Thread: The Trial

In Italy, Davide Vannoni made an astonishing claim: he could cure fatal illnesses with stem-cell therapy.
Yet, Nature News reports:

"Well over 100 people with conditions ranging from Parkinson's to motor neuron disease to coma — nearly half of them children — have already signed up to participate in the government-sponsored trial, despite there being no published evidence that the therapy could be effective. (...)

Last year, the US Patent Office issued a ‘pre-final’ rejection of Vannoni's patent — one that allows re-submission, although Vannoni has not yet resubmitted. The rejection noted that the application included insufficient details on methodology, that differentiation was unlikely to occur during the very short incubation time described, and that the appearance of nerve-like cells in the culture is likely to “reflect cytotoxic changes”.

Furthermore, in the patent (which is far from complete), the images are not new.
They are taken from a scientific paper (Schegel'skaya, E. A. et al., 2003), although the patent lacks the reference. Plagiarism?

The trial, which will test Vannoni's method, has been postponed three times because the medical entrepreneur has not yet revealed his method.
As such, a committee cannot start the trial that is intended to show the efficacy of this therapy.

It seems that the fuzz Mr. Vannoni created, should not be taken seriously. It merely fakes a last resort for dying children and adults.
If it turns out to be a scam, must this individual be punished according to you?


Source:
​Italian stem-cell trial based on flawed data : Nature News & Comment

Assuming it is fraud:

A class action lawsuit would be deserved, nothing beyond that though... It sets a weird precedent, all it means is that you've effectively established a system where things like this are reviewed case-by-case - just to see if the circumstances even qualify for legal proceedings: Just a waste of time and additional resources. The distinctions between what is legal and what is not would just be too convoluted, ie: Homeopathy. What's important is that whatever his reputation was, you can be sure of what it would become.

Edit: Apparently this precedent has already been set... Still wishy-washy though.

It does perhaps a little odd that people seem able to claim what ever they wish, quite often without ever having to had actually demonstrate anything. Perhaps it would be good to have a global standard for everyone wishing to make scientific claims must first satisfy. This way when someone comes out with a new claim the public can actually have confidence rather than either getting conned by charlatans or ignoring real genius. I can't help feeling a little resentful towards those who make medical claims though without really demonstrating them as it prevents others picking up the mantle or helping other people, that's if the claims are even genuine. But when these claims are false or misleading it is even worse as people believe and waste their time and money on frauds, it's in cases like this prison terms seem appropriate.

Im in favor of transparency, with initial data, methodology and results being accessible. Imo the primary goal should be the free flow of information, people should be informed that there is not yet any evidence the technique works (with a potential warning [unproven, potential misrepresentation or fraud]), and have the researcher person make his methodology accessible for review/improvement, and have the people decide based on this information if they want to go ahead with the test. Then if the researcher is shown to have broken laws in the process, he should be punished according to these.

If a method is to be published with data to prove it works, that usually means that there needs to be a test before it is proven, so I have no problem with a untested "test" (within reason).

There is no laws against "being" a charlatan or a dubious scoundrel, but laws against specific actions that a given society does not wish to allow, in this case, he should be punished according to laws in place (anti-false representation, fraud, consumer protection, etc) if he breaks any of those.

The problem I have with preventing a trial in a manner that could be too expedited/premature, is that a discovery can be counter intuitive and not explained from the framework of existing understanding.
Lets say acupuncture does work for a number of uses and that we dont "really" know exactly why that is, or worse there is a fanciful laughable explanation that is false. It could look like new age crack-pottery, but to be sure we need tests. If the test are successful, you can categorize the treatment as "valid for undetermined reasons".


EDIT: There are a number of instances where scientific authorities and or the best theories available said an experiment could not be/was impossible/etc and then experiments proved them wrong, though these are rare they are also often important in expanding our understanding or application of technologies. If these had been prevented on the grounds they go against conventional understanding or current consensus we would not be were we are now.

Update:

The trials that were meant to test the claims of the Stamina Foundation, are halted by Ms. Lorenzin (Italy's Health Minister):

"Acknowledging the concerns of a number of scientists in Italy, the country’s health minister, Beatrice Lorenzin, agreed to put a stop to a controversial stem cell clinical trial. “This is the end of the matter,” Luca Pani, president of the Italian Medicines Agency, told Nature. “And we are very happy.”"

(cf. http://www.the-scientist.com/?articl...Trial-Stopped/)

Rumors say Mr. Vannoni and his foundation are planning to set up trials in China.

forget to say, you can see with the pics of the front wheel bay, on the front panel you can se the resin on the edge of it....thats what happend when you paint the panels on the resin block...an then see that the way they attache the pieces isnt on the border...but partly over it....so youll have to cut an erase....but then have part of the piece unpainted......thats the Aires view of the thing.....so now ive got the retouch all of these things.....so funny Pat

/deleted post

It seems that the story did not end with the ruling of the scientific committee.

From Nature News:

"The regional administrative court of Lazio, Italy, today ruled unlawful the scientific committee that had advised the health minister not to proceed with a planned €3 million [$4.000.000] clinical trial of a controversial stem-cell therapy. That gives the Brescia-based Stamina Foundation, headed by Davide Vannoni, a second chance to push for the government-sponsored trial which the committee had declared as lacking a scientific basis and potentially dangerous."

(cf. Italian court rules science advisors unlawful : Nature News & Comment)

Let us hope that a second scientific committee will end this matter.

Update:

The second scientific committee reached the same conclusion as the previous committee: the stem-cell therapy proposed by Davide Vannoni is ineffective and possibly dangerous:

"The Italian health minister Beatrice Lorenzin declared on 2 October that her government will not support a clinical trial of a controversial stem cell therapy that it promised last year. (...) A committee of experts concluded in October last year that the treatment was phoney, but in December a court ruled that committee illegally biased. Lorenzin established a new committee earlier this year which has now drawn the same conclusion as its predecessor."

(cf. End of the road for rogue stem-cell therapy in Italy : Nature News Blog)

Originally Posted by Cogito Ergo Sum

Update:

The second scientific committee reached the same conclusion as the previous committee: the stem-cell therapy proposed by Davide Vannoni is ineffective and possibly dangerous:

"The Italian health minister Beatrice Lorenzin declared on 2 October that her government will not support a clinical trial of a controversial stem cell therapy that it promised last year. (...) A committee of experts concluded in October last year that the treatment was phoney, but in December a court ruled that committee illegally biased. Lorenzin established a new committee earlier this year which has now drawn the same conclusion as its predecessor."

(cf. End of the road for rogue stem-cell therapy in Italy : Nature News Blog)

Well, for the time being, stem cell treatments are very restricted. Not much to show for. No wonder crooks and hacks are quick to take advantage of all the media hoopla surrounding the field.

Originally Posted by Howard Roark

Well, for the time being, stem cell treatments are very restricted. Not much to show for. No wonder crooks and hacks are quick to take advantage of all the media hoopla surrounding the field.

Certainly, but people who oppose (embryonic) stem cell research are also a factor that leads to scientists spending less time in the lab and more time in court or in the media and internet.

Originally Posted by Cogito Ergo Sum

Originally Posted by Howard Roark

Well, for the time being, stem cell treatments are very restricted. Not much to show for. No wonder crooks and hacks are quick to take advantage of all the media hoopla surrounding the field.

Certainly, but people who oppose (embryonic) stem cell research are also a factor that leads to scientists spending less time in the lab and more time in court or in the media and internet.

I don't think that there are many people opposing, there is a Nobel prize winner who predicted zero to negligible results who is the main opponent but other than that, not much opposition. You cannot attribute the lack of results to "opposition", so far billions of dollars have been poured into stem cell research.

Thanks for this thread, it's very interesting