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FDA May Soon Be Replaced by Judicial Off-Label Activism

FDA May Soon Be Replaced by Judicial Off-Label Activism | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a deal that could change the way some companies market their drugs, the Food and Drug Administration has agreed to allow a pharmaceutical company to promote a drug for a use that the agency has not approved, the company said on Tuesday.

 

The agency on Tuesday downplayed the implications of the deal. In a statement, it said that the settlement applied only to the Amarin case and that its position on whether companies have a constitutional right to provide truthful information about off-label uses had not changed.

 

Under the settlement, Amarin would have to submit proposed marketing materials to the agency, which could then object if it felt the information was untrue or misleading. If the two parties could not agree, a federal judge would sort it out.

 

Leaving such decisions to a judge, not the F.D.A., concerned Dr. Joshua M. Sharfstein, a former principal deputy commissioner at the F.D.A. who is now an associate dean at the Johns Hopkins Bloomberg School of Public Health.

 

“The courts are at the precipice of taking over a fundamental F.D.A. function of calling balls and strikes in the drug market about what’s truthful and not misleading,” Dr. Sharfstein said.

 

Alan Bennett, a lawyer who represents the Medical Information Working Group, a coalition of drug and device companies that want the F.D.A. to expand their ability to talk about their products, said he agreed that the F.D.A., not the judiciary, was best able to evaluate information about drugs.

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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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Why Does Pharma Love Cancer? It's Where the Money Is. Duh!

Why Does Pharma Love Cancer? It's Where the Money Is. Duh! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It’s not going to come as a surprise to anyone who’s been paying attention to drug R&D trends that cancer is the number 1 disease in terms of new drug development projects. But it is amazing to see exactly how much oncology dominates the industry as never before.

 

At a time the first CAR-T looks to be on the threshold of a pioneering approval and the first wave of PD-(L)1 drugs are spurring hundreds of combination studies, cancer accounted for 8,651 of the total number of pipeline projects counted by the Analysis Group, crunching the numbers in a new report commissioned by PhRMA. That’s more than a third of the 24,389 preclinical through Phase III programs tracked by EvaluatePharma, which provided the database for this review.

 

That’s also more than the next 5 disease fields combined, starting with number 2, neurology — a field that includes Parkinson’s and Alzheimer’s. Psychiatry, once a major focus for pharma R&D, didn’t even make the top 10, with 468 projects.

 

Moving downstream, cancer studies are overwhelmingly in the lead. Singling out Phase I projects, cancer accounted for 1,757 out of a total of 3,723 initiatives, close to half. In Phase II it’s the focus of 1,920 of 4,424 projects. Only in late-stage studies does cancer start to lose its overwhelming dominance, falling to 329 of 1,257 projects.

 

Further Reading:

  • “Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good”; http://sco.lt/8UsdHd
  • “Ads for “Breakthrough” Cancer Drugs Are “An Ocean of Hype,” Say Oncologists”; http://sco.lt/5NIzOD
  • “New Cancer Drugs Have Limited Efficacy Extending Survival by Only 3.5 Months on Average”; http://sco.lt/5ySRYf
  • “Breakthrough Cancer Therapy DTC: Boldly Emphasizing the Positive”; http://bit.ly/pmn150402h
  • “Widespread Hype Gives False Hope To Many Cancer Patients”; http://bit.ly/2oEtZmx
  • “Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data;” http://sco.lt/5OtIdl
  • “Immunotherapy Drugs: A Chance to Live Longer or Die from Myriad Side Effects”; http://sco.lt/5Qsymn
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Harvard Opioid Study Calls for Crackdown on Big Pharma

Harvard Opioid Study Calls for Crackdown on Big Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Weak patenting standards and ineffectual policing” have helped turn the pharmaceutical industry into a key driver of the opioid epidemic, according to a study published in the Harvard Law & Policy Review.

 

The study, entitled “The Opioid Epidemic: Fixing a Broken Pharmaceutical Market,” argues that the failure to effectively regulate fraudulent marketing and anti-competitive practices by Big Pharma have contributed to the “over-utilization of costly and often harmful” branded prescription drugs.

 

At the same time, it has hindered access to low-cost generics, say the three authors of the study, Ameet Sarpatwari, Dr. Michael S. Sinha and Dr. Aaron S. Kesselheim—all professors at Harvard Medical School with appointments to the Brigham and Women’s Hospital.

 

“To boost profits, pharmaceutical companies have often engaged in false or misleading marketing,” the authors charge. “Over the past twenty-five years, the industry has paid $35.7 billion to settle claims of illegal marketing, including making false or misleading claims or failing to disclose known risks.”

 

A fundamental cause of the epidemic was—and continues to be—an over-prescription of opioids, the study says. From 2000 to 2010, the number of prescriptions for oral opioid analgesics rose 104%.

 

The authors call on the federal government to take a more “proactive” role in challenging pharmaceutical patents, and recommend that Congress authorize the Food and Drug Administration to “impose user fees that would fund comparative cost-effectiveness research and dissemination.”

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Opioid Drug Maker Mallinckrodt Spends Big Lobbying Lawmakers About Opioids

Opioid Drug Maker Mallinckrodt Spends Big Lobbying Lawmakers About Opioids | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Two federal investigations — one examining opioid sales, another about a multiple sclerosis drug whose price had soared to $34,000 a vial — were only part of the troubles Mallinckrodt faced as the year began.

The stock of the drug maker, whose United States headquarters are in St. Louis, was tanking. Wall Street worried that Medicare might reduce the half-billion dollars it was spending yearly on a Mallinckrodt drug with limited evidence of effectiveness.

This year, the company left the industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, after the group threatened to kick out companies that did not spend enough on research.

Mallinckrodt, however, has been increasing its spending in another area: It has been writing checks to politicians.

After making meager donations in 2015, the company’s political action committee began raising its contributions for congressional campaigns last year. Lawmakers in both the House and Senate collected $44,000 from Mallinckrodt in 2017’s first quarter, nearly nine times what they got from the company in the same period two years ago.

Mallinckrodt also spent $610,000 lobbying Congress, triple the amount of 2015’s first quarter. The company, which makes pain-control drugs as well as H. P. Acthar, an injectable gel prescribed for multiple sclerosis and other diseases, has lobbied on issues related to opioids, patents, Medicare and other matters, regulatory filings show.

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Women Lack Confidence Managing Chronic Conditions

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

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 | Scoop.it

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 | Scoop.it

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 | Scoop.it

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 | Scoop.it

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”; http://sco.lt/7CvfPN
  • “Towards Achieving the "Holy Grail" of Multichannel #Pharma Marketing”; http://sco.lt/8c56Qb
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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 | Scoop.it

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”; http://sco.lt/8UmbOz
  • “Merely a Flesh Wound! MannKind Swears Afrezza Not Dead”; http://sco.lt/7lCKOX 
  • “Sanofi's DTC ROI for Afrezza: Lost 53 Cents for Every $1 Spent!”; http://sco.lt/7Tz9eL 
  • “#Pharma Disease Awareness Marketing Infiltrates Soap Operas Like General Hospital”; http://sco.lt/88Gkwz 
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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 | Scoop.it

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 | Scoop.it

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”; http://sco.lt/5eex9t
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 | Scoop.it

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 | Scoop.it

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 | Scoop.it

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”; http://sco.lt/4vyNdJ
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 | Scoop.it

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": http://bit.ly/mascotgallery 

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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 | Scoop.it

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”; http://sco.lt/8myK2L
  • “Medical Device DTC Ads: Spooky, Outrageous Claims & Unregulated!”; http://sco.lt/9EHXg9
  • "Device DTC: Imagine How Far It Will Go!"; http://bit.ly/deviceDTC
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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 | Scoop.it

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: http://sco.lt/7XcYlN
  • Some #Biotech CEOs Earned Big Increases in Compensation Even as Their Companies Tanked: http://sco.lt/70MviL 
  • Glaxo to Pay First Woman CEO Less, Cites Lack of Experience: http://sco.lt/67Y7xB 
  • Pharma CEOs Living in an “Alternate Reality” But Getting Paid Exorbitantly High Real World Salaries!: http://sco.lt/7ooZaT 
  • Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!: http://sco.lt/6lVvf7 
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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 | Scoop.it

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 | Scoop.it

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 iSpot.tv 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!: http://sco.lt/5VHAjh 
  • Will You Miss Those ED DTC TV Ads When Viagra & Cialis Go Generic? John LaMattina Will: http://sco.lt/5bsTdh 
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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 | Scoop.it

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 | Scoop.it

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”; http://sco.lt/50tyML).

 

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 | Scoop.it

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 | Scoop.it

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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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 pharmaguy.com