Archive | May, 2013

Could Generic Prescriptions Be The Greatest Placebo Ever?

Those of you who know me know that I’ve been a huge advocate for generic prescriptions since the early part of my PBM/pharmacy career in 2001. It wasn’t long ago that I talked about unresponsible reporting when slamming generics and scaring the population. But, we all enjoy a good conspiracy theory which is about the only thing that makes sense reading the new Fortune article – Dirty Medicine – about Ranbaxy. Both articles are written by the same author, but this one scares me a lot more than the other one. This article reads like a fiction book but appears to be true.  It should scare you also and put a spotlight on the FDA.

Here are a few things from the article.

On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties — the most ever levied against a generic-drug company.

The company manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line. “This was not something that was concealed,” Thakur says. It was “common knowledge among senior managers of the company, heads of research and development, people responsible for formulation to the clinical people.”

It made clear that Ranbaxy had lied to regulators and falsified data in every country examined in the report. “More than 200 products in more than 40 countries” have “elements of data that were fabricated to support business needs,” the PowerPoint reported. “Business needs,” the report showed, was a euphemism for ways in which Ranbaxy could minimize cost, maximize profit, and dupe regulators into approving substandard drugs.

But, we know that generics have worked. People have gotten better so one has to assume this isn’t a massive fraud especially when 50% of generics have traditionally been made by the brand manufacturers themselves who would never risk their companies to do what Ranbaxy did. So, it made me wonder about the Placebo Effect. Did some drugs work simply because of that?  Is there anything else that would make sense for why this wasn’t discovered more quickly?

I’ve talked a lot about the Placebo Effect. There’s now even an app to make you feel better using the Placebo Effect.

I’m shocked that the PBMs, pharmacies, manufacturers, associations, wholesalers, and others aren’t out talking about this.  I would want to let the public know that this isn’t a systemic problem, but is one contained to one instance and that quality will be maintained…but maybe no one cares?

Relocation vs. Travel – Presenteeism and Health Implications

Surprisingly, I’ve been happily living in the St. Louis area for almost 20 years. I moved here after going to the University of Michigan for graduate school at Washington University, and I never thought I’d stay. My girlfriend (now wife) moved a year later, and we’ve loved it ever since. We’ve built two houses, had two kids, and made a lot of friends.

I’ve had chances to move many times to Kansas City, San Francisco, Boston, Columbia (SC), Florida, Minneapolis, New York, New Jersey, and several other cities. All of them I have turned down. So, one of the big questions I get asked now days is why are you moving out of St. Louis since you’ve commuted for so long and “enjoyed” it. That’s a tough one, but as someone who cares about my health, let me position this from a health perspective for all of you.

Ultimately, we’re moving for one reason which is to spend more time with my family. Of those 20 years, I estimate that I’ve spent at least 9 of them where I traveled 50-90% of the business days. You can do the math, but if I assume 15 days per month on the road over 9 years, that’s about 1,620 days that I’ve been gone or 4.4 years. That’s a lot of time to miss with your wife and kids.

But, I also see several health reasons for this:

  • Most people I know (including myself) sleep better at home and have a more regular routine. No early morning flights. No late night flights. No uncomfortable beds. No loud neighbors. No temptation to work until all hours of the night. And, as I’ve talked about many times, lack of sleep is a major contributor to productivity, decision making, and health.
  • You eat better at home and don’t have to eat out every meal which can affect your calorie intake and therefore your weight.
  • Long commutes have both mental and physical health implications (none of them good) as you can see in this article and infographic on LifeHacker along with this other article on ABC.
  • Being at home and spending time with your family can also affect them (as we know health is social). Here’s one example about eating with your kids that I often quote.

Of course, commuting has some productivity gains (if done right) from a work perspective:

  • You can work long days without worrying about other things that you should do when you’re home. (Why do you think consultants are so productive?)
  • You can find some nice quiet time on planes to work. (Although this has gone down over time with more crowded flights, more connecting flights, and smaller seats.)

You have to trade this off with productivity lost on travel days (e.g., I wake up every Monday at 4:30, leave for the airport at 5:30, land in Charlotte at 10:15, and get to my office around 11:30 with best case 90 minutes of work done).

But, moving definitely impacts your presenteeism as I’m learning (at least for a few months). After 20 years in one city, there’s a lot to do to move. You have to find new service providers (doctors, dentists, handyman, vet, hair), new schools, new sports teams, new stores, etc.

But, for those of you that aren’t convinced since you think travel is glamorous, let me share just a few stories with you.

  • On one of my toughest travel days, I had breakfast with a CIO in Boston at 6:30 am; caught a flight to Minneapolis to give a presentation over lunch; then caught a flight to have a dinner meeting in San Francisco. Long day.
  • In some weeks, I used to spend over 20 hours a week in a plane (not including airport time). Talk about sitting disease.
  • Just yesterday, when I tried to squeeze in one last trip before I moved, I got up at 3:30 to catch a 6:00 flight. I flew to Florida took a few calls, had a meeting, and then came back to the airport to catch an 8:oo PM flight home. That flight was delayed until 2:05 AM meaning that if I hadn’t just gone to get a hotel room (without any clothes or toiletries) that I would have gotten home 24 hours after I left the house.

Of course, the frequent flyer miles and hotel points are great. We’ve taken many a trip with it. I’ve given my parents free flights. Heck, we’ve even given our dog walkers free flights.

The key is to evaluate several factors which are what I’ve looked at:

  • Will you be traveling from which ever city you live in? Don’t move your family just to be traveling out of a new city.
  • Do you like the new city and would you consider living there long-term? For example, I know I probably would never like true city living in NY.
  • What is important to your family and is it present in the new city? This is a complicated one to find the right mix of services and education.
  • Can you afford to live in the new location without a major impact on your quality of life (or will your job account for this)?

Anyways, this has been one reason why I haven’t been blogging as much lately. The move is all consuming especially with lots of things going on at work. I have 4 more days in St. Louis before moving so we’re excited and nervous.

Personalized and Relevant Messages are Key to Successful Patient Engagement

Guest Post From The President of TeleVox Software

It shouldn’t come as a surprise to anyone that we live in a society yearning for instant gratification. We expect to get information in the blink of an eye, the answers we need within minutes and material goods delivered prior to the date that was promised. But what may surprise you is that even through the desire to have this information so quickly, the importance of providing a personalized message remains one of consumers’ biggest wishes. For instance, studies show that tailoring the message to the needs of patients as well as personalizing the messages are key to successful high-tech patient engagement. In fact, according to a recent TeleVox Healthy World Report, Technology Beyond the Exam Room: How Digital Media Is Helping Doctors Deliver the Highest Level of Care, 50 percent of patients expect information to be personalized to their specific needs. In the age of instant feedback and heightened technology, it is interesting to know that patients still desire a personalized approach in terms of their healthcare.

The days of simply setting forth wellness plans based solely on numbers and stereotypes are past us. Patients are looking for communications that are relevant to their lives, and it is their expectation that healthcare professionals will take time to engage in this level of personalization. Know Your Health also found that 53 percent of patients expect communications to be relevant to them as individuals. Relevant patient engagement can include personalized interactions, individualized treatment plans, and follow up. Patients thrive on a feeling of importance, ranging from a doctor knowing their name and medical history when they walk in to a follow-up call or email after the appointment to continue that personal connection.

Think about this: According to the same report, 21 percent of the population will refuse information if it is not tailored specifically to them. And, further, 13 percent of patients surveyed report they will ignore information sent their way if it doesn’t have their name on it. Why would providers want to miss out on connecting with an important part of the population by simply not including their name on any communication to the patient?  Including this step can ensure patient engagement is successful and save valuable resources, as the information conveyed will have a better chance of being received by patients.

Finally, taking time to connect with patients outside of their yearly exams or scheduled check-ups is another important link in ensuring that patients make positive decisions that ensure a healthy future. 68 percent of the population would like to receive educational tips that will help them live a better life via email throughout the year. Many Americans are concerned with the direction of the overall health and well-being of the country, but still aren’t taking steps to get where they need to be. However, healthcare providers can take steps to tailor messages that are relevant and personalized to patients to ensure successful high-tech patient engagement, and ultimately a healthier America.

Scott Zimmerman is a regularly-published thought leader on engaging patients via ongoing communication between office visits. He is the President of TeleVox Software, Inc, a high-tech Engagement Communications company that provides automated voice, email, SMS and web solutions that activate positive patient behaviors by applying technology to deliver a human touch. Scott spearheads TeleVox’s Healthy World initiative, a program that leverages ethnographic research to uncover, understand and interpret both patient and provider points of view with the end goal of creating a healthy world–one person at a time. Zimmerman possesses 20 years of proven performance in the healthcare industry, with domain knowledge in the surgical, interventional and pharmaceutical arenas. Prior to joining TeleVox, Scott served for nine years at GE Healthcare in a variety of cross-functional and global leadership roles in sales, services, quality, marketing, pricing, finance and product development. Scott is a graduate of the John M. Olin School of Business at Washington University in St. Louis.

No Fat Customers Please – #BoycottAbercrombie

My kids have worn Abercrombie and Fitch clothes for the past few years even thought I find the advertising suggestive and the store environment not particularly inviting for the average adult (loud music, small aisles, very young staff). Even with that, I was shocked to see some of the recent news about their attitude towards their customers in response to why they don’t stock XL and XXL clothing sizes. With today’s focus on customer experience and competitive retail environment, this seems like not only a bad business model, but one that is shallow and unhealthy.

“In every school there are the cool and popular kids, and then there are the not-so-cool kids. Candidly, we go after the cool kids. We go after the attractive all-American kid with a great attitude and a lot of friends. A lot of people don’t belong [in our clothes], and they can’t belong. Are we exclusionary? Absolutely. Those companies that are in trouble are trying to target everybody: young, old, fat, skinny. But then you become totally vanilla. You don’t alienate anybody, but you don’t excite anybody, either.” (source article)

But, a bad business model and a shallow minded CEO isn’t a reason to boycott a company. And, after growing up in a family where we boycotted many companies due to business practices, I never saw myself as someone who would support this “hippie” approach. That being said, I think that Abercrombie’s attitude is a real issue for the health of our kids for 3 reasons.

  1. We have a major obesity issue in the US. (from CDC)
    1. Childhood obesity has more than doubled in children and tripled in adolescents in the past 30 years.
    2. The percentage of children aged 6–11 years in the United States who were obese increased from 7% in 1980 to nearly 18% in 2010. Similarly, the percentage of adolescents aged 12–19 years who were obese increased from 5% to 18% over the same period.
    3. In 2010, more than one third of children and adolescents were overweight or obese.
    4. Overweight is defined as having excess body weight for a particular height from fat, muscle, bone, water, or a combination of these factors.3 Obesity is defined as having excess body fat.
    5. Overweight and obesity are the result of “caloric imbalance”—too few calories expended for the amount of calories consumed—and are affected by various genetic, behavioral, and environmental factors.
  2. We have a bullying issue in the US. (source)
    1. Over 3.2 million students are victims of bullying each year.
    2. 1 in 4 teachers see nothing wrong with bullying and will only intervene 4 percent of the time.
    3. Approximately 160,000 teens skip school every day because of bullying.
    4. 1 in 7 students in grades K-12 is either a bully or a victim of bullying.
    5. 56 percent of students have personally witnessed some type of bullying at school.
    6. Over two-thirds of students believe that schools respond poorly to bullying, with a high percentage of students believing that adult help is infrequent and ineffective.
    7. 71 percent of students report incidents of bullying as a problem at their school.
    8. 90 percent of 4th through 8th graders report being victims of bullying.
    9. 1 out 10 students drop out of school because of repeated bullying.
    10. Harassment and bullying have been linked to 75 percent of school-shooting incidents.
    11. Physical bullying increases in elementary school, peaks in middle school and declines in high school.  Verbal abuse, on the other hand, remains constant.
  3. We have a suicide issue in the US. (CDC fact sheet)
    1. Among young adults ages 15 to 24 years old, there are approximately 100-200 attempts for every completed suicide.
    2. In a 2011 nationally-representative sample of youth in grades 9-12:
      1. 15.8% of students reported that they had seriously considered attempting suicide during the 12 months preceding the survey;12.8% of students reported that they made a plan about how they would attempt suicide during the 12 months preceding the survey;
      2. 7.8% of students reported that they had attempted suicide one or more times during the 12 months preceding the survey; and
      3. 2.4% of students reported that they had made a suicide attempt that resulted in an injury, poisoning, or an overdose that required medical attention.

 

As adults, I believe we have a responsibility to break the cycle of bullying and set an example. This isn’t time to create a fraternity culture in adulthood. We have systemic issues to address in serious ways. I know we won’t be shopping at Abercrombie again, and I think my kids have lost their interest in wearing the clothes.

Why Do People Think Adherence Is So Easy?

I think we all know that medication adherence is a big deal. The most common number quoted is the $290B waste number from NEHI. There are numerous studies that confirm the value of non-adherence even one that just came out.

The amount of money spent on trying to improve adherence is huge! Pharma has worked on. Retail pharmacies have worked on it. Providers have worked on it. Insurance companies have worked on it. Employers have worked on it… And all of these have happened across the world.

At the same time, you see people get so excited about things don’t make any sense to me.

Let me take an easy example. A few months ago, a company called MediSafe put out a press release around moving medication adherence on statins up to 84.25%. Nothing against the company, but I read the press release and reached out to them to say “this is great, but it’s only 2 months of data…most people drop therapy after the first few months so who care…call me back when you get some good 12 month data.”

But, a lot of people got all excited and there was numerous press about this – see list of articles about them.

Now, tonight, I see another technology getting similar excitement. Fast Company talks about the AdhereTech technology which integrates a cellular phone with a pill bottle. And, it costs $60 a month. In my experience, companies wouldn’t even spend $2 a month to promote adherence so $60 is just impractical. The argument is that this is good for high cost specialty drugs that are oral solids not injectables. But, this isn’t a new idea. Glowcaps already built this model with a very slick interface and workflow.

And, I don’t know about you, but I think this would be obnoxious. And, I love data and am part of the QuantifiedSelf movement. I’m not sure I understand the consumer research here. I would have to believe all of the following to buy into this model.

  • Non-adherence people are primarily not adherent due to no reminders to take their medication on a daily basis.
  • People with chronic conditions that require high cost specialty drugs are going to change behavior because some bottle sends them a text message.
  • Manufacturers or some other healthcare company is willing to pay $60 a month for this service.
  • There won’t be message fatigue after a few months (weeks) of messaging.
  • Pharmacies would be have to be willing to change their workflow to use these bottles.

Yes. Will this work for some people…sure. But, if it helps 10% of people, then my cost is really $600 per success.

Should we be working on better solutions to address adherence…of course.

But, let’s stop trying to figure out some gimmick to fix adherence. Let’s look at root cause.

For example:

  • People don’t know why they’ve been given a medication.
  • People don’t understand their disease.
  • People can’t afford their medication.
  • People don’t know what to expect in terms of side effects.
  • People don’t see value in improving adherence.
  • People don’t know they have to refill their medications.
  • People aren’t health literate.

We have a lot of problems.

Presidential Physical Fitness Award – Reasonable? Role Models?

I must admit that I don’t remember taking the presidential fitness test as a kid. With that being said, I was surprised to learn from my daughter that in her class of club soccer, volleyball, and baseball players she was the only kid to meet the highest level (greater than the 85th percentile across several measures). She made it today by running her mile in 7:37.

So, what does this require? It made me curious. Here’s what you have to do:

benchmarks_presidential_large

Could you do that?  These seem pretty difficult to me.  I could probably do the mile in 6:06, but I doubt I could do 53 pull-ups.  And, I doubt I could sit and reach 7 inches beyond my toes.  (Looking at the 17 year old male standards.)

On the other hand, we certainly need our kids to be more fit.  We have a big childhood obesity issue.

Childhood Obesity

But, it also made me think about Michelle Obama’s efforts in this space.

Lets Move

I think these programs are good starts, but lets not forget that obesity is a social issue and kids learn from those around them.  Let me ask the uncomfortable questions about those who our kids look up to.

  • How many overweight coaches do you know?
  • How about overweight teachers?
  • How about policemen and firefighters?
  • How about clergy?

These are all key role models…not to mention us parents who are often overweight.

I guess my suggestion here to the President would be to think about how to use our massive government payrolls as a foundation for change. Let’s think about the Presidential Fitness Challenge and create a broader wellness solution to change the visual role models for our kids and figure out how to help companies invest in this.

For example, we know that sleeping is correlated to weight and health.  I was talking to my brother-in-law who is a police officer when he told me that they are expected to get 8 hours of sleep a night.  Imagine if companies set this expectation for their employees (sleep impact on work).  

“Sitting Disease” may make a great late night comedy story line, but it’s a reality of our information economy that has to be addressed.

sitting-disease-how-sitting-too-long-can-affect-your-health_5123e1818a55e