Spring has sprung, and so has news

April 10, 2009 – 3:50 pm

Spring seems to have officially sprung, at least in our little bit of the Northeast of the United States; buds are swelling, birds are tweeting, and my cats have been sitting in windows and pretending they’re great and mighty hunters, chattering at the feathered morsels flitting around so tantalizingly close outside. And this week, the news seems to be stirring as well: 14 pharmaceutical companies were chided by FDA about their Internet advertising through Google and Yahoo!; Pfizer identified its top research scientists and formed two research units (the good news is that there are a lot more Wyeth scientists to be involved than previously speculated); former Bristol-Myers Squibb executive Andrew Bodnar pled guilty for dishonest dealings with the federal government; former NEJM editor Marcia Angell opined that there are seven things Congress should do with FDA; Johns Hopkins banned pharma company gifts; Genentech voluntarily withdrew the plaque psoriasis drug Raptiva from the U.S. market; and Johnson & Johnson announced plans to chop 6% of its sales force, or 900 jobs.

Sponsored links confusion

FDA’s warning letters had bloggers buzzing. At DrugWonks, Peter Pitts laid out the implications and the applications of the warning letters. He believes that DDMAC has just confused matters. “Here’s something that isn’t opinion – sending out Warning Letters isn’t guidance – it’s punitive regulatory action,” he says. “It’s FDA acting tough without putting in the time and brainpower to explain how to address the perceived problem. That’s not what we need. That doesn’t advance the pubic health. Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.”

Mark Senak at Eye on FDA says the letters, from the FDA’s perspective, don’t actually mean much. “All of this begs the question - why doesn’t the FDA develop a guidance around new media? From their perspective, it is clear that they don’t think they have to do that,” Mr. Senak says. “They do feel that the regulations as written, cover the situation. And technically, they are correct. … However, perhaps now more than ever, as we hurdle towards Web 3.0, it is essential that the agency return to its era as a leader and now a follower. Dr. Hamburg would be well informed to take note. Communications has changed drastically and continues to evolve. The FDA must evolve with it and recognize its responsibility. To date, it has not.”

At Policy and Medicine, Thomas Sullivan believes the letters were sent for political reasons. “When 20 companies get hit for the same violation (’1 click policy – the balanced drug information was one click away’), it means that the regulation must have been misinterpreted for a very long time,” Mr. Sullivan says. “It is doubtful that the legal departments which must approve all advertising at all these companies would have let this by, unless there was some level of ambiguity in the rules. … With many states, collaborating on collective action against drug companies for violations in drug advertising practices, this serves as a good example of the FDA doing its job in regulating the industry; perhaps Congress will take notice and become less critical of the agency.”

According to John Mack at the Pharma Marketing Blog, when it comes to pharma marketing on the Internet, be careful of the advice you get from “experts”; and FDA’s next concern may the use of redirect URLs. He also casts the debate of whether Google will allow redirect URLs as an interesting fairy tale (as it turns out, the fairy tale came true, if you look at the comment from MedThink Communications).

Bob Ehrlich says at DTC-in-Perspective that the letters were a clear warning from FDA that there will be increased vigilance from the agency. “I doubt drug companies will drop the ad word use and instead will comply using more reminder ads,” he says. “Perhaps the loss of the indication tag line makes for fewer click throughs but I doubt a significant drop off. It will make an interesting analysis from Google.”

Wendy Blackburn at ePharma Rx says the warning letters and another piece of news, that FTC will start holding bloggers liable, will have far-reaching implications for pharma. “A bit of advice: Make sure your digital agency is pharma-savvy and knows what they are doing,” she says. “Unfortunately, you’re going to need that much more flexibility, understanding, and creativity to get your messages to market.”

Steve Niles at the Med Ad News Insider Blog asks, “What now for sponsored links in the wake of the 14 letters?” Unfortunately, “All these warning letters do is spell out what FDA didn’t like about sponsored links,” he says. “They do not offer any explicit rules or even guidance. And thus, marketers are still left to stumble around in the dark and make guesses about what they can get away with when it comes to paid search.”

Pharma’s participation in social media continues to be a matter of debate. Last week at the AdPharm blog, Maygone wondered how real can social media be in the world of pharma. “….outside of corporate blogs or Twitter pages, how many examples of are there of pharma using real social media are there - and by real social media, I mean online media that allows a back and forth conversation between various parties,” she says. “This back and forth conversation, and the ability to change, respond, influence, and engage with the people who create the content we read online is what makes social media so exciting to me.”

At the Pharma Strategy Blog, Sally Church addresses the issue of pharma and social media monitoring. “The thing with any monitoring, for social media or otherwise, is that cool graphics, pretty pictures and analytics on their own aren’t enough. … Suggesting a Facebook page or a Twitter account to essentially push out information is hardly a logical starting point or engaging with consumers and patients,” Ms. Church says. “Using just Twitter search and Google to monitor ‘brand awareness’ is amateurish; you need a lot more than that to provide a useful coherent product strategy.”

At S&R Communications’ S&R Blog, Pam Thompson suggests eight things that pharma brands can do on Facebook right now. “Given that the cost of a Facebook page is free, positioning social media as a part of your agency and your clients’ overall marketing plan is a no brainer,” she says.

Around and about …

At Beaker’s Blog, there’s the observation that the middle class of pharmaceutical company is rapidly disappearing.

If you’re looking for what are the upcoming drugs in development for serious illnesses, check out Sally Church’s Pharma Strategy Blog. Ms. Church talks about upcoming drugs for chronic lymphocytic leukemia; and also comments on Pfizer’s dropping Sutent for breast cancer. “Pfizer has already ended development of five late-stage drugs during the past six months for diseases including anxiety, obesity and pancreatic cancer,” she says. “At this rate, the Wy-Pfi is getting much more attractive by the day as the once promising Pfizer pipeline plops.”

And speaking of the new Pfizer research units, Chris Morrison at the InVivo Blog says the structure seems to be Pfizer in name, but Wy-Pfi in spirit.

At Bnet, Jim Edwards reports on Schering-Plough reps winning a ruling for them to be paid overtime; how former Bristol-Myers Squibb employee Andrew Bodnar got caught in his own lies on the BMS-Apotex deal on Plavix; and how AstraZeneca’s “smoke and mirrors” man has a new job in medical writing.

Dr. Daniel Carlat at the Carlat Psychiatry Blog looks at the Johns Hopkins gift ban. He’s not that impressed with it. “The bottom line is that Johns Hopkins has crafted a policy to generate good PR for the university, but which continues to allow a free flow of money, food, and educational gifts from the pharmaceutical industry to doctors,” he says. “Let’s hope that our other academic medical centers can do better.”

Some good news, at least for those who support industry-funded CME. Thomas Sullivan at Policy and Medicine says the ACCME will not be taking any action that could end industry support for accredited medical education. He also took note of the progress of gift ban legislation in several states, including that of Vermont, where the State Senate approved a pharmaceutical gift ban bill (you can read the text of the bill, S.48, here). “With the exception of Vermont, all these ‘Gift’ bans have gone down in flames, if you have friends Vermont, they may want to contact their state house member to protest this crazy bill,” he says.

Mr. Sullivan also criticizes the Wisconsin Journal Sentinel article about Unversity of Wisconsin CME that Dr. Carlat praised last week. “CME is education, and education requires making definitive statements, otherwise it is just educational mush,” he says. And he agrees it’s time to fight the pharmascolds.

One of those pharmascolds, Dr. Howard Brody at Hooked: Medicine, Ethics, and Pharma, has his own take on Dr. Thomas Stossel’s editorial in the Wall Street Journal.

Dr. Derek Lowe at In the Pipeline looks at the news that fewer pharma companies are being led by scientists and wonders what the heck is going on with Biogen Idec and Carl Icahn as the company’s stock price has taken off. He also comments on the new Pfizer research structure. “So, yes, we’ll see about all this,” he says. “But we won’t see for a while, and when we finally do see, it’ll probably be impossible to say just what we’re looking at.”

The anonymous blogger at Clinical Psychology and Psychiatry: A Closer Look, applauds the review of Alison Bass’s Side Effects in the American Journal of Psychiatry that was not exactly complimentary to Martin Keller of Brown University. “And for a major psychiatry journal to run anything, even a book review, that directly goes after a ‘key opinion leader’ who appears quite culpable in performing bad science – that’s a good sign,” the blogger says.

That whole Bextra thing last week? At his blog, Dr. Peter Rost helpfully points out a letter from a company employee he posted two years ago that talked about the document destruction related to that case as well as the conviction of another Pfizer employee in March for obstruction of justice.

Ellen Hoenig Carlson at the Notes from the Back of the Book blog comments on pharma companies’ use of Twitter. She likes what Boehringer Ingelheim is doing. “While other pharma companies have a presence on Twitter, so far BI is unique in achieving at least some conversational, and interactive blog-like style – and not just using it as a one-way PR feed,” she says.

Dr. Summer Johnson at the Bioethics Blog talks about how popular ePocrates’ application for the iPhone is.

Shwen Gwee of Vertex Pharmaceuticals says if you are kicking around Boston towards the end of April, actually know what Facebook and Twitter are, and are involved in the pharmaceutical industry, you might be interested in attending this event. Steve Woodruff of Impactiviti will also be there, leading an interactive discussion. “I am not going to go to the event to present conclusions, but to engage in a discussion,” he says. “And I’d like to prime the discussion there by beginning the dialogue here and now.” You can go tell Mr. Woodruff what you think!

Just when I think Dr. Nancy Smerkanich has given up blogging, she makes another post at the Octagon Research Regulatory Matters blog. This time, she looks at the recent pharma mergers and the changes at the top of FDA and HHS.

Looking at this comic at the S&R Blog, I wonder if I will be pen guy or a thumb drive girl at Bio 2009, which is in May in Atlanta. And speaking of BIO 2009 … if you will be there, tell me! Maybe we can meet up?

Happy Easter and a Happy Pesach to all those who celebrate!