Blood Products Advisory Committee Meeting Announcement (BPAC) December 14-15, 2010

[Esther12]

Alter sounds like he's going for it.

It's been so hard going on all this time with so little interest in finding out why we're ill. The relief of hearing someone like Alter talking about the need to work on finding a cause is almost upsetting.

 

[Cort]

leGrice said some months ago the contamination issue would be ruled out (or not) in next couple of weeks.
after all these waiting, we got nothing. still stoye/coffin versus judy and alter about comtamination yes or no...nothing has changed since the xmrv workshop, same discrepancies still exist, cant believe it...

They didnt do what le grice promised (solve contamination issue)
they keep repeating same arguments
wasting valuable time with doing nothing

You gotta wonder a bit what they are doing. LeGrice said that in the CFSAC meeting months ago...... I wonder if they are doing as much work as they said they would do.....

We asked this retrovirologist guy about the negative studies.....(I'm giving away all my talking points ) and he said with the CDC that they didn't put nearly the resources into it that he would've.....They basically didn't work as hard as they should've given what was at stake.

It's going to be interesting to see how many samples they all shared. I hope they were looking at a good chunk of them.

 

[George]

Business Week First Dog Out of the Gate

For comments go to http://www.businessweek.com/news/2010-12-14/chronic-fatigue-patients-shouldn-t-give-blood-fda-advisers-say.html

December 14, 2010, 7:53 PM EST


By Rob Waters

Dec. 14 (Bloomberg) -- People with chronic fatigue syndrome shouldnt donate blood until health officials complete a review into whether the disorder is tied to an infectious agent that might spread to recipients, U.S. advisers said.

The Washington-based American Red Cross, the nations largest supplier of blood products, announced Dec. 3 that it wont accept blood from potential donors diagnosed with the syndrome. Some studies have found that a virus called XMRV may be linked to the condition.

More than 1 million Americans have chronic fatigue syndrome, which leaves people exhausted and can cause joint and muscle pain, according to the U.S. Centers for Disease Control and Prevention in Atlanta.

A panel of experts convened by the U.S. Food and Drug Administration voted 9-4 today in Gaithersburg, Maryland, that the scientific evidence supports rejecting donations from people with the illness, Shelly Burgess, a spokeswoman for the agency, said in an e-mail.

 

[Cort]

Yes, I don't think XMRV is causing fatigue that quickly. Also most animals need to be really sick, before they display it openly. They don't want to show weakness, because of possible predators.

I imagine that you are right - they are hardwired to maintain a semblance of health even when they are ill.

When they infect rats, I think it is, with these types of viruses - some of them drag their hindlimbs around. Also, while lots of the cells in the body are resistant to the viruses - the cells in the nervous system apparently are not. Once you get a virus in the nervous system I think it could cause a huge number of symptoms.

Since fatigue is thought of in general as a central nervous system symptom....I wouldn't be surprised if it was caused by a virus....Look at MS - classic relapsing, remitting disorder characterized by severe fatigue......its possible a virus is at play or it was a virus that kicked off the autoimmune response.

 

[urbantravels]

http://www.bloomberg.com/news/2010-...-t-donate-blood-fda-advisers-say-in-vote.html

Chronic Fatigue Patients Shouldn't Donate Blood, FDA Advisers Say in Vote
By Rob Waters - Dec 14, 2010 4:32 PM PT



People with chronic fatigue syndrome shouldn’t donate blood until health officials complete a review into whether the disorder is tied to an infectious agent that might spread to recipients, U.S. advisers said.

The Washington-based American Red Cross, the nation’s largest supplier of blood products, announced Dec. 3 that it won’t accept blood from potential donors diagnosed with the syndrome. Some studies have found that a virus called XMRV may be linked to the condition.

More than 1 million Americans have chronic fatigue syndrome, which leaves people exhausted and can cause joint and muscle pain, according to the U.S. Centers for Disease Control and Prevention in Atlanta.

A panel of experts convened by the U.S. Food and Drug Administration voted 9-4 today in Gaithersburg, Maryland, that the scientific evidence supports rejecting donations from people with the illness, Shelly Burgess, a spokeswoman for the agency, said in an e-mail.

 

[Rivotril]

maybe the opcoming webcast will bring out more details

hopefully the singh paper will come out soon and if it confirms the wpi findings and is done fully blinded, we have another big horse in this race.

 

[Cort]

Did you know we have a Friend there? At Bloomberg news. Carole Woolf (is that it?). She is all over CFS. You just don't hear about her because she can't fit it into the paper. She has been working the money angle; she cannot believe the govt is spending so little money on this disorder - that fact so weird to her that she's been trying to figure out if something nefarious is going on.. She is a BIG supporter. She was at the last CFSAC meeting.....I'm not surprised it got in so quickly.

I see it was by Rob Walters though....even Bloomberg shows at the meeting..

 

[urbantravels]

Yikes, George is one fast puppy! Got in there before me with the same story.

It looks like Bloomberg may have had a reporter in the room. The business press (witness Amy Dockser Marcus at the WSJ) has been very on top of this story lately. Not at all surprising considering the business implications - new market for drugs, new market for tests, etc.

 

[urbantravels]

Cort's post slipped in ahead of mine.
Both George's link and my link were to the same story by the same Bloomberg reporter - Rob Waters, not Carole Woolf.

 

[George]

But it's still self deferral and you have to tell them that you have ME/CFS, they won't ask you if you have ME/CFS. So I don't see that we made any progress. Did we???

 

[urbantravels]

The FDA regulates blood products. So if they say donors should be deferred, it's no longer a suggestion.

Remember that just a few days ago that news story in Seattle and the backstory - the director of that blood bank didn't implement a deferral policy until the press came sniffing around. And he was the president of the AABB!

Yes, it's not as strong a deferral as we would like if it means they are not changing the donor questionnaire, but this decision does have a lot more force than the current AABB policy.

 

[urbantravels]

...that's of course IF the FDA decides to abide by the recommendation of its own advisory committee, which it "usually" does but isn't required to do.

I am recalling that an FDA advisory panel voted that Vicodin should be taken off the market (because of the danger of liver damage from the acetominephen)...in June 2009. However, Vicodin is still on the market.

 

[Cort]

Disagree. One can't present "Summary of Current Research on MLV-related Human Retroviruses and Disease Association" and play devils's advocate at the same time. This is an effort to "balance out the story" is quite the opposite.

And to repeat my previous request: Bring a complete theory for contamination or leave the friggin accusation and innuendo out of it.

Elaborate please. Who is the "they" who have "never found pMLV's that can do that in humans."

Yes it needs sequenced. The notion of seeing insertion of DNA of a human cell came from a PNAS reviewer. Who's calling for that today?

One can't present "Summary of Current Research on MLV-related Human Retroviruses and Disease Association" and play devils's advocate at the same time.

I just think that happens all the time...but the way to shut these guys up is to isolate the virus or prove its integrated into human DNA or provide some other data that shuts them up. Alter/Lo have more work to do....in order to silence the naysayers. They are working on isolating the virus - hopefully they will do so soon.

Haven't we heard several times from Coffin and elsewhere that pMLV's are not infectious in humans? That is my recollection.

 

[CBS]

But it's still self deferral and you have to tell them that you have ME/CFS, they won't ask you if you have ME/CFS. So I don't see that we made any progress. Did we???

I might be reading more into this than is warranted but my sense of the big gain from the day seemed to be Coffin's shift from being primarily skeptical to what seemed may have actually passed as excitement at the prospect of solving an important puzzle that has real consequences.

The skeptics (ME/CFS deniers) aren't going to let go of their preconceptions without a fight (and for some probably never) but Coffin seemed more interested at the end the day than at he was at the beginning.

 

[urbantravels]

Just my hunch, but I think that when Coffin plays devil's advocate it comes from better motives than Stoye's dismissive scoffing. I think Coffin bulldogs the tough questions because he genuinely wants to see them addressed.

 

[Lynn]

So does this mean that the "Don't ask, You Tell" policy is still in effect?

Lynn

* thanks to one of the FDA committee member's for coming up with that.

 

[anciendaze]

The following are my unsolicited opinions:

Coffin is acting like a real scientist with a problem to solve, not our sworn enemy. I'm afraid Stoye is simply acting like an... My analysis of the cost of stopping an epidemic suggests he will have lots of support from government administrators who don't know where the money will come from, or how they can control it. Much of this is theater for public consumption. Running only 4 samples through competing labs speaks for itself. Many people don't want this question resolved quickly.

WPI has not been doing straight PCR because they decided it would not be sensitive enough long ago, before the Science paper was published. The Lombardi paper used nested PCR. Anyone who paid attention earlier would have known they were operating at the limits of detection without waiting until now. The WPI/Cleveland Clinic/NCI collaboration learned how to culture the virus. Has anyone else? We have just seen another round of the "if you do this our way, you won't find anything". Was this trip even necessary?

Arguments that mitochondrial DNA could not be involved violate considerable observation that mitochondrial disease is part of the syndrome. The implication that this is impossible gets back to arguments about low replication fidelity, which is being observed in reported data. Arguments about the necessity of nuclear DNA must be tempered by those long forgotten observations of low ESRs in a subset of patients. This is due to misshapen erythrocytes. Mature (mammalian) erythrocytes do not have nucleii.

Meanwhile, back in the real world, things are definitely happening. Research efforts are being started with whatever funding can be scraped together. Companies who pay attention to the bottom line are tweaking existing antiretrovirals for XMRV and MLVs. (Check on Chimerix.) The fact that opposition tactics involve playing for time should be considered positive. Nothing that happened today shows it possible to stop this train.

 

[Lynn]

Wow anciendaze.

I think you are spot on.

And what about the 4 samples. I am not a scientist but that seems whack to me. How could you possibly ever come to a conclusion in an imperfect world with only 4 samples. I am appalled!

Lynn

 

[Anika]

Note re Bell "recovered" patients - Maureen Hanson

I don't know if someone already addressed this - but I think the "recovered" patients of Dr Bell that are being studied by Hanson may have been discussed in an article this summer by Bell and Bell. (viral results appear about the same in current and "recovered" patients)

My general memory (with the usual disclaimers of faultiness) is that the Bells found that CFS patients whose orthostatic intolerance improved or disappeared, considered themselves "recovered", but when looked at more closely, they were still having lots of other symptoms. So the OI accounted for much of the disability in functioning, but even when the OI and functionality improved there were still symptoms of illness.

I can't locate the article just now. I think the Bell and Bell article may have been in some online publication from a UK ME group, and you had to page through the very lengthy publication to read the Bell article - couldn't just clip and post it. Maybe someone with a better memory or google-ability can locate this.

 

[Cort]

Wow anciendaze.

I thin you are spot on.

And what about the 4 samples. I am not a scientist but that seems whack to me. How could you possibly ever come to a conclusion in an imperfect world with only 4 samples. I am appalled!

Lynn

I am just hoping that that is not the right number. It is so small - I just can't imagine...