A KOL By Any Other Name Would Smell As Sour

Nearly two-thirds (62%) of medical experts (physicians who could be deemed genuine experts) believe the pharmaceutical industry should replace the term Key Opinion Leader (KOL) – according to the results of a new international online survey to be presented today at the Medical Affairs Leaders Forum in Berlin, Germany. The survey was conducted by System Analytic, a company that helps pharmaceutical teams to "identify, map, and engage with their medical experts and key stakeholders."

According to the Pharma Marketing Glossary, Key Opinion Leaders are physicians who influence their peers' medical practice, including but not limited to prescribing behavior.

"Pharmaceutical companies hire KOL's to consult for them, to give lectures, to conduct clinical trials, and occasionally to make presentations on their behalf at regulatory meetings or hearings." (see "The Secret Lives of Big Pharma's 'Thought Leaders'").

It's a well-known fact that KOLs often are chosen more for their high prescribing habits than for their knowledge or other attributes that would enable them to influence their peers. The recommendation to change the name follows concerns by the senior medical community (who participated in the research) that the term ‘KOL’ is too ‘closely associated with the world of marketing’ and is often ‘used inappropriately’ for people who do not necessarily warrant the title.

But how do pharmaceutical executives feel about changing the name? What name should be used instead? And, most importantly, will changing the name really change the game?

Read more »

Lack of Adherence: A Haiku for Pharma

HealthPrize, a company that offers rewards to patients who take their medications, challenged ePharma Summit attendees and Twitter followers (hashtag: #epharma) to a Haiku contest.

The challenge is to write a Haiku - a 17-syllable verse form consisting of three metrical units (lines) of 5, 7, and 5 syllables. The catch? The topic must be medication adherence.

UPDATE: I won! The prize was a $100 Amazon.com gift certificate.

Here's my Adherence Haiku:

What do I mean by this?

Read more »

Impact of mHealth on Adherence and Patient Outcomes Needs Improving. How "Open, Crowdsourced" Data from Pharma Can Help

A study just published in the Journal of Medical Internet Research (JMIR) concludes that "there is potential for mHealth tools to better facilitate adherence to chronic disease management, but the evidence supporting its current effectiveness is mixed. Further research should focus on understanding and improving how mHealth tools can overcome specific barriers to adherence."

The study was a systematic review of 107 studies published in peer-reviewed journals. It aimed to evaluate the effectiveness of mHealth in supporting adherence of patients to chronic disease management -- which the authors call “mAdherence” -- and the usability, feasibility, and acceptability of mAdherence tools and platforms for chronic disease management.

The authors classified mAdherence tools and platforms into four main categories: SMS; phone plus software or application; phone plus specific instrument (medical device connected to phone via a cord); or phone plus wireless or Bluetooth-compatible device (see figure below):

Types of mobile tools used in mAdherence. Click on image to enlarge.

What were the results and how can the pharmaceutical industry help?

Read more »

I'm a Pundit, Yes I Am!

Andrew Spong, a pundit writing for STweM blog, just dissed pundits in an opinion piece titled "Pundits, prognosticators, philosophers, and practitioners: the exotic species of the health conversation on the social web."

"In addition to patient, healthcare professional, and provider voices on the social web," says Spong, "I can identify at least four other groups of participants: pundits, prognosticators, philosophers and practitioners."

Since I consider myself a pundit and I'm a "voice on the social web," I am primarily interested in what Spong has to say about us pundits.

"The pundit's stock-in-trade is opinion, of which they have an inexhaustible supply," says Spong, who himself has an inexhaustible supply of opinions such as this one.

"Pundits are invariably self-employed on the basis that nobody wants to pay to be subjected to an interminable stream of passive-aggressive jibes, yet no-one knows how pundits make a living. It's one of the great mysteries of the health conversation on the social web."

I don't know about other pundits, but I sometimes get paid to subject people to "an interminable stream of passive-aggressive jibes" or truth-to-power opinions as I like to call them.

STweM obviously thinks "practitioners" stand out from the crowd. "The practitioner is comfortable with the idea that the reception and ultimate success of any activity will be determined by how well it serves the needs of the user, not the needs of the publisher," says Spong.

I think I'm a practitioner too when it comes to social media. But I like the title "pundit" better. With apologies to Chicago, I wrote this little song about pharma pundits (sung to the tune "I'm a Man"):

Read more »

Millennials Trust Pharma Social Media, Mobile Apps & Advertising a Hell of a Lot More Than Their Geezer Parents!

According to findings released today from the Fifth Annual Makovsky/Kelton “Pulse of Online Health” Survey, the percentage of Americans who trust pharma-sponsored social media "a lot" or "completely" increased from 17% in 2014 to 21% in 2015.

The same survey also revealed another trend: In 2010, 88% of Americans were willing to visit a pharma-sponsored Web site (e.g., a drug.com site), whereas in 2015 that percentage decreased to 80%.

Fielded in January 2015 to 1,015 nationally representative Americans ages 18 and older by Kelton, the Makovsky Health survey investigated consumers’ behavior and preferences for engaging with online healthcare information. The margin of error is +/- 3.1 percentage points at the 95 percent confidence level.

Meanwhile, a Prevention Magazine 2011 survey found that 49 percent of respondents who went online for prescription drug information reported seeking this information on a specific brand's Web site. As a consequence of this influence of the Internet, FDA is currently studying how consumers interact with drug.com websites (read this Pharma Marketing News article: Are Drug.com Websites "Fair and Balanced?").

Before commenting on the above results, let me summarize a few other “Pulse of Online Health” Survey results -- especially those related to mobile and wearable devices -- that may be of interest to you.

Read more »

Oris : The Better Switch

Brand : Oris
Company : L&T

Brand Analysis Count : # 555

L&T which is one of the largest player in the construction and infrastructure industry  launched their brand Oris on the consumer electrical space in 2013.  It was recently that the brand has started making noise in the media.

Indian switches and distribution boards market in India is worth around Rs 2400 crore . The home segment itself is around Rs 1400 crore. The market is dominated by Anchor Electricals but now the market is flooded with national and international brands.

Switches has now moved from functional to aesthetic product. Design of the switches and similar electrical products has become an important attribute. Oris claims that it is inspired by music and the switches looks like the keys of a piano. Earlier Roma brand of switches also claimed to be inspired by the piano keys. The USP of the brand is the LED indicator which is branded by L&T as Intelli-i that helps to identify the position of switches in the dark. The company is also offering 12 year warranty for the switches.

Watch the ads here : Oris switches

It is interesting to note the L&T which is a well known Corporate brand has chosen to have a different brand name for its switches. It would have been easy if the company decided to call its switches L&T switches. One of the reasons would be to create a premium brand name and L&T as a brand name is not sexy. 

Since the brand name Oris is new, L&T is running another campaign building the association with the corporate brand L&T. Watch the ad : Leveraging L&T ( it is in Malayalam Language).

The tagline of Oris is " The Better Switch " which I would consider as an unimaginative tagline. Again since Oris is not going to be restricted to switches alone, a tagline anchored on switches is a myopic step. My understanding is that Oris would be later launching a range of electrical accessories including probably MCBs and in future may be fans lights etc. In that case, the company may have to scout for a new tagline. Instead , the company could have started off with a positioning which can be transferred to multiple products in future.

Where Have All the "Really Good" Marketers Gone?

My blogger friend Rich Myer asked this question on his New Media and Marketing Blog:

"Where are all the really good marketers?"

"Did you ever get the feeling that most brands are farting in the wind when it comes to their marketing?", Myer asks. "Every week more and more marketing executives are taken for a ride by people whose only accomplishment is getting people to buy their book. First, it was social media hype, then big data hype."

"So is big data at fault? The answer is no. It’s marketers who are really bad at marketing. Too many MBA types are trying to bring a logical approach to illogical consumers."

With apologies to Pete Seeger, I offer the following lyrics to accompany Myer's remarks (sung to the tune "Where Have All the Flowers Gone?"):

Read more »

Why Pharma Marketers Can't Be Trusted to Correct 3rd-Party Misinformation About Drugs Online

In its draft guidance titled "Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices," the FDA writes:

"If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any."

Peter Pitts, author of DrugWonks Blog, argues that whereas pharma brand marketers "figured out" that social media is "not ready for prime time in their 20th century 'blockbuster' marketing primer," corporate communicators see social media as the "wave of the present" but "don’t have the budgets to really make it happen to scale."

Pitts hints, however, that FDA's comments on correcting independent 3rd-party misinformation (e.g., on Wikipedia) is pretty much the industry's equivalent to "Ferris Bueller's Day Off" (see "Big Pharma, Social Media, and Ferris Bueller"). Carpe diem, no?

But a recent study offers evidence that pharma marketers -- and probably also pharma corporate communicators -- can't be trusted to correct 3rd-party misinformation about their products online.

Read more »

Can You Trust Patient Rankings of #Pharma Corporate Reputation?

Can You Trust Patient Rankings of #Pharma Corporate Reputation?

DTC Print Ads Need Consumer-Friendly Fair Balance Information

The FDA recently published revised draft guidance on "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements." (see "Disclosing Risk in DTC Print Ads: Introducing the 'Consumer Brief Summary'").

The brief summary is the part of direct-to-consumer (DTC) ads that conveys detailed risk information. Typically, this information appears on the back side of the print ad and is sometimes written in small type.

In the original guidance published in 2004, FDA suggested a "less is more" approach (see “FDA Draft Guidance for Print DTCA: Less than Feared”). At that time, FDA said it "believes that exhaustive lists of minor risks detract from and make it difficult to comprehend and retain information on the more important risks." In the revised guidance, FDA suggests specific, more readable formats for the brief summary. As shown in the example below, some DTC print ads have already used these formats in the brief summary section of the ad.

What no one is talking about, however, is the "fair balance" section of the ad. Let's look at a typical Rx drug print ad.

Read more »

Pharma Profits are Driven More by Marketing Spend Than by R&D Spend

Data from Forbes for 2013 document that the profit margins of banks and pharmaceutical companies ranked the highest (see here). Both industries have outlying margins (around 20%) and also outlying settlements with governments for violating marketing and other business-related laws (see chart on left).

In November, 2014, BBC reported that in 2013, US giant Pfizer, the world's largest drug company by pharmaceutical revenue, made an "eye-watering 42% profit margin."

The BBC article also included a table showing the total revenue, R&D spend, Sales and marketing spend, Profit, and Profit margin of the top 10 pharma companies.

The evidence shows that many drug companies spend far more on marketing drugs - in some cases twice as much - than on developing them. It's deja vu all over again in the ongoing debate of R&D spending vs. promotional spending. See a critique of the numbers here.

In any case, I was more interested in seeing if there was a positive correlation between pharma profits and marketing and/or research and development spending. So I prepared the following chart from the data.

Read more »

PharmaGuy's Mission Statement à la PHARMAGEEK!

I recently attended the SMi's 7th Annual Social Media in the Pharmaceutical Industry conference in London where I met Lionel Reichardt (PHARMAGEEK). He pulled me aside during the conference to do a video interview using his iPad. The following is the expertly-edited version of that interview, which is a nice synopsis of my presentation at the conference and my mission statement moving forward. Thank you Lionel!

How High Technology Can Help Improve Pharma's Reputation & Increase Sales

A pharma sales rep avatar

World of DTC Marketing blogger Rich Myer asked "How should pharma respond when attacked?" This was in response to the critique of pharmaceutical marketing practices by John Oliver (see here).

Myer started out with the premise that consumers just don't understand all the good that drugs do to improve health and save lives and how much money pharma companies spend on research. Which, as Myer says, doesn't "mean a damn thing if the consumer perception of the pharma industry is in the dirt."

Other than "work[ing] harder to earn trust and demonstrate everyday that we provide benefits to patients and society," Myer has no answer to his question.

Myer, however, implies that technology -- specifically the Internet -- stands in the way because what the pharma industry says in its defense "is not going to be heard in an age when everyone with Internet access is an opinion leader."

I would like to suggest, however, that the Internet and other digital technologies -- especially mobile -- can help pharma improve its reputation. How so?

Read more »

Some “Walter White” Pharma Sales Reps Make an “Ungodly” Amount of Money

Last Week Tonight with John Oliver is back on HBO and the pharmaceutical industry was the centerpiece of last night's show in which Oliver spent more than 17 minutes educating the audience on the industry's marketing practices.

Oliver began by citing some statistics such as annual sales of Rx drugs in America amount to over $1,000 per person. "Walter White could have made more money cooking up arthritis medications," quipped Oliver.

I'm not sure arthritis is where the real pharma money is these days -- maybe orphan drugs (see here and here) or cancer drugs (see here), certainly Hep C drugs (see here) are where the real money is.

Oliver focuses mostly on physician marketing and pharma sales reps. He begins by showing segments from direct-to-consumer (DTC) ads, all of which end with the phrase "ask your doctor," which of course is often the butt of jokes (see, for example, here).

"Oliver says Big Pharma wants you to talk to your doctor," says Time, "because they have spent billions of dollars marketing their drugs to physicians. Oliver’s research revealed that pharmaceutical companies spent $24 billion marketing directly to doctors last year. According to one study quoted by Oliver, 9 out of 10 top drugmakers spent more on marketing drugs than researching the drugs. In Oliver’s words, 'Drug companies are like high school boyfriends: they are more interested in getting inside you than in being effective once they are there.'"

I've written about many of the issues that Oliver speaks about in his segment and I will provide the back stories below. There was one thing in this segment, however, that stood out for me. It was a claim made by a GSK executive in a 2001 Advair launch video that the Department of Justice uploaded to its website as part of a whistleblower suit.

Read more »

Disclosing Risk in DTC Print Ads: Introducing the "Consumer Brief Summary"

On February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. One document was titled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.”

“Our new regulatory guidance,” said Mark B. McClellan, M.D., Ph.D., FDA Commissioner at the time, “provides new direction to sponsors on how to provide higher-quality health information to the public, based on recent evidence on what works and what doesn't in drug promotion” (read "FDA Draft Guidance for Print DTCA: Less than Feared").

But now even NEWER evidence - and complaints from the pharma industry - forced the FDA to issue a "revised draft guidance" titled "Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs," which you can find here (Docket No. FDA-2004-D-0500).

Released on February 9, 2015, this revision was ELEVEN years in the making. Compared to that, the four years FDA took to issue draft social media guidelines was lightening fast.

The guidelines address the requirement under provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which require that an advertisement for a prescription drug to disclose each side effect, warning, precaution, and contraindication from the labeling. This is referred to as the "brief summary requirement."

So what's new in the guidelines?

Read more »

Brand Update : Alpenliebe creates new category with Juzt Jelly

Perfetti, who is the market leader in candy category of the Indian confectionery market ,successfully created a new category of jelly confectionery through the brand Juzt Jelly. Launched in 2012, Juzt Jelly was able to catch the attention of the Indian consumers. The success of Juzt Jelly also prompted ITC to launch the challenging brand Candyman Jellicious.

Juzt Jelly is launched as a sub-brand of Alpenliebe. Alpenliebe launched in 1995 has moved from a sugar candy brand to an umbrella brand endorsing wide range of confectionery products ranging from lollipops,eclairs and jelly .

Juzt Jelly was launched through celebrity endorsement from the Bollywood actress Kajol. The brand had the tagline " mast jelly "

Watch the ad here : Juzt Jelly Launch ad

Later the brand moved to animation based campaign themed Jelly ki Duniya meaning The World of Jelly . 

Watch the ad here : Juzt Jelly Animation

The sugar confectionery category consumers are predominantly kids. Hence the animations and jingles catch their attention. The competitor Candyman has taken the jingle route to fight Juzt Jelly. The jingle " Wiggle Wobble " is quite popular. The entry of ITC is set to make the category bigger.

Although Juzt Jelly is available in strawberry , orange and lychee flavors , most of the marketing promotions is concentrated on the strawberry flavor. 

How Virtually Anyone Can Get an Rx for Amphetamine... Sorry, I Meant to Say Vyvanse

After writing yesterday's blog post about Monica Seles helping Shire promote Vyvanse for Binge Eating Disorder (B.E.D.), which is a new indication for the ADHD drug, I wondered if this would make it easier for young people to obtain prescriptions for Vyvanse, which is a Schedule II controlled substance with a high potential for abuse.

Like overweight college students, I too could use a little "pick me up" pill from time to time.

Since there is no lab test to confirm a B.E.D. diagnosis, all I have to do to get a prescription for Vyvanse is convince a doctor that I meet all of the DSM-5® diagnostic criteria for binge eating disorder, which Shire provides here on the BingeEatingDisorder.com website.


Of course, I have to "certify that [I am] a US health care professional and [I am] opting to receive information about binge eating disorder plus site updates, educational information, patient support resources, and other information from Shire," which anyone can do -- even me, who is definitely NOT a health care professional. No problem, that was easy.

But just in case you are reluctant to pose as a doctor and opt in for email from Shire, you can avoid the DSM and use Shire's handy "Binge Eating Disorder (B.E.D.) Symptom Checklist," which you can find on the "Talking With Your Doctor" page where "Starting the Conversation Is Key."

It's easy to use the Checklist and get a printout (pdf file) to bring to your doctor. Here's how I filled in the Checklist and the advice I got from Shire on "starting the conversation" with my doctor - a surefire way of getting a prescription for Vyvanse and the boost I need during my busy day.

Read more »

Shire & Seles Team up in B.E.D. to Promote Vyvanse. Celebrity Endorsement at Its Worst!

OMG! Is there nothing old athletes won't do for money?

Remember Monica Seles who was famously stabbed on the tennis court in 1993? No? OK, whatever. She's celebrity enough to hawk for Shire, which recently won PRIORITY approval from the FDA for a new indication for Vyvanse, it's ADHD drug:

Binge Eating Disorder or B.E.D.

According to Seles & Shire, which is hosting the website BingeEatingDisorder.com ("A Resource for Understanding B.E.D. in Adults"):

"Binge Eating Disorder (B.E.D.) is not just overeating. It is a real medical condition [my emphasis] that was formally recognized in 2013. B.E.D. is the most common eating disorder among US adults."

How many times have you heard the phrase "It is a real medical condition" before? Aside from Seles & Shire, who says B.E.D. is a real medical condition? Who "formally recognized" it in 2013 (just in time for Shire to ask for FDA approval)?

Read more »

Look Ma! No Bong! Afrezza Inhaled Insulin Device is a Cool Gadget

UPDATE (1/5/2016): Sanofi terminated its license agreement related to the development and commercialisation of MannKind's inhaled insulin therapy Afrezza, MannKind said today (here). MannKind noted that the deal will be terminated no later than six months from the effective date of Sanofi's notice or July 4. MannKind added that it "is reviewing its strategic options for Afrezza as a result of the termination."

In the post below I noted the exuberance of the diabetes community for this device and I gave Sanofi kudos for engaging this community via social media. I guess not even the best efforts to mobilize patients via social media in support of a product is guaranteed to be successful.

Also, Sanofi attributed the lower-than-expected sales of Afrezza to the FDA's requirement that patients undergo lung tests before starting treatment and while using the therapy as well as the broader need to raise awareness about the product (see "Sales of Afrezza Inhaled Insulin Stymied by FDA Says Sanofi").

 ------------ORIGINAL POST FOLLOWS--------------

Sanofi and MannKind Corporation announced today that Afrezza® (insulin human) Inhalation Powder, the only inhaled insulin, is now available by prescription in U.S. retail pharmacies nationwide. Afrezza is approved by the U.S. Food and Drug Administration to control high blood sugar in adults with type 1 and type 2 diabetes.

Afrezza is a drug–device combination product that consists of a dry formulation of human insulin delivered from a small and portable inhaler to help patients achieve blood sugar control. Afrezza is rapidly absorbed and has a short duration of action. It is administered at the beginning of a meal.

This is a vast improvement over the Exubera "Bong" that Pfizer attempted to launch back in 2007. In June of that year, Amy Tenderich, author behind award-winning blog Diabetes Mine, wrote:

"Because for any PWD [person with diabetes] with an actual social life, Exubera inhaled insulin is looking like a bomb. As I told the reps at the ADA conference frankly, the science behind it IS revolutionary, and we PWDs are grateful for strides in alternative insulin delivery, of course! But the Exubera Inhaler Device really is as bad as it looks in pictures. Worse, because the bulky 'white' plastic portions are not white at all, but that hospital-grade biege that reminds you of walkers and bedpans. An aesthetic nightmare, in the age of cool gadgetry" (see "Are you happy to see me, or is that just your Exubera Bong?").

The Afrezza device is definitely a cool bit of gadgetry! This may be the first time that a drug/device was designed based on fostering relations with patients via social media, something that Pfizer may have learned too late. How so?

Read more »