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.
The ADHS is pleased to announce that the editorship of its journal, *The Social History of Alcohol and Drugs*, will be taken over by Prof. Nancy D. Campbell (Rensselaer Polytechnic Institute), Prof. David Herzberg (Buffalo) and Dr. Lucas Richert (Strathclyde). The society would also like to express its gratitude for the work that outgoing editor, […]
The ADHS is excited to announce that its next bi-annual conference will be held between 12 and 15 June 2019, at the David F. Musto Center for Drug Policy Studies, Shanghai University, China. The conference will be organised by Prof. Jim Mills, of the University of Strathclyde and Prof. Yong-an Zhang of Shanghai University, who […]
Protest movements found physical space in the 1970s when activist entrepreneurs opened their own businesses. A new book tracks their rise and fall. Author @JoshClarkDavis joins us pic.twitter.com/BLu25m1BSh
A lot happened in the world of pharmaceuticals this year. The opioid crisis worsened. The FDA got a new chief. There were big failures and prices reemerged as a major issue. Industry needed to contend with the new Trump administration and gene therapy ‘came of age.’
By the way, here is one year in review article that showcases some of these ideas:
A lot of money was splashed out. ‘“Does that surprise you?” said Billy Tauzin, the former PhRMA CEO who ran the organization a decade ago as Obamacare loomed. Whenever Washington seems interested in limiting drug prices, he said, “PhRMA has always responded by increasing its resources.”’
In Canada, there’s efforts to reduce “sticker shock” when purchasing drugs.
The @nytimes story Ravaged by Opioids, Tribe Fights Big Pharmacies ignores more than a decade of calls by medical and public health experts to the media to stop the gross misuse of the stigmatizing term "addicted" when applied to newborns. https://t.co/FHcDSQYWLP
“CMAC (Continuous Manufacturing and Advanced Crystallisation), a pre-competitive consortium led by the University of Strathclyde to accelerate progress in pharmaceutical manufacturing, announces that Pfizer Inc has joined as a strategic member, alongside GSK, AZ, Novartis, Bayer, Takeda, Lilly and Roche.”
Lastly, St Thomas University (Canada) is hiring a cannabis/marijuana scholar. As the cannabis industry consolidates and the medicine is refined further, the job is a useful chance to contribute to the discussion. And it looks spectacular.
19-20 April 2018
University of Strathclyde, Glasgow
In cooperation with Wellcome Trust
The Centre for the Social History of Health and Healthcare would like to invite papers for Cannabis: Global Histories at the University of Strathclyde (Glasgow) on 19-20 April 2018.
One outcome of the recent Alcohol and Drugs History Society meeting (ADHS) in Utrecht was enthusiasm for a ‘histories of cannabis’ workshop/conference to gather together the increasing number of scholars researching the topic.
Paper proposals should be based on unpublished research and should include a 300-word abstract, including a brief CV (2 page maximum). The deadline is 1 September 2017. Participants would then be asked to submit papers of c.7000-8000 words by 15 January 2018. This will enable pre-circulation of papers and also early work on editing a collection of papers for publication.
The geographical location and timeframe are open, while topics may include but are not limited to:
policy and legislation
trafficking and terrorism
science and evidence
the rise of big cannabis
art and culture
Deadline for Proposals: 1 September 2017
Deadline for Papers: 15 January 2018
Please send your submissions or queries to :
Caroline Marley: firstname.lastname@example.org or
Lucas Richert: Lucas.Richert@strath.ac.uk
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.
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 toForbes – 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.
“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.
It’s my pleasure to promote the publication of an important Policy Brief on Cannabis by Kathleen Thompson. Over the past few years she has helped drive conversations about the consumption and control of marijuana. Her recent Policy Brief ought to be read by anyone and everyone! Here’s an extract.
LEGALIZATION OF CANNABIS: THE POLICY CHALLENGES AND OPPORTUNITIES
By Kathleen Thompson, PhD, MSW, RSW, BA (Hons)
“The commitment by the Government of Canada to legalize cannabis
and cannabis products presents a complex range of socio-economic
challenges and opportunities. Creating the right legal and regulatory
framework to address the implications, both good and bad, will be
key in determining whether legalization is deemed successful public
The federal government plans to introduce cannabis legislation in the
coming spring session of Parliament. The legislation will be based on
the recommendations contained in a report issued on November 30 by
a Task Force of experts who studied the issue for the past year. The Task
Force received input from more than 30,000 Canadians, organizations
and professionals. Entitled “A Framework for the Legalization and
Regulation of Cannabis in Canada”, the report recommends allowing
more flexibility in the current federally controlled cannabis cultivation
model. Specifically, the federal government would regulate a safe and
responsible supply chain of cannabis.”
Dr. Thompson has worked in health policy analysis and research as a bureaucrat and as a consultant for the last 25 years, specializing in the mental health, disability and corrections sectors.
In 2015, Dr. Thompson created the Cannabis Regulatory Research Group. The focus of the policy research group is on promoting collaborative public policy processes and evidenced-based research with the cannabis industry, governments, academia, civil society and at the United Nations. Additionally, Dr. Thompson consults with individuals and organizations on how to enter the legal cannabis industry.
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).