24 - 26 April 2017 | San Francisco, CA

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."

WRONG!

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:
  • PHARMA BRO’ MARTIN SHKRELI
  • ALLERGAN CEO BRENT SAUNDERS
  • PFIZER CEO IAN READ
  • MYLAN CEO HEATHER BRESCH
  • MARATHON CEO JEFF ARONIN
  • LILLY CEO DAVID RICKS
  • REGENERON CEO LEONARD SCHLEIFER
  • NOVARTIS CEO JOESEPH JIMENEZ
  • ACORDIA CEO RON COHEN

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.”

Thursday, January 26, 2017

DTC Drug Ads Are Effective, But Confusing to Patients Say Physicians

Results from a new "microsurvey" (N = 319) performed by InCrowd, a provider of real-time market intelligence to the life sciences and healthcare firms, reveal "perhaps surprising" U.S. healthcare provider (HCP) perceptions on the efficacy of direct-to-consumer (DTC) ads. Specifically, HCPs say DTC drug ads drove patients to asks three times as many questions today than they did 5 years ago, but 87% observed patient confusion with ads.

This sounds impressive, but looking at the data, HCPs say they receive only 6 questions about DTC drug ads per week from patients vs. 2 times per week 5 years ago. It just may be that HCPs are more aware of DTC ads today than they were 5 years ago and that is influencing their perception of the number of questions they receive from patients specifically about these ads.

The "confusion" results are more interesting.

A majority of HCPs surveyed (65%) said that patients do not generally understand the information provided by the pharmaceutical companies in advertisements, and nearly 87% of HCPs observed some level of confusion with the ads. 43% said that “some of my patients” can understand or interpret them, 41% said that “few” patients understand the ads, and 3% said that “none of my patients” can understand the ads.

The increased physician awareness of DTC ads and the patient confusion that they cause may explain why 35% of physicians surveyed said DTC ads should be banned when asked what they would do to change pharma's DTC campaigns. 31% said the ads should provide additional information, and 17% said they should "simplify" the message. Only a paltry 3% said they would include cost information (see chart).

That only 7% of HCPs said they would like to see side effects explained is surprising considering the results of another survey.

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