Editor’s Note: You can see Lucia Romero discuss her work on grassroots mobilization for access to medical cannabis in Argentina below. This builds on her post, published Tuesday, and wraps up our content from the excellent Cannabis: Global Histories conference. All videos were produced by Morgan Scott of Breathe Images. Enjoy!
“Right to Try” (Again): A history of the experimental therapy movement
In recent weeks and months, momentum has increased on Capitol Hill to craft “right to try” laws that would profoundly change the medical landscape. The national legislation will allow terminally ill patients more access to experimental therapies (drugs, biologics, devices) that have completed Phase 1 testing. Powerful pharmaceutical and biotech concerns have been largely quiet. The Trump administration, for its part, has underlined the issue, not only in the State of the Union Address but in VP Mike Pence’s active support.
Critics in academia and medical circles argue that the proposed “right to try” legislation would undermine public health and circumvent Food and Drug Administration (FDA) oversight, while supporters argue that severely ill patients ought to have more freedoms to take experimental pharmaceutical products. Current reportage of the movement has rightfully referenced the HIV epidemic, the film Dallas Buyers Club (2013), and the drive for improved access to unapproved drugs in the 1980s. However, these are not the only ways to view contemporary deliberations about the nation’s drug regulatory architecture.
The right to try movement – and any legislation – embody long-standing struggles about the most appropriate treatment for public and individual health. These struggles have pitted mainstream medical practitioners against interlopers, and regulators against drug companies. Compassionate language about desperate patients with few options has run alongside intense legal wrangling, consumer activism, and prolonged discussions about the validity of medico-scientific data.
And a song called ‘Try Again’!
RADICAL TEMPERANCE: SOCIAL CHANGE AND DRINK, FROM TEETOTALISM TO DRY JANUARY UNIVERSITY OF CENTRAL LANCASHIRE, PRESTON, 28-29 JUNE 2018 FEATURING KEYNOTE ADDRESSES BY: Professor Scott Martin, Bowling Green University, Ohio Professor Betsy Thom, Middlesex University This conference seeks to explore the radical aspects of the avoidance of alcohol. We are looking for contributions […]
This past week the UK Government released a Drugs Strategy. Here is some of the reaction to the document, which is available here.
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.
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.
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.
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)
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.
If you have other stories and media accounts that you think should be added, get in touch.
Check out my new piece with Hidden Persuaders. Check it out and get transported back to Miami, 1969!
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.
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.
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.
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:
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.”
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 Technology, James 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.
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
“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.