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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: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« ACS Webinars on Drug Discovery | Main | InterMune Comes Through »

February 25, 2014

For Immediate Rewording. Uh, Release.

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Posted by Derek

Here's a nice look at why you should always think about the source of the financial and business information you read. It details the response to a recent Pfizer press release about palbociclib, a CDK inhibitor that's in late clinical trials.

Someone at The Wall Street Journal wrote that it had "the potential. . .to transform the standard of care for post-menopausal women with ER+ and HER2- advanced breast cancer." Problem is, that phrase was lifted directly out of the press release itself (and sure sounds like it), and you really would hope for better from the WSJ. What we're seeing here is actually Pfizer's own spin on the (as yet unpresented) results of the PALOMA-1 clinical trial. Everything a company says at this point will be couched in terms of "could" and "has the potential" and "we hope", and will come with one of those paragraphs at the end about "forward-looking statements". When it comes to the first statements about clinical trials results, if there are no numbers, there is nothing to talk about.

Paul Raeburn, the Knight Science Journalism blog author who picked up on this, also found that someone at the AP (and others) went for Pfizer's spin, too:

The problem is that this story was covered by business reporters rather than medical reporters, who by and large are too smart to fall for a company's claim about a drug without seeing the evidence presented, reviewed, and debated.

The further problem is that because they are so smart, medical writers mostly declined to cover this story. Which left the business writers out there alone, telling the story the company wanted them to tell.

Well, "medical writer" is a broad term, and believe me, there are some slackjaws in that crowd, too. But point taken - anyone who's been paying attention, or anyone who's willing to spend a few minutes on Google, should have realized that Pfizer is trying to make the case for accelerated approval of palbociclib, especially after the recent failure of dacomitinib and strong competition from Novartis in exactly the same therapeutic space.

Pfizer, of course, is not going to come out and talk about how delighted they are about the Phase II results unless they can back that up with something. I hope that palbociclib bowls people over - a new therapy for breast cancer would be good news. But we haven't seen the data yet, and data are all that will (or should) make pulses race over at the FDA. So I think that the Pfizer press release was worth noting, but stories like the Fierce Biotech one linked in the paragraph above are the way to do it. Put the news in context - don't just reword the press release.

Comments (17) + TrackBacks (0) | Category: Cancer | Press Coverage


COMMENTS

1. Anonymous on February 25, 2014 8:18 AM writes...

In God we trust. Everyone else, show the data!

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2. mb on February 25, 2014 8:39 AM writes...

The thing to remember is that this is an issue with almost all science reporting. My feeling on this, at least they got it right since they copied it word for word. I have been interviewed by reporters and while they sit there and nod, almost every thing that is said is going right over their head. They took journalism, probably to avoid science and math, their reports when you actually know what they are reporting on, are almost always wrong.

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3. Teddy Z on February 25, 2014 9:19 AM writes...

#1...I prefer Trust but Verify.

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4. Anonymous on February 25, 2014 9:41 AM writes...

The book "flat earth news" by Nick Davies (Who perused the news international phone hacking story) claims that most journalism now is re-written press releases anyway.

As staff are cut back and forced to write more stories increasingly quickly writing up the PR copy is probably the only way to keep a job in journalism.

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5. Jesse McKeown on February 25, 2014 10:20 AM writes...

Is it entirely coincidence that "palbociclib" looks like "placiboclib"?

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6. The Iron Chemist on February 25, 2014 10:42 AM writes...

Whenever I feel despondent about the state of science, I can always take comfort in the fact that I'm not a journalist. THAT career's really gone down the tubes.

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7. Bernard Munos on February 25, 2014 10:55 AM writes...

Lilly was the beneficiary of a similar situation last week when it announced that ramucirumab had met end points in a Ph3 trial against NSCLC. No data provided to show whether this is clinically significant, but the stock promptly picked up 5%. (As is customary, the data will be disclosed at a future conference.) It just shows that the valuation is currently driven more by psychology than fundamentals.

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8. Anonymous on February 25, 2014 1:14 PM writes...

We work on the drug in my academic lab (used to be called PD0332991), and I can tell you that it is pretty incredible in how specific it is for cdk4/6 and how impressive the induced cell cycle arrest is. This is one I would bet on. Not sure how to bet on it, though. Does one potential blockbuster really affect stock price in a way that can be exploited if you really believe in it?

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9. PFE legal on February 25, 2014 2:04 PM writes...

#8, we will be investigating your compliance with our mutually established nondisclosure agreement. Legal has already obtained your IP address from Corante.

Permalink to Comment

10. Anonymous on February 25, 2014 2:21 PM writes...

#9
Ha! Go to pubmed, search PD0332991, and you will know everything I know.

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11. Derek Lowe on February 25, 2014 3:00 PM writes...

#9, that's the stuff to give those weasels. Besides, sending a lawyer to PubMed pretty much guarantees that you'll never see 'em again. . .!

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12. RTW on February 25, 2014 3:04 PM writes...

#8 Anonymous - Yes the exact same could be said for PF-00299804(Dacomitinib) which came before. It was quite an incredible drug in preclinical as well. Somehow or another it incredibly managed to fail in two recent trials? I was very shocked at the results. But on the other hand - we know now that EGFr inhibition does result in eventual EGFr drug resistance. So perhaps it was the study design? I think they allowed participants that had already been treated previously with an EGFr inhibitor. I suspect we won't see the end of 299804.

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13. Hap on February 25, 2014 3:27 PM writes...

If they don't have any new data, what are they writing a press release for other than to pester the FDA to give them accelerated approval? Why should people care?

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14. Anonymous on February 25, 2014 9:13 PM writes...

If I was the FDA I would put out a press release saying the FDA might potentially reject the drug, see if that stops Pfizer publishing such empty drivel in future.

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16. Anonymous Big Pharma Researcher on February 26, 2014 6:51 AM writes...

"...serves as a reminder for investors seeking stock advice on the Internet: what you read may not be what it seems...shows the tenuous existence of a biotech firm that largely built its profile on an unproven product, the potential vaccine called E75 and since trademarked as Neuvax...potential class-action lawsuit... insiders sold nearly $10 million worth of stock in the last two months."

http://www.oregonlive.com/politics/index.ssf/2014/02/lake_oswego_firm_galena_biopha.html

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17. GM on February 26, 2014 10:01 AM writes...

Isn't that how most of the press release's are without specific numbers? Usually they release the actual numbers at a major conference as a key presentation. Why do you think they would issue a press release if the trial didn't meet the primary end points? Also you cant pester FDA to approve a drug just based on press releases....

A lot of assumptions are being made:). Don't you want to see the data before you do that?

See press releases from other companies with similar language -


http://www.novartisoncology.com/newsroom/media-releases.jsp?id=1762942&year=2014&page=1

http://www.gsk.com/media/press-releases/2014/gsk-announces-headline-results-for-phase-iii-study-of-the-combin.html

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