Wednesday, November 14, 2012

Modern Modular Buildings

Modular Buildings create space on the premises and in the budget as they are cheaper than fixed buildings and serve the same purposes. The multiple prefabricated wall sections are called modules and the area of the modular building is determined by the number and size of the modules. These modules allow ease of assembly and quick installation for a novice and a professional. These structures gained popularity as schools expanded and required space for laboratories, sewing classes, woodwork rooms and after-school care. The pre-engineered buildings could no longer cater for the masses and people were looking for a cheaper way to expand than fixed buildings that would be costly and take too long to build. The building sounds of hammers and drilling would disrupt the peace and distract students, so these modular relocatable buildings were constructed off site and delivered to the school or assembled in the parking lot. Apart from the noise, building also causes mess and the labourers are noisy when they are in group and there is inadequate supervision. Most of the construction occurs at the factory and this makes deadlines easier to adhere to and it is more convenient for the client without the noise and hassle. Buildings can even be customised and the floor plan is agreed by client and designer.

Building that can switch.

When you get duty to work beyond city you will hard to move house and build new house. Actually it will not happen if you have portable home. Home relocatable buildings and allows you to carry your house everywhere. You need not buy more to build your home.

Monday, November 12, 2012

Public Citizen Tracks "Bad Pharma" Financial Settlements

Public Citizen, the citizen "watch dog" group, has documented all major financial settlements and court judgments between pharmaceutical manufacturers and the federal and state governments since 1991. Its latest report (here) covers the time frame from its last report (November 2, 2010) through July 18, 2012. According to this latest report:
"A total of 74 additional settlements, totaling $10.2 billion in financial penalties, were reached between the federal and state governments and pharmaceutical manufacturers between November 2, 2010 and July 18, 2012, with the first half of 2012 alone already representing a record year for both federal ($5.0 billion) and state ($1.6 billion) financial recoveries. Since 1991, a total of 239 settlements, for $30.2 billion, have now been reached (through July 18, 2012) between federal and state governments and pharmaceutical companies."
The following chart shows the yearly trend since 1991:

These data include Federal and State settlements. Between November 2, 2010 and July 18, 2012, state settlements were $2.5 billion vs. Federal settlements totaling $7.7 billion. "2012 already represents a record year for state financial recoveries," says Public Citizen,  which notes that this 2012 state windfall was "largely due to a single court judgment in Arkansas in 2012 that required Johnson & Johnson to pay the state $1.2 billion for the unlawful promotion of the antipsychotic Risperdal. To our knowledge, as of the publication of this report, the company has not yet paid the fine and plans to appeal the judgment." Hopefully, JNJ will eventually pay up and help AK balance its budget and then some!

I created the following pie chart showing which types of penalties were responsible for generating these massive Federal and State settlement amounts:

"Unlawful Promotion" -- off-label and other "deceptive" marketing practices -- represents largest slice of the pie. This is probably a low estimate because the category "multiple violations" must also include unlawful marketing violations. If only 25% of these were marketing related, then "Unlawful Promotion" would account for the MAJORITY of settlement fees.

The following table shows the TOP TEN settlements between November 2, 2010 and July 18, 2012:

Congrats to GSK for being at the top of the list!

One other piece of information I found interesting is that "qui tam" cases involving "whistle blowers" account for the vast majority of the financial settlements in recent years. In terms of percent of the settlement dollar amount, here's how it looks for the past few years:

  • 2009: 96%
  • 2010: 97%
  • 2011: 33%
  • 2012: 90% (through July 18)

Whistle blower cases in 2011 didn't result in big financial settlements; consequently, 2011 was a "down" year overall.

Happy Anniversary! First Ever Pharmaguy Social Media Procrastinator Award Goes to...

Today is the third anniversary of the first day of the 2-day November 2009, FDA public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here, here, and here).

Shortly after that hearing, some FDA staffers lead us to believe that FDA would come out with social media regulatory guidance for the pharma industry by the end of 2010 (see here). That never happened.

Instead, FDA kept procrastinating and throwing roadblocks in the way such as proposing further studies (see, for example, "FDA's Proposed Web Study Will Further Delay Social Media Guidelines").

Meanwhile, to add insult to injury, Tom Abrams, head of FDA's DDMAC (now OPDP), keeps showing up at industry meetings where industry leaders were expecting him to announce progress towards issuing draft guidance. At one such meeting in February, 2011, Abrams spent a scant 4 minutes discussing social media guidance (read this). At that meeting, he said FDA would NOT "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter. Those things are really big now, but you know what, two years from now who knows what the next thing [will be]?" Well, guess what? It's almost two years later and YouTube, Facebook, and Twitter are still BIG, if not BIGGER and nothing has come along that's bigger. [BTW, Abrams also pooh-poohed Groupon, which now seems prophetic! And Google eliminated sidewiki, which was a big concern at the 2009 public hearing (read this).]

In recognition of the role Abrams has played in all this procrastination regarding social media guidance from FDA, I hereby present to Abrams the first ever Pharmaguy Social Media Procrastination AwardTM.

This award, as you may notice, is the antithesis to the famous Pharmaguy Social Media Pioneer Award, which was recently given to the sanofi US diabetes team (see here).

The iconic Hawaiian shirt in the "Procrastinator Award" is dark, symbolizing the negative implications of procrastination versus the bright yellow, positive Hawaiian shirt image used in the "Pioneer Award."

Abrams continues to show up at industry meetings promising that social media guidance is a high priority at FDA and it will be coming soon -- perhaps as "soon" as July, 2014 (see here). Yet, we've heard it all before. That's why I think it is fitting that Abrams receive the the "Procrastinator Award."

If Abrams lives up to his latest promise -- which is doubtful, IMHO -- it would have taken the FDA only 4 years and 8 months to issue draft social media guidance. In terms of Internet/social media timeframes -- in which 2 years can bring BIG changes -- this is procrastination on an epic scale. But in terms of FDA guidance timeframes, 4 years and 8 months is par for the course (see, for example, "A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon").

Saturday, November 10, 2012

Mobile Apps vs. Mobile Optimization: Which Offers Pharma the Best ROI?

According to the "Mobile Health 2012" survey on the use of cellphones for healthcare that was just been released by the Pew Internet and American Life Project, "half of smartphone owners use their devices to get health information and one-fifth of smartphone owners have health apps."

Pharmaceutical marketers who wear "rosy glasses" may take away from that top line synopsis, which appears as the subtitle of the survey report (find it here), that it is time to develop Rx branded health apps -- such as adherence reminders -- for consumers. But if you look more deeply into the survey results, which I am sure you will do after reading this, you will find that only about 9% of U.S. Adults over the age of 18 (19% of the 45% of smartphone owners) "happen to have" apps that help them track or manage their health. Keep in mind that "having" does not equate to "using." We know from other surveys that the majority of these apps may have been used just a few times and then forgotten.

Also, 81% of those 9% have health apps for:
  • Exercise, fitness, pedometer or heart rate monitoring (includes specific types of exercise like running, ab workouts, yoga, etc.) - 38%
  • Diet, food, calorie counter - 31%
  • Weight - 12%
Other "uses" include "period or menstrual cycle" (7%), "blood pressure" (5%), and WebMD (4%).

So, on the one hand we have these disappointing numbers regarding mobile health apps. On the other hand, however, PEW reports that "in 2010, when the same percentage of U.S. adults owned cell phones, 17% of cell phone owners reported using their phones to access health information. Today, that number stands at 31%, almost double the previous figure." That's 31% of 85% of all U.S. adults over the age of 18, or 26% of all adults!

"Access health information" more or less refers to using the browser on the smartphone to access plain old web sites. IMHO, this means that drug companies would be better off optimizing their Web sites for mobile access than putting money into the development, distribution, and support of "apps." And, according to Klick Health, which is in the business of optimizing Web sites for mobile, "Google recently reported that 1 in 5 searches on Google are now from a mobile device. [Google] also asserted that ranking priority within mobile search results will be given to sites that are mobile optimized. This further underlines the need to ensure your website is optimized for mobile." For some interesting statistics from Google, see "Mobile-friendly sites turn visitors into customers."

"Sadly," reported Michael Maher, Senior Vice President of Marketing at Digitas Health (here), "a 2011 Mediapost audit showed just 19% of pharma sites are mobile-optimized, and Google estimates only slightly higher at 21%." A Digitas Health December 2011 survey found that of the top 25 pharmaceutical brands of 2010, only three had mobile websites specifically built to display on mobile browsers.

I wonder if the situation viz-a-viz pharma Web site mobile optimization has improved much in the last year.

Thursday, November 8, 2012

Will FDASIA Get FDA Off Its Butt to Finally Issue Social Media Guidance?

I noted with interest the headline in today's FDA News email: "OPDP: Social Media Guidance Will Be High Priority in 2013"." Here's the teaser copy that explains what's going one:
"The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says. Abrams outlined the offices priorities at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C. The social media guidance is of critical importance because the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates the agency produce the guidance by July 9, 2014."
I have three comments regarding this:
  1. I reported back in July 2012 (here), about a little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act", which was signed into law by president Obama on July 10, 2012. This provision simply states: "Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."

  2. This is NOT the FIRST time Abrams has promised that social media guidance was a "priority." At the November, 2009, FDA public hearings on social media, Abrams said he heard "loud and clear from folks in this room" (ie, pharma companies) that "we want guidance on social media... We heard that message. Let me tell you that we are devoting a lot of resources and effort to this" (read this: "Is It Time for Abrams to Leave?").

  3. Although it's nice that Abrams says social media guidance will be "at the top" of FDA's work plan for 2013, I wonder why it was REMOVED from the published work calendar as far back as 2011 (read this: "FDA Drops Social Media from Its 2011 Guidance Agenda").
So, will Abrams keep his promise this time? Pardon me for being a doubting Thomas. You think a "do nothing" Congress that's facing a "fiscal cliff" will spend any energy to make sure the above "provision" is adhered to by the FDA? I said it before and I'll say it again now: If FDA misses the deadline set by FDASIA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

Wednesday, November 7, 2012

Sanofi Accepts Pharmaguy's Social Media Pioneer Award

A few weeks ago -- before hurricane Sandy disrupted life as we know here on the east coast -- I presented the coveted bright yellow Hawaiian shirt/Pharmaguy Social Media Pioneer Award to Dennis Urbaniak, VP, Joan Mikardos, Senior Director, and Laura Kolodjesji, Senoir Manager, Patient Solutions, at Sanofi US Diabetes (see "Dennis Urbaniak, Joan Mikardos, and Laura Kolodjeski of Sanofi US Receive the 3rd PharmaGuy Social Media Pioneer Award").

Unfortunately, Dennis, Joan, and Laura were not available to accept the award personally. Since we're all into "non-personal" communication via email and YouTube, I am happy to post the following award "acceptance" video that Joan and Laura made at their New Jersey-based sanofi Hawaiian set (I am amazed that they found Hawaiian Leis for props!). Too bad that Dennis could not be there with Joan and Laura to strum on his Ukulele :-(

Tuesday, November 6, 2012

Pharma Testimonial Videos Overstate Efficacy More Often Than Other Ads

Mark Senak over at Eye On FDA Blog has analyzed 235 Warning Letters (WLs) and Notice of Violation (NOVs) letters issued by FDA's Office of Pharmaceutical Drug Promotion (OPDP) since 2005. He cataloged 600 violations, including:

  • risk omission or minimization, 
  • superiority claims, 
  • overstatement of efficacy, 
  • unsubstantiated claims and
  • broadening of indication

When Senak specifically looked at letters regarding pharma marketing videos (excluding TV DTC ad videos), he found that 80% of the violations concerned risk minimization (40%) or overstatement of efficacy (40%). Below is the remake of his pie chart of these data (for the original data see "Viewing Video’s Regulatory Profile").

What's interesting is that these videos -- mostly patient and physician testimonials -- overstate efficacy at TWICE the average for all kinds of promotions (40% for videos vs. 21% for all ads, including video). Senak postulates that "when people talk about their own experiences with a treatment, [they] may include reference to outcomes that is not typical or supported by clinical data."

An example of a video that overstated efficacy was a video testimonial featuring Ty Pennington posted on by Shire. FDA said "Both the webpage and video overstate the efficacy of Adderall XR; the video also omits important information regarding the risks associated with Adderall XR use."

The problem with FDA letters is they usually are sent well after the cow has walked through the open barn door! See, for example, "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!"

Monday, November 5, 2012

Survey: Should PhRMA Issue Mobile Health App Guiding Principles?

In February, 2012, in a blog post provocatively titled "An App for That, But For How Much Longer?", PhRMA's Kate Connors agreed with a Washington Times op-ed piece that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. In my own blog post, I cited this post as "FDA Mobile Regulatory Fear Mongering." You can read my blog post (here) to see why or you can read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.

More recently, I suggested that The Best Defense Against Zealous FDA Regulation is Self-Regulation (see "My POV Regarding Regulation of Pharma Mobile Medical Apps").

This survey asks your opinion regarding several issues faced by pharma companies when developing mobile applications (apps) for physicians and consumersI wonder how many people feel as I do. So, I posted the Regulation of Pharma Health Apps Survey to find out (see the survey embedded at the end of this post). This survey asks your opinion regarding several issues faced by pharma companies when developing mobile applications (apps) for physicians and consumers. Issues include impact of regulation by FDA, privacy, trust, accuracy, and 3rd-party certification as well as industry self-regulatory guidelines.

I recently interviewed Happtique CEO Ben Chodor who said "There are tens of thousands of medical, health and fitness apps on the market and their sheer number makes it difficult for health care professionals and consumers to locate apps that operate reliably, are based on valid information, and safeguard users' information" (listen to the podcast: "Taming the 'Wild West' of Mobile Health").

Sooner or later, IMHO, Congress is going to be investigating mobile health apps to see if further regulations -- not just FDA regulations -- are required. IMHO, the pharmaceutical industry (i.e., PhRMA) should differentiate itself from the "wild west" developers by being pro-active in issuing Guidelines for Mobile Health Apps Developed by the Pharmaceutical Industry in much the same manner as it developed other self-regulatory guidelines such as the DTC Guiding Principles and the Code on Interactions With Healthcare Professionals. However, this time, PhRMA should act BEFORE Congress or the FDA takes the first step!

What Do You Think?

The Regulation of Pharma Health Apps Survey asks whether or not you agree that it is in the drug industry's best interest to police itself and develop best practices or self-regulatory guidelines for developing trustworthy health/medical apps for consumers and physicians.

It also asks if you agree or disagree with the following statements:
  • Apps must include full disclosure regarding the company that has created the app or the sponsoring pharma company. This includes contact information. BRANDED apps MUST include ISI (important safety information) up front in an easily accessible manner (e.g., on start-up screen).
  • Apps that are BRANDED (i.e., mention drug brand names) must be available ONLY from the appropriate U.S. app site (e.g., Apple App Store) even if all the FDA-required ISI (important safety information) is included.
  • Apps intended to be used by healthcare professionals in the U.S. must be HIPAA compliant.
  • If an app collects personal information, it should include a privacy policy that explains how such data is protected (security), who owns the data, how users can access the data, where data is stored (on device or on remote web site) and instructions for opting out of data collection.
  • The pharmaceutical industry has to police itself with regard to development of all health apps regardless of what regulations FDA may impose.
  • The app should include appropriate disclaimers and terms of use that the user MUST agree to before the app will run.
  • All health/medical apps should be certified by third parties such as Happtique.
  • If an app relies on algorithms or formulas, it must be validated through rigorous testing and documentation to ensure it works properly (i.e,. calculations are correct).
Please take a few minutes to respond to this survey here. The summary of results will be published in a future issue of Pharma Marketing News. You may remain anonymous or you may provide your name and contact information if you wish to be quoted in the published summary. If so, I may contact you for more details and allow you to review your responses prior to publication.

Friday, November 2, 2012

Rodale's Study Cites My Estimate Regarding DTC Ad Spending; I'm Flattered, But...

My friend Richard Meyer over at World of DTC Marketing Blog posted some key findings and charts from the 2012 Rodale DTC Study (see "A new era for DTC marketing").

There's a lot of interesting data in that study, but I will focus on one chart that documents DTC (direct to consumer) ad spending by the pharmaceutical industry from 1997 through 2012. Here is the chart:

I noticed that the "DTC Ad Spend" data (top line) looked familiar. Sure enough, when I searched through my Pinterest "Charts & Data" board, I found a chart that I created back in April 2012 (see "Lipitor Holds Key to DTC Ad Spending in 2012"; the chart is shown below):

All the numbers regarding DTC Ad Spending are the same in the two charts. In other words, Rodale copied my data to the "penny," but did not credit me as the source. In fact, Rodale did not cite any third party as the source!

OK, I didn't get credit. Big deal. I'm not complaining because I didn't get my 15 minutes of fame. The problem is that my original post did cite the source of my data and the last two columns (for 2011 and 2012) were estimates based on a few assumptions. Here's what I said:
"This chart actually plots measured media data (excluding Internet display and search advertising) through 2010 from AdAge, which got the data from TNS Health. I calculated the 2011 total based on the 1% decrease reported by Nielsen (sorry, I don't have TNS data for 2011).  
"The final bar of the chart is my estimate for 2012, which is based on the premise that DTC ad spending for Lipitor will be less than half of what it was in 2011."
So, thank you Rodale for repeating my estimated data for 2011 and 2012, but you should have included the above information about how those estimates were calculated!

P.S. BTW, it is possible -- but not probable -- that my estimates were right on and the Rodale chart is based 100% on new data from AdAge/TNS/Nielsen.

Thursday, November 1, 2012

FDA's "Mobile Medical Apps" Scope of Oversight Pyramid: Confusion Abounds

"Consider the 'Mobile medical apps Proposed Scope for Oversight' issued by CDRH [FDA's Center for Devices and Radiological Health]," said DrugWonk Peter Pitts (here). "It’s a pyramid divided into three parts":

Pitts describes these parts of the pyramid:
  1. The top of the pyramid includes mobile medical apps that are traditional medical devices or a part or an extension of a traditional medical device. Clearly within the scope of being regulated as medical devices. 
  2. The middle section includes patient self- management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by CDRH, for enforcement discretion 
  3. The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.
So, FDA has reserved the term "Mobile Medical App" (MMA) to mean a medical app that meets its medical "device" definition. From now on I will have to be careful NOT to use that term/phrase when talking about mobile apps that clearly are NOT medical devices. I guess we should use "Mobile Health Apps" instead.

I notice that many reporters and drug industry people refer to "mobile medical apps" when describing apps that are CLEARLY at the bottom of CDRH's pyramid. An example is the article titled "11 Super Mobile Medical Apps" that offers these examples of apps, which clearly should NOT be called MMAs:
"Among the innovative mobile medical apps we found is one that lets doctors use interactive diagrams to show patients what's happening with their bodies, where procedures will be done, and exactly what will happen during different procedures. Alternatively, patients can use this app to get doctors to provide detailed visual answers to their questions."
Unfortunately,  FDA's co-optation of "mobile medical app" to refer to health apps requiring regulation as medical devices confuses the discussion, which up until now used the term to describe any health-related app that a physician or patient might use. This may be why PhRMA and other drug industry spokespeople are so fearful of FDA regulations hampering innovation within the "mobile health app" arena (see, for example, "FDA Mobile Regulatory Fear Mongering by PhRMA").