Pharmaguy's Insights Into Drug Industry News
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Xifaxan Sales Down - Will $9.8 M Super Bowl Ad Redeem "Bubble Guts"?

Xifaxan Sales Down - Will $9.8 M Super Bowl Ad Redeem "Bubble Guts"? | Pharmaguy's Insights Into Drug Industry News |

Valeant missed the sales mark for its irritable bowel syndrome drug, Xifaxan, which it called one of the company's “leading growth platforms,” when it reported its long-awaited fourth-quarter earnings on Tuesday.

Xifaxan saw sales of $210 million for the last three months of 2015, down from $220 million in the previous quarter. In December of last 2015, the company forecast sales of $390 million for Xifaxan in the fourth quarter of 2015, according to Business Insider.

Valeant's business model and pricing practices have been under scrutiny in recent months. 

The drugmaker ran a Xifaxan ad in the most recent Super Bowl broadcast, one of three pharma spots featuring during the February event.  The drugmaker spent $9.8 million for the 60-second spot, according to estimates from The ad features an animated intestine who scrambles to the bathroom during a bout of abdominal pain.

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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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Gilead Wins 2-Year Battle & Continues to Hide Hep C Drug Clinical Trial Data

Gilead Wins 2-Year Battle & Continues to Hide Hep C Drug Clinical Trial Data | Pharmaguy's Insights Into Drug Industry News |

After a two-year battle, a pair of public health advocacy groups obtained sought-after clinical trial data from regulators for two hepatitis C treatments sold by Gilead Sciences. But they failed to gain access to the most coveted information that would allow researchers to independently verify test results which were originally generated by the company.


The Yale Global Health Justice Partnership and Treatment Action Group sought patient-level data in order to better understand the safety and effectiveness of the two medicines. But they encountered a familiar argument from the company — as well as the Food and Drug Administration — that revealing such raw data may compromise trade secrets and patient confidentiality.


The FDA redacted certain data, “which would permit analysis, including validating the results that were reported by the company,” Dr. Joseph Ross, an associate professor at the Yale School of Medicine, who worked with the groups, wrote us.


The effort began nearly three years ago when the groups asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. As we wrote at the time, they sought this data because the medicines have been widely prescribed, thanks to high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.


Gilead, however, balked at releasing any data, so the groups then turned to the FDA, since the company had filed all sorts of clinical trial information with the agency in order to win regulatory approval to sell the drugs. But the agency indicated the Freedom of Information request would take up to two years to fulfill, so in June 2015, groups filed a lawsuit to force the FDA to cough up the data.


The advocacy groups argued in their lawsuit that doctors “lack(ed) the benefit of any independent assessment of the data.” And given the high cost of the drugs, the groups contended it is “crucial that policymakers be able to evaluate the cost-effectiveness … based on the underlying clinical data. …” The list prices for the drugs were $84,000 and $94,500 for 12-week regimens, before rebates.


Further Reading:

  • “What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data”;
  • “NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C”;
Pharma Guy's insight:

I'm on record for wondering if, in the long run, the claims of enduring cure of Hepatitis C may be over optimistic. There were reported relapses occurring in short clinical trials, so I would expect even more relapses in the real world long-term.

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We Are Buried in Silly DTC Ads Like Allergan's and Ironwood’s New Linzess Campaign

We Are Buried in Silly DTC Ads Like Allergan's and Ironwood’s New Linzess Campaign | Pharmaguy's Insights Into Drug Industry News |

Allergan and Ironwood have introduced a new campaign for Linzess that points out the difficulty of managing too many OTC constipation treatments such as laxatives, fiber and probiotics. Computer-generated images of bottles and boxes of OTC treatments literally pile on top of people in the TV ads.

The new work switches out the well-received Linzess “Tell Me Something I Don’t Know” work, which featured visually engaging, stop-motion TV commercials. It was the only DTC pharma advertising to win an Effie Award this year and ranked in the Sweet 16 of FiercePharma’s DTC March Madness contest.

The new “Wearing on You” campaign acknowledges the many OTC treatments, diet changes and other remedies people try when fighting stomach pain and constipation. If those aren’t working, the ads suggest, the condition may be chronic and require a prescription treatment.

Pharma Guy's insight:

How silly can pharma marketers get? Is there no limit? Is it all for the judges at award ceremonies?

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The Biotech Devil's Dictionary: A Guide to Biotech Buzzwords & Other Inane Jargon

The Biotech Devil's Dictionary: A Guide to Biotech Buzzwords & Other Inane Jargon | Pharmaguy's Insights Into Drug Industry News |

Biotech can be a breeding ground for jargon, coded language, and outright nonsense, as investors and scientists probe the depths of linguistic absurdity to explain why the thing they do is just that much more special than all the other things out there. We wanted to celebrate this proud tradition — and so, like a canny capitalist repurposing an old drug, we stole an idea.

Ambrose Bierce began “The Devil’s Dictionary” in the late 1800s, creating a satirical lexicon he updated weekly before wandering off to Mexico to die. We sought to replicate at least part of that story — hence, The Biotech Devil’s Dictionary. Entries appear semi-regularly in The Readout, our free daily biotech newsletter. (Shameless plug: Subscribe here!)

Here, in one place, are the entries we’ve compiled so far. If they offend you, just remember that Bierce defined a reporter as “a writer who guesses his way to the truth and dispels it with a tempest of words.” So there’s that.

Pharma Guy's insight:

Pretty funny!

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Subpeonas served to opioid producers in national investigation

Subpeonas served to opioid producers in national investigation | Pharmaguy's Insights Into Drug Industry News |

The subpoenas Monday for documents and information on business practices from the companies are a significant step forward in an investigation involving 41 attorneys general, Shapiro said.


“This multi-state group of attorneys general is the best public-interest law firm in America, and the attorneys in the Public Protection Division of the Pennsylvania Office of Attorney General are at the helm of this national investigation,” Shapiro said.


In June, Shapiro announced his office had joined the bipartisan commission of state attorneys investigating what role opioid manufacturers and distributors may have played in the growth of the opioid epidemic in Pennsylvania and across the nation.


Shapiro did not name any companies targeted in the investigation then. However on Tuesday he said the following companies are under investigation:


  • Endo International
  • Janssen Pharmaceuticals
  • Teva Pharmaceutical Industries and its U.S. subsidiary, Cephalon Inc.
  • Allergan Inc.
  • Perdue Pharma
  • AmerisourceBergen
  • Cardinal Health
  • McKesson


AmerisourceBergen, Cardinal Health and McKesson are distributors of the opioids, while the rest of the companies are opioid manufacturers.


Shapiro said the investigation was aimed at companies that make opioids and companies that transport them because both had a responsibility to curb the spread of addiction in the state and country.


“Manufacturers have had, and still have, a responsibility to tell patients, doctors and the public everything that they know about these incredibly addictive and dangerous drugs,” Shapiro said. “And distributors have a responsibility, give how hazardous these drugs are, to report suspicious shipments.”


Except for Perdue Pharma, the maker of OxyContin, all of the companies listed Tuesday have locations in Pennsylvania, but Shapiro told reporters “no one will be off limits during this investigation.”


Further Reading:

Pharma Guy's insight:

One PA opioid producer NOT on this list and "off limits" is KVK Tech, located right in my hometown of Newtown, PA! 

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This #Pharma CEO Speaks with Forked Tongue!

This #Pharma CEO Speaks with Forked Tongue! | Pharmaguy's Insights Into Drug Industry News |

One year ago, Brent Saunders tried to single-handedly reset the national debate over drug pricing.


The Allergan chief executive issued a “social contract” and vowed to keep price hikes below 10 percent a year. He argued that drug makers could — and should — act responsibly amid smoldering criticism over prices (read “Allergan's Brent Sauders' ‘Manifesto’ on Drug Prices & Access”; Few companies followed suit, but Saunders won a high profile for his efforts.


Now, though, an ingenious deal he struck to protect Allergan’s patents on a lucrative drug calls into question his campaign to do right by the American public.


In short, the social contract may be headed for the trash bin.


Here’s the story: Earlier this month, the drug maker agreed to transfer six patents for Restasis eye drops to the St. Regis Mohawk tribe. There is a complicated legal calculus behind this maneuver, but in essence, Allergan may have found an avenue for thwarting lower-cost generic competition.


How so? The Mohawk tribe is a sovereign entity. This means it’s immune from a type of patent challenge called inter partes reviews, which are handled by a special appeals board, not your usual court. Brand-name drug makers detest these reviews, because they are easier to file than conventional lawsuits and the appeals board is believed to have a lower bar for nullifying patents than the courts.


And guess what? Allergan faces just such a review of its Restasis patents. Transferring the patents to the tribe could eliminate this challenge.


If the maneuver succeeds, it’s good news for brand-name drug makers and their shareholders, because it’s yet another way to delay generic competition. The Allergan patents, by the way, are not scheduled to expire until 2024.


However, this could be bad news for consumers, who don’t want to wait longer for cheaper drugs. If so, Allergan’s gambit hardly seems like the way to fulfill a social contract predicated on delivering more affordable medicines.


“Saunders is being highly hypocritical,” said Michael Santoro, a professor at the Leavey School of Business at Santa Clara University, who has studied pharmaceutical ethics. “A social contract implies the interest of both parties is taken into account. In this case, the consumers don’t get a voice in the way the products are made available. It’s not really a contract.”


Further Reading:

  • "LA Times Columnist Not Drinking Kool-Aid Served Up by Allergan CEO Saunders"; 
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Docs Take Pharma Money to Hype Cancer Drugs on Twitter & Don't Disclose It!

Docs Take Pharma Money to Hype Cancer Drugs on Twitter & Don't Disclose It! | Pharmaguy's Insights Into Drug Industry News |

Some cancer doctors use Twitter to promote drugs manufactured by companies that pay them, but they almost never disclose their conflicts of interest on the social media platform, a new study shows.


“This is a big problem,” said senior author Dr. Vinay Prasad, a professor at Oregon Health and Science University in Portland. “Doctors are directly telling patients about their views on drugs, and financial conflict plays a role. But they’re not telling patients they have a conflict.”


Prasad and his colleagues analyzed the tweets and income of blood cancer specialists who posted regularly on Twitter and received at least $1,000 from drug manufacturers in 2014.


Of the 156 hematologist-oncologists in the study, 81 percent mentioned at least one drug from a company that gave them money, and 52 percent of their tweets mentioned the conflicted drugs, according to a study reported in a letter in The Lancet.


Earlier this year, Prasad published his first study on tweeting doctors. Nearly 80 percent of more than 600 U.S. hematologist-oncologists who tweeted had a conflict, his report in JAMA Internal Medicine found.


Celebrities use the hashtag #sponsored when they tweet about products from companies that pay them, Prasad said.


“Maybe we can learn something from the celebrities here,” he said.

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The Average American is Exposed to Over 1,000 TV Drug Ads per Year

The Average American is Exposed to Over 1,000 TV Drug Ads per Year | Pharmaguy's Insights Into Drug Industry News |

The lawmaker’s claim was eye-popping: Americans watch 16 hours of pharma ads a year, on average.


Sen. Claire McCaskill, a Democrat from Missouri, recited that statistic on Tuesday during a finance committee hearing on health care costs and coverage, arguing that such ads are “driving our pharma costs through the roof.”


Can that number possibly be correct? To check, we did the math on the back of the proverbial napkin.


The federal Bureau of Labor Statistics estimates that the average American watched 2 hours and 42 minutes of TV each day last year. The media research firm Nielsen pegged the number higher, at 4 1/2 hours of live TV a day in the first quarter of last year. So let’s average the two estimates for a ballpark figure of how many hours of TV Americans watch each day — 3 hours and 36 minutes a day, or 55 days (!) a year.


Ads usually take up a little over a quarter of airtime during popular TV shows, which means that the average American is watching about 15 and a half days of ads a year.


STAT found in a previous analysis of TV ads that spots from drug companies, both advertising specific products and promoting other corporate messages, represent a median of 5 percent of all the TV ads across broadcast and cable channels (read “Insights Into Which TV Shows Attract Pharma Ads & Why”;


From there, we can deduce that the average American is watching pharma ads for about 18.6 hours a year — pretty close to the number McCaskill offered.


Further reading:

Pharma Guy's insight:

That’s 1,116 drug ads per year per “average American” (15 years and older) or 3 ads per day! The original STAT title asks "Do Americans really watch 16 hours of pharma ads a year?" but it's more accurate to say that Americans are exposed to these ads, which are often ignored or skipped over rather than watched.

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Fueling the Opioid Epidemic: A “Key Strategic Imperative” for Insys #Pharma

Fueling the Opioid Epidemic: A “Key Strategic Imperative” for Insys #Pharma | Pharmaguy's Insights Into Drug Industry News |

In early 2015, an Insys Therapeutics employee called an insurer and provided misleading patient information in order to win clearance for a prescription for its Subsys painkiller. The conversation — in which the employee pretended to call from a physician’s office — was about a woman named Sarah Fuller, whose family later claimed she died because she was inappropriately prescribed the drug.


The phone call was made scarcely a year after a consultant warned the drug maker that it lacked needed policies for governing such activities, but Insys executives failed to take corrective action, according to U.S. Sen. Claire McCaskill (D-Mo.), who released a copy of the consultant’s report and a recording of the phone call as part of an ongoing investigation into the opioid crisis (see report here:


The details of both the phone call and the report help flesh out what is already a disturbing picture of unchecked pharmaceutical marketing that has emerged from a growing raft of documents in criminal cases and civil lawsuits involving the beleaguered drug maker. And the report arrives as opioid makers, in general, are accused of deliberately downplaying risks and improperly encouraging prescribing.


To boost prescriptions for Subsys, which contains the highly addictive fentanyl opioid, Insys allegedly employed numerous tactics. These included a familiar page from the pharmaceutical playbook in which some physicians were rewarded with speaking fees and other forms of compensation for writing outsized numbers of prescriptions, according to court documents.


Central to the Insys marketing plan, however, was a so-called reimbursement center, which was created specifically to contact insurers and persuade them to authorize prescriptions. In the health insurance world, prior authorization is an extra step that insurers use to weed out unnecessary prescribing. Often, this proves to be a challenging hurdle, especially when a medicine is pricey.


But Insys created this “center” because many insurers and pharmacy benefits managers often declined to green-light prescriptions that were not for breakthrough cancer pain patients. Authorities say the company sought to widen the market for its drug by illegally inducing doctors to prescribe the pill for other sorts of pain. This is known as “off-label” prescribing, which doctors are permitted to do.


An Insys spokeswoman did not respond to a request for comment.


Further Reading:

Pharma Guy's insight:

A smoking gun if ever I saw one!

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Novo Nordisk Agrees to Pay Fine But Denies "Wrongdoing"; i.e., Sales Reps Obscured Victoza's Risks

Novo Nordisk Agrees to Pay Fine But Denies "Wrongdoing"; i.e., Sales Reps Obscured Victoza's Risks | Pharmaguy's Insights Into Drug Industry News |

Novo Nordisk will pay $58.65 million to the Justice Department to resolve allegations that it instructed some of its sales representatives to share information with physicians that downplayed safety risks for Victoza, its type-2 diabetes medication.


The FDA approved Victoza in 2010, on the condition that the company implement a Risk Evaluation and Mitigation Strategy (REMS) to warn physicians about the potential risk of patients developing a rare cancer called medullary thyroid carcinoma. The drug now has a black-box warning.


The allegations against Novo include that managers instructed reps to “sandwich” the risk information between promotional messages in order to minimize that information. Reps also reportedly told doctors that the risk of cancer is only associated with mice and rats; that all diabetes drugs have boxed warnings and Victoza was no different; and that this type of cancer is “easy to treat” if a patient was diagnosed.


Because the reps gave doctors a misleading impression about the risks cited in the FDA-mandated REMS program, some physicians who prescribed Victoza were unaware of those risks, the Justice Department alleged. A government survey conducted in 2011 found that half of primary-care doctors were unaware of the cancer risks associated with Victoza.


In a statement, the drugmaker said it disagreed with the government's “legal conclusions” and denied wrongdoing. “We're pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients,” Doug Langa, Novo Nordisk's president and EVP and head of North America operations, said in the statement.


Novo reported that Victoza – part of a class of drugs called GLP-1s, which includes Eli Lilly's Trulicity – brought in $3 billion in sales in 2016. In addition, the drugmaker has pursued new indications for the therapy. In 2015, a formulation of Victoza was approved as Saxenda, a treatment for weight loss. Earlier this year, the FDA approved Victoza as a treatment to lower the risk of cardiovascular events like heart attacks and strokes.


Novo spent $128 million on direct-to-consumer advertising for Victoza in 2016, according to Kantar Media.

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One "Simple" Question: What Is the Future of Clinical Trials?

One "Simple" Question: What Is the Future of Clinical Trials? | Pharmaguy's Insights Into Drug Industry News |

Artificial Intelligence, mHealth, Internet of Things, big data, social media; there's no doubt that technology is changing clinical trials. However, everyone has different ideas about how best to use these technologies and where they are taking the trials of the future.

Additionally, with innovative trial designs, increasingly patient-centric approaches, biomarkers and personalised medicine, clinical trials could look very different in 5, 10 or 20 years.

We asked dozens of experts from every area of clinical trials one simple question: what is the future of clinical trials? Discover their answers here.

Pharma Guy's insight:

I offered an overly simple answer: mobile!

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Doctors Funded by #Pharma Promote Easing of FDA Regulations Prohibiting Off-Label Promotion of Drugs

Doctors Funded by #Pharma Promote Easing of FDA Regulations Prohibiting Off-Label Promotion of Drugs | Pharmaguy's Insights Into Drug Industry News |

One thing industry representatives can’t talk about is “off-label” uses of drugs. These are uses not officially approved by the FDA. Some drugs have powerfully positive off-label effects. Topamax, a seizure drug, can help with alcohol dependence. The blood pressure drug prazosin can help treat post-traumatic stress disorder.


Doctors benefit from hearing about such off-label uses, as they inform doctors about alternative uses of medications. However, existing law essentially bans industry reps from discussing off-label uses — even those that are widely popular in the medical community and proven to be effective and safe. Preventing sales reps from mentioning these uses can be detrimental to patients, especially considering that some conditions have no FDA-approved treatments. In these situations, off-label uses can be doctors’ only option for prescribing. Patients would benefit from having physicians be as informed as possible about effective off-label uses.


Allowing industry reps to discuss off-label drug use does not mean drug detailing should be unregulated. Drug companies and doctors alike have suffered major lawsuits for promoting drugs not approved by the FDA — in some cases significantly understating the risks of these medications to patients. The government needs to ensure that pharmaceutical reps share factual information that helps doctors make informed decisions, not advertise unsafe medications.


I’ve seen firsthand how industry-sponsored drug education can empower doctors with information about the newest treatments and ensure that patients have access to the best possible medicines. As lawmakers dig into the issue, they should ensure that information is exchanged responsibly. Lawmakers should avoid passing new legislation that further limits physicians’ understanding of which drugs can best benefit their patients. Better yet, they can sponsor policies that help facilitate objective information sharing, including that about off-label uses, between doctors and drug detailers.

Pharma Guy's insight:

This article claims that physicians need pharma to tell them about off-label uses of drugs. Why was this blatant promotional piece - originally titled "How pharma sales reps help me be a more up-to-date doctor" - published in STAT?


Robert Yapundich, M.D., is a neurologist practicing in Hickory, N.C., and a member of the Alliance for Patient Access. In 2015, he received $134,792 from 26 different pharma companies. The Alliance for Patient Access is probably funded in large part by pharmaceutical companies - it's Form 990 B lists contributions as "restricted" - that is, not available for viewing. It gets other funding through education programs for physicians who are probably paid by pharma to attend! Nice!

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Insights Into Which TV Shows Attract Pharma Ads & Why

Insights Into Which TV Shows Attract Pharma Ads & Why | Pharmaguy's Insights Into Drug Industry News |

If you feel inundated with pharma ads, it might have something to do with your taste in TV shows.


Depending on which show you’re watching, prescription drug makers are responsible for as many as 38 percent of ads during commercial breaks — or as few as virtually none at all. That’s according to data from the media research firm covering the valuable 8-10 p.m. primetime slot over the 12 months that concluded at the end of July.


Drug advertisers usually don’t target down to the level of specific TV shows when they’re buying ad spots… Typically, though, drug advertisers target demographic groups, such as women aged 65 and older, and buy spots during shows or times of day when those viewers are most likely to be watching.


Across well over 5,000 TV shows captured in iSpot’s data, a median of 5 percent of all ad spots came from pharma. That counts traditional spots promoting a prescription drug as well as corporate ads from pharma companies, such as a much-aired spot from Pfizer (PFE) celebrating its scientists.


Here’s a breakdown of pharma advertisers’ favorite — and least favorite — TV shows:


Among the 100 most-watched shows on TV, the whodunnit true-crime show “48 Hours” had the largest share of drug advertising; 19 percent of its ads came from pharma. It was closely followed by police procedurals like “NCIS: New Orleans,” “Blue Bloods,” a “Criminal Minds” spinoff, and “Hawaii Five-O,” all of which had pharma to thank for about 14 percent of their ads.


Why are these shows getting blanketed with pharma ads? One key reason: crime dramas like NCIS are wildly popular with the aging viewers drug companies are trying to reach, points out John Mack, who publishes the digital newsletter Pharma Marketing News.


More insights here.

Pharma Guy's insight:

There are also lots of pharma ads on political talk shows. Probably ads for drugs for anxiety, migraine, and depression are dominant here!

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Pennsylvania's Treasurer Says Big Pharma Must be Held Accountable for Its Role in Opioid Crisis

Pennsylvania's Treasurer Says Big Pharma Must be Held Accountable for Its Role in Opioid Crisis | Pharmaguy's Insights Into Drug Industry News |

Every day across the commonwealth [of Pennsylvania], 13 people die as a result of a drug overdose involving illicit or prescribed opioids. Those 13 people taken from us leave children without parents, students without teachers, and families with missing seats at the dinner table.


None of us has the luxury of claiming that this is not our problem. This is a Philadelphia crisis, a Pennsylvania crisis, a crisis that hits all of us. And just as other leaders are called upon to use the power at their disposal to fight the epidemic, I have a responsibility to use mine, as state treasurer, to do the same.


For the last 20 years, the pharmaceutical industry has been whitewashing the lasting impact of highly addictive narcotics through its use of marketing, effectively encouraging doctors and other providers to prescribe these powerful drugs in increasing, extremely dangerous levels.


This has infused our neighborhoods with the plague of addiction and significant misuse of drugs, leading to children being removed from their homes, overcrowded prisons, and a stagnant economy, as otherwise able-bodied Americans find themselves unable or unwilling to find work.


As Pennsylvania’s treasurer, my responsibilities include overseeing our state investments — your taxpayer dollars. These investments include Big Pharma companies, as the providers of the medicine and devices that our friends and neighbors need on a regular basis to survive.


Recently, I joined state treasurers from West Virginia and Illinois to demand that Big Pharma takes the necessary steps to combat the epidemic at its source. McKesson, located in San Francisco, is one of the nation’s largest prescription-drug wholesalers. While flooding communities with opioids, McKesson’s revenues have more than doubled from $93 billion to $199 billion over the past 10 years, with a $60 billion jump in 2015 alone.


These companies need to step forward and take active steps to address the growing challenges facing millions of prescription drug users across the nation.


Joe Torsella is treasurer of Pennsylvania. @JoeTorsella.

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What’s Holding Back Point-of-Care Marketing?

What’s Holding Back Point-of-Care Marketing? | Pharmaguy's Insights Into Drug Industry News |

While the quantity and quality of point-of-care advertising has been rising steadily in recent years, it's on the verge of an epic growth spurt. In May, investors such as Goldman Sachs and Alphabet pumped some $500 million in financing into Outcome Health. And in June, PatientPoint received a cash injection of $140 million.


While the dollar figures are impressive, it's not just money fueling POC's coming-of-age moment. The category's growth has also been facilitated by pharma's increasing desire for more targeted messaging, new technology that facilitates message delivery within the POC environment such as beacons and other forms of proximity marketing, and physicians' hunger for quality educational content that saves them time.


Of course, POC is plenty big already. Mark Boidman, managing director at Peter J. Solomon, which acted as a strategic advisor on the PatientPoint deal, says of the $8 billion or so spent on out-of-home advertising each year, about $500 million to $600 million is spent on POC messaging. Its growth, not surprisingly, has been propelled by the shift toward all things digital.


And the new infusions of cash will help the channel get bigger, and fast. Outcome Health, which says it is already blanketing almost 600 million patient visits a year, wants to wire the majority of exam rooms by 2020, explains Blake Chandlee, EVP and GM of industry strategy and emerging businesses. Similarly, PatientPoint is expanding its digital reach with programs that impact between 60% and 70% of prescribing volume in strategic specialties.


But whichever company is behind the brands trying to get their messages out, the idea is basically the same — and light years ahead of the “stacks of pamphlets for the waiting room” thinking that first put the category on the map.


But obstacles to growth still remain, ones that have prevented the category from realizing the soaring increases pundits have long predicted.


[“Clutter is a significant barrier for POC media companies trying to prove to drug makers an acceptable ROI for their products and services,” says Bob Ehrlich, Chairman, DTC Perspectives, Inc. “Patients also have their own entertainment system with their mobile devices and the growth of in office Wi-Fi makes them a viable entertainment option in waiting rooms. The challenge for POC companies providing information on disease or branded products is how to get their share of attention in that valuable 10-20 minute waiting period.”]


It hasn't helped that POC companies tout sky-high ROI figures. “I've seen people quote 20-to-1, or even higher. Yet when we do marketing-mix modeling, the POC investment doesn't show up quite that robustly,” Evans adds. Outside audits could help: “If you measure it yourself, it is naturally less credible.”


Further Reading:


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Specialty Brand Sales Excel Today, But What About Tomorrow?

Specialty Brand Sales Excel Today, But What About Tomorrow? | Pharmaguy's Insights Into Drug Industry News |

@QuintilesIMS teamed up with #PharmaForce to provide a framework for product launch assessment.


Download the entire report here.

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Ohio Flooded with Ridiculous, Unproven, Hi-tech "Solutions" to the Opioid Crisis

Ohio Flooded with Ridiculous, Unproven, Hi-tech "Solutions" to the Opioid Crisis | Pharmaguy's Insights Into Drug Industry News |

More than 4,100 people fatally overdosed in Ohio in 2016, even though state officials spent nearly $1 billion to combat the crisis. That prompted Gov. John Kasich this spring to announce that $20 million would be devoted to funding new research related to opioid abuse.


“We know more needs to be done.” David Goodman, director of the Ohio Development Services Agency, told STAT. “So we’re looking for new technologies to see if we can find other ways to fight this problem.”


Ohio’s Third Frontier Commission, an economic development initiative focused on tech startups, recently asked companies to submit funding requests. Over the summer 44 initial proposals flooded into the commission. These proposals have come from all kinds of applicants — doctors and device makers, biotech execs and engineers, scientists and recovery advocates — working on solutions as wide-ranging as the people touched by the opioid crisis.


Osteopathic physician Dr. Ben Bring wants $75,000 for his prototype of a micro-spandex glove called the MyoGlove to help doctors perform massage therapy for lower musculoskeletal pain — thereby keeping people away from opioids. Brad Pulver, president of Innovative Medical Equipment, hopes $810,000 would fund a clinical trial for the ThermaZone — an FDA-approved device that treats pain using a continuously cooled water pad (instead of frozen peas) — to study whether it reduces opioid use after surgeries.


More ridiculous, unproven, hi-tech “solutions”…

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Great DTC Commercial for Anti-Depressant Rexulti, But Depressing Facebook Presence!

Great DTC Commercial for Anti-Depressant Rexulti, But Depressing Facebook Presence! | Pharmaguy's Insights Into Drug Industry News |

Great DTC Ad for Anti-Deprtessant Rexulti, But Depressing Facebook Presense!


The US market for major depressive disorders will rise from $2.4 billion in 2015 to $4.6 billion in 2025. Rexulti, I [Rich Meyer] believe, is doing a great job trying to reach new patients with a great creative TV spot.


When visiting, the first message you see is “still struggling with depression, even on an antidepressant?” It ties in very nicely with the TV commercial showing people turning away from everyday situations while holding up a face with a smile on it. I believe the creative is hard hitting and targeted.



The website completes the creative with full integration and a host of helpful patient tools, but wouldn’t it be great to hear and see actual patient stories or patients talking about their battle with depression?


It seems that Rexulti is getting ready to take a huge slice out of the depression market, but they really need to take the next step and bring patients together to talk about depression.


On Facebook a search for Rexulti only results in class action lawsuit pages.


This of course is going to scare the hell out of potential patients and it’s something this brand can’t ignore of they really believe in their product.

Pharma Guy's insight:

Love the tiny notice: "Actor portrayal"!

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J&J Speaks Out as Florida Plans to Use an Old Drug in a Lethal Injection Execution @JNJCares

J&J Speaks Out as Florida Plans to Use an Old Drug in a Lethal Injection Execution @JNJCares | Pharmaguy's Insights Into Drug Industry News |

J&J no longer manufactures etomidate, although it discovered the drug back in the 1960s, but an untried three-drug concoction including the anaesthetic is set to be used in the execution of Mark Asay tomorrow.


Now off-patent, several generic drugmakers manufacture the drug and J&J seems unable to intervene directly to stop its use on death row.


J&J’s pharmaceutical division, Janssen, said in a statement: “We do not condone the use of our medicines in lethal injections for capital punishment.”


“Janssen discovers and develops medical innovations to save and enhance lives. We do not support the use of our medicines for indications that have not been approved by regulatory authorities.”


Maya Foa, director of Reprieve, the international rights organisation, said: “The world’s largest drug manufacturer has added its voice to the industry-wide consensus that opposes the misuse of medical products in lethal injection executions.”


“Pharmaceutical companies are clear that their drugs are for saving the lives of patients, not ending the lives of prisoners. In Florida particularly, Governor Scott should listen to clear and unequivocal statements from Johnson & Johnson and others calling time on this dangerous misuse of medicines, and stay the execution of Mark Asay on Thursday”

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Donald Trump appoints adviser who helps big pharma hike drug prices

Donald Trump’s new senior economic adviser has helped pharmaceutical companies lobby to charge astronomical prices for crucial drugs.


Last Monday, the White House confirmed that Tomas J. Philipson, a health care economist, was joining the President’s Council of Economic Advisors.


That announcement was made just hours after Trump publicly accused Merck CEO Kenneth Frazier of charging patients “ripoff prices” for drugs after he resigned from the President’s Manufacturing Council in protest at the president’s response to the violence at a white nationalist rally in Charlottesville, Virginia last weekend.


Drugmakers in the U.S. have faced withering criticism in recent times for soaring prices, including by Congress and the president, though he has yet to actually act on his promise to contain them.


Perhaps that explains why the official White House statement announcing Philipson’s appointment to the council includes a lengthy list of the universities he’s taught at but no mention of the company he co-founded, Precision Health Economics.


PHE describe themselves as a “world-renowned, cutting-edge consultancy firm” that specialises in health policy, economics, and analytics.


It all sounds impressive and relatively harmless, but according to a ProPublica investigation earlier this year, the company has been enlisted by pharmaceutical companies to mount relentless public relations campaign touting new treatments and persuading insurers, including U.S. government programs such as Medicare, to cover the costs.


Precision Health Economics has boasted at least 25 pharmaceutical and biotech companies as clients, including giants like Amgen, Gilead, and Pfizer. They also, coincidentally enough, have consulted for Merck — whose CEO Trump denounced for gouging prices just this week.


The company’s founders, including President Trump’s new economic adviser Tomas Phillipson, recruited an impressive group of high-profile academics to consult for these clients. Some in higher education have expressed concerns that such a tight relationship with industry might suggest bias. “I personally find, when your enterprise relies so substantially on a particular source of funds, you will tend to favor that source”, said Princeton economist Uwe Reinhardt.

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J&J CEO Gorsky Is a Follower, Not a Leader: @JNJCares - NOT!

J&J CEO Gorsky Is a Follower, Not a Leader: @JNJCares - NOT! | Pharmaguy's Insights Into Drug Industry News |

Johnson & Johnson (JNJ) chief executive officer Alex Gorsky was initially chastised last week for deciding to stay on President Trump’s manufacturing advisory council, before reversing course just as Trump announced the panel would be dissolved after a series of defections.


A trio of internal memos sent to J&J employees, reviewed by STAT, offer some insight into Gorsky’s reasoning.


An exodus from the council began with Merck chief executive Ken Frazier, one of the most prominent African-American business leaders in the country, two days after Trump’s initial comments on Saturday, Aug. 12. Originally, Gorsky planned to sit tight. In a memo distributed on Monday, Aug. 14, Gorsky essentially argued that J&J had an opportunity to influence the Trump administration:


First Gorsky defended his decision to stay: “When we are a part of the conversation, we help ensure that healthcare remains the global priority it should be.”


Simply put, there are shareholders to consider and Gorsky was willing to wait it out.


Gorsky doubled down the next morning. In yet another memo on Tuesday, Aug. 15, he more explicitly reiterated his earlier argument that a seat at the table is better than no seat at all. And he did so even after acknowledging complaints from some employees and shareholders.


“In the end, I have concluded that Johnson & Johnson has a responsibility to remain engaged, not as a way to support any specific political agenda, but as a way to represent the values of Our Credo as crucial public policy is discussed and developed. …if we aren’t there standing up for our belief in diversity and inclusion, or if we fail to speak out when the situation demands it, then we have abdicated our Credo responsibility. We must engage if we hope to change the world and those who lead it.”


The Credo, for those unaware, is a long-standing mission statement etched on the J&J headquarters building in New Brunswick, N.J., that makes a commitment to act responsibly to health care providers, employees, communities, and shareholders. . (Some will argue J&J breached its Credo for episodes of illegal marketing that generated big fines or poorly handled product recalls, but that’s another story. For more on that, read “How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Fine”;


His Tuesday memo would have appeared to end the episode, but then, Trump struck again. Later that same day, the president outraged and upset many people once more with off-the-cuff remarks that indicated he assigned equal blame to those who attended the Charlottesville, Va., rally organized by white supremacists and neo-Nazis, and to those who protested the march.


On Wednesday, Aug. 16, Gorsky wrote a third memo to employees.


“…the president’s remarks at his press conference yesterday — equating those who are motivated by race-based hate with those who stand up against hatred — were completely unacceptable. Therefore, I decided to resign from the White House Manufacturing Advisory Council. By working with other members of the manufacturing council on a united withdrawal, I realized we would make the most significant impact.”


Trump showed his true colors with his initial remarks. Why wasn’t that enough to bail right then and there?


PharmaGuy’s comments:

In other words, Gorsky was a follower, not a leader!

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Big Media Companies Launch Health Mags to Capture #Pharma Ad Biz While WebMD et al Struggle

Big Media Companies Launch Health Mags to Capture #Pharma Ad Biz While WebMD et al Struggle | Pharmaguy's Insights Into Drug Industry News |

Condé Nast, Time Inc., and Vice Media have all recently launched health content businesses, in a bid to meet the growing demands of health-conscious consumers and also take a slice of the roughly $6 billion pharma advertising pie.


“It doesn't surprise me that media companies are getting into pharma advertising, given the total value at stake in pharma sales,” said Brian Fox, senior partner at McKinsey.


What exactly is at stake? Well, pharma spending on digital ads was flat, at $515 million in 2016, according to data compiled by Kantar Media. But total pharma spending on advertising in the U.S. market rose 4.6% in 2016, to $5.8 billion, driven by a 6.4% jump in spending on magazines, to $1.7 billion, and a 4% increase in TV spending, to roughly $4 billion.


This may be one reason Time Inc. in July launched a point-of-care magazine as part of the February kickoff of Time Health, a brand focused on video and digital editorial content, among other offerings.


These further investments by traditional media publishers into the healthcare and pharmaceutical space may mean several things. Publishers in general are facing a broad advertising slowdown and looking for new revenue options, while consumers are demanding more health news and content. And the move away from banner ads and toward data-driven strategies has created opportunities for highly trafficked consumer sites to market their reach.


Publicis Health worked with Condé Nast on a print media program for Xiidra, Shire's new treatment for dry-eye disease. The campaign was unique for Shire for several reasons: It featured one of the drugmaker's few consumer-facing products and actor Jennifer Aniston served as a spokesperson, a rare pharma appearance by an A-list celebrity. Unbranded and branded ads were featured in titles like Bon Appetit, Condé Nast Traveler, and Vogue.


Condé Nast's new health marketing division, which launched in April, is multifaceted. The group gives its advertisers with access to its predictive data optimization platform and also develops branded and sponsored content. In addition, Condé Nast has promised to increase its editorial coverage of health and wellness —- primarily through the now online-only Self magazine, which published its last print issue in February. On June 29, Self launched a section that aggregates stories about 30 different conditions and diseases affecting women.


Tonic, Vice's new editorial health site, takes a slightly different approach. The site, which bills itself as “real wellness advice for imperfect humans,” recently featured editorial news stories about counterfeit skin-whitening creams and virtual STD testing.


While the privately held Vice works directly with healthcare brands to create branded and sponsored content, it does so with the understanding that the Vice voice — described as “engaging and human” by John Duncan, Tonic's associate publisher — is present. Vice's perspective is that much online health content is presented or written in a way that is disconnected from the consumer. By contrast, Tonic features “trustworthy information that you can access, and it cuts through the industry-specific language,” Duncan said.


During the 10 months during which all three media properties launched, companies like WebMD and Everyday Health — traditional sources of online pharma advertising — have struggled.

myarts's comment, August 23, 3:39 AM
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Mylan Achieved an ROI of 2.7 by Overcharging Medicaid for EpiPen!

Mylan Achieved an ROI of 2.7 by Overcharging Medicaid for EpiPen! | Pharmaguy's Insights Into Drug Industry News |

Mylan will pay $465 million to settle claims that it overcharged states for its signature EpiPen, according to a Thursday Department of Justice press release. The company also signed an agreement with the federal government to enter into a review of its Medicaid pricing practices.


For years, Mylan classified EpiPen in a way that forced Medicaid to overpay for the product, according to the Centers for Medicare and Medicaid Services. The company may have overcharged taxpayers as much as $1.27 billion over 10 years, the Department of Health and Human Services’s watchdog organization said in May.


Lawmakers slammed the federal agencies on Thursday for letting Mylan get off the hook too easily with the settlement. Sen. Richard Blumenthal (D-Conn.) called it “completely insufficient,” and Sen. Chuck Grassley (R-Iowa) cast is as “disappointing” in statements. Mylan, meanwhile, called the settlement, “the right course of action,” and said that the product has been reclassified under Medicaid as of April 1.


[“Mylan ripped off the government big time,” said Public Citizen, “and the U.S. Department of Justice is letting the company get away with it. Mylan misclassified EpiPen in such a way as to provide less generous discounts to Medicaid purchasers than the law requires.


Today’s shameful settlement is for barely a third of the amount of the rip-off, and it fails to include an admission of guilt – an appalling omission for a decade-long scheme that enabled Mylan to fatten its bottom line by more than a billion.]


Further Reading:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”;
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”;
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”;
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”;
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”;
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”;
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”;
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”;
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”;
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”;
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”;
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Is There an “Unconscious” Bias in Hiring Women for Top Positions in BioPharma?

Is There an “Unconscious” Bias in Hiring Women for Top Positions in BioPharma? | Pharmaguy's Insights Into Drug Industry News |

There’s no better time for women to advance their career in biotech, recruiter Robin Toft said. But many just aren’t asserting themselves as they could.


Toft, who runs San Diego-based life sciences recruitment agency The Toft Group, said there’s “a universal awareness” that companies with diverse boards perform better, and that mixed management teams are more effective. Companies are actively looking for women to fill top roles. But women just need to step up to the plate, she said.


“I personally don’t see a boys’ club in biotech,” Toft said — adding that the she doesn’t think this is conscious.


“It’s my personal experience with biotech that if a woman who shows up who is competent and confident, she will get every consideration,” she said. Women are not intentionally discriminated against: “It’s absolutely my experience that women are in demand,” she said.


But even so, isn’t there often unconscious bias in hiring women?


Employers need to understand that unconscious bias exists, Toft said — and they often hire in their own likeness. So the easiest way to bypass this phenomenon is to consciously advance some women to executive roles, and then allow them to play a role in hiring — so they will hire in their own likeness, Toft said.


Further Reading:

Pharma Guy's insight:

According to women surveyed (see chart), "Unconscious bias in my workplace" is the #2 factor holding them back.

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Merck CEO Frazier Quits Trump Advisory Council in ‘Stand Against Intolerance and Extremism’

Merck CEO Frazier Quits Trump Advisory Council in ‘Stand Against Intolerance and Extremism’ | Pharmaguy's Insights Into Drug Industry News |

The head of U.S. drugmaker Merck & Co. has resigned from a manufacturing advisory council to the Trump administration in an apparent protest of the president’s failure to condemn in stronger terms the white supremacists who marched and waged violence in Charlottesville, Va., over the weekend.


Merck issued a statement Monday morning on Twitter from Chairman and Chief Executive Kenneth Frazier, saying, “America’s leaders must honor our fundamental values by clearly rejecting expressions of hatred, bigotry and group supremacy, which run counter to the American ideal that all people are created equal.”


”As CEO of Merck and as a matter of personal conscience, I feel a responsibility to take a stand against intolerance and extremism,” Mr. Frazier said in the statement.


Almost an hour later, Mr. Trump posted on Twitter: “Now that Ken Frazier of Merck Pharma has resigned from President’s Manufacturing Council, he will have more time to LOWER RIPOFF DRUG PRICES!”


Trump joins other online wackos who have bad-mouthed Frazier. For more on that, see “Merck CEO Ken Frazier's Inspirational Facebook Message Gets No Respect from Followers”;

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United States Opioid Crisis is a Warning to the World: Pharma Partly to Blame

United States Opioid Crisis is a Warning to the World: Pharma Partly to Blame | Pharmaguy's Insights Into Drug Industry News |

Writing recently in The Lancet, Stanford’s Keith Humphreys, PhD, shines a spotlight on the expanding globalization of the opioid epidemic. He urges leaders in other nations to learn from the United States’ mistakes and take immediate action to prevent an international crisis


Humphreys cites sobering statistics showing more than 530,000 Americans died from drug overdoses between 2001 and 2015. “The USA was an ideal environment for opioid prescribing to explode and thereby produce an epidemic of overdose and addiction,” he writes, describing the cultural, legal and industry-based forces that fueled the crisis.


Of particular relevance to other nations is the role that some opioid drug manufacturers have played in the spread of opioid use, he said. In the piece, Humphreys discusses how opioid drug manufacturers — responding to physicians’ concerns about the poor management of chronic pain — began marketing their products as effective, low-risk medications in the 1990s.


Humphreys calls out particular pharmaceutical companies including Purdue Pharma and Mundipharma International for engaging in deceptive practices such as understating the addiction risk of their opioid products. With the U.S. taking steps to curtail the issue of excessive opioid use, drug manufacturers like Mundipharma are likely to continue efforts to further expand sales internationally, Humphreys writes.


Further Reading:

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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