Month: December 2013

Coming Out of the Closet: The Pharmaceutical Sample Closet

Evans, Steven, Brown, and Smetana published the following research in Journal of the American Board of Family Medicine (JABFM) “Sample Closet Medications Are Neither Novel Nor Useful”  PDF is here. No need to read further the headline does a great job. Well allow me to capture some of the more damning points.

  • In 2009 80% of cardiologists, 70% of family physicians, and 67% of internists reported receiving samples
  • Samples get handed out in 20% of office encounters
  • 12% of all Americans receive drug samples yearly
  • Physicians and their staff frequently use sample drugs. (Bank CEOs get helicopters HCP get samples)
  • 82% of patients being given sample were insured for the year and had income 200% above federal poverty line (So much for samples helping the poor)
  • Samples skip EMR and the pharmacist which mean no potential for counseling
  • Physicians using samples bypass preferred drug choice

 

Drug samples are “almost never time worn and well-tested drugs … and usually comprise the newest drugs on the market.” Many new drugs on the market are “me too” drugs, a new drug within an existing class of medications that offers minimal additional therapeutic benefit. In addition, the long-term safety of newly approved drugs is often unknown.

Newly approved drugs, including those most likely to be found in samples closets, are often not novel or useful. For example, in one analysis of new drugs approved by the US Food and Drug Administration (FDA) in 2008, not a single new drug was both novel and relevant to primary care. Many newly approved drugs are heavily marketed as samples.

Need we continue? Okay

  • Only 5 of the 23 medications are first in a new class. Can you say me too?
  • Most sampled medications are not useful (20 of 23 sample closet medications had no studies demonstrating superior patient outcomes)
  • Safety and tolerability data was only found for 26% of the sample closet drugs
  • The closet samples are not first line agents in published guidelines
  • As if you need to ask these samples are more expensive when compared to generics
  • Finally, when the free sample are gone patients continue with the same medication at a higher cost.

This is a small sample but is the first of its kind. Bravo. The authors note that the number of physicians accepting sample was 64% in 2009 down from 78% in 2004. 

The strategy has worked for pharma and perpetuates the use of name brand drugs over generics and uses the physician to be the detail person with the patient. This research shows this strategy works. What can be done by pharma to make the sample closet a truly productive and valuable place for helping those in financial need. Coupons may not fair any better. 

Marketing vs.R&D in Pharma: As if It’s a Fair Fight

John LaMattina a contributor at Forbes caught my attention with the following headline “Should The Marketing Division Set Strategy For Pharmaceutical R&D?” He presents a fair and balanced look at this idea starting with a quote from George W. Merck 

“We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.” (taken from “Built to Last, James C. Collins and Jerry I. Porras, 1994)

And he presents the reality that back in the olden days it was simpler to go from idea to market and cheaper too. Okay I’ll buy into that. And he ends with the need for a strong bond between scientists and the commercial dudes. Mom and apple pie. Somewhere in the middle he makes the case for the long-term testing in patients for safety, efficacy, and differentiation from current standard of care. 

He lost me here. Differentiation means, at least to me, you compare the compound to a competitor. Nearly all drug trials are comparing to placebo and rarely compare to the leading standard of care drug in the category and for good reason. If I’d had spend $100s of millions to get here why risk it in a head to head comparative trial. As in the link below.

But that is changing and we will be seeing more and more of this: “Glaxo’s diabetes drug fails to beat Takeda’s Actos in head-to-head study” If you want to claim superiority head-to-head will be required. 

CDC Recommends Ladder Safety App: That Beats Apple’s 5 Star Rating

FALL INJURIES PREVENTION IN THE WORKPLACE
The CDC is recommending apps to help workers identify ladder selection, positioning, accessorizing, and safe use. The data seems clear

Falls are a persistent hazard found in all occupational settings. A fall can occur during the simple acts of walking or climbing a ladder to change a light fixture or as a result of a complex series of events affecting an ironworker 80 feet above the ground. According to the 2009 data from the Bureau of Labor Statistics, 605 workers were killed and an estimated 212,760 workers were seriously injured by falls to the same or lower level.

I wonder if the app maker is sending users notifications to rate this app? You know rate this app now.

GlaxoSmithKline Not to Pay Physicians for Endorsements: Meh

James Hamblin writing at The Atlantic has a short piece on the announcement by GlaxoSmithKline to Stop Paying Doctors for Endorsements. Hamblin’s primary point is that GSK will not pay physicians to “give speeches about their products at medical conferences”. And further down Hamblin writes

Doctors still have to learn about new medications somewhere, of course. It is in everyone’s interest that doctors are made aware of the newest pharmaceutical developments. We are most likely to trust that information when it comes through the filter of respected colleagues. How many such doctors would misinform their peers just to get paid?

A couple of points I believe are missing from this piece. If you refer to the NYT article that had the original announcement a second change was being made, pharmaceutical sales people will no longer be paid in part based on number of Rx written. That tied with physician payments may have a more positive effect. 

Physician speakers/lecturers/KOL’s at medical meetings are not out and out hocking drugs like barkers in a side show. These national and state medical meetings are run by medical societies and associations like the American Heart Association, ASCO, American Academy of Dermatology, etc. Pharma gets to side show their products in the exhibit halls. The lectures are primarily CME programs and as such are under very strict and managed rules dictating bias, fair balance, and disclosure of speakers conflicts of interest, identified needs assessment, etc. And most, if not all, of these lectures are the product of third party educational companies or medical societies etc. They are not executed by pharma nor are they dictated by pharma. Pharma will give grants to companies who identify topics, speakers, needs, etc all to solve a clinical issue. So we do not know if GSK will stop supporting CME through medical education companies and societies. The Sunshine Act allows speakers paid by a medical education company or a medical society not to have to disclose that fee for speaking was from pharma since it was from a third party. Kind of money laundering? 

Truth be told pharma does hold and pay for non-CME promotional education. There is no hiding pharma sponsored education. Those who attend these meetings come to learn about the drug straight from the horses mouth. Of course we all know studies that were even slightly negative about the drug never get into the monograph.Good luck in critical appraisal without full disclosure. So at these promotional education activities GSK won’t be paying physicians. I doubt if they will be abandoned all together. The speakers may be in house physicians. But physicians will be paid for CME just not directly from phama. And these CME lectures will have balance and transparency and address a clinical need. 

It is also important to note that those physicians who are speaking at the CME events are most likely investigators on the clinical trials and are very knowledgeable about the therapeutic area and disease. That is why they are speaking and are trusted. So directly paying physicians to lecture on a drug/disease will not amount to much. We will have CME doing the lions share of the educational work. But there is much to not known right now and we will have to wait and see how GSK executes this portion of their announcement. 

Pharmaceutical sales people not having income linked to Rx is big. I have seen this question asked in other places, how will GSK know who is producing? I imagine management will know because pharma will never surrender knowing the number of Rx each physician is writing. The issue is going to be, GSK can’t fire the underproducing sales person based on Rx since they are not being paid for that. So what will be the measure? How well educated on a disease or drug topic is the physician, does knowledge translate into Rx, is the sales persons physicians satisfied with GSK, etc? Also this may change that whole I don’t want to see a pharma rep attitude of physicians. Since the rep is not being paid for Rx perhaps the physician would be willing to spend more time or even speak with them. Nah the sales person is a GSK shill. Will the sales person still stock the sample closet? 

There are some bigger issues here that are not addressed by this window dressing. First and foremost is the product monograph. When a drug is approved by the FDA based on clinical trials it has a single product monograph identifying all known knowledge about the drug, the disease, side effects, etc. We now know trials that impact the drug negatively do not make it into the monograph. We need full disclosure to the FDA during the approval phase so that all data is known. This is important so a physician can truly perform a critical appraisal. 

I am not fooling myself, most physicians are busy wire to wire day in and day out. They do not have the time or inclination to deconstruct a monograph or a sales aid in order to make a critical appraisal of the drug. They trust that the FDA has done its job when it approved a drug for sale for an indication. And consider that most practices are made up of different types of patients some with a plethora of issues that need to be weighed against the drug. That is where the pharma company sales person, promotional materials etc help the busy physician. By identifying the salient issues and science. Of course truth in advertising and selling is similar to the Easter Bunny. And pharma is rated in trustworthiness at the bottom of the trust barrel. So how do we return pharma to a trusted place? While helping the overworked physician to make head or tails out of promotional material. 

I would like to think that GSK would want to provide a series of educational programs CME or otherwise to teach HCPs how to perform critical appraisal on clinical trial data. Make the HCP the gate keeper not of Rx alone but of how to access and use knowledge. Give them the tools to reject, accept, or apply appropriately where drug xyz can be used and on whom. A wise man once said a pharma should not seek a 100% share of a market but a 100% share of those patients who will benefit the most and most appropriately from the drug. Differentiation in a crowded marketplace will come from educating your audience to see the value and designing the drug and its clinical trial to show that value.

I just saw this post on The Healthcare Marketer Blog “Should Physicians Disclose Potential Conflicts of Interest to Patients?“. The simple answer is yes. And it fits with the discussion above the more the patient knows the better he or she can align their values to their physician. This drives the physician to improve their knowledge and care since the patient is facing them asking questions. This post introduces the Who’s My Doctor a movement promoting and driving transparency on the part of the physician. 

Check out the Total Transparency Manifesto for Dr. Leana Wen to see what real transparency looks like. 

There are a lot of moving parts in this discussion and finding the right balance is going to be a long fought battle. We are seeing more and more patients raising questions about their care and making demands to know and understand treatment. Patient engagement is at the heart of this change and will continue to drive it. Perhaps we have a bright future in our healthcare system to spite current events. And GSK has drawn a line in the sand that we will see if others cross. 

The Internet and CBT: Improving Care Beyond the Visit

Mansson, Ruiz, et. al published and original paper in JIMR “Development and Initial Evaluation of an Internet-Based Support System for Face-to-Face Cognitive Behavior Therapy: A Proof of Concept Study” examining Internet-delivered CBT (ICBT). The authors tested a new treatment format using a combination of ICBT and face-to-face. The study involved 15 patients with mild to moderate anxiety or depression or both. There were 8 therapists. First interview was at 9 weeks and 12 month follow-up. 

The authors noted that both the platform and iPad were thought of as beneficial by patients. Therapists found improved intersession communications and ease of sharing. Which the authors noted maintained continuity for missed sessions due to travel distance. It is worth noting there was no missing data nor dropouts from treatment. Perhaps the Internet mitigate dropout rates. And again we are seeing the movement to expansion of healthcare outside the face to face. 

Maybe Showtime Web Therapy with Lisa Kudrow is not so crazy after all.  

Diabetes Management: The Holy Grail of Self-Management Goes On-line

Chen, Chauang, et. all publishing an original paper in JMIR titled “Evaluating Self-Management Behaviors of Diabetic Patients in a Telehealthcare Program: Longitudinal Study Over 18 Months“. The goal of the study was to identify behaviors of patients with diabetes as it relates to online application, measure impact of teleheathcare, and determine changes in glycosylated hemoglobin level. Managing diabetes even for the most committed patient is a daily and ongoing task. And for those less committed it takes real effort. This is a long well designed study that cannot be easily summerized. 

The study examined 7 self-care activities and was run for 18 months used a third generation mobile telecommunications glucometer, online self management system, and phone constant service. This is a rather robust system and one that I am not sure is readily available. 

The online system was based on personal health record criteria where patients health data and personal information are captured and managed by the patients. This is interesting from a learning perspective since we can assume these patients are seeking solutions to the problems they have and are motivated as adult learners. 

Asynchronous text messages were provided and patients and caregivers could use the online diabetes self-managment system or SMS text messaging. The online system included blood glucose, BP, heart rate, weight, insulin injection, daily diet, and daily physical activities. The data entry was made as simple as possible. 

The online diabetes self-management system included the monitoring items and the diabetes-related information, such as blood glucose, blood pressure, heart rate, body weight, insulin injection, daily diet, and daily physical activities. Information that was measured with equipment that did not have transmission networks required manual input. Dietary intake could be recorded through the use of either text or images. Additional information to enable self-management and goal setting for glucose control were generated (eg, the mean, median, standard deviation, and maximum and minimum daily blood glucose values). The variations in blood glucose and other parameters are presented together graphically to enable the user to observe the effect of each behavior. The frequency of self-monitoring of blood glucose (SMBG) was recorded and compared with the set goals to determine whether adjustments were needed. Body mass index (BMI) was calculated, and the suggested calorie intake and ingredient volume for each meal were displayed. An additional care-provider interface was designed so that caregivers could get a quick overview of patient status. Case managers were able to log in and view the data uploaded by the patients, identify abnormal events, and make phone calls. The online diabetes self-management system sent an SMS text message to care providers when the data exceeded the alerting range.

This study provided a teleconsultant service to support patients with diabetes self-management. The case managers for this study, including a nurse and a dietitian, were the care providers who interacted with the patients from a distance. They were responsible for monitoring patient status, answering questions about self-care activities, regularly keeping in touch with the patients through telephone calls or text messages, and encouraging them to perform self-management. The care plans and goal setting were formulated through a discussion with each patient during his or her enrollment. The case managers monitored the data uploaded by the patients. They gave advice and reminded the patients to perform self-care activities. In this study, the case managers were not involved in medication adjustments. They did, however, collate patient data and bring the information to the clinic when the patient returned for an appointment. They communicated with physicians to suggest adjustments when needed.

Conclusions
This study showed that using a sophisticated technological design supported the patients with diabetes in self-management. It appears that telehealthcare is effective in enhancing blood glucose monitoring, and the patients in the program showed improvements in glycemic control. The self-care behaviors affected patient outcomes and the changes in behavior required time to show effects. Telehealthcare has a positive effect on patients with diabetes, and it may encourage more technological interventions for diabetes care.

From my perspective this is a terrific study that’s examining healthcare in two of the more difficult areas, diabetes and the elderly. That is no mean feat on any level. The fact they were successful is telling. But it is worth noting that this was sophisticated study using technology and telephonic support. And the time to see results was extended. The ease to duplicating this on a large scale will be a challenge but it should not stop us from doing it since diabetes and obesity will be significant issues in cost and healthcare for America.

Hey Hipster You Get Your Food Locally. What About Healthcare? Hyperlocal is the Buzz.

Could Healthcare Be Local Tech’s Next Big Opportunity? Street Fight has an interview with Medicast co-founder and CEO Sam Zebarjadi. Medicast is an Atlanta startup where patients and doctors are connected. Physicians come to patients’ homes, offices or hotels to deliver care in <2 hours. The interview is interesting since it discusses the issue of local markets which is the new black. You all know about the green market and local foods. Well we now have hyperlocal. This fits with my chestnut It’s not WebMD but MyMD…local personal and real knowledge from the person you trust the most. 

We are moving away from a large systemic healthcare approach to doctors wanting to get more local. In the next few years we will be in a transformative space, where we are going to see a lot of changes and everyone has the common goal of making healthcare more affordable, within closer reach, and of providing more preventative care.

Zebarjadi makes a cogent case for the patient physician connection that can exist beyond the appointment and waiting room or telemedicine which I did not know is outlawed in nearly 20 states. 

The entire interview is short but filled with ideas and future direction. I see this as part of the new healthcare landscape as we move forward. 

Brother Can You Spare a GB or EMR?

A favorite health economist Jane Sarasohn-Kahn writing on HealthPopuli “Data Altruism: people more likely to share personal health data for the sake of others and to save money” takes a look at finding in the Healthcare Innovation Barometer published this December. 

  • 44% of Americans would be willing to anonymously share genetic information vs. 47% of people in other countries surveyed
  •  
  • 33% of Americans would be willing to share health records, vs. 47% of other health citizens
  • 31% of Americans would be willing to share medical records versus 45% of global peers.

The following surprised Sarasohn-Kahn, “people at the global level are more willing to share information to help others in three categories, genetic info, health and medical records”. Frankly I am surprised as well. Yet it speaks to social media and its ability to erode old thinking. 

And who are affluent data altruists? They are higher income persons who are more likely to share information and have greater exposure to tech and toys. This speaks to the need help bring the lower socioeconomic demographics into an online, connected, computer world. It will move this idea of sharing forward and downward. 

This is short optimistic piece that I hope points to an upside of the technology and human needs. 

Do We Really Understand Strategic Analysis in the Digital Age?

“Most of all, strategy is becoming less about assets and capabilities and more about connections and access.  It’s not so important anymore what you have—or even what you know—but how you can forge networks of purpose which can adapt in real time.” This is from Digital Tonto’s blog post ” 5 New Principles of Strategy for the Digital Age“

How many of our marketing clients and agency partners understand I mean really understand this new world? They treat it as a series of tactics without consideration for strategies. 

Katie Couric: “Evidence Based Medicine, Who Cares. My Evidence is Jenny McCarthy.”

I am sure many of you have seen the stories, posts, article, etc. about Katie Couric’s abysmal understanding of HPV vaccination and her complete failure to address the evidence. I have linked to five articles on this topic. Please link to these or Tweet links to them so we can raise awareness for this reckless and selfish act on her part all in the name of improving her Q Score.

Her FB page has no place to leave a comment but it does have a place to ask Katie a question. I asked her if she knows what evidence based medicine is? You could do that too.

Respectful Insolence has the following post “Katie Couric on the HPV vaccine: Antivaccine or irresponsible journalist? You be the judge!” This is a long well referenced piece and the answer is clear even before you read word one. She is pandering to a fringe audience to raise her Q Score.

David Kroll contributor at Forbes “ Katie Couric and Cervical Cancer Prevention with the HPV vaccines, Gardasil and Cervarix” This is an excellent overview of the topic on HPV and cancer.

A two-dose regimen also has significant implications for preventing HPV-triggered cancers worldwide, especially in regions with poor access to sustained healthcare. Worldwide, 500,000 women are diagnosed each year with cervical cancer alone, and 250,000 will die of their disease.

Matthew Herper on the Forbes Staff “Four Ways Katie Couric Stacked the Deck Against Gardasil”. Great deconstruction of what Couric did and why it was so wrong.

But deaths – including deaths by seizures or unexplained causes – do occur for all sorts of reasons, without explanation, and just because a death happened 18 days after a vaccine was given, as in the example on Katie’s show, does not mean the vaccine caused it. So far, investigations trying to link Gardasil and Cervarix to serious side effects have come up empty.

Emily Willngham Contributor at Forbes “Katie Couric Promotes Anticancer Vaccine Alarmism“. This is a good analysis of Couric who has worked tirelessly to help prevent death from colon cancer. Willingham closes with the following:

Lives may well have been saved (colonoscopies) because of her name recognition and promotion. What will the balance become, I have to wonder, now that she has used her profile instead in ways that may very well influence parents to opt out of a life-saving anti-cancer vaccine for their children?

Alexandra Sifferlin writing on Time.com “Is Katie Couric The Next Jenny McCarthy?” The subhead on this sums it up well “A former Playboy Bunny spreading misinformation is bad enough”. We have just found a respected journalist or on air personality French kissing Jenny McCarthy…. ewwwww. gross on so many level.