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U.S. Seeks Records of 80,000 Novartis `Sham' Events for Doctors

U.S. Seeks Records of 80,000 Novartis `Sham' Events for Doctors | Pharmaguy's Insights Into Drug Industry News |

The U.S. is asking Novartis AG to provide records of about 80,000 “sham” events in which the government says doctors were wined and dined so they would prescribe the company’s cardiovascular drugs to their patients.

The Swiss drugmaker and the Manhattan U.S. Attorney are engaged in a whistle-blower lawsuit that alleges Novartis provided illegal kickbacks to health-care providers through bogus educational programs at high-end restaurants and sports bars where the drugs were barely discussed.

In a filing Friday, the U.S. said it needs Novartis to provide information to support its allegation that the company defrauded federal health-care programs of hundreds of millions of dollars over a decade by inducing doctors to prescribe its medications through sham speaker events.

“The requested documents go to the core issues in this case: whether educational materials were provided at these events; which doctors actually attended the events; how much money was spent on meals and honoraria; and indeed, most fundamentally, whether the underlying documentation shows that a particular event actually took place,” the government said in its court filing.

Last year Novartis agreed to pay $390 million to settle a lawsuit in which the U.S. government claimed the Swiss company paid kickbacks to pharmacies to boost sales of some of its prescription drugs. The company neither admitted nor denied liability.

The case is U.S. v. Novartis Pharmaceutical Corp., 11-CV-0071, U.S. District Court, Southern District of New York (Manhattan).

Pharma Guy's insight:

Back in 2013, the U.S. Justice Department  filed a civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers (read the details here).

DOJ claims that Novartis violated the Anti-Kickback Statute by paying doctors to speak about certain drugs, including its hypertension drugs Lotrel and Valturna and its diabetes drug Starlix, at events that were often little or nothing more than social occasions for the doctors. 

Many speaker programs were held in circumstances in which it would have been "virtually impossible for any presentation to be made, such as on fishing trips off the Florida coast," the suit claims.

"Other Novartis events were held at Hooters restaurants."


Read "Novartis Wines -- er, Beers -- and Dines Docs at Hooters!"; 

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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 |

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!”;
  • “TEVA #Pharma Is Not "Worker Centric" - Fires Union Workers to Save Money”: ;
  • “Only 20% of Teva's Illegal Pay-to-Delay Profits Goes to US Treasury”:

Via johnmacknewtown
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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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 |

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”;
  • “If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse”;
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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 |

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”;
  • “Academic Research Goes Where No Pharma was Willing to Go: Develops a Universal Flu Vaccine”;
  • “Your Next Flu Vaccination May Not Be as Effective as You Think”;
  • “Flu Shot Doesn't Work as Well as #pharma Clinical Data Suggests”;
  • “Pharma Needs to Step Up & Help Develop a Universal Flu Vaccine";


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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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 |

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


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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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 |

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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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 |

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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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 |

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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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 |

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 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.” 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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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 |

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



  • 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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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 |

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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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 |

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!”;
  • “Celgene ‘Gets Away with Murder!’ Raises Prices Again and Again.”;
  • “Mylan Execs ‘Untroubled’ by EpiPen Price Increases. Suggest Employees, Critics & Congress Go F**k Themselves”;
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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 |

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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PhRMA Dumps Lots More Money Into Coffers of Pols & Patients

PhRMA Dumps Lots More Money Into Coffers of Pols & Patients | Pharmaguy's Insights Into Drug Industry News |

Facing bipartisan hostility over high drug prices in an election year, the pharma industry’s biggest trade group boosted revenue by nearly a fourth last year and spread the millions collected among hundreds of lobbyists, politicians and patient groups, new filings show.


It was the biggest surge for the Pharmaceutical Research and Manufacturers of America, known as PhRMA, since the group took battle stations to advance its interests in 2009 during the run-up to the Affordable Care Act.


“Does that surprise you?” said Billy Tauzin, the former PhRMA CEO who ran the organization a decade ago as Obamacare loomed. Whenever Washington seems interested in limiting drug prices, he said, “PhRMA has always responded by increasing its resources.”


The group, already one of the most powerful trade organizations in any industry, collected $271 million in member dues and other income in 2016. That was up from $220 million the year before, according to its latest disclosure with the Internal Revenue Service.


PhRMA spent $7 million last year to prepare its ubiquitous “Go Boldly” ad campaign and gave millions to politicians who were up for election in both parties in dozens of states. It lavished more than $2 million on scores of groups representing patients with various diseases — many of them dealing with high drug costs.


Some of the biggest patient-group checks went to the American Autoimmune Related Disease Association, for $260,000; the American Lung Association, for $110,000; the Juvenile Diabetes Research Foundation, for $136,150; and the Lupus Foundation of America, for $253,500.


PhRMA also gave big money to national political groups financing congressional, presidential and state candidates. The conservative-leaning American Action Network got $6.1 million. The Republican Governors Association got $301,375. Its Democratic counterpart got $350,000.



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Grading FDA Commissioner Gottlieb & PhRMA's "Go Boldly" Campaign

Grading FDA Commissioner Gottlieb & PhRMA's "Go Boldly" Campaign | Pharmaguy's Insights Into Drug Industry News |

Food and Drug Administration Commissioner Scott Gottlieb earned high marks from [a STAT Plus] survey respondents.


One respondent explained why Gottlieb deserved an F: “I see no vision or mission except keep Trump happy. Good luck.”


But the vast majority sang his praises.


  • “He’s shown an independence from the pharmaceutical industry that I was not expecting and seems dedicated to balancing safety with efficiency.”


  • “He’s a moderate! Speeding things along but not foolishly.”


  • “Dr. Gottlieb seems interested in getting other agencies to do their jobs. He seems interested in improving competition and drug shortage to the best of FDA’s ability — although these problems are pharma’s to fix — not FDA’s.”


Further Reading:

  • “Dr. Scott Gottlieb’s Plan to ‘Get Things Done’ at #FDA is Approved by #Pharma”;
  • “Does Pharma Really Want to Abandon the ‘Gold Standard’ of the FDA Approval Process?”;
  • “Pharma Scientists Concerned About Gottlieb’s Industry Ties”;


The trade group PhRMA has tried to reframe the drug price debate with its “Go Boldly” campaign, paid for by a hike in membership fees. In decidedly lukewarm reviews, more than a third of respondents gave that initiative a modest 2 on a scale of 1 to 5 (with 5 being a rave). Roughly a quarter split between 1 (the worst) and 3 (meh), though one respondent noted that “featuring industry scientists was a great choice, from a PR standpoint.”


Among the other comments:


  • “All the ‘bold’ in the world doesn’t matter when people can’t afford treatments.”


  • “The ads are good. … People like pharma for the drugs it produces. Its R&D is not what galls people. It’s pricing and business practices.”


  • “There’s a ‘Go Boldly’ campaign?”


Further Reading:

  • “He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent”;
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Big Pharma Spending Money on TV Ads Like a Even More Drunk Sailor!

Big Pharma Spending Money on TV Ads Like a Even More Drunk Sailor! | Pharmaguy's Insights Into Drug Industry News |

With one month still to go, 2017 is already a record-breaking year for pharma advertising. TV ad spending totaled $3.2 billion through the end of November, according to data from real-time TV ad tracker That’s well ahead of the full-year 2016 TV spend of $3.11 billion.


The record comes even after a fairly low spending month in November when the top 10 pharma brands spent just $159 million on TV ads, a big drop from $199 million spent in October.


For November, AbbVie’s Humira was in its usual top position, although its spending dropped by more than $10 million from October. Pfizer and Bristol-Myers Squibb's anticoagulant Eliquis rejoined the spending list at No. 2, followed by Novo Nordisk’s Victoza and Pfizer’s Xeljanz in the same positions as the previous month, but with lowered spending for both.


Joining the top 10 spenders for the month was Pfizer’s pneumococcal vaccine Prevnar 13, which debuted a new TV commercial in October and has been ramping up spending since then.


Further Reading:

Pharma Guy's insight:

According to Kantar Media, pharma spending on TV ads in 2016 was $4.1 Bn., however, says it was $3.11. I'm not which is closer to the truth, but it's the trend that matters here, I suppose.

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“Blue-Green Coat Marketing”: How Some Drug Companies Use Nurses to Illegally Promote Drugs to Docs

“Blue-Green Coat Marketing”: How Some Drug Companies Use Nurses to Illegally Promote Drugs to Docs | Pharmaguy's Insights Into Drug Industry News |

Three more drug makers allegedly relied on schemes in which nurses were used to illegally promote its diabetes medicines to physicians, according to recently unsealed lawsuits. The documents describe how Gilead Sciences (GILD), Amgen (AMGN), and Bayer Pharmaceuticals (BAYRY) hired nurses to talk up treatments to doctors and their patients, an arrangement that purportedly violated federal kickback laws.


The companies avoided concerns that sales reps might get little to no face time with doctors and simultaneously helped save physicians from the expense of providing follow-up care, according to the lawsuit. The approach is sometimes known as “white coat marketing,” which the lawsuit noted is considered problematic by authorities because it may blur trust between doctors and patients. [But nurses do not wear white coats – they wear blue or green coats]


In each lawsuit, the drug makers allegedly used various means to improperly use nurses to promote their medicines. One way supposedly involved using a third party to deploy nurse educators to tout drugs [see my insights]. The companies also provided free nurses and reimbursement support services to save physicians money and to induce them to prescribe their medicines, according to the lawsuits (here is one and here is the other).


As a result, the schemes allegedly caused Medicare and Medicaid to inappropriately pay for prescriptions that were “tainted by kickbacks,” according to the lawsuits. The lawsuits also named other companies that were engaged to further their goals, including Covance, HealthStar Communications, and AmerisourceBergen. We asked each of them for comment and will update you accordingly. An Amgen spokeswoman declined to comment.


A Bayer spokesman, meanwhile, writes us that the company “believes that this case has no merit and categorically denies each of the allegations in the complaint. It is important to note that the U.S. Department of Justice and 31 states were provided an opportunity to participate in this matter and upon review of the allegations specifically declined to intervene. Bayer looks forward to defending this matter and these medications.”


The allegations are nearly identical to claims that were contained in yet another lawsuit that was filed against Eli Lilly (LLY). All three of the lawsuits, which were filed last June in a federal court in Texas and unsealed more recently, were initiated by Health Choice Advocates, a unit of a health care research that describes itself as a whistleblower.

Pharma Guy's insight:

In 2006 I wrote about attending a conference where Innovex -- a division of Quintiles, the contract research people -- talked about the role of "Clinical Educators" (CEs) as adjuncts to pharmaceutical sales reps. CEs are essentially specially trained nurses that either work directly with physicians, their staffs, or with patients to do disease management, educate patients and enhance patient compliance with treatment -- all things that physicians should be doing themselves but are either too lazy to do or just not willing to do.


The use of nurses by Big Pharma in the US may be a new phenom and has attracted media attention. Another potential problem is the conflict between non-promotional and promotional aspects of CE programs. Innovex admits that CEs are "dedicated" to the sponsor's product (Business Week says "Admittedly, the nurses talk up their employers' products, both to the patients and to medical personnel in doctors' offices."). Where is the line drawn?

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Will Amazon "Crush" Pharma? DTC Marketers Should Prepare for the Inevitable

Will Amazon "Crush" Pharma? DTC Marketers Should Prepare for the Inevitable | Pharmaguy's Insights Into Drug Industry News |

Amazon's unrelenting drive to take over the world continues. The latest potential target of the online retailer's ambitions: prescription drugs.


According to reports, Amazon is exploring entering the retail pharmacy market in the U.S., a $400bn a year business that many believe is ripe for disruption. While a final decision has apparently not yet been made, it's not too early for pharma marketers to start considering the prospect of Amazon entering this huge market.


What it might mean for pharma marketers

The news of Amazon's interest in selling prescription drugs has, for obvious reasons, spooked investors in major pharmacy players like CVS, Walgreens and Express Scripts, all of which risk being disrupted by Amazon the way so many other businesses have.


For pharma marketers, Amazon's entry into this market could increase the importance of their direct-to-consumer marketing efforts… one of the best ways [pharma marketers] can prepare for the potential entry into the pharmacy market would be to evaluate their direct-to-consumer efforts in light of a changing landscape in which digital channels like social media increasingly trump established channels like television.


Amazon as frenemy?

While Amazon's entry into the retail pharmacy market could prove to be a net positive for pharma companies well-positioned to take advantage of it, there is also the potential that Amazon could become a frenemy.


How? As drug supply chain expert Stephen Buck, co-founder of Courage Health, pointed out, Amazon could eventually decide to manufacture its own generic medications. If that happened, pharma companies would find themselves competing with a company that also acts as, perhaps, one of their more important distribution channels.


This possibility too also demonstrates the importance of direct-to-consumer marketing, as pharma companies will want to do everything they can to establish the superiority of their drugs over generics that could one day be manufactured by Amazon.

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Crisis in $12B U.S. Opioids Market? From Cannabis?


The U.S. opioids market was valued at US$ 12,046.3 million in 2015 and is expected to witness a moderate CAGR of 5.2% during the forecast period (2016–2024).


According to the New York Times analysis of state data, in 2016, drug overuse led to death of 59,000 to 65,000 people in the U.S. and majority (about two-third) of death were due to opioids overuse and this number is witnessing an increase. According to a survey of National Institute of Drug Abuse (NIDA), deaths due to the overdose prescription of opioid pain relievers have more than tripled in the past 20 years, escalating to 16,651 deaths in the U.S. in 2010. It can be concluded from the analysis of the data (data from the survey and New York Times data), that death due to opioids have more than doubled in the past six years.


In October 2016, though the Government of the U.S. declared opioids crisis as an emergency. The declaration is expected to help in increasing awareness among the public about overuse of opioids. It would also make doctors and pharmacy stores hesitant to over-prescribe or overstock opioids. The government has approached leading pharmacy chains, insurance companies, and others, for cooperation. For instance, Attorney General of over 35 states sent a letter to the America’s Health Insurance Plans, national association whose members provide coverage for health care and related services, urging its members to reconsider coverage policies that may be fueling the opioid crisis in October 2017. Such measures can ensure proper usage of opioids and favors the market players in the U.S. opioids market.



Increasing incidences of chronic pain is expected to drive growth of the U.S. opioids market

According to the American Academy of Pain Medicine (AAPM), 2011, around 1.8 billion people suffered from chronic pain. Moreover, according to the National Institute of Health (NIH) estimates in 2015, one in 10 people in the U.S. suffered from chronic pain. Increasing prevalence of chronic pain is expected to result in high prescription of opioids pain relievers, which in turn is expected to fuel the market growth. Easy availability and favorable insurance policy are other major drivers for growth of the U.S. opioids market.


The analysis of Medicare prescription drug plans, which covers 35.7 million people in the second quarter of 2017, by ProPublica — an investigative journal and The New York Times — a leading U.S. newspaper, revealed that only one-third of the covered people had any access to other types of pain killer and less-risky opioids. This was attributed to low cost of opioids drugs. The scenario might change, however, due to strict monitoring from government and regulatory bodies. 


Cannabis as potential alternative for pain relief can be a threat to the U.S. opioids market

Cannabis could be the alternative therapy for opioids. Currently, medical marijuana is legal in 28 states and the District of Columbia even though it is illegal under federal law. According to a research published in Annals of Internal Medicine, in majority of cases, between 45% and 85%, medical marijuana is used for pain management. However, there is some ambiguity about medical marijuana effectiveness in pain management. Cannabis could be used as effective therapy after establishment of clinical trials. 

Some major players operating in the U.S. opioids market include Purdue Pharma L.P., Titan Pharmaceuticals, Inc., Boehringer Ingelheim GmbH, Janssen Pharmaceuticals, Inc., Sanofi S.A., Sun Pharmaceuticals Industries Limited, Mallinckrodt Pharmaceuticals, Egalet Corporation, Endo Pharmaceuticals plc, Allergan, plc, and Pfizer Inc.


Further Reading:

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ViiV Employs Patient Ambassadors to Start in First Branded (Triumeq) TV Ads for HIV Treatment - Warning Card Included!

ViiV Employs Patient Ambassadors to Start in First Branded (Triumeq) TV Ads for HIV Treatment - Warning Card Included! | Pharmaguy's Insights Into Drug Industry News |

GlaxoSmithKline's ViiV Healthcare is taking its dedicated history in HIV treatment and community involvement to the small screen. New TV advertising for its HIV fighter Triumeq features five people living with HIV talking about their diagnoses and treatment, as well as images showing how they’re “Moving Forward.”

It may also be a first for an HIV drug; while HIV awareness ads have aired on TV before, no other branded HIV drugs, at least in recent history, have aired TV spots. Healthcare professionals, advocates and people living with HIV have been asking ViiV for some time why they weren’t advertising on TV, Andrew Perry, ViiV VP of marketing in the U.S., said in an email interview.

“Given the importance of presenting realistic, positive images of the life a person being treated for HIV can lead, we felt like it was the right time to broaden our approach,” he said. “… We felt that now more than ever we must present a realistic, modern view of what the life of a person living with HIV can look like if their HIV is appropriately treated—and to do that on television for the first time. Reaching some people living with HIV can also be difficult, so television advertising is one more way to broaden our reach to help ensure no one living with HIV is left behind."

Some of the people who star in the TV spot already appear in other media for Triumeq. ViiV also used an organization that connects patients with companies looking for ambassadors and advocates, Perry said, acknowledging the “brave step” these patients have taken.

“Appearing on TV is a daunting commitment, and publicly disclosing their HIV status in a national TV campaign required an amazing level of bravery for each of our ambassadors. We are so grateful for their courage in sharing their status and their journey,” he said.

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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 |

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”;
  • “Regeneron CEO Len Schleifer vs Pfizer CEO Ian Read on Drug Prices Redux”;
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The Original Scientific Preprint Revolutionaries Were Quashed by the Medical Journal Industry

The Original Scientific Preprint Revolutionaries Were Quashed by the Medical Journal Industry | Pharmaguy's Insights Into Drug Industry News |

The movement to make biology papers freely available before they have been peer-reviewed, let alone published in a reputable journal, finally succeeded in 2013, when bioRxiv (pronounced bio-archive) was launched by Cold Spring Harbor Laboratory. But 50 years before, the National Institutes of Health tried something similar: distributing unpublished scientific papers, or preprints, to a handpicked group of leading researchers.


The effort was intended to speed the dissemination of potentially important advances, but it was met with such hostility from some eminent biologists and journals — one called the papers “shoddy merchandise” — that it was shut down after just six years, a historian reported recently in PLOS Biology:



In 1961, the National Institutes of Health (NIH) began to circulate biological preprints in a forgotten experiment called the Information Exchange Groups (IEGs). This system eventually attracted over 3,600 participants and saw the production of over 2,500 different documents, but by 1967, it was effectively shut down following the refusal of journals to accept articles that had been circulated as preprints.


“It’s fascinating to see that the same things happened 50 years ago,” said bioRxiv co-founder Richard Sever, who had never heard of the earlier preprint effort (which, of course, used snail mail). “The business concerns of the journals, the scientists who warned about the terrible things that would happen if information that wasn’t peer-reviewed got out — that was very much what we experienced with bioRxiv.”


The long-forgotten NIH effort began in 1961, when an official named Errett Albritton, then 70, dreamed up “Information Exchange Groups.” They initially consisted of “leading investigators” in a narrowly defined field, such as “computer simulation of biological systems,” found Matthew Cobb, a scientist and historian at the University of Manchester, who stumbled on dusty documents about it in the archives of Cold Spring Harbor Lab.


Researchers sent in drafts of their soon-to-be-published (they hoped) papers, and the NIH made copies and mailed them to members of the relevant specialty group. The idea, as one supporter wrote, was to allow scientists “to be fully informed in record time of all important developments in the field.”


Not everyone saw it that way. Francis Crick, co-discoverer of the double helix structure of DNA, told Albritton in a 1961 letter that “there is far too much careless and rapid communication already in every area of this field of study,” referring to genetics. “The idea of increasing it even in this semi-public manner fills me with horror.”


Further Reading:

  • “Medical Journals Serve as Big Pharma Drug-Marketing Platform: Study by COI ‘Enabler’”;
  • “The Privatization of Peer Review: #BigPharma Would Benefit”;
Pharma Guy's insight:

Does bypassing medical journal peer review fill you with "horror?" I think some pharma marketers may like the idea. But not the FDA, I hope!

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Trump Is Turning U.S. Health Agencies Into a “Pharma Swamp”

Trump Is Turning U.S. Health Agencies Into a “Pharma Swamp” | Pharmaguy's Insights Into Drug Industry News |

President Trump has vilified the pharmaceutical industry and made bold promises to lower prescription drug prices. But when it comes to staffing the health care agencies empowered to oversee those efforts, he has turned regularly to the pharmaceutical industry.


His Food and Drug Administration chief, Scott Gottlieb, was a longtime industry investor and adviser to major players like GlaxoSmithKline and Bristol-Myers Squibb. A senior adviser at the Health and Human Services Department, Keagan Lenihan, joined the administration after running the lobby shop for the drug and distribution giant McKesson. Tim Clark, the White House liaison for political personnel at HHS, was still lobbying for pharma company Eisai earlier this year. And Trump has a former Gilead lobbyist, Joe Grogan, reviewing health care regulations at the Office of Management and Budget. The chief of staff at HHS, Lance Leggitt, lobbied for a whole host of drug clients, even last year.


This week the president named Alex Azar, who spent more than a decade at the pharmaceutical giant Eli Lilly, as his health secretary nominee.


It’s a lengthy list that highlights just how reliant Trump is on the industry he has promised time and again to rein in. And his picks stand out when compared with those of previous administrations. In a STAT review of the public biographies of more than five dozen top health officials and advisers across the Obama, Bush and Clinton administrations, only a handful of individuals appear to have joined the administration directly from the private sector.


“The trends in pharmaceuticals kind of run in parallel to the trends in the financial sector and Wall Street — you have an industry that Trump ran against pretty aggressively, with pretty strident language in 2016, and he is now seeing those industries as essentially farm clubs. He’s going to bring them up to the major leagues of his administration,” said Jeff Hauser, who runs the Revolving Door Project at the Center for Economic and Policy Research. “It’s unusually stark and unapologetic.”


Further Reading:

Dorothy Retha Cook 's curator insight, December 12, 2017 3:46 AM

An creative way to eliminate the poor, sick and health care needy using the government to get it done. If the assistance with health care cost including but not limited to medication and supplement life support and like manner of things needed to stay alive then it is true that those people that need them but can not afford to pay the cost of their medical needs will eventually die and by doing so in like manner and for like reasons the government are murderers using an creative method of elimination that when done by others they are punished by the same governmental system of doing things. Now this is the land of remove the oxygen and let them die, no more medication let them die, no more health care assistance for the poor, middle class and the in need let them die, the land of taking care of everyone else's but its own, the land of racisn,classism made legal. What has really happened? Nothing really its just that what use to be classified done behind closed doors has been made open to the public in a way that say's can you hear me now and dead sick people can't respond, they should have heard that one coming. Some did and did nothing to stop it but make it appear they did something. Sad world but real world we live in.

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Should We Stop Suggesting Physicians are "Bought" by Pharma Gifts?

Should We Stop Suggesting Physicians  are "Bought" by Pharma Gifts? | Pharmaguy's Insights Into Drug Industry News |

Every few months, another study is released with the same general theme: Gifts from pharmaceutical companies compel docs to prescribe more costly drugs.


Last June, it was JAMA Internal Medicine suggesting that a single meal swayed doctors’ prescribing habits. Now, a review of Washington, D.C.-based physicians is again painting the entire profession in a bad light.


In a study published in the journal PLOS One, 2,873 Medicare Part D prescribers in the nation’s capital were analyzed based on their prescribing habits. The study found that 39% of the docs received gifts from pharmaceutical representatives in 2013—ranging from meals to ownership interest in products.


These physicians wrote 2.3 more prescriptions per patient claim, prescribed $450 more in medications per claim and prescribed 7.8% more branded drugs compared with those who did not receive a gift. The study also cited internal medicine and family medicine as two of the specialties most associated with significantly increased average cost of prescription claims.


[BTW, these were not physicians. Read “Nurse Practitioners and Physician Assistants are Also Swayed by Gifts from Pharma”;]


… to simply claim that “gift equals increased prescriptions” is not only disingenuous, it’s offensive to all doctors throughout the U.S. (not only those based in D.C.) And it is just unnecessary information to share with patients without explaining more of the details of these exchanges, which is simply not available in every case.


Physicians will do what is best for their patients. It’s time that studies like this start putting some facts behind their inflammatory research.

Pharma Guy's insight:

I think research results go beyond "suggesting" - there's proof! You know, based on data. Similar to how pharma is able to "suggest" that drugs work :)

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Public Citizen Calls Upon FDA to Ban Hypertension Drug That Has Unique Serious Risks But No Unique Benefit

Public Citizen Calls Upon FDA to Ban Hypertension Drug That Has Unique Serious Risks But No Unique Benefit | Pharmaguy's Insights Into Drug Industry News |

The U.S. Food and Drug Administration (FDA) should ban the sale of a certain hypertension medication because it can cause life-threatening health risks, Public Citizen said today.


Keeping the medication on the market would continue to put hypertension patients’ lives at risk for the sake of corporate profits, the organization warned.


Public Citizen is petitioning the FDA to stop the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.


The condition is called sprue-like enteropathy because of its similarity to sprue or celiac disease – a gastrointestinal illness triggered by gluten ingestion. However, unlike with celiac disease, sprue-like enteropathy does not improve with a gluten-free diet.


The petition noted that with millions of prescriptions for olmesartan-containing medications filled each year, immediately banning the drug is essential to prevent avoidable serious harm to thousands of patients.


In 2012, researchers at the Mayo Clinic published the first study documenting the link between olmesartan use and sprue-like enteropathy. By 2013, the FDA had concluded that olmesartan “can cause” sprue-like enteropathy and issued a safety warning about the medication. However, rather than pulling olmesartan from the market, the agency required only the addition of a weak warning about this risk to the product’s labeling.


Since 2012, numerous studies together have documented more than 150 cases of this disorder in patients worldwide who took this medication. The studies found that most of the patients experienced serious complications – including profound malnutrition and kidney injury – and required hospitalization.


In addition, many other medications exist that are equally effective for treating hypertension and do not pose these risks to patients. In short, the petitioners say, olmesartan “has unique serious risks but no unique benefit.”


“There is overwhelming evidence that olmesartan causes severe sprue-like enteropathy and that the risk of this life-threatening complication is far greater with olmesartan than with the other seven FDA-approved ARBs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “There is no justification, other than corporate profits, to subject any patient to this danger when there are so many effective but much safer alternatives for treating hypertension.”

Pharma Guy's insight:

Interesting that this comes when new hypertension AHA guidelines may mean millions more Rx's for such drugs.

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Which Opioid Addiction Treatment Reigns Supreme? Vivitrol or Suboxone?

Which Opioid Addiction Treatment Reigns Supreme? Vivitrol or Suboxone? | Pharmaguy's Insights Into Drug Industry News |

A long-awaited study has found that two of the main medications for treating opioid addiction are similarly effective, a finding likely to intensify the hard-fought competition between drugmakers seeking to dominate the rapidly expanding opioid treatment market.


The study, funded by the federal government, compared Vivitrol, which comes in a monthly shot and blocks the effects of opioids, and Suboxone, which is taken daily in strips that dissolve on the tongue and contains a relatively mild opioid that helps minimize withdrawal symptoms and cravings.


Researchers found that 52 percent of those who started on Vivitrol relapsed during the 24-week study, compared with 56 percent of those who started on Suboxone.


But the study, conducted with 570 adults addicted mostly to heroin, also found a substantial hurdle for Vivitrol. Because the medication can be started only after a person is completely detoxed from opioids — a process that can take over a week — more than a quarter of the study participants assigned to Vivitrol dropped out before being able to take their first dose. Suboxone can be started shortly after withdrawal symptoms begin, and only six percent of those assigned to take that drug dropped out before taking an initial dose.


Drug manufacturers have been competing fiercely to develop and market medications to treat opioid addictions, which have propelled a steep increase in the number of drug deaths in the United States. Last year, 64,000 Americans died from drug overdoses, up 22 percent from the previous year.


There is significant money at stake. Under a law passed by Congress in 2016, the Trump administration is sending $1 billion to states to deal with the epidemic over the next two years, with directions to prioritize so-called medication assisted treatment. Mr. Trump’s opioid commission recently implored Congress to swiftly appropriate more money.


Suboxone, made by Indivior, is the older, cheaper, and much more widely studied and used of the two medications. The manufacturer of Vivitrol, Alkermes, has tried to catch up by marketing its drug as a cleaner alternative, emphasizing that Vivitrol is the only federally approved addiction medication that does not contain an opioid.


Vivitrol is also the most expensive addiction medication, with Medicaid paying about $500 per shot, according to Alkermes, and private insurers paying $1,000. Suboxone tends to cost a third to half as much.


Further Reading:

  • “Alkermes - Maker of Powerful Opioid Zohydro - Lobbies Hard for Its Expensive Treatment for Addiction!”;
Pharma Guy's insight:

Don't you just love it when a company that helped create the current opioid addiction crisis may profit from its treatment?

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Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own. See