’s [2401] referring to? Web site, physical
documents, legal documents from the Office of
Compliance? It’s vague. We don’t know which
documents he’s referring to. The FDA is a giant
organization. They have millions of pieces of paper.
Which document is Mr. Bishin referring to in making
this statement?
JUDGE DeBUSSCHERE: Overruled.
Do you remember the question, Mr. Ogden?
App. 207
A Please repeat it.
Q (By Mr. Bishin) The question is, isn’t it true,
Mr. Ogden, what you stated is not true and that
the FDA’s publications do not state the criteria for a
new, for a change in a device that has already been
cleared?
A My answer to that would be that the FDA
has a guidance document which specifically addresses
whether a manufacturer should submit a 510(k)
when they are changing their device.
Q That’s right. And that document is called,
that document is called, quote, Deciding when to
submit a 510(k) for a change to an existing device,
unquote. Isn’t that correct?
A Yes.
Q. All right. And in that device, they specifically
say, don’t they, that the key consideration, the key
consideration is whether the change, quote, could
[2402] significantly affect the safety or effectiveness
of the device, unquote? Isn’t that what it says?
A It says that, yes.
Q That’s what it says. And in talking about the
device, it says that the regulatory criteria statement
of premarket notification must be submitted when
the device is one that the person currently has in
commercial distribution or is reintroduced into com-
mercial distribution and is about to be significantly
changed or modified in design, components, methods
App. 208
of manufacture or intended use, the following con-
stitutes significant changes or modifications that
require a premarket notification. One, a change or
modification of the device that could significantly
affect the safety or effectiveness of, the device; e.g., a
significant change or modification in design, material,
chemical composition, energy source or manufacturing
process. Two, a major change or modification to the
intended use of the device.
Isn’t that what they say?
A Yes.
Q Okay. Now, you don’t know whether this
device that Dr. Ames purchased — First, let me strike
that for a moment.
The FDA does not require a clearance, does it, of
a [2403] device, simply because it changes its name;
isn’t that correct?
A That’s correct, with the caveat that, as long
as the name change does not imply a new indication
for use or intended use.
Q_ As long as the labeling doesn’t say that; isn’t
that right?
A Yes.
Q Okay. So that if the manufacturer of their
DCM changed the name to listen or used that name
as its brand name, that wouldn’t require a new
clearance for DCM, would it?
App. 209
A Correct.
Q Now, secondly, if the manufacturer of the
DCM decides to offer it with software that did not
significantly change the, that did not raise any new
issues of safety or effectiveness and which did not
have any different labeling from the labeling that was
approved by the FDA, that would not require any new
clearance either, would it?
A That’s correct, as long as there was no need
for any clinical data to show substantial equivalence.
Q Okay, that’s right. Now, when you deal with
people who are seeking either clearances or ap-
provals, do you ever, do you ever suggest to them or
have you ever suggested to them changes in the way
they make their application?
[2404]A Yes.
Q For example, when you get a premarket noti-
fication from a manufacturer and it has, maybe, a
number of different uses on it, have you ever said,
well, you know, we’re not going to be able to clear that
with those uses listed on the label, but if you take
some of them off, then we might be able to clear it?
Have you ever done that?
A Yes.
Q And in some of those situations, have you
then cleared the device?
A Yes.
App. 210
Q Okay, good. Now, have you ever had a situa-
tion where someone has come to you for premarket
approval and you’ve told them something like, well,
we can’t give you a premarket approval right now be-
cause you just haven’t gotten enough data for us yet,
we need more clinical trials than this to do this, or
you had some other reason, and so you said to them,
but you know what you can do, if you want to get this
on the market, you can change your labeling so that
you have a labeling which indicates that it has the
use of a predicate device, and we can give you a
clearance to get it on the market, but you’ll have to
limit your labeling claims to the ones that are ap-
proved in the clearance. Have you ever [2405] done
anything like that?
A Yes.
Q And that’s something that — You are not the
only one who’s done that; isn’t that correct?
A Correct.
Q I mean, that’s part of the service function of
the FDA’s device division in working with and helping
manufacturers who seem like reputable businessmen;
isn’t that right?
A Yes.
Q Now, are you familiar with the bone screws
that have caused so much litigation in this country,
bone-screw litigation that was — I can’t remember the
name of the company. Was it Accupath?
App. 211
Did you deal with that in your division?
A It was dealt with in my division, yes, but
not in my branch. So I’m only peripherally aware of
the bone screws, which I believe are called pedicle
screws?
Q That’s exactly right. Those are the ones I had
in mind.
So that was just something you talked about in
the FDA maybe at lunch but you actually didn’t
officially have to deal with?
A Correct.
Q And those bone screws, they are the subject
of that fairly recent United States Supreme Court
case, [2406] Buckman v. Plaintiffs’ Legal Committee?
Do you remember that?
A Im not aware of that case.
Q Allright. Are you aware of the issue that was
involved with regard to the bone screws that, origi-
nally, the manufacturer applied for, applied for a
clearance for the bone screw as it was to be used as a
pedicle screw in the spine, and the FDA turned them
down? Do you remember that?
A Not specifically.
MR. ARMSTRONG: Objection, Your Honor,
just to this line of questioning, on the relevance.
MR. BISHIN: Well, I’m done with it.
App. 212
Just a moment. I’m not done with him.
How many minutes do I have, Your Honor?
JUDGE DeBUSSCHERE: Objection sus-
tained, on the issue of bone screws.
MR. BISHIN: How many minutes do I have,
Your Honor?
JUDGE DeBUSSCHERE: You have ten
more minutes. That will be 2:00.
Q (By Mr. Bishin) I have ten pages of questions
for you, Mr. Ogden, but it’s not going to happen,
obviously. So I have to pick and choose my best
questions.
Now, any individual or entity can seek a clear-
ance; [2407] isn’t that right, Mr. Ogden?
A Yes.
Q Let’s assume that an inventor seeks a clear-
ance and he gets one from the PTA for a particular
device. Are you still with me?
A Yes.
Q Okay. And then the inventor decides to assign
his device to a company. Are you still with me?
A Yes.
Q Okay. And the company then manufactures
the device and distributes it. That company does not
App. 213
need to seek its own clearance for that device; isn’t
that right? It can rely on the inventor’s clearance?
A That’s correct.
Q Now, bear with me, please. The FDA, when it
decides whether or not a, when it deals with a notion
of intended use, unquote, quote, intended use, un-
quote, it deals, it tries to make the determination of
the intended use of a device that’s submitted to it as
part of its general evaluation and approval process;
isn’t that correct?
A Yes.
\+ And when it does that, it limits itself, does it
not, to the use that is stated on the labeling that is
submitted with the application; isn’t that correct?
[2408] A I would change that around to say that
the device is limited to the labeling for which it is
approved, not when it’s submitted.
Q The device is limited, the device cannot be
marketed or promoted for any other use than the one
on its label that’s been approved; isn’t that correct?
A Yes.
Q You look at labels, and then you approve the
label; isn’t that correct? When you approve the device,
you are approving the label; isn’t that correct?
A Yes.
App. 214
Q_ If you don’t like the label, you are not going to
approve the device; isn’t that correct?
A Yes.
Q But on the other hand, when the manufac-
turer submits a device to you and says that this is the
use and the only use we’re going to put on this label,
you can’t go beyond that and say, well, we’re not going
to give you the clearance or approval because we
think that people are going to use it for something
else; isn’t that correct?
A Correct.
Q You are bound, just as the manufacturer is
bound by what’s on the label, you are bound by what’s
on the label, too. The statute specifically saya that,
doesn’t [2409] it?
A Yes.
Q Now, Mr. Ogden, you’ve met with or talked to
Mr. Armstrong how many times prior to this testi-
mony that you are giving today?
MR. ARMSTRONG: Objection, Your Honor,
relevance.
JUDGE DeBUSSCHERE: Goes to — It’s
relevant.
Go ahead and answer the question, Mr. Ogden.
A I believe, five or six times.
App. 215
Q@ (By Mr. Bishin) You’ve spoken to him five or
six times. Now, I tried to talk to you, didn’t I?
A You left a message on my voice mail, yes.
Q Actually — We won’t go into that. But I left a
message, I say I left you eight messages. But you say
you did receive a message of mine, didn’t you?
A Yes.
Q_ And you did not call me back, did you?
A _ I did not.
Q So you’ve never spoken to me except when I
was deposing you or when I’m examining you right
now; isn’t that correct?
A Yes.
Q But you have spoken to Mr. Armstrong five or
six times
* * * *
[2412] Q And there’s also something called an
investigational device exemption; isn’t that correct?
A Yes.
Q When you get any one of those things, that
means you can market a device, isn’t that right, or
not the latter one, you can’t market it, but you can
send it in interstate commerce; isn’t that correct?
A Right.
App. 216
Q Now, when the FDA approves a 510(k)
premarket notification, that is not, that does not
mean that the — Well, let’s say when it disapproves.
Let’s say when it disapproves. That doesn’t mean that
the device is not safe or effective for the intended use,
does it?
A It means that agency has found the device to
be not substantially equivalent to a predicate device,
and therefore, does not go to market.
Q@ That’s right. It has to be substantially equiv-
alent to a device that’s already on the market. It may
be safe, it may be effective, but it’s not substantially
equivalent. And therefore, it’s not entitled to a 510(k)
clearance; isn’t that correct?
A Yes.
Q Now, we get to a premarket approval. Those
are the ones that require a lot of data and support;
isn’t that right?
[2413] A Typically, yes. Safety and efficacy.
Q You have to have, you have to make a strong
showing to the FDA ordinarily, don’t you, that there’s
efficacy and safety —
A Yes.
Q —to get one of those.
And sometimes, that can take years and years;
isn’t that true?
App. 217
A Yes.
Q And those can be very expensive, can’t they?
A That’s what I hear. I don’t have any personal
knowledge of that.
Q They take a lot of the FDA’s time, don’t they?
A They do.
Q So they are expensive to us, the taxpayers;
isn’t that correct?
A Yes.
Q So there’s business time involved, too.
Now, you turn down a premarket, when you re-
fuse to give a premarket approval, that doesn’t mean,
does it, that the device is unsafe or ineffective nec-
essarily, does it?
A We would turn it down based on the device
having failed to be shown safe and effective for the
intended use they were applying for.
[2414] Q Right. In other words, they haven't
given you enough evidence yet for you to give them
the right to go to market; isn’t that right?
A That could be one scenario, yes.
Q Well, let’s talk about that one scenario. Now,
that can happen, and the manufacturer eventually
or some other manufacturer eventually can get a
App. 218
premarket approval by getting more information to
the FDA; isn’t that correct?
A That could happen, yes.
Q Or could be some scientific development
which would make it kind of clear that the device is
effective or is safe or something of that sort, and
therefore, merely calling that to the attention, of the
FDA might change its mind. That’s a possible sce-
nario, too, isn’t it?
A Yes.
Q So in other words, the FDA, when it with-
holds its sanction to go to market, it’s doing it in
order to be, to be safe, but it doesn’t necessarily mean
that any device it doesn’t permit to go to market isn’t
a good device or isn’t effective. It simply means it
hasn’t met the criteria the F'DA is letting down at this
time or at that particular time for getting such an
approval or clearance; isn’t that correct?
A For that labeling.
Q For that !abeling, that’s right.
+ + * +
[2419] ask about the hypothetical?
MR. BISHIN: Now, I’m forgetting what I
wanted to ask about. One of the things I wanted to
ask about is the hypothetical.
JUDGE DeBUSSCHERE: Go ahead.
App. 219
RECROSS-EXAMINATION
BY MR. BISHIN:
Q First of all, what you said was that if the
manufacturer was, even though they had a clearance
that covered one use, they were only selling it for
another use to, I don’t know who, the same cus-
tomers, that your understanding was that the com-
pliance division would take, would want you, would
want them to come in and seek another clearance.
That’s what you testified to, isn’t it?
A Yes.
Q You don’t know if the manufacturer of the
device that Dr. Ames purchased was selling it to
people for only one use, do you?
A Ido not.
Q You don’t know what claims the manufac-
turer of that device was making at the time that he
sold that device to Dr. Ames, do you?
A Correct.
[2420] Q You don’t know what that label looked
like at that time; isn’t that correct?
A Yes.
Q You don’t know how Dr. Ames was using the
device; isn’t that correct?
A Correct.
App. 220
Q Now, Mr. DeMarco told you not to speak to
me. He didn’t tell you not to speak to Mr. Armstrong;
isn’t that correct?
A Yes.
MR. BISHIN: [ll stop there, Your Honor.
JUDGE DeBUSSCHERE: Opportunity for
panel members to ask questions.
Mr. Tennis, do you have any questions?
MR. TENNIS: Yes.
EXAMINATION BY THE PANEL
BY MR. TENNIS:
Q Hello, Mr. Ogden. First of all, a simple ques-
tion. Everybody has been talking about labels. Is that
something that’s on a sticky thing you put on a
device, or is that a term that’s used in some of the
literature that goes with the device?
A We use the term “labeling” in a broad sense.
It means any written or voice information that ac-
companies the
* * * *
App. 221
[2935] STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
IN THE MATTER OF THE
LICENSE TO PRACTICE
AS A PHYSICIAN AND
SURGEON OF: ) No. 02-06-A-1012MD
GEOFFREY S.AMES,M.D. ) Day4—PM
License No. MD00026961,
Respondent. )
— — —
VERBATIM TRANSCRIPT OF PROCEEDINGS
(Filed Oct. 22, 2004)
APPEARANCES
Health Law Judge: Arthur E. DeBusschere
For the Respondent: WILLIAM R. BISHIN
Attorney at Law
701 Fifth Avenue, Suite 4040
Seattle, Washington 98104
For the Department
of Health: KEITH D. ARMSTRONG
Assistant Attorney General
1125 Washington Street Southeast
Olympia, Washington 98504
Commission Members
Also Present: Sunanda Uberoi, M.D.
Janice Paxton, PA-C
Cabell Tennis, J.D., Public Member
App. 222
Renton, Washington
Jauary 16, 2004
Robert H. Lewis & Associates
Certified Court Reporters
5113 Pacific Highway East, Suite #1
Fife, Washington 98424-2639
Tacoma: (253) 952-2030 * Toll Free: 1-877-952-2030
Reported by Robert H. Lewis CSR# 2441
[2936] INDEX
EXAMINATION OF DAVID R. MARTIN, MD
By Mr. Bishin 131
By Mr. Armstrong 177
By Mr. Tennis 180
By Ms. Paxton 182
By Dr. Uberoi 187
EXAMINATION OF MR. CLARK
By Ms. Paxton 191
By Mr. Tennis 194
By Mr. Bishin 195
By Mr. Armstrong 197
[2957] JUDGE DeBUSSCHERE: We’re
back on the record. Mr. Clark was testifying, I think
they were finishing up questions. Mr. Bishin, do you
wish to call Mr. Clark or have Dr. Ames testify?
App. 223
MR. BISHIN: I think we have to let Dr.
Martin testify.
JUDGE DeBUSSCHERE: Okay, Dr. Martin,
and we'll have to excuse Mr. Clark, because otherwise
I don’t know how much time it will take for Mr. Clark,
because we’ve scheduled Dr. Martin for one o'clock, so
I think that’s what we have to do. So we'll have to call
you in your room I guess. Are we all ready to go?
JUDGE DeBUSSCHERE: Yes. Your next
witness, Mr. Bishin.
MR. BISHIN: Dr. David Martin, have a
seat right there, Dr. Martin.
JUDGE DeBUSSCHERE: Would the court
reporter swear this witness in.
* * * *
DR. DAVID MARTIN,
having been first duly sworn by the Notary, testified
as follows:
JUDGE DeBUSSCHERE: Can you tell us
your full name.
THE WITNESS: David Reed Martin.
JUDGE DeBUSSCHERE: And it’s M-a-r-t-
i-n?
[2938] THE WITNESS: That’s co: rect.
JUDGE DeBUSSCHERE: Your’ witness,
Mr. Bishin.
App. 224
EXAMINATION
BY MR. BISHIN:
Q Dr. Martin, it would not be impolite for you to
not look at me and talk to me when I’m asking you
questions, but instead talk to the panel and the
presiding officer because they’re the ones who have to
really hear. So as unnatural as that may seem, would
you try your best to talk in that direction; thank you.
Would you state your occupation, please?
A Ima family physician and an acupuncturist.
Q An acupuncturist. And can you describe kind
of generally the kind of practice you have, a little bit
more elaborately so we understand kind of the details
of it?
A I currently have a private practice in Seattle
focused on, primarily on constitutional acupuncture;
there’s a lineage of acupuncture called thigh element
acupuncture and I see usually eight to 10 people a
day for anywhere from 45 minutes to two hours each,
working with the energetic constitution of the
individuals.
People come for basically the whole variety of
Western medically trained reasons, although usually
not for very acute causes that would more likely take
them into an [2939] emergency room.
Q Okay. Do you find yourself involved with
patients who have allergies?
App. 225
I certainly do.
Do you ever treat patients for allergies?
I do.
Q Are vou familiar with the _ general
conventional medicine with respect to allergies?
> O P
A Im familiar, yes.
Q And does conventional medicine, conven-
tional approach to allergies, does it differ in signifi-
cant respects from the approach that you have with
respect to allergies?
A Yes. The entire framework that is used to
treat allergies in acupuncture is different from
Western medicine.
Q I'm going to go into that in a moment, but I
just wanted to have a topic heading for this exami-
nation. Would you please give us your entire edu-
cational experience; where you went to school after
secondary school and what degrees you received,
what formal training you had; would you tell us that?
A Yes. I went to college at Dartmouth College
and majored in math, physics, and engineering; did a
year of gracuate study at the Thayer School of Engi-
neering at |sartmouth College, primarily focusing on
computer [2940] architecture and theoretical physics
prior to going to the medical school program at
Harvard University, joint program between Harvard
and M.I.T. for people with strong quantitative science
backgrounds; graduated from the medical program at
App. 226
Harvard Medical School in 1983 and attended three
years of family medicine residency at University of
Oregon Health Sciences Center; and then did two
years of the Robert Wood Johnson Fellowship in the
faculty at the University of Washington, Seattle.
Subsequently in 1994, ’95, and ’96, I trained in
acupuncture at the Wu Hsing Toe School in an
apprenticeship role in Seattle, graduated from there
and took the national boards in acupuncture just in
2001. Mainly because some people who look at medi-
cal doctors practicing acupuncture from the acu-
puncture field don’t necessarily think they have any
credentials.
Q So your M.D. is from Harvard then?
A That’s correct.
Q And do you have any informal training of any
kind that supplements your formal education; any
other kinds of courses that you’ve taken in specific
fields of any kind?
A _ I’ve taken, you know, I do what would be the
equivalent of continuing education, usually at least a
week or two a year in observing senior acupuncturists
in a particular lineage of acupuncture; and I’ve over
recent
+ * . *
[2960] Q And when you treat them how do you
do it?
App. 227
A In the same manner that I described in the
example. I look at their constitution and I treat them
based on their constitution; and if there are specific
areas they are having allergies in, such as allergic
rhinitis, they may get specific symptom-oriented
points done for those. But in the way that I’m
treating them to cure their allergies, is the way that I
described.
Q In the field, in the broad field of acupuncture,
do acupuncturists, do the, does a respectable opinion
in acupuncture areas believe that allergies are
something acupuncturists are competent to treat?
A Ym not aware of allergies being treated, being
studied in any large studies as a group. Allergic
rhinitis, for example, is one area that has been
studied and is, you know, recognized by the World
Health Organization as being one of the areas that
acupuncture is involved in treating in individuals.
Asthma, not really specifically allergy-related asthma,
but asthma as a whole is also recognized as another
area that acupuncture is useful in treating.
You know, as with Western medicine, there are
many areas that acupuncture is used for that there
have not yet been randomized control double-blind
studies done for and there’s some reason to believe
that such studies don’t [2961] necessarily have the
same applicability in a medicine based on energetics.
The same utility I would say, in medicine based on
energetics as they do in Western medicine because of
App. 228
the effects of the consciousness of the practitioners
and the outcome of the studies.
Q Id like to go into that a second, but that
wasn’t my question. My question was, not does
Western science accept acupuncture for allergies, but
does acupuncture accept acupuncture for allergies?
A Acupuncture accepts acupuncture for aller-
gies. Now again, according to the different lineages
there are different, some lineages have very little to
do with allergies and other lineages have a lot to do
with allergies and will treat them and will suc-
cessfully.
I can think of many, many examples of acu-
puncture that is useful for treating allergies; so from
my perspective, yes.
Q Id like to get back to something —
MS. PAXTON: Mr. Bishin, can I just ask
one question about a definition; lineages. How are
you using that term?
A Just that the way acupuncture has been
passed down over the years was really for thousands
of years in small groups, in families and there are
kind of different perspectives and different aspects
that are developed in
* * * *
[2963] not deal with these same levels of existence as
Asian medicine on which acupuncture is based, on
App. 229
which acupuncture represents; is that what you’re
saying?
A Well, in my understanding Western medicine,
most of Western medicine is biomedicine, it’s based on
material reality; there are aspects of medicine, psy-
chology, psychiatry, which bring in other levels, you
know.
There are kind of psychosocial levels brought in,
but that still occurs within a framework where it’s
almost understood implicitly that the mind, if you
will, is generated by the brain and it all has a
material basis and that’s not the point of view from
the East where consciousness is actually more fun-
damental than the material level of reality.
Q Could you elaborate a little bit more on what
sense is consciousness more fundamental than the
material level?
A When [I say it’s more fundamental, I mean
that in the particular world view that acupuncture is
based on and I'll give a more concrete example of this,
but that treating things on the energy level can heal
things on the physical level.
And so the physical level in some sense is
dependent on, or doesn’t determine the energy level
the way the energy level can determine the physical
level, and in my early experience in acupuncture I
was shocked at times
* * + *
App. 230
[2968] used where a glass container is placed on the
skin and it’s burned inside it to create a vacuum;
bleeding can be used, a variety of different —
Q_ And is acupressure related to acupuncture?
A Yes. It uses the same points, basically stimu-
lates the points with a non-invasive means rather
than a needle.
Q And you say non-invasive means, what kinds
of means are we talking about?
A Just pressure and often an amount of motion
or pressure on the point.
Q Is it possible to do acupressure with some-
thing like what’s in front of you; do you recognize
that?
A Certainly.
MR. ARMSTRONG: Objection, vague.
JUDGE DeBUSSCHERE: The question’s
vague; could you please have the witness —
Q (By Mr. Bishin) Would you please describe
what’s in front of you, the device?
A It’s not something that I’m familiar with as a
specific device, although it appears to me that it’s
along the line of devices that provide a mechanical
level of stimulation to these points which are then
placed on points on the body to give mechanical
stimulation to those points.
App. 231
Q Would you just briefly describe for the record,
what it is you're holding in your hand?
> * * *
[2970] system.
A Yes. You know, I will often use some acu-
pressure in my treatment if the point doesn’t need the
amount of stimulation that acupuncture will give it;
acupressure is useful. I often use acupressure with
children who don’t need very much stimulation. So
the same fundamental view is underlying acupres-
sure as well as acupuncture.
Q Now, in the acupuncture community, is acu-
pressure ever used to treat allergies?
A Yes.
Q Are you familiar with any schools or methods
that do treat allergies with acupressure?
A Several different schools, there’s NAET,
Nembudripad Allergy Elimination Technique; there’s
TAT, Tapas Acupressure Technique; there are others,
Allergy Relief System, ARS is another technique.
Q These all use acupressure for this purpose?
A Right.
Q@ And are these regarded as respectable among
the acupressure/acupuncture community?
MR. ARMSTRONG: Objection; respectable.
App. 232
MR. BISHIN: [I'l say there is a doctrine of
law, Your Honor, that says respectable minority, I
don’t want to get into the majority because there
aren’t any, you judge by the standards of that
respectable minority, that’s [2971] why I’m asking
with respect to minorities.
JUDGE DeBUSSCHERE: Overruled.
MR. BISHIN: Would you read back the last
question, please?
THE REPORTER: (Complying)
A There are certainly groups, again there are
many lineages of acupuncturists and some acu-
puncturists would use modalities like this. And there
are many people practicing these particular modes of
allergy treatment within the acupuncture community
as a whole.
And from my particular personal perspective, I’ve
certainly seen clients of mine get treated with these
methods and get relief from their allergies, some-
times in ways that I am clear that it came from the
treatment.
For example, I had one, about 33-year-old
woman, who had had G.I. distress and skin allergies
for years and had been through Western medical
treatment for years; had been on elimination diets
fairly strict, keeping off all wheat, all dairy, a variety
of other things I can’t recall at the moment; and she
went into NAET treatment and over the course of a
App. 233
year all of her allergies completely resolved. She now
eats whatever she wants to and has no problems.
Q (By Mr. Bishin) The types of people that
practice NAET, do they have the standard kinds of
certification and [2972] credentials that are con-
sidered to be respectable or desirable in the acu-
puncture community?
A Because NAET is an acupressure technique it
doesn’t necessarily require the licensing that is re-
quired of acupuncturists. It does require that people
be, as I understand it, and I’m not an expert on this,
but as I understand it NAET training is open to
people who are licensed in one way or another to treat
people for illnesses. And there is a set of courses that
people go through at NAET and I think there’s an
ongoing education requirement to be considered a
practicer of NAET or registered practitioner, that
kind of thing.
So there is a training protocol for it and the
acupuncturists who practice it are certified as acu-
puncturists by means of the way that they got there
in the first place.
Q So the types of people that practice it,
though, are there among those people, people who
have credentials that are generally recognized by the,
even by the medical community but certainly by the
acupuncture community?
A Yes.
Q For example, do physicians practice NAET?
App. 234
A I imagine that they do; you know, you’re
asking me a little bit more than I’m familiar with
about the NAET practitioner group. Most of the
people that I know that [2973] practice NAET are
acupuncturists, but I know that chiropractors prac-
tice it and I know that doctors can practice it. I just,
to this point in my acquaintance with people, haven't
found specific doctors that practice it.
Q@ Now, how would you compare the success of
acupuncture and acupressure in treating allergies
with the success of Western medicine?
A Could you ask me a more specific question?
Q Iwas hoping you would break it down. First
of all, let me, are there significant number in your
opinion of instances and situations in which acu-
puncture or acupressure is able to get positive results
for people who are suffering from allergies when
Western medicine is unable to deliver such results?
A Yes.
Q Can you tell us a little bit about that, more
general things?
A Well, you know, the options within Western
medicine for treating allergies are few. There are a
number of methods for symptomatically reducing the
effects of allergies.
There are for some types of allergies, such as
allergic rhinitis and allergy-related asthma, there
are immunotherapy protocols that can be used in
ge oe 6 a.
’
App. 235
Western medicine, but immunotherapy protocols are
not particularly [2974] helpful for food-related
allergies or food-intolerance as far as we know.
And so there are often not a lot of ways to cure
allergies from the Western medical perspective. And
even when using immunotherapy there are risks,
there are, you know, dozens of people have died over
the last few decades due to scratch tests and due to
immunotherapy applications in Western medicine.
From the acupuncture perspective, you know,
what’s bothering the person that is looked at as an
allergy from the Western perspective is seen as a
pattern that isn’t necessarily labeled as an allergy,
and often the individual can be brought into an
equilibrium where that is not, doesn’t bother them
nearly as much from the acupuncture perspective,
and with very little side effects, a little bit, of an ouch
with a needle.
Q So the side effects, are there any situations in
which death has occurred because of the acupuncture
or acupressure treatment of allergies?
A None that ’m aware of. They are very rare in
acupuncture as a whole if a needle that is too long is
stuck in the wrong place, in the lung for example, it
can cause a pneumothorax which can be, can lead to
death if appropriate help and recognition of the
syndrome is not, but that’s very, very, very rare. I’ve
never heard of it
* 7 * *
anemia A cae Sie ant) L chee tae
App. 236
[2976] there are RASP tests that look at the
antibodies in the blood stream.
But, you know, getting a skin test and even more
so with the RASP test, the standard directive in a
medical textbook would be that you can’t trust them
whether they’re positive or whether they’re negative.
A RASP test is at best confirmatory to some degree if
you're considering there’s an allergy in some area.
There are many, many false positives, there are false
negatives, they just cannot be counted on as a
diagnostic method, and so they’re available and
they’re part of the Western medical system, but
they’re not very accurate.
Q@ Let me ask you, are you familiar with
kinesiology or muscle testing?
A Only secondarily, it’s not part of my practice,
I’ve never studied it.
Q But in the course of, is it something that’s
done by acupuncturisis as part of —
A It’s not really part of acupuncture as a whole,
but it’s a part of alternative medicine. I’m familiar
with it in my wider familiarity with people who
practice alternative medicine. I know chiropractors
who use it, some naturopaths who use it, you know,
it’s integrated often into methods like NAET that are
used by acupuncturists, but it’s not a specific part of
[2977] acupuncture.
App. 237
Q_ In the alternative world is it something that
is considered to be a respectable device by a sig-
nificant number of people?
MR. ARMSTRONG: Objection; if I under-
stand counsel, he’s saying kinesiology is a device.
JUDGE DeBUSSCHERE: Objection sus-
tained; can you clarify your question?
Q@ (By Mr. Bishin) I won't characterize it as a
device or a process or anything. Is muscle testing or
kinesiology considered to be among a significant
number of people in alternative medicine a useful
phenomenon?
A Well, I would say two things; one is based on
the fact that a considerable number of people in
alternative medicine. use it, that it must be con-
sidered useful.
It, in my experience, is useful in the hands of
some individuals and I’ve seen people who seem to be
very effective in the treatment they give based on
kinesiology, but I can’t give you any literature kind of
overview or assessment of the field as a whole other
than it is definitely respected by people when it’s in
the hands of certain people.
Q Now, you were talking a little bit near the
beginning of this examination about whether or not
the most typical
* * * *
App. 238
[2985] there are a possibility of things like that.
It also mentions that there are times in the
process of treatment with acupuncture when the
symptoms the individual is having may flare up and
be worse than they were previously.
Q One last question. You mentioned the term
EDS, electrodermal screening?
A Yes.
Are you aware of —
I think I mentioned electrodermal device.
Device?
Yes.
> O PrP ©
Q Do you know if electrodermal device can
diagnose an allergy in the skin?
A Idon’t know the answer to that. I actually did
some research on that for this particular occasion and
the last time that the Clinics of North America put
together a panel statement, entire issue evaluating
allergy diagnosis and treatment, which was in 1995,
they said that electrodermal screening was as yet
untested.
And when I did a Medline search I found nine or
10 papers that came up with the words electrodermal
allergies over the last nine years, and there are some
of those that report that in double-blinded trials they
are successful in diagnosing allergies, and there were
App. 239
some of [2986] them that said there is no effect; and
this goes back to this example about the issues of the
mind and the problem with doing the research that
we were talking about.
And like in many areas early studies don’t all
tend to go the same direction; so, you know, I think
my assessment would be in some peoples’ hands these
work.
Q Okay. The second part of my question is,
would electrodermal screening, would that cure an
allergy based on your experience and knowledge?
A Well, my understanding of the term electro-
dermal screening isn’t a diagnostic treatment.
Q@ Okay, so it’s not a treatment; it’s a diagnostic
tool?
A Well, electrodermal screening particularly is
screening for something and if it’s electrodermal
allergy screening you're talking about screening for
allergies.
MR. ARMSTRONG: That’s all; thank you,
Doctor.
JUDGE DeBUSSCHERE: Questions from
the panel members; Mr. Tennis?
App. 240
EXAMINATION
BY MR. TENNIS:
Q You said at some point that, so we’re dealing
with the difficulty of the two worlds you live in, the
Harvard M.D. world and the acupuncture world, that
you changed the sign on your office; did I hear you
correctly?
[2987] A Oh, what I was referring to is in my
medical practice, at that time at Group Health there
was a little sign up saying that I’m not in the office on
Mondays because [m starting up an acupuncture
practice; so a lot of people wanted to come because of
that and I took that sign out of there because it just
wasn't the best way to start working with people.
Q Okay, I thought you had an acupuncturist in
sign or something like that.
A No, they were separate offices.
Q@ And you were in Group Health but now
you're in private practice?
A That’s, right.
Q Colleagues or just by yourself?
A In the physical location that I’m at, there’s a
naturopath and a Ph.D. counselor and I have people
coming through for training, that kind of thing, so
there are colleagues there but I’m the only five-
element acupuncturist full-time.
App. 241
Q Do you use any devices in your treatments or
practice?
A Idon’t.
MR. TENNIS: That’s all I have.
JUDGE DeBUSSCHERE: Dr. Uberoi?
A (Continuing) I mean other than needles and
moxa; the needles got off the experimental device a
few years ago for (2988] acupuncture, the FDA kept
them as an experimental device for I don’t know, 10
years or so.
JUDGE DeBUSSCHERE: Dr. Uberoi, do
you have any questions?
DR. UBEROI: Just give me a few seconds.
JUDGE DeBUSSCHERE: I'l ask Ms.
Paxton and then you can come back.
EXAMINATION
BY MS. PAXTON:
Q@ Dr. Martin, I’m not sure because of your
previous response about kinesiology if you’re able to
answer this question, but [m going to shoot it
towards you and see what you can do with it. We’ve
been told that there’s muscle testing involved with
allergy testing in this case to find out what actual
food in this case rather than a pollen or grass or
whatever is the culprit in somebody’s allergy?
App. 242
A Right.
Q And that there is a way of delivering that
message to the person, to the patient in conjunction
with pressing down on an arm and resistance. Are
you with me so far?
A Yes.
Q In this case we have been dealing with this
machine which is to your left, which without going
through all the what is it and who is it and all that,
that its to your
* * + *
[2993] EXAMINATION
BY DR. UBEROI:
Q One is that would you treat somebody with
DR-5 element acupuncture schooling just based on a
RASP test, RASP test on like egg allergy six, the
person says I don’t like eggs but I keep eating them
and I don’t have any symptoms; I understand you
might want to treat the patient anyway for other
things and balance.
A_ I, generally when I talk with people on the
phone about whatever they’re coming in for, even if
it’s something I know is very amenable to acu-
puncture, I ask them generally speaking if this is just
a bother and they just want the symptom to go away
or whether they’re really looking at this as having
something to do with their overall balance and
App. 243
lifestyle and they’re really willing to work on another
level about what is this symptom, why is it coming.
From my understanding, a RASP test showing an
egg allergy with no symptoms needs no treatment by
anybody. And the only reason that I would treat
someone like that is if they really were in a place of
wanting to get constitutional acupuncture for its
preventative benefits rather than treating them.
Q Right, okay; one more question. When you
said treatment you mean — I wouldn’t want to use the
word energy
App. 244
[2519] STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
License No. MD00026961,
Respondent.
IN THE MATTER OF THE ?
LICENSE TO PRACTICE )
AS A PHYSICIAN AND ) Docket No.
SURGEON OF: ) 02-06-A-1012MD
GEOFFREY S. AMES, M.D. Day 3
)
~~
VERBATIM TRANSCRIPT OF PROCEEDINGS
(Filed Oct. 22, 2004)
A-P-P-E-A-R-A-N-C-E-S
HEALTH LAW JUDGE:
ARTHUR E. DeBUSSCHERE
FOR THE RESPONDENT:
WILLIAM R. BISHIN
Attorney at Law
701 Fifth Avenue, Ste. 4040
Seattle, Washington 98104
FOR the Department OF HEALTH:
KEITH D. ARMSTRONG
Assistant Attorney General
1125 Washington St. S.E.
Olympia, Washington 98504
App. 245
COMMISSION MEMBERS PRESENT
SUNANDA UBEROI, M.D. JANICE PAXTON, PA-C
CABELL TENNIS, J.D.,
Public Member
Renton, Washington
January 15, 2004
REPORTED BY JEAN ERICKSEN, CCR
[2520] INDEX
PAGE
RESPONSE TO MOTION TO DISMISS 5
REBUTTAL TO MOTION TO DISMISS 74
PATIENT 2
DIRECT EXAMINATION
CROSS EXAMINATION
REDIRECT EXAMINATION
DR. UBEROI
MS. PAXTON
RECROSS EXAMINATION
PATIENT 3
DIRECT EXAMINATION
CROSS EXAMINATION
REDIRECT EXAMINATION
DR. UBEROI
App. 246
FURTHER RECROSS EXAMINATION 246
MOTIONS 249
* * * *
[2692] afternoon break. It’s now 3:55 p.m., and the
Respondent is presenting his case in chief.
Let’s go off the record while I dial the number.
(Off the record.)
JUDGE DeBUSSCHERE: This is Health
Law Judge Arthur E. DeBusschere, and this is a
matter before the Medical Quality Assurance Com-
mission. Mr. Bishin has identified you as a witness,
okay?
PATIENT 2: Yes.
JUDGE DeBUSSCHERE: All right. Let me
briefly give you more introduction so you understand
who’s calling you.
My name is Arthur E. DeBusschere. [m the
presiding officer, health law judge presiding over this
hearing. This hearing is being conducted at the
Renton Holiday Inn select hotel in one of the
conference rooms.
This conference room, the hearing is being re-
corded by a court reporter, so testimony that you will
be giving will be recorded by a court reporter. There
are commission, Medical Quality Assurance Com-
mission members here, three commission members,
App. 247
Mr. Tennis, Doctor Uberoi and Ms. Paxton are
commission members that are hearing this.
[2693] The Assistant Attorney General, Mr. Keith
Armstrong, is here representing the Department of
Health, and Mr. Bishin is here with Doctor Ames,
representing, Mr. Bishin is an attorney representing
Doctor Ames, who is also present.
This is a public hearing, so there are two or three
other individuals in the room.
Patient 2, I'll ask the court reporter to swear you
in.
Can you hear me okay? I should have asked you
that first. Can you hear me okay?
PATIENT 2: Yes, I can.
JUDGE DeBUSSCHERE: If you can speak
up the most you can, I would appreciate it.
PATIENT 2: Okay.
JUDGE DeBUSSCHERE: Will the court re-
porter swear this witness in.
* * * *
PATIENT 2: Having been first duly sworn,
testified as follows:
JUDGE DeBUSSCHERE: Could you tell us
your full name.
THE WITNESS: Patient 2.
App. 248
[2694] JUDGE DeBUSSCHERE: And your
last name is spelled Patient 2?
THE WITNESS: Right.
JUDGE DeBUSSCHERE: Patient 2, your
testimony is being transcribed by a court reporter.
What I will ask the court reporter to do, because of
the Health Care Information Act, and you have been
identified as a patient, is that Mr. Bishin and Mr.
Armstrong and maybe the panel members who might
ask you questions, can refer to you as Patient 2, but
the court reporter will transcribe your name as
Patient Number 2.
THE WITNESS: Okay.
JUDGE DeBUSSCHERE: So the record
will reflect Patient Number 2 testifying, but you'll be
identified as Patient 2 and testify as Patient 2.
Mr. Bishin, your witness.
* * * +
DIRECT EXAMINATION
BY MR. BISHIN:
@. Good afternoon, Patient 2.
Good afternoon.
Can you hear me?
Yes, I can.
OP? © pP
Patient 2, can you tell us where you live?
App. 249
[2695] A. I’m sorry, I can’t hear you as well as I
thought I could.
Q. I’m going to move a little bit closer, so ’'m
more in line with the speaker phone. Can you hear
me better?
A. Yes, I can.
Q. Patient 2, where is your place of residence?
A. Richland, Washington, address 2612 Saddle
Way.
Q. And what is your employment?
A. I am employed by Duratek Hanford Com-
pany as quality assurance manager of the project
Hanford Management Contract on behalf of Fluor
Hanford.
Q. What does that position entail?
A. The position entails managing the overall
quality assurance program for this prime contract at
the nuclear facility, as well as performing, managing
the performing arts, assessments of ongoing work
activities.
Q. Can you tell us a little bit more about what
quality you are assuring?
A. We are assuring quality in accordance with
MGM 830 Subpart A, which are the Nuclear Safety
Quality Assurance Requirements, a federal regula-
tion.
App. 250
Q. Okay, and how long have you been doing this
[2696] job?
A. This current job approximately five years,
but I have 20 years experience at Hanford, 32 years
overall in quality assurance.
Q. Thank you. Approximately how many em-
ployees of your company report to you?
A. Nine.
Q. Now, are you familiar with Doctor Geoffrey
Ames?
A. Yes, I am.
Q. Can you tell us how it came about that you
became familiar with him?
A. It was actually my wife that was looking for
a new doctor, and Doctor Ames was just opening his
practice in Richland there. She called and made an
appointment. She liked him, and most importantly,
she liked the fact she had finally found a doctor that
was willing to LISTEN to her, and he became our
family physician.
Q. Okay. Now, in the course of your relationship
with Doctor Ames, have you ever consulted him with
respect to any allergies of any kind?
A. Yes, I have. I had a couple of significant
allergies one of which was to tomatoes, and the [2697]
reaction I was having to tomatoes was that it would
cut off my windpipe and would cause me to go
App. 251
through a series of rather severe throat clearing
exercises until I could breathe again.
The other allergy was an allergy that turned out
to be to sugar. I had no idea what that one was until I
went to Doctor Ames, but I was getting very severe
headaches that I noticed after eating certain foods.
Q. Okay, and did Doctor Ames treat you for the
allergy that was connected to tomatoes?
A. Yes.
Q. All right, and do you know what the result
was?
A. The result was very positive. After the
treatment I have been able to eat tomatoes ever since.
@. And you have never had any symptoms?
A. No side effects.
Q. I burden of proof? [sic]
A. I said I have been able to eat tomatoes ever
since the treatment, with no side effects.
Q. So the symptoms that you described before,
disappeared entirely?
A. Im sorry.
[2698] Q. I said are you saying that the
symptoms that you just described about your throat
disappeared entirely?
A. Yes, that’s true.
App. 252
Q. Now, with respect to the sugar, were you
treated for that?
A. Yes, I was.
Q. All right, and let me ask you this: what was
the treatment that was employed for the tomatoes?
A. The treatment involved Doctor Ames using
the machine, and I’m sorry, I don’t recall the name of
the machine, but it involved me holding a probe in
one hand, and Doctor Ames would give me a strength
test which consisted of me lying on my back with my
left Armstrong up in the air, and he would apply
pressure to my arm.
If it was a negative reaction, I was able to resist
the pressure very easily, however if it was a positive
reaction, I was unable to resist, and my arm would
fall.
Did he then treat you after that?
Yes, he did.
2 > ©
What was the nature of the treatment?
A. Again, I don’t remember the name of the
apparatus, but it involved a technique of him using
[2699] the machine going up and down my spine, and
then he would massage certain areas on my hands
and feet.
Q. And I'll come back to the device for a
moment a little bit later on. With regard to the sugar
allergy, did he treat you for that, also?
App. 253
A. Yes, he did, and that was most interesting
because we didn’t have any idea what could be
causing it, so he actually tried multiple causes, and
all kinds of different foods, and I was able to resist
the strength portion of the examination on everything
except sugar. When we finally tested for sugar, my
Armstrong collapsed. It was just incredible.
Q. All right, I was going to wait to talk about
the machine, but since you have said it again, when
your arm collapsed, did you make an effort to resist?
A. Absolutely. Absolutely. It had become sort of
a challenge, you know, because he asked you to give
him strength, so you really tense your arm up, and
there is quite a bit of strength exerted in that, and
that’s what makes it more amazing, when you do find
the thing that you're allergic to, your resistance is
almost completely gone.
Q. Let me ask you this: Did he do this pro-
cedure on your back once he —
[2700] A. Yes.
Q. I burden of proof [sic], in connection with the
hypothesis that you had a sugar allergy?
A. Yes.
Q. He did, all right. Did you have any evidence
that it had any effect?
A. Yes, he tested me again, as he did before, and
I was able to resist it completely.
App. 254
Q. What happened to your symptoms, though,
was there any affect on your symptoms?
A. The symptoms have disappeared. I’m now
able to eat sugar, which might be unfortunate, but,
yeah, I can eat sugar just fine now.
Q. Okay, and let me just make sure for the
record to clarify this. With respect to the tomato
allergy, when he tested you, did he test you with that
same muscle testing procedure, with testing your
muscle and having you hold the probe, and then
testing your muscle again?
A. Yes.
Q@. And you became weak when he typed in
tomato; is that what you’re saying?
A. That’s correct.
MR. BISHIN: That’s all I have, Your Honor.
aa - aa oe
[2707] A. Ido not.
Q. Patient 2, have you ever been diagnosed with
sugar allergy or tomato allergy before Doctor Ames?
A. No, sir.
Q. Have you had any treatment by another
health care provider, after Doctor Ames treated you
for sugar and tomato?
A. Not for allergies.
App. 255
Q. Have you ever had allergies come up on any
other test by another profession?
A. No.
Q@. You mentioned — let me ask you a question
about, you mentioned that there were multiple exams
for the sugar?
A. Im sorry, I missed that. Would you repeat it,
please?
Q. You mentioned that you had multiple exams
to determine that it was a sugar allergy that you had;
is that correct?
A. Yes. Yes, he tried a whole variety of different
kinds of foods on me before we arrived at sugar.
Q. So he would type in a different food, and
then do the testing, and he would go to another food
and then do the testing, is that the procedure?
[2708] A. Yes, exactly.
Q. Thank you, that’s all I have.
JUDGE DeBUSSCHERE: Redirect on the
questions asked.
Mr. Bishin, do you have any _ additional
questions?
MR. BISHIN: Yes.
App. 256
REDIRECT E INATION
BY MR. BISHIN:
Q. I have a couple of questions, Patient 2. I just
want to make sure for the record, because I’m not
sure what the answer turned out to be.
As I understand your testimony the testing
involved muscle testing and holding this probe in
your hand, and Doctor Ames typing something into a
computer; is that right?
A. Yes.
Q. And the treatment involved this procedure
on your back?
A. Yes.
Q@. Okay, and when Doctor Ames, when you
came to Doctor Ames with the food allergy, did he
take a history from you, did he ask you about your
symptoms, and anything else?
A. Absolutely.
[2709] MR. ARMSTRONG: What was that
answer? I didn’t hear you.
JUDGE DeBUSSCHERE: Absolutely.
Q. How long after you started seeing Doctor
Ames did you come to him for the tomato allergy?
A. Gosh. You’re asking an old man a memory
question here. I have been going to Doctor Ames for
approximately 10 years, my wife and I. My tomato
App. 257
allergy probably showed itself somewhere around five
or six years ago.
@. Okay. So had Doctor Ames taken histories of
you before you came to him with the tomato allergy?
A. Yes.
Q. Do you know if he had a substantial chart for
you prior to the tomato allergy?
A. My file there is pretty thick, yes.
Q. Okay, I think that’s all I have. Thank you
very much. We now have to hear from the Panel.
JUDGE DeBUSSCHERE: Patient 2, this is
Health Law JUDGE DeBUSSCHERE Art DeBusschere.
The Panel members may want to ask you some
questions. I'll ask each of them individually if they do.
Mr. Tennis, do you have any question of Patient
2?
MR. TENNIS: No, thank you.
a * * *
[2714] tomatoes were cooked tomato or a raw tomato,
that you would have that reaction of swelling or
shortness of breath?
A. No. I would have the same reaction. It was a
closing of my throat, sort of gagging and throat
clearing rather violently, more violently than I liked
it.
App. 258
Q@. Okay, and how soon after you had your
treatment for the sugar allergy, did you try sugar?
A. I wasn’t as anxious after that one, because
the headaches really hurt, so I would try little
portions, and then you know there is so many foods
that contain sugar, it’s almost impossible to avoid
them unless you stay away altogether.
I was picking up normal sugars in regular foods,
and stuff like that, and it was probably within 24
hours that I decided to try a bite of a cookie,
something I knew had a lot of sugar in it, and I had
no reaction.
Q. Is there anything else, besides your sugar
allergy and tomato allergy, that you have an allergy
to?
A. I’m not aware of any allergies right now.
Q. Thank you very, much.
JUDGE DeBUSSCHERE: Patient 2, there
may
App. 259
[2805] STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
IN THE MATTER OF THE
LICENSE TO PRACTICE
AS A PHYSICIAN AND Docket No.
SURGEON OF: 02-06-A-1012MD
GEOFFREY S. AMES, M.D.
License No. MD00026961,
Respondent.
DAY 4—A.M.
VERBATIM TRANSCRIPT OF PROCEEDINGS
(Filed Oct. 22, 2004)
A-P-P-E-A-R-A-N-C-E-S
HEALTH LAW JUDGE:
ARTHUR E. DeBUSSCHERE
FOR THE RESPONDENT:
WILLIAM R. BISHIN
Attorney at Law
701 Fifth Avenue, Ste. 4040
Seattle, Washington 98104
FOR THE DEPARTMENT OF HEALTH:
KEITH D. ARMSTRONG
Assistant Attorney General
1125 Washington St. S.E.
Olympia, Washington 98504
COMMISSION MEMBERS PRESENT
SUNANDA UBEROI, M.D. JANICE PAXTON, PA-C
CABELL TENNIS, J.D.
Public Member
App. 260
Renton, Washington
January 13, 2004
REPORTED BY JEAN ERICKSEN, CCR
[2806] INDEX
PAGE
PRE-HEARING CONFERENCE 3
JAMES CLARK
DIRECT EXAMINATION 34
CROSS EXAMINATION 81
REDIRECT EXAMINATION 110
EXAMINATION BY MR. TENNIS 112
EXAMINATION BY DR. UBEROI 114
* * * *
[2838] Go ahead, Mr. Bishin.
JUDGE DeBUSSCHERE: We have to swear
the witness in, and would you tell us your full name,
please?
THE WITNESS: James Hoyt Clark.
JUDGE DeBUSSCHERE: Would you swear
in the witness.
* 7 * oe
JAMES H. CLARK,
having been first duly sworn, testified as follows:
App. 261
DIRECT EXAMINATION
BY MR. BISHIN:
@. Mr. Clark, where do you live?
A. Ilivein Linden, Utah.
JUDGE DeBUSSCHERE: Excuse me. Can
you speak up, and face a little more this direction so I
can hear you. I’m a little bit of hard of hearing.
A. Ilivein Linden, Utah.
Q. You don’t have tw talk to me, even though I’m
asking the questions. Talk to the Panel. They’re the
ones that have to hear you. If I don’t hear you, I won’t
be bashful.
A. Okay.
Q. You live in Linden, Utah did you say?
[2839] A. Yes.
Q. What is your occupation?
A. I am a bioengineer that does development
work and software programming.
A bioengineer that does what?
Software development.
Do you have a company?
Yes, I do.
oP & Pp &
What is the name of the company?
App. 262
A. I have a company Health Dimensions
International. It’s an R & D company.
Then I have Star Tech Health Service. That’s a
distribution company.
Q. What’s an R & D company?
A. Research and development.
Q. What does that company do?
A. That company does software programming
for systems and computers in the alternative health
field.
Q. And Star Tech Health, what is the nature of
its business?
A. Star Tech Health is a manufacturer and dis-
tributor in training and service of alternative health
instruments.
Q. What kinds of devices does it have on the
[2840] market at the present time?
A. Primarily Computerized Electrodermal
Screening Devices.
Q@. What is a computerized Electrodermal
Screening Device?
A. It’s a device that is used in alternative health
care to take galvanic skin response measurements.
App. 263
Q. Okay. Now, galvanic skin response, can you
tell us briefly what that is; is that pretty much what
Doctor Sherman testified to the other day?
A. Yes, it was.
Q. Can you briefly remind us what a galvanic
skin response device is?
A. The galvanic skin response device is an ohm-
meter. It is calibrated to the specifics of what you’re
measuring, in this case the skin. It puts a very small
current through the body and then measures the
resistance of the electrons as they flow through.
Q. Now, the device that your company makes,
can you tell us, Doctor, are there more than one
model?
A. Yes. There are a number of models, the
Orion, the Pegasus and the Mira.
Q. Those are the names of the three models?
A. Yes.
7 . . *
[2845] A. They’re device listings, the device
listings that we submitted to the FDA.
Q. And those device listings are for what?
A. The Orion, Pegasus, Mira.
Q. Now, do these devices indicate that they are
relying on the Digital Conductance Meter Clearance?
App. 264
A. Yes, they do.
Q. Where do they do that?
A. In the proprietary name, line, Box 9 on the
device listing form.
Q. Okay. Now what does the, what was the
response of the FDA to your sending in this device
listing indicating these devices were all digital con-
ductance meters under the classification under HCC?
A. The FDA responded that they already had
the listings, and did not need this information.
Q. Okay. Now, Mr. Clark, Id like to go into your
background a little bit, if we may. Can you tell us
what your education is after secondary school, please.
A. Okay. I attended Trinity University in San
Antonio, Texas, and for a year was in physics. I then
transferred to Texas A & M University, and graduated
in 1973 in bioengineering. I conducted [2846]
research while I was there also. Then I went to the
University of Texas Medical Branch in Galveston,
Texas.
There I attended studies in medical biochemistry.
I found while I was there that I didn’t like test tubes,
I liked devices, and I went and worked in Houston at
the medical center there at the speech and hearing
institute, developing information for autistic children
while there.
I then returned to Texas A & M, and took a few
classes there. Soon after that, after finishing those
App. 265
classes, I went to Utah and I was able to attend
Brigham Young University.
While I was there I got training as an emergency
medical technician.
I received a Master’s Degree in exercise physi-
ology and a minor in digital electronics. I graduated
with a Master’s Degree in 1978.
Q. Okay. Is that the extent of your formal
education?
A. I also returned to Texas A & M and took
physiology from the vet school while studying hyper-
baric medicine.
Q. So that would be the extent of your formal
education, is that correct?
[2847] A. Yes.
Q. What about your informal education?
A. I have attended a number of classes where I
learned about microprocessors and how to use them.
Q@. When did you first become involved with
galvanic skin response devices?
A. In 1978.
Q. Can you tell us a little bit about how that
happened?
App. 266
A. After graduating with a Master’s Degree I
was involved with some colleagues in developing
courses for microprocessor training.
Microprocessors were a new concept at the time,
and one of the people that I was working with met
some businessmen that were bringing in Dermatron,
a German electrodermal skin device, importing them
into the United States, and they wanted to have the
device computerized.
The German manufacturer was not interested in
computerizing it. They had been making their derma-
tone for 20 years and selling them around the world,
and the idea of computerizing was not interesting for
them.
I was asked, because of my background, if I could
computerize the device, and that’s when I [2848]
started on the development.
Q. What was that year again?
A. In 1978.
Q. Since that time how much of your pro-
fessional or business time has been spent dealing
with galvanic skin response devices?
A. Almost the entire time, 26 years.
Q. So for 26 years you have been in this
particular area; is that right?
A. Yes.
App. 267
Q. During that time did you become familiar
with the industry, is there an industry of galvanic
skin response devices?
A. Yes.
Q. Did you become familiar with the comput-
erized types of galvanic skin response devices?
A. Yes. I’m _ considered the father’ of
Computerized Electrodermal Screening.
Q. Why is that?
A. Because I was the first one to computerize it,
some people out there that have done major pub-
lications in alternative health, gave me that title.
Q. Did you start developing your own
computerized galvanic skin response devices?
[2849] A. Yes, I did.
Q@. Let me ask you, you testified that the — let
me ask you this first: Have you been qualified as an
expert on computerized galvanic skin response
devices?
A. Yes.
Q. By whom?
A. I was an expert witness for a trial in South
Dakota before the state court there, and I also was a
witness for an educational board in, chiropractic
board in Minnesota.
App. 268
Q. Have you had occasion to observe what goes
on in the market for GSR devices, if I may call them
that?
A. Yes, I have, worldwide.
Q. Have you traveled outside the United States
on business related to galvanic skin response devices?
A. Yes, I have.
Q. How often have you done that?
A. Acouple of times a year.
Q. Let me ask you this. About how many manu-
facturers are there of galvanic skin response devices
that engage in the kinds of alternative, that design
their products for alternative health care [2850] uses
in the United States, would you say?
A. They are probably about 20 to 30 major
manufacturers.
@. And they all manufacture and distribute this
kind of device in the United States?
A. I would say this kind of, yes.
Q. And how about outside the United States,
any idea how many manufacturers there are of these
devices?
A. There are a number of German and Russian
and French manufacturers.
App. 269
Q. And let me ask you this: These devices, are
there any states in the United States where these
devices are not used?
A. No. They are used throughout the United
States.
Q. Are there any states that specifically accept
Electrodermal Screening as a modality for a health
care practitioner?
MR. ARMSTRONG: Objection.
JUDGE DeBUSSCHERE: Basis?
MR. ARMSTRONG: He has asked the
witness are there any states that accept EDS as a
modality. That’s not relevant to this case. It’s not
relevant to the whole, it’s not relevant, period.
[2851] JUDGE DeBUSSCHERE: It’s rele-
vant to the issue of Respondent’s case, that his
treatment is non-traditional treatment, and whether
it’s within the mainstream or without the main-
stream, which has been an issue raised.
MR. ARMSTRONG: So whether a state
accepts it makes it mainstream or not mainstream, is
that what you said?
JUDGE DeBUSSCHERE: It’s a factor in
that consideration, so objection overruled.
Q. Are there any states that specifically sanc-
tion EDS, the use of these devices for EDS?
App. 270
A. Yes, there are a number of states, specifically
Florida and Massachusetts, allow the use of EDS or
EAV, as it’s also called by the German designation, or
it’s called German Electroacupuncture. They allow
the use of the instrumentation under the acupuncture
regulations.
Other states, particularly Arizona and Nevada,
allow the instrumentation under homeopathic regula-
tions.
Q. In those states they allow homeopathy, in
other words?
A. Yes, they do.
Q. Now, in the United States, as we have [2852]
learned so far, it’s true, isn’t it, that the FDA will not
clear a device for Electrodermal Screening; is that
correct?
A. That is correct.
Q@. Has the FDA cleared devices other than
yours, as galvanic skin response devices?
MR. ARMSTRONG: Objection, Your Honor.
MR. BISHIN: He’s an expert in this field,
Your Honor.
MR. ARMSTRONG: He just made the
statement that the FDA has cleared, the FDA cleared
EDS, and then he made an answer, and he said other
than your device, has the FDA cleared. That’s not
been established.
App. 271
MR. BISHIN: No, no, other than his device,
has the FDA cleared galvanic skin response devices.
JUDGE DeBUSSCHERE: I'l allow that
question, if that’s the objection. Go ahead.
Q. Has the FDA cleared galvanic skin response
devices, computerized galvanic skin response devices,
that are used in the health care industry, other than
clearing yours?
MR. ARMSTRONG: Objection, Your Honor.
JUDGE DeBUSSCHERE: Overruled. Can
you [2853] answer that?
A. [Im not sure. Do you mean other EDS
devices?
Q. Yes, manufactured by others, not you.
A. Yes, they have.
Q. About how many others have been cleared?
A. Iknow of three other companies.
MR. ARMSTRONG: All right. I renew my
objection, Your Honor, to the whole line of questioning
regarding the galvanic skin response devices. The
objection is for vagueness.
JUDGE DeBUSSCHERE: Your objection is
on the record, and so you have that, so you don’t need
to make, in regards in your objection to vagueness on
galvanic skin response devices and EDS devices, your
objection to vagueness is on the record. You have that.
App. 272
It’s part of the record. You don’t need to make an
objection every time the question is asked. Thank
you. Next question.
Q@. These are the devices. Are you familiar with
what the FDA has cleared them for?
A. Yes, Iam.
Q. And what has the FDA cleared those other
devices for?
A. Some devices for biofeedback, and one device
[2854] for patient data acquisition.
Q. Okay. Now these particular companies, how-
ever, they are devices used for Electrodermal Screen-
ing by practitioners, is that correct?
A. Yes.
Q. Now has the FDA ever taken any action
against those companies that distribute, the ones that
have the clearances that distribute these devices?
MR. ARMSTRONG: Objection, Your Honor.
What the FDA has done with another company is not
relevant to this hearing, because we're talking about
the LISTEN device and his company. We can talk
about crimes in other countries all day long. No
relevance here. Waste of time.
JUDGE DeBUSSCHERE: There has been
questions on direct with Mr. Ogden of what FDA
action, whether or not they take action or not action —
App. 273
MR. ARMSTRONG: Against this company.
JUDGE DeBUSSCHERE: -— with regards to
the process procedure and action, what the FDA has
done, so it’s relevant in that respect.
MR. ARMSTRONG: Since we’re not talking
about federal violations any more, it’s still not [2855]
relevant.
JUDGE DeBUSSCHERE: Your objection is
overruled.
MR. BISHIN: Would you read back my
question, please.
(The pending question was read.)
A. Ihave not heard of any.
Q. Now, would you expect to hear, if they had?
A. It’s asmall industry, yes.
Q. Now has the FDA ever taken any action
against you for distributing these devices?
A. None.
Q. Have they ever sent you any regulatory
letters telling you to cease and desist?
A. None.
Q. Have they ever brought any lawsuits against
you?
A. No, they have not.
App. 274
Q. Have they ever called you and said we don’t
think you should be doing this?
A. No.
Q. Doyou have a history with the FDA?
A. Yes, I do.
Q@. When did you first have contact with the
FDA?
[2856] A. The first contact would have been
about 1990, somewhere in the early 90s, when we
were setting up an IRB with the LISTEN system, and
even though we received information that it was a
Non-Significant Risk device, we submitted informa-
tion to the FDA all about the IRB, and about the
actions of the IDE.
Q. Okay, and IDE means Investigational Device
Exemption?
A. Yes.
Q. So your first contact with the FDA was in the
1990’s, you said?
A. Yes.
Q@. Have you had contacts with the FDA since
the early 90s?
A. Yes. I have communicated with them during
submissions that I have had. I have been to the FDA
in their building in Rockville, Maryland, meeting
App. 275
with department heads, and with other staff that
they had.
Q. And about how much time would you say you
have spent dealing with the FDA over the last, |
guess it’s 11 years, something like that?
A. Yes. In any given year it probably represents
four months of my work.
[2857] Q. Let’s go into, and what has been the
subject of your contacts with the FDA?
A. The subject was because of submissions.
Q. What particular product?
A. With the LISTEN system and with the
Digital Conductance Meter.
Q. And also the Orion?
A. With the —
MR. ARMSTRONG: Objection, leading the
witness, suggesting the answer.
JUDGE DeBUSSCHERE: Objection sus-
tained, leading the witness.
Q. Have you also had contact with the FDA
regarding the Orion?
A. Yes, I have.
Q. Is that the extent of the subjects of your
contacts with the FDA?
App. 276
A. Yes.
Q. So is it fair to say that basically you have
been in contact with the FDA regarding these kinds
of products since 1992?
A. Yes.
Q. Let’s talk about the beginning of your rela-
tionship with the FDA, FDCA in 1992, say that had to
do with Investigational Device Exemption.
[2858] A. Yes.
Q. Let me ask you this before, let me, since you
have mentioned that, call something to your attention
here. I believe this is Respondent's Exhibit 4 on page
ten. Would you take a look at Respondent’s Exhibit 4,
please.
A. Yes, I have looked at this.
Q. What is Respondent’s Exhibit 4?
A. My company sent the FDA a letter in, as it
states, February of ’92, requesting advice information
on the Investigation Device Exemption, particularly
for whether the instrumentation was Non-Significant
Risk or not.
Doctor Blackwell responded back that it was a
Non-Significant Risk device.
Q. What's the significance of being a Non-
Significant Risk device, why would you want to know
that?
App. 277
A. The IRB, the Institution Review Board and
processor manufacturer come under the abbreviated
regulations for conducting the research, instead of
what are referred to as a formal study.
Q. What is the significance of that, for the
Panel?
Q. Well, basically with a Non-Significant Risk
[2859] device you don’t even have to tell the FDA that
you exist. Now we knew that beforehand, because the
IRB that we had set up had already defined the
instrument as a Non-Significant Risk, but we still
wanted to contact the FDA and be able to see what
their —
Q. My question has to do with what is the
significance of abbreviated, whatever it was you said,
abbreviated requirements described in Section
812.2B of the IDE regulation, what is the sig-
nificance of that?
A. The importance as a Non-Significant Risk
device, it’s considered it’s not harm.
Q. Thank you. Let me ask you this: When you
have a determination that it’s a Non-Significant Risk,
do you have to have the FDA actually approve your
investigation and research?
A. No, you do not.
Q. Do you have to tell them anything about the
research?
A. No, you do not.
App. 278
Q. When does the FDA get involved, then when
you have abbreviated requirements for an investi-
gational device?
A. When you submit your PMA, your pre-
market approval information to the FDA.
[2860] Q. In other words, after you finish doing
your research, and you’re ready to ask for an
approval?
A. That’s correct.
Q@. At some point — let me just go back. I
neglected to ask you something general about these
devices. You testified that the FDA does not clear
these devices for Electrodermal Screening.
MR. ARMSTRONG: Objection.
MR. BISHIN: That’s a preface to a
question. It’s already been testified to.
JUDGE DeBUSSCHERE: Overruled.
Q. Although the FDA does not clear them, what
is the position of other countries with regard to these
devices?
A. The instrumentation is accepted in many
other countries.
Q. Is it accepted by government authorities for
EDS use?
A. Yes.
App. 279
Q. Can you give us some of the countries in
which that’s true?
MR. ARMSTRONG: Objection, Your Honor.
Objection to this one, and I already objected to the
last question. It’s not relevant, not needed. There’s
a lot of products and devices accepted in [2861]
Korea, not here, a lot of things accepted in other
countries.
It’s not relevant to determine if Doctor Ames
treated Patient 1 with a LISTEN device, not even
related to allergy treatment. This is getting way into
a historical. Waste of time, not relevant, and won’t
help the Panel.
JUDGE DeBUSSCHERE: Mr. Bishin, do
you want to respond?
MR. BISHIN: This is related to the
reasonableness of the decision to use this device.
MR. ARMSTRONG: Because other coun-
tries accepted it?
JUDGE DeBUSSCHERE: It goes to the
issue of non-traditional treatment, which is Respon-
dent’s under RCW 18.130.180(4). Objection overruled.
Q. Can you tell us the names of some of the
countries that allow these devices to be marketed as
EDS devices?
A. European countries, African countries,
Australia.
App. 280
Q. Can you tell us some of the European coun-
tries?
A. Germany, France, England, Spain, Italy,
Greece.
[2870] hear?
MS. PAXTON: Yes, that’s-what I wanted to
hear, Thank you.
Q. All right. Now Exhibit 1 is dated — you don’t
have it in front of you any more. This was sent on
August 18th; is that right?
A. Yes.
Q@. Now prior to this submission in August of
1992, did you make an earlier submission for a 510 K
clearance in that year?
A. Yes, I did.
Q. Do you remember when you did that?
A. Ididitin January of ’92.
@. And what was the, what was that for?
A. That was for the LISTEN system.
Q. And what happened to that particular sub-
mission?
A. The FDA responded with some questions. I
responded back. Then the FDA rejected that sub-
mission because of acupuncture claims.
App. 281
Q. Can you state a little bit more, a little bit
more elaborately what the nature of their objection
was?
A. Just the information on acupuncture, that
they had basis points.
[2871] Q. What particular claims did they say
that they vvouldn’t be able to clear?
A. Just the simple connection with acupunc-
ture.
Q. Whether it could be used in some way for
acupuncture; is that what you’re saying?
A. Yes.
Q. Then after that clearance was rejected, why
did you submit this clearance for the Digital Con-
ductance Meter?
A. It was after that I had conversations with
the FDA in the submission of the LISTEN 510 K. I
asked what things could be done for submission, and
they said I needed to exclude the acupuncture claims,
and submit the instrumentation without the acu-
puncture claims.
Q. And is that why you submitted the DCM
submission?
A. Yes.
App. 282
Q. Do the people you submitted it to, were they
the same people you had been talking about with the
LISTEN?
A. Yes.
Q. Was your purpose in getting the DCM
clearance, was that to, in effect, clear the LISTEN?
A. It was to clear the ohmmeter and the [2872]
capability for the LISTEN system without the
acupuncture claims.
Q. Was it to clear the LISTEN system?
A. Yes.
Q. Was it in order for you to be able to market
the LISTEN system?
MR. ARMSTRONG: Objection. He asked
the question and answered it.
MR. BISHIN: No, I changed it —
JUDGE DeBUSSCHERE: Overruled. It’s
not asked and answered. What was your question?
Restate it.
Q. My question was did you seek the DCM
clearance in order to be able to market the LISTEN
device?
A. Yes, I did.
Q. And after you obtained the DCM clearance,
did you market the LISTEN device?
App. 283
A. Yes, I did.
Q. Were the people that you were dealing with
at the FDA aware of this?
A. Yes.
Q. Had they ever complained about that?
A. No.
Q. Now, in making your submission to the FDA
[2873] about the Digital Conductance Meter, that
second 510 K submission, tell the Panel what it was
that you actually submitted, what were the compo-
nents of the device that you submitted to the FDA?
A. The components were the galvanic skin re-
sponse, ohmmeter circuitry, the computer, the soft-
ware and the signal generator.
Q. Okay, and the signal generator, was any
question ever raised about that at all, by the FDA?
A. Yes.
Q. What question was raised?
A. The question was what were the signals,
what did they look like. I had to get a specific oscillo-
scope to be able to print out all the square wave, sine
wave and triangle wave for the FDA, and submit that
as an addendum.
@. Did they approve that?
A. Yes.
App. 284
Q@. So they accepted the DCM with the signal
generator at this point; is that correct?
A. That’s correct.
Q@. Now what exactly does the signal generator
do?
A. It sends out a signal just like music, but in
this case it doesn’t go to speaker, it just goes [2874] to
a probe antenna device.
Q. You say it sends out a what again?
A. An electromagnetic field is what it generates.
Q. What kind of electromagnetic field does it
generate?
A. Apulsing.
Q@. And it’s just one electromagnetic field? Tell
the Panel how the signal gets generated.
A. The signal is based on a digital pattern,
zeros and ones in this particular, zeros and ones, and
when they come out they make different patterns,
different electromagnetic fields.
Q@. Are you saying the signal generator will
generate different electromagnetic fields?
A. Depending what the operator does, yes.
Q@. How many different electromagnetic fields
can the signal generator generate?
App. 285
A. It’s a computer, so it can generate just about
anything that somebody would request.
@. What do you mean by just about anything?
A. Any kind of pattern, a variety of different
patterns.
Q. There is more than one kind of electro-
magnetic field, is that what you’re saying?
[2875] A. The electromagnetic field is the same.
The pattern can be different, there are multiple
different patterns.
Q. Patterns of what?
A. The patterns can simulate foods, they can
simulate products, they can simulate a number of
different things that are in the environment.
Q. Can you explain to the Panel a little bit
about what you mean by simulating, for example,
food?
A. The concept of the signal is it simulates
things just like a homeopathic product, that it has the
signal for the particular product.
Q. Now, this device can be _ used for
Electrodermal Screening; isn’t that correct?
A. Yes.
Q. Is it also used by NAET practitioners?
A. Yes, it is.
App. 286
Q. Is it used in the same way it’s used by EDS
people?
A. No, there is a different protocol.
Q. Does the signal generated have a special role
for NAET practitioners?
A. Yes, it does.
Q. What is that role, as you understand it?
A. It’s to be able to output a signal to see if
[2876] it will, in this case, provoke work with applied
kinesiology.
Q. Now, I want to call your attention again to
the clearance for the Digital Conductance Meter.
MR. TENNIS: Exhibit?
MR. BISHIN: I’m just trying to find it. It
should be the 1996 document, Exhibit 2, page three.
I want you to read to the Panel the, and for the
record —
MR. ARMSTRONG: Objection. The Panel
can read for themselves.
MR. BISHIN: This is for the record.
JUDGE DeBUSSCHERE: Let’s see.
MR. BISHIN: I’m going to ask a question
about this, Your Honor.
App. 287
JUDGE DeBUSSCHERE: Okay, objection
overruled, but you can renew your objection if he tries
to repeat it.
Okay, go ahead, Mr. Bishin.
Q. I'll read the bottom paragraph to you, be-
cause [ want to ask you what this means.
“This letter will immediately allow you to begin
marketing your device as described in 510 K pre-
market notification. An FDA finding of
* + * *
[2879] A. Yes.
Q. What is the concern, that the public might be
misled by a clearance?
A. Yes. The documentation says so, and they
have told me in person.
Q. So therefore any materials that you sent to
Doctor Ames would not reference the clearance; is
that correct?
A. That is correct.
Q. Now I want to talk to you a little bit about
this particular device, and its various uses. Is there
any danger, any physical danger in using this device?
A. No, there is not.
Q. And it does use electricity and it does emit
these electromagnetic fields and patterns, as you
have just’indicated. That might sound to lay people
App. 288
as if it would be dangerous. Can you tell us why it
isn’t?
A. When you do the submission to the FDA, the
FDA has no specific electronic standards. You have to
go to other groups, underwriter laboratories, elec-
tronics, electrical engineers, called the I triple E. You
have to use circuitry chips that have been tested so
that they have the isolation that you [2880] need.
The particular circuitry in this was developed
over 10 years ago, I believe, and the chip that was
available then is called an isolation amplifier chip,
and it was submitted to the FDA. I had to submit the
electronic literature, the underwriter laboratory, the I
triple E standard that it fell under, and the FDA gave
clearance for this instrumentation to touch the skin.
Q@. Has anybody ever complained about being
harmed by this device?
A. No.
Q@. You never received a complaint from a
customer?
A. No.
Q. Have you ever heard of customers of any
other manufacturer of these types of devices, com-
plaining that they were injured by this device?
A. No.
@. Have you ever heard of any lawsuits for
product liability being brought because of this device?
App. 289
A. No.
@. The signal generator, does it, how much
energy or power does it emit when it’s being used in
[2881] the way you described earlier?
A. Less than the actual ohmmeter circuitry.
Q. And the ohmmeter circuitry is what?
A. It can be up to five volts and eight to 10
microwaves.
Q. And the FDA never raised any concern about
the safety of this device; isn’t that correct?
A. That’s correct.
Q. That’s why you have a Non-Significant Risk
determination; is that correct?
A. That’s correct.
Q. Now, just to give you a little about the his-
tory, you testified to submitting a device to the 510 K
pre-market notification for the device under the name
LISTEN, and you testify that it was rejected, and
then you went to the DCM, it was accepted, so you
started marketing the LISTEN.
You're not marketing the LISTEN any more; isn’t
that correct?
A. That’s correct.
Q. You’re marketing these devices that you
mentioned to us before. Tell us a little bit more, fill in
App. 290
the picture of what happened there, why did you stop
marketing the LISTEN device?
A. In 1997 a corporation came in and requested
+ * + *
[2883] Q. Now, drawing your attention to the
device that you identified before, the one to your lefi,
which you have called the LISTEN, have you ever
been contacted by the Washington State Department
of Health, or any representative of the Washington
State Department of Health, with respect to that
device?
A. No, I have not.
Q. So they have never inquired, tried to find out
any information from you about that device; is that
correct?
A. That’s correct.
Q. Okay. Now were you ever contacted by any-
body from the office of the Attorney General in the
State of Washington with respect to that device which
I’m referring to, the LISTEN device to your left?
A. No.
Q. Has anybody from any governmental agency
or any employee of the State of Washington, as far as
you know, ever attempted to find out anything from
you about how this device functions?
A. No.
———SsSw
App. 291
Q. Has anybody from the State of Washington,
employed by the State of Washington, as far as you
know, ever attempted to find out if this device poses
[2884] a risk to anyone?
A. Idon’t know.
So you don’t know whether they have or not?
I don’t know whether they have or not.
I’m asking if they have contacted you.
> oO Pp &
No, they have not contacted me.
Q@. Have you ever had a report that anybody at
your company was contacted by anybody from the
State of Washington with respect to this device?
A. No.
MR. BISHIN: Im going to rest at this
particular time with this witness.
JUDGE DeBUSSCHERE: Let’s go off the
record for one minute.
(Discussion off the record.
JUDGE DeBUSSCHERE: Back on _ the
record. Mr. Armstrong, cross-examination?
MR. ARMSTRONG: Yes.
JUDGE DeBUSSCHERE: Do any of the
Panel members need a break? We’ll just go off the
record for one minute.
App. 292
(Discussion off the record.)
JUDGE DeBUSSCHERE: Okay, we're back
on the record. Mr. Armstrong, cross-examination?
MR. ARMSTRONG: Yes.
* * * ca
[2891] A. They weren’t different, no.
MR. BISHIN: Objection.
Q. Well, I asked did you submit the exact same
thing, and you said no?
MR. BISHIN: Object to the vagueness of it.
You included labeling in there, and included some
other things.
MR. ARMSTRONG: Well, there’s a lot that
goes in 510 —
JUDGE DeBUSSCHERE: Objection over-
ruled. The question has been answered. Your next
question.
Q. You answered it, correct?
JUDGE DeBUSSCHERE: No, he answeved
did you exhibit the exact same thing. He said no.
Next question.
Q. For the DCM submission in August you
submitted it, what was the labeling claim for that
submission?
A. Biofeedback.
App. 293
Q. Was it submitted for anything else, as in
allergy treatment?
A. No.
Q. Allergy diagnosis?
A. No.
Q. Curing of any ailments?
[2892] A. No.
Q. Can the device that you submitted in August
1992, the DCM, can it be used to diagnose allergies,
food allergies, used to diagnose food allergies?
MR. BISHIN: [1 object to the question’s
vagueness. Used by whom, and what does the word
“can” refer to? Is he asking him a question about
whether or not it has the capability of performing a
health care function.
It’s a little bit, depending on what the meaning of
the question is, it may be calling for an answer from
him that he can’t give, because he is not a health care
provider.
On the other hand it’s a —
MR. ARMSTRONG: That’s a good point.
JUDGE DeBUSSCHERE: I'll sustain the
objection. Just restate your question, Mr. Armstrong.
App. 294
Q. Mr. Clark, can the DCM which you sub-
mitted in August 1996, is it capable of presenting a
medical diagnosis for food allergies?
A. No.
Q. Are you a medical doctor?
A. No.
Q. Are you able to tell us what a medical [2893]
doctor could tell us regarding a medical diagnosis, are
you able to provide a medical diagnosis to the Panel
here today?
A. AmI?
Q. Yes.
A. No.
Q. The LISTEN device that was submitted in
January 1992, does that machine have the capa
bilities of providing a medical diagnosis for allergies?
A. No.
Q. How about curing allergies?
A. No.
Q@. Does the LISTEN device or the DCM, which
you submitted both of them, and so you know the
capabilities of both, do they have the capabilities of
providing acupressure to human skin, can those
devices perform acupressure on the human skin?
A. Acupressure, as a mechanical —
App. 295
Q. Yes.
A. No.
Q. So they can’t provide acupressure?
A. That’s correct.
Q. The LISTEN device that was rejected in
1992 because whatever require™nts were not met,
did you change any of the functions or capabilities,
and [2894] re-submit it in August?
A. No.
Q. Or did you have another whole different
product that you re-submitted in August?
MR. BISHIN: He answered the question.
He said no.
MR. ARMSTRONG: I asked a different
question, and I don’t have the answer yet.
JUDGE DeBUSSCHERE: Okay, that
question stands. You didn’t get a chance to complete
your second question. Complete your next question,
and then you can object if you wish, Mr. Bishin.
Q. In August 1992 did you submit a new or
different or modified device for submission for your
510 K, new or modified?
A. The acupuncture claims were removed.
That’s the difference.
Q. So you just changed the claims?
App. 296
That’s correct.
There were no specification differences?
That’s right.
No software differences?
That’s correct.
Opp & P
No electronic differences?
A. That's correct.
[2895] Q. The voltage that it output was the
exact same?
A. Yes.
Q. So you just took the same device, took off the
claims, and it was approved, and it was approved for
what?
A. It was cleared.
MR. BISHIN: Objection. Asked and an-
swered.
JUDGE DeBUSSCHERE: Overruled, You
can answer it. Restate the question.
@. What was the DCM that was submitted in
August 1992, what was it cleared for?
JUDGE DeBUSSCHERE: That was asked
and answered.
MR. BISHIN: That’s why I objected.
jected.
App. 297
MR. ARMSTRONG: That’s why you ob-
Do you own the patent for the LISTEN device?
A. No.
Q@. Who has the patent for the LISTEN device?
A. Nobody has the patent.
Q. It’s not patented?
A. No.
Q. How about the DCM?
[2896] A. No.
Q. There’s no patent for the DCM?
A. No.
Q. How about the new products, the Orion?
A. There are applications for the Orion that I
received a patent for in the year 2000, for outputting
signals for treatment with additional hardware, in-
cluding lasers, infrared and other modalities.
Q.
Would that make it a different product than
is sitting right here?
A.
Q.
Yes.
So you have received a patent for a device
that’s not sitting in this room?
A.
Yes.
App. 298
Q. This device that’s sitting in this room, which
we're calling the LISTEN, is not patented?
A. Yes.
Q. When the FDA cleared the DCM device, did
they clear it for EDS, Electrodermal Screening?
A. No.
Q. So it’s not cleared for Electrodermal
Screening?
A. No.
Q@. Even though in use, it has the capability of
[2897] Electrodermal Screening, it’s not cleared for
that?
A. Yes.
Q. Does that mean that practitioners that you
sell the device to, that they can use it for Electro-
dermal Screening?
MR. BISHIN: Objection. Question of law
about off-label use.
Q. I’m asking your understanding.
JUDGE DeBUSSCHERE: I ruled that it’s a
question of law of whether or not, but he’s asking
here in particular what his understanding is. You can
answer the question.
MR. ARMSTRONG: Your Honor, I with-
draw the question because it’s dealing with a legal
App. 299
conclusion. I don’t want Mr. Bishin to be able to ask
about off-label use either. If you’re going to allow me
to, ’ll be glad to allow him to, but I don’t want him to
answer the question because —
JUDGE DeBUSSCHERE: I said I ruled
that the question about what is off-label use is a
question of law, but that you can ask this individual
about his understanding.
MR. ARMSTRONG: I'll withdraw the ques-
tion, motion to strike my own question.
JUDGE DeBUSSCHERE: Your statement,
you
* . * .
[2922)}A. Yes.
Q. Now, you said there are other people selling
similar things.
A. Yes.
Q. IfI buy one in Germany, is the signal coming
out going to be the same for egg?
A. I don’t know. So many of the instruments
that are out, they’re ones that have taken my soft-
ware. They actually took my LISTEN and incorpo-
rated on their system, so those I’m aware of.
Q. How do you learn this, I mean where did you
learn that you could transmit egg with a signal, fish
with a signal, and how did you decide what the
App. 300
signals would be, I mean what’s the theory or
whatever behind it?
A. The theory is I actually had to wait for the
full definitions, NIH, and through the patent office,
and the patent office stated that by them simulating
a homeopathic, and therefore I am putting in a signal
that represents egg, for example, and that particular
signal simulates having the egg there.
I can go through that process. It’s a lot shorter
than 10 minutes, but I can give you that.
Q. Well, that’s okay. I don’t need the process.
Probably I don’t understand the process [2923]
anyway.
What I’m trying to say is there a logic, science,
something that’s accepted by more than one person,
you; is there a dictionary, I mean can somebody else
make one like that?
A. Yes, there are ciher people that if they knew
what I knew, the National Institute of Health, Office
of Alternative Medicine issued a Panel report in 1993.
This was 14 years after I developed it, and they pre-
sented in there that non-ionizing, non-thermal, fre-
quency specific electromagnetic fields, can produce a
beneficial or a harmful affect.
Q@. I understand that. I have done a course in
homeopathy myself.
Forgive me, I think I have to be excused for a
minute here. I have a pager I have to answer.
App. 301
JUDGE DeBUSSCHERE: Let’s take a five-
minute recess, and depending on when you're ready.
We'll go off the record.
(A break was taken.)
JUDGE DeBUSSCHERE: We’re back on
the record. Mr. Clark is testifying.
Doctor Uberoi you were asking questions. Go
ahead.
App. 302
[3019] STATE OF WASHINGTON
GEOFFREY S. AMES, M.D.
License No. MD00026961,
Respondent.
DAY 5
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
IN THE MATTER OF THE )
LICENSE TO PRACTICE )
AS A PHYSICIAN AND )
Docket No.
SURGEON OF: 02-06-A-1012MD
)
)
)
VERBATIM TRANSCRIPT OF PROCEEDINGS
(Filed Oct. 22, 2004)
A-P-P-E-A-R-A-N-C-E-S
HEALTH LAW JUDGE:
ARTHUR E. DeBUSSCHERE
FOR THE RESPONDENT:
WILLIAM R. BISHIN
Attorney at Law
701 Fifth Avenue, Ste. 4040
Seattle, Washington 98104
FOR THE DEPARTMENT OF HEALTH:
KEITH D. ARMSTRONG
Assistant Attorney General
1125 Washington St. S.E.
Olympia, Washington 98504
App. 303
MEMBERS P ENT
SUNANDA UBEROI, M.D. JANICE PAXTON, PA-C
CABELL TENNIS, J.D.,
Public Member
Renton, Washington
February 10, 2004
REPORTED BY JEAN ERICKSEN, CCR
[8020] INDEX
PAGE
GEOFFREY AMES, M.D.
DIRECT EXAMINATION 8
CROSS EXAMINATION 110
EXAMINATION BY MS. PAXTON 136
168
EXAMINATION BY DR. UBEROI 150
RECROSS EXAMINATION 163
CLOSING ARGUMENT BY MR. ARMSTRONG 182
CLOSING ARGUMENT BY MR. BISHIN 200
REBUTTAL BY MR. ARMSTRONG 232
DISCUSSION 238
aa * + +
[3026] everything that covers that matter, so it’s now
an opportunity for the Respondent to continue the
presentation of his case.
Your next witness, Mr. Bishin?
App. 304
MR. BISHIN: My next witness is Doctor
Ames. Doctor Ames, will you please take the stand.
JUDGE DeBUSSCHERE: Doctor Ames, I
know that you were sworn in at the last time we had
the hearing in this case, but I would again ask that
you be sworn in for today’s hearing. Would the court
reporter swear this witness in.
GEOFFREY S. AMES, M.D.,
having been first duly sworn, testified as follows:
DIRECT EXAMINATION
BY MR. BISHIN:
Q. Doctor Ames, where were you born?
A. I was born in Methodist Hospital in Dallas,
Texas.
How long did you live in Dallas, Texas?
Eight years.
Where did you go from there?
Richfield, Connecticut.
How long did you live there?
> Or & Pp
Until my junior year in high school, age 17.
* * * *
[3036] allergy.
I was amazed. She was also amazed that a
simple treatment could cure my weed allergy, where
App. 305
she also tried immunotherapy for years, and it did
not work on her.
Q. Why were you amazed at the cure for weed
allergy?
A. Because the standard practice for treating
food allergies is just avoidance. It’s very hard to cure
a food allergy, so most allergists will just say avoid
that food.
Allergy shots or sublingual allergy drops have
limited success in treating food allergies.
Q. Okay, so that particular sort of a chance
encounter, you're saying about NAET, how did that
lead you to get further acquainted with the NAET
therapy?
A. Weil, I did call her office and I looked at her
web site to learn more about it.
Q. Who is this?
A. Sorry, Doctor Nambudripad.
Q. All right, so did this person you met at
Doctor Rea’s center tell you about Doctor
Nambudripad?
A. Yes. She gave me the web address.
(3037] Q@. So the next thing you did was to go on
the Internet and check out the web site; is that it?
A. Yes. Subsequently I took more courses from
the American Academy of Environmental Medicine
App. 306
and the American Academy of Otolaryngic Allergies,
and I also met fellow colleagues who had already
previously taken NAET Courses.
Q. How did you know that they had taken these
courses?
A. I asked them. I said have you ever heard of
NAET, and they said, Sure, I have already taken
basic and advanced courses. I asked them how does it
work, and they said it works fantastic. You must go
down there and try it out yourself.
Q. Now, who were these people, these were
people who were attending the same courses in
allergy medicine, is that what you're saying?
A. Yes. One is Doctor Brownstein, Doctor David
Brownstein, an author there in Michigan.
Q. Were they doctors, these people?
A. Medical doctors.
Q. How many doctors would you say you spoke
to?
A. Around 20 doctors.
Q. So you talked to about 20 doctors at these
various courses about NAET?
[3038] A. Yes.
Q. Okay, and of these 20 that you spoke to, did
they all practice it?
App. 307
They all practiced it.
These are medical doctors?
> & Pp
These are medical doctors.
Q. So having spoken to them about it, what
generally did they tell you besides the fact that they
thought it was fantastic; what was fantastic about it?
A. Well, they said it’s very quick. Patients don’t
have to come back for years, and spend lots of money
in getting treated. It’s very safe. Nobody has ever died
from it, it’s harmless, there’s no side effects, and they
said they get fantastic results.
They might not be able to cure everybody of
allergies, but it’s the best therapy they have ever
encountered.
Q. You say “nobody has ever died of it.” Why
would they mention that?
A. Because just doing a prick test, an intra-
dermal skin test testing for allergies can be dan-
gerous. Say a person is very allergic to peanut allergy,
they can actually die from testing, or they could have
a severe reaction from immunotherapy. If
* * . *
[3042] First of all, did she lecture during the 16
hours?
A. She lectured pretty much the whole time.
Q. Was it really a full 16 hours?
App. 308
A. Yes.
Q. How much lecturing did she do?
A. She lectured the whole time, except when
giving demonstrations and during breaks.
Q@. Can you describe her, how she appeared to
you, and what your evaluation was of her in the
presentation?
MR. ARMSTRONG: Objection, Your Honor,
relevance.
MR. BISHIN: I can’t hear you, Counsel.
MR. ARMSTRONG: Objection, relevance.
JUDGE DeBUSSCHERE: Overruled.
A. First of all she has a Ph.D. in Oriental
medicine. She’s a doctor of chiropractic and a trained
kinesiologist.
She’s very enthusiastic about her approach,
because she, herself was allergic to every food in the
world except rice and broccoli. For three years all she
ate was rice and broccoli.
She had to wear the same blouse every day for
three years. She would wash her blouse out each
* * * *
[3044] she was saying?
A. She had told us that she had already cured
herself of her allergies, and that she had already
App. 309
treated thousands of people, and cured them of their
allergies.
She had a symposium once a year for people that
have taken the courses to come back and give their
case histories.
Q. Did any of the physicians or health care
practitioners of this course or other courses you went
to, ever verify or support what she was asserting?
A. Yes, definitely.
Q. That’s what they were referring to when
they talked about fantastic results?
A. (Nods head.)
Q. Is that correct?
A. Yes.
Q. You have to answer the question verbally.
So you went to these courses, and you said you
were still skeptical at that particular time. Did you
decide to pursue an interest in NAET at that time?
A. Yes, I did. I decided I would choose five of my
worst allergic patients, and give them free
* * * +
[3051] kinesiology, but it was all new to me. I had
never had any kinesiology courses before, and I was
still skeptical.
App. 310
Q. Now, have you found any evidence that
supports the idea that this works?
A. Well, I have literally two of the strongest
people in the entire world as my patients. They’re the
world power lifters in their age categories. They
actually hold world records.
I can tell them to use all their might, and put an
allergen in their hand, and their arm will go totally
weak. I also did this with a Kennewick police officer
in his 20’s. He could definitely out power me, and —
Q. What was his dimensions?
A. He was around 220 solid muscle, and I found
out he was allergic to eggs. It made his arms totally
weak with just one finger.
Q. What do you mean by one finger?
A. I just used my index finger to pull his arm
down. He couldn't hold his arm up.
Q. When did that happen, when did these
experiences occur?
A. Well, they happened in the past by at least
two power lifters. I actually saw them in December.
[3052] @. Now, at the beginning you weren't
seeing these power lifters when you initially encoun-
tered NAET, were you?
A. No.
App. 311
Q. What was the evidence at the time you
started to take this seriously?
A. Well, empirical evidence. I would do it on my
patients. ’'m not trying to hurt their arm. I only use
about 10 pounds of pressure. [m not trying to
overpower the patient, or the patient is not trying to
overpower me. Every time I put the allergen in their
hands, their arms would go weak, and I would
correlate that with blood testing.
When the blood test was positive, at the same
time the arm would go weak, when I test them for
that allergen. I had a very good correlation of blood
testing.
Q. Tell us how you did that, to assure that you
weren't in some way affecting your little test of its
effectiveness?
A. Well, I always try to do blood testing first,
unless patients can’t afford it. Let’s say somebody has
a very strong reactivity to a food, then I'll test
different things that they might not be allergic to, for
instance, calcium or salt or vitamin
* * * *
[3066] moment.
Can I show this to the witness, Your Honor?
JUDGE DeBUSSCHERE: Yes.
Q. Showing the witness Exhibit 5. I believe it’s
Exhibit 5. Yes, Respondent’s Exhibit 5.
App. 312
Will you take a look at that, please?
A. Yes.
Q. Does that refresh your recollection about
when you took the UCLA course?
A. Yes.
So about when was that?
November ’97 to May ’98.
Had you bought the device by that time?
Yes.
You had bought it by then?
Yes.
> OP oP
Q. So it was somewhere between the NAET
course and this course that you bought the machine?
A. Yes.
Q. When did you have these conversations with
Mr. Clark, how many months before you bought the
LISTEN device?
A. Approximately three to four months. I would
call him up about once a month and talk to James
Clark or his brother Bill Clark, and ask questions
[3067] about these machines.
Q. Would that have been after or during or
before the first NAET course?
A. That would be after the first NAET course.
App. 313
Q. Okay. Why did you take the UCLA acu-
puncture course, having had the NAET course, why
did you feel you needed that course?
A. Well, prior to medical school I had the
opportunity to learn acupuncture as a non-
practitioner in Marin County, California, and that got
me interested in going to medical school, so acu-
puncture has always been of interest to me.
I understood that, according to acupuncture
theory, that diseases could be caused by a blockage of
energy in a meridian, and an acupuncturist, over
time, could cure allergies with acupuncture.
I also had patients who were addicted to ciga-
rettes, nicotine, and some pain patients, and I wanted
to use acupuncture on these patients.
Q. Why didn’t you think that the NAET would
take care of that?
A. The NAET can be used to treat smoking
addiction, but acupuncture is also another good
therapy for that. Sometimes one therapy might not
work on a patient, so I wanted to further learn more
* * * *
[3076] because some people are not familiar with
acupuncture. I don’t give them a thorough course on
acupuncture theory. I wouldn’t have time to see
patients if I did that. That might take me an hour.
Q. Okay, but you do tell them something about
it?
App. 314
A. Yes.
Q. What do you tell them, to the best of your
recollection; do you have a standard little routine?
A. Oh, yes. I tell them that the theory is that
the allergen held in their hand, if you’re allergic to it,
will close down the acupuncture meridians. The
meridians go, the organs and the muscles.
Doctor Goodheart discovered that in 1964 that
muscle will become weakened when exposed to an
allergen, so then I describe the process that I'll be
doing on them, the kinesiology test, which arm [’1] be
using, et cetera, and then I tell them that Ill be
giving you simple acupressure along the back, and
that you must stay away from the allergen for 24
hours if there is going to be a cure.
Q. Is that all part of the NAET protocol?
A. Yes.
Q. Itis?
[3077] A. Yes.
Q. Now let’s turn if we can — let me ask you
this: Do you tell these people that this is not a
conventional form of therapy?
A. Yes, I tell everybody that.
Q. What words do you generally use?
App. 315
A. I say this is not a conventional form of
therapy, it’s a form of acupuncture, but we're not
using needles, we’re using acupressure.
Q. Do you ever use anything like a written
statement of Informed Consent for this?
A. Every patient signs an Informed Consent
before getting the first treatment.
Q. What generally does the Informed Consent
say?
A. The Informed Consent basically says that,
what NAET is, what it does, and basically that it has
no side effects.
Q. Does it tell them that it’s not conventional?
A. Ihave to look at it to refresh my memory.
Q. What's the point of it if you’re not going to
tell them it’s not conventional?
A. What’s the point of the Informed Consent?
Q. Yes.
+ + + *
[3090] as Exhibit Number 8.
MR. BISHIN: Could the presiding officer
show it to the Panel so they have a chance to look at
it. It’s not very long.
JUDGE DeBUSSCHERE: [I'll have the
Panel members look at Exhibit Number 8.
App. 316
(Pause in proceedings.)
JUDGE DeBUSSCHERE: Exhibit Number
8 has been reviewed by the Panel members, and now
Doctor Ames has it before him.
Your next question, Mr. Bishin.
Q@. Doctor Ames, tell us when you ask patients
to look at this and sign this form that’s been marked
as Exhibit 8?
A. Right before they get NAET treatments.
Q. Right before they get it?
A. That’s right.
Q. Did Patient 1 sign this document?
A. No.
Q. Why didn’t he sign it?
A. Because I never treated Patient 1 with
NAET.
Q. So you never offered it to him?
A. Il offered that he could —
@. You never offered Exhibit 1 to him?
A. No, I never offered Exhibit 1 to the [3091]
patient.
Q. Can you tell us when you — let me ask you
this. Have you reviewed your entire chart and file for
Patient 1?
App. 317
A. Yes.
Q. Did you find a signed copy of that Informed
Consent form in that file?
A. No.
Q. If you had treated him, would you have
expected to find it in that file?
A. Yes.
Q. What is your practice with regard to that?
A. When people come in for chronic fatigue, it
takes me so long on the second visit, that I have
people get the NAET on the third visit, if they decide
to go with NAET.
On the second visit I thoroughly demonstrate
NAET to the patient, so they know whai they’re
getting into.
Q. So my question is when would you normally
have them sign it?
A. On the third visit.
Q. On the third visit, and this was only the
second visit; is that what you're saying?
A. Correct.
[3092] Q. Now, is this a routine of yours, is this
a routine that you follow generally, strictly, loosely,
what?
A. I follow this routine strictly.
App. 318
Q. That’s sort of your protocol?
A. Yes.
Q. Was that your protocol at the time that you
saw Patient 1?
A. Yes.
Q. Now let’s go to that second visit, if you
would. Could you describe for us what happened at
that visit, to the best of your recollection, what you
did?
A. The second visit I described what was
abnormal in his laboratory values, and how to correct
these. I also described to him that he may have food
allergies because the RAST test showed positive to
different foods, so I said that you could do an
avoidance of these foods to see if you feel better, give
yourself a re-challenge, since these are not life-
threatening food allergies, they’re igG food allergies
or delayed allergies.
Q. Let me interrupt you. I want to lay a
foundation as to just exactly what was going on
during this meeting.
(3093) At this particular visit did you have
reports from the laboratory about Patient 1?
A. Yes.
Q. And did you bring those to the attention of
Patient 1?
App. 319
A. Yes, the patients —
Q. Yes or no.
A. Yes.
Q. Did you discuss the findings of the
laboratory?
A. Yes.
Q. All right. Did you go over each finding?
A. Yes.
Q. You did, all right. Now much time would you
say you took to go over the findings from the
laboratory?
A. It takes most of the visit.
Q@. About how much time would it take?
A. About at least a half hour, up to 30 to 40
minutes.
Q. When you talk about discussing the results,
what does that consist of?
A. Explaining, first of all, to the patient what
these labs mean, because they have never seen these
values, and they don’t understand what the labs
[3094] mean.
Then explaining what diseases are caused, or can
be caused by these abnormal labs.
App. 320
Q. You mean what disease these may be a sign
of?
A. Yes.
Q. Okay, and what else would you be telling
them?
A. I would be telling them that we have
different ways to correct these. In the future you can
do repeated lab tests, and see if they change, and if
they do change, your fatigue will probably get better,
since these abnormal labs can oftentimes be
associated with fatigue.
Q. Now, this review of the lab results is that
what you would have started with at this visit?
A. Yes.
Q. And after you had finished doing that review,
would you have done anything else?
A. Yes, I thoroughly described the NAET tech-
nique. I demonstrated the technique to the patient,
like I do with my other patients, so they know what
they’re getting into, so I don’t have to do this on the
third visit.
Q. So you say you demonstrated it?
* : * -
[3100] A. Yes.
Q. Why would you have done that?
App. 321
A. Because when [m demonstrating it, I don’t
like to get patient’s oil from their hands on the probe,
so I put paper around it.
Q. I think you testified on cross-examination
several days ago, I guess last month, that you always
lave the patients take off their jewelry; is that
correct?
A. Yes.
Q. And did you have Patient 1 take off his
jewelry?
A. No.
Q. Why not?
A. Because he wasn’t being treated.
Q. Now Patient 1 told you that — let’s see. He
testified that you had told him that you didn’t need
the device any more because, or you hardly needed
the device any more because you could now do that it
does by telepathy; do you recall that testimony?
A. Irecall that testimony, yes.
Q. Okay. Now did you say that to him?
A. No, I never said that.
Q. Did you say anything to him that had any of
[3101] the elements of that statement, or that might
suggest that to a reasonable person?
App. 322
A. Well, the only thing I can think of is I tell
some people that we can test for psychological
allergies or subconscious allergies by saying the word,
and sometimes that will provoke a weakness,
sometimes that will not provoke a weakness.
Q. Now, it is true that you have testified
already that you can do this testing without using the
device, right?
A. Of course, yes.
Q. So you don’t need the device to do the
testing; is that correct?
A. No.
Q. Is it possible you told him that?
A. Yes. I tell almost every patient that I tell
them they can bring in real foods or their dog hair or
their house dust in a baggy, or their dirt around their
house, so [ tell all patients that, most patients.
Q. Okay, so to the extent that he thought you
were saying that you could do it without the device,
that would be true?
A. Yes.
Q. That part of it would be true?
[3102]A. Yes.
Q. Do you think you have any telepathic powers
to emit these frequencies?
App. 323
A. No. Otherwise I'd be able to understand my
wife a lot better. I don’t have any telepathic powers.
Q. Okay. Let’s talk a little abovt, have you had
a chance to review Patient 1’s records?
A. Yes.
Q. Is your review sufficient, taken with your
memory of it, to have an opinion as to whether he
would be likely to have memory problems?
A. Yes.
MR. ARMSTRONG: Objection, Your Honor.
JUDGE DeBUSSCHERE: Basis of the ob-
jection?
MR. ARMSTRONG: The basis of the ques-
tion is whether his memory and the records gives
him sufficient to have an opinion on his memory
problems.
JUDGE DeBUSSCHERE: What’s your ob-
jection?
MR. ARMSTRONG: No foundation to es-
tablish that the doctor has said anything about
memory problems. Now Counsel has mentioned
memory
* * . .
[3113] The allergies were also causing muscle
pain and fatigue.
App. 324
Q. How did all this affect her life at that point;
what was she reporting?
A. Well, it made it real miserable. For someone
who has never had allergies, it’s hard for them to
understand how miserable one can be. She was in
muscle pain, she had fatigue and it was just real hard
for her to function, sometimes cloudy thoughts from
the allergens, and always having to blow her nose.
Q. You say she had muscle pain. Did she have it
throughout the day, part of the day, for a few
minutes?
A. She would have it every day. It would vary in
intensity. Sometimes it might only be a two out of 10,
where 10 is the worst pain, or sometimes it might be
five or seven out of 10, but every day she would have
some muscle pain.
Q. Which particular muscles are we talking
about?
A. Most of the muscles in the body.
Q. Most of the muscles?
A. Most of the muscles, that’s right. Most of the
trigger points typically found in allergy
* + * *
[3116] A. Yes.
Q. Now, how would you describe the difference
between Patient 3 at the present time, and her
App. 325
condition when she came to see you about the
allergies?
A. She was a happier person. She has more
energy, less nasal stuffiness, less generalized muscle
pain. She feels the NAET has done this for her.
Q. Now, you didn’t use the device to test her,
though; is that correct?
A. Ihave used the device to test Patient 3, but I
usually have her bring in samples from around her
property and environment, little bags. We test new
pollens that are arriving in the spring, and so forth.
Q. All right, let the ask you this: As the
presiding officer indicated, the number of patients we
were able to call was limited by the presiding officer.
If you had been able to call all the patients who have
done well with your therapy, how many would you
have called?
A. I would have called hundreds, at least
hundreds. I have treated at least hundreds of
patients many times with NAET, with great success.
* * * *
[3119] A. Utah.
Q. After you received it, did it ever leave your
office?
A. Yes. I brought it home once, and just kept it
there while I was studying how to use it, since I'd
rather study there than at my office.
App. 326
You never gave it to anybody?
No.
You never sold it to anybody, did you?
No.
> 2 > ©
Q. You already testified you never charged for
its use?
A. No, I never charged ever for the use of this
machine.
Q. And you indicated before that when you do
the NAET, sometimes you use it and sometimes you
don’t; is that correct?
A. That’s right.
Q. When you don’t use it do you charge less
than you do when you do use it?
A. No.
Q. You charge exactly the same price?
A. Exactly the same price.
Q Have you ever had any problems with the
device?
[3120] A. No.
Q. Did it ever cause anybody to have a shock, or
anything of that sort?
A. No.
App. 327
Q. Has it ever occurred to you that it might
pose some kind of a danger to a patient?
A. No.
Q. Why not?
A. I talked to Jim Clark. He said that he was
working with the FDA, and has been working with
the FDA, and his machine is legal to sell to
practitioners, doctors.
I can’t feel any current going through this
machine, and none of my patients have ever felt
anything.
Q. Just give me a moment. I’m pretty close to
the end here. Oh, let’s talk a little bit about ham. You
recall that Patient 3 said that you apparently tested
her by just saying the word ham; is that correct?
A. That’s correct.
Q. Would you describe that event to the Panel
so we can get that issue fully covered.
A. Sure. I said the word ham, and I did a
kinesiology technique, and her arms went weak. In
[3121] the advanced course in NAET we —
Q. Just a moment, before you get into that. Why
did you say the word ham?
A. Because I wanted to see if she had a
subconscious or psychological allergy to ham.
Q. Why did you think of the word ham?
App. 328
A. Because she had eaten ham the prior night,
as well as a few other foods, and she had an allergic
reaction, she thought she was allergic to something
she had eaten the night before.
Q. So she actually came to you with that
suspicion?
A. Yes.
Q. All right, and what was the reaction; do you
recall, to the ham?
A. She tested physically allergic and psycho-
logically allergic to ham.
Q. What was her actual reaction that brought
her into your office?
A. I can’t recall the exact symptoms that she
had.
Q. Okay. so in any event, you took a history; is
that correct?
A. Yes.
@. You asked her what she had eaten?
[3122] A. Yes.
Q. She reported that one of the things she had
eaten was ham; is that correct?
A. Yes, that is correct.
Q. So why did you test her with the word ham?
App. 329
A. Because when I took the advanced course
Doctor Nambudripad told us that sometimes people
have a psychological allergy to a food, and you can
say the food out loud, and the arm will go weak. Since
it only takes me a split second to say ham, I might as
well test for it, and her arm did go weak.
Q. Why did you say ham rather than use the
device?
A. I did use the device, and she tested positive
for ham on the device.
Q. Was that after you said ham?
A. No. I tested her for the physical allergy to
ham first using the device. Then I tested her for the
psychological or subconscious allergy saying the word
ham after using the device.
Q. Now you can continue your answer about
why you did this.
A. Well, to be real thorough. Some people can
have a subconscious allergy to something, say for
instance Patient 3 ate ham when she was a little
[3123] child and threw up, or had some kind of
allergic reaction, or maybe it wasn’t even ham, but
she associated ham with some other food, and she felt
sick afterwards, so she may have been yelled at by
her father while she was eating ham. Sometimes that
can get imprinted on the mind as an emotional
allergy or a subconscious allergy, so when one says
the word, you can evoke a weakness.
App. 330
Q. Are you telling us something that you were
told by Doctor Nambudripad?
A. This is what we were told and taught in her
advanced course.
Q. Did she have any evidence to support this?
A. She had empirical evidence. She doesn’t have
the double blind studies, or anything like that.
Q. Did she do any demonstrations that sup-
ported this?
A. Yes.
Q. She did?
A. Yes.
Q. Doyou recall any of them?
A. I can’t recall the exact foods, but she did
demonstrate in class.
Q. Is there any scientific evidence that saying a
word can have that kind of psychological affect on
[3124] people?
A. Yes, of course there is.
Q. How?
A. There's lie detectors. When, say a child was
molested as a youth, you can say the word moles-
tation, or name the person that molested the child,
and get a response on the lie detector, which is
App. 331
actually a galvanic skin response machine, and that
will actually influence the acupuncture meridians.
Q. Did you treat Patient 3 for the ham?
A. Yes.
Q. Did she ever report that same reaction
again?
A. No.
Q. Did she eat ham after that?
A. Yes.
Q. She did, okay. Just for the record would you
tell us a couple of the more dramatic results that you
have gotten from your therapy with life-threatening
allergies.
A. I had a man that had a life-threatening
allergy to fish, all fish, and he was real frustrated,
because he used to fish with his son all the time, and
he couldn't even take the fish off the
* * + >*
[3137] did not know anything about FDA law,
clearance or approved or registered, anything like
that.
Q. Didn’t you say earlier today in your
testimony that you wouldn’t have a machine in your
office if it wasn’t FDA-approved?
A. I wouldn’t have a machine in my office, I
believe, that wasn’t FDA-cleared, I said.
App. 332
Q. Cleared could be what you said. What’s the
difference between registered and cleared?
A. I don’t know the definition of this, I’m sorry.
These are legal terms. I’m not an expert on this.
Q. What did you mean when you said FDA-
registered; in your mind, what was your under-
standing?
A. Jim Clark had told me that the machine is
approved to sell to doctors, and he has never had any
complaints from the FDA, and he was allowed to sell
this machine to doctors. That’s what I meant by that,
when I wrote this letter.
Q. And you believed it?
A. I believed Jim Clark, yes.
Q. Do you rely on most of the statements, how
about everything; Mr. Clark has been open and
honest with you about his machine, correct?
[3138)A. Yes.
Q. And you rely on the information that he
gives you, correct?
A. Yes.
Q. You also testified earlier you consulted him,
after you got the machine, you consulted him often, to
try to find out questions about the machine, right?
A. No, that was before I bought the machine.
App. 333
Q. Oh, before you bought the machine.
A. Iconsulted with him.
Q. After the machine you didn’t call him up and
ask questions, periodically?
A. No. I sent my nurse to one of his courses to
learn how to use the machine. I didn’t have any
complaints about the machine. I had no reason to call
him.
Q. Well, maybe I misunderstood. I thought
earlier you testified that you called him maybe once a
month, called him up constantly and —
A. You did misunderstand me, you didn’t hear
me. I said I called him before I purchased the
machine once a month.
Q. About how many times did you call him, if
you can remember?
[3139] A. Around three times.
Q@. About three times, all about the machine
and its operation, or some other purpose?
A. Well, I wanted to find out his dealing with
the FDA, I wanted to see how well the machine
works, how other people were satisfied, and different
questions like that.
Q. Now, as far as investigating, do you have
devices in your office, you have already testified that
you do a thorough research and protocol to increase
App. 334
the safety of your patients when you're doing
treatments.
How about the devices that you use, medical
devices, electronic devices, what type of thorough
examination do you conduct to ensure that those
devices are safe for your patients?
A. Well, basically I don’t use many devices. I
use vials and needles. I have an auto-plate machine,
and I don’t really use, I have a tongue depressor. I
don’t really use any big devices.
Q. What about the device that you had last
time. It was a hand-held device, and looks like some
tongs?
A. Right.
Q. What about that machine?
* *K * *
[3155] later, so that clarifies that. Thank you,
When this all started and the Department
started to question you after Patient 1 had put in the
Complaint regarding the LISTEN device, why did you
just not quit using it, the whole thing?
A. Why didn’t [I quit using the LISTEN device?
Q. Why didn’t you quit, and say I won’t use it?
MR. BISHIN: I have to object to this. This
goes to what the Department told him, what letters
were sent to the Department, what he responded to
App. 335
it. The question assumes that there was a focus in the
Department’s investigation on the machine.
I can understand why Miss Paxton would have
thought that was the case, but it’s an assumption.
MS. PAXTON: But we’re talking about the
LISTEN device.
MR. BISHIN: We’re talking about it now,
but that’s not what he was led to believe they were
most concerned about when the investigation started.
That’s the problem.
You’re going back to the history of this whole
thing, and you’re assuming what was going on during
the time of the, well, I guess you're talking
* * * *K
[3156] about when the investigation was going on,
that’s correct, isn’t it?
MR. ARMSTRONG: May I respond?
MR. BISHIN: You’re assuming what was
said in that investigation.
JUDGE DeBUSSCHERE: Objection noted.
Mr. Armstrong, your response?
MR. ARMSTRONG: I don’t have a clue
what Mr. Bishin is talking about, but my objection is
he’s mischaracterizing what the Panel member is
assuming. That’s improper. He has no clue.
App. 336
JUDGE DeBUSSCHERE: [ll overrule the
objection, and you can ask the question.
Do you remember what the question was, Doctor
Ames?
THE WITNESS: No.
Q. (By Ms. Paxton) In the beginning, when you
were made aware there was a problem, or at least
scmeone thought in the Department there was a
problem, because you were using the LISTEN device
as part of the problem, why didn’t you say okay, I’m
going to quit using the device?
A. In the very beginning I wasn’t aware that I
had a problem using the device, from the statement of
charges. Once I know the statement of charges, I
knew [3157] that the LISTEN machine doesn’t harm
anybody, it doesn’t hurt anybody, it’s perfectly safe. It
facilitates my practice.
If I use vials I might only be able to test 50
percent of the ailergies. If I use the machine I can test
more allergens and help that patient more, screen
more allergens using the machine, so it really saves
my practice time.
Q. Okay. When you got the LISTEN device, and
you testified that it came with an operating manual,
but basically nothing else?
A. Bill of purchase.
App. 337
Q. Okay, bill of purchase. Did you ever wonder
why it didn’t come with any other piece of material
that would explain risk or benefit?
A. No, I never wondered that.
Q. Do you wonder it now?
A. No.
Q. Why not?
A. Because when I contacted Jim Clark a few
times, he told me that he works with the FDA and
he’s allowed to sell this machine, and he has no
problems. The FDA has never been sued by, the FDA
has never told him that he can’t sell the machine.
Q. So am I understanding you to say therefore
* * * *
[3167] positive kinesiology test.
With a psychological or subconscious allergy, we
say the word out loud and in some patients their arm
goes weak. We're taught in the advanced course in
NAET that this is how we test for psychological
allergies.
Q. How do you know this to be true?
A. Doctor Nambudripad has been doing NAET
for many years, and she has many case examples on
this, and I took her word for it.
Q. So it’s more anecdotal information rather
than scientifically-based?
App. 338
A. Yeah, it’s more anecdotal or empirical, but I
could see how it worked in the lie detector example
this morning, AND how different words can influence
the lie detector. People can call you a bad name or
something, and all of a sudden you get a lot of
nervous responses, so I could see how it could work.
I have never really done a ‘ot of research on this.
It only takes me a fraction of a second to say the word
out loud. She taught us to do this in the advanced
course, so I do it.
MS. PAXTON: Thank you, Doctor.
JUDGE DeBUSSCHERE: Doctor Uberoi,
you
¥ + * *
[3169] Q@. Okay -
A. I’m not going to have food in my office.
Q. Soit’s a kitchen area in the office?
A. Yes.
Q. And it’s not an office in the home?
A. It’s not an office in the home, no.
Q. The nurse, do you employ an R.N. L.P.N., the
nurse who went to learn this machine?
A. She was a registered nurse.
Q. R.N.?
A. RN.
App. 339
Q. What was her role in learning the machine,
what was she going to be doing after the training on
the machine?
A. Originally I wanted her to basically teach me
how to use the machine, until I had time to go in
there and take a course myself. I knew I wouldn't
have time to take a course right away, so I sent her
down there to learn how to use the machine.
Q. Did you go and learn it yourself, or did you
just learn from her, and that was —
A. I learned from her, the manual, and then the
way I use the machine is not electrodermal screening.
I do a different technique.
Q. Is the nurse still working with you?
* * * co
[3178] two, we check for antithrombin antibodies. We
do a whole different blood cascade, because these
patients have different coagulopathies. They can’t get
better unless their fibrinogen goes below 300 usually.
In some people with Chronic Fatigue Syndrome
you might see fibrinogens around 600 or even higher,
and it can be environmental, genetics. There is
different causes for it. It affects organisms.
Q. So you put them on Heparin?
A. Not always. There’s Nattokinase, an enzyme
that lowers fibrinogen, there’s curcumin.
App. 340
Also detoxification of the body of heavy metals
will also lower fibrinogen.
Q. So why was she so attached to the machine,
rather than to the NAET therapy, because she said
don’t take my machine away from my doctor, then I
won't be able to get my treatment?
A. The reason why, I can scan for hundreds of
allergens in a 15-minute office visit, where if I didn’t
have the machine, I might only be able to scan for
maybe half that amount, or even one-third that
amount, and I might not find the allergen, so that
patient wouldn’t get a treatment that day, so the
machine saves me a lot of time.
Q. My last question, when any patient comes to
[3179] you, are they coming to you as an M.D. or as
an NAET practitioner, I mean are they coming to you
for everything, looking for —
A. They’re coming to me usually from word of
mouth. They already know that I’m an M.D. because
it’s on my door and it’s on my business cards that I’m
an M.D..
Q. So they come expecting that you will take
care of everything for them?
A. No. No, I can’t do that, that would be
impossible. I mainly specialize in chronic fatigue
states and allergies.
App. 341
Q. So you cannot tell them that you will take
care of them the best way you think will be best for
them, like —
A. No, some —
Q. — nasal sprays and desensitization or NAET
or acupuncture, or —
A. It depends on what their complaint is. If they
come in with cardiac problems, they’re definitely
going to be referred to a cardiologist. If they have
problems with sleep apnea, I refer them to a
pulmonologist.
So if they come in for allergies, I do avoidance
therapy. I give them antihistamines, [3180] steroid
nose sprays, tell them to clean up their house and
environment, and then I offer them NAET.
DOCTOR UBEROI: I’m done.
JUDGE DeBUSSCHERE: Thank you. It’s
now an opportunity for follow-up questions by the
questions asked by the Panel members.
Mr. Bishin, do you have any follow-up questions?
MR. BISHIN: The only question I have is
a question to everybody. My recollection was that
Patient 3’s testimony, and it may be wrong, is that
she was concerned about losing her doctor, not losing
the machine.
App. 342
MS. PAXTON: Did I say that? I think in
the end she did say, please don’t take the machine
away from him.
MR. TENNIS: Yes, she did.
DOCTOR UBEROI: She said please don’t
take my machine away from him.
MR. BISHIN: I guess I never heard that
before.
MR. ARMSTRONG: She said it over and
over.
DOCTOR UBEROI: Yes, she did. It was
like she was so attached to the machine.
[3181] JUDGE DeBUSSCHERE: Any other
questions, Mr. Bishin?
MR. BISHIN: No.
JUDGE DeBUSSCHERE: Mr. Armstrong,
question, follow-up questions asked by the Panel
members?
RECROSS EXAMINATION
BY MR. ARMSTRONG:
Q. Doctor Ames, let me see if this is your
understanding, that assessment is equivalent to
diagnosis when dealing with a patient?
A. There is a preliminary diagnosis doctors do
when a patient presents with a complaint, and then
App. 343
there is a final assessment that might be correct or
incorrect, but that’s what the doctor works on for his
plan.
So I start with a working assessment and then I
try to finalize it to a final assessment, but the final
assessment could be wrong, but we can always do
more blood tests to see if it confirms my assessment,
or different testing.
Q. Where does the LISTEN machine come in, is
it at the preliminary assessment or is it at the final
assessment?
A. The LISTEN machine is more of a prelim-
inary [3182] assessment. It’s part of a preliminary
assessment.
Q. If it’s part of a preliminary assessment, don’t
you go straight to treatment with NAET?
MR. BISHIN: Bea little clearer, Counsel.
Q. I’m trying to find out where the LISTEN
machine is in the scheme of your assessment. You’re
saying it’s more in the preliminary assessment, but I
think in your testimony — correct me if I’m wrong on
this — that once you assess using the machine, which
is quicker than using the vials, you go straight into
treatment, which is NAET, correct?
A. Well, the assessment consists of a detailed
patient history. The patient will usually tell me what
their allergen is, or I'll be able to figure out from their
history.
App. 344
I also do blood work, okay, and then I do NAET
testing using patient samples that they bring in, or
the machine, and then I formulate a theory that they
might have an allergy by muscle tests. I do
kinesiology tests, and if their arm goes weak, then I
can presume that they may have an allergy.
Q. Then you go into treatment, correct?
A. Then I go into treatment, and if their symp-
toms go away, that further helps my assessment.
[3183] That tells me that they probably did have that
allergy, because their symptoms went away.
Q. Okay. I think one of the board members
asked you about the EAV system, Electroacupuncture
Volt —
A. Voll, according to Doctor Voll.
Q. You were talking about making antigens,
and you said that the LISTEN device can make vials,
correct, did I get that correct?
A. The LISTEN machine can make antigens.
Q. How do you, as a medical doctor, know that
it’s correct and accurate, how do you know that device
is making correct vials?
A. The reason I know that is because since I’m
very skeptical, I have the patients bring in real foods
or real pollens, and I'll type in milk, and they will
bring in a glass of milk, and they get the same
response with kinesiology testing.
App. 345
The only time I would not get the same response
might be house dust, because their house dust might
have cat hair in it, for instance, the machine might
have a different read, or molds, for instance. The
machine holds about 80 different molds, because we
know there’s thousands of different molds, some
haven’t even been discovered, but besides
* * * *
App. 346
AMES v. WASHINGTON STATE
DEPARTMENT OF HEALTH MEDICAL
QUALITY ASSURANCE COMMISSION
On Petition for Writ of Certiorari to
The Supreme Court of the State of Washington
NO. 80644-6
OBJECTIONS, ARGUMENTS, RULINGS,
AND COLLOQUIES AMONG
PRESIDING OFFICER AND COUNSEL
Clerk’s Certified Report of Proceedings
1985-86, 2123-24, 2134-38, 2137-38, 2140,
2167-69, 2243-44, 2262-68, 2519-20, 2533-2535,
2542-45, 2547-49, 2551, 2556, 2569, 2575-76,
2648-49, 2680, 3019-20, 3200, 3205, 3213, 3217
App. 347
[1985] STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
IN THE MATTER OF THE _ )
LICENSE TO PRACTICE )
AS A PHYSICIAN AND ) er
SURGEON OF: ) 02-06-A-1012MD
GEOFFREY S. AMES, M.D. nay 1
License No. MD00026961, )
Respondent. )
VERBATIM TRANSCRIPT OF PROCEEDINGS
(Filed Oct. 22, 2004)
A-P-P-E-A-R-A-N-C-E-S
HEALTH LAW JUDGE:
ARTHUR E. DeBUSSCHERE
FOR THE RESPONDENT:
WILLIAM R. BISHIN
Attorney at Law
701 Fifth Avenue, Ste. 4040
Seattle, Washington 98104
FOR THE DEPARTMENT OF HEALTH:
KEITH D. ARMSTRONG
Assistant Attorney General
1125 Washington St. S.E.
Olympia, Washington 98504
App. 348
COMMISSION MEMBERS PRESENT
SUNANDA UBEROI, M.D. JANICE PAXTON, PA-C
CABELL TENNIS, J.D.
Public Member
Renton, Washington
January 13, 2004
REPORTED BY JEAN ERICKSEN, CCR
[1986] INDEX
PAGE
PRE-HEARING CONFERENCE 3
OPENING STATEMENTS
MR. ARMSTRONG 68
MR. BISHIN 74
DIRECT EXAMINATION OF DR. AMES 93
CROSS EXAMINATION OF DR. AMES 163
REDIRECT EXAMINATION OF
DR. AMES 170, 186, 188, 198
EXAMINATION BY MR. TENNIS 174
EXAMINATION BY DR. UBEROI 177, 197
EXAMINATION BY MS. PAXTON 185
DIRECT EXAMINATION OF PATIENT 1 201
2 + “ ~
[2123] doctors are using it for, is that what you’re
saying?
Q. Yes.
App. 349
A. What’s your question?
Q. The question is if the item is not approved by
the FDA or doctors you know, would you still use it
for an alternative use? [m saying aspirin is not
approved. You can’t use aspirin for any medical
purpose in the United States, but you want to use it
for another purpose.
MR. BISHIN: You can’t use it or you can?
MR. ARMSTRONG: You cannot use it for
headaches.
A. Doesn’t that already say that aspirin is
illegal for any doctor to prescribe?
Q. There are no doctors that use aspirin for
headaches, that’s my example, nobody uses it for any
medical purpose whatsoever.
MR. BISHIN: Your hypothetical is aspirin
is not being legally marketed?
Q. And you were going to use it for a different
purpose than headache. Would that be an authorized
use as a medical practitioner?
A. I would not use aspirin in that case.
Q. You would not. Okay, so if I understand you
[2124] clearly, if its not an approved product or a
drug, you would not use it for a different use?
MR. BISHIN: Objection —
A. That’s not what you said.
App. 350
JUDGE DeBUSSCHERE: One - second,
Doctor. Objection to what?
MR. BISHIN: He said he would not use it
for a different use, what different, different from
what?
JUDGE DeBUSSCHERE: [I'll sustain the
objection, [’m not sure — objection sustained. The
question is vague.
MR. ARMSTRONG: Maybe I’m just not
being clear. I’ll move on to another aspect of it.
Your understanding of off-label use, Doctor, is
that it’s something that needs to be approved, it can
be used for alternative use for what it’s approved for.
A. To use it for another use?
Q@. As an general term. I’m just using it as a
general term.
A. Yes.
Q. If the item is not approved, then off-label use
doesn’t apply, does it?
A. Ifthe item is not approved by what
se + * *
[2134] Q. Look down at the bottom right-hand
side, where it talks about inside range, outside range
and reference.
A. I don’t know where you're looking.
App. 351
Q. Same document, the right side at the bottom.
MR. BISHIN: Your Honor, I’m objecting to
this entire line of questioning. It has nothing to do
with this case. There is nothing that’s complained
about lead or lead testing or any treatment for lead,
or anything of that sort. It’s completely irrelevant to
this case.
JUDGE DeBUSSCHERE: Mr. Armstrong, I
assume you were talking about the Department’s case
here on allergies. I thought maybe you were pursuing
this on the vein that he was, his treatment with
regard to allergies.
MR. ARMSTRONG: Yes, that is part of it.
The Department’s case is on his treatment with
patient 1, period, not allergies only, all of the things
he did. The patient’s complaint was based on his
treatment with Doctor Ames, not the LISTEN device
of Doctor Ames. It was on all of his visits.
One of the things that the patient is going to
testify about is metal toxicity and Doctor Ames’ tests,
what tests he didn’t conduct, and [2135] whether that
was above or below the standard of care, according to
medical judgment.
MR. BISHIN: He’s not going to testify over
my dead body. That is not in the Statement of
Charges, Your Honor. The regulations that govern
this proceeding are very specific about specifically
stating the factual basis on the Statement of Charges,
and that is not in the Statement of Charges.
App. 352
We did not prepare a defense to anything leading
to that, although counsel is telling us that this is
about the entire treatment, everything that went on.
That’s not what the Statement of Charges is
about. Everyone here can look at the Statement of
Charges and see what the Statement of Charges
refers to. It refers to this device and to the muscle
testing that went on, and to some statement allegedly
made, and to the FDCA implications of this particular
device.
There is nothing about lead testing or any other
kind of treatment, or anything else in the Statement
of Charges.
MR. ARMSTRONG: Your Honor, may I
respond?
JUDGE DeBUSSCHERE: You may respond.
[2136] MR. ARMSTRONG: Contrary to
what counsel is alleging here, paragraph 1.13 of the
Statement of Charges talks about the different tests
that Respondent ordered, urine, blood and hair anal-
ysis tests. That is in the Statement of Charges.
Clearly the evidence that is going to be presented will
address those factors.
What the Department is alleging is_ that
everything that is listed in the Statement of Charges
falls under the negligent practice, and falls below the
standard of care.
App. 353
It doesn’t tell you exactly every single detail,
because the Statement of Charges doesn’t need to do
that. We just need to give the Respondent a general
basis of what our charges are.
JUDGE DeBUSSCHERE: Okay. The charge
is based on the Respondent’s use of the LISTEN device,
and that is unprofessional conduct as alleged in RCW
18.130.184. There is no allegations here that he, and I
put that in my pre-hearing order, that his use of the
hair analysis was unprofessional conduct.
MR. ARMSTRONG: If you look at 2.2.
JUDGE DeBUSSCHERE: You said that all
of these, some of these alleged facts are conclusions of
law. They’re not facts at all, and so I cannot, the
[2137] way the charges are written alleges that the
Respondent committed unprofessional conduct using
this machine, this LISTEN device, and particularly in
his diagnosing and treating food allergies, this
patient’s allergies.
There’s no other allegations of unprofessional
conduct regarding any other mistreatment. The fact
and the allegations that the Respondent ordered
urine, blood and urinalysis tests is not notice that he
committed unprofessional conduct under RCW
18.131.184 on that alone, and I said that in my pre-
hearing order.
You yourself said in your opening statement that
this is a matter of food allergies, whether or not there
was unprofessional conduct with food allergies.
App. 354
I thought your line of questioning that to do with
Doctor Ames, questioning him in regards to providing
treatment for food allergies, not the fact that he is
going to be charged for, I think you were talking
about lead poisoning. That point wasn’t alleged and
that is not part of the statement of charges here.
If he was charged with lead poisoning for this
patient it should have been stated in the [2138]
Statement of Charges.
MR. ARMSTRONG: Would you like me to
respond?
JUDGE DeBUSSCHERE: You don’t need to
respond. I made a ruling. The objection is sustained.
MR. ARMSTRONG: Well, I'd like to make
an offer of proof.
JUDGE DeBUSSCHERE: You may make
an offer of proof.
MR. ARMSTRONG: On the record, under
2.2 in the Statement of Charges, 1.1 through 1.13 are
the factual allegations. It says in 2.2 that —
MR. BISHIN: Your Honor, I object. This is
not an offer of proof, this is further argument. An
offer of proof is an offer of evidence. You’re showing
the tribunal what evidence you would have
introduced if you had been allowed to do so. This is
just further argument and it’s typical of what counsel
does, continually re-arguing and wasting everybody’s
App. 355
time, arguing and re-arguing the same point. This
has been going on throughout this entire proceeding.
JUDGE DeBUSSCHERE: Mr. Armstrong,
Do you have your offer of proof?
* * a” *
{[2140] have not changed one bit of our evidence, it’s
just that he is uncomfortable with how the question is
coming out.
MR. BISHIN: I object again. This is not an
offer of proof. Even if it were an offer of proof, it’s not
necessary. What he’s pointing to is the Statement of
Charges.
The Statement of Charges is on the record, it’s
right there. An appellate court can see the Statement
of Charges without any statement or argument by
counsel.
JUDGE DeBUSSCHERE: I have made my
ruling. Lead toxicity is not part of the charges, as I
have stated in the Statement of Charges. Next
question.
Q. Doctor Ames, I want to go back to the
LISTEN device itself, and how you use it. You don’t
use it as an EDS, Electrodermal screening, you don’t
use it for that purpose?
MR. BISHIN: I object, asked and answered.
MR. ARMSTRONG: I’m trying to get an
undertanding.
App. 356
JUDGE DeBUSSCHERE: It has been asked
and answered.
* # * *
[2167] Paxton, do you have questions?
MS. PAXTON: I do, but I want clarity first
from you, JUDGE DeBUSSCHERE.
JUDGE DeBUSSCHERE: Okay.
MS. PAXTON: I want to go back to the
First Amended Statement of Charges, because I never
did get clarity, and the attorneys may say asked and
answered, but I’m sorry, that doesn’t go for me, and so
excuse me, gentlemen, but I have to ask this again.
In 2.2 it talks about the facts alleged in
Paragraphs 1.2 through 1.14. as that which
constitutes unprofessional conduct, so I need help
once again, to understand why you excluded 1.13 as
not part of that which constitutes unprofessional
conduct.
JUDGE DeBUSSCHERE: I didn’t exclude
1.13 as a fact. It was a fact that was alleged, but the
allegations alleged that there was conduct that was
unprofessional under RCW 18.131.84, incompetence,
negligence, malpractice with results causing injury to
a patient, which creates an unreasonable risk that
the patient may be harmed.
The fact that the Respondent ordered urine,
blood, blood tests, hair analysis tests is a [2168]
factual allegation, but there is insufficient facts there
App. 357
to notify the Respondent that the fact that he ordered
a urine test is unprofessional conduct, or the fact that
he ordered a blood test is unprofessional conduct, or
the fact that he ordered a hair analysis, or a
combination of those.
There is insufficient information in the State-
ment of Charges to give notice to the Respondent that
such conduct was unprofessional.
The substance of the Statement of Charges
references that the patient used the LISTEN device,
and such conduct was unprofessional. If I were to
allow, if the Statement of Charges had more infor-
mation, in fact, stated that the Respondent’s conduct
in giving blood tests or
This text is long and has been trimmed here. Open the source document for the complete record.
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