Big Pharma Round-Up

A round up of the recent Big Pharma and FDA stories.

Antibiotics in Farm Animals Drop:

https://www.theatlantic.com/health/archive/2017/12/antibiotics-farm-animal/547904/

Teva Pharmaceuticals is being reshaped:

Rebooting the FDA:

https://www.politico.com/agenda/story/2017/12/13/fda-approval-alternatives-000593

On AstraZeneca:

https://www.digitallook.com/news/broker-recommendations/astrazenecas-drug-pipeline-call-reinforces-barclays-top-pick-in-sector–3031953.html

 

Top 5 Stories of 2017:

https://investingnews.com/daily/life-science-investing/pharmaceutical-investing/5-top-pharmaceutical-stories-2017/

FDA clears the Apple watch:

The FDA is going to go after price gouging:

And supplement makers:

Bipartisanship on Drug Prices:

https://www.bloomberg.com/news/articles/2017-12-14/bipartisan-approach-on-drug-prices-emerging-after-health-fights

https://www.medscape.com/viewarticle/890002

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I’ve more than likely missed some angles and stories. Drop me a line if you have suggestions.

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Here’s a flyer for 30% off my Big Pharma book!

Richert_Flyer_2017

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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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Frightening Pharma

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Blood, Sweat, and Tears

FROM THE CBC:

It was probably one of the most bizarre medical cases a team of Italian doctors had ever seen.

A 21-year-old woman was admitted to hospital with a condition that caused her to sweat blood from her face and from the palms of her hands. This despite any sign of skin lesions.

The case was highlighted Monday in the Canadian Medical Association Journal (CMAJ).

Doctors say the patient had a three-year history of bleeding. There was no obvious trigger, and the spontaneous bleeding could happen while she slept and during physical activity. More intense bleeding happened when the patient was under stress, with episodes lasting anywhere between one and five minutes.

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Canadian medical historian Jacalyn Duffin says at first she was skeptical whether people could sweat blood. She thought the Italian doctors were being duped. But after an exhaustive review of historical literature and more recent reports on cases of hematohidrosis, or sweating blood, she’s a believer.

“After all the research that I’ve done, I am convinced of the plausibility and the possibility that it exists,” she said. Duffin, who is also a hematologist, wrote a commentary that accompanies the journal article.

She acknowledges that hematohidrosis syndrome is incredibly rare. The medical history has been “muddled” with references in religious literature to the crucifixion of Christ, she says and the two are very difficult to separate.

“But case reports start appearing in the 16th century, and quite distinct from anything to do with the crucifixion, or Christianity”, she says. “There are mentions of the phenomenon as far back as Aristotle … prior to the time of Jesus,” she told CBC News from her home in Kingston, Ont.

Read the full article here.

http://www.cbc.ca/news/health/blood-cmaj-health-hematohidrosis-disease-1.4365126

Scream

Arthur Janov, the pioneer of Primal Scream therapy, recently passed away. Here are some thoughts about the context in which developed his therapy…

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Fifty years ago, in 1967, the California-based Arthur Janov was operating in a strange mental health environment.

That year Scottish therapist R.D. Laing published The Politics of Experience, which questioned orthodox therapies. Psychologist Timothy Leary’s psychedelic experiments were publicly called out in the pages The New Republic. In 1967’s The President’s Analyst, James Coburn played a psychotherapist more than willing to seduce his attractive female patients. Disenchanted, he eventually leaves Washington, D.C. to settle in a hippie commune. The National Institute of Mental Health (NIMH) was finally acting on the 1963 Community Mental Health Act. In 1966, the first Community Clinic opened. By 1967, 53 more opened across the country.

Arthur Janov, with degrees from UCLA and a PhD in Psychology from Claremont Graduate School and sporting a shock of curly hair, created Primal Therapy in 1967. Tapping into the California counterculture and appealing to celebrities with his avant-garde approach, Janov created an unconventional therapy that resonated throughout the 1970s and beyond.

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Antiestablishment undercurrents challenged the American love affair with mental health expertise at this time. Debate was rife. It took place over psychiatric nosology (a fancy way of saying the classification of mental illnesses), scientific legitimacy, and the value of evidence-based diagnosis. The debate focused on the forces of modernization, psychopharmacology, (de)institutionalization, and social psychiatry.

There was significant chatter about mind control: The Manchurian Candidate. LSD brainwashing. MK ULTRA. This latter state-sponsored and well-funded CIA project, of course, included trippy research on behavioral therapy, chemically-induced brain concussions, brain wiping, hypnosis, extrasensory perception, cutting-edge polygraph techniques, sleep research, and on and on and on.

Ex-patient groups, whose members referred to themselves as ‘survivors’ or freed ‘slaves,’ garnered more attention. All this tumult was regarded as a “child of its rebellious, anti-establishment times.” Yet intra-professional restlessness was far from new, and it carried into the 1970s.

A majority of mental health experts recognized that the system was in disarray, a jumbled mess that President Jimmy Carter had to reform. To this end, Carter, who embodied for many the limits and austerity of the era initiated a presidential commission to investigate mental health in the U.S.

The term radical fluctuates from era to era and individual to individual, but this historical moment was definitely unique. Thinking about the 1960s-1970s probably conjures up images of Bobby Seale and Huey Newton’s Black Panther Party, which was organized in October 1966 and challenged the status quo by activating and channeling African-American disenchantment – in addition to forming coalitions with domestic and foreign organizations. Yet, the 1970s also calls to mind the Weather Underground, a homegrown terrorist organization intent on fomenting revolution, and which detonated a series of bombs in 1970.

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Biopsychiatry, antipsychiatry, and a host of alternative therapies rose against this backdrop. Amid these changes, Arthur Janov pioneered and championed primal therapy with his 1970 book, The Primal Scream: The Cure for Neurosis. It was a form of therapy in which patients entered extreme emotional states to allow for the jettisoning of any deep-rooted “Primal Pain” experienced in childhood. In addition, the method was often accompanied by shouting and screaming. These “post-Primal” patients would attain a genuine normality, thereafter occupying healthy, neurosis-free bodies.

As indicated in the title of his book, he did not shy away from the curative and indeed the transformative nature of his therapy. In a series of books between 1970-1972, including The Anatomy of Mental Illness and The Primal Revolution, Janov contended that patients who concluded his therapy effectively would overcome the diseased state common to most people. He suggested, too, that his therapy offered physical cures. Repression, in Janov’s estimation, stunted physical development, and successful Primal Therapy would enable the natural growth of breasts, hair, and hands.

Janov, born and raised in California, had worked as a psychotherapist for the Los Angeles Children’s Hospital and Veterans Administration, among other places, when in 1967 he developed his theory. It was an atmosphere of questing energies and transformation in California, and one that also gave rise to Transactional Analysis and other New Age ideas.

Janov’s therapy struck a chord with the countercultural set and other Americans hungry for alternative approaches to the mainstream establishment. Finding the limelight, he went on mainstream television programs, called traditional psychiatry a hoax, and told how of how the establishment scorned him. His papers could not get published, and his colleagues walked out on his presentations. The press hated him, too, he said. Undeterred, Janov pronounced “Primal therapy is THE therapy, nothing can stop it.”

He cagily played around with themes of intergenerational antagonism, repression caused by postwar society, and the ways in which physical experiences and emotions as trumped neutral reasoning; more than that, he touted altered states of consciousness and the more specific view that personal (and perhaps national) liberation depended upon the violent overthrow of corrupt systems. These altered states, however, did not include pot, LSD, or MDMA, and had to be reached without any artificial aids. Janov fully rejected the use of illegal intoxicants, uninhibited sexual activity (“free love”), and transcendental meditation.

Seeking out altered states was not a pathway to fulfilment in his view but rather an unconscious compulsion of an unwell mind. John Lennon and Yoko Ono, who of course experimented with many substances, underwent Primal Therapy in 1970 after The Beatles disbanded —and, along with a “primal concept album” John Lennon / Plastic Ono Band (1970), helped popularize the therapy.

In assessing the mental health landscape and Primal Therapy of the 1970s, Alfred Yassky, the Executive Director of the American Psychotherapy Seminar Center, based in Manhattan, held that the tectonic plates of mental health shifted. Americans were different. The therapeutic geography had perceptibly altered. As he put it, Americans are becoming alienated and are hungering for a sense of meaning, identity, happiness, and even salvation, we are wanting more from therapies and therapists. One way of putting it is that in many ways psychotherapy has taken over the function of religion. Therefore, the therapist is supposed to take over the function and roles of shaman, guru, wiseman, minister, rabbi, or priest. We are expected to help with spiritual matters on the one hand and scientific on the other…

Primal Therapy, which shone brightly until the 1980s, helped to fill that gap.

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The mental health arena in the 1970s witnessed several new entrants, with the rise of patient groups, new therapies tailored for mass consumption, and the continuance of psychedelic psychiatry. Patient-consumers could dip toes into New Age medicine, and draw from the fountain of naturopathy and homeopathy, as well as Eastern-influenced medicine or teachings from sources like the Esalen Institute in California.

They might sample alternative mental health therapies, including Primal Scream Therapy or Transactional Analysis, or find psychic solace in the form of new religious movements. Primal Scream, in short, filled a void for many Americans. It let them shriek and wail to their heart’s content.

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For more short pieces on strange therapies and radical mental health, see below.

This piece is about radical psychiatry and pacification in the 1960s

http://www.bbk.ac.uk/hiddenpersuaders/blog/agents-of-pacification/ 

This article is about Transactional Analysis and its founding in the 1960s

https://thepsychologist.bps.org.uk/volume-30/september-2017/harnessing-fierce-energy-counterculture

Slightly different, this piece is about heroin and end-of-life discussions in the 1980s.

http://www.cmaj.ca/content/189/39/E1231.full.pdf+html

Disability and the Welfare State

Following party conferences, it seemed worthwhile to raise the issue of disability politics and the welfare state. The topic is tackled by Dr Jameel Hampton. As he describes it: “Created during and after the Second World War, the British Welfare State seemed to promise welfare for all, but, in its original form, excluded millions of disabled people.”

His recent book examines attempts “to reverse this exclusion.” Considering the recent emergence of the history of disability in Britain as a major area of research, the book can add to the conversation.

According to C Norris, in Oxford University Press’ This Year’s Work in Critical and Cultural Theory,  “Disability and the Welfare State in Britain is a remarkable achievement. Hampton’s excavation and elucidation of archival material related to the Disability Income Group, as well as other key players in the debates over disability and statutory welfare in Britain in the twentieth century, is both important and impressive.”

* Dr Jameel Hampton teaches at Liverpool Hope University (hamptoj@hope.ac.uk)

 

Heroin in the hospice: opioids and end-of-life discussions in the 1980s

Which drugs should be available for people nearing the end-of-life and suffering pain? What are the limits of appropriate opioid use in modern medicine and within society? The story of heroin in palliative care during the 1980s remains largely untold, and it’s one thoroughly infused with politics, social values and cultural norms of the time.

I write about this in my forthcoming book and in the newest edition of the Canadian Medical Association Journal. Here are the highlights.

1. In 1979, a celebrity doctor and syndicated columnist, Kenneth Walker, who wrote under the pseudonym W. Gifford-Jones, launched a nationwide campaign to legalize heroin (diacetylmorphine) for Canadian patients with terminal cancer.
2. This story showcases how the politics of pain, opioid addiction, and proper end-of-life therapies present enduring challenges in Canadian society, challenges which remain vital today
3. The early 1980s was an historical moment that saw a renewed discussion of opioids in end-of-life care, but also a time in which the prescribing of strong opioids such as oxycodone began to increase in the United States and Canada.
Please read my full article in the Canadian Medical Association Journal.

Harnessing the Fierce Energy of Counterculture

Mental health knowledge and practice was highly contested in the 1960s and 70s. Struggles over homosexuality and radicalism, drug use and replicable drug trials, were part of a unique countercultural moment. These were wild times. Transactional analysis, developed by Eric Berne and Claude Steiner, was also part of this fiercely energetic moment.

In January 2017 Claude Steiner (pictured above), a clinical psychologist, passed away in California. According to his obituary in the San Francisco Chronicle, Steiner’s last words were, ‘Love is the answer’ and ‘I’m so lucky’. He had led a long and full life, and left behind an important legacy in psychology. Steiner was a founder of the Radical Therapist Collective, protested at American Psychiatric Association and American Psychological Association meetings, and edited a collection of Readings in Radical Psychiatry in 1975. Steiner also published a short children’s story called The Warm Fuzzy Tale in 1969 and Games Alcoholics Play in 1970. In 1974, he followed these books up with Scripts People Live, which was a bestseller in the United States. Most importantly, Steiner was influential in developing and popularising transactional analysis.

Steiner was born in France, relocated to Mexico, and then moved to California in 1952 to study physics. But in the aftermath of atomic explosions in Hiroshima and Nagasaki, and seeing how physics was associated with nuclear weapons, he rejected the field. The link to bombs and bomb-making put him off. Transferring to psychology and eventually obtaining his doctorate from the University of Michigan in 1965, he became a close associate of Eric Berne. Set against the backdrop of a topsy-turvy mental health landscape, it is clear that their story had an important impact on psychology – during a unique moment in time – through the creation of transactional analysis.

The full article can be read here

Enjoy. And I’ve written similar work on the 1960s and mental health:

with Social History of Medicine…

https://academic.oup.com/shm/article-abstract/27/1/104/1707848/Therapy-Means-Political-Change-Not-Peanut-Butter?redirectedFrom=fulltext

and Hidden Persuaders…

http://www.bbk.ac.uk/hiddenpersuaders/blog/agents-of-pacification/

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Fracture

Playing soccer has been a hobby/passion/thing to do for the majority of my life.

There’ve been no significant injuries to speak of. Until now.

So let’s talk about ‘the knee’ and pain.

new brace and crutches

A reckless and ridiculous challenge during my last game resulted in a minor fracture of the knee – and some major sit-on-my-butt time.

(Probably best that I go no further in describing the tackle, lest my blood begins to boil once more.)

So, I’ve got a near future filled with crutches, an immobilizer brace, ice, anti-inflammatory drug. Luckily, the future doesn’t hold surgical interventions! For now.

A swollen left knee

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Treatment for dummies (like me):

The treatment depends on the type of fracture. If you have an open wound with the fracture (I didn’t!), you may need treatment to control bleeding or prevent infection. You may need surgery to:

1) Remove all small fragments of bone
2) Wire the kneecap fragments together, if possible
3) Remove the kneecap if it has shattered
4) Your provider may put your leg in a brace, splint, knee immobilizer, or cast to keep your knee from moving while it heals.
5) Your healthcare provider may prescribe pain medicine.

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Pain medication? Well yes. I have been using Extra Strength Advil. And the occasional beer. Sometimes I think I need something stronger. Other times, no.

The National news last night discussed the rise of the opioid crisis and located one of the hot zones in Ohio. The story by Vik Adophia was powerful, well-conceived and executed.

(It’s worth noting that the state of Ohio is suing 5 major drug companies for precipitating the opioid epidemic. The manufacturers of the prescription painkillers are: Purdue Pharma LP, Johnson & Johnson’s Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd’s Cephalon unit and Allergan Plc.)

Here are some of the top stories related to pain and opioids in the past few days.

Trump declares opioid abuse a national emergency in U.S.

Drug industry faces ‘tidal wave’ of litigation over opioid crisis

Canadian health advocates eye Portugal’s drug model to combat opioid crisis

Record number of drug-related deaths, as opioid crisis hits UK

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After the knee injury, I immediately thought of Christopher Nolan’s Batman trilogy.

So what’s the future hold…

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I also thought of Kobe  Bryant’s injury history. And as you can see – the Mamba’s knees featured regularly.

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Stay tuned for periodic updates.