Donald Trump’s FDA and the ‘United States of Oxy’

How will the pharmaceutical industry be impacted under the Trump administration? Who’s the new FDA Commissioner? How will e-cigarettes be effected? How will the opioid crisis be impacted?

Trump’s FDA and “the United States of Oxy”

By Lucas Richert

The US Food and Drug Administration (FDA) may be headed for a major overhaul under the Trump presidency and the agency’s new head, Scott Gottlieb. At a recent meeting with pharmaceutical industry leaders, President Trump asserted that “we’re going to be cutting regulations at a level that nobody’s ever seen before.” His most recent statements, made at a White House confab, echoed loudly throughout the medical and pharmaceutical industries.

Just talk? It’s tough to say, yet supporters of pharmaceutical deregulation have long wanted to reduce bureaucracy and lessen oversight of drugs and devices. Critics, by contrast, contend the drugs market could be destabilized and public health undermined. The tricky task will be to strike the proper balance of speed and safety, as well product innovation and consumer protections.

An American drugstore, circa 1963. Courtesy of Library of Congress.

Scott Gottlieb, a physician and regulator recently approved to lead the agency by the US Senate in a 57-42 vote, pledged he would lower prices, reduce approval times, and fight the widespread abuse of opioid painkillers. This kind of addiction, said Gottlieb, was “a public health crisis of staggering human and economic proportion.”

This rhetoric and attempted reforms at FDA are not new, but the devastating painkiller crisis certainly is.

Opioids

Gottlieb’s critics noted that he was too closely tied with the pharmaceutical industry to tackle the opioid epidemic. “We are suffering this public health epidemic because big pharma pushed pills they knew were dangerous and addictive, the FDA approved them, Senator Ed Markey (D-Mass) told reporters. The United States had been turned into the “United States of Oxy,” Markey added.

The FDA approved OxyContin, a powerful opioid to treat severe pain, such as in the case of patients with terminal cancer. With mild pain, though, the FDA deemed the dangers of addiction too great, and has not allowed the marketing of Oxy for such pain.

Not able to solve the opioid alone, the FDA nonetheless will play an important role. He has made this case quite forcefully. However, Gottlieb’s critics (mainly Democrats) have pointed to his past views on the regulation of opioids. In particular, he has suggested that policies restricting pharmacies and drug distributors might burden innocent patients.

This will be one of the defining issues of his career.

E-cigs

The Food and Drug Administration’s move in May, 2016 to crack down on e-cigarettes brought regulation in line with existing rules for cigarettes, smokeless tobacco and roll-your-own tobacco. This had been highly anticipated after the FDA issued a proposed rule over two years ago.

“Millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical,” U.S. Secretary of Health and Human Services Sylvia Burwell stated during the announcement of the new rules. She asserted, too, that health officials still didn’t have the scientific evidence showing e-cigarettes can help smokers quit, as the industry asserts, and avoid the known ills of tobacco.

The Trump administration recently approved a delay in the FDA’s e-cigs guidelines. It was a decision that divided officials in the public health establishment. And it’s undoubtedly true that several Trump administration officials, including FDA chief Gottlieb, have connections to the e-cig and tobacco industry.

From March 2015 to May 2016, according to Bloomberg, Gottlieb was a director of Kure Corp., a Charlotte, North Carolina-based firm that distributes e-juices and vaping pens in coffeehouse-style lounges known as vaporiums. Of course, he had a financial interest in the company as of March, according to financial and ethics disclosures, and promised to sell his stake if confirmed as head of the FDA.

“How to regulate e-cigarettes is one of the most critical questions on tobacco regulation that the FDA is going to be facing in the coming years,’’ said Vince Willmore, a spokesman for Washington-based Campaign for Tobacco-Free Kids.

Vaping will also be a significant issue for Gottlieb and the FDA. Getting the regulation right matters – not just in the U.S., but places like Glasgow and Vancouver.

FOR MORE ON E-CIGARETTES:

Why aren’t we regulating e-cigarettes?

Do We Regulate E-Cigs, Ban Them, or What?

Red Tape

The writer Matthew Herper suggested recently how “talk of speeding up [drug] approvals for serious diseases first gained traction in the early 2000s.” Actually, the trend extends much further back. Debate about quickening drug approvals has a complex and compelling history.

The FDA under President Ronald Reagan, for instance, offers a useful tool to evaluate the Trump administration’s approach to the FDA and the drug industry.

In mid-January, as Mr. Trump awaited his inauguration and the transition team worked furiously to establish his cabinet and select suitable agency nominees, the FDA generated serious debate. Trump met with Jim O’Neill, a venture capitalist, and a close friend of PayPal’s Peter Thiel. He met with Balaji Srinivasan, a cofounder of genetics testing firm Counsyl.

Both men subscribed to the idea – now conservative doctrine, according to Forbes – that the FDA prevented a flood of new drugs from hitting the market. Neither held an M.D., which has been for years a prerequisite for the FDA’s top job. Yet, by 20 January the frontrunner for the Commissioner’s job was Gottlieb, who had made it known publicly he believed the FDA should trim bureaucratic red tape and approve drugs in a speedier fashion.

Trump ultimately settled on Gottlieb, whose selection was welcomed by the pharmaceuticals sector. His ties to industry were questioned by Democrats, but the vote wasn’t close.

The Gipper’s FDA

Ronald Reagan, whether as a candidate or later President of the United States, did not desire the dismantling of the FDA, but neither did he trust it. In his optimistic view, its authority, like that of many other regulatory agencies, simply needed curtailing.

In 1975, he told an audience at the American Enterprise Institute, a conservative think tank, that the FDA was hurting Americans, yet also made clear he did not wish to totally “eliminate the responsibility of the FDA…”

The problem, as Reagan saw it, rested in the restriction of freedom of choice for American consumers, since the agency had established itself “as the doctor and decided that they will tell us what medicines are effective.”  He felt that a degree of regulation was necessary to protect Americans from each other, but the FDA had overreached and, as bureaucracies do, went beyond “protecting us from poisonous or harmful substances…”

In 1980, the Republican presidential ticket of Ronald Reagan and George Bush promised to change Washington. President Jimmy Carter represented failure, Republicans argued, be it botched rescue attempts and helicopter crashes in the desert, the loss of the Panama Canal, or an impotent economy. The jaunty and upbeat Reagan succeeded in shifting the policy discourse about the size and scope of federal government programs; harkening back to halcyon days, he moved the conversation about which government program to launch (or expand) to how much of a program’s or agency’s budget ought to be cut.

In 1981, the debate about drug regulation continued to polarize people; finding a middle ground was often difficult, and as the new administration took power, the outgoing FDA Commissioner Goyan articulated a consensus-oriented, centrist approach to drug regulation. Think tanks such as the Heritage Foundation and American Enterprise Institute promulgated changes to the FDA’s mission as a means of unleashing the once-mighty American pharmaceutical industry. This would fuel the U.S. industry and the greater economy.

For some, the FDA transcended presidential politics and ideology.  It protected all Americans – conservative and liberal – as it carried out its duties. “My view,” said the bearded, grey, and somewhat feisty Jere Goyan, “is that government regulation needs to strike a balance between preserving the maximum freedom for individuals while at the same time establishing the rules that are needed for us to live together, to survive as a society.”

Jere Goyan and President Jimmy Carter. Courtesy of Library of Congress.

By voting for Reagan, Americans indicated they wanted “modifications” to the current models – reform rather than removal. “It would be a mistake,” Goyan argued, “a tragic one, to interpret the election results to mean that the public wants a lessening of the standards that provide the foundation for the food and drug industries in this country, standards that make our food and drug supply the best in the world.”

Often, his approach went unheeded, overwhelmed by disputes about individualism and consumer choice and bureaucratic incompetence. One the one hand, many Americans regarded FDA staff members “as a bunch of demented bureaucrats running amok,” even though the agency’s “balanced” regulation of drugs was both “socially valid and moral.”

On the other hand, the president of the Pharmaceutical Manufacturers Association illustrated an alternative. Lewis Engman felt that taking medicines, like smoking cigarettes, was a matter of personal choice. “Any time you interfere with the basic market system,” he said in 1981, “you’re in trouble…the consumer is his own best guardian.”

Impossible as it was to know how the new president would transform the FDA in early 1981, political pundits, economic analysts and pharmaceutical industry insiders suggested that Reagan meant less regulation, which meant industry growth. The President of the National Association of Retail Druggists (NARD), Jesse M. Pike, sent a congratulatory letter to Reagan. It emphasized how delighted NARD was to see him in the White House and just how his regulatory reform beliefs would be good for business. In Pharmaceutical TechnologyJames Dickinson wrote, “everyone expects life to be easier for industry under the new Reagan Administration.”

Apparently, the Washington cocktail circuit was rife with speculation about the new administration repealing the Kefauver-Harris 1962 drug efficacy requirements – a move that would further enhance prospects for industry growth. This was nonsense, according to knowledgeable policymakers and reporters. Still, the fact that the notion was even bandied about, however fancifully, represented a substantial change in the debate about drug regulation.

Reagan promoting Chesterfield, circa 1952

The press envisaged a pharmaceutical industry boom in the near future. Newspapers reported how “The Drug Business Sees a Golden Era Ahead” and that pharmaceutical associations were positively giddy. Rep. James Scheuer (D-NY) publicly denounced the agency’s over-cautiousness and emphasized the need for immediate reform. It was risk averse, to the detriment of sick Americans. Moxalactum, he argued, was an American-made antibiotic for pneumonia used by Marshal Tito in Yugoslavia – yet it was not available in the United States. The narrative Scheuer framed was that the FDA was protecting Americans to death – and this before the onset of the HIV/AIDS crisis.

Mounting enthusiasm about pharmaceutical growth in the wake of the Reagan election was palpable. Reports indicated that the pharmaceutical industry and investors were confident about the future – a golden era – in this new regulatory climate. There was bullishness about drug stocks in general, and many predictions that pharmaceutical companies would start to generate more and more earning in 1981 and 1982. Overall, these stories proved to be accurate.

Ronald Reagan, however, had pledged in 1980, with trademark sincerity, not to gut the FDA. Rather, he made oblique references to the agency’s storied history and resorted to prosaic comments about the danger of hidebound power-hungry bureaucracies. “There’s a certain amount of regulation that is always necessary to protect us from each other,” he told CBS’s Walter Cronkite. “And that I recognize. We don’t want to, for example, eliminate the responsibility of the FDA…”

Much can be gleaned from Reagan’s public statements about the Food and Drug Administration, but they fail to reveal the entire picture. On May 20, 1986, Reagan described a meeting between Paul Laxalt, Jack Dreyfus, and himself. Dreyfus, who had “spent $50 mil. of his own money” was attempting to have the epilepsy drug Dilantin approved and found a roadblock in the form of the FDA. According to Reagan’s personal diary: “The villain in the case is the Fed. Drug Admin & they are a villain.”

 Red Herrings and Empowered Patients

Under the Trump administration, will the FDA play the villain role? President Trump will build on earlier Republican efforts to streamline the agency, whether these took place during Reagan or Bush presidencies. He has promised to remove barriers for overseas drugs and support ‘Right to Try’ laws, which will attempt to provide access to unapproved drugs. Indeed, some of these measures may help patients. And the Trump administration will be the right track if it can safely accelerate drug approvals, promote production and use of generics, and lower drug prices through increased competition.

Gottlieb and others have suggested they would radically restructure the drug approval process –  even if that remains something of a red herring argument. QuintilesIMS Institute, among various other organizations, have determined that the total time between patent and approval has dropped 31% since 2008. Yale researchers hold that the FDA is already considerably faster than Europe and Canada when it comes to approving drugs.

Another area of regulation that ought to be monitored closely is advertising. Every other nation besides the US and New Zealand has concluded that advertising powerful drugs for treating complex illnesses makes no sense when your target market lacks the qualifications to fully grasp the risks. How will powerful painkillers be regulated in the years ahead.

The drug industry wants to empower patients, to invest them in the writing of prescriptions. Looking ahead, it will be important to watch the administration’s and FDA’s role in faciliating this.

FOR MORE ON PATIENT ACTIVISM

Quarrelsome cannabis in the UK

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

“The [industry] idea is that consumers are central players in their health management and therefore have a right to be informed of different drugs,” Lewis Grossman, a specialist in food and drug law, told the Los Angeles Times.

Yet, the practice of medicine should not be placed in the hands of amateurs and junk scientists. In the post-truth era, however, when an opioid epidemic soars and drug prices are hitting Americans in the pocketbooks, these “facts” could be lost in the noise.

**

 

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

Lucas Richert is a Lecturer in History at the University of Strathclyde (Glasgow, UK). He is the author of Conservatism, Consumer Choice, and the Food and Drug Administration during the Reagan Era. He’s currently at work on a second book, tentatively called Strange Medicines: Drugs, Science, and Big Pharma in Culture.

Ultrarunning: Nature and Native Americans

Mo Farah, you wuss! It’s time to take it to the next level with ultrarunning. Here’s an excerpt from “Beer, candy fuelled ultrarunner’s record-breaking race,” by Lindsey Crouse.

***

At a time when “endurance running” no longer means mere marathons – and even 160-kilometre races are attracting the masses – Karl Meltzer, a former ski-resort bartender, has proved he can suffer longer and faster than almost anyone else. When he staggered onto Springer Mountain in Georgia before dawn Sunday, Meltzer set a record for completing the Appalachian Trail. He covered the 3,524 km over 14 states in 45 days 22 hours 38 minutes.

p-20160629-00377_hires_jpeg_24bit_rgb

As commentator Lindsey Crouse put it, Meltzer, 48, is a little different from other titans of the newly booming ultrarunning scene. He is six years older than Scott Jurek, who was featured in the bestselling book about almost-barefoot endurance running, Born to Run – and who set the former Appalachian Trail record last year (46 days 8 hours 7 minutes).

In a sport checkered with mantras such as “clean living,” Jurek sustained his trek on a vegan diet. Staples of Meltzer’s diet, by contrast, included Red Bull and Tang. Jurek incurred a $500 (U.S.) fine and public outrage for opening Champagne at the summit of Mount Katahdin in Maine during his record run. When Meltzer finished on Sunday, he walked down the mountain, sat in a chair and sated himself with pepperoni pizza and a beer. It was the latest milestone in an unusual professional racing career.

Meltzer moved to Utah to ski in 1989 and started running the next year. He came to long-distance racing in his late 20s. Primarily a skier, he worked as a bartender at the Snowbird ski resort but took summers off to run. Now, based in Sandy, Utah, he became an ultrarunner in 1996 after completing a 160-km race nearby in just more than 28 hours. In a sport built on superlatives – faster, longer, more, more, more – his 160-km trail race portfolio is formidable: He has won 38 of them, more than anyone else in the world.

That’s intense.

***

What’s the story with Ultras? How it works.

According to the IAAF, ultra races are contested over two different types of race modalities, either over a set distance or a set time. Examples of the former would be 50km, 100km and longer events while illustrations of the latter would be something like 6hr, 24hr, and multi-day events. Both are gaining popularity with the masses and bring their own unique challenges to the racers.

Races are organised on a) trails where athletes get to enjoy the serene environment of a forest. b) track when athletes do not have to venture too far from their start/finish areas and are always within visible region. c) road where athletes can enjoy their road running days and run through both quiet and busy streets. Some ultra races are a combination of two or more of the available terrain, and some also span a few stages and are run over a course of days.

How popular?

As reported by The Guardian, despite the growing interest, the organisation of ultras is still rather disparate, with independent races popping up all over the place, giving the sport a slightly amateurish feel, with camaraderie playing a large part. Some of these are billed as a gentle introduction to ultras. Others, such as Whistler’s Meet your Maker make no bones about what they are: 50 miles of undulating singletrack alpine terrain. So if you really want to run across the US’s national parks, there’s an ultra for you. And if you fancy tackling 4,600m of altitude gain in Luxembourg’s Little Switzerland, you’re in luck.

ultra

“Running has seen tremendous growth in the past 20 years,” says Topher Gaylord of Mountain Hardware, an outdoor equipment company that has turned its attention to ultras enthusiastically. “There’s been a tenfold increase in trail events, and the events have seen a massive rise in participation because it’s such a natural way to engage with the environment.”

Nature and Native Americans

Often, the discussion around modern ultrarunning in the U.S. (and to a lesser extent, Canada) revolves around nature and the ways in which Indigenous peoples ran, and ran, and ran some more…

As Andy Milloy phrased it “In the Beginning: Native Americans,” without horses, using only dogs as pack animals, Native Americans were conditioned to cover great distances on foot from an early age. It was recorded that Apache Indians, who were renowned for their toughness, at the age of 15 or 16 had to undertake a long run over rough country carrying a load on their back. Young men would be expected to go without sleep in a vigil that could last 48 hours. They then were required to go out into the wilds for two weeks, living through their own skill and toughness. An adult Apache could travel on foot over the roughest terrain from fifty to seventy-five miles a day, keeping this up for several days at a stretch.

Outstanding runners in such a culture would become key figures in holding together widespread associations, such as the Iroquois Confederacy, or even loose groupings of proximal tribes, by carrying news and other urgent messages. A typical example of the role such runners played is recorded in Peter Nobokov’s excellent book “Indian Running.” In the 1860s a messenger runner of the Mesquakie tribe in his mid-fifties ran 400 miles from Green Bay, Wisconsin to warn Sauk Indians along the Missouri River of an enemy attack. Such messenger runners were probably part of the culture of the Sauk, Creek, Omaha, Kickapoo, Osage, and Menominee tribes, and possibly many others. Such runners dedicated their lives to this endeavour, following a strict diet and often practicing celibacy. On their runs they would carry a dried buffalo heart.

***

 

Cocaine Fury

It was tight. It was very, very close. However, Colombians rejected a peace deal to end 52 years of war with Farc guerrillas, throwing the country into confusion about its future. With counting completed from 98% of polling stations, the no vote led with 50.23% to 49.76%, a difference of 61,000 votes. Not much.

According to the major news sources, including the Guardian, The verdict on the deal between the government of Juan Manuel Santos and the Farc means it cannot now be implemented. Polls before the vote predicted that the yes camp would win with a comfortable 66% share. Santos had been confident of a yes result and said during the campaign that he did not have a plan B and that Colombia would return to war if the no vote won. His opponents, led by former president Alvaro Uribe, said a win for their side would be a mandate for the government and rebels to negotiate a “better agreement”.

The Deal

Under the agreement rejected by voters, the Farc’s 5,800 fighters and a similar number of urban militia members would have disarmed and become a legal political party. Whether or when that will happen now is unknown.The deal would have allowed rebel leaders to avoid jail if they confessed to their crimes such as killings, kidnappings, indiscriminate attacks and child recruitment, something that many Colombians found hard to swallow.

At the same time, Sunday’s outcome amounts to a setback for the United States and the Obama administration, which had backed Santos and pledged to boost U.S. aid to Colombia by nearly 50 percent, to $450 million a year. The fate of that funding proposal is now up in the air.

time-cover
1979

 

The Future

After nearly six years of negotiations, many handshakes and ceremonial signatures, Colombia’s half-century war that has killed 220,000 and displaced 7 million is not over.

“I am the first to recognize the result,” said President Juan Manuel Santos in a televised address, flanked by members of the government peace negotiating team, who looked stunned. “Now we have to decide what path to take so that peace will be possible. . . . I won’t give up.”

Bernard Aronson, the U.S. special envoy for the peace process, talked with Colombia’s ambassador in an emergency meeting Sunday night. “We believe Colombians want peace, but clearly they are divided about terms of settlement,” he told the Washington Post. “We will continue to support Colombian authorities as they try to build a lasting peace with justice and security.”

****

In other cocaine news:

Tyson Fury

The world heavyweight champion Tyson Fury, who last week pulled out of his proposed rematch with Wladimir Klitschko citing mental health issues, has allegedly tested positive for cocaine. Fury, who holds the WBA and WBO world titles, was informed last Thursday night that his A sample from a random urine test on 22 September had tested positive for the substance benzoylecgonine, the central compound found in cocaine. Fury pulled out of the rematch a day after the test.

After the initial postponement, Fury was pictured shortly afterwards buying England fans alcohol in France at Euro 2016. In the past, the boxer has publicly hinted at taking the drug, in addition to his mental health. Speaking last April on the topic of his depression, Fury stated:  “It’s either high or low. I’m either off my head on cocaine or down on the floor from a tranquiliser injection. Most of the time, I’m just down and depressed like today, because for every high there’s a low.”

Fury’s WBA, WBO and IBF belts could be on the line if the allegations are confirmed.  He later tweeted a picture of himself in Tony Montana’s chair.

“Say hello to my little friend!”

scarface

 

Sources:

Business Insider, The Guardian, The Independent, Washington Post, and Time

The 10 Best Drug Movies of the Past 50 Years

Cheech and Chong. Tony Montana. Reefer Madness. Blow. These are some of the characters and films that normally come to mind when you bring up drugs in cinema. But let’s get real, folks. It goes so much deeper.

Drug movies are both fascinating and titillating. Whether it’s the “War on Drugs” or depictions of the counterculture or portrayals of Big Pharma and the business community, all sorts of movies have been made about the illicit drug trade, pill-popping, and even more that simply feature drug use. But what are the best drug movies of the past 50 years? High Times has got some ideas. Buzzfeed has done it. And so has IMDB.

Now it’s time to offer a fresh take on the list.

Before we begin, though, let’s establish a boundary or two. What is a drug movie, one might ask? The best way to think about it has to be through heavy drug use and a focus on the drug trade, organized crime, or medical marketplace. This means that Dazed and Confused, which only has mild drug use, doesn’t make it. Neither does The Program, with James Caan. Or Rocky IV.  Or the relatively new Alice in Wonderland. These films feature some drugs use and are trippy to watch, but to make this list drugs have to be absolutely central to the plot. There are other rules, too. First off, alcohol is NOT a drug. (In fact, there’ll be another alcohol list in the future.) Second, power – money, politics, sex, the ability to get others to do what you want – is NOT a drug. Finally (thank fuck), altered perceptions or dream sequences, but which are NOT based on explicit drug use, are thrown out. So, for example, Raising Arizona, The Matrix, or Fight Club have to get bumped from consideration.

Here’s my Top Ten and watch those other more standard lists go Up in Smoke.

10. Sicario (2015)

French Canadian director Denis Villeneuve crushes it. Again. With Sicario (meaning hitman), he drops us into the grisly world of drug enforcement.

I’ve been an outgoing proponent of Denis since Incendies (2010), and he’s continued to crank out brooding and thought-provoking pictures, including Enemy (2013) and Prisoners (2013). After having worked with Jake Gyllenhaal for both films in 2013, he casts Emily Blunt, Josh Brolin, and Benicio Del Toro to headline his take on the War on Drugs’s primary theatre of war – the US/Mexico border.

Emily Blunt is once more playing Ellen Ripley. (Think Edge of Tomorrow – wait, is that what it’s called?). Really, it’s not a bad place to be. She’s steely-eyed and intrepid. And she’s posing moral questions as the focal piece of the film.

sicario new yorker image
Source: New Yorker magazine

The soundtrack is hauntingly grim, the acting is understated, and the cinematography – by the incomparable Roger Deakins – is spartan. Rapid cutting is superseded by long, lingering shots. Movement gives way to stillness. A great example is one of the signature battles of the film, when a traffic jam, not a car chase, ramps up the tension. Deakins, who was burned at the Oscars once more, uses most of the arrows in his quiver to generate one of the most gorgeous films of 2015-2016. By itself, that’s enough to make this list.

 

9. Good Fellas (1990)

GoodFellas tells the true story of Henry Hill, played by Ray Liotta in a star-making performance and it wasn’t till Blow (2001) and Narc (2002) that he reached such heights once more. Am I fond of Liotta? Somewhat. But not a lot. I like Liotta as much as, say, Al Gore or John Kerry or, I don’t know, porridge. In this, however, Liotta’s compelling. His Henry Hill is chaotic and flawed. He’s shallow and violent, as well as understandable and all human. At times, I find myself cheering him and pitying him simultaneously. When he suggests, “as far back as I can remember I always wanted to be gangster,” I shake my head and, at the same, kind of wonder. Hmm? This is a testament to Liotta’s best and breakout performance.

In 1990, Martin Scorsese wasn’t unique in addressing organized crime. A tipping point, it seems, had been reached, and audiences that year were treated to an abundance of mafia, mob, and crime films, including: Miller’s Crossing, King of New York, The Krays, The Grifters, and, yes, The Godfather Part III. But GoodFellas stands apart and above.

As Henry is initiated into the world of guns and drugs, gambling and prostitution, he is mentored by Robert De Niro’s Jimmy Conway and Joe Pesci’s Tommy Devito. Both actors have been understandably lauded for their vibrant portrayals of tough guys. Eventually, Henry and his wife Karen (played by Lorraine Bracco) discover the sex and violence of organized crime is thoroughly intoxicating, just as much as the cocaine that they inhaling.

This movie – its soundtrack and cinematography, and so much more – is just as addictive.

8. The Constant Gardner (2005)

Big Pharma. Big Bad Pharma. This is the subject of John Le Carre’s novel and ultimately the movie, directed by Brazilian director Fernando Meirelles. The story is disjointed, relies on flashbacks, and, according to Roger Ebert, is a far distance off ‘a logical exercise beginning with mystery and ending at truth…” Instead, we are pulled into a maddeningly elusive conspiracy and a fragmented narrative in which Ralph ‘Rafe’ Fiennes (i.e., Voldemort, The Red Dragon, Hades, and M) plays a widower in search of the truth. Why is his wife dead? Who is responsible?

His answers rest in the multinational pharmaceutical corporations. In particular, a company that is using Kenya’s population for fraudulent testing of a fictitious tuberculosis drug (“dypraxa”). The drug has known harmful side effects, but this is disregarded, as is the health of the African test subjects. Of course, this sort of testing is based in reality and spots like China, Estonia, Romania, Tunisia, as well as other African countries, have served as fertile testing grounds.

Fiennes, playing Justin Quayle, confronts Big Bad Pharma and suggests that the pill we take – whether for Tuberculosis or Tachycardia –  is more than just an ‘an inanimate fucking object.’

If you like underdog tales, especially ones where caricatured corporations are fucked over by the ‘little guy’ (see Erin Brockovich, The Insider, Michael Clayton, etc.), this movie is for you.

7. Easy Rider (1969)

It’s difficult to begin with Easy Rider, which nearly everyone regards as one of the greatest and most influential drug movies of all time.

Disclosure: I should not have watched Easy Rider at an early age. I found it incredibly jarring. I was in grade 9 and not at all battle-hardened or street-smart. The cruel ending forced me into a funk. It challenged me to think about human nature, the nature of the United States, and served as a bewildering counterpoint to many of the testosterone-fuelled and predictably satisfying action movies (think Arnold, Jean Claude, Sylvester) to which I was exposed in the 1980s.

Wyatt and Billy didn’t deserve that! Who were they bothering? What, there’s not going to be any payback? That’s it?! Jesus Christ. Dammit.

Plot and Characters: Peter Fonda plays Captain America with the old stars and stripes on his back, helmet and bright long-barrelled motorbike. Dennis Hopper plays the sidekick, sporting pioneer trooper buckskins, long mustache and hair. They’re touring around the beautiful USA and shit happens to them: there’s a drug deal, parades, bordellos, Mardi Gras, LSD trips, and unexpected violence.

Easy Rider is a quintessential American road movie.

And the best part of the piece is Jack. This is his breakout. Vincent Canby, writing in the NY Times in 1969, was tepid, even haughty, about the film, but he sure loved Nicholson:

jack

‘Suddenly, however, a strange thing happens. There comes on the scene a very real character and everything that has been accepted earlier as a sort of lyrical sense impression suddenly looks flat and foolish.Wyatt and Billy are in a small Southern town—in jail for having disturbed the peace of a local parade—when they meet fellow-in-mate George Hanson (Jack Nicholson), a handsome, alcoholic young lawyer of good family and genially bad habits, a man whose only defense against life is a cheerful but not abject acceptance of it. As played by Nicholson, George Hanson is a marvelously realized character, who talks in a high, squeaky Southern accent and uses a phrase like “Lord have mercy!” the way another man might use a four-letter word.’

In Jack, we trust.

6. Apocalypse Now (1979)

Francis Ford Coppola had a mental breakdown during shooting, as he wrote the script on the fly and had to negotiate with a hard-partying, spaced-out crew, in addition to the fickle President Marcos of the Philippines. Coppola had to fire the original leading man, Harvey Keitel. Then, Martin Sheen – the replacement – had a heart attack.

Marlon Brando showed up to film his scenes as Colonel Kurtz much like Shaq often did to start the Lakers training camp – in less than ideal shape. Coppola would also have to tread carefully with the mercurial Brando, who hadn’t learned any lines and insisted on being filmed in shadow. And Dennis Hopper. Dennis Hopper being Dennis Hopper, well, he was regularly stoned on marijuana, cocaine, speed and many other drugs. He was manic. Crazed. Demented. A feature of this list a second time, he didn’t have much acting to do in portraying a whacked-out photojournalist drunk on the Colonel’s Cool-aid.

The story, based loosely on Conrad’s Heart of Darkness, follows a booze-fuelled, PTSD-suffering, lone-wolf agent as he journeys up a river to find a rogue soldier, Kurtz, who has slowly gone mad, raised his own army, and established his own territory in Vietnam. As this troubled agent/assassin, Willard (first Keitel, then Sheen), heads up the river, the visuals gets increasingly trippy. The imagery, in short, becomes more hallucinogenic. By the time Kurtz converses with Willard, the audience has gone way down deep into the proverbial rabbit hole.

The film is improvisational and chaotic. It’s intoxicating and brazen. And it’s a masterpiece.

5. Dallas Buyer’s Club (2013)

In the excellent 2013 movie, Dallas Buyers Club, we are exposed to valiant patient activism during the AIDS crisis in the United States. Based on the true story of AIDS-stricken Ron Woodroof, a cocaine-snorting cowboy and homophobic Texas tradesman, the film shows a shockingly thin Matthew McConaughey battle his sickness, inner demons, and the authorities in Texas Mercy Hospital, the drug industry, and government.

I’ve reviewed the film elsewhere and I’ve used it to try and communicate the complexities of medical marijuana dispensaries, in particular. I remain convinced that the movie provides a harrowing, insider overview of drug regulation and the politics of medicine in modern society.

Woodroof, who’s unhappy with his illegally purchased zidovudine, known as AZT, and on the edge of death, seeks out alternative and experimental drugs from a doctor in Mexico. Then, Ron, being the savvy entrepreneur/hustler that he is, quickly establishes a club (charging a $400 membership fee) to sell his smuggled wares, including vitamins, DDC, and Peptide T. In doing so, he runs afoul of the Food and Drug Administration and the Drug Enforcement Administration and is essentially forced to confront the existing power structure of drug regulation.

At one point in the film, he storms a town hall meeting of citizens, drug company leaders, and FDA regulators and, while still quite ill and attached to his IV bag, Ron starts finger-pointing. “People are dying. And y’all up there are afraid that we’re gonna find an alternative without you.” Inevitably, bums shift in chairs. Chests are puffed up. And murmurs echo in the room. “You see,” Ron continues, “the pharma companies pay the FDA to push their product. They don’t want to see my research. I don’t have enough cash in my pocket to make it worth their while.”

The film has strong performances, namely McConaughey and Jared Leto, who plays his cross-dressing compadre. Jennifer Garner,  on the cover of a recent Vanity Fair and recovering from the newest Batman’s infidelity, offers up some of her best work.

With Dallas Buyer’s Club we see the problems inherent in the relationship between big business, regulators, and interest groups. And while the film didn’t get it all right, it’s still a stimulating film and a significant reminder about the power of Big Pharma, the complicated nature of drug regulation in the 20th century, and the ways in which everyday citizens like Ron Woodroof can influence the system.

…THE END? NOPE

FOR THE TOP FOUR, VISIT http://www.alternet.org/drugs/10-greatest-drug-movies-past-50-years WHERE THIS ARTICLE WAS PUBLISHED.

SUPER SPECIAL THANKS TO MATT TODD, WHO WAS INSTRUMENTAL IN WORKING THROUGH THIS LIST WITH ME. WE DIDN’T ALWAYS AGREE, BUT SUCH IS LIFE. HE AND I WILL BE RELEASING A MODIFIED (HISTORY-LADEN) VERSION OF THIS ARTICLE IN THE NOT-TOO-DISTANT FUTURE.

HAPPY CANADA DAY!

 

Podcast Announcement – Radical Mental Health Therapy

I recently had the pleasure of joining Chris Hoff on The Radical Therapist Podcast. You can listen to our lively discussion about the 1960s, long-haired hippies, and mental health services during a period of big-time change. You can download the Pod here or through iTunes. Thanks for listening and sharing! #mentalhealthawareness #healthpolicy

1400x1400radicaltherapist

Paperback Writer – Book Announcement

‘Dear Sir or Madam, will you read my book?
It took me years to write, will you take a look?
It’s based on a novel by a man named Lear
And I need a job, so I want to be a paperback writer
Paperback writer’

— The Beatles

I’m delighted to announce that my book – A Prescription for Scandal – is now available in paperback. Basically, it’s much cheaper. Please share and, hell, you might as well buy the book. If you’re interested in a discount, follow the link here Richert_Flyer_PBK and download the coupon.

 

51WG19Aa8GL

 

 

And so on and so on!

Book Description:

Everyone knows someone or some story that reminds us of the incredible power of the pharmaceutical industry in our everyday lives. We see the advertisements during football games and food show. We see them in Men’s Health as well as Shape and Cosmo. The ads are everywhere. And by most accounts we’re consuming more and more pills every year.

For as long as I can remember I’ve had an interest in the pharmaceutical industry. My grandfather was a physician at Royal University Hospital and my mom was anti-Big Pharma through and through. So I definitely recall plenty of stimulating discussions around the supper table. At the same time I’ve always been intrigued by our influential neighbour to the south, the United States.

My new book, Conservatism, Consumer Choice and the FDA during the Reagan Era: A Prescription for Scandal, tries to understand the American drug industry in the era in which I grew up, the 1980s. Ronald Reagan was President. Dynasty, Dallas, and The Dukes of Hazard were on [the] tube. And I was caught up in G.I. Joes and my next soccer practice. Little did I know then that these were watershed years for pharmaceutical companies. But they were.

In writing this book, I tell a sometimes frightening story about how the regulation of Big Pharma got twisted, turned, and pulled upside down by politicians, consumer groups, and drug industry leaders. At the centre of this tug-of-war was the Food and Drug Administration, an independent government agency that was constantly under pressure during the 1980s. The stakes were extremely high. Lives were at stake. People’s health rested in the balance.

In 2016, these things haven’t really changed. We still need to make tough choices about the role prescription and non-prescription drugs play in society. Sure, the drug industry has done important things for our health, and yet it also has too much power and influence in our lives. I hear this all the time. I’m hopeful that my book can shed some light on how we’ve gotten to this point and help us think about the future.

 

Crackdown? Regulating E-Cigarettes

In the Regina Leader-Post today I write about Canadian e-cigarette rules. Both the U.S. and E.U. have moved ahead with new rules. Should Canada?

*

Why Aren’t We Regulating E-Cigarettes?

Recently, the regulation and use of e-cigarettes in Canada, the U.S. and European Union has raised serious challenges for consumers, politicians, and health officials. Now, the U.S. and the EU have moved forward with new policies and Canada is being left in the dust.

In the U.K., an estimated 2.6 million people use e-cigs, prompting more calls for regulation. And this week, new regulations go into effect.

These include rules that limit the size of refill containers and the potency. All packaging must be “child proof.” Manufacturers will be asked to submit to government scrutiny. Finally, if three EU member states express a willingness to ban e-cigs, it will be possible to start a process banning them across the whole of the union.

Last week, the U.S. government also took broad steps to crack down for the first time on e-cigarettes, which have been growing in popularity among teens and are projected to be a $4-billion industry this year.

The Food and Drug Administration’s move brought regulation of e-cigarettes in line with existing rules for cigarettes, smokeless tobacco and roll-your-own tobacco. This action had been anticipated after the FDA issued a proposed rule two years ago on how to supervise the e-cigarette industry.

“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 said. She suggested that health officials still don’t have scientific evidence showing e-cigarettes can help smokers quit, as the industry asserts, and thus avoid the known ills of tobacco.

In Canada, considering that both the Harper Conservatives and Trudeau Liberals have dithered on crafting any meaningful policy, perhaps it would be easiest simply to follow the lead of the EU or U.S.

First, e-cigarettes have not been proven as a legitimate and conclusive aid in quitting smoking. Anecdotally, many believe they are a useful harm-reduction tool. Many former smokers praise the devices, while many physicians and public health experts also support their use. Yet, there is anything but scientific or medical consensus on the e-cig.

Second, the flavoured liquid that substitutes for nicotine lacks proper regulatory standards, so the safety is problematic. Business owners either can craft the liquid themselves or purchase it from anywhere they wish. This raises questions of security. It’s basically a “wild west” market. Without appropriate controls over the liquid mixing process or the supply and distribution chain, consumer protection is weakened. It is unthinkable that a pharmacy down the block could operate in an unregulated, unstandardized environment.

Also, a recent report in the U.S. found that e-cigs have “sickened rising numbers of young children,” and in most cases this involved swallowing liquid nicotine. In Lethbridge, an e-cig exploded in the face of young Ty Greer. It “lit his face on fire,” knocked out teeth and seared the back of his throat. The young man will bear the scars of this accident forever.

Do such examples mean we ought to crack down hard and regulate this market out of existence? No. Does this mean we should think proactively? Yes.

Alberta, Saskatchewan and Newfoundland and Labrador are the only provinces that have not banned sale of electronic cigarettes to minors, according to the Non-Smokers Rights Association.

Les Hagen of the group Action on Smoking and Health said what happened in Lethbridge is another reason why e-cigarettes must be regulated federally and provincially. By contrast, Jesse Kline of the National Post has told us, “Don’t believe the fear campaign — e-cigarettes can save millions of lives.”

It is time for federal leadership. We need rules that meet the needs of consumer protection and business owners, and balance health concerns for children with harm reduction for adults. According to federal Health Minister Jane Philpott, “Health Canada is actively reviewing health and safety data and scientific studies on vaping products, including e-cigarettes.” She noted a report will be issued reasonably soon.

It will be a tricky task, especially with the marijuana file looming large.

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

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.

Picture2

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.

Picture1

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.

Picture4

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.

The Rise of Big Cannabis on Shaw TV

The Rise of Big Cannabis Symposium that I recently aired on Shaw TV in Saskatoon, Prince Albert, Moose Jaw and Swift Current stations.

The first airing was this weekend on March 19th @ 9:30pm

Other dates to follow:
March 21st – 11pm
March 23rd – 9:30pm
March 24th – 10pm
Bonus airing in Saskatoon on March 27th – 11pm