Amicus Curiae Brief — Nike, Inc. v. Kasky

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IN THE

Supreme Court of the Urnitey States

NIKE, INC., et al...

Petitioners,

MARC KASKY,

Respondent.

On Writ of Certiorari to the

Supreme Court of California

BRIEF OF AMICUS CURIAE PFIZER INC

IN SUPPORT OF PETITIONERS

JEFFREY B. KINDLER BERT W. REIN

GEORGE W. EVANS Counsel of Record

STEVEN C. KANY ROSEMARY C. HAROLD

ARNOLD I. FRIEDE WILEY REIN & FIELDING LLP

PV IZER INC 1776 K Street, N.W.

235 East 42nd Street Washington, DC 20006-2304

New York, NY 10017-5755 (202) 719-7000

(212) 573-2323

Counsel for Amicus Curiae

February 28, 2003

| ene enn ene ee

WiILSON-EPES PRINTING CO., INC. — (202) 789-0096 — VASHINGTON, D.C. 20001

TABLE OF CONTENTS

TABLE OF AUTHORITIES

INTEREST OF AMICUS CURIAE

SUMMARY OF ARGUMENT

ARGUMENT

I. THE DECISION BELOW IMPERMISSIBLY

FAILS TO ACCORD ANY WEIGHT TO

THE PREEMINENT FIRST AMENDMENT

VALUE OF FREE AND ROBUST DEBATE

ON MATTERS OF PUBLIC CONCERN

A. Business Speakers Such As Nike Make A

Valuable Contribution To Discussion On

Matters Of Public Concern That May

. First Amendment Principles Generally

Applicable To Debates Over Matters Of

Public Concern Support Nike’s Right To

Contribute To This Public Discussion

THE COURT SHOULD RESOLVE THIS

CASE BY ESTABLISHING A MEANS OF

BALANCING THE GOVERNMENT INTER-

EST IN REGULATING THE COMMER-

CIAL MARKETPLACE AGAINST THE

CONSTITUTIONAL VALUE OF ROBUST

DEBATE ON MATTERS OF PUBLIC

CONCERN

TABLE OF CONTENTS—Continued

A. The Court Should Recognize, At A Mini-

mum, A Constitutional “Right Of Reply”

That Would Allow Business Speakers To

Respond To Criticism Of Their Products,

Services, Or Business Operations Publicly

Raised By Third Parties .............:csseeeeeeeeees

B. Alternatively, The Court Should Clarify

That - The Government Interest In

Protecting the Fair Functioning of the

Marketplace Is Subject To Overall Central

Hudson Balancing Analysis Before

Sanctions May Be Imposed On

Commercial Speech Addressing Matters

Of Public CONCEM...........ceccccrcscsscovesessereeeees

CONCLUSION. .........ccsccssssossssossccsscesessesssesessonsssssssossoes

Page

iil

TABLE OF AUTHORITIES

FEDERAL CASES Page

44 Liquormart Inc. v. Rhode Island, 517 U.S.

a 26

Arkansas Writers’ Project, Inc. v. Ragland, 481

ee 15

Associated Press v. United States, 326 U.S. |

EE 9

Bartnicki v. Vopper, 532 U.S. 514 (2001)............. 14, 23

Bates v. State Bar of Arizona, 433 U.S. 350

a 22, 27

BE & K Construction Co. v. NLRB, 122 S. Ct.

Ee 20, 24

Board of Trustees of the State University of New

York v. Fox, 492 U.S. 469 (1989) .....ccccccccccceeees 23

Bolger v. Youngs Drug Products Corp., 463 U.S.

a 7,9, 22

California Motor Transport Co. v. Trucking

Unlimited, 404 U.S. 508 (1972) ........cccccccceeeeees 23

Central Hudson Gas & Electric Corp. v. Public

Service Commission, 447 U.S. 557 (1980)........ passim

City of Cincinnati v. Discovery Network, Inc.,

| ee eee 22, 26

City of Ladue v. Gilleo, 512 U.S. 43 (1994).......... 15

Consolidated Edison Co. of New York v. Public

Service Comission of New York, 447 U.S. 530

a a 15

DeBartolo v. Florida Gulf Coast Building &

Contruction, 485 U.S. 568 (1988) .............ccc0000 16

Dun & Bradstreet v. Greenmoss Builders, 472

a 19, 20

Eastern Railroad Presidents Conference v. Noerr

Motor Freight, 365 U.S. 127 (1961)............0000 20

Edenfield v. Fane, 507 U.S. 761 (1993) ..........000 passim

First National Bank of Boston v. Bellotti, 435

Eee passim

TABLE OF AUTHORITIES—Continued

Page

Gertz v. Welch, Inc., 418 U.S. 323 (1974)...14, 19, 23, 28

Greater New Orleans Broadcasting Association

v. United States, 527 U.S. 173 (1999)... 22

Hynes v. Oradell, 425 U.S. 610 (1976)... 20

Ibanez v. Florida Department of Business &

Professional Regulation, Board of Account-

ancy, 512 U.S. 136 (1994) ....ccceccceeeeeeenees 22, 25, 26, 27

In re R.M.J., 455 U.S. 191 (1982).........ccccceceeeeseees 27

Lorillard Tobacco Co. v. Reilly, 533 U.S. 525

(| 22

Martin v. Struthers, 319 U.S.141 (1943) .........0006: 20

Mine Workers v. Pennington, 381 U.S. 657

|_| Eee 20

New York Times Co. v. Sullivan, 376 U.S. 254

(BBG) .ccecccceccccsccccersencesescssscnssssonsssossssonsssnsnscsnseess passim

Ohralik v. Ohio State Bar Association, 436 U.S.

CL , _ 22, 23, 26

Pacific Gas & Electric Co. v. Public Utilities

Commission, 475 U.S. 1 (1986) ............ccceeeeeeeees passim

Pearson v. Shalala, 164 F.3d 650 (DC Cir.

ee 27

Peel v. Attorney Registration and Disciplinary

Commission of Galifornia, 496 US. 91

(| 16, 27

Philadelphia Newspapers v. Hepps, 475 U.S. 767

| 28

Posadas de Puerto Rico Associates v. Tourism

eM LS: || 26

R.A.V. v. City of St. Paul, Minnesota, 505 U.S

STD (RGB ceccccesccsseccesssesessccssssnsssensssssesesssesensoseses 15

Revo v. Disciplinary Board of the Supreme Court

for the State of New Mexico, 106 F.3d 929

C0 Ia Cle. BD DT acccccccccccssvssnsssescsescesesessesssssssssssess 25

TABLE OF AUTHORITIES—Continued

Page

Richmond Newspapers, Inc. v. Virginia, 448 U.S.

en a TE 21

Riley v. National Federation of the Blind of

North Carolina, 487 U.S. 781 (1988)................ 17, 29

Rubin v. Coors Brewing Co., 514 U.S. 476

ee a 22, 26

San Francisco Arts & Athletics, Inc. v. U.S.

Olympic Commission, 483 U.S. 522 (1987) ...... 20

Shapero v. Kentucky Bar Association, 486 U.S.

Ee ee 27

Texas v. Johnson, 491 U.S. 397 (1989) .......ccccc. 28

Texas Monthly, Inc. v. Bullock, 489 U.S. |

ea 15

Thomas v. Collins, 323 U.S. 516 (1945).....ccc0c000+. 15

Thompson v. Western States Medical Center, 122

ES passim

Thornhill v. Alabama, 310 U.S. 88 (1940) ............ 15

United States v. Edge Broadcasting, 509 U.S.

En ENN 22, 26

United States v. O’Brien, 391 U.S. 367 (1968) ..... 28

Virginia State Board. of Pharmacy v. Virginia

Citizens Consumer Council, 425 U.S. 748

eT 14, 22

Watchtower Bible & Tract Society of New York,

Inc. v. Village of Stratton, 536 U.S. 150

ee 20, 28

Waters v. Churchill, 511 U.S. 661 (1994) ............. 15, 16

Whitney v. California, 274 U.S. 357 (1927),

overruled in part by Brandenburg v. Ohio, 395

ee ee ieeresettntinnrncnentnianentsrnatintinmntuntaase 15

Zauderer v. Office of Disciplinary Counsel of the

Supreme Court, 471 U.S. 626 (1985) .......ccc000 27

TABLE OF AUTHORITIES—Continued

STATE CASES Page

Kasky v. Nike, 79 Cal. App. 4th 165 (2000) .......... 16

Kasky v. Nike, Inc. 45 P.3d 243, (Cal. 2002), cert |

granted 123 S. Ct. 817 (2003) ........s-seeeeereererenes passim

STATUTES, RULES AND REGULATIONS

21 U.S.C. § 301 ef S€q........ccecessersereesennennenenennennenes 3

Cal Bus. & Prof. Code § 17200 ef S€q. .........00+0+++ 4,7

Cal Bus. & Prof. Code § 17204 .........:ccccceeeeeeeees 8

Cal Bus. & Prof. Code § 17500 ...........c.csseseeneeees 7

Sup. Ct. R. 37.3(8) ...-sesesesssesesesessesesnsnenenenenenenansnenes l

Sup. Ct. R. 37.6.....ccccesesessesssssssnsnsnsesersenenensnnanenenss l

INTEREST OF AMICUS CURIAE

Pfizer Inc (“Pfizer”) is the world’s leading research-based

pharmaceutical company. Pfizer discovers, develops, and

manufactures prescription drugs and other consumer health

care products that are marketed worldwide.' Because Pfizer

scientists and doctors operate at the cutting edge of knowl-

edge in science and medicine, the company possesses a vast

body of information relating to health care matters, including

the characteristics of its products and the many health

conditions they treat, as well as the scientific, economic, and

political contexts in which issues surrounding them arise.

Pfizer exercises its First Amendment right to address the

public—including physicians who prescribe and patients who

use its products—in a number of different ways. The com-

pany is a substantial advertiser seeking to disseminate

information to promote the sale of its products. Other Pfizer

promotional material, such as the company’s extensive web-

site, provides considerable factual data on health conditions

as well as commercial information about Pfizer products.

When it advertises or promotes at its own initiative, Pfizer

recognizes that the government has a legitimate interest in

regulating the commercial marketplace to ensure that con-

sumer decisions are not distorted by false or misleading

commercial information.

Pfizer also speaks out on public health and policy issues

that may relate, directly or indirectly, to the company’s

products and operations. For example, the company

' Pursuant to Sup. Ct. R. 37.6 (“Rule”), Pfizer states that no counsel for

a party has authored this brief in whole or in part, and no person or entity

other than Pfizer has made a monetary contribution to the preparation or

submission of the brief. Pursuant to Rule 37.3(a), Pfizer has obtained

consent of the parties to the filing of this brief. The requisite consent

letter from Respondent Marc Kasky was submitted to the Court on

Feb. 14, 2003. Petitioners Nike Inc., ef al., filed a blanket consent letter in

this docket on Feb. 3, 2003.

comments generally on broad public policy issues through its

Pfizer Forum series of sponsored editorials and through pub-

lic statements of its senior officers. In that capacity, Pfizer

believes, as this Court held in First National Bank of Boston

v. Bellotti, 435 U.S. 765 (1978), that it should be entitled to

the same First Amendment protections as any other speaker.

In addition, Pfizer responds to matters of public concern, as

Nike did in the case at bar, through vehicles such as media

releases, interviews, and letters to the editor. These responses

are not limited to abstract statements on political topics or

societal trends but rather typically involve discussion of spe-

cific products in the context of news about scientific devel-

opments or consumer issues. In the last several months, for

instance, mainstream media have tracked test developments

concerning the long-term safety of hormone replacement

therapy (“HRT”) for women. The public discussion has

included questions as to whether HRT products different from

those tested in a recent groundbreaking study would produce

different results. Drug effectiveness also is a matter of public

discussion, especially within the scientific community and the

specialty media that serve it. For example, the federal gov-

ernment recently published the results of a landmark study

designed to compare three different types of drugs used to

treat coronary heart disease, thereby touching off ongoing

debate in both professional and consumer circles over the

results. Pfizer manufactures both HRT products and one type

of the heart disease drugs tested. In responding to these

debates and protecting its commercial position, the company

often enters into areas of scientific controversy involving

competing priorities; balancing of risks, costs, and benefits;

and other scientific and/or economic trade-offs in which what

is “misleading” can be as much a matter of viewpoint as

of knowledge.

Pfizer is significantly handicapped in its responses by the

threat of action under state laws like the California statute at

issue.” The company believes that such handicaps, when

applied as in this case, are antithetical to the First

Amendment and to the public’s interest in being fully

informed on important health care issues. Pfizer thus views

this case as an opportunity for this Court to secure the First

Amendment rights of commercial speakers in addressing

matters of public concern that involve their products and

operations, subject only to the same governmental restrictions

and reviews legitimately imposed on other participants in

public debate. Pfizer urges that this Court either (a) adapt the

existing commercial speech doctrine set forth in Central

Hudson Gas & Electric Corp. v. Public Service Commission

of New York, 447 U.S. 557 (1980), and its progeny, to give

express recognition to a right of equal reply; or (b) clarify its

Central Hudson criteria to recognize that the governmental

interest in safeguarding the commercial marketplace from

false and misleading statements is not an absolute exception

to the need to examine the strength of that interest in specific

circumstances, the means by which that interest is advanced,

and the potential overbreadth of its intrusion into protected

public debate.

SUMMARY OF ARGUMENT

This case presents a collision between the State of

California’s claimed interest in protecting its citizens from the

adverse influence on commercial transactions of allegedly

false and misleading statements and Nike’s First Amendment

* Pharmaceutical manufacturers also are subject to extensive regulation

under the Food, Drugs & Cosmetics Act of 1906, as amended, with

respect to their speech about drug products. See 21 U.S.C. § 301 ef seq.

In connection with an inquiry of the Food and Drug Administration

concerning the application of existing constitutional principles to FDA

speech regulation, Pfizer has recommended formal recognition of a pro-

tected right of response. See Letter of George W. Evans, Associate Gen-

eral Counsel, Pfizer Inc, to Dockets Management Branch, Food & Drug

Admin., Docket No. 02N-0209 (dated Dec. 11, 2002) (attached).

interest in participating as an equal in ongoing public debate

on “globalization” issues that potentially affect both its

product sales and future governmental actions. The majority

of the California Supreme Court sought to resolve this

collision by determining whether Nike’s speech should be

classified as “commercial.” Answering in the affirmative, the

majority then treated California’s regulatory interest as

absolute and gave no further attention to Nike’s speech rights

or to the interests of California citizens in hearing both sides

on this matter of public concern. The majority premised its

analysis on what it understood—erroneously, Pfizer

believes—to be this Court’s teaching that states may ban or

sanction “false or misleading” commercial speech without

regard to the context in which the speech arises or the adverse

impact of such state action on the marketplace of ideas.

The decision below leaves Nike, and similarly situated

commercial entities, at a dual disadvantage in participating in

public debate that involves their products or business opera-

tions. First, as a substantive matter, their speech—unlike that

of other participants—is subject to liability under the Cali-

fornia Business & Professions Code § 17200 et. seq.

(“Code”) if judged false or misleading, with consequent

potential for significant economic and criminal penalties.

Second, as a procedural matter, this judicial review of their

statements under the Code can be triggered at the discretion

of their critics. There can be little doubt of the adverse effect

that these dual handicaps impose on business participation in

the increasingly frequent public debate about products and

business operations, and consequently on the process of

debate itself. It is equally apparent that this outcome cannot

be squared with fundamental First Amendment values or this

Court’s long endorsement of the process of robust collision of

ideas through which truth emerges.

Although the record before this Court demonstrates broad

business, media, and public interest group concurrence that

the decision below must be reversed, there is- far less

agreement on an appropriate rationale. Following the lower

court’s lead, the parties and most amici focused their attention

at the certiorari stage on the issue of whether Nike’s speech

should be considered “commercial.” They proposed that the

Court either abolish the commercial speech category or

narrow it in a way that would place Nike’s speech outside of

it. Pfizer, while not questioning that the commercial speech

criteria might usefully be clarified, believes that a different

analysis would better meet the issues presented in this case.

Accepting arguendo that the subject matter of Nike’s

speech might trigger a legitimate state interest in regulating

the commercial marketplace, Pfizer irges the Court to hold

that any such interest still must be weighed against the

competing value of vigorous public debate. In order to

decide the case on the narrowest basis, the Court should

recognize an overriding “right of reply,” which would permit

commercial entities to meet their adversaries on an equal

substantive and procedural footing in a discussion or debate

over matters of public concern. This holding would require

reversal of the decision below because the lower court, in

applying the Code, reached the opposite result. A recognized

right of reply would free a commercial entity to fairly protect

its interests and inform the public decisional process

whenever critics, or the independent editorial judgment of the

media, subjected the entity’s products, services, or business

operations to public scrutiny.

On a broader basis, Pfizer believes that the facts of this

case give the Court a unique opportunity to clarify its com-

mercial speech precedents and to harmonize them with more

general speech doctrine. The commercial speech label might

best be viewed simply as a determination that the content

could directly influence the conduct of commercial trans-

actions and thus trigger a legitimate state interest in pre-

venting false or misleading information from distorting those

transactions. As with other state interests that the Court has

identified in its commercial speech precedents, however, the

suppression of allegedly false or misleading information

should not be a paramount interest that forecloses the full

Central Hudson balancing analysis. Rather, that interest must

be weighed, as Central Hudson instructs, against coun-

tervailing interests in free expression and the value of a clash

of positions on matters of public concern. Where, as here,

vigorous public debate already exists, the state has at best

only an attenuated interest in making its courts—rather than

the competition among ideas in that debate—the vehicle for

preserving market integrity. Moreover, despite the assumed

“hardiness” of the speech, based on the speakers’ economic

interests and their detailed knowledge of their own products

and business operations, permitting an action to go forward

under the Code also creates substantial risk of chilling speech

which is neither false nor misleading. Application of the

operative factors of the Court’s Central Hudson test to

challenged speech restraints in such cases would provide both

a basis for reversal here and a better foundation for recon-

ciling state interests in marketplace integrity and competing

free expression values.

ARGUMENT

I. THE DECISION BELOW IMPERMISSIBLY

FAILS TO ACCORD ANY WEIGHT TO THE

PREEMINENT FIRST AMENDMENT VALUE

OF FREE AND ROBUST DEBATE ON

MATTERS OF PUBLIC CONCERN

The dispute here evolved in circumstances typical of those

that often surround other high-profile matters of public

controversy. Nike’s critics began airing their views publicly

in the mid-1990s, linking the company’s alleged unfair

foreign labor practices with the larger policy debate over

“economic globalization.” Kasky v. Nike, Inc., 45 P.3d 243,

264 (Cal. 2002), cert. granted, 123 S. Ct. 817 (2003). Those

criticisms led to a widespread series of media reports that cast

a cloud over Nike’s image—and fed into discussion about the

——i ——

need for national or international policy initiatives to address

globalization concerns. /d. Nike responded to the specific

criticism of the company in several ways, including com-

missioning an independent assessment of its foreign sub-

contractors’ labor practices and issuing press releases and

other public statements to rebut its antagonists. /d. at 248.

All the while, and up through the present day, public debate

over globalization continues in “uninhibited, robust, and

wide-open” fashion, see New York Times Co. v. Sullivan, 376

U.S. 254, 270 (1964), not only through the media but through

demonstrations in the streets of many cities across both the

nation and the globe.

Mr. Kasky, one of Nike’s critics, took a step beyond the

usual arenas for public debate by filing suit against the

company under the “unfair business practices” and “false

advertising” provisions of the Code. Kasky, 45 P.3d at 247.

The relevant provisions, by their terms, are designed to pre-

vent fraudulent transactions in the commercial marketplace.

See Code §§ 17200, 17500; see also Kasky, 45 P.3d at 249

(recognizing the Code as a “consumer protection law”).

Here, the California Supreme Court acknowledged the public

debate in which the challenged speech arose but nonetheless

focused its legal analysis solely on the question of whether

the speech at issue was “commercial.” /d. at 247. Relying

principally on the so-called Bolger factors, the majority

scrutinized Nike’s identity as a business speaker, its eco-

nomic interests in its products and the image behind them,

and the potential customers in the audience toward which

Nike’s speech was aimed. /d. at 254-256 (citing Bolger v.

Youngs Drug Prods. Corp, 463 U.S. 60 (1983)). The court

concluded that Nike’s speech was commercial and, as a con-

sequence, subject to unconstrained false-or-misleading review

under the Code. Kasky, 45 P.3d at 259. The court then

terminated its review, without considering how any counter-

vailing First Amendment concerns might weigh in the

constitutional balance.

As a result, Nike now faces potential burdens that only it,

but not its critics, must bear for airing its views in the public

debate. Mr. Kasky is seeking a host of remedies, including,

inter alia, disgorgement of “all monies” that Nike acquired

through its alleged deception, Nike sponsorship of a “Court-

approved public information campaign” to remedy the

alleged misinformation, and, of course, attorneys’ fees. Id. at

248. Moreover, because the Code lacks the usual procedural

safeguard provided by traditional standing requirements,

which ordinarily set actual injury as a condition for main-

taining an action, see Code § 17204 (permitting action to be

prosecuted by “any person acting for the interests of .. .

general public”); Petition for Writ of Certiorari at 3, Nike v.

Kasky (2002) (No. 02-575) (“Brief of Petitioner”) (citing

respondent’s original complaint conceding no injury or

“personal knowledge” of facts), it has, in effect, allowed Mr.

Kasky to speak twice in the public debate—first by objecting

as a private citizen to Nike’s labor practices and then by

cloaking himself in the garb of the state to chill the com-

pany’s response. Nike, in contrast, may speak only once, and

then only at the risk of severe sanction.

Were the Court to uphold the ruling below, the decision

would severely retard, if not suppress entirely, the ability of

any seller of products or services in California to respond to

public criticism of its products, services, or business opera-

tions if its responses might affect its sales. In addition,

because of California’s prominence in the national economy,

the decision below also would effectively retard speech by

business speakers throughout the United States on many

matters of public concern. These include the many political

topics, societal trends, consumer issues, and scientific

developments that affect the perception of product or service

quality or of business integrity.

A. Business Speakers Such As Nike Make A Valu-

able Contribution To Discussion On Matters Of

Public Concern That May Implicate Their

Products, Services, Or Business Operations

The heart of the ruling below is the notion that the eco-

nomic motivation of the speaker—in and of itself—is suffi-

cient to determine whether Nike, or any business speaker, has

equal freedom to participate with other speakers in debate

over matters of public concern.’ Kasky, 45 P.3d at 257. This

case does not reprise the question of whether corporations

have the same rights as others to speak generally on ballot

issues or other broad policy controversies. See Bellotti, 435

U.S. 765; Pacific Gas & Elec Co. v. Public Utils. Comm’n of

Cal. 475 U.S. 1, 8 (1986). Nor does this case call into

question the speech rights of businesses in their self-initiated

sales efforts. See, e.g., Thompson v. Western States Med.

Cir., 122 S. Ct. 1497 (2002). The decision below actually

raises a new question for this Court: Even assuming that a

business entity’s speech on a matter of public concern may

affect its sales, should that foreclose a careful balancing of

the government’s consumer protection interest against the

constitutional value of affording all “diverse and antagonistic

sources,” Associated Press v. United States, 326 U.S. 1, 20

(1945), equal First Amendment protection when that business

entity is contributing to public debate?

* Although the lower court articulates a new three-point definition of

commercial speech and defends its rationale at length, Kasky v. Nike, Inc.,

45 P.3d 243, 256-259 (Cal. 2002), cert. granted, 123 S. Ct. 817 (2003), all

elements of the new analysis reduce to economic motivation. This

motivation identifies as commercial not only the “speaker” but also the

“intended audience” and the “content” of essentially all of the speaker’s

messages—as well as the speaker’s reasons for existing, and speaking, at

all. In identifying economic motivation as the linchpin of its commercial

speech definition, the lower court latched onto, and extended, one of the

defining factors set forth in Bolger v. Youngs Drug Prods. Corp., 463 U.S.

60, 66-67 (1983).

The California Supreme Court, struggling with the com-

mercial speech definition, never even considered this ques-

tion. The Constitution, however, requires it. So, too, does

life in the real world. The Court already has been presented

with many examples illustrating how business speakers may

provide useful input on matters of public concern that involve

their products, services, or business operations. E.g., Brief of

Amici Curiae of Council of Public Relations Firms, et a/., at

5-6, 13-5, Nike v. Kasky (2002) (No. 02-575) (“Amicus Brief

of Public Relations Firms”) (citing, e.g., agricultural products

manufacturers’ scientific arguments concerning genetic

modification of crops, technology companies’ opinions on

immigration policy as it affects high-tech workers, energy

companies’ assessments of wind- and solar-power devel-

opments). The record also shows that business enterprises are

important sources of information and viewpoints for media

coverage of such issues, and that these sources may wither if

the ruling below stands. Brief of Amici Curiae ABC, Inc., ef

al., at 4-11, Nike v. Kasky (2002) (No. 02-575) (“Amicus

Brief of News Media”) (noting business trade press warnings

about speech liability risks post-Nike).

So many public debates today involve what might be

considered “business” issues that unnecessary restraints on

corporate speech relating to products, services, or business

operations would deprive listeners of valuable information

that can contribute both to their economic decisions and their

understanding of the broader debate. See, e.g., Pacific Gas &

Elec., 475 U.S. at 8. Journalists for decades have been

trained specifically to use concrete factual examples to illus-

trate larger policy debates precisely because that approach is

an effective device for explaining complex issues to an

audience. See, e.g., The Missouri Group, News Reporting

and Writing, at 265 (1980) (“Specific detail gathered by

observant and questioning reporters always wins out over

general description.”); id. at 272 (“telling a story” by focusing

on “part of the whole . . . makes large institutions, complex

ee —

issues and seven-digit numbers meaningful”). It is therefore

nonsensical to suggest that either the media or their business

sources can make the best possible contribution to public

debate if corporate entities are free to speak only in gen-

eralities. Kasky, 45 P.3d at 260-261.

Pfizer, as a pharmaceutical manufacturer, is knowledgeable

about and interested in many matters of public concern that

touch upon the company’s expertise. Health issues—includ-

ing the identification of diseases and conditions, treatment

options, research developments, and the cost and availability

of health care—plainly are topics of public discussion and

debate. To provide the Court with some indication of the

scope of public concern over health matters that involve

drugs or medical devices, Pfizer has compiled a brief

appendix of selected media clippings gathered since October

2002, which cover topics ranging from potential new vac-

cines to prevent cancer caused by a widespread virus to

ongoing disputes about alleged psychiatric side effects of a

certain acne treatment. See App. at 22a, 25a.

As noted in the Interest of Amicus statement, supra,

prescription drug products are often topics of intense public

discussion. Certainly the scientific data released under the

auspices of the National Institutes of Health in July 2002

concerning HRT therapy has evoked widespread discussion

in consumer circles, as well as debate in the professional and

scientific communities. See, e.g., Gina Kolata & Melody

Petersen, Hormone Replacement Study A Shock to the Medi-

cal System, N.Y. Times, Jul. 10, 2002, at Al; Ceci Connolly,

Doctors Working to Clear the Fog of Hormone Study, Wash.

Post Jul. 28, 2002, at Al; Regina McEnery, Experts still

disagree on wisdom of hormone therapy, Cleveland Plain

Dealer Oct. 8, 2002, at B4; Prithi Yelaja, More HRT studies

in the works, Toronto Star, Jan. 16, 2003, at K4; Nancy

Weaver Teichert, Confusion persists over menopause care:

Hormones or not? Women and doctors search for answers,

Sacramento Bee, Jan. 29, 2003, at Al; see also App.

at 9a, 18a. Manufacturers of various HRT products, who

have developed and collected extensive data on women’s

health and the effects of their drugs, can make valuable

contributions to that ongoing discussion. See Melody

Petersen, Wyeth Criticizes Media Coverage of Hormone

Replacement Drugs, New York Times, Jul. 24, 2002, at C8.

Even though these manufacturers have an economic interest

in their products, it would serve no constitutional purpose to

discourage them from at least responding to, if not initiating,

assertions or questions about the risks and benefits of the

therapy options—such as weighing the benefits of treating

menopausal symptoms and the relative risks of heart disease,

cancer, osteoporosis, etc., implicated in the studies. See; e.g.,

Teichert, supra.

The HRT issue also illuminates a significant weakness in

the justification for applying lesser First Amendment protec-

tion to business speech on matters of public concern. The

lower court in Nike dutifully recited the long-standing ration-

ale for the greater restraints imposed on commercial speakers:

the business speaker is best positioned to know the “truth”

about its products and is more likely to persist, because of its

economic motivation, in speaking out about them. Kasky, 45

P.3d at 253. Neither rationale works in the HRT context.

There is yet no scientific consensus with respect to HRT

therapy; scientists and other research professionals are now

debating the implications of the 2002 data, while doctors and

their patients are discussing whether HRT is advisable based

each woman’s needs and health profile. Given the ongoing

therapeutic ferment, there is no reason to believe that HRT

manufacturers would persist in airing their views on the topic

in the face of Code sanctions—even though listeners would

benefit from that information.

Scenarios like this are not uncommon with respect to other

pharmaceutical products or, indeed, any product or service

that may implicate evolving scientific developments. For

instance, medical researchers, physicians, and patients cur-

rently are discussing and debating the meaning of two head-

to-head studies of different hypertension medications. In

December 2002, researchers released the results of the largest

clinical study of blood pressure treatments ever conducted in

the United States. See, e.g, News Release, National

Institutes of Health, NHLBI Study Finds Traditional Diuretics

Better Than Newer Medicines for Treating Hypertension,

(Dec. 17, 2003), available at www.nhlbi.nih.gov/new/press/

02-12-17.htm (announcing results of Antihypertensive and

Lipid-Lowering Treatment to Prevent Heart Attack Trial,

known as “ALLHAT”); David Brown, Study Calls Diuretics

Best Against Hypertension, Wash. Post, Dec. 18, 2002 at Al.

The study centered on comparisons of three alternative types

of drugs, one of which Pfizer manufactures. More recently,

however, a separate study came up with contrary results: “In

what seems to be a classic whipsawing of medical news, a

new Australian study appears to contradict conclusions from

a recent U.S. trial that found older, inexpensive diuretic

medications were just as good or better than costlier new

drugs for treating high blood pressure.” Ulysses Torassa,

Hypertension study findings in conflict; One says newer,

costlier therapies better, the other says older treatments just

as good, S.F. Chron, Feb. 13, 2003 at A4. Professionals

reacting to the studies noted that certain population groups

seem to respond better to one alternative treatment or

another—and made the indisputable observation that the

matter is far from resolved. Torassa, supra (quoting epide-

miologist stating, “I don’t think we can sort this out

immediately. We’ll have to digest it and do some pooling of

the data with different studies.”); Scott Hensley, Hyperten-

sion Report Disputes Earlier Study, W.S. Journ., Feb. 13,

2003 (noting “backlash” among some doctors against

U.S. study).

Denying full First Amendment protection to drug manu-

facturer speech on HRT and hypertension therapies would not

result in better consumer or regulatory decisions on the sub

jects. It would simply chill the prospects that business

information and viewpoints would emerge publicly. This

type of outcome, whatever the economic arena may be, would

not simply hurt business speakers. Categorically reducing the

First Amendment protection afforded to “economically moti-

vated” speech in all instances would deprive listeners of data

and opinions on issues that matter to them. It is also unnec-

essary, in a society that values its free enterprise system, to

demean all business speech arising within a public debate

simply because it could also redound to the speaker's finan-

cial benefit. Courts cannot assume that listeners, when deter-

mining for themselves the worth of a particular message, are

incapable of taking both the content and the speaker s

motivation into account—regardless of whether the situation

is a commercial one or not. See, e.g., Bellotti, 435 US. at

791 n.31 (“The First Amendment rejects the ‘highly

paternalistic’ approach of statutes . . . which restrict what the

people may hear.”) (quoting Virginia State Bd. of Pharmacy

v. Virginia Citizens Consumer Council, 425 U.S. 748, 770

(1976).

B. First Amendment Principles Generally Applic-

able To Debates Over Matters Of Public

Concern Support Nike’s Right To Contribute

To The Public Discussion

If the facts here had been assessed solely against the free

speech principles that usually apply to discussion on “matters

of public concer,” see, e.g., Gertz v. Welch, Inc., 418 US.

323 (1974); Bartnicki v. Vopper, 532 U.S. 514 (2001), the

case would not be before this Court now. There is no dispute

here that this case arose within the context of a public debate

initiated by others—and that the materials at issue are Nike’s

replies to its critics. Kasky, 45 P.3d at 263. In the normal

course of public discussion, responses from interested parties

are both expected and encouraged because the First Amend-

ment carries a presumption that truth will best emerge from

the “collision” of ideas that results from open channels of

communication. See, e.g., New York Times, 376 U.S. at 266,

269-271 & n.19 (even false statement contributes by bringing

about a “clearer perception and _ livelier impres-

sion of truth, produced by its collision with error”) (citing

Mill, On Liberty (Oxford: Blackwell 1947), at 15). Should

any speech uttered during the debate be false or misleading,

the preferred constitutional remedy for exposing it is more

speech, rather than less. See, e.g., Whitney v. California, 274

U.S. 357, 377 (1927) (Brandeis, J., concurring), overruled in

part by Brandenburg v. Ohio, 395 U.S. 444 (1969).

The presumption carries particular force in settings such as

Nike, where multiple speakers are engaged in the discussion.

In protecting the conditions required for robust debate to

flourish, the Court has repeatedly demonstrated a concern for

the concept of the “level playing field.” See, e.g., Thornhill v.

Alabama, 310 U.S. 88 (1940); Thomas v. Collins, 323 U.S.

516 (1945); Waters v. Churchill, 511 US. 661 (1994)

(termination improper when nurse spoke out on matter of

“public concern” involving hospital). This overarching

concern encompasses disapproval of discrimination on the

basis of speaker identity or viewpoint. See, e.g., Bellotti, 435

U.S. at 776; R.A.V. v. City of St. Paul, Minn., 505 U.S. 377

(1992) (improper restraint based on viewpoint); cf. City of

Ladue v. Gilleo, 512 U.S. 43 (1994) (inequitable regulatory

treatment of signs based on content); Texas Monthly, Inc. v.

Bullock, 489 U.S. 1 (1989) (inequitable tax treatment of

publications based on content); Arkansas Writers’ Project,

Inc. v. Ragland, 481 U.S. 221 (1987) (same). Accordingly,

the Court has repeatedly acted to protect the ability of

speakers—both corporate and individual—to discuss matters

of public concern without having to confront either direct

recrimination or indirect restraint. See, e.g., Bellotti, 435 U.S.

at 776; Consol. Edison Co. of N.Y. v. Pub. Serv. Comm'n of

NY, 447 U.S. 530 (1980) (utility allowed to provide bill

inserts on matters of public controversy); Pacific Gas &

Elec., 475 U.S. 1 (utility not obligated to carry counter-

speech to political editorials inserted in gas bills); Waters,

511 U.S. 661; DeBartolo Corp. v. Florida Gulf Coast Bldg. &

Constr., 485 U.S. 568 (1988) (peaceful handbilling by union

permitted at shopping mall). The Court’s precedent reflects

an understanding that the give-and-take process of any

dialogue benefits those who listen, as well as those who

speak, especially when the debate occurs in a public arena.

Pacific Gas & Elec., 475 U.S. | (First Amendment serves

significant societal interests wholly apart from the speaker s

interest in self-expression”); Bellotti, 435 U.S. at 776 (“The

Constitution often protects interests broader than those of the

party seeking their vindication.”).

Under these general First Amendment principles, there is

no justification for the state to suppress one side of the debate

over Nike’s labor practices abroad or the larger issue of

globalization generally—although that is precisely what the

Code, as applied by the court below, would permit. Kasky v.

Nike, 79 Cal. App. 4th 165, 175 (2000) (“Though drafted in

terms of commercial speech, the complaint in fact seeks

judicial intervention in a public debate.”) No one contends

here that the Code was designed to police discussion on

matters of public concern. Both sides have access to the

public arena to air their views and the facts they offer to

support those views. The public would benefit from exposure

to robust debate on the issues. There is no reason to believe

that listeners would be unable to take the |; —— of

ers, economic or otherwise, into account in evaluating

eden the merit of the information and ideas being

exchanged—which the Court has recognized they can do

even when confronted with direct sales pitches. Peel v.

Attorney Registration and Disciplinary Comm 'n, 496 U.S. 91,

105 (1990) (rejecting notion that recipients of commercial

speech “are no more discriminating than the audience for

children’s television”). There also is no reason to believe that

any arguably false or misleading information would be left

unrebutted in the course of this ongoing debate, just as occurs

in discussions of other matters of public concern. See

Amicus Brief of News Media at 18-20 (news coverage calling

certain Nike assertions into question). In short, from the

public debate side of the collision of interests presented in

this case, there is no justification for the State of California,

or persons acting in its stead, to determine whether some

speakers’ assertions are so untrustworthy that they must be

suppressed, or punished, while allowing other speech to flow

freely. See, e.g., Riley v. Nat'l Fed'n of the Blind of N.—., 487

U.S. 781, 791 (1988) (“the government, even with the purest

of motives, may not substitute its judgment as to how best to

speak for that of speakers and listeners . . .”).

il. THE COURT SHOULD RESOLVE THIS CASE

BY ESTABLISHING A MEANS OF BALANC-

ING THE GOVERNMENT INTEREST IN

REGULATING THE COMMERCIAL MARKET-

PLACE AGAINST THE CONSTITUTIONAL

VALUE OF ROBUST DEBATE ON MATTERS

OF PUBLIC CONCERN

The potential chilling effect of the decision below has

prompted a host of interested entities, including several that

do not often find common cause, to combine in urging this

Court to reverse the California Supreme Court’s decision.

Most follow that court’s lead by focusing on the commercial

speech definition but, in so doing, part company on how best

to reach the desired outcome. See, e.g., Brief of Amicus

Curiae Center for the Advancement of Capitalism at 9-12,

Nike v. Kasky (2002) (No. 02-575) (repudiate the commercial

speech doctrine entirely); Amicus Brief of News Media at 12-

15 (define commercial speech as only that which “does no

more tha. propose a commercial transaction’’); Brief of Peti-

tioner at 21, 25 (suggest defining commercial speech as only

that which refers to a specific product or service); Brief of

Amicus Curiae U.S. Chamber of Commerce at 10-11, Nike v.

Kasky (2002) (No. 02-575) (distinguishing “business opera-

tions” from “product or service”).

Pfizer recognizes that the harms to public debate arising

from the decision below could be avoided by defining Nike’s

statements as something other than commercial, thus placing

them constitutionally beyond the reach of the Code. Yet a

narrowed definition, or outright rejection, of the state’s inter-

est in regulating commercial speech could also devalue

California’s legitimate interest in regulating commercial

transactions. Pfizer recognizes that fair and honest commer-

cial dealings are the foundation of a healthy free enterprise

system, and the government has a role to play in policing that —

marketplace. Because consumer protection is a valid

government concern, a failure to recognize the state interest

in regulating commercial speech would not be warranted.

Further efforts to define commercial speech, however,

would simply resurrect old problems or create new ones. The

suggestions offered here illustrate that point by simply adding

potential complications to the existing ambiguities. Defining

commercial speech as that which does no more than “propose

a commercial transaction” begs the question that has

bedeviled the Court for years: What constitutes a proposal?

Should it always require the use of the term “buy” or the

inclusion of a price term? Does form matter, or context? The

potential variants are daunting. Against that prospect, there

may be some surface appeal to the idea of limiting the

commercial speech label to only those communications that

explicitly refer to a product or service. But that alternative

sweeps too much high-value speech into diminished con-

stitutional protection. Many legitimate matters of public

concern do involve actual products and services. See supra

Section I.A; Appendix. Furthermore, contrary to the

conclusion of the court below, Kasky, 45 P.3d at 260-61, the

public “concern” often cannot be discussed sensibly without

reference to those products or services. See, e.g., Amicus

Brief of Public Relations Firms at 11-13 (Tylenol/cyanide

tampering incident and its subsequent impact on product

packaging of many kinds). A similar infirmity infects the

notion that discussion of “business operations” could some-

how be easily segregated from discussion of products or

services. Business operations that become a matter of public

concern often may be bound up in the development of

products or services, see Amicus Brief of News Media at 3,

6-7, such as the testing that leads to the creation of new foods

or drugs. See App. at 25a, 32a. The distinction is too easily

blurred to be definitive.

Pfizer believes that the decision below can be reversed

without either attempting again to perfect the commercial

speech definition or substantially overhauling the Central

Hudson balancing test. Set forth below are two alternatives

that share a common foundation: both recognize that cases

such as Nike present competing interests that warrant a more

careful balancing assessment tha.. the California court under-

took here. The government’s interest in safeguarding the

commercial marketplace from false and misleading state-

ments cannot, in every circumstance, trump the competing

value of vigorous public debate on matters of public concern.

On the other hand, the government’s consumer protection

goals also are worthy of consideration in circumstances where

a business speaker’s messages may directly affect sales of its

products or services. Weighing these interests under the

facts presented by any particular case would better serve

both interests.

Applying a balancing approach to cases such as Nike—

whichever mechanism is chosen—would comport with much

of the Court’s Central Hudson precedent as well as other free

speech jurisprudence. The weighing of competing interests

is, of course, common in First Amendment law generally.

See, e.g., Gertz, 418 U.S. 323 (balance in defama-

tion tips in favor of speech freedom when plaintiff thrust

into matter of public controversy); Dun & Bradstreet v.

Greenmoss Builders, 472 U.S. 749 (1985) (balance in defa-

mation tips back toward plaintiff in matters of only private

concern); San Francisco Arts & Athletics, Inc. v. United

States Olympic Comm., 483 U.S. 522, n. 16 (1987)

(characterizing commercial speech doctrine as one of several

First Amendment balancing tests). Similar balancing is

employed even in cases that pit the economic goals of

otherwise valid government statutes against First Amendment

rights. For example, the Court has determined that federal

antitrust restraints must give way when they threaten to

prevent the exercise of First Amendment rights to petition the

government for redress of grievances. See, eg, E. RR.

Presidents Conference v. Noerr Motor Freight, 365 U.S. 127

(1961), Mine Workers v. Pennington, 381 U.S. 657 (1965);

BE & K Constr. Co. v. NLRB, 122 S. Ct. 2390 (2002). In

such cases, though the antitrust restraints serve a valid

government interest in ensuring the competitive operation of

the commercial marketplace, the statutory regime cannot be

used to bar persons from making coordinated efforts to lobby

the legislature—even in pursuit of legislation that would hurt

competitors—or pursuing good-faith court challenges to

competitors. Noerr, 365 U.S. at 137 (Court will not “lightly

impute to Congress an intent to invade . . . freedoms”

protected by the Bill of Rights); Pennington, 381 U.S. at 664.

Similarly, valid government concerns for personal privacy are

not sufficient to foreclose completely any reasonable door-to-

door efforts to engage in religious or political advocacy or to

solicit charitable donations. See Watchtower Bible & Tract

Soc’y of N.Y., Inc. v. Vill. of Stratton, 536 U.S. 150 (2002);

Hynes v. Oradell, 425 U.S. 610 (1976); Martin v. Struthers,

319 U.S. 141 (1943). The government’s interest in protecting

the fairness of commercial transactions is, of course, valid,

but it is not different in kind from these other interests that the

Court has weighed against the constitutionally protected

benefits of free speech.

A. The Court Should Recognize, At A Minimum,

A Constitutional “Right Of Reply” That Would

Allow Business Speakers To Respond To Criti-

cism Of Their Products, Services, Or Business

Operations Publicly Raised By Third Parties

A direct way to address the competing interests presented

here would be to craft a specific mechanism to protect public

discourse. Unnecessarily handicapping a business speaker

from responding to public attacks on its products, services, or

business operations encroaches on widely cherished notions

of fundamental fairness in addition to the level playing field

concept that underlies basic First Amendment principles. See

supra Section I.B. Even if such responses might benefit the

speaker’s sales, that effect does not negate or outweigh the

contribution that the speaker can make to public under-

standing of the issues under discussion. See, e.g., Bellotti,

435 U.S. at 777 (“the inherent worth of the speech in terms of

its capacity for informing the public does not depend on the

identity of its source, whether corporation, association, union,

or individual”).

Pfizer therefore believes that, absent broader doctrinal

changes, the Court should afford commercial speakers in

these circumstances a constitutional “right of reply” that

carries the same full First Amendment protection enjoyed by

the noncommercial entities in the debate. This limited

safeguard would serve the rights of both speakers and

listeners. By guaranteeing that all speakers enjoy equal free-

dom to discuss the issues, the safeguard would properly

resolve this case; the Code’s liability standard would not

automatically apply to Nike’s rebuttals and effectively cut off

the public debate prematurely. Instead, in this case and others

like it, a right of reply would help foster the best possible

dialogue on matters of public concern, thereby safeguarding

the process of public debate upon which our government

policymaking ultimately depends. Jd. at 783; Richmond

Newspapers v. Virginia, 448 U.S. 555, 587 (1980) (“the First

Amendment embodies more than a commitment to free

expression and communicative interchange for their own

sakes; it has a structural role to play in securing and fostering

our republican system of self-government”).

A right of reply would also dovetail with the First Amend

ment value accorded to the process of dialogue generally,

even in commercial speech cases. The “lesser” protection

afforded to commercial speech is in some tension, as a con-

ceptual matter, with situations that involve significant inter-

changes between two or more speakers. Advertising typically

is perceivea as one-way communication: the seller speaks to

potential consumers. Government consumer protection

policy is predicated on the premise of unlevel playing field;

the power that se'lers derive from their greater financial

resources and knowledge about their wares, see Kasky, 45

P.3d at 257-58, supports the imposition of additional legal

constraints upon them to protect consumers. Nearly all of the

Court’s commercial speech cases fit the “one-way speech”

paradigm, whether the identified government interest was

traditional consumer protection or not. See, e.g., Bates v.

State Bar of Ariz., 433 U.S. 350 (1977) (newspaper ads);

Bolger, 463 U.S. 60 (direct-mail flyers); City of Cincinnati v.

Discovery Network, Inc., 507 U.S. 410 (1993) (course

catalogs); Rubin v. Coors Brewing Co., 514 U.S. 476 (1995)

(package labels); Lorillard Tobacco Co. v. Reilly, 533 USS.

525 (2001) (placards and billboards); United States v. Edge

Broad., 509 U.S. 418 (1993) (broadcast commercials);

Greater New Orleans Broad. Ass'n. v. United States, 527

U.S. 173 (1999) (same); Virginia State Bd. of Pharmacy, 425

U.S. 748 (unspecified form of “advertising”); Cent. Hudson,

447 U.S. 557 (same); /banez v. Florida Dep't of Bus. &

Prof’! Regulation Bd. of Accountancy, 512 U.S. 136 (1994)

(same); Western States, 122 S. Ct. 1497 (same). The few

cases involving exchange of views, however, required a

balancing of the state’s asserted interest in marketplace

integrity, Ohralik v. Ohio State Bar Association, 436 U.S. 447

(1978), or institutional integrity, Board of Trustees of the

State University of N.Y. v. Fox, 492 U.S. 469 (1989), against

the potential suppression of useful information. Indeed, in

Edenfield v. Fane, the Court specifically acknowledged the

ability of consumers to filter commercial communications

and evaluate them in “rational and considered decision

making.” 507 U.S. 761, 775 (1993).

In broader public debates, a right of reply would enhance

listeners’ ability to obtain information useful to them both as

consumers and citizens. Furthermore, because the right of

reply would be triggered only when a third party criticizes a

commercial entity, the potential seems negligible that a;com-

mercial speaker would induce criticism in order to launch a

false or misleading response. The initial-criticism of the busi-

ness entity—as well as later critical rebuttals—creates a sub-

stantial commercial risk. In any event, the debate itself serves

to alert consumers that certain issues involving the enterprise

are in dispute, leaving them free to act as they see fit.

Recognition of a right of reply would not open the door to

abuse. There should be no fear about the courts’ ability to

limit the safeguard by determining whether the response

addresses legitimate matters of public concern; they already

do so in other First Amendment contexts. See e.g., Gertz, 418

U.S. 323 (defamation legal standard turns on whether issue is

private or public concern); Bartnicki, 532 U.S. 514 (media

may publish surreptitious wiretap on matter of public

concern). Courts also are quite capable of distinguishing a

valid exercise of First Amendment reply rights from situa-

tions in which a speaker may attempt to use the safeguard,

once triggered, to avoid valid consumer protection regulation.

In analogous settings, the courts have successfully dealt with

similar evasive or abusive use of the First Amendment as a

defense against legitimate economic regulation. See Cali-

fornia Motor Transp. Co. v. Trucking Unlimited, 404 U.S.

508 (1972) (rejecting “sham” claim of Noerr-Pennington

ines iI as

protection of First Amendment right to petition); BE & K

Constr., 122 §. Ct. at 2396 (“while genuine petitioning is

immune from antitrust liability, sham petitioning is not”).

To assist lower courts in this task, the Court could specify

consideration of several factors likely to be relevant in most,

if not all, cases where a right of reply is asserted. In Pfizer's

view, courts might properly review three principal factors.

The first would be specificity, i.e., does the speech directly

relate to the message to which the business speaker is

responding. The second would be proximity, ie., is the

speech disseminated reasonably close in time to the initial

message that prompted the response. The third would be

proportionality, i.e., is the speech reasonably directed to the

audience exposed to the initial criticism and does it exclude

references to products, services, or business Operations not

germane to the identified public concern.

Recognition of a right of reply within the existing Central

Hudson framework would level the playing field for all

speakers participating in debates concerning important public

issues. It also would help to eliminate the chill imposed by

the mere threat of litigation under the Code, because it should

allow many challenges to business participation in public

debate to be dismissed on preliminary motion, in a manner

similar to the use of the “public figure” defense in defamation

actions. See, e.g., id. at 2401 (citing New York Times, 376

U.S. at 279, as example of procedural mechanism affording

needed “breathing space” First Amendment requires). The

right of reply therefore would serve fundamental First

Amendment values both substantively and procedurally.

B. Alternatively, The Court Should Clarify That

The Government Interest In Protecting the

Fair Functioning of the Marketplace Is Subject

To Complete Central Hudson Analysis Before

Sanctions May Be Imposed On Commercial

Speech Addressing Matters Of Public Concern

Should the Court wish to address larger doctrinal issues,

this case offers an excellent opportunity to explain that

determining that commercial speech is neither false nor

misleading is not a predicate step to application of the full

balancing analysis embodied in Central Hudson. In other

words, allegations that the speech at issue is false or mis-

leading should not create an absolute exception to the need to

examine the strength of the government’s consumer protec-

tion interest in the specific circumstances, the means by

which that interest is advanced, the potential for less restric-

tive measures to alleviate any legitimate concerns about

deception, and the countervailing risk of suppressing truth-

ful speech of “public value.” Restating Central Hudson to

clarify that suppression of deceptive commercial speech is a

legitimate government interest which must be weighed in the

balance—like any other valid government interest—would do

little more than describe how this Court, and subordinate

ones, have been handling contentions that commercial speech

can be sanctioned as false or misleading. See, e.g., Edenfield,

507 U.S. 761; Ibanez, 512 U.S. 136; Revo v. Disciplinary Bd.

of the Sup. Ct. for the State of N.M., 106 F.3d 929 (1 ith Cir.

1997).

As demonstrated below, an accurate understanding of the

essential teaching of Central Hudson and later precedent

would have caused the California Supreme Court to affirm

dismissal of Mr. Kasky’s claims. The California court,

however, simply took as a given that the state had plenary

constitutional power to ban or sanction “false or misleading”

commercial speech in all circumstances. It was than forced to

a mee ee a ee

wrestle with the difficulties presented by the facts solely by

analyzing the scope of “commercial speech.” Kasky, 45 P.3d

at 247. In seeking to extend that scope to preserve what it

deemed the state’s legitimate regulatory interest—.e.,

preserving the integrity of commercial transactions where a

commercial speaker addressed its potential customers on

issues affecting sales—the court below stopped short of even

considering how application of the Code would affect the

contribution of Nike’s non-misleading speech to overall

public debate and whether less restrictive means of protecting

California’s regulatory interests were available. The critical

paradigm of Central Hudson, by contrast, requires a careful

balancing of those competing values. See, e.g., Jbanez, 512

U.S. at 143 (“[t}he state’s burden is not slight”); Edenfield,

507 U.S. at 768-69 (need to consider impact of restriction on

protected speech).

While this Court has said that false or misleading speech

plays no legitimate role in the commercial marketplace, it has

never explained why pursuit of the regulatory objective of

protecting consumers from deception should trump para-

mount First Amendment values. See, e.g., Cent. Hudson, 447

U.S. at 565; Posadas de Puerto Rico v. Tourism Co., 478 U.S.

328, 350 (1986); Edge Broad., 509 U.S. at 429. In 44

Liquormart, Inc. v. Rhode Island, the Court declared that “the

State’s power to regulate commercial transactions justifies its

concomitant power to regulate commercial speech that is

‘linked inextricably’ to those transactions.” 517 U.S. 484,

499 (1996). Thus, regulation to guard against consumer

deception plainly serves legitimate state interests, as do

regulations to guard against intemperance (44 Liquormari,

517 U.S. 484; Rubin v. Coors, 514 U.S. 476); prevent

unauthorized distribution of unapproved new drugs (Western

States, 122 S. Ct. 1497); maintain professional relationships

(Ohralik, 436 U.S. 447; Edenfield, 507 U.S. 761); and protect

street safety and aesthetics (Discovery Network, 507 U.S.

410). Nothing in logic or this Court’s precedent, however,

Se OL Re ee a ee

justifies elevating anti-deception interests above all other

legitimate state interests for purposes of Central Hudson

analysis.

Indeed, building upon the teaching in Central Hudson that

the government may not “completely suppress information

when narrower restrictions on expression would serve its

interest as well”, 447 U.S. at 565, this Court and lower courts

have limited state power to act against speech which, while

potentially misleading, could be made accurate by additional

disclosure. See In re R.MJ., 455 U.S. 191, 205 (1982)

(“states may not place an absolute prohibition on certain

types of potentially misleading information . . . if the

information also may be presented in a way that it is not

deceptive.”); see also Peel, 496 U.S. 91; Bates, 433 U.S. 350;

Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999); of

Shapero v. Kentucky Bar Assoc., 486 U.S. 466 (1988). In

addition, claims of “false or misleading” speech have been

rejected where challenged statements “were in fact easily

verifiable . . .”, Zauderer v. Office of Disciplinary Counsel of

the Sup. Ct., 471 U.S. 626, 645 (1985); see also Edenfield,

507 U.S. at 772, and the Court has further restricted state

power to use the “paternalistic assumption that the recipients

of [advertising] are no more discriminating then the audience

for children’s television.” Peel, 496 U.S. at 105; see also

Ibanez, 512 U.S. at 137. Finally, in Edenfield, the Court

identified “ensuring the accuracy of commercial information

in the marketplace” as a “substantial state interest” and

expressly required that the state’s assertion of that interest be

weighed against other Central Hudson factors when the facts

of the case indicated that “truthful and non-misleading

expression will be snared along with the fraudulent or

deceptive commercial speech.” 507 U.S. at 768-69. Thus,

any assumption that prohibiting deceptive commercial speech

is an absolute constitutional value cannot be supported.

To recognize this evolving jurisprudence, the Court

now should make plain that a determination or allegation

that speech affecting commercial transactions is false or

misleading constitutes the beginning, rather than the end, of

the First Amendment analysis. The state’s interest in pre-

venting commercial deception must still be assessed, as

Central Hudson teaches, for substantiality in the relevant

circumstances and balanced against the competing free

speech values of the dissemination of non-misleading infor-

mation and the contributions of that information to vigorous

public debate—while also taking into account the availability

of less speech-restrictive means of advancing the state’s

interest. See id.; Western States, 122 S. Ct. at 1503. ha

competing values outweigh the relevant state interest, °

Amendment jurisprudence makes clear that the msn of

some deceptive information is a necessary price for the

protection of greater interests. New York Times, 376 U.S.

254; Gertz, 418 U.S. 323; cf. Philadelphia Newspapers -v.

Hepps, 475 U.S. 767, 774 (1986) (even in “private figure”

defamation, evidentiary burden placed on plaintiff because

“constitutional requirement of fault supersedes . . . common

law’s presumptions as to fault and damages’).

In short, this case provides the Court an opportunity to

establish the universality of the Central Hudson balancing

approach across all commercial speech cases. In so doing,

the Court also would harmonize its commercial speech

doctrine with mainstream First Amendment analysis, where

the weighing of asserted state interests against the values of

free expression is commonplace. See, e.g., Watchtower Bible,

536 U.S. 150 (free speech and religious liberty v. privacy);

New York Times, 376 U.S. 254 (personal reputation v. public

debate); Texas v. Johnson, 491 U.S. 397 (1989) (patriotic

symbolism v. criticism of government); United States v.

O’Brien, 391 U.S. 367 (1968) (maintenance of military draft

system V. criticism of government).

Applying the Central Hudson balancing analysis to the

case at bar makes clear that the decision below must be

reversed and the complaint dismissed on First Amendment

grounds. Even assuming, as pleaded by Mr. Kasky, that

Nike’s descriptions of its foreign labor practices were false

and misleading and therefore could deceptively induce

consumers to buy the company’s products, the state interest in

suppressing this deception is attenuated for three important

reasons. First, because there is ample counter-speech in the

marketplace of ideas, which gives listeners a more sophisti-

cated appreciation of the facts, the need for state interaction

to “set the record straight” on their behalf is limited at best.

Second, because the Nike statements at issue do not directly

advocate purchase of the company’s products and relate only

remotely to consumer purchasing decisions, the state’s con-

sumer protection interests are further limited. Third, because

the proceedings were initiated without regard to actual decep-

tion or consumer injury, the state interest is concomitantly

reduced.

California’s limited interest in suppressing Nike’s allegedly

deceptive speech is potentially advanced by the Code—via a

number of draconian remedies, including injunction and

orders for massive restitution. Yet while these remedies

might be said to “directly advance” California’s consumer

protection interest, there is no basis for holding them to be

appropriately tailored to First Amendment interests. See, e.g.,

Western States, 122 S. Ct. at 1507. First, in circumstances

where counter-speech is readily available, First Amendment

values counsel reliance on the collision of ideas and the good

sense of listeners rather than the judgments of state officials

to prevent deception. See, e.g., New York Times, 376 U.S. at

270 (discussing “profound national commitment to the

principle that debate on public issues should be uninhibited,

robust, and wide-open”); Riley, 487 U.S. at 791 (“free and

robust debate cannot thrive if directed by the government”).

Second, when public controversy inevitably means that fact

statements, judgments, and policy views will be intertwined,

there is a substantial risk that Code remedies will suppress the

latter with the former, contrary to this Court’s rejection of

over-inclusive deception remedies. See, e.g., Edenfield, 507

U.S. 761. Third, actual cases of detrimental consumer decep-

tion could be dealt with under a better-tailored California

conduct remedy. A more precisely framed statute would

provide a cause of action to an injured consumer where the

gravamen of the complaint would be an intentional attempt to

market fraudulently by, inter alia, the knowing or reckless

use of false or deceptive statements to affect consumer

behavior. Requiring both actual consumer injury and

the defrauding of consumers through intentionally false

statements—two criteria which Mr. Kasky’s complaint

cannot meet—would adequately safeguard California’s

interest in protecting consumers against ciassic deceptive

advertising and promotion while also giving public debate

over business-related issues the breathing space it needs to

flourish.

In addition, addressing Nike through this clarification

would have essentially the same procedural effect as

recognition of a constitutional right of reply proposed supra

Section II.A. Disputes could often be resolved early in the

adjudicatory process, thereby forestalling the additional

chilling effect posed by the threat of prolonged litigation.

CONCLUSION

Pfizer believes that the facts of this case afford the Court

an extraordinary opportunity to accommodate both general

First Amendment principles and legitimate state interests in

commercial regulation by recognizing a constitutional “right

of reply” or by clarifying the universal application of the

Central Hudson balancing analysis. For reasons set forth

above, Pfizer respectfully requests this Court to reverse the

judgment below and order that the complaint be dismissed.

JEFFREY B. KINDLER

Senior Vice President and

General Counsel

GEORGE W. EVANS

Associate General Counsel

and General Counsel to

Pfizer Pharmaceuticals Group

STEVEN C. KANY

Senior Assistant General

Counsel

ARNOLD I. FRIEDE

Senior Corporate Counsel

PFIZER INC

235 East 42nd Street

New York, NY 10017-5755

(212) 573-2323

February 28, 2003

Respectfully submitted,

BERT W. REIN

Counsel of Record

ROSEMARY C. HAROLD

WILEY REIN & FIELDING LLP

1776 K Street, N.W.

Washington, DC 20006-2304

(202) 719-7000

Counsel for Amicus Curiae

APPENDIX

Pfizer Inc

235 East 42nd Street

New York, NY 10017-5755

December 11, 2002

Dockets Management Branch

Food and Drug Administration

5630 Fishers Lane

Rockville, MD 20852

Re: First Amendment Issues

Docket No. 02N-0209.

Dear Sir or Madam:

Pfizer Inc (“Pfizer”) hereby submits (Exhibit A) proposed

regulations concerning one facet of the Food and Drug

Administration’s (“FDA’s”) First Amendment inquiry—a

sponsor’s right to respond to public statements by an

independent third party concerning a drug that is subject to an

approved or pending New Drug Application (“NDA”) or

Investigational New Drug (“IND”) application. This is a

particularly important and timely issue given the pending

Supreme Court certiorari petition in Nike v. Kasky, 71

U.S.L.W. 3319 (Oct. 16, 2002). In that case, the petitioner

seeks clarification of the circumstances in which a

manufacturer’s response to third-party attacks constitutes

speech subject to strict scrutiny under the First Amendment,

rather than commercial speech subject to intermediate

scrutiny. Pfizer believes that providing FDA with specific

proposed regulatory language safeguarding a manufacturer’s

right to respond to such third party attacks will assist the

agency in considering whether and how to amend its

regulations or guidances in order to conform with First

Amendment principles. It will also demonstrate that

codification of First Amendment principles is a feasible and

natural outgrowth of the agency’s current constitutional

review and should be aggressively pursued by FDA.

Although Pfizer has illustrated its proposal in the form of

draft regulations, it would be equally appropriate for FDA to

incorporate these safeguards in the form of a guidance.

Pfizer observed in its initial comments that the First

Amendment embodies a “presumption that truth will best

emerge from the collision of ideas that results from open

channels of communication” and that “more speech,” rather

than less, is the best remedy for exposing misleading speech.

Comments of Pfizer Inc. at 44 & n.155 (Sept. 13, 2002)

(“Pfizer Comments”) (quoting Whitney v. California, 274

U.S. 357, 377 (1927), overruled in part, Brandenburg v.

Ohio, 395 U.S. 444 (1969)). These principles apply with

particular force to prescription drugs. “Given the benefit and

risk calculus involved in the use of any drug, there is ample

room for public debate over drug use and constitutional value

in letting all speakers play an equal role in that debate.” Pfizer

Comments at 45. Thus, First Amendment interests are best

served when all interested speakers are allowed an equal

opportunity to debate publicly the merits and risks of a drug

product. This is at least as important—perhaps even more

important—than a debate about the ethics and legality of

Nike’s labor practices in third world countries at issue in the

Kasky vs. Nike case.

As Pfizer stated in its initial comments, however, FDA’s

current regulations single out drug manufacturers as the only

class of speakers who cannot join freely in this public debate.

Instead, manufacturers are governed by “pervasive, extensive

regulations that tightly control what manufacturers may say

about their products and attempt to transmogrify advertising

and other promotional communications into comprehensive

instructional messages.” /d at 111. “FDA, by requiring

manufacturers to include an exhaustive list of a product’s

risks as well as its benefits, . . . hampers drug manufacturers’

ability to respond truthfully to attacks on their products.”

Id. at 113.

The agency’s regulations appear to be premised on the

concept that the manufacturer is the only speaker concerning

its drug product and that regulating manufacturer speech is

the sole means of ensuring that physicians and consumers are

fully advised about drug benefits and risks. This is largely not

the case. There are myriad speakers—from medical journals

to patient advocacy groups to HMO benefits managers to

dietary supplement manufacturers—each of whom has

differing motivations in initiating public debate concerning

various prescription drugs and different messages that they

would like to convey /d. at 12-13. Once debate is initiated by

an independent third party, the First Amendment commands

reliance on the clash of conflicting views rather than

government regulation to establish the truth. Thus, “{it]

simply serves no public health purpose to inhibit a

manufacturer, who is likely to be the most knowledgeable

source of scientific data concerning a particular drug, from

providing useful information about the drug when that drug’s

utility is thrown into public controversy by a third party.”

Id. at 115.

Pfizer’s proposed regulations seek to level the playing field

by affording manufacturers the right to respond to

independent third party statements about their products

without subjecting these responses to FDA’s stringent

prescription drug labeling and advertising requirements. Such

speech is not properly characterized as labeling or advertising

because physicians will not rely on it to ascertain the

operative instructions for the safe and effective use of a

product. See id. at 71-74. Nor can the speech be deemed

commercial speech. Far from doing “no more than propose a

commercial transaction,” such speech constitutes the same

type of scientific debate that others initiated concerning a

particular drug product. See Pittsburgh Press Co. v Pittsburgh

Comm'n on Human Relations, 413 U.S. 376, 385 (1973).

As neither labeling nor advertising, but rather scientific

speech, such responses should benefit from full First

Amendment protection.

Pfizer has carefully crafted its proposed regulations to

ensure that manufacturers cannot evade FDA’s requirements

by characterizing statements as responsive, when they are not

or when a response is knowingly or recklessly is false. For

example, where a manufacturer knows that it is making a

false statement or has serious doubts about its truth, that

speech remains fully subject to FDA’s otherwise applicable

advertising and labeling requirements. Similarly, if the

agency can establish that the speech at issue is not the type of

responsive speech that the proposed regulation intends to

cover because, inter alia, it does not respond to a specific

statement made by another concerning a product, is not made

in reasonable proximity to the time at which the need to

respond to the public criticism of the drug arises, or is

disproportionate in scope and in the extent of dissemination

to the initial third party statement, FDA may subject that

speech to its labeling and advertising regulations. These anti-

evasion principles are borrowed from the law of self-defense,

and would permit the manufacturer effectively to defend its

products in the crucible of public debate on the same

constitutional footing as the myriad other speakers in the

marketplace.

Pfizer urges the agency to consider carefully the proposed

regulations and to amend its regulations and guidances to

reflect the approach taken in Pfizer’s proposal. By so doing,

FDA will remedy the inequity that currently exists between

unregulated entities, who may attack drug products at will

without being subject to any speech restrictions, and

manufacturers, who are arguably in the best position to

disseminate information concerning their products but who,

under current regulations may risk enforcement action if their

response is not tightly controlled in ways that largely dilute

the force of the communication without measurably

enhancing the truthfulness of the message conveyed.

Respectfully submitted,

PFIZER INC

By: /s/ George W. Evans

George W. Evans

Associate General

Counsel, Pfizer Inc

General Counsel,

Pfizer Pharmaceuticals

Group

By: /s/ Arnold L. Friede

Arnold L. Friede

Senior Corporate Counsel

Exhibit A

Pfizer’s Proposed Right of Response Regulation or Guidance

NDA and IND Holder’s First Amendment Right of Response

Section 202.901. Constitutional Exemption for Sponsor

Responses to Public Debate.

Where the sponsor of a pending or approved NDA or IND

for a prescription drug disseminates statements in response to

public statements disseminated by an independent third party

which concern the nature, quality, utility or characteristics of

that drug, including but not limited to safety or effectiveness,

FDA shall not deem those statements to be labeling or

advertising as defined, respectively, in 21 U.S.C. § 321(m)

and Section 202.1(1)(2) of these regulations. FDA has

determined that the First Amendment bars the agency from

subjecting such responsive elements of public debate to any

of the requirements governing prescription drug labeling or

advertising under the Federal Food, Drug and Cosmetic Act

or FDA’s implementing regulations.

Section 202.902. Anti-Evasion Safeguards.

(a) The exemption in Section 202.901 for responses to

third-party statements shall not be used to evade

independent otherwise applicable labeling and adver-

tising requirements. In determining whether a commu-

nication is a responsive communication protected by

Section 202.901, the Commissioner shall take the

following factors into account:

1. Specificity. Whether the communication

addresses with specificity, by identifying time

and place, and, if applicable, title or subject

matter of the relevant publication or utterance,

the third party statements about the nature,

quality, utility or characteristics of the sponsor’s

drug to which it responds.

Necessity. Whether the communication identifies

with particularity the need to respond to the

relevant third party statements for the benefit of

the audience.

Immediacy. Whether the communication is

disseminated in reasonably close proximity in

time to the relevant third party statement given

the nature of the media utilized in responding and

the requirements for advance commitments for

space and the like. The need to respond may

arise, inter alia, (a) at the time a third party

statement is disseminated; (b) at the time that the

sponsor reasonably learned about the statement;

or (c) at the time the statement becomes a matter

of serious public importance due to, for example,

greatly expanded public dissemination.

Proportionality. Whether the scope and

dissemination of the communication is

proportiona! to the dissemination of the relevant

third patty statement to which it responds. The

scope of the communication is proportional if it

is reasonably tailored to address the

representations in the third party statement. The

dissemination of the communication is

proportional to the dissemination of the public

criticism if the audience reach and frequency of

publication of the media used to respond is

comparable to the audience reach and frequency

of the media used to disseminate the criticism in

the first instance.

(b) A statement shall not be deemed to be covered by

Section 202.901 if the Commissioner establishes that

the sponsor disseminated it with actual knowledge

that a representation of fact was false or with

substantial awareness of its probable falsity or a

serious doubt about its truth.

Authority: United States Constitution, Amendment I.

THE NEW YORK TIMES, SUNDAY, NOVEMER 10, 2002

Menopause Without Pills: Rethinking Hot Flashes

This article was reported by Gina Kolata, Milt

Freudenheim and Robin Marantz Henig and was written by

Ms. Kolata.

In the few months since a study of a widely used hormone

regimen found that its risks outweighed its benefits, the

prevailing view of menopause has undergone a momentous

shift.

For decades, women have been told that the symptoms of

menopause—hot flashes and night sweats as well as vaginal

dryness that could make sex a painful ordeal and libido a

distant memory—were burdens they should not have to bear.

With hormone therapy, they would feel like the clock was

turned back. At the same time, they could protect themselves

against osteoporosis, and probably even reduce their risk of

heart attacks and strokes.

When the study, known as the Women’s Health Initiative,

was halted in July, many doctors changed their message. Try

to live with your symptoms, these doctors now say. Or find

other ways to deal with them. And forget about using

hormones solely to protect yourself from diseases; there are

other, better ways.

It is an almost unheard of transformation of the medical

landscape, said Dr. Barbara J. Turner of the University of

Pennsylvania, who studies the pace of innovation. Doctors

“turned on a dime,” she said.

But it is impossible to tell how many patients turned with

them, and what happened when they did.

There is no obvious pattern of responses to the new reality.

In interviews, gynecologists and internists say some patients

have stopped taking hormones, only to resume their use when

they find symptoms intolerable. Others say most women who

10a

stop taking the pills have little or no trouble. They note that

even before the study was halted last summer, more than half

of the women who started hormone therapy stopped it on

their own within a few years.

Still other doctors are devising their own methods of

weaning women from the drugs—suggesting they wear

estrogen patches and gradually trim them down to nothing, or

increase the interval between pills. In this, however, they are

acting on their own. There are no practice guidelines, no

rigorous studies on what works best.

Eventually, the Women’s Health Initiative will have data

on how its participants fared when they were advised to stop

taking their hormone pills. For now, the only data come from

drug company sales figures, which show that many women

taking Prempro, the hormone combination made by Wyeth

that was tested In the study, have stopped, their number

falling to 1.5 million from 2.7 million.

But in Wyeth’s loss, other companies see an opportunity.

For example, sales of Evista, made by Eli Lilly & Company,

rose by 24 percent in September. Evista, which can actually

elicit hot flashes but protects bone, has some estrogenlike

properties, but the company emphasizes that it is not a

hormone.

“There’s this whole open market” said Valerie Layne, a

nurse practitioner at Hightstown Medical Associates, a

private practice in New Jersey where she says the Eli Lilly

sales representative is now a frequent visitor. “They know our

alternative now is their drug,” Ms. Layne said. “Even though

honnone therapy may be O.K., everyone is too afraid to

continue.”

The Burst Bubble

The study that caused this uproar, the Women’s Health

Initiative, involved 16,000 women who wer* randomly

lla

assigned to take either Prempro, a popular combination of

estrogens and progestin, or a placebo. The researchers halted

the study prematurely when the accumulating data indicated

that even though hormone therapy can reduce cholesterol

levels, women who took Prempro had slightly more heart

attacks, strokes and blood clots. They also had slightly more

breast cancer. These risks exceeded the regimen’s benefits, of

slightly less colon cancer and slightly fewer fractures.

Women who were taking Prempro were advised to stop

taking the pills immediately, and the scientists said there was

no reason to believe that the findings applied only to

Prempro. Until proven otherwise, they said, women and their

doctors should assume that all hormone therapy that involved

estrogen and progestin bears the same risks.

The study did not test other hormone regimens, but many

researchers say it cannot be assumed that they are any safer.

At first, many doctors, gynecologists in particular, reacted

with anger and denial.

“We have had a real love affair with hormone therapy,”

said Dr. Susan L Hendrix, a study investigator and

gynecologist at Wayne State University in Detroit. When the

study said it might not be a panacea, “it was like telling

someone they have an ugly baby.”

Dr. Isaac Schiff, who is the chairman of obstetrics and

gynecology at Massachusetts General Hospital in Boston,

said it was his impression that many gynecologists were upset

because their own clinical experience had told them that the

drugs were a boon to women. Internists, he added, who had

been prescribing hormone therapy to prevent conditions like

heart disease and osteoporosis, tended to be more accepting

of the study’s findings.

Dr. Schiff explained: “As a gynecologist, you have a

patient who comes into your office who is troubled with hot

12a

flashes or she has severe vaginal atrophy and she says sex is

not pleasurable. You prescribe hormone therapy and she

comes back four months later and says, ‘Oh, doctor, | feel so

much better.’ An internist does not have someone come back

and say, “Thank you, doctor, my heart feels better.’”

Yet many gynecologists, even those who say they think

hormone therapy has been demonized, say they have changed

their message.

“In the old days, I used to say, ‘Look, there’s no evidence

that this in going to hurt you,”” said Dr. Andrew Good, a

gynecologist at the Cleveland Clinic. “Now I can't say that

with the same enthusiasm.”

Dr. Jan L Herr, a gynecologist at Kaiser Permanente

Medical Group in San Rafael, Calif., said the new message

has meant that women have had to change their expectations

of life in their middle years. She asks women who find their

symptoms of menopause unbearable to try the lowest possible

dose of hormone therapy, which may not rid them of their

symptoms.

“They have to be satisfied with feeling better, but not

perfect,” Dr. Herr said. “They had always wanted to feel

perfect,” with no hot flashes, no night sweats, no vaginal

dryness. “They had always said, Why should I feel like I’m

55? 1 want to feel like I’m 30.’” Now, she said, women have

to get used to feeling as if they are 55.

‘Honey, It’s the Hormones’

Iretta Taylor, a customer service adviser in Houston, said

she tried to live without hormone therapy but decided she

would rather not.

Ms. Taylor, 49, explained: “I went into menopause at a

very early age, at about 40, and it was a very bad, very

emotional time. I was edgy, depressed, | thought I was having

a nervous breakdown. | had hot flashes, too, and a hollow,

dry look, and dryness in the vaginal area, which was no fun.

l3a

“As soon as I started taking H.R.T, it all went away,” she

said, referring to hormone therapy by its old name, H.R.T.,

for hormone replacement therapy. “A co-worker told me,

‘Your skin looks so fine.’ It did; I had a real glow.

“When I heard all the horror stories last summer |

stopped,” She said. “I didn’t even call my doctor; I just

stopped. Right away I started to feel bad again. | thought at

first that it was psychosomatic, but then I realized, ‘Honey,

it’s the hormones.’

“I asked my doctor, ‘Please put me back on H.R.T.,’ and he

did.” Now, she said: “I feel like a woman is supposed to feel.

If they ban this in the United States, I'll drive down to

Mexico to get it. That’s how much I need my H.R.T.

The question is, Are women like Ms. Taylor the exception

or the rule?

“It’s very clear that there is some proportion of women

who did not react well to cold turkey,” said Dr. Marcia L.

Stefanick of Stanford University, who as principal inves-

tigator for the Women’s Health Initiative lectures about the

study and its results. “They are very vocal. But then I ask the

audience, How many of you went cold turkey and had no

problem whatsoever?” She is finding that “the vast majority

of women are doing fine.”

Dr. Herr turns to data from the days when she and others

urged all women to take hormones. After two years, she said,

80 percent were not taking the drugs—they simply stopped

filling their prescriptions. That tells her, she said, that many

women are not bothered by severe symptoms, or choose to

live with them. Doctors, she added, are more likely to hear

from the women about their difficulties, which can skew their

perspective.

They may not see women like Elizabeth Benney, who is 69

and runs a horse farm in Upton, Mass. She never had a hot

14a

flash, never had a night sweat, but started taking hormones

about 15 years ago to alleviate vaginal dryness and avert

osteoporosis, worried because her mother had had the disease.

She feared that if her bones thinned and she was thrown from

a horse, they might fracture.

Last July, “when the news came out,” she said, “I decided

to stop.” She did so with some reluctance, worried that the

vaginal dryness would return and that her skin might

age without the hormones. To her surprise, nothing happened.

She feels and looks fine—no different, she says, from when

she was taking the pills. Her bone density is fine, she added,

so she does not appear to be at risk for fractures. —

Doctors say some women are remaining on estrogen

because they believe it keeps their skin looking young. The

studies, so far, “are not nearly as well done as one would

like,” said Dr. Barbara A. Gilchrest, chairman of the der-

matology department at Boston University School of

Medicine. But, Dr. Gilchrest said, there is credible evidence

that hormone therapy can thicken skin by increasing the

amount of collagen, or prevent its loss. It is not clear when

questions about these or other possible uses of hormone

thereapy will be answered. Some studies, like ones asking if

the therapy protects against Alzheimer’s disease, are con-

tinuing. But given the findings so far, there is some question

whether it would be ethical to conduct studies of cosmetic

uses. Many women, however, are already convinced.

“You wouldn’t believe how many women want to stay on

estrogen for their skin,” said D. Margaret M. Polaneczky, a

gynecologist at the Iris Cantor Women’s Health Center in

New York. “You could have an hourlong intellectual

discussion about all the risks and benefits of hormone

replacement therapy, about how it might be better to consider

some other drugs for, say osteoporosis prevention, and you

think you’ve both agreed. But just as you’re getting ready to

15a

write a prescription for Fosomax, she'll say, “Wait a

minute—I’ve changed my mind, I think the estrogen is

making my skin look younger, I’m going to stay on it.””

Some can wean themselves from hormones only gradually,

using schemes their doctors invented. Some doctors ask

women to try doing without hormones on weekends,

gradually extending the hormone-free days into the week.

Others advise taking a pill every other day for a few weeks,

then every third day, gradually going down to no pills at all.

Dr. Hendrix prescribes hormone patches and tells women to

cut them each week, snipping them down until there is

nothing left.

“Is there any science to this?” Dr. Hendrix asked,

“absolutely not. We’re on a rapid learning curve.”

The Alzhelmer’s Hypothesis

Dr. Rowan T. Chlebowski of the Harbor U.C.L.A.

Research and Education Institute, an investigator with the

Women’s Health Initiative, has been spending time talking to

coctors about what the study’s data mean, and how to go on

from here. His experience, he says, is a window on the

lingering confusion. While the initial message is clear—that

women should be asking themselves why they are taking

hormones rather than why they are not taking them—it is

overlaid with all sorts of what if’s.

What if a woman takes hormones for only a year or so and

then stops? The answer is, no one knows, Dr. Chlebowski

said. “It is almost certain your risk will be reduced, but then

it’s a question of, well, what is the risk compared to the

benefits?”

What if, doctors ask, they sit down with a woman and

figure out what her risks are? They could suggest to women

at risk of breast cancer or heart disease that they try to do

without hormone therapy and advise that women at risk for

colon cancer or osteoporosis take it.

l6a

If only it were so simple, Dr. Chlebowski said. One

problem, he said, is that there is no reliable way to determine

which women are at particular risk for specific diseases,

whether it is breast cancer, heart disease, osteoporosis or

colon cancer.

“There’s a kind of assumption that a doctor can chat with

you about your risk—-Did your mother have a heart attack? —

and that that would have an influence on what you’re doing.”

The problem, he said, is that “our current methods don’t do

very well” in predicting risk.

Some doctors also wonder if there might be critical periods

when estrogen might protect against heart disease, osteo-

porosis or Alzheimer’s.

While there are drugs to protect against heart disease and

osteoporosis, there is nothing yet to prevent Alzheimer’s. So

if the window-of-opportunity hypothesis has any urgency, it

might be with that disease.

“I think it is the most compelling reason to take estrogen,”

said Dr. Stanley Birge, a gerontologist at Washington

University in St. Louis.

But other experts say that at this point it is simply wishful

thinking to say that estrogen therapy is protective, but only if

it is started early. Nevertheless, some women say that for now

they will accept hormone therapy’s small excess risk in hopes

that by starting therapy early they will gain a potentially large

benefit.

The Alzheimer’s hypothesis “is a supposition,” said Dr.

Deborah Grady, who directs the University of California San

Francisco/Mount Zion Women’s Health Clinical Research

Center.

While some laboratory and animal studies have indicated

that hormone therapy might protect brain cells, it is not clear

what would be required to prevent Alzheimer’s. In some

17a

studies, like one published last week, women who were

taking hormones had less Alzheimer’s disease, but in others

they did. Dr. Grady said that in several studies, women who

took estrogen actually preformed worse on cognitive tests.

But Dr. Stefanick said that until researchers completed

rigorous studies asking if estrogen can protect against

Alzheimer’s disease, the question will linger.

18a

THE WALL STREET JOURNAL

Friday, October 25, 2002

HRT WORRIES GIVE HEADACHES

TO DRUG MAKERS

By Vanessa Fuhrmans

IN JUST FOUR MONTHS, hormone-replacement therapy

has turned from a growing business into a major headache for

many drug makers.

Consider Schering AG. Just a few months ago, the

German company, which had been a key player in pioneering

the birth-control pill 40 years ago, had two new treatments for

menopausal symptoms on course to be approved in the U.S.

next year. And it was forging ahead in more experimental

hormone markets, having recently acquired rights to a

testosterone therapy for men.

But in July, the Women’s Health Initiative, an ongoing

federally funded study, announced a possible link between a

popular hormone pill and heightened risk for breast cancer,

heart attacks and stroke. The international storm that

followed has buffeted Schering’s stock price, and the

company has lost more than a quarter of its market value.

In the past two weeks, the Food and Drug Administration

has rejected two menopause treatments from Schering

awaiting approval, setbacks that could force Schering (which

isn’t related to Schering-Plough Corp. of the U.S.) to conduct

new studies.

gee ener .

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“I don’t want to play it down,” says Schering Chief

Executive Hubertus Erien. “It was a real surprise and a real

disappointment.”

The Women’s Health Initiative study looked only at the

most popular hormone replacement, Wyeth’s Prempro, a drug

once taken by as many as six million women. But news of

possible health risks have raised questions about safety of a

whole range hormone-replacement drugs. Some researchers

warn that it isn’t possible to rule out risks associated with

short-term HRT.

This week, the U.S. Preventive Services Task Force, a

medical panel that helps set federal government policy.

recommended against the routine use of estrogen and

progestin for the prevention of chronic post-menopausal

symptoms, such as osteoporosis.

Yesterday, at a conference sponsored by the National

Institutes of Health on hormone-replacement therapy, Wyeth

executives called on regulators and health experts to clarify

what the study’s findings really mean for women in need of

treatment for acute menopausal symptoms, such as hot

flashes, night sweats and vaginal dryness. The company also

presented data that it says show the hormone therapy’s

benefits outweigh the risks when it used as a short-term

treatment.

“More than 85% of women who start hormone therapy

seek relief from menopausal symptoms,” says Victoria

Kusiak, vice president of medical affairs for Wyeth. “They

need to know what the results of WHI mean for them.”

Other companies also have been affected by questions

about health risks of hormone replacement therapy.

Prescription orders for Prempro have fallen nearly 50% since

July, according to NDC-Health, a health-care information-

services company. Orders for Wyeth’s estrogen pill, Premarin

have tumbled 18%.

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Many women have stopped filling prescriptions for other

products too: Orders for Pfizer Inc.’s FemHRT have dropped

by 13%, Solvay Pharmaceuticals’ Estratest by 16% and Galen

Holdings PLC’s Estrace by 15%.

“Right now, everything is getting painted with the same

broad brush stroke,” says David Archer, professor of

obstetrics and gynecology at Eastern Virginia Medical School

in Norfolk, Va. Pfizer says its sales representatives have been

pointing out to doctors that FemHRT wasn’t used in the WHI

study. Officials at Galen and Solvay couldn’t be reached.

FDA also is taking a more-cautious approach to hormone-

based treatments. At conference yesterday, FDA officials told

drug and health-care industry officials that the WHI study

would have implications for how new estrogen drugs are

developed and tested.

Schering, a big player in women’s health products, remains

small in hormone-replacement treatments, deriving just 7% of

its global sales from them. Angelig, the Schering hormone-

replacement pill that the FDA rejected last week, wasn’t

expected to be nearly as popular as Prempro in the U.S.

market for menopausal treatments (Regulatory authorities in

Europe are still reviewing it.)

Schering’s popular birth-control pill, Yasmin, is based on

the same kind of progestin as the one used in Angelig.

Worries that health risks could taint Yasmin have recently

weighed down Schering’s shares, which yesterday were

trading about 30% below their 52-week high, reached

June 28.

Schering won’t say why the FDA withheld approval for

Angelig. But Werner-Karl Raff, head of Schering’s fertility

and hormone-therapy businesses, says, “It is understandable

that it is difficult to assess new HRT preparations,” in the new

debate over such treatments. Schering says it will begin new

talks with the FDA over how to address its concerns about the

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hormone-replacement pill. The FDA refuses to discuss, or

even acknowledge, decisions to reject new-drug applications.

Schering’s Dr. Erien says despite the doubts now swirling

around the safety of many hormone treatments, he is

convinced hormone-replacement therapy remains a viable

business, even for small players such as Schering. “Our

strategy is unchanged,” he says. “We want to have a greater

share of that market.”

Schering currently has just one hormone-replacement

product on the U.S. market: Climara, an estrogen patch. This

month, the FDA rejected a new version, Climara Pro, that

also includes progestin, citing questions about the

documentation of one of the main studies of the drug.

prescriptions for Climara, with U.S. sales of $83 million,

have fallen by roughly 14% in the U.S. since July.

In sales calls to doctors, Schering is stressing that its

hormone products use plant-based molecules, in contrast to

Wyeth’s Prempro, which is derived from the urine of preg-

nant mares. Because HRT products made from nonanimal

sources metabolize in the body differently, it’s possible they

contain less risk. But there aren’t any studies to back up

this theory.

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THE STAR-LEDGER

THURSDAY, DECEMBER 12, 2002

LAWMAKERS BLAST ROCHE, FDA

ABOUT ACCUTANE

By Jonathan Casiano

Star-Ledger Washington Bureau

WASHINGTON—The Food and Drug Administration and

a New Jersey drug maker were sharply criticized by members

of Congress yesterday for failing to tightly regulate use of the

acne drug Accutane.

The medicine, produced by drug maker Hoffmann-La

Roche, is known to cause birth defects and has been blamed

for teenage suicides.

“The FDA’s response to the birth defects and psychiatric

events has been inadequate, irresponsible and unacceptable,”

Rep. Bart Stupak (D-Mich.) said during a hearing before the

House Energy and Commerce subcommittee. “The drug

manufacturer, Hoffmann-La Roche, has continued to put

profits before peopie.”

Stupak, who blames Accutane for his 17-year-old son’s

suicide in 2000, has led the fight against the hugely popular

drug, prescribed to an average of 600,000 people each year.

Roche President and Chief Executive George Abercrombie

told the congressional panel fewer prescriptions and sagging

sales are evidence patients are increasingly aware of

Accutane’s risks.

“We have acted in a responsible manner by adopting

precautionary measures to communicate psychiatric infor-

mation to prescribers and patients,” Abercrombie testified.

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But Stupak was joined by other lawmakers expressing

concern about misuse of the powerful medication.

“This drug is perhaps more dangerous to pregnant women

than Thalidomide, yet women are still getting pregnant while

taking it,” said Rep. Peter Deutsh (D-Fla.), comparing

Accutane with the notorious 1960s morning sickness pill that

caused birth defects. “It’s a tragedy.”

Stupak claimed Accutane was the cause of more than 200

teen suicides—a figure disputed by Roche, which has its U.S.

headquarters in Nutley—and at least 172 birth defects.

Along with Deutsh and other lawmakers, he called for new

controls, including creation of a mandatory FDA registry that

would require every patient taking Accutane and every doctor

prescribing it to enter a national database so the side effects

could be monitored.

Currently, participation in a pregnancy prevention and

monitoring program for Accutane is voluntary. The program

includes two pregnancy tests, a commitment to use

contraception while on the drug, a signed letter of consent

and follow-up surveys to monitor side effects. Only 43

percent of female users are fully participating in the program.

FDA officials defended their regulation of Accutane,

arguing that clear warnings of possible birth defects and

psychological side effects appear prominently on the front of

Accutane packaging.

They also pointed out that scientific studies have yet to link

Accutane to depression, suicidal thoughts or suicide.

“All the evidence (on suicides) is anecdotal,” said Janet

Woodcock, director of the FDA’s Center for Drug Evaluation

and Research. “There is no scientific link to take this drug

off the market.”

Abercrombie, the Roche CEO, said his company has

curtailed its aggressive advertising campaign for the drug and

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distributed an extensive battery of literature for patients and

doctors.

He added that Accutane is one of the few medications for

any disease that requires signed consent by the patient before

being prescribed.

Accutane, the brand name for isotretinonin, is the only

proven treatment for very severe cases of acne, prompting

many dermatologists to enthusiastically recommend it despite

its side effects.

Since its inception in 1982, the drug has treated more than

13 million people and last year earned $750 million for

Roche, making it one of the drug maker’s top products.

During the hearing, the subcommittee also heard from

patients who benefited from Accutane and from Cornell

dermatologist Diane Berson, who called it a “life-changing”

medicine.

“Accutane is an extremely valuable drug which I feel must

remain available for dermatologists to prescribe to those

patients who clearly need it,” Berson said.

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THE WALL STREET JOURNAL

THURSDAY, NOVEMBER 21, 2002

Tackling a Killer

Vaccine to Prevent Cervical Cancer Shows Promise

In Interim Test, Merck Product Blocks Key Forms of Virus

That Can Lead to Tumors

Unusual Marketing Challenges

By Gardiner Harris

Cervical cancer kills almost as many women world-wide as

breast cancer. A vaccine under development has the potential

to cut the toll steeply.

The vaccine is still in testing and wouldn’t available until

2006. But a just-published study gives an indication of its

power and the developer, Merck & Co., is already wrestling

with tricky marketing questions the vaccine would present.

They arise because for the vaccine to be most useful,

politicians, bill-payers and the parents of millions of

adolescent children would all need to sign on.

Most cervical cancer is caused by sexually transmitted

strains of human papilloma virus, or HPV. This is an

extremely common family of viruses that also causes warts

on hands, feet and genitalia, in both sexes. Just two strains of

HPV are believed responsible for 70% of cervical can-

cer. Merck’s vaccine might prevent infection from those

two strains.

In the study published today, about 2,400 women aged 16

to 23 who had had five or fewer sexual partners received a

version of the vaccine, while others got a placebo. Seventeen

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months later, 41 women who received placebos had become

infected with a strain of HPV that can lead to cervical cancer.

None of those who got the vaccine were infected. An

accompanying editorial in the New England Journal of

Medicine, which published the Merck study, said it demon-

strated that “cervical HPV infection—and, by association,

cervical cancer—can be prevented by vaccination.”

The study was an interim one. Merck is now doing a final

“Phase III” study that, if it proves both effectiveness and

safety, could lead to marketing approval. Food and Drug

Administration officials have told the company they want to

know not only whether the vaccine blocks viral infection but

also if it prevents precancerous lesions on the cervix, the kind

detected by Pap tests. Meanwhile, two other groups,

including the National Cancer Institute, are developing

competing vac~*nes.

Cervical cancer kills at least 4,000 U.S. women annually

and about 230,000 world-wide. The vaccines won’t end the

disease, not only because many women already are infected

with a form of HPV that can cause cancer but also because

vaccine distribution is apt to be spotty in developing

countries. More than 80% of the 470,000 annual cases of

cervical cancer occur in those countries. Once an HPV

infection takes hold, any resulting cancer can be treated, but

the viral infection itself can’t be eliminated.

“Is this the end? It is not,” says Martin Kast, a researcher at

Loyola University in Chicago. Dr. Kast leads one of nearly

20 groups across the world that are working to create an HPV

vaccine that would help those who already have cancer. Such

a vaccine is many years away, Dr. Kast says.

To be most effective, an HPV vaccine would have to be

given to girls before they had been exposed to the virus

through sex. Thus, from a marketing perspective, the

vaccine’s maker could face a delicate task in persuading

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parents to vaccinate their young daughters against a virus that

they wouldn’t be subject to until they became sexually active.

Although boys obviously aren’t subject to cervical cancer,

a vaccine would have greater impact if it were also given to

boys, since they do get HPV and can pass it along. Most

boys infected with HPV have no symptoms at all, not even

genital warts. Hence another marketing challenge: Merck is

concerned that it might not be easy to persuade parents to

have their 10- or 12-year-old sons vaccinated.

Potential Hurdle

Even politics could pose a hurdle, some within Merck

believe. Assuming marketing approval, the company would

hope to get the U.S. government to pay for the vaccine as part

of an existing program that now pays for half of childhood

vaccines. But marketers are concerned that some conservative

politicians might challenge the use of tax dollars for a vaccine

that would essentially make sex safer.

HPV infection by no means dooms a woman to develop

cervical cancer. It’s estimated that less than 1% of women

who become infected with the cancer-causing forms of the

virus develop cervical cancer or a worrisome condition called

“severe dysplasia.” Years or decades may pass between

infection and disease.

Infection is very common. One study of female students at

Rutgers University in New Jersey found that 26% were al-

ready infected with HPV when they arrived as freshmen. The

rate was 60% after three years of college.

Other studies have indicated that women have a 20%

chance of getting an HPV infection with their first inter-

course. Condoms help prevent transmission but aren’t a

guarantee. The virus can also be passed by simple touching.

Merck has a track record of successfully running “edu-

cational” marketing programs that boost awareness of medi-

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cal problems, such as high cholesterol and osteoporosis, and

then promote a Merck product as the solution. But the many

questions surrounding the distribution and use of an HPV

vaccine initially led some Merck executives to debate

whether investing in the project made economic sense.

Having gone ahead and shown great progress, Merck now

is gearing up its enormous marketing muscle to promote the

HPV vaccine as a life-saver. Its thousands of salespeople

would first visit pediatricians, OB-GYNs and family-practice

doctors to convince them of the vaccine’s importance. Then

the company might begin a large advertising campaign. It

would aim to see the vaccine used not only in young people,

both girls and boys, but also in mature, sexually active

women.

Its usefulness in such women would be less clear.

Researchers have focused on four common strains of sexually

transmitted HPV. Only two can lead to cervical cancer. If a

woman was already infected with both, the vaccine might not

help—it doesn’t kill the virus. If she was infected with one of

the two, vaccination could still help lower her odds of getting

cancer.

Merck is formulating the vaccine to block all four of these

HPV strains, partly as a way to make vaccination easier to

sell to parents of young boys. Merck has indications the

vaccine might be 90% effective in preventing genital warts

when given to people not yet exposed.

Merck’s marketing plans concern one top researcher at the

National Cancer Institute. John Schiller, a senior investigator

there, frets that if Merck over-sold the benefits, some women

might become less vigilant about getting Pap tests, leading to

missed opportunities for diagnosis. “If companies are driving

the public-relations campaign, it may be difficult to point out

that this vaccine is only 70% protective against cancer,” Dr.

Schiller says.

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Working Feverishly

Merck has been working feverishly on its vaccine since

1993, two years after a researcher in Australia figured out

how to construct tiny shells of the virus that would fool the

body into attacking the virus. By then, teams from the |

Nationai Cancer Institute and MedImmune Inc., a Maryland

biotechnology company, were already working to develop

HPV vaccines.

The study published today shows Merck has leapfrogged

both competitors. Dr. Schiller estimates that Merck is at least

a year ahead of his effort and that of MedImmune.

GlaxoSmithKline PLC, which licensed the MedImmune pro-

gram, declines to comment except to say its vaccine is in

Phase II trials, which gauge dosage and give some indication

of effectiveness. Though the study published today was also

a Phase II study, Merck is now well along in the final Phase

III efficacy test needed for marketing approval.

Researchers observed more than 100 years ago that

prostitutes had very high rates of cervical cancer, leading to

speculation that a sexually transmitted virus caused it. In the

mid-1970s, a German researcher isolated HPV in cancerous

tissue.

Merck had no plan to use the HPV virus itself in a vaccine.

Not only can even a killed virus occasionally prove

dangerous, but this virus is all but impossible to grow in a test

tube. Researchers have found that the shell of a virus will do

just as well in gearing up the immune system for a fight.

A researcher named Kathrin Jansen began Merck’s

program in early 1993, surreptitiously working on HPV

because she was discouraged with her other work. “It really

got started under the radar,” she says. She asked a Merck

yeast expert, Loren Schultz, if he could coax yeast into

making HPV shells.

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The decision to use yeast would prove crucial. Med-

Immune and the NCI both used host cells derived from

butterfly caterpillars. While those were easier to use in

small quantities, they are very hard to use in large-scale

manufacturing.

The two scientists picked apart the genetic code of HPV-

11, a strain that commonly causes genital warts. Using the

Australian work as a guide, they figured out that a particular

sequence of the code created the virus’s protein shell. They

stuck that sequence onto the genetic code of baker’s yeast,

added sugar and waited.

Nothing happened. “We might have gotten discouraged at

that point if we hadn’t had a lot of experience with yeast,”

said Dr. Schultz.

But Merck has a library of many strains of baker’s yeast,

developed over decades and used by the company to make a

hepatitis-B vaccine. Dr. Schultz knew that yeast strains all

behave differently. The huge yeast library would prove a

boon to Merck’s effort.

Dr. Jansen also needed to choose what forms of HPV to

tackle. There are nearly 100 strains in all, a third of which

can be sexually transmitted. Researchers had discovered that

HPV-16 and HPV-18 were the most common causes of

cervical cancer. Two others, HPV-6 and HPV-II, were

thought to cause most genital warts.

Dr. Schultz now struggled to coax his yeast into growing

the shells of all four strains—hitting a brick wall with one

strain. Meanwhile, Dr. Jansen wanted to do a quickie test to

see if an HPV vaccine could work, so she tried vaccinating

cottontail rabbits against an HPV-like wart. The rabbits didn’t

get warts.

It was time to decide whether to start tests in humans—a

hugely expensive undertaking. She brought her results to

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Edward Scolnick, Merck’s chief of research. He figured the

science made sense and Dr. Jansen had the grit to get the

project done, so he approved spending the money.

Now Merck’s yeast experts had to figure out a way to grow

huge quantities of HPV shells. That proved another big

technical hurdle, which another Merck yeast expert, Hugh

George, finally solved. Even when he did, shells for three of

the four HPV strains came out mangled, “like goofed-up

balls” instead of geometric gems, as one researcher put it.

Only when they applied salt and acid did the balls, made up

of 72 different proteins, reorganize themselves into the proper

shape.

Merck believes its vaccine can not only block cervical

cancer but also prevent genital warts in boys. But it hasn’t

yet figured out how to prove this, because of the difficulty of

collecting tissue samples. For girls, a Pap test is enough. In

boys, Merck found it has to use something akin to a nail file

to get enough skin cells for a proper lab sample. “We had a

team meeting and I asked everybody how we could get good

samples from men, and the room cleared out pretty quickly, “

says Dr. Jansen. “I gave my husband some tools. He never

could get a good sample, and he wouldn’t let me try.”

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THE WALL STREET JOURNAL

WEDNESDAY, NOVEMBER 20, 2002

Stents May Become Useful Tool

In the Prevention of Strokes

Procedure That Catches Loosened Plaque Is Crucial

To the Carotid Treatment

By RON WINSLOW

CHICAGO—Stents, the tiny metal devices that have

transformed treatment of heart patients, could become an

important tool in preventing strokes, a new study suggests.

But the study points up the importance of using tiny filterlike

devices in conjunction with the stents in stroke prevention.

Currently, about 200,000 patients a year undergo a surgical

procedure on neck arteries called carotid endarterectomy.

The procedure aims to avert a potential stroke by clearing out

obstructions in the artery that transports blood to the brain.

But the operation itself comes with significant risk of

complications, and researchers have been seeking safer and

more effective ways to remove the blockages.

In the new study, headed by Jay S. Yadav, of the Cleveland

Clinic, 307 patients with severe blockage in their carotid

arteries were randomly assigned to getting the experimental

stent procedure or the operation. The patients had additional

health problems that significantly increased their risk of

complications from either procedure.

Importantly, the stent, a wire-mesh scaffold that resembles

a ballpoint pen spring, was combined with a small, umbrella-

like filter device that doctors deployed downstream of the

blockage to capture any debris that became dislodged during

the placement of the stent.

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In both the surgical and stent procedures, the effort to treat

the artery can cause small particles of disease-causing plaque

to break off and get carried with the blood into the brain

where they can cause strokes and other problems.

The study found that after 30 days, nine, or 5.8% of the

156 patients assigned to the stent and filter device either died

or suffered a heart attack or stroke. That compared with 19, or

13%, of the 151 patients who had the surgery, a relative

reduction of 54%.

Dr. Yadav presented the results at the annual scientific

meeting of the American Heart Association here. Johnson &

Johnson’s Cordis unit, which markets a variety of stents and

is developing a filter called Angioguard, sponsored the study.

Angioguard isn’t yet on the market. Several other companies,

including Guidant Corp. are developing similar devices for

use in the carotid arteries.

In the experimental procedure, the filter is deployed first,

threaded into the carotid artery in a closed position past the

blockage and then opened. Subsequent placement of the stent

often causes a “cheese-grater” effect that can dislodge bits of

the plaque. That is what the filter basket is intended to

capture. “We saw visible particles in 80% of these filters,”

Dr. Yadav said. While that raises the possibility that a

clogged filter could block or slow necessary blood flow to the

brain during the procedure, Dr. Yadav said that wouldn’t

likely cause a major problem. Deploying the stent—the step

that is most likely to lead to the debris breaking off—comes

at the end of the procedure, so the doctor can quickly retrieve

the basket and restore normal blood flow with little risk of

adverse consequences, he said,

“The contribution of the protection device would appear to

be an important part of the study,” said Sidney Smith,

cardiologist at University of North Carolina at Chapel Hill

and chief science officer of the American Heart Association.

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The results were “impressive,” he added, but said both longer

follow-up data from this trial and other studies of lower-risk

patients are needed to determine how widely the technique

might be used.

Dr. Yadav described the 30-day findings as preliminary

and said the plan is to follow patients for one year. The type

of high-risk patients included in the study account for about

one-third of those who undergo carotid endarterectomy each

year. Other studies, including one sponsored by Guidant, are

exploring whether carotid stenting will prove beneficial for

lower-risk patients.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.