Playing soccer has been a hobby/passion/thing to do for the majority of my life.
There’ve been no significant injuries to speak of. Until now.
So let’s talk about ‘the knee’ and pain.
A reckless and ridiculous challenge during my last game resulted in a minor fracture of the knee – and some major sit-on-my-butt time.
(Probably best that I go no further in describing the tackle, lest my blood begins to boil once more.)
So, I’ve got a near future filled with crutches, an immobilizer brace, ice, anti-inflammatory drug. Luckily, the future doesn’t hold surgical interventions! For now.
Treatment for dummies (like me):
The treatment depends on the type of fracture. If you have an open wound with the fracture (I didn’t!), you may need treatment to control bleeding or prevent infection. You may need surgery to:
1) Remove all small fragments of bone
2) Wire the kneecap fragments together, if possible
3) Remove the kneecap if it has shattered
4) Your provider may put your leg in a brace, splint, knee immobilizer, or cast to keep your knee from moving while it heals.
5) Your healthcare provider may prescribe pain medicine.
Pain medication? Well yes. I have been using Extra Strength Advil. And the occasional beer. Sometimes I think I need something stronger. Other times, no.
(It’s worth noting that the state of Ohio is suing 5 major drug companies for precipitating the opioid epidemic. The manufacturers of the prescription painkillers are: Purdue Pharma LP, Johnson & Johnson’s Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd’s Cephalon unit and Allergan Plc.)
Here are some of the top stories related to pain and opioids in the past few days.
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Paper proposals should be based on unpublished research and should include a 300-word abstract, including a brief CV (2 page maximum).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: email@example.com 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.
Since the re-emergence of science in Europe in the High Middle Ages down to the present the relationship between science and religion has been a very complex and multifaceted one that cannot be reduced to a simple formula or a handful of clichés. Many of the practitioners, who produced that science, were themselves active servants of their respective churches and many of their colleagues, whilst not clerics, were devoted believers and deeply religious. On they other had there were those within the various church communities, who were deeply suspicious of or even openly hostile to the newly won scientific knowledge that they saw as a threat to their beliefs. Over the centuries positions changed constantly and oft radically and any historian, who wishes to investigate and understand that relationship at any particular time or in any given period needs to tread very carefully and above all not to approach their…
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;
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.
Circulating Now welcomes guest blogger Erika Dyck, PhD, Professor and Canada Research Chair in the History of Medicine at the University of Saskatchewan. Today, Dr. Dyck shares some insights on a recently digitized film in the Library’s collection highlighted in our Medical Movies on the Web project.
For Rebels, it’s a Kick…
It’s the late 1960s. Teenagers, a hip voice clues us in, are always looking for kicks, and today’s teens express themselves with cool fashions, groovy hairstyles, and kooky pranks. Not so long ago, our narrator played the character of “Plato,” a troubled teenager, in the 1955 classic Rebel Without a Cause. In that film, Plato idolizes the reckless machismo of young Jim Stark (played by James Dean). In an epic display of bravado, Jim and another boy play a game of “chickie run” in which they drive their cars in parallel directly toward a cliff. Jim leaps…
As announced in January, h-madness is embarking on a set of major changes to the website and its management. It is our belief that it is time for the site to take on a more lively feel and for a wider and diverse circle of specialists in the field to be involved in generating content for h-madness.
This means, among other things, bringing on board scholars from all stages in their careers and from across the world. To that end, we are issuing a general Call for Collaborators. More specifically, we invite scholars conducting research, writing, and/or teaching on the subject of the history of madness and mental health who are interested in becoming involved in helping to run h-madness to submit a statement of their interest in one or more of the following positions:
1. H-Madness Advisory Board
The advisory board’s main job will be to serve as a…