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").

I 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.

My POV Regarding Regulation of Pharma Mobile Medical Apps

The pharmaceutical industry has to police itself with regard to development of medical apps. There has to be good documentation of the testing of apps to ensure their correctness.

That's the summary of my point of view (POV) regarding the pharma HOTSPOT topic: "Should Pharma reconsider its mobile application approach with FDA guidance looming?" See the annotated video below:


A "counterpoint" was offered by Dr. Chetan Vijayvergia, PhD, Director of Medical Strategy, Ignite Health, on Ignite Health's Pharma HOTSPOT web site. Dr. Vijayvergia's point was "The apps that are currently being created in the Pharma space don’t have a predicate in the FDA database. Pharma needs to reconsider the mobile approach to actively help the FDA shape industry guidance" (see here).

Vijayvergia contends that the current FDA draft guidance for MMAs "casts a very wide net" and if pharma app developers are not careful, their apps can get "dinged as an MMA [mobile medical application]" and be subject to regulation as a medical device.

The fear that FDA is casting too "wide a net" over MMAs was first expressed by PhRMA (see "FDA Mobile Regulatory Fear Mongering by PhRMA"). IMHO, the FDA was pretty clear about staying away from most health-related apps aimed at consumers such as diet apps, etc.

The Best Defense Against Zealous FDA Regulation is Self-Regulation!

In addition to offering FDA its POV regarding what is and what is not a MMA subject to medical device regulation, the pharma industry, IMHO, should begin policing itself to develop MMAs that comply with standards such as Happtique's App Certification Program; listen to this podcast regarding that:

Listen to internet radio with Pharmaguy on Blog Talk Radio

You may also enjoy reading these previous posts regarding pharma mobile medical apps:

• FDA Issues Long-Awaited Guidance - for Mobile Medical Apps. Janssen, Look Out!
• Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story
• The Problem with Unregulated "Calculator" Apps for Physicians: Buggy Software!

Does Generic Competition Stifle Branded Pharma Innovation?

Sure, use of generic drugs saves payers -- U.S. Gov't, insurances companies, and patients -- money. But does generic competition harm the innovation of new and improved drugs?

According to a report published by the Generic Pharmaceutical Association (GPhA), the answer is no. Let's look at some of the data.

First, the GPha claims that generic prescription drugs in the U.S. saved about $193 billion in 2011 alone and over $1 TRILLION in the last 10 years (see "Generic Savings in U.S." for a copy of the report and top figure in the infographic shown here; click here for a full-size view of the infographic).

Given that there is just one prescription drug pie to share, that must mean that the branded pharma industry's slice has decreased somewhat proportionately, even though the whole pie may has grown over the years (by what %?).

But GPha does not discuss THAT in its report. Instead, it focuses on "innovation" and the defense of the 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman), which had the dual objectives of incentivizing the development of new brand drugs (the patent term restoration part) and facilitating the approval of generics to lower consumer costs (the drug price competition part).

The Hatch-Waxman Act has recently come under attack as being too favorable to the generic drug industry. An article in the November 2011 issue of Health Affairs, for example, argued that "generic usage has increased so markedly that the incentive to develop new drugs has been harmed" (said GPhA). From the abstract of that article:

"Generic drug usage and challenges to brand-name drugs’ patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation" (see "Evolving Brand-Name And Generic Drug Competition May Warrant A Revision Of The Hatch-Waxman Act").

As evidence that this is not true, GPha presented new drug approval data from the FDA. The data it presented was similar to the middle chart in the infographic shown here. The GPhA chart only went back 10 years to 2002, whereas the chart shown here goes back to 1994. Although the trend in new drug approvals by the FDA is downward between 1994 and 2011, in recent years (ie, since about 2002), it is trending upward.

Drug approvals by FDA may not be the best indicator of innovation, however. Consequently, I added to the infographic another chart from the FDA that also shows the number of NDAs (new drug applications) filed with the FDA in the last 10 years.

I notice that the number of approvals seems to be directly related to the number of NDAs filed. The FDA often argues that it is not its fault if less drugs are approved in any given year -- it's the fault of fewer NDAs being filed (ie, lack of innovation by the drug industry).

In any case, the GPhA argument seems to have merit. So much so that the branded drug industry -- i.e., its trade association, PhRMA -- chose not to dispute the evidence, but made lemonade from GPhA's lemons.

PhRMA pats itself on the back, saying that "without the development of new medicines by innovator companies, there would be neither the new medicines essential to progress against diseases nor generic copies." Here's more from PhRMA on that:

"[GPhA's report] documents one of the many benefits achieved by new medicines developed by biopharmaceutical research companies. Cost savings attributable to generic drugs represent one stage of the prescription drug lifecycle. Such savings are possible because innovator biopharmaceutical research companies – the most research-intensive sector in the U.S. economy – produce medical advances through pioneering scientific work and long-term, expensive investments. Over time, these innovative new medicines lead to generic copies that patients use at low cost for many years" (see "PhRMA Statement on Prescription Drug Costs").

What do you think?

Does generic drug competition harm the innovation of new drugs?
	Yes
	No

Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite.

A little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA, pdf), which was signed into law by president Obama on July 10, 2012, simply states:

SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE INTERNET.

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.

Does that mean the FDA will deliver? If not, it wouldn't be the first time that a government agency missed deadlines imposed by Congress.

Usually, Congress specifies that regulatory agencies must issue regulations that spell out how to comply with the laws it passes. Regulations, therefore carry the weight of law. FDA Guidance (guidelines), however, is just FDA's current thinking on a topic. "It does not create or confer any rights for or on any person and does not operate to bind FDA or the public."

So, if FDA misses the deadline set by PDUFA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

The only thing interesting about this provision of the PDUFA act is why it was included and who lobbied to have it included? It couldn't have been Pfizer (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"), but it could have been PhRMA (see "PhRMA Statement on FDA Social Media Guidance Delay").

PhRMA Demands that FDA "Cabin" Its Discretion to Regulate DTC Ads

In a 20-page comment submitted to the FDA on May 14, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA), advised the FDA to "proceed cautiously and in a manner that fully protects the free speech rights of advertisers and patients" with regard to the agency's recent Draft Guidance for Industry on Direct-to-Consumer (DTC) Television Advertisements."

Recall that the Food and Drug Administration Amendments Act of 2007 (FDAAA) gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement" (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

In its comments, PhRMA uses the word "cabin" as a verb, as in "clearly defined standards that cabin the reviewing official's 'unbridled discretion'" and "objective standards to cabin FDA's discretion."

Why does PhRMA want to banish FDA to a "cabin" in the woods as far it's discretion to pre-review DTC ads is concerned?

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, which is cited several times in PhRMA's comments. For example, PhRMA reminded the FDA (as if that was necessary) that the Supreme Court "recently affirmed that '[s]peech in aid of pharmaceutical marketing .... is a form of expression protected by the Free Speech Clause of the First Amendment.' Thus," says PhRMA, "when the FDA restricts the speech of pharmaceutical manufacturers and other regulated entities, the restrictions are subject to scrutiny under the First Amendment."

But the Supreme Court Court is not likely to scrutinize "informal guidance," which is not legally binding. Therefore, PhRMA is pushing the FDA to issue regulations, which carry the weight of law. "Regulations that unduly burden truthful, non-misleading commercial speech about a lawful product," says PhRMA, "hinder consumer choice ... and rarely survive constitutional scrutiny."

Of course, FDA wants to prevent "misleading" drug ads from being aired. Right now, however, it can only cite ads as "misleading" AFTER they have already been aired.

I'm not going to delve into the legal arguments that PhRMA puts forth. You can read them yourself here. I just find it interesting that the drug industry is pushing FDA to stop issuing non-binding guidances in this case as well as in the case of social media (see "WLF & Pfizer Ask Court to Block FDA Guidance on Social Media"). I also like how PhRMA uses "cabin" as a verb, hence the cabin image that accompanies this post.

Hat Tip to @AlecGaffney for alerting me to the publication of PhRMA's comments in the Federal Register, where "occasionally interesting reading [is] to be had."

Resurgence of Pharma Lobbying Spending

According to Open Secrets, which tracks industry lobbying, "the pharmaceutical industry as a whole spent $69.6 million on lobbying in the first three months" of 2012 (see "Pharma, Utilities and Big Ag Lead Lobbying in 2012"). Included in that category are "Health products" other than Rx medicines. Looking at just "Pharmaceutical Manufacturers" (including PhRMA, the drug industry's U.S. trade association), the total lobbying spend in the first quarter of 2012 was $48.1 million.

Here's a chart of the biggest spenders in this category so far:

Annual pharmaceutical lobbying -- as measured in dollars -- increased more or less steadily since 1998, but peaked in 2009 at $186.1 million. If the spending in 2012 continues at the pace of the first three months, the pharmaceutical industry will spend approximately $192.4 million in lobbying for the year (see chart; the 2012 bar is projected as 4 X Q1).

Open Secrets contends that the pharmaceutical industry is "clearly focused on protecting the existing provisions of Medicare Part D, which subsidizes the cost of drugs. Critics in Congress have targeted the program for its huge cost, and some want it to be more transparent about how reimbursements are set. Also at issue," says Open Secrets, "is whether the government should be able to negotiate drug prices with the companies, something that is currently prohibited."

The pharmaceutical industry is keen on preventing changes to Medicare -- especially changes that would allow the government to negotiate prices. Back in October, 2011, the Campaign for Modern Medicines (@Modernmeds) and Eli Lilly & Company (@LillyPad) hosted at least one Tweetchat on Medicare Part D to "help raise awareness on the value of the current system, and to learn how to prevent potential changes to it" (see "More Pharma Twitter Chats: Medicare is Topic" and "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?").

Although it is difficult to link lobbying spending with specific bills in Congress, the drug industry -- especially through PhRMA -- is also lobbying hard to get a favorable PFUFA (FDA funding) bill passed (see, for example, "Angry PhRMA, Level 1: PDUFA").

Of course, 2012 is also a presidential election year and that will likely keep lobbying -- including donations to candidates and their political parties -- at a high level throughout the year. Here's some interesting data showing the trend in pharma donations by political party (see more such data here):

It seems that the drug industry was intent on getting Republicans elected in 2000 and 2002 and when that was accomplished, they cut back and reaped the benefits of the status quo, or as some would say the "do nothing" Congress.

FDA Mobile Regulatory Fear Mongering by PhRMA

In a blog post provocatively titled "An App for That, But For How Much Longer?" (here), 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. You can read the op-ed in this threaded archive: "How safe is that app? Should pharma apps be registered as medical devices?".

The op-ed author, Joel White, executive director of the Health IT Now Coalition, "suggests that this effort would lead to increased costs as well as constraints on user access to these apps, which 'may cause developers to move on to other, less burdensome endeavors.' In the end, this could hinder the way that patients can actively improve their own care," said Conners.

Before I get to destroying the case made by Connors and White, I should point out how these two people are related. White is the president of JC White Consulting, a registered lobbying firm (see here) retained by the Health IT Now Coalition and PhRMA, among others (see here). In her blog post, Connors said "A few days ago, I missed an op-ed in the Washington Times that I just came across today – and I’m glad I did." Joel, you should have DM'd Kate! Whatever! It's nice that White gets paid to write this "independent" op-ed piece that PhRMA can cite as if it were independent! Guys! Wake up! It's the era of transparency! Unfortunately, you can fool some -- maybe even most -- of the people all of the time and that is what keeps PhRMA in business.

Anyway, back to "FDA Mobile Regulatory Fear Mongering." I say "fear mongering" because it can't be true that White and Connors failed to read FDA's July guidance in which it stated that the agency does NOT consider the following types of apps to be mobile medical apps for purposes of the guidance:

"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."

PhRMA/White do not quote FDA because to do so -- as I just did -- would kill the argument that FDA mobile guideline/regulations will stymie pharma from developing apps and will "hinder the way that patients can actively improve their own care." You should also read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.

Meanwhile, there are medical apps being created by pharma that SHOULD be regulated by the FDA, IMHO. These are "calculator" apps designed to be used by physicians during diagnoses. One such app had to be "recalled" because of a bug that generated incorrect results. Unfortunately, thousands of physicians may not have heard of the "recall," which merely removed the app from app stores, not from the phones of physicians who downloaded the app. These physicians may still be using the buggy app. See "The Problem with Unregulated 'Calculator' Apps for Physicians: Buggy Software!"

P.S. Connors pointed out that PhRMA has its own medication reminder app for patients: "In fact, we at PhRMA have helped support the Script Your Future campaign, which itself includes medication reminders as a tool."

Just for fun, I signed up to receive reminders. I was, however, somewhat put off by the long legal disclaimer, which said, in part:

"You acknowledge and agree that we provide the reminder service and access to the reminder service as an "as is" and an "as available" basis, that your use of the reminder service is at your own risk, and that we make no representations, warranties or covenants whatsoever with respect thereto. For greater certainty, we do not guarantee that the reminder service will be available, run error-free or uninterrupted, that we will correct all errors or deficiencies related thereto or that all messages sent by you will arrive at their intended destination on time."

ROTFL! In essence, PhRMA says it makes no promises that this app will be useful. How is this supposed to help me improve my care if PhRMA does not even care to fix errors or deficiencies? Not a very consumer-friendly attitude, I must say! BTW, I am sure the FDA did NOT require PhRMA to write that.

Pfizer & PhRMA Lobby in Support of SOPA

Steve Jobs once said that he'd rather be a "pirate" than join the navy. What he meant was you must think out of the box to innovate. But the world's "innovative" drug industry is the "navy" as far as lobbying in support of the "Stop Online Piracy Act" goes.

The legislation's short title is SOPA (H. R. 3261; find it here). There are several anti-SOPA Facebook pages and at least one called "Boycott SOPA (the companies lobbying for it)." You can get the official list of companies and organizations lobbying in favor of the bill here. Pfizer and PhRMA are on that list. Why? See below.

Many technology companies and web sites have organized a day of protest (today) against this bill and the companion "PIPA" bill ("Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011" or the "PROTECT IP Act of 2011"; find it here). Protesting companies include Google, which has put a censorship bar across its log, and Wikipedia, which has shut down totally today.

Here's some background as published today in the New York Times (here):

The bills in Congress, pushed by Hollywood studios and other big media companies, target websites that let users download pirated movies, TV shows, music and other material in violation of U.S. copyright law. Most of these sites are outside of the United States, but the legislation would give the Justice Department and private companies tools to block them from American consumers. 

For example, Google could be forced to drop an offending site from its search engine results. Or the government could go to court to stop a U.S. company that facilitates online payments to a suspected infringing site. Internet companies say they have neither the time nor the resources to monitor every link on a website or post by a user.

Google, Facebook, eBay and other new media companies also object to rogue sites, but they have repeatedly said the Stop Online Piracy Act, or SOPA, in the House of Representatives goes too far, hurting investment, innovation and the open nature of the Internet. 

Why do Pfizer and PhRMA support these bills? Simple. They believe it is necessary to prevent "counterfeit" medicines from being sold to US consumers by companies outside the US. At least that's why I think they are supporting these bills. I don't find any press releases or blog posts about it on Pfizer's or PhRMA's site. Perhaps they will respond to this post and tell us in their own words why?

If the industry needs help from the government to prevent counterfeit medicines from reaching US consumers, why not support specific laws for that purpose instead of this legislation that potentially can be used to limit the rights without due process of many online publishers -- who do not have anything to do with counterfeit medicines?

UPDATE (Jan 19, 2012): AstraZeneca Backs Counterfeit Drug Legislation

As if AZ heard what I said about pharma sponsoring more specific anti-drug counterfeiting laws, I just learned that's exactly what AZ is doing. From the AZ Health Connections Blog:

AstraZeneca sent a letter to members of Congress today to express support for legislation that would increase penalties for those convicted of counterfeiting prescription medicines. The letters sent to bill sponsors Rep. Patrick Meehan, Sen. Patrick Leahy, Sen. Chuck Grassley and Rep. Linda Sanchez note that the issue of counterfeit medicines is particularly serious via “Internet pharmacies”:

While the total incidence of counterfeit medicines sold in "brick and mortar" pharmacies in the U.S. is estimated to be less than 1 percent of the total market value, the World Health Organization estimates that over 50 percent of medicines purchased from Internet sites without a physical address are counterfeit. 

You can see the World Health Organization fact sheet on the issue here.

The letter concludes:

 Although the trafficking of counterfeit drugs is currently illegal in the United States, the penalties for such activity are the same for the trafficking of other products. The Counterfeit Drug Penalty Enforcement Act would significantly and meaningfully increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public. The proposed sanctions and sentencing guidelines would serve as powerful deterrents to pharmaceutical counterfeiting, greatly benefitting patient safety and health. 

 Additional details on the bill can be found here.

Are Pharma Reps Important to Docs or Not?

Back in March, 2011, I reviewed a PhRMA sponsored survey of physicians the results of which PhRMA claimed shows that "nearly eight out of 10 physicians view pharmaceutical research companies and their sales representatives as useful sources of information on prescription medicines" (see "New PhRMA Survey of Physicians: Are Sales Reps as "Useful" as PhRMA Wants Us to Believe?"). If you look at a chart of the relevant data (see below), however, you see that the 80% mentioned by PhRMA includes 53% of physicians who find sales reps only "somewhat useful." Only 26% of physicians surveyed found reps "very useful."

Yesterday, I came across the Wolters Kluwer Health Point-of-Care survey of physicians, part of which looked at where physicians receive information to make decisions about diagnoses, treatment and ongoing patient care (see press release and executive summary here). This study asked physicians: "How often do you use the following sources to gain information used to diagnose, treat and care for patients?" The results are shown in the following chart:

The trends are comparable (eg, prof'l journals are rank near the top and sales reps rank near the bottom in both surveys), but you can't group the Wolters Kluwer categories "frequently" and "occasionally" together as well as you can group together PhRMA's "very useful" and "somewhat useful" categories. Because of the way PhRMA designed it's study -- using categories that can easily be combined -- they were able to spin the results favorably, whereas no such spin of the data is possible in the Wolters Kluwer survey.

So, looking at ALL the data, IMHO, the best that can be said in answer to my question is that most physicians find pharma sales reps among the least important sources of information they use to help them diagnose, treat and care for their patients.

P.S. (27-MAR-2012) I just came across another study attempting to answer the question "Do physicians find sales reps useful?" The study comes from Cegedim Strategic Data (CSD), a provider of integrated healthcare market research. CSD analyzed physician-reported diary entries of recent sales calls. Results from over 30 countries showed that overall 93.8% of physicians worldwide, both GPs and specialists, "find sales representative calls useful and of value to their practice, based on over 5.6 million product detailing mentions" (find more details here).

I believe CSD's methodology asks physicians to evaluate recent sales calls. This technique eliminates physicians who did not receive any sales calls, which skews the data to favor physicians who like sales reps to begin with. The CSD study does not compare usefulness of reps compared to other sources of information.

In any case, it's amazing how many studies are out there and how difficult it is to get a straight answer to a simple question.

Angry PhRMA, Level 1: PDUFA

Yesterday I suggested a real "kick-ass" pharma-related game would be ANGRY PHRMA (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!"). Below is shown "Level 1: PDUFA," the goal of which is to "knock down" those Senators trying to give FDA new regulatory powers as part of the bill -- or as PhRMA describes it, those "additional provisions that could create unintended burdens on the regulatory process" (see "PhRMA Statement Regarding Prescription Drug User Fee Act Reauthorization"). PhRMA specifically disagrees with REMS because it “has led to a breakdown in FDA’s review process and has eroded some of the positive progress derived from earlier PDUFA agreements" (see "PDUFA 2012 – Background From PhRMA’s Perspective").

OK, that's the boring, policy wonk explanation. Let's get down to  some serious Senatorial "butt whooping" fun!

EXTRA CREDIT: Name at least 2 Senators that PhRMA needs to work on.

I'll try and come up with more levels of play for my ANGRY PHARMA game, but I need your help. Suggest an issue that PhRMA is or needs to be angry about and who the adversaries (little piggies) are. Also, describe the pigs' fortress that the Angry PhRMA Birds must knock down.

Chris Viehbacher, PhRMA’s Chairman, Masters the Art of "Proofiness"

I just started reading the book "Proofiness: The Dark Arts of Mathematical Deception" by Charles Seife. The book promises to "conduct a thorough investigation into why so many of us find it so easy to believe things that are patently ridiculous. Why, for example, does anyone take seriously the idea that some vaccines can cause autism..."

I only read the first few pages of the introduction last night, but immediately realized that what I learn from it will help me interpret the BS I often hear from pharmaceutical marketers and spokespeople.

The author defines "proofiness" as "the art of using bogus mathematical arguments to prove something that you know in your heart is true -- even when it is not." One tool used by masters of this art is fabricated statistics, which Seife calls Potemkin numbers in analogy to Potemkin villages (fake settlements purportedly erected at the direction of Russian minister Grigory Potemkin to fool Empress Catherine II during her visit to Crimea in 1787; see here).

I didn't have to go out hunting for examples of Potemkin numbers in pharmaland -- it came right to me via a tweet from @PhRMApress: "VIDEO: What Gets PhRMA’s Chairman Up Every Morning? http://t.co/MftWTiSA via @PhRMA @SanofiUS"

The first words spoken by Chris Viehbacher, PhRMA’s chairman and the CEO of Sanofi, included an impressive Potemkin number:

"One of the things that makes me most proud to be part of this industry is seeing that life expectancy has gone from 67 to 81 in a generation. It really shows the positive impact we've had on people and families across America."

A life expectancy of 81 years?! In my heart, I wish it were true, but my brain tells me it is not.

I immediately stopped the video and used Google to peak behind the facade of these numbers. After all, an increase in life expectancy of 14 years in a single generation is so positive sounding that I want to believe it, but so huge that I suspected it wasn't true.

Here's a US life expectancy chart (edited to fit better) I found via Google (World Bank data; here):

According to these data, the US life expectancy (LE) increased only about 5 years in the last generation (1979 to 2009). I don't think US LE increased an additional 3 years since 2009 (the latest year for which real data is available). Viehbacher used Potemkin numbers to impress us with a 14-year difference, whereas the real data only supports a 5-year difference.

Where did Viehbacher come up with his LE numbers? Perhaps he got the 81 years figure from this CNN article, which cited it as the highest life expectancy -- enjoyed by residents of Fairfax County, Virginia.

That same article, however, mentioned that Holmes County, Mississippi, had the lowest LE number -- 66 years. A woman in Holmes County can expect to live 73.5 years, "the average life span that women in the healthiest nations had in 1957 and have since far surpassed." In other words, there are people in the U.S. who have LE's that lag behind those of the world's healthiest nations, "in some cases by 50 years or more." Those numbers should keep Mr. Viehbacher awake ALL night!

The other problem relating to the LE issue raised by Viehbacher is his implication that the pharmaceutical industry is solely responsible for the increase in US LE (except in Mississippi, that is), which is an exaggeration. Other factors include declines in cigarette smoking. increase access to health care for vulnerable populations (eg, children), etc.

The rest of the interview has Viehbacher citing other numbers that support Medicare Part D -- such as each patient receiving a $1200 benefit as a result of the program, which BTW the drug industry does not want to improve by subsidizing the closing of the infamous "doughnut" hole. The study (see here) was paid for by PhRMA, a fact that Viehbacher failed to mention. Whether or not these Medicare Part D numbers are "Potemkin numbers" or other forms of suspicious "proofiness" is something I don't have the resources to get into now. Maybe after I finish Seife's book I will have more anti-deception tools at my disposal.

UPDATE

Christian Clymer, Deputy Vice President, Public Affairs, PhRMA, sent me the following followup to this post via email on 28-SEP-2011:

It's good to know you're keeping up with The Catalyst. I just wanted to clarify some of the statistics you've pointed out, regarding life expectancy and the savings generated by Medicare.

The 81 years life expectancy cited by Mr. Viehbacher is consistent with CDC/U.S. Census Bureau statistics for 2010 that show average life expectancy of 81 years for women (81.4 years, to be exact). (source: http://www.data360.org/dsg.aspx?Data_Set_Group_Id=195) In 1950 the average life expectancy in the U.S. according to CDC was 68 years. That's a dramatic rise in just two generations. The CDC numbers are also reflected in this chart… http://www.phrma.org/us-life-expectancy-1950-2007.  

While all reputable data sources (e.g., WHO, CDC and others) may vary somewhat on the numbers, they all demonstrate the same fact: there has been a marked increase in average life expectancy in the U.S. and across the globe. Our industry wouldn't presume to take credit for these statistics, but we are proud of the role that we continue to play in helping people live longer, healthier lives, as we've noted on PhRMA.org in the past. (New Medicines Transforming Patient Care http://www.phrma.org/new-medicines-transforming-patient-care)  

Regarding the Medicare savings, Mr. Viehbacher was referring to a recent study in JAMA, conducted by Harvard researchers with no sponsorship from PhRMA or individual companies. Indeed, that study found that Medicare saved $1,200 annually for each beneficiary who had previously lacked comprehensive drug coverage prior to Part D. Those savings came from a reduction in non-drug costs such as hospitalizations and nursing home admissions. (http://www.phrma.org/catalyst/jama-study-reiterates-success-medicare-part-d and http://theincidentaleconomist.com/wordpress/part-d-cost-offsets/)    

Just thought you'd want to know.

I hope Chris doesn't mind me adding this response, which I sent to him in reply:

I would point out that Viehbacher mentioned ONE generation ("a generation"), not two, which may have been just an honest mistake, I'm sure. Of course, white females live about 5 years longer than us guys! So, you're not really comparing apples to apples (ie, females to females) when you cite 81 for females in 2010 and 68 for the general population (I assume) in 1950. As for the JAMA Medicare study, I'll have to take a look at it.

If FDA Published Social Media Guidelines as a Facebook Page, PhRMA Would "Like" It!

PhRMA -- the US pharmaceutical trade association -- just now published an oblique critique of the FDA for fiddling with issuing its promised social media guidelines while pharma Facebook pages burn in response to new commenting policies (see "What We'd "Like": FDA's Social Media Guidance").

"After all," said PhRMA's Kate Connors, "the FDA is quite active online, with Facebook and several Twitter accounts. Our companies aim to be able to be just as engaged in discussions about health and science as the agency that regulates them, because we thoroughly believe that better information can ultimately lead to better health. To that end, we continue to wait for FDA’s guidance, and to hope that it comes soon."

Whoa! FDA you've just been "bitch-slapped" by PhRMA!

Pharma Planet of the Apes!

Grady Forrer over at the Pharmaceutical Research and Manufacturers Association (PhRMA) blog laments that the new version of Planet of the Apes -- a movie I don't think he has actually seen -- does not jibe with reality (see Movie Dark Fantasy vs. Biopharmaceutical Reality).

"I do want to rail for a moment against the trite movie convention of the evil pharmaceutical company purposefully or negligently perusing research which results in harm to patients or, as in this case, humanity as a whole," said Forrer, who urges viewers to resume their disbelief after seeing the movie. I assume he means disbelief that science and the pharmaceutical industry can do harm. I'm all for that, up to a point.

Anyway, I thought Forrer's comments deserved a graphic that perhaps illustrates PhRMA's fear of how surviving humans might view the pharmaceutical industry's role in creating the NEW Pharma Planet of the Apes:

The Twelve Steps of Pharma Social Marketers Anonymous

Welcome to Pharma Social Marketers Anonymous (PSMA)! You are among friends.

Soon, you will take important steps on the path to overcoming your fear of social media. The first step is to admit you are powerless over social media and that your online life has become unmanageable.

Are you ready to take ALL 12 steps toward recovery?

Here are the Twelve Steps of Pharma Social Marketers Anonymous:

1. I admitted I was powerless over social media—that my online life had become unmanageable.
2. I came to believe that a Power greater than myself – innovative outside digital ad agencies – could restore me to sanity.
3. I made a decision to turn my will and my online projects over to the care of the first social media agency that walked through my door and impressed me with their knowledge and experience, even if it all was with packaged goods and other lightly regulated industries.
4. I made a searching and fearless moral inventory of my marketing practices and found they lacked social media innovation (sigh!).
5. I admitted to my digital agency, to myself, but certainly NOT to my superiors, the exact nature of my wrong way of thinking about social media.
6. I am entirely ready to have my digital agency remove all the defects of my character and my social media marketing plan.
7. I humbly asked the digital agency's creative director to alleviate my social media visionary shortcomings.
8. I made a list of all persons I had called for social media marketing advice (including Pharmaguy), DM'd them all via Twitter, and said “Nah, nah! I got an expensive agency to help me!” I also included some suggestive photos.
9. I made these posts to such people whenever possible, and I even did it in public posts when to do so would insult them or others.
10. I continued to take personal inventory of my social media marketing projects and when I could not prove ROI, I promptly hid that shortcoming from my superiors.
11. I sought through public hearings at FDA and comments to the Federal Register to improve pharma's lot with the FDA as to social media marketing. I thought I understood that government agency and prayed only for knowledge of FDA’s willingness to help us and that Abrams would finally give his people the power to issue social media guidance.
12. After having had a spiritual awakening as the result of these Steps, I carried this message to my colleagues at industry conferences, through Twitter, and at PhRMA social media "summits" urging all I met there to practice these principles -- whatever they are (I have no idea) -- in all their social media marketing affairs.

The Twelve Steps of Pharma Social Marketers Anonymous was inspired by this article ("Pharma Needs an Innovation Intervention") in BusinessWeek written by G. Michael Maddock and Raphael Louis Vitón, principals at Maddock Douglas, an ad agency that has no pharma company clients (you can't count Johnson and Johnson because they claim they are not a pharmaceutical company).

The article opens with the following AA type of rhetoric: "Are you struggling to break your addiction to a bad business model, or are you living in denial? Either way, admitting that you have a problem is the first step toward solving the problem."

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

OMG! They Give Awards for the Most Money Spent Lobbying Congress!

Last night, John Castellani, president and CEO of PhRMA -- arguably the single largest Washington lobbyist (aka "advocacy group") -- was the recipient of the 2011 Bryce Harlow Business-Government Relations Award, which is given to individuals who have made "significant contributions" to the advocacy profession.

More like significant contributions to politicians!

John also had the "thrill" of meeting one of those politicians PhRMA has undoubtedly helped fund over the years. According to this obsequious post on PhRMA's blog, "John ... had the added thrill of being introduced by House Speaker Boehner. Many in attendance were touched by this gesture of professional respect and friendship on the part of the Speaker."

Yeah, I bet they are friends! Did Boehner bawl or just kiss John? Whatever. I'm sure PhRMA is happy with Boehner's efforts to derail health care reform -- especially the part that tries to close the donut hole in Medicare!

Regarding Social Media Advice & Guidelines, PhRMA Will Follow FDA's "Lead"

Now that the British pharmaceutical industry has published its advice to members about using social media for drug promotion (see "Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma), the logical question to ask is "Should PhRMA (the US industry's trade group) follow ABPI's (the Association of the British Pharmaceutical Industry) lead and update its Direct-to-Consumer (DTC) Guidelines to cover drug promotion to consumers via the Internet and social media?" Although such advice and guidelines are voluntary and do not carry any legal weight, it would help the drug industry, which is not waiting for FDA guidance and is already doing quite a bit of promotion via social media.

When I asked PhRMA if it had any response to the Brit's published guidance and if PhRMA would follow ABPI's lead and update its DTC Principles to include "advice" on how to apply those principles online, I received this response from PhRMA attorney Jeff Francer (via Jeff Trewhitt, PhRMA's Media/Public Affairs spokesman):

"The Food and Drug Administration is taking the lead, and we're eagerly awaiting the guidance the agency is completing."

To which I responded:

"Ha Ha! I'm sure you guys know more about where FDA is going and when it will get there than I do!"

Whatever guidance the FDA may issue, it only will inform the drug industry how to stay within the LETTER of the law (ie, fda regulations). What's needed, IMHO, is some guidance on BEST PRACTICES that the industry should follow. Those best practices can go BEYOND the letter of the law.

PhRMA's voluntary DTC guidelines, for example, include principles that ban REMINDER drug ads (see definition here) on TV and Erectile Dysfunction ads on TV shows that children are likely to watch. Those principles go well BEYOND what the FDA requires.

Why not start thinking of social media principles that also go beyond what the FDA requires? That I believe is the role of voluntary guidelines and something appropriate for PhRMA to take the lead in developing.

PhRMA Statement on FDA Social Media Guidance Delay

By now everyone is aware that the FDA has missed its SECOND deadline for issuing some form of guidance to the drug industry for the promotion of Rx products via the Internet and specifically via social media (see, for example, "No News is No News – DDMAC Fails to Produce Guidance").

Of course, further delay in issuing such guidance is very frustrating for the dozens of stakeholders who the FDA invited in November 2009 to make presentations at a public hearing.

To highlight that frustration, on April 1, 2011 (April Fools Day), I created a bogus PhRMA Statement, which included these memorable lines:

"Due to FDA’s limited resources and an increasing workload, FDA should seek out help developing social media guidance. PhRMA intends to continue to serve as a constructive partner in that regard. So why not give us a call or tweet us? We’ll be happy to draft some guidelines tout de suite."

and

“FDA says it wants the draft guidances ‘well thought out’ when they are issued. I mean, how difficult can it be? PhRMA Intern will be returning after the Spring semester is over and we can assign her to the project."

and

“FDA’s failure to act in this matter is a slap in the face of the pharmaceutical industry, which urgently requires social media guidance. ‘Let's Build Something Together’ is a famous tag line from Lowe’s Home Improvement. That sums up our position with regard to building FDA social media guidance as well."

The joke was successful as far as April Fools go and PhRMA had to act fast to contain the media's confusion. Christian Clymer (@CCatPhRMA), Social Media Lead for PhRMA, tweeted this in response to my post:

"Have you been fooled? See @pharmaguy April Fool's joke and PhRMA's real statement here... http://bit.ly/gEqjyz"

The link in his post leads to another note on PhRMA's blog:

April Facts v. April Fool's

by Kate Connors on 4/1/2011

Perhaps you’ve seen John Mack’s April Fool’s post that says he’s gotten a copy of PhRMA’s “statement” on the Food and Drug Administration’s delayed social media guidelines.

Mack’s post, which presents a fictitious statement, has made the rounds this morning, underscoring the immediacy of social media.

Here is our actual statement, released yesterday.

Go ahead and read PhRMA's ACTUAL statement. I think if PhRMA allowed itself to speak frankly, the real PhRMA Statement would have closely resembled my April Fools version. Now that April Fool's is over, I have removed the fake statement from this blog. See you NEXT April 1!

New PhRMA Survey of Physicians: Are Sales Reps as "Useful" as PhRMA Wants Us to Believe?

"New Survey Emphasizes Value of Biopharmaceutical Company Engagement With Healthcare Providers" is the main point PhRMA (Pharmaceutical Research and Manufacturing Association - the industry trade association) emphasized in its press release (here) regarding a survey of physicians it sponsored. PhRMA also pointed out that nearly 9 out of 10 physicians considered company-sponsored peer education programs to be "up-to-date, useful and reliable."

That's good news for pharmaceutical marketers who spent $24 billion between October 2009 and September 2010 on physician-targeted promotional spending, not including nearly $1 billion on continuing medical education (more data on promotional spending will appear in a Pharma Marketing News article to be published later today). It's good news because the survey justifies devoting the bulk of that promotional spend to support physician detailing by sales reps.

Of course, it's always educational to go beyond the PR and the trade publication stories that merely rephrase the PR (eg, this story) to learn something new, even some things the drug industry may not want you to learn.

For instance, look at this survey result that PhRMA doesn't mention:

What I notice is that only 22% of physicians surveyed said that patient access to the care they need is "working best." There is some survey results interpretation issues here, but it seems that access to care may be a problem in the US according to physicians. And without access to care, everything else -- including the value of medicines, the quality of care in general, and the value of pharmaceutical sales reps -- means nothing. Of course, "access to care" is probably a physician buzz-phrase related to the shortcomings of "managed care" and even "Obamacare."

The very first sentence in PhRMA's press release emphasizes that "Nearly eight out of 10 physicians view pharmaceutical research companies and their sales representatives as useful sources of information on prescription medicines." What PhRMA does NOT say, however, is more telling. Take a look at this survey result:

What I notice is 38% of physicians find Web-based sources of medication information "very useful" versus 26% who find sales reps very useful for that information. Hmmm... either sales reps are not doing their job as well as the Web or maybe they are doing their jobs TOO well -- ie, providing company-sanctioned and biased information rather than information physicians think is useful. Or you could look it another way -- maybe docs are finding a lot more useful "off-label" information on the Web (and CME, which ranks #1?) -- information they technically cannot get from sales reps.

As with any survey, it is difficult to interpret the results of this survey, which allows for all sorts of spins. You can find the entire survey results attached to this Pharma Marketing Forums post.

PhRMA Slaps Sleazy, Self-Serving Spin on GAO Drug Price Analysis

"We are pleased the GAO appropriately took into account the facts about how the biopharmaceutical marketplace works in its analysis of prescription medicine pricing trends," said PhRMA CEO John J. Castellani in his organization's Statement Regarding GAO Report. "The [GAO] report's key finding shows prices have been increasing at a rate of 2.6% [my emphasis] annually, which is lower than overall medical inflation," said Castellani.

Castellani focused exclusively on the GAO analysis of one "basket" (basket #4) of drugs that was "based on the active ingredient rather than drug name...in order to account for the growing national shift in consumer utilization from brand-name to generic versions of drugs." In other words, the basket included generic and brand name drugs. For example, “Zocor/10mg/oral/tablet” and “simvastatin/10mg/oral/tablet” would be considered the same drug for purposes of this fourth basket because they are the brand-name and generic versions of drugs with the same active ingredient, even though they have different names.

Of course, PhRMA does not represent the generic drug industry, so you can forgive Castellani for not mentioning the REAL "key findings" of the GAO report; ie, between Q12009 and Q12010, brand name drugs increased in price by 7.1% whereas generic drug prices decreased by 1.5% (see chart below, which also includes data from Barclays Capital):

Meanwhile, a Los Angeles Times story proclaims "U.S. drug prices outstrip other medical costs: GAO" and a Wall Street Journal's story is titled "Drug Prices Rise Despite Calls for Cuts" (find that story, which highlights the Barclays Capital analysis, along with the GAO report here).

One other problem with PhRMA's statement is this: The 2.6% price increase cited by Castellani is the AVERAGE increase in price between 2006 and 2010. That, indeed, is LESS than the 3.8 percent average annual increase in the consumer price index (CPI) for all medical goods and services -- which INCLUDES drugs -- during the same period. Looking only at 2009-2010 GAO data, however, the price increase was 4.3%. In comparison, the CPI for "Medical care services," which EXCLUDES drugs, rose 3.0% for the 12 months ending January, 2011, according to this Bureau of Labor Statistics press release.

Whether or not drug price increases are greater or lesser than general medical costs is a moot point. Why doesn't the industry share some of the pain many people are feeling during this harsh economy and DECREASE the price of its products as did the generic drug industry? Yeah, like that would happen!

PhRMA Intern's Secret identity Revealed!

Way back in 2006 I reported what I thought was a violation of PhRMA's DTC Advertising Guidelines to its Office of Accountability. I received a response TWO months later from a certain "Emily M. Johnson." It was such an unprofessional communication that I complained about it my Pharma Marketing listserv. A reader thought Emily was a "lowly, hassled intern" and she should not be blamed for the poor response. That was enough for me to invent "PhRMA Intern" (see "Adventures of PhRMA Intern!", a CLASSIC Pharma Marketing Blog post).

I imagined that PhRMA Intern was a recent graduate of an Ivy League school and might even be related to Ken Johnson, PhRMA VP of Communications.

I thought that I would never learn the TRUE identity of PhRMA Intern. Just now, however, I received this anonymous comment to another blog post:

"You peaked my curiosity about Emily Johnson. According to LinkedIn, she graduated from college in 2001, grad school in 2003, and then immediately became Director of PhRMA (no joke):

http://www.linkedin.com/in/emmiej

"After 5 years at PhRMA, she became a Senior Associate at a PR firm. Quite a step down from Director of PhRMA."

Emily graduated Rutgers University in 2001 and received an MPP at Georgetown University in 2003. All during that time she was a "Director" at PhRMA. Wow, PhRMA is really liberal with its job titles! Imagine an intern still a freshman in college with the title "Director"! But why didn't she include this title in her letter to me?