Welcome to the September 2025 chapter newsletter. 

CHAPTER NEWS

• Professional Development Webinar

• Secretary Vacancy

• Call for Interviews!

• Join our AMWA North Central LinkedIn Community

FEATURE ARTICLES

• Book Club Notes: Bottle of Lies

• Member Moment: Adam Fix

JOB BOARD

• Announcements

CHAPTER NEWS

Professional Development Webinar

We're looking forward to seeing you at the upcoming AMWA North Central Chapter's professional development webinar Plain Language Principles (With Use Cases) and AI Tools (With Cautions) on October 28th. The webinar is hosted by Ellen Kuwana, MS. 

Ellen is a trained neuroscientist and award-winning science writer and editor who has more than 25 years of experience in biomedical research and science communications at large research institutions. Join us to learn how to make your writing more accessible for readers of all levels without dumbing down content and sacrificing accuracy.

Please check your inbox for event details and Google Meet link or reach out to angieherron@amwanorthcentral.org with any questions about the event.

Secretary Vacancy

The AMWA North Central Chapter is looking for a volunteer to fill the secretary position. If you would like to join us or have any questions regarding open roles, please reach out to bod@amwanorthcentral.org. 

Call for Interviews!

“Member Moment” column is looking for members to be featured in upcoming editions of the Newsletter. If you are interested in being interviewed and sharing your career journey, insights, and a few personal tidbits, please reach out to Tess van Ee (tssvanee@gmail.com) to get on the interview list. This is a great way to get to know our vibrant community and we appreciate your participation!

FEATURE ARTICLES

Book Club Notes: Bottle of Lies

By Paul W. Mamula, PhD

The rain blew through, the clouds parted, and we enjoyed an outdoor, in-person book club meeting at Como Park Pavilion on September 22, 2025. We discussed Bottle of Lies: The Inside Story of the Generic Drug Boom by Katherine Eban. The book arose from a tip about patients complaining that some drugs they took were not working. Their physicians’ responses deemed the complaints “psychosomatic,” but Joe Graedon, who authored The People’s Pharmacy1 thought otherwise and suggested Eban investigate. (Those desiring a video sample can watch Eban’s interview.2)

Tidbits About Bottle of Lies

Bottle of Lies is 410 pages divided into 7 parts (28 chapters) and an additional 53 pages of acknowledgments, glossary, notes, and index. The book jumps back and forth over 10 years, a style that can be distracting for some.  

Much of the book focuses on the generic drug industry and investigates improprieties and growth of one company, Ranbaxy, manufacturer of generic versions of Lipitor, Accutane, and AIDS drugs. It follows the company from its attempts to deceive through the eventual $500 million fine levied by the FDA. The book also provides a look into generic drug production and the slim profit margins, along with management strategies to cut expenses (to the detriment of quality control), often diluting on active ingredients, and favorably altering test results.

Central to the book is Dinesh Thakur, a chemical engineer and whistleblower. Thaur joins Ranbaxy in India after a career in the United States and is shocked at the shoddy drug production and the risk to patients worldwide, some of which caused deaths. He uncovers fabricated data, backdated quality control documents, and phantom facilities, but when he presents his findings to senior management, they order them suppressed. Thakur’s PowerPoint presentation becomes known to FDA regulators through a leak and it provokes an investigation. Mary Knatterud said, “I had no illusions before reading this book about profit-obsessed corporations, yet I was astounded by the blatant top-down corruption of generic drug manufacturers, particularly in India. I was also saddened, though not surprised, by the FDA’s woefully understaffed inspection capacity and overly politicized bureaucracy.”

Addressing the fraud and detailing the inspectors’ efforts was fascinating and terrifying. The investigative section reads much like a thriller, with FDA inspectors being manipulated and threatened by company employees. The FDA’s inspection problems arose from the dearth of investigators, logistics of overseas travel, and lack of company cooperation. The investigators prevailed with Ranbaxy eventually being fined, yet problems remain in the generic drug industry. Knatterud reiterated “shock at the outrageousness of so many details in the book, including the number of patient deaths—worldwide, including in the United States—due to fraudulently produced generic drugs, the murder of a whistleblower in India (p 140), and the apparently deliberate sickening of an FDA inspector via ‘slipped tap water into his food’ (p 362).” 

Manufacturers of Generic Drugs

Eban explains the production and regulatory processes well. She notes that about 90% of the US drug supply is generic, rather than brand name, and almost 80% of all drugs, either brand name or generic, are manufactured in China or India. Generic drugs are required to be manufactured under strict regulation, but enforcement is lax. Manufacturing plants must be inspected and certified; however, logistics of the overseas inspection demands that visits be announced beforehand, giving unethical companies the chance to cheat. The delay gives them time to fabricate documents, shred incriminating ones, alter internal laboratory data, and clean up deficient manufacturing areas. Some findings reported are frightening. Knatterud added, “Just the ick factor of contaminants in generic pills was appalling, from ‘medicine covered in mold’ (p 270) to a ‘bug stuck halfway inside the capsule, alive and wiggling’ (p 270) to ‘tiny shards of blue glass’ (p 294) to ‘black metallic particles’ (p 305).” Unannounced inspections can catch problems but doing so takes dedicated inspectors who are scarce.

Shoddy Products for Poor Countries

Eban does an excellent job of describing how the generic industry grew and legislation that stimulated it, as well as the companies’ financial pressures. One common cheat is dual track production: adjusting drug composition for given markets—products intended for the United States or Europe comply with established practices, while those destined for Africa or poorer countries get lower quality or diluted products. Others have noted this phenomenon,3,4 although the practice continues. In Bottle of Lies, when Thakur confronts his superior about this practice for AIDS drugs sold in Africa, the supervisor said, “Who cares? It’s just blacks dying.” (p 113).

Superiors also framed risk as risk to the company, not patients. Knatterud pointed out “this telling discrepancy in interpreting even what the simple noun ‘risk’ refers to:

Thakur had filled in the column [in his spreadsheet] for risk to patients with the words ‘high,’ ‘medium,’ or ‘low,’ depending on how much data, and what kind, was missing from the company’s records. But at the meeting, the company executives reviewing the spreadsheet had misunderstood the column as meaning risk to the company (p 114).

Continuing Problems 

Many major companies have no idea what takes place in their generic or brand name manufacturing. Problems in the process represent concerns for patients worldwide. Eban’s epilogue sums up the efforts up to 2019, but India and China still produce most generic products and problems remain. Eban notes that company ethics, CGMP (current good manufacturing practice), and FDA regulation are all that serve to prevent a healthcare disaster.1 Given the current decimation of regulatory agencies, patients will continue to face risk of ineffectual drugs and contaminants. 

Editorial Quibbles

The book is well written but with some problems, eg, distracting repetitive sections and repeated quotes. Because the book covered a 10-year span, some repetition might be expected, although tighter editing might have avoided this problem. 

Knatterud agreed, noting the book “well-edited, with only a couple minor slip-ups, eg, ‘memorandum’ when the plural memoranda was needed (p xvii), a missing and, and an intrusive comma (p 242).”

In sum, Bottle of Lies is a worthwhile, but disturbing, read.

References

Graedon J, Graedon T. The People’s Pharmacy. New York: St Martin’s Press, 1998 [The book has been updated and reissued many times]

Katherine Eban: National Book Festival - YouTube  Sep 26, 2020 [Accessed Sept 21, 2025]

Caudron J-M, Ford N, Henkens M, et al. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 2008;13(8):1062-72

Mason RP, Jacob RF, Gerard SA. Atorvastatin generics obtained from multiple sources worldwide contain a methylated impurity that reduces their HMG-CoA reductase inhibitory effect. Pharmacol Control Lipids Lipoproteins 2013;7(3):P287

Member Moment: Adam Fix

By Tess Van Ee  

Adam Fix currently serves as the President of our North Central Chapter. Over the summer, I sat down with him (virtually) to chat about his circuitous path into medical writing and what he finds most rewarding about being part of AMWA.

Tess: Let’s start with an easy question. What did you want to be when you grew up? 

Adam: The only realistic job I ever had any interest in was being a teacher or educator. Both of my parents did that in some capacity. Throughout grad school, while I was earning my Ph.D., my goal was to become a tenured professor at a college or university. That was the plan, but it didn’t work out for a number of very good reasons.

Tess: What was the focus of your graduate studies?

Adam: My degree was in the history of science and medicine. It wasn’t a direct route from there to AMWA.

Tess: What made you pivot to medical writing?

Adam: The pandemic struck exactly the moment that I was entering the job market, and demand was low and supply high for the type of job I wanted. So, I started looking for technical writing jobs. I freelanced on Upwork to gain non-academic writing experience. Eventually, I got slightly better gigs, filled out my resume, and after about nine months, I got a job writing marketing material for 3M. The freelancing stage was the hardest but probably the most important part of the journey—I wouldn’t have gotten my first real job without that experience.

While I was looking for work, I did a lot of networking. That’s how I met Kendra, who told me about AMWA. I also met medical writers at the 3M healthcare group (now Solventum), who connected me with freelance work. I also did the AMWA Essential Skills Certificate. The connections, experience, and education put me on the medical publications writing career path. I worked at Bio-Rad first and then moved to ThermoFisher. Mike Franklin, who volunteers for AMWA, helped me land that job.

Tess: What drew you to publications?

Adam: Publications writing really takes advantage of the academic research and project management skills I learned during my time in academia. It’s a familiar area for me. I don’t use the subject matter from my Ph.D., but I do use the writing and research skills.

Tess: What do you find rewarding about your current role? 

Adam: I get the chance to learn about a bunch of different scientific fields. I get to read about all these different study designs and approaches to studying immunology, surgery, or whatever it might be.

Tess: What have your roles been in AMWA? 

Adam: I volunteered for two years as the Publications Chair, and then I became the President-Elect before moving into the President role.

Tess: What motivates you to participate in AMWA? 

Adam: The ultimate goal is to further your career in some way. It’s hard to predict what things you do now will bear fruit later. My initial idea was to stay involved, keep interacting with people, and keep meeting people, with the hope that one of those thousand little things I did would bear some fruit. That’s what happened. It takes time, but it does eventually happen.

Tess: What things have you learned from volunteering for AMWA? 

Adam: A lot of it is gaining fluency in the micro-language of medical writing. In other words, learning what people in this profession talk about, how they interact, and how to speak that language. That basic fluency in the profession is something that comes out during interviews. It’s really important to show prospective employers that you can speak their language.

Tess: What would you tell people who are unsure about participating in AMWA? 

Adam: The number one benefit of being in AMWA is that it will further your career eventually. If you stick around and are consistently involved, there’s an increasing probability that it will pay off in a major way. There are long-term benefits that are hard to see when you first join.

JOB BOARD

Announcements

Are you looking for work? You know someone who’s hiring? Please reach out! The job board will be updated in every issue of the monthly newsletter. If you’d like to add your name to this list, please contact Dora Miedaner (dora.miedaner@gmail.com).