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.

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

When you’re developing and executing on strategy for your medical clients, you can’t do it alone – and you can’t do it in silos, either. It’s imperative that all of the groups involved – advertisers, clinical researchers, communications, marketers, med ed, promotions, public relations, social media – are all spending time with each other on a regular basis.

In times when budgets only get smaller, timelines only get shorter and workloads only get larger, it can seem like a luxury to cross-pollinate your team by spending time with each other. It’s all very well for the initial brainstorming session and whenever the client comes to visit, but for every day, many prefer to keep each group buckled down, focused on their own activities.

But that hyper-focused mentality can be just the problem. Everyone involved with a brand is on the same team but there are many very different focus points going on at once. To draw out the “team” analogy, each member of a sports team is focused on something different, although everyone is working toward the same goal of success for the group.

If they never think about each other’s work, though, they’re not going to be very good as a team at all. Sometimes it helps for a right fielder to come in and see how the game looks from the catcher’s point of view. A midfielder must know what the goalie is thinking. These teammates have very different responsibilities, but have to understand what else is going on in order to play together successfully.

Perhaps this is a trite comparison, but it’s never been as apt as in current times, where – as stated above – everything must be done faster and cheaper than ever. Understanding drives efficiency. When you know what your teammates are doing, you know how to do your work to help them with theirs. You’re thinking of your collective goal, not your immediate task.

So even if you’re not wearing matching jerseys, remember who you’re working with. Tear down your silos, your boxes and walls. Start rotating positions with your teammates and help everyone remember your end goal: making it possible for your brands to improve health for patients.

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

From  Steve Dubansky, MD, SVP, Medical Director, Palio

Below you’ll find a thought-provoking and informative editorial from the March 30 issue of the New England Journal of Medicine. The author is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics. He asks, but only begins to answer, the fundamental question above. Below are 2 quotes from the piece that should intrigue you enough to want to read on. At the editorial’s conclusion, you’ll find a hyperlink to a 1-minute-and-20-second excerpt from Dr. Avorn’s lecture on this topic at Harvard Business School.

“The evidence base available to clinicians to guide their therapeutic choices is still heavily shaped by industry-sponsored studies that often compare new products with placebo, measure their worth in terms of surrogate markers such as laboratory test results, or both.”

“They [package inserts] live on as tangled obfuscations filled with minimally usable data and liability-averting warnings.”

Perspective

Teaching Clinicians about Drugs — 50 Years Later, Whose Job Is It?

NEJM | March 30, 2011 | Topics: Drugs, Devices, and the FDA

Jerry Avorn, M.D.

This year marks the 50th anniversary of the Kefauver hearings, the pivotal 1961 Senate debate that transformed prescription drug approval and use. When Senator Estes Kefauver (D-TN) introduced legislation to regulate the drug industry, the Food and Drug Administration (FDA) still did not have legal authority to require pharmaceutical companies to demonstrate that their products actually worked. What physicians knew about prescription drugs was shaped predominantly by the claims their manufacturers made about them, and the evidence base underlying such claims was often rudimentary, or worse.

Closely related to the thinness of the science was the question of how information about a drug’s benefits and risks should be evaluated and communicated to physicians — and by whom. Then as now, pharmaceutical companies mounted aggressive promotional campaigns for their products. An unsigned 1961 Journal editorial titled “Ethical Drugs — Who Shall Educate the Physician?” noted with concern that “manufacturers spend about four times as much on the promotion of drugs as the total cost of running all the medical schools.” As a result, the editorial continued, “the majority of physicians get their first and often their only information about newly available drugs from these sources, which at best may be strongly prejudiced and at their worst are unreliable and misleading.”¹ No mechanism existed for robust, arm’s-length governmental determination of a drug’s efficacy and for the dissemination of such data — a solution that many clinicians did not favor in any case. As a result, practitioners were often left with little disinterested guidance about the usefulness or safety of new medications in comparison with their alternatives.

Among other things, the Kefauver legislation sought to have the federal government provide a more even-handed, public source of drug education for physicians: a leaflet that would accompany every prescription medication describing “all the information about the activity, uses, and untoward effects of the drug”; a compendium of such information for all products “in convenient and readable form” to be distributed widely; and an annual list of medications with high potential for serious side effects.

The American Medical Association (AMA), skeptical about any public-sector role in health care, argued that this was not a proper activity for government and that such communication should be the responsibility of the profession itself, along with industry. The AMA had been attempting to fill this function through its Council on Drugs, a group of researchers and clinicians that evaluated new medications and issued a “Seal of Acceptance” to those meeting its standards. Only drugs thus accepted could be advertised in the AMA’s journals.² However, NEJM‘s editorialist lamented in 1961 that the AMA had largely dismantled these programs, a decision that led to “encouraging the introduction of relatively inferior drugs . . . [and] the deterioration in the quality of advertising and promoting such drugs. These changes have done little to help but may have done much to confuse the physician in his efforts to practice good medicine.” The Journal noted that this failure undercut the AMA position that a governmental program was not needed.

The pharmaceutical industry and the AMA attacked Kefauver’s bill, and the idea that the government should play a central role in evaluating medications for efficacy and disseminating information about them seemed headed to legislative defeat. Then came the thalidomide disaster. That drug was being heavily promoted in Europe as a sedative and antinauseant, particularly for use during pregnancy, but a more cautious FDA approach had spared Americans the epidemic of fetal limb-reduction defects that plagued countries with more permissive drug regulatory systems. Empowered by this crisis, the Kefauver hearings resulted in a new law that gave the FDA the authority to require evidence of efficacy and safety before a drug could be marketed.³ The debates about disseminating drug information eventually led to the now-familiar “package inserts” that fit the law’s requirement for completeness, even if they have still not lived up to its larger goals of usability and readability.

Half a century later, the editorial’s question, “Who shall educate the physician?” is still hotly contested. Opposition to a role for government did not carry the day then but has dominated debate ever since; the letter of Kefauver’s legislation about drug information has been followed in one narrow sense, though its spirit has not fared as well. The evidence base available to clinicians to guide their therapeutic choices is still heavily shaped by industry-sponsored studies that often compare new products with placebo, measure their worth in terms of surrogate markers such as laboratory test results, or both.

The recent comparative effectiveness movement holds great promise for improving this evidence base, if it survives politically. Package inserts have been legally mandated, but until recently their content was determined primarily by the manufacturer, not the FDA. They live on as tangled obfuscations filled with minimally usable data and liability-averting warnings. Proposals for improving them are floated periodically, and 2007 legislation may give the agency more power to address this problem. But for the most part, the 1961 vision of an unbiased, user-friendly, practical summary of benefits and risks produced by the government for each prescription drug has not come to pass.

On the education front, recent reforms have only partially addressed concerns about the undue influence of drug companies on what physicians know (or think we know) about medications, mediated through aggressive promotion, less visible and more indirect public relations campaigns, and a manufacturer-dominated continuing medical education industry. The 1961 editorial’s reference to “ethical drugs” — an old term for prescription medications — seems oddly archaic in a time of scandals about deceptive marketing practices and heavily advertised, costly medications that turn out to have major unreported risks.

One positive response to the editorial’s question has been the outreach activities that have evolved to disseminate noncommercial drug information to clinicians. The Agency for Healthcare Research and Quality (AHRQ) has long tried to provide a public-sector source of evidence-based information on drugs and other interventions. It initially did its job so effectively that in the mid-1990s it was nearly defunded after pressure was exerted by advocates for treatments that were more lucrative than effective.⁴ A chastened AHRQ has remained engaged in this area but is reluctant to issue therapeutic guidelines that could again threaten its existence.

As the United States turns away from 1960s-era belief about government’s role in protecting the public health, and as concern grows about industry’s influence on federal policy positions, the answer to who shall educate the physician is increasingly unlikely to be “Uncle Sam.” Instead, an emerging answer may be public–nonprofit collaborations for which the government provides funding but profession-based nongovernmental entities with no ties to industry generate the scientific content. One illustration is the growth of support for “academic detailing” — educational outreach programs in which independent researchers and clinicians systematically review data for a given therapeutic area and develop noncommercial, evidence-based recommendations about treatment choices. Pharmacists, nurses, and physicians are then sent to visit practitioners in their offices to present these findings, drawing on the successful marketing strategies of industry but without its sales-oriented spin.⁵ Several states, insurers, and federal programs currently fund academic detailing programs based on content developed by nonprofit organizations free of industry ties. As concerns grow about the safety, complexity, and affordability of our expanding pharmacopoeia, demand for these programs increases.

Fifty years after the Journal grappled with these issues, they are even more relevant, and the need to provide reliable drug information to physicians is even more pressing. Enlightened by our tumultuous experience with medications and drug communications over the past half-century, we are still working on a sustainable answer to this question that lies at the heart of medical practice.

Source Information

From Harvard Medical School and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital — both in Boston.

References

1. Ethical drugs — who shall educate the physician? N Engl J Med 1961;265:910-912

2. Greene JA, Podolsky SH. Keeping modern in medicine: pharmaceutical promotion and physician education in postwar America. Bull Hist Med 2009;83:331-377

3. Carpenter D. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton, NJ: Princeton University Press, 2010.

4. Gray BH, Gusmano MK, Collins SR. AHCPR and the changing politics of health services research. Health Aff (Millwood)2003;W3-283-W3-307

5. Avorn J. Devising an antidote. In: Avorn J. Powerful medicines: the benefits, risks, and costs of prescription drugs. New York: Alfred A. Knopf, 2005:313-38.

http://www.youtube.com/watch?v=uONt4kumkIk

Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media.

From Mary Rose Burnham, PhD, Senior Medical Writer, Palio

My love of good gossip aside, I will not be dishing on my or anyone else’s marriage in this post – although I think my parents had a pretty good one that I can only hope to emulate.  The title of this post refers to a book by poet David Whyte called “The Three Marriages,” the imagery of which was borrowed by pediatrician Stephen Ludwig, MD, in his acceptance speech after receiving the 2010 Joseph W. St. Geme Leadership award from Children’s Hospital in Philadelphia.

Dr. Ludwig’s talk was entitled “Striving for Polygamy,” but not in the way you might think!  He used Whyte’s image of “three marriages” to talk about a different approach to the ever-elusive work-life balance.  Most of us, me included, tend to think about work-life balance as opposite poles between which we careen like ping-pong balls in an attempt to manage the demands of work and non-work. Whyte advocates a more harmonious approach, in which this balance is really a melding of the three marriages in everyone’s lives – family, work, and self.

As Ludwig states in his speech: “These three marriages sit within each of us. Our striving must be to keep them alive, balanced, passionate, and in harmony. They are all part of our selves. They are all important.”

Ludwig then goes on to suggest that in order to sustain all three marriages and keep them vital, we cannot view them as being separate from one another, or even in opposition. Rather, we must seek ways to integrate them. Create a blended family, if you will.

So this got me thinking. Because of the way we tend to think about work-life balance as opposite poles, we also tend to think in terms of “drawing lines” between the different worlds. We’ve all dealt with this issue on one level or another. Maybe my co-workers, for example, don’t really need to know (or care) about the time I smuggled cigarettes into the senior living facility for Crazy Old Aunt Florence. And socializing outside of work?  Sometimes it seems like navigating that mine field requires diplomatic skills on par with trade negotiations with China.

But according to Dr. Ludwig, it’s not only OK to blur those lines a little bit, it’s actually a good thing. And by allowing the lines between work, family and self to become less rigid, the life balance we all seek may actually become more attainable.

Dr. Ludwig offers a few suggestions for the aspiring polygamist:

• Find time for silence, which the poet Whyte pointed out is important. “Silent time is how you really get in touch with yourself,” Ludwig says.
• Develop close personal ties with a few selected coworkers. It’s a risk worth taking for support, friendship, and a sense of loyalty.
• Monitor your work hours and “take the steps to measure them and adjust them to the level that you and your family feel acceptable.”
• Limit the use of electronic devices. “You need some self-imposed rules on when to turn them off. No one needs to be available all times of day and night.”

“Our striving is to create a marriage of the marriages,” Ludwig concludes. “Then, if you are very fortunate, as I am today, you find yourself in a special sweet spot — surrounded by family and friends, recognized for the work you love to do, and enjoying the personal gratification.”

Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media.

From Steve Dubansky, MD, SVP, Medical Director, Palio

In 1999 the Institute of Medicine published a report entitled To Error is Human: Building a Safer Health System. The report cited two major studies stating that from 44,000 to 98,000 patients die in hospitals each year as a result of preventable medicine-related errors. Moving with its usual alacrity, the government ordered the FDA to fix the problem in 2007. Congress, realizing the urgency, passed a law asking the FDA to offer a solution by September 30, 2010.

Yet, as noted by Stephen Barlas in P&T in October 2010, “…the FDA to date has no guidance, much less regulations, on the naming of drugs. Typically, when a drug company applies for approval of a new product, the FDA uses techniques such as human factors development and failure modes and effects analysis to determine whether the name is acceptable.”

Presently the agency and their agencies assure themselves that new drugs avoid drug names that have orthographic or phonologic similarities to drugs already on the market. Physicians have notoriously bad handwriting, and I assume that either we mumble more than the average person, or pharmacists on the other end of the line have a higher than normal prevalence of hearing loss.

The FDA reviews about 400 drug names a year and rejects about one third of them. The institute for Safe Medical Practices in conjunction with the Joint Commission publishes a LONG list of look-alikes or sound-alikes. Examples listed (http://www.ismp.org/) include:

In addition to look-alikes and sound-alikes, the agency now proscribes using names that imply efficacy (Paingona, Snotclyr) and dosing interval (Onlyonceawik). They will reject drug names that are misleading, including names that suggest the name of one or more but not all of the drug’s ingredients, or names that imply the drug is superior to a competitor. It wasn’t always this way: Lopressor (lower blood pressure), Coreg (help regulate heart rhythm) come to mind.

In Act II, Scene II of Romeo and Juliet, Juliette Capulet says to Romeo Montague, “Deny thy father and refuse thy name.” She suggests it because their love is more powerful than the feuding between the Montagues and Capulets. She follows with, “What’s in a name? That which we call a rose by any other name would smell as sweet.” She’s simply saying she loves Romeo and the Montague name is of little concern to her. For Juliette, a name is an artificial and meaningless convention, not nearly as important as the individual who bears it. For too many pharmaceutical companies, the names of their products are now becoming similar meaningless appellations.

There are appropriate restrictions on naming, but it seems as if the FDA has totally emasculated efforts to allow creative and meaningful product names. Some brands do seem aptly named (Femara has an obviously womanly tone) and Sonata (I can hardly say it without dozing off). But while many names are aptly named, many others are awfully named. You know what brands I’m speaking about. Their names seem to have been made up by a computer or a random drawing from a scrabble box, often nothing more than an incomprehensible and/or unpronounceable olio of letters.

Many might say that their names are integrally connected to the success of this or that blockbuster brand. I say “Phooey.” Brands are blockbusters most often because they are novel, first-in-class products in disease states with a real need and a high prevalence, or they have real (or perceived) advantages over their competitors. But a name that actually tells you something about the drug certainly can’t hurt sales. Lipitor, a #1 selling statin from start to patent expiration this year, wasn’t first to market, but it had great data and a name that surely implied “lipid” to any physician.

Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media

From Steve Dubansky, MD, SVP, Medical Director, Palio

“Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.” ~First Amendment to the constitution

The First Amendment has served as the basis of constitutional support for many complex issues since its ratification with the other 9 amendments in the Bill of Rights on September 25, 1789.

In 2007 the Vermont legislature passed a law banning the sale and use of prescriber-identifiable prescription records to market and promote drugs unless the prescriber okays use of the data. The First District Court upheld the law despite the protestations of the plaintiffs, IMS and colleagues (PhRMA included) who requested the law be held unconstitutional. Undaunted by their loss in the First District, IMS Health, PhRMA and friends asked the 2^nd Circuit U.S. Court of Appeals to review the case and repeal the law. The First Amendment was the basis for their appeal.

Vermont lost the case in the 2^nd District Court of Appeals when the court was insufficiently convinced by Vermont’s defense of their law, a defense that suggested:

1.   The First Amendment was not the issue because their law regulated commercial activity and not free speech.

2.    Even if one argued that the law interfered with free speech, it would not violate the First Amendment because it spoke to the state’s essential interest in protecting medical privacy, controlling drug costs, and promoting the public health.

The data miners and PhRMA argued that the Vermont law limited their access to prescriber-identifiable data and thus restricted their constitutional right of free speech, because the law restricted not only commercial activity but also commercial speech. My son-in-law, a bright young legal scholar, explained to me that there were legal precedents that apparently blurred for the court what seems to me to be a very clear distinction between free speech and commercial activity/commercial speech.

Vermont has now requested that the Supreme Court review the case and reinstate the law, and, in large measure because the 2 district courts differed in their decisions, the Supreme Court agreed to do review it. Vermont’s attorney general, William Sorrell, lauded the court’s decision: “Vermont doctors pressed for this law because of their concerns about privacy and because they view this data mining practice as an intrusion into the way doctors practice medicine. We look forward to defending this important law in the Supreme Court.”

I know very little about the law and next to nothing about subtle interpretations of same, but common sense tells me that this situation does not speak to the abrogation of free speech. Rather, it seems as if companies who earn a living by mining data simply wish to continue to do so. They certainly have the right to do so, but not completely unencumbered by law, and certainly not at the expense of my right to privacy. I practiced general pediatrics for 6 years and hematology-oncology for 24 more, and I didn’t learn till very late in my medical career that companies bought and sold my prescribing information. I found it wrong then, and my attitude hasn’t changed. I don’t want my prescription data known, let alone commercially available. How and what I prescribe is no one’s business except for me and my patients.

Put another way, I really mind if I’m mined.  Selling prescriber data is to free speech and the First Amendment as fish are to bicycles. The Vermont law seems eminently fair, but like medicine, the law is not always clear cut and perfectly consistent. Now only the Supreme Court can decide whether a law that restricts access to information in nonpublic prescription drug records, and affords prescribers the right to consent before their identifying information in prescription drug records is sold or used in marketing, violates the First Amendment.  The Court is expected to do so in April of this year, with a decision made before the end of the court’s term in June. Despite my pessimism, well grounded by observing the almost unalloyed pro-business attitude regularly exhibited by the Roberts court, I still hold out hope that Attorney General Sorrell and the State of Vermont will be convincing in explaining why the First Amendment does not apply in Sorrell vs IMS Health.

(The attitudes expressed in this blog are those of the author and not necessarily those of Palio)

Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media.