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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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November 12, 2012

Oh Yeah, Now That You Mention It, They're Dead

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Posted by Derek

The overhyped nature of stem cell therapies is a topic that's come up here several times. In the latest developments, Pluristem, Inc., is threatening to sue Bloomberg New for their recent report, titled "Girl Dies As Pluristem Sells On Gains With Miracle Cells". Gosh, it's hard to see why the company would take exception to a headline like that, but here's how the piece leads off, in case things weren't clear:

Pluristem Therapeutics Inc.’s (PSTI) stock doubled in Nasdaq trading from May through September, helped by three news releases announcing that patients’ lives had been saved by injections of the company’s experimental stem cells.
After the stock soared on the positive news, two top executives profited by selling shares at the highest price in more than four years as part of a pre-determined program. When the first of those patients, a 7-year-old girl with a bone- marrow disease, died four months after the company said her life had been saved, Pluristem was silent. The company raised $34 million selling shares a week later.

Not so good. But as that link in the first paragraph shows, Pluristem's response has not cleared things up very much. In the same press release in which they demanded a correction from Bloombert, they revealed that another of their three initial patients had also died after four months, which also had not been announced before. The earlier press releases for all three patients are well-stocked with phrases like "medical miracle" and "life-saving". As long as this sort of thing is going on, the stem cell field will continue to have problems.

Update: interestingly, this post seems to have brought a lot of Pluristem's stock market fans flocking. And I mean this in the best possible way, but their appearance here does not inspire confidence.

Comments (30) + TrackBacks (0) | Category: Clinical Trials | Press Coverage


COMMENTS

1. neto on November 12, 2012 8:53 AM writes...

the cells only support the existing bone marrow but cant hill the cancer. they did their job. I put a Tusik on blumberg

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2. Morten G on November 12, 2012 9:19 AM writes...

facepalm.gif

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3. Hap on November 12, 2012 9:23 AM writes...

Wouldn't the death of one of the patients in your trial be considered a material event? Aren't you supposed to disclose those when they happen?

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4. avatar on November 12, 2012 9:25 AM writes...

good news for pluristem soon to come and it seems like some one wants his share for cheap...
i still belive in the company.

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5. Ortep on November 12, 2012 9:30 AM writes...

The company administers an experimental therapeutic and doesn't monitor the progress? No way. Conveniently unreported for financial gain. As long as this type of unethical behavior goes on, it becomes even more difficult for biotech/pharma as a whole to convince the conspiracy theorists that the whole industry isn't evil.

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6. suave shampoo on November 12, 2012 10:12 AM writes...

Hype. Sell. Find out the box is empty. (repeat)

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7. Nekekami on November 12, 2012 11:04 AM writes...

If it hadn't been for the companies earlier claims of "medical miracle" etc, I'd have said Bloomberg would have owed them an apology of sorts... But given the earlier claims, and the fact that two out of three initial patients had died within 4 months KIND of makes those claims somewhat hollow...

Couple that with the obvious stock pump and dump, and you have reasons for putting them on various business ethics watchlists...

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8. Dror on November 12, 2012 11:35 AM writes...

Dear Derek - I read your article and I'm embarrassed. Since I was following Pluristem's response all along when these events took place - I know for 100% that Pluristem's management was 100% transparent on this case. Back then I read CEO Zami responding to the news about the death of the child in the press. There was no need for an official company press release - legal or another. I think what you do is a more unprofessional than what you refer to Pluristem. I'm sure you were a bit more evidence-based in your PhD. At least they don't poison healthy people like the drug companies - a place where you found your living all your life.

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9. אופיר on November 12, 2012 11:54 AM writes...

מושחטים!!!!אתם רוצים לקנות בזול את פלוריסטם???לא יעזור לכם פלוריסטם תצליח על אפכם וחמתכם!!!!עם ישראל חי

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10. אופיר on November 12, 2012 11:54 AM writes...

מושחטים!!!!אתם רוצים לקנות בזול את פלוריסטם???לא יעזור לכם פלוריסטם תצליח על אפכם וחמתכם!!!!עם ישראל חי

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11. אופיר on November 12, 2012 11:55 AM writes...

מושחטים!!!!אתם רוצים לקנות בזול את פלוריסטם???לא יעזור לכם פלוריסטם תצליח על אפכם וחמתכם!!!!עם ישראל חי

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12. אופיר on November 12, 2012 11:56 AM writes...

מושחטים!!!!אתם רוצים לקנות בזול את פלוריסטם???לא יעזור לכם פלוריסטם תצליח על אפכם וחמתכם!!!!עם ישראל חי

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13. Rord on November 12, 2012 11:57 AM writes...

Market Alert! Fantastic penny stock investing opportunity. PSTI‎ - Pluristem Therapeutics Inc - is primed to pop on Tuesday. Invest now.

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14. אופיר on November 12, 2012 11:57 AM writes...

מושחטים!!!!אתם רוצים לקנות בזול את פלוריסטם???לא יעזור לכם פלוריסטם תצליח על אפכם וחמתכם!!!!עם ישראל חי

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15. STEVE on November 12, 2012 12:28 PM writes...

The company needs to me fined twice what it made by that move, they put all stem cell therapy in to question in folks minds, never a good thing. My old mum has had stem cell therapy for fibromyalgia and after some immediate minor positive results, has also had some not so great results, but stands firm at this point that it is 'working' she's keeping her self busy by running a website following her progress and answering any questions etc www.stmcellpatient.net Jean Beardsall

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16. newnickname on November 12, 2012 12:58 PM writes...

@1: What does "I put a Tusik on blumberg" mean? What's a "Tusik"? A curse?

@9 (10, 12): Please post in English, but just ONCE. (Hit "Post" once and be patient for Corante's slow servers to process the submission.)

@11: With the expletives deleted, I think #11 says "Post in English."

@8 Dror: RESPONDING to a direct question is not the same as widely releasing a positive news statement. I disagree that there was no need -- legal or otherwise -- for a new press release. There was an ETHICAL need.

I find it very hard to believe that no one at Pluristem knew what was going on. I don't know about Israel, but in the US you still need FDA approval for compassionate use and there are additional requirements such as to provide follow-up treatments, if needed.

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17. Erez on November 12, 2012 2:09 PM writes...

I think its a spin. The product is good and it proved itself for what its worth. The results are still mind blowing with a potential to bust a market, even if 2 out of 3 past away. We can not determine their deaths were related to the product abd if you have been following the stock the way i have then you would know that every once in a while the company releases a statement or there is this analyst recommending and it inflates and then deflates but all in all the potential is still there

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18. Dr. Manhattan on November 12, 2012 2:12 PM writes...

Dror said: "I think what you do is a more unprofessional than what you refer to Pluristem. I'm sure you were a bit more evidence-based in your PhD. At least they don't poison healthy people like the drug companies - a place where you found your living all your life."

The next time you get an infection, please do NOT take our poisonous antibiotics. If you have surgery, please do NOT take our poisonous anesthetics or our poisonous pain relief compounds. If you develop high blood pressure, please do NOT take our poisonous ACE inhibitors or beta-blockers, and do not lower your cholesterol woth our poisonous statins.

Have a nice soothing, yogurt based enema instead...

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19. Hap on November 12, 2012 2:41 PM writes...

Dr. Lowe had talked about previously what defined "material information":

As a lawyer in this business once said to me at a meeting, "I have to make sure that no one in this company trades our stock on material information. And material information is defined as something that makes you think about trading the stock."

If the improvement of the patients given their stem cells was material information, why weren't their subsequent deaths material information? The latter ought to have made someone think about selling the stock, but the company didn't say anything. That seems curious.

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20. Dror on November 12, 2012 4:17 PM writes...

To Dr. Manhattan: you have a point! I know I was generalizing too much. Still, many drugs and especially psychiatric drugs are ineffective and destructive. I've heard that from psychiatrist doctors who don't believe in the drugs they subscribe to their patients. I also read about a very recently on Newsweek http://www.thedailybeast.com/newsweek/2010/01/28/the-depressing-news-about-antidepressants.html

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21. B on November 12, 2012 4:34 PM writes...

It is interesting how this company appears to have developed a cult-like following...

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22. MoMo on November 12, 2012 4:36 PM writes...


How come only 3 patients were reported in the news releases?

Shouldn't they have waited for more tangible and realistic and statistical results?

Is there such a thing as statistical results in compassionate use therapy?

They didn't know of their death at the time of the financing?

Didn't they monitor these patients daily post-treatment?

Too many questions that only the invested, resolute or time will answer.

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23. eugene on November 12, 2012 6:06 PM writes...

So, what was it that killed that girl more than 180 days later? Maybe it'll turn out like gene therapy and it was some side-effect that they didn't expect. Like the stem cells causing a new tumor to grow... that needs just about a year to develop and kill

Hey, if Pluristem can put out a bullshit press release not based on trial data, then I can do it to. Maybe Dror and Erez would be advised to back down when the going looks bad from a scientific standpoint even, not only ethical by now with all these deaths. Certainly that's the advice to Pluristem. Do clinical trials and release the results at the end and don't try to hype the results too early. Otherwise you'll have Orac writing about a story about you.

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24. WT on November 13, 2012 2:50 AM writes...

The patients are what they call heroes, necessary sacrifies for the goods of others...... in short: collateral damage.....

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25. WT on November 13, 2012 2:50 AM writes...

The patients are what they call heroes, necessary sacrifies for the goods of others...... in short: collateral damage.....

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26. Anonymous on November 13, 2012 2:55 AM writes...

looks like you have the Pluristem PR team on to you Derek...

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27. Anon on November 13, 2012 10:18 AM writes...

Some of these comments read like they do on the Yahoo/Google/etc-stock message boards.

You really want to see these things work, especially when it involves adolescents. Should a company like this go under, where would the some of that internal information go? Is there any mechanism in place to take lessons learned back to someone like the NIH for public disclosure? Or is the only hope for those scientists to move on to related companies where they can share what they learned?

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28. Academic on November 13, 2012 4:38 PM writes...

I have followed Derek's blog for many years and this is the first time I am actually writing a post. I am both embarrased and scared reading about how, almost fanatically, some posts at the forum argue. From how they phrase themselves it is clear that they have no scientific background at all. Arguments like:
- The product is good, the girl could have died from something else.
or
- I once read in a non peer review magazine that some drugs are bad, which makes it ok for me to insult Derek and makes my claims very trustworthy.

And in the end they always end with (between the lines). "Skip the ethics talk (read "we do not understand that") this is about money".

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29. Derek Lowe on November 13, 2012 8:40 PM writes...

#28 Academic:

No worries; this isn't the usual crowd around here. My mention of the company brought in a bunch of its fanatic stock boosters, and like stock fanatics everywhere, they're largely a bunch of tunnel-visioned yo-yos. They won't hang around, unless I mention The Beloved Stock again. A lot of small "story stocks" have these followers; there seems to be an endless supply of them.

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30. מסעדת דגים on October 3, 2013 8:48 AM writes...

Hi, I check your new stuff on a regular basis. Your writing style is awesome, keep
doing what you're doing!

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