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Regeneron CEO Len Schleifer vs Allergan Chief Brent Saunders re Controversial Native American Tribe Patent Deal

Regeneron CEO Len Schleifer vs Allergan Chief Brent Saunders re Controversial Native American Tribe Patent Deal | Pharmaguy's Insights Into Drug Industry News | Scoop.it

One of the drug industry’s most persistent critics happens to be one of its most famous faces. And Dr. Leonard Schleifer, founder and CEO of Regeneron Pharmaceuticals, didn’t disappoint in his latest performance.

 

“It’s nuts,” Schleifer said Thursday of Allergan’s controversial move to protect patents by transferring them to a Native American tribe. Brent Saunders, Allergan’s CEO, made waves and headlines alike last year with a promise to do right by society. To Schleifer, the patent deal violates Saunders’s vaunted social contract and, plainly, “makes your company look bad.”

 

The debate, which took place at Forbes’ annual health care conference, was classic Schleifer, whose schtick routinely breaks up the monotony of drug industry panels that tend to feature wealthy white men agreeing with one another before a live audience.

 

But some analysts caution that Schleifer’s tell-it-like-is persona might have a downside — that he, like Saunders, may one day find his bold words used against him.

 

Further Reading:

  • “Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics”; http://sco.lt/7spJWD
  • “Regeneron CEO Len Schleifer vs Pfizer CEO Ian Read on Drug Prices Redux”; http://sco.lt/8kHMET
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Medical Marijuana Can Save Lives - Here's the Evidence

Medical Marijuana Can Save Lives - Here's the Evidence | Pharmaguy's Insights Into Drug Industry News | Scoop.it

This week, Attorney General Jeff Sessions paused a discussion of the opioid epidemic to, once again, go after marijuana. He suggested that addictive pain medication wasn’t the only problem and that many heroin addicts start out “with marijuana and other drugs.”

 

There is a relationship between cannabis and opioids, but Mr. Sessions has it backward. Marijuana isn’t a gateway drug to opioid addiction; it’s a safer alternative to pain medicines. Mr. Sessions’s vow to crack down on marijuana will only make the opioid epidemic worse.

 

We know that 40 percent of all opiate overdose deaths involve a prescription opiate. So having legal access to cannabis as another option for pain relief may actually reduce consumption of opiates.

 

I know it sounds counterintuitive, but consider the evidence. To start, a large study assessed the effect of medical-marijuana laws on opiate-related deaths between 1999 and 2010 in all 50 states and reported a 25 percent decrease in opiate overdose mortality in states where medical marijuana was legal, compared with those where it wasn’t. The study found that in 2010, medical-marijuana laws resulted in an estimated 1,729 fewer deaths than expected.

 

Other epidemiologic studies found similar results. A study published last year examined opiate-related deaths in Colorado between 2000 and 2015. Researchers compared mortality rates before and after the state legalized recreational cannabis in 2014. For controls, they chose two nearby states: Nevada, which legalized only medical cannabis, and Utah, where all cannabis use is illegal. The study found a 6.5 percent drop in opiate-related deaths after recreational cannabis became legal in Colorado.

 

Likewise, other researchers examined the link between medical cannabis and opiate use in a group of patients with chronic pain in New Mexico, one of the states hardest hit by the opioid crisis. They reported that subjects who had access to medical cannabis were 17 times more likely to stop using opiates for pain compared with those not using cannabis.

 

Because these are all observational studies, they cannot prove a causal link between cannabis use and lower opiate-related mortality. Still, the consistent epidemiologic evidence is hard to ignore.

 

Why might cannabis work so well as an alternative to opioids? It does offer some mild pain relief. But more significant, both opiates and cannabis — like all recreational drugs — cause the release of dopamine in the brain’s reward pathway. That signal conveys a powerful sense of pleasure and craving. Thus, cannabis might pre-empt some of the rewarding effects of opiates, decreasing the general desire to use them.

 

There is also intriguing preliminary evidence that cannabidiol, a major component of marijuana, can blunt craving in individuals with opioid dependence following a period of abstinence.

 

If cannabis were actually a dangerous gateway drug, as the attorney general suggested, it would be very easy to see in the data. We would find that medical-marijuana laws increased opiate drug use and overdose deaths, when in fact just the opposite has happened.

 

Author: Richard A. Friedman is a professor of clinical psychiatry and the director of the psychopharmacology clinic at the Weill Cornell Medical College

 

Further Reading:

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PTx Buys ex-Sanofi Anti-Radiation Drug Leukine Because These Days You Never Know!

PTx Buys ex-Sanofi Anti-Radiation Drug Leukine Because These Days You Never Know! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Partner Therapeutics, a Boston startup formed last week by a pair of Merrimack and Seragon executives, has made its first move: it’s acquired an ex-Sanofi cancer drug with hopes that the FDA will OK it for radiation poisoning. Like… the kind from an atomic bomb or a nuclear plant disaster.

 

Seems like a rare and uncommon event to target, but founder and CEO Bob Mulroy says it’s best to be prepared.

 

“You would hope you’d never need a drug like this for this kind of incident,” Mulroy told The Boston Globe. “But I think that, should an incident like that occur, being prepared for it is a very important thing.”

 

The Globe and others are positing that insults slung between President Trump and North Korean leader Kim Jong Un are fueling fears of nuclear war, leading to demand from people and governments to stockpile radiation sickness drugs.

 

The medicine is called Leukine, and it’s currently approved to treat acute myeloid leukemia patients fighting infections after undergoing bone marrow transplants. But data presented at the 2016 American Society of Hematology meeting showed Leukine’s ability to boost survival in monkeys exposed to radiation if injected 48 hours after exposure. That’s interesting, considering Amgen’s radiation sickness drugs Neupogen and Neulasta must be injected almost immediately after exposure to radiation for it to work.

Pharma Guy's insight:

This drug is not yet approved by FDA for anti-radiation and it's not likely PTx will ever seek approval for that because Trump will ensure it will have a HUGE off-label life!

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Trump: New HHS Secretary Will "Get Those Prescription Prices Way Down." New HHS Secretary: "LOL!"

Trump: New HHS Secretary Will "Get Those Prescription Prices Way Down." New HHS Secretary: "LOL!" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Trump used the swearing-in of the new secretary of health and human services as an opportunity to decry high prescription drug prices and pledge to bring them down — an intention he has long trumpeted but on which he has yet to follow through.

“He’s going to get those prescription drug prices way down,” Trump said as he introduced Alex Azar at the White House Monday.

“Prescription drug prices is going to be one of the big things,” Trump said of Azar’s new job. “Whenever I speak to Alex, I speak to him about that, I think, prior to anything else. And I know you can do it. You know the system. And you can do it because it’s wrong.”

 

Further Reading:

  • “Public Citizen: Azar Would Be Detrimental to Americans’ Access to Health Care”; http://sco.lt/8kYVzl
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HHS Tweet Touts the Trump Administration’s “Accomplishments” Like Its “Sham” Response to the Opioid Crisis, Withdrawing Regulations, and Cutting Open Enrollment Budget by 90%!

HHS Tweet Touts the Trump Administration’s “Accomplishments” Like Its “Sham” Response to the Opioid Crisis, Withdrawing Regulations, and Cutting Open Enrollment Budget by 90%! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A new report released by the Department of Health and Human Services highlights the greatest hits of the Trump administration in 2017.

 

Among the highlights touted: efforts to identify federal regulatory burdens that hurt patients, as well as ways to lower high prescription drug costs. The result, the report said, was a “net decrease in the burden imposed by HHS regulations as well as positive reforms in a range of Medicare payment rules, actions from the Food and Drug Administration, and ongoing reviews of further areas for action.”

 

Regulatory rollbacks

To reduce burdensome regulations, the report notes that HHS withdrew 70 regulatory actions taken by the Obama administration, took 68 deregulatory actions and only introduced 27 regulations. In addition, CMS Administrator Seema Verma went on a listening tour to talk to providers, doctors and clinicians about regulatory burdens.

 

Open enrollment cutbacks

But many of the accomplishments listed in the report were controversial. For example, HHS says it conducted a “successful, consumer-friendly open enrollment period at significantly lower cost than in previous years, attracting similar levels of enrollment with more focused investments in marketing:” Yet the enrollment numbers are generally credited to the fact that private insurers stepped up advertising efforts to compensate for the fact that the federal government cut its ad budget by 90% and the amount of time citizens had to enroll in plans.

 

Response to opioid crisis

The report is also proud of the administration’s work to combat the opioid crisis in the U.S., citing Trump’s declaration that the epidemic was a national public health emergency and raising public awareness to the issue. But the response has been criticized by many who note that without funding, the declaration was meaningless. Last week former Democratic Rep. Patrick Kennedy, one of six members appointed to a bipartisan commission in March by President Trump to address the opioid crisis, called the work done by the task force a sham because the administration hasn’t put any money behind the actions the group suggested to combat the epidemic (http://sco.lt/6xPgUj).

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AIDs Advocates Accuse Gilead of Creating "Unethical" Barriers to Truvada Access

AIDs Advocates Accuse Gilead of Creating "Unethical" Barriers to Truvada Access | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A trio of AIDS advocacy groups is accusing Gilead Sciences (GILD) of drastically limiting a key component of an AIDS prevention treatment in an “unethical” manner that may violate federal guidelines.

 

At issue is a Gilead drug called Truvada, which is combined with one of two other medicines to form nPEP, or non-occupational post-exposure prophylaxis, the term used to describe preventive treatment. Observational studies suggest the combination can reduce the risk of acquiring HIV infection when started within 72 hours of exposure and continued for a month.

 

However, the drug maker has purportedly created barriers to access, according to the advocacy groups. They maintain that, through a patient assistance program, Gilead has limited access to just once in a lifetime, and has also implemented “hardship review criteria” and procedures for obtaining subsequent prescriptions that have not been clearly articulated.

 

“We believe this policy is unethical and incompatible with CDC guidelines and we implore you to immediately end such an unreasonable policy, in favor of a transparent and accommodating policy that ensures unencumbered and streamlined access to nPEP for those vulnerable to HIV infection,” the groups wrote to a Gilead executive in a letter on Thursday.

 

The groups noted that nPEP is believed to be effective if provided within 72 hours, as suggested in CDC guidelines for HIV prevention, but they argued that the access stipulations imposed by Gilead may make it difficult, if not impossible, for someone to obtain treatment. The other drugs combined with Truvada are either Tivicay, which is marketed by ViiV Healthcare, or Isentress, a Merck (MRK) drug.

 

“We’re afraid this policy is overly stringent,” said Tim Horn, who chairs the Fair Pricing Coalition, one of the organizations that, along with Treatment Action Group and the National Alliance of State & Territorial AIDS Directors, wrote Gilead to complain. “We don’t even know what the hardship qualification is in order to obtain treatment.”

 

A Gilead spokesman declined to comment.

 

Further Reading:

  • “Gilead, Support Your "Truvada Whores!" HIV activists target Gilead for holding back on Truvada marketing”; http://sco.lt/5wgFsn
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One Show Renews Health & Pharma Ad Awards Saying Pharma Ads Have “Gotten More Creative.” LOL!

One Show Renews Health & Pharma Ad Awards Saying Pharma Ads Have “Gotten More Creative.” LOL! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharma is back in the One Show creative advertising awards lineup.

 

The awards show, put on by nonprofit The One Club for Creativity, has added the Health, Wellness & Pharmaceutical category for 2018, more than a decade after it discontinued and separated the “One Show Rx” pharma-specific show.

 

The One Club reinstated the categories after a board vote in December. This time, the pharma and health categories will be integrated into the main One Show with the awards—called Gold, Silver or Bronze Pencils—given out at ceremonies on May 9 and 11.

 

The separate One Show Rx ran from 2001 through 2004, but the board decided to pull the show—even though it was financially successful—because “the level of work being done at the time wasn’t worthy of awarding a One Show Pencil,” CEO Kevin Swanepoel said.

 

But that's changed, the One Club board now agrees.

 

“With a lot of shows now rewarding the (pharma and healthcare) work, creatives are pushing the boundaries and the work has gotten a lot more creative,” Swanepoel said. He added that better work also helps attract better talent and encourages pharma and healthcare clients to be more “brave” in trying new or envelope-pushing ads, lifting the overall quality even further.

 

Further Reading About Those “Creative” Pharma Ads:

  • “A "Good" Use for Man Boobs: Winning Grand Prix Lions Creativity Award”; http://sco.lt/8LZ6af
  • “Lions Health Awards Jury President Thinks "Smelly Fish" Award was "Charming" & "Best We Could Do"!”; http://sco.lt/8djQun

 

************

Awards. What Are They Good For?

 

Awards, huh, yeah!

What are they good for?

Absolutely nothing

Uh-huh

Listen to me

 

Ohhh, awards, I despise

Because it means gala dinners

Of rubber chicken and butter knives

 

Awards mean tears

To thousands of advertisers’ eyes

When their ads are broadcast on nightly TV

But never affect consumers’ lives

 

Awards, they ain't nothing

But a heartbreaker

Awards, friend only to the magazine publisher

They’re an enemy to all pharma kind

The point of awards blows my mind

Awards have caused unrest

Within the new media generation

Disrespect then co-optation

 

Ooooh, awards, have shattered

Many a young man's dreams

Made him cynical, bitter and mean

Drug pipelines are much too short and precious

To waste time vying for awards today

Awards can't increase DTC's ROI

They can only raise an ad agency's pay

 

Creativity, ROI and good communications

Tell me, is there no place for them today?

They say we must give awards to know what’s best

But Lord knows there's got to be a better test

 

Awards, huh!

Good God y'all!

What are they good for

Stand up and shout it

Absolutely nothing

 

With apologies to the Motown 1970 hit “War” by Edwin Starr.

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The D.C. Pharma Lobbying Swamp is Bigger & More Slimy Than Ever! PhRMA & BIO Set a New Record in 2017

The D.C. Pharma Lobbying Swamp is Bigger & More Slimy Than Ever! PhRMA & BIO Set a New Record in 2017 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The two big groups that lobby on behalf of drug companies set a new record for their collective spending in the first year of the Trump administration.

Shelling out a combined sum of nearly $35 million to lobby the federal government in 2017, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization upped their expenditures at a time when the sweeping tax overhaul was on the line and fears of a crackdown on drug pricing were top of mind. Remarkably, however, the record-setting spending push came in spite of the fact that neither group took a position on the biggest health policy story of the year, the long and steady Republican quest to repeal and replace the Affordable Care Act.

PhRMA came just short of breaking its own record. The group spent more than $25 million — just about $700,000 shy of its spending total in 2009, at the height of the debate over the ACA in the first year of the Obama administration. BIO spent more than $9 million, the most since at least 1999, the earliest year quarterly lobbying spending is available online for the two organizations.

The groups spent their lobbying dollars on some of the issues that generated big headlines of 2017: the new law that rewrote the tax code. Legislation concerning drug pricing. Right-to-try. Drug importation. Accelerated pathways for drug approvals. Policy issues around incentives to encourage development of drugs for rare diseases. And the confirmation of Alex Azar, President Trump’s pick to lead the Health and Human Services Department. 

 

Click here (subscription required) to see the TOP 15 Pharma company lobbyists!

Pharma Guy's insight:

This swamp will never be drained! The "PharmaGovernment Complex" is alive and well!

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Azar Approved by Senate Finance Committee and on His Way to Being Confirmed as New Head of HHS in the Senate

Azar Approved by Senate Finance Committee and on His Way to Being Confirmed as New Head of HHS in the Senate | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Senate Finance Committee voted Wednesday to advance President Trump’s nominee to serve as head of Health and Human Services. The vote was 15-12, with Sen. Tom Carper of Delaware the only Democrat to support him.

 

Azar now faces a Senate floor vote, where he is expected to be confirmed.

 

Two Democrats, Sens. Heidi Heitkamp of North Dakota and Joe Manchin of West Virginia, have said they would vote for Azar's nomination, giving Republicans more than enough votes to pass him. Republicans have a 51-49 majority in the Senate, and Cabinet nominees need only 51 votes to be confirmed.

 

Heitkamp called Azar, a former Eli Lilly executive and HHS veteran under the George W. Bush administration, “incredibly competent.”

 

Still, some Democrats have railed against Azar, and have said that he raised the prices of multiple drugs while he was the head of Eli Lilly’s U.S. division from 2012 to 2017. Democrats are skeptical that Azar will do enough to rein in drug prices.

 

Azar has said that the system does not incentivize drug makers to lower prices. He said that combating high prices will be one of his top priorities.

 

Further Reading:

  • “Public Citizen: Azar Would Be Detrimental to Americans’ Access to Health Care”; http://sco.lt/8kYVzl
  • “If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse”; http://sco.lt/67pLZR
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AbbVie, Pfizer Drive 2017 #Pharma TV Ad Spending to Record High

AbbVie, Pfizer Drive 2017 #Pharma TV Ad Spending to Record High | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Think you saw a lot of TV ads for drugs in 2017? That's because you did. Pharma spending on national TV ads for 2017 climbed even higher than in 2016—by more than $330 million. The total tally was $3.45 billion, compared with $3.11 billion in 2016, according to data from real-time TV tracker iSpot.tv.

 

The full list of the top 20 TV ad spenders below, courtesy of iSpot.

 

  1. AbbVie’s Humira: $341 million
  2. Pfizer’s Lyrica: $216 million
  3. Pfizer’s Xeljanz: $167 million
  4. Eli Lilly’s Trulicity: $145 million
  5. Pfizer and Bristol-Myers Squibb's Eliquis: $142 million
  6. Merck’s Keytruda: $127 million
  7. Bayer and Johnson & Johnson's Xarelto: $120 million
  8. Eli Lilly’s Taltz: $116 million
  9. GlaxoSmithKline’s Breo: $103 million
  10. Novartis’ Cosentyx: $100 million
  11. Novo Nordisk’s Victoza: $98 million
  12. AstraZeneca’s Farxiga: $87.4 million
  13. Boehringer Ingelheim and Eli Lilly's Jardiance: $86.9 million
  14. Bristol-Myers Squibb: Opdivo: $82 million
  15. Celgene’s Otezla: $78 million
  16. Gilead’s Harvoni: $75 million
  17. Allergan’s Linzess: $73 million
  18. Novartis’ Entresto: $71 million
  19. Otsuka and Lundbeck's Rexulti: $69 million
  20. Johnson & Johnson’s Invokana: $63 million

 

Further Reading:

Pharma Guy's insight:

According to Kantar Media, pharma spending on TV ads in 2016 was $4.1 Bn. See chart.

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America's Big Pharma Firms Spend More on Shareholders Than R&D and the New U.S. Tax Laws Won’t Change That

America's Big Pharma Firms Spend More on Shareholders Than R&D and the New U.S. Tax Laws Won’t Change That | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At the J.P. Morgan Healthcare Conference in San Francisco this week, executives of big, U.S.-based pharma and biotech firms spoke approvingly of new U.S. tax laws, saying they will "even the playing field" with foreign competitors, lower effective tax rates and increase financial flexibility.

 

Several companies, including Johnson & Johnson, Merck & Co. and Eli Lilly & Co., said the laws would not fundamentally change their capital-allocation strategies. If we take them at their word, then what does that mean?

 

It means research and development spending will be about the same; dealmaking will be opportunistic and difficult to predict; and a lot of money will go back to shareholders in the form of dividends and buybacks.

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How DTC Made Restasis a Blockbuster in the U.S. Even Though Its Efficacy Is Unproven In The Rest of the World

How DTC Made Restasis a Blockbuster in the U.S. Even Though Its Efficacy Is Unproven In The Rest of the World | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Rich Meyer of DTC Marketing Blog Meyer says: "I’m having a hard time understanding how anyone with a conscience could work for a company like Allergan. Transferring patents, rights to a native American tribe (Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics) to try and circumvent the law and using DTC to market a drug that did nothing, according to JAMA but increase health care costs."

 

According to the JAMA article:

 

Restasis is not approved in the European Union, Australia, or New Zealand, where in 2001 registration applications were “withdrawn prior to approval due to insufficient evidence of efficacy. But Americans pay for Restasis—a lot: $8.8 billion in US sales between 2009 and 2015, including over $2.9 billion in public monies through Medicare Part D.

 

An important reason may be the extensive marketing campaign to sell a disease—chronic dry eyes—and its treatment. From 2007 to 2016, Allergan spent $645 million on television, magazine, and electronic ads including its mydryeyes.com website.

 

The website recasts ordinary unpleasant life experiences as disease: “those who experience stinging, burning, and watering eyes might attribute these symptoms to the weather, allergies, contacts or even their eye makeup, when in fact they may be suffering from Chronic Dry Eye (CDE) disease.” Mydryeyes.com invites people to take a quiz. The results come with a warning: “Don’t wait; over time, CDE disease may get worse and may have potential health consequences for your eyes, including damage to the front surface of the eye, an increased risk of eye infection, and effects on your vision.”

 

Based on the evidence, why should consumers, private insurers, and the federal government spend billions of dollars on a marginally effective drug for a condition that many would not consider to be a disease? Restasis might never have reached blockbuster status if payers, clinicians, and consumers had easy access to independent drug information.

 

Further Reading:

Pharma Guy's insight:

An Allergan spokesperson told PMLIVE that "the success of the [Restasis DTC] campaign can primarily be attributed to the fact that the team took a deeper dive into the patient's journey and experience, bringing to life the moment when a patient realises she doesn't just have dry eyes, she has a disease called chronic dry eye." All this hubbub about "a deeper dive into the patient's journey and experience" is secondary to the age-old advertising formula of "reach and frequency." $645 million buys a LOT of TV and magazine ads!

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Drop in life expectancy an "indictment of the American health care system" and hope in new drugs by pharma industry

Drop in life expectancy an "indictment of the American health care system" and hope in new drugs by pharma industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The economy may be growing and the stock market booming, but Americans are dying younger — living shorter lives than previous generations and dying earlier than their counterparts around the world.

 

It is easy to place the blame squarely on our nation’s opioid epidemic, but if we do that we miss seeing the abysmal new life expectancy data from the Centers for Disease Control and Prevention for what they are — an indictment of the American health care system.

 

According to the CDC, the average life expectancy at birth in the U.S. fell by 0.1 years, to 78.6, in 2016, following a similar drop in 2015. This is the first time in 50 years that life expectancy has fallen for two years running. In 25 other developed countries, life expectancy in 2015 averaged 81.8 years.

Pharma Guy's insight:

From CDC: “In 2016, life expectancy at birth was 78.6 years for the total U.S. population—a decrease of 0.1 year from 78.7 in 2015 (Figure 1). For males, life expectancy changed from 76.3 in 2015 to 76.1 in 2016—a decrease of 0.2 year. For females, life expectancy remained the same at 81.1.”

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Public Citizen: Azar Would Be Detrimental to Americans’ Access to Health Care

Public Citizen: Azar Would Be Detrimental to Americans’ Access to Health Care | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Saying that it would be detrimental to Americans for Alex Azar to be secretary of the U.S. Department of Health and Human Services (HHS), more than 60 organizations today urged senators not to confirm him.

In a letter, the groups – representing patients, health care providers, public health experts, women, people of color, workers, consumers and people of faith – said they are deeply concerned by statements made by Azar as well as his record at the pharmaceutical firm Eli Lilly and Company.

“We believe that elevating Mr. Azar to Secretary of HHS would be detrimental to Americans’ access to quality, affordable health care across the country,” the letter said.

The groups oppose Azar because:

• He has denounced the Affordable Care Act (ACA) even though it expanded health insurance coverage and access to health care services for millions of Americans.
• Azar has spoken in favor of converting Medicaid funding into block grants, which would end guaranteed coverage and cap federal funding of program costs without regard for program needs, thereby threatening the services on which millions of Americans depend.
• Azar has said that he does not believe the expansion of Medicaid under the ACA has been successful. However, the evidence shows the contrary; states that expanded their Medicaid programs under the ACA have experienced large reductions in uninsured rates and have seen reduced disparities in coverage by income, age and race/ethnicity.
• Azar will not commit to supporting mandatory no-cost-sharing contraceptive coverage by insurers. Access to contraception without charge ensures that costs do not prevent access to important preventative care, reducing unintended pregnancies that can lead to adverse maternal and child health outcomes.
• Azar’s record at Eli Lilly raises doubts about his willingness and ability to serve the needs of U.S. patients and consumers. While Azar was president of Lilly USA, Eli Lilly’s U.S. affiliate, its insulin skyrocketed from $74 to $269. As a result, patients have skipped refills, injected expired insulin and starved themselves in ineffective attempts to control blood sugar levels.
• Eli Lilly is facing multiple class-action lawsuits alleging violations of the Racketeer Influenced and Corrupt Organizations (RICO) Act, the Sherman Antitrust Act, the Employee Retirement Income Security Act, and numerous state fraud, unfair trade practices and consumer protection laws related to the company raising insulin prices in lockstep with Novo Nordisk and Sanofi. Eli Lilly is also facing a suit brought by the federal government and 31 states alleging False Claims Act violations involving a scheme to boost insulin sales, as well as investigations by at least five state attorneys general.

“At a time when our country is facing a crisis of access to affordable medicines, we need an untainted and credible advocate for patients and our health care system,” the groups wrote. “A former prescription drug company executive with a history of spiking the prices of lifesaving medicines simply is unqualified to address the needs of our national health care system. … the health care of all Americans requires a [S]ecretary of HHS who puts the public above profits and who champions evidence-based approaches over ideology.”

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Flu Vaccine May Provide NO PROTECTION AT ALL from H3N2 Virus, the Dominant Strain This Year

Canadian influenza researchers reported Thursday in the online journal Eurosurveillance that the first reckoning of how well the flu vaccine is protecting against H3N2 viruses this year in North America has a dismal answer: not very.

 

Their midseason estimate, based on data from the four provinces where roughly 80 percent of Canadians live, suggested that the H3N2 component of the vaccine is 17 percent effective at preventing infection. Last year it was estimated at 37 percent in Canada and 34 percent in the U.S.

 

In working-age adults, the estimated protection is lower still: 10 percent. That is in line with the protection level Australia saw in its harsh winter 2017 flu season.

 

And in the case of the assessment of the H3N2 component, the confidence intervals cross zero, which means the researchers cannot rule out the possibility there was no benefit from that part of the vaccine.

 

The report does not estimate how well this year’s vaccine protects against H1N1 viruses. Skowronski said there has simply been too little H1N1 disease in Canada so far this winter to make that calculation. 

 

Whatever the reason, the findings confirm the fact that people who’ve been vaccinated are among those contracting flu this season.

“This is low protection. And the overall message is: People who have been vaccinated should not consider themselves invincible against this H3N2 virus that’s circulating,” said Dr. Danuta Skowronski, lead author of the report and an influenza epidemiologist at the British Columbia Center for Disease Control.

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Increase in Prescription Drug Prices Greater Than Any Other Category of Health Spending

Increase in Prescription Drug Prices Greater Than Any Other Category of Health Spending | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Total health spending per person is now growing at faster rates than prior years, with 4.6% growth in 2016 compared to. 4.1% growth in 2015, which followed 2 years of sub-3% growth from 2012 to 2014. Spending growth in each year from 2012 to 2016 was almost entirely due to price increases. We saw particularly large increases in spending and price for administered drugs, emergency room (ER) visits, and surgical hospital admissions. (Source: The Health Care Cost Institute’s (HCCI) 2016 annual report on U.S. health care cost and utilization?

 

Consumer out-of-pocket (OOP) spending per person increased, but grew more slowly than total spending. This difference in growth led to a decline in OOP spending as a share of total spending.

 

From 2012 to 2016, they observed increases in prices each year and across nearly all service categories. The greatest cumulative price increase was seen in prescription drugs, with 24.9% price growth.

Pharma Guy's insight:

It will be interesting to see data for 2017 whenever that becomes available and then for 2018, one year after the drug industry fully takes over HHS!

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Bad “Buzz” Beats Super Bowl EyeBalls When It Comes to Drug Ads

Bad “Buzz” Beats Super Bowl EyeBalls When It Comes to Drug Ads | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Drug ads often seem ubiquitous during regular TV programming. However, one time they definitely are not is during the advertising event of the year: the Super Bowl.

 

This year's Super Bowl advertiser roster is a familiar lineup, packed with the usual snack, beer, car, and technology brands, and an occasional public service announcement. Brands in those categories have far fewer regulatory guidelines for ads and more freedom to produce silly, moving, or eye-catching spots, whereas pharma brands are usually much more cautious.

 

"I don't think it's a lack of people or agencies presenting ideas of how to get into the Super Bowl [resulting in a lack of drug ads]," says Kevin McHale, MD and executive creative director at FCB Health's Neon. "There are a lot of clever pharmaceutical advertisements that have great consumer appeal in recent years in the U.S., so we're seeing a great evolution of healthcare advertising."

 

While big pharma does spend an astounding amount on advertising each year, with one media tracking firm estimating it exceeded $6 billion collectively in 2016, many marketers don't see a Super Bowl ad as the best use of their money.

 

While a surprise appearance is a possibility, no healthcare companies have bought spots, according to lists of Super Bowl XLII ads from Advertising Age, AdWeek, and iSpot.tv. However, pharma companies have tried their luck during the big game. Jublia, a prescription toenail fungus drug, bought a spot in two recent Super Bowls, using NFL legends and animated football imagery to tie its brand to the game.

 

AstraZeneca's 2015 opioid-induced constipation disease awareness ad tried to bring out the clever side of a health issue, but promoted backlash for making light of a serious problem.

 

Further Reading:

Pharma Guy's insight:

Most Super Bowl ads get extra benefit from all the “positive” buzz in the press before and afterward. In the case of drug Super Bowl ads, that buzz was decidedly “negative” last year. I guess in advertising, unlike publicity, there is such a thing as bad.

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More State Lawmakers – Seemingly Having Nothing Better to Do – Push Bills to Allow Off-Label Drug Promotion

More State Lawmakers – Seemingly Having Nothing Better to Do – Push Bills to Allow Off-Label Drug Promotion | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Over the past month, lawmakers in three states — Missouri, Colorado, and Mississippi — have introduced bills that would allow drug makers to promote their medicines for so-called off-label uses, so long as the information given to doctors is truthful.

 

The efforts come less than a year after Arizona adopted such a law, making it the first state in the U.S. to permit off-label promotion. The bills also arrive amid ongoing pressure on the Food and Drug Administration to loosen regulations for off-label promotions, which is one of the most contentious issues to roil both the agency and the pharmaceutical industry.

 

At issue is a fierce debate over patient safety and free speech.

 

Doctors can prescribe a medicine for an off-label — or unapproved — use, but drug makers have battled restrictions on their ability to distribute such information, such as reprints of medical studies. The companies believe free speech is being curtailed and have lobbied Congress and the FDA to loosen regulations. For its part, the FDA worries public health can be jeopardized by promotions that go too far.

 

As we noted previously, drug makers were emboldened by a pair of court rulings in recent years that determined companies can disseminate off-label information, so long as it is truthful and not misleading. But one decision, which was issued by a federal appeals court, extends only to Connecticut, New York, and Vermont, creating uncertainty about whether the issue would be tested elsewhere.

 

“States have more important things to legislate, such as what is the official state tree, which would have more consequence and statewide impact.” - PETER PITTS, CENTER FOR MEDICINE IN THE PUBLIC INTEREST

 

The FDA, meanwhile, has not yet taken any action. A year ago, the agency issued a memo that, instead of suggesting possible solutions, simply summarized key points framing the long-running debate and carefully rebuffed many of the suggestions made by drug makers and others that support expanding pharmaceutical marketing.

 

As a result, the Goldwater Institute, a libertarian think tank, is helping to fill the void.

 

The Arizona law was conceived by the institute, which spearheaded the controversial right-to-try movement designed to give patients access to experimental medicines. The institute vowed to duplicate that campaign by introducing off-label bills around the country and a Goldwater spokeswoman noted the new bills are based on its models. The institute is also supporting the legislation, Naomi Lopez Bauman, director of healthcare policy, told us.

 

Further Reading:

  • “Arizona First State to Pass Law Allowing Pharma to Promote Drugs Off-label to Docs”; http://sco.lt/8HKcPR
  • “Doctors Funded by #Pharma Promote Easing of FDA Regulations Prohibiting Off-Label Promotion of Drugs”; http://sco.lt/5z4LJ3
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The Emerging "PharmaGovernment Complex"

The Emerging "PharmaGovernment Complex" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Alex Azar’s job hop from drugmaker Eli Lilly to the Trump administration reflects ever-deepening ties between the pharmaceutical industry and the federal government.

 

A Kaiser Health News (KHN) analysis shows that hundreds of people have glided through the “revolving door” that connects the drug industry to Capitol Hill and to the Department of Health and Human Services.

 

Azar was confirmed on Wednesday as HHS secretary, joining other former drug industry alumni in top positions.

 

Nearly 340 former congressional staffers now work for pharmaceutical companies or their lobbying firms, according to data analyzed by KHN and provided by LegiStorm, a nonpartisan congressional research company. On the flip side, the analysis showed, more than a dozen former drug industry employees now have jobs on Capitol Hill—often on committees that handle healthcare policy.

 

“Who do they really work for?” said Jock Friedly, LegiStorm’s president and founder, who called that quantity “substantial.” “Are they working for the person who is paying their bills at that moment or are they essentially working on behalf of the interests who have funded them in the past and may fund them in the future?”

 

In many cases, former congressional staffers who now work for drug companies return to the Hill to lobby former co-workers or employees. The deep ties raise concerns that pharmaceutical companies could wield undue influence over drug-related legislation or government policy.

Pharma Guy's insight:

I’d like to say one or two words about what I call the “PharmaGovernment Complex,” which is the collusion between the pharmaceutical industry, lawmakers, and government agencies.

 

There has always been “collusion” between the pharmaceutical industry and lawmakers who have profited from financial contributions from the industry as well as help from industry “hired guns” (lobbyists) to craft laws benefitting the drug industry. I’ve spent a lot of time writing about this in the past. Obviously, my efforts and the efforts of many others to shine a light on this has achieved nothing. The amount spent on lobbying during the first nine months of Donald Trump’s presidency, reports the Center for Responsive Politics, was higher than in any corresponding period since 2012. In fact, "The D.C. Pharma Lobbying Swamp is Bigger & More Slimy Than Ever!"; http://sco.lt/6srYJd

 

And all this lobbying has paid off BIG! The Department of Health and Human Services – including the Food and Drug Administration (FDA) – has now been taken over completely by the pharmaceutical industry. Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, now leads the FDA and Alex Azar, who served for five years as president of Lilly USA, is now U.S. Secretary of Health and Human Services. As Public Citizen says, "Big Pharma’s political coup [is] complete. The industry whose business model is built around government-funded research and development, government-granted monopolies and government purchases of its overpriced medicines" now has its foxes in all the government health hen houses!

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Trump’s Opioid Commission is a “Sham” and For Victims of the Opioid Epidemic It’s Been a “Government Shutdown from the Start”

Trump’s Opioid Commission is a “Sham” and For Victims of the Opioid Epidemic It’s Been a “Government Shutdown from the Start” | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Republican-led Congress has turned the work of the president's opioid commission into a "charade" and a "sham," a member of the panel told CNN.

"Everyone is willing to tolerate the intolerable -- and not do anything about it," said former Democratic Rep. Patrick Kennedy, who was one of six members appointed to the bipartisan commission in March. "I'm as cynical as I've ever been about this stuff."


President Donald Trump declared the opioid epidemic a 90-day public health emergency in October, but did not make any new funding available. In November the president said he would donate his third quarter salary to the Department of Health and Human Services to help fight the crisis.

Trump to donate part of his salary to combat opioid addiction
Critics say the declaration did virtually nothing to change the status quo and that overdose deaths have continued to mount in the months since. The public health emergency declaration was, in fact, set to expire on January 23, but as the government was headed toward a shut down on Friday, Acting Secretary of the Department of Health and Human Services Eric Hargan renewed the national public health emergency for another 90 days.


"This and the administration's other efforts to address the epidemic are tantamount to reshuffling chairs on the Titanic," said Kennedy. "The emergency declaration has accomplished little because there's no funding behind it. You can't expect to stem the tide of a public health crisis that is claiming over 64,000 lives per year without putting your money where your mouth is."


CNN sought to catch up with the six members of the opioid commission, including former New Jersey Governor Chris Christie who headed the panel, about their views on progress made and what more needs to be done. We also wanted to speak with Kellyanne Conway, the White House's point person on the opioid crisis.


Only Kennedy and Bertha K. Madras, a deputy director of the White House Office of National Drug Control Policy during the George W. Bush administration, agreed to speak.


With the recent government shutdown, Kennedy blasted Trump for "playing politics instead of pursuing solutions for issues that impact the lives of Americans."


"For people and families struggling with addiction in this epidemic, it's essentially been a government shutdown from the start," he said.

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After Being Fined Over $500 Million for Being Corrupt, TEVA #Pharma is Laying Off 200-plus Workers in It's North Wales PA Home Base

After Being Fined Over $500 Million for Being Corrupt, TEVA #Pharma is Laying Off 200-plus Workers in It's North Wales PA Home Base | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Teva’s far-reaching cost cuts are hitting close to home—not just in Israel, but at its North American headquarters, too.

The embattled company is laying off more than 200 workers in and around its North Wales, Pennsylvania, home base, it said in a WARN notice filed with the Pennsylvania Department of Labor and Industry. Those layoffs are effective Friday.

Specifically, the generics giant has pink-slipped 65 employees across three buildings in Horsham, Pennsylvania, and North Wales, 96 across sites in Fraser and Great Valley, Pennsylvania, and 47 more at a West Chester, Pennsylvania, location.

The layoffs come as part of new Teva CEO Kåre Schult's plan to squeeze $3 billion from the company’s annual costs as it struggles under some serious dealmaking debt. In December, the company said it would pare down its workforce by 25%, shedding thousands more jobs than industry watchers expected.

 

Further Reading: 

  • “Teva, Which Recently Became a PhRMA Member, Among 6 Drug Firms Being Sued by 20 States!”; http://sco.lt/4nFwPZ
  • “TEVA #Pharma Is Not "Worker Centric" - Fires Union Workers to Save Money”: http://sco.lt/8Ikr9l ;
  • “Only 20% of Teva's Illegal Pay-to-Delay Profits Goes to US Treasury”: http://sco.lt/5eDXyz

Via johnmacknewtown
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johnmacknewtown's curator insight, January 19, 1:21 PM
In December, 2017, Teva agreed to pay nearly $520 million to the U.S. Department of Justice and Securities and Exchange Commission to resolve violations of the Foreign Corrupt Practices Act. The criminal fine to the DOJ totaled more than $283 million, while Teva ponied up $236 million to the SEC.
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Google Venture Arm Backs Universal Flu Vaccine

Google Venture Arm Backs Universal Flu Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A private British company developing a vaccine that would be the first in the world to fight all types of flu has raised 20 million pounds ($27 million) from investors including GV, the venture capital arm of Google parent Alphabet Inc.

 

Vaccitech, a spin-out founded by scientists at Oxford University’s Jenner Institute, said on Monday the cash would help fund its vaccine through a two-year clinical trial involving more than 2,000 patients and expand other projects.

 

A so-called universal flu vaccine that elicits immunity against parts of the virus that do not change from year to year is a holy grail of medicine - but so far it has proved elusive.

 

Current flu vaccines have to be changed each year to match strains of virus circulating at the time. The hope is the new one-size-fits-all vaccine will provide better and longer-lasting protection.

 

Vaccitech’s new vaccine works by using proteins found in the core of the virus rather than those on its surface. Surface proteins stick out like pins from the virus and change all the time, while those in the core are stable.

 

If all goes well, Vaccitech’s shot could potentially be ready for launch in 2023, although 2024 or 2025 might be more realistic.

 

Further Reading:

  • “Why Flu Vaccines Are Not as Effective as They Should Be”; http://sco.lt/94oV4T
  • “Academic Research Goes Where No Pharma was Willing to Go: Develops a Universal Flu Vaccine”; http://sco.lt/5kHIOn
  • “Your Next Flu Vaccination May Not Be as Effective as You Think”; http://sco.lt/9CKgl7
  • “Flu Shot Doesn't Work as Well as #pharma Clinical Data Suggests”; http://sco.lt/4pRtTd
  • “Pharma Needs to Step Up & Help Develop a Universal Flu Vaccine"; http://bit.ly/PMBalbum012913

 

Pharma Guy's insight:

It takes a technology company to provide money for a universal flu vaccine while Big Pharma still uses egg "technology" to develop INEFFECTIVE vaccines!

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Mytheos Holt: The Cancer Drug Market That Big Pharma is Planning for America

Mytheos Holt: The Cancer Drug Market That Big Pharma is Planning for America | Pharmaguy's Insights Into Drug Industry News | Scoop.it

2018 has barely finished dawning, and already, the pharmaceutical industry once more has egg on its face from outrageous price hikes.

 

This time, the culprit is pharmaceutical startup NextSource, which apparently has taken a 40-year-old cancer drug known as lomustine, and ruthlessly hiked its price from $50/pill in 2013, to $768/pill now. In other words, they’ve raised the price of the drug by over 1400% over the past five years.

 

NextSource’s defense for why this has happened has to be read to be believed. CBS News reports that the company’s CEO, Robert DiCrisci, claims that the company set the price based on the costs it incurred in developing the drug, and “the benefits it provides patients.”

 

Now, obviously, the drug has been around for 40 years, so the costs of developing it to NextSource, which only acquired the rights to it in 2013, have likely been nonexistent. Which means that the company set the price entirely on the basis of the fact that the drug benefits patients, or to put it more bluntly, the fact that patients need the drug in order to not die. “Nice life you’ve got there, shame if anything happened to it,” is essentially their reasoning. Granted, NextSource is far from the only pharma company to hike its prices with the new year – the practice is still distressingly widespread – but it is the most egregious.

 

Make no mistake, Big Pharma very much wants us to remain at the mercy of their monopolistic practices, and not to be subjected to market forces. The fate of lomustine is what they would impose on every single drug on earth, if they could. You can tell because every legislative or policy-driven attempt to introduce market forces, or to curb price gouging in their absence, is on Pharma’s hit list.

Pharma Guy's insight:

It's like mobsters shaking down mom and pop businesses!

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Drug Makers Signal Lack of Interest in Developing Vaccines During Crises

Drug Makers Signal Lack of Interest in Developing Vaccines During Crises | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Every few years an alarming disease launches a furious, out-of-the-blue attack on people, triggering a high-level emergency response. SARS. The H1N1 flu pandemic. West Nile and Zika. The nightmarish West African Ebola epidemic.

 

In nearly each case, major vaccine producers have risen to the challenge, setting aside their day-to-day profit-making activities to try to meet a pressing societal need. With each successive crisis, they have done so despite mounting concerns that the threat will dissipate and with it the demand for the vaccine they are racing to develop.

 

Now, manufacturers are expressing concern about their ability to afford these costly disruptions to their profit-seeking operations. As a result, when the bat-signal next flares against the night sky, there may not be anyone to respond.

 

A number of flu vaccine manufacturers were left on the hook with ordered but unpaid for vaccine during the mild 2009 H1N1 flu pandemic. By the time the vaccine was ready — after the peak of the outbreak — public fear of the new flu had subsided. Many people didn’t want the vaccine, and some countries refused to take their full orders. GSK, Sanofi Pasteur, and Novartis — which has since shed its vaccines operation — produced flu vaccine in that pandemic.

Pharma Guy's insight:

Maybe if vaccines were more effective and delivered on time, it would be a different story

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PinUp: Welcome to 2018 - Less Health Insurance, Shorter Lifespan, and Limper Sex Life

PinUp: Welcome to 2018 - Less Health Insurance, Shorter Lifespan, and Limper Sex Life | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Welcome to the January 5, 2018, issue of Pharma Industry News Update (aka PinUp).

 

**********ARTICLES***********

  • Pfizer Raises Wholesale Price of 148 Drugs, Including Viagra

  • Azar Would Be Detrimental to Americans’ Access to Health Care

  • Drop in life expectancy an "indictment of the American health care system"

 

Access this issue here.

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Pfizer raises average wholesale price of 148 drugs by 6-13.5 per cent, including Viagra, made in Cork Ireland!

Pfizer raises average wholesale price of 148 drugs by 6-13.5 per cent, including Viagra, made in Cork Ireland! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharma firms have imposed price rises of several times the rate of inflation on more than 1,000 products in the United States, a new year move that risks a political backlash at a time of intense scrutiny on healthcare costs.

 

Pfizer, the largest stand-alone pharmaceutical company in the US, raised the average wholesale price of 148 drugs by between 6 and 13.5 per cent, according to data, with a mean average increase of 8.8 per cent.

 

The list included several of its best-known medicines such as Viagra, the erectile dysfunction treatment made in Cork, and Lyrica for nerve pain.

 

Other large drugmakers, including Allergan, GlaxoSmithKline, Gilead, Shire, Biogen, Teva, Baxter and Viiv also increased the US list prices of their medicines on January 1st, according to the data.

 

For the most part, pharmaceutical companies held the increases at less than 10 per cent, but they still tracked well ahead of inflation, currently 2.2 per cent in the US.

 

Some pharmaceutical groups implemented much larger increases. Hikma, the London-listed drugmaker, raised the price of several strengths of morphine – which was first marketed in the 1800s – by between 75 and 90 per cent, taking a 25-pack of vials from $30 (€24.50) to $58 (€50).

 

Further Reading:

  • “A Dick Move by Pfizer: Raises Price of Viagra & Other Drugs by as Much as 28% in One Year!”; http://sco.lt/65j0rp
  • “Celgene ‘Gets Away with Murder!’ Raises Prices Again and Again.”; http://sco.lt/7rguzx
  • “Mylan Execs ‘Untroubled’ by EpiPen Price Increases. Suggest Employees, Critics & Congress Go F**k Themselves”; http://sco.lt/8AhrKz
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