Biotech and other bits

May 29, 2009 – 4:44 pm

Bio 2009 may be over, but the afterglow remains. I met a lot of great people, mostly because of Twitter (I’m on there as ChristianeTrue in case you want to follow me, and I will usually follow you right back). I did three blog posts from BIO – about Singapore’s efforts in biotech and medical research, talks with Dr. Alan Sachs from Merck and Dr. Sean Harper from Amgen about their companies’ research, and Deloitte’s Paul Keckley about his recent paper on comparative effectiveness – as well as Tweeting various sessions. And I still have some other stuff to write from BIO, but that took a backseat this week to my laundry pile (my husband did do the dishes while I was away), meetings, and the never-ending task of magazine layouts.

The overwhelming theme at BIO was big pharma partnerships with, and acquisitions of, biotechnology companies. And just hours after the convention ended, Johnson & Johnson broke the news that they were paying $1 billion for Cougar Biotech. This week, Exelixis and Sanofi-Aventis announced an exclusive collaboration deal for novel targeted oncology therapies.

In interesting examples of pharmaceutical outreach, GlaxoSmithKline started a corporate blog, and Sanofi-Aventis launched its own Internet TV station featuring corporate videos.

In other news, Dr. Peggy Hamburg became FDA commissioner; FDA released draft guidelines on how risk information should be presented in pharmaceutical and medical device DTC; the American Society of Clinical Oncology annual meeting started this week; PLoS Biology published an article that examines the lessons learned from the autism/vaccine wars; J&J had happy news about FDA’s issuing a complete response letter for rivaroxaban; and AP Pharma reported that they are cutting 34% of their jobs.

Around and about …

I think IguanaBio has the best headline ever about ASCO: ASCO starts today, secrets revealed, media going crazy. The writer also had a series of posts before the conference. As for me, I dread ASCO because my e-mail inbox will be choking on a tide of press releases – often the same news sent directly by the pharma company, someone from the pharma company’s PR agency, and someone else from the same PR agency or someone representing the clinicians presenting the studies asking if I want an interview. And then there’s the helpful followup phone calls where someone very young-sounding starts reading the entire press release to me. PR fail all the way, folks.

Lots of people had observations about the DTC draft guidelines. Rich Meyer at World of DTC Advertising asks, “What happened to the era of cooperation?” “While these are only draft guidelines I wonder why the FDA & DDMAC do not solicit the advice of drug company DTC marketers and digital and ad agencies,” Mr. Meyers wonders. “After all these people tend to be experts in marketing and advertising and surely they could provide some insights into how people are obtaining and using health information (i.e. prescription drugs) and the best way to help them get good credible information.”

At Eye on FDA, Mark Senak says FDA’s non-guidance on relating risk information is FDA’s loss - industry’s opportunity. “According to FDA’s DDMAC, the Internet has not really taken hold yet,” Mr. Senak says. “The word ‘Internet’ appears only a single time in the entire 27-page document, making the document largely irrelevant. Apparently, rather than provide guidance on how the Internet is used by companies to convey information to the public, DDMAC would rather issue policy by Warning and Untitled Letter, playing an endless and non-informative game of Whack-a-Mole.” The gain he mentions is that the pharma and advertising industries have 90 days to comment on the guidance.

John Mack at the Pharma Marketing Blog reads the tea leaves to draw some meaning about the FDA guidance. “Be reasonable and read the DDMAC draft guidance at least through page 16,” he says. He also points out that the proposed rules are not media-agnostic.

At DrugWonks, Peter Pitts says the draft guidance contains a “pretty subjective proposition” about net impressions. “In other words, rather than creating brighter lines so that industry can be in compliance, the agency is opting for even greater regulatory ambiguity,” he says. “Not good.”

And speaking of DTC, Ellen Hoenig Carlson at AdvanceMarketWoRx’s Notes from the Back of the Book highlighted Med Ad News‘ May story on DTC advertising, which emphasized that DTC still has a role in promotional strategies.

Chris Morrison at the In Vivo Blog examines the Sanofi-Aventis Exelixis deal. Also at the In Vivo Blog, Roger Longman explains why the GlaxoSmithKline/Pfizer HIV joint venture is a good path forward for both companies.

Over at the FDA Law Blog, Jamie K. Wolszon and Jeffrey S. Wasserstein outline Vermont’s new law regulating pharma gifts. “The law leaves open several questions,” the writers say. “For instance, it is unclear whether the law would permit the dissemination of promotional materials (other than FDA-approved labels), or Risk Evaluation and Mitigation Strategies (REMS)-type educational materials as ‘other items that serve a genuine educational function provided to a health care provider for the benefit of patients’? Or is this ‘other items’ language limited to educational materials such as textbooks or anatomical models? Moreover, how does one determine the value of items that are not easily assessed such as loaner devices, articles and FDA-approved labels?” Good questions. Good luck, Vermont pharma marketers!

Dr. Daniel Carlat at the Carlat Psychiatry Blog tries to unravel the mystery of who actually proposed commercial support-free CME.

Lena Chow at City of Paris gives tips on how to create successful in-house agencies. “For my colleagues who would like to elevate the output of their in-house agencies, I’d like to offer my observations, but with one caveat,” she says. “I define in-house agencies as dedicated resources (i.e., a designated department) led by communication professionals, not errant product managers who are frustrated copywriters or art directors.” Hear that, product managers? Don’t quit your day job!

Dr. Derek Lowe at In the Pipeline gives us a good laugh on Friday, in his tale of lab equipment woe. (If you do bring in the Pomeranians, make sure you get footage and post it on YouTube.) Then there’s fun with delayed-blast reagents and how the Guardian let folks take free shots at homeopathy practitioners

Dr. Howard Brody at Hooked: Ethics, Medicines, and Pharma, and Merrill Goozner at GoozNews talk about what they see as PhRMA’s stealthy campaign to derail comparative effectiveness research. Dr. Brody writes here, and Mr. Goozner writes here.

Michael McCaughan at the InVivo Blog examines the pharma industry’s apparent fear about comparative effectiveness research. “…biopharma companies should be leading the charge on comparative effectiveness,” he says. “Instead, the perception is that industry opposes CER. That is not the official position of any company, to our knowledge, but that is beside the point. Right now, it looks like industry is afraid of CER – as if it doesn’t believe what it says about drugs being cost-effective.”

At DrugWonks, Dr. Robert Goldberg writes about the way forward for comparative effectiveness and highlights the dark side of consumer-driven healthcare (he picks up the story of a British mom who bought her daughter Botox injections for her 18th birthday).

Dr. Roy M. Poses at Healthcare Renewal examines the conflicts of interest disclosed by new FDA Commissioner Peggy Hamburg.

Dr. Adam J. Fein at Drug Channels also looks at Dr. Hamburg’s disclosures, finding a surprising link with drug wholesalers.

Jonathan Richman at Dose of Digital talks about how pharma can use digital strategies to reach out to caregivers. (As for me, I don’t need another app. If my non-driver husband is told by his doctor to go to a hospital lab to get bloodwork to check his liver enzymes as he goes back on Tegretol, we make the appointment, and the hospital tells us it’s a five-hour wait regardless, an app that reminds me to schedule an appointment will only make me go aggro.)

At Furious Seasons, Philip Dawdy is doing his summer fundraiser. If you find his journalistic work useful, think of a donation as a subscription fee.