[Bob]

Reservatrol Study Canceled

by Bob on Tue May 04, 2010 4:17 pm

While I understand the desire to get information into the hands of everyone and applaud that, the article on the cancellation of a Reservatrol study gets my raspberry award.

They say that the study was canceled due to safety concerns but failed to state what those concerns were. As far as I'm concerned, GSK may as well have placed a Mr. Yuk sticker on their product for all time. To me, GSK's logo is now a skull and crossbones. Even when prompted by the Beacon for more information to fill the black hole created by an information-less article, the drug manufacturer was anything but forthcoming.

Safety! Yeah, that's the ticket, safety. Give me a break. This organization is engaged in studies of drugs with far reaching consequences --offered to people who are desperate for a cure or at least Complete Response. That places a heavy responsibility on the developers to be open and above board on all facets of the study. Research which is kept in the shadows or hidden by bottom-line preserving functionaries is useless. Research is only helpful when it is disseminated throughout the affected community.

What safety concerns reared their heads? What befell the hapless study participants? When prompted by the Beacon for further information, the reply was a non-statement that indicated some study members suffered issues similar to those experienced by other Multiple Myeloma sufferers. What? Did they die? Are they permanently disabled as chemo disabled me? What exactly is going on over there in the shrouded shadows of their experiment? I doubt that they canceled because people got nauseous or developed a little peripheral neuropathy.

Is it any wonder that so many people distrust the corporations we must rely on for medical assistance?

Nope.

[Boris Simkovich]

Re: Reservatrol Study Canceled

by Boris Simkovich on Tue May 04, 2010 6:41 pm

Hi Bob,

Thanks for your feedback regarding the Beacon's recent article on the suspended resveratrol trial.

From the way you started your posting, I thought you were going to describe objections to what the Beacon staff wrote in our article. But, as I read through your posting further, it seems that you are mainly objecting to GSK's handling of the trial suspension and what it is saying about the reasons for the suspension.

Is that correct? Is your beef mainly with GSK? Or is there something we should have done differently in the way we reported the news?

For what it's worth, we are continuing discussions with GSK in an attempt to learn more about what happened during the SRT501 myeloma trial. As soon as we know anything that might be of help to the Beacon's readers, we will publish it.

- Boris.

[Boris Simkovich]

Re: Reservatrol Study Canceled

by Boris Simkovich on Wed May 05, 2010 10:00 am

We've added an update to the resveratrol study with some information about the specific safety issue that was observed during the SRT501 trial. Here's the text of the update:

Reports indicate that the SRT501 trial was halted after 24 patients had enrolled in the trial. Of the 24 patients, five developed a kidney condition called cast nephropathy. Cast nephropathy is so commonly associated with multiple myeloma that it is often called “myeloma kidney.” It also is one of the main contributors to kidney failure in myeloma patients.

We will continue to work with GSK to understand more about what exactly happened during this trial and what implications it may have for myeloma patients.

[Pat Killingsworth]

Re: Reservatrol Study Canceled

by Pat Killingsworth on Wed May 05, 2010 4:58 pm

Very impressive the way The Myeloma Beacon broke this story first! Like Bob, I too would like more information about why the study was suspended. Stay on it, guys and gals! Keep up the great work! Pat

[Beacon Staff]

Re: Reservatrol Study Canceled

by Beacon Staff on Thu May 06, 2010 11:47 pm

The Beacon had a chance yesterday to speak with executives at Sirtris Pharmaceticals about the suspended resveratrol trial, and we learned a lot of additional, useful, information. We've put all the information together in a new article that we just published.

Please let us know if there are any additional questions about the trial that we should pursue, or if there is anything in the article that is not clear.

[hi there]

Re: Reservatrol Study Canceled

by hi there on Fri Jul 23, 2010 10:52 pm

The Beacon Staff got more out of Sirtis than anyone else that I read, even if not much. I would guess there isn't any cover up regarding the reason the study was suspended (not canceled). I wish the Beacon Staff would have asked how those who still want to take SRT 501 are doing since that seemed to be a positive sign. Of course, Sirtris probably wouldn't have let out any information. There were around 60 patients in the trial, some on placebo, and several stopped. But that leaves a few who could leak how well they are responding to SRT 501, right?

Also, the SRT 501 trial on liver/colon cancer ended last winter, but half a year later and no study has been published. Does that mean it failed, or would it normally take 8 months to publcation?

Another aspect to consider is that SRT 501 is not a New Chemical Entity like Sirtis' other compounds in trials , although I guess it is patentable. It is a resveratrol blend, which likely means high dosages of resveratrol that is sold by Biotivia and others may have a similar effiacy (or lack of.)

i hope the Beacon Staff can get more answers, but it may be impossible.