US Political History: More than Trump

2018 HOTCUS Winter Symposium

The State of the State: What is American Political History Now?

9.30-11.15: Session 1

New Ways of Re-envisioning African American Political History through the Archives

‘Sex, Lies and Photography: An Alternative Civil Rights Archive’, Althea Legal-Miller, Canterbury Christ Church University

‘Reframing Black Participation in Southern Courts’, Melissa Milewski, University of Sussex

‘Writing in Opposition: Congressional Correspondence of White Backlash, 1964-1968’, Neal Allen, Wichita State University

‘“The Mau Maus are Coming!” World Affairs and White Segregationist Media in the 1950s and 1960s’, Scott Weightman, University of Leicester

Conservatives and the State in Postwar America

‘Restlessness Under Reaganism: Conservative Visions of the State and the Origins of the Culture Wars’, Karen Heath, University of Oxford

‘Competing Visions: Conservatives and Reagan and Nixon’s Vision of the State’, Tom Packer, University of Durham

‘A New Policy History of the Nixon Presidency’, Mitchell Robertson, University of Oxford

‘Intervention Out of Sight: The Reagan Administration and the US Automobile Industry’, Daniel Rowe, University of Oxford

Reinterpreting International and Diplomatic History

‘Where Transnational and Diplomatic History Meet: Cultural and Scholarly Exchanges and US-China Relations Below the Nixon Summit’, Pete Millwood, University of Oxford

‘The Israeli-American Special Relationship: Beyond Political and Diplomatic History’, David Tal, University of Sussex

‘A Field That Never Was: Intelligence and the History of US Foreign Relations’, Calder Walton, Harvard University

‘Patrolling the Beat: Police Actions at Home and Abroad, 1919-1934’, Benjamin Welton, Boston University

11.15-11.30: Break

11.30-12.30: Plenary

‘“As God Rules the Universe: Reflections on the People and the State in Early America”’, Professor Ira Katznelson, Columbia University and University of Cambridge

12.30-1.30: Lunch

1.30-3.00: Session 2

Race, Representation, and the Politics of Respectability: The Problematic Memorialisation of African American Female Activists

‘The Politics of Respectability and Gender: “Passing” in Early African American Photography’, Emily Brady, University of Nottingham

‘The Radical Repercussions of Respectability: The Activism of Dr Dorothy Height’, Lauren Eglen, University of Nottingham

‘“Heroic Souls”: The Memory of Tubman, Truth and Black Female Abolitionists’, Charlotte James, University of Nottingham

Social Movements Embracing the State, or Vice Versa?

‘The Road to Self-Determination: Aboriginal Policy in the United States and Australia, 1960-1993’, Dean Kotlowski, Salisbury University

‘The Right Treatment: Alternative Medicines, Anti-Science and the Ascension of Conservatism’, Lucas Richert, University of Strathclyde

‘How to Build a Man Bomb: Matriachalism and the Men’s Rights Movement’, Keira Williams, Queen’s University Belfast

Beyond the Beltway? Executive and Legislative Politics

‘“The Last Election Means the Buck Stops Here”: Gerald Ford, the House Democrats and the Limits of Congressional Government, 1974-1977’, Patrick Andelic, Northumbria University

‘A White Backlash? Rumford, Riots and the Rise of Reagan’, Dominic Barker, University of Oxford

‘Reading Ronald Reagan in the Age of Donald Trump’, Daniel Geary, Trinity College Dublin

3.00-4.30: Session 3

States and Anti-Statism in an Era of State Building

‘Anti-Intellectualism, Anti-Statism and the Study of American Politics: Rethinking the “Demise” of American Political History’, Louisa Hotson, University of Oxford

‘“Democracy is Sweeping Over the World”: A Transnational American Twenties’ Andreas Meyris, George Washington University

‘All Policing is Political: The Municipal and National Dimensions of the Politicization of Security in New York City, 1918-1945’, Yann Philippe, Université de Reims Champagne-Ardenne

‘Rethinking the New Deal in an Age of Trump and Brexit’, Jason Scott Smith, University of New Mexico

Connecting Ideas, Culture, and Ideologies

‘Middle Class as a Historical Category of Legitimation in the American State’, Matteo Battistini, University of Bologna

‘Inverted Totalitarianism and Political Protest in the 1960s and 1970s’, Sophie Joscelyne, University of Sussex

‘Diplomats in Chief: Culture, Politics and the Presidency’, Thomas Tunstall Allcock, University of Manchester

4.30-5.00: Break

5.00-6.00: Roundtable: What is American Political History Now?

Professor Jonathan Bell, UCL Institute of the Americas

Dr Kate Dossett, University of Leeds

Professor Ken Osgood, Colorado School of Mines

6.00: Close

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As my advisor recently put it, ‘there are many more important things in the world than Trump’s rants!’

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To publish, or not to publish, that is the question!

No, not Hamlet. This is the question Joseph Stromberg asked himself while writing for Slate.

In a fabulous piece on Lambert Academic Publishing, he decided (as a laugh) to publish his Master’s dissertation.

The joy of seeing your work in print.

He wasn’t moving on in academia. He didn’t care. Rather, this was a good way to write an article about taking “a trip through the shadowy, surreal world of an academic book mill.” It’s a great piece, and well worth a read.

Now, I’ve been asked by Lambert Academic Publishing to move ahead and turn an article of mine into a full-on book.

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Last month I published a short piece in the Canadian Medical Association Journal on heroin and end-of-life discussions in the 1980s. I’m proud of it.

Now Lambert wants a piece of the action. The message was polite enough.

A few things struck me, though.

One, I’m not a medical doctor. But I do have a PhD. Perhaps try the proper salutation – namely, Dr Richert.

Second, they don’t want to see the ‘potential’ wasted. Not sure what that means? It sounds nice, I must admit. Lambert’s looking out for me.

Third, I’m advised to ‘take a moment’ to consider before I blindly say no. My half-thought-out retort to this: sometimes even a blind man can see. So there.

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I’m not even close to the first (or 10th or 100,000th) person to raise the issue of predatory publishing and book mills.

But now I’ve got my own story, apart from the mountain of spam emails I get every week.

For more in-depth info, here’s a short excerpt from the Stromberg piece I mentioned above:

‘…I did a bit more research into LAP Lambert and found that it’s really just the tip of the book-mill iceberg. Both it and AV Akademikerverlag GmbH & Co. KG are part of an enormous German publishing group called VDM that publishes 78 imprints and 27 subsidiary houses in English, French, Spanish, German, Italian, and Russian, and plans to soon open up shop in Turkey and China. It has satellite offices in Latvia and Uruguay, but the majority of its English- and French-speaking staff are based in the tax haven of Mauritius, off the coast of Madagascar. Founded in Düsseldorf, Germany, in 2002 by a man named Dr. Wolfgang Philipp Müller, the company is notorious for using on-demand printing technology to package all sorts of strange content in book form and selling it online. The company declines to release financial data but claims to publish 50,000 books every month, making it, by its own accounting, one of the largest book publishers in the world.

‘How can it possibly churn out this many titles? Although a huge number are academic texts, hundreds of thousands result from an even stranger process: They’re built entirely from text copied from Wikipedia articles. On VDM’s own online bookstore, Morebooks.de, the listings for books like Tidal Power, Period (number), and Swimming Pool Sanitation (published by VDM’s Alphascript and Betascript imprints) directly acknowledge this fact. Thousands are listed for sale on Amazon, all with the same cover design (albeit with different stock photos swapped in) and the same three names (Frederic P. Miller, Agnes F. Vandome, and John McBrewster) listed as the “authors.” Some go for as much as $100. Though the practice is technically legal—most Wikipedia content is published under licenses that allow it to be reproduced—critics say that it’s unethical and deceitful for the company to profit from content freely available on the Web.’

Watch out, folks!

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Yoga, 2018

According to Becky, over at The Art of Healthy Living, there are even more yoga trends than I first thought. Below she talks about what’s going to be hot in the yoga world during 2018.

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Novelty Yoga

Seriously I’m not even too sure what’s left, because it certainly feels as though everything has been given a yogic twist this year. There’s been…

Goat Yoga

You’ve heard of dog yoga (the experts like to call it ‘Doga’)…well the next level up is goat yoga (does that mean it’s called ‘Goga’?). Basically it’s a load of people doing yoga outside in the presence of some goats. Riiiiiight….and the benefit is what exactly? Well, the organisers say that the goats help create more feel good hormones, lower anxiety, provide comfort and reduce loneliness. OK so let’s get this straight, you’re doing downward dog and a goat jumps onto your back and that is….relaxing?..pleasant?..painful?…The goats are certainly having a lot of fun jumping around in a human playpark, but we’re not entirely convinced that the risk of being pooped on by a goat is all that worth it!

Beer Yoga

Really? Yes…really! Originating in Germany, the land of beer…but perhaps not yoga, the idea is that by swigging from a bottle of beer whilst practicing yoga it helps to encourage participants to relax more in an environment they feel more familiar and at home with i.e. the pub. We think this could really take off, especially in terms of getting more men out there trying yoga. What next…? Gin Yoga? Jäger Yoga? Proseccoga?

Couple Yoga

Grab your partner and get up close and personal with them whilst flowing through some yoga positions. Take a fitness friend by all means, but if you don’t know them well you’re certainly going to after one of these sessions! We think yoga is verging on the tantric anyway, so we see this getting big in 2018 among the trendy fit couple crowd. Apparently couple yoga improves levels of communication, encourages trust and is the ultimate way to add some sparkle back into a relationship.

Floating Yoga

The ultimate in core stability, float yoga is all about perfecting those tricky yoga positions whilst balancing on what is effectively a surfboard. Can be done on or off the water, depending on how good you are and whether you mind getting wet, but if you want next level yoga then this is deffo it. We think this will become a huge thing in 2018, especially as all the trendy fitsters are trying it out in LA…it’s only a matter of time!

And the list could seriously go on and on, there’s…Disco Yoga, Rooftop Yoga, Chromayoga (colour therapy yoga), Yoga on Ice (Snow-ga), HIIT Yoga, but we reckon it’s all about the animals. Hey if you can have Goat Yoga surely there’s a need for…yoga with frogs (Froga) or how about yoga with alpacas (Alpacoga), deffo gonna be a ‘thing’ 😉

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Becky also discusses other fitness trends coming your way in 2018:

Slacklining (which sounds like a chapter in the hangman’s ‘guide to successful neck-breaking’)

Boxing Mashups (like an afternoon of recycling old cardboard in the garage?)

Bounce Off (a kid’s game, right?)

Napping (uh, ok)

Water Workouts (as in swimming…)

 

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Thanks for reading. For more of my own writing on yoga, see here

https://lucasrichert.com/2016/10/18/yoga-boys-boys-of-yoga/

https://lucasrichert.com/2017/06/12/yoga-trends-2017/

https://lucasrichert.com/2017/06/13/two-more-yoga-trends-2017/

Hench

By Morgan Scott

Guest Post

(HENCH: strong and fit with very well-developed muscles; used about men)

1. Schwarzenegger: the Trendsetting Terminator

I have to admit it, growing up in the 1980s, myself and many males (and females) were in awe of bodybuilding action hero, the Austrian Oak, The Terminator himself, Arnold Schwarzenegger.

Schwarzenegger was of course not the first bodybuilder, but he was the first to bring this bizarre body-expanding behaviour into the limelight, beginning with the release of acclaimed documentary, Pumping Iron.

Schwarzenegger was and is a fascinating man. He left Austria to live the American Dream over in the US. What he didn’t know was that he would become the epitome of the American Dream. He nailed it. His vehicle? Bodybuilding. Schwarzenegger was already a local European bodybuilding champ but he knew America was the place to be to achieve his ultimate dream, to conquer bodybuilding and then conquer the movie business.

After winning Mr. Olympia 6 times he was going to hang up his posing trunks until he was convinced by the producers of Pumping Iron to carry on for one more season. They wanted to follow his quest for a  7th Mr Olympia title, which he ultimately achieved.

Years later in an interview, he confessed that he started to see the ridiculousness of it all, posing in little trunks.

From building up his body, Schwarzenegger went into acting. His breakthrough movie role came as Conan the Barbarian in 1982. The director John Milius actually told Schwarzenegger that he was too jacked for the part and that he actually had to lose muscle weight. This was the opposite of what bodybuilding was all about. However, a large part of bodybuilding is bulking and shredding where you would bulk up in off competition season and shred body fat leading up to one. Schwarzenegger had it covered and got it sorted ready for Conan.

Schwarzenegger had some challenges in his way; his English was terrible and he had a strange accent, plus Hollywood actors were just not huge behemoths back then. He also had a weird unpronounceable name and no acting experience. Well, the rest is movie history.

However, he was unique and he spurred an epidemic of muscle growth. In the wake of the Schwarzenegger phenomenon, gym memberships soared and muscles across the globe groaned and swelled in search for the ‘Pump’ and a body that would have Michelangelo’s David second-guessing himself.

Why do people build bodies in the first place? Why do they emulate Schwarzenegger? Success and motivational coach Tony Robbins tells us that one of the six human needs as to why any of us do what we do is Significance. We want to be seen, we want to ‘be’ somebody and what better way to be noticed, by having to walk into a room sideways. But do we need huge muscles to be significant in the world? At what point does growing your biceps become pathological?

Don’t get me wrong, having an awesome torso is a great thing to have. You look great, you feel great, clothes fit you well and you don’t have to worry about whether your beer belly looks big in this. What I’m wondering about is that line which separates ‘normal’ behaviour and when you enter into an obsessive world where size and body fat percentages becomes body dysmorphia – when the obsession overtakes the rational and becomes a problem, trumping the significance you seek.

2.Experiences

During my time lifting weights in gyms I got speaking to ‘the lads’ squeezing the iron now and again. I was curious as to why they were building such massive bodies. These were not the guys who were training for a particular sport or who were fitness trainers nor movie stars. These guys built for personal goals.

When asking them why they did it, I would usually get one of two answers, one being “Woman” (or men) or as one charming young man put it bluntly “Pussy!” So sex is high on the agenda. The second answer was “Because I was bullied at school.” Both answers certainly lent themselves to the motivation of feeling significant.

Social media, particularly Instagram, has become a cultural mirror feeding a worrying narcissistic trend to achieving the perfect body. Before, we only had floor-to-ceiling mirrors in gyms to flex and pose, to see our progress and satisfy our ego. Now we have a platform to tell the whole world about our triceps with a selfie. Just another way to feel significant, especially if hundreds, if not thousands of followers can double tap on your virtual torso to give you a heart. #mustbewinninginlifenow?

OK, sure, it’s not all about feeding ones ego; it’s also about mastering oneself and feeling good. The body may be the easiest bit of us to master, because even if your soul and spirit are in shatters, at least we might protect them in slabs of muscle.

Lifting weights also feels good. When bench pressing 100 kg you’re certainly in the present and not thinking about that work report. It’s the rush, the pump and even the delayed onset of muscle soreness (DOMS) a couple of days after is a great feeling, we’ve triumphed, we’ve mastered our body.

I do worry that most young men are growing up being seduced by what the media and advertisers portray as the perfect body. Often the ideal is an unrealistic one at that, where anything less suggests unworthiness.

3.Final Thoughts

I remember talking to an old mate, who was into bodybuilding at the time, and he said “I just want to get Huge. I want to be a monster!” He was in his late thirties when it’s much harder to achieve ‘huge’ and he seemed to be a lost boy trapped, seeking a measure of significance.

I asked “But why do you want to be huge?” The chances of becoming a world champion bodybuilder were slim to zero and becoming the next Schwarzenegger, even slimmer. He just stared into space searching for an answer.

Let’s not forget that the idea of the perfect body is driven by profiteers preying on our fragile persona and a need for significance in the world. Just buy this widget and you too can have a body like this. Young men are even turning to steroids to reach perfection sooner, but at what cost?

Can we get more sex without spending hours in the gym? Can we heal our broken selves without having to get Hench? Can we still get in shape and look great without XXL shirts? Sure we can. If it’s significance we seek, can we achieve it in other ways and channel that energy into making a difference in the world?

Damn right you can.

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I’m delighted that professional photographer Morgan Scott shares his images and ideas. His exciting portfolio can be found here: https://www.instagram.com/morganscottuk/

Instagram: MorganScottUK

Twitter: MorganScottUK

Watch out for more posts from Morgan in the future.

Agents of Pacification, Agents of Change: Radical Psychiatry in 1969

Check out my new piece with Hidden Persuaders. Check it out and get transported back to Miami, 1969!

Two More Yoga Trends, 2017.

Apparently, I missed some yoga trends in my most recent post. There are others.

For example: beer yoga.

Beer Yoga is yoga…with, yes, beer. German yogis BierYoga are reportedly the major first innovators, offering classes and workshops after seeing it being taught at the Burning Man festival. Since January, the idea’s spread internationally. Here are two recent articles on beer yoga.

http://www.bbc.co.uk/news/av/world-asia-39711513/have-you-got-the-bottle-for-beer-yoga

http://www.gq.com/story/beer-yoga-is-a-thing

Then there’s Kilted Yoga, which is pretty self-explanatory.

http://www.bbc.co.uk/news/uk-scotland-39076023 

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Thanks to Maaike de Vries for pointing these out.

Yoga Trends, 2017: Present and Future

Health and fitness trends evolve. Technology and imperatives in business force change. Consumers in health want fresh ideas and products. From Tae Boe to Thighmasters. From Bowflex to Bodyblade and belt massagers. Yoga is no different.

Yoga is becoming increasingly popular in the United States. About 37 million Americans practiced yoga at the beginning of 2016 and more than 80 million Americans were likely to try yoga at some point in the year, according to a study in Yoga Journal.

With all these potential pupils, teachers innovate. They employ new techniques and tricks. They use props and blend practices. Here are some examples in 2017.

  1. Yoga Retreat/Vacation
  2. Mobile Yoga (as in phones and apps)
  3. Live Music Yoga
  4. Yoga Therapy
  5. Acrobatic Yoga

Say what you will about these types of yoga, they’re coming your way. (That is, if they haven’t already!)

Yoga Retreats & Vacations

From the Guardian newspaper. “You can’t move for downward dog opportunities these days. The explosion of yoga in western countries means there’s a studio on every other street and such a variety of styles and options, that choosing a holiday or retreat can be overwhelming. So where to start? It makes sense to try a weekend away before committing to a whole week. One possibility is to choose a teacher you know or like the sound of and see if they’re running anything that suits. Or you could pick a venue you fancy and see what teachers are hosting holidays there. Think about what you want too – some combine yoga with other activities (maybe good for those with non-yogi partners), some are vegan, some don’t ban booze – it’s always worth asking before you book.”

Mobile Yoga

Here, mobile yoga studio have modified so that the “studio” travels to where the people may be…at work, shopping, at play, in the community. Yoga apps brings teachers right to your home!

From the New York Times: “Soul Stretch Mobile Yoga is a novel concept to the Cleveland area,” explains Rose Sabin, co-owner of the company with her daughter-in-law, Natalie Sabin. The mobile studio concept has worked well in other cities, “like Los Angeles, New York, Chicago” according to Sabin, “but this is Cleveland’s first mobile yoga studio.” Sabin’s goal for the company is two-fold: first, to bring yoga to the people by making it accessible and secondly, to help promote local businesses by bringing the unique offering of yoga class to a community business. As an advertising agency owner, Sabin understands all aspects of running a small business like certifications, insurance and marketing. She would like to help other business owners by allowing them to offer her company’s services and “expose more people to the beautiful, healing therapy of yoga.”

Recommended apps, courtesy of Healthline:

  • Yoga.com Studio
  • Pocket Yoga
  • Global Yoga Academy
  • Yoga Studio
  • Daily Yoga
  • Fitstar Yoga
  • 5 Minute Yoga

Live Music Yoga

Pretty straightforward. Here’s an example.

Yoga Therapy

Yoga Therapy, according to the British Council for Yoga Therapy, is the use of Yoga where there is a specific health need or needs. It is framed this way:

“Yoga Therapy uses the tools that you would find in many Yoga classes; postures, working with the breath, meditation, awareness of the body and/or mind, relaxation, and these are directed to the needs and ability of the person concerned. The aim is to promote good health for the person as a whole – the emphasis of this work may be towards the body, the mind, the emotions or a combination of these. A health problem may be primarily in one of these aspects, for example, back pain caused by poor posture. Yoga Therapy would then focus on working with the body and Yoga postures. If the back pain is exacerbated by stress, then including Yoga to help calm the mind, for example breathing techniques, will be very useful too. Our health is a dynamic combination of body and mind. Long term physical conditions are commmonly associated with depression and a variety of feelings – sadness, loss, frustration, anger. Our emotional health affects our physical health too, although this is difficult to quantify. Yoga can bring us awareness of the body and mind; and more understanding of how to help the body, emotions or patterns of thinking and provides a practical approach to developing a positive state of health.”

For Georg Feuerstein in the Huffington Post, “Yoga therapy is of modern coinage and represents a first effort to integrate traditional yogic concepts and techniques with Western medical and psychological knowledge.”

Acrobatic Yoga

According to the official website of AcroYoga, “it is a beautiful blend of ‘the wisdom of yoga, the dynamic power of acrobatics and the loving kindness of Thai massage’.” It was founded by Jenny Sauer-Klein and Jason Nemer in 2003. The 3 main aspects of this form of yoga are trust, playfulness and a sense of community. Acro Yoga constitutes 3 elements: the Solar Acrobatic Practice, the Lunar Healing Arts, and the Yogic Practices.

There are several benefits as described on Stylecraze.com, including:

  • It develops amazing core strength.
  • Acro yoga has all the benefits of yoga and the healing properties of Thai massage.
  • It is improves balance, flexibility and coordination of the body.
  • It gives better control over one’s body.
  • It builds relationships and strengthens them. Acro yoga is based on trust and dependability of two people on each other. It helps in building strong partnerships.
  • It is a great way to workout with your spouse. It is a super romantic form of exercise. It brings people together.

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What does 2018 hold?

The editor of Yoga Journal, Carin Gorrell, has some thoughts:

That makes a lot of sense. Have you seen a change in which styles of yoga have been more popular over the years? I can’t necessarily track it through the decades, but I would say that vinyasa is more of a recent trend. Historically I think it was more Iyengar, more of that traditional track. What I’m seeing rising in popularity now is definitely the more restorative classes, like Yin. Part of that is because people are recognizing the greater benefits. There’s been a lot of research on what restorative can do for you beyond just stress relief. I’m also seeing a rise in the popularity of Kundalini...I think it’s really interesting and not necessarily what I would have anticipated.

Maybe a reaction to the it’s-all-about-sweat set. How do you feel about the crazy amount of commercialization around yoga in the past few years? Is it good or bad for yoga? Honestly, we get overwhelmed by the number of new products out there, and it’s hard to determine what’s good and what’s worth your dollars. And what’s so awesome about yoga is you really don’t need much to do it. It’s “have mat, will practice” pretty much. All the other stuff can be great and fun but is maybe not necessary. We hear all different opinions—some people really want to know what the best new yoga pant is and then some don’t, they just want to stick to the practice and be more traditional about it. I think it probably does get more people on the mat, though, and that’s a good thing.

Born to Run: For Mindfulness and More

Have a Fitbit? Do you pound the pavement? Hit the road? Do you do it for body? Or mind? Likely both!

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In January 2017, psychotherapist William Pullen published a new book, Run For Your Life. It’s an interesting read.

Here’s a description of the work:

“Anyone who has ever gone for a run, jog or even a walk knows that uplifting, happy feeling they get at the end of their journey. Some call it the ‘runner’s high’, others put it down to endorphins, here William Pullen teaches us focus that incredible energy to experience our emotions in motion.

“In Run for Your Life, Pullen argues that we need a radical new approach to mindfulness – an approach which originates in the body itself. DRT offers just that.

“Whether the you are looking for strategies to cope with anxiety, anger, change, or decision-making, Run for Your Life offers carefully-tailored thought exercises (and talking therapies for pairs or groups) inspired by mindfulness and Cognitive Behavioural Therapy, specifically designed to be implemented whilst on a run or walk. The book is designed to offer space for you to reflect on your practice and see your progress as you run through life’s ups and downs.”

Intriguing.

Pullen, a London-based psychotherapist, came up with Dynamic Running Therapy (DRT) and there’s an app to go along with the book.

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It immediately made me think of the first (silly) article I wrote as a PhD student in London.

(Man, it’s funny to recognize that eleven years have elapsed since the publication of the article above!)

The idea then was that running might alleviate some of the PhD blues. But Pullen has taken it to a whole new (and more) comprehensive level. His book is definitely worth a read.

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http://www.youtube.com/watch?v=nCBASt507WA

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FOR MORE ON FITNESS AND HEALTH

Donald Trump’s FDA and the ‘United States of Oxy’

How will the pharmaceutical industry be impacted under the Trump administration? Who’s the new FDA Commissioner? How will e-cigarettes be effected? How will the opioid crisis be impacted?

Trump’s FDA and “the United States of Oxy”

By Lucas Richert

The US Food and Drug Administration (FDA) may be headed for a major overhaul under the Trump presidency and the agency’s new head, Scott Gottlieb. At a recent meeting with pharmaceutical industry leaders, President Trump asserted that “we’re going to be cutting regulations at a level that nobody’s ever seen before.” His most recent statements, made at a White House confab, echoed loudly throughout the medical and pharmaceutical industries.

Just talk? It’s tough to say, yet supporters of pharmaceutical deregulation have long wanted to reduce bureaucracy and lessen oversight of drugs and devices. Critics, by contrast, contend the drugs market could be destabilized and public health undermined. The tricky task will be to strike the proper balance of speed and safety, as well product innovation and consumer protections.

An American drugstore, circa 1963. Courtesy of Library of Congress.

Scott Gottlieb, a physician and regulator recently approved to lead the agency by the US Senate in a 57-42 vote, pledged he would lower prices, reduce approval times, and fight the widespread abuse of opioid painkillers. This kind of addiction, said Gottlieb, was “a public health crisis of staggering human and economic proportion.”

This rhetoric and attempted reforms at FDA are not new, but the devastating painkiller crisis certainly is.

Opioids

Gottlieb’s critics noted that he was too closely tied with the pharmaceutical industry to tackle the opioid epidemic. “We are suffering this public health epidemic because big pharma pushed pills they knew were dangerous and addictive, the FDA approved them, Senator Ed Markey (D-Mass) told reporters. The United States had been turned into the “United States of Oxy,” Markey added.

The FDA approved OxyContin, a powerful opioid to treat severe pain, such as in the case of patients with terminal cancer. With mild pain, though, the FDA deemed the dangers of addiction too great, and has not allowed the marketing of Oxy for such pain.

Not able to solve the opioid alone, the FDA nonetheless will play an important role. He has made this case quite forcefully. However, Gottlieb’s critics (mainly Democrats) have pointed to his past views on the regulation of opioids. In particular, he has suggested that policies restricting pharmacies and drug distributors might burden innocent patients.

This will be one of the defining issues of his career.

E-cigs

The Food and Drug Administration’s move in May, 2016 to crack down on e-cigarettes brought regulation in line with existing rules for cigarettes, smokeless tobacco and roll-your-own tobacco. This had been highly anticipated after the FDA issued a proposed rule over two years ago.

“Millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical,” U.S. Secretary of Health and Human Services Sylvia Burwell stated during the announcement of the new rules. She asserted, too, that health officials still didn’t have the scientific evidence showing e-cigarettes can help smokers quit, as the industry asserts, and avoid the known ills of tobacco.

The Trump administration recently approved a delay in the FDA’s e-cigs guidelines. It was a decision that divided officials in the public health establishment. And it’s undoubtedly true that several Trump administration officials, including FDA chief Gottlieb, have connections to the e-cig and tobacco industry.

From March 2015 to May 2016, according to Bloomberg, Gottlieb was a director of Kure Corp., a Charlotte, North Carolina-based firm that distributes e-juices and vaping pens in coffeehouse-style lounges known as vaporiums. Of course, he had a financial interest in the company as of March, according to financial and ethics disclosures, and promised to sell his stake if confirmed as head of the FDA.

“How to regulate e-cigarettes is one of the most critical questions on tobacco regulation that the FDA is going to be facing in the coming years,’’ said Vince Willmore, a spokesman for Washington-based Campaign for Tobacco-Free Kids.

Vaping will also be a significant issue for Gottlieb and the FDA. Getting the regulation right matters – not just in the U.S., but places like Glasgow and Vancouver.

FOR MORE ON E-CIGARETTES:

Why aren’t we regulating e-cigarettes?

Do We Regulate E-Cigs, Ban Them, or What?

Red Tape

The writer Matthew Herper suggested recently how “talk of speeding up [drug] approvals for serious diseases first gained traction in the early 2000s.” Actually, the trend extends much further back. Debate about quickening drug approvals has a complex and compelling history.

The FDA under President Ronald Reagan, for instance, offers a useful tool to evaluate the Trump administration’s approach to the FDA and the drug industry.

In mid-January, as Mr. Trump awaited his inauguration and the transition team worked furiously to establish his cabinet and select suitable agency nominees, the FDA generated serious debate. Trump met with Jim O’Neill, a venture capitalist, and a close friend of PayPal’s Peter Thiel. He met with Balaji Srinivasan, a cofounder of genetics testing firm Counsyl.

Both men subscribed to the idea – now conservative doctrine, according to Forbes – that the FDA prevented a flood of new drugs from hitting the market. Neither held an M.D., which has been for years a prerequisite for the FDA’s top job. Yet, by 20 January the frontrunner for the Commissioner’s job was Gottlieb, who had made it known publicly he believed the FDA should trim bureaucratic red tape and approve drugs in a speedier fashion.

Trump ultimately settled on Gottlieb, whose selection was welcomed by the pharmaceuticals sector. His ties to industry were questioned by Democrats, but the vote wasn’t close.

The Gipper’s FDA

Ronald Reagan, whether as a candidate or later President of the United States, did not desire the dismantling of the FDA, but neither did he trust it. In his optimistic view, its authority, like that of many other regulatory agencies, simply needed curtailing.

In 1975, he told an audience at the American Enterprise Institute, a conservative think tank, that the FDA was hurting Americans, yet also made clear he did not wish to totally “eliminate the responsibility of the FDA…”

The problem, as Reagan saw it, rested in the restriction of freedom of choice for American consumers, since the agency had established itself “as the doctor and decided that they will tell us what medicines are effective.”  He felt that a degree of regulation was necessary to protect Americans from each other, but the FDA had overreached and, as bureaucracies do, went beyond “protecting us from poisonous or harmful substances…”

In 1980, the Republican presidential ticket of Ronald Reagan and George Bush promised to change Washington. President Jimmy Carter represented failure, Republicans argued, be it botched rescue attempts and helicopter crashes in the desert, the loss of the Panama Canal, or an impotent economy. The jaunty and upbeat Reagan succeeded in shifting the policy discourse about the size and scope of federal government programs; harkening back to halcyon days, he moved the conversation about which government program to launch (or expand) to how much of a program’s or agency’s budget ought to be cut.

In 1981, the debate about drug regulation continued to polarize people; finding a middle ground was often difficult, and as the new administration took power, the outgoing FDA Commissioner Goyan articulated a consensus-oriented, centrist approach to drug regulation. Think tanks such as the Heritage Foundation and American Enterprise Institute promulgated changes to the FDA’s mission as a means of unleashing the once-mighty American pharmaceutical industry. This would fuel the U.S. industry and the greater economy.

For some, the FDA transcended presidential politics and ideology.  It protected all Americans – conservative and liberal – as it carried out its duties. “My view,” said the bearded, grey, and somewhat feisty Jere Goyan, “is that government regulation needs to strike a balance between preserving the maximum freedom for individuals while at the same time establishing the rules that are needed for us to live together, to survive as a society.”

Jere Goyan and President Jimmy Carter. Courtesy of Library of Congress.

By voting for Reagan, Americans indicated they wanted “modifications” to the current models – reform rather than removal. “It would be a mistake,” Goyan argued, “a tragic one, to interpret the election results to mean that the public wants a lessening of the standards that provide the foundation for the food and drug industries in this country, standards that make our food and drug supply the best in the world.”

Often, his approach went unheeded, overwhelmed by disputes about individualism and consumer choice and bureaucratic incompetence. One the one hand, many Americans regarded FDA staff members “as a bunch of demented bureaucrats running amok,” even though the agency’s “balanced” regulation of drugs was both “socially valid and moral.”

On the other hand, the president of the Pharmaceutical Manufacturers Association illustrated an alternative. Lewis Engman felt that taking medicines, like smoking cigarettes, was a matter of personal choice. “Any time you interfere with the basic market system,” he said in 1981, “you’re in trouble…the consumer is his own best guardian.”

Impossible as it was to know how the new president would transform the FDA in early 1981, political pundits, economic analysts and pharmaceutical industry insiders suggested that Reagan meant less regulation, which meant industry growth. The President of the National Association of Retail Druggists (NARD), Jesse M. Pike, sent a congratulatory letter to Reagan. It emphasized how delighted NARD was to see him in the White House and just how his regulatory reform beliefs would be good for business. In Pharmaceutical TechnologyJames Dickinson wrote, “everyone expects life to be easier for industry under the new Reagan Administration.”

Apparently, the Washington cocktail circuit was rife with speculation about the new administration repealing the Kefauver-Harris 1962 drug efficacy requirements – a move that would further enhance prospects for industry growth. This was nonsense, according to knowledgeable policymakers and reporters. Still, the fact that the notion was even bandied about, however fancifully, represented a substantial change in the debate about drug regulation.

Reagan promoting Chesterfield, circa 1952

The press envisaged a pharmaceutical industry boom in the near future. Newspapers reported how “The Drug Business Sees a Golden Era Ahead” and that pharmaceutical associations were positively giddy. Rep. James Scheuer (D-NY) publicly denounced the agency’s over-cautiousness and emphasized the need for immediate reform. It was risk averse, to the detriment of sick Americans. Moxalactum, he argued, was an American-made antibiotic for pneumonia used by Marshal Tito in Yugoslavia – yet it was not available in the United States. The narrative Scheuer framed was that the FDA was protecting Americans to death – and this before the onset of the HIV/AIDS crisis.

Mounting enthusiasm about pharmaceutical growth in the wake of the Reagan election was palpable. Reports indicated that the pharmaceutical industry and investors were confident about the future – a golden era – in this new regulatory climate. There was bullishness about drug stocks in general, and many predictions that pharmaceutical companies would start to generate more and more earning in 1981 and 1982. Overall, these stories proved to be accurate.

Ronald Reagan, however, had pledged in 1980, with trademark sincerity, not to gut the FDA. Rather, he made oblique references to the agency’s storied history and resorted to prosaic comments about the danger of hidebound power-hungry bureaucracies. “There’s a certain amount of regulation that is always necessary to protect us from each other,” he told CBS’s Walter Cronkite. “And that I recognize. We don’t want to, for example, eliminate the responsibility of the FDA…”

Much can be gleaned from Reagan’s public statements about the Food and Drug Administration, but they fail to reveal the entire picture. On May 20, 1986, Reagan described a meeting between Paul Laxalt, Jack Dreyfus, and himself. Dreyfus, who had “spent $50 mil. of his own money” was attempting to have the epilepsy drug Dilantin approved and found a roadblock in the form of the FDA. According to Reagan’s personal diary: “The villain in the case is the Fed. Drug Admin & they are a villain.”

 Red Herrings and Empowered Patients

Under the Trump administration, will the FDA play the villain role? President Trump will build on earlier Republican efforts to streamline the agency, whether these took place during Reagan or Bush presidencies. He has promised to remove barriers for overseas drugs and support ‘Right to Try’ laws, which will attempt to provide access to unapproved drugs. Indeed, some of these measures may help patients. And the Trump administration will be the right track if it can safely accelerate drug approvals, promote production and use of generics, and lower drug prices through increased competition.

Gottlieb and others have suggested they would radically restructure the drug approval process –  even if that remains something of a red herring argument. QuintilesIMS Institute, among various other organizations, have determined that the total time between patent and approval has dropped 31% since 2008. Yale researchers hold that the FDA is already considerably faster than Europe and Canada when it comes to approving drugs.

Another area of regulation that ought to be monitored closely is advertising. Every other nation besides the US and New Zealand has concluded that advertising powerful drugs for treating complex illnesses makes no sense when your target market lacks the qualifications to fully grasp the risks. How will powerful painkillers be regulated in the years ahead.

The drug industry wants to empower patients, to invest them in the writing of prescriptions. Looking ahead, it will be important to watch the administration’s and FDA’s role in faciliating this.

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“The [industry] idea is that consumers are central players in their health management and therefore have a right to be informed of different drugs,” Lewis Grossman, a specialist in food and drug law, told the Los Angeles Times.

Yet, the practice of medicine should not be placed in the hands of amateurs and junk scientists. In the post-truth era, however, when an opioid epidemic soars and drug prices are hitting Americans in the pocketbooks, these “facts” could be lost in the noise.

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Lucas Richert is a Lecturer in History at the University of Strathclyde (Glasgow, UK). He is the author of Conservatism, Consumer Choice, and the Food and Drug Administration during the Reagan Era. He’s currently at work on a second book, tentatively called Strange Medicines: Drugs, Science, and Big Pharma in Culture.