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Newsletter: Oct 2023

Welcome to the October 2023 chapter newsletter.  CHAPTER NEWS  FEATURES  CHAPTER NEWS Chapter Members Attending the AMWA National Meeting By Michael Franklin, MS Several members of the North Central Chapter will be attending this year’s annual AMWA meeting. Naomi Ruff and Susan Miller agreed to share the reasons they’re attending this year’s conference. “This will […]

AMWA Chapter Meeting, Quang Restaurant, Part Deux

By Paul W. Mamula, PhD

The North Central Chapter’s Zoom meeting on August 30, 2023, featured 3 long-time AMWA members who provided their tips for effective writing: Nissa Mollema, Phillips (industry); June Oshiro, Mayo Clinic (academic); and Naomi Ruff, RuffDraft Communications LLC (freelance). (Members can read speaker profiles in the July 2023 Newsletter). Their presentations were a follow-up to our August 16 meeting that was held at Quang, a Vietnamese restaurant in Minneapolis. This article will be a short precis. The speakers will provide more in-depth articles in later issues, so please watch for them.

Making Lemonade Out of Lemons

For those who didn’t attend either event, a brief explanation is due. Because of a mix-up with Quang management, we were left without a meeting room, leaving us at one large table in the middle of a noisy restaurant. Although the food was good and all speakers had printouts available, the acoustics precluded any mini-lectures. We decided to make the August 16 meeting into a networking event and rescheduled the meeting as a virtual event. The dinner gave us time to connect and sample the Vietnamese cuisine. Thanks to quick thinking, we turned 1 meeting into 2. Turnout for both events was very good.

Industry Work: Nissa Mollema, PhD

Nissa Mollema is a Senior Clinical Development Scientist at Phillips and has held a variety of positions in small, medium, and large medical device companies. She notes that working and writing in industry has many differences compared with her previous experience in academia. In industry, it is common to spend quite a bit of time discussing and clarifying the big picture before beginning to write. Among the considerations are the audience (inside the company or external stakeholders), information (promotional or scientific), and document use (one-time use or multi-use publication requiring updating). One must ensure that the material is truthful, accurate, and balanced. Critical to the process is being a good storyteller. Sometimes this is contingent on the material; some material is derived from a template, whereas other material allows for creative flexibility.

The industrial process is different from other writing, because work is often done in groups or with collaboration with interested parties. The review process can be challenging, because of the multiple partners. Reviewers have their department and historical perspectives which can be a positive. One must also manage multiple drafts, a process that involves combining files and version control of documents. It also requires follow-up in that documents often have a procedure in place for review. For medical devices this can be formulaic and lengthy.

Finally, she notes that the medical writer brings many skills to the table, and the expertise can be a big plus for the writing team. Sharing your knowledge can be beneficial. For example, some advanced MS Word skills can speed up processes (and impress staff and supervisors). Prioritizing is critical for determining where to invest energy for the biggest impact for the project (and your personal advancement).

The Academic Life: June Oshiro, PhD

June Oshiro is a biomedical editor and Consultant at the Mayo Clinic and offered several tips for juggling job and life. She urges writers to set realistic goals and manage expectations. Doing so requires collaborating with supervisors to reach mutually beneficial work plans. Of importance is being transparent about personal issues that may come up (eg, illnesses, care of children or parents). Using time-management techniques and partitioning work and personal time can help. Using tools such as the Pomodoro method or Forest app can help with work scheduling, while allocating a “worry time” to deal with personal issues can help separate tasks and allow one to focus.

Other time and task saving tips for writers include using software to read text aloud for proofreading, keeping a daily record with tasks to do, (eg, Bullet journal), using ChatGPT (as a thesaurus and reverse-lookup dictionary not as a writing or editing tool), and changing page size to avoid scrolling to read footnotes. Because individual work styles vary, writers will have to tailor what works best for them. Keep expectations realistic: seek to improve work by 1%.

The Freelance Life, Naomi Ruff, PhD

Naomi Ruff is president (and sole member) of RuffDraft Communications LLC. She has a PhD in Neuroscience and began freelancing in 2000, following her postdoctoral stint in Northern California. Her projects range from writing to copyediting on multiple life science and medical topics. She offered tips on business as a freelancer.

The first point she emphasized was to diversify one’s business. Working on diverse subject matter, mixing large and small projects, and working on different document types help to smooth workloads and maintain income flow. The variety and mix help to cope with stresses accompanying freelancing.

Above all, one needs to treat the business as a business. It is important to keep good records (invoicing, income, expenses), monitor time spent, and build lists of potential clients. Many programs are available for these tasks and will help keep business matters separate from personal matters, an important consideration at tax filing deadlines.

As a freelancer, one is responsible for everything, so being proactive about professional development is important. Useful steps are taking workshops or webinars; reading books, articles, and blogs; trying new software; and engaging colleagues. Much information is just a few pages, keystrokes, or phone calls away.

Also important is having a network of colleagues. These can be derived from workplace contacts, professional organization listings, or word-of-mouth contacts. These can help you create a referral list for different types of work when there are projects you can’t take, need advice about projects, or require graphics or statistical support. From the business perspective, it can be very helpful to hire an accountant and contract lawyer. Don’t be afraid to reach out; remember, no one is an expert at everything.

Naomi notes that one of the big advantages of being a freelancer is having the flexibility to maintain a good work-life balance. Doing so requires some fine-tuning when starting out, and once settled can be adjusted to deal with life events or personal health issues. With all these considerations, one must always be aware that at times one may have too much or too little work.

Job search tip

By Adam Fix

As some of you know, I’ve been job searching for the past few months and recently took a 1-year contract at Bio-Rad Laboratories. So, needless to say, I’ll be back on the hunt this time next year. To celebrate this semi-victory, I’ve assembled a list of tips and tricks for anyone embarking on their job search. For more advice, please check out the Ultimate Guide to Becoming a Medical Writer on the AMWA website.

  1. Connect with people on LinkedIn

Log in to LinkedIn and search for “medical writer” (or similar phrasings) in your area. Find people who have the jobs you’re looking for, ideally at the companies you’re targeting. Send them a Connect request with a brief message introducing yourself.

Besides “medical writer,” good keywords to search for might be:

  • Medical affairs
  • Scientific communication
  • Scientific affairs
  • Technical writing
  • Content writing

While you’re on LinkedIn, make sure your professional headshot and other aesthetic details of your profile are all up to date.

2. Join professional associations in your area

If you’re reading this, you’ve already done that! But other associations worth looking into (listed in the AMWA Ultimate Guide) might include:

  • Association of Health Care Journalists
  • Board of Editors in the Life Sciences
  • Council of Science Editors
  • Drug Information Association
  • Editorial Freelancers Association
  • International Society for Medical Publication Professionals
  • National Association of Science Writers
  • Regulatory Affairs Professionals Society
  • Society for Health Communication
  • Society for Technical Communication

3. Do at least one informational interview per week

Once you’ve connected with people on LinkedIn, ask them if they’d have time for a quick informational interview. If they agree, be sure to ask them these three questions:

  • What are the day-to-day responsibilities of your job?
  • What specific, concrete steps did you take to get your job?
  • What skills, experiences, certificates, or other qualifications would you recommend to help someone get a job like yours?

At the end of the interview, ask them to inform you of any new job openings at their company. Stay in touch on LinkedIn and keep the contact “warm,” so to speak.

I’ve done dozens of informational interviews over the years. Many were dead ends, but some proved invaluable. For example, a phone call with Kendra Hyland was what inspired me to attend an AMWA event and join this chapter back in 2020.

  1. Tailor your resume to the job

Find your dream job. Next, find the job description. Rewrite your resume such that it matches the language and keywords of the job ad as closely as possible.

For example, suppose the job description cites such key responsibilities as:

  • “Effectively communicate the appropriate level of detail based on the audience”
  • “Successfully negotiate project schedules, plans, and milestones”

Work similar phrases into your resume, ideally on the first page. Always lead with a verb, ideally one that accurately conveys an improvement of some kind you contributed to: developed, enhanced, optimized, overhauled, boosted, etc.

For style points, Canva has lots of free resume templates.

  1. Search for jobs daily

Do a little bit of job hunting every day. I made it my goal to apply to at least one job every day. During slow hiring periods, this was not always possible. But when possible, I checked LinkedIn every day and filled out at least one application. Every application raises your chances of success ever so slightly; the more the better.

  1. Practice your “why do you want this job?” speech

The single most common interview question is without a doubt “why do you want this job?” Sometimes it’s formulated differently — “tell us about yourself and what attracted you to this position” — but the principle is the same.

You must be ready to answer this question with confidence and conviction. The best way to do this is to practice your answer. Practice it, out loud, over and over again until you can get through the whole thing without rambling or stumbling.

  1. Practice your STAR stories

STAR stories are short story nuggets comprising a situation, task, action, and result. They’re how you answer those pesky “tell us about a time” interview questions:

  • Tell us about a big project you worked on. How did you organize tasks and keep everything on track?
  • Tell us about a time your manager was dissatisfied with you.
  • Tell us about a conflict you had with a coworker.
  • Tell us about a part of your job that you don’t enjoy as much.

One of the best hacks I learned for answering these questions is that your STAR story doesn’t have to be one story. Feel free to mix and match details from different aspects of your work, and weave them into a factually accurate, but composite, story drawn from many different accounts.

Always end with a strong “result” statement, like “our team completed the project on time and exceeded goals by 25%” or something similar.

  1. Make a list of questions to ask during an interview

This sounds like the easiest part of the interview, but it’s actually the hardest. Hiring managers want employees who understand the job and care about the right things; asking the wrong question can torpedo your chances faster than almost anything.

Here are questions I’ve had success with in the past:

  • What about my resume piqued your interest, what stuck out to you? May I ask why you wanted to speak with me today?
  • Walk me through a typical project. How does it begin? How does it progress? When does the project end?
  • What is your project management system? How do you organize tasks, track KPIs (key performance indicators), and keep everyone on schedule?
  • Tell me about a recent project or accomplishment with this team that you’re particularly proud of.
  • What do you find rewarding about working here? What does working at this company mean to you?

A rule of thumb is to have one question for every 15 minutes of the interview, plus one. For example, a half-hour phone screen requires at least three questions from you at the end.

 

Chapter Advisory Council Update

by LeAnn Stee, North Central Chapter Representative

Mission of the Chapter Advisory Council (CAC)

The CAC serves to maintain a connection between chapter leaders and the AMWA Board of Directors by advising the AMWA board on the organization’s strategic direction as it affects the chapters and acting as a sounding board about issues that have an impact on chapters and the national organization.

Third Quarterly Meeting of 2023

The AMWA CAC meeting was held on August 10, 2023 (Teams meeting).

Updates From the AMWA Board of Directors: Jen Minarcik

  1. AMWA Fiscal Year 2023-2024 Priorities:
    • Plan and promote the 2023 and 2024 AMWA Annual Conferences
    • Maintain value to attract and retain members
    • Develop and implement a diversity, equity, and inclusion (DEI) strategic plan
    • Conduct a compensation study
    • Support technology updates and office transition
    • Create and promote online learning programs
    • Enhance and expand certificate programs
  2. AMWA DEI Initiative
    • AMWA is working with a DEI consultant to develop a strategic plan that will include goals, a timeline, and key strategies
    • The strategic plan should be finalized by the end of the year
  3. AMWA Membership
    • Membership continues to increase. As of June 30, 2023 (end of fiscal year), there were 4,814 members (for the 2021-2022 fiscal year, the number was 4,520)

Updates From AMWA Headquarters: Sharon Ruckdeschel, director of membership and systems for AMWA

  1. Fall Chapter Activity and Financial Reports
  • Chapter activity and financial reports were due August 1, 2023
    • The annual financial report is due even though summary information is included in the activity report
    • The fiscal year for every chapter is July 1 through June 30
    • Submitting the report on time is important: deadlines are in the chapter agreement, support checks need to be distributed, and a Chapter Trends report needs to be compiled
  • Chapters will receive their support checks in early September. Chapter treasurers are encouraged to deposit them quickly
    1. 2023 Medical Writing and Communication Conference, October 25-28, 2023
  • Chapter dinners will be on Thursday, October 26
  • Chapter Officer Networking Session will be on October 28
  • A conference mobile app will be available
  • 481 people were registered as of August 7

The next CAC meeting will be held on Thursday, November 9, 2023

Questions, comments or new additions to the newsletter? Please contact the Publications Committee Chair. And remember, you can also read this newsletter on the chapter website. You can find previous newsletters on the website as well.

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Newsletter: Aug/Sept 2023

Welcome to the August/September 2023 chapter newsletter.  CHAPTER NEWS  CHAPTER EVENTS  FEATURES  CHAPTER NEWS New Publications Committee Chair (i.e., Newsletter Editor) By Michael Franklin, MS As a long-time member of AMWA, I’m excited to have the time to return to volunteering as the newsletter editor. Many years ago I was more active in AMWA, even […]

Read a Good Book?

Three Science Fiction Selesctions to Heat Up Your Summer

By Paul W. Mamula, PhD

I suggest 3 books for your summer reading: RedDevil 4, Interface, and The Terminal Man. All have a common theme of state-of the-art medical technology gone wrong. Although they were published over a span of 50+ years, the older ones still hold up and the newest deals with contemporary medical technology. The books came to mind in several ways, and I wanted to suggest the titles, describe how we found them, and share some trivia.

RedDevil 4, A Techno Thriller

The first book is RedDevil4, a medical thriller by Eric C Leuthardt, MD, published in 2014. I discovered it shortly after interviewing Michael C. Park, MD, a neurosurgeon at the University of Minnesota in 2017 for a story about implantable devices to control tremors in Parkinson disease patients. The technology works by implanting electrodes that are connected to a pacemaker-like device. Pacemaker signals stimulate the brain and mitigate the tremors, giving patients a more normal life. While the therapy is new and cutting edge, brain modulating technologies have regularly provided the basis for a genre of science fiction.

Leuthhardt is an active neurosurgeon and biomedical engineer, and his background gives the story a vibe that sets it above the usual murder mystery. The tale is set in 2053 when most people have a neural implant that they use for multiple purposes, including work and messaging. The story unfolds with 3 successive murders, each one perpetrated by a man who has no criminal history and cannot remember any aspects of the crime. The perpetrators lack any obvious connection other than being linked into the system. How Detective Edwin Krantz and his partner find the culprit takes readers on an unexpected romp into the world of artificial intelligence (AI). The book is interesting because experts have begun to warn of potential dangers of AI, which makes such stories a little less like fiction.

Interface, A Technology Misused

Neal Stephenson and J. Frederick George’s Interface has a similar basic plot of medical technology co-opted for malevolent political purposes. The book tells the tale of a presidential candidate who has a stroke and receives an experimental implant that opponents use to control his behavior. This tale is now dated by its technology (no cellphones; use of audio tapes and faxes, limited computer technology) but aside from those details, the story presents a taut thriller. The book was a selection in 2017 for our book club’s September (dinner meeting) selection, and I was pleasantly surprised how well the story held up. I was nervous about suggesting it, some 23 years after first reading it, but our book club readers liked it. It served as a change of pace from our usual selections. (See Book Club Notes, North Central AMWA Newsletter October 2017).

The book’s authorship has an amusing history. The book was republished twice. I read the book in 1994, when it was published as a work by “Stephen Bury.” The book was reissued under its actual authors, Neal Stephenson and George Jewison (pen name of Stephenson’s father-in-law), about 10 years later and again several years later with Neal Stephenson and J Frederick George (his father-in-law’s actual name) as authors. I saw that book published with the authors Neal Stephenson and George Jewison in 2006. A few years later, I purchased and reread the book only to realize that the book was the same one I had read in 1994. Jean Cook, our then newsletter editor, asked me about the different authors when she copyedited my Book Club Notes, and I clarified the odd history. I suppose it pays to check one’s bookshelf and read copyright pages.

Terminal Man, An Early Neuromodulation Tale

The Terminal Man was Michael Crichton’s third novel and second bestseller. It was published in 1972. Crichton, an MD who opted out of a medical career to write fiction, had come into prominence as a new author with his second novel, The Andromeda Strain—He wrote the screenplay for the movie version just before he graduated medical school. The Terminal Man presents the story of a man treated with an implanted electrode and neural stimulation to control violent psychotic attacks. The episodes were triggered by abnormal brain impulses that turned a mild-mannered computer engineer into a violent brawler. How this technology goes awry is the basis of the story, but in the 1970s using electrodes and nerve stimuli in the brain was very new. Crichton included a technical bibliography in The Terminal Man that referenced the research papers he employed writing the book. Although the book is old, the basic story holds up well. (See the movie if you don’t want to read the book). A curious fact: My wife worked for a physician at Cedars-Sinai Medical Center in Los Angeles who was a classmate of Crichton’s at Harvard Medical School and thought that Crichton erred by not going into medicine. Those curious about Crichton’s views about his career choice can read his book, Travels (1988).

Our Book Club Selections and Science Fiction

While RedDevil4 is based on contemporary technologies, The Terminal Man and Interface by Neal Stephenson also employed then-current technology in their stories. (See Book Club Notes, North Central AMWA Newsletter October 2017). Despite their age, the latter 2 books still make entertaining biomedical fiction.

Our book club had begun to select works of medically related science fiction to spice things up a while ago. We chose Interface as a book club selection in 2017, after we read Ticked, a true story about how an implantable device put a patient’s Tourette’s syndrome in remission (See Book Club Notes, North Central AMWA Newsletter October 2016). During our discussion, we thought about other possible science fiction novels and came up with one that served as the basis for a technology-gone-wrong genre—The Terminal Man—although we didn’t select it for the book club. The Terminal Man was initially mentioned by one of our AMWA speakers, Tim Denison, PhD, as the basis for cautions about early implementation of technology and for the rejection of Medtronic’s initial patent for neural modulation as “not an original idea.” (See North Central AMWA Newsletter, December 2014). Coincidentally, while looking through my notes about Dr Denison’s talk for background for this article, I noticed that one of Dr Denison’s slides cited one of Dr Leuthardt’s articles on neuroprosthetics.[1]

So, there you are, 3 science fiction books with a biomedical theme for your summer. Happy reading!

References

  1. Leuthardt EC, Schalk G, Moran D, Ojemann JG. The emerging world of motor neuroprosthetics: a neurological perspective. Neurosurgery 2006 Jul;59(1):1-14 doi: 10.1227/01.NEU.0000221506.06947.AC.

AMWA Essential Skills Certificate Course: Thoughts and Observations (Part 2: Punctuation)

By Adam Fix

Every writer has opinions on punctuation. But did you know that the AMWA Essential Skills course includes an entire 172-page guide to proper punctuation? Here are some rules of thumb I learned from Part 2:

  1. When nesting parentheses, the rule is “outer round inner square.” Start with () and use [ ] for additional nested parenthetical expressions inside the (). For example:
  1. Don’t use commas to separate parts of a sentence that have the same subject. Consider the following sentence:

This does NOT need a comma after “2001” because “patient” is the subject of both the first and the second part of the sentence. It’s all one clause.

  1. AMWA recommends hyphens, NOT en-dashes, to join words of equal significance into a phrase. For example, this form is correct:

However, be aware that other style guides may recommend en-dashes for this purpose.

  1. Write “preoperatively and postoperatively” instead of “pre- and postoperatively.” This is because these words are not normally hyphenated, so abbreviating them with a hyphen as in the incorrect choice above would be inconsistent. Moreover, having the reader wait to complete what comes after the hyphen in “pre-” demands more effort. Punctuation should make writing easier for the reader to interpret, not easier for the writer to write concisely.
  2. Our very own Mary Knatterud makes a guest appearance on p. 11, credited as “a true punctuation maven.” Mary establishes “the four C’s of punctuation” as follows:

Looks like solid advice to me!

Questions, comments or new additions to the newsletter? Please contact the Publications Committee Chair. And remember, you can also read this newsletter on the chapter website. You can find previous newsletters on the website as well.

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September 4, 2023 · Filed under Newsletters

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Newsletter: July 2023

Welcome to the July 2023 chapter newsletter.  Mark your calendars! The AMWA North Central Chapter will host an in-person event Wednesday, August 16th at 5:30. Please join us at Quang Restaurant (2719 Nicollet Ave, Minneapolis, MN 55408) for a dinner and panel discussion on the habits of highly effective medical writers. Our guest speakers include […]

Chapter Advisory Council Update

By LeAnn Stee, North Central Chapter Representative

Mission of the Chapter Advisory Council (CAC) 

The CAC serves to maintain a connection between chapter leaders and the AMWA Board of Directors by advising the AMWA board on the organization’s strategic direction as it affects the chapters and acting as a sounding board about issues that have an impact on chapters and the national organization.

Second Quarterly Meeting of 2023

The AMWA CAC meeting scheduled for May 2023 was not held because of a death in the family of one of the council leaders.

The information that follows was taken from the meeting agenda.

Updates from the AMWA Board of Directors: Jen Minarcik

  1. Initiative Update: Diversity, Equity, and Inclusion
  2. Chapter Trends Report
  3. Recipients of the 2023 Alvarez Award and the 2023 McGovern Award have been chosen and will be announced in the coming weeks

 

Updates From AMWA Headquarters: Sharon Ruckdeschel, director of membership and systems for AMWA

  1. AMWA Membership
  1. Spring Chapter Compliance
  1. Fall Chapter Compliance
  1. 2023 Medical Writing & Communication Conference: registration will open in June

AMWA Essential Skills Certificate Course: Thoughts and Observations

By Adam Fix

They say English is one of the hardest languages to learn. But you don’t know the half of it until you’ve clawed your way through the AMWA Essential Skills Certificate course. I recently took the course myself, and here are some thoughts on Part 1.

Every weird quirk of our language is discussed. Did you know that “the number” takes a singular verb but “a number” takes a plural verb? For example:

Every potential grammatical pitfall is exposed. Here’s a puzzler: What’s wrong with the following sentence?

If you said that the participial phrase “based on the test results” lacks a noun to modify, good job! Participial phrases (phrases that begin with a verb form, in this case “based”) can only function as adjectives. In this form, this sentence does not include the modified noun. We might rewrite it as follows:

Here, “based on the test results” is clearly modifying “recommendation.”

All in all, I learned more about language and grammar from this course than from my entire Ph.D. program curriculum. My brain feels like a wrung sponge.

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July 16, 2023 · Filed under Newsletters

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Newsletter: June 2023

Welcome to the June 2023 chapter newsletter.  Instead of a specific music recommendation, this month I’d like to share with you a very cool internet hidden gem. MNspin is a repository of local Minnesota music that I discovered by accident one morning, happening upon a pile of free bumper stickers while browsing a guitar store […]

Read a Good Book? Who We Are and How We Got Here by David Reich

By Paul Mamula, PhD

For those curious about current thinking concerning the origins of Homo sapiens and the peopling of the world, Who We Are and How We Got Here: Ancient DNA and the Science of the Human Past by David Reich provides an excellent overview. Reich bases most of his work on analyses of ancient and modern DNA samples but includes archaeological and cultural information when possible. Reich employs DNA from fossil human ancestors to construct how modern humans came to be and analyses of more modern populations to assess human distribution over time. He learned isolation and sequencing procedures from Svante Pääbo, the researcher who perfected the techniques for use on ancient DNA. 

The book consists of 3 sections (12 total chapters), each chapter of which begins with a helpful timeline. Each chapter also has multiple maps that highlight the likely population movements. Reich posits a “family bush” that has many intertwined branches rather than the familiar “family tree” with distinct branches. His work explains our African origins, migrations out of Africa, back migrations and interbreeding to describe how modern humans evolved and later spread. Although the analyses are based on relatively few samples, his views become more likely and clearer as the evidence mounts. The book makes a nice summary of human evolution to date. The book also includes an extensive set of chapter notes and references for the curious. I found them helpful to refresh my knowledge of several of the topics discussed. 

Reich’s computer analyses of Neanderthal, Denisovan (an Asian contemporary of Neanderthals), and modern humans shows that ancient human ancestors likely interbred. He deftly explains how a hypothetical African origin and many back migrations could yield modern populations. Given that we now have DNA evidence, we can rule out the minor skeletal differences that many early anthropologists used to exclude Neanderthals as direct human ancestors. He also provides population migration scenarios for most regions, including the Near East, the Indian subcontinent, and the Americas. Although data are still being collected, his arguments are compelling. 

Of particular interest are his analyses of more recent population movements, notably the peopling of the Americas. I found Chapter 7 fun, because I started out in a physical anthropology PhD program at Arizona State University (I earned an MA there before leaving for a PhD program in medical genetics). Reich does an excellent job of unifying the DNA sequence and cultural data. I found it fascinating because his analyses echo those of many anthropologists—including one of my professors, the late Christy G. Turner II—who proposed 3 migrations into the Americas after glacial melting opened an ice-free corridor. Although some of the fossil material and archaeological evidence suggested these findings, Reich (and Turner) suggest that much of the human fossil (and potential DNA) evidence is likely submerged along the Pacific coast, one of the likely migration routes. 

Reich also addresses more recent controversies. He describes Arizona State University’s misuse of Havasupai blood samples without permission for performing studies not mentioned in the informed consent forms. The misuse led to a lawsuit and a fine, big embarrassments for ASU’s anthropology department. The episode provoked resistance to further research among the Havasupai and other Native tribes. He also discusses the impact that the Native American Graves Protection and Repatriation Act (NAGPRA) has had on the field. NAGPRA has led to the return of skeletal material held in museums and universities to original tribes. Many of these skeletal collections were looted from graves, and their possession by non-Native Americans had been a sore point for years. He also spends some time describing the findings that led to the repatriation of the “Kennewick Man’s” skeleton. The 8,500-year-old skeleton had European-like features but predated any known European migration in the continental United States. The skeleton was claimed by 5 tribes in Washington state and its possession was tied up in the courts for several years. DNA ultimately resolved the issue and demonstrated that the skeleton was not of European origin and belonged to a single tribe. 

Reich’s book presents the state of knowledge of human evolution and will probably be reissued as more information and ancient DNA become available. I recommend the book as a “one-stop shop” for anyone interested in human origins. 

Podcast recommendation: Old Time Radio Mystery Theater 

If you’re feeling uber-nostalgic, check out this blast-from-the-past podcast recommendation courtesy of Carmen Peterson! Old Time Radio Mystery Theater is pretty much what it sounds like: crackly old radio dramas from the era when your radio weighed 100 pounds and took up a corner in your sitting room. Mix an Old Fashioned, sit back in your armchair and listen to some spooky ghost stories, hardboiled detective adventures or whatever else strikes your fancy. 

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June 2, 2023 · Filed under Newsletters

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Newsletter: May 2023

Welcome to the May 2023 chapter newsletter. Not too much going on this month, but please check out some new member profiles from Julie and Anna below, as well as some book club notes from Paul.  For this May’s music, let’s try some cool summer jazz. “Night Dreamer” by Wayne Shorter is a deeply introspective […]

Book Club Summary: The Illusion of Evidence-Based Medicine

By Paul Mamula, PhD

Our book club met via Zoom on April 24, 2023, and discussed The Illusion of Evidence-Based Medicine: Exposing the Crisis of Credibility in Clinical Research by Jon Jureidini and Leemon B McHenry. The book reviews clinical trials that were used to justify use of antidepressant drugs for children and adolescents that along the way to approval used altered study results, employed ghostwriters, and actively promoted off-label use. These were later discovered and ultimately resulted in criminal proceedings and fines. 

About the Book 

The book was published in 2020 and reviews 2 clinical trials. Study 329 was conducted by SmithKline Beecham (now known as GlaxoSmithKline [GSK]) for paroxetine (an SSRI antidepressant) and CIT-MD-18 was tested by Forest Laboratories for citalopram and escitalopram. The book is 8 chapters long and walks readers through the studies and their shortcomings. It also includes 12 Appendices of excerpts from interviews, depositions, and letters to the editor. The authors also describe their reevaluation of CIT-MD-18 and efforts to get the reanalysis published. Chapter 8 proposes solutions to the problems in the current clinical trial system. Chapter notes, bibliography, and acknowledgements round out the book.   

The Controversy and Outcomes 

The controversy in The Illusion of Evidence-Based Medicine revolves around altered criteria used for assessing success in one trial and inclusion of unblinded study participants in the other, both of which changed negative results into positive ones. Both companies also coached marketing staff on how to promote off-label use. Exposing the malfeasance took place over the period 2004 to 2012 and was sparked by investigations in the United States and the United Kingdom. The authors weave the clinical trial irregularities and follow-up but their presentation is a little muddled. Jureidini and McHenry published additional assessments of the trials before their book was published in 2020,1-3 and a summary article in BMJ in 2022.4 Ultimately GSK and Forest had to pay for their irregularities. GSK settled for $3 billion, an amount that also included a $1 billion fine for “preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.”5 Forest Laboratories paid $313 million to resolve criminal and civil liabilities for misuse of their drugs6 and another $164 million for criminal violations.7 

Complaints and Solutions  

The authors make a good case for complaints about the trials that include the companies: 

Since these events occurred in the early 2000s, some of these issues, notably ghostwriting, have been partially addressed; however, many issues remain. The authors proposed solutions, but we wondered how much these would cost and how they could be implemented. Nonetheless, more money from independent sources for trials, better study design, and more effective tracking would be welcome. 

The authors present suggestions for mitigating the problems in Chapter 8, and these are also highlighted elsewhere.7 These include: 

Jureidini and McHenry also explain other problems that include discussions about Cochrane Reviews, restrictions on pharmaceutical marketing, and suggestions about government investigations, litigation, and punitive damages. These measures would go a long way to rectifying the current situation. 

Quibbles 

We all liked the book but had a few complaints. Kendra Hyland said, ”The book was an informative and eye-opening insight into how pharmaceutical companies manipulate clinical trials and the results to promote drug sales. While the book needed some editing and was redundant at times, it was worth the read.”  

I also liked the book but also found multiple editing deficiencies that included 2 reversed figures (5.1 and 5.2), out of order tables, and a few missing and erroneous references. Perhaps this reflects the decision to use a small independent publisher. The book had been accepted by mainstream publishers but the authors decided to use an independent publisher to avoid any possible conflict of interest with the pharmaceutical industry and to reduce costs. One wonders if the editing might have been better with a larger publisher. I read an Australian copy obtained via interlibrary loan that employed an odd typeface that was glaring and hard on the eyes. 

We found the book a little hard to follow, particularly because the appendices refer to different trials, include letters to editors, and transcripts from different cases. The authors might have incorporated those in the text for smoother reading. I found it distracting to have to flip back and forth. Readers also felt that the authors generalized broadly. Laura Chapin said, ”At times I felt the authors painted every single person as guilty ‘baddies’ operating maliciously, though I question the reality of so many people taking part intentionally and knowingly. It marked a specific time in history that’s interesting to compare to current writing and publishing practices as I’m familiar with. I found it to be thought provoking read overall. Although I don’t work in the pharmaceutical industry, it encouraged me to view my work in medical devices with a different lens.” 

Next Up 

Our next book club will meet on September 25, 2023, to discuss Man’s 4th Best Hospital by Samuel Shem. It is a novel that revisits the characters from Shem’ House of God (Book Club selection for April 26, 2010) and Mount Misery (book club selection for April 30, 2012). Man’s 4th Best Hospital follows the physicians as new corporate owners seek to improve the hospital’s ranking. The characters were based on actual people and provide an interesting look at how medicine has evolved since that original novel. Readers can get also get an overview of the novel and the controversy surrounding it in a recent discussion in JAMA.8 Join us for the discussion (even if you haven’t read the book!). 

References 

  1. Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351: h4320 Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence – PMC
  2. Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Study 329 continuation phase: Safety and efficacy of paroxetine and imipramine in extended treatment of adolescent major depression. Inf J Risk Saf Med 2016;28(3):143-161 Study 329 continuation phase: Safety and efficacy of paroxetine and imipramine in extended treatment of adolescent major depression – PMC
  3. Jureidini JN, Amsterdam JD, McHenry LB. The citalopram CIT-MD-18 pediatric depression trial: deconstruction of medical ghostwriting, data mischaracteriszation and academic malfeasance. Int J of Risk Saf Med 2016;28(1):33-43 The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance – IOS Press
  4. Jureidini J, McHenry LB. The illusion of evidence based medicine. BMJ 2022;376:o702. doi: 10.1136/bmj.o702
  5. Thomas K, Schmidt MS. Glaxo agrees to pay $3 billion in fraud settlement. The New York Times, July 2, 2012 GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement – The New York Times
  6. Office of Public Affairs. Department of Justice. Drug Maker Forest Pleads Guilty; to Pay More than $313 Million to Resolve Criminal Charges and False Claims Act Allegations. September 15, 2010. Drug Maker Forest Pleads Guilty; To Pay More Than $313 Million to Resolve Criminal Charges and False Claims Act Allegations | OPA | Department of Justice
  7. Office of Public Affairs. Department of Justice. Forest Pharmaceuticals Sentenced to Pay $164 Million for Criminal Violations. March 2, 2011. Forest Pharmaceuticals Sentenced to Pay $164 Million for Criminal Violations | OPA | Department of Justice
  8. The House of God at 40: The Characters Speak. Published online July 10. 2019 video 51 min JAMA 2019;322(6):486-487 doi:10.1001/jama.2019.9499 The House of God at 40: The Characters Speak | Humanities | JN Learning | AMA Ed Hub

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May 1, 2023 · Filed under Newsletters

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