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Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016
I will be Speaking at FDA's Part 15 hearing on "Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products" on 9 November, 2016 (read "FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion
The purpose of this meeting is to obtain "input on issues" related to off-label product communications about by pharmaceutical and medical device companies (see here
). I will presenting the preliminary results of my Direct-to-Consumer Off-Label Promotion Survey
in my allotted time of 8 minutes.
Here's the list of speakers: Wednesday, 9 NovemberWelcome and Administrative Announcements
Leslie Kux, Associate Commissioner for PolicyOpening Remarks
Dr. Robert Califf, Commissioner
Read more »
- Mr. Jeffrey Francer, Pharmaceutical Research and Manufacturers of America (PhRMA)
- Ms. E. Cartier Esham, Biotechnology Innovation Organization (BIO)
- Ms. Khatereh Calleja, Advanced Medical Technology Association (AdvaMed)
- Ms. Kellie Combs, Ropes & Gray LLP
- Ms. Coleen Klasmeier, Sidley Austin LLP
- Mr. James Czaban, DLA Piper LLP (US)
- Mr. Daniel Biank, DuVal & Associates, P.A.
- Ms. Sandra Kalter, Medtronic PLC
- Ms. Esther Carbon, RTI Surgical, Inc.
- Ms. Danelle Miller, Roche Diagnostics
- Dr. Sandra Milligan, Merck
- Mrs. Penny Levin, Teva Pharmaceuticals
- Dr. Edith Perez, Genentech Mr. Frank Wilton, American Association of Tissue Banks (AATB)
- Mr. Nicodemo Fiorentino, G&M Health, LLC
- Ms. Zoe Dunn, Hale Advisors
- Ms. Tracy Rockney, OneSource Regulatory
- Dr. Samuel Nussbaum, Anthem, Inc.
- Mr. Michael Hoak, Humana
- Ms. Jennifer Graff, National Pharmaceutical Council
- Ms. Susan Cantrell, Academy of Managed Care Pharmacy
- Dr. Vikas Saini, The Lown Institute
- Mrs. Suzanne Robotti, MedShadow
- Mr. John Mack, Pharma Marketing News
The Day Pharma Tchotchkes Died
Back in February, 2009, shortly after the Pharmaceutical Research and Manufacturers of America (PhRMA) imposed a voluntary ban on gifts to physicians (aka "tchotchkes"), I predicted that tchotchkes would become nostalgia items in the future, reminding pharmaceutical sales reps and physicians of the "good old days" (read "Viagra Boxers: An Example of Proto-Nostalgia tchotchke
I was reminded of this prediction by a recent article (here
) in MM&M, which claimed:
"These relics of the past have a certain value for those on the hunt. One eBay seller hopes to fetch $20 for a blue pill-shaped Viagra promotional clock that doubles as a business card holder, an item that was once a big weapon in the Pfizer sales rep's arsenal of freebies."
I think the Viagra jock strap/boxers would command much much more money on eBay!
In any case, the subtitle of the MM&M article ("The Day the Tchotchkes Died") inspired me to rewrite the lyrics of "American Pie" as "American Pharma Pie." I imagine a physician singing my version of the song. "Read More" to see the lyrics, which also touches upon the ramifications of the Payments to Physicians Sunshine Act
.Read more »
Pharma Has Funded Hilary to Tune of Nearly $1 Million This Cycle, But Supports Republicans Overall
According to the latest data from the Federal Election Commission released on Monday, September 12, 2016 (here
), Hilary Clinton has received more than $990,000 in funds from the healthcare/pharma industry although the industry has donated nearly 50% more money to Republican presidential candidates than to Democratic candidates.
Apparently, Trump doesn't need no stinkin' money from pharma, which only gave him about $95K. Does that mean that Trump will come out swinging harder at pharma during tonight's presidential debate than will Clinton?Read more »
Do Drug Ads Need to Scare Consumers to Motivate Them?
I was quoted in an AdAge story (see embedded summary at the end of this post) about the recent spate of scary drug ads seen on TV and in print. The title of the article - "Halloween Already? Big Pharma Marketers Try Terror Tactics to Scare Up Sales" - was bit over the top but, hey, that's how you sell content.
The article quoted me as saying "a trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine." I have posted about that here on Pharma Marketing Blog ( read "Branded as Well As Unbranded Vaccine Ads Are the Scariest!
My comments hit a nerve with Bob Ehrlich, Chairman of DTC Perspectives
, who wrote in an email to his subscribers: "Drug ads are meant to motivate action. Showing what can happen when not vaccinated is not fear mongering. I have been reviewing DTC ads for over 20 years and there is no new trend to using scare tactics." [Ehrlich doesn't mention me by name. Sigh!]
I can only say that I stand by my opinion based on my paltry 16 years of reviewing DTC advertising via Pharma Marketing News
and ~12 years here on this blog.
Mr. Ehrlich had some other things to say in defense of scary drug ads. Read more »
FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion
In what's been described as a "surprise move" (here
) the FDA recently published a notice that it will hold a 2-day public hearing this November to obtain "input on issues" related to off-label product communications about by pharmaceutical and medical device companies. FDA defines off label use of drugs as, "Use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling."
FDA's authority to prevent or even regulate off-label promotion by pharmaceutical companies is dwindling. After losing to Amarin in court ("FDA Deal with Amarin: Does It Mean More or Less Off-Label Promotion?
"), FDA suffered another setback when it settled a case with Pacira Pharmaceuticals (here
In both cases, the plaintiffs argued that off-label marketing was protected free speech
as long as the information was truthful and not misleading. While the FDA still insists it has the ultimate authority to decide what is and is not truthful, other entities - most notably the Washington Legal Foundation (WLF) - have claimed a stake in the debate.
FDA issued some "draft guidance" in February, 2014, but this did not mollify WLF, which claimed that the guidance document is in "direct violation of a 1998 permanent injunction (WLF v. Friedman) it obtained against the agency to prevent it from trampling on industry's purported First Amendment rights." WLF said it "intends to enforce its injunction and will seek contempt of court citations against FDA officials who violate its terms" (read "WLF to FDA Regarding Distribution of Off-Label Reprints: See You in Court!
The FDA cannot win the "First Amendment" battle and has hinted in the public hearing notice that it may have to allow pharma companies to engage in off-label communications directly to "patients and consumer audiences" and not just to physicians.
If you stay awake reading the Federal Register Notice (here
) and get to the questions for which the FDA is seeking input, you'll find this unusual set of questions:Read more »
Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements?
I read with interest today's email missive from Bob Ehrlich, Chairman of DTC Perspectives. He was talking about the "Dry Eye DTC Battle" between Allergan's Restasis and the new kid on the bloc: Shire's Xiidra (two i's - get it? aka two "eyes").
Ehrlich pointed out that Shire enlisting Jennifer Aniston is a "big get. Getting a movie star to promote the dry eye condition must have cost Shire a lot in talent fees," said Ehrlich.
"Obviously they think she is worth it. Her ad just went on air under the 'myeyelove' title" (read "Jennifer Aniston is Shilling for Shire!
Ehrlich noted that Aniston is getting "lots of commercial endorsements these days. She is touting skin care brand Aveeno and plugging the comforts of Emirate Airways. I am sure Shire considered whether we at a Jennifer saturation point. My feeling is we can take a couple more campaigns before she gets overused."
My view is that celebs are being overused by pharma marketers these days. Why?Read more »
Branded as Well As Unbranded Vaccine Ads Are the Scariest!
reporter Rebecca Robbins (@rebeccadrobbins) interviewed me about what's behind ominous unbranded "disease awareness" ads, I opined that if you’re a drug maker, “you don’t want to attach a dark image to the brand — so you’re attaching this dark imagery to a medical condition instead,” which leaves room for a branded ad that shows “the bright side: that there’s this product that can save the day” (Read "#Pharma 'Disease Awareness' Ads: Are They 'Stealthy' Fear Mongering Set Pieces?
That "conventional wisdom" or "rule" -- if it is one -- obviously does NOT apply to many ads for vaccines, especially lately. Take, for example, the TV ad for Trumenba - Pfizer's Meningitis B vaccine. I saw this ad for the first time last night:
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As described by iSpot.tv (here
) the Trumenba ad "follows the series of events that lead up to this young man being in a hospital with Meningitis B. The source of the infection is traced back to a party where the teenager shared food, drinks and a kiss with friends. Trumenba offers a vaccine to prevent future spread of the disease." Bummer! You can't even enjoy an innocent kiss without fearing for your life! This is obviously a "dark" and scary ad aimed at the parents of teenagers for whom this vaccine is indicated (up to age 25).
Why are scare tactics the marketing strategy du jour
in branded and unbranded vaccine ads? Read more »
Now May Be the Time for Pharma to Get Serious About Instagram
Despite the fact that FDA recently cited Duchesnay for a violative Instagram Diclegis ad that featured celebrity Kim Kardashian (read "Kim Kardashian Instagram post draws FDA warning
"), Instagram may be the social medium of choice of pharma marketers now that it has added a new feature.
Until now, I didn't think Instagram was good for pharma. While its demographics (see charts below) may skew too young for marketing most of the products pharma has to sell, it is a growing population. Plus, now that Instagram is owned by Facebook, the demographics -- especially among women (the best target for drug marketing) -- will likely shift to resemble FB's demographics.
|Click on image for an enlarged view.|
According to eMarketer, now that Instagram is open to all advertisers, by the end of 2016, 48.8% of marketers are expected to use the platform (read "Instagram Set to Rock the Social Media Marketing World
Due to FDA regulations, the necessity to expend resources to monitor comments for adverse reactions (read "One (BIG) Reason Pharma Shouldn't Reconsider Instagram
"), lack of expertise in measuring social media ROI, etc., pharma marketers have not given social media a warm reception no matter what the platform. But the new Instagram feature I just learned about, may make it more appealing to pharma marketers. Continue reading to see why I feel this way.Read more »
Do Desperate Consumers Believe Cancer Drug DTC Ads?
In a recent NYT OpEd piece, Matt Jablow, whose wife died of lung cancer, called the TV ads for BMS's cancer drug Opdivo "utterly misleading and exploitive" and said that if BMS really wishes to thank patients like his wife who participated in the Opdivo drug trials, it should pull the ads (read the OpEd piece here
The Opdivo ad had already been criticized during an investor conference call by a Deutsche Bank analyst who questioned the value of direct-to-consumer (DTC) ads to promote Opdivo (here
). Of course, the analyst was more concerned about BMS wasting money on ads that would have no effect on the sales of the drug, which are likely to grow "whether or not the company promoted the drug to patients."
The FDA has proposed (see here
) to re-study the effect of superimposed text, or text placed over an image, on viewers' understanding of a DTC ad like that for Opdivo, which super-impose the words "A Chance to Live Longer"on buildings in big, bold text.
Meanwhile, some drug industry advertising experts have criticized Jablow's OpEd piece itself as being "disingenuous."Read more »
Total CME Funding Drops, But Income from Pharma Increases
The AMA & many other physician groups are lobbying in support of a Senate bill to exempt drug and device makers from reporting the value of continuing medical education (CME), journal reprints, and textbooks provided to physicians (see here
At the same time, while total accredited CME income is decreasing, the pharma industry is upping its financial support of CME, according to the 2015 Annual Report
of the Accreditation Council for Continuing Medical Education (ACCME).
|Data from ACCME Annual Reports. Click on image for an enlarged, more readable view.|
However, pharma may be channeling money to CME through organizations that are not required by law to report the value of their support for CME.Read more »
FDA's Dependence on User Fees & "Institutional Corruption" Blamed for Dramatic Increase in Drug Adverse Events and Deaths
An estimated 128,000 hospitalized patients die each year from Adverse Drug Reactions (ADRs. aka Adverse Events, AEs), which matches stroke as the 4th leading cause of hospital deaths (see here
). Deaths and serious reactions outside of hospitals would signicantly increase the totals. This does not include deaths and hospitalizations from over-dosing, errors, or recreational drug use. We know this because of hundreds of thousands of drug "Adverse Event Reports" (AERs) received by the FDA every year directly from healthcare professionals (HCPs such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, lawyers and others), and drug companies, which are normally required to send AERs it receives from HCPs to the FDA.
The following chart shows the trend in AERs received by the FDA from 2004 through 2015.
I have analyzed data from 2003 through 2014 to look at the number of AERs submitted by HCPs versus consumers, the number of serious adverse events versus the number of adverse events involving death, and the correlation between serious AEs and user fees paid to the FDA by drug companies. I see some interesting trends in the data.Read more »
Novartis Respects the Patient Perspective and Pays for It Too! But Is It Absolutely Transparent?
On Patientpower.eu, David Palacios, Head of Global Patient Relations, and Sanja Njegic, Head of Patient Advocacy & Relations in Europe at Novartis, explain how their company has moved from working with doctors and payers to working directly with patients. The interview was recorded at Eyeforpharma Barcelona 2016.
allowfullscreen="" frameborder="0" height="300" mozallowfullscreen="" src="https://player.vimeo.com/video/169505006" webkitallowfullscreen="" width="500">
“We developed last year what we call the 'patient declaration,' which is a public statement about what patients can expect from us,” said Palacios. “It is an internal and external commitment. By having this document everybody in the company needs to work seriously to honor what we said in the patient declaration. That has triggered a lot of discussion internally.”
Some of that discussion must have been around "transparency" with regard to compensating patients -- especially patient bloggers and patient advocates -- for their opinion, much like pharma has traditionally paid physician Key Opinion Leaders (KOLs) for their opinions. Did that discussion result in any relevant disclosure in the "patient declaration?"Read more »
Real Dog Patient Stories Send Sales of Sileo Rocketing!
"Data gives credibility, but stories provide truth," says Ash Rishi, Co-Founder and Managing Director of COUCH (read "Patient Storytelling Marketing
Social media and patient stories are a "match made in heaven" and several pharma marketers are using social media to listen to REAL patient stories and to leverage those stories to help motivate other patients. This is as true for dogs as it is for humans as evidenced by Chase's story (see him on the left).
Before I get to that, some background.
It is estimated that one-third of dogs in the U.S. suffer from noise aversion and they especially hate the Fourth of July with all its fireworks, firecrackers, rockets and other noise makers. That "unmet medical need" was met by Sileo, an FDA-approved canine prescription drug developed by Zoetis. Sileo treats noise-averse dogs without sedating them.
Luckily for Chase, Sileo was approved just in time. Here's his story as translated by Google Translate.Read more »
Apple's ResearchKit Mobile Apps Make Strides in Clinical Research, But Is iPhone User Demographics an Issue?
As reported in the trade media, GSK developed an iPhone app for use in "clinical research" (read "GSK Develops Rheumatoid Arthritis App for Clinical Trial Using Apple's ResearchKit
"). It is claimed that this "[marks] the first time a drugmaker has used the health system for the iPhone to conduct clinical research."
ResearchKit is a set of tools for collecting participant consent, conducting surveys and assigning active tasks to participants that they can perform to help researchers achieve specific study goals.
Keep in mind, however, that this use of a ResearchKit iPhone app is not part of a clinical study involving an actual medicine. As reported by GSK here
"We are the first in our industry to use Apple’s ResearchKit as part of our research, this time looking at the impact a patient’s disease has on their day-to-day life. We’re not testing a medicine right now. The medicines development process starts with learning from real patients by including their insights and health goals into our research. That’s exactly the information we hope to gather about rheumatoid arthritis, a debilitating disease which can impact patients’ lives at many levels.
"The PARADE study will use the iPhone app to conduct surveys and iPhone sensors to collect and track common symptoms of rheumatoid arthritis: joint pain, fatigue, and mood. It will also track activity and quality of life measures for 300 patients over a three-month period."
This is not, however, the first use of Apple's ResearchKit in the development and use of mobile apps for "clinical research."Read more »
Everything You Wanted to Know About Vaccine Marketing, PR, Earned Media, Lobbying, and "Anti-Vaxxers"
Anti-HPV vaccines (e.g., Merck's Gardisil) are back in the news these days.
Last night, NBC Nightly News reported "Study Shows Alarming Rise in HPV-Related Cancers." The takeaways are (1) HPV infection causes cancers, (2) those cancers can be prevented with new vaccines, but (3) not enough kids are getting vaccinated.
A woman with cervical cancer attributed to HPV says at the end of the piece "I don't know how you can not prevent your child from getting cancer if there is a way to do it."
This comes on the heels of a new Merck campaign that blames parents for not getting their children vaccinated (see "Merck Ad Blames Parents & Asks: 'Mom, Dad, Did You Know'
Click on "Read more" for the details, including numbers form the CDC, and links to articles and blog posts related HPV vaccine marketing over the years.Read more »
Valeant Takes Advantage of Orlando Massacre to Promote Hair Removal Device to LGBTQ Community
Solta Medical (owned by Valeant, a company formerly run by a gaggle of gangsters! See here
) launched a new hair-removal laser in September.
It hasn't been selling well.
And then came the Orlando massacre of gays and lesbians in a night club and bingo! Valeant marketers decided to co-opt the resulting sympathy for the gay and lesbian community by launching a social media effort dubbed "No More Hair, More Pride" that targets millennials and the "LGBTQ" - lesbian, gay, bisexual, transgender, and ? - community (see here
I don't know about you, but I would love more "long, straight, curly, fuzzy, snaggy, shaggy, ratty, matty, Oily, greasy, fleecy, shining, gleaming, streaming, flaxen, waxen, Knotted, polka dotted, twisted, beaded, braided, Powered, flowered and confettied, Bangled, tangled, spangled and spaghetti" HAIR! allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/7dyl0j3WU6Y" width="420">
Medication Adherence Won't Get Better Unless Pharma Marketers Accept Some Blame
Adherence, as defined in the Pharma Marketing Glossary
, is "Percent of doses of a drug taken as prescribed for entire period of study (compliance + persistence)." In short, "sticking to the proper self-administration of treatment." Lots of patients (perhaps as many as 50% according to the World Health Organization) -- even patients taking life-saving medication -- are not as "adherent" as they should be, which means that the treatment does not work as advertised and drug companies lose money. This has been discussed ad nauseum.
There have been many attempts by the drug industry to improve medication adherence, but it has made very little progress. "Things can only get better" says this article
published by PMLive. How so?
The article suggests that "the answer could lay in understanding [patient] behaviours, engaging HCPs and... making medicine fun
" [my emphasis]. ROFLOL! I'm going to ignore the "fun" reference for now and concentrate on the fact that this answer focuses the blame on pharma's customers and ignores the elephant in the room.Read more »
Digital, Not DTC Advertising, Is the Real Reason Why Patients are "Wasting the Time" of Healthcare Professionals
Recently, the American Society of Health-System Pharmacists (ASHP) joined the physicians of the American Medical Association (AMA) in a call to ban ALL direct-to-consumer (DTC) ads (see here
). ASHP’s new policy states the following: “To advocate that Congress ban direct-to-consumer advertising for prescription drugs and medication-containing devices.”
Physicians and pharmacists spend too much time having to explain TV ad drugs that “aren’t appropriate for patients,” said Kasey Thompson, chief operating officer and senior VP of ASHP’s office of policy, planning and communications.
The AMA agrees. It said that DTC advertising “causes headaches for physicians who must constantly debate patients’ who are convinced a drug is right for them because they have seen it advertised” (see here
These healthcare professionals (HCPs) seem impatient with patients who wish to have a say in their treatment options. But it’s not DTC advertising that's the cause of this newfound patient “uppityness.” It's Digital, Stupid!Read more »
More Free Pharma Lunches Served to Docs = More Prescriptions of the Sponsored Drug
Most physicians do not seem to know that "there is no such thing as a free lunch." Medscape's 2012 Ethics Report survey, for example, revealed that 72% of 23,710 physician respondents answered "Yes" to the question "Do you feel that you could be unbiased with prescribing habits if you accept lunches from pharmaceutical representatives?" (see here
But, according to other researchers, such thinking is a "slippery slope" on which "Physicians fail to recognize their vulnerability to commercial influences due to self-serving bias, rationalization, and cognitive dissonance" (see "Physicians Under Pharma's Influence: Are Physicians Powerless Pawns of Pharma Psychology?
Time and time again, when I write about physicians getting free lunches delivered by sales reps, someone always comes forward and says something like "It's ridiculous to think that I can be influenced by a $10 lunch!"
But what if it was a $20 lunch? More recent research indicates those lunches have significant ROI in terms of prescribing brand name drugs.Read more »
Are Women Execs Ready to Break Through the Drug Industry's "Glass Ceiling?"
These are historic days for women. For the first time ever, a woman (Hillary Clinton) will be a major political party's nominee for president of the United States. The odds are that Clinton will break through that particular "glass ceiling" this November and women are supporting her effort. (image)
According to OpenSecrets.org (here
"Hillary Clinton has raised a higher percentage of her campaign funds from women than any major party presidential candidate in recent history.
And Donald Trump has the dubious honor of achieving the exact opposite: He has raised less from women than any other major party’s nominee at this point in the presidential cycle since at least 1989 (which is as far back as our data goes).
The race dynamic makes for the largest gender gap in presidential fundraising history. Clinton has raised 53 percent of her campaign’s contributions of more than $200 from women, a Center for Responsive Politics analysis shows, while the comparable figure for Trump is a mere 28 percent. The divide is nearly twice what it was in 2012, when President Barack Obama raised 44 percent of his funds from women versus former Massachusetts Gov. Mitt Romney’s 28 percent.Pharma's Glass Ceiling
According to Women in Bio (WIB), an organization of professional women in the life sciences, "women hold just a small number of corporate board seats. In 2015, the 2020 Women on Boards Gender Diversity Index of Fortune 1000 companies showed that 17.9% of corporate directors were women. That number drops to 10% in biotech companies. These numbers are disproportional when you consider that women comprise about half of the total U.S. workforce, hold half of all management positions, and are responsible for almost 80% of all consumer spending."
Women, it appears, support breaking the political glass ceiling, but what about the pharma industry glass ceiling?Read more »
The Impact of Pharma's Consumer Advertising Spend on Patient-Physician Interactions
|Click on image for an enlarged view.|
According to Kantar Media:
"Consumer ad spending by drug makers in 2015 reached $6.09 billion ... after $5.12 billion was spent in 2014 and $4.29 billion was spent in 2013. These totals include spending on branded prescription drug ads plus unbranded ads by drug companies promoting awareness of a health condition and directing consumers to get more information, usually leading them to a company website where the prescription drug is offered as a treatment option" (read "Pharma Drug Ads: A Glass Half Empty is a Glass Half Full
These numbers differ from the direct-to-consumer (DTC) ad spend data reported previously by Kantar Media (read "Annual Spending on Direct-to-Consumer Drug Advertising Ties an All-Time High
"). The chart at the left shows the updated data.
Kantar Media’s CRO, Jon Swallen, noted that all the Kantar Media reports I've referenced included branded plus unbranded DTC. "The difference in spending estimates are attributable to (1) slight differences in the universe of media outlets that were tabulated; and, (2) updates to historical ad pricing and spending data that were received after publication of the earlier report."
In any case, Kantar Media also presented some interesting data regarding the yearly trend in the number of Rx drugs with $500,000+ in annual ad spend as well as physician and consumer attitudes toward DTC advertising.Read more »
Physicians Like Pharma Sales Reps About As Much As They Like Snail Mail!
Let's face it. Pharmaceutical sales reps are old-school as far as healthcare prescribers are concerned.
A newly released (2016) Annual Healthcare Professional Communication Report (see insert below) by HealthLink Dimensions surveyed over 700 physicians and PAs (HCPs) found that only 11% of respondents preferred to be contacted by pharma through in-person visits from company reps. That's the same percentage who prefer snail (direct) mail.
Meanwhile, 68% prefer to be contacted through email, which confirms what other surveys have found (e.g., Medical Marketing Service's 2016 Physician Pharmaceutical Survey; read "Physicians Want #Pharma Info, But Mostly Via Email That Can Be Ignored Better Than Reps!
Click on "Read More" below for more results from the HealthLink survey and how they compare with other research about physician communication preferences.Read more »