UK Drugs Strategy – July 2017 – Same old, same old?

This past week the UK Government released a Drugs Strategy. Here is some of the reaction to the document, which is available here.

Media Roundup.

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From The Independent:

 

The Government’s latest policy relaunch aimed at tackling illegal drugs amid soaring death rates has been heavily criticised by campaigners who say it fails to get to grips with the problem.

The UK Drug Strategy 2017 was announced by the Home Office as its flagship initiative to reduce use of illicit substances and improve addiction recovery rates.

Drug misuse has been falling in recent years, figures show. Some 2.7 million 16- to 59-year-olds in England and Wales took illegal drugs in 2015-16, down from 10.5 per cent a decade ago.

However, the latest available figures also reveal deaths are soaring. Some 3,674 drug poisoning deaths involving legal and illegal substances were recorded in 2015, up from 3,346 in 2014 and the most since comparable records began in 1993. Cocaine deaths reached an all-time high in 2015, and deaths involving heroin and/or morphine doubled over three years to reach record levels.

The new Home Office strategy identifies new emergent threats, including drugs previously known as legal highs such as Spice – the drug blamed for causing a “zombie plague” in city centres, which is now causing havoc in the prison system.

Chemsex drugs like crystal meth, GHB/GBL and mephedrone, which are taken before or during sex to boost the experience, are also identified as a growing problem among users who expose themselves to blood-borne infections and viruses, according to the strategy.

It promises “targeted interventions” and close collaboration between sexual health services and other relevant groups, as well as more help for addicts to find houses and jobs and better controls at borders.

However, it immediately came under fire from people and organisations campaigning to reduce the harm caused by drugs.

Some argued that by refusing to countenance any sort of decriminalisation it could never make any serious dent in a trade controlled by organised criminals at an estimated cost to society of £10.7bn a year.

Models in countries such as Portugal were cited, where decriminalising drugs and treating their use as a health issue has reduced consumption, addiction and funding for criminals.

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From the Daily Mail:

The Government has ‘no intention’ of making cannabis legal in the UK, officials have announced in a new blitz on drugs.

Despite a growing body of evidence showing the world’s favourite recreational drug to be safe, possession will remain punishable with jail.

Experts have slammed the Home Office’s controversial decision, describing it as a ‘missed opportunity’ to legalise the herb.

But ministers pointed to various studies that have shown cannabis to be detrimental to human health, with significant links to schizophrenia.

Such worrying associations have existed for decades, and were responsible the decision to reclassify the drug to a Class B nine years ago.

In recent years, Spain, South Africa, Uruguay and several states in the US have made cannabis legal for recreational use.

Pressure has been increasing on the UK to follow suit and update its drug policy, with many citing weed’s medicinal properties.

But Ian Hamilton, a drug researcher based at York University, told MailOnline the UK’s updated stance shows it’s falling behind.

‘Missed opportunity’ 

He said: ‘The government has missed an opportunity to provide less harmful ways of people accessing and using cannabis.

‘The UK is falling behind many other countries who are adopting progressive policies towards drug use.

‘These countries have embraced the evidence and recognise that punishing people who use drugs does not improve their health and adds to social inequality.’

Cannabis is currently a Class B drug in the UK, and anyone found in possession can face up to five years in prison.

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From The Guardian:

The wait is finally over for those of us working in the drug policy and drug treatment sectors. The Home Office published its new drug strategy on Friday, two years after its planned deadline in 2015. Sadly, however, this is not a case of good things coming to those who wait. For a 50-page document, there’s very little in the new strategy that can earn it its name.

Against a backdrop of increasing policy innovation in the wider world, the main aims of this strategy are largely unchanged from the previous 2010 version. There’s still a focus on recovery, rather than harm reduction. A continued commitment to tackling the problems caused by drugs through the criminal justice system, rather than through the health system. A point blank refusal to consider decriminalisation, or any reforms to the Misuse of Drugs Act.

Worse, what good initiatives there are in the strategy – and there are some – seem to have been dreamed up by minds unfettered by the reality of public health, criminal justice and policing systems squeezed to breaking point.

Andy Burnham, giving the keynote address at a conference in Manchester last week aimed at developing a more connected response to the city’s rising spice epidemic, echoed the thoughts of many in these fields: “Where is the money? Our frontline services are being overwhelmed. I didn’t hear any mention of any extra funding in the radio this morning. It seems quite hollow, what was being said.”

First then, for the good news. Greater efforts are going to be made to provide effective, evidence-based drug prevention and education to young people. Gone are the school visits from the trite ex-user or the finger-wagging police officer: effective resilience training is in.

Prisoners, too, are to be given more help into recovery, their progress monitored closely. Far clearer and more explicit guidelines have been given on the value of opioid maintenance treatments, which allow so many people with opioid dependence to live their lives, and crucially, prevent overdoses.

The people who slip through the cracks of dual diagnosis from mental health and problem substance use are to be better catered for, rather than shunted between services reluctant to take on complex and demanding cases.

Of the rather pedestrian reforms, these are the brightest spots. However, with cuts to local authority public health budgets totalling £85m this year, and ringfenced drug treatment budgets expected to be cut by £22m, it’s anyone’s guess as to where the money will come from for such initiatives. More likely that these reductions will further eat into essential services such as needle exchanges, and hamper local authorities’ ability to properly assess the performance of the services they commission.

(Read the whole article using the link above)

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From The Huffington Post:

The Government’s new drugs strategy has been condemned as “business for usual” for failing to embrace radical solutions to soaring drug deaths.

The Home Office announced its long-awaited strategy that pledges to crack down on drug dealers and cut demand by expanding education on drugs and alcohol and expanding the Prevention Information Service.

Writing on HuffPost UK, Home Secretary Amber Rudd said the plan would target “unscrupulous drug dealers” while trying to do more to “protect the vulnerable – to prevent them falling into the cycle of drug abuse and to help them turn their lives around”.

While the new strategy does call a rise in drug deaths “dramatic and tragic”, it was condemned as “business as usual” by one advocate for change.

Niamh Eastwood, executive director of drug law experts Release, told HuffPost UK the strategy should have mooted ending criminal punishment for possession, following the lead of other countries.

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If you have other stories and media accounts that you think should be added, get in touch.

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.

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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.

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.

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.

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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

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.’’

 

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

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

 

 

Medical History on the Move

I have a new blog post on the University of Toronto’s site.

 

I’m incredibly excited to be working with CBMH/BCHM and University of Toronto Press over the summer months. It will be my pleasure to help out with journal’s migration to the UofT’s publishing platform. As part of this transition, we are moving all of the back issues onto UofT’s server, and in some cases enhancing them, with abstracts and keywords. The journal is about to publish its 66th issue, so there are lots to consider!

As the journey commences this summer, I’ll be posting and tweeting about the process – all of the amazing stops and bumps in the road, as well excellent articles and contemporary health and medicine issues dating back to the mid-1980s. I’d guess holidays would come first, but I encourage you to share and participate in the voyage as much as you can!

For updates see, @DrLucasRichert and LucasRichert.com

Lucas Richert, PhD

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The Business of Body Parts and Body Products

Ewww. The business of body parts and body products? What? Sounds gruesome. Kinda grisly and macabre. But, as we discuss assisted suicide, selling plasma, or Canadian transplant tourists, in the media the way that we conceptualize the buying and selling our bodies will be vital.

Just like the poster for Daybreakers says, our bodies are a crucial “natural resource.” Hopefully not for a Vampire elite.

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In the newest edition of the Canadian Bulletin for Medical History, I review Banking on the Body , which opens with an account of Connie Culp, the first American woman to undergo a face transplant after having been severely disfigured by a shotgun blast to the head. Yeah, a shotgun!

The groundbreaking surgery in 2008 included a new mouth, nose, and cheeks and, afterwards, Culp was once again able to talk, smile, and smell.  It was a transformation of Culp’s appearance, her quality of life, and so much more.

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For Kara W. Swanson, an Associate Professor of Law at Northeastern University, this procedure transformed all human faces and signified that it was “now a body product” to be “harvested from one body for use by another” (1).  Culp’s story is one of medical ingenuity and ultimately positive, but it also fits within a larger history where “…the human body has become a source of property and value, as well as a source of hope to the dying and the disfigured” (2).

The book is really quite excellent. By examining human milk, blood, and semen, it clarifies how bodies and body products have been organized and exchanged in the United States over the past century. In doing so, Swanson highlights the significance of two interrelated concepts –  the banking metaphor and the gift/commodity dichotomy – and provides lessons for Canadian policymakers.

In 1937, Dr Bernard Fantus of Cook County Hospital in Chicago borrowed the term bank from the world of money and markets to describe the process of stored blood in his hospital. Blood banks were a fresh way to think about maintaining the American blood supply and, not surprisingly, came under fire for the implied association between body products and money.

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Yet, Fantus’s aim was not to promote commercial enterprises. Amid the toil and deprivation of the Great Depression, Fantus sought to “subvert the market allocation of blood solely to those who could afford to pay.” Cannily, “…by treating blood as money, he was trying to circumvent the need to pay money for blood” (7-8). The term bank proved resilient and the banking metaphor has grown as the dominant way of understanding the tradable value of “disembodied fluid,” as well as other body parts (7).

While the two hundredth anniversary of Mary Shelley’s Frankenstein inches closer and we continue to make advancements in the transplantation of human body parts, as in the case of Connie Culp, this sophisticated book has the potential to guide policy and frame future debates on bodies as both personal and civic property.

My review of Banking on the Body: The Market in Blood, Milk, and Sperm in Modern America can be read here.

Clarify Pot Policy for Veterans

Today I wrote a short viewpoint for the Star Phoenix. The article is on medical cannabis for Canadian veterans.

Auditor General Michael Ferguson has raised important questions about the increasing use of medical marijuana by Canadian military veterans.

As authorities contemplate enforcement actions and zoning bylaws relevant to marijuana dispensaries, and the federal Liberal government prepares for legalization in 2017, Ferguson is urging the Department of Veterans Affairs to address the amount of medical cannabis being prescribed to veterans. He found the quantity prescribed was “poorly documented” and not always evidence-based.

Ferguson focused more broadly on how Veterans Affairs has been managing drug benefits for former servicemen and women, some of whom have complicated health issues and suffer from mental health conditions such as post-traumatic stress disorder. The AG made it plain that it’s time to cut through the haze and clarify marijuana policy for veterans.

The core problem rests with the amount of cannabis veterans are authorized to take. In 2014, Veterans Affairs doubled the amount to 10 grams per day for eligible veterans. Yet, for Health Canada this is twice the amount it considers safe. An internal Health Canada document showed that more than five grams has the potential to increase risks to the cardiovascular, pulmonary and immune systems, as well as psychomotor performance. It has a chance of increasing the risk of drug dependence.

Ferguson’s office could not find any evidence to support this decision to increase the threshold. Veterans Affairs Minister Kent Hehr expressed shock in March that his department lacked an “informed policy” on the use of medical cannabis, even as number of claims by veterans for medical marijuana grew more than tenfold over the past two years.

According to figures provided by Veterans Affairs, 112 veterans were reimbursed for medical marijuana in 2013-14, The following year, it was 628. By March 2016 that number has risen to 1,320.

Mike Blais, president and founder of Canadian Veterans Advocacy, has been abundantly clear about veterans’ consumption of medical marijuana: “I think there should be no cap, and that every case should be judged on individual merit and that the doctor’s prescription is paramount.”

At the same time, Canadian Forces have taken an alternative stand. In 2014, H.C. MacKay who was then the deputy surgeon general of the Canadian Forces, made clear that “with respect to marijuana use for medical purposes, we have identified what appears to be a very significant policy divergence between Veterans Affairs Canada and Canadian Armed Forces.”

In short, even though Veterans Affairs was funding medical marijuana, the military’s health service did not recognize it for medical use. With respect to PTSD, the Canadian Forces have also suggested there is insufficient evidence to authorize marijuana use and could even be detrimental to veterans’ health.

Marijuana remains a highly contested medicine for various scientific, political and social reasons. That is obvious. However, the auditor general report reaffirms how it and the policies surrounding the medical treatments for Canadian veterans require significant clarification.

Lucas Richert teaches the history of pharmaceutical and recreational drugs at the University of Saskatchewan.

Below the CBC covers the story.

Are you an Anti-Vaxxer?

Why do we question vaccines? And who are the thought leaders involved? Are they respectable, or are they hacks? And, more importantly, what can we glean from past debates about vaccines? In Elena Conis’s new book, we get a sense of this – and so much more.

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In the newest edition of Social History of Medicine, I review Elena Conis’s new book, Vaccine Nation: America’s Changing Relationship with Immunization.

In tracing over 50 years of vaccine controversy, we get to know the key institutions, opinion leaders, and major ideas that have driven debates. We are exposed to federal law, feminism, and, oh yeah, Jenny McCarthy and the mass media.

She began her career in 1993 as a nude model for Playboy magazine and was later named their Playmate of the Year. McCarthy then parlayed this fame into a television and film acting career. She is a former co-host of the ABC talk show The View.

McCarthy has also written books about parenting and has become an activist promoting research into environmental causes and alternative medical treatments for autism. In particular, she has promoted the idea that vaccines cause autism and that chelation therapy helped cure her son of autism.

Both claims are unsupported by medical consensus, and her son’s autism diagnosis has been questioned. McCarthy has been described as “the nation’s most prominent purveyor of anti-vaxxer ideology”, but she has denied the charge, stating: “I am not anti-vaccine…”

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In Conis’s book, we get a better understanding of how someone like McCarthy can drive the policy process and shape our View on vaccines.

Here is a brief excerpt from the review:

“Vaccines are significant medical interventions that naturally induce powerful economic, social, and political reactions. Vaccines have helped shaped narratives about American scientific and technological ingenuity, as well as therapeutic progress, yet they have also been ‘cast in the image of their own time’ (p. 10), The pathway to effective, accepted vaccines has been neither simple nor straightforward.

In Elena Conis’s penetrating new book, Vaccine Nation, this fluid negotiation over vaccines for polio, pertussis and Human papillomavirus (HPV), among others, is on full display. We are exposed to a ‘wildly diverse set of influences, including Cold War anxiety, the growing value of children, the emergence of HIV/AIDS, changing fashion trends, and immigration’, that have shaped vaccine acceptance—as well as resistance (pp. 2–3). Conis, a former journalist, offers punchy and accessible prose as she skilfully traces the ebb-and-flow of vaccine history from the 1960s to the present.”

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If you’re interested, PBS has done a great job covering anti-vaccination in the U.S.

Weed vs Alcohol

The city of Prince Albert, in northern Saskatchewan, has just released a report that tackles the staggeringly high rate of alcohol use/abuse among P.A’s residents. One of the recommendations to combat the alcohol is the legalization of marijuana. In a StarPhoenix report, Charles Hamilton discusses pot and alcohol policy in both big and small communities. It is called “Pot may curb alcohol abuse in P.A., report indicates.”

Hamilton’s full article can be found here, but here’s the beginning – and I weigh in, too.

Some Prince Albert city councillors are balking at a suggestion that legalized pot could help reduce binge drinking in the city.

The city released it’s “alcohol strategy” this week, a culmination of years of work to document and offer ways to combat problems with underage and binge drinking.

However, some are taken aback by the report’s suggestion that legalized pot could help curb chronic alcohol abuse.

“I personally have concerns,” Coun. Rick Orr said. “I think it’s another one of the items that we have to deal with from a community addictions point of view.”

Other suggestions in the report include eliminating the city’s drive-thru liquor stores, cutting back the business hours of establishments where liquor is sold, and having more cultural training and education among young people about the dangers of drinking.