wisletter

Founder: Myrl Jeffcoat
E-Mail: myrl_jeffcoat@yahoo.com

February 25, 2000

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Justice in America
As an implant victim, Christa Farley, who has a complaint against BMS pending, is among many that have found themselves "fired" by their own breast implant plaintiff attorneys. Mrs. Farley found her lawyer had filed a Motion to withdraw in a Texas Court in November 1999 without her knowledge. The Motion to withdraw was granted to her lawyer without either the lawyer or the court informing her of this action.

Only weeks later was Mrs. Farley to find out by accident that she no longer had representation. After her lawyer had withdrawn, but prior to Mrs. Farley being informed that her attorney had withdrawn, she received a request from him to sign a Power of Attorney for a claim entered by a third party for the Dow Bankruptcy.

Mrs. Farley has tried hard to find new representation. Her search for a lawyer has been fruitless.

Mrs. Farley was able to get some information from a sympathetic law firm. They stated, "We are sorry but our hands are bound. We have promised BMS that we will not take any new cases concerning breast implant litigation, nor take any cases to trial.

IS THIS JUSTICE IN AMERICA. . .Is there an attorney among the readers, who would like to address this state of affairs, many of our victims are finding themselves in??? How in America, can any of this be legal or moral???

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Medical Journal Apologizes for Violating Own Standards
Sent to us by Ruby Rahn. . .Thank you Ruby The New York Times

February 24, 2000
Medical Journal Apologizes for Violating Own Standards
By LAWRENCE K. ALTMAN
The New England Journal of Medicine, one of the world's top-ranked scientific publications and a leading critic of doctors' financial ties to industry, apologized yesterday to its readers for violating
its own financial conflict-of-interest policy 19 times over the last three years in choosing experts to review drug therapies.

The journal said it had failed to disqualify the authors of the 19 reviews even though the authors had told them about their financial ties to drug companies that marketed therapies described in the articles.
"This is the most serious mistake for which we have had to apologize," Dr. Marcia Angell, the editor in chief of the journal that began publishing in 1812, said in an interview.

The journal's policy would have required it to select authors who had no ties to the companies making the drugs discussed in the articles. The policy is intended to avoid bias in reporting information about drugs that doctors prescribe for their patients.

The reviews covered therapies for such ailments as hair loss, breast cancer, AIDS, diabetes, postmenopausal osteoporosis, alcoholism, asthma, glaucoma, meningitis, attention-deficit-hyperactivity disorder, and sickle cell anemia.

Dr. Angell said the error did not necessarily invalidate any of the information in the articles because all 19 reviews were also subjected to the peer review process, in which experts reviewed the manuscripts
before publication. "So I assume there is no reason to assume that the information is not good information," Dr. Angell said.

But, she added, "If you ask me, was there any bias in these articles, I cannot answer that question. That's why we have a conflict-of-interest policy because it is always possible for bias to fly under the radar screen.

There is no way I can say whether it did or didn't." Dr. Angell said she and the other peer reviewers did not detect any bias. The seriousness of the journal's policy lapse in part reflects its leadership in setting policies that require authors to disclose their financial ties to industry and in questioning the growing trend for industry-sponsored research at universities and medical schools.

Dr. Angell said hers was the only scientific journal with a policy that disqualifies scientists from writing reviews and editorials if they have "current, recent past, or planned future financial associations" with a
company that stands to gain from a product discussed in the editorial or review article. Reviews and editorials differ from reports of original research in the journal. While the original research reports findings, the reviews summarize and assess trends on the research topic, like drug therapy, from journals published around the world.

The journal learned of the policy lapse through articles in the Los Angeles Times, Dr. Angell said. The newspaper reported one such violation last September and then reported an additional seven in October.

But the letter of apology did not credit the newspaper's articles because "it did not seem particularly relevant" to do so, Dr. Angell said in the interview. She said, however, that she has been "forthright" in citing the accuracy of the Los Angeles Times articles in interviews with reporters from other news organizations.

After the publication of the newspaper's articles, the journal reviewed more than 40 articles published since January 1997 in a series on the latest drug treatments for particular diseases and ailments. Dr. Alistair J. J. Wood, a pharmacology professor at Vanderbilt University, edits the "Drug Therapy" series.

Although the journal abided by its policy in disqualifying authors of reviews and editorials who received significant research funds from companies making the drugs discussed in an article, it did not disqualify
authors whose institutions received such grants or authors who served as consultants to the drug companies. The journal study found a total of 19 articles that violated the policy, including the eight reported by the Los Angeles Times. The apology, published in the form of a letter to readers in today's issue of the journal, included specific references to the 19 articles, along with the names of drug manufacturers cited in the articles. The drug companies included most of the major companies and little-known biotech companies.
The lapse resulted from "poor coordination among the editors and carelessness within the office," Dr. Angell said in the interview. "It was a mistake, to put it as bluntly as possible."

Dr. Angell, Dr. Wood and Dr. Robert D. Utiger, another editor, signed the letter of apology. In it, the editors said that they had taken steps to prevent a recurrence without spelling them out. In the interview, Dr. Angell said one step was to improve communication among the editors. The journal, which is owned by the Massachusetts Medical Society and earns about $20 million a year, largely from drug company advertisements, employs six full-time editors and other part-time editors.

Another step will be to tighten the conflict-of-interest policy. The journal will change the wording of the letter signed by authors of editorials and reviews to require disclosure of who paid their grants during the two years preceding the request for the article. Authors will also have to disclose what percent of the total grant support comes from industry.

Dr. Angell expressed confidence that the journal would continue to find authors who meet its policy qualifications for reviews and editorials. The journal often has editorials about articles it publishes. Occasionally, Dr. Angell said, the journal could not publish such an editorial because none of the experts asked met its policy requirements.

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NEJM - Disclosure of Authors' Conflicts of Interest: A Follow-Up
This article has been sent to us by Ruby Rahn. . .Thank you Ruby.
The New England Journal of Medicine --
February 24, 2000 -- Vol. 342, No. 8

Disclosure of Authors' Conflicts of Interest: A Follow-Up
http://www.nejm.org/content/2000/0342/0008/0586.asp
We noted in the November 18 issue (1) that Dr. Vera Price, the author of a Drug Therapy article published in the September 23 issue, (2) had received major research support through her university from companies that manufactured drugs discussed in her article and that she had recently consulted for those companies. Although she informed us of these arrangements at the time her article was solicited, we failed to respond in accordance with our conflict-of-interest policy, which would have disqualified her.

Because of the inconsistency between our stated policy and practice in this case, we reviewed the files and spoke with the authors of the Drug Therapy articles published since January 1, 1997, to determine whether there were similar inconsistencies. We have now completed our review. We found 18 instances in which one or more authors of Drug Therapy articles received major research support through their institutions from relevant companies or served as consultants for those companies at the time they were invited to prepare their articles. The authors had informed us of these arrangements, and the
editors in Boston were aware of them and approved them. The list is as follows:

Lemon S, Thomas DL.
Vaccines to prevent viral hepatitis.
N Engl J Med 1997;336:196-204.

Dr. Lemon received grants from SmithKline Beecham Pharmaceuticals.
Hoofnagle JH, Di Bisceglie AM.
The treatment of chronic viral hepatitis.
N Engl J Med 1997;336:347-56.

Drs. Hoofnagle and Di Bisceglie received grants and other support from Abbott Laboratories, Chiron, Eli Lilly, Glaxo Wellcome, Roche, Schering-Plough, and Viratek.
Delmas PD, Meunier PJ.
The management of Paget's disease of bone.
N Engl J Med 1997;336:558-66.

Drs. Delmas and Meunier received grants from Boehringer Ingelheim, Merck, Novartis, Procter & Gamble, Rhone-Poulenc Rorer Pharmaceuticals, and Sanofi.
Quagliarello VJ, Scheld WM.
Treatment of bacterial meningitis.
N Engl J Med 1997;336:708-16.

Drs. Quagliarello and Scheld received grants from Pfizer and Roche.
Holleman F, Hoekstra JBL.
Insulin lispro.
N Engl J Med 1997;337:176-83.

Dr. Holleman received grants from Eli Lilly and Hoeschst Marion Roussel.
Rudick RA, Cohen JA, Weinstock-Guttman B, Kinkel RP, Ransohoff RM.
Management of multiple sclerosis.
N Engl J Med 1997;337:1604-11.

Drs. Rudick, Cohen, Kinkel, and Ransohoff received grants from Athena Neurosciences, Berlex Laboratories, Biogen, Connective Therapeutics, and Pharmacia-Upjohn.
Eastell R.
Treatment of postmenopausal osteoporosis.
N Engl J Med 1998;338:736-46.

Dr. Eastell received grants from and served as an advisor to Eli Lilly and Procter & Gamble and served as an advisor to Novartis and SmithKline Beecham Pharmaceuticals.
Flexner C.
HIV-protease inhibitors.
N Engl J Med 1998; 338:1281-92.

Dr. Flexner received grants from Abbott Laboratories and Agouron Pharmaceuticals.
Hortobagyi GN.
Treatment of breast cancer.
N Engl J Med 1998;339:974-84.

Dr. Hortobagyi received grants from Bristol-Myers Squibb and Targeted Genetics.
Alward WLM.
Medical management of glaucoma.
N Engl J Med 1998;339:1298-307.

Dr. Alward received a grant from Alcon Laboratories.
Osborne CK.
Tamoxifen in the treatment of breast cancer.
N Engl J Med 1998;339:1609-18.

Dr. Osborne received a grant from and served as a consultant to AstraZeneca.
Drazen JM, Israel E, O'Byrne PM.
Treatment of asthma with drugs modifying the leukotriene pathway.
N Engl J Med 1999;340:197-206.

Drs. Drazen, Israel, and O'Byrne received grants from and served as advisors to AstraZeneca, Boehringer Ingelheim, Glaxo Wellcome, Merck, Schering-Plough, Sepracor, SmithKline Beecham Pharmaceuticals, and 3M.
Elia J, Ambrosini PJ, Rapoport JL.
Treatment of attention-deficit-hyperactivity disorder.
N Engl J Med 1999;340:780-8.

Dr. Elia received grant support from Celegene.
Steinberg MH.
Management of sickle cell disease.
N Engl J Med 1999;340:1021-30.

Dr. Steinberg received a grant from Theradex.
Swift RM.
Drug therapy for alcohol dependence.
N Engl J Med 1999;340:1482-90.

Dr. Swift received grants from Dupont, Lipha, and Pfizer.
Knopp R.
Drug treatment of lipid disorders.
N Engl J Med 1999;341:498-511.

Dr. Knopp received grants from Bayer, Bristol-Myers Squibb, Kos Pharmaceuticals, Merck, Parke-Davis, Pfizer, and Wyeth-Ayerst.
Ferris FL III, Davis MD, Aiello LM.
Treatment of diabetic retinopathy.
N Engl J Med 1999;341:667-78.

Dr. Davis received grants from Agouron Pharmaceuticals, Eli Lilly, Miravant Medical Technologies, Novartis, and Roche, and Dr. Aiello received a grant from Eli Lilly.
Vance ML, Mauras N.
Growth hormone therapy in adults and children.
N Engl J Med 1999;341:1206-16.

Dr. Vance received grants from Eli Lilly and Pharmacia-Upjohn, and Dr. Mauras received grants from Alkermes, Eli Lilly, Genentech, Merck, Pharmacia-Upjohn, and Wyeth-Ayerst.

We regret our failure to apply our policy correctly.
Steps have been taken to ensure against any recurrence.
Marcia Angell, M.D.
Robert D. Utiger, M.D.
Alastair J.J. Wood, M.D.

References

1. Price VH, Angell M, Wood AJJ.
Authors' conflicts of interest: a disclosure and editors' reply.
N Engl J Med 1999;341:1618-9.

2. Price VH.
Treatment of hair loss.
N Engl J Med 1999;341:964-73.

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Daubert brief by 18 amici scientists AGAINST "new science"

The following brief and introductory message has been sent to us by Marti Jacobs. . . Thank you Marti for sending our way.
At last, have found the brief we want to OPPOSE. Listen up everybody, this
is the ONE AND ONLY brief to focus on matching it with opposition. You can
find articles galore ABOUT Daubert, but this is the one filed by scientists
in the actual Daubert case. We need to find scientists to present an
ANTI-DAUBERT brief in any Dow Corning/Dow Chemical litigations when they have
a preliminary "Daubert" hearing.
This brief was submitted by 18 scientists who entered the brief as an Amicus
Curiae Brief (as "friends of the court"). They were in support of NOT
allowing scientific experts to testify in the actual Daubert case because
they oppose the testimony of certain experts who were not accepted by the
mass of the medical community.
This case has taken the issue of expert testimony too far. This insanity
must be turned around. Good grief, at this rate (of bias against new medical
findings and the discovery of new diseases and notice of medical product
failures); we'd still be thinking that Darwin's Theory of Evolution is in
question!
We all know what the bias is in our case -- the medical community supporting
their plastic surgeons and medical device manufacturers for the BIG BUCKS.
Oh yes, and insurance companies not wanting to pay for more expensive
alternatives to breast implants for reconstruction after mastectomy.
Here is part 1 (of 3) of the brief. We must find 18 scientists (or more) to
file an Amicus Curiae Brief that opposes this one:
In The Supreme Court Of The United States
October Term, 1992
__________
WILLIAM DAUBERT and JOYCE DAUBERT,
Individually and as Guardians ad litem for
JASON DAUBERT, and ANITA DE YOUNG,
Individually and as Guardians ad litem
for ERIC SCHULLER,
Petitioners,
v.
MERRELL DOW PHARMACEUTICALS, INC.,
Respondent.
___________
On Writ Of Certiorari
To The United States Court of Appeals
For The Ninth Circuit
___________
BRIEF AMICI CURIAE OF NICOLAAS
BLOEMBERGEN, ERMINIO COSTA, DUDLEY
HERSCHBACH, JEROME KARLE, ARTHUR
LANGER, WASSILY LEONTIEF, RICHARD S.
LINDZEN, WILLIAM N. LIPSCOMB, DONALD B.
LOURIA, JOHN B. LITTLE, A. ALAN MOGHISSI,
BROOKE T. MOSSMAN, ROBERT NOLAN, ARNO A.
PENZIAS, FREDERICK SEITZ, A. FREDERICK
SPILHAUS, DIMITRIOS TRICHOPOULOS AND
RICHARD WILSON IN SUPPORT OF RESPONDENTS
___________

Martin S. Kaufman
Counsel of Record
Douglas Foster
Atlantic Legal Foundation
205 East 42nd Street, 9th Floor
New York, NY 1001 7
(212) 573-1960
Attorneys for Amici Curiae
TABLE OF CONTENTS

TABLE OF AUTHORITIES........ ii
INTEREST OF AMICI CURIAE........ 2
SUMMARY OF ARGUMENT........ 3
ARGUMENT
I. PETITIONERS' ARGUMENTS AND THOSE OF CERTAIN AMICI IN SUPPORT OF
PETITIONERS MISCONSTRUE THE PRINCIPLES APPLIED BY THE COURTS BELOW........ 5
II. PUBLICATION AND PEER REVIEW ARE ESSENTIAL FOR DETERMINING WHETHER
SCIENTIFIC PRINCIPLES OR METHODOLOGIES ARE ACCEPTED IN THE SCIENTIFIC
COMMUNITY........ 8
III. THERE ARE FUNDAMENTAL DIFFERENCES IN THE MEANING OF "TRUTH" IN THE LEGAL
AND SCIENTIFIC REALMS........14
IV. PETITIONERS' PROPOSED APPROACH IS INADEQUATE AND DANGEROUS........ 23
CONCLUSION......... 26
APPENDIX.......... A1

TABLE OF AUTHORITIES
CASES
Branion v. Gramly, 855 F.2d 1256 (7th Cir. 1988) . . . 15

Brock v. Merrell Dow Pharmaceuticals, Inc., 874 F.2d 307, modified, 884 F.2d
166 (5th Cir. 1989), cert. denied, 110 S. Ct. 1511 (1990) . . . . . . . 23
DeLuca v. Merrell Dow Pharmaceuticals, Inc., 911 F.2d 941 (3rd Cir. 1990) . .
. . . . . . . 23
Lynch v. Merrell-National Labs, 830 F.2d 1190 (1st Cir. 1987) . . . . . . . .
. . . . . 23
Richardson v. Richardson-Merrell, Inc., 857 F.2d 823 (D.C. Cir. 1989), cert.
denied, 110 S. Ct. 218 (1990) . . . . . . . . . . . . . . 23
Turpin v. Merrell Dow Pharmaceuticals, 736 F.2d 737 (E.D. Ky. 1990), aff'd,
959 F.2d 1349 (6th Cir.1992), petition for cert. filed . . . . . . . . 23
Wilson v. Merrell Dow Pharmaceuticals, Inc., 893 F.2d 1149 (10th Cir. 1990) .
. . . . . . 23

STATUTES and RULES
Fed. R. Evid. 401 . . . . . . . . . . 16
Fed. R. Evid. 402 . . . . . . . . . . 16
Fed. R. Evid. 403 . . . . . . . . . . 16
Fed. R. Evid. 404 . . . . . . . . . . 16
Fed. R. Evid. 408 . . . . . . . . . . 16
Fed. R. Evid. 702 . . . . . . . . . . 19
Fed. R. Evid. 703 . . . . . . . . . . passim
Fed. R. Evid. 802 . . . . . . . . . . 16
Fed. R. Evid. 803(1)-(24) . . . . . . . . 16

MISCELLANEOUS
Austin Bradford Hill in Environment and Disease:
Association or Causation?, 58 Proceedings of
the Royal Society of Medicine 295 (1965) . . . . . 14
L. Loevinger, "Standards of Proof in Science and Law",
32 Jurimetrics J. 327 (1992) . . . . . . . 14
Roger Penrose, The Emperor's New Mind (1989) . . . 19, 20
Karl R. Popper, The Logic of Scientific Discovery (1959) . . . . . . . . . .
. . . 14
I Responsible Science: Ensuring the Integrity of
the Research Process, 38 (Nat'l Academy of
Sciences (1992)) . . . . . . 14

INTEREST OF AMICI CURIAE
Amici are eighteen scientists, scholars, and teachers of science. Amici
include six Nobel Laureates -- Nicolaas Bloembergen in Physics, 1981; Dudley
R. Herschbach, in Chemistry, 1986; Jerome Karle, in Chemistry, 1985; Wassily
Leontief, in Economics, 1973; William N. Lipscomb, in Chemistry, 1976; Arno
A. Penzias, in Physics, 1978. Several are recipients of the National Medal of
Science and other distinguished prizes and awards in their respective fields.
The fields of expertise of amici include chemistry, physics, meteorology,
medicine (including, of particular relevance to this case, epidemiology,
environmental medicine and teratology). Many of them are recipients of
multiple honorary degrees in addition to earned doctorates in various fields
of science. Many are or were editors and contributors to scientific and other
scholarly journals, and are authors of authoritative works in their
respective areas of expertise. Most are professors at several of the most
highly regarded institutions of higher education in the United States, and
one a former president of one of the most prestigious research universities
in the world. They hold many other distinctions for achievements in fields of
science and academia. Amici are authors of numerous articles, studies,
monographs and textbooks. Many are frequently called upon to serve on
official commissions, review boards, advisory committees and institutes.
Amici have no interest in the outcome of this case, any other "Bendectin
case", or any case in which injury is allegedly caused by pharmaceuticals. We
appear solely as individuals, on our own behalf, to inform the Court of our
views as to the appropriate criteria for acceptable scientific evidence, and
to respond to certain misconceptions that pervade some of the amicus briefs
filed in support of Petitioners and which could adversely affect the judgment
of this Court if uncorrected. Our interest transcends the issues in this case
or the positions of any party.

SUMMARY OF ARGUMENT
The courts below strove to ensure that opinion testimony that was the result
of methods of inquiry not generally accepted as valid in a particular field
of scientific endeavor would not become the basis of decision by a jury of
individuals with no particular knowledge or experience in scientific or
technical matters. We believe that this effort is of great importance and the
goal salutary. Scientific terminology and scholarly credentials can, and
often do, have an inordinate effect on a lay person's perception of the
authoritativeness of a scientist even when, or more precisely, just because,
the lay person is usually not able to evaluate the intrinsic merit of the
propositions advanced by the scientist. We do not suggest that scientists or
other scholars belong to a caste superior to lay jurors, but we do believe
that the scientific community as a whole is better able to evaluate the data
and methods used by scientists.
The impact and influence of scientific rhetoric can easily sway and mislead a
jury. Opinion testimony based on scientific techniques or methodology that
are not generally accepted by the scientific community is not reliably valid.
Testimony must be based on facts or data reasonably relied upon by experts in
a particular field. Testimony not so grounded will not assist the trier of
fact to understand critical facts in issue, and is more likely to mislead.
Publication and peer review, while not guaranteeing that particular methods
of scientific investigation or data are accurate, are vital means of
permitting the scientific community to see the data, to understand them, to
test them, to evaluate the methods and show, either that the data or methods
of a particular scientist are correct and appropriate and do lead to valid
conclusions or, if such be the case, are not correct and thus do not lead to
valid conclusions.

ARGUMENT

I. PETITIONERS' ARGUMENTS AND THOSE OF CERTAIN AMICI IN SUPPORT OF
PETITIONERS MISCONSTRUE THE PRINCIPLES APPLIED BY THE COURTS BELOW
The main thrust of Petitioners' factual presentation is, we submit, based on
an incorrect reading of the decisions of the Court of Appeals for the Ninth
Circuit and the District Court. Petitioners contend that the court of appeals
and the district court excluded the affidavit and deposition testimony of
plaintiffs' expert witnesses because those witnesses reached conclusions that
were not "generally accepted" in the scientific community. Petitioners
identify the "central issue in this case" to be whether the "rule...that
expert scientific opinion evidence is inadmissible unless it has attained
general acceptance in the relevant scientific field..." is the proper rule of
evidence. [See Brief for Petitioners' (hereafter "Pet. Br.") at 14]
Neither the district court nor the court of appeals excluded the testimony of
plaintiffs' experts because their opinions had not gained general acceptance.
Rather, the court of appeals affirmed the dismissal because the methodology
used by plaintiffs' key expert had not been demonstrated to be generally
accepted as a reliable technique in the scientific community. [Joint Appendix
(hereafter "JA") 238] As the court of appeals stated: "For expert opinion
based on a given scientific methodology to be admissible, the methodology
cannot diverge significantly from procedures accepted by recognized
authorities in the field." [JA 239]
The district court excluded the testimony of plaintiffs' experts on two
separate bases: first, that the epidemiological bases relied upon by
plaintiffs' experts (which in fact were reanalyses of data collected by
others that had been reported in published studies and that had reached a
conclusion contrary to those of plaintiffs' experts) had not themselves been
published or subject to peer review and second, that the published studies
did not state that Bendectin increased the relative risk of limb reduction
defects to a statistically significant level. [JA 232-236] Thus the district
court did not exclude the evidence of plaintiffs' experts because the court
disagreed with their conclusions, but because their epidemiological
methodology had not been subjected to scrutiny by the scientific community
and because their conclusions were legally insufficient.
The court of appeals also did not focus on the conclusions of plaintiffs'
experts, but rather whether the methodology used is "generally accepted as a
reliable technique," [JA 239].
Petitioners, based on their misreading of the decisions below, set up a straw
man: that the courts below imposed publication and peer review as the sine
qua non for admissibility of expert opinion. The court of appeals did not
establish such a general rule, but instead found that the method of
reanalysis of epidemiological studies employed by plaintiffs' experts would
be generally accepted in the scientific community only when it has been
subjected to scrutiny and verification by others. [JA 240-241]
Certain of Petitioners' amici likewise create strawmen. Chubin, Hackett,
Ozonoff and Clapp (hereafter "Chubin, et al." or "the Chubin amici"), for
example, incorrectly argue that the lower courts devised "two mischievous
presumptions: an apparently rebuttable presumption that anything that is
published in a peer review journal is "good science" and therefore
admissible; and, conversely, an "evidently irrebuttable" presumption that
unless a theory, fact, or analysis has been previously published in a
peer-reviewed journal such ideas and information cannot be "good science" and
cannot form the basis for admissible expert testimony. [Chubin Br. at 3]. If
the courts below had in fact done that, we would not submit a brief
supporting the judgment below. As shown infra, the process of publication and
peer review merely leads to a rebuttable presumption of validity.
Amici "Physicians, Scientists and Historians of Science" (hereafter "Ronald
Bayer, et al.") argue that "Judgments based on scientific evidence, whether
made in a laboratory or a courtroom, are undermined by a categorical refusal
even to consider research or views that contradict someone's notion of a
prevailing `consensus' of scientific opinion" [Bayer Br. at 2; emphasis
supplied], and further that the courts below converted peer review into "a
litmus test for scientific truth." [Bayer Br. at 3], and, finally, that the
courts below acted like inquisitors, searching out and condemning "heresy"
[e.g., Bayer Br. at 11, 14, 15], rather than forums for the discovery of
"truth". These arguments do not address the issues genuinely before this
Court, for the lower courts neither conducted inquisitions into "heresy", nor
did they exclude evidence because the expert witness' conclusion contradicted
some "consensus".

II. PUBLICATION AND PEER REVIEW ARE ESSENTIAL FOR DETERMINING WHETHER
SCIENTIFIC PRINCIPLES OR METHODOLOGIES ARE ACCEPTED IN THE SCIENTIFIC
COMMUNITY
Publication and peer review are central to the scientific enterprise of
corroborating or falsifying methods, data, theories and conclusions advanced
by scientists to explain natural phenomena. We agree with Chubin, et al. that
publication and peer review are not the final answer to the question of "What
is truth?" While it is correct, as Chubin, et al. assert [Chubin Br. at 6],
that peer review journals do not replicate and verify the experiments,
research and analytical techniques, or data reported in the papers submitted
for publication, peer review does not end with publication -- publication is
only a starting point of peer review. The function of publication is to make
data and methods available to the scientific community beyond the scientist's
inner circle and beyond the editorial staff and referees of the journal:
publication exposes the work to the scientific world at large, which then has
the opportunity to replicate and confirm, or fail to replicate and falsify,
the scientist's proposition. Of course, peer review journals do not "warrant"
that the ideas or information contained in the articles they print are
"accurate, valid, certain, reliable or true" [Chubin Br. at 6]. Indeed,
scientists do not assert that they know what is immutably "true" -- they are
committed to searching for new, temporary, theories to explain, as best they
can, phenomena. It is nothing more than a red herring to argue that peer
review does not guarantee "truth". Of course, the "mere fact" of publication
does not mean that the ideas and information reported in an article are
generally accepted by, or represent the consensus views of, the relevant
academic community. Again, publication is the first step in obtaining a
(temporary) consensus: Without publication other scientists would be unaware
of the idea and so there would never be a consensus.
We disagree strongly with the assertion of Chubin, et al. that the fact that
ideas and information have not been published in a peer review journal does
not mean that they are not generally accepted. While failure to publish does
not imply that the ideas are "generally rejected", or that they cannot
represent "good science", it does mean that the scientific community has not
had the opportunity to test and confirm the "discoverer's" findings and
ideas, or to satisfy itself that proper methods were used and that the
methods and results represent "good science".
There is a major difference between the presentation of evidence for the sake
of establishing "truth" in science on one hand and law on the other.
Typically, in the legal process a specific conclusion is the goal of the
evidence offered. Thus there is a strong motivation to be selective because
of bias. Quite often, the experiments will have been conducted with a pending
case or at least potential litigation in mind. On the other hand, scientific
journals are typically concerned with progress in a particular field, and in
making progress with sound methodology. The journal will let the conclusions
fall where they may. Individual scientists who might have an interest in
reaching a particular conclusion at the expense of rigor in methodology are
challenged in the peer review process. One important advantage of publication
and peer review, as compared with cross-examination and contradictory
testimony of the adversary's expert, is that peer review by the scientific
community at large enables scientists who are truly disinterested in the
outcome of a particular litigation, the prospects of a particular product,
the financial success of a particular industry, or even "justice", will have
the opportunity to test, evaluate and either confirm or refute data, findings
or theories. We submit that this neutral process is of great value both in
science and in the courts.
Certainly, without publication and subsequent peer review ideas cannot become
"generally accepted". Indeed, the notions of confidentiality or "privilege"
and "general acceptance" are antithetical. The court of appeals below was
correct in remarking that the work of "experts" prepared for the specific
purpose of litigation, and not published or peer reviewed, cannot be said
with any confidence to utilize generally accepted principles and methods [JA
241, n.3].
Techniques can be considered widely accepted when they are used to produce
results that are accepted time and again for publication in reputable
reviewed media. The publication once of a new technique, no matter how
esteemed the reputation of the author or the journal, gives it no inherent
validity. That first publication simply says the editor and reviewers feel
the article is of interest and do not immediately see why the methodology or
theory will not work. The consequent exposure, then, of the technique to the
scientific community allows for discussion and hopefully its replication. Its
continued use, and acceptance in peer review journals, provides some
assurance of validity, but does not provide any guarantee.
When experts are asked to draw a conclusion in a courtroom, their expertise
must be established. Acceptability is established in science when a scientist
produces results that have appeared in peer review journals and have stood
the test of subsequent challenges. Publication is not a sufficient test by
itself.
Scientific "orthodoxy" should be tested in the laboratory, in the meeting
rooms and hallways at scientific meetings and on the pages of journals, and
not in the courtroom. Ronald Bayer, et al. use the term "good science" [Bayer
Br. at 3 and passim]. "Good science" is science that is done well, not
necessarily science that produces the desired results. It is impossible to
determine what results are correct. In that sense, good science is that
science that undergoes the scrutiny of peer review, not only in the
publication process, but after publication, when the scientific community
examines the published data, findings and theory and then tries to replicate
the data and the findings.
Publication in a peer review medium is therefore a necessary but not
sufficient condition.
Contrary to the conclusion of the Chubin amici, we submit that because of the
technical, and increasingly technical, nature of much of the expert testimony
offered in court, the jury and the cross-examination process are not adequate
to ensure that scientific evidence has been derived from facts or data
generally relied on by experts in the field. Publication and peer review do
serve that important purpose.
If the courts below had used a phrase such as "universally recognized
scientific truths", as Petitioners and certain amici at least imply, they
would have adopted a clearly unacceptable criterion. But that is not what the
lower courts in this case did. They simply recognized the central role
publication and peer review play in the process of detecting and reducing the
use of "bad science" in litigation.

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