(Update 12/04 – This breaking news blog entry is moved to the top as the blogosphere continues to react.)
More on this HDL-raising drug’s stunning collapse. There’s talk Pfizer stock will drop to $20. I’m disappointed myself, since there is no reliable way to raise HDL, save for niacin and fibrates. I thought they were idiots not to test it alone, but only in conjunction with Lipitor. Was it the combination of the two that lead to the increased deaths? We’ll never know now.
Clinical Cases and Images:
“We are back to square one — there is no highly effective pharmacological treatment for low HDL apart from Niacin which usefulness is limited by unpleasant side effects (flushing) and poor glucose control in diabetic patients.”
“As painful as it must have been, Pfizer did the right thing. They will feel the sting in their stock price over the short term, but in the long term, they saved many more lives with their bold decision and will survive to develop another blockbuster drug another day.”
“This is a complete clinical disaster: the world’s largest drug company just ditched their potential biggest drug. And this comes two days after a press conference where they talked about how they were planning to submit it for approval within months. Development of torcetrapib, the cholesteryl-ester transfer protein inhibitor designed to raise HDL levels, has been halted. Last week, that sentence would have been the subject of nightmares at Pfizer, but now it’s the top of the news. No alarm clock buzz will make it go away. If you’re looking for an example of just how difficult drug development is, look no more.”
“Back in mid-October, Pfizer Chief Executive Jeffrey Kindler, at a Wall Street analyst meeting, softened Pfizer’s message on torcetrapib’s chances for early and resounding success. At that time, everyone was focused on the worry was over the discovery that torcetrapib raised systolic blood pressure an average of three to four millimeters of mercury.
Would a few millimeters prevent the risk-adverse FDA from approving the drug no matter what the benefits or did Mr. Kindler know something his medical consultants and chief medical officer did not know?”
Peter Rost, gleefully taking the opportunity to kick Pfizer when it’s down:
“Of course, in the drug industry, bad stuff happens. But in this particular case, the whole scientific world had been worried about the fact that torcetrapib raises blood pressure. Not a good thing for a cardiovascular drug. But that didn’t stop the Pfizer executives from hyping torcetrapib. Until it turned out that “one of the most important developments in our generation” was really a killer drug””quite literally.
And this is what makes Pfizer”˜s CEO Mr. Kindler and Pfizer’s research chief Dr. LaMattina officially the most clueless executives in the drug business.”
“I wonder if Pfizer is literally giving up on torcetrapib completely, or will they develop this for a high risk population? My guess is that Pfizer will give up completely, and not want to risk Baycol-like lawsuits.”
Update 12/04 –
“But beyond that it is also a pointer that some of the easy “targets” such as heart disease and diabetes may be nearing their natural limits for medication therapy, and that lifestyle changes, the old “diet and exercise” may really be the best way to deal with them””allied of course with the generics which were the blockbusters of yesteryear. Almost all the growth in the drug business in the last few years seems to be in niche and very expensive biologics for virtually orphan diseases.”
Molecule of the Day:
“Torcetrapib wasn’t the only in-pipeline CETP inhibitor (in fact, Pfizer has others), but this is going to make everyone take a long, hard look at the class.”
Steven Nissen, M.D. via the NY Times:
“This drug, if it worked, would probably have been the largest-selling pharmaceutical in history.”
“And if it had worked, and was the largest selling drug in history, then Pfizer would have been constantly attacked for their greed and excessive profits. Will any activists now lament the $1 billion lost? . . .
. . . Anti-market “activists” frequently demand that profits for companies like Pfizer be “limited”. Yet there is no way to limit losses. And more drugs fail than succeed. For every one drug that goes to market thousands are shelved. And of those that do go to market only 30 percent cover their costs.”
Update #2, 12/04 –
“Withdrawing this drug is a victory for patients, although we mourn those who died prematurely participating in this study. These studies are a victory for careful research and independent monitoring boards.”
Jim “Mad Money” Cramer:
“Maybe they really are a bunch of jokers at Pfizer. Either that, or their timing is just nightmarish. I can’t believe that two days after the company discussed a new cholesterol drug at its analyst day that they scrap it.”
Update #3, 12/04 –
The Reflecting Pool:
“Why is this receiving such attention? Why do we worry about Pfizer’s health so much, when primary prevention trials – which could obviate the need for these heart drugs altogether – fail consistently? If we spent half of what Pfizer spent on R&D (or marketing for that matter) – we’d have lots to work with in primary prevention.
But no…that’s not our culture. Pfizer can turn psychogenic erectile dysfunction into a disease and then sell us costly medications for it. They can do anything.”
WSJ Law Blog:
“The legal community is already atwitter about whether litigation will ensue from torcetrapib’s demise. Says defense attorney Richard Scheff, a partner at Montgomery, McCracken, Walker & Rhoads: “You can bet there are very creative, smart plaintiffs’ lawyers who have their thinking caps on as you and I are talking right now.”
The company is unlikely to get hit with personal injury lawsuits because the patients took torcetrapib in clinical trials. According to Roger Morris, health group chair at Quarles & Brady, there’s some fairly standard language used in informed consent that typically absolves companies of liability in clinical trials at the negligence level or below. “They can still be liable for gross negligence or fraud,” Morris says, adding that this is rare.”