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Advice and Resources for the Biotech Industry

Advice and Resources for the Biotech Industry

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Summer Reading List 2018

It’s time once again for my annual roundup of some of the best books I read this year. As usual, my focus is on non-fiction tales from the world of science, medicine, and technology. A master list of all books that I recommend can be found here, and you can also check out my previous book recommendations from 2017, 2016, and 2015.

Given how much news coverage North Korea has generated this year, let’s start out with a humor book about North Korea. A funny book about North Korea? Really? Yes, and it provides a number of insights into a country that many feel is a clear and present danger to the U.S. Still interested? Get your hands on a copy of
My Holiday in North Korea: The Funniest/Worst Place on Earth by Wendy Simmons (2016). Ms. Simmons is an inveterate traveler, and decides to take a vacation (if it can be called that) in an amusing hellhole that she refers to as NoKo. Under the constant visage of her two state-provided companions, Older Handler and Fresh Handler, Simmons sets about seeing the sights of Pyongyang and beyond. Every hour of every day of her trip is programmed, with little ability to make any substitutions. Nearly every place she visits in the showcase city of North Korea seems to suffer from the same problems: no electricity (or lights not turned on, or missing), no running water, and no toilet paper. She is treated with suspicion and, being an “American imperialist”, made to feel that she is constantly under a microscope. She worries that she will do something wrong that will result in her imprisonment or expulsion. She visits schools, factories, hospitals, as well as numerous sites dedicated to the memories of both Dear Leader and Great Leader (though dead, they are still said to lend a guiding hand to the country). Her descriptions of the awful food, dated facilities, empty hospitals, and massive construction projects (being done without benefit of any power tools) are hysterical. Interactions with virtually everyone that she meets are tightly regulated, and the suffocating environment gradually wears her down. The book is lavishly filled with her photos (permission, of course, was needed to take nearly each and every one of them). It’s great that she has shared her cultural journey with us, because the Hermit Kingdom is a place that most of us will never want to go to (and a recent change in current policy forbids Americans from visiting).

Rigor Mortis: How Sloppy Science Creates Worthless Cures, Crushes Hope, and Wastes Billions by NPR reporter Richard Harris (2017) is a detailed examination of the problem of data irreproducibility in both basic biology as well as clinical medicine. The book touches on numerous studies that revealed the problem, which has been around for a long time but appears to be getting much worse as pressure builds on academic scientists and doctors to make that great discovery that will advance their careers. Some of the problems discussed include relying on bad statistics, contaminated and misidentified cell lines, unrecognized genetic differences between strains of mice, and low quality reagents that don’t do what they’re supposed to do. Classes in avoiding data irreproducibility are seldom offered to graduate students, which is one of the reasons that the problem persists at so many research institutions. Solutions proposed by a number of different well respected scientists are covered, but the author points out that little progress has been made in adopting these steps. That’s because at least some of the fundamental causes of the problem are inherent to the culture in our society, and getting that to change is (not surprisingly) incredibly difficult. The book should be required reading for those in the biological sciences and medicine. It would help researchers recognize the inherent biases that are endemic in academia, and learn from the mistakes of their peers.

Overdiagnosed: Making People Sick in the Pursuit of Health by H. Gilbert Welch, Lisa Schwartz, and Steve Woloshin (2012) was one of those rare books that really changed my way of thinking. The author’s premise, which is clearly explained with numerous examples backing up his thinking, is pretty straightforward. To quote him, “I believe overdiagnosis is the biggest problem caused by modern medicine.” Like a lot of people, I thought that looking for problems in people who are asymptomatic could be useful in helping to find illnesses that had not yet manifested themselves. Welch makes a strong case for just the opposite: following this path actually winds up harming patients by putting them through follow-up tests that can result both in physical injury and psychological damage (from fear and worry). With many diagnostic tests or protocols one must screen hundreds, if not thousands, of people just to find one individual who has that problem. He also explains how the medical criteria used to diagnose a person as “sick” and in need of treatment have been greatly expanded over time. What used to be considered normal blood pressure is now regarded as high, and the same is true for cholesterol levels. The closer a test result is to the demarcation line between normal and “sick”, the less likely it is that a person will be helped by treating that particular condition. Subjects covered in the book include mammograms, PSA tests, osteoporosis, abdominal aortic aneurysms, damaged knee cartilage, and cancer. Highly recommended.

In a very similar vein, and also well written, is
Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer by Shannon Brownlee (2008). This book essentially follows the same path and comes to similar conclusions as Overdiagnosed, but focuses a bit more on the next step. Once you’ve been overdiagnosed, and that information is acted on, then you become overtreated. Reading these two books back to back would cement the ideas deep in your mind. The two books cover much of the same territory, but this book spends a bit more time on economic factors facing medicine these days, and why that has led to patients being overtreated. For example, it looks at the peculiar economics of medicine, where supply often drives demand, and not vice versa. If a hospital invests in new, high tech equipment (proton beam irradiators, surgical robots, more ICU beds), you better believe that will get booked up quickly as the availability will drive doctors to use them. If you’ve wanted to know exactly why hospitals can be the worse place for sick patients to be, this book will answer your question.

Much of this same information is presented on a follow up book by Dr. Welch entitled
Less Medicine, More Health: 7 Assumptions That Drive Too Much Medical Care. The book is a more streamlined version of Overdiagnosed, and I believe it’s intended for a more lay audience. Clearly written, it makes the same persuasive argument as Overdiagnosed, but with many more personal stories about the author folded into the mix. A good guide for those of us who are contemplating the state of our medical care (or that of a loved one), especially if we’ve been met by frustrations about our interactions with the medical-industrial complex.

Several years ago Washington Post correspondent T.R. Reid took his bum shoulder on an international road trip to examine and compare the health care systems in a number of countries outside the U.S. (including France, England, Canada, and Japan). He reported on his findings in
The Healing of America (2010) at a time when interest in our healthcare system was already at a fever pitch with the launching of the Affordable Care Act. Reid returns to mine this same approach, only this time covering taxes, in his new book A Fine Mess: A Global Quest for a Simpler, Fairer, and More Efficient Tax System (2017). I found both of his books enlightening. The comparative approach appeals to common sense. After all, why shouldn’t we take advantage of what’s been tried in other countries to see what worked, and what didn’t? Taxing policies have evolved over time in virtually every country, and one particular policy has been adopted by nearly every developed nation in the world. That policy is abbreviated BBLR, which stands for a conceptual foundation approach of having a broad base and low tax rates. Reid explains why this approach is so often favored and does a terrific job comparing and contrasting U.S. tax policies with those in other countries. He also examines the history of taxation in America, presented in an historical context of wars and population growth. Among the policies that he effectively winds up advocating for in the U.S. is a value added tax, which are widely used across Europe. He also explains why doing away with the mortgage payment and charitable contribution deductions are actually a good idea. Overall, reading this book is a good way to learn about national and international tax policies, how they develop, and why they change over time.

Another excellent and timely read is
An American Sickness: How Healthcare Became Big Business and How You Can Take It Back by Elisabeth Rosenthal (2017). The book covers roughly the same territory as Maggie Mahar’s Money Driven Medicine (2006), but has the advantage of being written after the Affordable Care Act became law. The author delves into numerous facets of our healthcare system and finds nearly all of them guilty of price gouging American consumers. This includes doctors, hospitals, medical billers and coders, insurance companies, drug and medical device makers, and those who develop and push unnecessary diagnostic tests. The overall conclusion is the same one reached in the earlier book. The medical industrial complex (a term coined in 1980 by Dr. Arnold Relman, former editor of the NEJM) has taken over our healthcare system and it is being driven by profits, not a need to help people. Left out in this book are the pharmacy benefit managers, but you can find a nice expose about them here. The latter part of the book is comprised of suggestions for how consumers can reclaim our healthcare system, but this is by far the weakest part of the book. The suggestions are on the face of it reasonable (challenge every bill, demand explanations for every test order or procedure experienced, etc). However, this would be incredibly time consuming for most people, and will lead to more frustrations when answers to the questions are not provided. It would be difficult to do under the best of circumstances, and even harder when one is battling a serious illness. More useful are the few pages in the back of the book directing the reader to resources that they can tap into to find help for specific problems.

Check out
One in a Billion: The Story of Nic Volker and the Dawn of Genomic Medicine (2017) by Mark Johnson and Kathleen Gallagher. This is an inspiring “medical detective” tale about a little boy with an un-diagnosable illness that is slowly killing him. Doctors have ruled out a number of different diseases, but can’t figure out what he is suffering from. All treatments tested prove to be worthless. The journey has been harrowing, with much of Nic’s life spent in the hospital and with more than 100 surgeries behind him. His mother shares her diary that recounts all that her son (and her family) have endured in an effort to find an effective treatment. The situation cries out for a new approach. Fortunately, Nic’s doctors have long been hoping for a chance to cross a new frontier of molecular medicine, and their young patient leads them over this threshold. He becomes the first person to have his genome (or more accurately, his exome) sequenced to try and determine exactly what might be wrong with him. The good news (spoiler alert) is that the efforts are successful. A single gene defect is identified that is likely causing Nic’s illness, and this knowledge is used to develop a clinical treatment plan that appears to have saved Nic’s life. The book illustrates the challenges in developing precision medicine treatments, covering both the promise and difficulties observed along the way. The cost of Nic’s medical care during his first 10 years exceeded $6 million, but savings would likely have been achieved had his illness been diagnosed at an earlier age. The science is not explained as well as it could have been, but this book serves as a good intro to some of the bioethical issues that have come to the forefront in the early days of the new millennium (and this was before the discovery of CRISPR-cas).

I really liked The Death of Expertise: The Campaign Against Established Knowledge, and Why It Matters by Tom Nichols. This is an important, insightful, well-written, and (unfortunately) rather depressing book. The author lays out a well-constructed argument explaining why experts’ opinions are no longer valued, and how this sorry state of affairs has come about. Much of the blame falls into two areas: failure to teach people critical thinking skills, and the accessibility of information on the Internet. People can go online and find information quite readily on a variety of different subjects. For some reason, however, this little bit of info causes many folks to think they know a great deal more about a subject than they actually do. They confuse information with knowledge and understanding, thereby enabling themselves to challenge the opinions of scientists, doctors, and scholars who have spent a lifetime studying particular subjects. The experts themselves are forced to share some of the blame over this sad state of affairs. This mostly stems from an inability to communicate effectively with people who are not so well educated/informed, and a tendency to extend their “expertise” into areas outside of the core areas that they really know well. They also have a tendency (foisted on them by the media) to make predictions, not just educate the rest of us. These often wind up blowing up in their faces, causing lay people to question their wisdom and expertise. I found little in this book to argue with, but the overall tone is negative, and potential solutions that I was hoping to find at the end of the book were notably absent. Criticism is also pointed at our education system, especially universities, which he says compete on customer service, but have de-emphasized teaching students how to think. Media share the blame as well because many journalists these days are forced to write about subjects that they don’t understand and have no background in. The author is concerned that the “dissing of experts” trend described in the book puts our democracy at risk and undermines efforts to fix many of our nations most pressing problems. Sadly, most of the people who might benefit from considering the arguments in this book will never pick up a copy.

Having recently visited the Nordic countries, I loved The Nordic Theory of Everything: In Search of a Better Life by Anu Partanen (2016). This book is built around a very interesting comparison of Nordic societal values and how those compare with what we have here in the U.S. The author, a Finnish journalist, moved to the U.S. for a relationship and was shocked at how stressful life was in the U.S. compared to back home. She wonders how Americans manage to cope with challenges in getting and paying for healthcare, childcare, taxes, and education that are virtually unknown in Finland. The book is constructed around the Nordic theory of love, and how Nordic societies are all organized culturally to promote the individual growth and empowerment of their citizens. Partanen describes the rationale for how these cultural and economic norms came to be (e.g. virtually all citizens get nearly free healthcare, childcare, education, and retirement benefits). Their taxes are higher than in the U.S., but people there aren’t burdened with huge health insurance costs and other costs such as paying for childcare and college. The book would have benefited by including some charts and graphs to illustrate the various rankings of different countries, but was still very interesting. As someone who has long admired the Scandinavian countries for what they have accomplished for their citizens, it was good to see these impressions fleshed out with actual details of what’s been accomplished. The Nordic countries, as the author points out, differ from the U.S. in one important clear way: they are much more homogeneous societies than we have here. This raises one key question: could the U.S. actually put in place some of the policies practiced in the Nordic countries and get them to work in such a diverse and multicultural society? It’s an interesting idea to think about as income inequality and other economic trends continue to diminish the lives of many Americans. If you enjoy this book, you can continue on to The Year of Living Danishly: Uncovering the Secrets of the World’s Happiest Country (2016) by Helen Russell. Covers similar territory for Denmark instead of Finland. Also a fun read about a woman who moves to Denmark when her husband takes a job at Lego!

Glass House: The 1% Economy and the Shattering of the All-American Town by Brian Alexander. I have to start out by saying that this was a depressing book to read, as it meticulously recounts the decades-long decline of the town of Lancaster, Ohio. Picked as the model of an All-American town by Forbes magazine in 1947, it was a community on the rise. Good schools, nice parks, little crime. The major employer in town, the Anchor-Hocking glass factory, provided decent paying jobs with good benefits for many, no college degree required. Throughout its history, the company always made money and remained competitive, even as other glass companies moved production overseas. What eventually brought the company low was its acquisition by private equity firms, leading to a slow decline as fast-money Wall St. types gradually pocketed much of the value of the company while leaving it swimming in debt. Interwoven with the decline of the company and its factories are stories about how the opioid epidemic ruined the lives of many who either worked at the Glass House, or were the children of people who did. This switching of the narrative back and forth makes the book a bit exasperating to read, as you lose your place in the financial story as the personal tales are woven in. Still, it’s an important story that points a damning finger at some of the villains whose financial shenanigans helped transform the heart of America into the Rust Belt.

Medical care, if it could be called that, was scandalously bad in the mid-1800’s. To get a flavor of how horrendous things were in the surgical suite, read Lindsey Fitzharris’s historical treatise
The Butchering Art: Joseph Lister’s Quest to Transform the Grisly World of Victorian Medicine (2017). You were in a world of hurt if you were sick or badly injured at that time. Anesthetics like ether and chloroform were just being introduced, which allowed surgeons to focus more on technical skill than merely speed. Hospitals were incredibly dangerous place for patients, as post-surgical infections killed off a significant number of them. The concept of cleanliness and the germ theory of infectious diseases were still unknown. Surgical gowns were filthy and rarely changed, hands weren’t washed between operations, and sawdust was widely strewn about the operating rooms to absorb all the blood. Gradually, this state of affairs began to change through the efforts of British Dr. Lister, who instituted procedures (such as cleansing wounds with carbolic acid) that greatly reduced the mortality rate from surgery. His efforts to do this, not surprisingly, were met with tremendous opposition from the medical establishment. A couple of stories in the book are particularly haunting: Lister performs a radical mastectomy on his younger sister on his dining room table, and successfully treats Queen Victoria for a large abscess at Balmoral Castle. A thoroughly engaging book that makes one glad not to have been living in Victorian Times!

I’ve read a number of exposes that detail the excesses and corruption that plague many biopharma companies. Good examples of the genre include
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients by Ben Goldacre (2013), White Coat, Black Hat: Adventures on the Dark Side of Medicine by Carl Elliott (2011), and Pharmageddon by David Healy (2013). I was unaware, however, just how problematic the medical device field is until I read The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It by Jeanne Lenzer (2017). This was a frightening read for one primary reason: devices, unlike drugs, generally do NOT have to prove either safety or efficacy before they come to market. The author weaves a detailed web of information against the background story of one patient who suffered greatly as a result of a malfunctioning device that was implanted to treat his seizures. The cure was much worse than the disease and nearly killed several different times and in multiple ways. Specific stories detailed in this horror show compilation of devices gone wrong include Cyberonic’s vagus nerve stimulation (VNS) device for epilepsy, DePuy’s metal-on-metal artificial hip replacements, and Medtronic’s sponges (impregnated with bone morphogenic protein 2) in the necks of people getting spinal fusions (it’s not approved for that location). If you are having a bad reaction to a drug you can (often) simply stop taking it and recover. In the case of many medical devices, however, once they are implanted they are there permanently. It is impossible to remove them, and when they go bad there is little that can be done for a patient. The book also illuminates a less-than-stellar industry track record of sharing problems found with their devices with the FDA. The final chapter is a call to arms against this sector of the medical-industrial complex, with recommendations for whom to call if you run into problems. Highly recommended!

Finally, and it’s outside my usual science realm, is
Alt-America: The Rise of the Radical Right in the Age of Trump by David Neiwert (2017). I have to say that this was one of the most depressing books I’ve ever read, given the subject matter. It traces the growth of right wing groups in the US, primarily since the 1980’s, and then illustrates how Trump’s election has energized these groups. It also focuses on how Trump himself has become a darling of white nationalists, and how pleased these groups were with his election. Well-written and authoritatively referenced, it will likely tell you more than you ever wanted to know about how the alt-right came to be, and the strategies they use to get their hate-filled messages out. You may need to take a shower after reading it, however.

Happy reading!