Healthy Skepticism Library item: 5460

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Publication type: news

From Pfizer, Irrational Exubera?
Business Week online 2006 Jul 17
http://www.businessweek.com/magazine/content/06_29/b3993052.htm

Full text: JULY 17, 2006 From Pfizer, Irrational Exubera?

The SEC Isn’t Finished With Hedge Funds

NEWS: ANALYSIS & COMMENTARY

From Pfizer, Irrational Exubera?
Its insulin inhaler may not be as big a diabetes blockbuster as expected

Janet Ruhl may be Pfizer Inc.‘s (PFE) worst nightmare. Ruhl, who injects a small amount of insulin each day to control her diabetes, has been dissing Pfizer’s soon-to-debut diabetes remedy on her new blog and on a Web discussion group. The treatment, Exubera, is the first product that lets diabetics inhale insulin powder rather than inject the drug. But Ruhl, a 57-year-old software developer and author from Gill, Mass., says she thinks Exubera will be hard to use and could cause lung damage. “It looks like a terrible idea,” Ruhl says.
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Pfizer executives have told Wall Street analysts Exubera could ultimately bring in $2 billion a year in sales. But amid mounting resistance from patients and physicians, some analysts now wonder if it will be worth even half that much. “We feel they will fail to gain traction,” says Sanford C. Bernstein & Co. analyst Richard T. Evans. Dr. Michael Berelowitz, a senior vice-president at Pfizer, responds that there is “quite a lot of pent-up interest” in the drug.

Pfizer could use a new blockbuster. In the month of June alone, its $12 billion cholesterol-buster Lipitor came under attack when a competing drug went generic; it pulled out of a partnership to develop a promising insomnia treatment; and its blockbuster antidepressant Zoloft lost its patent protection. With the loss of such gold mines, the pressure on Exubera only increases.

Exubera’s big virtue was supposed to be that it’s inhalable, but even that could prove to be a liability. Some patients in the clinical trials suffered lung problems. Pfizer recommends that physicians withhold the drug from patients who perform poorly on a lung-function test. Those who get the drug will need to have their lungs retested periodically. With such hassles, “there’s not a lot of enthusiasm,” says Dr. Joel Zonszein, director of the clinical diabetes program at Montefiore Medical Center in New York.

Pfizer’s pricing plan could also be a turnoff. The list price of $122 to $140 a month is at least 33% higher than that of injected insulin, according to a June 22 report from Cowen & Co. That means most health insurers will charge their highest co-pays for the drug, and they could impose limits on who can get it, dooming prescribers to endless paperwork and phone calls.

Then there are the clumsy qualities of the inhaler. Exubera’s insulin doses come in only two sizes, making it hard for patients to tweak their intake based on their meal or exercise plan for the day, warns Dr. Richard A. Jackson, a senior physician at the Boston-based Joslin Diabetes Center. Plus, when the device is unfolded, it’s about the size of a can of tennis balls. Some patients may be embarrassed to use it in public. Pfizer executives have been talking up Exubera as the pain-free alternative for patients who are afraid of syringes. But the runaway success of a new drug called Byetta — which patients inject twice a day — has sent the whole idea of the needle-phobic patient right out the window, physicians say.

Pfizer considers Exubera a revolutionary new choice, and Berelowitz says the company has launched “a hugely extensive education campaign” to train physicians and nurses how to incorporate the device into a complete diabetes care regimen. To ease lung-safety fears, the company has launched a trial of 5,000 Exubera users. “We’ll study them for as long as it takes” to ensure the drug is safe, Berelowitz says.

With Exubera doubts on the rise, Pfizer is on the offensive. Its sales machine is gearing up to target diabetes specialists and general practitioners. Pfizer has not revealed its advertising plans, but Bernstein’s Evans estimates the company will spend more than $50 million a year pitching Exubera directly to consumers. With competitors racing to develop inhalers that are less clunky than Exubera, Pfizer is hard at work on version 2.0. “We’re not going to sit back,” Berelowitz says. READER COMMENTS
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Nickname: kathym
Review: Since everyone is so anti-pharma, let’s just close down all the pharma companies and forget about treating any kind of condition. Everyone will be so much better off without big bad pharma.
Date reviewed: Jul 10, 2006 5:57 PM
Nickname: qcmicrobiology
Review: How can everyone feel and/or think so badly about Exubera? I work at the facility where this wonderful new, innovative drug is being manufactured, and to hear so much negativity is disturbing. For years we have heard so much about people wanting something other than shots to deliver their insulin, now that it has become available, the usual group of naysayers have come out of the closet and jumped on the bash-the-drug-company bandwagon. Why not talk to the individuals who have been using this product in clinical trials for the past 3-5 years and see what they have to say? I’m sure you will hear a whole different story. And no, Pfizer is not out for only money with this drug. If that were the case it would have been scrapped years ago. This has been the most expensive drug to ever bring to market, with no profits being seen for a few years, so that is not a valid argument. Why not try a new one for a change, or try to research your stance before leaving ill-informed comments?
Date reviewed: Jul 10, 2006 5:44 PM
Nickname: KGI
Review: Do not underestimate the power of Pfizer’s sales and marketing team. The company sells a blockbuster for erectile dysfunction!(Who knew there would even be a market for that?). The bottom line is that Exubera is not perfect, but it is the first inhalable insulin invented. Given that any other alternatives (Byetta LAR, Insulin pills (Merck I think.), and Aradigm and Mannkind’s inhalable device) is still years from approval, Exubera may just grab enough of a lead.
Date reviewed: Jul 10, 2006 5:41 PM
Nickname: mie
Review: Saveyorlungs, why do you blame the doctors? We don’t gain any benefit financial or otherwise. The concern is, why was this drug approved prior to this 5,000 patient study to assess possible lung damage, are Pfizer’s employees so geared to PFE’s stock price and their bonuses that only now will they do a study that really should have been performed initially?
Date reviewed: Jul 10, 2006 4:59 PM
Nickname: SaveYourLungs
Review: What a waste of money all the way around. The billions would have been far better spent trying to cure diabetes. We know for certain that injected insulin does not damage lungs. Shame on the doctors who have made so much money on this. Did they forget the oath that states “do no harm”?
Date reviewed: Jul 10, 2006 4:21 PM
Nickname: Dan
Review: This article is a complete joke. How is it now that blog opinions are news? The fact is, patients who were part of Exubera studies begged not to have the inhaler taken away from them after the studies. Pfizer has mentioned this, as did an article over the weekend that said many people in Canada were begging to get Exubera approved. Many of those people were part of the study. Instead of actual patient experiences BusinessWeek cites a blog? This is shameful, and indicative of a reporter who wanted to do all of their research within a 10 minute window. http://www.canada.com/topics/bodyandhealth/story.html?id=f0e3a8f8-e4b9-4846-b6fc-879a2a505447&k=53923
Date reviewed: Jul 10, 2006 3:36 PM
Nickname: Derek Lowe
Review: I expressed similar doubts earlier this year (http://pipeline.corante.com/archives/2006/02/15/pfizer_takes_a_deep_breath.php), but my readers were divided on the issue. But one way or another, Pfizer has problems.
Date reviewed: Jul 10, 2006 3:32 PM
Nickname: Pat
Review: I have encountered this idea that some physicians have that needle phobia is easily curable. They are so wrong. I would not like it but will definitely pay an additional 30% for the ability to not see another diabetic shot. I am also realistic in that if there are only two levels of shots then the use of a booster by shot may need to be available.
Date reviewed: Jul 10, 2006 3:18 PM
Nickname: Moedoc
Review: As a physician, I see no reason to prescribe this. Insulin, no matter what form it comes in, is not the answer to the problem of diabetes.Giving insulin is analogous to putting ethanol in a Hummer; we need to decrease the demand, not change how the supply id delivered.
Date reviewed: Jul 10, 2006 2:55 PM
Nickname: chet
Review: The thing is, no matter what drugs you use you are taking a chance at making something else go wrong—like for instance, your liver. Drugs may be good for combatting a problem and at the same time it will be creating another. The drug companies don’t care because all they are interested in is the money.
Date reviewed: Jul 10, 2006 2:29 PM
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