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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

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June 10, 2010

Nativis: In Which the Distant Footfalls of Lawyers Can Be Heard

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Posted by Derek

I've received a letter from John Kingma, the Chief Financial Officer of Nativis. I reproduce it below word-for-word (Here's the PDF of the original, in case anyone would like to check):

Dear Dr. Lowe,

The scientific nature of your blog seems to have taken a turn for the worse with the negative personal attacks on John and Lisa Butters and othe rmatters related to Nativis. The comments have gone far beyond reasoned scientific debate, skepticism and criticism. In fact, the overall tone seems to have degenerated into something resembling the Internet bulletin boards of old, with personal attacks, sexual comments and statements that may well amount to libel and defamation of character.

It appears to us that that the same person, using multiple names, is responsible for many of the negative personal comments (indications are that this is a person who bears a personal grudge against John Butters, and who now seems intent on ruining his reputation and that of Nativis). It seems clear to us that you have permitted unprofessional, bizarre, and even potentially activity prohibited by law to be conducted by this commenter and others on your blog site, activity that clearly overrides the scientific debate.

No one in the Nativis family has experienced anything so outrageous and unprofessional as the content of your blog site. I don't know if the current non-scientific banter is what you intended for your blog - essentially now a forum for personal attacks. Not only have you allowed theses attacks to be posted, you have also been selective in posting (screening out) information that would be more favorable to Nativis, such as the positive pre-clinical research data that John Butters provided you, showing how drug signal therapy reduced tumors in mouse models.

Moreover, apart from personal attack comments, your blog also contains comments from a person who announced his attempts to gain access to Nativis's facility. In fact, he visited Nativis's site, posing as a representative of your blog, The Pathfinder. When he was turned away by security, he reportedly took photographs or videos through office windows. His actions were reported and encouraged on your site. His actions may well have been illegal.

We have asked counsel to take a look at what is happening on your blog and the activities by commenters promoted there, and to recommend a course of action. But everyone at Nativis would rather get past this unfortunate situation and spend 100 percent of our time advancing our technology.

In that regard, may we suggest that in the best interest of all parties that you moderate your blog, focus on the scientific debate, delete all personal attacks and prevent personal attacks from occurring in the future? That would seem fair and reasonable, while also keeping the scientific debate going.

Thank you, in advance, for the consideration. I look forward to your response.

Sincerely,

John E. Kingma
Chief Financial Officer

Well. I suppose that the rest of this post should begin with "Dear Mr. Kingma:"

I am, as you see, in receipt of your letter of June 9. Allow me to comment on it, so that we may understand each other.

Your first objection is that the tone of some of the comments to my two posts on Nativis have "gone far beyond reasoned scientific debate". A less charitable observer might say that the claims that Nativis makes for its technology have long since occupied that territory. But I've actually tried to be charitable. Until your letter arrived, most of the criticism I'd received from readers and colleagues in the industry was that I'd been far too tolerant in my discussion of your company.

Your CEO, in addition to sending me papers on such disparate subjects as the Mossbauer effect (and offering generously to send along a large book on quantum electrodynamics), did indeed provide a graph of what is said to be the effect of your most advanced. . .well, let's call it a "therapeutic agent" in a mouse model. This does not help me as much as you seem to believe it does. Imagine some other company claiming that they can show effects in a mouse xenograft model though the intervention of invisible pink unicorns - and providing a dose-response curve as proof. Extraordinary claims, which yours surely are, require extraordinary evidence, and I don't see how you can possibly provide enough in a blog forum to convince your critics. Besides, this would be a waste of your time. You will surely be generating a tremendous amount of data in preparation for your company's IND application, and I certainly can't ask you to share all of it. Convince the FDA, and you'll have gone a long way to convincing everyone else.

Now, to your observations about my blog's comment section: I do not actively moderate it, except to occasionally remove duplicate posts. No real moderation has been needed: the tone of discussion around here is unusually civil, for the most part. It's especially so compared to the rest of the blog world and the Internet as a whole - not just "of old", but every day of the week. If no one in the "Nativis family" has ever experienced anything so outrageous as the contents of this blog, permit me to observe that you appear to have led sheltered lives.

Believe me, you will hear worse from other people as you go on developing your company's approach to drug therapy. I mean this in the best possible way, but the material that Nativis uses to explain and promote its technology does not inspire confidence in trained observers. I assume that you're well aware of this; if you're not, you should be. And that's fine - huge breakthroughs in the sciences often have that effect on people. But the problem is, nonsense has the same effect. If I may quote the late Carl Sagan on this very problem, "They laughed at Galileo. They laughed at Einstein. But they also laughed at Bozo the Clown."

Your company's claims are so startling, and so far beyond what most scientists would assume to be possible, that you truly have no alternative but to fall into one of those two categories. A red nose, a fuzzy wig, and floppy shoes are waiting for anyone who makes such claims. Your job is avoid being fitted for them. To that end, you do not have to convince me, or any random bunch of people on the internet. You have to convince the patent offices, the journal editors, and the regulatory authorities. My advice is to devote your time and effort to that task, and to stop worrying about what people say about you on blogs.

Worse things have been said on this site about other (far larger) companies; worse things are said all over the internet a thousand times a second. I certainly do not endorse the making of defamatory comments about people, but I fear that some of the very comments you might object to might not be seen that way by every observer. If I start taking down every comment that offends anyone who writes to me, there will be no end to it.

If you read my posts, you will see that I have not encouraged anyone to engage in illegal conduct. That goes for the entire 8-year archives of the blog, for that matter. I did not encourage anyone to visit your site in any way, and did not comment when someone reported that they did so. I live and work on the other side of the country from you, and my readers are responsible for their own actions. By the way, if the person you speak of did identify themselves as a representative of "The Pathfinder", as you state, then their connection to a blog called "In the Pipeline" is unclear.

As to whether some individual is engaging in a campaign of defamation against your company and your CEO, I can see no evidence of that in my blog's records. The uncomplimentary comments seem, from what I can tell, to have come in from a wide variety of separate sources - you truly have brought people together. On the other hand, some of the glowing endorsements and defenses of your company have come in under different names from the exact same IP addresses. Make of that what you will.

Mr. Kingma, you (and John Butters, and all the other officers and employees at Nativis) should be out there working to revolutionize the entire drug industry. If you can do what you say you can, that's exactly what will happen. Any scientist on the trail of something this wonderful, this huge - and potentially this profitable - would not allow anything to deter them from claiming their place in history. Go do that. I'll be overjoyed if you manage to pull it off. But having heard, after only two blog posts, from both the CEO and the CFO of your company makes me wonder about how you choose to use your time.

Sincerely,

Derek Lowe

Comments (138) + TrackBacks (0) | Category: Blog Housekeeping | Regulatory Affairs | Snake Oil


COMMENTS

1. SRC on June 10, 2010 12:45 PM writes...

OK, that tears it. They should just put Kevin Trudeau on the SAB and be done with it.

Kudos on your response, Derek. People who have the goods will usually bore you to tears with details. People who threaten skeptics to silence them generally have bupkis.

Permalink to Comment

2. anchor on June 10, 2010 12:50 PM writes...

Derek: Bravo! The people who contribute to your blog are well trained scientists (chemists, biologists and others), who have seen lot more failures on a day to day basis working for major pharmaceutical companies. We can all see and separate truth from fiction. My problem with the Nativis is that their claim is "too good to be true". I trust my other friends can chime here as well. I thank you for bringing to this forum the "guard dog" mentality and not that of a lap dog. Thanks again.

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3. MTK on June 10, 2010 12:55 PM writes...

Seems that one side effect of photonic-based therapies is thin skin.

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4. Biotech on June 10, 2010 12:57 PM writes...

Derek,

I am not pharm guy although I had a pharmaceutical degree. I just moved to Boston area, if you need someone to punch this "elite", feel free to let me know. Good blog!

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5. alig on June 10, 2010 1:07 PM writes...

Dear Mr Kingma and Mr. Butters,

You have the same character as Mr. Kevin Trudeau and Mr. Madoff.

Permalink to Comment

6. Hap on June 10, 2010 1:08 PM writes...

I assume they read the blog (and the comments about visiting Nativis) and saw that someone had visited and put two and two together. Of course, what exactly that has to do legally with Dr. Lowe is...unclear.

The internet isn't moderated. If you threaten people who question your theories or actions, your threats will be readily available to anyone who wants to find out about you, which would be something the people at Nativis might want to keep in mind.

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7. Sili on June 10, 2010 1:08 PM writes...

If no one in the "Nativis family" has ever experienced anything so outrageous as the contents of this blog, permit me to observe that you appear to have led sheltered lives.
That's what I thought. Heh. Should I ask the Pharynguloids to join in the fray? Just to make your regulars look like dainty little spinsters in comparison.
and offering generously to send along a large book on quantum electrodynamics
Ooooh! Can I have it if I promise to donate to your defence fund? Blake Stacey's pushed me to have a look at the Sidney Coleman lectures, but I definitely need some notes to read alongside.
Until your letter arrived, most of the criticism I'd received from readers and colleagues in the industry was that I'd been far too tolerant in my discussion of your company.
Yah. Sorry to say it, but you tend to be too kind. But I'm sure some here will level that accusation on you for your attitude to Anthropogenic Global Warming as well. Damned if you do, damned if you don't.

Thanks for sharing, dr Lowe. This is growing as much fun as LaClair.

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8. bbot on June 10, 2010 1:08 PM writes...

>In fact, the overall tone seems to have degenerated into something resembling the Internet bulletin boards of old, with personal attacks, sexual comments and statements that may well amount to libel and defamation of character.

Is he unfamiliar with the internet bulletin boards of Right Now, Currently? Personal attacks have not exactly gone out of favor.

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9. RB Woodweird on June 10, 2010 1:15 PM writes...

Reality doesn't need a lawyer.

Permalink to Comment

10. Brian Baldridge on June 10, 2010 1:15 PM writes...

Fantastically measured and professional response. Let the brigands retort!

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11. RB Woodweird on June 10, 2010 1:15 PM writes...

Who was it that said "Reality doesn't need a lawyer"?

Oh yeah, that was me.

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12. Laura on June 10, 2010 1:16 PM writes...

Imagine if the more ... colorful ... bloggers over on Scienceblogs (e.g., DrugMonkey and Isis the Scientist) were to have taken up this material.

What interested ME is that you didn't receive a letter from a lawyer, in house counsel or otherwise, from the named parties, but from the CFO. I am not sure what that tells me, but it is unusual in my mind.

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13. JasonP on June 10, 2010 1:23 PM writes...

OK hold on a minute:

"posing as a representative of your blog, The Pathfinder."

No I didn't, I said it here in the blog as a JOKE, but when I stopped by I gave my REAL name to the security guard and I asked if I could stop by, ask questions and inquire about job opportunities.

"When he was turned away by security, he reportedly took photographs or videos through office windows"

No, I did not, I took a picture of the sign out front, while standing on public property.

I DID look into the window, from the sidewalk leading out, as I was walking by, to see what I could, which was little, which is what I stated all in my post.

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14. JasonP on June 10, 2010 1:25 PM writes...

"sexual comments"

Oh come on. Well...unless you think Queen Elizibeth or Captain Kirk are sexy...

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15. LF Velez on June 10, 2010 1:39 PM writes...

I teach rhetoric for a living. If the nice people at Nativis want to cut any ice at all with pharma chemists, they might start by describing their products/MOA in ways that sound more like _chemistry_ and less like light-activated homeopathy. Simple as that.

I suspect the reviewers at the FDA would prefer that as well...

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16. Anonymous on June 10, 2010 1:42 PM writes...

Derek, how does this company's technology ring with you? This sounds like the same quackery as Nativis

"Scientists have discovered a way to customize a vitamin specifically for your body based on a DNA assessment. By analyzing a persons DNA, they are able to determine deficiencies within the body and design a vitamin so you know you are getting exactly what your body needs. This is going to change the health and wellness industry as we know it." ....from a company called GeneWise

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17. RandChemist on June 10, 2010 1:42 PM writes...

Excellent!

Talk about missing the point. Completely whiffed if.

Some of the criticisms have been harsh, but that is my opinion.

A number of good points have been made, especially that it was not a lawyer that wrote the response. Talk about trying to bluster!

All in all, the group here is pretty calm most of the time.

Organized? Ha. Paranoid much? Seems like.

Reminds me of the nervous lawyer character done by Martin Short on SNL. "I'm not being defensive....!"

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18. dearieme on June 10, 2010 1:43 PM writes...

"... in the Nativis family..": OFFS.

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19. leftscienceawhileago on June 10, 2010 1:46 PM writes...

Sad thing is a few linkedin profiles showed that they did hire people with have legit phds...

Shows you how desperate the postdoc life is these days...

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20. J-bone on June 10, 2010 1:53 PM writes...

Somebody predicted this would happen in one of the earlier Nativis threads, can't remember who. Something about a SLAAP lawsuit or something was mentioned.

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21. Dennis on June 10, 2010 1:56 PM writes...

"I do not actively moderate it, except to occasionally remove duplicate posts."

And what a tiring and never-ending task that must be.

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22. madkathy on June 10, 2010 2:01 PM writes...

Both letters made me laugh out loud. But to be completely fair, Derek, there is a typo in your reproduction that does not exist in the original letter from Mr. Kingma ("othe rmatters").

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23. Hap on June 10, 2010 2:07 PM writes...

I think "Be careful" or someone similar said that (that someone might be looking to induce slander on Nativis and then make some money), around comment 55 or so of the original Nativis post. I responded with a "SLAPP suit" link because I think that CA has laws which pound hard on people who sue to silence critics (and hence they incorporated in the wrong state if that were their raison-d-etre). In addition, the Generex suit would seem to indicate the folly of suing your critics to silence them.

There needs to be a Corante programmer chained to his desk deleting dupes until they can get their servers to not suck.

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24. startup on June 10, 2010 2:16 PM writes...

"...bizarre, and even potentially activity prohibited by law..."

Oooh, really this scary looks!

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25. CMCguy on June 10, 2010 2:40 PM writes...

Keep plugging away Derek as enjoy the intellectual stimulation and then occasional entertainment from posts like this one that rivals the comic strips. Bizarre is the word I would apply to the CFO letter although have seen related responses in those who wish to divert attention from real issues (i.e. attack the messenger syndrome).

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26. Larson on June 10, 2010 2:46 PM writes...

If you want a smoking gun I suggest you all look at the international patent application put out by Nativis.

"SYSTEM AND METHOD FOR PRODUCING CHEMICAL OR BIOCHEMICAL SIGNALS"

You can view the application on the wipo website link below for application PCT/US2005/026678.

http://tinyurl.com/34ueqad

If you visit the USPTO.gov public pair file wrapper system you'll note they have apparently abandoned that patent application in the United States national phase.

How are they going to market this in the US without a patent?? I supposed they could have filed another application, but as you can see by the above link they are pursing the above application in the national phases of other countries.


What a joke!

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27. Skeptic on June 10, 2010 2:53 PM writes...

Derek should join his favorite organization called the SEC so they can both pretend to be an enforcement agency. That would be in preference to his usual routine of laying a guilt trip on his fellow gullible med chems as to why the outsourcing is really taking place. And lets not do away with Friday Night Amazon book recommendation.

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28. Anonymous on June 10, 2010 3:00 PM writes...

Interestingly, the patent listed above by Larson cites a few publications. For example...

http://www.ncbi.nlm.nih.gov/sites/pubmed/10790721

However, a more recent paper which tried to reproduce the same findings, in a very tightly controlled manner, failed to do so...

http://www.ncbi.nlm.nih.gov/sites/pubmed/16394263

I'll take FASEB J. over Med Hypotheses any day of the week!

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29. commonsense on June 10, 2010 3:03 PM writes...

Sorry Mr. Kingma, I don't think a fraud will be able to beat out the promotion of legitimate science and the freedom of speech in court. In fact, why don't you take this to court and see who actually believes you? Too scared, eh?

Also, I'm not sure what kinds of "sexual comments" you somehow managed to see in the threads. Are your powers of photonic perception a little mixed up today?

Props to JasonP, john b, and sciencegirl on the other blog. Keep up the good work. And Derek, your blog is excellent. If something this innocuous is threatening to Mr. Kingma, he needs to find himself a new job. Maybe as a patient in clinical trials for hypersensitivity treatments? :P

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30. SRC on June 10, 2010 3:08 PM writes...

How are they going to market this in the US without a patent??

Ah, they're going to use the photonic imprint of a patent.

Permalink to Comment

31. commonsense on June 10, 2010 3:13 PM writes...

@SRC: As well as a photonic imprint of the US. Why sell to people when photonic imprints are so much better, right?

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32. You're Pfizered on June 10, 2010 3:17 PM writes...

Press release dated today:

http://finance.yahoo.com/news/Nativis-Receives-Patents-in-bw-4182193177.html?x=0&.v=1

Permalink to Comment

33. McChenist on June 10, 2010 3:24 PM writes...

Ooooh, its the old, time-honored, "I'm right and all those [large number] of people calling me dumb are really just one guy with a bunch of alts" method of internet arguing. That's classic!

Permalink to Comment

34. commonsense on June 10, 2010 3:26 PM writes...

@You're Pfizered: Seriously? Aggressive brain cancer? Is this report real or a photonic imprint?

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35. SRC on June 10, 2010 3:27 PM writes...

@commonsense

Right. And we can pay them in photonic imprints of dollar bills. Woohoo!

Permalink to Comment

36. Anonymous on June 10, 2010 3:29 PM writes...

that response was perfect in every way. well put!

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37. Evorich on June 10, 2010 3:42 PM writes...

It seems that they are true to form, in that they're far more focused on convincing through threats and empty promises than through actual science.

As scientists we have all endured a career of debate and criticism for mostly very reasonable work/ideas. We've gone away and proved people wrong (or right!). I don't remember ever offering to sue anyone for asking a tough question at ACS!

As I said before, I'm just sad that the Whidby investors have put their money into this - and actually that they didn't put there money into a technology that might genuinely possibly help people, and help themselves by potentially giving themselves a return.

I can only think that they've getting stick from their investors, and hopefully CNBC, and that's why they feel as though they have to fight back - however mis-guided that it.

Permalink to Comment

38. JasonP on June 10, 2010 3:44 PM writes...

You know I can glue two differently shaped pieces of wood together, call it a 'Wood Based Harmonizer' and patent it. Depending on what I claim it can do, I can patent it, just about anywhere. Does not make it anything more than two pieces of wood glued together however. The patent office is happy to take your patent fee.

Permalink to Comment

39. Don Corleone on June 10, 2010 3:45 PM writes...

Some of Bernie Madoff's victims are quite "sophisticated", you might say. So I wasn't surprised by why some people give money to this POS. Don't we forget a sucker is born every femtosecond.
I just wish that general public is as inquisitive as the "gullible" chemists. That is another reason why we need better science education in this country.
But on the other hand, how do companies make money if general public becomes smarter? Photonic imprint youth serum, any one? This revolutionary serum will make you look like Brad Pitt, smart like Einstein, and rich like Bill Gates. For first 20 fellow chemists, you will receive free Fedex Next Day shipping . . .

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40. commonsense on June 10, 2010 3:58 PM writes...

@SRC: We could definitely make this go on forever. It's actully quite entertaining. Thanks for the diversion! ;D And thanks again to Derek for promoting the freedom of thought and speech.

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41. EC on June 10, 2010 4:00 PM writes...

They got the patents filed. Even works on cholesterol via PCSK9. They could send some of their PCSK9 siRNA drug signal to an independent lab for a pharmacology study. PCSK9 reduction works in normal rodents to decrease plasma cholesterol. Should be a pretty easy test. Why not have an independent scientist come in a code the "treatment samples" so it's a double-blind test? I think you could find a few volunteers in San Diego.

Permalink to Comment

42. Don Corleone on June 10, 2010 4:00 PM writes...

Some of Bernie Madoff's victims are quite "sophisticated", you might say. So I wasn't surprised by why some people give money to this POS. Don't we forget a sucker is born every femtosecond.
I just wish that general public is as inquisitive as the "gullible" chemists. That is another reason why we need better science education in this country.
But on the other hand, how do companies make money if general public becomes smarter? Photonic imprint youth serum, any one? This revolutionary serum will make you look like Brad Pitt, smart like Einstein, and rich like Bill Gates. For first 20 fellow chemists, you will receive free Fedex Next Day shipping . . .

Permalink to Comment

43. Don Corleone on June 10, 2010 4:04 PM writes...

Some of Bernie Madoff's victims are quite "sophisticated", you might say. So I wasn't surprised by why some people give money to this POS. Don't we forget a sucker is born every femtosecond.
I just wish that general public is as inquisitive as the "gullible" chemists. That is another reason why we need better science education in this country.
But on the other hand, how do companies make money if general public becomes smarter? Photonic imprint youth serum, any one? This revolutionary serum will make you look like Brad Pitt, smart like Einstein, and rich like Bill Gates. For first 20 fellow chemists, you will receive free Fedex Next Day shipping . . .

Permalink to Comment

44. commonsense on June 10, 2010 4:04 PM writes...

@SRC: We could definitely make this go on forever. It's actully quite entertaining. Thanks for the diversion! ;D And thanks again to Derek for promoting the freedom of thought and speech.

Permalink to Comment

45. the bard on June 10, 2010 4:22 PM writes...

in a Haiku mood today...

Thin skinned charlatans
With promised data so grand
Always “wait and see”

Permalink to Comment

46. Hap on June 10, 2010 4:22 PM writes...

38-40: Other than the last patent on the list (which doesn't seem to have much to do with the rest of the patents - it sounds more like mainstream nanotech), none of them seem to refer to the ability to generate field equivalents of drugs. The three patents they are highlighting (the latest of which was five months ago) seem to be about detection and characterization of drugs, and don't seem to be about the implementation of the signals as drugs, which is what the press release is emphasizing. ("Look, we have drugs (sort of) coming out soon, and preclinical data (which no one else can see), and soon we'll be treating cancer patients.")

But if you're generating new treatments for difficult-to-treat diseases, wouldn't their medical implementation be the key item to patent, since it's what you're going to make money on? So why no patents, particularly since you're supposed to be running trials shortly, or do the patents (despite their titles) contain actual claims of implementation?

Permalink to Comment

47. Don Corleone on June 10, 2010 4:22 PM writes...

I am sure some of us remember the table-top "cold fusion" fiasco back in later 80's and earlier 90's. But at least, there were vigorous scientific debate and experiments about it.

Permalink to Comment

48. Firma on June 10, 2010 4:32 PM writes...

It seems fairly clear that the Nativis people are less concerned with hostility/skepticism of their purported technology, than they are with the character assassination that has gone on here the past few days. Personally I agree with them. There is a difference between saying their technology doesn't make sense, or that they should put up or shut up with regards to specific data/research, and saying John Butters has the same character as Bernie Madoff, for instance. That is defamation of character. That is not scientific debate. That is not ridicule of their technology. Nor does it further any scientific debate. It's character assassination. A community as educated as this one should be capable of discerning between skepticism, no matter how pointed, and defamatory personal attack.

I'm sure I'll be flamed now, so be it. Someone needs to have said this.

Permalink to Comment

49. Firma on June 10, 2010 4:32 PM writes...

It seems fairly clear that the Nativis people are less concerned with hostility/skepticism of their purported technology, than they are with the character assassination that has gone on here the past few days. Personally I agree with them. There is a difference between saying their technology doesn't make sense, or that they should put up or shut up with regards to specific data/research, and saying John Butters has the same character as Bernie Madoff, for instance. That is defamation of character. That is not scientific debate, nor does it further any such debate. That is not ridicule of their technology. It's character assassination. A community as educated as this one should be capable of discerning between skepticism, no matter how pointed, and defamatory personal attack.

I'm sure I'll be flamed now, so be it. Someone needs to have said this.

Permalink to Comment

50. Firma on June 10, 2010 4:40 PM writes...

It seems fairly clear that the Nativis people are less concerned with hostility/skepticism of their purported technology, than they are with the character assassination that has gone on here the past few days. Personally I agree with them. There is a difference between saying their technology doesn't make sense, or that they should put up or shut up with regards to specific data/research, and saying John Butters has the same character as Bernie Madoff, for instance, or making a factual assertion that he is a con artist. That is defamation of character. That is not scientific debate, nor does it further any such debate. That is not ridicule of their technology. It's character assassination. A community as educated as this one should be capable of discerning between skepticism, no matter how harshly pointed, and defamatory personal attack.

I'm sure I'll be flamed now, so be it. Someone needs to have said this.

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51. Firma on June 10, 2010 4:40 PM writes...

Oops, sorry for the dubblepost.

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52. Aspirin on June 10, 2010 4:49 PM writes...

-That is not scientific debate, nor does it further any such debate

Let Nativis show us some real, rigorous scientific data, and we can have a scientific debate. As Derek mentions, a dose-response plot for pink unicorns does not exactly cut it.

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53. ProteinChemist on June 10, 2010 4:49 PM writes...

I have to agree with Firma - we should leave it at discussion of the science and that's it. If the material and methods end up being proved wrong, then that is that. There are a lot of start-ups that never saw a completed product that had a much more accepted approach than Nativis.

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54. Don Corleone on June 10, 2010 5:12 PM writes...

@Firma, For the record, nowhere in my posting, I mentioned John Butters has the same character as Bernie Madoff. So please do not put words in my mouth. My point is when something smells fishy, it usually is. And people can be easily fooled even for the sophisticated people.

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55. Evorich on June 10, 2010 5:13 PM writes...

"I have to agree with Firma - we should leave it at discussion of the science and that's it. If the material and methods end up being proved wrong, then that is that. There are a lot of start-ups that never saw a completed product that had a much more accepted approach than Nativis."

Noooooooooo - this is what we're trying to tell you! Biotech's are never based on so little evidence, and such fanciful claims. They usually fail but at least they aren't claiming to break the laws of physics! You're totally missing the point. You're trying to turn this into an even sided scientific debate but it is impossible to have one here.

And Firma - there are very few posts focusing on the individuals involved.

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56. Vader on June 10, 2010 5:44 PM writes...

Normally I prefer to say "your science sounds awfully shaky; here's why I'm skeptical" instead of "you're a flaming idiot at best and a charlatan at worst." However, the more outrageous the claim, the more I have trouble resisting the latter.

Apparently quite a few others here feel the same way.

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57. cynical1 on June 10, 2010 6:13 PM writes...

Can you deuterate a photonic imprint? And can one patent it?

Well, since I just put it in the public domain, I might have shattered a few dreams. Sorry.

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58. Hap on June 10, 2010 6:15 PM writes...

1) I'm guessing Firma's referring to the last post on the "Waiting and Seeing" thread, which is OTT (although I wouldn't be fessing up any money to invest in Nativis anytime without some serious data, even if I had any money to do so, and if they had the data, they wouldn't need anybody's money). The response, of course, sounds like classic Dilbert:

PHB : I should fire you for mocking me.

Pseudo-Scott Adams char: Why? Because I would mock you less?

2) Lots of drugs fail, for lots of reasons. Nativis' treatments would be based on an entirely new physical phenomenon, though, with lots of consequences for almost everything. If such a phenomenon were occurring, you wouldn't need an IND or trial data to validate it - lots of tests in vitro (or outside a biological system) would suffice to dispel people's disbelief. There would also be lots of intermediate targets (can you cause activation of receptors with the signal of their ligand, for example?) which would substantiate the existence of the phenomenon. The lack of any of these sources of data not only makes people question the reality of the underlying phenomenon, but also seems to make an already risky drug discovery (in a matter of speaking) mission even riskier because of the lack of a secure foundation. (It could fail for lots of reasons, many of which don't relate to the claimed field behavior.)

None of this makes much sense. Threatening people doesn't make it make any more sense.

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59. Firma on June 10, 2010 6:15 PM writes...

@Don Corleone... you may not have said, it but it was said:

5. alig on June 10, 2010 1:07 PM writes...
Dear Mr Kingma and Mr. Butters,
You have the same character as Mr. Kevin Trudeau and Mr. Madoff.

@Evorich... The educated response to fanciful claims should be any combination of logic, correction and yes occasionally ridicule. However, just because an individual makes a claim that breaks conventionally accepted laws of physics, this does not justify or qualify personal attack. Especially not within a community that purports to enjoy the benefits of exceptional educations and training in proper means of discourse.

Put more simply... skepticism =/= defamation. It doesn't boil down any simpler than that.

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60. Biotech on June 10, 2010 6:19 PM writes...


I don't understand why this company doesn't want people to discuss about its technology, is this American way?

"There are a lot of start-ups that never saw a completed product that had a much more accepted approach than Nativis"

Please list all of them if you dare!

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61. John on June 10, 2010 6:34 PM writes...

I would have to agree with Firma that the character assassination and the critique (or even ridicule) of the technology are very different issues, ethically and probably legally as well.

If you want to see what it is like to have the shoe on the other foot, head over to Pharmalot and look at all the posts over there saying that everyone in pharma should be incarcerated. Its not productive, and forming judgments that go beyond the available evidence is not good science either.

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62. SRC on June 10, 2010 6:45 PM writes...

OK, I've quickly read a couple of their PCT filings (WO06015038, WO03083439), and here's the deal:

They are using extremely sensitive methods in conjunction with Faraday cages and Helmholtz coils to detect signals roughly in the audio range (the specifications explicitly call for a lowpass filter to cut off frequencies above 50 kHz), and after performing the Fourier transform of their signals get stuff that looks an awful lot like...an NMR spectrum, with multiplets and all. There's no way they should get that kind of resolution from pure rotational spectra in solution.

A quick back of the envelope calculation indicates that protons should come into resonance in the audio frequency range at around 0.5 G.

You're going to laugh, but ...

My take: I have the sneaking suspicion that these guys may have just reinvented NMR, using the earth's magnetic field.

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63. sciencegirl on June 10, 2010 6:51 PM writes...

I personally am just not following Firma and ProteinChemist or the CFO himself.

Exactly why is John Butters' background irrelevant to the conversation? Why is it "defamation of character" to state facts?

In his previous life, John Butters was, in fact, a failed land developer. He did, in fact, declare bankruptcy in 1997 and did, in fact, lose a lot of people an awful lot of money. He was, in fact, sued by one of his investment groups for mismanagement and a judgment was, in fact, filed against him. He does not, in fact, have any educational background in any branch of science. (Ditto on his wife, Lisa)

I didn't even mention the fact that the 1997 bankruptcy wasn't John Butters' first one because I couldn't find a case number for the one that occurred a decade or so previous to it.

To me, it seems like there are a lot of things people can (and did) say about the implausibility of the Nativis science claims. All of that aside, especially given the lack of hard data, it doesn't seem especially nasty or distasteful to be questioning the source of these miraculous claims. Funny that although Mr. CFO is whining about things getting "personal," he is not refuting any of the facts I presented. Apparently, we are just supposed to shut up about these "irrelevant" facts so Nativis can round up investors in peace.

Awesome response, Derek.

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64. SRC on June 10, 2010 6:54 PM writes...

I should mention that the idea (as I understand it) is to measure the EM emissions of drugs and then to irradiate patients with radiation that is characteristic of the drug.

Hard to see how irradiating patients with electromagnetic radiation in the audio range is going to do a thing, but if it does, maybe people will start wanting to live near power lines!

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65. SRC on June 10, 2010 7:00 PM writes...

Postscript: the geofield NMR conjecture also explains why they need to use stochastic resonance methods - the white noise EM radiation with which they irradiate the sample provides the excitation to knock over the spins. Let the spin system decide which Fourier components of the white noise appeal to it!

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66. Idiotraptor on June 10, 2010 7:21 PM writes...

Sciencegirl@80:

A very compeling commentary; I'm in full agreement with you.

I just viewed the Eco-Captitalist video clip in which Nativis "family" members offered their explanation of the company's technology; it was completely inane.

I am a life science Ph.D. who has worked for three biopharmas over the last 15 years. As such I can comfortably say that, in situations such as this, absence of evidence most likely indicates evidence of absence.

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67. Matt on June 10, 2010 7:31 PM writes...

As of now, if you conduct a google search of Nativis, the link to this blog post comes in third, and the initial Waiting and Seeing post comes in second. I'm sure Butters and Kingma must be thrilled.


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68. AEK on June 10, 2010 7:34 PM writes...

An interesting take on a possible provenance of Nativis is posted at: http://www.quackometer.net/blog/2010/06/the-curious-case-of-nativis-the-forsaken-nobel-prize-winner-and-the-ghost-of-jacques-benveniste.html

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69. Anonymous BMS Researcher on June 10, 2010 7:45 PM writes...

Another interesting Google hit for Nativis is here:
http://www.quackometer.net/blog/2010/06/the-curious-case-of-nativis-the-forsaken-nobel-prize-winner-and-the-ghost-of-jacques-benveniste.html

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70. Derek Lowe on June 10, 2010 7:49 PM writes...

SRC, that's a really interesting idea. The Nativis press story mentions SQUID technology, which is just what you'd have to use for that sort of detection. In fact, I believe that people are messing around with microTesla MRI machines - cheap magnet/expensive detector, versus the standard expensive magnet/cheap detector setup.

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71. SRC on June 10, 2010 7:57 PM writes...

Derek,

Exactly. When it occurred to me, a lot of disparate and troubling pieces snapped into place and made sense.

That's not to say that the conjecture is correct, but if I were at Nativis, I'd check it out pronto.

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72. frequent visitor on June 10, 2010 8:13 PM writes...

I read this blog about 5-7 times a week, and have been doing so for the last 3 years, and I will say during the stock market issues in 2008-2009, there was the occasional investor who threw dirty messages, but other than that, I think that most who avidly read AND comment on this blog maintain scientific integrity even through this.

Skepticism is a major part of our field, and we have a tendency to call it like we see it. I think Derek has done an excellent job of creating a blog that maintains its professionalism, and for any company to formally question that via letter is pretty crazy. Keep up the good work Derek.

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73. partial agonist on June 10, 2010 8:14 PM writes...

"A 'skeptic' does not mean him who doubts, but him who investigates or researches, as opposed to him who asserts and thinks that he has found."
-essayist Miguel de Unamuno

Congratulations Derek on your thoughtful, measured, and fair reply. Their letter indicates a fundamental lack of understanding of what scientific inquiry is all about. We will not see evidence to help us decide. No arbiter we have ever heard of who is not on their payroll will ever vouch for them. They will not offer any commentas whatsoever about specific questions. Substantial claims require substantial evidence.

Absent that (and we aren't going to get it) I would be thrilled if under a confidentiality agreement they would show just a smidgeon of their data to any of the many fair-minded Nobel laureate scientists residing RIGHT THERE in La Jolla. I would love to see the data for free and under confidentiality, but though I am an assistant professor with 19 years of med chem experience (14 in pharma), my word wouldn't carry much weight. A Nobel laureate would. Bring Barry Sharpless over for lunch. Alternatively, call up any of the many notable recently retired pharmaceutical industry Giants who have made REAL discoveries and can separate the fluff from the substance. Call up John La Mattina. Call up Bruce Maryanoff. If ANYONE of that ilk looks over even a small fraction of their data and says "Hold on, there is something here" then 99% of us would clam up and eagerly await the possible dawning of the photonic drug age.

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74. joeylawn on June 10, 2010 8:38 PM writes...

Dear Mr. Kingma,

You just got Owned.

Now go away.

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75. Polymer Bound on June 10, 2010 8:45 PM writes...

Drug delivery via fiber optics? Count me in.

I bet they end up merging with Verizon to expand their FIOS service.

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76. 3rdPhotonBlind on June 10, 2010 9:15 PM writes...

I present a remake of the song Jumper:

Patent Jumper

I wish you would step back from that patent, my friend.
You could cut ties with all the lies
That you've been living in.
And if you do not want to see me again
2 x I would understand

The angry CFO, a bit too insane
Icing over a secret pain
You know you don't belong...

You're the first to fight
You're way too loud
You're the flash of photon light
On a burial shroud
I know something's wrong...

Well everyone I know has got a reason
To say
Put the past away...

I wish you would step back from that patent, my friend.
You could cut ties with all the lies
That you've been living in,
And if you do not want to see me again
2 x I would understand

Well, he's on the table
And he's gone to genetic code,
And I do not think anyone knows
What they are doing here...

And your friends have left
You've been dismissed
I never thought it would come to this
And I
I want you to know
Everyone's got to face down the demons
Maybe today
We can put the past away.
-fin-

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77. anon on June 10, 2010 9:30 PM writes...

I LOVE this! Hahaha!

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78. anon on June 10, 2010 9:31 PM writes...

I LOVE this! Hahaha!

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79. 3rdPhotonBlind on June 10, 2010 9:46 PM writes...

Would be better with changing 'put the past away' with 'put the patent away' now that I think of it.

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80. Jose on June 10, 2010 10:34 PM writes...

Staggering- a rather, ahem, uninformed CFO, threatening legal actions concerning ideas with no real scientific evidence whatsoever. The kook-o-meter is truly pegged on this one!

Hey Mr. Kingma, you might consider googling "N-rays"- although, that wasn't willful deception....

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81. John on June 10, 2010 10:36 PM writes...

@SRC: Motivated by your comments, I took a brief look through their recent patents and found they've mostly attempted to patent well-known ULF MRI techniques.

Ex: "In some embodiments, the magnetic particle is formed by precipitating a magnetically active material within a polymer sphere while a strong external magnetic field is applied, causing the precipitate to have a net non-zero magnetic field and 50 the polymer sphere to have a distinct North and South pole." (7575934)

A randomly selected recent abstract:

"In magnetic resonance imaging (MRI), there have been three basic techniques to encode the spatial origin of the signals, i.e. Fourier and radio frequency encoding and the use of sensitivity information of sensor arrays. In this paper, we introduce a new encoding method, which we call polarization encoding. The method utilizes sets of polarizing fields with various spatial profiles; it is tailored for MRI at ultra-low fields (ULF MRI). In ULF MRI, signals from a prepolarized sample are typically detected using an array of SQUID (superconducting quantum interference device) sensors at microtesla fields. The prepolarization is achieved with a field of the order of 10-100mT preceding the signal acquisition. In polarization encoding, the prepolarizing field is varied in a way to gain additional information about the sample. The method may also prove useful for modalities that in the absence of any precession aim to image the DC magnetization profile of a sample."
("Polarization encoding as a novel approach to MRI"; J Magn Reson.)

You'll find the basic ideas discussed in the literature for quite some time.

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82. Firma on June 10, 2010 10:42 PM writes...

How dense are some of you people? Clearly the objection has been to what they perceive as defamation/character assassination. Beyond which, you really think these people are going to be interested in a debate on the merits at this point, with anyone here? I'd certainly not be.

Sincerely, they don't have a scientific/technical leg to stand on until such a time as they produce data that backs them up, but you lot are as disturbing in your defense of the indefensible (defamation as proper and acceptable skepticism) as Nativis is in their assertion of the unproven.

What a lot, on both sides. Perhaps science is doomed after all, having well and truly become the new religion. That is to say, reactionary and insular to a fault.

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83. Am I Lloyd peptide on June 10, 2010 10:52 PM writes...

Seriously people, calling something bovine waste because it looks and smells like bovine waste is hardly "character assassination". In all of Mr. Kingma's response, is there any extensive discussion of the data?? All he is doing is complaining about the not-so-defamatory nature of the comments and some random fact about a guy taking pictures of his company for some random blog. If you want scientific debate, you speak science.

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84. bloggirl on June 10, 2010 10:53 PM writes...

A day will come when a member of your family or a close friend will be cured using Nativis technology. Yes, it's hard to understand. No different than trying to explain to people 1000 years ago what sand would one day be transformed into into as they stand there looking at you like you're insane with sand falling from their hands. This is a lot to wrap your mind around. But look at the people on board. The man who created taxol. He created it. And he believes that Nativis is going to revolutionize the delivery of it. Jerry Radich, bone marrow transplant expert, head of reserach at Fred Hutch, a revolutionary Cancer Research Center.
If you have known someone who has gone through serious cancer treatment, you know that all of the pain and misery that comes with cancer is caused by the toxins in the medicine. Nativis technology claims to be non toxic. That would be amazing. So much suffering would be relieved.
Dwelling on negativity gets everyone no where. We need radical change in medicine. We need visionaries. People willing to spend years of their lives staying focused, not being swayed by all the naysayers. Instead of trashtalking and stalking and digging into people's private pasts, why not find a passion of your own. Delve into an idea that could help people. Or do something as simple as making food for the poor, volunteering at a school. Being kind. Being supportive of big dreams and big ideas is what we should be doing. The possibilities would be endless.

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85. Firma on June 10, 2010 10:56 PM writes...

Ignoring the fact that there have been a few over the top comments in previous threads won't make them go away. Clearly the Nativis people are riled up over such assertions as, "X,Y,Z = Madoff", not hostility towards their as of yet unsupported scientific claims. I can't be the only one that gets this.

Then again, blogs do work in this fashion, In the Pipeline shouldn't be any different I suppose.

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86. bloggirl on June 10, 2010 11:06 PM writes...

Hey Science girl! How's Queen Anne?

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87. Modicom on June 10, 2010 11:43 PM writes...

The power behind both words, and how they're written and interpreted goes beyond one person's speculation, or idealism. In saying this, I may very well be putting myself along the lines of 'hypocritical', though in the same breath, I honestly believe that the sole drive behind blogs, is to obtain readers. Without them, how do you get information out or across?

That said, the modus operandi here runs the thin-line between genuine critic, and attention seeker via negative feedback on something that could potentially turn out to be not only ground breaking, but life-changing. Negativity gets you, where, exactly, other than temporarily in with the popular crowd? I don't see how picking it apart, and repeatedly giving it negative feedback, criticism, and comparison with various scams, is supposed to be a skeptical assertation of an up and coming medical breakthrough.

The critic himself said earlier, that he does not have the knowledge to actively understand the mechanisms behind Nativis. To quote the commenter 'partial agonist';

["A 'skeptic' does not mean him who doubts, but him who investigates or researches, as opposed to him who asserts and thinks that he has found."
-essayist Miguel de Unamuno]

If this is the understanding behind the ideal of skepticism, then who is this knowledge-lacking critic, to call himself a skeptic in the first place?

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88. sciencegirl on June 11, 2010 12:29 AM writes...

Blog Girl - Not sure how Queen Anne is because I live in West Seattle.

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89. Jose on June 11, 2010 12:58 AM writes...

bloggirl- "But look at the people on board. The man who created taxol. He created it."

Ahmmm, I am pretty sure some fancy-pants enzymes have this distinction. Moreover, if you are referring to KCN (?) well, Holton beat him fair and square and his sad little ego couldn't take it.

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90. EpiStudent on June 11, 2010 1:33 AM writes...

I have been reading this blog consistently for about a year now, and it is one of my favorites for several reasons. The quality of the comments, which any regular reader can tell come largely from intelligent people with training and experience in the natural sciences, is one reason. Another is the measured tone in which the blog posts are written, which has only lent credence to the comments and occasional speculations that I have read. A third would be some of the humorous material posted here (I'm thinking of the Angewandte Chemie translations and the expositions of specious science - mostly short funny comments in the midst of sincere analysis).

I have to comment and say that this is my favorite series of posts because they have elements of all of the great things about this blog, and, as a bonus, they're waaaaay longer than normal. Thanks Nativis! And thank you even more, Derek!

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91. clinicalpharmacologist on June 11, 2010 1:41 AM writes...

Derek

A beautifully measured response, congratulations on your restraint.

We have a hypothesis, controversial but a hypothesis none the less. So, as scientists, we should support it being tested. One (or more) properly conducted, fully powered, randomised, placebo controlled double blind clinical trial(s) in any condition thought likely to be helped by the technique should settle the question.

In the end, the technique either helps people with disease or it doesn't. If it does, we can revisit the basis of medicine. If it doesn't, then it should be scrapped. I know what I think, but, evidence trumps preconceptions every time.

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92. Chemoptoplex on June 11, 2010 2:11 AM writes...

Is it just me, or does their technology sound like a rehash of Ra's al Ghul and Scarecrow's plot from Batman Begins, except delivering Taxol via microwaved water instead of mystical fear juice?

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93. TomR on June 11, 2010 2:23 AM writes...

First hit on "Nativis" on Google search directs to this blog, and not the corporate web site. That's awesome.


I'd guess Google has deeper pockets than Dr. Lowe, so maybe it would be a smarter legal strategy to filing a claim against Google for linking to this debunking, err, I mean, defamation, er yeah.


Someone should call Dr. Radich at the Hutch, no way he knows that his name is being associated with this type of nonsense. Talk about *real* defamation.


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94. thankyou on June 11, 2010 2:27 AM writes...

sciencegirl

West Seattle. Thankyou.

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95. Shelley on June 11, 2010 2:38 AM writes...

Sciencegirl, No way! I'm house sitting in West Seattle (Beach Dr)!

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96. processchemist on June 11, 2010 3:50 AM writes...

@bloggirl

No man created taxol (a secondary metabolite produced by taxus brevifolia). It's IMPOSSIBLE that now or in 100 year anyone will be cured with this technology because of the declared mechanism. In the best case scenario, it will be transformed in another kind of radiotherapy. What's the difference between matter and radiation? Matter (in the common sense of the term, structured aggregation of atoms) is localized. Radiation moves at the speed of light. What Nativis people should demonstrate is that what they call the "photon field" of a small drug molecule can inhibit in vitro the activity of the target. By the way: a photon field is quite a nonsense. A field (gravitational, magnetic, electric) is a space where a *force* is defined. A photon is the particle form of a radiation. A radiation is an obscillation of the electromagnetic field. So, what's the meaning of "photon field"? A region of space where for any point is defined a photon? hilarious.

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97. DrSnowboard on June 11, 2010 5:50 AM writes...

So hypothetically, if the 'field' is generated from a compound does that not make it a delivery method? Wouldn't you still need to license the compound - the invention doesn't work without it..

Is the 'field' chirally discriminating? Can you use the inactive isomer as your control experiment? How does the company expect to avoid environmental exposure to naturally occuring sources of the 'field' ?

What effect does high volume Pendulum have on cells...?

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98. Thumperska on June 11, 2010 6:23 AM writes...

So, the only evidence of efficacy they sent along was from a mouse xenograft model? This is hardly a convincing way to prove efficacy. In some models you can see significant differences between saline treated and no treatment cohorts. there's no immune system, usually little stroma, and none of that pressure that keeps a drug from penetrating the tumor. You saw the data Derek, did they use photonic saline as a control? Xenograft models are a bare minimum for moving a drug down the pipeline. If you can't do that, you're frelled.

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99. Firma on June 11, 2010 6:51 AM writes...

Re: Thumperska... Yes, I too would be interested in knowing precisely what was sent to Derek. What protocol was followed, was it in house or contracted, what were the results, etc?

If Derek was not placed under NDA, which it seems unlikely given the circumstances of the data's provision, not to mention the inference within Kingma's letter, it seems he could share with us what was shared with him.

A single xenograft model is not indisputable proof of anything, but it would be a step in the right direction. Something, anything.

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100. Anonymous on June 11, 2010 7:33 AM writes...

you really think these people are going to be interested in a debate on the merits at this point, with anyone here? I'd certainly not be.

That's funny, because you won't shut the hell up about it. I'd hate to see how much verbal diarrhea comes from you if you WERE interested.

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101. alig on June 11, 2010 7:58 AM writes...

Con men steal people's money with lies. The better the con man, the more money they can steal.

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102. partial agonist on June 11, 2010 8:43 AM writes...

"The man who created taxol. He created it."

Taxol is a natural product. The pacific yew tree created it. Depending upon your belief system, I guess, God created it, not any person having anything to do with Nativis.

I assume that you are referring to William Comer, on their SAB, was president of research and licensing at Bristol-Myers Squibb during the development of taxol. He helped bring taxol to market long after a hoarde of academic and NIH scientists paved the way, showing the science was compelling. He led the "money men" at BMS who did the in-licensing. I am not minimizing that role-- it was a vital in making taxol a sucessful drug. However, he didn't "create" taxol.

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103. Vader on June 11, 2010 9:12 AM writes...

bloggirl,

"Nativis technology claims to be non toxic. That would be amazing. "

Yes, it would.

But I mean it in a very different way from you.

It's a huge red flag, actually.

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104. molecular architect on June 11, 2010 9:14 AM writes...

#84 & 102

102's comments about taxol are correct. Comer had nothing to do with the scientific development of taxol. Let's give credit where credit is due.

Taxol was discovered by Monroe Wall and Mansukh Wani at Research Triangle Institute. The National Cancer Institute's Developmental Therapeutics program did the bulk of the development work over a two decade timespan during which Big Pharma was not interested due to the complexity of the molecule and their general lack of interest in oncology. It was only in the mid-90s, after NCI had proven the clinical efficacy, when NCI actively sought a CRADA (Cooperative research and development agreement) with industry that Bristol Myers Squibb became involved.

Derek, I think your response to this inane letter (threat) was perfect. That these "researchers" got folks like Comer and Radich on their SAB is beyond belief.

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105. LeeH on June 11, 2010 9:48 AM writes...

If Nativis fails, Mr. Butters can always go back to his day job on South Park...

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106. Nat on June 11, 2010 9:56 AM writes...

I was wondering if this was conceptually similar to NMR - not that I've ever heard of NMR inducing specific allosteric effects in individual proteins in live tissue, of course. I scanned through the WIPO patent application and I think it just left me more confused than before. A few interesting questions:

1. The patent only covers recording the drug signal and "playing it back", which I guess would involve placing the patient in a magnetic field. This sounds improbable enough by itself, but where is the description of the process to make an orally ingestible product?

2. One of the claims of the patent is that it can overcome the bioavailability problem (logical enough, I guess), but that wouldn't apply to the oral medication, would it? How is the drug signal absorbed into the bloodstream, and how does it cross cell membranes?

3a. The patent mentions that the lack of accumulation of product or toxic metabolites will reduce side effects. However, aren't most chemotherapeutic agents toxic because they're so non-specific, not because of byproducts or accumulation? These things attack any rapidly-dividing cells, they screw up the cytoskeleton and intercalate DNA bases, and I can't see any amount of photonic mumbo-jumbo overcoming that.

3b. If they can make a drug signal stable over a relatively long time-frame in water, why wouldn't that also accumulate in the body?

4a. The latest press release touts an orally ingested drug signal of siRNA, which is where I really got suspicious. Skipping over the issue of delivery mechanism, this means that the drug signal can form an RNA double helix with the PCSK9 mRNA, then be bound by the Argonaute protein, which degrades the mRNA. The structure of this complex is published, and very interesting to look at in the context of the press release. Are they really claiming that they can generate an electromagnetic signal in water that reproduces the hydrogen bonding and charged phosphate backbone of RNA precisely enough to substitute for one of the RNA strands in that complex?

4b. I assume that they'd need to measure the signal of the drug in isolation in water. But a single-stranded siRNA molecule won't form half of a helix without the complementary strand, so it will have a much different conformation than what's seen in the Argonaute complex. Is the drug signal therefore conformation-independent, and if so, how is this compatible with such specific effects on target proteins?

I know absolutely nothing about quantum electrodynamics, but I don't think watching Feynman lectures would make the answers any clearer.

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107. ProteinChemist on June 11, 2010 9:59 AM writes...

@101/105/etc.: If we are going to discuss the merits (or lack thereof, as seems to be currently the case), why these completely pointless comments?

If the CEO had a bankruptcy in the past and it was a result of his defrauding investors, that is an issue, yes, but it only has an auxiliary impact on the validity of the technology. Does it mean that a close look should be taken, especially by potential investors? Yes - but it doesn't mean that the technology itself is not valid. The technology may not be valid, but that is not due to the past issues of the CEO. Did people run background checks on the CEO of GSK after the recent 'stolen article' fiasco? And wasn't that worse?

Of course, the same applies to the CFO's response - why hold Derek responsible for something he has no control over - his readers? I think that Derek had the right of it in his first post. This is a completely novel, unproven methodology with (currently) very little data, one way or the other. If more data comes out, great. Then maybe we can really see what is or isn't going on and there can be a more fruitful discussion.

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108. Hap on June 11, 2010 10:26 AM writes...

The technology could be valid - if there isn't data, there isn't data, and you don't know if it's real or if it's not (though the default is probably that it's not until something shows up). But, if we're supposed to take someone's word that said tech has been developed, then their character and previous history comes into play - whether their word has been good in the past is a good estimate as to whether it is likely to be good now (as a start - people change). So, if you have a sketchy past history and a lack of (apparent) background in the concepts that underlie the technology you claim, well, people are going be unlikely to accept your claims at face value.

Simpler experiments (than the FDA approval of an NDA for one of Nativis's treatments) would suffice to show that this phenomenon actually exists and is usable (the uncertainty of drug development and the lack of complete biological and chemical knowledge makes the lack of passage of a drug candidate not diagnostic of a bad underlying concept). They would also make it easier to convince the people/organizations who can actually give credence to the tech - patent offices, for example. Why not do those first? Their success (reproducible occurrence) would make the criticism go away very quickly.

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109. commonsense on June 11, 2010 11:43 AM writes...

Google hits are 4, 6, and 8 now for this blog. I bet the sorry peons at Nativis, for lack of something to do, have been asked by their superiors to repeatedly click on the company website so that this blog doesn't show up as the first hit.

Props to SRC and 3rdPhotonBlind (loved your remake! :D ), and thank you Derek for hosting this discussion.

Oh, and Firma? Go ahead, scream at me for calling the people at Nativis peons. I want to watch this.

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110. JC on June 11, 2010 11:46 AM writes...

Protection from photonic fields is achieved by wearing a tinfoil hat.

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111. Placebo on June 11, 2010 12:15 PM writes...

Nativis,

Let's settle this matter ... "Show me the data"

By the way, I wonder if the FDA reads this blog ...

Uh Oh.

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112. billyziege on June 11, 2010 12:34 PM writes...

bloggirl wrote: "If you have known someone who has gone through serious cancer treatment, you know that all of the pain and misery that comes with cancer is caused by the toxins in the medicine."

First off, let me say that it is dangerous to use the word "all". I have had family members who died from cancer, one of whom died untreated until the last days. From what I know, most of his treatment was pain meds since I believe he opted out of chemo and radiation treatment (it was too far gone.) Let me tell you that he was in a lot of pain.

Also having a wife with Lupus, I can tell you pain is often associated with a condition prior to its treatment or even its diagnosis. In fact, for a lot of people it is why they seek treatment (it was for us). While I know drugs often have very serious side effects, one of which can be pain (which is usually much less serious than say losing color vision or initiating kidney failure, side effects that my wife has suffered under her treatment), saying that "all of the pain and misery that comes with cancer is caused by the toxins in the medicine" is absurd. Being sick is horrible and often painful. The "cures" may also be painful, but there are many drugs aimed at just improving quality of life.

Also, having pursued a PhD in theoretical high energy physics in which I had a lot of experience with the standard model (of which QED is part,) I guess I may be more qualified than most to understand Nativis' technology. From my understanding, a "photonic field" when treated with statistical techniques becomes the electromagnetic field. Measuring this field is essentially what we already do in say X-ray crystallography, radio, or human vision.

Since there are only four forces in the standard model (including gravity which has technically not been quantized and really isn't part of the standard model) and that pretty much the force that acts on the level of macroscopic molecules in solution is the electro-weak, it makes sense that the true "electronic signature" of an object should be able to reproduce the effects of that object, but referring to QED does not elucidate how this reproduction will take place. If they want to convince people who know QED, then they are going to have to elucidate to us through what technique(s) this "photonic field" or "electronic signature" (my words) is going to be made without a reference to the placement of a known particle (such as an atom) as is currently done. However, as can be seen on their web site, instead of telling us what techniques are being explored or trying to refer us to current research, they claim that they are basing their technology of the work on Dirac and Feynmann and refer us to a field of theoretical knowledge even most of physicists don't completely understand. By the way, theory is much different than application. While they're at it, they might as well throw in Einstein, Boltzmann, Maxwell, Copernicus, Lao Tze, and Plato and refer us to the curvature of space-time. It would be even more convincing.

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113. HappyDog on June 11, 2010 1:27 PM writes...

bloggirl,

My wife has cancer, so I am familiar with the "pain and misery that comes with cancer is caused by the toxins in the medicine". Still, it's not a good enough reason to buy snake oil. We've challenged her docs every time they've said or recommended something we don't understand. She usually aks me if what the docs say makes any sense. Would I recommend that she sign up for a clinical trial with the non-toxic Nativis technology? Not on her life (and I mean that quite literally). The bottom line is that Nativis technology doesn't make any sense, either to physicists or to drug developers. Scientists are trained skeptics. The commenters on the blog are doing what trained scientists do; asking to see the data and confirm the reproducibility of the results. Without the data, a falsifiable hypothesis, a clear description of the experimental details, and the ability to reproduce the results, it simply isn't science.

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114. Anonymous on June 11, 2010 2:07 PM writes...

I understand the Butters read this blog, so I hope they can put me in contact with their Whidbey Island investors. I have a plan for a voodoo doll acupuncture business. The customers (I mean patients) simply have to mail in their co-payment and a copy of their insurance card. Within a few hours, they should feel better. No need for them to come into the boiler room (I mean clinic) and no need for more than one office in the country.

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115. Pharma Giles on June 11, 2010 2:32 PM writes...

Derek: Much I believe that you are right to rebuff this ludricrous and pathetic attempt to scare you into pulling the plug on this debate, you should not cast aspersions on the work of Nativis's scientists. They are doing dedicated and highly original research, as shown here...


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116. Biotech on June 11, 2010 2:49 PM writes...

HappyDog,

I can understand your wife's situation, but I don't think you want Nativs to use your wife to get more funding to continue something doesn't make sense. Right?

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117. Wayne on June 11, 2010 3:35 PM writes...

An interesting thought excercise: lets assume for a moment that you can indeed create some sort of forcefield within a patient that imitates the presence of a known physical drug. Would that be good or bad? A quick list of things you wouldn't have to worry about anymore are PK (just stay in the machine), covalent protein binding (no real molecule), and toxic metabolites; however, you would still inhibit hERG, CYP's, other receptors you'd rather not touch, etc. Which of these things results in toxicity? Nobody knows for sure, but we all have an opinion (the control experiment is difficult to run).

The most interesting questions to me is 'do you really want your 'drug' to go everywhere?' How many drugs are safe because they stay out of certain compartments, and how many nonefficious compounds do not work because they don't get in? Which outnumbers the other? Again, problematic control reaction.

As I see it, even if Nativis's claims are 100% true, its not going to fix every problem we've got on the medchem side. How long would you have to stay in this machine? Is it portable? Are all the known drugs we've got efficacious when dosed continuously?

The results of this putative technology don't appear to match the predicted outcomes. I try to keep an open mind, but not so open that my brains fall out.

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118. Wanda on June 11, 2010 3:40 PM writes...

I am neither judge nor jury on this matter. It's time for the science set to start thinking in terms of the future. Who's to say what is and isn't possible in the realm of biology.

Maybe Nativis wants to consider applying for a grant - which would help to validate their research - here is one through NSF:

"The Biophotonics program supports innovative photonic research for applications in human health.
Basic research and innovation in photonics that is very fundamental in science and engineering is needed to lay the foundation for new technologies beyond those that are mature and ready for application in medical diagnostics and therapies. Developing molecularly specific sensing (molecular photonics), imaging, and monitoring systems with high sensitivity and resolution would be an enormous accomplishment with powerful applications to both biology and medicine. Advances are needed in contrast and targeting agents, ultra-thin probes, wide field imaging, and rapid biomarker screening.
Low cost and minimally invasive medical diagnostics and therapies will require novel integration of photonics, molecular biology, and material science."

Good luck, Nativis. You've a huge burden of proof ahead of you, but those who say "never" and "impossible" have been proven wrong before.

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119. SRC on June 11, 2010 4:05 PM writes...

"The Biophotonics program supports innovative photonic research for applications in human health.

Basic research and innovation in photonics that is very fundamental in science and engineering is needed to lay the foundation for new technologies beyond those that are mature and ready for application in medical diagnostics and therapies. Developing molecularly specific sensing (molecular photonics), imaging, and monitoring systems with high sensitivity and resolution would be an enormous accomplishment with powerful applications to both biology and medicine. Advances are needed in contrast and targeting agents, ultra-thin probes, wide field imaging, and rapid biomarker screening.

Low cost and minimally invasive medical diagnostics and therapies will require novel integration of photonics, molecular biology, and material science."

Wanda, this program is directed to optical (i.e., visible light) imaging for medicine. Nothing whatever to do with Nativis. Zip. Granted, some of the terms sound similar to the layman.

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120. Bunsen on June 11, 2010 8:12 PM writes...

I must say that I'm impressed by the charitable attitude with which so many people here approach extraordinary claims. There's been extensive discussion about exactly what pharmacological effects invisible pink unicorns might or might not have, with most people being willing to give a pass on the question of the unicorns' existence just for the sake of discussion.

I'm afraid I can't bring myself to be that generous regarding the hypothetical equines. Nativis' claims about "photon fields" and their chemical action are five-nines, reagent grade, bovine-derived excrement, packaged in quantum electrodynamical gibberish. Fortunately, one does not need to understand the packaging to understand the nature of the contents.

They claim that it is possible to replicate the (desirable) effects of a chemical with externally-created electromagnetic fields. We know that chemical interactions are mostly mediated by electrostatics, so it may seem superficially plausible that measuring the electromagnetic field created by a molecule then re-creating it would replicate some of its chemical behavior. And quantum mechanics tells us that electromagnetic fields are all superpositions of photons, so creating the right bunch of photons might imitate the behavior of the chemical. There are two things fundamentally wrong with this:

First, you can't create arbitrary electromagnetic fields wherever you want them. The fields obey certain equations, and one of them says that the divergence of the electric field is proportional to the density of electric charge. In order to create the electric field that a hydrogen atom creates, you have to have electric charge in the same places that a hydrogen atom has it. Radiation and external static fields simply can't do it.

Second, electromagnetics is only half the story when it comes to chemical interaction. The other half is the Pauli exclusion principle, which requires the presence of actual, physical electrons to push other electrons around, not just some arbitrary source of electric charge. No electromagnetic fields from any source can stand in for the particles themselves here.

To give a mechanical analogy of Nativis' electromagnetic claims, let us consider the interaction of a man with a 1000-lb church bell. We begin with two observations:

1. When the bell is subjected to certain mechanical stimuli, it makes a "bong" sound.
2. If we hit a man with the bell, he will fall over.

From this, Nativis would claim that by saying "bong" at a man (i.e. replicating the phononic signal of the bell), he will be knocked over. Furthermore, saying "bong" at a point in the air will cause the next man to walk past that point to be knocked over by the residual phononic signal of the bell. Still further, while saying "bong" replicates the (arbitrarily designated as "desirable") effect of knocking men over, it eliminates the (arbitrarily designated as "undesirable") side-effect of knocking women over.

It is not reactionary to say that such claims are absurd. It is not closed-minded to refuse to spend large amounts of time and money on studies to determine gender-resolved knockover rates under the action of "bong" sounds. If someone purports to sell the service of knocking men over by saying "bong" at them, it is neither defamatory nor libelous to call that salesman a liar and a charlatan, and to warn potential investors and customers away from becoming the marks of a petty con man.

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121. Firma on June 11, 2010 9:30 PM writes...

Derek, if you are in receipt of some of this data might you ask Nativis if you could share it with us? It seems you are in possession of some small piece of the bigger picture, that could be analyzed by some of the *Ahem* more intelligent posters here as to its content and what it may or may not suggest about their work at large.

People are asking for data and while its not been publicly forthcoming from the Nativis people, they have apparently already shared some of it with you.

Thoughts?

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122. Derek Lowe on June 11, 2010 9:43 PM writes...

Firma, they sent me a graph of their treatment versus two controls. I'm not obligated to share it with the wider world; Nativis has a web site of their own, and nothing's keeping them from posting their data. If they do so, I'll gladly link to it.

But my pink unicorn argument still applies. It's a perfectly ordinary-looking xenograft experiment, but it's being used as proof for something that's very far from ordinary. And as proof, it's nowhere near enough.

Besides, xenografts are not the most robust and reliable things in the world. Why not start small and work up? I suggested a number of experiments in my first post - things that I believe any reasonable scientist would think of. But apparently nothing like any of them have been tried.

Can they take the "photonic signature" of, say, ciprofloxacin and kill bacteria with it? Differentiate preadipocytes with the photonic signatures of growth factors? Set off a second-messenger assay with the signature of an agonist - and block it with the signature of an antagonist? I'd be a lot more impressed by any of these than by a xenograft assay. They're more direct, less complex, and there are fewer ways they can give misleading results.

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123. qetzal on June 11, 2010 10:16 PM writes...

Firma,

If I showed you a graph from a xenograft model and claimed it showed that I can cure tumors in mice from a thousand miles away by singing the Mickey Mouse theme song backwards, would you believe it? Even if the graph showed a difference versus control at p less than 0.01?

Or would you conclude that whatever caused the difference between the two groups, it couldn't possibly be due to my Distant Song Therapy (patent pending)?

Nativis's "photonic signature" is just about as plausible as Distant Song Therapy.

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124. David OHara on June 11, 2010 10:19 PM writes...

When I read their website, my personal BS meter went off scale. Pure techno-gibberish, like listening to the resolution of a problem on Star Trek "if we measure the photon field using Quantum Electro-Dynamics we can cure his brain cancer........". Is their site real or is it from the Onion?

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125. Anne on June 12, 2010 12:57 AM writes...

@Bunsen (120): Brava.

@bloggirl (84): I have to say this only because I am astonished no one else has, at least not forcefully enough. You say "you know that all of the pain and misery that comes with cancer is caused by the toxins in the medicine." And I say that is completely false.

First off, there is the very good argument made above that cancer itself causes a great deal of the pain. But the pain and misery that you are speaking of, which does indeed result from chemotherapy, is not caused by "toxins" in the medicine - it is caused by the medicine *itself*. Cancer therapeutics are, by definition, attacking cells that belong to the person in whom they are growing. These drugs are asked to pick out the "bad" self cells from the "good" self cells and kill them. They're not very good at that. Scientists have tried many ways to make cancer drugs selective for cancer cells, but as far as I know they have never been 100% successful. The result is that the drugs run rampant through the body, and the hope is often that they will kill the cancer cells before they manage to kill the person. It's a race, a miserable, excruciating race in which you have to ingest poison in order to fight the worse poison within you. This is an incredibly difficult race, and is one of the many reasons that cancer is so daunting to treat.

There are no mystical "toxins" hiding in chemotherapeutics. If there were some separate agent causing misery that could be distinguished from the drugs themselves, don't you think we would have purified them out? Well, we have - drugs are pure, single compounds, and everything they do is due to their own action.

An action that cannot, I must add, be reproduced by "photon field" magic.

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126. Sili on June 12, 2010 4:48 AM writes...

Bunsen wins. The thread, an Internet and 42 Everythings.

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127. SRC on June 12, 2010 12:27 PM writes...

Here's a link to WO06073491. (Click on "Initial Publication without ISR (A2 28/2006)").

Check out Figure 25D on page 110, which depicts the autocorrelation spectrum of glyphosate.

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128. milkshake on June 12, 2010 2:22 PM writes...

Derek, this is a very calm response from you. I hope that these nice people realize that if they go beyond writing omnious letters - for example if they try to intimidate you with a bullshit lawsuit based on the "but-but-it-makes-us-look-bad" argument, they will attract a hell lot more publicity of the very kind which they are perhaps trying to control (judging from their CFO letter). They would make you a hero.

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129. Former process chemist on June 13, 2010 9:13 AM writes...

I've been away from your site far too long. This is awesome. I've worked in small drug companies and the FDA and this is just a battle royale for me - thanks!

I find it fascinating that a blog actually fills a great niche to piece together all the other bits of the story.

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130. Former process chemist on June 13, 2010 9:13 AM writes...

I've been away from your site far too long. This is awesome. I've worked in small drug companies and the FDA and this is just a battle royale for me - thanks!

I find it fascinating that a blog actually fills a great niche to piece together all the other bits of the story.

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131. Former process chemist on June 13, 2010 9:14 AM writes...

I've been away from your site far too long. This is awesome. I've worked in small drug companies and the FDA and this is just a battle royale for me - thanks!

I find it fascinating that a blog actually fills a great niche to piece together all the other bits of the story.

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132. Anonymous on June 13, 2010 10:52 AM writes...

I understand the Butters read this blog, so I hope they can put me in contact with
their Whidbey Island investors. I have a plan for a voodoo acupuncture business.
The customers (I mean patients) simply have to mail in their co-payment and a
copy of their insurance card. Within a few hours, they should feel better. No
need for them to come into the boiler room (I mean clinic) and no need for more
than one office in the country.

Permalink to Comment

133. MIMD on June 13, 2010 6:43 PM writes...

On the other hand, some of the glowing endorsements and defenses of your company have come in under different names from the exact same IP addresses. Make of that what you will.

May I use the term "sock puppet?"

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134. Anonymous on June 15, 2010 5:22 PM writes...

HAHAHAHA!!! Imagine, even if he could do it, how the heck do you even begin to prove to the FDA that the stuff you put in the bottle is what you say it is. Seriously, imagine him trying to draft together cGMP batch records and stability protocols around something you can't measure!!!

Kind of like the crazies who sell "ionized" water in stores.

This type of stuff, where people pretend to do science or drug discovery, is quite upsetting to those who have committed their lives to it.

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135. Mandelbratwurst on June 16, 2010 5:32 AM writes...

Any chance we could re-write this as a tractable scientific hypothesis?

Pseudo-fact: Aretha Franklin can shatter a glass with her voice (I've seen it on TV).

Hypothesis: It's possible to shatter a glass in the presence of knives, forks, spoons and plates by application of appropriately tuned vibrational energy.

Fantasy: A single biomolecule could be selectively denatured in a complex biological matrix (let's start with an in vitro assay) by external application of EM radiation tuned to vibrational and rotational signature of that molecule.

If THAT works, people might start to listen, but I'm not really sure that's what they mean.

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136. Jonadab the Unsightly One on June 21, 2010 8:26 AM writes...

> Is he unfamiliar with the internet
> bulletin boards of Right Now, Currently?

They're not all the same. In the Pipeline, for instance, is far more civil than Slashdot or fark, to say nothing of the likes of 4chan (which makes usenet look like a Socrates dialog), but there are other fora out there, and some are (reasonably) civil. Perlmonks springs immediately to mind.

So perhaps the ones he's currently following are some of the civil ones. It's possible.

But yeah, he ought to be able to find better uses for his time than responding to every critical blog post on the internet, even if some of them are potentially libelous. Good PR comes from focusing on the positive. There will always be critics.

Even when a medical product is *widely* accepted and very profitable (like, say, Lipitor), there are still people out there who remain critical, people who claim that it's just a big conspiracy of the pharma companies and their cronies (Congress, the FDA, CIA, and MVD, your family doctor, your HMO, the President, BP and Exxon, the governments of Israel and Bahrain, the Pope, grey-skinned aliens, ...) to charge people a lot of money for drugs that don't do anything worthwhile and instead just make you sick even more so you have to go back to the doctors again for even more drugs... Some of these criticisms are just baseless, and others are completely ridiculous, but people are still going to make them. Get over it.

Libel law exists so you can stop a particularly high-profile opponent (like, say, a major competitor) from baselessly running your name through the mud in public, and that's fine as far as it goes, but you're never going to stop ALL criticism, nor should you want to try.

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137. bernie on June 27, 2010 12:53 PM writes...

I am surprised they did not threaten to report your blog to the Obama Administration.

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138. clazy8 on July 2, 2010 10:32 AM writes...

Nativis might want to see whether this guy has infringed on their patents. Or maybe not.

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