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.

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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.

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EpiPen Price Gouging is Old News

On Thursday, Mylan announced a series of steps that will make its EpiPen more affordable for some patients. Over the past few years, Mylan had raised a standard two-pack of EpiPens to roughly $600. It had cost $100 in 2009. Then, following a recent uproar, including a public tongue-lashing from Hillary Clinton and a US Senator whose daughter uses the product, Mylan NV (MYL) said Wednesday it would help reduce the cost of the emergency allergy drug for people who are struggling to afford it. Clinton, for her part, became  excoriated Mylan’s “price gouging,” kicking off another selling spree on Wall Street, where Mylan’s stock has plummeted roughly 11% and the Nasdaq Biotech index saw a 3.4% decline, which was the worst of the summer.

Epipen

In a press release, Mylan said it would provide instant savings cards worth $300 to patients who have to pay full price for the drug out of pocket. That amounts to about a 50% price cut for people without insurance or for patients with high deductible plans.

“We responded this morning, first and foremost, ensuring that everybody that needs an EpiPen has an EpiPen,” Mylan CEO Heather Bresch said in an interview with CNBC. “As a mother I can assure you that the last thing we could ever want is no one to have their EpiPen due to price.” When asked why the price of EpiPen increased so much over the years, Bresch, who is the daughter of Senator Joe Manchin of Virginia, blamed “the system” which needs to be “fixed.” She said that with the savings card, “We went around the system. The savings card is equivalent to cash.”

In the course of Canadian coverage, it was assumed that Americans would be travelling north to grab cheaper EpiPens. And this is far from new.

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In 2013, I wrote about Americans purchasing pharmaceuticals from Canadian stores in Canadian Review of American Studies. The paper was called The Maple Peril and it explored the practice of cross-border drug reimportation, and considered the Bush and Clinton administration’s policies regarding the necessary balance between drug access, affordability, and safety.

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In the 1990s, lower drug prices in Canada forged a strong relationship between American consumers and the Canadian industry, leading to the expansion of illegal cross-border reimportation. This occurred in person or through Internet pharmacies. In Canada, the Patented Medicines Price Review Board (PMPRB) imposes federal price regulations, but a number of other reasons also drive down Canadian drug prices. For instance, lower prices on Canadian brand-name drugs are likely the normal result of market economics; that is, prices are matched to different supply and demand dynamics in the Canadian and American markets.

In 2001, as President Bush took office, thanks to Canadian regulations— as well as a weak Canadian dollar—Americans were saving 50 per cent to 70 per cent filling their prescriptions in Canada. In 2004, Canada’s review board reported that Americans paid an average 67 per cent more than Canadians for patented drugs; in 2003, while a three-month prescription for Merck’s cholesterol reducer Zocor cost $172 in Canada, American patients paid $328 for the same pills. The antiretroviral drug ritonavir (Norvir) cost as little as a $700 per year in Canada as opposed to $7,800 per year in the United States.

From the consumer’s standpoint, it was thus eminently rational – or, smart – to seek alternatives to American drugs. And it should come as no shock that drug prices became a major political and economic question mark within the Bush administration.

***** BEGIN PRICES BACKGROUND *****

The troubling matter of drug costs was first contested in the 1950s. Historian David Herzberg argues that ‘‘increasing competition and ever more intense advertising transformed the character of the once staid prescription drug business’’. The new, transformed pharmaceutical industry was challenged in the political arena when, in December 1959, Senator Estes Kefauver (D-TN) took up the general issue of administered prices. Through the Senate Subcommittee on Antitrust and Monopoly he investigated a host of industries, including ‘‘bread, milk, auto, steel, and electrical manufacturing’’ industries. He also focused on the American pharmaceutical industry’s monopoly and revealed a ‘‘series of price-fixing and collusion scandals’’.

During the ten-month hearings, 150 witnesses testified about cortical steroids, tranquilizers, antibiotics, and oral antidiabetics. Kefauver, who ‘‘favored an economy in which competition among small producers set prices,’’ asserted that the drug industry practised ‘‘price leadership’’ and suffered little foreign or domestic competition. His two principal experts, Dr. John Blair and Paul Rand Dixon, were media savvy and compared a drug’s production costs to its wholesale and retail prices; thereafter they brusquely questioned representatives of the pharmaceutical industry and neatly underlined the fact that consumers in the United States were paying a hefty sum for their medications. In one extraordinary example, the markup was 7000 per cent.

Kefauver’s subcommittee hearings, aided by the Thalidomide scare in 1962, eventually led to the passage of the 1962 Kefauver-Harris Act. Compulsory licensing and greater patent regulation, significant
pricing reforms, were excluded from the final product. Still, Kefauver’s legislation had a lasting impact. It increased the power of the FDA—the ultimate authority on whether a drug goes to market—and mandated a drug be both safe and effective; the new law also established standardized manufacturing procedures.
According to physician Jerry Avorn, the new law represented a ‘‘watershed moment in the nation’s approach to medications.’’ The legislation ‘‘completely changed the way doctors and patients thought about drugs’’. Just as important, Kefauver (and his pricing hearings) was the forerunner for a cascading set of consumer oriented hearings which focused on the growing power of the pharmaceutical industry’s advertising as well as the addictive nature of stimulants and sedatives.

***** END OF PRICES BACKGROUND *****

While President Bush adopted an amorphous position on reimportation, his appointments at the HHS and FDA did not.

In 2002, Tommy Thompson, who had already scuttled the legalization of reimportation, combined US national security imperatives and a policy opposing counterfeit drugs. In his estimation, drugs reimported to the United States from Canada constituted a clear and present danger to American consumers and, building his case, drew parallels with the new War on Terror launched after 11 September 2001. Thompson warned that ‘‘opening our borders to reimported drugs potentially could increase the flow of counterfeit drugs, cheap foreign copies of FDA-approved drugs [what the rest of us call generics], expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions.’’ Thompson’s argument concluded with a reference to the recent terrorist threats in Washington DC and around the country: ‘‘In light of the anthrax attacks of last fall, that’s a risk we simply cannot take’’.

In 2002, FDA officials underscored the necessity for vigilance against the dangers of drug importation. After chronicling the FDA’s recent legal struggles with counterfeit criminal enterprises in Alabama, Los Angeles, and Texas, one FDA leader recounted the seriousness of drug importation’s risks to public health. ‘‘Throwing open the door to drugs purchased by individuals directly from Canadian sellers,’’ Hubbard said of potential legalized importation, ‘‘will encourage unscrupulous individuals to devise schemes using Canada as a transshipment point for dangerous products from all around the globe’’.

Another tactic was to direct advertisements at consumers. One particular ad, sponsored by the drug industry, depicted two identical looking pills over the caption Quick. Pick the Capsule that Hasn’t Been Tampered With. The advertisement cited the support not just of the FDA and HHS, but the US Customs Service and Border Patrol and the DEA, arms of government usually concerned with protecting
Americans from very different kinds of drugs. The ad warned, furthermore, that allowing Americans to fill prescriptions in Canada ‘‘could open America’s medicine cabinets to an influx of dangerous drugs,’’ and it closed with an appeal to ‘‘Keep Black Market Drugs Out of America’’.

Ominous government advertisements also influenced Americans not to purchase drugs from Canada. A poster sponsored by the FDA and CBP also cast doubts on the safety and quality of foreign drugs. In an ad titled ‘‘Buying Medicine from Outside the U.S. Is Risky Business,’’ a vicious green snake, with fangs bared and piercing golden eyes, is shown squeezing a bottle of pills. To the right of the viper, the ad asked Americans: ‘‘Think it’s safe buying medicine from outside the United States? Think again.’’

 

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Essentially, the recent story of the EpiPen is far from new. Thanks for reading!

Here’s Bernie on prices after the Martin Shkreli story…

 

 

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.

 

Fentanyl vs. Alcohol

The Canadian Broadcasting Corporation (CBC) told us today that there’s been a rise in Fentanyl-related deaths in Saskatchewan. No doubt, this is a major issue. But I also wanted to contextualize this story with some information about booze.

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According to the information collected by the Office of the Chief Coroner, there have been 41 fentanyl-related deaths in the province from 2010-15. These numbers do not include overdose deaths determined to be suicides.

Alyson Edwards, director of public affairs for the Saskatoon Police Service, said this is an “extremely” important issue.

“Not just deaths, but the number of near-misses, the number of overdoses where fentanyl may have been a factor,” Edwards said. “These are all concerns to us because this drug seems to be a drug of choice among young adults and it just won’t end well if that continues.”

The full story is here: http://www.cbc.ca/news/canada/saskatchewan/41-fentanyl-related-deaths-saskatchewan-since-2010-1.3484346

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This bears consideration, of course. But what about booze? What about alcohol-related deaths? What about alcohol-related injuries? Considering I study the history of drugs and alcohol, I had to dig a bit…

I went to SGI – ie., Saskatchewan Government Insurance.

There’s a revealing report from 2016 that demonstrates how Fentanyl is not necessarily the only drug we ought to be worrying about.

Injuries Due to Alcohol-Involved Collisions

2010: 779; 2011: 642; 2012: 736; 2013: 590; 2014: 536 = 3,283

Deaths Due to Alcohol-Involved Collisions

2010: 71; 2011: 66; 2012: 69; 2013: 42; 2014: 59 = 307

Bear in mind, too, that this doesn’t take into consideration 2015.

Am I suggesting we ignore Fentanyl? No way. Am I suggesting that 41 deaths is unimportant? Again, no way. I think it’s a serious concern.

Yet, we should also take stock of the more lethal, legal drug in our province.

Plasma Clinics Deserve Debate

There has been much media coverage about the opening of Canadian Plasma Resources’ first clinic in Saskatoon. I’ve been a part of that debate, having written for the Star Phoenix just yesterday.

Canadian Blood Services has a number of videos that explains the plasma business in Canada and beyond. Thanks to John Dexter for finding these videos on Youtube.

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