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The Litigator’s Guide to
Combating Junk Science
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The Litigator’s Guide to Combating Junk Science
© 2013 Innovative Science Solutions 2
The Litigator’s Guide to Combating Junk Science
Table of Contents
Introduction .................................................................................................................................................... 3
What Is Junk Science? ................................................................................................................................ 5
Anti-Junk Science Websites ..................................................................................................................... 7
Anti-Junk Science Books ......................................................................................................................... 11
Resources for Regulatory Guidance ................................................................................................... 13
Resources for Scientific Standards ..................................................................................................... 16
Placebo and Nocebo Effects ................................................................................................................. 20
About Innovative Science Solutions .................................................................................................. 21
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Introduction
Science plays a critical role in the courtroom. Access to scientific research and an
understanding of scientific principles enable the litigator to build a powerful case.
The team’s expert witnesses can effectively communicate to the judge and jury
technical concepts that support the central arguments of the case.
Five types of legal cases often rely on scientific information:
• Personal Injury: Scientific evidence is typically presented in mass torts
involving allegations of personal injury from a product, an environmental
exposure, or a chemical exposure. In these cases, plaintiffs rely on scientific
studies to demonstrate a link between the exposure and the injury. The
defense presents scientific research to cast doubt on the purported causal
relationship between the exposure and the injury.
• Consumer Fraud: To counter the plaintiff’s claim that a product failed to
achieve the results promised, the defense argues that its marketing claims are
supported by reliable scientific evidence. Plaintiffs will present evidence that
questions or counters the defense’s data.
• Medical Malpractice: To counter the plaintiff’s claim that a healthcare
provider’s error resulted in harm, the defense will present scientific studies to
demonstrate the provider adhered to the generally accepted standard-of-care.
• Securities and Shareholders Lawsuits: In securities and shareholder lawsuits
involving medical devices or pharmaceutical products, the defense presents
scientific evidence to demonstrate that the information relayed to
shareholders was reasonable and reliable.
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• Patent Challenges: Opposing parties in patent infringement cases will most
likely agree on the fundamental science. But the plaintiff will present specific
scientific evidence to support the claim that the patent does not meet the
necessary requirements.
The parties involved in any legal dispute will typically engage in a legitimate debate
about the validity of the scientific evidence presented. Even the experts often
disagree when interpreting scientific data.
However, dubious or bias scientific information is occasionally presented in court
cases, influencing the outcome. Judges and juries who lack the background and
knowledge to properly evaluate the validity of scientific data tend to accept the
information placed before them.
When a case relies on misinformation, unsubstantiated claims, and misleading data,
opposing counsel can successfully counterattack with access to the right resources.
In the following pages, we provide you with the tools and resources you need to
combat junk science in the courtroom.
• What Is Junk Science identifies examples of junk science.
• Anti-Junk Science Websites provides access to resources dedicated to
exposing junk science.
• Anti-Junk Science Books lists publications focused on illuminating the issue of
junk science.
• Resources for Regulatory Guidance provides access to government resources
that will allow you to counter misinformation with scientifically sound
principles.
• Resources for Scientific Standards provides access to reputable online
resources that present generally accepted scientific methods.
• Placebo and Nocebo Effects provides the latest research on this medical
phenomenon, which is central to many pharmaceutical cases.
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What Is Junk Science?
Legitimate controversies erupt daily in political arenas, the news media, the
courtroom, and the court of public opinion. In these debates, valid evidence usually
emerges to support both sides. However, we have observed a number of
controversies in which one side relies on faulty data – or junk science – rather than
rigorous scientific methodologies.
Junk science refers to scientific research that fails to meet the criteria characteristic
of a rigorous scientific investigation, such as falsifiable hypotheses, replication, peer-
review and publication, general acceptance, neutrality, objectivity, and adherence to
the scientific method. Purveyors of junk science typically have an agenda, and
research and results are driven by non-scientific motives that are often political,
financial or ideological.
To illuminate the issue, we provide below examples of controversial claims based on
junk science, and links to resources refuting these questionable claims.
Controversial Claim #1: Electromagnetic radiation causes adverse health effects.
Junkscience.com - EMFs and Cell Phones
National Institute of Environmental Health Sciences - Electric and Magnetic Fields
Controversial Claim #2: Endocrine disruptors disturb human hormone balances.
SafeChemicalPolicy.org - Endocrine Disruptors
Sciencebasedmedicine.org - Endocrine disruptors—the one true cause?
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Controversial Claim # 3: Hydraulic fracturing leads to adverse health effects for
nearby residents.
Junkscience.com - Penn pilot study: Group of Bradford Co, Pa. residents concerned
about health effects of hydrofracking
K&L Gates Law Firm - Junk Science Meets Hydraulic Fracturing: Unfounded
Environmental Scare Threatens Energy Development
Controversial Claim #4: Multiple chemical sensitivity causes a host of adverse health
effects.
Junkscience.com - Multiple Chemical Sensitivity Testimony Inadmissible Under
Daubert, Court Says
Skepdic.com - multiple chemical sensitivity (MCS) from Skeptic’s dictionary
Controversial Claim #5: Vaccines lead to autism.
Junkscience.com - The risk of autism is not increased by ‘too many vaccines
too soon’
Nature - A case of junk science, conflict and hype
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Anti-Junk Science Websites
The following online resources are dedicated to exposing junk science. They offer a
wealth of information that counters assertions based on unreliable data.
Bad Science
Dr. Ben Goldacre, author of the bestseller Bad Science, continues his campaign
against junk science in his witty and insightful blog of the same name. In his book
and blog, he exposes the tenuous scientific claims of newspapers, doctors,
government reports and drug companies.
Bjorn Lomborg
Bjorn Lomborg, an adjunct professor at Copenhagen Business School, a bestselling
author, and a frequent media commentator, challenges mainstream concerns about
the environment. In news articles and social media posts, he strives to focus
attention on effective solutions to environmental issues.
Debunked & Exposed
Maintained by JunkScience.com, Debunked & Exposed offers Debunkosaurus™, a
Wiki-based tool for researching health scares and scams.
Gary Taubes
Gary Taubes is a science writer and the author of Nobel Dreams (1987), Bad Science:
The Short Life and Weird Times of Cold Fusion (1993), and Good Calories, Bad
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Calories (2007). He has won the Science in Society Award of the National Association
of Science Writers three times and was awarded an MIT Knight Science Journalism
Fellowship for 1996-97. Taubes’ books deal with controversies in the field of science.
Nobel Dreams takes a critical look at the politics and experimental techniques
behind the Nobel Prize-winning work of physicist Carlo Rubbia. Bad Science
chronicles the short-lived media frenzy surrounding the Pons-Fleischmann cold
fusion experiments of 1989.
JunkScience
“All the Junk That’s Fit to Debunk.” As its motto indicates, JunkScience.com’s mission
is to reveal the facts behind junk science in the media and the courtroom.
JunkScience takes on Global Warming theorists, the EPA, the American Heart
Association and others.
Not Even Wrong
William H. Kinney, associate professor in the University at Buffalo Physics
Department, named his website after the Wolfgang Pauli quote “It is not even
wrong.” The website is described as “A page dedicated to the ample evidence that
we need better science education.” Topics include vaccines and autism, EMFs, plastic
softeners, silicone breast implants, and more.
QuackWatch
QuackWatch is an international network of advocates who are concerned about
health-related frauds, myths and misconduct. Activities include investigating
questionable claims, debunking pseudoscientific claims, and distributing reliable
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publications, among others. Visitors can search the website’s vast database of
questionable products, services and theories by topic.
Science-Based Medicine
Science-based medicine evaluates medical treatments and products in a scientific
context. “Good science is the best and only way to determine which treatments and
products are truly safe and effective,” according to the website. Recent articles have
analyzed placebo prescribing, cancer screening tests, and SPECT scans.
Science-ish
Science-ish, a blog on the Maclean’s magazine website, checks health-related news
against the evidence to hold politicians, opinion leaders, and journalists accountable
for the information they disseminate.
Skeptoid
Skeptoid is a weekly podcast dedicated to debunking the widespread
“pseudosciences.” According to the website, “Skeptoid attempts to expose the folly
of belief in non-evidence based phenomena, and more importantly, explains the
factual scientific reality.” Topics include hydraulic fracturing, high-fructose corn syrup,
DDT, vaccine ingredients, cell phone radiation, and more.
STATS
Are you interested in the latest research questioning the purported connection
between cell phone use and brain cancer? Do you want to know why a leading
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expert condemned the crusade against BPA? Do you question the supposed link
between sugary beverages and obesity? You can find information on these topics
and more on the STATS website, an affiliate of George Mason University that aims to
correct scientific misinformation in the media and public policy. STATS offers
analyses of the latest research on key issues and links to revealing articles.
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Anti-Junk Science Books
The following books offer insight into the insidious nature of junk science and how
we can guard against it.
Junk Science Judo: Self-Defense against Health Scares and Scams
Steven J. Milloy
Cato Institute, 2001
218 pages
Book Description: This book is a simple, easy-to-read guide to debunking health
scares and scams before you get hurt.
Galileo's Revenge: Junk Science In The Courtroom
Peter Huber
Basic Books, 1993
288 pages
Book Description: A scathing indictment of the growing role of junk science in our
courtrooms. Peter W. Huber shows how time and again lawyers have used—and the
courts have accepted – spurious claims by so-called expert witnesses to win
astronomical judgments that have bankrupted companies, driven doctors out of
practice, and deprived us all of superior technologies and effective, life-saving
therapies.
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Voodoo Science: The Road from Foolishness to Fraud
Robert Park
Oxford University Press, 2001
240 pages
Book Description: In a time of dazzling scientific progress, how can we separate
genuine breakthroughs from the noisy gaggle of false claims? From Deepak
Chopra's "quantum alternative to growing old" to unwarranted hype surrounding the
International Space Station, Robert Park leads us down the back alleys of fringe
science, through the gleaming corridors of Washington power and even into our
evolutionary past to search out the origins of voodoo science. Along the way, he
offers simple and engaging science lessons, proving that you don't have to be a
scientist to spot the fraudulent science that swirls around us. While remaining highly
humorous, this hard-hitting account also tallies the cost: the billions spent on
worthless therapies, the tax dollars squandered on government projects that are
doomed to fail, the investors bilked by schemes that violate the most fundamental
laws of nature. But the greatest cost is human: fear of imaginary dangers, reliance
on magical cures, and above all, a mistaken view of how the world works. To expose
the forces that sustain voodoo science, Park examines the role of the media, the
courts, bureaucrats and politicians, as well as the scientific community. Scientists
argue that the cure is to raise general scientific literacy. But what exactly should a
scientifically literate society know? Park argues that the public does not need a
specific knowledge of science so much as a scientific world view – an understanding
that we live in an orderly universe governed by natural laws that cannot be
circumvented.
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Resources for Regulatory Guidance
The following government websites contain a plethora of valuable resources that can
be tapped when confronting junk science. Available information includes research
studies, databases, publications, news, regulatory guidelines, and a host of other
materials.
Food and Drug Administration (FDA)
The FDA is responsible for protecting public health by ensuring that foods are safe,
wholesome, sanitary and properly labeled (except for meat from livestock, poultry
and some egg products, which are regulated by the U.S. Department of Agriculture).
The FDA is also charged with ensuring that human and veterinary drugs, vaccines
and other biological products and medical devices intended for human use are safe
and effective. In addition, the FDA is responsible for protecting the public from
electronic product radiation, ensuring that cosmetics and dietary supplements are
safe and properly labeled, regulating tobacco products, and advancing public health
by promoting product innovations.
The following links to FDA guidances provide authoritative information related to
dietary supplements, food health claims, and radiation-emitting products:
Dietary Supplements - Draft Guidance for Industry
Food Health Claims - Guidance for Industry
Radiation-Emitting Products
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National Institute for Occupational Safety and Health (NIOSH)
The NIOSH is responsible for conducting research and making recommendations to
prevent work-related injury and illness. The mission of NIOSH is to generate new
knowledge in the field of occupational safety and health and to put that knowledge
into practice to benefit workers. To accomplish this mission, NIOSH conducts
scientific research, develops guidance and authoritative recommendations,
disseminates information, and responds to requests for workplace health hazard
evaluations. NIOSH is part of the Centers for Disease Control and Prevention (CDC)
within the U.S. Department of Health and Human Services.
United States Environmental Protection Agency (EPA)
The EPA’s mission is to reduce environmental risks based on the best available
scientific information. The agency is charged with protecting human health and the
environment by developing and enforcing regulations based on laws passed by
Congress.
United States Geological Survey (USGS)
The USGS provides impartial information on the health of the Earth’s ecosystems
and environment, the natural hazards that threaten humans, the natural resources
we rely on, the impacts of climate and land-use change, and the core science
systems that help us provide timely, relevant, and useable information. The USGS
provides reliable scientific information to describe and understand the Earth;
minimize loss of life and property from natural disasters; manage water, biological,
energy, and mineral resources; and enhance and protect our quality of life.
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United States Department of Agriculture (USDA)
The USDA is responsible for developing and executing U.S. federal government
policy on farming, agriculture, forestry and food. The agency provides leadership on
food, agriculture, natural resources, rural development, nutrition, and related issues
based on sound public policy, the best available science, and efficient management.
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Resources for Scientific Standards
The following independent organizations provide information on generally accepted
scientific standards and practices. Specific knowledge of scientific principles will
enable you to formulate an argument discrediting junk science.
The Cochrane Collaboration
From the Cochrane website:
“Cochrane Reviews are systematic reviews of primary research in human health care
and health policy. Cochrane Reviews are internationally recognized as the highest
standard in evidence-based health care. They investigate the effects of interventions
for prevention, treatment and rehabilitation. They also assess the accuracy of a
diagnostic test for a given condition in a specific patient group and setting. They are
published online in The Cochrane Library.
Each systematic review addresses a clearly formulated question; for example: Can
antibiotics help in alleviating the symptoms of a sore throat? All the existing primary
research on a topic that meets certain criteria is searched for and collated, and then
assessed using stringent guidelines, to establish whether or not there is conclusive
evidence about a specific treatment. The reviews are updated regularly, ensuring
that treatment decisions can be based on the most up-to-date and reliable
evidence.
Cochrane Reviews are designed to facilitate the choices that practitioners,
consumers, policy-makers and others face in health care.”
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Consolidated Standards of Reporting Trials (CONSORT)
From the CONSORT website:
“The main product of CONSORT is the CONSORT Statement, which is an evidence-
based, minimum set of recommendations for reporting RCTs. It offers a standard
way for authors to prepare reports of trial findings, facilitating their complete and
transparent reporting, and aiding their critical appraisal and interpretation.
The CONSORT Statement comprises a 25-item checklist and a flow diagram, along
with some brief descriptive text. The checklist items focus on reporting how the trial
was designed, analyzed, and interpreted; the flow diagram displays the progress of
all participants through the trial.”
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
From the PRISMA website:
PRISMA “is an evidence-based minimum set of items for reporting in systematic
reviews and meta-analyses.
The aim of the PRISMA Statement is to help authors improve the reporting of
systematic reviews and meta-analyses. We have focused on randomized trials, but
PRISMA can also be used as a basis for reporting systematic reviews of other types
of research, particularly evaluations of interventions. PRISMA may also be useful for
critical appraisal of published systematic reviews, although it is not a quality
assessment instrument to gauge the quality of a systematic review.
The PRISMA Statement consists of a 27-item checklist and a four-phase flow
diagram. It is an evolving document that is subject to change periodically as new
evidence emerges. In fact, the PRISMA Statement is an update and expansion of the
now-out dated QUOROM Statement. This website contains the current definitive
version of the PRISMA Statement.”
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Grading of Recommendations Assessment, Development and Evaluation
(GRADE)
From the GRADE website:
“The Grading of Recommendations Assessment, Development and Evaluation (short
GRADE) Working Group began in the year 2000 as an informal collaboration of
people with an interest in addressing the shortcomings of present grading systems
in health care. The working group has developed a common, sensible and
transparent approach to grading quality of evidence and strength of
recommendations. Many international organizations have provided input into the
development of the approach and have started using it.”
U.S. Preventive Services Task Force (USPSTF)
From the USPSTF website:
“Created in 1984, the U.S. Preventive Services Task Force (USPSTF or Task Force) is
an independent group of national experts in prevention and evidence-based
medicine that works to improve the health of all Americans by making evidence-
based recommendations about clinical preventive services such as screenings,
counseling services, or preventive medications. The USPSTF is made up of 16
volunteer members who come from the fields of preventive medicine and primary
care, including internal medicine, family medicine, pediatrics, behavioral health,
obstetrics/gynecology, and nursing. All members volunteer their time to serve on the
USPSTF, and most are practicing clinicians.”
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The National Research Council (NRC) and National Academy of Sciences (NAS)
From the NRC website:
“The National Research Council, created under the NAS charter in 1916 by executive
order of President Woodrow Wilson, extended the scope of the NAS in its advisory
role. The National Academy of Engineering (NAE) and the Institute of Medicine
(IOM) were founded under the NAS charter in 1964 and 1970, respectively. Together,
the NAS, NRC, NAE and IOM enlist the aid of the nation’s most knowledgeable
scientists, engineers, health professionals, and other experts who volunteer their time
to produce reports that have led to some of the most significant and lasting
improvements in the health, education, and welfare of all the world’s citizens. The
Academy's service to government has become so essential that Congress and the
White House have issued legislation and executive orders over the years that
reaffirm its unique role.”
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Placebo and Nocebo Effects
The placebo effect refers to a positive health outcome that results from a patient’s
belief that a treatment will be effective. The nocebo effect is the antithesis – it refers
to the symptoms patients experience due to their anticipation of those symptoms.
Both are real, physiological phenomena that can be measured using standard
scientific techniques. The placebo effect plays a significant role in lawsuits against
drug companies. Clinical drug trials typically include a placebo control group,
allowing researchers and the Food and Drug Administration to effectively evaluate
the efficacy of any new medication. The nocebo effect is also a factor, as participants
taking the placebo occasionally experience negative side effects.
The following resources provide essential background information on the placebo
and nocebo effects:
Pain Physician Journal - Placebo and Nocebo in Interventional Pain
Management: A Friend or a Foe - Or Simply Foes?
Journal of Biobehavioral Medicine - Drug-Related Information Generates
Placebo and Nocebo Responses That Modify the Drug Response
Badscience.net - Ben Goldacre on the Placebo and Nocebo Effect
Philosophical Transactions B (Biological Sciences) - Harnessing the placebo
effect: the need for translational research
The Psychiatrist - The placebo effect
The New Yorker - The Nocebo Effect: How We Worry Ourselves Sick
Discover - Are Warnings About Drug Side Effects Actually Making Us Sick?
Nocebo Effect - Think Sick and You’ll Be Sick
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About Innovative Science Solutions
Innovative Science Solutions (ISS) is a leading scientific consulting firm for the
worldwide pharmaceutical, biotechnology, and medical device industries. Our expert
team of scientists, regulatory strategists, and consultants provide a wide range of
fully integrated services to industry and counsel.
From strategic insight for FDA Advisory Committee meetings to scientific expertise
for complex litigation, ISS delivers specialized and effective solutions for your legal
and regulatory challenges. Let our proven combination of experience and innovation
work for you.
David H. Schwartz, Ph.D.
Head of Scientific Support to Counsel
A “scientific detective,” Dr. Schwartz excels at analyzing how science and law interact.
As head of ISS’s Support to Counsel practice, he helps clients defend and support
pharmaceuticals, industrial chemicals, medical devices, foods, and dietary
supplements in the courts, the regulatory arena, and the market place. With a talent
for communicating complex scientific information, Dr. Schwartz has become a go-to
for lawyers, business professionals, and financial and investment firms. Dr. Schwartz
specializes in providing strategic and tactical support to counsel in legal cases
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involving complex scientific issues. He has played a lead role in winning multi-billion
dollar legal cases for clients. With the sheer weight of the scientific data he’s able to
collect, evaluate, and present as evidence, he’s helped counsel win cases before
going to trial, saving ISS clients time and money.
Dr. Schwartz counts Daubert hearings among his biggest successes. His expertise
guides the ISS team across all disciplines related to the health sciences: toxicology,
epidemiology, environmental health and safety, biostatistics, pharmacology, and
regulatory affairs.
He has pioneered programs to critically review the scientific foundation of an
adversary's case and provided persuasive, evidence-based responses. For 20 years,
he has worked with the legal community evaluating product safety and defending a
host of products and exposures, including the following: welding rods, cellular
phones, ionizing and non-ionizing radiation, hydraulic fracturing and other drilling
technologies, breast implants, wound care products, dietary supplements, general
healthcare products, and a host of over-the-counter and prescription pharmaceutical
agents (including: antidepressants, dermatologics, anti-malarials, anxiolytics,
antipsychotics, and diet drugs).
Prior to founding ISS, Dr. Schwartz served as the Director of Scientific Litigation
Support for the law firm McCarter and English, where he played a principal role in
the safety evaluation of Prozac. Since then, he has guided clients using scientific
principles to defend products before, during and after launch.
Dr. Schwartz received a Ph.D. in Neuroscience from Princeton University and
postdoctoral training in Neuropharmacology and Neurophysiology from the Center
for Molecular and Behavioral Neuroscience at Rutgers University.
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Steven M. Weisman, Ph.D.
Head of Clinical and Regulatory Support
Dr. Weisman knows how to bridge the gap between science and marketing. As head
of ISS's Clinical and Regulatory Support practice, he focuses on the development of
scientific and regulatory approaches that increase a product's market potential. He's
an invaluable resource for scientific litigation support for products in crisis and,
under his guidance, ISS has encouraged firms to proactively monitor the safety and
effectiveness of their products and develop systems that reduce liability claims.
Dr. Weisman has over 20 years of experience in pharmacology, toxicology,
pharmaceutical product development, clinical and regulatory affairs, and marketing
evaluation and communication.
He played a leading role in the pharmaceutical industry's response to the removal of
PPA (phenylpropanolamine) from over-the-counter products. He's worked extensively
on management initiatives for opiate safety, antibiotic drug resistance, and
emergency contraceptives. He's even credited with establishing the safety and
continued marketing of artificial fingernail products.
Dr. Weisman is a leading authority on the switch of prescription-only products to
over-the-counter status and is widely published in these areas. His development and
support work includes shepherding the analgesic, Aleve, from a prescription-only
product to its popular over-the-counter form, and promoting the cardiovascular uses
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of aspirin for heart attack and stroke prevention. He is also recognized for effective
regulatory strategies that maximize the global market potential of regulated
products. His expertise in claim substantiation has helped clients successfully defend
against challenges to their marketing initiatives and saved them millions of dollars.
Prior to founding ISS he ran the Pharmaceutical and Food practices at a major
scientific consulting firm in Washington, DC. Before that, he served as Global
Director of Medical and Clinical Affairs at Bayer, Director of Strategic Research at
Sterling Winthrop, and held similar positions at Hoffman La Roche and Procter &
Gamble. He has organized and presented at numerous symposia, FDA advisory
committee meetings, and other regulatory venues, worldwide. He manages the FDA
advisory committee process for many of the largest pharmaceutical concerns and
represents companies before regulatory authorities in major markets around the
world.
Dr. Weisman received his Ph.D. in Pharmacology from Cornell University Medical
College and completed his postdoctoral training in Immunopharmacology at the
Roche Institute of Molecular Biology.
For more information, please contact us at 973.889.1600 or