24 - 26 April 2017 | San Francisco, CA

Thursday, February 23, 2017

To Boost Sales, Gilead's Hep C Awareness Ad Focuses on Baby Boomers

Direct-to-Consumer (DTC) drug ads are less and less effective according to several studies including the eyeforpharma Whitepaper “The Great DTC Shake-Up: Patient perspectives on direct-to-consumer advertising.”

One reason for this is a "negative reaction to the use of what could be perceived as 'scare tactics' or shock value to garner attention in a crowded media environment."

In that report, I was quoted as saying “scare tactics might be good for awareness.” Now, however, I'm beginning to rethink that, especially when disease awareness ads are scaring a large portion of the population to get tested for a medical condition they most likely do not have.  A case in point is a new Hepatitis C disease awareness ad by Gilead Sciences focused on "Baby Boomers."

Let's look at the numbers and do some math.

Friday, February 17, 2017

Bob Ehrlich of DTC Perspectives Should Do Better Research & Fact Checking Before He Calls Out Media for "Misreporting" on DTC Off-Label Promotion

I just received an email missive from Bob Ehrlich (@BobEhrlich_DTC), Chairman of DTC Perspectives, Inc., with the subject line "Media Misreporting Advertising Off-label Use."

Ehrlich said "I was shocked to see media stories saying DTC may expand to cover off label use. What! This erroneous idea came from an FDA open meeting held 11/16 to discuss off label use based on court cases allowing drug companies the right to discuss them."


I first reported that the FDA was interested in hearing comments about off-label drug promotion to "patient and consumer audiences" back in September, 2016, after reading this in the Federal Register Notice (read "FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion" and find the notice here):
 "To what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences [my emphasis]? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers' lack of medical training and expertise in critically evaluating this type of information?"
Obviously, Ehrlich did not bother to read the notice and only reads Consumer Reports, which published results of a survey it did on the topic and reported at the hearing. Regarding that, Ehrlich said:
"The lay press thinks that FDA might open the floodgates of off label use in DTC. A publication as reputable as Consumer Reports had a story 11/9/16 titled 'FDA Considers Allowing Drug Ads for Unapproved Treatments.' I am not sure why Consumer Reports made the leap from possibly loosening the regulations for discussions with doctors all the way to DTC. That story seemed to be picked up by many news organizations who said drug ads may increase because of off label uses."
Yo! Bob! Consumer Reports may have got the idea from my blog post made two months BEFORE it published its story or maybe it did what a good news organization should do and actually read the FDA notice, which was pusblished in September, 2016.

Ehrlich may also have confused this LA Times opinion piece with a news story that was published just last week: "Off-Label Direct-to-Consumer Drug Advertising 'Just Isn't Healthy'".

Ehrlich closed with this:
"I think the FDA will take years to study this issue and not do more than the courts push them to do. They are just figuring out how drug companies can use the Internet about 20 years late. They are worried consumers will get confused figuring out how to click on the fair balance. So, I do not think off label use is on their list of DTC to do projects, not for a decade or two."
He may be right about the timeline, especially after Trump signed an executive order that calls for government agencies to pull two regulations for every new regulation they implement. The FDA may just "sit on its hands" and issue no new regulations for a good long while and that will NOT be good for the drug industry (read "FDA Regulation Cutting Will Impact Drug Approvals Too").

Pharma CEOs Speak Out About Drug Prices

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

CEOs include:

Monday, February 13, 2017

Pharma is Spending More on DTC Advertising But Its Effectiveness is Decreasing, Says New Survey

“The DTC Attitudes, Behaviors, and Preferences Survey” conducted by Health Stories Project – Insights (HSPi) and published within the eyeforpharma Whitepaper “The Great DTC Shake-Up: Patient perspectives on direct-to-consumer advertising” in partnership with Health Perspectives Groups shows that as investment in DTC increases its effectiveness is decreasing. Only 22% of patients interviewed liked seeing advertisements for prescription drugs versus 52% in 1999.

What is more, says eyeforpharma, Pharma’s approach to DTC is "decoupling from patient needs causing patients to disengage from traditional tactics. Only 39% of patients interviewed thought that advertisements for prescription drugs helped them have better discussions with [their] doctor versus 62% in 1999."

"These worrying results," says the report, "show that pharma is not just failing to maximize the value from this increasingly expensive investment but that the current approach to DTC is actually undermining industry efforts to reposition itself as an industry focused on patient needs."

What are the reasons for this? Let's look at the data first.

Monday, February 06, 2017

Who Is the Most “Fantastic” Person Trump Has in Mind to Lead the FDA?

In a recent email, STAT: The Readout asked "Who's the next Mr. (or Ms.) Fantastic?":

"President Trump has a 'fantastic person' in mind to nominate as his new FDA commish. While we wait for his announcement, we're asking for your vote: Who is most likely to hear 'You’re Hired!?'"

5 candidates were put forward. It turns out that NONE is a woman.
  • Balaji Srinivasan, the long shot: This Silicon Valley darling may have expressed just a touch too much derision for the FDA on Twitter.

[From STATnews] Srinivasan, for his part, has claimed the FDA creates “catastrophes” to increase its funding and that drug development takes too long. “Drug development prior to FDA shows that modern regimen is not necessary for safe innovation,” he tweeted. He also suggested in a tweet that “Yelp for drugs would do a better job." Ref: “Trump ‘Putin-ative’ Candidate for FDA Leader Would Have Converted Agency to ‘Yelp for Drugs’.”

UPDATE: Srinivasan is no longer a candidate for FDA Commissioner, reports STATnews. "Washingtonians know that before one’s name is floated as a candidate to run a federal agency, it’s imperative to delete one’s nasty tweets about said agency.”

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