Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer.
Dr Gonzalez, a recent expert speaker at one of the NL expert education seminars, has had his therapy heavily criticised in this recent article published in the respected Journal of Clinical Oncology.
At first sight it can seem that the paper roundly demolishes the pancreatic enzyme and lifestyle treatment recommended by Dr Gonzalez, and adds considerable value to the mixed chemotherapy treatment provided as the competing arm of the therapy.
In fact this paper has already been lauded in the arenas frequented by the more committed anti-alternative or non RCT evidenced medicine as a gross failure of the enzyme therapy to show any benefit in the care of pancreatic cancer patients.
Surely this must be considered an experts review, especially as the lead author Dr John Chabot was the appointed independent trial Principal Investigator at Columbia? He would know and report accurately what went on – wouldn’t he?
It appears, regrettably that all may not be as it seems. The quality of evidence for publication in main stream journals has received well deserved criticism in the press and in the heavy weight scientific journals as diminishing the credibility of the publishing journal and by association other hard working scientists. This JCO paper may well end up being assigned to one of those heavily discredited ‘published in error’ lists in the coming weeks, especially if Dr Gonzalez and his supporters are given a suitable platform to have their criticisms heard.
On Dr Gonzalez’s web site a detailed and frankly disappointing catalogue of internal problems, data manipulation and patient selection are described as having dogged this trial for years. Indeed, so corrupted has the data and events been that this JCO article or at least a very similar version was refused earlier publication by the JAMA journal – one has to ask why?
Of particular confusion is the absence of Dr Gonzalez from the paper – explained on his site by the explanation – he knew nothing of the paper. Even to an impartial observer the exclusion of a principal investigator from a published article of that investigators study seems incongruous.
Further questions relating to the impartiality of the principle Investigator Dr John Chabot are also raised, and indeed it seems clear that he has been dogged with less than complimentary feedback from his peers over his handling of allocated patients and his care in obtaining appropriate consent.
Dr Gonzalez makes a powerful case for the trial being structured and managed to deliberately reduce the likelihood of the patients being capable of following his recommended therapy being suitably assigned. This, and further revelations about the trial may be read in great detail on Dr Gonzalez’s web site.
A poignant and telling series of paragraphs extracted from Dr. Linda Engels’ letter written as the official NCCAM spokesman for the study to Dr. Chabot, dated January 27, 2005 gives a flavour of the controversy:
There have been numerous and very difficult scientific, operational, and procedural challenges in carrying out this trial. These have been well documented and frequently discussed.
…In spite of everyone’s best efforts, it appears as if the current design and implementation of the study may have resulted in accrual into the two study arms of patient populations that are not comparable. As a consequence, it is very difficult (if not impossible) to ascertain treatment effect with certainty.
Given all of the challenges, the surprising outcomes, and the uncertainties about balance between the two arms, it is highly likely (if not certain) that reviewers of the data from this study will raise substantive and legitimate concerns about the comparability of the two populations. As a consequence, it is virtually certain that the controversy surrounding the study will not be settled by the data from it.
What can we conclude?
This JCO paper seems to have failed to acknowledge many of the complications linked to the study and does not appear to include all relevant and full disclosure requirements. Remarkably it was published without the knowledge of one of the principle investigators and it, or one very similar was rejected by JAMA.
The apparent ‘clarity of outcome’ is severely compromised by the long running internal and external complications and irregularities. At the end of the day, this innovative study has failed the pancreatic cancer patient – it does not provide clarification of the Gonzalez protocol of adequate quality to be confident the data is free of corruption and the outcome of the chemotherapy treatment appears at this stage to be overly optimistic.
This will not be the first or last research paper to draw criticism, especially in the field of cancer treatments, it must be hoped that the journal and the relevant authorities will react in a timely manner to address the apparently blatant contradictions of due care and process and that the therapies may be re-examined under a new and independent team.
Chabot JA, Tsai WY, Fine RL, Chen C, Kumah CK, Antman KA, Grann VR. Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer. J Clin Oncol. 2009 Aug 17. [Epub ahead of print] View Abstract