Medical Device Marketing Don't Need No Stinkin' ROI!

"Standards for devices exist, they just don't make sense," industry critic Dr. Diana Zuckerman, president of the National Research Center for Women & Families, said in a Consumer Reports release (also read this CBS report "Investigation: Most medical devices implanted in patients without testing"; see video below).

"An investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:
  • Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.
  • There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”
  • Without major changes in the system, there’s not much that patients can do to protect themselves.
According to Consumer Reports, the majority of medical implants are not tested to make sure they are safe. Most of the time device manufacturers only need to pay the Food and Drug Administration (FDA) a fee of about $4,000 with minimal testing in order to get approval for marketing. Compared to drug approval, this is a walk in the park.

In fact, sometimes device manufacturers bypass this minimal approval process altogether as did Johnson and Johnson's Ethicon unit (see "J&J Marketed Medical Device Without FDA Approval").

Not only is the approval of medical devices by FDA more lax than the process used to approve drugs, medical device marketing is worlds apart from Rx drug marketing as I learned from a presentation made by a Medtronic marketing VP. The presentation focused on a case study of a marketing campaign for the Prestige Cervical Disc.

That case study showed that out of an estimated 5 million spine surgery candidates (patients) in the US, Medtronic only needed to capture 125 of them to break even on a very successful marketing campaign that reached 6.2 million local TV viewers, 80.5 million radio (especially satellite radio) listeners, 4 million print readers, and 73 million Internet browsers. (Get more details about that case study by downloading this Pharma Marketing News article: "Medical Device Marketing: Worlds Apart from Rx Drug Marketing"; use discount code 'DEV444' BEFORE April 15, 2012 to get it FREE!).

While drug advertisers would sweat and moan over whether such a campaign would have a positive ROI (return on investment), medical device marketers don't need to worry about no stinkin' ROI because of such low numbers of conversions required AND also because very little resources need to go into premarket testing in order to get FDA approval.

Although the FDA has met most of its goals for fast-track medical device approvals, it's taking substantially longer to issue decisions on devices than it used to, concluded a report from the Government Accountability Office (GAO). The GAO said:
"FDA has begun to take steps to address GAO’s 2009 recommendation about high-risk devices that are allowed to enter the U.S. market through the less stringent 510(k) process, but progress has been limited. High-risk devices include those which are implantable or life sustaining. In 2009, GAO recommended that FDA expeditiously take steps to issue regulations for the device types classified as high risk that are currently allowed to enter the market via the 510(k) process. Since then, FDA has set strategic goals to address these device types, but has issued a final rule regarding the classification of only one device type. As of April 1, 2011, FDA’s action on the 26 remaining types of high-risk devices was incomplete. Thus, these types of devices—such as automated external defibrillators and implantable hip joints—can still enter the U.S. market through the less stringent 510(k) process. GAO found that, since its report was issued in January 2009, FDA has cleared at least 67 510(k) submissions that fall within these high-risk device types. FDA has taken some additional steps to enhance premarket device safety since GAO’s 2009 report was issued—for example, it commissioned the Institute of Medicine to conduct an independent review of the premarket review process—but it is too early to tell whether any forthcoming changes will enhance public health."
To get a copy of the GAO report, see the end of this post: "FDA Taking Longer to Approve Medical Devices, Says GAO"

Diabetes Opinion Leaders Paid by Roche to Curate Content on New Twitter-based Social Media Site

Diabetes Nest, according to its "About" statement, "is a Twitter-based diabetes network designed to help people discover the best conversations from the most meaningful voices. The Nest was created by Ignite Health and sponsored by Roche Diabetes Care, makers of ACCU-CHEK® products and services."

Ignite Health, an InVentiv Health agency, maintains the site. Fabio Gratton, chief experience officer at Ignite Health, said:
"Few argue that social media has transformed how patients and their caregivers share healthcare information and find support. But the sheer volume of content can be overwhelming. 
"So we asked ourselves how we could best help the diabetes community find and engage in the most timely, relevant and important conversations. The result is a simple, intuitive, compelling and ultimately self-sustaining diabetes social media community.” Diabetes Nest aggregates, sorts and ranks tweets from a curated list of diabetes experts" (read more here: "Roche Sponsors Diabetes Nest Twitter-Based Social Media Site").
All five of those "diabetes experts" are long-time patient bloggers who are "compensated for their time, effort and invaluable guidance." Caretakers include:
  • Amy Tenderich (Diabetes Mine blogger)
  • Gina Capone ("gina - your diabetes BFF" blogger)
  • Kerri Sparling ("six until me" blogger)
  • George Simmons (co-host of DSMA Live on BlogTalkRadio)
  • Scott K. Johnson (co-host of DSMA Live on BlogTalkRadio and blogger at Scott's Diabetes)
Roche "has no control or influence over the content or frequency of the Caretakers' tweets."

Roche Diabetes Care has long been wining and dining diabetes bloggers at yearly "Roche Social Media Summits" held in nice places like resorts in Orlando, Florida. When I learned of the first summit held in 2010, I blogged that "Some Social Media Patient Opinion Leaders Want to be Paid Pharma Professionals." Diabetes Nest is, to my knowledge, the first such time that bloggers have been paid to be "consumer opinion leaders" in a manner similar to how pharma often pays physicians to be "key opinion leaders."

At a patient panel discussion during a 2010 conference, Allison Blass (Patient Blogger, Diabetes Activist, Lemonade Life), said "You need to pay some one's full time salary," referring to the desire of some pharma companies to interact with patients in online communities. "The only way to sustain growth and involvement in a [online] community," said Allison, "is to have someone who actually does it [manage social media interactions with patients] as their job... to become the person who is known and loved by the community."

Not that there is anything wrong with being compensated for your time, but pharmaceutical companies have to be careful how they provide compensation. In the case of Diabetes Nest, Roche probably supplies an "unrestricted grant," which is supposed to specify that the grantor (Roche) has no control over the content created by the grantee. The "grantee" in this case is probably Ignite Health, which owns Diabetes Nest (see NOTE below). Ignite Health is an advertising agency that works with pharmaceutical companies.
NOTE: Doing some WHOIS snooping, I learn that the domain diabetesnest.com is registered to "TWTCLK" and the administrative contact is Fabio Gratton, both located at the same address in San Clemente, CA. 
A pharmaceutical company providing unrestricted grants or other funds to an advertising agency in support of a patient site related to a product line is a bit controversial, IMHO, especially if there intends to be a "Chinese" wall between the funding and advertising interests. This kind of thing got pharma companies into trouble with the likes of Senator Grassley when "unrestricted grants" were provided to ad agencies to run independent accredited CME programs for physicians. ACCME, which accredits CME, now requires that CME providers to be independent of ad agencies to avoid conflicts of interest.

Disclosure: Fabio Gratton is a friend of mine and a very nice guy who deserves a lot of credit for his high quality, ethical work with pharmaceutical clients. He has been a frequent guest on my BlogTalk Radio show (eg, listen to "Facebook Timelines for Brands: The Implications for Pharma Companies"). He is not a client of mine, but he could be in the future. Knowing Fabio, I am sure he would welcome a discussion of "conflict of interest" in pharma-sponsored social media. The timing of this post may be a problem for him as he and his wife are expecting their first child any day. He must be very busy. Any way, I hope some day I get to visit him in San Clemente! 

Will Pharma Experience It's Own "Pink Slime" Social Media Crisis?

No doubt you have heard about "pink slime," the beef additive made from leftover trimmings. According to an article in today's Wall Street Journal (here), "the additive, which has long been used as a cheap filler in hamburger meat without anyone knowing or caring, has become the latest example of a product to fall prey to a social-media feeding frenzy after celebrity chef Jamie Oliver detailed how it is made in a TV special. Facebook, Twitter and other social media sites took it from there. Supermarkets and school districts across the country have been shunning it after mounting public pressure."

To counteract that "public pressure," which Tyson Foods Chief Operating Officer Jim Lochner said is merely a "two-week event," USDA and governors from several "pink slime" producing states (eg, Rick Perry, Texas) are mounting a counterattack. Iowa Gov. Terry Branstad said "We're going to consume it. We'll do everything we can to set the record straight."

"This is so clearly a movement that's been driven by consumers," said Willy Ritch, a spokesman for U.S. Rep. Chellie Pingree (D., Maine), who is pushing for a ban of the filler in school lunches.

USDA chief Tom Vilsack pointed to the difficulty of getting ahead of opposition to a product -- even if it is deemed safe by the government -- in a world fueled by social media. He also highlighted a disconnect that continues to grow between people and where their food comes from.

It's possible that the drug industry will one day face it own "pink slime" crisis because there is also a "disconnect" between consumers and where their drugs come from and the ingredients they contain.

Recently, we have seen cases where active ingredients in medicines have been replaced by miscellaneous substances having no medical benefit and cases where manufacturing problems have led to contamination such as Johnson and Johnson's problems with children's medicines (see, for example, "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?").

These problems may be glitches in an otherwise safe drug supply chain, but did you know that up to 80 percent of the active ingredients in drugs used in the United States are made overseas? Hopefully, those ingredients meet high standards. Yet up to 149 Americans died in 2007 and 2008 after taking heparin, a blood thinner, contaminated during the manufacturing process in China.

What's often not mentioned, however, are the "inactive" ingredients in the pills we take. Viagra, for example, contains the following inactive ingredients:
  • microcrystalline cellulose
  • anhydrous dibasic calcium phosphate
  • croscarmellose sodium
  • magnesium stearate
  • hypromellose
  • titanium dioxide
  • lactose
  • triacetin
  • FD & C Blue #2 aluminum lake
Patients are warned to discontinue taking medicines if they are allergic to any of the ingredients.

These ingredients are the "pink slime" of the drug industry. But whereas "pink slime" only constitutes a small percentage of ground beef, these "inactive" ingredients comprise the bulk of the pill's weight and volume.  AND they are probably made overseas with very little FDA supervision.

One of these ingredients may be as controversial to patients as "pink slime" is to hamburger eaters. In fact, this was the case with Johnson and Johnson's baby shampoo that consumers learned contained cancer-causing chemicals. That issue was big on social media for a while until J&J promised to phase out the product in the U.S. (it has been completely pulled from the shelves in other countries).

The food industry is blaming "misinformation" amplified via social media as the main cause of the consumer backlash against "pink slime." They have launched a two-pronged campaign to deal with the crisis: (1) issue "corrective" information, and (2) warn of higher prices if "pink slime" is no longer used in hamburger meat.

This sounds similar to how drug companies view social media -- i.e., a vast network of "misinformation" about their products. The biggest argument social media advocates use to convince pharma to "engage" with consumers on social media is so that they can be "part of the conversation" and provide "scientifically correct" information about their products to counterbalance all the "misinformation" out there.

The first step is to learn what consumers are actually saying about drugs on social media. The drug industry is actively engaged in that kind of monitoring right now.

FDA Says No to Importation of Drugs That Save Lives, But Yes to Drugs That End Lives

In the FAQs section of FDA's consumer web site (here), it answers the question: "Why can’t I import some drugs that are approved and sold in the United States?" thusly:
"Many drugs obtained from foreign sources that claim or appear to be the same as U.S.-approved drugs are, in fact, of unknown quality and may even be counterfeit. There is also a possibility that drugs coming to U.S.consumers through Canada, or that claim to be from Canada, may not actually be Canadian drugs. FDA cannot assure the authenticity, safety, or effectiveness of drugs from foreign countries."
However it does allow an exception at its discretion: "FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:
  • The drug is for use for a serious condition for which effective treatment is not available in the United States;
  • There is no commercialization or promotion of the drug to U.S. residents;
  • The drug is considered not to represent an unreasonable risk;
  • The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
  • Generally, not more than a 3-month supply of the drug is imported."
Certainly, that exception does NOT apply to sodium thiopental, an anesthetic used to put inmates to sleep before other lethal drugs are administered. Obviously, inmates are not importing this drug for "their own use."

However, the FDA has allowed prison officials in various states to import sodium thiopental after the drug’s U.S. manufacturer announced last year that it would no longer produce it.

As reported in the Washington Post (see here), U.S. District Judge Richard Leon blocked the importation of sodium thiopental on grounds the Food and Drug Administration "ignored the law in allowing it into this country." The Obama administration argued it had discretion to allow unapproved drugs into the U.S. Leon said the FDA’s actions were "contrary to law, arbitrary, capricious, and an abuse of discretion." He said that plain language of the law says that an article that appears to be misbranded or unapproved "shall be refused admission."

FDA cites safety concerns when it enforces the law of which Judge Leon speaks. A case in point, was the importation of tainted cancer drug Avastin (see "The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors").

Ironically, Judge Leon cited the same safety concerns:
"By opening up the 'closed' drug system by allowing an unapproved drug — thiopental — into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public," he wrote.

An App for Troubled Sleepers that Lunesta Would Love... Maybe.

What makes a mobile app effective?

That was the question posed by Jim Dayton (@JimDayton), Snr Dir Emerging Media at Intouch Solutions, at the iPharmaCONNECT conference this past Monday. As I suggested in a previous post, Dayton was not able, IMHO, to answer the most important questions about effectiveness; namely, provide truly useful KPIs (see "Pharma Social Media Religion Versus Science").

Today, I can explore what makes an app effective based on my personal experience with an app called "Sleep Cycle." Available in the iTunes store (here), Sleep Cycle is "an alarm clock that analyzes your sleep patterns and wakes you in the lightest sleep phase - a natural way to wake up where you feel rested and relaxed." After setting the alarm to the time you wish to wake up, you put your iPhone under your pillow (actually, next to it as shown in the photo below) and the app collects data about your sleep pattern during the night.

The app uses the iPhone's accelerometer to detect and measure your movements during the night. According to the developers, Sleep Cycle calculates the optimal time to wake you up during a 30 minute window that ends at your set alarm time.

It was amazingly simple to use. That's the first characteristic of an effective app.

But does it work? I must admit I had my doubts. It could be like those pads that draw out bad karma from the soles of your feet while you sleep. Yeah, sure. After my first use last night, I can say that it definitely worked!

Here's the chart showing how I slept last night:

The app DID wake me at a deep sleep point at 4:57 AM - 3 minutes before 5 AM, which was the time I set it to.

But could the chart just be faked? The app could have generated a random series of peaks. How would I know? Here's why I know it is for real. At about 1 AM in the morning we experienced a power failure that lasted only a minute or so. It was enough to wake me and my wife. The red arrow indicates the highest peak in my sleep cycle because I (and my wife) definitely woke up after hearing alarms from other digital devices in the bedroom -- such as beeps from the cable box as it turned back on.

What's the utility of such an app? First of all it's fun! Secondly, it records real data that I can use to help me get a better night's sleep. If I were being treated by my doctor for insomnia, I could send the data by email to my doctor. If I was being treated with a drug like Lunesta, I could determine if it really helped (although I should know it helped or not without charting my movements during sleep).

The third reason why this is an effective app is the most important one. I will use it every night. The novelty won't wear off because it fits into my routine of charging my iPhone every night when I sleep -- right there next to me on the night stand. This is an app that keeps your phone charging while it works instead of wasting battery life!

One last thing. The app is NOT free -- it costs $0.99, which is practically free, but makes me feel that I have a stake in using it. No matter how much money you make, you not likely to toss a dollar bill into the trash.

Sunovion Pharmaceuticals (formerly Sepracor), which markets Lunesta (a sleep aid drug), could have developed this app, but here's a better suggestion: SPONSOR it through advertising. I'm not quite certain how advertising works on smartphones, but I have seen free apps that include ads that pop up when the app is started or during its use. It's not usual for ads to appear in apps that you pay for, but Sunovion can pay the developers $0.99 for each app download that includes its ad -- the app would be free to users.

Sleep Cycle is one the top apps in terms of downloads all over the world. It claims "We are now helping more than 1 000 000 people to wake up rested!

#1 Top Paid app in Japan
#1 Top Paid app in Germany
#1 Top Paid app in France
#1 Top Paid app in Russia
#1 Top Paid app in Netherlands
#1 Top Paid app in Taiwan
#1 Top Paid app in South Korea
#1 Top Paid app in Sweden
#1 Top Paid app in Norway"

While number of downloads is not a KPI for developing a successful app (except for a paid app, that is!), it is a metric that advertisers love to use to judge where they should place ads.

How are branded drug ads within smartphone apps monitored by the FDA? What PhRMA DTC guidelines are applicable? How could this be done in countries that don't allow DTC advertising?

Those are all good questions to ponder. First of all, I'm not aware of any direct-to-consumer (DTC) drug ads running within apps. There are no PhRMA or FDA guidelines for advertising drugs on smartphones. But I can imagine that "reminder ads" would pass muster. For example, a simple ad that just mentions Lunesta with the green moth logo and link to lunesta.com would seem to be OK (in the U.S.) although I personally don't like reminder ads. Another option is to run ads that do not mention the drug at all - like this Google ad that links to lunesta.com:

I'm not sure how much Sunovion pays for this ad every time someone searches for "insomnia." It could be less than $0.99.

P.S. One fly in the ointment: I'm not completely sure that Sleep Cycle measured just MY movements during the night or the combined movements of me and my wife. If it's the latter, that would make the data useless for diagnosis by my physician.

This illustrates a major problem with health apps like this; ie, Garbage In, Garbage Out. It's similar to problems I have already noted in apps that are not vetted by being FDA-regulated or by independent testing (see "Some Unregulated Physician Smartphone Apps May Be Buggy"). I probably can make a lot of money being the "Consumer Reports" of health apps!

Pharma Social Media Religion Versus Science

My goal in attending conferences like CBI's iPharmaCONNECT, which is currently in progress in Philadelphia, is to come away with at least one new topic worthy of discussion. Thanks to yesterday's session on "What Makes a Health App Effective?" presented by Jim Dayton (@JimDayton), Snr Dir Emerging Media at Intouch Solutions, I have a topic I think worthy: Are we getting too much religion (preaching to the faithful) versus science (useful data) at these conferences?

Dayton was reviewing the story and "success" of GoMeals, the iPhone/iPad/Android app developed by Sanofi Aventis that is intended to help people with diabetes count their calories whether at home or eating out at restaurants. I have reviewed this program in a previous post (read "The iPad as a Pharma Marketing Platform").

One piece of data that Dayton presented was the fact that the GoMeals app has been downloaded about 415,000 times since it was launched in November 2009. Of course, it is widely known that nearly 85% of the people who download apps use them maybe once or twice and then never use them again. I did that with GoMeals. I stopped using it when my favorite local restaurants were not included in the database.

Also, like me, maybe many people downloaded the GoMeals app to multiple devices (eg, iPhones and iPads).

Thus, the number of downloads of an app is NOT a useful KPI (Key Performance Indicator), IMHO.

Dayton did mention that GoMeals enjoyed an abandon rate slightly less than the 80-85% average I mentioned above. But he couldn't (or wouldn't) give the audience any hard data regarding that or practically anything else that might be considered a true KPI.

Dayton, of course, is limited in what he can reveal about his client's product. It's obvious, however, that Sanofi considers GoMeals a success because it has continued to update the program and supports it with a web site and a twitter account. All of this requires a certain commitment of resources. But is this commitment justified by relevant data or just because the faithful believe in the program? Do you justify money spent by science or by religion?

Sanofi obviously collects useful data from GoMeals users. For example, the application includes a survey that asks questions such as:

  1. Do you or anyone in your household who uses GoMeals have diabetes?
  2. How often do you use GoMeals?
Answers to these critical questions would provide some true KPIs. Unfortunately, we don't know what the answers are unless Sanofi chooses to reveal them.

That lead me to ask an unusual question during the panel session yesterday; namely, why doesn't Sanofi reveal these data? The only answer I got was that GoMeals was considered an important part of the marketing plan and therefore that information was proprietary.

I understand that there is a lot of competition among pharma companies in the Type 2 diabetes arena and a lot of this has to do with diets, meals, and menus rather than the benefits of the drugs being marketed (see "Three Companies Compete for Diabetes Market Share Using Recipes Rather Than Product Efficacy"). If competing on helping diabetics with meal planning is the most important part of your marketing plan, then sure, you got to keep this stuff secret.

But how important are mobile apps in pharma's integrated marketing approach? It's got to be a very small part of the pie in terms of resources. If Sanofi revealed what percent of the GoMeals users actually had diabetes, would that be giving too much away?

Why should pharma companies reveal more hard data that can prove (or disprove) the effectiveness of social media and mobile apps? If the SM and mobile evangelists want to convince us that pharma should be doing more in this area, they need to give us some hard data in support of that. If they hide these data and just report "soft," meaningless numbers, I think they are preaching, not teaching.

Will Drug Samples Soon Be a Thing of the Past?

We all know that the number of pharmaceutical sales representatives have declined significantly since the high point in 2007 when approximately 105,000 members of this species were alive and well in the U.S.

Sales rep visits that included samples have dropped even faster. According to Cegedim Strategic Data (SD), the number of detailer visits that included samples has decreased 35% from 116 million in 2007 to 76 million in 2011 (see " Spending on Drug Samples Continues to Decline").

There are lots of reasons why sales rep visits that include drug samples is declining. For one thing, many physicians are refusing samples because they think they promote more expensive treatments. However, it's more likely due to cutbacks to the sales force. "If we're seeing a decline in samples at this point, today one of the major drivers is the drop in the overall number of sales calls being delivered," Jerry Maynor, director of marketing and business development for CSD's U.S. division. eSampling, where physicians can order samples without the sales rep, is a very minor activity that does not account for the trend (only 5% of doctors want to receive samples by mail only).

What percent of total details include samples? That gets complicated because numbers are all over the place. In 2008, there were 92.93 million details according to data reported here. But CSD says 106 million details in 2008 included samples. Of course, that's a mathematical impossibility. I will have to track down more compatible numbers.

How much do drug companies spend on samples? That's a number in dispute, depending on how you calculate the value of samples (ie, retail value of samples vs. Average Wholesale Price; see here). By CSD's estimate, in 2007, drugmakers spent nearly $8.4 billion on samples. That figure fell to about $6.3 billion in 2011, the most recent data available.

Should Pharma Ponder Pinterest? Novo Nordisk Is!

This is an image from the Pinterest Social Media Board of my friend Jay Byrant:

Looks like he "pinned" that image from a CNNMoney Technology Blog post (here), which asks "Is Pinterest the next Facebook?"

I don't know if Pinterest is the next Facebook or not, but if it is, Pharma marketers are likely to stay away from it at least until they figure out how it works.

While pharma ponders Pinterest, others are using pharmaceutical company names as their Pinterest usernames and URLs. D┼żesika Fizor, for example, staked a claim to http://pinterest.com/Pfizer/. Fizor's boards include "juicing," "homie," "belly goodness," and "things i like that are clothes."

Boards are categories into which users of Pinterest arrange pictures that they upload from their computers or steal, er, I mean PIN from other sites or from other Pinterest users ("repinning").

Here are some other "pharma" Pinterest usernames that have been claimed:
These Pinterest pages are still available. I suggest the brand companies hurry up and claim them:
Novo Nordisk is on Pinterest!
Meanwhile, Novo Nordisk has a legitimate Pinterest page (http://pinterest.com/NovoNordisk/)! Novo actually has 11 "pins" posted to several "boards": 4 pins in "Patients," 1 pin in "About Novo Nordisk," and 6 pins in "World Diabetes Day." Two other boards -- "Health Care Professionals" and "Careers" -- are empty.

I "repinned" the image from  the "About Novo Nordisk" board to a new board I created on my Pinterest site titled "Pins from Pharma Companies" (here). I was also able to "like" that image (pin) and post it to my Facebook wall as well:

Of course, I also attached a comment to the original pin on Novo's Pinterest site. My comment: "Nice image! I posted it to my Facebook wall."

I wonder if the Novo Nordisk Pinterest site is legitimate (seems so) and if their legal/regulatory people know about it (maybe not). I know that comments submitted to pharma Facebook pages have been the industry's Archille's heel (see "Janssen to Shut Down Psoriasis 360 FaceBook Page Due to Lack of Commitment"). I wonder if the same will be true of Pinterest?

My Pinterest page is here: http://pinterest.com/pharmaguy/

P.S. Novo Nordisk confirmed via Twitter that the Pinterest page is legitimate. But I wonder why the Facebook button on the page links to the page of someone called "Kasper Kofod" (here)?

Who is Kasper Kofod (seen on the left)? He may be a Novo Nordisk employee -- he is friended by Craig DeLarge who definitely works for Novo here in the U.S.

P.P.S. I just learned from LinkedIn that Kasper Kofod is Social Media Manager at Novo Nordisk in Denmark (see his profile here). He is @kofod on Twitter.

It's strange that Kasper would use his personal Facebook page as a link on Novo's Pinterest site.

P.P.P.S. I posted this to Twitter and heard back from Kasper who informed me that the link to his personal FB page was inadvertent. By the time you read this it will probably be fixed. Any way, it allowed me to make a new friend and get a glimpse of who is behind the social media curtain at Novo Nordisk :-)

The Definition of Insane Pharma Marketing

It may have been Einstein who defined insanity as doing the same thing over and over again and expecting different results. When I analyze a recent survey of pharmaceutical marketing executives, I believe that definition fits them to a T!

The headlines read: "Pharma execs expect to increase use of doctor-focused social media" (here), but when you dig down into the data, you discover that there's practically nothing many of these guys don't think they will spend more money on when it comes to communicating with physicians -- except, that is, print journal advertising.

The data I speak of comes from a Booz & Co survey of 156 senior industry executives from Europe and the U.S. You can find that survey attached to this post. Below is the relevant chart of the data:

First of all, 156 is not a significant N and the error here must be at least ±20 percentage points error. Thus, the 58% of execs who say pharma will increase spending on "MD-oriented Social Media" could actually be 38% (ie, less than a majority). Secondly, these data are probably skewed in favor of executives working in the EU. Booz only says "All survey participants work in either the United States or one of the big five European Union countries, and they represent a diverse range of pharmaceutical companies."

Whatever! These VPs (15%), directors (52%), and managers (20%), most of whom are responsible for a product portfolio (46%) or a specific brand (33%), are an optimistic bunch. Practically speaking, except for the case of print advertising, NONE of these guys think spending will decrease in the next two years for any "communication vehicle!" This despite the belief of many of them (43%) that the sales-force time for their products will decrease.

Obviously, to believe otherwise is to question your existence on this planet!

Strangely, however, 68% of the execs agree or strongly agree that "the current commercial pharmaceutical model is broken and needs significant repair." And practically 0% believe the model is NOT broken!

Isn't part of that model exactly what they say will see increased spending in the next two years? I mean, most of the "channels" in the chart above are part of the current "model," no? There's nothing new there.

In other words, these guys think the model is broken, but they are going to spend more on the model in the next two years! That's the definition of insane pharma marketing!

Janssen to Shut Down Psoriasis 360 FaceBook Page Due to Lack of Commitment

Janssen Pharmaceuticals has announced it will shut down its Psoriasis 360 Facebook page, which was first launched in October, 2010. At the time, I praised this Facebook page as the "first [pharma FB site] to publish ALL comments BEFORE they are reviewed" (see "Markets as Conversations: Can You Have a Discussion with 'Psoriasis 360' on Facebook?").

Janssen cited its inability to moderate posts made to the Psoriasis 360  wall, one-third of which "mention[ed] a specific drug by name, or talk[ed] about the efficacy of a particular treatment is (or its side effects)." In such cases, Janssen had to ask for the post to be removed or to "pull" it, which I guess was too much work for them to handle after Alex Butler, former Janssen Digital Strategy and Social Media Manager, left the company. Alex was the person responsible for Psoriasis 360. For his efforts, I awarded him (not Janssen) the first ever Pharmaguy Social Media Pioneer award (see "First Pharmaguy Social Media Pioneer Award Given to Janssen's Alex Butler").

In a statement published on the Psoriasis 360 FB wall, the "Psoriasis 360 team" said "we have found ourselves removing a larger and larger proportion of posts, stifling worthwhile discussions." According a PMLiVE article, Janssen said that "within the last three months alone a third of all posts to the page had to be removed, the majority because they mentioned prescription-only medicines, but a 'significant minority' were disallowed because they included offensive language" (see here).

If one-third of the comments had to be removed or blocked, that means that two-thirds of the comments were NOT blocked. The total number of such comments I find on the Psoriasis 360 site is about 379, including 95 comments submitted by the "Psoriasis 360 team" itself. There were also several comments made by associates of Psoriasis 360 such as from "www.psoriasis360.com." That leaves 284 comments, which represents about 2/3 of the total comments Janssen had to review over the course of 18 months. Doing the math, I estimate that Janssen reviewed about 423 comments during that time for an average of 24 comments per month or less than 1 per day!

Holy cow! What a burden to bear!

What really happened was that when the social media pioneer Alex Butler left Janssen late last year, no one was left to manage the site and Janssen obviously did not feel it was worth it to devote 0.125 FTE (ie, one hour per day) to do the job or to outsource the moderation of comments.

It's obvious that Facebook did not offer Janssen a good return on investment however they may have defined that. There is still a psoriasis 360 YouTube site, which is NOT required to allow comments.

What I don't like about this is not the lack of commitment to social media conversation on Janssen's part, but using regulations as an excuse for its lack of commitment. Reviewing one comment a day is NOT a regulatory hurdle difficult to overcome. Even on sites that are not regulated -- such as this blog -- weeding out unsavory, "offensive," or spammy comments is a fact of social media life that has to be dealt with. Love it or leave it. Janssen has chosen to leave it.

Bean Counters Stifle Pharma Market Research

The drug industry is laying off people left [brain] (research) and right [brain] (marketing and sales). Market research (MR) -- definitely a left brain activity -- is currently experiencing a downsizing that will have "implications for those in the trenches," according to Marc Iskowitz, writing in Medical Marketing & Media (see "State of Market Research: Analyze This"). Iskowitz summarized results of the Pharmaceutical Marketing Research Group (PMRG) Second Annual State of the Industry (SOI) Survey, conducted in collaboration with TGaS Advisors. Full survey results will be available at PMRG's Annual National Conference.

Here's some trend data from the survey that documents the downsizing:

"The reasons behind the downsizing are well known to anyone who follows the pharma industry," notes MM&M. "Brands are maturing and thus requiring less overall analytical support."

The workload of the MR staff, however, has increased according to Todd Francis, VP and head of commercial support and enterprise marketing for Sanofi US. Francis was quoted as saying "With reduced [research] headcount, [and] the same number of marketers asking the same amount of questions, you become less able to think about what you need to be doing next and more focused on the questions that are being asked."

But, who exactly is doing this work? Outside vendors are relied upon more and more to do market research. According to Karen Tibbals, former Director Market Research at Schering (Merck), this is stifling innovation in marketing research primarily because of the industry's preferred vendor system (see "Pharma needs truth tellers, not preferred vendors"). Tibbals now is a Self-employed Consultant, Trainer, Speaker and a Masters of Divinity Student at Earlham School of Religion (see her LinkedIn profile).

Tibbals also writes a soul-searching blog focused on the state of pharma marketing research "because I am concerned about the direction of the field. There have been changes taking place due partly to global economic trends. While I understand the forces behind the trends, I want market researchers to start to think about how they respond to the trends and not just react. I see danger in pure reaction, danger for the future of the market research field."

"With Finance and its henchmen in Purchasing and HR running pharma's operations, intangibles such as insight, veracity and innovation are low priorities when it comes to selecting suppliers," wrote Daniel Hoffman, the author of the Philly.com story cited above. "Finance and its minions claim that such qualities, in fact, don't really exist because they are not easily quantifiable or amenable to spreadsheet analysis. Absent such characteristics, marketing research becomes a commodity service that the pharmas can retain on a lowest cost basis. Some companies even go so far as to make supplier candidates compete for retainers by means of negative auctions -- lowest bidder wins. Since it works for hog bellies and soybeans, why not use it for marketing research?"

"Automation and outsourcing are giving us faster and/or cheaper, but not better," says Tibbals (see here). "Better has to come from people who are interacting, and thinking. In the effort to cut costs, care has to be taken that what is cut doesn’t affect the ability to improve, to provide more value and to serve as a competitive advantage for the corporations that pay the salaries."

[Note: PMRG is a Pharma Marketing Network (PMN) advertiser. PMN helps promote PMRG's Annual Conference. I am not paid to write blog posts such as this one by PMRG or any other advertising partner.]

China Enjoys a Burst of Pharma Marketing Spending While U.S. & Japan See a Decrease

Cegedim Strategic Data (CSD) reports a decline of 3.4% in worldwide audited pharmaceutical marketing investments for 2011 (see "Pharma Marketing Global Spend Dipped 3.4% in 2011"). In China, however, pharma spending on sales rep detailing physicians increased by 23% in 2011 compared to 2010. That activity represents about 81% of the total pharma marketing spend in China compared to 60% globally.

"This is typical of emerging markets," noted Christopher Wooden Vice President for CSD Global Promotion Audits.

Another type of marketing spend that is "typical" for emerging markets is meetings where physicians are invited to listen to key opinion leaders or specific promotions. In China, meeting spending was up 43% in 2011 vs. 2010. That represents 17% of the total marketing spend in China. Sampling, on the other hand, represents only 1% of the marketing spend, whereas in in the U.S. 21% of pharma's marketing spend is on samples. Note that CSD costs samples according to Average Wholesaler Cost rather than retail value.

Japan, on the other hand, saw a "surge" in pharma marketing spend in 2010 over 2009, but there was a "pull back" in 2011 with a 12.5% drop overall. Detailing was down 12% and spending on meetings, which accounts for almost 30% of the marketing mix, was down 11% to $7.4 Bn.

Using my math, that means that total pharma marketing spend in Japan in 2011 was about $24.7 Bn (7.4/.3) compared to $29.2 Bn in the US.

In the U.S., pharma marketing spend was down by about 4% overall, with detailing dipping 6% in 2011 compared to 2010 (see "2011 U.S. Pharma Company Promotion Spending" and chart below).

Pfizer "Clinical Trial in a Box" Failure: The Dead Rat Comes Home to Roost

After Years of Telling Consumers Not to Trust the Internet, Pfizer Discovers that It Cannot Convince Patients to Participate in Internet-based Clinical Trials. Duh!

As reported on Pharmalot (here): "Last year, Pfizer announced plans to run the first clinical trial to allow patients to participate from home by using computers and smartphones instead of going to a clinic or doctor’s office. The idea was to create a model for saving money that will rely on personal technology to more easily recruit patients and monitor their progress. Known as a ‘clinical trial in a box,’ the study is testing the Detrol overactive bladder drug in 10 states and gained an FDA blessing. However, Pfizer ran into some snags winning over patients."

Craig Lipset, Head of Clinical Innovation at Pfizer, explained it this way: "I think some of the staunch advocates for using online and social media for recruitment are still reticent to claim silver bullet status and not use conventional channels in parallel. In terms of health literacy, the patient population is largely unaware of clinical trials and participation. You’re going in at a level where there’s still a lot of basic learning needed for individuals to make informed decisions about whether to participate. And doing that without an interaction with a healthcare provider is a challenge."

I wouldn't say there's a lack of "health literacy" regarding decisions to participate, but more lack of credible information and TRUST, which is what Lipset is talking about in the last two sentences quoted above.

As Lipset admits later on in the interview with Pharmalot:

"In a world where we’ve been telling people not to trust (web) sites online and then to ask them to do everything online is still a challenge. A very important takeaway is that online is great, but make sure these folks know they’re not alone and have a sense of contact that they need… The twist here was to go from awareness to randomized participant entirely online, and this is where ensuring some human contact as well as an optimized online process have proven extremely important."

Is this a case of the "dead rat" coming home to roost? See "Was a Rat Harmed in the Filming of This Pfizer Commercial?"

A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which 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." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

Before I get to the "loophole," here's a summary of the guidance.

Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.

Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:
  • Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug 
  • Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act) 
  • Category 3: All TV ads for Schedule II controlled substances 
  • Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling 
  • Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter  
  • Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision
"Specifically, these categories allow the Agency to review and provide comments on TV ads for prescription drugs with particularly serious risks," says the FDA

Regarding the 45-Day Review Period, FDA says:

"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."

That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.

What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.

"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review."
After writing this, I had short Twitter conversation with Alexander Gaffney (@AlecGaffney), health wonk and writer of news for @RAPSorg & Regulatory Focus. Regarding FDA's requirement to review videos and not just storyboards, Alec said the guidance would likely cuts down on "poor marketing" spending, which I interpreted to mean "pushing the envelope" spending. In the past, pharma marketers could submit a storyboard (cheap) and run the ad without waiting for comments from the FDA. The ad could push the regulatory envelope and run its course on TV before the FDA could issue a warning letter. I commented on this previously. Read "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"
The "Loophole"
FDA does not define what exactly it means by "dissemination." Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for "pre-dissemination" review. The video can then be embedded in the drug.com website or promoted via Twitter.

The bright line between TV and online video is getting more blurry every day. I currently am able to watch Youtube videos on my TV via Apple TV. Of course, it is not the same as regular TV ads that I can skip over thanks to my new cable box that allows me to record programs and play them back later. And I may be the only person that would actively search out drug TV ads published on YouTube!

Would a pharma company want to do this? Maybe, if it does not violate the "letter" of the law; ie, is not classified as "dissemination." That would let the company off the hook for violating the law, but FDA could still cite the YouTube version as violative (ie, as it does right now). A violative YouTube version of the video could result in an FDA warning letter, which probably would be issued months after the ad was first uploaded.

Just my thoughts and a comment that I think the FDA should consider when developing its FINAL guidance.

Up Yours, Rush Limbaugh, Say Women Lawmakers!

In Virginia, state Senator Janet Howell reacted to a bill that requires women to get an ultrasound before an abortion with an amendment requiring doctors to perform a rectal exam and stress test before prescribing impotence pills.

I'm pretty sure Rush Limbaugh would not like to have a rectal exam every time he went in to refill his Viagra prescription!

Peter O’Toole, a Pfizer spokesman, said by phone that the company doesn’t comment on specific legislation.

HT: Pharmalot ("Want Viagra? See A Sex Therapist And Notary First!")

Also see "Women Lawmakers Turn the Tables on Men Who Take Viagra".

Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?

"Coupons for drug co-payments are illegal and drive up long-term health-care costs for all, a consumer group and four trade-union health-insurance plans said Wednesday in announcing lawsuits against eight pharmaceutical companies," reported the Philadelphia Inquirer (see "Trade union health plans sue 8 pharma companies over drug coupons").

The eight drug companies being sued are:
  1. Abbott Laboratories
  2. Amgen
  3. AstraZeneca
  4. Bristol-Myers Squibb 
  5. GlaxoSmithKline
  6. Merck & Co.
  7. Novartis
  8. Pfizer
The lawsuits claim that although coupons reduce the consumer’s out-of-pocket cost, the health insurer still pays the previously negotiated price to the drug company. "With no savings from generics, health plans will need to charge patients more to keep up with rising costs, the lawsuits say."

That was precisely my criticism of Pfizer's attempt to compete with generic versions of Lipitor by offering consumers coupons that lowered the co-pay to $4:
"Most patients taking Lipitor won't even know what's going on except that their out-of-pocket co-pay will be decreased," I said. "But as more patients pay a portion of their employer-sponsored healthcare coverage, they should be concerned that employers may pass along the added expense (to them) to their employees. And even though the Pfizer-PBM deal will end in six months and Lipitor co-pays will rise back up, it would still hurt employers who will remember the shakedown when they adjust their employee benefit plans!" (see "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE").
In a comment submitted to the Inquirer, Wells Wilkinson, JD., Director, Prescription Access Litigation Project, said:
"If a drug is a patient’s only option, and it has no real alternative, then we applaud when companies like Pfizer help patient in need afford their medications.

"But copay coupons are not aimed at patients in need, they are marketing tools that target people with insurance. Distributed for drug companies by doctors and pharmacists alike, they can be coupled with tv ads that promote an expensive drug. For instance, Lipitor is competing with other statins that cost one-fifth to one tenth as much. In fact some statins (like lovastatin, pravastatin) are so inexpensive you can get them for $4 without any insurance at all. Does it help the consumer in the long run to trick them into using a coupon, and passing on $120 in costs to their health plan, when they could buy a low-cost statin that is just as effective for $4 with no cost to their employer or health plan?

"Consumers need to see that there are real costs to using coupons – costs that drive up their premiums and their employers costs for health care. Forgoing copay coupons and using lower cost drug also helps save funds that they may need later, or that their coworkers need for the really expensive drugs with no alternatives.

As more and more drugs lose their patent protection and become available at competitive prices, consumers should use these first, and take advantage of market competition to keep our health care costs down."
It should be noted that federal Medicare and Medicaid programs prohibit the use of coupons because they can hurt the programs, which have to pay for higher-cost drugs that the coupons promote.

Pfizer had nothing to say except "While many health plans have raised their co-pays and/or are encouraging switching to generic medications to achieve cost-savings, these treatments may not be appropriate for all patients."

The drug industry continues to claim that generics are "different" than brand name drugs and therefore "may not be appropriate for all patients." It's also an argument the industry makes against "biosimilars" or follow-on biologics. What do you think?

Are generic versions of non-biologic drugs such as Lipitor appropriate for patients who were previously prescribed the brand name drug?
Yes, always
Yes, in most cases
No, never
I have no idea


Charlie Kimball - Novo's Branded Spokesperson - Makes Expensive TV DTC Debut

Charlie Kimball, the Indy racecar driver spokesperson for Novo Nordisk's NovoLog Flexpen, which is used to treat Type 1 diabetes, made his debut as star of his first direct-to-consumer (DTC) TV ad. Not only does the ad feature Novo's product, it also promotes Kimball's Indy team Chip Ganassi Racing. A win-win!

I saw the commercial on the CBS evening News last night. Kimball did a great job.

I couldn't find a version of the commercial on the Internet, but I DID find a video titled "Charlie Kimball and Novo Nordisk" in which Kimball discusses how the commercial was made. One thing that the video demonstrates is why pharma spends so much money on broadcast (ie, TV) DTC. It's not just the loads of money spent on buying airtime on the major networks. It is also the cost of producing the commercial itself. This is what Kimball discusses in the video (embedded below).

Kimball is amazed by all the people involved such as director, assistant director, key grip, not to mention the production crew's four trucks, two motor homes, and catering trailer. All together, 50 people were involved said Kimball.

In the past, Kimball had only been tweeting (see, for example, "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!" - the #3 Google search result for "sleazy tweet"!) and making personal appearances, which is more of a PR effort than a marketing effort. My guess is that PR costs much less than marketing and employs fewer people compared to marketing's BIG item productions such as TV ads.

So, thank you Charlie and Novo Nordisk for helping America solve it's unemployment problem!

The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors

Authorities investigating the importation of low-cost foreign pharmaceuticals into the U.S. have identified a supply chain that may have allowed fake cancer drugs to reach U.S. clinics, according to investigators and documents reviewed by The Wall Street Journal (see "Doctors, Drug Distributors Tied to Imports of Fake Avastin").
"In the case of the fake Avastin, its global route isn't yet clear, but what is known illustrates the circuitous path that pharmaceuticals can take before reaching consumers. Wherever the counterfeit Avastin was manufactured—possibly China—investigators are examining a zigzagging route that may have taken the product through Turkey and Egypt before it was sold to Swiss and Danish wholesalers and then to Mr. Haughton's U.K. wholesaler, River East Supplies Ltd., according to pharmaceutical-industry and law-enforcement officials. River East then shipped the product to U.S. doctors through a Tennessee distributor, according to Mr. Haughton."
It is illegal to import drugs that are approved by regulators in other countries, but not the FDA. It is also illegal for US citizens to knowingly or unknowingly purchase such drugs. This includes the doctors and clinics at the end of the chain who purchased the Avastin at below market prices ($1995 vs $2400 for a 400-milligram vial).
"Buying foreign-sourced drugs that don't meet FDA approval can carry criminal penalties for doctors who purchase them and then bill Medicare. Penalties can apply even to doctors who weren't aware the drugs were foreign."
It is even MORE illegal -- ie, immoral -- to purchase FAKE, counterfeit drugs such as the Avastin in question, which contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche.

Here's my view of the Fake Avastin Supply Chain (sorry, but I couldn't fit all the complicit distributors in the image; eg, I left out Switzerland):

WHOOPS! I forgot the last element of the supply chain, the VICTIM, aka PATIENT!

Bad News for Potent Cholesterol Drug Users, but Not Me!

Two pieces of bad news for people who take "potent" anti-cholesterol statin drugs came into my email in-box today.

The first was about yesterday's New York Times OpEd piece published by a well-known cardiologist who said Americans are being "over-dosed" with statins to treat high cholesterol (see "We're overdosing on cholesterol-lowering statins says Top(ol) cardiologist").
"It is only with the more potent statins -- Zocor (now known as simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) -- particularly at higher doses, that the risk of diabetes shows up," said Dr. Topol. "The cause and effect was unequivocal because the multiple large trials of the more potent statins had a consistent excess of diabetes."
Coincidentally, I also received news that the FDA refused to approve Merck's experimental anti-cholesterol drug "MK-0653C" - an combination of generic Lipitor and Zetia (see "FDA Nixes Merck's New Combo Cholesterol Drug").

Merck hoped that the new drug would be better received than Vytorin, which combines a less-powerful statin produced by Merck (Mevacor - also off patent) with Zetia. Vytorin has been dead in the water since 2008, when studies showed that it worked no better than generic Mevacor alone to reduce plaques in arteries (see "Should I Stop Taking Zetia?").

I'm taking all this bad news personally since most of these drugs were recommended to me by my physicians over the past several years.

I've already documented how my GP wanted to switch me from Pravachol -- a weaker statin -- to Crestor and then she recommended I switch to Lipitor when it was about to go off-patent (see "Crestor Grapples to Compete with Lipitor: #Fail!"). Before that, my cardiologist recommended Zetia.

But I have refused to succumb to the "new is better" argument that these physicians were making. I was never impressed by Zetia and thought it was too much trouble to take two pills. Merck has been trying hard to combine Zetia with a generic statin to overcome precisely that adherence problem and to boost Rx sales of Zetia, which is not very effective on its own.

Too bad for Merck. It hasn't had much luck making a purse out of a sow's ear!

Meanwhile, my resistance to taking a stronger statin such as Crestor seems to have been the right decision for me because there is more diabetes in my immediate family than heart disease.

It seems these days that taking advice from a physician is like taking advice from a stock broker -- you can win or lose following their advice, but they win no matter what!

J&J Lowers Its Reputation Expectations

I recently received this simple tweet from @JNJComm (Johnson and Johnson's official corporate Twitter account):

#JNJ is pleased to rank 12th among @FortuneMagazine’s most admired companies! > cnnmon.ie/xM27z8

Hmmm... JNJ might be pleased that #12 is better than #17, which is where the company stood in last year's most "admired" list of companies.

However, when you look at JNJ's standing within the pharmaceutical industry, you see a different, ie, downward, trend as shown in the chart on the left (click on it for a larger view). A similar trend is seen in the Harris QR data.

So, I don't think JNJ should lower its expectations and be "pleased" with how it is performing against its competitors who are certain to leverage this loss of reputation to their advantage.

Reminder Ads OK in EU But Not in US. Huh?

The Geneva-based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) expanded its practice code to cover all interactions with health-care professionals, medical institutions and patient organizations, including a ban on doctors from receiving payments to attend conferences (see "Big Bad Pharma, Bribery and the New EU Industry Code").

According to the above cited source (WSJ's "Corruption Currents" blog) this was a bit like closing the barn door after the cows have left:
"This comes at a time when the association’s members are trying to drum up business in developing countries, some of which have state-run health systems. Employees of such systems, including doctors and nurses, can be considered foreign officials under the U.S. Foreign Corrupt Practices Act, a 1977 law that bars bribing foreign officials for business purposes.

"To that end, the Securities and Exchange Commission and the Justice Department are in the midst of a sweep of the industry. In April 2011, Johnson & Johnson agreed to pay $70 million to resolve violations, and The Wall Street Journal reported in November 2011 that Pfizer Inc. will pay more than $60 million when its settlement gets finalized.

"Both companies, the Journal reported, ratted on their competitors.

"Those competitors included AstraZeneca, Merck & Co., Bristol-Myers Squibb Co., GlaxoSmithKline PLC and others that have disclosed investigations for possible FCPA breaches. Eli Lilly & Co. was in advanced talks in April 2011 with the Justice Department, and the company said Feb. 24 in its annual results it’s at the same level with the SEC.

"Letters of inquiry to several of the companies, dating back more than a year, laid out several types of of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals."
Any way, I decided to download the new "IFPMA Code of Practice" to see if there was anything interesting or actually new (you can find it attached to the post here). The code is intended to cover "interactions with healthcare professionals, medical institutions and patient organizations, and the promotion of pharmaceutical products."

This section popped out at me:
5.2 Reminder Advertisements

A “reminder” advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. For “reminder” advertisements, “abbreviated prescribing information” referred to in Article 5.1 above may be omitted. 
The "abbreviated prescribing information" include "an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications, precautions, and side-effects."

In other words, it is perfectly OK to promote drugs to healthcare professionals and patient organizations using reminder ads that do not include safety information. Note: these ads must be print ads in professional publications because no such ads would be allowed on mass media such as TV, which reaches consumer audiences. Promotions  of Rx drugs to consumers is not allowed in the EU, reminder ads included.

The U.S. pharma industry does not have a "practice code" for advertising or "marketing" to healthcare professionals, medical institutions and patient organizations. It does, however, have "Guiding Principles" for direct-to-consumer (DTC) advertising, published by PhRMA (the U.S. industry trade association) in December, 2008. Principle 13 states "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." I.e., NO REMINDER ADS!

Of course, PhRMA's principles leave open the door for running DTC PRINT ads, although I haven't seen many of these in the consumer publications I read. The exception is BOTOX, marketed by Allergan, which has NOT signed on to PhRMA's principles (see "PhRMA Intern vs. BOTOX!").

So, why does the IFPMA Code of Practice specifically carve out an allowance for "reminder ads?" Is that a technique often used in the EU to win over the hearts and minds of healthcare professionals? I don't get it.

Google Pharmacy Phish

I received an e-mail today announcing the launch of "Google Pharmacy" that promised it will "improve the Google experience for people buying pills and using pharmaceutical interfaces." It included a nifty-looking Google logo that replaced the "oo" with two pills (Viagra and Cialis):

Of course, this is a "phishing" expedition - "a way of attempting to acquire information such as usernames, passwords, and credit card details by masquerading as a trustworthy entity in an electronic communication" (wikipedia).
  1. I haven't clicked on the link "Visit Google's Accredited Pharmacy" although I was tempted to do it because of my interest in Google's past misdeeds that involve collusion with "rogue" pharmacies (see "Google Settles with DOJ - Admits Aiding Illegal Online Drug Sales") and 

  2. Google's failed attempts to co-opt the pharmaceutical/health sector (see "Google Health is Being Shut Down").
Actually, perhaps Google should actually launch an accredited pharmacy site where people can LEGALLY purchase Rx drugs online! That might help buff up it's tarnished promise to "do no evil."