Pharmaguy's Insights Into Drug Industry News
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Some #Biotech CEOs Earned Big Increases in Compensation Even as Their Companies Tanked

Some #Biotech CEOs Earned Big Increases in Compensation Even as Their Companies Tanked | Pharmaguy's Insights Into Drug Industry News |

Last year was a bruising one for the biotech industry. But a handful of biotech executives saw their compensation swell even as their companies tanked on Wall Street.


STAT reviewed federal filings from all 162 companies on the Nasdaq Biotech Index. The index as a whole fell by 19 percent last year, so it’s no surprise that CEOs as a group made 25.5 percent less in 2016 than they had taken home the year prior.


But five outliers — Cempra, Endo International, Ophthotech, Pacira Pharmaceuticals, and Seres Therapeutics — gave their executives huge raises even though their stocks actually fared far worse than the index average. One CEO got a 385 percent pay increase after his company’s shares fell by more than 70 percent.


Such disparities can be maddening to investors. Executive pay is meant to be aligned with shareholder return. If you took a bath on a stock, you’d rather the company’s CEO didn’t recoup a bonus big enough to buy an infinity pool.


“It’s something that I fret about, because my compensation is performance-related,” said Eden Rahim, a portfolio manager at Next Edge Capital in Toronto. “If I’m down, I’m not earning anything. And then you see these guys who are well-compensated and don’t really deliver the goods.”


That disconnect sometimes stems from poorly thought-out incentive plans that end up rewarding failure, said Aalap Shah, managing director at Pearl Meyer, an executive compensation consultancy in New York. Other times, bad years force boards to strike a delicate balance, paying CEOs enough to keep them around but not so much as to spark an investor revolt.


“This is something that is always very hard for shareholders to swallow, but oftentimes directors have to make the tough call to give compensation that looks misaligned,” Shah said. “They do that because they still believe the management team is the one that’s right for the company and its strategy.”


Further Reading:


  • “Glaxo to Pay First Woman CEO Less, Cites Lack of Experience”;
  • “Pharma CEOs Living in an “Alternate Reality” But Getting Paid Exorbitantly High Real World Salaries!”;

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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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Women Lack Confidence Managing Chronic Conditions

Women Lack Confidence Managing Chronic Conditions | Pharmaguy's Insights Into Drug Industry News |

According to a recent study by West and Kelton Global, only about half (52%) of women with a chronic illness feel very confident in their ability to manage their chronic condition. Less than half (48%) say they're at least somewhat confident that they know what their current health metrics are, and just 28 percent are confident that they know what their target metrics should be. More than one-quarter (26%) of women feel that managing their condition is brining on stress and anxiety, which only exacerbates health challenges. Around 38 percent of women say they want more individualized care, including tips and tools specific to them.

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Can We Pin Pharma's Bad Reputation on Trump?

Can We Pin Pharma's Bad Reputation on Trump? | Pharmaguy's Insights Into Drug Industry News |

The pharma industry’s reputation among patient groups in the U.S. has sunk to a recent low, and some are pointing to the country's leader as the reason.


Only 29% of groups recently surveyed by research firm PatientView believe pharma has an “excellent” or “good” corporate reputation, the most negative rating in the U.S. since 2013. That compares with 38% of global patient groups that view pharma positively, according to a new U.S.-only breakout report by PatientView.


PatientView founder and CEO Alex Wyke said in an interview that U.S. President Donald Trump may have something to do with the stat.


“Trump has changed the whole dynamics in the way pharma companies are viewed, not just in the USA but worldwide. 2016 was notable in that patient groups marked the industry down for many of their activities, but most notable was the ability of companies to adopt fair pricing policies—from the perspective of patient groups," he said via email.


Those moves to "price products fairly" only received positive reviews from 7% of U.S. groups. The other area where pharma companies are trying hard, but apparently failing in patients’ eyes, is providing services beyond products, often called "beyond the pill" services. Just 14% of groups rated the industry's efforts as “excellent” or “good.”


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Many Patients Taking Drugs for Alzheimer’s Do Not Actually Have the Disease

Many Patients Taking Drugs for Alzheimer’s Do Not Actually Have the Disease | Pharmaguy's Insights Into Drug Industry News |

A significant portion of people with mild cognitive impairment or dementia who are taking medication for Alzheimer’s may not actually have the disease, according to interim results of a major study underway to see how PET scans could change the nature of Alzheimer’s diagnosis and treatment.

The findings, presented Wednesday at the Alzheimer’s Association International Conference in London, come from a four-year study launched in 2016 that is testing over 18,000 Medicare beneficiaries with MCI or dementia to see if their brains contain the amyloid plaques that are one of the two hallmarks of the disease.

So far, the results have been dramatic. Among 4,000 people tested so far in the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, researchers from the Memory and Aging Center at the University of California at San Francisco found that just 54.3 percent of MCI patients and 70.5 percent of dementia patients had the plaques.

A positive test for amyloid does not mean someone has Alzheimer’s, though its presence precedes the disease and increases the risk of progression. But a negative test definitively means a person does not have it.


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Nektar Therapeutics Pursues a Novel Approach to Solving Opioid Abuse Problem

Nektar Therapeutics Pursues a Novel Approach to Solving Opioid Abuse Problem | Pharmaguy's Insights Into Drug Industry News |

To tackle the runaway opioid addiction crisis, some drug makers have tried to make pain pills harder to abuse without changing the opioid molecule itself. This strategy often misfires: People figure out ways to bypass the abuse-resistant technology, allowing the unmodified opioid to enter the brain quickly, resulting in a euphoric high.


Clinical trial data released Tuesday bolsters the case for a different approach: Changing the opioid molecule itself. That’s what Nektar Therapeutics is doing with an experimental opioid tablet, known as NKTR-181, that’s designed to cross the blood-brain barrier more slowly. The goal: relieve pain, but with less euphoria and a lower potential for abuse.


A phase 3 study released last March demonstrated NKTR-181 met the first goal: It reduced pain significantly more than a placebo in patients with chronic back problems. In the new study, drug users were given escalating doses of NKTR-181 and conventional oxycodone. Asked to rate likability, the drug users preferred oxycodone over NKTR-181, achieving the primary endpoint of the human abuse potential study.


“No one has ever taken more than the prescribed amount of an opioid,” said David Juurlink, an expert on opioids and drug safety at the University of Toronto.


His sarcasm may not come through in print, but Juurlink points to data from Nektar’s study showing the likability of the highest tested dose of NKTR-181 — higher than what would normally be prescribed — was on par with a common dose of oxycodone. Using oxycodone as the point of reference was also a bit of a dodge, added Juurlink, because it is inherently more likable than morphine or hydrocodone.


Nektar’s Doberstein concedes an addict willing to swallow a handful of NKTR-181 tablets could get the same high as a smaller amount of oxycodone, but it would take three times as long.


“The rush that opioid abusers are seeking comes in that first hour, but you don’t see that with NKTR-181,” he said.

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The Periodic Table of Pharma Multi-channel Marketing

The Periodic Table of Pharma Multi-channel Marketing | Pharmaguy's Insights Into Drug Industry News |

For those of you not familiar with these marketing twists on the Periodic Table, over the past few years, people have created periodic tables for various marketing disciplines including SEO, marketing attribution and web design.


Our Periodic Table of Pharma Multi-channel Marketing has been designed to provide pharma marketing folk with an at-a-glance overview of all the key elements needed for multi-channel marketing activity.


We hope it’s reasonably self-explanatory although here are the eleven areas that we’ve focused on:


  1. Research
  2. Strategy
  3. Channels
  4. Owned Media
  5. Paid Media
  6. Earned Media
  7. Content Relevancy
  8. Content Format
  9. Data and Analytics
  10. Martech
  11. KPIs


Further Reading:

  • “#Pharma Not Yet Ready for Multi-Channel Marketing, Says Novartis Head of Digital”;
  • “Towards Achieving the "Holy Grail" of Multichannel #Pharma Marketing”;
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Diabetes Reality Show is in Reality a Vehicle for Proselytizing a Self-help Scam, a Last-Ditch Marketing Gambit, and an Running Ad for a Luxury Resort

Diabetes Reality Show is in Reality a Vehicle for Proselytizing a Self-help Scam, a Last-Ditch Marketing Gambit, and an Running Ad for a Luxury Resort | Pharmaguy's Insights Into Drug Industry News |

The man who boasts of changing the face of diabetes spreads his arms out wide, like the Christ the Redeemer statue, but in neon orange shorts and bare feet. He looks earnestly into the rolling camera.

“Welcome to ‘Reversed,’” he intones. Seated behind him are four of his disciples: Americans with type 2 diabetes who’ve flown to this tropical beach town to participate in a reality TV show marketed as a momentous opportunity to restore their health. Over eight days, they’ll learn to exercise and eat right and bare their struggles in cathartic therapy sessions.

Their host, Charles Mattocks, is a smooth-talking, fast-moving entrepreneur, who has leveraged his family fame (his uncle was Bob Marley) and his own medical history (he uses diet and exercise, not insulin, to manage his diabetes) to set himself up as a guru to diabetics everywhere.

In an age where nearly 1 in 10 Americans has diabetes, a disease that can bring a lifetime of painful complications, patients are often desperate for miraculous turnarounds — and there’s a booming trade in supplements, diets, and self-help books that promise answers. Now, there’s a TV show, too.

But “Reversed” is unlikely to prove anyone’s salvation.

The show, which will begin airing next month on cable, is at once a vehicle for Mattocks to proselytize his gospel of self-help, a marketing gambit by a pharma company that’s running out of money, and a season-long advertisement for a luxury getaway at the sparkling resort where it was filmed.


Further Reading:

  • “Don't Have Much of a Marketing Budget? Mannkind Sponsors Diabetes Reality TV Show in Jamaica”;
  • “Merely a Flesh Wound! MannKind Swears Afrezza Not Dead”; 
  • “Sanofi's DTC ROI for Afrezza: Lost 53 Cents for Every $1 Spent!”; 
  • “#Pharma Disease Awareness Marketing Infiltrates Soap Operas Like General Hospital”; 
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Does Boehringer Ingelheim Have “The Balls” Needed to Compete?

Does Boehringer Ingelheim Have “The Balls” Needed to Compete? | Pharmaguy's Insights Into Drug Industry News |

When Boehringer Ingelheim had the chance to snatch a prize biotech company from under a rival’s nose a few years back, it decided to pass. That 2011 decision didn’t sit well with some members of the family that controls the 132-year-old German drugmaker.


“We didn’t have the balls to acquire something like this,” Mathias Albert Boehringer groused to his second cousin, Christoph Boehringer, via text message. “I expected as much.”


The exchange, disclosed this year in court testimony, exemplifies the stresses facing Boehringer Ingelheim. With a younger, more ambitious generation in charge now, it’s set an internal goal of boosting sales by almost 60 percent by 2025, to 25 billion euros ($28.5 billion). Currently, that would rank it among the world’s top 10 drugmakers. Still, the company remains secretive and reluctant to take bold steps.


The family’s attitude limits Boehringer Ingelheim’s ability to take risks as it tries to compete with pharma giants such as Merck & Co. and Bristol-Myers Squibb Co. in the high-stakes and costly business of developing new drugs for illnesses such as cancer, obesity-linked liver disease or Alzheimer’s. The company has repeatedly ruled out selling shares in an initial public offering, closing off one avenue that would allow it to make bigger bets.


“The whole dynamic is much more controlled and less rock-and-roll than a publicly listed firm,” said Ludo Van der Heyden, a professor at INSEAD, the French business school.

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Pharma Commercial Support of Accredited CME Programs Rose About 3% in 2016

Pharma Commercial Support of Accredited CME Programs Rose About 3% in 2016 | Pharmaguy's Insights Into Drug Industry News |

The pharmaceutical industry spent more on accredited continuing medical education in 2016 than it did in 2015, with spending hitting $704 million last year, up from $693 million in 2015 — a 1.5% increase.


[Note: If you include advertising and exhibit income - almost all of which is paid by pharma - then the year-over-year increase is more like 2.9%.]


In 2016, about one-quarter — 28% — of all CME investment came from the phama industry, according to an annual report from the Accreditation Council for Continuing Medical Education (ACCME).


Investment in CME from advertising and exhibits also increased modestly, by 3% over the same year-over-year period, CME providers reported.


Overall investment in CME programs increased slightly to $2.5 billion in 2016, up from $2.4 billion in 2015, and the number of CME events also rose in 2016 by 7%. More than half, or 54%, of all revenue generated by CME programs came from registration fees.


CME providers increasingly took their programming to live online formats this year, with 17% more of those kind of activities reported in 2016 compared to 2015.


Further Reading:

  • “Industry-funded Testosterone CME Courses Downplay Risks, Lead to Overuse in Older Men”;
Pharma Guy's insight:

At its height in 2003, pharma support of CME totaled $971 million. Today, pharma's support is only 73% of what it was back then. Unless the increase in support picks up dramatically, it may be a very long time before we see numbers like those in 2003.

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OIG Identifies Docs Who Over-Prescribe Opioids to Retirees (Medicade Part D Recipients)

OIG Identifies Docs Who Over-Prescribe Opioids to Retirees (Medicade Part D Recipients) | Pharmaguy's Insights Into Drug Industry News |

In the latest bid to stem the opioid epidemic, investigators at the Department of Health and Human Services have identified excessive prescribing patterns in Medicare Part D involving hundreds of doctors and plan to work with law enforcement authorities to curtail the practice.


In a new report, the HHS Office of Inspector General found that 401 prescribers last year wrote more than 256,200 prescriptions for nearly 90,000 Part D beneficiaries who were deemed to be at serious risk because they received “extreme” amounts of opioids or appeared to be doctor shopping.


The prescribing patterns not only suggest these prescribers are contributing to the opioid epidemic, which was blamed for 33,000 deaths in 2015, but is also costing taxpayers significant sums.


To wit, 1 of every 3 Part D beneficiaries received a prescription for an opioid — or 14.4 million out of 43.6 million enrollees — for which the plan paid almost $4.1 billion in 2016. About 80 percent of the prescriptions were for Schedule II or Schedule III controlled substances, such as Vicodin and Percocet, which have a high risk of abuse.


In one instance, a Florida physician wrote prescriptions for just one Part D beneficiary in one day for three different opioids: oxycodone and two forms of fentanyl. In all, this doctor prescribed opioids for 125 people who received “extreme” amounts, and Medicare shelled out $1.6 million.

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Allergan CEO Talks Anti-Lip Enhancement For Teens, But Will Docs Listen?

Allergan CEO Talks Anti-Lip Enhancement For Teens, But Will Docs Listen? | Pharmaguy's Insights Into Drug Industry News |

Allergan is targeting some newer, fast-growing markets with its aesthetic drugs portfolio—but the under-18 crowd isn’t one of them.


In a Wednesday blog post, CEO Brent Saunders laid out the reasons he struggles with the idea of using some of his company’s own treatments in minors—and asked others in the field to share their opinions.


“As the father of two high-school-age girls, I am sensitive to the societal pressures they face—to look a certain way or meet a certain standard,” Saunders begins. When that world intersects the world of medical aesthetic tech—through the “inappropriate use of medical aesthetic procedures among minors—it is time to speak up,” he added.


With his blog post, Saunders is wading into a debate larger than his own business, addressing the tough-to-achieve markers of beauty that pop stars, actors, models and fashionistas set for young girls and women, consciously or not. The way he sees it, “emotional maturity is critical to the decision-making process involved to fully understand treatment options and their potential implications,” and “many teenagers lack that level of maturity.”


Prettifying injections and treatments generally are used off-label in teens. Allergan's in particular—which include blockbuster toxin Botox and filler Juvederm, aren't FDA-approved for minors, Saunders points out. "To be clear, Allergan’s medical aesthetic products are approved for adults," he writes.


The post, which he titled “Building a Consensus on Medical Aesthetic Treatment for Minors,” comes as interest in aesthetic treatments grows among younger patients. Saunders cites the lip injection trend that’s taken off among teens, and points out that girls are increasingly using soft tissue and hyaluronic acid dermal fillers, too.


“With each passing year, the rates of inappropriate use of aesthetic treatments among this teenage population are likely to increase,” he wrote.

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Former Insys Sales Reps Bribed Docs To Prescribe Opioids To As Many Patients as Possible

Former Insys Sales Reps Bribed Docs To Prescribe Opioids To As Many Patients as Possible | Pharmaguy's Insights Into Drug Industry News |

Two former sales reps pleaded guilty on Tuesday to bribing doctors in exchange for prescribing the powerful Subsys painkiller sold by Insys Therapeutics, which is under numerous investigations by state and federal authorities for its role in the opioid epidemic.

In both instances, the sales reps pleaded guilty to violating the federal anti-kickback law for participating in a speaker program that prosecutors say was used to reward doctors and other medical practitioners for prescribing Subsys, which contains fentanyl and carries a high risk of dependency.

Insys claimed its speaker program was designed to educate medical providers about its drug. But federal authorities maintained the primary purpose was to induce doctors to write prescriptions for as many patients as possible. The drug was approved only to treat people suffering breakthrough cancer pain.


Further Reading:


  • “Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign”;
Pharma Guy's insight:

Insys is a "bad player" in the opioid market!

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A Tiny, Trash-Talking "Wrestler" is New Mascot for Novartis Carcinoid Tumor Disease Awareness Campaign

A Tiny, Trash-Talking "Wrestler" is New Mascot for Novartis Carcinoid Tumor Disease Awareness Campaign | Pharmaguy's Insights Into Drug Industry News |

Pharma’s newest spokescharacter is a tiny, trash-talking professional wrestler. He’s part of a new disease awareness campaign for carcinoid syndrome from Novartis, created by Klick Health.

The gaudy, spandex-wearing wrestler, like persistent stomach pain and gastrointestinal issues, won’t leave a suffering man alone—punching, kicking and trash-talking him through everyday life. The TV spot, interactive display banners and social media posts direct people to a “What Am I Wrestling With” website that suggests constant sufferers may need to consider a different diagnosis.

The site introduces carcinoid syndrome, a rare condition caused by hormones released by an abnormal growth called a carcinoid tumor. As it notes, carcinoid tumors “are very uncommon and are usually small and slow-growing.” However, the symptoms of carcinoid syndrome include GI issues, such as recurring diarrhea, as well as maladies such as irregular heartbeat, skin flushing and difficult breathing. The site includes a 30-second self-quiz about signs and symptoms.

While the campaign is disease awareness only and doesn’t mention or link to any branded products, Novartis is the maker of Sandostatin LAR, a $1.6 billion seller that's used to treat acromegaly and severe diarrhea and flushing associated with carcinoid syndrome. That drug is facing generic erosion from a slew of companies this year, including Teva, Sun Pharma, Sagent Pharmaceuticals and Wockhardt.

Klick interviewed dozens of people who have the kinds of persistent GI problems the campaign seeks to highlight to check their reaction to the work, from the wrestler TV and banner ads that talk about GI discomfort to a website that raises the possibility of this type of cancer. The agency said it got no negative feedback.

“While it might seem at first blush as a mismatch between tone and the information or the possibility that it ultimately raises, I think we’re bringing more of our own biases or expectations than actually exists in people that are in that dynamic,” Elliot Langerman, chief creative officer at Klick, said in an interview.

Pharma Guy's insight:

I'll have to add him to my "Gallery of Drug Advertising Mascots": 

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Boston Scientific Ad for Watchman Medical Device Takes Shot at Blood Thinners!

Boston Scientific Ad for Watchman Medical Device Takes Shot at Blood Thinners! | Pharmaguy's Insights Into Drug Industry News |

This spring, viewers in four U.S. metro areas — Tampa, Detroit, San Diego, and Phoenix — saw the first television commercial aired by Boston Scientific, a 38-year-old maker of medical devices.


The ad, aimed at families of the millions of older Americans with irregular heartbeats, portrays a distraught adult daughter driving her father to the hospital. A doctor tells them about one of the Marlborough, Mass., company’s newest products: an implantable device called Watchman that seals a pocket in a patient’s heart chamber to prevent blood clots that can trigger strokes.


Such televised pitches are rare for medical device companies, which, unlike prescription drug makers, traditionally have steered clear of consumer marketing. But they are part of a strategy by Boston Scientific to promote a new generation of products designed to propel it into a top position in the markets for cardiac, endoscopic, urological, and other devices.


Boston Scientific’s chief medical officer, Ian Meredith — an interventional cardiologist and researcher recently recruited from Australia — conceded there was “a lot of hand-wringing” over whether to launch the television commercial. Ultimately, the company decided it was important to educate patients with atrial fibrillation, who bruise and bleed from the anticoagulant blood thinners typically prescribed to dissolve clots. Executives are gauging the ad’s effectiveness before determining whether to air it in additional markets, such as Boston.


“This is a very socially impactful ad,” Meredith said. “It’s really identifying that there’s an alternative for people who can’t take anticoagulation or who are struggling with anticoagulation [medicines]. And a lot of primary care doctors don’t realize this option’s available.”


Further Reading:

  • “Ad: 7th Annual Digital Marketing for Medical Devices - Save 15% use code PMN15”;
  • “Medical Device DTC Ads: Spooky, Outrageous Claims & Unregulated!”;
  • "Device DTC: Imagine How Far It Will Go!";
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Which Pharma Executive Made the Most Money Last Year? The Answer May Surprise you!

Which Pharma Executive Made the Most Money Last Year? The Answer May Surprise you! | Pharmaguy's Insights Into Drug Industry News |

Tracking executive pay follows a familiar pattern: Collect compensation disclosures, read said documents as they pile up, and when the usual suspects have all filed their annual reports and proxy statements, put the numbers into a spreadsheet and sort descending.


It’s pretty much guaranteed Johnson & Johnson’s CEO will be near the top of the list, regardless who’s in the job. Same for Abbott Laboratories—until it spun off its pharma business, AbbVie, whose CEO is now a regular. Same for Bristol-Myers Squibb—from Jim Cornelius to Lamberto Andreotti and now Giovanni Caforio, M.D.


What’s not guaranteed is that the chairman of a generics maker in hot water with the U.S. government and American parents—Mylan’s Robert Coury—would step off the company’s employee roster and into the nonexecutive chairman’s job and reap a $97 million package with the move.


Further Reading:

  • The 5 Most Overpaid #Pharma CEOs in the World:
  • Some #Biotech CEOs Earned Big Increases in Compensation Even as Their Companies Tanked: 
  • Glaxo to Pay First Woman CEO Less, Cites Lack of Experience: 
  • Pharma CEOs Living in an “Alternate Reality” But Getting Paid Exorbitantly High Real World Salaries!: 
  • Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!: 
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Teamsters Say "Nay!" to McKesson for Its Role in the Opioid Crisis

Teamsters Say "Nay!" to McKesson for Its Role in the Opioid Crisis | Pharmaguy's Insights Into Drug Industry News |

In the latest bid to hold drug distributors accountable for the opioid crisis, a major union is urging McKesson shareholders to vote against executive compensation and appoint an independent chairman.


The International Brotherhood of Teamsters, which claims to have “substantial holdings” in the wholesaler, sent a letter on Monday to McKesson shareholders, arguing the pay package given chief executive officer John Hammergren is “excessive,” because the distributor has “emerged as a central figure” in the nation’s opioid epidemic.


Specifically, the union pointed to a “record” $150 million fine that McKesson paid earlier this year for failing to report suspicious orders, as well as an agreement to suspend sales of controlled substances from warehouses in four states. The Drug Enforcement Administration described the move as among the “most severe sanctions” ever to involve a drug distributor.


In arguing against his pay package, the union maintained that the settlement with the DEA “appears to have been excluded from the profit metrics used in both the company’s short- and long-term incentive plans.” Meanwhile, Hammergren received a 150 percent “individual performance modifier,” which boosted his annual bonus by $1.1 million, the Teamsters wrote to McKesson shareholders.


The union chided the McKesson board for following a “long-standing practice of insulating executive pay from the legal and regulatory liabilities built up by” company practices. The Teamsters also pointed to litigation charges taken over allegations the distributor conspired to raise average wholesale prices for medicines. The union believes these appeared to have been excluded from calculating executive pay.


“With criticism mounting over McKesson’s role in helping to fuel the nation’s opioid epidemic, recent pay decisions also send completely the wrong message to shareholders, regulators, lawmakers, and the public about executive accountability,” the Teamsters wrote.

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Viagra DTC TV Ad Spending Deflates Like Tom Brady’s Balls

Viagra DTC TV Ad Spending Deflates Like Tom Brady’s Balls | Pharmaguy's Insights Into Drug Industry News |

TV networks are trying to keep a stiff upper lip as the once-lucrative erectile dysfunction sector has begun sagging like a doctored football in Tom Brady's throwing hand. According to multiple insiders, a certain little blue pill has all but vanished from the airwaves, and its absence will be particularly conspicuous during the upcoming NFL season.


Nearly 20 years after the FDA first approved its use as an ED remedy, Pfizer's Viagra is losing its patent exclusivity, and that's a bitter pill to swallow for the TV business. Viagra hasn't aired a national TV advertisement since May 15, and network ad sales executives said the brand is unlikely to resurface, having sat out the 2017-18 upfront bazaar.


Football fans should notice the dearth of Viagra spots as early as Sept. 7, when NBC is set to broadcast its annual NFL Kickoff Game. When the Chiefs and Patriots square off in Foxborough, their clash will not be interrupted by pitches for what was until recently the NFL's top-spending pharmaceutical brand; according to data, Viagra last season invested nearly $31 million in pro football inventory.


Ad sales bosses say that the disappearance of one of the NFL's top 40 highest-spending advertisers is a function of Viagra losing its exclusivity in the face of the impending launch of a generic version of the brand. Teva Pharmaceuticals is set to roll out a far cheaper variant of the compound on Dec. 11.


"Once a generic gets in the mix, that usually spells the end of any direct-to-consumer advertising for the legacy brand," said one ad sales exec. "Rather than continue to market something they no longer have exclusivity over -- which really can only help boost sales of the new generic pill -- the pharmaceutical company will reallocate that portion of its budget back into its brands that are still exclusive."


Further Reading:

  • A Dick Move by Pfizer: Raises Price of Viagra & Other Drugs by as Much as 28% in One Year!: 
  • Will You Miss Those ED DTC TV Ads When Viagra & Cialis Go Generic? John LaMattina Will: 
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HexaBlockbusters! Sales of Each of the 9 Best-Selling Prescription Drugs in 2016 Topped $6 Billion.

One primary reason behind the continued increase of prescription drug costs is the greater number of specialty drugs that have been introduced by biopharmaceutical companies. These specialty drugs are used to treat complex or rare chronic conditions. Many of them are biologics, which are drugs derived from living cells.

The flip side of the rising costs of prescription drugs is that some drugmakers are making a lot of money. Here are the nine best-selling prescription drugs of 2016, all of which generated sales of more than $6 billion.

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Pharma Payments to HCPs Topped $8 Billion in 2016. Allergan & Celgene Paid Out the Most!

Pharma Payments to HCPs Topped $8 Billion in 2016. Allergan & Celgene Paid Out the Most! | Pharmaguy's Insights Into Drug Industry News |

Payments from drug and device companies to physicians and teaching hospitals hit more than $8 billion in 2016 according to Open Payments data recently released by CMS.

All told, nearly 631,000 physicians and approximately 1,146 teaching hospitals received $8.18 billion in payments and ownership and investment interests in 2016, according to tallies compiled by the CMS. Last year's total was $7.52 billion.

About half of the overall payments were for research and $2.7 billion were in payments not related to research. A little more than $1 billion stemmed from ownership or investment interests.

Of the largest pharmaceutical companies, Allergan paid out the most in 2016 with $66 million in total payments. Dr. George Patrick Maxwell, a plastic surgeon in Nashville, is listed as the highest payment recipient from Allergan, with $4.6 million.

Celgene was the second-highest spender with a total of $54 million in payments last year. Of its recipients, Boston oncologist Dr. Kenneth C. Anderson a took in the most, with $1.9 million.

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Judging the Benefits and Harms of Drugs: More Transparency Needed

Only trustworthy evidence will earn the public’s trust

How should society judge the safety and efficacy of drugs? This was the question posed by England’s chief medical officer, Sally Davies, in February 2015. Citing controversies about oseltamivir (Tamiflu) and statins, as well as growing disquiet about overmedication by doctors and conflicts of interest among researchers, she feared an erosion of public trust and asked the Academy of Medical Sciences to undertake a review. In June that same year, editorialists in The BMJ called on the academy to recommend “simple practical improvements that would address legitimate concerns.” The academy has now published its report. Does it deliver?

From the outset of the review, the academy confirmed that there is a problem. Its survey found that only one in three members of the public trusts the results of research. It also found that more than four fifths of general practitioners and two thirds of British adults disbelieved the results of trials funded by the drug industry.

In response to this finding, which the chair of the report, John Tooke, called “startling,” the academy has produced a wide ranging report that says many of the right things. But the overall result is disappointing. In their 2015 editorial, Heneghan and Goldacre warned against focusing on gaining the public’s trust through false assurances. They proposed instead improving the evidence base through changes in the funding, conduct, and dissemination of research. The academy report includes welcome calls for researchers to involve patients and be more transparent.

Via Richard Meyer
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Despite Being "Horrific," Sage's Postpartum Depression Disease Awareness Campaign is a Success!

Despite Being "Horrific," Sage's Postpartum Depression Disease Awareness Campaign is a Success! | Pharmaguy's Insights Into Drug Industry News |

It’s an arresting advertising image: a close-up photo of a woman with a baby pacifier in her mouth and a tear rolling down her cheek. The disease awareness campaign from Sage Therapeutics is tagged, “When it comes to postpartum depression, silence sucks.”


The response, on the other hand, has been anything but silent. But engaged responses and online discussions are just what Sage says it intended.


“The intent of the campaign was to bring awareness and education and provoke a productive discussion around a condition that has been largely stigmatized and ignored,” Ryan Arnold, D.O., Sage's VP of medical affairs, said in an interview about the campaign, media coverage and pushback. The outdoor work in Boston, where Sage is based, was a one-city, one-month pilot project, he said.


In mid-June a story in Stat noted how the campaign's imagery had “hit a nerve” (read “Sage's Postpartum Depression Awareness Campaign ‘Infantilizes’ Women Say Critics”;


The outcry on Instagram ranged from “so offensive on so many levels” to “which genius marketer came up with ‘let’s shove a pacifier into a crying woman’s mouth to peddle PPD drugs?’ This is horrific.” Sage responded to the commenters with detailed explanations about its intent and beliefs, although the women were generally not having it.


Web traffic to the site is up, with average views topping more than 1,000 per day, Arnold said. While that could be attributed to people investigating just what the ad campaign is about, he added that Sage has also seen an increase in people clicking through on its advocacy group links and advice on talking to a doctor, with more than 2,500 through last week. Its advocacy group partners confirmed correlating upticks, he said.


When asked whether Sage will continue to use the woman-and-pacifier imagery, he deferred on specifics and simply said the company is evaluating feedback and discussing how to evolve the campaign.

Pharma Guy's insight:

Just like slowing down to watch an accident on the highway! It's so educational and so sad.

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Financing and Distribution of Pharmaceuticals in the United States

Financing and Distribution of Pharmaceuticals in the United States | Pharmaguy's Insights Into Drug Industry News |

Adapted from a figure by the Congressional Budget Office.1 Services represent contractual relationships between entities. Rebates are payments from manufacturers to pharmaceutical benefit managers. Chargebacks are payments from manufacturers to distributors. Retailers include pharmacies, hospitals, group purchasing organizations, and mail-order programs. AMP indicates average manufacturer price; WAC, wholesale acquisition cost.

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Americans Consume More Opioids Per Person Than Any Other Country

Americans Consume More Opioids Per Person Than Any Other Country | Pharmaguy's Insights Into Drug Industry News |

America has about 4 percent of the world’s population — but about 27 percent of the world’s drug overdose deaths.


That’s one of the startling conclusions from a recent report by the United Nations Office on Drugs and Crime.


The US has always been ahead of much of the world in drug overdose deaths — for a variety of reasons. For one, Americans are relatively wealthy, so they can afford to buy drugs. But there also appear to be cultural and socioeconomic factors at play, driving a broader increase in “deaths of despair” — such as suicides, alcohol, and drug overdose deaths — in recent years. (If you ask experts what these factors could be, you can expect them to name, well, basically everything — a weak social safety net in the US compared with other developed countries, poor access to health care in general, subpar mental health care and addiction services, manufacturing jobs moving out of the country, cuts to local government services like parks and recreation, individuals losing a sense of spiritual or existential meaning, and so on.)


But recently, America has gotten much worse due to its massive opioid epidemic, which has contributed to a huge spike in drug overdose deaths over the past couple of decades. In 1999, fewer than 17,000 people died from drug overdoses. In 2015, that grew to more than 52,000.


This is, for now, largely an American problem. After pharmaceutical companies heavily marketed their opioids in the US, and doctors followed through with massive numbers of prescriptions, America became the world’s leader in consuming opioids — with UN data putting the US at the top of opioid consumption. (Notably, other developed countries have tighter restrictions on pharmaceutical marketing than the US does.)

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Allergan CEO Saunders Says Martin Shkreli is a "Mentor"

Allergan CEO Saunders Says Martin Shkreli is a "Mentor" | Pharmaguy's Insights Into Drug Industry News |

Sarah Hassan was new to the hedge fund world in 2010 when a longtime friend of her father suggested she meet a “rising star” in the industry: Martin Shkreli.

The friend, Brent Saunders, the chief executive of pharmaceutical giant Allergan, said he had had “some phenomenal returns” by investing in one of Shkreli’s funds, Hassan told a federal jury in Brooklyn this week. “Mr. Saunders had suggested we meet up because I was trying to learn about the hedge fund world. He thought Martin could be mentor,” she said.

Hassan eventually met Shkreli for lunch at a Manhattan restaurant, during which he recommended some books to read and gave general advice about wading into hedge fund investing. Hassan would go on to invest $300,000 in one of Shkreli’s hedge funds, MSMB Capital.

So marked the start of business relationship that produced a handsome windfall but would eventually lead to Hassan testifying this week against Shkreli as he stands trial for defrauding investors and committing securities fraud. Hassan’s dealings with the Wall Street bad boy offered a window into the workings of the lucrative hedge fund world, and illustrated the tension at the heart of the prosecution’s case: the victims ultimately made money.

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Charity Funded by #Pharma Draws IRS Probe

Charity Funded by #Pharma Draws IRS Probe | Pharmaguy's Insights Into Drug Industry News |

The U.S. Internal Revenue Service has opened a probe into the tax-exempt status of a charity funded by pharmaceutical companies, threatening a lifeline the industry uses to help patients buy expensive drugs for cancer, multiple sclerosis and other diseases.


The agency is exploring whether the Chronic Disease Fund, a patient-assistance charity funded largely by drugmakers, gave “impermissible” benefits to its corporate donors, according to federal court filings. An IRS analysis found that 95 percent of the $129.3 million the charity spent on co-payment support in its public programs in 2011 went to patients taking drugs made by the very companies that had donated the money, according to court papers.


Donations from drug companies “are nearly all returned to those same pharmaceutical manufacturers as payments for the drugs they make,” attorneys for the IRS said in papers filed in federal courts in California, Pennsylvania and other states, seeking information related to the probe. “In effect, CDF is serving as a conduit for its pharmaceutical manufacturer ‘donors,’” government lawyers said.


The IRS has sent summonses to Roche Holding AG’s Genentech unit, Biogen Inc., Johnson & Johnson, Teva Pharmaceutical Industries Ltd., Novartis AG and Bayer AG, seeking information on donations to CDF. Biogen, Novartis and Bayer said they’re cooperating with the IRS summonses, and Teva declined to comment. J&J said it has no control over how co-pay charities operate. Roche declined to comment on ongoing legal matters.


The IRS probe adds to the growing scrutiny of charities that help poor patients pay for expensive drugs. As prices have soared, pharmaceutical companies’ contributions to patient-assistance charities have sparked accusations that the donations are, in effect, a profitable form of marketing subsidized by U.S. taxpayers. The seven biggest co-pay charities, which cover scores of diseases, reported combined contributions of $1.1 billion in 2014 -- more than double their 2010 figures.


In 19 of 24 disease-specific funds managed by the Chronic Disease Fund that received drug company funding in 2011, 90 percent of the spending ended up going to patients taking the primary donor companies’ drugs, according to an analysis by an IRS agent contained in court filings. The vast majority of the funds had just a single corporate donor, according to the IRS analysis.


Genentech, the biggest funder of CDF in 2011 according to the IRS analysis, donated more than $70 million for at least nine disease funds that year. In seven of the disease funds Genentech supported, almost all the co-pay assistance ended up going to patients taking Genentech drugs, the IRS said.


Another big donor was Celgene Corp., which gave $48.8 million in 2011 to support a fund for multiple myeloma patients, according to the IRS analysis. It was the only drug company donor to the fund and 98 percent of the money CDF spent in that fund went to patients taking drugs from Celgene, the IRS said. Celgene declined to comment.

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Implants - Like Probuphine to Treat #Opioid Addiction - Could Replace Pills

Implants - Like Probuphine to Treat #Opioid Addiction - Could Replace Pills | Pharmaguy's Insights Into Drug Industry News |

It’s hard to imagine the $450 billion pharmaceutical industry—which makes almost half of its sales on pills, according to QuintlesIMS—abandoning the simple medical tablet altogether, but increasingly it has competition.

Especially formidable is the new class of pharmaceutical implants, matchstick-size devices that deliver drugs to patients over a period of weeks or months, are coming into their own. Titan Pharmaceuticals and Braeburn Pharmaceuticals, for example, have an FDA-approved implantable that, once inserted in the patient’s upper arm, treats opioid addiction by providing continuous doses of buprenorphine.

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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