The madness before BIO 2009 …

Yes, the big convention is in Atlanta, starting officially next week but with events over the weekend. I’m going. In the last frantic run-up before the convention, my inbox has been flooded with e-mails from PR people eager for a few minutes of my time to meet executive X from company Y. Oy. My iCal Monday, Tuesday, and Wednesday has turned into solid blocks of green between the meetings I’ve scheduled and the sessions I want to hit. I’ll be live-Tweeting from the sessions as well as doing some blogging, and I am even on a panel. (I was added at the very last minute and the Website has not been updated, but I find it pretty neat that I was even asked. Have no fear, though, this does not mean I will turn into a special snowflake.) So before clearing out today, I’m writing a short roundup of what made the pharmabloggers and Twitterheads chatter this week. We had President Obama’s meeting on healthcare on Monday, in which he called for reducing the costs of healthcare and everyone pledged to get savings of $2 trillion in the next 10 years; the President held another meeting on Tuesday to review ideas of how to reduce health costs in the workplace. It was revealed by Sen. Charles Grassley that University of Texas researcher Karen Wagner failed to come clean about the all moolah she was paid by GlaxoSmithKline. FDA made everyone laugh and then cry when the agency sent out a warning letter to General Mills telling the company to stop promoting Cheerios as a drug. Then Pfizer made everyone pretty much keel over on Thursday when it pledged to provide its drugs to Americans who recently lost their jobs. Bristol-Myers Squibb’s turned-sour-arrangement with a patient who had endorsed Abilify made the front page of the Wall Street Journal. And then on Friday, Sanofi-Aventis launched its own “TV” station.

Around and about …

Mark Senak at Eye on FDA suggests that the agency’s priorities were askew when it sent the Cheerios warning letter. “When issuing a regulatory letter, the FDA has a choice - either issue a Warning Letter which suggests a violation is so serious that it creates a public health threat - or an untitled letter or notice of violation which suggests something annoying but less severe,” he says. “Here, the FDA issued a Warning Letter. For Cheerios. Hello? … And speaking for myself, I don’t think this type of action helps re-establish FDA’s credibility.” Agreed.

Mr. Senak also has some interesting thoughts on comparative effectiveness and what it’s supposed to achieve.

CNBC’s Mike Huckman looks at the “deal” between surgical company Intuitive Surgical and Gray’s Anatomy, which featured the company’s DaVinci S surgical robot on this week’s episode. Intuitive says no money changed hands, but a reader of Mr. Huckman pointed out that Intuitive has been encouraging DTC for hysterectomies and prostate surgeries and that viewers might ask for the robot seen on Gray’s. I have to somewhat disagree. It’s not DTC, but DTP, aimed at the people who make purchasing decisions for practices and hospitals, who might look at all that robotic goodness and say, “Cut me off a slice of that!” (no pun intended). And as for the practices and hospitals who already possess the marvel, they can tell worried patients about to go under the robotic knife, “We have the same robot that was used in Gray’s Anatomy, you’ll be fine!”

Beaker’s Blog writes more about the appearance here, pointing out that the robot is more than just a piece of equipment, but has “evolved into a status symbol for cutting-edge hospitals around the world.” See, it’s high-tech bling!

Beaker’s Blog also picks up the interview with Novartis CEO Daniel Vasella that CNBC did. Dr. Vasella spoke at one of Med Ad News‘ conference lunches awhile back, and was a great conversationalist at the table (George Will, on the other hand, was quiet and just ate his steak).

Mike Christel at the R&D Directions Insider Blog picks up the opinions of BIO President and CEO Jim Greenwood that most of the biotech industry should outlast the recession. He also makes some cracks about what he’s calling “the Great Cheerios Caper of 2009.” “Right now, I still can’t get over the fact that FDA is targeting breakfast cereal, especially those soggy, nondescript, bland little Os I used to scarf down as a kid,” he says. “You would think there are more important issues at hand for the agency and likely next commissioner Margaret Hamburg.”

John Mack at the Pharma Marketing Blog points out that with Pfizer employees stepping up to help Americans who have lost their jobs, GlaxoSmithKline looks even more foolish over its press release blunder last week. A thought I just had; will the Pfizer and Wyeth folks who have lost their jobs recently be eligible for this program? Hmmmm.

Rich Meyer at World of DTC Marketing is questioning why there is a deafening silence from other top drug companies about starting programs similar to Pfizer’s. “One would have expected that, following Pfizer’s lead, others would have followed suit but my guess is that they are too busy figuring out ROI and the process of implementing a program like Pfizer’s,” Mr. Meyer says.

Dr. Howard Brody in Hooked: Ethics, Medicine, and Pharma speculated about what the big guys are most scared of in healthcare reform.

Dr. Daniel Carlat likes Shire’s transparency in promotional tactics. But he doesn’t like what he perceives as a coverup of Abilify’s akathisia side effects; he writes more in that vein here and comments on the Wall Street Journal story that he is giving Andy Behrman the benefit of the doubt.

Jim Edwards at Bnet was less disposed to cut Mr. Behrman, who he called a “professional patient,” a break. “In a must-read story in the WSJ today, Behrman comes off like an embittered prostitute, angry at the pimp who no longer procures her tricks,” Mr. Edwards says. Damn!

Mr. Edwards also responds to Eli Lilly CEO John Lechleiter’s op-ed piece in the Wall Street Journal, saying pharma should get used to hearing “a government-run plan” when it comes to healthcare reform.

Reacting to the BMS-Behrman brou-ha-ha, Wendy Blackburn at ePharma Rx comes to the defense of pharma and patient spokespeople. “There are plenty of pharma companies that handle patient relationships responsibly, plenty of patients that behave ethically, and thousands of people who have benefited from other patients sharing their stories in meaningful ways,” Ms. Blackburn says. “And of course the WSJ chose NOT to focus on them. In my experience companies are extremely conservative, careful and ethical with these relationships.”

Merrill Goozner at GoozNews says the BMS-Berhman story proves that the tide has turned against direct-to-physician marketing. He also says the FDA’s reprint policy seems to be in flux.

Meanwhile, Steve Niles at the Med Ad News Insider Blog says the death of the pharma sales force is unlikely.

Kurt R. Karst at the FDA Law Blog outlines the decision of the U.S. District Court in New Jersey to let stand the patent term extension for levofloxacin, the active chemical in the antibiotic Levaquin. The generic pharmaceutical company Lupin is appealing the decision, claiming that since the levofloxacin is the enantiomer of floxacin, it was “present” when floxacin was approved and therefore not eligible for a patent extension. Mr. Karst explains FDA’s confused stance over the matter of enantiomers.

I respond at the Med Ad News Insider Blog to CurrentMedicine.TV’s assertion that doctors are Internet morons and electronic healthcare records will never work. I also had something to say about an EU court’s ruling that media comment on medicines may constitute advertising and the FDA Cheerios letter.

Also at the Med Ad News Insider Blog, Steve Niles talks about how the industry has stepped up to meet the H1N1 threat.