Sunday, February 26, 2012

Pharma Celebrity Spokespersons: Unrepentant, Secretive, and (Expletive Deleted)!

I have documented the rise and fall of several pharma celebrity spokespeople (see, for example, this list) . This past week two such celebrities made the news: Paula Deen and Danica Patrick. These are two examples of celebrities with "baggage" that may hurt the image of their pharma company partners. Paula Deen's baggage concerns secrecy and her unrepentant recipes whereas Danica Patrick's baggage includes swimsuit and bikini pictures and colorful language. I just imagined Paula and Danica "switching" their baggage (ewww!).

Paula Deen continues to express no regrets about delaying her announcement that she has Type 2 diabetes for nearly three years until she secured a lucrative deal as "a paid pitch person for drug maker Novo Nordisk's new online program, Diabetes in a New Light, and for its pricy (sic) drug, Victoza, which she takes" (see USA Today article, "Paula Deen: no regrets"). She will continue to cook sugary, fattening meals as she always has done, declaring "I'm Southern by roots. I was taught (to cook) by my grandmother and nothing I can do would change that."

However, she said that "when she begins shooting new episodes of her show this spring, the recipes will offer something for everyone, including people who want healthier recipes."

Unfortunately, there will also be a delay before those new recipes are available because "filming and production schedules are set well in advance, it could take up to two years before those episodes are aired," notes the USA Today article.

Meanwhile, Deen remains silent about how much she is being compensated by Novo Nordisk to be a paid spokesperson, citing an excuse as American as her own "Savannah High Apple Pie" (see recipe, which includes at least 2 and a half cups sugar, one whole stick of butter, and 2 cups butter-flavored solid shortening (recommended: Crisco)):

"Yes, I am being compensated," she said Friday. "It's the way of the world. It's the American way. But I am taking a portion of that compensation and giving it back to the (American) Diabetes Association."

Deen would not reveal what portion of her compensation she would donate to the American Diabetes Association. That too is the "American" way?

To learn more about Novo's reasons for choosing Paula Deen as a spokesperson, I invite you to read the Pharma Marketing News article "Novo Nordisk Defends Choice of Paula Deen as Diabetes Spokesperson". You can download this article after taking a short survey that asks two short questions:
  1. When it is proper to use paid celebrities - e.g., movie stars, TV personalities, sports figures - as spokespeople for drug brands?
  2. Should pharmaceutical companies reveal how much they pay celebrities?
You can Take the Survey here and see the results to date afterward as well as getting a FREE copy of the article.

"Was das F**k!"

That's what Danica Patrick, spokesperson for Boehringer Ingelheim's DRIVE4COPD™ awareness campaign said after teammate Cole Whitt "nudged" her rear in the Drive4COPD 300 race this past Saturday. Actually, Danica spoke in English, but that is what I imagine Boehringer Ingelheim executives were saying when they heard about this latest news about their "bad girl" spokesperson.

"The (expletive) 88 hit me while we were in a big pack! What the (expletive)?" Patrick screamed. ESPN has the video and audio from her in-car radio (here).

"I don't think it's ever great when teammates come together," Patrick said. "So we'll have to figure out what happened and move forward." Patrick didn't complain, however, in the beginning of the race when another racer, Dale Earnhardt Jr., "pushed" her to the lead position at the beginning of the race. She dropped way behind after that and grazed the wall once on her own before the second incident occurred.

Coincidentally -- or maybe NOT! -- the DRIVE4COPD Web site (here) is undergoing a revision (see below). I entered my email address to be "notified when the new site is live." Will Danica still be there?


[UPDATE. 29 Feb 2012]
I was contacted by a Public Relations person at Boehringer Ingelheim Pharmaceuticals, Inc. who said:
"Just wanted to clarify an item in your recent post re pharma celebs. The DRIVE4COPD website has been "under construction" since December 28, 2011, as we work to revise it to reflect changes to the campaign going into its third year. Since 2010, Danica Patrick has helped drive education and awareness about COPD among NASCAR fans and has been a committed and passionate spokesperson for the cause due to her family’s personal connection to the disease. The status of the website has nothing to do with any specific recent events and is on track to be fully up and running by next month. "
Thanks for the update. I didn't really think one thing had anything to do with the other :-)

Thursday, February 23, 2012

FDA's Drug Shortages Team: Why Are They Smiling?

"Hope on the Horizon," is the title of today's FDAVoice blog post by Margaret Hamburg, M.D., FDA Commissioner. The post (here) highlighted a presentation made by a patient at an FDA drug shortage briefing on Tuesday. The "FDA Drug Shortages" team -- pictured below -- "has been working day and night to address this problem," said Hamburg.

"While there is no simple solution to resolving drug shortages," said hamburg, "we are doing all that we can to make sure patients have access to the critical medicines they need when they need them. I’d like to give a special thanks to the FDA Drug Shortages team and all the other staff throughout our agency for their hard work and leadership on this topic."

Here's the "FDA Drug Shortages" team:


Why are they smiling? Also, what's with the uniforms? Is it to give FDA agents an "aura" of authority -- as opposed to REAL authority -- when they meet with pharma execs to address this problem?

Advice to J&J's New CEO Alex Gorsky: Start Tweeting, Blogging, and YouTubing

Alex Gorsky will have to address trouble at J&J's consumer business when he becomes CEO, notes the Wall Street Journal (see here).

Sure, "those who know Mr. Gorsky laud his skills diagnosing problems by reviewing reams of data and visiting the company's front lines, motivating experts on staff to fix the issues and then holding the staffers responsible," but can he tweet? That's what I want to know.

Gorsky should learn from the mistakes of his predecessor, Bill Weldon, who flubbed handling the growing PR crisis by not adequately, IMHO, leveraging social media to assure consumers he was working to resolve the issue. More importantly, however, Weldon did not use social media to interact directly with consumers.

Gorsky should have his own Twitter account, Blog, and YouTube Channel. And ALL of them should allow comments. Open the social media floodgates and learn why J&J is now ranked #7 instead of #1 or #2 in the Harris Poll Reputation Quotient study.

You might object and say that a CEO of a huge corporation such a J&J simply does not have the time to engage in social media. That may be the case. But I advise Gorsky to learn from celebrities and political candidates -- have surrogates (ie, PR people) handle the day-to-day interactions and make sure you approve what they say in your name. But EVERY day make at least one personal tweet or reply to a tweet and every week write a blog post. Once a month, do a YouTube video update. Is that too much to ask of a CEO?

I cannot find a Twitter account for Gorsky, whereas at least 5 J&J junior executives have such accounts according to my "Pharma Social Media Pioneers" database (here).

The only social media account I can find for Gorsky is a LinkedIn page (here). It is out of date! Mr. Gorsky, how come you only have 160 links? Not only should you update your page and start linking to more people on LinkedIn, you should have a "vanity" URL. Mine is www.linkedin.com/in/pharmaguy. How about www.linkedin.com/in/Gorsky? Whoops! That's already taken! What about www.linkedin.com/in/AlexGorsky? That's taken as well. Too bad. You should have thought of this sooner.

Having a personal social media presence, however, is even more important when the NEXT crisis occurs -- and, Mr. Gorsky, it will occur, believe me.

During a previous JNJ PR crisis, I was asked what I would do in JNJ's shoes by Melissa Davies -- a mom and Social Media Practice Lead at Return on Focus, a company that helps companies market their brands. Melissa asked:
"John, could you share some thoughts on what you would advise JNJ to do as part of a more fully developed social media response strategy? Are you thinking the company should have more Tweets, engage on more sites, etc.? I'm curious what you think the ideal roadmap looks like."
My response:
"For what it's worth, I believe this situation calls for more information and conversation no matter what the channel or the road.

But since we are talking about social media, let's stick to that.

Because the CEO has been targeted, is expected to meet with Congress, and posted a message to JNJBTW, he should lead the discussion. In addition to a formal letter posted to the corporate blog, how about opening up a YouTube channel in which he and McNeil executives talk directly to their audience and provide updates. They should allow comments -- and respond to as many as necessary.

Twitter can work with this to keep people informed about what is going on and link to specific videos.

If the CEO talks to Congress, get the transcript and post it before anyone else does. Ask readers to comment on how well or not so well questions were answered by the CEO and what was missing.

Of course, there needs to be some progress if you are going to give updates. Actions speak louder than words. Social media won't solve the problems.

Right now, I feel that JNJ doesn't have a handle on what's causing the problems. At least that's what I suspect from the reports I have heard. Maybe there are complicated manufacturing issues that involve things JNJ doesn't want to be made public (eg, importation of tainted supplies from China)? Maybe this is a good opportunity to provide a virtual tour of a Good Manufacturing facility with interviews of employees.

I don't know if this is a roadmap or not, but when your company's reputation is at stake, the leaders have to be visible. You can't just say "one of our companies has let you down" and leave it at that. What are you going to do about it so that it doesn't happen again? is what people really want to hear from the people who are in charge, not the PR department."
What do you think Mr. Gorsky? Is that good advice? Would you consider doing something along these lines yourself?

Wednesday, February 22, 2012

Pharma Marketing Vs. Insurance Marketing: What Pharma Can Learn from Geico

Often, when proponents of pharma eMarketing get together at industry conferences, or cry into their beers at receptions afterward, they lament the fact that the drug industry isn't doing as much as other industries in the "e" arena. Sometimes, they cite eMarketing campaigns of companies like Procter & Gamble (P&G) and ask, Why aren't drug companies doing that?

The responses to that question generally fall into the category of "It's Regulations, Stupid!" That is, FDA regulations are hampering what pharma marketers can do online. The packaged goods industry -- of which P&G is a member -- is not regulated like the drug industry is regulated. True that!

So, let's look at another industry that IS regulated: the insurance industry. Where do insurance marketers spend their dollars and how does that compare with pharma? It just so happens that I came across some data that might shed some light on that (see the chart below; click on the chart to enlarge).


The data come from Kantar Media. The Internet data does NOT include search advertising. The insurance data is for the first three quarters of 2011 (total spend = $3.56 Bn) whereas the data for pharma is for 2010  (total spend = $4.3 Bn). To compare apples to apples, in 2010 the insurance industry media spend pie looks like this: TV, 54%; Print, 6%; Internet, 21%.

No matter how you look at it, the insurance industry favors Internet over print whereas the opposite is true for pharma. Why?

Here's what I have learned from personal experience. In my family -- and probably in your family too -- health decisions and purchases are generally the domain of my wife, whereas insurance decisions and purchases are my responsibility. It's no secret that pharma marketers target mostly women. My wife reads magazines like Prevention, etc. that feature a lot of drug ads. I don't read these magazines. While I have seen print ads for insurance companies, they haven't made much of an impression on me, whereas TV ads have.

So, from my personal experience, it's logical that both industries allocate a big portion of their media spend on TV advertising, but only the drug industry spends a lot on print advertising.

What's surprising, however, is the insurance industry's 28% of total media spend on the Internet (versus 5% for the pharma industry).

Coincidentally, yesterday I received an e-mail message from Geico about their "Family Pricing Program" for my son Greg. (We are Geico customers, having both our car and home insurance with them.) The message said:
"If Gregory is getting ready to graduate, preparing for a new job, or looking to establish a little independence, our Family Pricing program allows you the freedom of moving Gregory to his own policy while he continues to receive the same great rates you're currently receiving."
That spooked me a bit because Greg just started his first full-time job after graduating and I mentioned to my wife that soon it will be time for Greg to get his own insurance policy! I tweeted:
"Got email from Geico about transferring my son 2 his own car insur plan now that he has a job. How'd they know I was just thinking that?"
Of course, they didn't know what I was thinking, but it was nice to know that they anticipated what I may be thinking! Geico knows a lot about me and my family. They know our ages, our sex, our driver's license numbers, our driving records, what kinds of cars we own, etc. I had to give them that information to get insurance. No big deal.

So, it would be easy for Geico to anticipate that Greg recently graduated and that he may have a new job. Further, they know from experience that parents want to get their kids off their insurance plans ASAP.

After I posted that tweet, I received this response from "Shay" tweeting from the @GEICO_Service Twitter account:
"We would be more than happy to give him a quote! He can go to geico.com or give us a call at 1-800-861-8380. -Shay"
That was a pleasant note that makes this whole experience even more personal than if I just got an e-mail message.

When I complained that Greg was likely to push back on the idea of paying his own insurance, Shay reassured me that "We will do everything we can!" and added: "Thank you so much for being part of the GEICO family!"

I don't think I can leverage this new found "family" relationship to get an even better deal from Geico, but the experience made me an even better fan of Geico -- I was already impressed with their online services. Hopefully, if we ever need to make a claim, I will be equally impressed.

Can the pharmaceutical industry do something similar? I'm not sure. The first hurdle for pharma is breaking away from print. As I said, pharma marketers may depend upon print to reach their core audience -- women. But they may be ignoring social media's ability to reach that core -- listen, for example, to this podcast: "How to Score With Women (as a Marketer) via Social Media."

Keep in mind, however, that social media marketing is virtually "free" compared to print advertising, which is something the packaged goods industry is learning (see "The Coming Pharma Digital Depression"). Given that, even if pharma moves big time into social media marketing, I'm not sure the spend pie would look much different. The insurance industry probably spends a lot more on internet display advertising and e-mail direct marketing than does the pharma industry. These activities are much more expensive than paying Shay to reach out to me via Twitter!

Tuesday, February 21, 2012

Pfizer Mobile Public Toilet App Rated Top 25 by George Costanza

I just love following Fabio Gratton on Twitter. Yesterday he posted this tweet:

"Has anyone download this Pfizer app? (only available in Israel). Terrific idea! http://t.co/JAMzbIa4 #mhealth"

When Fabio says something is terrific, I have to see it.

The app he was talking about is Pfizer’s ‘public restroom’ iPhone app, which targets consumers in Israel. BTW, there are in fact no public toilets in Israel!

So, how do you find a public toilet where there is none?

"We launched a GPS app that locates the nearest toilet – restaurants included!”, said Tali Rosin, public affairs and policy manager with Pfizer Israel. According to a reviewer (here), "users can add toilets not already in the app’s database, and can also grade toilets they visit for criteria such as cleanliness, availability of toilet tissue, or whether they needed to ask for a key."

Now THAT's a mobile app that George Costanza would rate among his TOP 25! Actually, Pfizer's app was among Apple App Store’s coveted “Top 25” most-downloaded apps and was downloaded over 15,000 times in about 3 months after it was launched in September 2011.

You could refer to this app as the Mobile George Costanza Public Toilet Finder:



The app is designed to raise awareness about Overactive Bladder (OAB). People with OAB would find this app useful because the condition is characterized by frequent urges to urinate. I bet it's also useful for tourists.

NOTE: It's only useful if the database includes good coverage of a city with lots of ratings from other users. Otherwise, it's a simple matter to walk into any restaurant and ask to use the toilet. You don't need an app for that! I suspect there are a lot of "George Costanzas" out there who may not have OAB, but like to know where the best toilets are located, just in case.

The app also includes an RSS function that automatically sends news feeds to the app. I am not sure what kind of news -- maybe tweets from Pfizer. Interestingly, it also facilitates calls from within the app to Pfizer's hotline.

Pfizer claims that the app has a positive ROI and has lead to an increase in product sales (I suppose for Toviaz, its OAB drug; see here).

Mass Media DTC Trumps Mobile Marketing
So why don't we see such "innovative" smartphone pharma apps here in the U.S.?

Simple. We have direct-to-consumer (DTC) BRAND advertising via mass media and the Internet here in the U.S. That EASILY trumps NON-BRANDED disease awareness social media and mobile apps in terms of awareness. That is one reason why pharma's spending on social media and mobile marketing is so minuscule.

Another reason why the availability of DTC marketing in the U.S. leads to minuscule eMarketing is that brand managers spend so much on mass media DTC there is very little left in the budget for "e" of any sort and a big chunk of that goes to building web sites and buying search engine ads to drive traffic to those web sites, IMHO.

Monday, February 20, 2012

How the Placebo Effect & Marketing Can Improve Health & Increase Pharma Profits

Big pharmaceutical companies are drastically cutting back on research and development. The economics just do not support the model that has been the driving force of the drug industry over the past 15 years.

According to a Forbes analysis reported by Matthew Herper, "The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion" (see "The Truly Staggering Cost Of Inventing New Drugs").

Some pundits suggest that lowering the cost of performing clinical trials will help get more drugs to market faster. Andrew von Eschenbach, former FDA Commissioner and now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative, suggested that instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies" (see here).

However, Herper points out that the "main expense is failure. AstraZeneca (AZ) does badly by this measure because it has had so few new drugs hit the market." AZ spent about $59 billion on R&D between 1997 and 2011, but only managed to get 5 new drugs approved. According to simple arithmetic, that means each of these 5 drugs cost about $11.8 billion to develop.

That's an interesting number. A very similar number came up during last night's 60 Minutes segment on "Treating Depression: Is there a placebo effect?" (see it here). It turns out that antidepressants sales in the U.S. bring in $11.3 billion a year to pharmaceutical companies that sell them -- including AstraZeneca!

Could it be that the drug industry is merely "breaking even" in the anti-depressant market?

I suspect they are probably making a pretty good profit -- but that profit may be diminishing as more and more anti-depressants go off patent. In fact, it has been suggested that 60 Minutes dared to air this expose -- four years after the research was first published -- because the "news" can no longer harm the drug companies that CBS depends upon for advertising -- most of the drugs mentioned are off patent (see “You’re telling me this now?” Why the news is suddenly critical of statins and antidepressants).

I did a blog post about antidepressants and the placebo effect two years ago in January 2010 (read "A Common Goal of Research and Marketing: Fool the Doctor"). In that post, it was noted that clinical evidence suggests these drugs are not any more effective than a placebo in patients with less severe depression. But drug company marketing to physicians does not mention this. Thus, physicians are led to believe that the drugs ARE effective for all patients with depression.

As pointed out in the 60 Minutes piece, "a clinician who cares, who takes the time, who listens to you, who asks questions about your condition and pays attention to what you say, that's the kind of care that can help facilitate a placebo effect." That goes double if the clinician actually believes what he or she is prescribing is a drug with proven efficacy.

Consequently, marketing to physicians along with direct marketing to consumers can play a huge role in "facilitating" a placebo effect. Which leads me to this idea: pharmaceutical companies should be in the business of developing placebos rather than dangerous, ineffective chemical compounds. There would be no need for expensive clinical trials and it would be easy for FDA to adopt von Eschenbach's idea to approve these new "drugs" before they are proven effective. It will be up to marketing to make them effective by facilitating the placebo effect!

Of course, to be successful, this new approach to drug development must be done surreptitiously and the FDA must conspire with the drug industry (not too much of a stretch there). After all, if everyone knows that the drug industry is manufacturing placebos, the game is up -- doctors will know that they are prescribing placebos and so would patients. That knowledge will render the placebo ineffective. This is a case where a knowledgeable patient is at a disadvantage.

It should be noted, however, that many physicians in some countries knowingly prescribe placebos. Results of a survey published in the British Medical Journal (BMJ) indicate that "about half of the surveyed internists and rheumatologists reported prescribing placebo treatments on a regular basis. Furthermore," say the researchers, "physicians who use placebo treatments most commonly describe them to patients as a potentially beneficial medicine or treatment not typically used for their condition; only rarely do they explicitly describe them as placebos" (read this).

Friday, February 17, 2012

J&J Recalls Grape-flavored Children's Tylenol: Another Missed Opportunity for Social Media

[Great minds think alike! Be sure to read Update at end of this post.]

Here's another case where CHEAP social media -- ie, YouTube -- could have been used by a pharmaceutical company to support patients using its products, but was not.

Johnson & Johnson DID use social media -- Twitter -- to inform followers of its decision to recall of U.S., Infants’ TYLENOL® Oral Suspension, 1 oz. Grape. According to a letter sent to J&J employees' Denice Torres, who’s the President of McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, said:
"We’re recalling the product at the retail level after receiving a small number of complaints from consumers who reported difficulty using the product’s SimpleMeasure™ dosing system. SimpleMeasure™ includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the dosing syringe. No adverse events associated with this issue have been reported to date and the risk of a serious adverse medical event is remote."

The letter was posted on the JNJBTW Blog (see here), to which the Twitter post mentioned above linked. J&J will offer people a refund, which is good. But are they abandoning the new dosing system, which is also a good idea? Perhaps it needs a new design, but even so, it should include instructions for use -- and not just written instructions, which many people won't understand. Video would be better.

So, I immediately thought: "Why didn't J&J post a video on YouTube that showed people how to use the dosing syringe?"

Such a video would be almost as easy and cheap for J&J to create as the post to JNJBTW. And it would be more likely to be seen by consumers because YouTube is the second -- maybe now the first -- most used search engine on the Internet! The video could also be embedded within the product web site. [Or even at the end of blog posts such as this one!]

I did a quick search of the product web site and found no information on how to use the SimpleMeasure™ dosing system and no video.

Last week I attended the ePharma Summit, which included a popular presentation titled "I wish I'd Done That! Social Media." Presenters would review competitors' social media campaigns that they liked.

What we really need is a session on "The Social Media We Should Have Done, But Didn't!." I think I will gather my contenders for this session and post them here!

Meanwhile, I hope this gives J&J an idea.

UpDate:
I just learned learned via a Twitter post from @JNJComm at 10:05 AM that there is a YouTube video on How To Use Infants' TYLENOL® SimpleMeasure™: Watch a video about how to use Infants’ TYLENOL Simple Measure > http://www.youtube.com/tylenol

Thursday, February 16, 2012

Funny or Die Spoof: "Paula's Victoza Injected Sneaky Snacks!"

"All of my desserts are injected with Victoza to lower my blood sugar and keep me immortal," says "Paula Deen" in the spoof YouTube "Paula Deen's Diabetes Ad" posted by Funny or Die (see video here).


Next: Saturday Night Live!

Wednesday, February 15, 2012

Is Pharma Part of Problem or Solution to Current State of US Economy?

When Americans were asked "Thinking about the role each of the following sectors played in the current state of the American economy, do you think each of the following sectors is a part of the problem, a part of the solution, or are you unsure?," only 15% said the pharmaceutical industry was part of the solution, according to the 2012 Harris Poll Annual RQ survey. 50% said the industry was part of the problem (see chart below):



According to Harris, that puts the drug industry on the cusp of being a "malefactor" - an industry that Americans blames for economic woes. You can find the complete Harris report here.

Meanwhile, PhRMA, the industry's trade association in the U.S., continues to churn out press releases that warns Americans that if the government passes such-and-such law or over-regulates such-and-such activity of the pharmaceutical industry, it will result in the loss of thousands, nay millions!, of American jobs.

For example, in a response to the President's Fiscal Year 2013 Budget, PhRMA stated "America's biopharmaceutical industry is a key driver of economic growth; the President's proposed budget would weaken our ability to innovate and create jobs. This is not an investment in America's future and these proposals should not be considered" (see "PhRMA Statement on the President's Fiscal Year 2013 Budget").

Of course, the drug industry can be both part of the solution and part of the problem. It depends on whose problem/solution you are talking about.

It's part of the solution for white collar workers who work in the U.S. pharma industry, have Rx medical coverage, and can afford prescription drug co-pays. Blue-collar workers and retired folk who depend more on government "safety nets," however, may see  high drug prices and the drug industry's antipathy toward Medicare rebates as part of the problem. The latter are not among the typical U.S. pharma work force since the drug industry is shipping more and more blue-collar manufacturing jobs overseas to countries like China.

Not only does this NOT support jobs in the U.S., it also endangers our drug supply.

In a story about counterfeit Avastin in the U.S., the link between overseas drug manufacturing and counterfeit or tainted drugs in the U.S. was suggested: "Most Americans don't question the integrity of the drugs they rely on. They view drug counterfeiting, if they are aware of it at all, as a problem for developing countries. But the latest incident, which follows the appearance of other fake drugs in the U.S.—including counterfeits of the weight-loss treatment Alli and the influenza treatment Tamiflu—suggests it is a growing risk, especially as more medicines and drug ingredients sold in the U.S. are made overseas [my emphasis; see "Roche warns of fake cancer drug in US"). For more on this, see "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?"

Is Pharma Part of the Problem or Solution to America's Economic Woes?
Solution
Problem
Both, as you say
Unsure
  

Tuesday, February 14, 2012

Former FDA F├╝hrer von Eschenbach Favors Approving Drugs for General Use Without Proof of Efficacy!

Andrew von Eschenbach, famous for resigning as FDA commissioner and leaving the agency leaderless on the very day that Obama was inaugurated (see Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss"), is now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative.

If von Eschenbach has his way, FDA will be out of the business of approving new drugs based on efficacy, but will merely rubberstamp any drug that won't kill humans outright! In essence, the entire U.S. population will become non-volunteer experimental subjects. A drug's efficacy will be proven (or not) in the marketplace.
Instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy," says von Eschenbach in a WSJ Op-Ed piece (see here), "after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."

This is free market economics gone wild!

Currently, "post-market studies" are a undertaken to test the SAFETY of drugs as they are used in the real world. Such studies are not required of all drugs. What von Eschenbach proposes is to use post-market studies to test if drugs work as advertised, not if they are safe.

The problem is that post-market studies are NOT scientific because there are no controls to determine a baseline against which to measure efficacy. It's easy to find safety problems because that does not require controls.

I am amazed that von Eschenbach headed up the FDA and before that the National Cancer Institute! The fact that he is advocating tossing the scientific method aside takes my breath away considering that he is now well-positioned in the conservative political arena and no doubt has hopes that a future Romney or Gingrich administration will appoint him FDA commissioner or worse, Secretary of the Department of Health and Human Services!

Pharma Social Media Silent About Drug Shortage: Boehringer, Novartis, #FAIL!

The pharmaceutical industry is not interested in using social media to inform or support patients using their products. It's only interested in using social media to push out positive news about their companies and products. This is evident by the industry's deafening silence regarding the shortage of cancer drugs such as methotrexate, a drug used to treat children's leukemia among other maladies.

Letters from the American Society of Clinical Oncology, American Cancer Society of Pediatric Hematology/Oncology and Children's Oncology Group, a nationwide network of researchers, were sent to top executives at four U.S. makers of the drug pleading for help. Two of these companies -- Ben Venue Laboratories and Sandoz -- are owned by major non-U.S. Rx pharma companies (Boehringer Ingelhein and Novartis, respectively). The letters state in part:
"As you know, since December we have seen a significant decline in the country’s production of preservative-free Methotrexate (MTX). This drug is critical to the treatment of children with ALL. Approximately 3,500 children and teenagers are diagnosed with ALL each year, with cure rates approaching 90%. Without this drug, patients are at dramatically heightened risk of dying."
As reported in the Chicago Tribune (see here), "the FDA says the main reason for the shortages is manufacturing deficiencies leading to production shutdowns. Shortages also are resulting from companies halting production of drugs with low profit margins, companies consolidating in the generic drug industry and supplies of some ingredients shrinking."

"Established in 1938, Ben Venue Laboratories is the manufacturing arm of Bedford Laboratories, a Boehringer Ingelheim company," says the company's web site. "Bedford Laboratories is one of the largest generic injectable pharmaceutical companies in the United States, offering a broad range of multisource injectables across multiple therapeutic classes."

In November, 2011, Ben Venue Laboratories (Boehringer Ingelheim), for example, shut down its manufacturing and distribution operations at its site in Bedford, Ohio due to significant manufacturing and quality concerns (see here).

Meanwhile, the Twitter accounts of Boehringer and Novartis roll merrily along posting positive tweets about their commitment to cancer patients, while completely ignoring the cancer drug shortage issue. Here are some recent tweets:

  • @BoehringerUS: "@WHO estimates that 84 million people will die of cancer between 2005 and 2015 without intervention. #WorldCancerDay"
  • @Boehringer: "@martin_dudziak Very true. We are also committed and believe in continued research & clin trials as a major key factor in fighting cancer!"
  • @MylanNews: "Mylan Committed to Expanding Access to High Quality, Affordable #HIV/AIDS Treatment. Company Honors #WorldAIDSDay"
  • @Novartis: "Novartis continues to research ways to control tumor growth in advanced #breastcancer"
The Rx drug industry is betting its future on developing complex biologics to treat major diseases such as cancer. If the current crisis is any indication about how successful they will be in (1) manufacturing biologics and (2) using social media to inform the public about the products and support patients who depend on these products, then, IMHO, I  doubt they will be successful.

P.S. Meanwhile, Boehringer is developing a Facebook "game," Syrum, which is designed to "educate" the public on how the drug industry develops drugs (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!"). I suggest the company's PR people can better spend time and resources using Facebook to support their patients. Currently, BI's Facebook page does not mention the drug shortage problem nor anything else that can be considered helpful to patients who take their drugs!

Monday, February 13, 2012

Greece & US Top List of Big Drug Spenders - A Shared Sign of Debt Risk?

"Greece’s continuing high level of spending on medicines is a striking example of the broader problems facing the country as it battles under international pressure to cut public expenditure and rein in the nation’s debt," say the authors of a Financial Times article (see "Athens struggles to rein in medical excess").

If drug expenditure per capita and as a per cent of GDP is a measure of a country's financial instability, then the U.S. is in the same league as troubled Greece (see chart on left).

Interestingly, a Merck executive blamed rampant consumerism!

"There were no controls on spending in the past, the whole system favoured consumption," says the director for Merck, the US pharmaceutical group, in Greece. "It was not only supplier-led, but demand-led by doctors and patients."

The same could be said of the U.S., the gold standard among health systems that "favor" consumption. But if that Merck pharma executive were to say the same about the U.S. system, he probably would be sent off to an "emerging" market such as Russia.

P.S. Actually, we are not comparing apples to apples here. Greece is a one-payer healthcare system, whereas in the U.S. there are several payers -- including consumers. So, in terms of state debt, healthcare expenditures are a bigger factor in Greece than in the U.S. However, in the U.S. personal debt caused by healthcare expenditures can keep the economy sluggish and have an impact on the ability of the U.S. to pay its debts and fund the future.

Saturday, February 11, 2012

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.

Friday, February 10, 2012

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.

Thursday, February 09, 2012

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.

Wednesday, February 08, 2012

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.

Tuesday, February 07, 2012

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!

Thursday, February 02, 2012

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.

Wednesday, February 01, 2012

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.]