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.

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!

 

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.

 

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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.

 

Dallas Buyers Club and Saskatoon Marijuana

I just penned a short piece on Dallas Buyers Club and the current debates about medical marijuana in Saskatoon, SK for the Star Phoenix.

Dried Buds
Dried Buds

With the federal election fast approaching, the Harper government’s move to enlarge Canada’s marijuana industry, and the RCMP’s potential actions against dispensaries here in Saskatoon, a lot is happening!

 

The piece begins this way:

In the award-winning 2013 movie, Dallas Buyers Club, we are exposed to heroic patient activism during the AIDS crisis in the U.S. Based on the true story of AIDS-stricken Ron Woodroof, a hard-partying Texas tradesman, the film shows a strikingly thin Matthew McConaughey battle his sickness and the legal authorities in Texas.

images

Woodroof, who’s unhappy with his illegally purchased AIDS medicine, and on the edge of death, seeks out alternative and experimental drugs from a doctor in Mexico. Then Ron, being the savvy entrepreneur that he is, quickly establishes a club (a dispensary) to sell his unregulated, sometimes dangerous, imported medicines. In doing so, he operates outside the law and is forced to confront the existing power structure of drug regulation. At one point in the film, Ron storms a town hall meeting of citizens, drug company leaders, and regulators and starts finger-pointing. “People are dying. And y’all up there are afraid that we’re gonna find an alternative without you.”

Saskatoon’s current struggle with illegal marijuana dispensaries has many parallels.

Mark Hauk, who operates Saskatoon’s first medical marijuana dispensary, is one of 13 pot club owners across Canada who has recently received a notice from Health Canada warning of possible RCMP raids.

These stores and clubs are illegal because they procure and sell their products outside the federal medical marijuana system, which was overhauled and expanded last year to allow industrial-scale production of pot products that are mailed directly to licensed patients.Dallas-Buyers-Club-poster-2013-movie-poster-HD

While this system was certainly upgraded through the Harper government’s Marijuana for Medical Purposes Regulation, there are still areas for improvement.

According to Neil Boyd at Simon Fraser, “…it is really quite bizarre that they’re using a mail-order system for marijuana as medicine; that’s not the way medicine is usually dispensed. Medicine is usually dispensed through a visit to a physician and through a pharmacy.”

The entire opinion-editorial, which is called “Pot problems have a familiar ring,” can be found here.

Happy Halloween, and a Freaky Fen-Phen Article

heart foundationskull-taking-drug-opiate-addictionCRI_172252

Happy Halloween, everybody!

The best part of the day is not the cute kids in their adorable costumes. Or the wild parties. Or seeing Michael Jackson’s Thriller over and over and over again. No. The best part has to be the treats.

As I was casually munching chocolate bars with my coffee this morning (Wunderbar is my favourite, hands down!), I thought about the implications. For many Canadians and Americans, cleanses are the answer. Some hit the gym, while others get more drastic and take all sorts of diet pills. Often, it is buying the hot new diet pill, like Time magazine shouts below.

Fen-Phen was one of the hottest diet drugs of the 1990s; unfortunately, it proved dreadfully unsafe. In the Encyclopedia of Pharmacology of Society, I offer a short overview of this weight loss therapy. I recount some of the more ghoulish aspects of the drug. I provide insight into the macabre nature of diet pills, much as I did with another frightening article called Trimming Down.

sage coverfenphencover

This textbook, which is about 2000 pages, will be a fantastic resource for all those people wondering about the role of drugs – including diet drugs – in everyday life. Honestly, the price of the book is blood-curdling, but it’s certainly worth the chills. It answers some crucial questions: How powerful is the drug modern industry? What’s it’s role in society, and how are we influenced by it? Who are the major players? And what does the future of drugs hold?

So, have a great Happy Halloween. Enjoy the candy and costumes. Me, I’m going to probably dole out some treats and watch the Princess Bride, as per household tradition. Remember, a book of Pharmacology and Society’s girth would be a great tool to take out all manner of goblins, ghouls, or rodents of unusual size (ROUS)!

Cheers! Enjoy your treats.