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No such thing as bad publicity?

Published by Cendi Eblin on January 31, 2012.

If you aren’t privy to the controversy surrounding celebrity chef Paula Deen’s recent announcement that she not only has type 2 diabetes—but that she is also the new spokesperson for a diabetes medication called Victoza—I am truly surprised as to how you wound up at this blog posting.

Basically, you’ll find both criticism and support all over the Internet from fellow chefs, healthcare providers, and concerned people.

One perspective you won’t find much of is toward the drug company that hired her, prompting her to “come out” with her condition. This is both curious and disappointing.

The pharmaceutical industry has historically been painted as a profit-driven, insensitive villain—a credibility crisis that has, only in recent years, been somewhat softened through the tireless efforts to provide authentic support and advocacy for patients and healthcare providers through funding for research, education, and community development.

I recently read an article that summed the Deen situation up with the words “there’s no such thing as bad publicity,” in terms of her (however slight) change of branding, and promotion for Victoza. Maybe this is true in other categories…is it true in pharma?

I’ll bet that fellow drug marketers are still trying to figure out how this can be interpreted as a good thing—how hiring a celebrity chef who would be attacked for her decision to “sell out” and be a spokesperson (c’mon, who wouldn’t have seen it coming) can cast a light that is anything but negative for the pharmaceutical industry. Perhaps some market conditioning could have prevented all this backlash.

Apparently, when Novo Nordisk contacted Deen, they did not know she was diabetic—they merely asked for lighter recipes for their “Diabetes in a new light” initiative. But when she responded with “how did y’all know I had diabetes?” their choice of partners (or at least their timing with Deen) might have been reassessed.

With several successful diabetes products on the market, Novo Nordisk is already a well-known name in diabetes care. So are they really worried about product awareness?

Or could this be a master plan to stir up awareness for the disease-state itself, which could be prevented with the right lifestyle choices?

Mmmmaybe. But in the midst of such controversy, no one seems to be making that connection—and it isn’t doing any favors for the reputation of the industry as a whole.

As for Paula, she’ll be fine. After all the dust settles and the news is no longer sensational, she will have lost some followers who find her hypocrisy and irresponsibility distasteful, but she will have gained new ones, namely among the millions of Americans with type 2 diabetes who can relate, as well as those who previously dismissed her because of the unhealthy nature of her otherwise delicious comfort-food recipes. For this, the publicity is necessary for awareness.

As drug marketers, we need to create a sense of advocacy and support for patients, healthcare providers, and their respective disease states. Simply put, the pharmaceutical industry has been trying to earn as much good publicity as possible. So we have to wonder, is this one step forward or two steps back?

Categories: Health and wellness marketing
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Non-physician prescribers–the new marketing frontier

Published by Brenda Rizzo on January 9, 2012.

We seem to forget about this very influential group of prescribers who make independent decisions based on their assessment about how to treat a condition. Across all 50 states nurse practitioners (NP) and physician’s assistants (PA) are able to prescribe. Each state has their own specific rules that can limit or expand those roles, but they are all able to prescribe. So now that you have considered this audience, how do they want to be marketed to?

That depends on their specific specialty. An NP who works in long term care may be more focused on reimbursement channels and routes of administration, given the population they serve. NP’s who work in family practice may be looking for educational support for a busy and varied practice. NP’s who work in women’s health may be looking for assessment tools as they manage health concerns of women in transition to menopause. We don’t know until we have asked.

Here at GSW we have assembled a group of NPs and PAs to consult with a variety of specializations that we can contact to get their opinion. Sometimes it can be as easy as a phone call, or we can survey them as a whole. We can even get them together on a chat room online or do a focus group. This has become a very valuable tool. We have found insight into the way they practice, how they make prescribing decisions and how they would like to get information on new drugs. We have asked them to suggest tools that would be helpful to their practice and evaluate tools along the way as we develop them. We had nurses involved in advising us about an online educational tool that has been valued by several of our clients, and adapted for their use.

Our panel includes NPs and PAs from all across the country with areas of specialization from neonates to geriatrics, from inpatient settings to outpatient clinics, from doctor’s offices to operating rooms. It is a temptation to guess what they need or want from a pharmaceutical company, but when we ask them we are often surprised at what they really value. This has helped us to stay focused on creating value added materials/benefits that help them to serve their patients as well as see the value of what we are trying to sell.

Some overall themes that I have observed in working with NPs and PAs are:
 • They are very passionate about the patients they serve. It is not enough to put a patient on birth control; they also have to talk with her about how to avoid sexually transmitted diseases. It is not enough to put someone on an anti-hypertensive, they also educate on how to change their lifestyle to improve their blood pressure. It is not enough to treat their acne; they want to know how their breakouts are affecting their self-esteem. They tend to consider the whole patient, not just the disease state they are treating.
• Affordability is a big issue. If the benefits of the drug outweigh the additional expense then they will help the patients to understand this. But if their perception is that there is an alternative that is more affordable then they probably will not consider the more expensive option. Giving a patient a more expensive drug that they can’t fill, due to the cost, when there is an alternative that is generic does not fit well with their point of view.
• Patient Education is an aspect of patient care that they “own.” Tools to help them be more effective are an added value to their practice. They don’t mind if it has a brand name on it or is specifically about a particular product as long as it is not trying to tear down or bring a bad light to competing products/points of view. They do not expect all educational tools and support to be unbranded.
• They value being viewed as experts in their area of specialization. Anything that can promote acknowledgement of that expertise is desired. Train the trainer, speaking engagements, certifications, or awards are valued. They feel a lack of recognition in general and when they obtain recognition it elevates their visibility in their community.

Finally each area of specialization utilizes NPs and PAs in a very unique way. You don’t gain insight in asking a NP that works with adults what a NP in pediatrics would need. Asking a PA that works in palliative care would not know what a PA in the operating room needs. So seek out insight from NPs or PAs that actually work in the area where you are interested in influencing.

NPs and PAs are organized; they belong to professional groups, both locally and regionally. Many participate in online chat rooms, or visit educational websites. But ask them, “where do you get your information?” Then you know what they want or need and where they will look for it.
Have you created any programs for non-physician prescribers? How did you develop it? Any insights from your programs that you would be willing to share? This is a rich area that needs to be explored for effective communication.

Categories: Healthcare marketing innovations
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What impact will follow-on biologics have for pharmaceutical marketers?

Published by Michael Scott on June 6, 2011.

The answer, like most things, is “it depends.” An important question remains to be answered: Are Congress and the FDA really going to declare “interchangeability” between an innovator biologic medication and a follow-on biologic? With interchangeability, you’d have a situation much like that with most current generic drugs. Brands will have a short time to recoup costs and will be competing with generics that can be substituted by a pharmacist without the intervention of the doctor.

Just a few short years ago FDA said that it “has not determined how interchangeability can be established for complex proteins.” The Biotechnology Industry Organization (BIO) states that “the current state of science is not sufficient to establish interchangeability for complex follow-on biologics.”

Follow-on biologics have already been approved, but not as interchangeable products
An explosion of generic drugs has resulted from the generic pathway established in 1983 by the Hatch-Waxman Act: Section 505(b)2 of the Food, Drug, and Cosmetics Act (FDCA), which allows for an abbreviated new drug application (ANDA).

According to FDA Guidance for Industry: Applications Covered by Section 505(b)2, an ANDA is “an application…where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.” In other words, the generic manufacturer can rely on published literature and the FDA’s finding that the original branded drug is safe and effective. The ANDA pathway generally does not require costly Phase III studies, but it was not written to apply to biologics.

In 2004, FDA stated that it could not reach a final decision concerning the approval of Omnitrope, a follow-on recombinant human growth hormone (rhGH) manufactured by Sandoz, through the 505(b)2 ANDA process (the application used Pfizer’s Genotropin as its reference). FDA felt that it was an issue that had to be settled by Congress because there was so much uncertainty in the scientific and legal issues surrounding biologics.

A response that continues to raise more questions, years later
Ordered by a federal district court to hold a hearing on the ANDA, FDA approved Omnitrope in 2006 but issued a 53-page “decision letter” addressing petitions from Pfizer, BIO, and Genentech requesting that FDA not allow this ANDA for a biologic (protein) product. At the very beginning of the letter, FDA spells out several items that its response does NOT address, including:

  • Interchangeability—Omnitrope was designated as a “BX” generic; these are “drug products for which the data are insufficient to determine therapeutic equivalence”                            
  • Scientific issues with protein products, especially those not well-characterized by currently available analytical techniques (rhGH was considered by FDA to be “extensively and adequately characterized”)

In addition, Sandoz had conducted three original Phase III trials in pediatric patients with growth failure. So this decision did not establish a precedent.

Fast-forward five years
The Biologics Price Competition and Innovation Act, signed into law in 2010, attempts to provide a pathway to interchangeability for biologic medications in general, despite the fact that—as far as I know—researchers have not solved the issues wisely avoided by FDA in 2006. The law as written states that the follow-on biologic must show data from “analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive compounds.”

For FDA to declare a follow-on biologic “interchangeable,” the manufacturer must show that “the risk in terms of safety or diminished efficacy of alternating or switching between use of the [follow-on] biologic product and the reference product [innovator or brand] is not greater than the risk of using the reference product” alone.

Follow-on = Me-too?
Right now, it seems to me that the only way to demonstrate interchangeability (lack of additional risk) would be through large, costly Phase III studies. The price of entry into manufacturing biologics is high, so the steep discounts seen for generics will not materialize (follow-on biologics could easily be 80%-90% of the price of the original). And given the fact that it may be reckless, in the current state of knowledge, to declare a follow-on biologic “interchangeable” (allowing substitution without the knowledge of the physician), will patients and physicians choose a 10% discount for a “biosimilar”?

So the situation won’t be remotely comparable to generics, if science prevails. You’ll be looking at biologics that are based on an innovator product, priced at 90% of the original, with no automatic substitution. Unlike chemical “me-toos” (new brands in a class, such as statins), follow-on biologics will not be able to promote better efficacy or safety. I think for now, biotech innovators have little to worry about, and follow-on biologic manufacturers face an uphill battle.

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2D barcodes and augmented reality buildings point to opportunity for pharma

Published by Michael Scott on December 27, 2010.

In 2006, I went to Japan to help localize an intranet for a major pharmaceutical company. Nothing about this portal for managing your own career fit naturally into Japanese culture.

Having lived in Japan for 4 years, I could see that we would have difficulties right from the word “career” itself (which had to be borrowed from English as “ka-ri-ru”). Other cultural and linguistic problems involved the merit-based system replacing seniority, the necessity for employees to speak up to managers and take control of their own careers in a culture where “the nail that sticks up gets hammered down,” and the appropriate translation of various buzzwords such as “competencies,” “skill set,” or even “promotion.”

Here a QR code, there a QR code, everywhere…

But as I walked around, I noticed something that had changed in the time I had been away from Japan. This was almost 5 years ago, but it seemed that almost every ad, subway poster, store sign, package, fast food wrapper, or business card—pretty much any flat surface—had “QR codes.”

I had no idea what these strange shapes were. But one member of our group—the user experience architect (guru, actually)—explained what they were and lamented that they were not yet used more widely in the US.

A typical QR code

Actually, QR codes are the most common type of 2D bar codes. Normal barcodes are 1-dimensional: they can only store information along a single linear axis. (By the way, in Japan a bad comb-over is referred to as “bar code hair.”) But 2D bar codes can store information in 2 dimensions (horizontal and vertical). They were originally developed in Japan by Denso-Wave, an affiliate of Toyota, to track parts in vehicle manufacturing. “QR” stands for quick response, since these codes were developed to be quickly and easily read by scanning equipment.

Continue reading ’2D barcodes and augmented reality buildings point to opportunity for pharma’

Categories: Break-through advertising
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I hate pharmaceutical advertising

Published by Eric Davis on June 14, 2010.

Why? Because it’s just not good. Or at least 97.694% of it isn’t.

You can see for yourself. Flip through the journals. Does anything you see really stop you? Surprise you? Move you?

Very little of it is daring. Or mysterious. Or original.

It doesn’t speak. It just … exists.

It clamors for attention through garish brand colors, ridiculous metaphors, and trite portrayals of the human experience.

Of course this can be said of most current consumer advertising, but pharmaceutical advertising is a notorious repeat offender of these crimes against creativity.

Then why am I here?

I love a challenge. I’m not just saying that because these golden handcuffs are surprisingly comfortable.

Honestly, I’d rather force change where change is needed most.

Countless art directors and copywriters share the dream of someday working for a revered ‘creative-driven’ client like Apple or Nike or Harley Davidson. Someone who ‘gets it.’

But what is ‘it’ really worth? Personally? If every creative shares that same vivid dream, how many actually get the opportunity to live that dream?

I’d rather work for the Crispin Porter of pharmaceutical agencies than one of the myriad consumer shops that simply ape CPB ‑ for better or worse.

I’d rather innovate sales tools and messages in an environment where direct selling is still the preferred method. (When was the last time you bought anything from a door-to-door salesman?)

I’d rather bring new technologies, platforms, and strategies to a world where it takes 10 or 11 months to produce an eight-page brochure. (Let’s be honest about what a sales aid really represents.)

I’d rather change the future of a business unable to mutter the word ‘future’ because of the omniscience of the FDA. (Does the world really think physicians are that dumb?)

At least here, the opportunities to shift the focus, change the dynamic, and move people profoundly are plentiful … and will be noticed.

Sure I hate pharmaceutical advertising for what it often is.

But I love it for what it could become.

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Liberating a brand by redefining the target audience

Published by Brenda Rizzo on April 28, 2010.

When marketing a healthcare brand to a professional audience typically the physician is considered to be the only intended audience. But there are many non-physician healthcare professionals that also make independent prescribing decisions, and are often overlooked. Identifying those targets can be confusing and the laws that regulate their prescribing behaviors differ from state to state. But there are many similarities once the different roles are understood.

Types of prescribers.

Non-physician prescribers include:

  • Nurse Practitioners (NP)
  • Clinical Nurse Specialists (CNS)
  • Advance Practice Nurses (APN)
  • Certified Registered Nurse Anesthetists(CRNA)
  • Certified Nurse Midwives (CNM)
  • Physicians Assistants(PA)

NPs typically specialize in an area like primary care, pediatrics, women’s health, cardiac, oncology, etc. Depending on the state they practice in, they can either be independent providers of care or are in a practice arrangement with an attending physician.

Clinical Nurse Specialists are masters prepared nurses that in some states (not all) have prescriptive privileges. Typically they work in hospital and/or inpatient medical care organizations, but when they are in private practice it is most commonly in the area of mental health.  APN is an umbrella term that describes nurses that have gone into advanced practice. Not every state uses this term but when it is used it can include NPs, CNS, CRNAs and CNMs in their category. Physician’s assistants also have prescriptive authority. They are licensed to practice medicine only with physician supervision.  The level of supervision required varies from state to state.

How to connect with them.

When considering marketing to these non physician prescribers what should be different about the way you convey your message? The level of sophistication of evidence needs to be the same as it would be for a physician. Making separate marketing messages about the clinical features of a drug or device for this audience would be a mistake. However, providing collateral materials that help them to function in their role would be valued. For example; patient education materials that would support their role in counseling, or assessment tools that would help them to identify problem/needs more readily. These materials cannot be created for the express purpose of selling the product, or educating the patient about a condition that can only be treated by your solution. It must be as unbiased as possible and the intent must be about supporting their role as a non-physician prescriber and to improve patient care.

Non physician prescribers can also be reached through professional organizations, at national and regional meetings, through journals and webinars. They also have the need to obtain continuing education hours to maintain licensure, so pharmaceutical and/or medical device companies can support this effort through unrestricted educational grants, just like they do with continuing medical education.

Categories: New ideas and approaches
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Personalized medicine is here. What role do pharmaceutical marketers play?

Published by Michael Scott on April 12, 2010.

Remember the Jetsons? High rise apartments floating in the clouds, personal spaceships, and robotic maids. Do we have any of these things? Nope, nope, and…well, maybe, if you wait until about 2015, have plenty of disposable income, and feel comfortable telling something that looks like Robocop that it missed a spot.

But while you’re bemoaning your inability to purchase a jet pack, some pieces of the future are here, now—and have been for some time. Take “personalized medicine,” for example. It doesn’t mean the development of “tailored medicine” for an individual patient, but something much more practical: the use of medical information for better patient diagnosis and more targeted, effective treatment.

For example: Targeted help for 25% of breast cancer patients.

Herceptin is the best-known example. Approved for the treatment of breast cancer in 1998, it’s indicated for patients in whom the HER2 receptor protein is overexpressed, which occurs in about 25% of all primary breast cancers. This sort of genetic variation is often referred to as a biomarker.  A clear, compelling (even for non-scientists) MOA video can be found on the website.

These new insights are currently most used in oncology, since cancer has a strong genetic component and there are great variations in response to the same therapy. Take Iressa, used in the treatment of non-small lung cancer. It targets and blocks the activity of EGFR-TK, an enzyme involved in cancer cell proliferation and survival. About 10-20% of non-small cell lung cancers in Europe and about 40% in Asia are due to tumors with an EGFR-TK mutation, which are especially sensitive to treatment with Iressa.

Is this another ode to the end of the blockbuster era?

Not really. For drugs like abacavir, used in the treatment of HIV, it could mean more confidence among prescribing physicians. Some patients have severe adverse reactions to abacavir, but it was found that they could be identified by a genetic variant.

As more and more drugs are developed with companion diagnostic tests, companies can spend less on drugs that have less chance of being approved. They can also take another look at subgroups from clinical trials to identify the patient populations most likely to respond to a drug. Rather than limiting possibilities, the use of biomarkers allows drugs to be marketed to appropriate patients. Companion diagnostics can lead to improved clinical trial data, greater chance of FDA approval, and even allow so-called “niche” drugs to become first-line therapies for the right patients. The FDA now recognizes 32 distinct biomarkers, and more guidance is forthcoming.

Continue reading ‘Personalized medicine is here. What role do pharmaceutical marketers play?’

Categories: Healthcare marketing innovations
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