Neurosurgeons barred from human research after experimental infections | Hacker News Reader

Neurosurgeons barred from human research after experimental infections

blogs.nature.com

41 points1337biz13 comments

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

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.

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?

GBM patients who suffer from infections have a prolonged life expectancy compared to those who don't. The idea is that the infection causes an immune response that also fights the cancer. That's the basis of the research.

My opinion: GBM is a death sentence. It claims some of the worst survival statistics of any cancer.

http://www.ncbi.nlm.nih.gov/pubmed/22215883

Looking at that review you can see that median survival is 7.6mo with the 2yr survival rate hovering around 9%.

I'm not familiar with the protocol they were approved for or what their alleged deviations from the protocol were but, given the gravity of the situation, some experimenting is definitely in order. The standard of care is a barely a hair better than doing nothing at all.

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/2012/07/22/4648465/banned-ucd-doctor-i...

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.

"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?

> 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?

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.

> 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?

>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, duress and desperation are distinctly different things.

If it was me looking at a 91% chance of not being here in two years, I think I'd be inclined to seek out alternative and experimental treatments. When it's better than 10:1 odds against being able to see my niece and nephews grow up, I think I'd even consider intentionally infecting myself with bacteria to get that chance. And, I'm saying that now, as a healthy, youngish guy, so I can only imagine what I'd be thinking if I actually had a GBM growing inside me.

If you would like to take the same training many American biomedical researchers do, as a minimum requirement, you are welcome to make a login and affiliate yourself with an institution (any institution you could conceivably think you might ever want to do research with is acceptable, they will all want valid, recent completion certificates during your review process)

https://www.citiprogram.org/Default.asp?

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-...

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

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