Big Pharma Round-Up

A round up of the recent Big Pharma and FDA stories.

Antibiotics in Farm Animals Drop:

https://www.theatlantic.com/health/archive/2017/12/antibiotics-farm-animal/547904/

Teva Pharmaceuticals is being reshaped:

Rebooting the FDA:

https://www.politico.com/agenda/story/2017/12/13/fda-approval-alternatives-000593

On AstraZeneca:

https://www.digitallook.com/news/broker-recommendations/astrazenecas-drug-pipeline-call-reinforces-barclays-top-pick-in-sector–3031953.html

 

Top 5 Stories of 2017:

https://investingnews.com/daily/life-science-investing/pharmaceutical-investing/5-top-pharmaceutical-stories-2017/

FDA clears the Apple watch:

The FDA is going to go after price gouging:

And supplement makers:

Bipartisanship on Drug Prices:

https://www.bloomberg.com/news/articles/2017-12-14/bipartisan-approach-on-drug-prices-emerging-after-health-fights

https://www.medscape.com/viewarticle/890002

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I’ve more than likely missed some angles and stories. Drop me a line if you have suggestions.

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Here’s a flyer for 30% off my Big Pharma book!

Richert_Flyer_2017

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Blood, Sweat, and Tears

FROM THE CBC:

It was probably one of the most bizarre medical cases a team of Italian doctors had ever seen.

A 21-year-old woman was admitted to hospital with a condition that caused her to sweat blood from her face and from the palms of her hands. This despite any sign of skin lesions.

The case was highlighted Monday in the Canadian Medical Association Journal (CMAJ).

Doctors say the patient had a three-year history of bleeding. There was no obvious trigger, and the spontaneous bleeding could happen while she slept and during physical activity. More intense bleeding happened when the patient was under stress, with episodes lasting anywhere between one and five minutes.

***

Canadian medical historian Jacalyn Duffin says at first she was skeptical whether people could sweat blood. She thought the Italian doctors were being duped. But after an exhaustive review of historical literature and more recent reports on cases of hematohidrosis, or sweating blood, she’s a believer.

“After all the research that I’ve done, I am convinced of the plausibility and the possibility that it exists,” she said. Duffin, who is also a hematologist, wrote a commentary that accompanies the journal article.

She acknowledges that hematohidrosis syndrome is incredibly rare. The medical history has been “muddled” with references in religious literature to the crucifixion of Christ, she says and the two are very difficult to separate.

“But case reports start appearing in the 16th century, and quite distinct from anything to do with the crucifixion, or Christianity”, she says. “There are mentions of the phenomenon as far back as Aristotle … prior to the time of Jesus,” she told CBC News from her home in Kingston, Ont.

Read the full article here.

http://www.cbc.ca/news/health/blood-cmaj-health-hematohidrosis-disease-1.4365126

Disability and the Welfare State

Following party conferences, it seemed worthwhile to raise the issue of disability politics and the welfare state. The topic is tackled by Dr Jameel Hampton. As he describes it: “Created during and after the Second World War, the British Welfare State seemed to promise welfare for all, but, in its original form, excluded millions of disabled people.”

His recent book examines attempts “to reverse this exclusion.” Considering the recent emergence of the history of disability in Britain as a major area of research, the book can add to the conversation.

According to C Norris, in Oxford University Press’ This Year’s Work in Critical and Cultural Theory,  “Disability and the Welfare State in Britain is a remarkable achievement. Hampton’s excavation and elucidation of archival material related to the Disability Income Group, as well as other key players in the debates over disability and statutory welfare in Britain in the twentieth century, is both important and impressive.”

* Dr Jameel Hampton teaches at Liverpool Hope University (hamptoj@hope.ac.uk)

 

Immoral or Merciful? Canadian Doctors Divided on Medically Assisted Death — Longreads

Some doctors are struggling with allowing Canadians to die on their own terms.

via Immoral or Merciful? Canadian Doctors Divided on Medically Assisted Death — Longreads

Here I share a powerful article by Krista Stevens.

Cannabis ‘Policy Brief’ Announcement

It’s my pleasure to promote the publication of an important Policy Brief on Cannabis by Kathleen Thompson. Over the past few years she has helped drive conversations about the consumption and control of marijuana. Her recent Policy Brief ought to be read by anyone and everyone! Here’s an extract.

LEGALIZATION OF CANNABIS: THE POLICY CHALLENGES AND OPPORTUNITIES

By Kathleen Thompson, PhD, MSW, RSW, BA (Hons)

“The commitment by the Government of Canada to legalize cannabis
and cannabis products presents a complex range of socio-economic
challenges and opportunities. Creating the right legal and regulatory
framework to address the implications, both good and bad, will be
key in determining whether legalization is deemed successful public
policy.
The federal government plans to introduce cannabis legislation in the
coming spring session of Parliament. The legislation will be based on
the recommendations contained in a report issued on November 30 by
a Task Force of experts who studied the issue for the past year. The Task
Force received input from more than 30,000 Canadians, organizations
and professionals. Entitled “A Framework for the Legalization and
Regulation of Cannabis in Canada”, the report recommends allowing
more flexibility in the current federally controlled cannabis cultivation
model. Specifically, the federal government would regulate a safe and
responsible supply chain of cannabis.”

The full document, which has been sent to law enforcement and government officials across Canada, can be read on the Johnson-Shoyama website or downloaded here thompson-policy

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Large Indoor Marijuana Commercial Growing Operation With Fans, Greenhouse, Equipment For Growing High Quality Herb. Cannabis Field Growing For Legal Recreational Use in Washington State
Large Indoor Marijuana Commercial Growing Operation With Fans, Greenhouse, Equipment For Growing High Quality Herb. Cannabis Field Growing For Legal Recreational Use in Washington State

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ABOUT KATHLEEN THOMPSON

Dr. Thompson has worked in health policy analysis and research as a bureaucrat and as a consultant for the last 25 years, specializing in the mental health, disability and corrections sectors.

In 2015, Dr. Thompson created the Cannabis Regulatory Research Group. The focus of the policy research group is on promoting collaborative public policy processes and evidenced-based research with the cannabis industry, governments, academia, civil society and at the United Nations. Additionally, Dr. Thompson consults with individuals and organizations on how to enter the legal cannabis industry.

 

 

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.”

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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

Cocaine and Colombia

The first line of a recent Washington Times story about cocaine in Colombia spells the country incorrectly. ‘Ninety-five percent of the cocaine sold on the streets of the United States today comes from Columbia.’ Don’t get me wrong, we all make mistakes. But c’mon. Really? Then, the rest of the article mixes the spellings.

It’s weird.

Here’s what’s going on, according to the Economist:  “In October some 200 FARC troops here, like up to 15,000 of their comrades across the country, will assemble at a designated area and start putting their weapons into containers under the watchful eyes of a UN mission that will later supervise their destruction. ‘There’s optimism, but there’s also a lot of mistrust,’ says a burly man who is the civilian leader in the FARC territory and gives his name as ‘Grossman.’

The FARC’s disarmament and conversion into a political party is the crux of a peace agreement forged over four years of hard talking in Havana and signed in Cartagena on September 26th. It is not quite true to say, as Juan Manuel Santos, the president, told the UN General Assembly on September 21st, that ‘the war in Colombia is over.’ There are other illegal armed groups. But the struggle between the FARC and the state, exacerbated in earlier years by right-wing paramilitaries, was by far the biggest conflict. It was responsible for most of the 220,000 deaths due to conflict and thousands of kidnappings seen over the past five decades. It displaced perhaps 6m people.

cocaine-image

The agreement comprises 297 dense pages. It is of enormous complexity and involves controversial trade-offs, especially between peace and justice. Politically, if not legally, it can only come into effect if it is ratified by Colombian voters in a plebiscite on October 2nd. Polls suggest that around 60% of those that turn out will vote Yes. But will enough do so to meet the minimum 4.5m votes (13%) campaign in which the naysayers, inspired by Álvaro Uribe, a former president, accuse Mr Santos of selling out democracy and claim he could and should have struck a harder bargain. The Yes campaign counters that its opponents really favour war.”

Essentially, this was the best deal that could be struck.

Even the conservative Washington Times, which can’t even spell the country’s name properly, agrees.

“The White House, the Drug Enforcement Administration, State Department and Department of Defense all have means to coordinate with and assist Colombia in fighting drugs. It’s time to recognize the FARC peace deal for what it is — necessary but dangerous — and take steps to avoid the growth of a narco-state in Colombia that could well fuel a drugs-and-crime epidemic in the United States.”

With all the discussion over Donald Trump’s cocaine habit, Colombian policy seemed particularly relevant!

Here’s a classic!

 

 

University of Strathclyde

I just started a new job as a Lecturer at the University of Strathclyde, based in Glasgow. I’m absolutely thrilled to be a part of the School of Humanities and Social Sciences. It was a big, big move – from Saskatchewan to Strathclyde – and, to be honest, I’m still making the adjustment.

( Chips v. Fries ** Football v. Soccer ** Jumper v. Sweater ** Pants v. Underwear ** and so on, and so on…)

Luckily, the transition has been eased by amazing new colleagues, who are quite simply awesome. All the worst horror stories you hear about in academia, including internecine squabbling or raging egomaniacal personalities colliding with each other over hum-drum topics, aren’t an issue here. There’s way too much collegiality and friendliness. Everyone’s chipping in. It’s weird. And I like it.

I will be helping with two modules: (1) Disease and Society & (2) Madness and Society. It’s gonna be a blast!

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…

 

 

Sports and Sports Medicine in CBMH/BCHM

Do you have an Olympic hangover? Missing the thrills and excitement? You’re not alone. People are clearly pining for more of Bolt and Biles, Phelps and the Fijians. But fear not. You can get your fix in CBMH/BCHM.

Back in 2011, the journal held a special issue on sports and medicine. The editors, Eileen O’Connor and Patricia Vertinksy, argued that “elite sport” and “sports medicine are increasingly at the forefront of public consciousness, especially when the Olympic Games come to town…”

But they’re aim was to push beyond the Olympics. It would be an error, they suggested, to “confine the historical study of sport medicine to the world of high level athletics,” considering the linkages “between exercise, sport and medicine for all age groups and in different regions of the world goes back millennia.”

Nevertheless, the Olympics get some attention! Thankfully. In James Rupert’s Genitals to Genes: The History and Biology of Gender Verification in the Olympics and Parissa Safai’s A Healthy Anniversary? Exploring Narratives of Health in Media Coverage of the 1968 and 2008 Olympic Games, readers are exposed to scientific and mass media analyses of the games. Both are excellent and topical articles!

*****

The former is very interesting, especially since the 800 metre women’s final was the most controversial race of the Olympics. Some in the race openly questioned whether Caster Semenya of South Africa should have been allowed to compete due to a condition called hyperandrogenism, where an athlete’s testosterone level is elevated. It’s also been suggested that Francine Niyonsaba and Margaret Wambui might also have a similar condition. According to the National Post, Poland’s Joanna Jozwik, who was fifth in Saturday’s final, and Great Britain’s Lynsey Sharp, who was sixth, both openly questioned the fairness of female athletes competing with high levels of testosterone.

rio-olympics-postmedia-melissa-bishop-of-team-canada-finis
Canadian Melissa Bishop placed 4th

*****

If you’re interested in sports in specific geographical regions, then you can also get your fix. Bouchier and Cruikshank, in Abandoning Nature: Swimming Pools and Clean, Healthy Recreation in Hamilton, Ontario, c. 1930s-1950s, address Canada. Gertrud Pfister tackles “Sports” Medicine in Germany and Its Struggle for Professional Status, whereas the prolific public historian Vanessa Heggie showcases Sport (and Exercise) Medicine in Britain: Healthy Citizens and Abnormal Athletes. It’s a remarkable set of essays.

And below was a remarkable race!

For more on what I’m doing with the CBMH/BCMH, please see the announcement here.