March 2014 the epidemiology monitor final

Revelations About Potential Conflicts Of Interest Spur Conversation About Ethical Behavior For Epidemiologists Are Epidemiologists Truly Independent?

Our special double issue in Jan/Feb about the ties between prominent epidemiologists and private industry has set new records with thousands of subscribers seeing and sharing our content through our website or on Facebook.

And epidemiologists are not of one mind about the existence of conflicts of interest or what to do about them if they occur.

This March issue reports on the feedback received, a commentary defending the late Pat Buffler and work in private practice more generally, and two letters from co-drafters of ethics guidelines for the International Society for Environmental Epidemiology.

Readers are invited to weigh in on one or more of these articles. Email your comments to epimon@aol.com.

Readers Give Their Quick Takes On Conflicts Of Interest On The Special Responsibility Of Population Scientists To the Editor: “The same principles that apply to clinicians, times 7 billion, ought to apply to population scientists. To clarify further, I assume we can all agree that minimizing conflicts of interest (COIs) for clinicians is so extremely critical for patients so they can feel safe and reassured that they receive the best possible treatment. By extension then, population scientists (whose actions/research affect not one patient at a time, like it is the case with clinicians, but they affect entire populations!) ought to be even clearer on their COIs and in fact, because of the tremendous impact their research may have, it should not be acceptable for them to have any COIs at all (reported or not).�

Eva Schernhammer, MD, DrPH Harvard School of Public Health and Harvard Medical School - Continued on page 2

In This Issue -3In Defense of Pat Buffler and Private Consulting -5Ethics Way Forward -7In Memory of Linda Cowan - 11 An Interview With Alfredo Morabia - 13 On The Light Side - 13 Free IEA Airfare Drawing - 14 Excerpt from: "Enigmas of Health and Disease" - 26 Marketplace

March 2014 Volume Thirty Five Number Two

-Comments continued from page 1 The Epidemiology Monitor ISSN (0744-0898) is published monthly (except August) by Roger Bernier, Ph.D., MPH at 33 Indigo Plantation Rd, Okatie, SC, 29909, USA. All rights reserved.

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On The Influence Of Money In Epi Research

Good Science Is Good Business To the Editor:

To the Editor: "Obviously keeping secrets about influences of any sort is bad in itself.

But the pervasive underlying problem is that noted in the last paragraphs. My defining image of academic public health was how the discussions of "research" at the faculty meeting of a major SPH (one Prof Buffler herself helped build) consisted of nothing but celebrating grant income and talking about how to get more. There was literally no mention of actual research.

When the mindset is all about celebrating more money, with work being merely a way to get more money, why is it any surprise that the field attracts (or creates) people who follow the money?

But it does not stop there. The dominant money (the grants) are treated as if they have no influence on what research is done and what results are sought, when the diametric opposite is true. When the pervasive attitude is that seeking the overtly and explicitly corrupting money (that which is based on doing particular research that the funder favors and getting the "right" answers) is the goal of the profession, it seems rather hypocritical to get so excited about hidden speculative conflicts of interest that result from relationships."

“I have worked in industry for years and take my epidemiology very seriously. I have found that in industry good science is good business. It is very important to industry to assure good science is used to evaluate risk from their products and processes. If there is a problem, industry wants to know it first. Likewise, if there is no problem, this needs to be championed.”

Jim Collins Dow Chemical

On Temporality To the Editor: “The sine qua non of epidemiologic causation analysis is temporality.

Why is there a conflict of interest if a scientist first develops an opinion or approach based on the science and after that an industry asks him/her to present that opinion or approach before a public forum. It is the opinion that caused the industrial association, not vice versa. We must be careful about which came first.”

Steve Lamm Consultants in Epidemiology and Occupational Health ■

Carl V. Phillips

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Senior Epidemiologist Defends The Late Pat Buffler And His Work In Private Practice Commentary by Robert Morgan, MD “The earth is not flat, the earth is not round, the earth is crooked.” While that may describe the sorry state of the world, it is up to all of us to make that world less crooked and more fair. The series of articles in the recent EpiMonitor correctly shone a light on some of the unfairness of the Heath Report in the Pat Buffler matter. Full disclosure: I was Pat’s friend for almost 40 years. The Heath report hardly ranks as investigative journalism.

Rather, it is a slanted review of part of the life of a distinguished academician.

In his interview, Heath is reported to have said, “Our mission, as with any investigative reporting, is to expose abuses and wrongdoing as a way to curb them.” So what abuse or wrongdoing is he reporting?

Buffler Membership Heath implies that Buffler’s membership on the FMC Board of Directors was a shocking and secret conflict of interest. As a public company, FMC annually publishes the names of the Directors, their compensation, and their stock ownership position. Hardly secret, hardly shocking that Pat’s name appeared every year of her membership. And as to disclosing that Board membership on publications and grant applications, that would be appropriate only if the topic related to FMC or its products. It is also possible that if she disclosed a possible conflict, the journal did not publish it. That has happened to me twice (including the New England Journal of Medicine).

Did Heath read all her grant

applications to support his claim that she never disclosed her FMC relationship?

Criticism in Science Heath is very critical of Buffler for taking money to critique other scientist’s work. A good scientist welcomes critical review and doesn’t worry about who funded the criticism. In science, the quality of the data and the validity of the criticisms are more important than authorship or funding. The best mechanism for truth in science is peer review. Dr. Buffler’s papers were subjected to the same peer review process as other submissions.

Was there any peer review for the Heath report? Although he criticizes her funding, did he point out that his funding comes from an organization whose Board of Directors is chaired by a famous plaintiff’s lawyer?

Scientists and Industry The University of California has effectively answered many of Heath’s allegations concerning funding. I agree with their policies and there is no suggestion that she violated any of the rules. Industry has a responsibility to produce safe products and ensure the health of workers, consumers, and the community. One of the ways they can exercise that responsibility is by grants and contracts to the best and brightest academic scientists. The suggestion that scientists are being - Buffler continues on page 4

“...it is a slanted review of part of the life of a distinguished academician."

“...the quality of the data and the validity of the criticisms are more important than authorship or funding."

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-Buffler continued from page 3

“ Is it wrong for corporations to hire the best possible expertise to address these issues?”

“Corporations have a responsibility to examine the safety of their product... "

bought by industry money is grossly unfair to most persons receiving grants or contracts from industry.

That suggestion is also a favorite allegation of plaintiffs’ lawyers when faced with peer-reviewed industryfunded science that weakens or refutes plaintiffs’ claims.

Private Practice Relevant to the discussion of industry funding is my article of 1982 in the Epidemiology Monitor (June 1982, Vol 3 Number 6 available online) for a discussion of what I have termed the private practice of epidemiology. I have spent over forty years doing research with industry funding. Like the University of California, we retained all original data in the event that any other competent scientist wished to reanalyze it. Our policies were always clear: we (not the client) designed the studies; we (not the client) decided on publication; we always disclosed funding sources in our research publications; clients did not have the right to edit any of our publications. We submitted our work to peer-reviewed journals. Yet even so, one paper sent to the American Journal of Public Health was rejected outright (without peer review) because the Editor at the time told us he would not publish a negative study funded by industry. Another twist to the well-recognized and continuing problem of publication bias in science.

Outside Consulting

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Likely, most academic epidemiologists do some outside consulting. That practice needs no

defending. Sometime the consulting is stimulated by litigation or fear of litigation. Both plaintiffs and defendants use experts and both sides pay well. Sometimes, the consulting activity addresses concern over product safety, worker safety, or community health. Is it wrong for corporations to hire the best possible expertise to address these issues? Is it wrong for a company to place an academic with community health and safety expertise on the Board of Directors?

Government research funds are scarce and tough to get. Industry money is available, and should be used. Corporations have a responsibility to examine the safety of their products, the health of their workers, and their health effects (if any) on the community. Academics and non-academics (like me) should use those funds for research. Heath’s apparent thesis is that industry should not fund health research.

Does he really wish to remove a major source of funds in a time of federal cutbacks? Who would make up the shortfall in funds?

Funding Source The Heath report says that, “Buffler co-authored 15 articles in scientific journals paid for by companies or industry groups….” His sentence is amibiguous. Did the companies pay the journals? Did they pay Buffler to write the articles? Or did they pay for the research that went into the articles? Only Pat Buffler can answer the questions and she is not here. I suspect the research was funded by industry but Pat wrote the articles on her own time, as I would. And what -Buffler continues on page 10

Two Of Four Co-Drafters Of ISEE Ethics Guidelines Weigh-In On Revelations of Conflicting Interests And Suggest Way Forward To the Editor Thank you for your coverage of issues of critical importance to our profession in the January/February 2014 issue of the Epidemiology Monitor, entitled “Ethics Turmoil in Epidemiology”.

Ethics violations and conflicting interests, while always present, appear to have escalated over the past decade, and it is imperative that we develop a framework for addressing these issues.

As a start, I suggest that we return to the core values of our profession. If you examine the mission statements of virtually every school of public health, department of epidemiology, or public health agency, you will note that they contain the terms a) advance the health of the public; b) promote wellness; c) improve human health.

Simple Question Thus, in evaluating ethical conduct, the primary question is quite simple: Is the individual or institution engaging in an activity, or taking a position, that is deleterious (potentially or directly) to the health of the public, or does not promote or improve public health? If the answer is yes, then these activities inherently conflict with the basic tenets and mission of our field. A sense of betrayal and wrongdoing ensues, because there is an inherent assumption that professionals and institutions in the field of public health are devoted to the improvement of public health, and will not engage in activities, or take positions, which would have any other goal than to

protect and promote health and well-being.

Role of Money We must accept the fact that the role and influence of money is ubiquitous, and not surprising, since every professional, and every institution, requires funding in order to survive. (In the case of governmental agencies, add the role of political pressures). There is rarely true independence in carrying out our work. Professionals have a right to perform work for industry, and institutions may accept funding from industry. However, it has been shown that research conclusions and policy positions can be and often are influenced by the source of funding and/or political considerations.

There is, therefore, a widelyrecognized need for transparency in declaring affiliations and funding support – and this extends to institutions and public health agencies.

Ethics Code Ethical expectations and codes of professional/institutional conduct have already been developed. For example, The International Society for Environmental Epidemiology (ISEE) has adopted Ethics Guidelines for Environmental Epidemiologists, (revised over a three-year period by a subcommittee of the ISEE Ethics & -ISEE continues on page 6

“...there is an inherent assumption that professionals and institutions in the field of public health are devoted to the improvement of public health...”

" There is rarely true independence in carrying out our work."

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-ISEE continued from page 5

“...that guidelines are not sufficient to protect against powerful forces that may influence human judgment and behavior.”

Philosophy Committee, and accepted by the ISEE Governing Council in 2012. These guidelines may be found on the ISEE website ( http://tinyurl.com/l6f2u8a) and in summary form in Environmental Health Perspectives (Environ Health Perspect 120:a299-a301 (2012). http://tinyurl.com/m5v5etz [online 01 August 2012). We acknowledge, however, that guidelines are not sufficient to protect against powerful forces that may influence human judgment and behavior.

epidemiology.

Recommendations

“There should be a strong professional and public mandate for adherence to a basic code of ethics on the part of all stakeholders. ”

We must establish forums for open and ongoing public dialogue about these issues, including a mechanism for exposing cases of ethics breaches.

There should be a strong professional and public mandate for adherence to a basic code of ethics on the part of all stakeholders. Public health institutions and agencies must lead by example; they must adhere to these principles in their relationships with outside funders, and must insist on a standard of conduct and transparency on the part of professionals within their organizations.

Shira Kramer, MHS, PhD President Epidemiology International Hunt Valley, MD

To the Editor:

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Thank you for your thorough reporting, driven by a balanced range of well-formulated questions, on the topic “Ethics Turmoil in

Epidemiology” (Epi Mon Jan-Feb 2014). I commend you for bringing this conversation to the forefront for epidemiologists.

After a challenging several years spent through the mid-1980s convincing our profession’s leadership to address the topic of ethics, we have, since the late 1990s, ethics guidelines for epidemiologists and several of its subspecialty areas. And, since then, in 2012, we have revised guidelines from the International Society for Environmental Epidemiology (ISEE).

To paraphrase one well-placed epidemiologist quoted in your report, we have guidelines up the kazoo, but no mechanism for their enforcement.

Enforcement Problem In our professional organizations, there is, at this time no infrastructure through which enforcement could be applied; nor are there the financial means to do so. All that we have at our disposal is the application of peer pressure to keep one another on track, in relation both to the research and practice domains of our field. The public trusts us to take our mission seriously; we trust one another to adhere to our mission in epidemiology. Our mission proclaims, among other things, that we will aspire to protecting the public interest over any other interest.

Speaking Truth To Power We owe a great debt of gratitude to David Heath at the Center for Public Integrity in Washington, DC, for exposing Buffler’s “other side”, and to Kathleen Ruff, for her ability in forcing issues of transparency and accountability.

-ISEE continues on page 9

Linda Cowan, Former University of Oklahoma Epidemiologist And Department Chair, Dies At Age 65 An Epidemiologist Who “Gave Life To Numbers And Made Them Tell A Story” Linda Cowan, a dedicated and much respected epidemiologist and former chair of the Department of Epidemiology at the University of Oklahoma passed away on December 31, 2013. She died unexpectedly of infectious causes brought on by complications of underlying liver disease, according to her husband John.

“Joy and Expertise”

Excerpts from her obituary are published here along with comments from some of her colleagues and former students. They weave a portrait of her as an epidemiologist and a person that made her a credit to her profession.

Another colleague on the Heart Study, said “Linda added much life and joy to the Study in addition to her solid scientific expertise. I remember her most for challenging investigators if she thought something had been overlooked and for her smile and enthusiasm at meetings and at dinners where she injected lots of laughter and interesting conversation. While she has not been part of the crowd for a while, she is part of our history and our success. It leaves a hole in our hearts to have lost her.”

“Exceptional and Exemplary”

“We Are All Africans”

A departmental colleague, Elisa Lee, said Cowan “participated in the Strong Heart Study (SHS), the largest and longest NIH funded multi-center study of cardiovascular disease in American Indians, for more than 20 years. She was an outstanding epidemiologist, very serious about every aspect of the study and I believe she was equally serious about every other study in which she was involved. Linda would not permit any sloppy design, imperfect conduct or incomplete analysis. Her dedication to research was exceptional and exemplary. She was a warm person, always positive, optimistic, cheerful and eager to contribute. The conversations were always exciting and interesting when she was around.”

Helene Carabin, another departmental colleague told the Monitor that Cowan was very enthusiastic about solving methodological challenges observed in epidemiological research. Her advice about methodological aspects was sought by students and faculty alike. She had touched on such a variety of subjects that she could discuss epidemiology methods applied to pretty much any problem.

"She was an outstanding epidemiologist, very serious about every aspect of the study...”

"I remember her most for challenging investigators if she thought something had been overlooked...”

According to Carabin, Cowan spent the last part of her career largely focusing on the study of epilepsy in sub-Saharan Africa, and especially that caused by neurocysticercosis, a zoonotic infection endemic where - Cowan continues on page 8

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-Cowan continued from page 7

“...generous, kind and convinced that epidemiology was a key tool in improving the health of the poorest of the poor...”

sanitation and pig management practices are poor and undercooked pork is consumed. “This was the opportunity for her to use her knowledge of the epidemiology of epilepsies and apply it to a different context which contained plenty of methodological challenges. She also got involved on a project aiming at estimating the frequency and monetary burden of cysticercosis in Burkina Faso.

There she truly felt at home and would always mention how she could now understand that "we are all Africans".

Her love for those children that would come and look at her camera after taking their picture and her dedication to trying to prevent epilepsy which is a devastating disease to have in SubSaharan Africa was who Cowan truly was --generous, kind and convinced that epidemiology was a key tool in improving the health of the poorest of the poor… She will be greatly missed but never forgotten.”

“Best of the Best”

“She was the best of the best...”

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One of her African colleagues from Benin commented at the news of her passing, “what an inestimable loss. We her students will remember the rigor and seriousness she brought to our work.” Another colleague from Rwanda said “I remember well her sharp and lively spirit—she gave life to numbers, and made them tell a story.” Another young colleague said, “Dr Cowan had set the bar so high as an Epidemiology Professor and advisor that we could not possibly attempt to follow in her footsteps.

She was the best of the best and I feel very privileged to have known and worked with her.”

Stellar Mind and Smile Ellen Gold, Professor of Epidemiology at the University of California Davis who knew Cowan from graduate school days, told the Monitor “…among my many memories of her perhaps foremost was her warm, welcoming smile and her brilliance. She was one of the smartest doctoral students that I encountered in my graduate student years at Hopkins. And her smile was persistent, despite her health struggles – being diagnosed with chronic active hepatitis while she was a doctoral student and struggling with all the symptoms and morbidity associated with that disease. I remember her stellar smile and how energetic she was after she received her liver transplant a number of years later.

Her doctoral dissertation was a historical cohort study of women seen at the JHH Infertility Clinic whom she followed for occurrence of breast cancer, following up on the observation that delayed age at first pregnancy was related to increased risk of breast cancer. She tried to determine if hormonal (primarily progesterone) deficiency was related to increased breast cancer risk (Cowan et al: Amer J Epidemiol 1981;114:209-214). I still use it as an example in my graduate teaching to show that a historical cohort study can be done for a doctoral dissertation.

- Cowan continues on page 12

-ISEE continued from page 6 Without people like Heath and Ruff, I suggest that evil (bad professional conduct) would know no bounds, in part because people, including professionals, tend not to confront those who do ill, and we are also fearful, given our institutional structures and processes, of challenging power. So, we must welcome the role of people who are independent and working to defend the public interest, such as Heath and Ruff, because it is only through speaking truth to power that our democratic processes are sustained, enriched, and, indeed, strengthened. It is thanks to such people that our attention has been drawn to the need to better fulfill our collective mission.

On Human Frailty Clearly, the profession of epidemiology has mechanisms to acknowledge the good conduct of people like Buffler and Boffetta, but no mechanisms to manage their bad/questionable conduct.

Instead of allowing our profession to become less relevant to the public interest and thereby see less public support for our discipline, or, perhaps through our inaction, “inviting” government to intervene in potentially intrusive ways in how our profession is organized and functions, I suggest that first we need to recognize human frailty for what it is. There are those among us, and indeed above us, whose motivation allows them to justify replacing the public interest with their own self-interest, perhaps with a heavy dose of greed to fuel their zealousness.

Guidelines/codes will never be of help to such people in controlling their behaviors; and, certainly not when institutions are complicit in unethical

conduct on the part of such colleagues.

If we see “money as being the root of all evil” in the world, let us apply it by “following the money” to expose the relationships between our colleagues and our institutions.

The Way Forward Over my career, I have strived to promote guidelines for socializing our students to normative practices that serve the public interest by appealing to their sense of morality, to better ensure integrity in science. But, this, now well-demonstrated, does not always work. To be more effective in delivering on our mission, there are several actions that we might want to propose in order to prevent a loss of public support, or even the possibility of government intrusion in our profession, in light of these two exposés. In addition to peer pressure, holding scientists publicly accountable when they act unethically is something that we can do.

"...holding scientists publicly accountable when they act unethically is something that we can do."

Recommendations True democracy can function with only a well-informed public, one informed not by corporate science designed to foment uncertainty through, for instance, generating "junk science", but by science conducted with integrity in the public interest. It is true that refutation is essential for advancing science. But, our applied science has been infiltrated by junk science, and this, in turn, is influencing litigation and public policy. If we are to take our role as professionals seriously, I recommend that a substantially improved federal science, technology and innovation strategy should, among -ISEE continues on page 10

"...our applied science has been infiltrated by junk science..."

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-ISEE continued from page 9

-Buffler continued from page 4

other things:

difference does funding make?

Scientific studies should be judged by the research design, data, and interpretations, not funding. The scientific tradition of peer review and repetition of studies provides at least some safeguards against industry buying the science it wants.

•

"...we need now to stand up to global moneyed influences to ensure greater balance in our mission to protect the public interest."

"Many of these persons are nothing more than paid assassins"

•

offer incentives to not-for-profit professional organizations/societies (like the IJPC-SE at <www.jpc-se.org>) in support of capacity building to expose junk science, particularly where applied science works at the nexus of policy; and introduce disincentives (i.e., regulatory penalties) for those found to be engaging in the production of junk science.

While not all “corporate” science is bad science, we need now to stand up to global moneyed influences to ensure greater balance in our mission to protect the public interest.

Colin L. Soskolne, PhD Professor Emeritus, University of Alberta, Edmonton, Alberta, Canada Adjunct Professor, Faculty of Health, University of Canberra, ACT, Australia ■

The Epidemiology Monitor is now available FREE to all subscribers.

Subscribe today at: www.epimonitor.net/Subscribe.htm

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Paid Assassins If Heath wants to do some real investigative reporting, he should look into the funding of the group of selfproclaimed scientists who do no original work, but criticize those who do, and who accept sizeable fees from attorneys to prepare ammunition against legitimate experts. Many of these persons are nothing more than paid assassins hiding behind several “public interest” organizations or publications. Since I am often an expert witness, I know I am a ready target for character assassination. At least I can defend myself. Pat Buffler cannot. In the long run, science will have to discern the truth from conflicting articles. Meta-analysis, properly done, may provide one of the methods for settling controversy.

It will be unfortunate if Heath’s report discourages scientists from accepting industry grants or contracts out of fear of public attacks on character and credibility. Let science go forward, whatever the funding source, and continue the usual processes of peer review and further studies to confirm or question published findings. ■

Book News An Interview With Alfredo Morabia, Author Of Upcoming English Edition Of “Enigmas of Health And Disease” Free Sample Chapters Being Published in March And April Issues Of The Epidemiology Monitor An English edition of a 2001 French book targeted at meeting a public need to better understand epidemiology entitled “Sante: Distinguer croyances et connaissance” by Columbia University’s Alfredo Morabia has been adapted for publication as “Enigmas of Health and Disease”. The English edition is scheduled to appear in June 2014 and by special arrangement with Columbia University Press, the Prologue entitled “A Science Named Epidemiology” and a chapter entitled “Epidemiologic Literacy and ‘Earthly Self-Realization’ “ are being published in the March and April issues respectively of The Epidemiology Monitor. Readers interested in purchasing the book prior to publication may do so at a 30% discount by visiting the webpage for the book and using the promo code “ENIMOR”. The webpage is: http://tinyurl.com/lx4dvf8 We interviewed Alfredo Morabia to get his thoughts about the new release.

Epi Monitor: What was your main motivation for writing this book?

Morabia: It was to popularize epidemiology and highlight its role in generating most of our knowledge about prevention and treatment. As a historian and epidemiologist, I sought to recount the fascinating stories that make-up the discipline in a way that would raise awareness to its crucial importance in people’s

everyday lives.

Epi Monitor: How do you think it will be useful?

Morabia: It can be useful if it makes epidemiology more visible to nonepidemiologists, if it makes epidemiologists aware that the tools they use today have been refined over 350 years of methodologic trials and errors, and if it strengthens the current movement towards teaching epidemiology in middle and high schools.

”I sought to recount the fascinating stories that makeup the discipline..."

EpiMonitor: Why did you decide to translate the book into English at this time?

Morabia: The first version of the book, in 2010, was in English. I looked for a publisher. When Odile "It can be useful if Jacob said she was interested, it was it makes a no brainer. I re-wrote the book in epidemiology more French. From her small Parisian visible to nonoffices in a vintage apartment of the epidemiologists...“ Quartier Latin, full of books and pictures of her authors, Odile Jacob has built herself a reputation of being able to work with scientists to bring science to the public. She is tremendously respected in the book publishing trade and beyond. She has mostly French authors but publishes American authors too, including Barack Obama and Colin Powell. The deal and main decisions were made directly with her, in - Enigmas continues on page 14 11

-Cowan continued from page 8 Great Loss

"Her untimely passing was a great loss to the epidemiology community..."

The University of Iowa’s Bob Wallace told the Epi Monitor he “had the privilege of working with Linda at the beginning and at the unfortunate end of her career. She was a bright and rising star when she joined several of us in the Lipid Research Clinics program, and she made several important contributions there to the population study of blood lipids and lipoproteins. I didn’t really interact with her much until we served jointly on an Institute of Medicine board many years later. There, she served with great distinction and participated with wisdom and grace, and it was a pleasure to again interact with and learn from her. Her untimely passing was a great loss to the epidemiology community,” he said.

Early Years

"She served 27 years of dedicated teaching, research and service in the Department of Biostatistics and Epidemiology...”

Linda was born and grew up in Illinois, attended Michigan State University and graduated with a degree in nursing in 1970 and earned a masters degree in nursing education from the University of Maryland in 1972. She then worked as a research assistant and instructor at the University of Maryland developing a strong interest in medical research. She graduated with both a Masters in Public Health (1975) and Ph.D. (1979) from Johns Hopkins before accepting a post-doctoral fellowship to Harvard University where she did research in neuroepidemiology from 1978-1979.

First Job

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Linda and her husband then moved to Norman Oklahoma and Linda worked

for four years as an Assistant Member in the Lipids Research Clinic Program in Oklahoma City before being hired in 1983 as an assistant professor in the Department of Biostatistics and Epidemiology of the University of Oklahoma, becoming a full professor in 1995.

Research She expanded her research studies to include heart disease, focusing on Native American populations, and later to neurological diseases, particularly epilepsy in children. In the last few years of her career she spent time in Africa.

Teaching and Service She was a gifted teacher and researcher winning the Oklahoma University Regents Award for Superior Teaching in 1993 and was named a George Lynn Cross Research Professor in 1996. She served 27 years of dedicated teaching, research and service in the Department of Biostatistics and Epidemiology, including serving as chair for more than 3 years, retiring in January of 2011. She published more than 100 papers in peerreviewed journals.

As noted in her full obituary, Linda was a great lover of art and enjoyed visiting many museums throughout the world. A celebration of Linda Cowan’s life will be held for friends of hers on Friday night April 4, 2014 at the Sam Noble Museum of Natural History in Norman. To read the full obituary published in Cowan’s local newspaper, visit the website of the Norman Transcript at: http://tinyurl.com/os7f576 ■

On The Light Side Multiple Entries Submitted In Funniest Marriage Vow Contest Deadline Extended to April 30--Enter Now To Win $500 Our latest humor contest to create the funniest marriage vow for epidemiologists has attracted multiple entries, but still only a limited number of entrants. Since we know from previous contests that much good humor resides in the epidemiology community, we have extended the deadline. To tap this humor resource and to get your creative juices flowing, here are a few examples of the entries received. Top these entries, and earn $500. There is no limit on the number of entries, and readers are encouraged to submit multiple vows. Send your entries to epimon@aol.com The vow we used to kick-off the contest was: “I promise I will always fail to reject you” Among new entries in our contest are: “I promise to love you in morbidity and in health, until mortality do us part.”

“I promise to love you no matter the significant difference between our expected and observed times together.”

“I promise that all other relationships are spurious.”

“I promise to not egregiously violate your assumption of normality.”

“I promise with 99% confidence level that you are my significant better half”

“I promise that the housework will be uniformly distributed.”

"I promise to never let the posterior distribution change your prior beliefs."

"Let's regress to the mean together, now and forever!"

"I select you conditionally from this day forward, to walk with you stepwise until our association achieves significance."

"I promise to conduct a randomized, double-blind clinical trial of our love once a year for the duration of our marriage."

"I promise to be reliable and valid, sensitive and specific, and unbiased and efficient."

"Like a citizen of Framingham, I will voluntarily consent to your study of my heart."

"I take you as my propensity score match from this baseline observation forward, for better outcomes or for worse outcomes, for greater SES or for lower SES, in case and in control, to sample and to resample without replacement, till all-cause mortality do us part." ■

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"A portion of the funds collected for registration fees, goes to support bursaries for young, new epidemiologists from low to middle income countries. We hope that by providing an incentive to register early, we will boost registration and be able to apply more funds to bring these young minds to the Congress.

While Alaska is truly a land like no other, Anchorage is an exciting, cosmopolitan and hospitable city at the edge of Alaska's great scenic wilderness.

With its unique blend of characteristics, no city better mixes Alaska's breathtaking natural beauty with modern amenities.

We look forward to sharing what this beautiful state has to offer with the participants of the 20th IEA World Congress of Epidemiology" Tina Day Director Vision Meeting Experts Betty Mansour, PhD. Univ. of Alaska, Anchorage

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IEA To Hold Drawing For Free Airfare To Alaska--First Of Its Kind Offer For An Epidemiology Meeting Organizers of the upcoming triennial meeting of the International Epidemiological Association in Anchorage Alaska next August will hold a drawing to distribute a free coach class airline ticket to a lucky epidemiologist who registers in March 2014. Registrants in March who do not win the random drawing will be reentered to win hotel accommodations

or a conference registration to be drawn in April and May. The airline ticket will be from the continental US, Hawaii, Puerto Rico, or Canada.

Registrants will be eligible to win only one prize. Persons who have already registered by March 1 will be eligible to win a prize as well. ■

-Enigmas continued from page 11 person, on the phone, and by email.

She listens and argues and builds an authentic author-publisher interaction. The delay between the French and the English adaptation was only due to the time it took to find the right American publisher and prepare a new version.

Columbia University Press was enthusiastic, found a new title, added pictures of epidemiologists, had a professional create a new index, and was sensitive to the details. I liked that.

or formally taught in classrooms.

The third point is the logical segue of the first two: in order for citizens to be able to discuss evidence with health care professionals or with policymakers, they need to learn epidemiology at school. History makes it possible to start in middle schools.

Epi Monitor: Has your thinking changed in any significant way since, the book appeared in French, and if so what would you add to the book if it were appearing for the first time this year?

Epi Monitor: What is your favorite part of the book and why?

Morabia: I am more knowledgeable now than I was three years ago. If someone had translated the book verbatim from French, I would have changed a few words or sentences here and there. Huge changes in my view but probably unnoticeable for most readers. My mistake was to translate the book myself. I was talking to a different audience and felt the need to write differently. In the end, the French and English versions are very similar contentwise, but if you compare the tables of content or compare the books page by page, the two versions don’t match. ■

Morabia: I don’t have a favorite part, but chapter 15, “Epidemiologic Literacy and ‘Earthly SelfRealization’” is the center of gravity of the book. It tells what I have learned from my own book. First, population thinking is the only difficult concept in epidemiology, because it is unrelated to our daily experience or to our psychological development. Second, the most basic epidemiologic concepts remain abstruse as long as they are not selftaught through conducting studies

See page 26 for more information

Excerpt from "Enigmas of Health and Disease" by Alfredo Morabia

Prologue A Science Named Epidemiology Whether you are consumer of health services, practicing clinician, health professional in training, health journalist, epidemiologist, or epidemiology student, this book explains how and why epidemiology has evolved in 350 years from being a science of epidemics to being indispensable for the discovery of effective ways of preventing health harms, prolonging life, and treating diseases.

"...epidemiology has become a science that compares groups of people."

To solve enigmas of health and diseases, epidemiology has become a science that compares groups of people. Group comparisons are a tool to study the health effects of many aspects of human life, including lifestyle factors such as tobacco smoking, lack of exercise, excess caloric intake, oral contraceptive use, alcohol; social conditions such as education, income, occupation, and neighborhood; and environmental exposure such as air pollution. Comparing groups is also at the core of the scientific methods needed to assess the efficacy of medical procedures for prevention and treatment.

Here is an example of group comparison: take a group of people who exercise and another who donâ&#x20AC;&#x2122;t. For the following ten years, count all the new cases of heart attacks occurring in each of the groups. At the end of the ten years, compare the frequency of heart attacks in each of the two groups. If exercise protects, you would expect heart attacks to be less frequent among the active than among the inactive group. Thus, in its simplest form, a group comparison can be used to determine whether a disease occurs more often in a group that is exposed to some factor than in a group that is not exposed to that factor.

Most of the time, performing a group comparison is the only option to - 15 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia identify causes of diseases or whether treatments work. Think of all you know about the health effects of tobacco, diet, physical activity, occupational exposures, screening tests, drugs, medical care, social and economic living conditions, and other aspects of your life that may impact your health. Think of questions such as: What is a healthy diet? How many times per week should

"I prefer to speak of knowledge than of evidence."

we exercise? Is this drug effective? Should we put babies to sleep on their belly or on their back? And so on for the health effects of sunscreen, alcohol, tobacco, drugs, contraception, and safe sex. If some scientific knowledge exists about the health consequences of these issues, it most likely is a find based on group comparisons.

I use the term knowledge as opposed to beliefs. Don’t read it as a synonym of truth, but rather of evidence. I prefer to speak of knowledge than of evidence. Group comparisons produce data. These data are tangible; they can be evaluated, criticized, and then confirmed or not. Whether the results of a group comparison are confirmed or not, whether they were true or untrue, we have learned something, we are more knowledgeable and can progress. We have the option of getting more data, better data, different data to improve our knowledge. In contrast, beliefs are products of our imagination. They are mere opinions with which we can agree or disagree, but whose origin we cannot evaluate. When I say cigarettes don’t cause cancer because my neighbor who is now ninety-five has smoked since he was fifteen and does not have any cancer, I express my belief based on my interpretation of a selected observation. You may be of a different opinion because a good friend of yours, a smoker, died at age fifty of lung cancer. We may argue forever, no one being able to tell who is right or who is wrong until we can rely on knowledge. This example may seem mundane, but many, many circulating health statements on important issues, such as vaccines, are of that sort.

I am not saying that we should discard opinions and beliefs. As the nineteenth-century German professor of hygiene Max von Pettenkofer used to say, “If we had to live only on what has been ascertained scientifically, all of

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Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia us, as many as we are, would have perished long ago.” We need health beliefs.

They are part of us and cannot be dissociated from us. My point is that it is important to distinguish knowledge from belief. Group comparisons can help us do that with regard to health issues. Most of the health claims we find on the Internet or among our acquaintances are beliefs. Considering these beliefs on a par with knowledge can be a source of unwarranted anxiety or of ill decisions. My claim in this book is very simple and unpretentious: checking whether a health statement is based on a group comparison or not is an effective way of separating health knowledge from health belief.

Epidemiology is already important in our everyday life. Where does the knowledge supporting the warnings on packs of cigarettes about the dangers of tobacco come from? Epidemiology. Why do you trust that the screening test

"...epidemiology is the science underlying most of the practical knowledge about whether measures to prevent and treat illness work."

recommended by your doctor can contribute to your living longer?

Epidemiology. Which science provides the methods to determine whether surgery is effective for lower back pain? Epidemiology. In 2009, David Leonhardt asked Barack Obama “how going to the doctor will be different in the future; how they will experience medical care differently on the other side of health-care reform.” In his answer, the president emphasized “the importance of using comparative-effectiveness studies as a way of reining in costs” and the possibility for doctors to say to patients: “You know what, we’ve looked at some objective studies out here, people who know about this stuff, concluding that the blue pill, which costs half as much as the red pill, is just as effective, and you might want to go ahead and get the blue one.” What are the “comparative-effectiveness studies” that President Obama mentioned in relation to the health-care reform? Epidemiology.

Thus, epidemiology is the science underlying most of the practical knowledge about whether measures to prevent and treat illness work. There is, of course, a wealth of other health knowledge that is not based on epidemiology, related to the anatomy, physiology, and pathology of the human body; to the cellular effects of drugs or microorganisms; to the

- 17 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia molecular structure of the toxicological and infectious causes of diseases; and so on. The full list of all the domains in which health knowledge progresses without resorting to group comparisons would be very long. But rarely do they provide knowledge that is immediately relevant for prevention, treatment, or screening.

Epidemiology in the Media The results of group comparisons can be found daily in the health sections of newspapers and magazines. Here are some titles gleaned from English-speaking media: “Walking Six Miles Each Week Could Reduce Chance of Getting Alzheimer’s” (Daily Mail, United Kingdom, November 29, 2010) “Cell Phones and Cancer: A Study’s Muddled Findings” (Time, May 17, 2010) “People Who Drink as Few as Two Soft Drinks a Week Face Nearly Twice the Risk of Developing Deadly Cancer, Study Finds” (CBSNews Healthwatch, February 9, 2010) “Diet: Eating Fish Found to Ward Off Eye Disease” (New York Times, March 22, 2011) “Scientists Identify Genes for ‘Extreme Longevity’ ” (AOL News, July 1, 2010) “Alzheimer’s Gene ‘Linked to Vitamin D’ ” (Telegraph, May 30, 2011) “Politicians Should Not Prescribe Pills” (Financial Time, July 14, 2010) “Progestin: Hormone Replacement Therapy Study Halted” (CNN Health, July 9, 2002) “Good Week for People Who Make Their Grievances Heard at Work” (The Australian, May 28, 2011) “Vitamins ‘Lower Risk of Autism’ ” (Sydney Morning Herald, May 27, 2011) “Research Shows Extra Calcium Unnecessary” (The West Australian, May 25, 2011) - 18 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia “Study Shows Caffeine Might Prevent Pregnancy” (Ottawa Citizen, May 25, 2011) All of these articles comment on the results of group comparisons performed

"...equating epidemiology with the science of epidemics is etymologically correct."

using epidemiologic methods. Some news agencies have specific epidemiology sections on their websites, reporting the results of group comparisons.

Even though epidemiology’s importance has grown in our everyday life, I suspect many people do not recognize it every time they come across its results. Several explanations come to mind for this relative lack of visibility.

Epidemio-logy Most medical specialties are named according to their subject matter: cardiology deals with the heart, gastroenterology with the stomach and the gut, neurology with the nervous system, and so on. The same is true for most human and social sciences, such as sociology, psychology, economics. What is epidemiology about?

When I introduce myself as an epidemiologist, people sometimes seek advice for a skin problem because they think I am an “epidermologist.” More often they will ask: “Oh, you must be knowledgeable about the HIV epidemic?” To which I reply, “Not particularly, sorry.”

The fact is that equating epidemiology with the science of epidemics is etymologically correct. The term epidemiology literarily evokes a medical specialty that deals with contagious epidemics. Indeed, in the nineteenth century epidemiology was the science of epidemics. The recurrent epidemics of cholera, a scourge that periodically ravaged the world, stimulated the creation of a professional association of epidemiologists in 1850 called the London Epidemiologic Society.

1 Today’s epidemiology, however, does not exclusively study infectious - 19 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia diseases. Its scope has expanded to the identification of all determinants of human health, whether they occur as epidemics, with rapidly changing frequencies over short periods of time, or not. Epidemiology is apt to study the health effects of many characteristics of human life. It also provides the science needed to assess whether medical procedures, treatments, and screening tests are salutary.

"The crucial role of epidemiology can elude the public because its methodologic contribution remains in the background when the results of a study are disseminated."

The examples used in this book and the headlines mentioned earlier give an idea of the breadth of topics to which epidemiology can be applied in order to assist in the acquisition of health knowledge.

Methods Versus Matter Why did epidemiology keep its nineteenth-century name if it no longer applies? Maybe because it is challenging to give a name to a mode of research characterized by the use of group comparisons. Epidemiology is not associated with a particular domain of medicine or public health.

All domains of medicine and public health rely on epidemiology. In the “war” against cancer, the “battle” against polio, the “fight” against obesity and alcoholism, or the “struggle” against health inequalities, epidemiology provides the strategists, not the domain experts. Experts are, respectively, cancerologists, vaccinologists, nutritionists, alcohologists, and social scientists.

Some experts may also be epidemiologists, and epidemiologists may also be domain experts, but the strictly epidemiologic component of the endeavor is to identify the populations to be compared and the modes of collecting, organizing, and interpreting the data.

The crucial role of epidemiology can elude the public because its methodologic contribution remains in the background when the results of a study are disseminated. The discovery of an anticholesterol drug that decreases the risk of heart attacks appears as a success of cardiology or - 20 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia lipidology rather than of epidemiology even though the design and conduct of the study relied on epidemiology.

Science and Know-how Because epidemiology has an ambiguous name and an activity often out of public view, its contribution to health knowledge is not always obvious. On top of these obstacles we add its theoretical complexity. Comparing groups requires a scientific training and a know-how that pertain to epidemiologists.

Are experts really needed to identify comparable groups? The answer is yes.

Epidemiologists are experts at identifying and recruiting groups of people that can reasonably be compared. This is not a trivial activity.

Some group comparisons have simpler designs than others. For example, there are experimental designs in which a potentially beneficial

"Epidemiologist s are experts at identifying and recruiting groups of people that can reasonably be compared."

treatment is attributed to some patients but not to others using a chance procedure equivalent to tossing a coin. In such randomized controlled trials (a term explained in chapter 8), it is easy to perceive that the groups will be comparable. A great deal of the difficulty is technical and lies in the performance of the experiment. These trials are ideal for evaluating whether treatments have beneficial health effects or not. At the same time, it is not possible to toss a coin to allocate a potentially deleterious exposure or behavior. Would you prescribe either a pack of cigarettes containing true tobacco or cigarettes free of tar and nicotine to (up to then) nonsmokers in order to determine if the health of those who smoke true tobacco declines faster than of those who smoke fake tobacco? Of course not, and therefore the effects of tobacco products on health need to be studied with people who have already chosen to smoke or not. Both groups differ substantially beyond their smoking habits. They live different lives and have different motivations for participating in epidemiologic studies. How can we reach out to them? How can we ensure that the findings among people who agree to participate in the - 21 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia study are relevant for the population at large? These situations cry for creative study designs; otherwise, the results will be fraught with error and invalid.

Let me use here an example from my own experience. My colleagues and I conducted one of the first group comparisons of whether women who

"These situations cry for creative study designs..."

smoke cigarettes or who breathe air polluted by cigarette smokers were at increased breast cancer risk. Jane Brody of the New York Times asked, “Could cigarette smoking account for the mysteriously rising incidence of breast cancer among American women?” She went on to describe the design of the group comparison: “The study, conducted among 244 women with breast cancer and 1,032 women free of the disease, revealed that the more a woman smoked, the greater were her chances of having breast cancer. Thus, for women who smoked less than half a pack a day, the breast cancer risk was doubled; for those who smoked 10 to 19 cigarettes a day, the risk was 2.7 times greater, and for those who smoked a pack or more a day, the risk was 4.6 times greater.”

In that study, we carefully tried to recruit all new cases of breast cancer in the population over a two-year period. We simultaneously drew a random sample of the general population to serve as comparison group. We interviewed the participants about their lifelong exposure to active and passive smoking. The fact that smoking was more common in women diagnosed with breast cancer than among comparable women who weren’t did not necessarily imply that smoking caused breast cancer. Because breast cancer is more common in women who never had children, we needed to make sure that this was not the reason for the observed difference. If nonsmokers have more children, then that might be the explanation behind their lower risk of breast cancer. The same reasoning applied for all the known and postulated causes of breast cancer. There are alternative explanations and methodological errors to consider before presenting an observed relation as potentially causal.

The conduct of group comparisons requires a theoretical background taught in schools of public health and a technical know-how acquired through - 22 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia practice. This book is not about epidemiologists’ theoretical background or know-how.

This Is Not a Textbook The book you are reading is not a “popular” textbook of epidemiology because no technical expertise in these methods is required to use epidemiology in everyday life. When epidemiologic results become accessible to the public in newspapers, in popular media, or on the Internet, they usually have already been deemed valuable by the scientific community. Their authors have, in

"The statistical component of epidemiologic studies is rarely if ever mentioned in the news coverage of epidemiologic findings."

principle, already convinced the scientific journal editors and experts that their findings were rigorous enough to be published and shared with others. At that stage, when results become news for the public, the technical aspects of the group comparison are not crucial anymore. Readers of public news media need to be able to understand how the groups were compared, who was compared, and how much health benefit or health harm was observed. This book addresses the public’s need.

Even knowledge of math is unnecessary. Of course, epidemiologists use statistical techniques to analyze the data they collect. These methods can be quite sophisticated, but the users of a statistical analysis do not need to understand the mechanics of that analysis to be able to interpret the study results. The statistical component of epidemiologic studies is rarely if ever mentioned in the news coverage of epidemiologic findings. It is extremely unusual for a newspaper to mention whether “the number of participants was large enough to detect the effect of a treatment or of a preventive factor if it existed” or to provide “the probability that similar or more extreme findings would have been observed in another study if there were no association.”

Epidemiologic and statistical expertise is needed before the results are disseminated. It is not crucial after that point. I hope to convince you of that.

However, the concepts explained in my book, such as population

- 23 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia thinking and group comparisons, are noble. I did not try to vulgarize them or simplify them in order to make them accessible, as I would have had to do for statistical or technical issues. What you can learn in this book about

"...epidemiologyâ&#x20AC;&#x2122;s great contribution to health care and public health lies in a fairly simple discovery"

epidemiology you will not have to learn again or in a different way. But if your interest in epidemiology has been piqued by this book, I recommend that you consult a more traditional text that presents the basic concepts and methods.

Overall, epidemiologyâ&#x20AC;&#x2122;s great contribution to health care and public health lies in a fairly simple discovery: group comparisons are indispensable to acquire health knowledge about prevention, treatment, and screening efficacy.

Because this truth does not make intuitive sense, it took several centuries and many enigmas of health and disease to become commonly accepted. It is the historical sequence of some of the scientific mysteries epidemiology unraveled that I will replay in the coming chapters.

Timeline For those who wonder how to approach the chapters of this book, here is some information that may be useful. First, regarding the order in which the chapters can be read. Each chapter stands alone, but there is a timeline across chapters 2 to 13. Chapter 2 goes until the end of the sixteenth century; chapter 3 covers the seventeenth and eighteenth centuries; chapters 4 and 5 cover the nineteenth century; chapter 6 covers the first half of the twentieth century; chapter 7 covers the second half of the twentieth century; and chapters 8 to 13 are about the end of the twentieth and beginning of the twenty-first centuries.

In order to avoid technical digressions in the main text, I have added four appendixes, written in the same style as the rest of the book, for readers who want to follow the technical discussion in more detail.

Finally, the notes link the text to the bibliography and allow you to find the sources or explore a topic further. In the notes, articles and books are cited

- 24 -

Excerpt from "Enigmas of Health & Disease" by Alfredo Morabia by the author’s name followed by the year of publication (e.g., Snow 1855) because the full reference can be found in the bibliography.

Conflict of Interest People who read the French edition of this book have asked me where the financial resources to write and publish it came from. Did some industry support me? Could some of my statements be tainted by the need to protect my sponsor's interests? I found these questions absolutely legitimate. After all, I used to ask every person who published in Preventive Medicine, the journal I was chief editor of, to sign a conflict-of-interest form disclosing any link to

"Could some of my statements be tainted by the need to protect my sponsor's interests?"

corporate interests, which might alter the researcher’s independence. Why would I not be similarly obligated to my readers?

This disclosure is quite simple. I did not receive support from corporate sources. I used the material and documents from the lectures I give in various academic settings and wrote the book mostly during my spare time. A 2012 three-year grant from the US National Library of Medicine has allowed me to dedicate much more time to study the history of epidemiology. Even though the National Library of Medicine project is not directly related to this English adaptation of Santé, it has definitely increased my expertise in the topics covered in this book. My publishers, Odile Jacob in France and Columbia University Press in the United States, have been responsible for the cost of publication of this book. ####

- 25 -

XX IEA World Congress of Epidemiology August 17-21 2014 Anchorage, AK, USA We invite you to join us at the 20th IEA World Congress of Epidemiology. It will be held in beautiful Anchorage, Alaska, USA and hosted by the University of Alaska Anchorage and many of our local, state, tribal and federal partners.

The Congress is divided into 6 major plenary tracks: Circumpolar Health; Climate Change and Health; Health Disparities, Ethics of Human Rights and Social Justice; Innovations in Epidemiologic Methods; Hot Topics in Epidemiology; and Infectious Disease. There will be many presentations on other areas of Epidemiology and Public Health Practice as well, so there will really be something for everyone!

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Assistant Professor Environmental Epidemiology The Department of Epidemiology, Graduate School Public Health (GSPH) invites applications for a non-tenure stream faculty position at the Assistant Professor level focusing on environmental epidemiology. This position requires a doctoral degree in epidemiology, and extensive experience in the conduct of environmental epidemiologic investigations including case-control and cross sectional studies involving acute effects of pollution and health endpoints. He or she must have a record of excellence in research, teaching and training in environmental epidemiology with experience in linkage studies with public health data. Familiarity with exposure assessment and the use of surveillance data is required. Experience in occupational health research is also desired.

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