The 21st “Bore” and “Misinformation”

The 21st “Bore”
http://www.thetwentyfirstfloor.com/?p=8001

blogged about this post from Burzynski:
http://www.northdevongazette.co.uk/news/race_against_time_for_ilfracombe_cancer_sufferer_1_1966373
“Highly respected peer-reviewed journals are unlikely to accept interim results on clinical trials

We tried to submit such data, but were rejected

This is one of the reasons why we did not publish additional articles on clinical trials since 2006, because we decided to wait for the completion of the clinical trials which occurred just a few months ago

Since July 2012, we have prepared numerous manuscripts which describe the results of clinical trials, and we continue this process at present

These manuscripts are at various stages of peer review and submission to medical journals, and it is beyond our control when they will be published”

The 21st “Bore” then posts:

“Problematically for Burzynskis publishing ambitions the STABLE DISEASE category is not recognized by FDA as a measure of response”

Is this Burzynski critic posting “misinformation” ?

Guidance for Industry – Food and Drug Administration

Guidance for Industry

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

U.S. Department of Health and Human Services Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

May 2007 Clinical/Medical

“STABLE DISEASE should not be a component of ORR

STABLE DISEASE can reflect the natural history of disease”
(Pg. 10 of 22 = actual pg. 7 of PDF)

“Also, STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
(Pg. 11 of 22 = actual pg. 8 of PDF)

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf
TTP – Time to Progression
PFS – Progression-Free Survival

Time to Progression and Progression-Free Survival
TTP and PFS have served as primary endpoints for drug approval

The 21st “Bore” continues:

“I can think of no credible or prestigious journal that would publish data from clinical trials that reinvented the terminology of the field

For fear that in doing so those running the trial were trying to make their results look a lot more impressive

Well, I just proved that that was not the case

The 21st “Bore” proceeds

“The issue of publication remains central

If Burzynski wants to defend against his critics he has to publish and he has to explain, adequately and believably, why he has stubbornly and resolutely failed to do so thus far

It is this refusal to make evidence and data available … that … has lead me to the conclusion that this is a scandal of medical ethics and medical research”

Burzynski already provided the reason that the final results of the Phase II clinical trials were not yet published, so the only conclusion that I can reach is that this critic enjoys “beating the proverbial dead horse,” especially since the Declaration of Helsinki does NOT indicate WHEN final publication should take place
http://www.wma.net/en/30publications/10policies/b3
PDF:
http://www.wma.net/en/30publications/10policies/b3/17c.pdf
PDF:
http://www.who.int/bulletin/archives/79(4)373.pdf
PDF – History:
http://history.nih.gov/research/downloads/helsinki.pdf

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