And now back to the blogs …

June 24, 2008 – 7:00 pm

Well, this is supposed to be a blog review, after all. Let’s see what’s out there.

Pharmalot and WSJ Health Blog

One of the things I like to do is compare the two and see what their takes are on some of the weekly stories. This is what Ed Silverman at Pharmalot notes about FDA’s decision to delay a final decision on prasugrel. Mr. Silverman says, “In an investor note tonight, Tim Anderson, a pharma analyst at Sanford Bernstein, writes: Lilly ‘continues to decline answering whether they expect an advisory committee to be held prior to final FDA action. There is currently scheduled a tentative meeting date in August, but it is unclear at present what the agenda for this meeting could be. We believe prasugrel will indeed be put before an expert panel prior to final FDA action.’”

Mr. Silverman wondered earlier in the week whether prasugrel will stop the bleeding at Lilly, picking up an investor note from Barbara Ryan at Deutsche Bank.

At the Wall Street Journal Health Blog, Jacob Goldstein writes about the delay decision here, also noting that the clock is ticking on the Plavix patent. “In today’s tough FDA safety climate, a three-month delay seems pretty minor – less serious, for example, than an ‘approvable letter’ that could have forced the company to gather more data or even conduct an entirely new study,” Mr. Goldstein says.

Mr. Silverman and Mr. Goldstein both wrote about which companies spend the most on lobbying. The press release from the Center for Public Integrity can be found here. Mr. Silverman’s version of the story is here. Mr. Goldstein’s post on the issue is here.

Both also wrote about how the VA is sending a warning about Chantix’s side effects to 32,000 vets. Mr. Goldstein writes about the news here. Mr. Silverman’s version of the story is here.

The news about activist shareholder Carl Icahn’s defeat at the hands of Biogen Idec also made both blogs. Mr. Silverman talks about the news here, and Mr. Goldstein writes about it here. “So what’s next for a standalone Biogen?” Mr Goldstein wonders. “Perhaps the most important question facing the company is the future of its multiple sclerosis drug Tysabri.”

But Mr. Silverman and the crew at the Wall Street Journal Health Blog don’t pick up on the exact same stories every day (that would be boring). Other interesting news from Pharmalot: FDA is claiming to approve medical devices faster; ; Mr. Silverman writes about a study that argues the private sector was responsible for widely used drugs or drug classes; a Sanofi-Aventis rep in Hungary who is suing over anti-semitism; an FDA panel is to weigh heart trials for diabetes medicines; Pfizer paying a $975,000 fine for air pollution; a Wolters Kluwer study that shows generics have grabbed a big share of Medicare Part D; whether key opinion leaders are just expensive sales reps; how Congress wants to restrict some Internet sales of drugs; and how Merck is delaying Cordaptive until 2013.

At the Wall Street Journal Health Blog, Scott Hensley tells us about Doctor Radio, the newest offering from Sirius Satellite Radio (I wonder how much of the programming may be indirectly funded by the pharmaceutical industry); Sarah Rubenstein reports that Walgreens is shrugging off the threat from retailers pushing cheap generics; Mr. Goldstein looks at which retailers have jumped on the cheap generics bandwagon, how the AMA does not want retail clinics in stores that also sell tobacco, a scientist who is devoting the rest of his life to finding an AIDS vaccine, and how an early link between Neurontin and depression was ignored; and Alicia Mundy says FDA got left out on Paxil risk documents.

Around and about …

Let’s take a look at what the other pharmaceutical blogs are writing about.

Philip Dawdy at Furious Seasons looks at how Lilly may be pursuing a knee pain indication for Cymbalta; how a Massachusetts senator is gearing up to use bipolar disorder as a defense in his trial for sexual assault; what a Wyeth executive says about Pristiq’s withdrawal problems; and how British company Psynova is developing a biomarker blood test for schizophrenia. The latter has Mr. Dawdy particularly annoyed. “I’m sorry but how would it transform treatment?” he asks. “By enabling doctors to force meds on people sooner so we can watch the rotten results of the PRIME study play out on a culture wide level? By giving doctors a form of ‘evidence’ they can take to a judge to get a court order to force someone onto Zyprexa who isn’t a danger to anyone? Will we force it upon small children who act out in class? You’ve got to wonder. Anyway, I doubt these sorts of gene tests being bandied about for various mental disorders will prove out in the real world, but I am a skeptic by nature.”

Merrill Goozner at GoozNews is particularly amused by Dr. Scott Gottlieb’s column in Tuesday’s Wall Street Journal about Medicare. He also looks at the BMJ’s take on key opinion leaders.

Dr. Derek Lowe at In the Pipeline examines prasugrel. “If I had to predict - and hey, I write this blog, so I’ve got a license to do that sort of thing - I’d say that the agency will ultimately approve the drug, but with label restrictions,” he says. “…There’s another 10,000 patient study under way which might clarify the situation, or might just emphasize what a tied-up tangle it all is. In the end, I think that the FDA will let the drug be sold until that one finishes up, with the option to revise its opinion when the data come in. The three-month delay will serve to show how seriously they’re taking all the safety issues - a big political consideration these days - and to work up the most bulletproof labeling they can come up with.”

At the InVivo Blog, Ramsey Baghdadi agrees that Lilly’s prasugrel will get approved – eventually. “In the end, based on the tea leaves, that FDA will approve prasugrel with a warning (not black-box) on bleeds and a REMS program that includes a prescribing MedGuide for patients, a physician education program and a postmarket study,” he says. “Now it’s just a game of wait and see.”

Also at the InVivo Blog, M. Nielsen Hobbs wonders whether Daiichi and Ranbaxy got a wedding favor from Pfizer. “…Ranbaxy was the first-to-file challenger for Pfizer’s mega-blockbuster Lipitor, and they’ve been in court ever since,” he says. “But now the fight seems to be over: A week after Ranbaxy and Daiichi announced they were tying the knot, Ranbaxy and Pfizer said they were cutting a deal to end their legal entanglement.”

Dr. Lowe also looks at the aurora kinase inhibitors in development, and problems with research funding in the European Union. Going back, we find that his predictions about Alli sales have come true. “I think that the new, slimmed-down GSK organization is wasting money on this whole idea,” he says. “But hey, Marketing thinks it’s a great opportunity …”

And speaking of Alli, John Mack at the Pharma Marketing Blog is issuing a challenge: “Take Alli - I dare you!” “I am a believer in first-hand experience – especially if I am to criticize something,” he says. “Therefore, I am taking the ‘alli Dare.’ I will go out and spend good money on an alli starter kit and see if I need those brown pants. I dare any other alli critic to do the same!” Good luck, Mr. Mack, and hope your dry-cleaning bills don’t go up too much! But he does make another point here in that the resignation of the main blogger for alliConnect “specifically signals the end of the alliConnect Blog – or at least the transparency it has championed – and may portend the retreat of pharma marketing away from Web 2.0 principles in general.”

Rich Meyer at World of DTC Marketing says “.. the agreement of some drug makers to limit DTC for new products for six months after approval is a copout and stinks of executives who are not willing to walk the walk and talk the talk when it comes to DTC,” and that the biggest losers are the patients “who need to know about new treatment options that could help maintain the quality of life and prevent some horrible diseases.”

At DTC-in-Perspective, Bob Ehrlich looks at the voluntary DTC moratorium.

Peter Pitts at DrugWonks comments on the Manhattan Research report that most R&D innovation in the pharmaceutical industry comes from the private sector. “I know, duh – but these are important facts to keep repeating and repeating in the appropriate context,” he says. “Because there are those who chose to manipulate the facts to tell their own version of the truth.” He also has more criticism about universal health care.

Dr. Robert Goldberg at DrugWonks responds to the criticism of his article by Healthcare Renewal’s Dr. Roy C. Poses. Those two just keep going at it.

At Healthcare Renewal, MedInformatics MD looks at two commentaries in medical journals about the exploitation of the poor in clinical research, which the blogger calls a “mild torture economy.” Dr. Poses also comments on the BMJ article about key opinion leaders’ role in pharmaceutical sales and marketing. “Although pharmaceutical, biotechnology, and device company spokespeople, and some of the industries’ cheer-leaders continue to insist that key opinion leaders are educators, this article underscores that they are merely high-priced marketers,” Dr. Poses says. “What is most insidious about the use of KOLs, however, is that many of them do not acknowledge that they are even influenced by the money they are paid.”

Dr. Daniel Carlat at the Carlat Psychiatry Blog also looks at the BMJ article. “It is another nail in the coffin of the notion that drug companies pay doctors to provide medical education,” he says. “It’s all about marketing.”

Dr. Carlat addresses the new proposed ACCME guidelines for medical education. “The one aspect of the ‘new paradigm’ that is a head scratcher is the stipulation that CME be ‘free of bias,’” he says. “That’s been a requirement for years, but has never been enforced. It appears that the organization has beefed up enforcement efforts – they say they have put 10% of providers on probation for breaches of their Standards of Commercial Support, up from 1% in the past. We’ll all have to stay tuned.” He also makes fun of a videoeditorial by George Lundberg, editor in chief of Medscape.

Steve Woodruff of Impactiviti outs bad treatment at his local hospital.

The U.K. satirist Pharma Giles strikes again, with this piece spoofing this piece by Dr. Lowe. He also makes fun of the reasoning behind GlaxoSmithKline’s layoffs of R&D workers.

OK, I know that I have been bad about keeping this blog regularly updated so far, but come on, CNTO411! Seriously, things can’t be that dead around there! But the prize for biggest corporate blogging gap has to go to Octagon Research. At least Marc Monseau at JNJBTW keeps on trucking, although I’m a little annoyed that although he and I were out at BIO 2008, Mr. Monseau and others from Amgen, Genzyme, and Vertex had a little talk about social media without me … the tears in my eyes, they are flowing, dude. Pretty please, the next time you decide to have a talk about bloggers and blogging, invite me?

The Prescription Project’s blog PostScript has an interview with Melody Petersen, author of Our Daily Meds.

The blogger at the Philly Pharm Bio Blog says the pharmaceutical industry should prepare for a smackdown from FDA.