Company Name: Pfizer Inc.
Public Availability Date: January 25, 2004Document Sections:
INQUIRY LETTER
APPENDIX 1
APPENDIX 2
INQUIRY LETTER
STAFF REPLY LETTER [INQUIRY LETTER]
December 17, 2003 VIA HAND DELIVERY Office of the Chief Counsel
Division of Corporation Finance
Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549 Re: Shareholder Proposal of Bill Egleston Securities Exchange Act of 1934 - Rule
14a-8 Ladies and Gentlemen: This letter is to inform you that it is the intention of Pfizer Inc. (the
"Company") to omit from its proxy statement and form of proxy for its 2004
Annual Meeting of Shareholders (collectively, the "2004 Proxy Materials") a
shareholder proposal and statements in support thereof (collectively, the
"Proposal") received from Bill Egleston (the "Proponent"). The Proposal "requests[s]
that procedures be established to provide needed and necessary information to
study participants when their participation is terminated ... on a timely basis
... [and] that Pfizer work with the FDA and all other drug manufacturers and
study administrators to insure that this is a universal policy." A copy of the
Proposal is attached hereto as Exhibit A. Pursuant to Rule 14a-8(j), enclosed herewith are six copies of this letter and
its attachments. Also in accordance with Rule 14a-8(j), a copy of this letter
and its attachments is being mailed on this date to the Proponent, informing the
Proponent of the Company's intention to omit the Proposal from the 2004 Proxy
Materials. The Company presently intends to file its definitive 2004 Proxy
Materials on or after March 6, 2004. Accordingly, pursuant to Rule 14a-8(j),
this letter is being submitted not less than 80 days before the Company files
its definitive 2004 Proxy Materials with the Securities and Exchange Commission
(the "Commission"). BASES FOR EXCLUSION
The Company hereby respectfully requests that the staff of the Division of
Corporation Finance (the "Staff") concur in our view that the Proposal may be
excluded from the 2004 Proxy Materials on the bases set forth below:
I. Rule 14a-8(i)(4), because the Proposal relates to the redress of a personal
grievance against the Company; II. Rule 14a-8(i)(7), because the Proposal concerns a matter relating to the
Company's "ordinary business operations;" III. Rule 14a-8(i)(10), because the Company has already substantially
implemented the Proposal; and IV. Rule 14a-8(i)(3), because the Proposal contains many false and misleading
statements in violation of Rule 14a-9. ANALYSIS
I. The Proposal May Be Excluded Pursuant to Rule 14a-8(i)(4) Because it Deals
With a Personal Grievance Against the Company. The Proposal should be excluded from the 2004 Proxy Materials pursuant to Rule
14a-8(i)(4) because it relates to the redress of the Proponent's personal
grievance against the Company, the Company's board of directors and its
officers. As the Proponent explains in his Proposal, he "participated in a study
regarding diabetics to see if Atorvastatin (Lipitor) would be beneficial in
diabetics to prevent future complications by controlling (lowering)
cholesterol." As he further explains, after his participation ended in February
of 2003, I asked if I had been taking Lipitor or the placebo. The administrator could not
tell me, as they claimed they did not know... During March, 2003, I noticed my
usage of Humalog decreased 30% to 50%. I had an independent blood test drawn on
July 10, 2003 and the total cholesterol value was 168. This was an increase from
my typical value of 125. Was the decrease in insulin usage and the increase in
cholesterol due to not taking Lipitor, or were the changes due to alterations in
my lifestyle? I contacted the administrator and explained the changes. I wanted
to know if I was taking Lipitor or the placebo during the study. I was again
told they could not tell me, as they claimed they did not know.
As the Proponent makes clear, he has a personal stake in this matter: "I do not
want to start taking Lipitor if I wasn't taking it during the study. How can I
make an informed decision about my health care if I do not know all of the
facts?" (emphasis added). The Proponent further explains in his August 15, 2003
letter to Henry A. McKinnell, Jr., Ph.D., the Chairman and Chief Executive
Officer of the Company (the "Proponent's Letter"), that he is motivated by a
personal interest: "I do want to know if I was on Lipitor or a placebo." A copy
of the Proponent's Letter is attached hereto as Exhibit B.
The Company sympathizes with the Proponent's frustration at being randomly
blinded to the treatment he received. Unfortunately, federal regulations do not
allow the Company to provide the information the Proponent seeks at this time
because the study physician handling the Proponent's case determined that the
Proponent did not qualify to learn what medication he received under the
established protocol submitted to the Federal Drug Administration ("FDA"). See
21 CFR §§312.23(a)(6), 312.30, 312.50. As the Company explained in its November
26, 2003 response to the Proponent's Letter (the "Response Letter"),
We understand that, as a participant in a long-term clinical trial such as
ASPEN, it can sometimes be frustrating to be randomly blinded to the treatment
received. It is only natural to be curious as to whether you were given the drug
being tested or a placebo, and given the details of your personal medical
history, it is understandable you have an interest in knowing the facts about
your participation. Unfortunately, we cannot give you those facts at the present
time, and I will do my best to explain why. All Pfizersponsored clinical trials
are conducted in strict accordance with applicable Federal (Food and Drug
Administration) and international (International Conference of Harmonization)
regulations and guidelines, as well as established Pfizer Standard Operating
Procedures and Policies ... "Unblinding" (allowing a patient or the
participating physician to have access to a particular treatment) is permitted
only in cases of medical emergency, and we understand that the study physician
handling your case has determined that your case does not qualify as a medical
emergency. A copy of the Response Letter is attached hereto as Exhibit C.
While the Proponent has an understandable personal grievance with the Company, a
shareholder proposal is an inappropriate mechanism for remedying it. According
to the Staff, the intended purpose of shareholder proposals is "to place
stockholders in a position to bring before their fellow stockholders matters of
concern to them as stockholders in such corporation." Release No. 34-3638
(avail. Jan. 16, 1945) (emphasis added). Accordingly, the Commission has
consistently explained that shareholders must use the proposal process to
communicate on matters of interest to them as shareholders, and not as a means
for remedying a personal grievance or advancing a personal interest.1 The
Commission explained that even proposals presented in broad terms that "might
relate to matters which may be of general interest to all security holders" may
be omitted from a registrant's proxy materials "if it is clear from the facts
... that the proponent is using the proposal as a tactic designed to redress a
personal grievance or further a personal interest." Id.
The Staff has consistently concurred in the view that companies may exclude
proposals under Rule 14a-8(i)(4) when the proponents used the proposal process
to redress personal grievances, even when the proposals are presented in broad
terms of general interest. In Unocal Corp. (avail. Mar. 15, 1999), a shareholder
had a personal grievance with Unocal regarding the costs of remediation for
property containing underground storage tanks. His proposal included general
requests that Unocal "reimburse current site owners for all costs such as lost
rents, loss of value and out of pocket expenses caused by the existence of
tanks..." and that Unocal "at its expense remove all tank and resulting
contamination caused by the tanks left in the ground." While the proponent made
these requests in broad terms of general interest, the motivation was his
experience with storage tanks on his property. The Staff therefore concurred in
the view that the proposal may be excluded under rule 14a-(8)(i)(4). See also,
e.g., Core Industries, Inc. (avail. November 23, 1982) (permitting a company to
omit a shareholder proposal regarding union membership when proponent had
attempted to organize a union at one of the company's divisions); Dow Jones &
Co. (avail. Jan. 24, 1994) (allowing exclusion of proposal regarding executive
pay as a personal grievance where the proponents sought a favorable collective
bargaining agreement). As with Unocal, the Proponent utilizes the shareholder proposal process to
express his personal grievance with the Company (in this case, by submitting a
proposal to create procedures to allow him to learn whether he received the
placebo or Lipitor during the study). This is not an issue of interest to the
Proponent as a shareholder, but rather as a participant in a clinical trial. The
Proposal is a misuse of the shareholder proposal process and does not serve the
interests of the shareholders at large. Accordingly, the Proposal may be
excluded under Rule 14a-8(i)(4) as relating to the Company's ordinary business
operations. II. The Proposal May Be Excluded Pursuant to Rule 14a-8(i)(7) Because it Deals
With Product Research, Development and Testing, Which Are Matters Relating to
the Company's Ordinary Business Operations. The Proposal may properly be omitted pursuant to Rule 14a-8(i)(7), which permits
the omission of shareholder proposals dealing with matters relating to a
Company's "ordinary business operations." The Staff has explained that
shareholder proposals addressing management issues at corporate meetings are not
practical because they "deal with ordinary business matters of a complex nature
that shareholders, as a group, would not be qualified to make an informed
judgment on, due to their lack of business experience and their lack of intimate
knowledge of the issuer's business." 2 According to the Commission's Release
accompanying the 1998 amendments to Rule 14a-8, the underlying policy of the
ordinary business exclusion is "to confine the resolution of ordinary business
problems to managementand the board of directors, since it is impracticable for
shareholders to decide how to solve such problems at an annual meeting." 3 The
1998 Release also states that "[c]ertain tasks are so fundamental to
management's ability to run a company on a day-to-day basis" that they are not
proper subjects for shareholder proposals. The Commission also noted in the 1998 Release that the general underlying policy
of this exclusion "is consistent with the policy of most state corporate laws."
The Proposal falls within state corporate law as relating to the Company's
ordinary business. Under Section 141 of the Delaware General Corporation Law,
which is applicable to the Company, "The business and affairs of every
corporation organized under this chapter shall be managed by or under the
direction of a board of directors...." The subject matter of the Proposal is a matter of ordinary business operations
because it deals with the minute details of research procedures that are
formulated in accordance with federal law and professional medical standards.
Allowing this Proposal to be presented to the Company's shareholders would set a
precedent of shareholders overseeing companies' research and development
decisions, which is the province of management. As a result, the Staff has
consistently concurred in the view that companies may exclude shareholder
proposals relating to research and development decisions under Rule 14a-8(i)(7).
In E. I du Pont de Nemours and Company (avail. Mar. 8, 1991), the Staff
concurred that the company could omit a proposal to present a report to
shareholders regarding the Company's research expenditures related to finding
alternatives to the use of Chlorofluorocarbons ("CFCs"). As the Staff explained,
"the thrust of the proposal appears directed at those questions concerning the
timing, research and marketing decisions that involve matters relating to the
conduct of the Company's ordinary business operations." As with the proposal to
E.I. du Pont, the Proponent's Proposal seeks shareholder oversight of product
research. Specifically, the Proposal addresses the procedures for providing
information to participants in clinical studies, which is a matter of ordinary
business operations best left to medical professionals. See also, e.g., Merck &
Co., Inc. (avail. Jan. 23, 1997) (Staff allowed exclusion of research related
proposal, explaining that "the proposal is directed at matters relating to the
conduct of the Company's ordinary business operations (i.e., product research,
development, and testing)"); Union Pacific Corporation (avail. December 16,
1996) (allowing exclusion of a proposal requesting a report on the status of
research and development of a new safety system for railroads); Newport
Pharmaceuticals, Int'l., Inc. (avail. August 10, 1984) (allowing exclusion of
proposal regarding "allocation of funds for corporate research"); Arizona Public
Service Company (avail. Feb. 27, 1984) (allowing exclusion of a proposal
regarding "the amount and location of research and development activities").
The cited Staff letters illustrate that research decisions, such as those
determining the procedures for providing information to participants in clinical
studies, involve matters relating to the conduct of a company's ordinary
business operations. Accordingly, the Proposal may be excluded under Rule
14a-8(i)(7) as relating to the Company's ordinary business operations.
III. The Proposal May Be Excluded Pursuant to Rule 14a-8(i)(10) Because the
Company Has Already Substantially Implemented Procedures for Providing Necessary
Information to Study Participants in Accordance With Medical Guidelines.
The Proposal may properly be omitted pursuant to Rule 14a-8(i)(10), which
permits the omission of a shareholder proposal where a company has already
"substantially implemented" the elements thereof. The 1998 Release notes that
this rule merely reflects the interpretation earlier adopted in Release No.
34-20091 (avail. Aug. 16, 1983) under former Rule 14a-8(c)(10). Pursuant to the
1983 interpretation, the Staff has stated that "a determination that the Company
has substantially implemented the proposal depends upon whether its particular
policies, practices and procedures compare favorably with the guidelines of the
proposal." Texaco, Inc. (avail. Mar. 28, 1991). Where a company can demonstrate that it has already taken actions to address the
fundamental elements of a shareholder proposal, the Staff has concurred that the
proposal may be excluded as moot. See, e.g., The Gap, Inc. (avail. Mar. 8, 1996)
(proposal that company adopt guidelines precluding it from doing business with
certain suppliers substantially implemented and rendered moot); Nordstrom Inc.
(avail. Feb. 8, 1995) (proposal that company commit to a code of conduct for its
overseas suppliers that was substantially covered by existing company guidelines
was excludable as moot). The Company has already implemented the Proposal in accordance with Federal
regulations and international medical association standards. See 21 CFR
§§312.23(a)(6), 312.30, 312.50. The study physician handling the Proponent's
case determined that the Proponent did not qualify to learn what medication he
received under the established procedures. Based thereon, the Proponent
erroneously concluded that the Company has not implemented any procedure for
providing necessary medical information to study participants. However, as the
Company explained in its Response Letter, All Pfizer-sponsored clinical trials are conducted in strict accordance with
applicable Federal (Food and Drug Administration) and international
(International Conference of Harmonization) regulations and guidelines, as well
as established Pfizer Standard Operating Procedures and Policies ...
"Unblinding" (allowing a patient or the participating physician to have access
to a particular treatment) is permitted only in cases of medical emergency, and
we understand that the study physician handling your case has determined that
your case does not qualify as a medical emergency. The Proponent is simply mistaken in his belief that a procedure does not exist
for providing necessary medical information to study participants. As part of
the study protocols filed with the FDA, the Company established a procedure to
provide necessary medical information to study participants. Unfortunately, the
medical professional responsible for determining if the Proponent's medical
condition entitles him to discover what medication he received during the study
decided that the Proponent does not qualify. The Proponent's attempt to overcome
the decision of a medical professional through a shareholder proposal
establishing procedures that the Company has already substantially implemented
will not produce the desired results. Moreover, in accordance with the relevant
regulations and established Company procedures, the Company will "unblind" all
patient participants once the study is completed and after all of the
requirements for database release have been satisfied. As noted in the Response
Letter: "[w]e are working hard to complete the task of compiling the information
provided by patients like you. It is our goal that these efforts will render
results late next year. At that time the study physician will be able to give
you all the information you seek." Accordingly, the Proposal may be excluded
under Rule 14a-8(i)(10) because the Company has already substantially
implemented the Proposal. IV. The Proposal May Be Excluded Pursuant to Rule 14a-8(i)(3) Because Claims
that Study Participants are Unable to Discover Medically Necessary Information
are Materially False and Misleading and Impugn the Integrity of the Company.
The Proposal may be excluded in its entirety under Rule 14a-8(i)(3) because it
contains numerous statements that are false and misleading, in violation of Rule
14a-9. As explained in Section III above, the Company has already established
procedures for providing study participants with medically necessary
information. The Proposal, however, repeatedly claims that when the Proponent
asked whether he received the placebo or Lipitor, he was told that the study
administrator "could not tell me." Together with the proposal to establish
procedures to provide "necessary information to study participants," the clear
implication of the Proposal is that the Company has no procedure in place for
providing study participants with necessary information. This is false,
misleading and impugns the integrity of the Company. Pursuant to Rule 14a-8(i)(3), a company may exclude a shareholder proposal that
"directly or indirectly impugns character, integrity or personal reputation, or
directly or indirectly makes charges concerning improper, illegal or immoral
conduct or associations, without factual foundation." See Note (b) to Rule
14a-9; See also, e.g. Philip Morris Cos. Inc. (avail. Feb. 7, 1991); Standard
Brands (avail. Mar. 12, 1975). The Proposal claims that "Pfizer uses thousands
of human beings as guinea pigs" and that it withholds necessary medical
information from study participants. As the Proponent claims: "How can I make an
informed decision about my health care if I do not know all the facts." The
implication is that the Company will not provide necessary medical information,
which is misleading and impugns its integrity as a health-care provider.
The Staff has consistently concurred that companies may exclude proposals under
Rule 14a-8(i)(3) when the sheer number of statements that must be omitted or
substantially revised renders the Proposal false and misleading as a whole. As
stated in Staff Legal Bulletin No. 14, published on July 13, 2001 ("SLB 14"),
when substantial revisions and omissions are necessary, it is appropriate to
exclude the entire proposal. The Staff has permitted companies to exclude
proposals that did not contain sufficient citations or factual support. See,
e.g. Kmart Corporation (avail. Mar. 28, 2000) (exclusion of proposal containing
unsupported factual statements); Standard Brands, Inc. (avail. Mar. 12, 1975)
(exclusion of proposal cited statistics without factual support).
In American Home Products, Inc. (avail. Mar. 10, 1977), a shareholder proposal
contained statements that "the sale of infant formulas in developing countries
may be linked to rising rates of malnutrition and infant mortality." The Staff
agreed with the company's assertion that such statements could be excluded under
Rule 14a-9, noting that "they purport to [make] factual representations or
comments upon the possible effects from use of the Company's infant formula
products, but no factual basis has been provided in support of them." In the
same way, the Proponent claims that study participants cannot discover whether
they received the placebo or Lipitor even when medically necessary without any
factual support. Moreover, this claim is erroneous and therefore misleading.
The Proponent also states that when he wrote the Company regarding his request,
that he "expected a lame excuse" why "Pfizer does not have access to such
information." This is another derogatory and unsupported statement. Accordingly,
the Proposal may be excluded under Rule 14a-8(i)(3) because the assertions that
comprise the Proposal are unsubstantiated, contain a number of false and
misleading statements and impugn the reputation of the Company. Alternatively,
if the Staff permits the Proponent to make the substantial revisions necessary
to bring the Proposal within the requirements of the Proxy rules, the Company
respectfully requests that the Proponent revise the following statements:
1. Paragraph 3, Sentence 1: "The Participants are guinea pigs." This unsupported
statement impugns the character of the Company. 2. Paragraph 3, Sentence 3: "The study eventually ends, and the participants are
not provided with medicine or placebo." This statement is false and misleading
because the Proponent fails to provide any factual support.
3. Paragraph 5, Sentence 5: "The administrator could not tell me, as they
claimed they did not know." As discussed above, this unsupported statement is
misleading because it erroneously implies that there is no procedure for
revealing information to study participants when medically necessary.
4. Paragraph 6, Sentence 5-7: "I contacted the administrator and explained the
changes.. [sic] I wanted to know if I was taking Lipitor or the placebo during
thestudy. I was again told they could not tell me, as they claimed they did not
know." As discussed above, this unsupported statement is misleading because it
erroneously implies that there is no procedure for revealing information to
study participants when medically necessary. 5. Paragraph 8, Sentence 3: "I expected a lame excuse that Pfizer contracts the
testing with independent firms so Pfizer does not have access to such
information." As discussed above, this unsupported statement impugns the
reputation of the Company. 6. Paragraph 9, Sentence 1: "Whereas, Pfizer uses thousands of human beings as
guinea pigs, I request that procedures be established to provide needed and
necessary information to study participants when their participation is
terminated." This unsupported statement is misleading because it erroneously
implies that the Company has not already implemented a program to provide
medically necessary information to study participants and impugns the reputation
of the Company. 7. Paragraph 9, Sentence 3: "I further request that Pfizer work with the FDA and
all other drug manufacturers and study administrators to insure that this is a
universal policy." This unsupported statement is misleading because it
erroneously implies that the Company has not already worked with the FDA and
other medical organizations to create procedures for providing medically
necessary information to study participants. CONCLUSION
Based on the foregoing, the Company hereby respectfully requests that the Staff
not recommend any enforcement action if the Proposal is excluded from the
Company's 2004 Proxy Materials. In the alternative, the Company believes the
Staff should require the Proposal to be revised as discussed in Section IV
above. Should you disagree with the conclusions set forth in this letter, we
respectfully request the opportunity to confer with you prior to the
determination of the Staff's final position. We would be happy to provide you
with any additional informationand answer any questions that you may have
regarding this subject. Please do not hesitate to call me at (212) 733-4802 if
we can be of further assistance in this matter. Sincerely,
/s/ Margaret M. Foran
Vice President, Corporate Governance and Secretary
Attachments cc: Kathleen M. Ulrich, Pfizer Inc.
Bill Egleston -----FOOTNOTES-----
1 Exchange Act Release No. 34-19135 (avail. October 14, 1982) (the "1982
Release"). 2 Exchange Act Release No. 34-12999 (Avail. Nov. 22, 1976).
3 Exchange Act Release No. 34-40018 (Avail. May 21, 1998) (the "1998 Release"). [APPENDIX 1]
Bill Egleston, 509 Brentwood Rd, Marshalltown, Iowa, the registered owner of
2400 shares of Pfizer in street name, hereby submits the following:
Whereas, Pfizer is engaged in medical research and must conduct testing to
determine the efficiency of new drugs or different uses for existing drugs. This
form of testing employs the double blind method, where some participants are
given the study drug, and others in a control group are given a placebo.
The participants are guinea pigs during the study, not knowing if they are
taking the medicine or the placebo. This is correct, as such knowledge could
alter the lifestyle of the participants to effect the results of the study. The
study eventually ends, and the participants are not provided with medicine or
placebo. Whereas, I participated in a study regarding diabetics to see if Atorvastatin
(lipitor) would be beneficial in diabetics to prevent future complications by
controlling (lowering) cholesterol. The five year study was begun in 1997 and I
started participation August 5, 1997. Basically, I was monitored every 6 months
with blood work, EKG's, etc. The results of the blood work were provided to me
the following week, but the lipid values were "blinded". My family Doctor or
Endocrinologist did order other blood tests, so I was aware of my lipid values
during the study. In February of 2002, I was expecting to conclude my participation in the study,
but the administrator said the study was extended 18 months, so I signed on
through August, 2003. On February 25, 2003 I reported for my routine
appointment. I was told my participation was, terminated. I asked if I had been
taking Lipitor or the placebo. The administrator could not tell me, as they
claimed they did not know. (however, I was given a prescription for Advicor as
the doctor felt my HDL was lowactually it had increased during the study based
upon my independent blood tests. During March, 2003, I noticed my usage of Humalog decreased 30% to 50%. I had an
independent blood test drawn on July 10, 2003 and the total cholesterol value
was 168. This was an increase from my typical value of 125. Was the decrease in
insulin usage and the increase in cholesterol due to not taking Lipitor, or were
the changes due to alterations in my lifestyle? I contacted the administrator
and explained the changes.. I wanted to know if I was taking Lipitor or the
placebo during the study. I was again told they could not tell me, as they
claimed they did not know. I do not want to start taking Lipitor if I wasn't taking it during the study.
How can I make an informed decision about my health care if I do not know all of
the facts? On August 15, I wrote Henry A McKinnel, the Chairman and Chief Executive Officer
of Pfizer. I explained my problem and asked for his assistance in finding out if
I was taking Lipitor or the placebo. I expected a lame excuse that Pfizer
contracts the testing with independent firms so Pfizer does not have access to
such information. To my surprise, I have not heard anything from Mr. McKinnel or
anyone else at Pfizer. Whereas, Pfizer uses thousands of human beings as guinea pigs, I request that
procedures be established to provide needed and necessary information to study
participants when their participation is terminated. This must be on a timely
basis. I further request that Pfizer work with the FDA and all other drug
manufacturers and study administrators to insure that this is a universal
policy. [APPENDIX 2]
November 10, 2003 Bill Egleston
509 Brentwood Rd
Marshalltown, IA 50158
Tel: 641-752-4579
Email: bill@billegleston.com Pfizer Inc
235 East 42nd Street
New York, NY 10017-5755 Attention: Margaret M Foran Secretary
Dear Ms Foran Enclosed is a proposal to be included in the 2004 Proxy Statement
A portion of my brokerage statement is enclosed to verify that I am a Pfizer
shareholder. Please acknowledge receipt of this proposal by email.
Sincerely yours, /s/
Bill Egleston [INQUIRY LETTER]
January 2, 2004 Bill Egleston
509 Brentwood Rd
Marshalltown, IA 50158
Office of the Chief Counsel
Division of Corporation Finance
Securities and Exchange Commission
450 Fifth St, NW
Washington, DC 20549 Re: Pfizer letter Dec 17, 2003 Shareholder Proposal of Bill Egleston Securities
Exchange Act of 1934 - Rule 14a-8 Ladies and Gentlemen:
I would hope I have the opportunity to state my feelings about the letter you
received from Pfizer. My comments will not be as long, but I do want to make a
few general statements before I try to answer the specific Pfizer comments.
When I sent my proposal to Pfizer, I felt there were several possible courses of
action Pfizer could take: Acceptance: Pfizer could have said the proposal was a very valid concern and
encouraged stockholder approval. Remember, I am only asking that Pfizer take
steps to change current regulations so that participants in their studies are
given timely information about their medical history. Concern: Pfizer could have examined the facts I submitted (possibly insulin
usage increases when Lipitor is taken) and referred this to the medical staff
for evaluation of this possible side effect Action: Pfizer could have taken a stronger stance in helping me to discover if I
was taking Lipitor or a placebo. More about this later when I comment about the
Pfizer letter. Denial: Pfizer could have taken the action to fight my proposal with all the
weight of their legal staff. Obviously, this is the option Pfizer chose.
The Pfizer letter states pursuant to Rule 14a-8(j) that you require 6 copies. I
am enclosing 6 copies of my letter. I am assuming you have the Pfizer letter in
hand so I am not duplicating it. Now, I would like to offer my comments on the Pfizer letter. Notice I did not
use the term "rebuttal". I really am trying to obtain a solution that helps
everyone. ANALYSIS I. The proposal may be excluded ------- because it deals with a personal
grievance against the company. No, I do not have a personal grievance against Pfizer. Quite the opposite, I
like the company or why would I maintain an investment in Pfizer. Yes, I did
include personal information in the proposal, but I felt that it was necessary
to illustrate the need for change. I honestly don't like making this information
available to the millions of Pfizer shareholders. Will I personally benefit if
the shareholders approve the Proposal? No, it will take years to change the
regulations. Future participants in studies will benefit. Yes, that is what I
want to accomplish. II. The proposal may be excluded ----- because it deals with product research,
development, and testing, which are matters relating to the company's ordinary
business operation. Wow, what a catch-all category. Obviously, if I feel something should be changed
I am dealing with "ordinary business operations". (please excuse the sarcasm).
III. The proposal may be excluded ------ because the company has already
substantially implemented procedures for providing information to study
participant in accordance with medical guidelines. What? February 25, 2003 to maybe sometime in late 2004? I guess this is
"substantially implemented"? Pfizer points out that "The study Physician handling the Proponent's case
determined that the Proponent did not qualify to learn what medication he
received under the established procedures". As stated in the Pfizer letter to
Mr. Egleston, the participating physician did not declare a "medical emergency"
so I was not entitled to the medical history I requested. Obviously, there is a
procedure for unsealing the medical information in a timely manner----but what
is a "medical emergency"? I can certainly justify in my mind that I have a
medical emergency, although the attending physician knew I was not having a
heart attack, so in his mind I was not having a medical emergency. A quarterback
with a broken finger on his passing hand would have a difficult time
passing----but a lineman with a broken arm could play with a protective cast. A
cut finger might not change the performance of a jockey, but could stop the
performance of a pianist. What is a "medical emergency"? If the attending
physician had concurred I had a medical emergency, the requested information
would have been given to me on a timely basis and this whole "Proposal" would
never have happened. IV. The proposal may be excluded ----- because claims that study participants
are unable to discover medically necessary information are materially false and
misleading and impugn the integrity of the company. Please let me separate this into two parts. "claims that study participants are
unable to discover medically necessary information are materially false and
misleading" I could not find out the information I wanted. How is my proposal
"false and misleading". The second part would be "the proposal impugns the integrity of the company".
No, that certainly was not my intent. Remember, I sent a letter to Pfizer on
August 15th. and had not received a reply by November 10th. There was very
little time left to submit a shareholder proposal. Pfizer did verbally tell me
they had logged in my letter of August 15th and forwarded it to the Medical
Department. In researching my proposal, they could not locate the letter.
Exhibit "B" is a copy I sent by fax on November 17th. I might still not have an
answer if I had not submitted the proposal. In re-reading my proposal, I do admit that there is frustration and sarcasm.
There is probably frustration and sarcasm in this letter. If Pfizer had endorsed
my proposal, I could have deleted the paragraph about the August 15th letter,
And "guinea pigs" was out of place. The importance of the change in procedures I
would like to see made far out-weighs the verbiage I used in the proposal.
I look at statements 1 to 7 on pages 8 and 9 and do not recognize myself:---
"unsupported statement", "false and misleading", "factual support", "medically
necessary", "erroneously implies", "impugns the reputation", etc. What a villain
I must be. CONCLUSION I certainly feel my proposal has merit. I would encourage Pfizer to re-evaluate
their position and endorse the proposal. Wording changes can be made if this
would help Pfizer accept the proposal. Please let me know if I can be of further assistance.
Sincerely yours, /s/
PS: The study I participated in involved the medicine "Lipitor". This medicine
had FDA approval for lowering cholesterol levels. The study was to determine if
giving the medicine to diabetics would be beneficial in the long run as a
preventative step to future complications. At the conclusion of the study, any
physician could have prescribed this medicine. I point this out to illustrate
that the typical study involves "experimental" drugs that are not available for
prescription pending the lengthy FDA approval process.
[STAFF REPLY LETTER]
January 25, 2004 Response of the Office of Chief Counsel Division of Corporation Finance
Re: Pfizer Inc. Incoming letter dated December 17, 2003
The proposal requests that procedures be established to provide needed and
necessary information to study participants on a timely basis when their
participation is terminated and that Pfizer work with the FDA and all other drug
manufacturers to insure that this policy is a universal policy.
There appears to be some basis for your view that Pfizer may exclude the
proposal under rule 14a-8(i)(7), as relating to Pfizer's ordinary business
operations (i.e., product research, development, and testing). Accordingly, we
will not recommend enforcement action to the Commission if Pfizer omits the
proposal from its proxy materials in reliance on rule 14a-8(i)(7). In reaching
this position, we have not found it necessary to address the alternative bases
for omission upon which Pfizer relies. Sincerely,
/s/ Song P. Brandon
Attorney-Advisor
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