Merck job cuts, Acomplia sales suspended, and other bits

October 24, 2008 – 3:52 pm

It started off as a nice quiet week, but then Merck reported that it would be shedding 7,200 jobs and closing three research labs, with 40% of the job cuts coming from the United States. Europe suspended sales of the antiobesity drug Acomplia. And the New York Times reported that drug prescriptions were down and would continue to be down for the year.

More job cuts, more industry turmoil

That we’re hearing this kind of news out of Merck is not surprising, and we will be hearing even more of it throughout the industry; at Pharmalot, Ed Silverman said with all of the changes in R&D focus, Pfizer employees should brace for layoffs.

As soon as the news came out about the job cuts at Merck, I headed over to Cafe Pharma and the Merck board to see what some employees had to say. Some were railing against the head of Merck Research Labs, Peter S. Kim. But there was some constructive criticism as well. At this thread and this thread, employees point out that the culture the company is stuck in created the problems, and to make any real changes, the culture and the leadership need to change. “Bottom line: you are not going to impact real change, just further decline because you are not trusted,” one poster says. “You got us here, you can’t get the org out of it, you need new people, new culture, and you old guys can’t create that.”

Forbes‘ Matt Herper at the Science Business Blog links to a story describing the closing of Merck’s Seattle research site, the former Rosetta InPharmatics. Xconomy’s Luke Timmerman says Merck wants 100 of the 300 employees there to move to a consolidated research center in Boston.

At In the Pipeline, Dr. Derek Lowe said the cuts do not seem to fit into the “traitorous execs in expensive suits and jobs to China” template, since 60% of the cuts are taking place outside the United States. But Merck will be outsourcing more research, he points out. ” I realize that there are many people who, although they may argue that outsourcing research is not all it’s cracked up to be, would still be against it even after stipulating its efficacy,” he says. “For these people, it’s wrong even if it does work. I will not be able to convince anyone in this camp, just as I don’t see them convincing me. If we’re arguing about numbers, there can possibly be an end to the discussion at some point — but if we’re arguing about morals, there can’t. I’m willing to make my own moral arguments, to go along with my utilitarian ones, but the audience for whom those appeals would be crucial is the one least likely to be convinced by them.”

There was a tiny bit of good news for Merck: On Wednesday, the CDC reported that experts analyzing the serious adverse event reports for Gardasil have not found a pattern that would suggest these events were caused by the vaccine. Mr. Silverman posts about that news here, and Mr. Goldstein, here.

Jim Edwards at Bnet says, “Thus it is time for all those reporters, lawyers and activists to start explaining to their audiences that perhaps, just perhaps, this is one vaccine that isn’t actually harmful.” And then he goes on to identify some of these critical media reports. “Don’t hold your breath waiting for any of these correctives,” he adds.

At World of DTC Marketing, Rich Meyer notes that pharma is the top industry in slashing jobs for several reasons, one trend being that the oncology products many companies are developing are not usually marketed via DTC. If the industry truly believes that DTC advertising educates consumers and patients, Mr. Meyers says, “then directors and managers need to fight to continue to both retain talent and attract new talent. We have learned too much as an industry to be discarded by senior mangers who are only interested in numbers and don’t understand the value of marketing. Who responds will be clear in the next 3-5 years. Those that made the investments in people and capabilities will excel … those that did not will continue to struggle to break through the clutter.”

The end of Acomplia

Remember Acomplia, which was supposed to be a revolutionary drug for controlling obesity? How times have changed. The EMEA’s Committee for Medicinal Products for Human Use recommended suspending sales of the drug, concluding that the benefits of Acomplia outweighed its risks. After assessing the available information on the benefits and risks of Acomplia, the CHMP committee concluded “that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking placebo.”

The drug was approved in Europe in June 2006, but failed to win approval in the United States.

Of course, Sanofi-Aventis remains committed to Acomplia. “Sanofi-Aventis believes that Acomplia will remain an important therapeutic answer to a highly prevalent and increasing unmet medical need,” the company says. “As discussed with the EMEA, Sanofi-Aventis will continue the ongoing clinical trial program except phase IV and is committed to provide additional evidence for the positive re-evaluation of the benefit/risk profile of Acomplia, including through
studies in diabetes and in patients at risk of cardiovascular disease.”

At the Wall Street Journal Health Blog, Jacob Goldstein had some observations about the sales suspension. “The suspension is a reminder that the clinical trials used to test a drug — in which patients are carefully selected and closely monitored — often don’t reflect the way medicines are used in the real world, where things tend to be messier,” he says, adding that the suspension is a vindication for FDA, where an advisory committee voted 14-0 not to recommend the drug for approval.

Around and about …

Novartis has been undergoing some turmoil with a management shakeup and the purchase of Nektar’s pulmonary unit. The Bloomberg article almost makes it sound like the executives such as Thomas Ebeling, who was head of the consumer unit, left of their own accord. Dr. Peter Rost at his blog (now just named The Peter Rost Blog) picks up an article from the German newspaper Die Welt with a firmer descripion of Mr. Ebeling’s exit. Thankfully, the good doctor translates for non-German speakers such as myself. ‘The famous German newspaper claims that Thomas Ebeling, who used to be the guy who was supposed to replace Vasella, has been kicked out,” Dr. Rost says. “They call it ‘Rauswurf’ which literally means ‘outkicking.’” One definition I found here says Rauswurf means “expulsion” or “sacking.” There’s no candycoating of reality at Die Welt, it sounds like.

Who is running the FDA advisory committees? Chances are, no one, says Kate Rawson at the InVivo Blog. Ms. Rawson reports that three-quarters of the advisory committees are without a permanent chair. “That might not be such a big deal, so long as FDA wasn’t holding many advisory committee meetings,” she says. “But that’s not the case. In fact, the agency will bring more new products before an advisory committee this year than it has since at least 2004. That’s a lot to juggle at a time when FDA is having a hard time filling those seats with permanent members.”

Philip Dawdy at Furious Seasons looks at the New York Times story that half of doctors routinely prescribe placebos. “Someone call me a plaintiff’s attorney because, if this practice is true (I don’t have any reason to doubt the study but I’ve not encountered placebo prescribing myself) then it likely violates a lot of ethical and, perhaps, legal precepts,” he says.

Thomas Sullivan at Policy and Medicine posts the most recent CME grant disclosures from pharmaceutical companies.

Mr. Silverman shares with us the news that PhRMA is behind the largest political issue campaign this election season. “A spokeswoman for the non-profit running the ads, America’s Agenda: Health Care for Kids, says the idea is not to influence races, but to keep the State Children’s Health Insurance Program at the top of the legislative agenda,” Mr. Silverman says. “So far, the group has singled out 15 House members and 13 senators who voted in favor of expanding SCHIP. … Why does PhRMA care? The industry supported the bill because people with insurance are more likely to visit a doctor, who is more likely to prescribe a med.”

Mr. Silverman also looks at the case of the disappearing journal article. Dr. Howard Brody at Hooked: Ethics, Medicine, and Pharma had examined the dispute, as well as Merrill Goozner from GoozNews. Mr. Goozner concludes, “So, Harvard students, the lesson for today is this: freedom of the press is a tricky affair, and if you stumble in its exercise and cross people with power — especially those who are supposed to be your teachers and mentors — you may be putting your reputation, not to mention your future prospects, at risk.”

The blogger at Clinical Psychology and Psychiatry: A Closer Look examines the results of a study that says children with bipolar disease grow up to be adults with bipolar disease. “Assuming that the diagnoses were valid, this study makes me think that: Kids who show really bad behavioral and emotional problems often become adults with major psychological problems,” this blogger says. “Not exactly earth-shatteringly surprising; [and] treatments for child/adolescent bipolar are not working very well.”

Matt Herper at the Science Business Blog says chalk up one more drug approval delay at FDA, Abbott’s TriLipix.

The Drug and Device Law Blog linked to an interesting blog post about the upcoming Wyeth pre-emption case from a physician who believes that the drug at the center of the case, Phenergan, should not be contraindicated for an IV push.

Having a hard time getting onto DrugWonks lately? You’re not alone, and there’s a reason for it. According to CMPI’s Peter Pitts, who blogs there with Dr. Robert Goldberg, the site has been under attack by hackers. The attacks have been reported to the FBI, Mr. Pitts says. I assume it was the hackers who filled the comments a few months ago with links to buy Viagra and other ED drugs. The attacks seem to be denial-of-service ones, which slow down or take out the site all together. “These people are criminals and cowards,” Mr. Pitts says. Good luck to your tech people in fighting off the hackers and hope that the /b/tards don’t get hold of any of your personal information!

Since the blog was up and running when I accessed it, I took a look at some recent posts. Here Dr. Robert Goldberg rips into Barack Obama for lying about John McCain’s healthcare plan and the media for exaggerating the dangers of prescription drugs. I can’t wait for the election to be over.

Dr. Daniel Carlat of the Carlat Psychiatry Blog welcomes a new blogger, Dr. Steven Reidbord, and shares Dr. Reidbord’s tale of how he believes that he was nearly duped into being a PR speaker for Wyeth’s Effexor under the guise of education. You can read Dr. Reidbord’s own words about this and get his explanation of why he was offended by the incident.

Dr. Adam J. Fein at Drug Channels explains to us why Walgreens’ purchase of McKesson’s specialty pharmacy business makes sense for the company.

On the lighter and geekier side, Dr. Derek Lowe at In the Pipeline talks about why he won’t work with triazadienyl fluoride. Although chemists strive not to achieve fire, flood, or explosions on the job, they love telling war stories about them.

Condor at Shearling’s Got Plowed examines Schering-Plough’s asenapine and highlights some guest commentary about the drug. From Condor’s perspective, asenapine won’t fly.

John Mack at the Pharma Marketing Blog had some complaints about Med Ad News‘ writeup of Allergan as Most Admired Specialty Company. Well, Mr. Mack, here’s the explanation. Med Ad News didn’t pick Allergan as Most Admired Specialty Company — our readers did, in online polling. But Allergan didn’t supply the writeup; Managing Editor Andrew Humphreys did, from examining Allergan’s own press releases and reports. Since the readers picked Allergan as the most admired among the top 25 specialty drug companies by revenue, he had to write about why they might have done so. Yes, we know about the falling sales of Botox and FDA investigations; I believe our readers do as well. Yet, they still picked Allergan, which meant we had to focus on the things that may have spurred their decision. As Mr. Humphreys put it to me, “My job is not to point out the problems for the companies that are voted as winners, because all companies have issues in one way or another. This story was about what makes them admirable. We have other forums to discuss issues such as drug advertising regulation.” By the way, I doubt “Joe the Investor” is reading us; our circulation is to the pharma and marketing industries and some academics. But your criticisms are being taken constructively; they’ve given me some ideas as to change the format of these writeups for next year. Stay tuned …