Speakers and Abstracts

Steve Abramson

Former Partner, Medical Education and Communications Company

"Mechanics of the Message: Insights from Industry Insiders"

Drawing upon their respective over 40 years of personal experience, we will describe how ad agencies, CME companies, and medical communication firms adapt science to shape and influence prescribing practices in the United States.  We will share personal anecdotes of helping pharmaceutical companies build blockbuster brands, with Steve Abramson focusing on CME, publication planning, conferences, thought leader development, and pre-launch strategy, and Lydia Green on creating marketing materials including  detail aids, advertisements in medical journals, and print and digital educational content for FDA-approved drugs. During their talk, they will touch on transformative changes in drug marketing in the 1990s, how companies misrepresent the truth, and explain why physician behavior contributes to overtreatment.

Garnet Anderson PhD

Women's Health Initiative

"Menopausal Hormone Therapy: Two decades of the Women’s Health Initiative effort to use data to overcome dogma"

In 2002, the Women’s Health Initiative randomized trial of estrogen plus progestin therapy was stopped early because of an independent monitoring board assessment that the associated harms exceeded benefits for chronic disease prevention in post-menopausal women. These findings overturned decades of beliefs, contradicted high-profile publications from lower-quality studies, raised alarms for thousands of women, disrupted clinical practice (particularly for gynecologists), and caused serious financial difficulties for the hormone manufacturer. The response by various stakeholders was proportional to their investment, either financially or intellectually, to this topic. A year and a half later, the WHI randomized trial of estrogen alone in post-menopausal women with prior hysterectomy was stopped, noting more balanced harms and benefits and the expectation that continuing the trial would not resolve the remaining issues. The estrogen-alone results have often been overlooked, except when ignoring the distinction between the two trials is advantageous. In this talk I will describe multiple criticisms of the WHI trials from a variety of sources to illustrate the ways that high- quality studies can be challenged as part of an effort to diminish their impact.

Sharon Batt PhD

Dalhousie University, Hailfax, Canada

"Diagnosing what ails the FDA"

Drawing from the 2022 PharmedOut white paper, “What Needs to Change at the FDA”, I will outline how the paper came about, highlight some of the symptoms that signal the FDA is ailing, and discuss remedies we proposed. I will look at how norms and policies at the FDA contribute to overdiagnosing disease in healthy humans. I will discuss how an insidious and, thus far, incurable virus -- industry funding of patient advocacy groups – has weakened the agency. I will point out some systemic vulnerabilities our working group identified within the FDA, including  overlapping reward programs and the “level playing field” norm. I will tie these seemingly disparate afflictions to the dilemma of overarching social ills, including innovation hype and big pharma’s grip on the agency.  Ending on an optimistic note, I argue that, with carefully targeted interventions, the FDA’s vigor can be renewed.

Paula Byrne PhD

National University of Ireland, Galway

"Are Statins Overused?"

Statins are one of the most commonly prescribed medicines in the world. Since they were licensed, their use has continuously expanded; currently , about one- third of older adults take them. Many studies and clinical guidelines focus on how statins successfully reduce low-density lipoprotein cholesterol (LDL-C) levels and how this is associated with reductions in cardiovascular outcomes.

However, our research has questioned some of these assumptions. I will present data on who use statins and why, and on their benefits in terms of absolute and individual risk reduction. I will explain how our work challenges the ‘lower the better for LDL-C’ assumption that underpins many clinical guidelines, as well as the problems of synthesizing data from trials that are very different clinically and statistically. Finally, I will propose some explanations as to why statins are so frequently prescribed and how societal assumptions and consensus underpin their position in the medical world.

Yulia Chentsova Dutton PhD

Georgetown University

“You are not sick, you are just in love”: Cultural script of distress and their psychological implications

People do not experience their symptoms in a cultural vacuum. The detection of changes in subjective experience is informed by cultural differences in emphases on different slices of phenomenological field, such as affective, somatic, cognitive, motivational or interpersonal cues. As people detect these changes, they interpret them through the lens of familiar scripts of normalcy versus distress and their sociocultural implications. Scripts of distress that align with culturally valued goals may be recognized as problematic yet valorized, whereas those that are at odds with culturally valued goals may be devalorized. In this talk, I would talk about psychological and sociocultural implications of applying valorized and devalorized scripts of distress to the subjective changes, with analysis of beneficial (e.g., increased recognition and access to care) as well as harmful (e.g., increased desire for social distance for biomedical scripts of mental illness, social expectancies) outcomes of this process. 

Lisa Cosgrove PhD

University of Massachusetts, Boston

"Dissecting the DSM: Conflicts of interest, treatment-resistant depression and prolonged grief disorder"

When the DSM III and 1987 DSM III-R were published, the field officially adopted a medical model;  hopes were high that the neurobiological basis of mental disorders would soon be accepted and that drugs like fluoxetine would prove highly effective. These hopes were clearly evident when the president of the American Psychiatric Association announced, in 1985, “our field is exploding with information, optimism, and enthusiasm. Psychiatry has moved from backwater to the forefront as a medical specialty, largely because of the research explosion, particularly in the neurosciences.” Where have thirty-eight years and four more editions of the DSM brought us? 

The purpose of this presentation is to explore that question by discussing 1) the implications of medicalizing distress, 2) DSM panel members’ industry ties (including in the latest edition, DSM 5-TR, published in 2022) and why these ties matter,  3) prolonged grief disorder and treatment -resistant depression as case examples of how medicalization can lead to inappropriate treatment. Instead of searching for “magic bullets,” psychiatry and related disciplines should adopt a “gentle medicine” approach by intervening less,  and focusing on the upstream causes of distress. 

Carl Elliott MD, PhD

University of Minnesota

"The Debasement Tapes: Degradation, Humiliation and the Unsettling Side-Effects of Dopamine Agonist Drugs"

Adriane Fugh-Berman MD

Georgetown University Medical Center

"Overpromotion of Drugs for Menopause: 50 years and Counting"

Estrogen has been promoted as the fountain of youth since the 1960s.  After it was shown to increase endometrial cancer rates 7-14 times in the mid- 1970s, prescriptions dropped.  In the 1980s, "hormone replacement therapy" incorporated a progestin to oppose estrogen, and "HRT" was promoted, without evidence, for preventing heart disease, dementia, and other diseases. In the 2000s, the Women's Health Initiative proved that risks outweighed benefits, and prescriptions plummeted again. But promotion of hormonal and non-hormonal treatments is gearing up again, with menopause being falsely depicted as a debilitating, disease-ridden, stigmatized period in women's lives. Pharma is writing this script. 

Colleen Fuller

Independent Voices for Safe and Effective Drugs

"Insulin Inc." 

Insulin was the first product of biotechnology. It was introduced to the market in 1982. Since then, the market has been reshaped, with an oversupply of insulin in the wealthier countries of the global north while up to half of the world’s people – most of them in the global south – have no access, a death sentence for those with Type 1 diabetes. Biotechnology boosted the efforts of the two largest manufacturers at the time to significantly expand their markets, into the United States (Novo Nordisk) and into Europe (Eli Lilly). Today these two companies, along with Sanofi, control 99% of the global insulin market. The oversupply of insulin in wealthier countries has supported a shift from a market composed mostly of those with Type 1 diabetes to one dominated by those with Type 2 diabetes. Yet evidence has shown since 1978 that insulin therapy results in more harm than good for people with Type II diabetes – who now compose approximately 80% of the insulin market.

Wayne Gao PhD

Taipei Medical University

"An Invented Cancer Epidemic; Promotion of Commercial CT Scans and Lung Cancer Overdiagnosis among Low-risk Asian Females in China, South Korea, and Taiwan"

This study examines the correlation between the promotion of commercial CT scans and the overdiagnosis of lung cancer in low-risk Asian female populations. The healthcare industry has promoted this practice without adequate randomized controlled trials (RCTs) to support its effectiveness. Screening campaigns were marketed as a means of early cancer detection, often highlighting "lung cancer in never smokers" (LCINS), which is a scenario long exaggerated by the tobacco industry. Consequently, early-stage lung cancer incidence increased rapidly in Taiwan, South Korea, and Shanghai, China, while there was no corresponding decrease in late-stage cancers. Virtually all the additional cancers detected represent population-level overdiagnosis, as most of the screening-detected indolent lung tumors were not destined to progress and cause harm or death in these asymptomatic populations. Detection of these indolent tumors caused a significant surge in costly workups,  procedures and potentially harmful surgical interventions. Unless RCTs can demonstrate some value to low-risk groups, LDCT screening should remain targeted only to heavy smokers.

Lydia Green RPh

RxBalance

"Mechanics of the Message: Insights from Industry Insiders"

Drawing upon their respective over 40 years of personal experience, we will describe how ad agencies, CME companies, and medical communication firms adapt science to shape and influence prescribing practices in the United States.  We will share personal anecdotes of helping pharmaceutical companies build blockbuster brands, with Steve Abramson focusing on CME, publication planning, conferences, thought leader development, and pre-launch strategy, and Lydia Green on creating marketing materials including  detail aids, advertisements in medical journals, and print and digital educational content for FDA-approved drugs. During their talk, they will touch on transformative changes in drug marketing in the 1990s, how companies misrepresent the truth, and explain why physician behavior contributes to overtreatment.

Laurence Klotz MD

Professor of Surgery, University of Toronto

"Find it Early! The pitfalls of early cancer diagnosis, with a focus on prostate cancer."

‘Get tested’, ‘Catch it early’, Early detection saves lives’. These stock phrases, and others, rest on the assumption that diagnosing cancer at an earlier stage results in better outcomes in terms of survival and quality of life.  However, the downsides of overdiagnosis, overtreatment, and the negative psychological effects of the ‘survivor’ label are often unacknowledged. These negative effects may outweigh the benefit of early detection.

Lead and length time bias limit the benefits of cancer screening.  The worst, most life threatening cancers are the ones most likely to be missed by screening. A useful analogy is to animals in a barnyard.  Turtles (indolent cancers) stay inside indefinitely.  Birds (aggressive, highly metastatic cancers) fly away.  Only rabbits, which hop around for a while and then jump out (cancers which are initially localized and acquire metastatic potential over time), stand to benefit from early detection. Thus for most cancers, early detection, no matter how intensively practiced, will not eliminate cancer mortality entirely.

Low grade prostate cancer develops in most men with age. These cancers are almost always slow growing and have no metastatic potential. The diagnostic paradigm of a PSA test, often elevated due to prostatic enlargement or inflammation, followed by a systematic biopsy of the prostate resulted in the frequent diagnosis of these clinically insignificant cancers.  From the late 80’s, when PSA testing was first introduced, until active surveillance became widely adopted, about 20 years later, 95% of newly diagnosed low- rade prostate cancer was treated radically, with surgery or radiation:  both carry the risk of lifelong side effects.   There is now a general consensus that testing men at medium-high risk, with imaging prior to biopsy and a much more selective approach to biopsying, results in an acceptable level of risk of overdiagnosis and overtreatment. However, these risks are still present, and represent a tradeoff of risk and benefit for men undergoing testing for early prostate cancer.

Parallel phenomena exist for many cancers for which screening tests are available, including breast, thyroid, kidney, and lung cancer. 

Gretchen LeFever Watson PhD

Clinical and Developmental Psychologist, Safety & Leadership Solutions

"Overprescription of Psychotropic Drugs in Children" 

ADHD will be used to showcase the fallout from increasingly widespread overuse of psychotropics in children. ADHD is the most common mental health diagnosis given to children. Although primary care providers typically initiate ADHD treatment, psychotropic prescriptions often convert children to psychiatric patients. In the U.S. (and elsewhere) a growing number of young patients are prescribed multiple types of psychotropics concurrently, which often involves antipsychotic drugs. Among pediatric patients, ADHD treatment is now implicated in one-quarter of reported adverse reactions to antipsychotic drugs. Due to geographic variations in ADHD treatment practices, national statistics are not always useful for monitoring ADHD treatment trends or motivating corrective action whereas evidence of local overprescribing has successfully motivated communities to reduce their over-reliance on psychotropics. With the proliferation of electronic health records (EHRs), it is now possible to readily generate psychotropic prescribing trends while preserving patient privacy and confidentiality. The power of EHRs should be leveraged to develop conflict-free mechanisms to track and public report local psychotropic prescription trends. A petition is under development which calls for de-identified tracking and reporting of psychotropic prescribing among pediatric patients in any U.S. community with a child psychiatric hospital and/or a clinical research organization (CRO) engaged in psychotropic drug trials.

Joel Lexchin MD

Professor of Family and Community Medicine, Temerty Faculty of Medicine, University of Toronto

"Bigger and Better: How Pfizer Sold Erectile Dysfunction and Viagra"

There are a number of medical causes of erectile dysfunction, but treating only those causes would have made Viagra (sildenafil) a modest commercial success. The question facing Pfizer was how to expand the market for Viagra and make it a blockbuster. Pfizer developed a five-part strategy to achieve its commercial goals:

• Inflate the number of men who have ED;

• Inflate the success rate for Viagra;

• Ignore other treatments for ED;

• Make the drug into one used for any degree of ED, and for men of any age;

• Convince the insurance industry to cover the cost of Viagra.

This talk will explain how Pfizer went about achieving each of these objectives and, in the seven years after it was approved, turned Viagra into a drug that made it $1.6 billion in 2005.

Barbara Mintzes PhD

Professor of Evidence-Based Pharmaceutical Policy, The University of Sydney Charles Perkins Centre and School of Pharmacy

"More Vim and Vigour: the Everlasting ‘Low-T’ saga"

Testosterone replacement products have an important place in therapy for disorders involving the testes, pituitary, or hypothalamus that affect men’s testosterone production. From around the year 2000, however, testosterone has been extensively promoted off-label for ‘Low-T’, also called “age-related hypogonadism” “late-onset hypogonadism” or “andropause”. Both in the United States (and internationally, there has been widespread “disease-awareness” direct-to-consumer advertising (DTCA) promoting a set of vague symptoms, including fatigue, mood changes, low sex drive,  sexual dysfunction, and loss of muscle mass as being caused by “Low-T”. The US Food and Drug Administration (FDA) allowed this advertising to run for more than a decade,  because no specific brands were mentioned and unbranded advertising is regulated by the Federal Trade Commission. In late 2014, following an advisory committee review of cardiovascular risks, the FDA effectively stopped the off-label promotion by restricting the indications of testosterone products to specified pathologies. A 2016 large-scale RCT of testosterone in older men found very limited effectiveness. Once established, however, the ‘Low-T’ diagnosis lives on,  despite safety and efficacy concerns. I will discuss the current situation in the U.S. and contrast the U.S .regulatory response with Canada and Australia, where there has been limited response from regulators,  but public payers have intervened with varying success to try to address off-label use. 

Susan Molchan MD

Psychiatrist

"Are New Alzheimer’s Drug Better than Older Drugs?"

The FDA has approved two monoclonal antibodies that target beta-amyloid protein, based solely on their effect on decreasing amyloid in the brain, as measured by PET scans. The FDA will soon be considering full approval for one of them, lecanemab, based on data from a large 18-month clinical trial, in which the drug appeared to slow decline over placebo on the primary clinical endpoint, as well as secondary endpoints. 

The effect size on these endpoints was small, though statistically significant, and in the range of the effect sizes seen with cholinesterase inhibitors, the drugs most commonly prescribed for Alzheimer’s disease since donepezil (Aricept) was approved in 1996. 

Some of the historical context of the amyloid-focused drugs and the cholinesterase inhibitors will be compared, as well as research on clinical, as opposed to statistical, significance, and the implications in terms of benefits to patients. 

Finally, the costs and adverse effects expected from monoclonal antibodies, from what we know about them today, will be contrasted to addressing preventable risk factors for dementia.

John Powers MD

Professor of Clinical Medicine, George Washington University School of Medicine

"What Needs to Change at the FDA: Innovation and Value in Health Care"

Value in health care is defined as interventions that improve patient outcomes. Innovation should mean better for patients, not just new. However, evidence shows that the minority of medical interventions approved for marketing in the US and globally cost more yet do not have evidence that they help patients live longer or live better compared to already available less expensive and better studied interventions.

Part of the US Food and Drug Administration’s  mission statement is to advance public health, inherently meaning improving patient outcomes. Yet the recent focus on medical interventions approved for marketing has been on increasing the speed of drug companies’ ability to market products and increasing the quantity of medical interventions whether or not there exists evidence that those interventions have added benefits for patients over available evidence.

The recent white paper “What Needs to Change at FDA” includes recommendations for improving the value of new medical interventions approved for marketing by FDA. This talk will discuss the recommendation in the white paper including improving the processes of evidence  development and review of medical interventions, and improving the value for money of those interventions.

Suzanne Robotti

President, MedShadow Foundation

"Notes From the Consumer Rep Seat at FDA Advisory Committees"

FDA Advisory Committees convene a select group of outside experts to advise the FDA on approving or rejecting a drug, biologic, or medical device. It’s a time for open discussion with the FDA and sponsors, and every meeting includes time for public testimony. While the Committees have limitations on what they can discuss and may be given clear indications by the FDA on their preferred outcome, Committee discussions can bring up surprises. Public testimony by adamant clinicians and emotional testimony by s clinical trial participants and consumer advocates can have a profound effect on members’ decision-making. 

I have held the Consumer Rep seat on the FDA Drug Safety and Risk Management Committee for the past five years. I will share insights into how the Committees function.

Tony Scialli MD

Emeritus Clinical Professor of Obstetrics and Gynecology, George Washington University

"The Myth of Menopause"

In the more than 50 years since I’ve been in medicine, menopause has been treated as a disease, often treated with medications. I’m here to tell you, menopause is not a disease. But doesn’t menopause cause diseases, for example, osteoporosis and coronary artery disease? Not really. Menopause is a feature of aging, and aging is associated with some diseases. So, why is menopause treated with medications? Because we don’t have pills for aging, but we do have pills for menopause. Pills, of course, cost money, and all pills have side effects. We as health care providers spend a lot of time trying to get women to take pills for menopause, but how much time do we spend promoting adequate nutrition and healthy behaviors? Given the huge size of the menopause market, it is no wonder that menopause continues to be promoted as a disease. But, believe it or not, menopause is normal.

Peter Whitehouse MD, PhD

Professor of Neurology, Case Western Reserve University and University of Toronto 

"Is our cognitive impairment more than mild: the latest but perhaps not so greatest from DSM-V (TR)?"

Age- Associated Cognitive Challenges have been well documented throughout history. For the last two hundred years the medical profession has struggled with characterizing the boundaries between dementia and aging, and between pathological changes and normal age-related changes. The power struggles between neurology and psychiatry manifest fully in the space of what we now tend to call “brain health”. Yet,  too often,  the voices of “patients”, families and society at large have been silenced -- and when heard,  too often distorted by medical interests.

In this presentation we will review the history of labeling pre-dementia,  starting with Benign Senile Forgetfulness and ending with Subjective Cognitive Decline. Attempts to push the clinical use of biomarkers in association with biological therapies and digital technology for diagnosis and treatment will be reviewed. We will also discuss the latest DSM V (TR, text revision) Neurocognitive Disorders supplement, especially the expansion of psychological and behavioral symptoms in MCI (Mild Cognitive Impairment or Mild Neurocognitive Disorder).