Viagra or Addyi: Which Sexy TV Ad Will Reign Supreme with Guys?

If you are half the man you claim to be, you no doubt have NOT skipped over the new Viagra TV ads, which feature a sexy woman  telling you not to worry about your erectile dysfunction – it’s more common than you think. Just pop a Viagra pill and you’re ready to go. Meanwhile, she’ll be waiting for you for a happy ending.

Soon, however, these Pfizer full bore sex ads will have competition from Sprout Pharmaceuticals, a small drug company located in Raleigh, NC.

As many media stories proclaim, Sprout Pharmaceuticals is a drug company with a potentially very big drug – “the world’s first pill to boost women’s sex drive.” It’s called Addyi (pronounced “addie”), which, according to Sprout CEO Cindy Whitehead (shown here holding Addyi pills in her hand), is “our representation of Everywoman,” whatever that means!

The FDA will soon announce whether or not it has approved Addyi, which the company plans to market as the “little pink pill.” The agency has rejected the drug twice in the past five years because of questions about its safety and effectiveness.

According to this media story, Whitehead assures that “Addyi is not meant to be prescribed to women looking for a little extra pizazz, or women who are bored with their husbands.” Yeah, right.

Sprout is said to have promised the FDA that it won’t run TV ads for 18 months. What will it do before then to market the drug, if approved. And what will those TV ads look like?

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My Book Is Published! Get a 35% Discount!

Good news! The book, Socialize Your Patient Engagement Strategy, which I co-authored with Letizia Affinito, has been published!

Socialize Your Patient Engagement Strategymakes the case for a fundamentally new approach to healthcare communication; one that mobilizes patients, healthcare professionals and uses new media to enable gathering, sharing and communication of information to achieve patient-centricity and provide better value for both organizations (in terms of profit) and patients (in terms of better service and improved health).

I am happy to say that the publisher has allowed me to offer you a 35% discount off the usual price! Use code G15JNY35 when ordering the book online here: www.gowerpublishing.com/isbn/9781472456328

I also have a few [autographed] copies I can give away to colleagues who wish to write glowing reviews such as this one by Mario R. Nacinovich, Jr. (@nacinovich), Managing Partner, AXON and editor emeritus of Journal of Communication in Healthcare:

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For Immediate Release: PHARMAGUY NOT HONORED AS ONE OF PHARMAVOICE 100

Annual list recognizes pharma industry leaders for their positive contributions to the life-sciences industry

NEWTOWN, August 13, 2015 – PharmaGuy, founder and CPO (Chief Pundit Officer) at pharmaguy.com has again NOT been honored as one of the PharmaVOICE 100.

The distinguished honorees are nominated by thousands of PharmaVOICE readers throughout the year and are selected based on substantive accounts describing how they have inspired or motivated their colleagues, peers, and even competitors; have affected positive changes in their own organizations; as well as having given back to their communities and other philanthropic causes.

“These individuals illustrate what it means to think bigger, do more, and lead with passion and integrity,” said Taren Grom, Editor and Cofounder of PharmaVOICE. “Based on their profiles, it is no surprise that our readers have identified this year’s honorees as some of the most inspiring, motivating, innovative, and outstanding leaders in the life-sciences industry today.”

“So, what am I? Chopped liver?”, quipped PharmaGuy quoting a phrase often heard in NYC.

For over 15 years, PharmaGuy (aka John Mack) has provided constructive criticism of the pharmaceutical industry providing a voice for insiders who share his views but who are unable to voice them on their own for fear that they will not be nominated as one out of hundred.

“Am I disappointed that I was not recognized by PharmaVoice?” asked PharmaGuy. “Not really -- the chopped liver comment was just a joke. Badda Bing! But seriously, why would I want to be one out of a hundred when I'm already one in a million?” quipped Pharmaguy.

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Kim Kardashian's Diclegis Instagram Post Raises Issues of Transparency, Drug Safety, and Learning from History - i.e., Thalidomide deja vu!

Duchesnay Press Release (click for enlarged view)

By now you've probably read several media reports about Kim Kardashian's enthusiastic Instagram post promoting Diclegis, a prescription morning-sickness medicine. That's only because the FDA sent a Warning Letter to the drug’s maker, Duchesnay Inc.

The FDA said the post failed to give information about the drug’s risks, which is something I reported here on Pharma Marketing Blog back in July ("OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!").

FDA's letter ordered the company to "immediately cease misbranding." Kim -- obeying orders no doubt from Duchesnay -- removed her violative Instagram post, but it lives on in the media seen by millions and also in a Duchesnay press release (Kim Kardashian West Found Morning Sickness Relief with Diclegis).

Of course, the press release also contains all the necessary risk information, including a very troubling side effect in children.

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Ethical Off-Label Drug Promotion: What Would It Look Like?

In a Forbes piece (here), former Pfizer VP of Research John LaMattina noted the "jarring" juxtaposition of two articles in the August 8th edition of the New York Times.

One article was the obituary of Dr. Frances Oldham Kelsey (see image on left, read Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101), a "legend for anyone involved in regulation and approval of new drugs."

The other was an article about a court ruling opening the door for pharma to promote their new (and old) drugs off-label (read Amarin Wins Off-Label Case Against FDA; Will Promote Viscera Off Label "ASAP").

You recall that thalidomide was already on the market in Europe as a sleeping aid, when the drug company Merrill submitted it for approval to market in the U.S. by the FDA.

Dr. Kelsey felt that there was insufficient safety data to justify U.S. approval. "Much to Merrill's dismay," notes LaMattina, "Dr. Kelsey was adamant that more testing was needed and refused to recommend approval of the drug. This delay proved to be more than justified."

Jump ahead more than 50 years to the off-label court case. What does the thalidomide experience teach us about off-label promotion?

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Should Medical Societies Curb the Use of Conference Twitter Hashtags by Pharma?

Twitter is becoming a common adjunct to medical conferences. Attendees and outside observers (including patients) can follow the online discussion via the official conference hashtag. Some experts predict that virtual attendees of medical conferences will soon outnumber physical attendees (read, for example, "The Emerging Virtual Medical Conference"). This is a concern of medical societies that depend on the income generated by these events. Related to that is the concern that commercial entities -- i.e., pharmaceutical and medical device companies -- can use Twitter to exert their influence over physical and virtual attendees before, during, and after the conference.

A study by Desai et al (here) examines the use of Twitter by commercial entities and concludes that due to the reach of their Twitter accounts these entities do exert an equal or greater amount of influence than healthcare providers via social media. The fear is that "third parties can use this influence to promote their products or services instead of sharing unbiased, evidence-based information," say the authors. They argue that whereas conference organizers mitigate "detailing" at live events -- e.g., not allowing third parties to select speakers at plenary and other sessions, not allowing third parties to pass out literature in-and-around classrooms, and restricting learner access to third parties to one geographic location ("exhibition hall") and only during specific periods of time that do not conflict with other scientific sessions -- there are no such restrictions in the virtual realm.

Consequently, the authors propose safeguards to limit third party -- i.e., pharmaceutical -- “detailing” via Twitter "backchannels" as they call it. What are these proposed safeguards? Are they necessary?

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Pharma's Influence ($ + Twitter) Over Medical Societies

(click on image for an enlarged view)

Today, I came across a Milwaukee Journal Sentinel and MedPage Today report (here) that links pharmaceutical industry payments to physicians and medical societies that determine treatment guidelines for drugs that they produce. The report focuses on the anticoagulant market and Gregory Lip, a British heart doctor with "extensive financial ties to the pharmaceutical industry. Lip has also served on treatment guidelines panels that have recommended greater use of the new [anticoagulant] drugs.

"Critics argue the financial relationships can lead to guidelines that make ineffective, costly or potentially harmful recommendations," says the report.

"Drug companies and some doctors counter that those with conflicts often are top experts in their fields and they provide essential insight to such committees. A 2012 Journal Sentinel/MedPage Today investigation found that treatment guidelines for conditions treated by the nation's most popular drugs, which accounted for $94 billion in sales at the time, were written by panels heavy with doctors with financial ties to drug companies. The investigation found that 66% of doctors on 16 guideline panels that listed conflicts had financial ties to drug companies. Nine guidelines were written by panels where more than 80% of doctors had financial ties to drug companies."

But pharma uses more than money to influence medical societies and its members. They also use Twitter. Hows so?

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