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Archive for February, 2010

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TODAY’S NEWS

If Shire were in Olympics, they’d now be on the speed skating short track – Shire has been boosted by the news that regulators in the USA will give a quicker review to the firm’s Fabry disease drug Replagal. The company has received fast-track designation from the US Food and Drug Admininstration for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. The drug has also been available under an early access programme in the USA since December following the temporary shutdown of a Genzyme manufacturing plant which caused the shortage of the latter’s Fabrazyme (agalsidase beta)more

Pfizer gets the FDA go-ahead for updated vaccine – Pfizer said Wednesday the Food and Drug Administration has approved an updated version of its best-selling infection vaccine for infants and children. Prevnar 13 is intended to reduce the risk of infection by 13 strains of pneumococcal disease in children 5 years old and younger. The disease causes ear infections, meningitis and pneumoniamore However, no standing ovation for experimental osteoporosis drug.

Scorecarding which drugs caused the most adverse events. I’m guessing Too Many Donuts trumps all of them combined…

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PLUS

The Pharma and Healthcare Wiki – one year old and full of value! My friend and co-conspirator Jon Richman launched this very valuable (and quite comprehensive) collection of social media resources and examples a year ago, taking off on my initial SocialRx page and making a great resource for the industry. Need to know what’s going on in eMarketing/eHealth/Social Media? Go there!

JUST FOR FUN

The world’s 18 strangest airports. I’ll say this for my home airport, Newark – you do get to see some awfully strange sights while shuffling for hours in the security lines…

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Pharmaceutical company Novartis has been experimenting with social media technologies, which is something I am entirely pleased about – every company in this industry that makes SocMed efforts should be applauded for doing so, even if some early applications are limited, tentative, and less than fully “social.” Pharma is a highly-regulated industry, and what looks ludicrously conservative to some on the outside can be quite leading edge in this highly-scrutinized bubble.

So I was very interested to see that Novartis recently unveiled a trifecta approach to building a cystic fibrosis (CF) audience. First out of the gate was CFVoice, “an online community for people of all ages living with cystic fibrosis. A place for motivation, inspiration and connection to the CF community.” This site has now been joined by CFChristopher, who is on Twitter and Facebook (fan page) – as Novartis explains it, “Christopher Morgan is a fictional character created by Novartis Pharmaceuticals Corporation as an educational resource for the cystic fibrosis community. His story is inspired by research and interviews with people with CF, their friends, healthcare providers and caregivers.”

These social media properties are completely “unbranded” from a product perspective, with Novartis’ sponsorship clear yet low-key, and they represent an effort to use on-line technology/communities to educate and support people with CF.

So, how are they doing?

Let’s start with the Twitter page, which has only been up for a few weeks. Not surprisingly, there are relatively few tweets, and they are a mix of links to CFVoice and Facebook, plus some efforts to sound semi-hip. Nobody is being followed, and as of this writing, there are only 55 followers (some of whom are Novartis employees). The idea here is to try to create a persona of someone living a life with CF – but thus far, there isn’t much meat on those bones. It’s just some pictures of a young-looking guy and I get no sense (yet) from Twitter what living with CF is all about. I hope that will change. The fact that Christopher is a fictional character is disclosed prominently here (as on Facebook), which is a definite positive. But how will CF patients react?

The Facebook page is in a similar state of development. About 100 fans, a few entries, some references to the Twitter account and the CF Voice site…just not much of interest yet. Because it’s still relatively new, I won’t call it “lame” yet, but if it remains on the current vector, that won’t be an inaccurate description.

Bottom line – creative concept but still in Phase 1 study mode. Tying Facebook, Twitter, and other web properties together is certainly a solid direction. We’ll wait and see.

The community website CF Voice is much more developed. Start here, with a well-made video story about the making of a song (Breathe). This is a great use of multimedia to underscore the realities of living with a disease.

The navigation metaphor is age-range related, with different sections for various age groups – smart, since CF is a condition that can afflict people at all ages, and needs differ (for instance, you’d never use this nav architecture for a condition like COPD).

I started playing a game in the 6-8 year old section, and my 8-year old heard the noises, came over, figured out the game in a snap, and told me what I was doing wrong (thanks, Seth!). This simple web-based games and challenges for kids are fun, appropriate, and educational.

The teen section has video testimonials of kids living with CF, and a Mentor U section for advice, along with podcasts and recipes. The design is up-to-date and straightforward, with good use of colors and graphics, and I could see this being an encouraging place for someone afflicted with CF to come and not feel alone in the world. The 18-24 section similarly has an age-appropriate library of videos and podcasts, along with other resources. There is even a movie (“Raising Meghan”) that follows one family’s struggle to prepare their daughter (who has CF) for an independent life.

There are tabs for Adults, and for Parents/Caregivers as well; a lot of the content categories (videos, recipes, spread the word, etc.) mirror the teen and young adult sections.

The site has a short film (23 minutes), “Becoming Christopher,” which introduces the Christopher character who is seen on Facebook and on Twitter. Good tie-in.

Novartis Pharmaceuticals sponsors the site, but the purpose of CF Voice is community creation and support for a condition, not marketing of a drug (Novartis’ CF drug is Tobi). The Terms of Use are well thought-out. Novartis apparently has an additional support site for the product, TOBITime, but for some reason it was not accessible to me at the time of this writing (nor was the ability to join the CF Voice community).

CFVoice was awarded a Medical Marketing & Media Gold Award in 2008 for best website. It’s a fine example of what a pharmaceutical company can do with an “unbranded” patient support site that adds value without promoting products. Two thumbs up for the entire approach, and let’s hope that “Christopher” finds his voice more effectively on Twitter and Facebook as well.

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TODAY’S NEWS

Why one hospital is restricting drug sales reps (news clip). Interesting perspectives on sampling.

Possible heart problem with HIV drug combo – The U.S. Food and Drug Administration said on Tuesday that HIV drugs Invirase and Norvir might lead to an abnormal heart rhythm when used in combination, according to preliminary data the agency is reviewingmore

Salix‘ antibiotic gets thumbs up from FDA panel – Salix Pharmaceuticals’ diarrhea drug Xifaxan should be cleared to treat patients with a debilitating liver disorder, but more study would still be needed after approval, a U.S. Food and Drug Administration advisory panel said on Tuesday. FDA’s outside advisers, in a 14-4 vote, said the antibiotic appeared to help patients with the liver condition, but that the company’s single clinical trial did not look at the sickest patients or follow subjects long enough given that the drug would be used until patients get a liver transplant or diemore

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From EyeonFDA blog – Is Congress the new FDA?

JUST FOR FUN

More Olympics goodies – the 20 Funniest Figure Skating Faces.

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TODAY’S NEWS

Big approval news for Gilead Sciences Gilead Sciences Inc., the world’s largest maker of HIV treatments, won U.S. approval of an inhaled antibiotic for lung infections in cystic fibrosis patients. The Food and Drug Administration cleared sales of the medicine, given the brand name Cayston, the company said today in a statement. Outside advisers to the FDA backed the product’s safety and effectiveness in a 15-2 vote on Dec. 10more

What is the future of “personalized medicine”? Probably, it’ll look a lot like this (encouraging story from NY Times). Plus, in a cooperative effort, Eli Lilly, Merck and Pfizer have formed an independent, not-for-profit company Asian Cancer Research Group (ACRG) to accelerate research and ultimately improve treatment for patients affected with the most commonly-diagnosed cancers in Asiamore

Of course, in this industry, there is often a mix of good news and bad – and “bad” usually means bad behavior by people who love dollars above sense: lack of openness at AZ?; secret tapes and GSK (plus, a “fixer” who spiked research?); research fraud by rogue doc; kickbacks and J&J; risk of depression assessment and Eli Lilly (are you alive? then you’re at risk!!!). Reminds me of some prior posts on the Gold-in Rule

Novartis looking to expand even more at East Hanover campus. Including themed food venues!

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I’m feeling much safer now. FDA finally comes out against “ear candling“! Next up, perhaps – a prohibition of USB-to-nasal-passage uploads??

JUST FOR FUN

Delightful (and BIG) pictures from Vancouver Olympics. Love the colors in the very first one. From Boston.com’s very nice The Big Picture section.

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TODAY’S NEWS

Big news for Novartis on two fronts – Novartis has received a couple of pieces of good news from regulators in the USA this morning who have approved its meningococcal vaccine Menveo and granted a priority review for the Swiss major’s investigational oral treatment for multiple sclerosis fingolimod…more

Avandia – the bad news just won’t quit. The heart attack factor, and the when-did-they-not-share-what-info questions. And a call to just pull it from the market. A rough patch for GSK.

BI gets FDA approval for new Extended Release version of Mirapex (for Parkinson’s)

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From Wendy Blackburn: 7 things I Learned at the ePharma Summit. And, from Betsy Raymond StevensonCuring Pharma. Restoring the industry’s reputation will mean a lot of hard work, not just a PR campaign.

JUST FOR FUN

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From Sally ChurchOnline video viewing accelerates – where is Pharma? Useful stats and a good question. And from the recent ePharma Summit – who is doing it best so far? (from Kevin Nalty and Clare O’Brien). PLUS – a free e-book, just made available by Kru Research - Using YouTube for e-Patient Communications.

What is South by Social Health (SWSH)? A one-day event this spring - Fabio Gratton explains.

Wendy Blackburn thinks that Pharma eMarketing is (finally) Coming of Age.

How to Take Advantage of Social Media in Highly Regulated Environments.

Jon Richman asks on his Dose of Digital Blog – should you be involved in on-line monitoring?

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Now, I have a question. Many pharma companies shy away from eMarketing/Social Media involvement and investments because of perceived risks. But now think about the drug development pipeline process – especially an example like this one. Can anyone REALLY argue that pharma doesn’t make long-term, chancy investments in hope of a possible but uncertain payoff in the future? And I must say – getting involved in on-line networking is a whole lot less risky, less costly, with much higher potential payoff, than many of these speculative pipeline ventures…

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TODAY’S NEWS

Big news on the leukemia front: NovartisTasigna gets priority FDA review for newly-diagnosed patients; and Roche/Genentech‘s Rituxan approved for CLL.

A quarter of new prescriptions go unfilled.

Statins: cardiovascular benefits far outweigh the diabetes risks – Statin drugs raise the risk of diabetes significantly, but the danger appeared puny compared with their cardiovascular benefits, researchers found in a meta-analysismore

Gilead looking to ride a Quad to victory in HIV – Gilead Sciences has gone some way to ensuring that its dominance of the HIV market continues after phase II data from its “Quad” pill presented at the Conference on Retroviruses and Opportunistic Infections showed non-inferiority to its second best-selling drug, Atriplamore

Pharma eMarketing round-up: some great links and a big, thought-provoking question.

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PLUS

Even Me-Too Drugs get the blues

JUST FOR FUN

I don’t recommend you try this at home! But what happens when an iMac meets a house fire? The result is…surprising, to say the least!

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