

Neurosurgeons barred from human research after experimental infections - 1337biz
http://blogs.nature.com/news/2012/07/neurosurgeons-barred-from-human-research-after-experimental-infections.html

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bugsbunnyak
This has strong whiffs of grudge-grinding and ass-covering.

My take is that the IRB was miffed at the end-run using an ethics committee
instead of the IRB. However, this is neither unprecedented nor illegal. Ethics
committees are widely used to oversee investigational or quasi-elective
procedures (ie "elective" off-label procedures for non-life-threatening but
massively debilitating conditions).

It is quite telling that both surgeons still have privileges, and indeed one
remains the department chair. The Sac Bee article and the FDA notification
letter contain no mention of medical licensure investigations.

There is a massive gray area between clinical judgement and IRB or FDA
purview. Drs. can and do use drugs and devices far, far off-label all the time
- and there is essentially nothing the FDA can do to the Dr. (however they can
come down hard on manufacturers for promoting unapproved uses)

The FDA and IRB do not regulate the practice of medicine and "medical
judgement"; those are constrained by medical boards, tort, and in extreme
cases prosecution for criminal negligence.

This was research misconduct only to the extent that they made the mistake of
involving the IRB in the first place.

background: <http://www.ncbi.nlm.nih.gov/pubmed/21552172> study pro:
<http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2039978/> study con:
<http://www.ncbi.nlm.nih.gov/pubmed/19404146>

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Locke1689
Reviewing the FDA report, it appears that the two physicians are guilty of
grave misconduct if they knowingly violated the treatment requirements set
forth by both the IBA and FDA.

That said, there's nothing _a priori_ wrong with the treatment, had it been
approved. Even if the result were the same. Experimental treatments are
experimental for a reason. In fact, many of our treatments for cancer,
including chemotherapy and radiation, are all poisons designed to kill the
cancer before it kills you. Introducing a poison into a patient's body in the
hope that, if you survive, you'll stop the cancer's progress is really the
rule more than the exception in modern cancer treatment.

We really don't have anything better.

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sekm
The first line of this article jolted me backwards.

At Universities in New Zealand, any type of experiment involving human
participants (even just talking to them) requires passing through an
exceptional amount of ethics-committee red tape.

I believe the ethics were derived after the experiments from WW2 on humans.
Regardless of whether or not these patients agreed, it still sounds
ridiculously unethical. Does anyone know of any animal research using the same
techniques?

~~~
tokenadult
Here is a link to the more detailed reporting on this same incident by the
Sacramento Bee:

[http://www.sacbee.com/2012/07/22/4648415/2-uc-davis-
neurosur...](http://www.sacbee.com/2012/07/22/4648415/2-uc-davis-
neurosurgeons-accused.html)

[http://www.sacbee.com/2012/07/22/4648465/banned-ucd-
doctor-i...](http://www.sacbee.com/2012/07/22/4648465/banned-ucd-doctor-is-
one-of-ucs.html)

 _At Universities in New Zealand, any type of experiment involving human
participants (even just talking to them) requires passing through an
exceptional amount of ethics-committee red tape._

The same is true in the United States. At the state university in this state,
which has a very extensive medical research program, the human subjects review
committee has to approve any new experimental protocol to be used on human
patients. What J. Paul Muizelaar and Rudolph J. Schrot, both neurosurgeons at
the University of California, Davis, reportedly did (as related in the article
submitted here on HN) is completely unethical, and not at all to be tolerated.
Their being barred from further medical research on human subjects, as
reported in the article, is an appropriate response. (And that is basically a
severe restriction on the faculty member's ability to raise grant funding.)

I write this as someone who has an immediate relative whose fiancee died of
the dreaded disease mentioned in the article. Finding a patient with a disease
with a grave prognosis is no excuse for doing something that is dangerous on
its face and unproven to be therapeutic. The rule "first do no harm" is still
a basic principle of medical practice.

~~~
AngryParsley
"Do no harm" makes no sense in this case. Glioblastoma multiforme is a death
sentence. These people were basically guaranteed to die of brain cancer within
a year. They were offered a therapy that had a very low chance of working.
They consented. It failed. They died.

It's a sad story, but experimentation is necessary to find effective
treatments. If you're like many people on HN, you'll agree that terminally ill
people should be able to commit suicide. If you grant that, why not let them
consent to experimental treatments?

~~~
sekm
> It's a sad story, but experimentation is necessary to find effective
> treatments. If you're like many people on HN, you'll agree that terminally
> ill people should be able to commit suicide. If you grant that, why not let
> them consent to experimental treatments?

While experimentation is a necessity - so are ethics. Apparently they did not
have the required approval to conduct the experiments.

I've heard that if you sign a contract under the threat of death that it is
not legally binding. Now I know the doctors aren't making the threat, but I
think the situation is remarkably similar, right?

~~~
uvdiv
_I've heard that if you sign a contract under the threat of death that it is
not legally binding. Now I know the doctors aren't making the threat, but I
think the situation is remarkably similar, right?_

No, they're polar opposites. If I hold a gun to your head and demand you do
something, I am (i) forcing you to do something that is (ii) against your
interests. If you're sick and I offer you an experimental treatment, I am (i)
not-forcing you to do something that (ii) is in your interests and benefit. It
could maybe save your life. A cancer patient is not legally incapacitated like
a child; she has the ability and right to make decisions influencing her own
life and death.

~~~
sekm
> she has the ability and right to make decisions influencing her own life and
> death.

True, but at the end of the day her decision is likely to rest on the advice
given to her from an authority. If the doctor isn't following the proposed
rules, then it makes the entire thing a fiasco. I guess I should be stressing
how important the doctor's role is in the decision process of the patient.

Just a side note, wouldn't the polar opposite of my mentioned case, be where a
person tells another person that if they sign a contract then they will kill
them?

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chimi
Here's a better link to the original bypassing this blog spam:

[http://www.sacbee.com/2012/07/22/v-print/4648415/2-uc-
davis-...](http://www.sacbee.com/2012/07/22/v-print/4648415/2-uc-davis-
neurosurgeons-accused.html)

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niels_olson
Thanks for posting this. As someone trying to get a protocol through IRB right
now, this helped put my frustrations in perspective. I think.

