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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 | Scoop.it

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 iSpot.tv. 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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Drug DTC TV Ad Actors Also Get Gigs at Medical Conferences

Drug DTC TV Ad Actors Also Get Gigs at Medical Conferences | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Ilana Becker can barely go a day without someone asking her, "'You're the girl with the stomach, right?' "

 

Many actors are known for their signature roles. In Ms. Becker's case, that role is of a dysfunctional digestive system. She plays Irritabelle, that adorably annoying redhead in tights in Arnold Worldwide's campaign for Allergan's Viberzi, a prescription drug to treat IBS-D, or irritable bowel syndrome with diarrhea (read “’Irritabelle,’ The Viberzi Irritable Sidekick”).

 

In the cottage industry of voice and commercial actors who play diseases and afflicted citizens in healthcare and pharma ads, there are a host of actors who welcome the chance to embrace the quirkiness.

 

Take, for example, Roger L. Jackson, the voice of Mr. Mucus. Mr. Jackson originated the voice and personality of the wiseguy ball of phlegm back in 2004, when the ads were handled in-house by then-owner Adams Respiratory Therapeutics, which later sold to RB.

 

The new Mr. Mucus with attitude is housed at McCann New York and voiced by comedian and "Silicon Valley" actor T.J. Miller. His Mr. Mucus is more sardonic hipster than tough-guy gangster, reading "sick tweets" or asking a restaurant patron "Is that a bisque?"

 

The pharma industry spent $5.6 billion on paid media in 2015, according to Kantar Media. And while it's not the top-spending industry—that would be categories like consumer packaged goods, telecom and automotive—pharma does spend disproportionately on TV advertising. Estimates put pharma TV spending at 60% to 70% of its total outlay.

 

Paul Guyet, who's been doing voice-over work since 2003, is a pharmaceutical commercial veteran. He's the current voice for Boehringer Ingelheim's heartburn medicine character Captain Zantac, created by independent agency Jomo and animators Aardman Animations, and was also one of the talking grocery store fish in AstraZeneca's "Take It From a Fish" digital video campaign that won a Cannes Grand Prix for the pharma category for Digitas LBi in 2015 (read “Like 3-Day Old Fish, #LionsHealth Grand Prix Prize Stinks!”).

 

In "Take It From a Fish," Mr. Guyet's piscine character, Sal, who is lying in a bed of ice in a grocery store case with his pal Marty, says that Martin Scorsese called him and wants him to be in his next film. Marty says, "Really, when's that filming?" Sal says in six months. Marty deadpans, "Yeah, don't think you're gonna be available."

 

Ms. Becker, who also does personal appearances at gastroenterology conferences for Allergan, said, "GI doctors are the best, they have such a great sense of humor. If someone watching is less embarrassed and more encouraged to live out loud, that makes me feel great."

Pharma Guy's insight:

Also see "Gallery of Drug Advertising Mascots"; http://bit.ly/mascotgallery

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More Pharma Marketing “Pirates” Needed, Says Rich Meyer

More Pharma Marketing “Pirates” Needed, Says Rich Meyer | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Rich says: In the era of super blockbusters pharma became addicted to super brands. The industry slowly transformed from healthcare to a dollars and cents business. I’m not naive to believe that pharma has to make profit, but when patients are going bankrupt paying for expensive cancer therapy co-pays something is wrong. When MS patients are stuck fighting the “system” to get the drugs they need something is very wrong and when pharma CEO’s take home tens of millions of dollars in pay while some employees work 12-14 hour days to try and make a difference the organization is in deep trouble.

 

So the question becomes “what are you prepared to do?”

 

What I hear, more and more, is that marketing teams are being downsized and that too many bureaucratic barriers remain in place to transform the organization from old models of DTC to digital centric patient marketing. When you think of how patients “get lost” in the system and need help the reluctance of pharma to invest in digital is even more puzzling.

 

Steve Jobs said that” it’s more fun to be a pirate” and he was right. We need more pirates in the industry who are willing to blow up current business models and prepare the organization for the future. There has never been a better time to challenge the status quo because the rewards of seeing a patient smile are worth the risks

Pharma Guy's insight:

Rich is definitely on a crusade to get pharma marketers to pay more attention to digital. I too made an effort by recognizing pharma social media "pioneers" who, I guess, can also be considered "pirates" (see "The Pharmaguy™ Pioneer Award" for pirates of yesterday).

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Anti-Vaxxers Emboldened by Trump’s Embrace of Vaccine-Autism Conspiracy Theory

Anti-Vaxxers Emboldened by Trump’s Embrace of Vaccine-Autism Conspiracy Theory | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Trump’s embrace of discredited theories linking vaccines to autism has energized the anti-vaccine movement. Once fringe, the movement is becoming more popular, raising doubts about basic childhood health care among politically and geographically diverse groups.

 

Public health experts warn that this growing movement is threatening one of the most successful medical innovations of modern times. Globally, vaccines prevent the deaths of about 2.5 million children every year, but deadly diseases such as measles and whooping cough still circulate in populations where enough people are unvaccinated.

 

In San Antonio, 80 miles southwest of the state capital, Texans for Vaccine Choice convened a happy hour to encourage attendees to get more involved politically. The event was among dozens of outreach events the group has hosted across the state. The relatively new group has boosted its profile, aided by a savvy social-media strategy, and now leads a contentious fight over vaccines that is gearing up in the current legislative session.

 

A leading conspiracy theorist is Andrew Wakefield, author of the 1998 study that needlessly triggered the first fears. (The medical journal BMJ, in a 2011 review of the debacle, described the paper as “fatally flawed both scientifically and ethically.”) Wakefield’s Twitter handle identifies him as a doctor, but his medical license has been revoked. The British native now lives in Austin, where he is active in the state and national anti-vaccine movement.

 

Trump has met with Wakefield, who attended an inaugural ball and told supporters afterward that he had received “tremendous support” for his efforts and hoped to have more meetings with the president.

 

But now immunization advocates are realizing that they can’t let vaccine critics go unchallenged, saying they need voices other than scientists and experts to make the case. They are recruiting teachers and grass-roots groups to explain how immunization protects families and communities.

Pharma Guy's insight:

Further reading:

  • “Trump Picks Vaccine Critic Robert F. Kennedy Jr. to Chair Vaccine Panel”; http://sco.lt/9J3GFt
  • “Off The Grid: Robert F. Kennedy Jr. Says Vaccines are Pay Dirt’ for #Pharma”; http://sco.lt/6smHDt
  • “Vaccines Are Path to Better Revenue Growth for Some #Pharma Companies”; http://sco.lt/582wTZ
  • “When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?”: http://sco.lt/7adpSb
  • “Want to Avoid Toxins in Your Flu & Other Vaccines? ‘Good Luck,’ Says Cleveland Clinic Wellness Doctor”; http://sco.lt/4gmHXl
  • “CDC’s #VaxWithMe Social Media Campaign has been updated”; http://sco.lt/8bQcuv
  • “Intelligent, High Income People Refuse Vaccinations”; http://sco.lt/67gVs1
  • "Everything You Wanted to Know About Vaccine Marketing, PR, Earned Media, Lobbying, and 'Anti-Vaxxers'"; http://bit.ly/29H0UOL
  • “Discredited Anti-Vaxxer Researcher Is “Very Positive” He Has an Ally in Trump”; http://sco.lt/76R4xF
  • “Better to Keep Vaccine Adverse Event Reports Secret, Concludes Study”; http://sco.lt/4gkjhJ
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Scientists Run for Office in Washington and Will March for Science Too!

Scientists Run for Office in Washington and Will March for Science Too! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Michael Eisen would like to teach Washington a thing or two about the scientific method.

 

Last month Eisen, an evolutionary biologist at U.C. Berkeley, announced plans to run for a seat in the Senate in 2018. As a Republican-controlled Washington has waged war against as basic truths and evidence-based reasoning, it has inspired a political awakening among a scientific community that often resists political engagement. With their work under attack, scientists like Eisen have concluded they can no longer sit idly by.

 

“So many political problems are practical problems,” Eisen recently told Gizmodo from his Berkeley office. “You study them, you collect data, you try to make the right decision. That is somehow absent from Washington.”

 

Eisen doesn’t hope to serve as merely another Congressional vote in favor of aggressive climate change policy or investment in renewable energy. He aspiration—to lend a scientific perspective to the political process itself—is summed up by his campaign slogan: “Liberty. Equality. Reality.”

 

He’s not alone: more than 2,500 scientists have expressed interest in running for office through new group called 314 Action, prompting the group to plan an event in D.C. next month [read “Science Not Silence! MARCH FOR SCIENCE - April 22, 2017”; http://sco.lt/8TdiaH] to give scientists a crash course in politics. Over the weekend, hundreds of scientists convened at a political rally “to stand up for science” in Boston’s Copley Square. At least one other scientist besides Eisen—Tracy Van Houten, a rocket scientist in Los Angeles—has already committed to run.

 

“I’m not exaggerating, the response from scientists has been pretty incredible,” Ted Bordelon, communications director for 314 Action, told Gizmodo. He said that 314 Action has received more interest from scientists than it ever expected.

Pharma Guy's insight:

I'm not a practicing scientist, but I have an MS and MPhil in Biochemistry, and I'm running for Newtown Township PA Supervisor! 

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How “Patient Advocates” Make Money from #Pharma with the Help of Agents Who Take a Cut

How “Patient Advocates” Make Money from #Pharma with the Help of Agents Who Take a Cut | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A health care company is hoping that it can connect some of the most influential and underutilized health experts—patients—with brands that are willing to pay for their knowledge and connections.

 

Leanna Mullen has Gaucher's disease, a rare genetic disorder that is associated with a variety of debilitating symptoms, from lung disease to arthritis. Mullen, a New Jersey-based television producer in her late twenties, has built up a vast network in the patient advocacy community and has used her media platform to raise awareness of her disease. Several months ago, she was contacted by a research firm called BrandTrust regarding a survey into the mental health of patients with Gaucher's. She was told that the information would be delivered to a pharmaceutical company, but she declined to disclose the company to me after signing a non-disclosure agreement.

 

If Mullen could recruit a diverse set of patients to participate in the research, she would be paid about 80% of a $10,000 fee. "I had the connections, and was able to recruit almost my entire demographic within two or three days," she says. Mullen was able to reach out directly to patients in closed Facebook groups and private forums, which would have been off-limits to recruiters. "Many people wanted to support research that will help make others' lives better," she says.

 

Mullen's name was initially floated to BrandTrust by a Boston, Mass.-based company called Wego Health, which has built up a vast database of patient influencers over the years. Wego's chief strategy officer, David Goldsmith, came up with the idea of connecting these patients directly with brands, after researching how other sectors, such as transportation and tourism, slowly adapt to new labor models as part of the "sharing economy" movement. He figured that health care was next.

 

With Goldsmith's new service, Wego Health Experts, brands can connect with patients for help with finding clinical trial participants, research and surveys, "awareness" campaigns, speaking engagements and so on. Goldsmith says some of these processes, such as clinical trial recruitment, used to take months and cost "tens of thousands of dollars," which typically went to third-parties rather than patients. But influencers like Mullen can often get the job done faster and for a fraction of the price, he adds. Wego makes money by taking a cut of the overall fee (in this case, the remaining $2,000 of the $10,000 offered via BrandTrust).

 

PROMISE AND PITFALLS

Compared to other industries, health care carries some unique opportunities, risks, and challenges. Nick Blum, general manager of Catalant, a company that connects big brands with freelance experts, stresses the need for full awareness of biases and agendas. "The key here will be transparency," he says. "Who has what relationship with whom, how does compensation flow, what incentives exist, and so on."

 

Mullen says she did not disclose in every discussion that she would be paid, as she figured that it would be obvious. "They're aware that there's usually some sort of headhunter," she says. Also, she figured that the risk would be low, as it was a survey rather than a clinical trial.

 

Bioethicists such as New York University's Arthur Caplan have some concerns about patients leveraging their influence on behalf of brands. He compares this approach to celebrities like Bob Dole and Barry Manilow appearing on television to tout pharmaceutical products they may never have used, ranging from Viagra to cholesterol medication. In the long run, he explains, there's always the risk that trust will be eroded.

 

Caplan suggests that guidelines should be formulated to clarify how patients should disclose conflicts of interest, if they're getting paid. That's particularly important if they're being asked to recruit for a potentially risky clinical study.

 

For her part, Mullen wouldn't agree to every project sent her way. She was willing to tap into her network for this project, as she could personally vouch for it having taken the study. And the money that she made helped her with expenses related to managing her disease. "For many of us, this could be an opportunity make others' lives better and become a part-time job," she says.

Pharma Guy's insight:

Further Reading:

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Dorothy Retha Cook's curator insight, February 21, 9:13 AM

Somebody else getting a bigger cut but who?

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Big Data, a Bullshit Course, & the March for Science

Big Data, a Bullshit Course, & the March for Science | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Tired of alternative facts, fake news, and breathless hyperbole, two professors at the University of Washington are trying to strike a blow for science.

 

Their weapon? A new course: “Calling Bullshit In the Age of Big Data.”; http://callingbullshit.org/index.html

 

The class website and colorful syllabus went online last month and almost instantly went viral.

 

“We woke up the next morning to chaos. We had 20,000 visitors, our mailboxes were full, we were getting book offers,” said Carl Bergstrom, a biologist who helped create the course.

 

Bergstrom’s teaching partner, Jevin West, an assistant professor in UW’s Information School, put it this way: “We just struck a nerve.”

 

Though the course will be held on UW’s Seattle campus — capped at 160 students, it filled in the first minute of online registration — the materials are available free online. Lectures are expected to be posted as well.

 

“What I’m finding among scientists is an uneasiness that goes back years, even decades, about an eroding appreciation of science, how it works, and how it’s incorporated into our society. And it seems to be in a crescendo right now,” physicist Rush Holt, chief executive of the American Association for the Advancement of Science, told STAT earlier this week (read “AAAS Should Formally Endorse March for Science”; http://sco.lt/5vcptp).

 

Scientists around the world are even organizing a series of marches on Earth Day in April, which they’re billing as “a call to support and safeguard the scientific community.”

 

[Read: “Go Boldly! March for Science!”; http://sco.lt/8TdiaH]

 

In Seattle, the professors hope to do their part by dissecting case studies — or, as they call it, “bullshit in the wild” — to demonstrate how scientific data can be manipulated to mislead the public. Examples include a Fox News report on food stamp fraud; the professors promise to explain “how Fermi estimation can cut through bullshit like a hot knife through butter.”

 

The duo has fielded many requests from other institutions who want to create their own courses using the material. In the name of scientific literacy and a reasoned populace, they are more than happy to share. “No copyright. No trademark. Use it. Take it. Run with it,” West said.

 

They’ve been pleasantly surprised to see an upswell of interest from high school and middle school teachers, too.

 

Many have asked if the course is a response to President Donald Trump, who has dismissed evidence of vaccine safety and called climate change a hoax. But the course was in the works long before the election. And while Bergstrom makes no secret of his disdain for Trump on his Twitter feed, he wants the course to remain apolitical. He promises to attack misrepresentations of science coming from politicians of any stripe.

 

“We need a citizenry that’s more informed and has the ability to call bullshit,” West said. “That’s good for everyone.”

 

 

Pharma Guy's insight:

Further Reading: “Is Pharma Marketing a Lot of BS?”; http://sco.lt/8RAgvx

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Why Isn’t Pharma Working Harder & Smarter to Develop a Better Flu Vaccine?

Why Isn’t Pharma Working Harder & Smarter to Develop a Better Flu Vaccine? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

This year’s flu vaccine is offering moderate protection against the main family of viruses causing illness, data released Thursday by the Centers for Disease Control and Prevention show (here: http://bit.ly/2kTmrGx).

 

Overall, getting a flu shot cut one’s risk of contracting flu and needing to see a doctor (my emphasis) by 48 percent this season, when the effectiveness of the various components of the vaccine were assessed together, according to the report published in the CDC’s online journal Morbidity and Mortality Weekly Report.

 

Far and away the most common cause of influenza so far this year is the influenza A virus family known as H3N2. [The vaccine is only 43% effective against illness caused by influenza A] Seasons in which H3N2 viruses dominate are typically harsh because the virus is especially hard on older adults. Older adults also get less benefit from flu vaccines than healthy younger people.

 

“Forty percent to 50 percent is a lot better than zero, but what it really begs the question is: Why are we not working hard to get new and better flu vaccines?” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy and a long-time advocate for the development of more effective flu vaccines.

 

“Last year we spent over a billion dollars researching new HIV vaccines — an amount that I think is an important investment. But the best estimate we can come up with is we only spend about $35 million globally on … research on new game-changing flu vaccines.’’

 

[Read “NIH Study Leads the Way for #Pharma to Develop a More Effective Flu Vaccine”; http://sco.lt/5fNcXJ and “One Step Closer to Universal Flu Vaccine”; http://sco.lt/7yOawr]

 

Last week Canadian researchers reported they are seeing about 42 percent protection from the H3N2 component of the vaccine north of the border. And European scientists reported vaccine effectiveness of 38 percent for H3N2 on Thursday.

 

Jacqueline Katz, deputy director of the CDC’s influenza division, said a theory behind the poor performance of the H3N2 component of the vaccine relates to the way flu vaccine is produced.

 

Most influenza vaccine is produced in hen’s eggs; the viruses have to adapt to grow in eggs. That’s true of all families of flu but for some reason the H3N2 viruses adapt in ways that introduce important differences. In essence, the viruses produced in the eggs are different from the viruses circulating in people and don’t adequately prime immune systems to recognize and fend off those viruses. In some years those differences are more pronounced than others.

 

Further Reading:

 

  • “Millions of patients given flu drugs with little or no benefit, study finds”; http://sco.lt/93x12P
  • “Adults Only Really Catch the Flu About Twice a Decade, Study Suggests: Another Good Reason Not to Get Flu Vaccine”; http://sco.lt/7yRU9J
  • “Does the Flu Vaccine Work? What 62% ‘Effective’ Really Means”; http://bit.ly/1duC2Cx
Pharma Guy's insight:

The effectiveness of flu vaccines is a disgrace! Use of old technology to develop the vaccine is partly to blame. I've been writing about this for a long time. Read, for example, “Does the Flu Vaccine Work? What 62% ‘Effective’ Really Means”; http://bit.ly/1duC2Cx

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Pharma CEOs Speak Out About Drug Prices

Pharmaguy’s Selected List of Pharma CEOs’ Words of Wisdom Regarding Drug Prices, Jobs, and Taxes

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PhRMA Offers Up Marathon Pharmaceuticals as “Sacrificial Lamb” to Trump?

PhRMA Offers Up Marathon Pharmaceuticals as “Sacrificial Lamb” to Trump? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical industry trade group hopes to convince you that it is not all bark and no bite.

 

In response to the outcry over Marathon Pharmaceuticals, which plans to sell a decades-old drug for $89,000 and also maintain a monopoly, the Pharmaceutical Research and Manufacturers of America slammed the company for “actions [that] are not consistent with the mission of our organization.” And the group promised a “comprehensive review” of its membership criteria (read “PhRMA Embarrassed by Marathon is Forced to ‘Review’ Membership Criteria – Is a Purge in the Cards?”; http://sco.lt/5XUvqL).

 

The goal is to “ensure we are focused on representing research-based biopharmaceutical companies who take significant risks to bring new treatments and cures to patients,” according to a statement from the trade group. PhRMA, by the way, has not bothered to publicly post this declaration of intent on its web site, but instead, only distributed it to those who asked for its official views on Marathon.

 

It is not clear what is meant by a comprehensive review, though. A spokeswoman declined to provide further details or describe further steps that may be taken, such as ejecting Marathon from its ranks.

 

In fact, it is not entirely clear what, if anything, might change.

 

One thing is certain: The statement reflects increasing heat on the pharmaceutical industry, which is under escalating attack over the cost of medicines, an issue that President Trump has vowed to address. Although Trump has accused drug makers of “getting away with murder” and otherwise made vague noises about drug prices, he has yet to suggest any concrete steps.

 

Nonetheless, the industry is anxious. Hence, PhRMA lobs this statement.

 

In effect, the trade group is trying to get ahead of the proverbial curve by intimating that Marathon might just become a sacrificial lamb. And the trade group is also hoping to create the impression that its members want to put some heft behind the regular claim that price-gouging drug makers are outliers, a mantra that has been regularly repeated over the past two years.

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Get on the Bus Rush! AAAS Should Formally Endorse March for Science

Get on the Bus Rush! AAAS Should Formally Endorse March for Science | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It’s not often you see a public celebration of science. But come April, thousands of people, scientists and others, are expected to march in support of the field and its contributions to society.

 

But the March for Science is also a response to the feeling among many scientists that they are under siege by a hostile Trump administration and distrusted by many Americans.

 

Navigating that tension is the American Association for the Advancement of Science (AAAS).

 

With the AAAS annual meeting taking place now in Boston, the group’s president, Barbara Schaal, and CEO, Rush Holt, met with STAT reporters to discuss why scientists need to be politically engaged, their views on the March for Science (“Science Not Silence! MARCH FOR SCIENCE - April 22, 2017”; http://sco.lt/8TdiaH), and why they worry that the Trump administration hasn’t appointed a science adviser in the White House or scientists in other agencies. Holt is a physicist by training and a former Democratic congressman, and Schaal is a biologist.

 

What’s your confidence level in this administration right now?

 

RH: If there’s an emerging disease that pops up in this country or elsewhere, I would say we are not prepared. We just have not succeeded in convincing the new administration that what we’re asking for is not a science plant inside the White House to look out for the interests of people in lab coats, but rather to get them to understand that it’s in their interest to integrate science and scientifically evaluated evidence into their policy making.

 

What’s been the reaction to the election?

 

BS: I have never seen my colleagues so galvanized than after this most recent election. People are talking about, what do we do? If you look at the membership of AAAS, it’s shooting up.

 

Are you worried about that backfiring?

 

RH: It’s a concern, but scientists have to be reminded that the response to a challenge to science is not to retreat to the microscope, to the laboratory, to the ivory tower. This requires vigorous defense. We think science is so beneficial to society that it should be defended.

 

Do you have a position on the March for Science?

 

RH: We have said that we are going to work energetically with our members, with our affiliate societies to see that the March for Science is a success.

 

BS: The folks that I talk to, they’re really in two camps. One group says this a potential disaster, it’s going to really politicize science, and it’s going to hurt the entire endeavor. And then there’s another group that says just get me on a bus, I’m coming.

 

Which camp are you in?

 

BS: I guess I’m thinking of the bus, but I’m not quite there yet.

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PhRMA Embarrassed by Marathon is Forced to “Review” Membership Criteria – Is a Purge in the Cards?

PhRMA Embarrassed by Marathon is Forced to “Review” Membership Criteria – Is a Purge in the Cards? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After maintaining a steadfast silence for the past 5 days, PhRMA is cutting Jeff Aronin loose.

 

The Marathon CEO and PhRMA board member triggered a tempest over his announcement last Thursday evening that he would price his newly approved steroid — a cheap, generic offering sold in many countries around the world as deflazacort — for $89,000 a year after landing an approval to market it for Duchenne muscular dystrophy. According to a number of patient advocates, they’ve been buying the drug from overseas for about $1,000 a year.

 

On Monday Senator Bernie Sanders and Congressman Elijah Cummings accused Aronin and Marathon of ripping off the system in the latest example of a drug executive looking to cash in after gaming the FDA’s approval process (read “Senators Launch Probe into Marathon's $89K Price Tag for ‘Cheap Steroid’ - Company Retreats”; http://sco.lt/7dIrHV). Now PhRMA says Marathon is guilty of conduct unbecoming to the industry, launching a review on membership criteria that would likely leave Aronin in the cold.

 

Their statement tonight:

 

We are pleased Marathon decided to pause the launch of their medicine to solicit additional input from patients and other stakeholders. Their recent actions are not consistent with the mission of our organization. In addition, the leadership of the PhRMA Board of Directors has begun a comprehensive review of our membership criteria to ensure we are focused on representing research-based biopharmaceutical companies who take significant risks to bring new treatments and cures to patients.

 

This is just the latest in a series of embarrassing controversies centered on charges of price gouging. Turing CEO Martin Shkreli got it started. Valeant was quickly swept up. And then Mylan took a turn in the public stocks. Now it’s Marathon’s time to stand in the spotlight.

 

By Wednesday night Aronin was more of a liability to PhRMA than a benefit. Just weeks ago the trade group began an ambitious marketing campaign aimed at highlighting the contributions of medical research. It was time, said PhRMA CEO Stephen Ubl in a thinly veiled jab at Shkreli, for more lab coats and fewer hoodies (“PhRMA's Dark Inspirational Video Starts a 6-Month Offensive: ‘Less Hoodies, More White Coats’"; http://sco.lt/4xLMLR).

 

At the time, Shkreli fired back that he had learned everything about raising prices from Marathon (read “’I Literally Learned from This Guy,’ Says Martin Shkreli of Marathon CEO Jeff Aronin”; http://sco.lt/5B6b2X).

 

For now, Aronin remains on the board at PhRMA. But his odds of making it much longer aren’t good.

Pharma Guy's insight:

Meanwhile, some in the industry are urging Big Pharma to Secede from PhRMA: http://sco.lt/8UQ2vh 

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Acorda Therapeutics CEO Ron Cohen is Optimistic That Drug Industry Can Make a “Fair Profit” and Still Get Respect

Acorda Therapeutics CEO Ron Cohen is Optimistic That Drug Industry Can Make a “Fair Profit” and Still Get Respect | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Acorda Therapeutics CEO Ron Cohen is pleased that Marathon Pharmaceuticals decided to pause the commercial activities of its new Duchenne muscular dystrophy treatment Emflaza in response to criticism of its high price tag.

 

“That's the sort of response that is helpful,” he said, during a call Tuesday with investors.

 

Last week, Marathon announced that Emflaza, its new DMD drug, would cost $89,000 per year (read “Senators Launch Probe into Marathon's $89K Price Tag for ‘Cheap Steroid’ - Company Retreats”; http://sco.lt/7dIrHV). The announcement caused outrage from patient advocates and lawmakers, including Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD), who accused Marathon of abusing the Orphan Drug Act, a program that grants drugmakers seven years of market exclusivity in exchange for bringing a rare-disease drug to market. A generic version of the drug, a corticosteroid, when sold outside the U.S., costs $1,200 per year, according to media reports.

 

Still, Cohen, a vocal proponent of the industry, said he is more optimistic than he was a year ago about reaching a point in which companies can make a “fair profit” while also rebuilding the trust of the public and the government.

 

The fact that the pharmaceutical industry is facing tremendous pressure to bring down drug prices and extend access is “no secret,” said Cohen.

 

In the past, there was “a lot of finger pointing across different pieces of the system,” he added (read “Pharma CEO Rips Insurance CEOs a New One! Exposes Salaries, Blames Them for High Drug Prices”: http://sco.lt/6kN065 and “High Rx Drug Prices? We’re Not to Blame Say Payers & Our Unbiased Poll Proves It!”; http://sco.lt/64g9mT). But that strategy was ineffective and only allowed external parties to attack drug companies even more, he said.

 

Political leaders “want to make sure that the U.S. remains a leader in those areas … and that gives us a foundation for having constructive discussions,” he said.

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The Condé Nast Traveller’s Guide to TV DTC Drug Advertising

The Condé Nast Traveller’s Guide to TV DTC Drug Advertising | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Eyeforpharma survey’s findings show that investment in DTC may be increasing but its effectiveness is decreasing. Numerous studies have shown that DTC TV spots are less than 20% effective in driving patients into their doctors to ask for an Rx (read “Pharma is Spending More on DTC Advertising But Its Effectiveness is Decreasing, Says New Survey”; http://sco.lt/7XpFsf).  

 

So the question becomes “why?” are DTC marketers so in love with TV?

 

[Rich Meyer] asked two senior executives to explain pharma’s love with DTC at a time when the channel is showing less of an ROI. Here are their responses…

 

A former senior pharma Director got a new job and all of her colleagues and vendors made a big farewell fuss over her. One of the biggest fusses was from her main agency, whose top account guy just said, that she was a really good client. She responded, “to be a great client, you have to have a great agency….” and she went on to list, not all the great revenues her agency had brought in for her and not even the awards their campaigns had won, but for exotic shooting locations that cost a small fortune. It quickly became apparent that these were all the “locations” her agency had determined were the “most cost-effective” locations to shoot her commercials. It was like something out of Condé Nast Traveler. She loved her agency because she loved the location-shooting life.

 

Then there is this…

 

A pharma company was launching a small product that would have only a short interval to make its peak sales before it was pushed off the market by generics. He was determined to do it smart with no TV, no mass media, just all digital… and targeted.” However, after submitting a great plan we didn’t hear back and then we learned why. A senior pharma executive told him “no one ever got promoted her for having a smart, efficient plan. The way you get promoted here is to have a killer TV spot.”

 

"I wish I could say that these are isolated incidents, but they aren’t," said Meyer. "While on shoot locations I have seen staff stay at expensive hotels and order expensive dinners and having the agency cover the charges so pharma executives don’t find out. I have seen DTC people buy things through their agency, supposedly for props, and hen wind up keeping the items. It’s more widespread than you think."

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Generic Drug Industry Trumps PhRMA’s PR By Re-Branding Itself. Should PhRMA Follow Its Lead?

Generic Drug Industry Trumps PhRMA’s PR By Re-Branding Itself. Should PhRMA Follow Its Lead? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Generic Pharmaceutical Association is no more. Meet the Association for Accessible Medicines.

 

Every industry group invested in the drug-pricing debate is gearing up and burnishing its brand. PhRMA, the brand-name pharmaceuticals lobby, has its “Go Boldly” campaign (read “PhRMA's Dark Inspirational Video Starts a 6-Month Offensive: Less Hoodies, More White Coats”; http://sco.lt/4xLMLR). Now the generics lobby is launching its own “education campaign” under a whole new name.

 

“The Association’s new identity will improve recognition that the generic and biosimilar medicines industry is one of the nation’s great health care success stories, and that competition from generics and biosimilars lowers the cost of medicine,” Chip Davis, its president and CEO, said in a statement. “Our medicines drive savings, not costs, and we stand ready to work with the President, Congress, patient groups and others to create real and lasting health cost solutions.”

 

Generics figure to be major players in any resolutions that Congress or the Trump administration come up with for the drug-pricing debate. On the one hand, many lawmakers and groups, even PhRMA, talk about speeding generics to the market as a way to encourage competition and organically drive down prices. Some of the recent pricing controversies, such as Turing’s roughly 5,000 percent increase in the price of a life-saving drug, have centered on drugs that have long ago lost their patent protection, but never saw a generic competitor introduced.

 

But on the other hand, there are also incidences of extraordinary price increases for generic drugs. And some policy proposals make generic drug makers nervous, too. Senator Chuck Grassley’s bid to crack down on so-called pay-for-delay deals — litigation settlements between brand-name and generic drug makers that delay the introduction of a generic drug — are one item in particular that, according to people who work with generics, make those companies uneasy.

Pharma Guy's insight:

It has been recommended that “Big #Pharma Should Secede From PhRMA” in order to differentiate itself from price gougers (http://sco.lt/8UQ2vh). But maybe a name change would be better to wow & bamboozle the public.

 

What name should replace Pharmaceutical Research and Manufacturers of America? How about Association for Serious Science & Medicine (ASS&M)?

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Senators Start a New Effort to Allow Importation of Certain Drugs from Canada. Will Trump Play Security Card?

Senators Start a New Effort to Allow Importation of Certain Drugs from Canada. Will Trump Play Security Card? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Now that Tom Price has been confirmed to head the US Department of Health and Human Services, a trio of lawmakers is after him to allow Americans to import medicines from Canada. And their names are familiar to anyone who has tracked this particular notion, which has regularly been proposed — and just as often ignored or swatted down — as a fix for the vexing problem of prescription drug costs.

 

In a letter sent to Price on Tuesday, the lawmakers — Senator Chuck Grassley (R-Iowa), Senator Amy Klobuchar (D-Mn.) and Senator John McCain (R-Az.) — urged the newly anointed cabinet member to use his statutory authority to fast-track importation from Canada under certain circumstances. And those circumstances include situations in which competition is lacking or there are sudden and huge price hikes.

 

This is only the latest attempt by these same lawmakers to find a way for Americans to import medicines from Canada. Over the past couple of years, they have each introduced legislation or written letters to HHS urging importation (read, for example, “Drug Importation Crisis: Terror Politics to the Rescue!”; http://bit.ly/2lPNX7G). But given that President Trump has informally voiced support for the idea — and twice attacked drug makers over high prices — they apparently see an opening to renew their call.

Pharma Guy's insight:

Back in 2004, under the Bush II administration, the FDA played the "terrorist trump card" in its battle against the legalization of the reimportation of drugs.Lester Crawford, the acting FDA commissioner at the time,  suggested that "a source of continuing concern" is that terrorists might tamper with prescription drugs imported from Canada. Will history repeat itself?

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“Repurposing” Drugs as “Orphans” Drives Up Prices

“Repurposing” Drugs as “Orphans” Drives Up Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

 

 Sen. Charles Grassley (R-IA) on Friday confirmed to Focus that he is gathering more information and discussing with his staff and interested parties a possible inquiry into the Orphan Drug Act’s abuses leading to high drug prices.

 

“Based on the reporting from Kaiser Health News [KHN] about how the orphan drug provisions appear to be stretched beyond their original intent, and the strong consumer concern about high drug prices, I'm interested in learning whether the unanticipated uses of the provisions are contributing to high prices for commonly used drugs,” Grassley said in an emailed statement to Focus. “My staff is meeting with interested groups and other Senate staff to get their views on the extent of the problem and how we might fix it. I also continue to work on other ways to help bring down drug prices, such as increasing competition with available products.”

 

Grassley’s comment follows a KHN investigation from January detailing how the incentives created by the Act’s provisions have led to more than 200 companies bringing almost 450 orphan drugs to market since the law took effect in 1983. The incentives are for diseases affecting fewer than 200,000 individuals in the US per year and include seven years of market exclusivity, tax credits for clinical trial expenses, user fee waivers and federal grants.

 

Dr. Gayatri Rao, director of the FDA’s Office of Orphan Products Development, told KHN that she would look into the investigation and pointed out that the “repurposing” of drugs does have scientific and patient benefits.

 

“We always talked about how we permit the second bite of the apple, third bite of the apple, as one small way to incentivize repurposing,” Rao told KHN, noting that industry and patient groups have been pressing the FDA for more incentives. “Now, all of sudden, it seems like, wow, this practice may be driving up prices.”

 

In 2015, researchers at Johns Hopkins called for reforms to the Act, saying loopholes have allowed drug companies to skirt its intent by taking advantage of its incentives for non-orphan conditions.

 

An article in PLOS Medicine in early January also noted: “Orphan-designated drugs to treat biomarker-defined subsets of common conditions have a number of characteristics that make them ill-suited to the orphan drug designation, including short development times and rapid expansion of off-label indications after approval. Application of the Orphan Drug Act in these cases risks wasting resources that might be better focused on truly rare conditions.”

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Senators Launch Probe into Marathon's $89K Price Tag for "Cheap Steroid" - Company Retreats

Senators Launch Probe into Marathon's $89K Price Tag for "Cheap Steroid" - Company Retreats | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Senator Bernie Sanders and Congressman Elijah Cummings have found their new poster boy for pharma price gouging. His name is Jeff Aronin, the CEO of Marathon Pharmaceuticals.

In a joint letter addressed to Aronin, the two lawmakers slammed the company’s “outrageous plans” to set a list price of $89,000 on their newly approved deflazacort, a cheap steroid that’s been available for decades in other countries around the world. And they launched an investigation into Marathon’s plans, demanding documents related to the actual cost of the program while insisting that Marathon “significantly lower the price” for releasing the drug.

Almost simultaneously, Marathon executed a strategic retreat, telling a group of representatives from various Duchenne groups at a policy meeting in Washington DC that they were calling a “pause on the launch,” according to one of the attendees, who asked not to be identified.

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Competition Leads to More Spending on Cancer Drug DTC Ads, Which Are Less Effective & More Controversial

Competition Leads to More Spending on Cancer Drug DTC Ads, Which Are Less Effective & More Controversial | Pharmaguy's Insights Into Drug Industry News | Scoop.it

DTC spending on ads for cancer drugs is a small part of the $5.2 billion the industry as a whole spent in 2015, but as Bristol-Myers Squibb and Merck battle for market share in immuno-oncology, that may be changing.

 

From June 2013 to February of this year, pharma companies have spent an estimated $223 million on more than 42,000 airings for DTC cancer-ads for Bristol-Myers Squibb's Opdivo, Merck's Keytruda, Dendreon's Provenge, and Amgen's Neulasta, according to iSpot.tv. At least half of that spending is for Opdivo ads that aired during the last year.

 

Before 2013, when the first Provenge DTC aired, it was unheard of for brands to use direct-to-consumer advertising for oncology drugs. DTC was a marketing play for the blockbuster consumer brands, the Lipitor's and Viagra's of the world.

 

Four years later, there are now two dueling immunotherapy ads on primetime TV promoting Keytruda and Opdivo for certain lung-cancer patients.

 

In 2016 Opdivo generated nearly three times the revenue that Keytruda did, with sales of $3.7 billion, compared to Keytruda's $1.4 billion. In the first nine months of last year, Bristol doled out $108 million in ad spend for Opdivo, while Merck spent $24 million on Keytruda in the same timeframe, according to Kantar Media. Up to this point, Merck had targeted oncologists through professional journal ads — outspending Bristol two-to-one ($2 million vs. $863,000) in the first half of 2016, also according to data from Kantar.

 

Now that Merck kicked off its new campaign, that figure is expected to rise. Merck has its own story to tell for Keytruda, Arnold said. “TV is a great way to tell that story and build that initial awareness, especially with an older population,” he said. “It's expensive. It's a shotgun approach, and it's not very targeted, but we know that it works for awareness.”

 

[However, according to a new study, DTC advertising is less and less effective in driving awareness. For more on that, read “Pharma is Spending More on DTC Advertising But Its Effectiveness is Decreasing, Says New Survey”; http://sco.lt/7XpFsf ]

Pharma Guy's insight:

********

Just Like DTC Ads, Pharma Cancer Drug Websites Emphasize Benefits Over Risks

 

Researchers from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) and research firm RTI International say that websites for cancer-drugs are ten times more likely to include quantitative information about all the benefits of a drug versus all its risks.

 

More here... http://sco.lt/8soJrV

 

Also read: "Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients"; http://sco.lt/8Imgdd  and " Breakthrough Cancer Therapy DTC Advertising Boldly Emphasizes the Positive"; http://sco.lt/80LqSX 

 

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Diabetes Drugs Ads Come on Strong in January 2017 TV ad Spending List While Movantik Makes Top 10

Diabetes Drugs Ads Come on Strong in January 2017 TV ad Spending List While Movantik Makes Top 10 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Diabetes drugs kicked off TV ad spending strong in 2017. Eli Lilly’s Trulicity led the category at No. 4 on the top 10 list of pharma national TV ad spenders for January, according to iSpot.tv, but AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana followed close behind at Nos. 6 and 7. Just missing the top 10 was Merck’s Januvia at No. 12 with spending of $9.5 million for the month, according to the real-time TV ad tracker's data.

The category's ad-spending spree comes as diabetes treatment spending is increasing in general. ExpressScripts, the U.S.’s largest pharmacy benefits manager, noted recently that diabetes is one of the two biggest spending categories in the country and increased by 19.4% in 2016.

While diabetes claimed three of the top spots on the January list, AbbVie’s anti-inflammatory Humira, the best-selling drug in the U.S., remained No. 1 with ad spending on indications for arthritis, psoriasis and Crohn’s/colitis totaling $35 million, according to iSpot. 

Overall, pharma ad spending among the top 10 rebounded to $173 million in January, after a three-month low in December of $159 million.

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“I Literally Learned from This Guy,” Says Martin Shkreli of Marathon CEO Jeff Aronin Who Set Price of Duchenne Drug at $89,000

“I Literally Learned from This Guy,” Says Martin Shkreli of Marathon CEO Jeff Aronin Who Set Price of Duchenne Drug at $89,000 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a controversial move, Marathon Pharmaceuticals is charging $89,000 a year for a decades-old drug that was approved by US regulators on Thursday, but has sold for a fraction of the price in other countries. Known as deflazacort, the steroid will be used to treat Duchenne muscular dystrophy, a rare disease that mostly affects young boys, causing muscles to deteriorate and leading to an early death.

 

The pricing, however, has upset some patient groups, who say that online pharmacies in the UK and Canada sell the medicine for about $1,000 annually, and the approval will preclude imports. They also note the drug received orphan designation, since it treats a rare disease for a small patient population, which means Marathon has seven years of exclusive marketing before rival medicines become available.

 

“It shows they have no appreciation for the cost to the health care system,” said Christine McSherry, who runs The Jett Foundation, a nonprofit group that advocates on behalf of children with DMD. “They’re taking a drug that costs less than $2 and jacking up the price. This affects entire landscape and this is sort of move that causes premiums to rise.” She pays $1,600 a year from a UK pharmacy.

 

This is not the first time that Marathon chief executive Jeff Aronin has generated controversy over his pricing strategies. In years past, the Federal Trade Commission and Senator Bernie Sanders (I-Vt.), a harsh critic of high drug prices, have attacked his moves, although more recently, a company that he once ran was praised by Martin Shkreli for its pricing maneuvers.

 

In 2008, the FTC filed a lawsuit against Ovation Pharmaceuticals, which Aronin ran at the time, accusing the company of price gouging and illegally maintaining a monopoly. Ovation bought the only two medicines that were approved to treat premature babies born with a potentially life-threatening congenital heart defect — and then increased prices nearly 1,300 percent.

 

The FTC eventually lost the lawsuit, but the episode did not go unnoticed by Shkreli. The infamous pharma bro, who gained notoriety after buying an older drug and raising the price by 5,000 percent — and then taunting critics on social media — recently praised Ovation on his web site. “These guys invented price increases,” he wrote. “I, literally, learned it from them.” And he noted Ovation was later sold for $900 million.

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Four Approaches to Lung Cancer Disease Awareness Marketing

Four Approaches to Lung Cancer Disease Awareness Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Lung cancer sure seems to receive short shrift within oncology. It claims more lives every year than breast, prostate, and colon cancer combined, yet somehow isn't perceived as life-threatening or “bad” as those other diseases.

 

As witnessed by the very existence of the following campaigns, that's in the process of changing. Each of the approaches is valid and more ambitious than a great majority of the campaigns that preceded them. Here's why they work — and why they matter.

 

#1: Merck: Focuses on the science in Test. Talk. Take Action. The awareness campaign is designed to call attention to treatment options for non-small cell lung cancer.

 

#2: Novartis: Novartis provides the easiest to comprehend immuno-oncology primer to date in Harnessing the Science of Immuno-oncology at Novartis. No, this explainer video isn't specific to lung cancer, but it approaches its mission by employing the widest of wide-tent tactics — cartoons and euphonic narration.

 

#3: Free to Breathe (many pharma corporate partners): Flip to Breathe comes across a bit too similar to the Ice Bucket Challenge, plus the how-to video isn't as clever as its creators might think.

 

#4: Astrazeneca: Tell some stories. The stories land with more impact when they're told by people with skin in the game. [Meanwhile, “Merck’s New Keytruda DTC Ad is a ‘TRU Story’ Told by a Fake Patient (Actor)”; http://sco.lt/6nURcH

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Much More Kybella TV DTC Advertising on the Way

Much More Kybella TV DTC Advertising on the Way | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Allergan plans to increase its investment in DTC for its chin-fat reducing injection, Kybella, to “an even higher level,” after the drug's sales [took it on the chin] at the end of 2016.

 

In the last three months of 2016 Allergan reported that Kybella saw sales of $12 million, compared to $14 million in the three-month period before that. The drugmaker acquired Kybella in its deal to buy Kythera Biopharmaceuticals in 2015. The drug was also approved in 2015.

 

Bill Meury, Allergan's chief commercial officer, on Wednesday told investors that the company plans to focus on training clinicians on how to use the product, identifying patients, and managing patients' expectations. “We're building a market,” he explained. “Our goal in 2017 is to drive utilization.”

 

Allergan's consumer-oriented promotional efforts for Kybella included a live event in March with Khloé Kardashian (read “Khloé Kardashian Shills for Kybella at Dermatologists' Offices & Soon on TV”; http://sco.lt/6TW6qX). The company also launched two DTC ad spots in August: one called Ancestors, in which a man laments the double chin he inherited from his otherwise distinguished ancestors (read “Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?”; http://sco.lt/5CPdfl), and Adra's Portrait in Action, which tells a near-identical story, but with a woman narrating.

 

Brent Saunders, the company's CEO, affirmed the company's confidence in direct-to-consumer advertising during the same investor call, “We spend the second most on DTC,” he said. For the data on that, see here: http://sco.lt/95gSRt

Pharma Guy's insight:

Further Reading:

  • “New Drug Kybella Zaps Double Chin: Facetious FAQ”; http://sco.lt/7MZwpN
  • “Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face”; http://sco.lt/8osXGD
  • “Allergen Seeks to Own Women's "Lower Face" with New Indication for Kybella. DTC to Follow.”; http://sco.lt/8Objqz
  • “A Social Media Unmet Medical Need: Fear of ‘Submental Fullness’ Invented by Kybella Marketers”; http://sco.lt/4jse3N
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Science Not Silence! MARCH FOR SCIENCE - April 22, 2017

Science Not Silence! MARCH FOR SCIENCE - April 22, 2017 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Since Mr. Trump’s election, many scientists have expressed concern about rumors and public statements on the new administration’s views on science, climate change and the role of federal offices like the Environmental Protection Agency [and the FDA!].

 

Mr. Trump has called climate change a hoax (although more recently said he would have an “open mind” about it) and appointed some officials to his transition team who dispute mainstream climate science. But there is much that is still unclear about his administration’s attitudes toward science.

 

The president has yet to appoint a science adviser and has not responded to open letters calling on him to do so from science policy groups including the American Association for the Advancement of Science (whose president, Rush D. Holt, is a physicist and former congressman).

 

Few scientists have gone as far as Dr. Eisen, but other researchers are now undergoing a political awakening, contemplating what their role should be for at least the next few years.

 

*************** MARCH FOR SCIENCE ***************

 

The March for Science is a celebration of our passion for science and a call to support and safeguard the scientific community. Recent policy changes have caused heightened worry among scientists, and the incredible and immediate outpouring of support has made clear that these concerns are also shared by hundreds of thousands of people around the world. The mischaracterization of science as a partisan issue, which has given policymakers permission to reject overwhelming evidence, is a critical and urgent matter. It is time for people who support scientific research and evidence-based policies to take a public stand and be counted.

 

ON APRIL 22, 2017, WE WALK OUT OF THE LAB AND INTO THE STREETS.

 

We are scientists and science enthusiasts. We come from all races, all religions, all gender identities, all sexual orientations, all abilities, all socioeconomic backgrounds, all political perspectives, and all nationalities. Our diversity is our greatest strength: a wealth of opinions, perspectives, and ideas is critical for the scientific process. What unites us is a love of science, and an insatiable curiosity. We all recognize that science is everywhere and affects everyone.

 

Science is often an arduous process, but it is also thrilling (read “PhRMA's Dark Inspirational Video Starts a 6-Month Offensive: ‘Less Hoodies, More White Coats’”). A universal human curiosity and dogged persistence is the greatest hope for the future. This movement cannot and will not end with a march. Our plans for policy change and community outreach will start with marches worldwide and a teach-in at the National Mall, but it is imperative that we continue to celebrate and defend science at all levels - from local schools to federal agencies - throughout the world.

 

Satellite Marches are solidarity events inspired by the March for Science, and organized independently by volunteers around the world. If you can't make it to Washington, D.C. then you can join or host a Satellite March near you. We encourage everyone to follow to local organizers to stay updated, and reach out if you want to help!

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Bayer/Janssen’s Xarelto COMPASS Trial Stopped Early - "Superior" to Aspirin But Without the Safety Profile

Bayer/Janssen’s Xarelto COMPASS Trial Stopped Early - "Superior" to Aspirin But Without the Safety Profile | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bayer/Janssen's bloodthinner Xarelto has shown clear efficacy in preventing major cardiovascular events (MACE) in patients with coronary or peripheral artery disease taking part in the COMPASS trial, prompting an early halt to the late-stage study.

 

The 27,000-plus patient trial was scheduled to finish next year but has been stopped early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE - including cardiovascular death, myocardial infarction and stroke - reached its pre-specified criteria for superiority versus aspirin.

 

Given the magnitude of the drug's effect, Janssen, Bayer and the Population Health Research Institute (PHRI), which collaborated on the study, said they will offer Xarelto (rivaroxaban) to study participants in an open-label extension trial.

 

"Despite established and effective treatments, incidences of CAD and PAD are rising globally," said Paul Burton, vice president, Medical Affairs, Janssen. "We are excited about the possibility of making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events, and look forward to discussing the COMPASS trial data with the US Food and Drug Administration as quickly as possible."

Pharma Guy's insight:

This article, which appears to be lifted directly from a press release, does not mention any of Xarelto's side effects. Johnson and Johnson and Bayer Corp. are being sued based on allegations that they deliberately concealed the blood thinner Xarelto potential fatal side effect of internal bleeding: http://sco.lt/6XbVHl  Meanwhile, AMA chastised lawyers for revealing Xarelto's side effects in TV Ads:  http://sco.lt/5RkA4X 

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Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations

Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen, the Natural Resources Defense Council (NRDC) and the Communications Workers of America sued the Trump administration today to block an executive order signed by President Donald Trump on Jan. 30 that directs federal agencies to repeal two federal regulations for every new rule they issue.

The plaintiffs are asking the court to issue a declaration that the order cannot be lawfully implemented and bar the agencies from implementing the order.

The order requires new rules to have a net cost of $0 this fiscal year, without taking into account the value of the benefits of public protections.

The suit, filed in the U.S. District Court for the District of Columbia, names as defendants the president, the acting director of the Office of Management and Budget (OMB) and the current or acting secretaries and directors of more than a dozen executive departments and agencies. The complaint alleges that the agencies cannot lawfully comply with the president’s order because doing so would violate the statutes under which the agencies operate and the Administrative Procedure Act.

"No one thinking sensibly about how to set rules for health, safety, the environment and the economy would ever adopt the Trump Executive Order approach – unless their only goal was to confer enormous benefits on big business,” Public Citizen President Robert Weissman said. “If implemented, the order would result in lasting damage to our government’s ability to save lives, protect our environment, police Wall Street, keep consumers safe and fight discrimination. By irrationally directing agencies to consider costs but not benefits of new rules, it would fundamentally change our government’s role from one of protecting the public to protecting corporate profits.”

Pharma Guy's insight:

Further Reading: “FDA Regulation Cutting Will Impact Drug Approvals Too”; http://sco.lt/6XmjR3

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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