Pharmaguy's Insights Into Drug Industry News
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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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What Can #Pharma Marketers Learn from Elon Musk Who Does Exactly Opposite What We're All Told to Do?

Entrepreneur and author Michael Simmons has studied Musk and his career and sees an alternate theory of success in the serial founder's biography.

"I call people like Elon Musk 'expert-generalists,'" Simmons wrote recently on Medium. "Expert-generalists study widely in many different fields, understand deeper principles that connect those fields, and then apply the principles to their core specialty."

Part of the idea, as Simmons explains it, is that instead of becoming all-knowing in a narrow field, as most of us are encouraged to do, Musk has always been ravenous to learn about a variety of things, which allows him to transfer things he's learned about one area to other areas where they might be applicable.

This is clearly what fuels some of his most innovative endeavors -- he made the connection between solar power and Tesla's electric cars, and between his interest in artificial intelligence and ways it will make Teslas autonomous. This type of "learning transfer" goes even further -- perhaps one day connecting Teslas to the neural lace implanted in a driver's brain.

This isn't a phenomenon solely animated by Elon Musk. Calls for more interdisciplinary studies and collaboration among various fields have been heard for decades as well.

But with increasingly crowded markets of all types, we assume that generalists are a dime a dozen and specialization is the better strategy not only to be competitive, but perhaps also to even command a premium for whatever your expertise might be.

But as Musk's story demonstrates, the truth may be that the decades-long boom in specialization has now left glaring gaps between deep trenches of expertise. Daring to be more of a generalist or a multiple specialist is an opportunity to throw a ladder down those trenches, lifting the experts out of their deep silos so they can help us all build new towers reaching fantastic heights for all to see and enjoy.

Pharma Guy's insight:

I have a friend who was always fond of saying "I know only one thing - marketing!" But is that good or bad? I'm thinking that marketers need to also be generalists and lift themselves "out of their deep silos" and do more thinking outside the box.

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Only One #Pharma in Top 10 Spends a Bit More on R&D Than on Marketing

Only One #Pharma in Top 10 Spends a Bit More on R&D Than on Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Terry Nugent: The chart above argues that only one of the listed companies spends more on research and development (R&D) than on marketing. That would be Roche. Kudos to them. But I think the chart is somewhat misleading for two reasons. 

First, I presume marketing includes sales, which consumes the vast preponderance of pharm a promotional spend. Sales is not marketing in my world.

Second, I think we have to start viewing pharma M&A of innovative biotechs as outsourced R & D. It would be illustrative to  redo the figures accordingly.

The truly interesting question then becomes which has better ROI: make or buy?


I hypothesize the latter.

Pharma Guy's insight:

Also see "Top 15 Spenders in Biopharma R&D"; http://sco.lt/8JHE01 

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The History of #Pharma Marketing from Cancer Cure Potions to "Cancer Cure" Drugs

The History of #Pharma Marketing from Cancer Cure Potions to "Cancer Cure" Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Discover the history of pharmaceutical marketing -- from the days of snake oil sales tactics to today's heavy regulation.


From the viewpoint of the pharmaceutical companies, direct-to-consumer marketing is advantageous for consumers. They argue that it helps to educate patients about different drug options, it encourages patients to get in touch with -- and have a dialogue with -- health care providers, and it helps to reduce the under-diagnosis (and under-treatment) of medical conditions.


Detractors would counter, however, that direct-to-consumer marketing often leaves patients misinformed, that it over-emphasizes the benefits that drugs provide, and that it leads to the unnecessary prescribing and over-utilization of drugs. Furthermore, the opposition contends that this type of marketing can strain patient/doctor relationships. (Just imagine someone watching a 30-second commercial and then trying to convince a doctor -- with 30 years experience -- that taking X drug is the best course of action.)


So, which side is correct in their assessments of direct-to-consumer pharmaceutical marketing? That's not for me (or this article) to say. Instead, I'm going to focus on the history of pharmaceutical marketing, and explore how we went from simple print ads to the side effects-filled TV spots that we know (and mock) today.


But first, here's a quick breakdown of the different types of drug ads that pharmaceutical companies produce. Getting familiar with these ad types will help you better understand how (and why) the government would eventually start regulating pharmaceutical marketing.

Pharma Guy's insight:

The drug industry still claims to have cured cancer. Read, for example, "Bayer's CEO Accuses Patients of Being Ungrateful B*stards! We Cured Cancer, Dammit!"; http://bit.ly/BayerCuredCancer 

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Jay-Z’s creative wisdom for biotech brands

Jay-Z’s creative wisdom for biotech brands | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For any image or symbol or creative act to mean something, it has to touch something deeper, connect to something true.

― Jay-Z


In Jay-Z’s recent book, Decoded, the above quote struck a chord with me. As healthcare marketers, we always connect our products to scientific data, clinical studies, and P values. In addition, there are the numerous safety data, tolerability profiles, and dosing schedules to promote.


But when the physician has a patient experience that delivers on these claims, only then will that physician believe enough to be touched and, ultimately, to look to place that product on his or her mental short-list for future patients suffering from those particular symptoms. Let’s break down the images, symbols, and creative acts in our business and show how they drive the brand experience.


Image. In the past, the brand image often went a long way to cement the positioning in the physician’s mind. With DDMAC and the current marketing environment, interesting creative work is rare—and stellar creative work is even more unusual. This does not mean strong creative is impossible. There are people who can navigate the conservative medical-legal system and deliver a stand-out creative product. Don’t settle for an older couple walking their dog on a beach; your brand deserves more.

Pharma Guy's insight:


Agencies often strive to deliver deliver a "stand-out creative product" but fail to "connect to something true." For more on that, read this Pharma Marketing News article: Patient Storytelling Marketing: Creativity vs. Truth in Pharma Advertising

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Data gives credibility, storytelling provides truth in pharma

Data gives credibility, storytelling provides truth in pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Now more than ever, we need to focus on making brands memorable and storytelling is the way to do this.


Every story follows a powerful narrative revolving around:


  1. a central arc (which is a situation or an incident to revolve around your story)

  2. a protagonist (the hero of the story, which should always be the brand)

  3. a antagonist (the villain!)

  4. the resolution (how was the villain defeated in the incident by the brand)


The main characters in any content marketing strategy are your brand and your customers, this is the most important reason for using content marketing personas. These personas allow you to play the role of your customers, showing you are empathetic to their needs. Why is this important? Ultimately this will increase engagement with your brand, as the stories you tell will resonate with them for longer.

Pharma Guy's insight:


I fail to see how fictional patient stories provides "truth in pharma." Some patient stories win awards, but the top award sometimes goes to the made up story and NOT the true patient story (i.e., TRUTH). Read, for example, this post:

Fictional Patient Story Wins Gold, Whereas Authentic Patient Story Wins Bronze at Lions Health 2014

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Pharma Guy's comment, August 6, 2014 6:25 AM
Absolutely, says @Ash_Rishi, author of the original article. "The story should always use real patients, otherwise it will not be authentic!" I said: "With social media there should be plenty of real stories worth sharing by pharma mktrs."
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Do Marketing Buzzwords Affect Pharma's Reputation Among Patients & Physicians?

Do Marketing Buzzwords Affect Pharma's Reputation Among Patients & Physicians? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

These terms are part of the marketing lexicon, which is not shared with pharma marketers' "target" audiences. It's only in the closed, small world of industry conferences, ad agency press releases, and marketers' LinkedIn pages that these terms are seen and heard. Therefore, my guess is that marketing speak has little effect on pharma's reputation among ordinary, every day patients and physicians.

Nevertheless, when pharma marketers use these buzzwords, I take out my "gun" because I, like Spong, do not trust that they are "truly putting patients at the heart of [their] business approach," whatever that means within a capitalistic organization these days. I know what Mr. Merck said about profits follow when the company puts patients first, but these days Big Pharma puts Wall Street interests first.

Pharma Guy's insight:


The industry has "abstained" from using a couple of these buzzwords, at least within topics presented at industry conferences. "Multi-Channel Marketing" and "market access" are still frequently-used terms, but "sales force effectiveness" and "closed-loop marketing" are hardly to be heard nowadays at industry conferences.

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Digital Pharma Marketing: Is the Industry Paying Enough Attention to Mobile?

Digital Pharma Marketing: Is the Industry Paying Enough Attention to Mobile? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Those who access health content are also doing so using more than just PCs. In April 2013, 35 percent of visitors used mobile devices to consume health information. A year later, almost half of health information-seekers used mobile devices to consume health content. This uptick in mobile usage suggests two things: an increased reliance in managing one’s health issues on-the-go, and an increase in tablet usage at home instead of the PC.  For those using mobile devices out-of-home to manage health issues, uses included understanding symptoms, treating a condition, or achieving one’s health goals. Comscore’s research indicates more specifically that on-the-go mobile users seek health information at doctor’s offices and while waiting for prescription refills at the pharmacy.

Pharma Guy's insight:


All the more reason why FDA needs to provide Rx drug promotion guidelines specific for mobile devices.


Read:

FDA's Social Media Guidance Webinar: A Third Guidance Needed for Mobile Devices?
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Did FDA Avoid the "Social Media Guidance Cliff"?

Did FDA Avoid the "Social Media Guidance Cliff"? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Section 1121 of the Prescription Drug User Fee Act (PDUFA) states: "Not later than 2 years after the date of enactment [signed into law on 9-July-2012], FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA" (see here). 

I call this the "Social Media Guidance Cliff."

Pharma Guy's insight:


Well, today is exactly two years after PDUFA V was signed into law. While FDA has issued a few social media guidance documents, it still has one more to go: Use of Links


FDA's "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014," which was published in January 2014, promised that it would publish that guidance sometime in 2014 (see here).


Section 1121 was not specific as to how many social media guidances FDA should issue before toddy's deadline. So I guess FDA is off the hook as far as complying with section 1121 is concerned.

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Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised?

Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At the end of June, the FDA sent a Notice of Violation (NOV) letter to Naumann Chaudry, Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences, citing a sponsored link on Google for VIREAD (you can find the letter here).


Unless Dr. Chaudry (he has a PharmD degree) has been hiding under a "regulatory rock" since 2009, it's difficult to imagine that he would have approved such an ad. Because as WE all know, FDA views such ads, which include the drug brand name AND indication but no fair balance safety information, as violative of the FD&C Act.

Anyone, such as Dr. Chaudry, who is a regulatory authority -- he's worked in a regulatory capacity for several pharma companies since 2004 -- should be aware of FDA's "received precedent" on this type of ad (i.e, 14 warning letters issued in April 2009).

VIREAD is associated with serious risks and includes a black box warning. To advertise such a drug without providing any mention of such risk is unconscionable.

But there are even more serious problems with this ad, that, IMHO, should get Dr. Chaudry in hot water with Gilead's CEO and perhaps fired!

Pharma Guy's insight:


What do you think? Should Dr. Chaudry be fired?

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Forget ROI! - Pharma must measure return on engagement

Forget ROI! - Pharma must measure return on engagement | Pharmaguy's Insights Into Drug Industry News | Scoop.it

One of the biggest challenges currently facing pharma is the increasing difficulty of not only reaching, but also influencing HCPs through traditional and non-traditional sales and marketing efforts. As we've known for some while, sales forces are getting ever increasingly smaller. In fact a recent study showed that just 27 per cent of sales visits result in the rep actually getting to see a HCP – on the flip side the survey showed only 23 per cent of the HCPs would rate the sales force performance as excellent.


At a time of increased competition, these findings are worrying. Costs are skyrocketing, engagement is decreasing, and the demand for RoI is higher than ever. With responsibility of every penny spent needing to be attributed, the vicious circle of unease continues to swell.


The bottom line is that the way RoI is measured is flawed. HCPs are not loyal to one brand; they could defect to another brand tomorrow. So measuring the investment in a 'campaign' is not the biggest measure anymore. We now need to treat HCPs as consumers. And in consumer marketing capturing brand loyalty has been practiced for decades.


I believe that it is time to drop our over reliance on just chasing those unattainable and arguably, misleading, RoI metrics. It is now the time to look at incorporating relationship and engagement metrics that build loyalty towards a brand.


Pharma Guy's insight:


"Treat HCPs as consumers," "build loyalty" ... if only pharma could offer physicians a "frequent prescriber rewards" program! But wait, the industry used to do just that -- and may still be doing so -- by offering high prescribers "consultant" gigs. In the old days, pharma gave away free trips to medical conferences and free dinners at nice restaurants. Now, with the Sunshine law in effect, it's not so easy to reward physicians that way any more.


The author, Ash Rishi, suggests that pharma adopt consumer practices to "use the power of emotion, to engage, to attract and then to retain customers"; e.g., HCPs. It seems to me that pharma mastered that practice years ago when it started hiring attractive, young sales reps. See, for example, this.


Regarding "each marketing tactic needs to put the patient at the heart of their branding strategies," emotions and loyalty programs are also used by pharma marketers. Just consider the emotional appeal of DTC ads and drug coupon loyalty programs (e.g., read Lipitor For You! Actually, For Card Carrying Members Only!).


Thanks to Rishi I now have another term to include in the Pharma Marketing Glossary: MOT. Rishi doesn't explain what this is, but here is what I learned: It stands for "Moment of Truth," which is a concept coined by Proctor & Gamble.


There are many variations of this term:

  • First Moment of Truth (FMOT) - the actual term first coined by P&G: "This is considered to be the decision point to buy a specific brand or product." (here)
  • Second Moment of Truth - also coined by P&G
  • Third Moment of Truth
  • Zero Moment of Truth (ZMOT) - coined by Google
  • BSMOT - coined by PharmaGuy: Can you guess the meaning?


The term "First Moment of Truth" (commonly called FMOT) was coined by Procter & Gamble in 2005 to define the first interaction between a shopper and a product on a store's shelf. This moment was considered one of the most important marketing opportunities for a brand, as P&G asserted -- and others believed -- that shoppers make up their mind about a product in the first few seconds after they encounter that product for the first time.


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Social media fails, says Rich Meyer, interpreting Gallup data

Social media fails, says Rich Meyer, interpreting Gallup data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Most consumers aren’t visiting social media sites to engage with brands — they are there to interact with people they know. According to Gallup research, the vast majority of consumers (94%) who use Facebook, Twitter, and other social networking channels do so to connect with family and friends. They are far less interested in learning about companies and/or their products, which implies that many companies have social media strategies in place that may be largely misdirected.


What does this mean for pharma marketers? 
  1. Social media alone is not going to deliver on the promise of patients asking for an Rx.  It is PART of an integrated marketing initiative to reach health searching consumers online.
  2. Pharma, which is heavily ROI driven, needs to think of social media, not as a conversion platform, but rather a way to help patients get the information they need to make health care decisions.
  3. DTC marketers should experiment with social media but have clear and concise objectives before allocating resources.
Pharma Guy's insight:

50 Ways (for pharma) to Use Social Media - does not include directly influencing consumers to "buy" your drug

Sung to the tune “50 Ways to Leave Your Lover” by Paul Simon

"The problem is all inside your head", FDA said to me
The answer is easy if you take it logically
I'd like to help you in your struggle to be AER free
There must be fifty ways to use social media

FDA said it's really not my habit to intrude
Furthermore, I hope my meaning won't be lost or misconstrued
But I'll repeat myself, at the risk of being crude
There must be fifty ways to use social media
Fifty ways to use social media

You just Tweet the right way, GSK
Make a new Blog, Janssen-Cilag
You don't need to be coy, Daiichi Sankyo
Just get yourself free
Hop on the bus, Novartis
You don't need to discuss much
Just drop the key(word), Lilly
And get yourself free

Ooo slip out the back door, Bayer
Make a new plan, Allergan
You don't need to be wiser, Pfizer
Just listen to me
Hop on the grid, Orchid
You don't need to discuss much
Just drop the search ad, Gilead
And get yourself free

FDA said it grieves me so to see you in such pain
I wish there was something I could do to make you smile again
I said I appreciate that and would you please explain
About the fifty ways

FDA said why don't we both just sleep on it tonight
And I believe in the morning you'll begin to see the light
And then FDA sent me a warning letter 
Boy, that didn’t make me feel any better!
Still, there must be fifty ways to use social media
Fifty ways to use social media
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FDA's Social Media Guidances Provide Little That's New, Says Coalition for Healthcare Communication

Indeed, at the Drug Information Association Annual Meeting held last week in San Diego, Abrams noted that he expected minimal use of space-limited media because of the agency’s requirements on risk information. Cooke wrote that OPDP’s call for risk information that includes the most serious risks associated with the product, as well as all boxed warnings, makes it “difficult to imagine a product that has fatal or life-threatening risk, contraindications or boxed warnings that could be contained within the space-limited context of a Tweet, which has a 140-character limitation.” For example, he cited one product’s boxed warning, which alone contains 692 characters.


This approach “would limit the availability of space-limited communications to the small subset of prescription products whose risk and benefit information” meet the agency’s requirements, Cooke said, adding that the framework set forth by the draft guidance “seems more amenable to the participation of products with limited risks and short benefit statements.” He told the Coalition that the agency “could have suggested some approved abbreviations to help companies meet the requirements in a limited space – such as using ‘risks incl death’ instead of ‘risks include’ and listing all possible inclusions –but it chose not to.”


In an e-mail to Bloomberg BNA June 17, James N. Czaban, chairman of the FDA Practice Group at Wiley Rein LLP, said that the risk/benefit guidance “is actually very limited in scope” because it does not address many other types of online activity. He also told BNA that “The idea that FDA would allow a black box warning to be condensed for use in the format of Google Sitelinks or even Twitter is quite surprising given existing promotional limitations on black box products, and the length and seriousness of such warnings for many drugs,” Czaban told BNA. “Will any company risk such an approach from a liability perspective, even if it could meet the space limitations?”


Czaban said that “the bottom line is that FDA’s guidance leaves many questions unanswered, and its examples are of limited utility.”

Pharma Guy's insight:


Here's how I believe pharma can create a compliant tweet INCLUDES a 692-character boxed warning: A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance

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It’s Time to Turn Off TV Doctors

It’s Time to Turn Off TV Doctors | Pharmaguy's Insights Into Drug Industry News | Scoop.it
From shady business deals to the lust for fame, television doctors are among the last people we should trust when it comes to health advice.


Though many of television doctors’ pedigrees are, in fact, impressive, it doesn’t exclude them from succumbing to the power trip that is the cult of celebrity.


The most recent example is Dr. Mehmet Oz, whose shilling of various ineffective weight loss supplements ultimately landed him in a congressional hearing that has cost him a fast-vanishing reputation. For Congress to call upon Dr. Oz is to essentially ask that a publicist be present and willing to issue a statement for green coffee.


Lucky for us, Oz somehow has a conscience and basic understanding of how the law works, forcing him to come clean. He further shamed the empire he’s built with statements made on the record against the exact things he’d been uttering on television. It’s a testament to the fever dream haze of celebrity that Dr. Oz’s defense lies squarely in the ability to prop up his audience, even through pseudoscience. To say that Oz is using a white lie to better the public would be letting him off too easy, however.

Pharma Guy's insight:


Remember, Dr. Jarvik, the erstwhile "real" physician that Pfizer hired to recommend Lipitor in its TV ads back in 2007? Since he was outed as an unlicensed physician (read the story here), the drug industry has been reluctant to use real physicians in TV drug ads (the exception is that Restasis doctor, the sight of whom drives me to flip the channel). 


There are, however, fake doctors portrayed by unknown actors in drug commercials and there used to be famous TV doctors -- e.g., Dr. Geiger played by Mandy Patinkin -- starring in TV drug ads. Haven't seen any of those lately.


You might like to read this: 

While Real Doctors Prescribe Placebos, Fake Docs on TV Prescribe Drugs Off-Label
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Could This Work for Pharma? Inspiration from Outside Industries

Could This Work for Pharma? Inspiration from Outside Industries | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Could this work for pharma? It is a question that any marketer in our industry should ask when they see a successful campaign from another industry. Of course, not everything will. Other industries aren’t restricted by the same regulations as pharma. But that doesn’t mean pharma can’t learn marketing lessons from other industries. Sometimes it might mean pushing boundaries, other times it might be something simple but still effective.

 

Marty Canniff, SVP Executive Creative Director, Intouch Solutions, came up with this road-safety campaign by Australia’s Transport Accident Commission - Graham, a vision of a human being who has evolved to survive car crashes.

Pharma Guy's insight:

Related article: “Could This Work for Pharma? Inspiration from Outside Industries”; http://sco.lt/60U2Vt

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Marketers Are From Mars, Consumers Are From Christie's Home State

Marketers Are From Mars, Consumers Are From Christie's Home State | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bob Hoffman is the former owner and CEO of ad firm Hoffman/Lewis. After 22 years of experience with his own ad firm, Hoffman is convinced that "the marketing and advertising industries are currently in state of great confusion."

 

Hoffman has become known as the "Ad Contrarian." He sold his firm in 2013 and since then the caustic, but funny ex-ad man has made a name for himself in critiquing the ad business.

 

Speaking at the Shift 2016 conference in London on Tuesday, he said that there are three major misconceptions clouding the industry: "All of these delusions have one thing in common: they take a little bit of truth and then they distort it and they exaggerate it and they torture it to the point at which it does our marketers more harm than good."

 

"Marketers are pouring more and more money into online advertising. They don't know what they're buying, they don't know who they're buying it from. They don't know what they're getting, they don't know how much they're paying. If there's a better definition of being on Mars, I'd like to hear what it is," he said.

 

Hoffman ended his presentation with the message: "The marketing industry has been spending too much time on another planet. We need to get back down to earth."

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Effective Marketing Can Cure Pharma's Election Issue Woes

Effective Marketing Can Cure Pharma's Election Issue Woes | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If the pharmaceutical industry doesn't "Get out the Vote" for innovation this election cycle, the consequences will be stormy waters, not business as usual, with a concerted attack on industry that threatens to spook the markets, lower valuations, and distract senior management.


Pharma Guy's insight:

The author of this piece is just trying to drum up business and
suggests some political campaign strategies to be more effective marketers in this political climate. 


One piece of advice: Be Authentic. "This year’s buzz word to explain the popularity of unlikely presidential candidates is 'authenticity',” says the author. "There’s a lot to be said about what being authentic means, but for advertisers, maybe it’s time to take a look at some effective healthcare marketing campaigns that definitely qualify."


Unfortunately, none of the campaigns mentioned as being "authentic" come from the pharma industry. One is from Big Government and the other is from Big Medical Conglomerate.

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Effect of PDUFA fees on FDA's drug approval process & regulation of approved drugs.

Effect of PDUFA fees on FDA's drug approval process & regulation of approved drugs. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A new study by researchers from Cambridge Health Alliance/Harvard Medical School, Boston Medical Center (BMC)/Boston University School of Medicine (BUSM), City University of New York School of Public Health, and Public Citizen, reveals that drugs released after the 1992 enactment of the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug approvals, were more likely to be withdrawn or have a black box warning.


In recent years, the number of warning letters issued by the FDA regarding Rx drugs has dramatically decreased. Some experts claim that this is due to fewer drugs being approved and marketed. However, is it possible that the rise in PDUFA payments -- which now account for about 65% of FDA's budget for regulation of drugs -- discourages the FDA from monitoring drug promotion and issuing warning letters?

Pharma Guy's insight:

 

It could be argued that even as PDUFA fees increased dramatically after 2001/2002, the number of warning letters issued remained pretty flat, which indicates PDUFA had no effect.

 

In 2001 FDA's Chief Counsel at the time was Bush-appointed Daniel E. Troy, who instituted a legal review of regulatory letters before they were issued and this policy change effectively hobbled the issuance of these letters by the FDA. Hence, fewer warning letters beginning in 2001/2.

The Government Accounting Office (GAO) submitted testimony that documented, among other things, how long it took the FDA to issue regulatory letters citing violative DTC materials during Troy's reign. 

 

For more on this, read: 

FDA DTC Review: The House that Troy Built

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Joel Finkle's curator insight, August 6, 2014 10:09 AM

Do PDUFA fees lead to approvals of unsafe drugs? The chart would appear to refute that.

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Even Though There Are Fewer Sales Reps, More Physicians Deny Rep Access

Even Though There Are Fewer Sales Reps, More Physicians Deny Rep Access | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to the spring 2014 AccessMonitor™ report from global sales and marketing consulting firm ZS Associates, pharmaceutical access to physicians continues to decline. Only 51% of physicians/prescribers now allow access to sales reps, down from 55% in 2013.


The decline in access continues despite the downsizing of the pharma sales force by one-third since 2008. But, the downsizing has actually helped pharma deliver better sales calls.

How? Read the original post to find out.

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Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By

Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.


Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.


Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. 


Health Canada is working with manufacturers to update the Canadian product labels regarding this risk. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

Pharma Guy's insight:


At the exact same time that Health Canada issued its warning, FDA denied a petition by Public Citizen’s Health Research Group calling for a black-box warning about these same risks. FDA said it needs “further exploration of a possible safety signal” before issuing any warning about the risks of heart attacks and strokes. 

 

Sidney M Wolfe, MD, Founder and Senior Advisor, Public Citizen’s Health Research Group, issued a statement claiming that FDA's inaction vs. Canada Health's action on this health risk is an indication that the agency needs "new, more public health-oriented leadership" (read the statement here).


BTW, Public Citizen has a pretty good track record of identifying drug risks years in advance of those drugs being withdrawn for the market due to the risks it identified. Read more about that & listen to Wolfe's comments in this post:

Sydney Wolfe's 7-Year Drug Rule/Itch


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Big Pharma Pushes for Off-Label Promotion

Big Pharma Pushes for Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels?


For decades, the answer overwhelmingly has been no. The Justice Department has aggressively pursued companies that run afoul of rules against such “off-label” marketing — racking up billions of dollars in settlements. And the Food and Drug Administration has held firm to the idea that sales pitches generally should not include information on uses not approved by the agency.


But in the long-running conflict between federal regulators and drugmakers over how companies promote their drugs for unapproved uses, the landscape could be shifting, if only in subtle ways, and the outcome could affect doctors and patients alike.


Prompted in part by recent federal court decisions, the FDA is reviewing its rules on what kind of data drug companies should be allowed to distribute to doctors regarding off-label uses, as well as how they should respond to unsolicited questions from physicians about those uses. Its goal is to issue new guidelines by the end of the year.


Critics of the current rules say allowing pharmaceutical companies, which know the most about their drugs, to share more information about off-label uses would lead to better-informed physicians and ultimately benefit patients. Others are skeptical, saying the industry could exploit even a minor loosening of the restrictions to hype drugs for unapproved uses, exposing patients to ineffective and potentially harmful treatments.

Pharma Guy's insight:


Some industry officials say the FDA has been slow to adjust to the reality of those court rulings.


“They were in denial,” said John Kamp, executive director of the Coalition for Healthcare Communication, which represents drug marketing agencies and medical publishers. “If doctors can talk to each other and major researchers can talk about off-label uses, the drug’s manufacturer should be able to talk about those uses, too.. . . If something is true and can be said by one party, it can be said by all other parties.”


 Aaron Kesselheim, a Harvard Medical School professor who has studied off-label promotion, asks: Who gets to decide what qualifies as “truthful” information when it comes to sharing data about unapproved drug uses?


What do you think? SURVEY: Distribution of Off-Label Reprints by Pharma: Are FDA's New Revised "Rules" Too Limiting?


Pharma Marketing Blog post: 

WLF to FDA Regarding Distribution of Off-Label Reprints: See You in Court!
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Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems

Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Is the FDA guilty of gender bias? A coalition of consumer advocacy groups and drug makers recently launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claims that there are more than two dozen drugs available to help men combat sexual problems, but none for women.


A key backer is Sprout Pharmaceuticals, a privately held drug maker that has been haggling with the FDA over approval of its flibanserin treatment. The drug was once owned by Boehringer Ingelheim, but later sold to Sprout after an FDA rejection. Last fall, the agency rejected the pill again and Sprout responded in December by taking the rare step of filing an appeal, even though such efforts often go nowhere.

Pharma Guy's insight:


Boehringer gave up on flibanserin -- so-called "Female Viagra" -- after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.

Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. By the way, a "satisfying sex act" can include ... wait for it ... masturbation!


Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo."

I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation.


Read more about that here: Lack Sexual Desire? Try, Try Again!

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Are Doctors Wary or Weary of Getting Drug Info from Pharma?

Are Doctors Wary or Weary of Getting Drug Info from Pharma? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
According to a new study from M3, you have an average of about 20 hours a week to capture a doctor’s attention while they’re online.  However, recently, the question hasn't been whether or not doctors areonline, but how do we reach them while they’re online.  Results of the M3 survey show that above all else, credibility may be the biggest factor in getting physicians attention. 

The study, which surveyed just over 1,000 general practitioners, shows that while doctors are spending time online and looking for a variety of information, many are weary [sic; I think the proper word is "wary," although HCPs may be growing tired of of the information being shoveled to them by pharma] of obtaining that information through pharma companies.  While two-thirds of respondents expressed at least some interest in relevant pharma products, a whopping 85% indicated that they prefer independent sources for their information.  In addition, 56% specified that a rep meeting would not be preferable to acquiring information online. 

More “anti-vendor” sentiment can be found in terms of where doctors are spending their time online.  Almost half (45%) said they never visit a device company website when sourcing information while 33% indicated the same for pharma company websites.  Consequently, 59% visit the website of a government body at least bi-weekly in obtaining this information. 

But what can pharma companies do to present themselves as more trustworthy?  Even hard data can often be manipulated and many have a hard time trusting statistics.  Certainly “unbiased” sources of information such as third party reports could be used to a degree.  Respondents also showed some openness to case reports with 39% citing them as useful. 
Pharma Guy's insight:


Quoting Any Yeoman on the LinkedIn discussion of this survey:


"Not sure their unwillingness to visit pharma sites is that closely linked to their level of trust in the industry but more a desire to find impartial information and reviews about the products they buy and use. It's exactly what I do when I am planning a significant purchase.


"The doctors polled in the M3 survey are users of Doctors.net.uk so they have a familiar and trusted platform to engage with pharma-sponsored and 3rd party content. Not all doctors have access to, or use, this facility so the results are not entirely representative. 

"However, the M3 report indicates that many doctors prefer concise information via independent platforms and if these platforms continue to provide the information why are doctors going to change their habits? What can Pharma offer that will catalyse a change in this behaviour? Why bother trying?"

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Understanding the psychological blocks in medicine-taking: how pharma can help

Understanding the psychological blocks in medicine-taking: how pharma can help | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Medicines adherence remains a massive problem for healthcare systems, the pharmaceutical industry and patients, leading to increased disease burden and personal risks. In this new white paper, Hannah Gagen looks beyond traditional approaches into the psychology behind adherence to understand the real challenges and solutions.

The major focus for the pharmaceutical industry is market access – making sure that novel medicines make it through the clinical and cost barriers to reach patients. But even once this has been surmounted a potentially bigger hurdle exists – adherence. Failing to take medicines as prescribed is expensive for healthcare systems and pharma, plus potentially damaging, or even life-threatening, for patients.

Despite numerous attempts to tackle non-adherence, it remains a significant challenge. But perhaps we are not looking at solutions the right way? Here, Hannah Gagen, from Boehringer Ingelheim, challenges traditional solutions and takes a more in-depth look at the psychological factors behind this problem and how they can inform new approaches that underpin a more collaborative resolution between doctors, patients and the pharmaceutical industry

Read this white paper from Boehringer Ingelheim to understand:

• Key definitions and metrics around medicines non-adherence

• Factors underlying intentional and non-intentional non-adherence

• Expert views on the psychology of adherence

• How pharma needs a new collaborative approach to tackling adherence

Pharma Guy's insight:


As Kevin Dolgin, president of French healthcare company Observia explains, there is still a long way for us to go. He points out that while patient adherence budgets have quadrupled over the past five years (to roughly $1 million on average per product per annum, according to US data), spending on traditional promotional channels are still 30 times higher, as shown in the figure above.


Check this out: 

The Adherence Problem: Are Patients Just Forgetful, or Are They Rebellious?
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What's pharma's impact on the mobile health app space? These 3 graphs offer some clues

What's pharma's impact on the mobile health app space? These 3 graphs offer some clues | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A report highlighting the mobile health app landscape charts pharma companies that have produced the most apps, such as Bayer, Merck and Novartis.


Bayer, Merck and Novartis top the list. Many of them are designed as companion apps for drugs and devices. An app that is available in several languages could also account for some of the relatively high numbers. Some areas of app development Bayer has covered include helping multiple sclerosis patients manage their meds. recording hemophilia A factor VIII infusions and monitoring diet, particularly for people with diabetes. Among the apps Novartis produced include tools for managing cystic fibrosis. Novartis’ oncology division produced a few apps too, such as My Acro Manager to help patients with Acromegaly track test results, medication updates and improve their knowledge of their condition. Medication adherence apps and a tool to track symptoms from HIV treatment are among Merck’s apps

Pharma Guy's insight:


Obviously, this is NOT a numbers game! It's all about utility, quality, and usability, which many pharma mobile apps lack. Read "The Sorry State of Pharma Mobile Apps"


At a recent eyeforpharma Philadelphia 2014 Summit, Carolyn Gauntlett, Senior Innovation Consultant with IMS Health, gave an interesting presentation titled "How to Make Sure You're Getting the Most Out of Your mHealth App Development."

This article summarizes some major points made in that presentation as well as data from the report "Patient Apps for Improved Healthcare: From Novelty to Mainstream" published by IMS Institute for Healthcare Informatics. 

Topics include (partial list):

  • Some Docs Prescribe More Apps Than Pills
  • So, Why Hasn't Mobile Health "Exploded?"
  • More Apps, Less Meds?
  • Few mHealth Apps Are Worthy
  • Figure: Health App Functionality Score Distribution
  • The Pharma App Black Hole
  • Poor ROI
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DTC Makes My Job Harder, Says Doc

DTC Makes My Job Harder, Says Doc | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Direct-to-consumer advertising is the biggest barrier to practicing medicine today, cardiologist Harmony Reynolds, MD, said in response to one of 10 questions MedPage Today is asking thought


1. What's the biggest barrier to practicing medicine today?

Direct-to-consumer advertising. These ads often frighten people about medication side effects without providing the right information about why a medication may be needed and why taking a small risk of side effects may be worthwhile. I don't think companies realize all of the effects these ads have. They make my job harder.

Pharma Guy's insight:


OK. One physician does not a consensus make. Her specialty is coronary artery disease and she seems to like prescribing high doses of statins. Ads for statins actually mention why they are needed and they don't overplay the risks, which are minimal.  So I am not sure why these DTC ads would be a barrier to Dr. Reynolds' practice of medicine.


In any case, drugs ads tend to understate the risks. About 40% of violations in drug ads cited by the FDA between 2004 and 2013 relate to "risk minimization." That's twice the percentage of violations relating to "overstated efficacy" (see chart here: Do TV DTC Ads Overstate Rx Drug Risks?).

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