Saturday, December 22, 2012

Tips for Commercial Modular Buildings

Commercial modular buildings can be a great solution for the small business that needs a physical location but cannot afford to rent or buy space in a traditional building. Many small businesses want a traditional physical location, but do not believe that they can afford one. However, if you are a small business owner, you know that the benefits of a physical location cab be considerable. You might want one simply so that you can move your business goods and supplies out of your family's home. Additionally, many businesses need a separate location and address for tax reasons. When you use commercial modular buildings, you will be making a smart business decision. You can save money that can go towards advertisement or investment. If you need an office, make sure you carefully consider all the benefits of a modular building.

Custom Portable Buildings

Meaning of the word custom has changed now. A few times ago custom meant built some scratch only for the owner, and scratches are just used for an overview. But now it is changed standard hardware and some extra equipment added according to owner’s request. Portable building added typical loft, work bench, and many other accessories and they become common in this industry. Standardization of portable buildings: - Now a day’s most of the builders want to work with some standardized template, and add extra standardized things. Standardization of buildings is an innovation that makes huge production with best quality product. And just because of this anyone can afford standard and good quality product. Nothing is wrong and with the customization process average buyer is easily available.

Tuesday, November 27, 2012

"Set of 100 BLACK Body Forms, Ladies Torso/Store/Lingerie/Swimwear Displays/Plastic Hangers" Overview

Our body forms create instant display so put on your newest lingerie, swimwear, panties, bras or t-shirts... For a minimal investment you can add a great display for your products or a great upgrade to any store hanging system. Available is sets of 100/set in BLACK Color at wholesale prices. (See our other listings for clear color) Exceptional quality at an exceptional price. We will accommodate requests for combination of Black & Clear Forms but only in lots of 10 per case. Please send us an email and specify your request for color combination of Black & Clear Forms.

Friday, October 12, 2012

Did Pharma Online Ad Spending Increase 50% in First Half of 2012?

"Entertainment, automotive, pharmaceutical and healthcare were the fastest growing vertical sectors for online advertising in the first half of the year, according to a new report from the Interactive Advertising Bureau" (IAB) reports ClickZ (here). The report (get it here) utilizes data and information reported directly to PwC by companies generating online / mobile advertising revenues, and publicly available corporate data. The following figure shows the online ad formats tracked and how much was spent on each in the first half of 2012 compared to the first half of 2011. Overall online ad spending was $17.0 billion in the first hlaf of 2012 compared to $14.9 billion in the first half of 2011 (a 14% increase).


Search accounted for 48% of the online ad spend and display-related advertising accounted for 33% (Display-related advertising includes Display/Banner Ads, Rich Media, Digital Video, and Sponsorship).

Here's the data comparing the total online ad spending by major industry category:



Online ad spending by "Pharma & Healthcare" increased by 50% (from 4% of the total to 6% of the total). Keep in mind that not all of this is specifically spending by the Rx drug industry because the category includes "pharmaceutical products, facilities, services, researchers, and biological products. Also comprises establishments providing healthcare and social assistance for individuals as well as personal care, toiletries, and cosmetic products."

6% of $17.0 billion is $1.02 billion. That could pan out to be more than $2 billion for the entire year -- again, not all of that will be spent by the Rx drug industry.

eMarketer has predicted that online ad spending by the health industry in 2012 will be $1.58 billion (see "Bogus Predictions of Pharma Industry Online Ad Spending"), which is significantly different than the IAB guesstimate 0f $2.04 billion based on the data for the first 6 months.

Why the difference? It could be that eMarketer is measuring something different. However, its 2011 number of $1.28 billion is virtually the same as what IAB said the healthcare industry spent online in 2011 (4% of $31.7 billion equals $1.27 billion).

$1.58 billion, $2.04 billion -- whatever. Pharma's share of that ad spend is probably 50% or $0.8 to $1.0 billion. Taking out the 48% attributed to search, we get $0.38 to $0.48 billion spent on other types of online advertising. This compares to about $4 billion pharma spends on all direct-to-consumer (DTC) advertising -- a number that does not include the online spending of any sort. In other words, online ad spending by pharma is still insignificant compared to offline ad spending.

Tuesday, October 9, 2012

It's Official: Doctors Prescribe Adderall to Help Kids Get Higher Grades at School

Dr. Michael Anderson, a pediatrician for many poor families in Cherokee County, north of Atlanta, routinely prescribes Adderall to kids who get poor grades in school. To do that, he first must commit fraud: submit a false diagnosis of attention deficit/hyperactivity disorder (ADHD) to Medicaid and/or private insurer.

The doctor admitted his fraudulent activity in a story published in today's New York Times (here). “I don’t have a whole lot of choice,” said Dr. Anderson. “We’ve decided as a society that it’s too expensive to modify the kid’s environment. So we have to modify the kid.”

He does this believing in his heart of hearts that ADHD is “made up.” His excuse? To prescribe the pills to treat what he considers the children’s true ill — poor academic performance in inadequate schools.
Dr. Anderson’s instinct, he said, is that of a “social justice thinker” who is “evening the scales a little bit.” He said that the children he sees with academic problems are essentially “mismatched with their environment” — square pegs chafing the round holes of public education. Because their families can rarely afford behavior-based therapies like tutoring and family counseling, he said, medication becomes the most reliable and pragmatic way to redirect the student toward success.
This is wrong on so many levels. For one thing, who made Dr. Anderson and other physicians who feel the same way judge and jury regarding what school is "adequate" or "inadequate"?

That, of course is not the main problem, which is prescribing a dangerous, additive drug to children who have no real medical need. This is clearly a case where a drug's benefit does not justify the risks that the patients are subject to. "Reported side effects of the drugs have included growth suppression, increased blood pressure and, in rare cases, psychotic episodes," says the NY Times.

Not mentioned by the Times is the dangers of addiction. ABC News recently ran a story documenting this problem: Dangers of Adderall Addiction Among Moms (see here or view the embedded video below).



If moms can become addicted to Adderall, their children can also become addicted. When they can no longer get Adderall, they will try other drugs easily available from physicians or on the street (see, for example,

This is so egregious that I must ask if Dr. Anderson has received payments from Shire Pharmaceuticals, which sells Adderall XR (the extended release version of Adderall, which Shire sold to Teva Pharmaceuticals). Unfortunately, Shire does not publicly disclose such payments. According to its compliance Web site (here), Shire only reports spending on HCPs (healthcare providers) to a "limited number of states as required by the individual state laws."

Related posts:

Monday, October 8, 2012

Psychiatry "Suicide" by Pharma

British psychiatrist and "Big Pharma gadfly" David Healy argued that his profession is “committing professional suicide” by failing to address its dangerously close relationship with the pharmaceutical industry. He made his argument speaking at an annual meeting of the American Psychiatric Association during a "well-attended session on conflicts of interest" according to this article.

Dr. Paul Appelbaum, a past president of the APA and director of Columbia’s Division of Law, Ethics and Psychiatry cited a study that showed "only 34% psychiatrists believe that receiving food or gifts affects their own prescribing patterns, 53% believe that it influences that of their colleagues... Research shows that this type of thinking — 'Everyone else is prone to biases and social factors, but not me'” — is common and confounds attempts to address conflicts.'At least some of our colleagues are wrong,' Appelbaum said drily of the study."

Healy offered some advice for how his profession can put some distance between it and the pharmaceutical industry.“The key issue in the short term is access to data. We have to insist on that,” he said. “We let industry come to our meetings and let them talk in our programs. I don’t think it’s huge problem that they get paid. The big problem is that if you ask for data, they can’t give it to you. That’s not science, that’s marketing masquerading as science.”

Daniel Carlat, M.D., director of the Pew Prescription Project, organized the session. Carlat once characterized pharma-sponsored Continuing Medical education (CME) as "a new twist on that well-known instrument of corruption, money laundering." Listen to the following podcast interview of Dr. Carlat on that issue:

Listen to internet radio with Pharmaguy on Blog Talk Radio

Friday, October 5, 2012

Who Has Actually Played BI's SYRUM Game? The Silence is Deafening!

During today's #hcsmeu chat session (see archive here) I asked "Truthfully - has any of my EU colleagues actually played SYRUM?"

There's been a lot of hype about Syrum previous to its launch by Boehringer Ingelheim (BI) in the EU (see here), but I've heard nothing post launch from anyone who has actually spent time playing the "game" (I'm told that it's not a form of "gamification").

"Who's the EU 'pharmaguy' who will take on this task and report back?", I asked.

Turns out that one person (Maria Öst, Sweden, aka @mariaatomaca) admitted she signed on to a beta account, but she didn't actually play the game. By signing on, Maria gave Syrum (and BI) permission to "post on [her] behalf" and "read [her] checkins" even if she does not play the game (see here).

According to @fision (Kai Gait, UK) Syrum opens "lots of potential opportunity in the future by accessing the interest graph of players" -- even if they don't actually play the game ("If a user doesn’t ‘disconnect’ the game, they [BI] still have access to data in theory," said @fision).

Felix Jackson (@felixjackson, UK, founder of medDigital) actually has played the game and said "I ... enjoyed it! I liked the way it showed me drug development." I thank Felix for taking the time to give me a live tour of the Syrum via Skype during which I saw a few peculiar things such as a masked avatar that looked like an Al Qaeda terrorist! I guess it was supposed to be a surgical mask. I've worked in a lab and I never saw anyone wear a mask. Maybe drug development labs are different.

One of the features of the game is that you can see friends on Facebook who have also signed on to play the game. You can "recruit" these friends to be members of your drug development team or you can collaborate with them. Unfortunately, none of Felix's FB friends -- including BI's John Pugh -- were able to collaborate with Felix because they didn't have any molecules under development (ie, they currently are not playing the game).

Meanwhile, Helen Harrison (@harrassedmom) alerted me to this "walk through" on YouTube:



By the time you read this, one or two other people I know on Twitter may tell me that they also have played Syrum. These people, however, are mostly like me -- not representative of Syrum's target audience, which is the general public. We won't know very much about how many of those people have signed on to play, how long they have played, etc., unless BI shares that information with us. That make take another 3 years -- I'll wait :-)

Wednesday, October 3, 2012

Shane Victorino: Adult ADHD Poster Boy

Adult ADHD (attention deficit/hyperactivity disorder) is the "next big thing" for pharma companies like Shire, which markets Vyvanse for the treatment of ADHD in adults. So says the author of a Salon article titled "Big Pharma’s newest invention: Adult ADHD."
“Immature adult market continues to offer greatest commercial potential,” read a 2008 press release to the pharmaceutical industry from the market research agency Datamonitor: “Estimated to be twice the size of the pediatric ADHD population, the highly prevalent, yet largely untapped, adult ADHD population continues to represent an attractive niche to target.”
So who might consider themselves part of this “untapped” market?

Well, former Philadelphia Phillies center fielder Shane Victorino for one. The "Flyin' Hawaiian" is now an adult ADHD celebrity spokesperson appearing in magazine ads like the one shown below and in video testimonials like the one you can find on ShanesStory.com.


If you talk to people in the know, Victorino is an ideal adult ADHD "poster boy." I've heard that Victorino was a mile-a-minute talker and often people around him wished he'd shut up. In a Shire-sponsored YouTube video, Victorino himself admits "always interrupting" his teammates and having problems focusing.

Interestingly, Victorino doesn't mention Vyvanse. It's unclear, therefore, if he benefited from Shire's drug, which entered the market in 2007, about 8 years into Victorino's major league career and about the time that Victorino became a starting player for the Phillies.

So it's unclear if Vyvanse -- or any other medication -- helped Victorino play ball as well as he did for the Phillies. Some have speculated, however, that his constant talking and interruption of teammates was one reason why the Phillies traded him. Could the trade be part of a devious Phillies plot to insert a disruption agent within the ranks of a rival team?

I'm just kidding, of course. Like many Phillies fans, I like Victorino and wish hime the best.

Unlike some other pharma-paid celebrities, Victorino is not promoting a brand of drug, but promoting awareness of a medical condition. Some people -- like the Salon article author -- claim that ADHD awareness marketing is a form of "disease mongering," which causes more people to be diagnosed with the condition than is necessary. But that's a whole other issue that I don't have time to get into now. You can read about disease mongering here.

Thursday, September 27, 2012

"Gamification" (eg, Syrum) is Just Another Way for Pharma to Mine Our Personal Data and Wisdom

Everyone I know in Pharma Twitterdom is enamored by the launch of Boehringer Ingelheim's SYRUM FaceBook game, which is available ONLY to European FB users. BI says the game is "educational" for physicians and the public:
"The research driven pharmaceutical industry is immersed in education - whether aimed at medical or pharmaceutical professionals or providing information directly to the public," says John Pugh, Director of Digital at Boehringer Ingelheim. "Gaming is an experimental way for Boehringer Ingelheim to do this. The challenge is to do this in a truly engaging, educational and entertaining way that immerses the player."
Syrum allows players to create and run their own pharmaceutical company, using a virtual laboratory to discover and develop imaginary medicines to improve the health of the world.

But "educating" the public may be a minor goal of Syrum. It surely is not something that can be measured as a key performance indicator (KPI) to justify the years and money invested in developing this "game."

So how does BI justify investing all this time and money to develop a game if it cannot measure how better educated the public is about drug development?

I believe that Syrum is designed to educate BI and NOT to educate us. It's much easier for BI to measure how much better educated IT has become due to Syrum than to measure how much better I have become from playing the game.

What do I mean by BI being "educated" due to Syrum?

Firstly, BI requires everyone who plays the game to open up their FB information for access by the company.

I was able to access the game while in Spain recently. Before I could play the game, however, I had to agree to allow BI to gain access to practically everything I do on Facebook (see screen shot below).


This stopped me dead in my tracks. Perhaps this is a normal permission request for all FB apps, but I was loathe to "allow" this kind of access for a pharma company app. It seems that BI wants to do some market research about the people who opt in to play Syrum. This kind of data could be a valuable KPI for Syrum.
I must admit that I am mystified by FB. For example, what does "Post on my behalf" mean? Whatever it is, it doesn't sound good. "Reading my checkins" also does not sit well with me. 
I'm not the only one who doesn't use apps due to privacy concerns. More than half of mobile application users have uninstalled or avoided certain apps due to concerns about the way personal information is shared or collected by the app, according to a nationally representative telephone survey conducted by the Pew Research Center’s Internet & American Life Project (see "Privacy and Data Management on Mobile Devices"). What applies to mobile apps also applies to FB apps - maybe even more so given FB's bad rep viz-a-viz privacy (see for example: "How Facebook Plans On Using Your Prescription Drug Purchase History, And How To Stop Them").
Another way that Syrum can educate BI rather than educating us is by allowing BI to cash in on "crowdsourcing" WITHOUT financially compensating the crowd!

BI says it has steered clear of therapeutic areas it is involved with as potential areas of interest in the Syrum game, although it has left the door open to change that. Perhaps BI's objective is to test the social aspects of the game and access the "wisdom of the crowd" to help it develop new drugs.

The pharma industry seems ready -- even desperate -- for help from the crowd to develop new drugs. Ten top U.S. and European drugmakers -- including BI -- started a nonprofit organization, called TransCelerate BioPharma, to collaborate on the problem of developing new drugs (see here).

Meanahile, Lilly's Clinical Open Innovation believes that crowdsouring can help fix drug development, which it claims is "broken." Lilly believes that "Open Innovation models – focused on clinical drug development – can result in transformational gains in value-to-patients and efficiency. We also believe that open data, linked, crowdsourced, consumed and curated by experts outside (as well as inside) the walls of pharma will bring innovative insights and wisdom. And that open communities will set and meet objectives to reduce costs and improve outcomes" (see "OMG, LCOI! Open Source Pharma: Creative Commons Coming To Pharma").

Perhaps Syrum is a precursor to that kind of "collaboration" - what I call "semi-open access" drug research. This could be of tremendous educational as well as FINANCIAL benefit to BI. And all it costs is the price of developing a game with very little payback to the crowd other than "fun" and "engagement!" P.S. On KPI I forget to mention was ROI on PR. BI recently retweeted this tweet from the PM Society: "RT @PMSociety: How is PR ROI for Syrum being measured? 50 pieces of press just from launch party. Value in positioning of @Boehringer". 50 easy "pieces of press" -- some kind of "POP"!

Tuesday, September 11, 2012

Mirror Mirror on the Wall, Who's the Most Innovative of Them All? Pharma, Social Media Wise, That Is.

The pharmaceutical industry has consistently promoted itself as an "innovative industry" by which it means it discovers new, innovative drugs through research. No one ever claimed the drug industry was very innovative in marketing in general or in its use of social media. However, consultant and strategist Andrew Spong, just came close to doing that in a post titled "Innovation: the name of the game for Boehringer."

"By dint of the sheer weight of evidence that has accrued over the past three years alone," says Spong, "Boehringer Ingelheim may reasonably be identified as the pharma company that sets the pace for the industry in digital environments...Boehringer merits recognition as the digital leader in the pharma industry not because of what it has achieved, but because of what its activities say about the cultural evolution that has taken place within the company."

Spong and many others are lauding Boehringer's Facebook Syrum game based solely on hearsay evidence -- Syrum won't be officially released until September 13, 2012 (see "BI to Launch Beta Version of its Syrum FaceBook Game on September 13, 2012"). The "weight of evidence" comes almost exclusively from tweets, blog posts, and press releases written by BI PR people and John Pugh, BI's Director of Digital.

I doubt if Spong or any other laudatory commentator has actually played the game. If they did, I am sure they would have mentioned it and actually written something new about it.

I am not sure what kind of "cultural evolution" is going in within BI, but I know that the company has exhibited some PR and marketing behavior that regulatory agencies have frowned upon (see, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons"). This is not indicative of a cultural evolution in pharmaland.

Spong also mentions BI's "experiments with outré humour" and links to this "Famously Unpronounceable" YouTube video as an example.



Spong neglected to mention that the above video is NOT found on the official BI YouTube site, which no longer hosts the video in question. BI yanked it because of negative comments from industry commentators such as myself who are “slow to acknowledge its transformation” (see “BI’s Famously Unpronounceable Video Lives On!”).

With regard to the Syrum game, BI has been milking that for almost a year making it one of the more spectacular examples of “vaporware” I have ever seen (again not culturally evolved). BI, IMHO, would have been much better off sticking with real world exhibits (see “'A Drug is Developed:' Easier than Launching an Educational Facebook Game about Drug Development?").

Before you label me solely as a negative commentator, I offer you this: “Boehringer Ingelheim Shows How to Support Patients via Twitter and Beyond”.

Just like every pharma company, BI has its social media triumphs and failures – or “Trials & Tribulations” as I like to call them. See my latest Slideshare presentation on that here.

Saturday, September 8, 2012

States' Rights: Regulation Via Settlement

"I believe in states' rights.... I believe we have distorted the balance of our government today by giving powers that were never intended to be given in the Constitution to that federal establishment."

Ever since Ronald Reagan said he believed in "stats' rights" that has been the rallying cry of Republicans up to and including Romney-Ryan.

For pharmaceutical companies, however, states' rights to enforce some federal laws via litigation is a problem. Take for example, the the $181 million settlement reached August 29 between 36 attorneys general and Jannsen Pharmaceuticals (a Johnson and Johnson company). According to a Forbes contributor, this settlement "confirmed that state AGs must indeed be reckoned with on off-label issues. What will get medical product companies’ attention is not the financial settlement, though. The real eye-opener was the precision of the settlement’s conduct requirements, most notably one restraint on speech which goes beyond the dictates of federal law" (see State Attorneys General Step to the Fore on Off-Label Drug "Promotion").

Relating to the distribution of off-label information/reprints about Risperdal (or any "Atypical Antipsychotic"; i.e., all of Jannsen's products that are FDA-approved formulations containing risperidone and/or paliperidone), Jannsen agreed that only Jannsen "Scientifically Trained Personnel" may distribute such materials and NOT sales or marketing personnel UNLESS Jannsen has a "pending filing with the FDA for approval of the new indication described in the reprint." "Scientifically Trained Personnel," according to the settlement are Janssen personnel who are "highly trained experts with specialized scientific and medical , usually with an advanced degree scientific degree (e.g., and MD, PhD, or PharmD)."

"While this specific agreement pertains only to antipsychotics, the principles are obviously applicable at a higher level of generality," said Arnie Friede in a interview with Pharmalot (here). And J&J/Janssen has said they won’t use sales or marketing personnel to disseminate any off-label reprints unless they’ve already submitted an application to FDA covering that particular use and they may well apply the same “rule” in the marketing of other FDA-regulated products. This restriction goes beyond a provision in the FDA Modernization Act that has since expired, which obligated companies to certify that they were conducting studies intended to support a supplemental application before disseminating an off-label reprint, even if peer reviewed, but which did not require actual submission of an sNDA."

Why did J&J/Jannsen agree to this settlement rather than fight the case in court? The Forbes writer suggests it was just a matter of money: "the cost-benefit calculus of fighting vs. settling likely led the companies to resolve the claims."

Perhaps, however, this case is not closed and the settlement could be declared null and void if the "Federealists" have their way: "Unless I’m missing something," said a commenter to the Pharmalot post, "it seems a sure bet that the industry, perhaps via its pals at Federalist Society et al, will file a preemption case that these state requirements interfere with DDMAC’s authority to regulate off-label promo and related. Indeed, I do think the case for federal preemption is considerably stronger here than for preemption of state product liability law. In the meantime, friends-on-the-court could use the case as an opportunity to open the wider issue of off-label promo (for a case down the road)."

It ain't over till the fat lady SUPREMES sings!

Friday, September 7, 2012

Adherence - Do We Really Need an App for That? Benefits Do Not Outweigh the Risks.

Adherence, as defined in the Pharma Marketing Network Glossary, is "Percent of doses of a drug taken as prescribed for entire period of study (compliance + persistence)." In short, "sticking to the proper self-administration of treatment." Lots of patients -- even patients taking life-saving medication -- are not as "adherent" as they should be, which means that the treatment does not work as advertised and drug companies lose money. This has been discussed ad nauseum (see the links to articles listed here).

There have been many attempts by the drug industry to improve medication adherence, but it has been a tough challenge. But the industry has not given up. The new battleground for combating non-adherence is the mobile smartphone and the smartphone app is the weapon of choice. An example is the Care4Today "secure mobile app and website" that was developed and recently released by Janssen Healthcare Innovation.

Jannsen claims that this app is more than just a new-fangled way to remind you to take your medicine -- Care4Today "serves as your self directed personal health assistant."

Here are the "key features:"
  • Customizable reminders and alerts on your mobile device:
  • Medications
  • Prescription
  • Refills
  • Appointments
You can also
  • Store key contact information
  • Store and password protect important medical contact information (Doctors, Pharmacies, and other important Care givers)
I downloaded this app on my iPad and was confronted by the screen shown on the left. It appears that I have to register on the care4today.com website before I can use the app, which I consider a stumbling block -- I hate registering on a pharmaceutical site. The terms are so long, tough to read and onerous that I just say "f**k it! I don't really no stinkin' app to remember to take my meds!"

But I soldiered on and registered. BTW, I could not click on the URL within the app to go directly to the website -- I had to quit the app, bring up my browser and enter the URL (or copy and paste from the app). BTW2, I hate running iPhone apps that are not specifically designed for my iPad as well. Just sayin'

Success! ...I think. I get a "Temporary Numeric Password" that is a 7-digit number. It says "Enter this Temporary Numeric Password into your mobile device." I do that and immediately get the message "The Numeric Password is a 4-digit number."

I guess it's time to call support! Whoops! Silly me - I didn't read carefully the new gray text that appeared in the boxes. It was asking me to "Enter a New Numeric Password," which should be 4 digits. This will prevent someone from gaining access to my data should I forget my iPad on the bus.

It took a couple minutes for the app to "synchronize" my data. In fact, it's still "synchronizing" while I am writing this. I'm guessing the app has crashed, but I will wait. Meanwhile, let me tell you more about this app.

The data you can enter on the care4today web site is very personal. It can be all you medications including dosages. It can include information about your doctor and pharmacist as well as all your appointments.

Whoops! Just got an error message: "Failed to establish network connection...For help go to care4today.com (code 08017203)." Whoa boy! If I were an 75-year old mensch, forgetaboutit! I'd quit this app in a heartbeat (ie, minute or two). But, I am your fearless pharma mobile app reviewer who will follow instructions.

Turns out I must call support again - that's what the website tells me to do. While I'm on the phone with "Donald," I try entering my numbers again and lo and behold, it syncs in a flash and I'm in!

I'm not going to get into all the features of this app such as how it helps you enter your prescriptions (i.e., it has a complete list of drugs that takes forever to scroll through -- it would be helpful if it found the drug as you begin spelling it out). My main concern is what Jannsen is doing with all this information.

I suspect that Jannsen may be using my information to do some market research and learn more about non-adherence. After reading the Privacy Policy, I see that Jannsen will "sometimes ... provide limited access to your personally identifiable information to our contractors and consultants, including vendors and suppliers that provide us with technology, services, or content for the operation and maintenance of our Application or data and analysis on Application use."

Jannsen will aslo use aggregated data: "We may combine user-inputted information, including personal health information and information regarding your use of the Application, with information from other users to create aggregated data that may be disclosed to and utilized by our affiliates and by third parties."

Jannsen will also use the app to send out ads about their products: "From time to time, we may ask for your consent for us to send other messages to you. For example, these messages may be directed to improving your understanding of the medications that you are taking as well as conditions for which those medications are typically taken. By providing your consent at those times, you will be specifically consenting to receive the types of messages described in the consent request."

Also ads from other companies: "From time to time, we may also ask whether you would like us to share your personal information with another company that may want to send you information about their products or services. If you consent to such transfer by us of your personal information to another company, please note that the information provided will be subject to such company's privacy practices and not within our control."

Which is all very good and fine with me -- except that it is too much possible sharing of personal information for me to trust the app. Or look at it this way: Do the benefits outweigh the risks? I think not.

P.S. I forgot this tidbit from the Terms: "We have no obligation to provide technical support or maintenance for the Application. At any time and for any reason, without notice or liability, we may modify or discontinue the Application or any part of it or impose limits on your use of or access to the Application."

Thursday, September 6, 2012

FDA Caught Speeding. Puts Public Safety at Risk.

"An FDA effort to speed approval of new medicines allowed drugs for stroke prevention, cancer and multiple sclerosis onto the market without proper safety analysis, according to two drug-safety experts," reports the Wall Street Journal in a review (here) of a "viewpoint" recently published in JAMA.

Peter Pitts of Drug Wonks says: "As usual, Janet Woodcock [Director of the Center for Drug Evaluation and Research at FDA] places the matter in the appropriate perspective. 'I'd like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,' Dr. Woodcock said. "The cancer community in particular says we haven't used accelerated approvals enough.'" Pitts adds this zinger:

"Here’s the truth -- there is no such thing as a 'safe' drug. It's the patient who must understand the risks required to achieve the benefit. That’s why the patient voice must be heard during all phases of the regulatory review process."

Unfortunately, I don't think Pitts actually read the piece in JAMA. The drug safety expert authors of that piece (Thomas J. Moore and Curt D. Furberg) did not claim that drugs approved by the FDA should be "safe." They made the argument that accelerated approval by FDA of several powerful drugs with UNKNOWN safety issues were no better at improving outcomes than drugs currently on the market whose safety issues are well-known.

"Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal," said Moore and Furberg, "the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered."

The authors cite several specific drugs that were fast-tracked for approval without adequate safety information available. I'd like to focus on one: Dabigatran for prevention of stroke. Dabigatran is marketed as Pradaxa by Boehringer Ingelheim (BI).

According to Moore and Furberg, Pradaxa benefited from "3 different FDA policies promoting innovation. This drug received both Fast Track and Priority Reviews and was studied in a single large phase 3 trial rather than in at least 2 pivotal trials, as normally required...Within less than a year of approval, 1 survey showed that dabigatran accounted for more serious adverse drug events reported to the FDA during the second quarter of 2011 than any other regularly monitored drug. Risk of hemorrhage was prominent in older patients (median age, 80 years), a subgroup for whom declining kidney function or other factors may have increased bleeding risk. Both a manufacturer package insert revision and the European Medicines Agency have called for closer monitoring of kidney function, a needed step because even moderate kidney impairment increases dabigatran levels more than 2-fold. In addition, unlike warfarin, no antidote is available for use in bleeding emergencies related to dabigatran. Evidence was beginning to emerge that dabigatran-related bleeding— whether from trauma or as an adverse effect—may be more difficult to treat than warfarin-related bleeding."

Couple this safety issue with the promotion of Pradaxa in the media as a "super pill" and a "revolutionary drug" (see "Bad Journalism or Bad Pharma?") and you end up with a real public safety issue that patients should be concerned about. BI itself stoked this Pradaxa-mania (read, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons" and "Full BOEHR(inger) Social Media Reporting of RELY Trial Results").

Sadly, Woodcock may have heard from "patient advocates" paid by pharma companies to testify before the FDA, but who advocates for the patients harmed by drugs like Pradaxa? Their stories are locked in the FDA's adverse event database, which is not generally cited during drug approval Hearings at the FDA.

Not to mention the impact of DTC advertising on the public's willingness to accept greater risk:

Thursday, May 24, 2012

D&D Next Playtest Review


It's been a little quiet around here you may notice. That'll be because I'm getting geared up to move out of my current place over the next month. So you might not hear much from me until I'm settled in. In the meantime I just downloaded the playtest documents for the latest generation of D&D and I've been giving it a look over and thought I'd share my thoughts. Before I start I should mention that I know there's a lot more info out there than just what is contained in the playtest documents...but at the same time that's obviously all still up in the air and the playtest document is what Wizards is currently using to represent the state of the game as it stands now so I'll stick to it for the purposes of this review.




Part 1: The Basic Rules

So, obviously the real, core material is pretty unchanged. You roll a 20 sided dice and the number that comes up makes you happy or sad depending on circumstances while other dice, with less sides, cheer from the sidelines. This is D&D after all, you're sure to get all your funny-lookin'-dice.

The first few pages are very familiar to veterans of 3rd and 4th edition. You make rolls by rolling a d20 and adding modifiers based on your ability scores and class features. The same goes for attacks, contested rolls, and saving throws. You compare this to a DC (or AC for attacks) to see if you succeed or not.

The first thing that stands out as different is that the numbers we'll be dealing with seem to be significantly smaller. Examining the example characters and the basic rules you quickly notice a lack of something...level-based modifiers. You've got your standard ability score modifiers (codified in 3e and continued in 4e) and some bonuses based on class or race...but nothing based on level. That's quite interesting...and examining the DM's section supports this. A DC 27 check is listed as "Immortal" difficulty, something only demigods are capable of. In third edition 27 would certainly be reachable well before 10th level. Sort of like Ability Checks in 3rd edition, they never scaled very high since they were just the ability score alone. An interesting development.

Saving throws are a bit different. You don't have Fort/Will/Ref saves (or the obscene sprawl of old-school saving throw types). Instead a Saving Throw is just an ability check made to resist or overcome something. So you can have a Strength saving throw (say to resist knockdown or grab a ledge) or an Intelligence Saving Throw that's used to resist illusions or attempts to make you dumb. Also interesting. 

Next we've got Advantage/Disadvantage, a deeper version of 4e's "combat advantage" modifier. Advantage and Disadvantage represent general, vague...er...advantages or disadvantages. I do wish this term was a little bit more elegant, the phrasing (while very accurate) seems a bit awkward. The mechanic is new, essentially you roll an extra d20 on a check/attack/save and take the best (for advantage) or worst (for disadvantage) result.

As I mentioned Ability Scores are pretty much identical to the 3rd/4th edition. You've got all your standard scores and the normal +1 per 2 points above 10 modifier. It seems like they might be trying to avoid extremely high ability scores (noting that 30 is "divine being" level). But overall nothing much new here.

Part 1 reaction:

Okay...so what are my thoughts for the basics? Overall nothing really new but overall positive. The simple, flexible ability score system (using universal modifiers rather than individual charts) and the d20 + modifier vs DC/AC system was one of the best innovations of 3rd edition and it's good to see that it isn't being tossed out. At the same time I like the trend I'm seeing for smaller numbers. Both third and 4th edition got truly obscene with the huge numbers they were throwing around at high levels and I think toning things down isn't a bad idea. Also, name aside, the advantage/disadvantage system is something I definitely approve of. It's a flexible modifier that can be thrown at just about any situation at any level and it'll still be helpful, it seems like an extremely useful DM tool. I do worry it may start to get overused...but we'll see. So far it looks a lot like 3e but with a bit more restraint and flexibility.

Part 2: Exploration

Complex movement/exploration systems has never been a huge part of the D&D experience, so I don't expect much of anything new here. It's stayed almost identical since 2e and taking a quick look reveals it's still pretty much the same now.

A round is still 6 seconds, movement still occurs in units of 5 feet. Difficult terrain costs extra movement.

There's a bit on stealth, mentioning the exact conditions required to hide and it's benefits (namely you can't be directly targeted and you have advantage on attacks you make). Honestly, I feel it goes into far more detail than is necessary on the exact conditions needed to hide, it comes off somewhat paranoid in an odd way, like it assumes that these rules will be abused and is trying to cut off potential weaseling.

Reaction:

As I said, almost no change at all from previous editions. It would have been interesting to see Wizards try something new with abstract movement or similar, but the old tried-and-true methods are just fine.

Part 3: Combat

The good old hacky-slashy. Slaying orcs and smashing...uh...other monsters that rhyme with orcs? Oh, I know. "Slaying orcs and turning corpse..s." Sort of works, eh?

The basic combat system is still quite familiar. Step one: Are you surprised by the horrible thing trying to eat your face? If not, then roll dice, see who goes first. Take turns until one of you no longer has enough limbs left to continue. Worth noting surprise now just gives a hefty (-20) penalty to initiative, rather than a free round. Which...kind of doesn't make sense...I mean -20 is pretty big but it's not unbeatable. Say the rolls work out and the ambusher actually loses initiative...what does that mean? Can the surprised creature attack...even if they may not even be aware that there's someone attacking them yet?

Turns have been simplified a bit. You can move (just move, no "move actions"), take one action (there's a simple list, pretty obvious choices) and take a reaction (that is an action during someone else's turn) which is normally limited to a held action or certain class abilities.

Attacks are still pretty much the same as they've been since THAC0 was taken out behind the shed and put down. Damage likewise. On the outside it's all still very similar. There's a few items of note...critical hits now do max damage rather than a multiplier. This includes all dice making it pretty deadly-sounding but at the same time only a natural 20 is a crit (no confirmations) so there's not much concern so far of "gaming" the critical hit system (although who knows what is to come). There's also two states that are fairly simple: Resistance and Vulnerability. Resistance to a damage type means you take half damage, vulnerability means you take double damage. A quick check on the sample bestiary indicates that this is going to be replacing DR/X by all indications.

Hit points are still around, and you get plenty of them (the 1st level sample wizard has 16). It's interesting to note that Wizards is being very clear that hit points represent an abstraction and you don't suffer any actual physical damage until you're at below half your hit points, and even then it's mostly scratches and bruises. Dying is generally pretty difficult (DC 10 constitution save every round, take 1d6 damage on a failure and three non-consecutive successes stabilize you) and doesn't happen until you hit -(level + con).

Healing is quite fast, obviously inspired by 4th edition's system. Out of combat you can "spend" HD to regain hit points by catching your breath (assuming you've got a healing kit). You heal completely with a full night's rest.

Then there's a list of conditions. Mechanically most basically boil down to different ways to gain advantage/disadvantage on various rolls.

Part 3: Combat Reactions

So, obviously combat is the meatiest part of the system so lets see...

Attack and damage are about the same as 3e (although again with lower modifiers) so I can't much complain, but not much to laud either. I do like the simplicity of the resistance/vulnerability system compared to DR, but the difference is fairly minimal.

Giving extra HP was one of my personal house rules so I can hardly complain about the hefty chunk everyone gets. I also like how getting extra hp with a new level works (you roll HD, but the minimum result is equal to your con modifier). While Wizards tries to justify the massive HP totals with reality by pointing to their abstract nature it still doesn't make any more sense than it did before (magical healing still causes it to recover and presumably things like falling, pools of acid or similarly obviously "deadly" damage is still treated as an abstraction). So basically if you were fine with hit points before you won't have anything to complain about, but if you didn't already like them then you'll probably feel the same way still.

Overall I approve of the "HD for Healing" system and I think we'll probably see it used in various interesting ways like 4e's Healing Surges. While I think that automatically recovering all your hit points with a long rest is definitely simpler (and prevents you from having to squeeze healing out of the party cleric every night) it does drain some of the drama out of injury. Even if you're on the verge of death so long as someone can help you get bacj to positive hp then you'll be fine in the morning. You'll never have a wounded party limping their way through the wilderness for more than a day before they're back to 100% strength.

The conditions are mostly fine. I particularly like the intoxication condition and the way "charm" has been reduced from the extremely vague "target becomes friendly" to two simple, clear-cut conditions.

Part 4: Equipment

Oh my, electrum pieces are back...for some reason. I'm sure they'll slide quickly back into obscurity again.

It's interesting to see that they're starting out by stating that magic items are "beyond simple gold". That's a heck of a departure from 3e and 4e if it holds up and it'll be interesting to see where they go with that. It makes sense given the more "toned down" nature of the game so far. Not much point in shrinking modifiers if you're just going to send them rocketing with a boatload of magic items.

Arms and armor are the fantasy classics. You've got your d8 longswords and your d4 daggers. We see that things like armor check penalties have been replaced with the fairly simple "disadvantage" system. Then we get a big list of general equipment. All very familiar for the most part, although there are some interesting touches here and there.

Part 4 reaction:

This is probably the shakiest of the sections so far. Which is a bit odd when you consider how little equipment has changed over D+D's lifetime. Unfortunately what they have changed seems to be mostly negative. There's been a lot of people complaining about the relative AC values especially, I can't say one way or another whether or not I agree yet. I suppose it depends on whether you feel a knight in full plate should be harder to hit than a lightning fast rogue in leather...it's a matter of preference really. I tend to assume that the rogue should be harder to hit, but suffer more from those blows that do get through. However, the armor is at the point where the "advantage/disadvantage" system might be getting overused. I'll withhold judgement for now however.

The weapons are mostly okay, although there's some things that look like typos or mistakes (clubs and maces are identical for instance...except that one costs over 10 times as much). In fact, one wonders why anyone uses any basic weapons other than clubs (one handed) or morningstars (2 handed). The only answer seems to be "different damage types", I do find myself missing the little touches in 3e that made a longsword and a battleaxe a bit different.

Part 5: Magic

The magic system is definitely the standard vancian magic that players of 2e and 3e will be familiar with. There's almost no sign of 4e's power system at all. Well, I say almost...

There's two things that harken back to it. There are "minor magics" which can be used at will, without memorization. These are mostly the little spells like light or detect magic but they also include magic missile and the (surprisingly powerful) ray of frost. So wizards and clerics will have a few things they can always cast, even when they run out of their more potent magic.

The other one is rituals. Now, these aren't really like 4e rituals...they're more variations on normal spells. You see, when you have a spell that you know, but haven't prepared, then you can cast a ritual version of it. The ritual takes longer and costs extra gold but it allows you to cast it without memorization.

Then we've got a list of spells that are mostly D&D classics. As of this document they all seem to have relatively fixed effects (another holdover from 4e) rather than scaling with level. So for example burning hands inflicts 2d4 + Int modifier damage. This means they're much more powerful at lower levels but don't scale immensely to higher levels. That's an assumption at least. This could simply be a simplified version for playtest. Many "status effect" spells have a relatively weak standard effect, and then a major effect against anything with 10 hp or less. For example sleep normally just halves your movement until you're injured...but if you have less than 10 hp then you're knocked unconscious.

Part 5: reactions

I was never a great fan of the vancian system, so I can't say I'm thrilled to see it return. But it's a tried and true system that has lasted D&D for decades so I can hardly blame them for keeping it around. I'll certainly manage to live with it. The minor magic rule is an interesting addition (a very familiar one for those who've played Pathfinder) and it means spellcasters are always "armed" to some degree.

I really like the "idea" of the ritual magic rules but there's almost no substance to it yet...only one spell in the playtest document has a ritual version and that spell is Alarm...something you would assume would only have a ritual version. So we'll see how that shapes up when there's more info.

Finally the spell effects themselves are interesting and I think I'm definitely seeing an effort to keep spellcasters from overtaking their mundane counterparts (a common complaint) but there's just not enough material yet (especially higher level material) to really judge success just yet.


It's getting late now. So I'll wrap this up and try and make a second update soon covering the class specifics and giving a final summary.










Tuesday, May 15, 2012

Podcast of Magnitude: Wrapping Things Up


   Just saw the Avengers movie last night with my gaming group. Very cool and very, very fun, although there was definitely at least one "DAMN YOU WHEDON!!" moment. Then of course we spent the rest of the night spouting quotes and reminding each other of scenes we had just seen less than an hour ago.

Anyway, I've also got a new Order of Magnitude recording. This one is pretty short and it covers the wrap-up of the Order's latest adventure and laying groundwork for their future games. Unfortunately one of the Order had to go off to college (DAMN YOU HIGHER EDUCATION!!) and we're waiting for his possible return and taking a bit of a break from the Order. I'll still have more recordings to post, like for instance the new Dresden Files game I've begun, but the Order will be on a hiatus for now.

Stay A While And Listen

Wednesday, May 9, 2012

RPG Wishlist

There are a lot of great RPGs out there...but not nearly enough! Here are a couple of games that I would buy the moment I saw them...but who knows if they'll ever exist. But in my mind this is what they would look like.


The Enchiridion
   The Enchiridion: The Hero's Manual or, in other words, Adventure Time! the RPG. Why make it the Enchiridion instead of a book cover with Fin and Jake bro-knuckling on top of a mound of their foes? Well, first because the Enchiridion cover makes a kick-ass looking RPG cover and second because the point of the game is to make your own hero. Sure, Finn and Jake are incredible but the goal should be creating your own crazy-awesome hero and their shadows are just too mighty to stand in all the time. The bulk of the book should involve detailing the known Lands of Ooo, the most awesome post-apocolyptic world out there.

The System: Well...really this doesn't matter too much. Just about anything that allows flexible, creative solutions to problems. PDQ would be great obviously, or something like my own still-in-progress DRIVE system. Heck, this might be a perfect fit for Donjon as well. Nothing point-buy based or class-based however. Adventure Time is too crazy awesome to be held down by such things.



Brutal Legend
  I mean seriously...who wouldn't want a Brutal Legend RPG? This stuff is gold! Just like adventure time half the appeal is fleshing out the intriguing, huge and mysterious world that the video game created and meeting the weird inhabitants...then shredding them with lightning bolts and flaming zeppelins from the sky!! The world of Metal is an insane adventure waiting to happen.

The System: This is a hard one. Ever since I finished Brutal Legend I've been trying to decide on the right system to run it for the inevitable tabletop game. This is one system where PDQ seems too light for me. Oddly one of the best options I've found is 4th edition D&D...just reskin the mystical classes (warlock=guitarist, cleric=singer, wizard=stage effects) and you're pretty good to go. However, I think Savage Worlds probably falls into the "just right" range for me. And it doesn't get much more Savage than the world of Metal.


So, you hear me Pendleton Ward and Tim Schafer...you hear me!! (probably not)

Well...if you do, then jump on kickstarter or write up a proposal and get this stuff made! And while I'm shouting unreasonable demands into the black void of the internet then also hire me to make them!


There. Ranting done. Anyone else got any RPG wishlists they'd like to share?

Tuesday, May 8, 2012

Dumb meme is...well it's just not that clever.


   Have you ever come up with a joke that you know is terrible but nevertheless you find hilarious? And then the joke gets stuck in your head like a bad pop song. It's like some kind of humor-based version of The Ring...I must pass it on to be free of it: