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



Updated: 2017-04-24T06:43:30.817-04:00

 



March for Science, Why I March

2017-04-22T10:24:19.196-04:00

Live from Washington, D.C. allowfullscreen="" frameborder="0" height="290" mozallowfullscreen="" scrolling="no" src="//www.washingtonpost.com/video/c/embed-live/58fb576be4b07c67ff09055b" webkitallowfullscreen="" width="480"> I will be heading to a satellite march in Doylestown, PA and speaking there. Here's what I will say:My name is John Mack and I live in Newtown.On Twitter I am known as PharmaGuy – that’s P-H-A-R-M-A, plus “Guy!” I PUBLISH a newsletter for the pharmaceutical industry. And I have a graduate degree in Biochemistry.Every day we benefit from medicines and vaccines created by scientists who work in pharmaceutical and government-funded research laboratories. We need to discover new drugs faster and defend efforts that make those drugs cheaper and more accessible to everyone. In doing so, however, we also need to defend the scientific methods the drug industry uses to prove that medicines WORK. A big part of that process is the Food and Drug Administration, which ensures that drugs are proven safe and effective through rigorous clinical trials.Today the Food and Drug Administration and other science-based agencies like the National Institutes of Health and the Environmental Protection Agency are under attack by the current administration, WHICH intends to increase SPENDING on the military and decrease SPENDING on these and other science-based agencies that help improve our lives. We should not have to sacrifice science for security.DEFUNDING science impacts us on a local level whether the issue is the quality of our air and water, fracking, opioid drug abuse, or the heroin epidemic. We need leaders who believe in data and scientific evidence to help solve these problems.More scientists must get involved in politics today just as Benjamin Franklin did during the American Revolutionary War.There is a war being fought today – a war against science. We must defend science in THIS war.Marching together is a good first step. But we must follow up by electing pro-science leaders and ensure that they rely on evidence, not beliefs, when making decisions about our health, our environment, and our general well-being.Thank you for listening and may Science be with you![...]



Speedy Drug Approval Versus Safe Drugs: Can We Have Both?

2017-04-19T13:33:29.978-04:00

More user fees paid to the FDA by the drug industry and the push for less rigorous scientific proof in clinical trials may lead to faster drug approvals, but also more deaths due to side effects. Where’s the balance between speed and safety?

For the last few years I have been tracking data from the FDA regarding how much money it collects from the drug industry in prescription drug user fees to see those payments influence more than just how quickly the FDA is able to approve new drugs for marketing.

One stark correlation I noted with the rise in user fees was the sharp drop in the number of warning letters the FDA sends out. I guess this is actually a negative correlation. Interesting...


But the fees seem to be working. In 1992 it took the FDA 19 months on average to approve new drug applications. Today, when user fees account for about 70% of FDA's budget for the review of new drug applications, it takes the FDA only 10 months to approve a drug for marketing (see here).

But what about drug safety, which is the other responsibility of the FDA?

Read more »



Making Sense of DTC Ad Spending

2017-04-05T14:32:19.387-04:00

About this time every year, I get data from Kantar Media and Nielsen regarding how much money the U.S. pharmaceutical industry spends on direct-to-consumer (DTC) advertising.

The data I’m most interested in are the total spend for the year and what portion of that is digital versus TV. But it can be difficult to ferret out that information from the two different sources, which often report different numbers.

Let’s look at the total spend first.

According to Nielsen numbers reported in the March 3 2017 issue of MM&M online, spending on direct-to-consumer pharmaceutical ads rose 9% to $5.6 billion in 2016 (read Direct-to-Consumer #Pharma Drug Ad Spending at an All-Time High).

In the March 29 2017 issue of MM&M, a Nielsen chart showed the 2016 DTC spend to be $5.8 billion (see Will It Be Downhill from Here for DTC Advertising?).

A difference of $200 million is peanuts compared to the whole, but it’s just slightly more than what Pfizer spent promoting Xeljanz to consumers in 2016.

Now these Nielsen numbers apply only to what’s called “measured media,” which includes TV, magazines, newspapers, radio, outdoor, and Internet banner ads. It does NOT include websites, web videos, web audio, sponsored links, social media, mobile applications, and emails. It also does not include search engine marketing, which has been estimated to be 40% of the total pharma digital spend (consumer and physician).

Kantar Media generally reports slightly higher numbers. For 2016, Kantar Media estimates that total DTC spending was about $6.4 billion. But this number includes $515 million of “digital.”

I’m not exactly sure what Kantar considers “digital” versus what Nielsen does. I think it’s pretty obvious, however, that the pharma industry cannot be spending $515 million on banner ads alone. Perhaps Kantar’s number includes search engine marketing targeted to consumers. In any case, if that number is subtracted from the total, you get $5.9 billion, which is close to what Nielsen reported.

$5.8 billion, $5.9 billion, $6.4 billion. Whatever! The number is very high. It’s more important to look at trends and what portion of the total is allocated to different channels.

Read more »



A Drug By Any Other Name

2017-04-03T13:14:31.705-04:00

The naming of drugs has been described both as a science and an art, which is also true about marketing in general.

No matter what side of the brain is involved, there must be a reason why drug names are often ridiculed as being "absurd." The issue even made it to Saturday Night Live skit in which Oscar nominee Octavia Spencer sued Merck for naming dozens of drugs after members of her family ("Pharma Gets Drug Names from Octavia Spencer’s Phone Contact List").

Perhaps my reporting of that skit was the reason why my long-time friend, Jonathan Richman, founder and director of Dose Marketing in Cincinnati, posted a study he did of prescription drug names on LinkedIn. His post – titled “The Absurdity of Pharma Drug Names” – railed against the many drug names that are difficult to spell and pronounce. He questioned the validity of the “urban legend” that drugs are named this was to make them more memorable.

Read more »



PharmaGuy To Compete for Recognition at Cannes Lion Health Festival

2017-04-02T07:27:52.854-04:00

April 1, 2017: PharmaGuy is excited to announce that the organizers of the 2017 Cannes Lion Health Festival have chosen him as one of the finalists to compete for this year’s Old Pharma Lions Award!

Judges are seeking out the greatest generation of older, awe-inspiring pharma marketing communications pundits. This year’s competitors will put their snarkiness to the test on a brief set by UNIPHARM, the world’s leading organization working to revive the reputation of the endangered pharmaceutical industry (for more on that, read "Pharma Industry Reputation Hits 7-Year Low According to Harris Poll").

Participants will be challenged to write a series of blog posts or Tweets that ridicule the notion that pharma creative ad awards -- including the Old Pharma Lions Award -- have any value!

The talented winners will be invited to attend Lions Health in Cannes, where they will receive their awards during the official awards show in front of thousands of experts from across the pharma communications world.

Entry Criteria
  • You must be 50 years old or over!
  • You must have pissed outside the tent of elite advertising agencies for at least 15 years!
  • Your application needs to be written in English – we will, however, accept emojis
  • Competition entrants must work as individuals, never ever as a team!
  • Students are not allowed to enter the competition, even if you are over 50!
See last year's award winner below.

Read more »



Which is Bigger: Pharma Profits or R&D Spending?

2017-03-28T07:58:34.716-04:00

On Mar 27, 2017, Public Citizen came out with a report that claimed "Pharmaceutical Industry Profits Are Nearly Double R&D Costs in 2013, 2014 and 2015". The email announcing the report said “Even the inflated estimates of R&D reported by the industry are dwarfed by the industry’s profits, which, for the 20 largest pharmaceutical companies, jumped from $100.5 billion in 2014 to $123 billion in 2015.”

“Big Pharma says that high prices pay for R&D, but it turns out they pay almost twice as much for sky-high corporate profits,” said Robert Weissman, president of Public Citizen. “The pricing system is broken and needs fundamental change.”

Today, another email from Public Citizen notified me that the organization “discovered a methodological issue in our report on medication costs and industry R&D spending. We have withdrawn the report and will repost it later this week with corrected data.”

Unfortunately, I did NOT download the report, so I can only speculate as to the nature of the “methodological issue.”

But I can cite some research that says Public Citizen is wrong.

Read more »



The Context Problem Foils Pharma Online Advertising

2017-03-27T09:41:00.554-04:00

(image)
Click on image to enlarge.
Last week I came across an article about Johnson & Johnson and other pharma companies pulling their ads from Youtube because they appeared adjacent to hate speech, e.g.; an anti-Semitic clip claiming the existence of a “Jewish World Order” (see the back story embedded at the end of this post or click here).

In an official statement Johnson & Johnson said it paused all YouTube digital advertising globally “to ensure our product advertising does not appear on channels that promote offensive content. We take this matter very seriously and will continue to take every measure to ensure our brand advertising is consistent with our brand values.”

According to a Bloomberg article, "While Google’s tools can be incredibly sophisticated, allowing ads to follow users from site to site, the software hasn’t fully matched the human judgment necessary to protect brands from inadvertently funneling cash to causes their customers would find objectionable. The high number of intermediaries in digital advertising further complicates the problem. So Google’s announced fixes may not completely solve the challenge."

This problem, however is NOT limited to Google, YouTube, and Facebook. It's also a problem for pharma digital marketers looking to place ads in major online media channels.

A case in point is the Janssen ad embedded in a STATnews story about a immunotherapy "breakthrough" (see image at left).

What's the problem with this and can pharma companies do anything to place limits on digital ad placement by taking account of context?

Read more »



How Many Adverse Event Reports Are Submitted to the FDA? Whatever the Answer, It's at an All-Time High!

2017-03-20T14:08:33.617-04:00

I've been tracking the number of adverse event reports (AERs) submitted to the FDA over the years based on data supplied by the FDA here. The latest update of that data was made in November 2015 showing the number of AERs FDA received in the first quarter (Q1) of 2015.

If you assume that the submission rate seen in Q1 of 2015 remained constant throughout the year, you get the following trend chart based on FDA's summary data table:

(image)
Click on image for enlarged view.
According this analysis, about 2.25 million AERs were submitted by healthcare professionals (HCPs) and consumers in 2015. An analysis by the Milwaukee Journal Sentinel and MedPage Today, however, yields drastically different numbers.

Read more »






DTC Advertising in the Era of High Drug Prices

2017-03-13T07:40:36.994-04:00

TV and, to a lesser extent, print direct-to-consumer (DTC) drug ads have often been blamed for the high price of drugs. For example:

Pharma marketers are no doubt concerned that the current political atmosphere, in which both Republicans and Democrats are calling for lower drug prices, is having a negative effect on the effectiveness of their ads as consumers tune out the message (read, for example, “Pharma is Spending More on DTC Advertising But Its Effectiveness is Decreasing, Says New Survey”).

Bob Ehrlich, Chairman of DTC Perspectives, in a recent email titled "Times of Turmoil Ahead" expressed concern that DTC marketers may not adequately understand consumer sentiment viz-a-viz high drug prices:
"Most of us practicing the art and science of DTC have no control over political decisions on drug pricing and drug approval. That being said, it is imperative DTC marketers understand the popular sentiment consumers are exhibiting towards drug companies."
How does high drug prices affect the work product of DTC marketers and what does Ehrlich propose that DTC marketers do to address consumer concern regarding high drug prices?

Read more »



How to Make WebMD Great Again!

2017-03-03T07:51:47.408-05:00

World of DTC Marketing blog author and pharma marketing consultant Richard Meyer has some advice for WebMD, which may be looking for a buyer (read “’Same Amount of Eggs, More Baskets’ – Lesson Learned by WebMD re Pharma Digital Spending”).

WebMD needs pharma and medical device companies, but pharma doesn’t need WebMD,” says Meyer who has some suggestions about how to Make WebMD Great Again

“Even though WebMD is the top health portal on the web, turning traffic into revenue is hard to do as a lot of websites have found out,” says Meyer. “There are opportunities, but WebMD has to act fast.”

Here is what Meyer would do to rescue the brand:

Read more »



Is "Right to Try" a Good Idea?

2017-03-02T07:08:32.940-05:00

Last night, President Trump called on the FDA to speed the approval of drugs to treat life-threatening diseases, "deriding the agency’s current process as 'slow and burdensome'," according to this STATnews article.

One solution to alleviating FDA’s “slow and burdensome” approval process and getting potentially life-saving drugs to patients is "Right to Try" laws that would allow people with fatal illnesses to gain access to experimental medicines, even though they are not enrolled in a clinical trial. VP Pence and other lawmakers support this approach (see here).

“We should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” said Jim O’Neill, a managing director at Mithril Capital Management, a venture capital firm run by Peter Thiel, the billionaire Trump donor and transition team advisor and candidate for FDA Commissioner (see here). “Let’s prove efficacy after they’ve been legalized.”

I decided to ask my readers if they think this is a good idea or not and to also submit comments to support their views.

So far, I've received nearly 50 responses to my survey and more than 30 interesting comments, some of which I share with you here. I invite you to take the survey and give me your opinion as well.

Read more »



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

2017-02-23T07:26:00.588-05:00

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.

Read more »



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

2017-02-17T10:22:16.520-05:00

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

2017-02-17T07:02:46.807-05:00

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

src="//www.slideshare.net/slideshow/embed_code/key/MVmqQikipeQNS5" width="535" height="435" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" style="border:1px solid #CCC; border-width:1px; margin-bottom:5px; max-width: 100%;" allowfullscreen>



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

2017-02-13T09:59:27.338-05:00

“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.

Read more »



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

2017-02-06T07:10:38.248-05:00

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.”

Read more »



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

2017-01-26T08:40:40.677-05:00

(image) 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.

Read more »



PhRMA Should Have Listened to THIS "Guy in a Hoodie"

2017-01-26T07:12:21.920-05:00

Back in December, 2015, year I suggested that the pharmaceutical industry put some distance between it a "Pharma Bro" Martin Shkreli. I said (here):

"Frankly, I'm getting tired of it all. Shkreli had his 15 minutes of fame. Let's move on. It's time for the pharma industry to get its 15 minutes of fame by doing something substantial to distance itself from the likes of Shrkreli."

But, I added a caveat:

"The mainstream drug industry cannot distance itself from 'wolves' like Shkreli merely through better corporate communications."

Unfortunately, the drug industry (aka The Pharmaceutical Research and Manufacturers of America aka PhRMA) did not listen to me and unleashed a TV ad that "cast Shkreli as a scoundrel in a hoodie who does not represent an industry of angels wearing white lab coats" (read "PhRMA Pissed That They Get No Respect, Lashes Out at Martin Shkreli, Gets Less Respect in Return!").

Yep, they should have listened to this guy in a hoodie - I just received my Brooklyn Tech hoodie in the mail. I'm proud to wear it too! I put the dark glasses on just to mess with you.

Any way, read on to learn more about what I recommended and view PhRMA's unfortunate TV ad that aside from casting some guy in a hoodie as a scoundrel also paints a dark image of medical researchers (keep an eye out for the dark image of a scientist peering through a microscope).

Read more »



Pfizer's New Viagra TV Ad Has a Unique Mobile "Call to Action"

2017-01-19T14:31:13.630-05:00

As reported by FiercePharma (here), Pfizer’s new TV commercial for Viagra, which encourages patients to text a keyword from their mobile phones to receive special discounts, appears to be "a first" for pharma Marketing.

I decided to have some fun with a few stills from the ad:





Does FDA Guidance About Pharma Communications with Payors Open a Path to Off-Label Discussions?

2017-01-18T11:10:29.015-05:00

At the November, 2016, FDA public hearing on off-label promotion, representatives of the drug industry made a case for allowing companies to inform payers of off-label uses of their products.

Payers “play such a gatekeeping role with respect to patients,” said Kellie Combs, an attorney for Ropes & Gray, who testified at the hearing on behalf of the Medical Information Working Group. “There's a real interest in getting information to payers as soon as possible.”

In addition, certain types of data, like demonstrating a drug's use in subpopulations and sharing pharmacoeconomic data, are examples of information that do not meet the FDA's criteria but are still valuable to payers, said Dr. Sandra Milligan, SVP of global regulatory affairs and clinical safety at Merck (see MM&M report here).

At the time, I asked “Will FDA Open a Path to Off-Label Promotion from Pharma to Payers & Not Patients or Providers?” (op cit). It appears that the path is now opening up, at least for drug companies to communicate “health care economic information” (HCEI) regarding their prescription drugs to payors. This opening is laid out in new draft guidance form the FDA titled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers” (find it here).

Here are some excerpts from this guidance…

Read more »



Fact Checking Puzzling Criticisms of a "Puzzling" DTC Study Proposed by FDA

2017-01-15T09:48:36.682-05:00

I get periodic emails from Bob Ehrlich, Chairman of DTC Perspectives, Inc., giving his opinion on various direct-to-consumer (DTC) advertising issues.

Although I often do not agree with Ehrlich on many issues, I value his perspective and often respond to him via this blog (read, for example, "Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements?"). We've even had a head-to-head podcast debate (listen to "Are Drug Marketers an Endangered Species?").

In a recent email missive, Ehrlich calls FDA’s recently proposed study of deception in DTC ads (read “Another FDA Study: Can HCPs and Consumers Recognize "Deceptive" Drug Website Promotions”) “the most puzzling FDA DTC study proposed to date.”

“I have problems with this proposed study on many fronts,” says Ehrlich. He also has at least ten questions about this study:

Questions:
  1. How are consumers supposed to know what is in the approved label to decide what is deceptive?
  2. So FDA will have consumers play detective like those games where you see two photographs slightly altered to spot the changes?
  3. Does FDA want consumers to be the vanguard of regulation and report claims they think are deceptive?
  4. Is FDA going to staff a hotline to receive consumer complaints?
  5. Consumers expect the claims in an ad to be vetted by FDA so what is the study goal in purposely putting in deceptive claims to see how misled is the consumer?
  6. What possible help could this study provide in future promotional guidances?
  7. A study that proves consumers can be deceived and might be unable to know they are being deceived proves what?
  8. Is FDA trying to prove consumers who do not know what is in the approved label can be easily fooled by rogue drug companies?
  9. If a drug makes deceptive efficacy claims, it is going to be more appealing to consumers. Hello, my new drug cures cancer. You interested?
  10. Is this deeper understanding using mock deceptive ads going to make FDA a better regulator?
I’d like to respond to some of these questions. But first, let me do some fact checking of statements Ehrlich makes.

Read more »



Top Pharma Companies on Facebook

2017-01-12T14:29:49.329-05:00

Back in August, 2011, Facebook opened up comments on ALL pharma pages, which meant that the pharmaceutical industry no longer was able to shut off comments on their product-related pages. Consequently, several companies decided to shut down their pages (read, for example, "Pharma Facebook Pages Being Phased Out" and "Janssen to Shut Down Psoriasis 360 FaceBook Page").

These days Facebook offers new opportunities and tools for the pharmaceutical industry to do promotions such as disease awareness campaigns (e.g., "Novartis, Queen Latifah, & American Heart Association Team Up on Facebook Live Broadcast") and ads that comply with FDA regulations (e.g. "Bayer's Betaseron Facebook Ad Uses a New Feature: Scrolling ISI" and "Will Drug Ads "Like" Facebook?").

Meanwhile, many top pharmaceutical companies have corporate Facebook pages. The following Slidehsare presentation is an analysis and review of Big Pharma Facebook pages.

allowfullscreen="" frameborder="0" height="435" marginheight="0" marginwidth="0" scrolling="no" src="//www.slideshare.net/slideshow/embed_code/key/Ae9yzYKdGDCqAl" style="border-width: 1px; border: 1px solid #ccc; margin-bottom: 5px; max-width: 100%;" width="535">

Further reading:



FDA Study is Designed to Justify a New BadAd Program for Consumers, IMHO

2017-01-09T10:30:36.851-05:00

The FDA plans to do two new studies supposedly to gauge the “ability of consumers and healthcare professionals (HCPs) to independently identify deceptive prescription drug promotion” (see the Federal Register Notice here).

A closer examination of the proposal, however, suggests that the real goal is to promote the Agency's BadAd program and open it up to consumers.

The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research. The program's goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.

There have been several cases where the FDA sent out warning letters based on notices it received from the BadAd program (read, for example, “OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!”).

According to a STATnews article, “Awareness [of the BadAd program] is low, however, according to a study published in 2015 in the Journal of Health Care Communications, which surveyed doctors, nurses and physician assistants who provide ambulatory care.

“The notice for the newest studies suggested the agency may consider creating such a program to prompt consumers to also report deceptive ads.”

I was quoted in the article, saying “It’s possible the Bad Ad program doesn’t go far enough and the FDA is looking to crowd source in order to use the power of consumers to help monitor industry advertising...It smells like they’re trying to gather data to decide whether to create another program.”

Here's why I think that is the goal of the FDA...

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Pharmaguy's Top Five 2017 New Year's Resolutions for the Pharma Industry

2016-12-29T10:20:08.202-05:00

As is my tradition – as well as the tradition for many other editors/pundits – it’s time for me to tell pharma what I’d like to see included in its list of 2017 New Year's Resolutions.

Last year I noted that 2015 wasn’t an especially good year considering that “the media and politicians have found a face for evil pharma and rising drug prices: Martin Shkreli!” (here).

It’s déjà vu all over again! Only this time many more evil pharma faces have come forward including the CEO of Mylan, aka “Pharma Sis” (read “Mylan ‘Gamed the System’ and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”), and top executives at “Crooked Valeant” (read “More Top Executives Flee Sinking Crooked Valeant Ship with $ Millions in Bonuses In Tow”).


Before getting to this year's resolutions, let's see if the industry followed any of the resolutions I suggested for 2016.

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