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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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May 27, 2010

Pfizer Halts a Trial Early - On Good News

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Posted by Derek

Pfizer was able to announce some good news today - their trial of Inspra (eplerenone) for patients with a particular combination of heart failure symptoms. The trial was halted early, but (for once) because the endpoints were reached so early that it would have been unethical to continue the placebo arm. It's always nice to hear about one of those; we don't get them that often.

The drug is an aldosterone antagonist which had already been approved several years ago for heart failure and hypertension, so it's not really a surprise that it worked in this population. But you never know, and Pfizer wanted to be able to get specifically recommended for patients of this type. And that they will.

Comments (17) + TrackBacks (0) | Category: Cardiovascular Disease | Clinical Trials


1. RandDChemist on May 27, 2010 8:31 AM writes...

This is the sort of thing that big pharma needs to do more of, explore connected avenues to make sure you maximize return on all the development. Even look at some that are not so well connected.

Good news for the science!

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2. Biotech guy on May 27, 2010 9:28 AM writes...

I currently take spironolactone (aldosterone antagonist) for heart issues. This generic medication seems to be working nicely, but I wonder how much Pfizer's new & improved version will cost??

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3. Hap on May 27, 2010 9:52 AM writes...

Probably a lot, but at least you know it works (and probably works well).

At least something worked out well.

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4. The Pharmacoepidemiologist on May 27, 2010 10:23 AM writes...

Actually, if the smartest guys in the room who these days are the ones running pharma companies (and who direct R&D at these companies) were physicians with a knowlege of where there are truly unmet medical needs and what research is needed to address those needs, there would be many more trials endings like this one. Unfortunately, the world doesn't hunger for another diabetes drug which kills people or a marginally effective Alzheimer's drug, or yet another cancer drug that for $50K a year will give patients another 4 weeks of life. In a nutshell, that's the problem: managements in over their head and just making it up as they go along. Playing house, especially pharma house, costs everyone a lot of money, and likely destroyed the public's confidence in the industry for a generation. And that distrust was well earned.

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5. anon2 on May 27, 2010 11:17 AM writes...

G.D. Searle

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6. anon on May 27, 2010 11:31 AM writes...

"Pfizer wanted to be able to get specifically recommended for patients of this type"

Wow, this is a big contrast to the usual pharma strategy of simply running adds and selling to promote off-label uses, and then when the FDA catches up to you six months later and slaps you with a fine, happily pay it because it's a couple of orders of magnitude less that what you made from the off-label marketing...

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7. anchor on May 27, 2010 1:02 PM writes...

“Pfizer was able to announce some good news today -their trial of Inspra (eplerenone) for patients...”. Well for people who have been in this business long enough, they will not be hoodwinked. Pfizer did not stop the trial for the sake of good news, as it claims. I reckon that they stopped the trial before the bad news came out. Longer clinical trials always results in bad news usurping the good one

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8. RandChemist on May 27, 2010 2:23 PM writes...


What evidence do you have? Some sources would be nice.

In the case of at least some clinical trials, if there is some clear therapeutic benefit to the patient, then the sponsor is obligated (ethically) to halt the trial.

Someone more knowledgeable can certainly provide more detail and correct anything that is wrong with what I've stated here.

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9. Jose on May 28, 2010 6:52 AM writes...

Off-topic, but high relevant to several earlier posts....

What Will Be the Hot Jobs of 2018?

"...a college student is studying for a science career in the fast-growing field of nanotechnology—working with materials at the molecular or atomic level. [snip] That makes her one of the lucky ones—a young adult whose career passion is in sync with one of the hot jobs of the near future.

Ms. McDonald found her passion through a community-college nanotechnology program funded by the National Science Foundation, where one official foresees hundreds of thousands of job openings in the field in the next five years."

Hundreds of thousands!?? Perfect overlap with all the currently laid off chemists!

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10. Jose on May 28, 2010 6:54 AM writes...

From the Wall Street Journal.

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11. anon on May 28, 2010 8:12 AM writes...

I wonder whether this utility was reasonably assumed a priori.

I guess increasing the willingness of large drug companies to conduct good clinical experiments (by threat of legal consequence) is a good thing.

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12. Matthew Herper on May 29, 2010 5:42 PM writes...

A couple quick points. Biotech guy: Inspra, which was launched in 2003, costs about $150 a month.

There is already a generic available, at about $100 a month. Spironolactone costs between $4 and $20, depending on your source, I'm told.

Inspra was never used much, because cardiologists didn't see it as that different from spironolactone. It's biggest differentiating factor is that it doesn't cause gynecomastia, but that's a rare side effect.

I was really excited when I saw this result cross, but on examination I don't think that this is going to boost Inspra sales much.

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