Full Disclosure: Did Government’s Experiment on Preemies Hide Risks?

[roo_ster]

http://pjmedia.com/instapundit/189690/
http://dailysignal.com/2014/06/03/uninformed-consent-nih-sacrifice-preemies-sake-research/

Saw this on instapundit

They were misled to believe everything being done was in the ‘standard of care’ and therefore posed no predictable risk to the babies. . . . Normally, medical personnel constantly adjust oxygen as preemies’ conditions change, based on their individual needs. But the SUPPORT study was designed to keep infants in their randomly assigned range, despite a baby’s individual needs. And in a decision that one government source says shocked seasoned researchers when they learned of it, the babies’ oxygen monitors intentionally were altered to provide false readings. The reason: so medical staff wouldn’t be tempted to adjust oxygen out of the babies’ study-assigned range.

I doubt all the subsequent problems these preemies had are due to the O2 diddling, but given the sample size, I bet some were...and the data collected bears this out.

Take a look at the names of the single mothers.  Yeah, pretty much "Hey, I am from the ghetto," names.  Think they have the wherewithal to understand a multi-page consent form written by bureaucritter lawyers with itty bitty type and vocabulary they have never encountered?  Me neither.  Do you think that these sorts (not so brights) were targeted by the study proctors?  Likely, in my opinion.  And even if the parents were on the ball, the consent form did not fully explain the risks and implications.

I get kind of worked up when I see clever, connected, or manipulative folk take advantage of people who are pretty obviously not capable of sussing out the manipulative web in which they may be ensnared.  Is that patronizing of me?  Heck yeah.  But I can look in the mirror and know I did not take advantage of old folks whose minds have been beaten down by age or younger folk who were not blessed with a swift mind.

the babies’ oxygen monitors intentionally were altered to provide false readings

Really, what can you say?  Did not these folks consider that mucking with instrumentation might have consequences? 

[MillCreek]

I wonder what the Institutional Review Board of the lead institution conducting the study (required by Federal law) had to say about the design of this study.

[roo_ster]

I wonder what the Institutional Review Board of the lead institution conducting the study (required by Federal law) had to say about the design of this study.

[Jocassee]

I really don't want to be an American anymore. And not in the Bergdahl sense. I just don't wanna play. Maybe it's because I'm getting sensitive in my old age but this kind of crap makes me feel dirty.

[SADShooter]

Fraud/negligence happens in research as in many occupations. If expectant parents were misled with resultant preventable harm, I'll gladly saddle up and polish my knot-tying.

That said, and without reference to the particulars of this study, the safeguards in place for both approval and operation of human subjects research are rigorous, with those for vulnerable populations being greater still. I can believe that low-level staffers may not have adequately explained a consent document. The notion that the NICHD reviewers, possibly the FDA, and the IRBs (safety panels) at the local facilities didn't evaluate the study design for prospect of harm and the DSMB* (Data Safety Monitoring Board for actual harm? Far less likely.

Full disclosure, the institution where I work is a listed participant. I don't know the local PI or the study, but I know the process we go through to get approval for EFIC (exception from informed consent) research on patients who are generally clinically dead, and the efficacy/safety standards we have to meet as a study progresses.

I can also state that many medical providers are zealous in adherence to traditional treatment methods, even while presented with direct evidence that they have a poor or unproven success rate. I would assume that the oximeter blinding was scrutinized and determined to be, if not safe, at least a neutral consideration.

*Generally required for a project of this type and scale.

[SADShooter]

I wonder what the Institutional Review Board of the lead institution conducting the study (required by Federal law) had to say about the design of this study.

Don't know, except to say "No Approval=No Study".

[roo_ster]

SADShooter:

How's about if the following were true?

And now, Public Citizen and nine prominent scholars in bioethics, law, and history are calling on the HHS Office of Inspector General to step in. On May 20, they went public with charges that senior NIH and HHS officials engaged in serious misconduct by interfering with an ethics office in HHS as it investigates the experiment on preemies.

...

“The most troubling part is that numerous high-ranking officials facilitated this interference by senior NIH officials,” Carome said, “despite the fact that NIH had obvious actual, direct conflicts of interest in the research under investigation.”

Also (Actual, not rhetorical questions.  I do not know the answer.):
1. Do hospital boards have the stones to say, "No thanks" to a study that might bring in $$$ and has been given the stamp of approval by gov't? 
2. How rubber-stampy are the hospital boards in general?

[roo_ster]

I really don't want to be an American anymore. And not in the Bergdahl sense. I just don't wanna play. Maybe it's because I'm getting sensitive in my old age but this kind of crap makes me feel dirty.

I hear ya.  Cruelty I used to shrug off nowadays tasks me.

[SADShooter]

SADShooter:

How's about if the following were true?
Also (Actual, not rhetorical questions.  I do not know the answer.):
1. Do hospital boards have the stones to say, "No thanks" to a study that might bring in $$$ and has been given the stamp of approval by gov't? 
2. How rubber-stampy are the hospital boards in general?

Re: the possible NIH malfeasance. If it happened, the actors should be placed at the disposition of any impacted, desirous parents for carte blanche justice. I would willingly assist any too infirm or otherwise act in proxy. It suggests a level of conspiracy I find challenging, as technical data would be hard to conceal/manipulate at the local professional level. Not impossible, but a considerable feat.

Re: your IRB questions.

1) Research also equals potential liability and public scrutiny. (Witness the case under discussion) and the attendant compliance structures. So, it is a risk management issue. (I'd page MillCreek, but he's already responded to the APSRM bat-signal). Another point is that many, not all, but many, studies are expected to operate on a lean budget, so in-kind support and cost-sharing come into play, and it isn't a huge net gain to the recipient bellying up to Uncle Sugar's trough. Private industry trials are generally a richer field. Keeping our program afloat financially is one of my primary tasks, and one source of the gray in my beard.

2) There are specific mandates for board composition, including multi-disciplinary medical members and non-medical advocates for vulnerable populations. In my experience they take the ethical obligations damn seriously. It's an unpaid drudgery that most people don't take on for fun or profit.

Case in point: I have a contract for incoming money on hold pending IRB approval. The institution will not sign off on the agreement until the IRB approval is verified. The IRB will not sign off until all stipulations have been fully addressed. This is for a DoD sponsored trial.

We did previously have a big, complex trial halted by the DSMB for futility. Interim results were inconclusive, and they determined enrolling more patients (which would have meant more money for participating sites) wouldn't change the outcome.

My boss is a Bronze Star recipient (Vietnam medic), well-regarded researcher, and an IRB Chair. My institution has four separate committees. He's out, but if I get a chance I'll ask him if he knows anything about this situation

[brimic]

Stuff like this can only surprise people who think we have  a moral and benevolent government

http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment

[Scout26]

Everyone thinks that .gov is a nice, soft, fluffy bunny, when in reality it's the crazed, vicous, blood-thirtsy rabbit from Monty Python and The Holy Grail.

[Firethorn]

Not really thinking about this specific study, but what happens when benevolent and ethical are at odds?

Everybody has sacred cows, practices that they think are the best.  But many were developed when our science was sloppier, what if they're NOT best practices?

Consider the issues of when to test for various old cancers, how often.

That being said, you need to have a compelling theory on how the proposed new system will be better.

[brimic]

Not really thinking about this specific study, but what happens when benevolent and ethical are at odds?

I don't think its that difficult...
Plenty of people are paid to take the risk of trying out new drugs- with their informed consent.
The same could be done with experimental procedures- allow the patient the option, if they live or die with the consequences without a lawsuit.
Experimenting on people without their consent is heinous, at best.