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.

FOR MORE ON PATIENT ACTIVISM

Quarrelsome cannabis in the UK

Trimming Down: The Debate over Weight Loss Drugs and the Push for a Leaner FDA, 1979-2001

“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.

**

 

Thanks for reading. For more, please follow the blog.

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.

Perpetuating the myths

An excellent post about science and comic books.

The Renaissance Mathematicus

Since the re-emergence of science in Europe in the High Middle Ages down to the present the relationship between science and religion has been a very complex and multifaceted one that cannot be reduced to a simple formula or a handful of clichés. Many of the practitioners, who produced that science, were themselves active servants of their respective churches and many of their colleagues, whilst not clerics, were devoted believers and deeply religious. On they other had there were those within the various church communities, who were deeply suspicious of or even openly hostile to the newly won scientific knowledge that they saw as a threat to their beliefs. Over the centuries positions changed constantly and oft radically and any historian, who wishes to investigate and understand that relationship at any particular time or in any given period needs to tread very carefully and above all not to approach their…

View original post 1,496 more words

CFP. Mental Health and Money: Past and Present

A Call for Papers.

Socioeconomic factors and mental health: past and present

Editors: Professor Matthew Smith and Dr Lucas Richert (University of Strathclyde, UK)

This article collection will examine how the relationship between socioeconomic factors and mental health has been and is understood in an array of different places and periods. Although much of the focus of current mental health research and clinical practice is on the neurological aspects of mental illness and psychopharmacological treatment, historical research demonstrates that a wide range of factors — from vitamin deficiencies such as pellagra, and infections such as syphilis to traumatic life events — have contributed to the onset and exacerbation of mental health problems. Among all these factors, one looms largest: socioeconomic status. On the one hand, socioeconomic inequality has been long recognised as a potential cause of mental illness, as the history of mental hygiene and social psychiatry during much of the twentieth century demonstrates. On the other hand, however, the mentally ill have also historically faced much socioeconomic hardship; today, a high proportion of the homeless and incarcerated in many countries suffer from mental illness.

By exploring this topic across time and place, this collection aims to provide a historical context for today’s mental health crisis, and also to inform current mental health policy, especially attempts to prevent or alleviate mental illness through social change.

Insights on a broad spectrum of themes are welcomed, including, but not restricted to

  • Homelessness and mental illness;
  • Social psychiatry and mental hygiene;
  • Community mental health;
  • Forensic psychiatry;
  • Race and mental health;
  • Psychiatry and various economic/political systems (e.g., communism, socialism, capitalism);
  • Socioeconomic factors and child mental health;
  • How health professionals deal with poverty and mental health;
  • Social policy and mental health;
  • Social activism and mental health.

This is a rolling article collection and as such proposals and submissions will be welcome throughout 2017. However, full submissions received by November 1 will be considered for publication as part of the collection’s formal launch in 2018.

Please do think about submitting.

LSD: Insight or Insanity?, 1968

From the NIH. A post by Professor Erika Dyck on the history of LSD.

Circulating Now from NLM

Circulating Now welcomes guest blogger Erika Dyck, PhD, Professor and Canada Research Chair in the History of Medicine at the University of Saskatchewan. Today, Dr. Dyck shares some insights on a recently digitized film in the Library’s collection highlighted in our Medical Movies on the Web project.

For Rebels, it’s a Kick…

It’s the late 1960s. Teenagers, a hip voice clues us in, are always looking for kicks, and today’s teens express themselves with cool fashions, groovy hairstyles, and kooky pranks. Not so long ago, our narrator played the character of “Plato,” a troubled teenager, in the 1955 classic Rebel Without a Cause. In that film, Plato idolizes the reckless machismo of young Jim Stark (played by James Dean). In an epic display of bravado, Jim and another boy play a game of “chickie run” in which they drive their cars in parallel directly toward a cliff. Jim leaps…

View original post 623 more words

Mad To Be Normal

Mad To Be Normal at the glorious Glasgow Film Theatre. The film stars David Tennant in the lead role and is directed by Robert Mullan.

I was lucky to sit on a panel afterward to offer some historical gems. It was a great conversation with Matthew Smith, Luke Fowler, Richard Warden, and the other attendees…

…oh yeah, and the film was really strong. Here’s a review in the Guardian.

 

 

Call for Collaborators for h-madness

H-Madness. History of Madness Announcement. Get involved.

h-madness

screenshot-from-2017-02-10-10-08-58

As announced in January, h-madness is embarking on a set of major changes to the website and its management. It is our belief that it is time for the site to take on a more lively feel and for a wider and diverse circle of specialists in the field to be involved in generating content for h-madness.

This means, among other things, bringing on board scholars from all stages in their careers and from across the world. To that end, we are issuing a general Call for Collaborators. More specifically, we invite scholars conducting research, writing, and/or teaching on the subject of the history of madness and mental health who are interested in becoming involved in helping to run h-madness to submit a statement of their interest in one or more of the following positions:

1. H-Madness Advisory Board

The advisory board’s main job will be to serve as a…

View original post 204 more words

PTSD, Peacekeeping, and Politics by Adam Montgomery

(It’s an honour to have Dr Adam Montgomery share his thoughts on trauma, the military, and PTSD. You can read more of his work in a forthcoming book, The Invisible Injured: Psychological Trauma in the Canadian Military from the First World War to Afghanistan.)

PTSD, Peacekeeping, and Politics

In the twenty-first century, it seems that trauma is everywhere. From soldiers to emergency medical workers, there has been a growing awareness since the new millennium about the effects of psychological trauma on long-term mental health outcomes. We now routinely hear about post-traumatic stress disorder (PTSD) after natural disasters, car or train accidents, sexual assault, and even war journalism.

But while the Western world is now keenly attuned to trauma and PTSD, each nation has had its own unique historical experience with this complex and thorny disorder. In America, the PTSD concept first grew out of the Vietnam War and the social alienation felt by returning American soldiers. Working with anti-war psychiatrists in the late 1970s, Vietnam veterans were able to gain recognition (and in some cases, compensation) for both the traumatic events they witnessed and a social ostracism which stripped them of any ability to tie their service to a nationally supported cause. PTSD was, for better or worse, as much a political disorder as a medical one in 1980s America.

Stemming as it did from socio-political turmoil, PTSD was initially dismissed by other Western nations as a unique, American-specific phenomenon; that is until they, too, discovered PTSD symptoms in their own citizens. In Britain, the Falklands War and subsequent difficulties faced by British veterans spotlighted the reality of PTSD and slowly forced the British government, psychiatrists, and military brass to accept the reality of war trauma. By the late 1980s, trauma and PTSD were seen as a natural outcome of witnessing death and destruction.

In Canada, a nation that had not been at war since the Korean conflict of the 1950s, PTSD was also viewed as an American-specific phenomenon throughout the 1980s. Despite ample experience with shell shock and battle exhaustion in the First and Second World War, the Canadian military quite simply forgot about trauma from the 1950s until the end of the Cold War.

Then, everything changed overnight. With the fall of the Soviet Union in 1991, the United Nations and its allied countries were thrust into a plethora of peacekeeping missions; in several regions where there was little or no peace to keep. In Rwanda and the former Yugoslavia, for example, Canadian peacekeepers were faced with numerous traumatic events, such as ethnic cleansing and combat with belligerent forces. Unfortunately, they returned to a Canada that cared little for their service.

Caught up in a series of scandals such as the murder of a Somali teenager by Canadian paratroopers in Somalia in 1993, the Canadian military and Department of National Defence wished to suppress any unpalatable overseas experiences. Thus, they initially denied peacekeepers faced any post-tour issues. But by the late 1990s, with Lieutenant-General Roméo Dallaire’s public battle with PTSD following his time as Force Commander in Rwanda in 1993-94, and a growing chorus of traumatized rank-and-file peacekeepers, PTSD became a cause for national concern.

The Croatia Board of Inquiry, called in 1999 to investigate the possible exposure of Canadian peacekeepers to toxins in Croatia, found quite another cause for soldiers’ suffering. After dozens of testimonies from peacekeepers, many of whom told tales about cleaning up dead bodies, watching belligerents’ bodies being dragged through the streets, and having guns pointed at their heads by Croat and Serb soldiers, the board concluded that soldiers’ trauma and subsequent health difficulties were caused not by toxins, but intense psychological duress.

Canadians at first demurred. Peacekeeping had become Canada’s defining contribution to global politics in the 1950 to 1980s period; it was viewed as a relatively benign and adventurous experience for Canadian soldiers. How could ostensibly peaceful tours cause the same after-effects as war? By questioning peacekeeping, Canadians had to turn inward and question their own national identity. Naturally, this introspection took time, and to some degree the peacekeeping myth – a belief that peacekeeping involves simply patrolling a well-defined zone of separation between belligerents and handing out candy to local children – endures.

What has changed, though, is Canadians’ understanding that a percentage of soldiers exposed to traumatic events, whether on peacekeeping or war operations, will return with long-term mental health challenges – the most obvious being PTSD. My book, The Invisible Injured, explores all of the aforementioned themes and events, and argues that PTSD and its antecedents should be viewed not just as medical conditions, but also as profoundly shattering social experiences which are intimately linked to politics as well as Canada’s need to define itself as a middle power in world events. PTSD’s effects include not just nightmares and flashbacks; they also include possible release from the military, pension battles, and social ostracism. In the post-Afghanistan era, when the Canadian government is making plans to once again commit Canadian soldiers to peacekeeping missions in Africa, history can once again play a role in demonstrating not just where we have come from, but where we are going.

 

Adam Montgomery is the author of the forthcoming The Invisible Injured: Psychological Trauma in the Canadian Military from the First World War to Afghanistan (McGill-Queen’s University Press, 2017).

injured

Beyond Vape Fear

Richard Roope, of the RCGP, has recently released a report on e-cigarettes.

images

Essentially, the Royal College of General Practitioners, the official channel for General Practice of Medicine in the UK, has given their informed recommendations to health professionals regarding smoking cessation and the use of e-cigarette.

The recommendations:

1. GPs provide advice on the relative risks of smoking and e-cigarette use, and provide effective referral routes into stop smoking services.

2. GPs engage actively with smokers who want to quit with the help of e-cigarettes.

3. Where a patient wants to quit smoking, and has not succeeded with other options, GPs should recommend and support the use of ENDS.

BEGIN DIGRESSION.

[GENEVA – Electronic nicotine delivery systems (ENDS), of which electronic cigarettes are the most common prototype, are devices that do not burn or use tobacco leaves but instead vaporise a solution the user then inhales. The main constituents of the solution, in addition to nicotine when nicotine is present, are propylene glycol, with or without glycerol and flavouring agents. ENDS solutions and emissions contain other chemicals, some of them considered to be toxicants.The World Health Organization (WHO) submitted a report on Electronic nicotine delivery systems to the sixth session of Conference of the Parties to the WHO Framework Convention on Tobacco Control (COP 6), which occured in Moscow, Russian Federation, from 13 to 18 October 2014.]

END DIGRESSION.

4. GPs recognise ENDS offer a wide reaching, low-cost intervention to reduce smoking (especially deprived groups in society and those with poor mental health, both having elevated rates of smoking).

5. All GPs encourage smokers who want to use e-cigarettes as an aid to quit smoking to seek the support of local stop smoking services.

Harm-reduction has come out on top. Vape Fear has lost this one.

****

I have written my fair share about e-cigarettes in Canada, the United States, and Great Britain.

For example:

* ‘Why Aren’t we Regulating E-Cigarettes?,’ Regina Leader-Post [May 16, 2016]

* ‘Let’s Get Proactive with E-cigarettes,’ Saskatoon Star Phoenix [April 24, 2015].

* ‘Lot of Smoke and Mirrors with Vape Policy,’ Saskatoon Star Phoenix [November 28, 2014]

Often, I have suggested a measured response. My sense is, a little bit of regulation can go a long way. Minor rules can make a major difference. Don’t go overboard, but the waters are rough. Vaping should play by the rules, basically.

With my last op-ed back in May, people in Canada weren’t impressed with my approach. Folks were not interested in a middle-ground perspective. Here’s a list of the harshest responses to my articles on vaping. I’m basically the Red Skull mixed with Lex Luthor for suggesting some thoughtful rules might be in order.

1. “Please take the check that you earned from writing this trash and take an ethics course. Or a journalism degree.”

(Uh, I didn’t get paid. Woulda been nice.)

2. “It’s pretty obvious you don’t quite understand how the system works here in Canada…”

(Does anybody. There are no regulations? Ha.)

3. “You help tobacco companies profit from murder.”

(Jeez, really?! C’mon it’s my birthday.)

4. “…governments are making decisions based on MONEY, NOT PUBLIC HEALTH.”

(No comment.)

5. “What tobacco lobbyist wrote this trash?”

(I’m no tobacco lobbyist, but I sure do think they’re funny in the movies. Aaron Eckhart, anyone?)

Anyway, read the piece and decide for yourself. And share. http://leaderpost.com/opinion/columnists/why-arent-we-regulating-e-cigs

Gin, Beer, and Chicken: Hogarth’s Art and More

A new piece of art commissioned by the Royal Society for Public Health (RSPH) re-imagines William Hogarth’s classic 1751 cartoon Gin Lane. It depicts a society preoccupied by junk food rather than gin.

This is pretty amazing timing, considering this is the focus of my Disease and Society lecture this week!

_91991260_meginlane300dpia3
Reimagined Version by Thomas Moore

According to the BBC, the original showed the damaging effects of a gin craze sweeping London as well as a population suffering from deadly infections common at the time. Cholera. Syphilis. You name it. In contrast, Thomas Moore‘s new picture shows how obesity and mental health issues are today’s big health threats.

The updated version shows a mother salivating over yummy junk food, which she is also feeding her child. In contrast, Hogarth’s 18th century version focuses on a mum more interested in gin and snuff, who is suffering from syphilis sores.

Another stark difference is the prominent payday lender shop, replacing the pawnbrokers of 1751. (Just need a betting shop in there!) Moore’s modern version highlights the popularity of high street chicken shops today, while Hogarth’s work shows people almost skeletal with starvation.

gin-land
Gin Lane by William Hogarth

And…Beer Lane

hogarth

****

FULL BREAKDOWN OF CHANGES

gin-lane-2016-annotated-jpg

The overall scene is the same street as presented in the original, but has been developed and modernized so that it is representative of a typical street scene in London, or indeed anywhere in the UK today.

  1. The central character has been reinvented. Where the original depicts a mother who is drunk and too pre-occupied with taking snuff to care for her baby, Gin Lane 2016 instead shows the mother preoccupied with eating junk food, which she has also fed to her child.
  2. A pawnbroker is one of the significant and thriving businesses in the original piece. In the modern version, this has been replaced by one of the payday lenders which have become a feature of many high streets, and are perhaps a 21st century equivalent. The desperation of one of the customers leaving the payday lender represents the mental ill health associated with debt.
  3. The chicken shop is a representative feature of the obesogenic environment which is at the heart of Gin Lane 2016 – busy, vibrant, and packed full of glum looking customers.
  4. The man contemplating throwing himself off the top of a building is a nod to the original in which a barber is seen hanging, having committed suicide because his customers could no longer afford to have their hair cut. Suicide is now the single biggest killer of men under 45 in the UK.
  5. The original arch has been converted into Gin Lane tube station, with commuters glued to their smart phones – a depiction of the busy, potentially lonely existence of many Londoners today.
  6. Junk food adverts provide another reflection of the ubiquitous power of marketing in our obesogenic environment.
  7. The distillery from the original piece has become a busy pub, replete with rowdy drunk customers.
  8. A news vendor hands out a paper with another headline about the threat posed by obesity.

Courtesy of https://www.rsph.org.uk/about-us/news/gin-lane-2016-iconic-artwork-reimagined-for-the-21st-century.html

****

My lecture this Friday will definitely be connecting the past with the present…

GIN AND JUICE

 

EpiPen Price Gouging is Old News

On Thursday, Mylan announced a series of steps that will make its EpiPen more affordable for some patients. Over the past few years, Mylan had raised a standard two-pack of EpiPens to roughly $600. It had cost $100 in 2009. Then, following a recent uproar, including a public tongue-lashing from Hillary Clinton and a US Senator whose daughter uses the product, Mylan NV (MYL) said Wednesday it would help reduce the cost of the emergency allergy drug for people who are struggling to afford it. Clinton, for her part, became  excoriated Mylan’s “price gouging,” kicking off another selling spree on Wall Street, where Mylan’s stock has plummeted roughly 11% and the Nasdaq Biotech index saw a 3.4% decline, which was the worst of the summer.

Epipen

In a press release, Mylan said it would provide instant savings cards worth $300 to patients who have to pay full price for the drug out of pocket. That amounts to about a 50% price cut for people without insurance or for patients with high deductible plans.

“We responded this morning, first and foremost, ensuring that everybody that needs an EpiPen has an EpiPen,” Mylan CEO Heather Bresch said in an interview with CNBC. “As a mother I can assure you that the last thing we could ever want is no one to have their EpiPen due to price.” When asked why the price of EpiPen increased so much over the years, Bresch, who is the daughter of Senator Joe Manchin of Virginia, blamed “the system” which needs to be “fixed.” She said that with the savings card, “We went around the system. The savings card is equivalent to cash.”

In the course of Canadian coverage, it was assumed that Americans would be travelling north to grab cheaper EpiPens. And this is far from new.

*****

In 2013, I wrote about Americans purchasing pharmaceuticals from Canadian stores in Canadian Review of American Studies. The paper was called The Maple Peril and it explored the practice of cross-border drug reimportation, and considered the Bush and Clinton administration’s policies regarding the necessary balance between drug access, affordability, and safety.

front_cover

In the 1990s, lower drug prices in Canada forged a strong relationship between American consumers and the Canadian industry, leading to the expansion of illegal cross-border reimportation. This occurred in person or through Internet pharmacies. In Canada, the Patented Medicines Price Review Board (PMPRB) imposes federal price regulations, but a number of other reasons also drive down Canadian drug prices. For instance, lower prices on Canadian brand-name drugs are likely the normal result of market economics; that is, prices are matched to different supply and demand dynamics in the Canadian and American markets.

In 2001, as President Bush took office, thanks to Canadian regulations— as well as a weak Canadian dollar—Americans were saving 50 per cent to 70 per cent filling their prescriptions in Canada. In 2004, Canada’s review board reported that Americans paid an average 67 per cent more than Canadians for patented drugs; in 2003, while a three-month prescription for Merck’s cholesterol reducer Zocor cost $172 in Canada, American patients paid $328 for the same pills. The antiretroviral drug ritonavir (Norvir) cost as little as a $700 per year in Canada as opposed to $7,800 per year in the United States.

From the consumer’s standpoint, it was thus eminently rational – or, smart – to seek alternatives to American drugs. And it should come as no shock that drug prices became a major political and economic question mark within the Bush administration.

***** BEGIN PRICES BACKGROUND *****

The troubling matter of drug costs was first contested in the 1950s. Historian David Herzberg argues that ‘‘increasing competition and ever more intense advertising transformed the character of the once staid prescription drug business’’. The new, transformed pharmaceutical industry was challenged in the political arena when, in December 1959, Senator Estes Kefauver (D-TN) took up the general issue of administered prices. Through the Senate Subcommittee on Antitrust and Monopoly he investigated a host of industries, including ‘‘bread, milk, auto, steel, and electrical manufacturing’’ industries. He also focused on the American pharmaceutical industry’s monopoly and revealed a ‘‘series of price-fixing and collusion scandals’’.

During the ten-month hearings, 150 witnesses testified about cortical steroids, tranquilizers, antibiotics, and oral antidiabetics. Kefauver, who ‘‘favored an economy in which competition among small producers set prices,’’ asserted that the drug industry practised ‘‘price leadership’’ and suffered little foreign or domestic competition. His two principal experts, Dr. John Blair and Paul Rand Dixon, were media savvy and compared a drug’s production costs to its wholesale and retail prices; thereafter they brusquely questioned representatives of the pharmaceutical industry and neatly underlined the fact that consumers in the United States were paying a hefty sum for their medications. In one extraordinary example, the markup was 7000 per cent.

Kefauver’s subcommittee hearings, aided by the Thalidomide scare in 1962, eventually led to the passage of the 1962 Kefauver-Harris Act. Compulsory licensing and greater patent regulation, significant
pricing reforms, were excluded from the final product. Still, Kefauver’s legislation had a lasting impact. It increased the power of the FDA—the ultimate authority on whether a drug goes to market—and mandated a drug be both safe and effective; the new law also established standardized manufacturing procedures.
According to physician Jerry Avorn, the new law represented a ‘‘watershed moment in the nation’s approach to medications.’’ The legislation ‘‘completely changed the way doctors and patients thought about drugs’’. Just as important, Kefauver (and his pricing hearings) was the forerunner for a cascading set of consumer oriented hearings which focused on the growing power of the pharmaceutical industry’s advertising as well as the addictive nature of stimulants and sedatives.

***** END OF PRICES BACKGROUND *****

While President Bush adopted an amorphous position on reimportation, his appointments at the HHS and FDA did not.

In 2002, Tommy Thompson, who had already scuttled the legalization of reimportation, combined US national security imperatives and a policy opposing counterfeit drugs. In his estimation, drugs reimported to the United States from Canada constituted a clear and present danger to American consumers and, building his case, drew parallels with the new War on Terror launched after 11 September 2001. Thompson warned that ‘‘opening our borders to reimported drugs potentially could increase the flow of counterfeit drugs, cheap foreign copies of FDA-approved drugs [what the rest of us call generics], expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions.’’ Thompson’s argument concluded with a reference to the recent terrorist threats in Washington DC and around the country: ‘‘In light of the anthrax attacks of last fall, that’s a risk we simply cannot take’’.

In 2002, FDA officials underscored the necessity for vigilance against the dangers of drug importation. After chronicling the FDA’s recent legal struggles with counterfeit criminal enterprises in Alabama, Los Angeles, and Texas, one FDA leader recounted the seriousness of drug importation’s risks to public health. ‘‘Throwing open the door to drugs purchased by individuals directly from Canadian sellers,’’ Hubbard said of potential legalized importation, ‘‘will encourage unscrupulous individuals to devise schemes using Canada as a transshipment point for dangerous products from all around the globe’’.

Another tactic was to direct advertisements at consumers. One particular ad, sponsored by the drug industry, depicted two identical looking pills over the caption Quick. Pick the Capsule that Hasn’t Been Tampered With. The advertisement cited the support not just of the FDA and HHS, but the US Customs Service and Border Patrol and the DEA, arms of government usually concerned with protecting
Americans from very different kinds of drugs. The ad warned, furthermore, that allowing Americans to fill prescriptions in Canada ‘‘could open America’s medicine cabinets to an influx of dangerous drugs,’’ and it closed with an appeal to ‘‘Keep Black Market Drugs Out of America’’.

Ominous government advertisements also influenced Americans not to purchase drugs from Canada. A poster sponsored by the FDA and CBP also cast doubts on the safety and quality of foreign drugs. In an ad titled ‘‘Buying Medicine from Outside the U.S. Is Risky Business,’’ a vicious green snake, with fangs bared and piercing golden eyes, is shown squeezing a bottle of pills. To the right of the viper, the ad asked Americans: ‘‘Think it’s safe buying medicine from outside the United States? Think again.’’

 

Clipboard01

 

*****

Essentially, the recent story of the EpiPen is far from new. Thanks for reading!

Here’s Bernie on prices after the Martin Shkreli story…