It was a banner year for FDA drug approvals. The approval of 30 new therapeutics is the second highest number in the past decade (2004 saw 36 approvals). There were 24 new molecular entities and 6 new biologics that address major unmet medical needs, hit new molecular targets, and/or leverage molecular profiling to add a degree of precision to the art of medicine. Analysts highlight the high degree of innovation in the 2011 approvals, which includes 11 first-in-class products and 11 orphan drugs.

Cancer had the highest number of new drug approvals with 8, and analysts note that the approval rate for cancer drugs is higher than in the past. Seven of the 8 newly approved cancer agents had received orphan drug status, which might have expedited the path to regulatory approval. Also notable is the approval of 2 cancer drugs – Xalkori^® (crizotinib [Pfizer]) and Zelboraf^® (vemurafenib ]Roche]) – that have companion gene diagnostic tests, which define patient populations who can respond to the drug and exclude those who will not. Therapeutic-diagnostic codevelopment programs led to shorter clinical trial development time and speedier FDA approvals in these 2 cases.

While most of the newly approved drugs/biologics were sponsored by large pharma, smaller biotech companies found success in getting products approved. Notable is the approval of Vertex’s Incivek^® (telaprevir) for the treatment of hepatitis C virus (HCV) infection. Incivek has been pegged as a blockbuster and is expected to change the face of HCV treatment. Despite the successful approval of biotech products in 2011, launch success has been poor. Human Genome Sciences launched Benlysta^® (belimumab), the first new treatment for systemic lupus erythematosus (SLE) in over 50 years but market uptake has been poor; perhaps due to high expectations on the part of investors and/or poor perception of the benefits on the part of physicians.

Overall, the FDA was efficient in their review of new drug applications (NDAs) and biologics license applications (BLAs), generally hitting their PDUFA timelines. Nineteen drugs were approved in the first round of review. There was an unusually high percentage of approvals in 2011 (>80%) compared with recent years (typically ~50%). Analysts expect fewer approvals in 2012.

Annual reports like this get me thinking about new business opportunities. There’s opportunity to seek out therapeutic agents that have great potential and several things we can take away from the recent crop FDA drug approvals:

• There’s opportunity with orphan drugs. One-third of the 2011 FDA approvals were orphan drugs. The high approval rate of orphan drugs has been a clear trend over the past half-decade, which will continue given the shift by drug developers towards potential “niche busters.” There’s a distinct business opportunity with orphan diseases in that there’s a small population of patients, but there’s significant market exclusivity for approved products
• Drug compounds with companion diagnostic tests could provide a unique business opportunity. We’ve all heard about the promise of “personalized medicine” for years. Personalization of therapeutics per se is a bit of an overpromise at this time for all but a few diseases; however, “precision medicine” is viable right now. Guiding the clinical use of a medication by using molecular profiling approaches is very beneficial from a marketing perspective. First, it can expedite the FDA approval pathway as we saw with 2 of the cancer drugs approved in 2011. Second, it inherently presents opportunity for unbranded prelaunch initiatives required to bring an understanding of the molecular pathway involved in the disease process and subsequently exploited as the mechanism of action of the drug. Third, once launched, a drug with a companion diagnostic test will reset the risk/benefit equation by identifying those patients who are most likely to respond to therapy or are at most risk for a particular side effect. There is a bit of a give and take. The product will be niched for a smaller patient population; however, the barrier to use of the drug would be substantially lowered when clinical outcomes can be predicted. This is particularly advantageous for new products where the long-term risk/benefit is unknown. Lastly, drugs with companion diagnostics will create the need for clinical decision support tools given the complexity of genetic information typically generated by advanced diagnostic testing
• Don’t discount small biotechs. Biotechs are coming of age. Consider Vertex with its newly approved HCV treatment, Incivek. The company was founded in 1989 and only now has a potential blockbuster. Human Genome Sciences’ Benylsta is a product that has emerged from the biotechnology boom of the mid-1990’s. Biotechnology is a powerful tool for drug discovery efforts that allows for better identification of lead compounds. The technology is constantly evolving, becoming more powerful. I anticipate more potential drug candidates come to fruition with small biotechs that have focused drug discovery efforts through the application of modern biotechnology
• Small biotechs need help with product launches. SLE is typically treated with general immunosuppressive drugs and has been the standard of care for 50 years, so the poor uptake of molecularly targeted Benlysta is surprising. But analysts have said that all biotech launches have been “very poor” last year, with the exception of Incivek. One reason could be that the phycisian audience doesn’t correctly perceive the benefit of the drug. Looking back, I cannot recall as much prelaunch conditioning for Benlysta as there has been for other big pharma–backed biotech products; specifically thinking about the prelaunch campaigns on the role of interleukin-6 in rheumatoid arthritis or RANK ligand in osteoporosis, which preceded the launch of Actemra^® (tocilzumab [Roche/Genentech]) and Prolia^® (denosumab [Amgen]), respectively. Perhaps the smaller biotechs do not have the prelaunch budgets that big pharma has, but clearly these initiatives are important and can be uniquely leveraged from a marketing perspective. Not that all this can be done on a shoe-string budget, but there’s a potential business opportunity to package a suite of prelaunch tactics aimed at the smaller biotechs

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Source:

The source article for my quick summary above, and my own food for thought, was published  (February 2, 2012) in Nature Reviews Drug Discovery.

Mullard A. 2011 FDA drug approvals. Nat Rev Drug Disc. 2012;11(2):91-95.

Meleik Goodwill, Medical Director, Palio

One of the classic definitions of marketing is delivering value in order to capture value. So it would seem that when someone’s got a question about your product, service or organization, you answer it. Your answer delivers value, allowing you, hopefully, to capture anything from a new customer to incremental brand awareness.

So when your organization is asked a question, the correct response – every time – is to answer it, right? The answer, it turns out, is a definite “maybe.”

One of the many things muddying up the answer is the proliferation of question sites – platforms like Quora, Yahoo Answers and others where members can post questions, relying on the collective intelligence of other members for input.

In theory, these are a great example of how enabling technology can aggregate expertise and collectively boost the knowledge available to anyone with an internet connection. And, most of the time, that’s the end result.

But there’s a big difference between 50 (or 5,000) strangers chiming in with suggestions on how to best fry a chicken, versus that same enthusiastic, opinionated and sometimes ill-informed group suggesting the best cholesterol medication, or whether vaccines are, in fact, safe.

Getting back to that chestnut about delivering and capturing value, the marketer’s instinct on things like this is usually some variant of “dive in!” After all, there’s an aggregated audience of people seeking information about your product or service, right? But the answer isn’t that clear-cut.

There’s a lack of clarity from regulators on how pharma should handle social-media messaging, and the very nature of question sites is that their messages have a level of permanence, typically indexed in search engines for future reference in a way that last month’s Facebook update comment is not. Plus, like dinner parties the world over, there are some people who show up just to argue – and a public, search-engine indexed fight with someone who just wants to tear down your brand isn’t moving the marketing program forward.

Does that mean pharma marketers should ignore these sites entirely? Not at all. A solid regimen of monitoring and privately responding to questions (a feature that Quora offers but Yahoo Answers does not) allows marketers to keep an eye on things and offer authoritative information when warranted.

Answers to public questions are not off the table, but as with so much of the online world, context is king – answering with an official corporate response on the popular site Reddit, for example, risks derision no matter how accurate and complete the response is, simply because the community values individual rather than corporate presence.

Question sites are one of the hundreds of new channels marketers must navigate. But whether it’s answering a prospect’s question or making a sales presentation, the fundamental question marketers deal with never really changes: How, with this particular audience and this particular channel or platform, can I deliver value?

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten

Andy Smith, EVP, General Manager, Director of Global Operations, Palio

Last year on Pixels & Pills, I wrote about the mainstreaming of social media, highlighting a report from Nielsen Co. that found Americans are devoting almost a quarter of their Internet time on social networking sites and blogs, a 43 percent increase compared to one year ago.

Now, a year later, social is still dominating, with the 2011 version of the Nielsen report finding:

• Social networks and blogs continue to dominate Americans’ time online
• Social media has grown rapidly – today nearly 4 in 5 active Internet users visit social networks and blogs
• Americans spend more time on Facebook than they do on any other U.S. Website
• Close to 40 percent of social media users access social media content from their mobile phone
• Social networking apps are the third most-used among U.S. smartphone owners
• Internet users over the age of 55 are driving the growth of social networking through the Mobile Internet
• Although a larger number of women view online video on social networks and blogs, men are the heaviest online video users, overall streaming more videos and watching them longer
• 70 percent of active online adult social networkers shop online
• 53 percent of active adult social networkers follow a brand, while 32 percent follow a celebrity
• Across a snapshot of 10 major global markets, social networks and blogs reach more than three-quarters of active Internet users
• Tumblr is an emerging player in social media, nearly tripling its audience from a year ago

Pharmaceutical companies shouldn’t overlook the value of social networks for connecting with patients and strengthening brand awareness. In fact, by limiting participation on social networks to blasts about new medicines or company news, pharma companies are missing out on an opportunity to better serve patients.

Social media’s interactive nature provides patients with the opportunity to become engaged in their own health care, whether that’s requesting a particular prescription during a physician visit or carrying product messages back to their own social network. Pharma companies that engage the end consumer – the patient – can extend their message through a cadre of brand ambassadors. Social media can also be useful to communicate drug/device safety alerts, deliver daily tips to support a better state of wellness, remind patients to refill prescriptions, recruit clinical trial participants or connect individuals with a support community.

While the Food and Drug Administration has yet to issue formal guidelines, some drug makers have been advised against using Facebook to promote prescriptions. However, the issue wasn’t the platform; its beef was that the promotion only articulated benefits, not the risks. The lesson is that transparency is essential. Beyond promoting a particular medicine, pharma should use Facebook to:

• Build relationships and spark discussions – not as a linear platform for conveying information
• Provide valuable, informative information – not just promotional content
• Spark one-to-one dialogue, and encourage patients to participate by sharing their own experiences
• Avoid avoidance; monitor what people are saying and should things go awry, offer clear messages and alternative avenues for getting information
• Work in tangent with other social networking platforms. Want a YouTube video to go viral? It’ll never happen without a coordinated Facebook campaign

Pharma companies should embrace social media for what it is – a valuable medium for carrying key messages, building relationships and increasing product loyalty. But that’s what it is – a medium. What doesn’t change is the core work of examining the marketing strategy, crafting transparent and clear messages, and engaging social media to add value and build relationships.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Todd LaRoche, EVP, Managing Director of Creative, Palio

There is no slow season in health care. Whether seeing patients in between personal and professional appointments or a spike in patient visits during cold and flu season, doctors are always busy. For sales reps, this results in a greater challenge getting face time with doctors.

Sales reps may not be used to communicating in a two-minute window, but doctors, nurses and office staff are conditioned to interact that way. Last year on Pixels and Pills, I wrote about being brief and getting to the point when communicating with doctors. That still holds true, but with more doctors tethered to their smartphones and iPads, we need to use technology to change how we communicate with doctors.

Give them what they want. Sales reps need to get better at tracking information related to each sales call, including the doctor’s contact information and preferred mode of communication, patient population needs and prescription-writing activity. With a compressed amount of time to detail new medicines and deliver marketing messages, it’s important to address those most relevant to each practice. Having better information, sales reps can then implement more doctor-centric strategies and design more relevant campaigns.

Get your high tech game on. It’s important to identify creative ways to convey information. For doctors who are digitally savvy and prefer electronic communication, an interactive iPad app or digital brochure can deliver value and foster stronger relationships – all while providing an efficient and more cost-effective means of communicating beyond the traditional face-to-face call. And, physicians can review information at a time that is convenient to them – not when they have an office full of patients.

Speak in sound bites. If you can convey information in a 140-character tweet, you can do it in the real world. But if you have mere minutes of a physician’s time – whether in the office or at a virtual event – a succinct presentation style can be a real differentiator.

Recognize that it’s all in the details. While overall sales and market penetration matter immensely to the organization’s bottom line, at the individual sales rep’s level there are other metrics worth tracking in this limited-face-time environment. Average amount of time spent discussing products with a physician, requests for additional information, volume of sample product distributed or prescription-writing activity are just three of many ways to track messaging effectiveness by proxy measures. Understanding how physicians want to receive and interact information can help you determine the best technology solutions to facilitate information exchange and meet their needs.

Technology is creating new and exciting opportunities for communication that enable us to take evolving communication preferences into account when providing new product information, clinical alerts or product updates. By incorporating communication technology, electronic promotional activity, and virtual events into our communication arsenal and demonstrating depth and breadth of product knowledge, sales reps can provide valuable interactions with doctors and achieve their objectives.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Gregory Alderisio, Senior Copywriter, Palio

Let’s say you see an ad in a magazine or on the Web and you absolutely hate the headline. Who do you blame? Naturally, the wretched, abominable writer. Or what if the art direction is so banal or so hideous you recoil in horror. Whose fault is that? Of course, the hapless, no-talent art director.

Pretty much everything wrong with an ad can be laid at the feet of two people: the AD and CW. It’s the same with the glory. A good headline: well, obviously that came from the unique mind of a gifted writer. An inspired visual? Kudos to the innovative genius of the art director. Why would it be any other way? A pair of people did the ad so let’s praise/stone them depending upon how it turned out. And of course at their year-end review, the creative team with too many boring, dull, moronically-simplistic ads gets labeled as lazy, timid or unimaginative. On the other hand, the team with award-winning work gets a raise, a bonus and a big fat ego.

Because that’s the way many agencies are run, it’s got to be a good system, right? Well, maybe not.

What if instead of praising or blaming two people for the work, we praised/blamed everyone? Not just in words, but in more tangible ways. Planners, account people, medical directors, creative directors, producers – what if all their raises, bonuses, perks and promotions depended upon the creativity of the work their accounts produced? Overnight agency output would improve. Because it can’t be just the creative team who’s motivated to do good work, that’s not enough. Two people alone can’t push good work through a sea of indifference and nitpickers. Every department has to want the good stuff and have a vested interest in getting it sold and seeing it produced.

This may sound self-serving but ultimately it serves the client because clients get better work that attracts more attention. And brands that get noticed are brands that have a better chance to succeed and make clients happy.

If we’re comfortable calling out creative work that’s dull and lifeless, we should be just as comfortable doing the same with a dull key thought, a me-too insight, or a toothless medical claim. We can’t just sleepwalk our way through customer research, message development and strategy generation then sell ho-hum ideas to our clients and expect the work produced to be brilliant.

When work is great, chances are it came from an inspired insight or a focused strategy and that contribution needs to be acknowledged. Great work is also impeccably produced so we have to recognize producers and art buyers when a finished idea looks just as cool as everyone imagined it would when it was merely a line drawing.

In other words, we all sink or swim together. The sooner every department is held accountable for the creative output in a concrete way, the quicker the entire agency will be devoted to bringing truly memorable ideas to the market.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Meleik Goodwill, Medical Director, Palio

Here’s something we get asked all the time: “How can we learn this social media stuff?”

This question comes everywhere – at family barbecues and school functions, hissed in work hallways and mumbled shamefacedly in the back of conferences.

What if you’re not 16? What if you’re not a nerd? What if you’re not growing up with this social media stuff in your blood? What if you don’t work with a bunch of tech geeks? What if you don’t even know where to begin?

What if you blew it off, thought it was a fad, but have seen the light and now honestly DO want to learn more about social media? Are you too late? Is there no hope for you?

Relax, question-askers of the world, and follow our quick and easy five-step plan to becoming a successful social media enthusiast.

• Slideshare. This repository of Powerpoint presentations has more devoted to social media explanation than you can imagine. Go visit and search for “social media,” and you’ll be inundated with well-written, basic, informational presentations. I’m particularly fond of this one, salty langugage and all: “What the F*** Is Social Media?”
• Mashable. Arguably the preeminent social media blog, Mashable is a fire hose of social media news. It will be a good source for you to learn a lot, if you
• A. Accept that it’s going to overwhelm you with news, and therefore
• B. Do not try to read all of it, and
• C. Do not get frustrated when you don’t understand every article.
• Social Media Examiner. Another team blog on social media, it’s a bit higher-level and definitely lower-volume than Mashable.
• Google. It sounds obvious, but it’s one that people forget quite often. Anytime you see a social media term that you don’t understand, let me reassure you: at least half a dozen people have written blog posts defining it. RSS? Follow Friday? SEO? Hashtag? Just ask.
• Ask. Whoever you are in life, at this point in time a safe bet is that most every person who reads this post knows someone who is well versed in social media. They got that way by finding it interesting, and as such, are going to enjoy talking about it. Never be afraid to ask. (This is also a great way to sort out the people who actually do know a lot from the people who just like to use popular buzzwords.)

Tiffany Ryan, VP, Account Services, Palio

What an exciting time to be working in HIV. After 30 years, the scientific community has deciphered the mechanism of viral replication, resulting in multiple drug classes targeting multiple points of replication. On the patient/provider level, therapies have evolved to meet market needs – efficacious drugs with improved tolerability and convenient dosing.

This disease state has grown and changed at unprecedented speed – shifting what was once a death sentence into a chronic, more manageable condition.

Recently, there have been some interesting new discoveries that could impact and shape the future of HIV medicine. Discoveries that intrigue, surprise, and potentially shift the future of HIV care.

Glowing Cats and HIV – Don’t let the whimsical (maybe a bit spooky) photo fool you. This is real science. Researchers at the Mayo Clinic conducted a gene-therapy based study that looked at the impact of inserting genes that are known for blocking FIV cell infection into feline eggs prior to sperm fertilization. A jellyfish gene was also inserted, to allow for tracking purposes, which caused the cats to glow green. The genes disable the virus’s outer shield during entry into the cell, thereby not allowing the virus to begin replication that occurs within the cell. The impact of this genetic defense approach will likely have applications for advancing future genetic therapies for people and cats alike with HIV/AIDS.

Cholesterol and HIV – An international team of immunologists published findings that could have implications on future vaccine development. Researchers found that removing the cholesterol contained in the viral envelope of the HIV molecule interfered with the way that the virus attempts to reprogram the body’s immune response to the infection.

Gaming and HIV – Fresh from the “complex problems are solved in creative ways” files, gamers have solved one of the many mysteries of HIV that have plagued the scientific sector for years. Foldit, a game developed by researchers at the University of Washington, is designed to help solve complex scientific problems through competitive games. In three weeks, gamers were able to create models that allowed for successful molecular replacement and subsequent structure determination of the protease enzyme. This information will be critical to informing new drug discovery and development efforts. However, maybe even more promising is that this game has been used to solve problems in other disease categories – namely cancer and alzheimer’s research.

The possibilities appear to be endless when you take the best of technology and combine it with human intuition. I, for one, can’t wait to see what comes next.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Bob Mason, EVP, Managing Director of Insight and Brand Strategy, Palio

The pharmaceutical industry isn’t known for its rapid embrace of technology, but the iPad has shattered that myth. Pharmaceutical companies such as Boehringer, Novartis and Abbott are using the devices to generate sales, provide information to investors and deliver medical information to health care professionals.

There’s no doubt that tablets are the pharmaceutical industry’s hottest trend. iPads and Android-based alternatives are an ideal fit for the pharma sales force as well as a range of health care and industry professionals. Pharma’s interest in mobile apps also delivers a range of previously impossible options. For example, with more people toting iPads, interactive competitions at industry conferences, games for patients to improve health outcomes or detailing and CRM applications for the sales force are all possible.

iPads are positioned to be game changers for the industry. And, they have yet to deliver on their true potential. Because iPads and other rival tablets enable users to consume media in new and exciting ways, pharma companies and their vendors should begin investigating and investing in new apps to power their business.

Pharma marketers have more opportunities to reach the target audience with robust, relevant Web, mobile and email experiences and interactions, well beyond the limitations of earlier mobile devices.  For the sales force, as the amount of time a physician spends with reps decreases, smartphone and tablet apps provide a more efficient and attractive way to present information to medical professionals.

Pharmaceutical companies are investing heavily in arming the sales force with iPads to better engage doctors during sales visits. If you’re considering using a tablet for a sales presentation, keep these two rules in mind:

Don’t use it just because you have one, or because you want to wow the customer. Whether used as a conversation starter or in place of a one-on-one meeting, your presentation can impact prescribing behavior. While whiz-bang graphics may be aesthetically appealing, it’s the content that matters. Include demos, reports, graphs, interactive medical calculators and decision support tools that illustrate clinical benefits or efficiencies at the point of care.

Do use it to simplify the sales call, and to show information you don’t want to leave in hard-copy form. A tablet lets you walk in the door with less “business baggage” – the note pads, the briefcase, etc. And having key  information on a tablet lets you show the data in an attractive manner without leaving behind information can occasionally find its way into the hands of a competitive sales rep.

How physicians receive information is constantly changing, but based on current trends, it’s obvious they like information in digital form. Using mobile devices for sales presentations can enable reps to differentiate themselves and deliver clear, concise and compliant messages.

Adoption of iPads is bringing new changes to the industry and will continue to serve as catalyst for future changes. Whether it’s medical education, patient communication, physician offices or pharmaceutical sales, we’ve only begun to scratch the surface. While 2011 was the year of the tablet, “there’s an app for that” will continue to influence pharma in how they deliver messages on the medium.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Todd LaRoche, EVP, Managing Director of Creative, Palio

There’s no denying it: Video games are addictive. The question for us to answer as an advertising agency that’s revolutionizing pharmaceutical and healthcare marketing, is “How can we leverage the high engagement potential of gaming to help (and healthfully) promote our clients’ brands?”

Parenting articles are rife with information on how to wean kids off games and fanzines are chock full of cheat codes, Easter eggs and behind the scenes stories. Nielsen reports that 10% of U.S. Internet time is spent playing games, which has now overtaken email as the second most popular online activity. Last year on Pixels and Pills, I wrote about how video games have changed our culture and influence the way we live and play, learn and communicate, and how we are entertained.

The Pew Research Center reports that more than half of American adults age 18 and older (53%) play video games, with the computer being the most popular gaming device. Games are not passively consumed like television; they require interaction and proactive thinking. And, they can be used to improve health and health care. Here’s how:

Extend messages to the offline world – Getting people to move more, think about what they’re eating and make smart choices has received prominent focus even from the White House. Washington-based Cascadian Farm provided a branded crop – blueberries – for Farmville players. More than fun, organizations striving to combat obesity can use games to deliver education and positively influence health whether on the farm or on the field.

Create new modes for learning – For medical students, poor test results can be more than just personal failure – they can mean life or death for patients down the road. Learning via simulation provides the opportunity for nurses, doctors and other medical professionals to develop and refine skills without compromising the safety of real patients. Games can also be fun, educational and helpful for patients, enabling them to test and deepen their understanding of health issues or contribute to better health outcomes. For example, video games can be effective therapy for stroke survivors. Using a Wii can improve patient motor functions, according to research presented at the American Stroke Association’s International Stroke Conference last year. Research projects at the Robert Wood Johnson Foundation include alternate reality games that teach substance abusers tactics to prevent real-world relapses and computer-based programs that use Wii technology to help Parkinson’s patients with balance.

Foster a sense of community – Social networks provide group support for difficult tasks or emotional situations. While some individuals are comfortable attending Alcoholics Anonymous meetings or caregiver support groups, others miss out on these valuable connections due to fear being exposed or unsuccessful. Social interaction in health care games may be useful in encouraging healthy behaviors like healthy eating or reinforcing the importance of following a prescription regime or in connecting people in similar situations.

The world of health-focused games is growing, covering a wide range of activities from rehab and physical therapy, disease management, health and behavior change, bio-feedback, epidemiology, cognitive exercise and nutrition and health education. Patient-centric health games can go far in advancing many health care goals: reversing the epidemic of obesity, driving down tobacco and alcohol use, improving the quality of health care delivery or enhancing the performance of public health system.

While achieving good health is serious business, it doesn’t mean that it can’t be fun.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Steve Dubansky, M.D., SVP, Medical Director, Palio

Rather than explain inverse proportionality mathematically, you can simply visualize in the above equation that when “P” increases, “V” decreases, and vice versa. If that still isn’t clear, try these:

1. Usefulness is inversely proportional to its reputation for being useful.
2. Car size is inversely proportional to the intelligence of its owner.
3. The severity of an itch is inversely proportional to your ability top reach it.
4. The availability of a ballpoint pen is inversely proportional to how badly it is needed
5. In political debate, heat is inversely proportional to knowledge.

But is this true:

“PUBLIC SAFETY IS INVERSELY PROPORTIONAL TO THE MARKETING OF DRUGS” ?

That is, is there an inverse relationship between the aggressiveness of pharma marketing and the health of the general public? In a recent thought-provoking article by Drs. Brody and Light in the American Journal of Public Health, the author posit that increased and aggressive marketing of pharmaceuticals may help undermine the general public’s health.¹

While agreeing that not all marketing of prescription drugs is bad for public health, Brody and Light attempt to make the case that the benefit:harm ratio is decreased as pharma marketing becomes more aggressive and less supervised. They believe that if pharma companies marketed their products in an evidence-based manner, there would be fewer negative effects on individual and public health. They state, “Unfortunately, with such a small percentage of the population eligible to receive the drug, an evidence-based strategy yields low sales, much to the chagrin of the shareholders.”

The marketing measures they believe responsible for more patients getting unnecessary and less-than-carefully-proven medications are:

1. Reducing the thresholds for diagnosing diseases. For example, despite evidence that maintaining strict glucose levels doesn’t benefit most patients, guidelines have continued to lower the glucose level necessary for diagnosing diabetes. This lowered threshold raises the number of patients needed to treat (NNT), and many patients are unnecessarily exposed to the risks of a drug they may well not need.
2. Using surrogate endpoints rather than patient-oriented outcomes. Generally, using surrogate endpoints increases the NNT for preventing hard (patient-based) outcomes. “More prevention is better than less prevention” may not be true in regard to surrogate endpoints isolated from real outcomes. The authors conclude, “Drug manufacturers sometimes find it more advantageous to market the test that measures the surrogate endpoints rather than the drug itself.”
3. Exaggerating safety claims. An example is the professed improved safety profile of newer antipsychotics in the elderly – a claim that has proven untrue. Another example: with the presumed safety of SSRIs, patients with very mild depression are given drugs that previously would not have been prescribed for their degree of illness, drugs that they do not need but may well give them side effects.
4. Creating new diseases. They offer prediabetes, prehypertension, and osteopenia – three “diseases” where treatment may be of no benefit but of some unnecessary harm.
5. Exaggerating efficacy claims. They give as a cautionary example the selective COX-2 inhibitor group of NSAIDs, which, despite performing no better than older NSAIDs, had tremendous uptake due to “massive marketing to physicians and the public,” assuring both groups these drugs were more effective and even safer than standard NSAIDs. Then there was a push to recommend them for prevention of colon polyps. At about that time the increased cardiovascular risks became so obvious that one of these inhibitors – rofecoxib – was removed from the market.
6. Encouraging unapproved uses. Since this practice is illegal, it’s only when a company is fined for off-label marketing that we become aware of it. Recent examples are gabapentin and olanzapine, but there are many others. A 2003 report showed 60% of antipsychotic prescriptions were off label, and 75% of all off-label prescriptions generally lack evidence of benefit.²

The authors raise some thought-provoking issues for modern pharma companies and their promotional partners to consider. The relevance of their concerns can be debated, but the fact remains: drugs can be dangerous. Prescription drugs annually appear to cause about 46 million adverse reactions, 2.2 million hospitalizations, and 111,000 deaths annually in the United States alone.³ On the other hand, during 20 years of practicing oncology, I and my colleagues often reminded ourselves and our patients that the only thing worse than the side effects of chemotherapy was no chemotherapy when patients needed it. That’s the key: for patients who need the drugs, drugs can be life changing and life saving.

We in pharmaceutical promotions must aid the FDA in “helping” the pharma manufacturers police themselves, and, to paraphrase Abraham Lincoln, to behave according to the better angels of their nature. The public health demands that of us.

References:

1. Brody H and Light DW. Am J Public Health. The inverse benefit law: how drug marketing undermines patient safety and public health. 2011; Mar;101(3):399-404.
2. Stafford RS. Regulating off-label drug use-rethinking the role of the FDA. N Engl J Med. 2008; 358(14):1427-1429.
3. Light DW, ed. The Risks of Prescription Drugs. New York, NY: Columbia University

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.