From FDA email, Prevalence Studies on XMRV and MLV-related Virus Infection in Human

[*GG*]

Diseases and General Population

http://www.fda.gov/downloads/Adviso.../BloodProductsAdvisoryCommittee/UCM234925.pdf

 

[Sherby]

Thanks for this info. Will show it to my GP next week. Sure he will be interested.

 

[Megan]

This is a great summary document, but there is something very misleading in it. If you simply count the boxes with X's in them versus the studies that are blank you get the following tally:

Prostate cancer
10 positive studies
3 negative studies

CFS
6 positive studies
8 negative studies

But if you look more closely, it is apparent that 5 of the positive prostate cancer studies do not show any association with XMRV and prostate cancer at all. These are listed below. It is very troubling that these 5 are marked with an 'X' which the summary document equates to a "positive finding". Clearly in this context "positive" only means they found any XMRV at all, but this is not made clear in the heading of the document or the note that says what the 'X' means.

According to my corrected tally, the correct figures representing disease association should read as follows:

Prostate cancer:
5 positive studies
8 negative studies

CFS:
6 positive studies
8 negative studies

Prostate studies that show no association with prostate cancer and are misleadingly marked with an 'X' in the FDA document:

1. Fischer et al, Prevalence of human gammaretrovirus XMRV in sporadic prostate cancer. J Clin Virol. 2008; 43:227-283. They find 1/87 prostate cancer patients (1/105 samples) positive for XMRV and 1/70 controls positive.

2. Switzer et al CDC Paper #149, Abstract 17th CROI meeting, 2010 http://www.retroconference.org/2010/Abstracts/37160.htm. They found low association in prostate cancer with 2/162 (1.2%) positive. There were no controls, but you dont have to be Einstein to work out even if there were that a 1.2% finding is unlikely to show a statistically significant association with prostate cancer.

3. Ikeda Y, et al. Prevalence of XMRV in prostate cancer patients at Mayo clinic. Abstract. International Workshop XMRV. 2010. Reviews in Antiviral Therapy, Volume 8, 2010. This study states in the conclusion of the abstract, "no statistically significant association was observed between the presence of XMRV DNA and prostate cancer"

4. Makarova N, et al. Prevalence of neutralizing antibodies against XMRV in clinical prostate cancer. Abstract. International Worskshop XMRV. 2010. Reviews in Antiviral Therapy, Volume 8, 2010. This one found 6% of prostate cancer cases positive in an antibody test but there were no controls, so it is not evidence of any association given that other studies have had control figures at around this percentage.

5. Fischer N, et al. XMRV prevlaence in prostate cancer tissue and the role of the prostate compartment in XMRV. Abstract. International Worskshop XMRV. 2010. Reviews in Antiviral Therapy, Volume 8, 2010. This one fount XMRV positives in 2/355 samples (0.6%), 0/70 controls and 0/40 blood samples from PC patients.

 

[Megan]

I hope the above issue only reflects FDA concern regarding the blood supply with a leaning towards banning people with prostate cancer as well as CFS from donating blood. However, I find it concerning because it is clear from reading this and the other forum that Mikovits has indicated that there is a push from some in the scientific community to create a 'split' between the prostate cancer findings and CFS findings to focus on prostate cancer and let go of CFS.

I recently communicated with a senior retrovirologist who told me that there was no link between CFS and XMRV but there did seem to be with prostate cancer. This comment was based on what the person had heard at a recent international conference on infectios diseases. The conference was called the ICAAC. This person was not yet aware of the findings of the XMRV conference.

The figures in the FDA document don't seem to me to support such a split, yet obviously this is what is being said by some (or more?) in the scientific community.

 

[George]

Which is really interesting. Do doctors believe everything they are told? (head slap) What am I thinking of course they do that's what makes them doctors. The researchers are the rejects that questions things. (big grins)

Dr. Coffin mentioned at the Prague CROI and in a separate interview as well that he thought the chance of XMRV being causative for Prostate Cancer was not there. Dr. Signh has indicated that XMRV and related MLV's are seen in the more aggressive tumors and that XMRV may be creating an environment more conducive to tumor growth.

Sometimes the prejudiced in something is so deep that people see only what they want to see and hear only what they want to hear.

 

[Cloud]

Which is really interesting. Do doctors believe everything they are told? (head slap) What am I thinking of course they do that's what makes them doctors. The researchers are the rejects that questions things. (big grins)

Dr. Coffin mentioned at the Prague CROI and in a separate interview as well that he thought the chance of XMRV being causative for Prostate Cancer was not there. Dr. Signh has indicated that XMRV and related MLV's are seen in the more aggressive tumors and that XMRV may be creating an environment more conducive to tumor growth.

Sometimes the prejudiced in something is so deep that people see only what they want to see and hear only what they want to hear.

Exactly...and they dismiss anecdotal information even in the form of millions reporting the exact same experience. Sometimes I think common sense is the better science.

 

[Esther12]

This is a great summary document, but there is something very misleading in it. If you simply count the boxes with X's in them versus the studies that are blank you get the following tally:

Prostate cancer
10 positive studies
3 negative studies

CFS
6 positive studies
8 negative studies

But if you look more closely, it is apparent that 5 of the positive prostate cancer studies do not show any association with XMRV and prostate cancer at all. These are listed below. It is very troubling that these 5 are marked with an 'X' which the summary document equates to a "positive finding". Clearly in this context "positive" only means they found any XMRV at all, but this is not made clear in the heading of the document or the note that says what the 'X' means.

That is interesting. I wonder to hat extent those discrepant figures are the result of an expectation affect on th part of researchers? With cancer they're more likely to push on looking?

 

[usedtobeperkytina]

Cloud, common sense is what has been missing in the whole history of ME/CFS. No matter what you see in the microscope, or don't see, the mistake is not listening to the patients and not listening to the physicians who see high numbers of these patients.

The problem is that part of the evidence was given no weight, no credibility, not listened to. It was rejected. They did not follow Osler's policy.

It's like a jury, if you have six witnesses go on the stand and independently give the same account of seeing a man shoot his wife, and an expert in forensics gives the same story of what happened based on blood splatters, even if there is no body and no gun, you got to give weight to what the witnesses say. Then add that the person supposedly killed has been missing and was a normal soccer mom. Witnesses are known for being wrong. Forensics can be misinterpreted. This is just like patients reporting their symptoms and physicians reporting what they see. So, one or two, heh, chalk it up to the patient is wrong and the physician is misreading it.

But, when you have four physicians in three different parts of the country, 100s of patients with similar reports, somewhere, common sense should help you see.

Tina

 

[Cloud]

Cloud, common sense is what has been missing in the whole history of ME/CFS. No matter what you see in the microscope, or don't see, the mistake is not listening to the patients and not listening to the physicians who see high numbers of these patients.

The problem is that part of the evidence was given no weight, no credibility, not listened to. It was rejected. They did not follow Osler's policy.

It's like a jury, if you have six witnesses go on the stand and independently give the same account of seeing a man shoot his wife, and an expert in forensics gives the same story of what happened based on blood splatters, even if there is no body and no gun, you got to give weight to what the witnesses say. Then add that the person supposedly killed has been missing and was a normal soccer mom. Witnesses are known for being wrong. Forensics can be misinterpreted. This is just like patients reporting their symptoms and physicians reporting what they see. So, one or two, heh, chalk it up to the patient is wrong and the physician is misreading it.

But, when you have four physicians in three different parts of the country, 100s of patients with similar reports, somewhere, common sense should help you see.

Tina

Agreed....And I think Sir William Osler has probably rolled over in his grave.

 

[Hope123]

He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all.
William Osler

 

[Otis]

Bingo.

And them we have sailors believing myths about sea monsters and a flat world propagated by those who have never left the shore but are 'writing the books' nonetheless.

Tick tick tick.