Thursday, May 29, 2014

Pharma DTC Advertising Spend vs. Time Consumers Spend in Various Media

I came upon an interesting chart in Mary Meeker’s state-of-the-Internet slide deck. Meeker — formerly of Morgan Stanley, at VC firm Kleiner Perkins since late 2010 — each year produces a curated set of data reflecting what she sees as the major trends in Internet usage and growth. The chart (below) shows how American attention is divided among various forms of media and how that division lines up with where advertising dollars go, as I learned here.

Click on chart for an enlarged view.
I assume that the Ad Spending data reflect the average for all industries in the U.S. and the Time Spent in Media reflects what the average U.S. adult consumer (18 to 65 age range?) is doing.

Obviously, the main point is that too much ad dollars are going to print (newspapers and magazines) and not nearly enough are going to mobile and the Internet.

How does the ad spending by the pharmaceutical industry look when plotted on a similar graph?

You say "Xareltor" and I say "Xalkori": Whoops! There Goes Another Patient!

How should you name a new drug product? "That question," reports Alexander Gaffney (here), "is the subject of a new draft guidance by the US Food and Drug Administration (FDA), which hopes to help industry in selecting a proprietary name that can clear the agency's various regulatory hurdles."

The guidance document, which can be found here, states: "If end users cannot readily distinguish among proprietary names that are similar phonetically (sound-alike names) or in their spelling or orthographic appearance (look-alike names), or are otherwise confusing or misleading, the patient might receive the wrong product or it might not be possible to correctly identify the product used."

A report released in 1999 by the Institute of Medicine (IOM) described medication errors as a significant public health concern that accounts for an estimated 7,000 deaths annually in the United States. Approximately 25% of medication errors reported to national medication error reporting programs result from confusion with drug names that look or sound alike. So, drug trade name confusion can cause nearly 2,000 patient deaths per year in the U.S.! Amazing!

I rewrote some famous song lyrics to mark the occasion:

Pharma: Your Brand Celebrity Spokespersons Are Worthless!

A survey developed by WP Engine and fielded by TNS found that nearly ALL consumers (96%) do NOT want to see stories about how celebrities use a company’s products (see "Majority of Americans Want Original Content Directly from Brands -- Not Stories About How Celebrities Use Products").

This should be a wake up call for pharmaceutical marketers, many of whom are wasting precious marketing dollars hiring celebrities to "talk" about their products.

The most famous pharma brand celebrity spokesperson is pro golfer Phil Mickelson who talks about Enbrel in TV ads. Even BEFORE he was hired by Amgen, Mickelson talked about Enbrel, making outrageous claims that would never pass FDA regulatory muster if they were repeated in an ad (see image on left and read "Phil Disclosure: Mickelson is a Serial Undisclosed Celebrity Endorser").

One pharma celebrity spokesperson achieved notoriety for posting the first ever Tweet mentioning an Rx brand name. Unfortunately, it was a less-than-stellar moment. I called the Tweet "sleazy Twitter spam" (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!"). Don't worry, Novo and I are still friends.

Another famous "celebrity" hired by a pharmaceutical company to promote a brand was "fired" for making inappropriate racial comments. Can you guess who it was?

Friday, May 16, 2014

Promotional Spending in 2013 of the Top 20 Big Pharma Spenders

I found an interesting table in the May 2014 issue of MM&M that presents promotional spending data for the top 20 -- based on total spend -- US pharma companies. The source of these data is a Cegedim Strategic Data (CSD) "Audit."

In this post I summarize some of the data in charts that you may find interesting.

According to CSD, these top 20 companies spent a total of $14,784 Bn on traditional professional detailing, eDetailing, Direct-to-Consumer (DTC) advertising, professional meetings, and journal advertising. This does NOT include the cost of supplying drug samples. Here's a chart showing how much each company spent totally versus on DTC:

Click on image for a larger view.

Obviously, some companies spend a great deal on DTC  (e.g. Pfizer), whereas others spend $0 or close to $0 on DTC. I'm sure that varies year to year and depends a lot upon the type of products being promoted and the life cycle stage they are in.

But what is the overall allocation of the promotional spend of these 20 companies? What portion of the spending pie is devoted to professional detailing, eDetailing, DTC, professional meetings, and journal advertising?

Thursday, May 15, 2014

Where's the DTC Ads for Prophylactic Use of Truvada? Gilead, Support Your "Truvada Whores!"

As reported in the New York Times (see here) the Centers for Disease Control (CDC) recommended Wednesday that hundreds of thousands of Americans at risk for AIDS take Truvada, a daily pill that has been approved by the FDA for "PrEP," pre-exposure (to HIV infection) prophylaxis, for gay men who have sex without condoms.

Participants in a clinical trial (iPrEX) who consistently took Truvada reduced their risk of HIV infection by more than 90 percent (99 percent among those whose blood samples showed drug concentrations consistent with daily use).

This should be good news for patients at risk of HIV infection as well as for Gilead, which markets the drug in the U.S. According to the NYT article, CDC's recommendation could mean a 50-fold increase in the number of prescriptions for Truvada — to 500,000 a year from fewer than 10,000. The drug costs $13,000 a year, and most insurers already cover it.

But there's a catch. Many AIDS advocates such as the AIDS Healthcare Foundation (AHF) are afraid that widespread use of Truvada to prevent HIV infection will encourage unsafe sex (e.g., sex without condoms) leading to other problems.

AHF also cites survey results that revealed possible adherence problems - such as unwillingness to pay the $60 per month estimated co-pay for the drug and medical tests required as well as fear of side effects.

On the Truvada website, Gilead has answers to these issues -- such as coupons to cover the co-pay costs of the drug and free condoms.

Gilead, however, needs to go beyond a drug.com website to get the message out. In fact, this sounds like a problem tailor-made for a mass-media (TV and print) direct-to-consumer advertising solution! But Gilead has no plans to advertise Truvada for prophylaxis, even though the FDA approved it for that use back in 2012.

Why not?

Not advertising helps Gilead avoid controversy, says the Times reporter. But I contend that in this case not advertising is itself controversial considering that Truvada is 99% effective in preventing HIV infection and that based on the "number needed to treat" data, Truvada is FOUR TIMES more likely to save lives than statins, another widely promoted preventive drug regimen (see chart above).

If Gilead decides to advertise Truvada for prophylaxis, I have some recommendations.

Monday, May 12, 2014

Will FDA Avoid the "Social Media Guidance Cliff"?

Section 1121 of the Prescription Drug User Fee Act (PDUFA) states: "Not later than 2 years after the date of enactment [signed into law on 9-July-2012], FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA" (see here).

I call this the "Social Media Guidance Cliff" because if FDA does not meet this deadline it is technically breaking the law of the land and that would be a first.

On January 14, 2014, the FDA published what appeared to be a hastily-cobbled document titled "Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics."

Although this document is focused on when and how pharma companies should submit forms to the FDA to fulfill regulatory requirements for postmarketing submissions, it does offer some insights regarding FDA's thinking on regulating "interactive media" and according to Stephen King, a Public Affairs Specialist at FDA's Center for Drug Evaluation and Research (CDER), it does address some sections of 1121 (see "FDA Publishes First Piece of Long-Awaited Social Media Guidance").

Section 1121 does NOT specify that the FDA must publish ALL the guidelines it promised after the November, 2009, public hearings by the July 3, 2014, deadline. Consequently, the January, 2014, guidance may be enough to satisfy the non-specific "letter of the law."

But what about all the other promised guidelines?

Tuesday, May 06, 2014

Brand vs Corporate: A Distinction without a Difference in Social Media

"Do you want someone from corporate communications talking to your audience or should it be someone from the brand team who understands your audience and can converse with them in a meaningful way that adds value to your brand?"

According to Rich Meyer, who asked this question on World of DTC Marketing Blog (here), the answer is the latter.

Meyer argues that "only someone from the brand team, who understands the who, what and why of the product, should be responsible for implementing social media not a mouth piece from corporate communications who every once in awhile Tweets a link."

It's natural that Meyer, who has a brand marketing interest and background, would favor one of his own for the job of communicating with consumers about brands. But I've come to realize that the distinction between pharma brand managers and corporate communications is a distinction without much of a difference these days, especially with regard to social media.

Monday, May 05, 2014

When Big Pharma Sells Older Drugs, Is "Putting the Patient First" Devalued?

According to a Reuters article, "Leading global pharmaceutical companies have started to view their vast portfolios of older, established prescription drugs as vehicles for raising large sums of cash to fuel development of new medicines with far higher profit margins" (see "Big Pharma stands to profit by cleaning out its medicine chests").

"The divestments could bring in more than $7 billion for Sanofi, north of $15 billion for Merck and over $5 billion for Abbott, the sources said, giving them considerable firepower to develop, or buy, promising experimental medicines."

I can’t help but interpret this trend as another example of how big pharmaceutical companies put profit before patients despite all the hype about being more patient centric.

True, higher profits may bring new drugs to market, but new drugs are likely to serve a much more narrow base of patients; e.g., targeted biologics and extremely expensive drugs like Sovaldi, which only wealthy patients can afford (see “Sovaldi - A Cure for the One to Ten Percenters”).

But the many more millions of patients who take “older” drugs are left without the kind of “beyond-the-pill” support big pharma has been hyping up recently.

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