Merck, BMS' Pargluva recommended for approval by FDA advisory committee

A Food and Drug Administration advisory committee voted 8-1 in favor of approving Bristol-Myers Squibb Co. and Merck & Co. Inc.'s oral Pargluva (muraglitazar) as a monotherapy for treating type 2 diabetes, Dow Jones Newswires reported.

The panel also voted 7-2 in favor of the drug being used in combination with metformin, but voted 6-3 against its use in combination with sulfonylurea drugs.

The Endocrinologic and Metabolic Drugs Advisory Committee was convened to discuss potential cardiovascular risks associated with the drug, which, if approved, would be the first in a new class of drugs called glitazars.

Pargluva studies were conducted in more than 3,000 patients and nine cardiovascular deaths were observed, Dow Jones reported, adding that an FDA reviewer said "the agency could not conclude the deaths were linked to the drug."

Panel member Dr. Thomas Aoki, an endocrinologist at the University of California at Davis, said he thought the potential risks could be monitored and managed, according to Dow Jones. An example he gave was that if patients rapidly gained weight as a result of fluid retention, they should call their physician and be taken off the drug.

Additionally, the FDA noted that just having diabetes increases a person's risk for cardiovascular problems and that other peroxisome proliferator-activated receptor drugs for diabetes are also associated with "dose-related fluid retention ... edema and congestive heart failure," according to Dow Jones.

If Pargluva is approved, Merck and BMS plan to conduct additional studies on the potential cardiovascular risks, Dow Jones stated.

 

Novartis' Starlix plus metformin may be safer...

Novartis' Starlix plus metformin may be safer initial combination therapy than glyburide plus metformin among drug-naïve type 2 diabetes patients

Novartis AG's Starlix (nateglinide) plus metformin may be a safer initial combination therapy than glyburide plus metformin among drug-naïve patients with type 2 diabetes, according to study results published in the September issue of Diabetes Care.

In a double-masked, two-year study, researchers randomized 428 drug-naïve patients with type 2 diabetes to either 120 mg of Starlix before meals or 1.25 mg of glyburide daily in addition to 500 mg of open-label, daily metformin for the initial four weeks.

During a subsequent 12-week titration period, investigators increased glyburide and metformin by 1.25-mg and 500-mg increments to maximum daily doses of 10 mg and 2,000 mg, respectively, if a subject's fasting plasma glucose (FPG) was at least 6.7 mmol/L biweekly. Starlix was not titrated. Researchers maintained blinding by using matching placebo for Starlix and glyburide.

During a subsequent 88-week monitoring period, researchers measured hemoglobin A1C, FPG and postprandial glucose excursions (PPGEs) during an oral glucose tolerance test.

Average HbA1C levels were approximately the same for both groups at baseline (8.4 percent for the Starlix arm vs. 8.3 percent for the other treatment group) and at week 104 (6.9 percent for the Starlix group vs. 6.8 percent for the glyburide arm).

Results indicated that both treatments achieved similar efficacy with differential effects on FPG versus PPGE.

However, hypoglycemia occurred in 8.2 percent and 17.7 percent of patients treated with Starlix/metformin and glyburide/metformin, respectively.

More than 90 percent of patients in both treatment groups experienced one or more adverse events (AEs); most were mild or moderate. Aside from gastrointestinal symptoms and those typically linked to falling glucose, the AE profile mirrored common ailments observed in the general population, the study authors said.

"Similar good glycemic control can be maintained for two years with either treatment regimen, but [Starlix]/metformin may represent a safer approach to initial combination therapy," the authors concluded.

How to Use a Podcast to Promote a White Paper That Generates New Business Sales Leads

How to Use a Podcast to Promote a White Paper That Generates New Business Sales Leads 09/07/2005 (Source: Marketing Sherpa) SUMMARY: First it was email newsletters, then webcasts, then blogs ... and now the newest, hippest, marketing tactic is podcasting. But, just because podcasting is incredibly hip doesn't mean it actually works for campaigns targeting high-level execs in the Fortune 1000. Or can it? Check out our exclusive Case Study detailing how one b-to-b marketer tested podcasting this summer. (Yes, includes sample podcast and results data:)

CHALLENGE "There's tons of clutter in the system," says Paul Dunay. As Director of Global Financial Services Marketing for BearingPoint (NYSE:BE), Dunay faces stiff competition from hundreds of marketers also trying to get attention from top executives in the Global 2000. When it seems like every other marketer on this planet is offering a Sarbanes-Oxley white paper, it's hard to stand out. So, earlier this year, Dunay commissioned a series of research studies, partnering with the Economist's Intelligence Unit, to discover what top global financial execs were really thinking about. He figured the data would make great exclusive content, plus he'd discover pain points future white papers could address. He was right -- the results were fascinating. But, given the competing clutter, even the most fabulous content in the world might not garner the attention it deserved. How could his research grab prospects' attention? CAMPAIGN Naturally, Dunay used his proven system for getting out the word about new white papers. (See link below for our Case Study on his system.) But he wanted to take things one step further. So, he budgeted $1000 extra per new white paper for a podcasting test. (see below for links about podcasting.) Step #1. Pick a format Podcasting only started about a year ago, and few b-to-b marketers have tested it yet. Dunay had to invent his format from scratch. He considered three very different formats: Interview format -- The first idea was to use audio clips from some of the survey interviews. Sounds compelling, top execs revealing their thinking. But, Dunay felt BearingPoint's audio quality would be a key part of the brand .. and recorded telephone conversations just don't have a high-quality production sound. Plus, the goal was to demonstrate BearingPoint's thought leadership, not that of other companies' executives. White paper format -- Dunay's second was to turn whitepapers themselves into podcasts. "We tried reading the whole dang thing into the recorder," he explains. Then he listened to the results. "It was 20 minutes long. I *really* wanted to like it. I listened to about 10 minutes but then I couldn't stand it anymore. It was so painful. It was killing me." You guessed it, using one media as shovel-ware for content developed for another media rarely, if ever, works. Content prospects love to read is not the same as content anyone wants to listen to. White paper summary format -- "I realized, the podcast has got to be no longer than that six-to-eight minute zone. We decided to do a Reader's Digest version of the white papers." Dunay started by creating a nifty must-listen title such as "7 pitfalls of..." Then he copywrote a formal script for the podcast. (This is unlike many podcasts which often have that hand-held-film-style casual flavor.) Step #2. Figure out how to measure results As a paper summary, the podcast became the perfect format to offer the full white paper from. So, instead of replacing a normal white paper, the podcast served as a tantalizing preview of what you'd get if you downloaded the entire white paper. In short - the concept was podcast as white paper marketing campaign. Just as they would for any white paper promo campaign, Dunay's team created a vanity URL to track incoming traffic and created a registration form landing page to post there. Dunay didn't focus on the number of podcast downloads. Instead his measurement goals were: a. percent of podcast listeners who download a white paper b. quality of these leads compared to other sources (determined by tracking via the inside sales department who qualified incoming leads.) c. future activities of these leads on BearingPoint's prospect education site section (determined by cookies over time.) Step #3. Develop the audio brand Dunay worked with his interactive agency to create a branded audio logo for the podcast (see link below for info on audio logos), and to select an actor as BearingPoint's official "voice." Worth noting -- just as with your graphic logo, the voice talent you pick becomes part of your brand over time. If you switch actors, it's a bit like switching logos. Prospects and customers can be confused. (In fact Audible.com has told us regular audio-version newspaper listeners complain vigorously when their regular voice is switched during the reader's vacation.) All vocals were recorded and mixed at a local recording studio. Step #4. Promote the podcasts Dunay wasn't sure if the podcasts would be a hit or not, especially as his key prospects tend to be fairly conservative. So he didn't roll out trumpets and strobe lights for the launch. Instead, the team posted the podcasts and announcements at several related sites including Podblaze, FreshPodcasts.com, and iTunes (all of which currently promote podcasts for free.) They also rolled out a press release and an email announcement to the house list. (Link to samples below.) Their first podcast launched quietly July 29, 2005. RESULTS Joy and exultation! Hundreds of executives downloaded the podcasts. Dunay had hoped that 10% of podcast listeners would respond to the white paper download offer. Instead, 30% did. This 30% proved to be just as qualified as other more standard lead generation streams. We suspect one key factor in this was Dunay's choice of topic. While his titles featured catchy-wording, they were specific and niche enough to cause prospects to be self-selecting. Dunay acknowledges that a clutter-breakthrough tactic will only work this well for a limited time. The novelty value will wear off and results will lessen. In response, he's cranking out as many podcasts as he can to grab the attention while it's hot. The team has put published five podcasts so far, with another three due for release shortly. Each is on a very different topic, designed to get new prospects in to read particular papers (rather than being designed as an ongoing series of 'radio shows' to the same audience.) Despite this 18% of listeners have downloaded more than one BearingPoint podcast - a number that startled Dunay. Best of all, Dunay's internal client was delighted with results. "My boss loves them so much he wants them in Chinese, Japanese, German, British English.... Now we have to produce those for our other national sites." Useful links related to this article: Creative samples, including an actual podcast from BearingPoint: http://www.marketingsherpa.com/bearp2/study.html e-tractions -- the Internet marketing solutions company that BearingPoint used to help create and promote the Podcasts: http://www.e-tractions.com Audiolink -- the recording studio BearingPoint is using: http://www.audiolink.com MarketingSherpa article 'The Brave New(ish) World of Audio Logos & Podcasting': http://library.marketingsherpa.com/sample.cfm?contentID=3049 (Open access)

Proof! Blogs Influence Medicine Purchases

Proof! Blogs Influence Medicine Purchases

by Tracy Inserra at 11:10AM (PDT) on September 7, 2005

A new report was released recently showing that blogs do influence purchase decisions.  Joe Pilotta of iMedia Connection  shares the findings of a BIGresearch’s Simultaneous Media Usage Survey (SIMM VI), in an article titled Blogs, Purchase Decisions and Race yesterday.  The report breaks blogging influences into three categories:

1. Medicine

2. Car/Truck

3. Electronics. 

The impact for the Electronic category surpasses the others but the influence blogs have on Medicinal purchases is obvious.

From the graph in the article it looks as medicine fares as follows:

• Hispanics are influenced somewhere around 3.5%

• African Americans come in just below 2%

• Whites are less influenced in this category at approximately 1%

This is only the beginning.  A year ago the influence of purchases due to blogs for electronics was much lower than it is today. 

Blogs are entering into the Pharma space

Blogs are entering into the Pharma space

by Tracy Inserra at 03:18PM (PDT) on August 16, 2005

 

Blogs are reaching closer to home for the Pharmaceutical Industry.  Yahoo is driving a strong message about health education with two of its blogs.

Yahoo’s Health Expert Blogs is a consortium of health expert’s blogging on specific topics ranging from yoga to cancer.  The latest diabetes entry as of 3:07 PM mountain time, August 16, 2005 is a hot topic in the drug delivery arena - Inhaled Insulin.  Inhaled Insulin was posted by Simeon Margolis M.D., PhD.  He is a professor of medicine and biological chemistry at the Johns Hopkins School of Medicine.  This article blog was written an hour and 2 minutes ago and already has two responses.  One which is a suggestion for developing a cure. 

If you are AstraZeneca, you will want to watch the Cholesterol & Heart Disease blog.  On Fri, Aug 12, 2005, 12:42 pm PDT a blog article was posted Crestor: Should You Be Taking It?  The first line reads ‘Physicians have reported more serious adverse events to the FDA with the use of Crestor than with three other cholesterol-lowering statin drugs. This finding obviously raises the question of whether you should be taking Crestor.’ This particular post doesn’t have any comments attached to it.  Is no comment good or a bad? 

Take the patient perspective for a moment and imagine the thoughts going through the Crestor® patient’s mind while reading this article. Then imagine this patient going back to read the other side of the story day after day. Three days go by and still no rebuttal, no answer from the pharma company, not even from another doctor.  Would it make the patient call his/her physician and change medications?  This is a definite possibility.  Can AstraZeneca win in this situation?    

Take these examples 10 fold or 1000 fold and imagine the power and potential a blog can have for your therapeutic area, drug, patient or physician base.  The possibilities are infinite. Blogs do not stand alone they solicit comments, RSS Feeds, Tags, Permalinks and Trackbacks.  Not to mention this is a global medium! 

A pharmaceutical company with a drug in one of Yahoo’s Health Expert categories should ask itself several questions.  The first question should be, do we know the ‘expert blogger’?  If so what is our relationship with this professional?  If the expert blogger is one of your thought leaders is this a good or bad situation to be in?  Are there legal ramifications?

The marketing department may ask questions such as ‘do we know the ‘expert blogger’  should we get him/her a sample?  Should we advertise on this page?

The other notable Yahoo blog is Blog for Hope.  This blog is a temporary blog effort  between Yahoo and the American Cancer Society.  The objective of this blog…promotion… is to ‘connect individuals in the fight against cancer.’  An ingenious idea, the blog has celebrities such as Deepak Chopra, Hillary Clinton, Sam Donaldson, Peggy Flemming and others share their personal stories via the blog.  Fran Drescher writes ‘I got famous, I got cancer, and I LIVED to talk about it. Once you wake up and smell the coffee, it’s hard to go back to sleep.

So let me sound the alarm! We must become better medical consumers. We must challenge our physicians…’  She has 397 comments as of this writing.

This is a great example of using blogs to reach the masses for health education.  

With blogs on the up rise Pharma should expect its patient and physician base to read a posting about the company, a therapeutic area, drug or drug class they manufacture a product for at least once a week if not more often. 

Pharma should ask itself four more very important questions in relation to blog media. 

1. Do we know enough about blogs? 
2. Are we prepared for this new revolution?
3. How do we keep track of this medium?
4. How do we respond?