The Problem with Unregulated "Calculator" Apps for Physicians: Buggy Software!

At this year's ePharma Summit in New York, I spent a lot of time listening to presentations about pharma mobile apps. There was, for example, a session entitled "I Wish I'd Done That! Mobile" during which panel members reviewed mobile applications they liked but that were produced by rival pharma companies. Surprisingly, although at least one panel member -- Jason Appel, Director, Physician Relationship Marketing, Amgen -- was involved in creating mobile apps for physicians, only consumer-oriented apps were featured.

Appel said he hasn’t seen any mobile physician apps that he wished he had done and agreed with a previous presenter that most were a waste of money. But of the literally hundreds of apps created by pharmaceutical companies, many are for healthcare professionals.

My friend @skypen (Fabio Gratton) has created a web site to keep track of them all -- it's called POCKET.MD. Fabio claims it is "the world's first and only free online service focused exclusively on providing the most comprehensive directory of mobile applications created by healthcare companies for medical professionals, patients, caregivers, and consumers." Here's a screen shot (click on it for an enlarged view):

Practically every pharmaceutical company has one or more apps. The ones I am interested in are apps designed to help doctors in their diagnosis of patients. Big among these are the "calculator" apps, which calculate things such as glomerular filtration rate (GFR), Medication Adherence Rating Scale (MARS), Delayed Graft Function (DGF) Risk, creatinine clearance, dosing algorithms, Body Mass Index (BMI), and, my favorite, Psoriasis Area and Severity Index (PASI).

According to POCKET.MD, the most downloaded app is Pfizer's "Pfizer Rheumatology Calculator" - a rheumatology disease activity calculator that Pfizer developed to allow physicians to "quickly and easily measure the disease activity of your patients without having to use manual calculations. The calculator is easy to use -- simply enter clinical data for your patient into the calculator and it will instantly provide you with the score in a variety of disease activity measures, including: ASDAS ESR & CRP BASDAI DAS28 ESR & CRP PASI And more..."

Unfortunately, this free Pfizer app is no longer available -- it had to be recalled because of "a bug in the app ... gives wrong results" (see "Pfizer recalls Rheumatology Calculator smartphone App").

Back in July, 2011, I warned that bugs in such apps could go un-noticed because there is no independent verification of the software -- no "Good App Seal of Approval" and certainly no FDA approval. See "Checking Under the Hood of Pharma Mobile Apps" where I point out this shortcoming in another PASI calculator mobile app.

But how do you recall a smartphone app? You can remove the app from the app stores around the world, which is what Pfizer did, but that only prevents new downloads. Most apps are downloaded to smartphones and it is not possible for the developer to remove these copies of the app from the phones. The users must do that. Considering that the "recalled" Pfizer app was the most downloaded app tracked by POCKET.MD, there must be many many users (physicians) out there who still have the app on their phones. Did Pfizer send these physicians a "Dear Doctor" letter informing them of the problem and advising them to remove the app from their phones? Probably not. Did the app include a disclaimer that protects Pfizer from being responsible for misdiagnoses due to its buggy app? Probably yes.

Bad Journalism or Bad Pharma?

My blogger friend Rich Meyer went on a bit of a rant against "bad journalism" and how pharma is often misrepresented in the news media (see "Bad journalism paints unfair picture of pharma industry").

The drug industry has consistently blamed the news media for painting an "unfair picture" (see, for example, my poll of readers here). I believe, however, that when you look at the evidence, you will find that there is a much higher percentage of articles in major media that paint a "positive picture" of the drug industry and often major news media merely quote verbatim from drug company press releases (see, for example, "The Cymbalta Buzz Machine is at Full Throttle!").

Recently, for example, Boehringer Ingelheim (BI) was chastised by the British Prescription Medicines Code of Practice Authority (PMCPA) for distributing a press release and briefing material for spokespersons that would in effect encourage members of the public to ask their health professional to prescribe a specific prescription only medicine. In fact, several news articles went even further and made some great marketing statements that BI could never make, such as referring to Pradaxa as a "super pill" and a "revolutionary drug." The stories also dissed the competition (warfarin) by referring to it as "rat poison" (see "BI Masters the Art of WOM through Its "Parrots," er, Spokespersons").

These are news stories about pharma products and not about the pharmaceutical industry itself, which is what Rich was focused on. Getting media to publish positive stories about products is very important to pharmaceutical companies. As for stories about the industry itself, well that's why they have the PhRMA trade association, which counterbalances negative stories in the press and competes with news media to influence lawmakers. They have a tremendous budget and the industry shouldn't worry too much about the sort of "bad press" Rich is talking about, IMHO.

In his post, Rich included a graphic image that depicts a TV "spoon feeding" a man sitting in front of the TV with a dazed look. I modified that image to depict how the pharmaceutical industry "spoon feeds" the media as evidenced in the PMCPA/BI case. I call it "Media as Middleman" or "Pharma Feeds Media Feeds Consumers."

Left out of this chain of influence are the Key Opinion Leaders who act as additional "middlemen" and put some further distance between pharma and the media, allowing for "plausible denial" - again as evidenced in the PMCPA/BI case.

Some time ago, I hosted the survey "How to Earn Back the Public's Trust," which asked respondents if they agreed that the media is the main culprit for pharma's bad public image because news media report mostly bad news about the industry and not the good that it does. Obviously, Rich Meyer agrees with this statement. However, only 51% of my survey respondents agreed strongly or somewhat (63% of pharma respondents agreed). While that was a majority, even more respondents agreed that other issues are at fault: such as "lack of transparency regarding negative clinical data" (81% agree) and "high costs of prescription drugs" (81% agree). See a more detailed analysis of this survey here.

Meanwhile, in an FCC Journalism Report, "complaints abound from seasoned reporters who lament the growth of 'press release reporting' and the lack of time they have to check out the veracity of information contained in a press release. Twenty eight percent of health reporters said that they personally get story ideas from public relations firms or marketing outreach somewhat or very often" (see "New FCC Journalism Report Paints Bleak Picture of Health Coverage"). A March 2009 Survey of American Health Care Journalists (AHCJ) found that just under half (44%) of staff journalists participating in the survey say that their organization sometimes (34%) or frequently (10%) bases stories on news releases without substantial additional reporting (see "Academics Exaggerate, Journalists Regurgitate. What About Bloggers?").

IMHO, this is "bad journalism," but of a type that tends to paint a more rosy picture of the pharmaceutical industry and the good it does.

Webinar: Pharma’s Social Media Trials and Tribulations

A Record of Social Media Events Impacting the Pharmaceutical Industry

The pharmaceutical industry is at a turning point in its adoption of new social media tools and applications for communication with healthcare professionals, consumers, patients, policymakers, and payers. Practically every pharmaceutical company has launched a social media project or application of one sort or another. To be sure, not all these efforts have been successful. This presentation explores what worked and what didn’t by highlighting the major trials and tribulations of pharma’s social media "road trip."

Topics and discussion points include:

• Is the Industry Ready for Social Media? Results of the Pharmaguy Social Media Readiness Self-Assessment Survey
• History of FDA's Promise to Provide Social Media Guidelines. What's Gumming Up the Works?
• The Major Milestones of Pharma Use of Social Media: The Good, the Bad, and the Ugly. All Offer Useful Lessons.

ePharma, the "Ron Paul" of Pharma Marketing - We Are the 1%

At yesterday's ePharma Summit conference session on "Jumpstarting Digital Capabilities in Pharma: Learning from Other Industries," the presenter, Pete Mehr, Chief Healthcare Strategy Officer at Merkle, Inc., asked the audience "If you agree with the general thrust of this conference, how come it hasn't happened?"

By "general thrust" he meant that pharma must get more involved in eMarketing and catch up with the rest of the world. "The tools are there. So how come the change is so hard?"

Unfortunately for Mehr, he was standing right in front of me when he asked that question, so I just had to respond.

"We are the one percent," I said.

Of course, that was meant partly as a joke and I knew it would not lead the discussion where Mehr wanted it to go. So, I did not get a chance to explain what I meant.

What did I mean? It relates to what I often think while attending these conferences; namely, we are preaching to the choir and that choir is a small minority within the pharma marketing biosphere. But in the bizarro world of pharma marketing, that choir is not the "richest" as it is in the real world, but the poorest.

eMarketing is only a small percentage of the pharma marketing spend and it always has been and it may always be. It's the "Ron Paul" of candidates seeking marketing dollars. It's nice for Republicans to have Ron Paul and his creative ideas, but the big wigs would not like to see him rise beyond single digits. Same with pharma marketing's "Ron Paul" -- eMarketing.

Although there was one pharma marketing big wig at the conference -- Charlotte McKines, Global VP, Marketing Communications and Channel Strategies, Merck & Co. -- she was the exception that proved the rule.

I don't know if the ePharma Summit audience understood what I was getting at, so I decided to write this post. Tell me what you think.

Bayer's CEO Accuses Patients of Being Ungrateful B*stards! We Cured Cancer, Dammit!

That's my takeaway from this comment by Marijn Dekkers, "outspoken" head of Bayer Pharmaceuticals, in which he not only disses patients but claims to have cured cancer!

"If you have cancer, you get a pharmaceutical product, and your cancer goes away. You're quick to call the doctor and [say] the staff at the hospital was great. But the pill that did it gets forgotten. We struggle with getting society to put value on what we do, and it becomes particularly important as we get under more pressure to develop the next pill" (read the WSJ article here).

This guy must be living on another planet. That planet, of course, is Planet Pharma where the drug industry rules, all cancer has been cured by the industry and where patients bow when they see a pharma CEO ride by in his open-air limo!

I've brought up the subject of pharma taking most of the credit for improving cancer survival rates when in fact most of the credit in those gross numbers is due to the fact that many people have simply quit smoking. Dekkers' remark, however, is the first time I've seen the drug industry take credit for curing cancers. Perhaps he was making unsubstantiated claims about regorafenib, a colon cancer drug Bayer is developing. It's hardly a cure. "The median overall survival of patients on experimental regorafenib was 6.4 months. That compares to five months for patients who were given a placebo" (see "Bayer, Onyx cancer drug shows modest improvement in survival").

On Quora, I posted the question: "How close are the pharmaceutical companies to "curing" cancer?" (see here) and got some interesting feedback. Dan Munro (@danmunro), Founder / CEO - iPatient, had this to say:

"While curing a given cancer is clearly a worthwhile goal - it is often not the primary focus - and early detection is still the leading indicator of successfully treating all cancers. Some cancers are simply pushed so far into remission that you're more likely to die of a different cancer or old age in your sleep. It's not a technical cure - but it's a practical one.

"The sad reality is this: The death rate for cancer (adjusted for the size and age of the population) has dropped only 5% from 1950 to 2005 (see here).  

"One weapon that will aid in their research for effective treatments was announced at CES earlier this month. Life Technologies Ion Proton Genetic Sequencer."

So, (1) the reality is that the death rate for cancer hasn't improved very much in the past 50 years, and (2) pharma's little "pills" haven't contributed much to that statistic. Shame on Bayer for taking credit where none is due!

Pfizer's Contraceptive Recall: A Statistical Needle in a Haystack!

All day yesterday, the news swirled through social media about Pfizer's voluntary nationwide recall of contraceptive tablets due to the possibility of "inexact tablet counts or out of sequence tablets." As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. That's a serious issue for any woman affected and it obviously warrants a recall.

Although Pfizer issued a timely press release dated 31 January 2012 -- which was picked up by the news media -- it did not post a tweet notice via @pfizer_news until about 5 PM yesterday. That tweet announced "Chief Medical Officer Freda Lewis-Hall Addresses Company's Voluntary Recall of Contraceptive Products" and linked to a YouTube video (embedded in this post below). A good use of YouTube -- although the video has only been viewed 444 times so far. But waiting for the video to be produced before sending out a notice of the recall via Twitter was not a good idea considering that nearly 24,000 people follow @pfizer_news!

I'm just curious why Pfizer didn't send out a tweet as soon as it published its press release on 31 January? In one step, 24,000 people could have been directed to the press release. Anyway, here's the video:



Did you hear Dr. Freda Lewis-Hall tell us how many packages Pfizer thinks were faulty? "We believe there are approximately thirty packs of birth control pills that may have received an inexact count or inactive tablets," she said. THIRTY! To retrieve these 30 packages, Pfizer recall 14 lots or approximately 1 million packages! I'm not a mathematician, but the odds that any of these 30 packages will be in the actual packages recalled must be very slim. After all, you can say you are recalling 1 million packages, but how many will actually end up back in Pfizer's warehouses? I imagine a voluntary recall is very INEFFICIENT.

30 out of 1,000,000 is 0.0003%. Even if a voluntary recall sweeps in 99.99% of the 1 million packages, that leaves 0.01% still out there. That's 33 times the number of faulty packs.

Mining FDA's AER Database: Heaven for Hypochondriacs, Hell for Pharma

A story in yesterday's WSJ Health featured AdverseEvents Inc., a start-up company that has streamlined the FDA's "often impenetrable" adverse drug event database and made it easy to search the adverse-event reports (AERs) for more than 4,500 drugs, free and online (see here).

I interviewed Brian M. Overstreet, founder and president of Adverse Events, last September on my Pharma Marketing Talk show. You can use the widget below to listen to that interview>



The pharmaceutical industry is a bit nervous about consumers getting easy access to FDA's "hidden" treasure trove of AERs:

Kate Connors, a spokeswoman for the Pharmaceutical Research & Manufacturers of America, which represents most drug makers, said the group isn't familiar with AdverseEvents and believes the FDA is the most appropriate source of information. "We think it's important for this information to be framed within context and to be properly evaluated," she says.

But the FDA passes the buck as far as being the authoritative source for AE info. As reported in the WSJ, FDA's site warns that its AER files "cannot be used to calculate the incidence of an adverse-event in the U.S. population." For consumers who want more information on drug side effects, "the best source is to read the product label and talk to your doctor or pharmacist," says Gerald Dal Pan, director of surveillance and epidemiology in the FDA's Center for Drug Evaluation and Research.

"Read the product label"! That's a joke, right? FDA hasn't made much progress simplifying drug labels either because of industry resistance or being forced to do endless studies on the issue (see, for example, "FDA Plans to Test New Standard for Easy to Understand Rx Labels").

Meanwhile, how risky are Rx drugs? I invite you to take "Harry's Drug Risk Parlor Game" and rate the overall risk of Rx drugs (you will be able to see the results to date afterward).

[Hat Tip to @Pernajl for the "heaven for Hypochondriacs" part of this blog post title.]