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A "Must Read" Blog for Insiders. --Wall Street Journal      "...often-entertaining, always informative..." --MedAdNews



Updated: 2016-12-09T10:48:10.656-05:00

 



21st Century Cures for Pharmaceutical Marketing

2016-12-09T10:48:10.663-05:00

In what Public Citizen described as an "Early Gift for the Pharmaceutical Industry" (see here), the Senate this week passed the 21st Century Cures Act (21st CC), which contains many provisions that will benefit the pharmaceutical industry and patients, according to many observers, including President Obama who said "We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer's..."

The Act will also benefit pharma marketers and usher in a new era of pharmaceutical marketing. How so?

Read more »



Can This Work for Pharma? The Continual Quest of Creative Advertisers

2016-12-08T10:26:08.907-05:00

FDA continues to issue fewer and fewer warning and untitled letters. As of today (8 December 2016) FDA has issued only 5 enforcement letters (4 untitled and 1 warning letter) compared to 9 letters in 2015.

Perhaps in 2017 FDA will issue no letters at all, especially if Trump has his way and Silicon Valley investor Jim O’Neill becomes the new FDA Commissioner. O’Neill is not a scientist or physician so it's no wonder that he has proposed that the FDA only require companies to prove drugs are safe before they are sold – not that they actually work (read this).

The other trend I see is FDA caving in to forces that oppose limiting the drug industry to promote drugs off label. For more on that issue, read these articles.
In terms of creepiness, this campaign has nothing over some creepy pharma campaigns I've seen (see, for example, my "Gallery of Scary Pharma Industry Advertising").

According to the Creative Director who submitted this example to PM360, Australia’s Transport Accident Commission’s "visually and emotionally jarring approach to the problem of connecting with the public about road safety was unique and inspiring. Rather than educate people on the tragedy of auto-related deaths with a metaphor or visual of a mangled person, they reframed the problem by looking broader and closer, and by thinking younger."

But these and other "fresh [creative] ideas" are not really new to pharma or they just won't work for pharma. Let's examine each one.

Read more »



FDA Compliant Diclegis Instagram Promo by (Good) Emily Maynard Johnson Can't Compete with (Bad) Kim Kardashian's Violative Post

2016-11-30T12:21:04.355-05:00

About 22 weeks ago, Emily Maynard Johnson, who appeared on ABC's The Bachelor and The Bachelorette, posted the following Diclegis promotion to her Instagram account:


I assume you've noticed that all the ISI (Important Safety Information) and side effects are mentioned either through links or, more importantly, within the post itself (you have to scroll down to see it).

This is in contrast to Kim Kardashian's Diclegis Instagram promotion that made news last year. That ad drew a prompt warning letter from the FDA to Duchesnay USA, which markets the drug, because the post did not mention nor did it link to any ISI or side effect information as required by FDA regulations (for more on that read "OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!" and "Celebrities + Social Media").

There are a couple of other important differences between these two celebrity Instagram endorsements/ads.

Read more »



The Evolution of the Written Word in the Social Media Information Age

2016-11-14T12:46:43.284-05:00

I started writing about the drug industry – specifically the commercial side of the industry – in 2002 with the publication of the first issue of Pharma Marketing News. At the dawn of the social media age in 2005, I started writing Pharma Marketing Blog and in 2008, I started tweeting.

By the end of 2016 I will have written over 4 million words, which is equivalent to eighty (80) average length non-fiction books! BTW, I also co-authored a book ("Socialize Your Patient Engagement Strategy").

Here is the breakdown of the current stats relating to my Internet publishing activities over the years:

Pharma Marketing News (started January 2002)
  • 639 articles 
  • Over 1.2 million words (1800 words per article
Pharma Marketing Blog (started January 2005)
  • 2393 posts
  • Over 2.3 million words (554 words per post)
 Pharmaguy on Twitter (started March 2008)
  • Over 26,000 tweets
  • Over 0.5 million words (21 words per tweet)
Do you see the trend?

Read more »



FDA Hears Results of Two Different Off-Label Surveys of Consumers at Recent Public Hearing

2016-11-20T09:17:23.468-05:00

At the recent Part 15 FDA hearing on off-label promotion (see here) results from two different consumer/patient surveys were presented. The first was presented by John Mack (i.e., me), Editor of Pharma Marketing News (PMN) and the second was presented by Dr. Doris Peter, Principal Investigator, Best Buy Drugs Project at Consumer Reports (CR).

The PMN survey was administered by inVibe Research, which collects responses via automated, voice-response surveys. Fifty-on respondents were reached via a network of patient community partnerships. These included 40 patient advocates, 20 chronic condition patients (diabetes, fibromyalgia, arthritis, CHF, etc.), and 9 caregivers.

The Consumer Reports survey was done by random-digit dialing so that the 1,011 survey respondents are "demographically and geographically representative of the U.S. population."

Thus, an important difference between these surveys is the first is patient & patient advocate specific whereas the second is generally consumer specific.

Let's compare the results of these two surveys.

Read more »



What is "Truthful and Non-misleading?" That is the Question FDA Must Answer to Allow Off-Label Communications by Pharma

2016-11-11T11:02:41.645-05:00

Yesterday, I attended and presented at FDA's Public Hearing on drug company communications regarding unapproved uses of drugs. My presentation had to do with off-label promotion directed at consumers and patients (find it here on Slideshare).

Just a few takeaways.

The phrase "truthful and non-misleading" was mentioned several times during the meeting, including by PhRMA (read "BIO #Pharma Industry Offers Its Own Set of Off-Label Communications Principles") and the Washington Legal Foundation (WLF).

In its testimony (here), the WLF said:
"Starting in the late 1990s with the Washington Legal Foundation cases, courts have consistently upheld corporations’ and their representatives’ First Amendment rights to communicate truthfully and non-misleadingly about the effects of their products. Courts have held that such a right is not limited by FDA approval of the use that is under discussion. Rather, the limiting factor on a company’s speech is a classic First Amendment test: whether the communication is false or misleading. Therefore, the FDA may only restrict health care companies’ speech regarding both approved and off-label uses if it is untrue or misleading to the listener. This test is grounded in both the Constitution and sound public policy. Pharmaceutical and medical device companies and their representatives possess the same rights to free speech under the First Amendment as other individuals, and patient care is strengthened by increased access to truthful information and innovation regardless of its origins." 
But defining what is true and non-misleading is difficult as many presenters noted.

Read more »



This Little Piggy... A New Pharma Nursery Rhyme

2016-11-03T08:37:22.076-04:00

I attended the 10th Annual Digital Pharma East conference in Philadelphia last week. One of the highlights for me was the "after party" hosted by Intouch Solutions at the Reading Terminal Market.

Intouch was celebrating the conclusion of its 2016 #ALLin program, which was yearlong cross-country campaign that involved traveling with a custom Airstream trailer and hosting "health hackathons." You can learn more about that in this interview of Wendy Blackburn, Executive Vice President at Intouch Solutions, in which she also talks about her views on how digital devices such as wearables will transform the pharmaceutical and healthcare industries.

While at the party, I saw an opportunity for a selfie with the Market's iconic pig statue.

This piggy's name is "Philbet," which was inspired by the market's Filbert Street location but with the f changed to ph as per local (i.e., the Phillie Phanatic) custom.

Other people photographed me with the pig including my friend Latizia Affinito (@laffinito) with whom I co-authored the book "Socialize Your Patient Engagement Strategy" (buy it on Amazon here).

At the time, I knew there was metaphor I could attach to the photo and the image shown here is what I came up with.

What's the basis of this metaphor?

Read more »



The Pharma Digital Health Accelerator Club

2016-10-30T10:31:40.720-04:00

My friend Fard Johnmar, founder and president of Enspektos, recently identified a few issues facing the drug industry as it tries keep up with digital innovation in the health field:
  1. Pharmaceutical executives are flooded with digital health opportunities: Many startups and established companies are coming to drug firms with a range of innovations, from mobile health solutions to smart pills. 

  2. Executives and leaders at these firms are having trouble triaging these innovations to determine which ones will meet key organizational, business and health goals.  

  3. Companies are working hard to drive digital health innovation from within: A number of firms have created internal innovation groups that are responsible for locating, developing and supporting the integration of digital health technologies into their operations. There is a special need for this work in developing countries like Brazil and China.
[Read: Can Pharma "Triage" All the Digital Innovation Ideas Coming Through Its Doors?]

Let's take a look at some innovations "flooding" the drug industry and how the industry is managing that flood.

Read more »



FDA Will Apply the "Uncanny Valley" Hypothesis to Test the "Eeriness" of Animated Characters in Drug Ads

2016-10-31T10:09:21.784-04:00

AbbVie, Astrazeneca, Eli Lilly, GSK, Merck, Regeneron Pharmaceuticals, plus others have submitted comments to the FDA regarding its plans to research animated spokes-characters in DTC Drug Ads (see Federal Register Docket ID: FDA-2016-N-0538).

Merck was not impressed: “While the proposed collection of information may be interesting to learn, it may not have practical utility for the general public and may be unnecessary for the proper performance of FDA's functions.”

Regeneron expressed a similar concern; i.e., "the results from this study should not be used to guide or influence FDA's current thinking on the use of animation in DTC ads."

But FDA is sticking to its guns.

“On the contrary,” says FDA in response, “this particular study has the potential to directly influence policy in an area that we have no prior research on. Although one research study cannot answer all questions, we believe we have designed the study in such a way that we will be able to provide information on the issue of animation in DTC ads. Because there is no previous research of this kind, this will be an informative study that will help FDA develop guidance and policy in the future, should the research reveal a need to.”

Meanwhile, The Advertising Coalition, representing national trade associations whose members prepare and deliver advertising through television, newspapers, magazines, the Internet, whipped out its 1st Amendment gun: “[T]his study must be viewed through the lens of two Supreme Court rulings that explicitly protect Commercial Speech, including advertising. In particular, the FDA must be mindful of the Supreme Court's ruling in Zauderer v. Office of Disciplinary Counsel, which held a state regulation of an advertising illustration unconstitutional and subject to strict scrutiny.”

But the comments I found most interesting had to do with the "Uncanny Valley” Hypothesis and measuring the “eeriness” of certain animated ads.

Read more »



Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016

2016-10-31T12:22:49.650-04:00

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 (updated 31 Oct 2016):

Wednesday, 9 November
Welcome and Administrative Announcements
Leslie Kux, Associate Commissioner for Policy
Opening Remarks
Dr. Robert Califf, Commissioner

  • Mr. Michael Labson, Covington & Burling LLP, on behalf of 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 and Ms. Coleen Klasmeier, Medical Information Working Group (MIWG)
  • Mr. James Czaban, DLA Piper LLP (US)
  • Mr. Daniel Biank, DuVal & Associates, P.A.
  • Ms. Sandra Kalter, Medtronic PLC
  • Dr. Andrew Koenig, Pfizer 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
  • Dr. Soumi Saha, Academy of Managed Care Pharmacy
  • Dr. Vikas Saini, The Lown Institute
  • Mr. John Mack, Pharma Marketing News

Read more »



The Day Pharma Tchotchkes Died

2016-10-12T07:09:41.151-04:00

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 »



Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?

2016-09-30T11:15:18.718-04:00

Perhpas you've seen the recent TV ad ("Ancestors") for Allergan's Kybella, a new drug approved for the treatment of double chins (read "Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face"). The ad claims that double chins may be inherited. You can view it on iSpot.tv here.

To prove the efficacy of Kybella, several screens are devoted to showing BEFORE and AFTER photos as in the following example:


You clearly can see from these "unretouched photos" of an "Actual KYBELLA patient" that the double chin is gone.

But are these photos really "unretouched." It all depends on what you mean by "unretouched." Let me explain.

Read more »



Pharma Has Funded Hilary to Tune of Nearly $1 Million This Cycle, But Supports Republicans Overall

2016-09-26T10:21:53.620-04:00

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?

2016-09-19T06:43:33.507-04:00

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

2016-09-04T13:34:04.597-04:00

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?

2016-09-03T06:45:34.004-04:00

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!

2016-08-31T10:15:53.129-04:00

When STATnews 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:

allowfullscreen="" frameborder="0" scrolling="no" src="https://www.ispot.tv/share/ARCj" style="bottom: 0; height: 100%; left: 0; position: absolute; right: 0; top: 0; width: 100%;">

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 »



The Addyi Report Card: Crooked Valeant Fools FDA Again

2016-08-19T08:48:18.430-04:00

(image)
Click on image for enlarged view or get PDF here.
"Fool me once, shame on you; fool me twice, shame on me," should be FDA's response to a report card released by the National Women’s Health Network advocacy group and shown here.

FDA was first "fooled" into approving Addyi based on a dicey self-assessment questionnaire, which formed the basis for the drug's efficacy in clinical trials (read "The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved") and by "patient advocate" testimony (read "The Power of Patient Input: How FDA Learned to Love & Approve Addyi") sponsored by Sprout, the company that brought Addyi before the FDA and which was bought by Valeant after the drug was approved.

Finally, Sprout's “Even the Score” campaign claimed that there was sexism inherent in the number of FDA-approved treatments for sexual disorders (read "Flibanserin (Addyi): The Title IX of Drugs or the Pill for No ill?").

Will the FDA be fooled again by "crooked" Valeant, whose business and accounting practices are under criminal investigation by U.S. prosecutors (see here)? Evidence from the Report Card says "Yes!"

Read more »



Now May Be the Time for Pharma to Get Serious About Instagram

2016-08-15T08:58:38.019-04:00

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.

(image)
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?

2016-08-12T09:56:09.106-04:00

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

2016-08-10T12:59:19.499-04:00

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).

(image)
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

2016-07-26T11:38:34.267-04:00

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?

2016-07-23T09:33:34.067-04:00

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!

2016-07-20T10:44:26.129-04:00

"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 »