It's complicated, but what should have been a talk was blocked (for political reasons). The paper examines the science of the inoculation of gliomas by two neurosurgeons with Enterobacter aerogenes. The paper gives guidance to IRBs on bacterial/microbial approaches to treatment of cancer so that others can avoid pitfalls and embrace this treatment modality safely and effectively. This is a tough paper for several reasons.
A. While parties in the institution have supported me, they do not want to be publicly associated. (Chair and Dean of med school resigned.)
B. It is an area that very few know well. Sepsis is taught, but it is not taught very well, and even among specialists in the field, the differences between human and animal are not understood. And the difference is critical.
C. This was an unapproved trial (although patients did sign consent forms) and the discussion is based on government documents obtained through the Freedom of Information Act (FOIA) (that were conformed to HIPAA). It is an example of many things going wrong.
So, I am looking for reviewers who would be willing to be listed when I submit the paper. The journal is still open, however I am leaning toward Negative Results in Biomedicine. Please let me know your qualifications and affiliation if you are interested.
Most journals today require submission of 3-5 suggested reviewers. I much prefer the old system, but this is how it works.
Hi Brian, I am bit skeptical about your study.
I have many questions than answers:
a. Is there any preclinical studies along the line of your proposal that you have done? Rodents, Rabbits, Cats, and monkeys? Any long-term observations? Additionally work has to be performed by someone who has the expertise to do so.
b. Your paper CANNOT give guidance to IRBs; IRBs should tell you what you can do and what you cannot do!
c. You have recruited subjects for an unapproved trial, which is unethical, despite the fact that the participants have consented. First of all your protocol as well as your consent needs to be approved by IRBs. Otherwise, how would someone know if the investigator told the truth or fabricated the information by hiding the truth. There is a potential for a law suit or a class action suit here.
d. 'the discussion is based on a document obtained to FOIA'. This is good for writing a paper in medical hypothesis, but not good enough to do a human experiment.
e. As an Editor-in-Chief, if such paper is submitted to my journal, it might not even get reviewed. It will be submitted right away! If I had to send out for a review, the first action would be to submit to an ethicist for a review prior to scientific review. If the ethicist did find any ethics violation, this might even bring additional issues.
f. 'the parties in the institution supported me' - What if you're one of the nicest guy on the block, and no one want to disappoint you by telling you the truth, but gave only a word of encouragement?
g. I see the reasons why people resigned. What happened to the two neurosurgeons who performed the inoculation of gliomas with Enterobacter aerogenes? Are they still in business?
Perhaps, I am giving you a disappointing response. However, I want to be honest with my opinion.
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