FDA Hearing/Dr. Manno's tough luckstatement/Dr. Olding/Conflict

[Guest guest]

Subj: FDA Hearing/Dr. Manno's " tough luck " statement

Thanks to Pam Dowd for sending this amazing,

outrageous comment from Dr. Manno, at the FDA Hearings

- April 2005.

This response was given when the panel gave their

reasons for their votes.

http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4101t3.htm

CHAIRMAN CHOTI: Dr. Manno?

DR. MANNO: I wish I had said that. I

voted yes much based on many of the things that Dr. Li

commented on, and I think that given the testimony

here, etcetera, from the public and what I heard from

the public the last time, if the doctors and the

company provide the information, I think we have got

enough to approve this and that the recipients of the

device will have a choice. And it isn't to have a

choice, they can make a choice and it's tough luck if

it doesn't work. (There was a long pause here as the

audience responded audibly to this statement.) No, I

don't mean that. I would like that stricken. No, I

believe it will work, I think, based on what I have

seen here and, please, I did not mean that the way it

sounded.

=======================================

Subj: FDA Hearing/Dr. Olding/Conflict of

Interest

Date: 5/3/2005 2:48:05 AM Eastern Standard Time

CHAIRMAN CHOTI: I would like to note for the record

that the voting members present constitute a quorum,

as required by 21 CFR Part 14.

Let me read a letter from Dr.

Olding, who was to be a member, a nonvoting member, on

this panel. He elected not to be present and

requested that the following letter be read, " Dear Dr.

Choti, I would like to request the following statement

to be read into the record at the time of the General

and Plastic Surgery Panel meeting.

" On December 2004, I agreed to serve on this panel

with great enthusiasm for its mission and with a full

understanding of the commitment and the need for

impartiality. Accordingly, I completed the required

conflict of interest statement in January 2005,

indicated that there are no conflicts.

" Subsequently, on March 21st, 2005, Medicus

Pharmaceutical Corporation announced plans to merge

with Inamed Corporation, a firm at issue. That merger

is subject to approval by stockholders, regulatory

approvals, and customary closing conditions according

to the companies.

" Upon learning of the planned merger, I immediately

notified the Executive Secretary of the proposed

merger and that I owned a quantity of stock in

Medicus.

" Initially, on April 1st, 2005, the Executive

Secretary indicated that my service on the panel would

not be affected by my stock holdings and the planned

merger, but one business day before this meeting, on

Friday, April 8th, I received a fax from Integrity

Committee and Conference Management Branch informing

me that due to the stock-holding value, between 50,000

and 100,000, in a firm that is slated to merge with a

firm at issue, I would be excluded from voting on the

panel. It does appear that I would be allowed to

'review and discuss matters before the panel,' even

though I am denied the right to vote.

" As the chronology demonstrates, the incipient

conflict was created by the decision of the two

companies to merge and not by any action on my part.

Indeed, I made the FDA aware of the situation.

" I was fully prepared and committed to continuing my

service on the panel impartially and a relatively

small stock-holding I have in the company, which until

March 2005 had no interest in the outcome of our work,

would have no bearing on my decision-making process.

" I do not feel it is appropriate for me to continue my

service on the panel as a partial member; that is, one

without voting rights. Since the FDA has concluded

that my voting may create an appearance of a conflict

due to my stock holdings, I do not want my continued

service as a nonvoting panel member to be suspect in

any way.

" I regret having to make this decision as I possess

important experience as a plastic surgeon for the

panel to consider. And my departure will leave only

one other professional with similar experience. But

the handicap that the FDA has placed upon me because

of the incipient conflict, not of my making, that

arose since my appointment to the panel makes my

decision necessary.

" Thank you for your consideration and understanding.

And good luck to you and the panel in your important

work. Sincerely, Olding. "