Feeds:
Posts
Comments

Archive for March, 2010

(Press Release embargoed until April 1) – ooops! Sorry….

In response to the endless backlog of work, and the constant carping of all of its constituents, FDA Chief Dr. “Big Maggie” Cheeseburg decided that the best way to clear things up was to do one massive, sweeping approval of everything on the docket and just start over.

“It’s like one of those Unification Church weddings.” said Ms Cheeseburg. “We told every staffer to just line up everything they have, and we stamped ‘Approved‘ on all of it. No muss, no fuss, no questions asked. Just call me Queen of Reset!

“The President appointed me with a charge to just ‘get it done.’ Looks like my job is done here. Can I be a Czar now?”

According to sources within the FDA, every drug that has been submitted for approval over the last 5 years is now fully approved for immediate marketing, no matter how tenuous the data. “‘Let the market decide’ is the new mantra here,” admitted one staffer who refused to be named. “Why should we go through all that paperwork hassle? If companies went to the trouble of submitting those piles of documentation for approval, then the drug must be OK. If not, we’ll all find out later.” Asked about potential patient deaths that might occur from unproven drugs, the source replied, “What? You’ve never heard of a mulligan?”

Drug manufacturers were ecstatic, especially over indications that any new drug approval applications submitted over the next 45 days would also be rubber-stamped as part of the Clear the Docket! holiday. Submissions included DarKissitor heart treatment from Hershey Pharmaceuticals, Cephalon’s ReVigil for nodding off during Cubs games, and GSK’s inhalable lung treatment Oxygenulate as add-on therapy with Advair Diskus.

Another inside source indicated to blogger/model Fabio that as of April 1st, all restrictions on social media marketing would be lifted. “The FDA will give no further guidance regarding on-line marketing because we just don’t care anymore. Say what you want. Talk among yourselves and leave us alone, for crying out loud. What are we, hallway monitors??”

It was reported that a Facebook Fan page for Wyeth immediately appeared, with a list of all their drugs by name, accompanied by a single-choice “Dislike” button. Comments were posted from on-line friends and fans such as Vladmir Putin, Sandy Cheeks, and the male model Fabio. It was later determined that the page was put up by an employee of another leading pharmaceutical manufacturer, who had forgotten that they had recently acquired Wyeth. The same rogue employee deneighed launching a Premarin the Mare Twitter account.

Belatedly, the FDA also voted unanimously to approve President Obama’s health overhaul, in exchange for another $100 billion of discretionary spending and weekend rides on Air Force One for staffers and their families.

————-

Prior Impactiviti spoofs

Connect with Steve Woodruff

Read Full Post »

I realized yesterday that for those who subscribe to the Impactiviti blog via e-mail, the delivery wasn’t occurring until that day after. A friend showed me how to fix that setting in Feedburner – so the Impactiviti Daily News should be arriving hot and fresh with your morning coffee. If you’re not already subscribed via e-mail, you can do that right here.

*****

TODAY’S NEWS

Jupiter, Crestor, and costs. Hmmmm…. And while we’re on Crestor, the TriLipix combo (Certriad) gets a stall from FDA.

The DNA/Patent dispute gets Funky.

Well, that’s a creepy reversal – drug firm investigates FDA.

RECOMMENDED

Social Media “Listening” Strategies – Impactiviti partners with top providers of social media services for pharma – including “listening” strategy/services, and community design and moderation. Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

The latest Impactiviti Connection e-newsletter is up! You can subscribe here.

PLUS

From the thoughtful Sally Church: Listening to Patients about Compliance.

JUST FOR FUN

30 Examples of perfectly timed action photography.

———-

Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

Visit the Impactiviti Job Board

Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

*****

Read Full Post »

*****

TODAY’S NEWS

Patenting genes called into question. Frankly, this is a legal/medical/sociological discussion that needs to happen.

Cephalon‘s jet lag indication on Nuvigil may be stuck on the runway for a while.

When companies – and agencies – can’t count. An expensively amusing tale.

The Top 20 Drugmakers, listed.

Another experimental cancer drug hits the wall. That’s two in two days. Bummer.

RECOMMENDED

POA/Sales Meeting Training – If you are responsible for training during periodic “live” meetings, let’s discuss the programs you’re looking for. The Impactiviti partner network can undoubtedly help.  Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

The latest Impactiviti Connection e-newsletter is up! You can subscribe here.

PLUS

Huw Tippett, head of global sales for Novartis, explains his firm’s new focus on creating customer value and unlocking value from key accounts – Why Pharma Needs a New Commercial Model.

JUST FOR FUN

What’s really inside your computer? Intel….or her?
EVENT - Coming up May 11 – BDI’s Social Communications and Healthcare Case Studies and Roundtables. I’ll be attending/facilitating. Use discount code IMPACT for $155 reg. rate: http://ow.ly/1sAT8

———-

Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

Visit the Impactiviti Job Board

Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

*****

Read Full Post »

*****

TODAY’S NEWS

Antisoma/Novartis experimental drug hits the proverbial wall on Phase III lung cancer trial. Study halted.

New test may predict which MS patients will most benefit from beta interferons. This is actually a big deal – Researchers at Stanford University analyzed mice with an induced disorder similar to MS and blood samples saved from humans with the disease. They found two different subtypes of disease, each driven by excess activity of a different set of infection-fighting immune cells. Only the patients with one sub- type responded to the MS drugs known as beta interferonsmore

Credibility, disclosure, Sanofi, Multaq, paid consultants. At the very least, not a real good “sniff test” here.

Speaking of disclosure, let me mention how we handle reporting pharma news, and making commentary at Impactiviti. Essentially, I call it like I see it – the good, the bad, and the ugly. Many of the companies mentioned in this blog are clients of Impactiviti. I am quick to highlight what is praiseworthy, and I don’t hesitate to call out deficiencies – whether a company happens to be a client or not. It is my hope to live, consult, and report with integrity, and my clients know to expect impartial writing and commentary here.

RECOMMENDED

Negotiations Training – Impactiviti’s vendor/partners have just what you need to help your account managers (and others) become more skilled negotiators.  Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

The latest Impactiviti Connection e-newsletter is up! You can subscribe here.

PLUS

Do pictures of insects covered with dew sound a bit gross. Trust me – these stunning photos are anything but!

JUST FOR FUN

Worth a visit if you’re ever in Eastern Connecticut – the Jonathan Edwards Winery. Especially be sure to try the local Cabernet Franc…

———-

Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

Visit the Impactiviti Job Board

Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

*****

Read Full Post »

*****

TODAY’S NEWS

Little Pricey Pill: A BusinessWeek slam on the Nexium approach to me-too drug marketing.

Pfizer and the Neurontin marketing fraud: $142M please.

Head-to-head MS drug effectiveness studies coming. This should be interesting.

RECOMMENDED

Video storytelling – Impactiviti’s vendor/partners have just what you need for directing and producing corporate videos.  Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

The latest Impactiviti Connection e-newsletter is up! You can subscribe here.

PLUS

But Are We Communicating? My rant on pharma communications, regulations, and social media.

JUST FOR FUN

Top 100 April Fools Pranks. ‘Cause it’s about that time…

———-

Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

Visit the Impactiviti Job Board

Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

*****

Read Full Post »

As someone deeply immersed in pharma communications, and especially the newer realm of social networking, I’ve been closely following the ongoing process of the industry/FDA dance, trying to figure out how social media/web 2.0 approaches “fit” with pharmaceutical manufacturers and their various audiences.

And I keep wondering if we’re going about the whole thing the wrong way.

Think about the fine print PI (Product Information) you see in a magazine, accompanying a prescription drug ad. How many people do you think really READ that? And, of that miniscule number, how many actually UNDERSTAND it?

This is not “communication.” It is “exposure of comprehensive required information.”

Now stop and think. If the joint goal of patients, doctors, regulators, and manufacturers is the right treatment given to the right patient at the right time for the right reason (shouldn’t that be the ultimate goal for all involved?), then what we need is more than mere CYA disclosure. We need communication, designed properly for each audience, and digestible in ways that reflect how we (in fact) genuinely communicate.

I’m in the process of selling and buying a house. And, roughly, there’s a 3-fold communication/thought process:

    1. Basic, initial go-or-no-go information that helps me figure out whether something might be for me (e.g., a 2-bedroom split-level with a flooding basement on a 0.2 acre lot near a highway is not of interest).
    2. A deeper layer of information that will let me whittle down further what matters, based on key points (e.g., a house visit with the realtor to really explore the place after all basic stuff has narrowed things down).
    3. All the inspection and contractual details that must be waded through (comprehensive disclosure) once we have a pretty good idea of direction (e.g., call the lawyers and examine the paperwork).

We don’t start with #3. But much of what passes for pharma communications is so hog-tied by regulatory pressure on the comprehensive disclosure front, that the cart is effectively placed before the horse – if the horse is even allowed to show up. Effective communication is severely hampered.

If we’ve done full disclosure, such that the FDA isn’t dropping big fines, yet we’re really not communicating effectively with about the right treatment for the right patient at the right time for the right reason, then I have to conclude that we’ve all failed. And that’s what I fear will happen with the proposed FDA guidance on social media in pharma – we’ll all be so tied up with the disclosure minefield that no one is paying attention to the real point – what does it mean to effectively communicate on every level about prescription drugs and health?

There are basic principles of instructional design and “layered” multi-channel communication that seem to me far more vital than an endless “cover your backside” fear-based pursuit of comprehensive disclosure. I’d far rather see time and creativity invested in designing a prescription drug product information portal with layers of information (digestible for all audiences), multimedia education, and controlled interactivity than figuring out how we’re going to stuff a full PI into a coffee mug, a magazine insert, a TV ad, or a tweet. Can’t we take advantage of all this linked and multi-channel approaches to communicate more effectively and completely, rather than less so?

Social media provides wonderful new ways to establish information-sharing and build bridges with stakeholders across the entire healthcare chain, from drug manufacturers all the way through to patients. But if we look at it through all the old lenses, I suspect we’ll end up with the same old communication constipation that we have now. That would be a shame.

End of rant. Your ideas and feedback welcome in the comments.

——

Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

Visit the Impactiviti Job Board

Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

Read Full Post »

*****

TODAY’S NEWS

What about those bone fracture risks with biophosphonate drugs? The jury is still out – A new study gives reassuring news about the safety of Fosamax and Reclast, bone-building drugs taken by millions of American women. It found that long-term use does not significantly raise the risk of a rare type of fracture near the hipmore

Monthly hepatitis C treatment looking promising – Human Genome Sciences Inc. said Wednesday a midstage study of the potential hepatitis C treatment Zalbin showed a monthly dose of the drug candidate could be as effective as a weekly dose of the standard treatment. The Rockville, Md., company said interim results from the study support evaluation of the monthly dose in a bigger, late-stage trial. The midstage study was conducted by Novartis, which is developing the drug with Human Genome Sciences. It combined the drug with ribavirin in 391 patients with forms of chronic hepatitis Cmore

Massive Multaq Mess Might Mean Major Meltdown – The scale of Sanofi-Aventis (SNY)’s Multaq mess is starting to become apparent: The heart drug, hailed by the company as a €1 billion-plus blockbuster prior to its launch, may miss Wall Street sales estimates by as much as €1.3 billion, according to analysts at Jefferies International. When investors wake up and downgrade their expectations for the atrial fibrillation drug, Sanofi’s stock may suffer, they say…more

Genzyme - feeling fines.

RECOMMENDED

Employee Assessment – including Executive Management assessment – Impactiviti’s vendor/partners have just what you need for top assessment programs and services.  Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

PLUS

Another reason to like Gilead Sciences (besides the fact that they have the best logo in the industry) – they actually have a rational pay plan for their top executive. What would it look like if pharma upper executive pay were based on annual performance for these measures: Profitability ratio (earnings vs. # of employees – something Gilead excels at, by the way); company share increase over a 3-year running average; and regulatory compliance? We might then see real pay-for-performance!

JUST FOR FUN

———-

Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

Visit the Impactiviti Job Board

Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

*****

Read Full Post »

Older Posts »

Follow

Get every new post delivered to your Inbox.

Join 27 other followers