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06/03/2007 12:20 PM ID: 62829 Permalink   

FDA Says: "You're a Lab Rat"

 

The FDA is bypassing longstanding ethics rules and allowing medical researchers to experiment at will on those seeking medical treatment, without their knowledge or consent.

Most vulnerable will be those patients who are too ill or injured to speak for themselves. Researchers are only required to make prior public disclosures of their activities. A posting on Craigslist.org is considered legally sufficient.

Researchers have done just that in King County, Washington. That means that some, perhaps all patients are automatically enrolled in research studies, unless they opt out in advance. To opt out, you must know which study administrators to contact.

 
  Source: seattletimes.nwsource.com  
    WebReporter: awhompbamboom Show Calling Card      
  Recommendation:  
ASSESS this news: BLOCK this news. Reason:
   
  18 Comments
  
  well  
 
makes you want to rush off to the doctor no?
 
  by: ssxxxssssss   06/03/2007 12:41 PM     
  @ sx  
 
That would make me rush OUT of King Co, Was.

Well, verrrrrrrry carefully at least.

This is so wrong on so many levels.

I swear, any more it's just plain dangerous to go TO the hospitals.
 
  by: Discarded Vet   06/03/2007 04:04 PM     
  FDA  
 
The American public needs to turn OFF American Idol and pay more attention to their own government. of course this would be a lot easier to do if the Government would stop pushing drugs on everyone and pulluting the air and water (Can you say Fluoride?)!
 
  by: BikerDude   06/03/2007 07:36 PM     
  Actually  
 
Hospitals are still safer than they used to be when you basically only went to a hospital to die.
 
  by: luc1ddr3am     06/03/2007 08:50 PM     
  but wait, there's more  
 
The article goes on to say that to opt out, you not only need to know which study administrator to contact, you need to contact them, you need to request and obtain a special official stainless steel bracelet, *and* you need to be wearing it at the time you enter treatment. Apparently it's not enough to carry the ugly thing about in a pocket or purse, and a tattoo is right out. A spouse, relative, doctor or lawyer on the spot will not be able to protect you.

So if you must get your arm ripped off in a bar fight/terrorist bombing/bizarre gardening accident, make sure it's not the one with the bracelet on it.

This is a national phenomenon, not just in Washington State.
 
  by: awhompbamboom     06/03/2007 09:16 PM     
  i like  
 
how you don't mention in your summary that this sort of wavier is *only* for emergency care.

Situations where you are going to be dead in very short order if something isn't done immedatily. Like your heart has *already* stopped.

Standard techniques in restarting hearts have a very high failure rate (unlike on TV) and discovering new methods is a boon to us all. Except you can't very well give consent when your heart has stopped and in situations like these there's no time to contact family to ask for permission -- every minute in cardiac arrest drops your chance of survival by 10%.

Life isn't like in TV land and if your heart monitor suddenly goes flat that they can shock you back to life. If you go into cardiac arrest, you only have a 15% chance of being kept alive until you get to the hospital. Once there, you only have a 46% chance of survival - that a 6.75% overall survival rate, and even amongst those, 97% of the survivors will experience mild to moderate neurological damage.
 
  by: ouka   06/03/2007 11:39 PM     
  Well, if there was any doubt  
 
As to whether or not its better to be a criminal in jail than a freeman, well, this answers it.
 
  by: GogeVandire   06/03/2007 11:53 PM     
  @ouka  
 
If you read the article a little more closely, it says that there is little to no oversight or guidelines as to who is actually worked on and what is done. Much depends on the study being done and the people doing the study.

For example, why not do this as an opt-in instead of an opt-out situation? Why not request a bracelet that gives permission for such experiments, or allow people to carry any kind of opt-out id, or even to sign up for a national opt-out database, instead of requiring everyone to have an official id? Why not at least make more of an effort to publicize this nationally? This isn't on any of the major news outlets. Why not?

I'm all for research that promotes advances in medicine and science. But this policy makes it too difficult for people to control their own medical care. Who's going to regularly track every single possible public forum in case some research group decides to post? How much lead time is required before researchers begin experiments? What proofs are required that the experimental treatments are better than the current ones? What if the researchers inject someone with something derived from a pig, without checking to review their religious background?

I stand by my summary. This is not how a nation dedicated to freedom treats its citizens, regardless of any hoped-for benefits.
 
  by: awhompbamboom     06/04/2007 02:02 AM     
  It has been tried here...  
 
Something like this was tried here. A kid was in a bad accident with head injuries, but was doing fine until they decided to give him "experimental" treatment, then he died.
 
  by: elderban99     06/04/2007 04:48 AM     
  @ awhompbamboom  
 
".....This is not how a nation dedicated to freedom treats its citizens....."

HEAR HEAR !!!

Pretty much blows away the Organ Doner portion of a drivers license eh?
 
  by: Discarded Vet   06/04/2007 04:52 AM     
  @awhompbamboom  
 
“If you read the article a little more closely, it says that there is little to no oversight or guidelines as to who is actually worked on and what is done.”

I beg your pardon? The summary says exactly how people have thus far been chosen, what treatments will be performed, and how long they will be performed. Furthermore, the studies are “regulated down to the tiniest detail” and waiver of implied consent is granted only in “very carefully defined, narrow circumstances.”

If you think this is about a bunch of doctors going about willy-nilly trying new ideas out you are very much mistaken. They are all styled after Phase III trails, which are about as rigorous and red-taped filled as anything on the planet, with the possible exception of filing for a permit to build a nuclear reactor.

“For example, why not do this as an opt-in instead of an opt-out situation?”

Hello? Emergency care? Life-and-death situations? You have time to ask them to opt-in? How many people do you think would sign up? People don’t like to think about their own mortality. The bulk of people who would approve in principle with signing up for such a database wouldn’t “get around to it”. It’s just human nature.

You have a patient in front of you whose heart has stopped beating. Every minute you spend working out the consent details decrease survivability by 10%. Do you have time to confirm who the person in front of you is? To get his name and SSN? To connect to a database and verify his personal identification? To check to see what sort of treatments are authorized and which ones aren’t?

You know that using standard techniques he’s got less than a 7% chance of living. Or maybe the standard techniques aren’t working. You have an experimental technique that might help keep him alive, do you use it without consent?

Hell, people are suing now when they learn that their loved one *could* have received an experimental treatment that *might* have saved their life but was denied because the doctors withheld it because of consent or applicability issues.

How do you think current emergency care techniques were devised? Trial and error. Doctors have to have the freedom to try new things otherwise our level of advance stagnates. With the case of care techniques this is very much the case because you have to have someone dying in front of you before you can begin to test a new technique out. It isn’t like most drug trials where you have a defined set of people that have illnesses that you can try to treat over the course of weeks and months.

“Who's going to regularly track every single possible public forum in case some research group decides to post? How much lead time is required before researchers begin experiments? What proofs are required that the experimental treatments are better than the current ones? What if the researchers inject someone with something derived from a pig, without checking to review their religious background?”

There is oversight built in to the very concept of this measure. Not just because of Ethics Boards at the hospitals themselves or because the hospital’s lawyers are well-aware of the litigious nature of our society (which would be enough for me personally) but because these experimental treatments are still FDA regulated and there are established oversight committees in the form of a Data Monitoring Committee and an Institutional Review Board that govern ALL such experimental procedures.

As for why it’s not in the news now, it’s because it’s not really new news. The consent waiver guidelines were established back in 1996.
 
  by: ouka   06/05/2007 11:38 PM     
  @Ouka  
 
Thanks for replying. There's a lot of merit in what you're saying. I make no pretense of being a medical expert, I'm not. I've already agreed that research has its place in hospitals and in medical treatment.

But what does that change? You still disagree with my summary. I can't help that; there's more in the article than can be said in a few short paragraphs, and I mentioned what I believed were the pertinent facts and gist of the article. You would have written this differently. Fair enough. The link was there for all to follow.

I still fundamentally disagree with you. However rigorously tested and approved, however benign the experiments, people are still being experimented on without their knowledge or consent. They learn nothing from their participation and they aren't compensated for the risks they assume. They can't opt out on the spot. Their loved ones can't opt out for them. Some can't opt out at all; I have a severe nickel allergy and can't wear this bracelet, yet carrying it isn't good enough. Like it or not, even if I am mistaken on some of the specifics here, people ARE being treated like lab rats. That violates commonly accepted standards of treatment that most people understand and accept. Most people believe that experimentation is on an opt-in basis. That's why I say this is unethical.

You can't guarantee this policy will remain benign. Look at Walter Reed, look at how drug companies are co-opting the FDA. Priorities change, budgets get cut, people leave, cronies get appointed, drug companies exert influence, people make mistakes, miscommunication happens, and so on. Nobody set out to abuse our vets at Walter Reed, but it happened. Because people are being treated like lab rats here, this sets up a shift in expectations as to what is and is not ethical. Once safeguards begin to erode, their welfare can all too easily be cast aside in favor of other considerations. I have enough friends and relatives in the medical industry to know that quite often, money comes first.

You say it's been like this for a long time, and it's now commonly accepted practice, not news. Well it's news to me, pal, and I'm not alone. Check out the reaction to that article:

http://seattletimes.nwsource.com/...

Obviously people didn't know, they do want to opt out, and in many cases they can't; the bracelets aren't available.

I accept that you disagree with me on the opt-in basis. You make valid points about human nature. But if you've got time to check for a bracelet, you've got time to check someone's medical records; a notation can be made there; you can put their name in red, for example, so doctors don't have to hunt for a little check box. If you know nothing about the person you're about to operate on, you shouldn't be experimenting anyway; how do you know you're not doing more harm than good? How do you know he's not got some crazy allergy or pre-existing condition that might warrant a different course of treatment?

You can put a dot on a driver's license like the organ donor program, or set up a national opt-in database that a nurse or EMT can instantly bring up and query on a cheap Blackberry en route to the hospital or right in the surgery room. You can permit people's loved ones to opt-out for them. You can also do a better job of informing and educating people what the situation is well beforehand, so they at least have the choice and opportunity to opt out even if they put it off, and they at least enjoy a better understanding of what to expect at the hands of the medical community. As the follow-up article shows, this part has been bungled.

It's not the trial and error part that I take issue with, Ouka, it's the experimenting on people without informed consent, it's the FDA, the research community and the medical community making all these decisions while the people whose lives are most at stake have little to no participation at all.

Would you be so sanguine, I wonder, if it were the banking industry acting like this, if without your knowledge or consent, your bank allowed some accountant to access to your accounts to perform experiments on ways to do a better job of money management for all. Oh sure, you could have opted out, if you'd done so before the accountant was given access, if you'd known how to opt out, if if if.
 
  by: awhompbamboom     06/08/2007 08:21 PM     
  @awhompbamboom  
 
As a researcher at one of the largest hospitals in the US, I'll chime in on some of this. Ouka is doing an exceptional job, though.

"They learn nothing from their participation and they aren't compensated for the risks they assume."

That is a shame, and some of what I read makes me uncomfortable of the ethics involved. The case of the synthetic blood experimentation was an example of going too far. However, what makes me more uncomfortable is how research today has gotten SO restricted that there are some things that cannot even be tested anymore. The famous experiments of the past which told gave us so much psychological knowledge could never be done today because they could feasibly be harmful (by causing stress). In this case, emergency procedures need testing, and how else is it to be done? You cannot even PAY people to get off their lazy -sses sometimes just to answer a few questions, and one may never get a large enough sample waiting for people first to opt in, then to nearly die. Fifty years from now, they may have a usable data pool, and that's just not practical. The logistics of specific situations and treatments need to be considered, and in certain circumstances, special exceptions to the usual regulations may need to be made. This is not an endorsement of sending medicine back to the days when it took shots in the dark at treatments, but rather to accept that in some areas we need to allow for some trial and error again. I think people, and the source, have a skewed view of this; viewing it as, "People may die because they're doing this!" Doers anyone, the source included, stop to consider that maybe people are dying because they're NOT (when applying the standard treatment)?

"I have a severe nickel allergy and can't wear this bracelet"

I would guess these are usually made of surgical stainless steel, which needn't contain nickel.

"That violates commonly accepted standards of treatment that most people understand and accept. Most people believe that experimentation is on an opt-in basis. That's why I say this is unethical."

People also understand medicine to be something like a repair service. You go in, a repairman operates follows that manufacturer's repair procedures, and you leave as good as new. I don't know how many people I've heard express a flawed opinion that medication is supposed to "cure," as if a drug not doing so for them means the drug doesn't work. Bottom line - people have a very simplistic understanding of medicine and what is required for it to be effective. Research SHOULD be voluntary...but we have to consider that maybe there are situations where that is not possible if we want to improve our ability to save lives.

"You can't guarantee this policy will remain benign....Priorities change, budgets get cut, people leave, cronies get appointed, drug companies exert influence, people make mistakes, miscommunication happens..."

...and "things fall apart; the center cannot hold." Any well-regulated system can break down, but that does not mean that we cannot deviate from a well-worn path, ever, for fear of getting lost. Neither Ouka, nor I, can guarantee this will remain benign...but the Institutional Review Boards standard to the hospitals who perform these tests can. Consisting of doctors, ethicists, patients, and other community members, these studies are all scrutinized and monitored to the tiniest detail. That includes monitoring the results to the point of determining if one treatment is so much more effective that the other must be discontinued and the study ended.

"But if you've got time to check for a bracelet, you've got time to check someone's medical records; a notation can be made there; you can put their name in red, for example, so doctors don't have to hunt for a little check box."

That's really, really untrue. Computerized record systems are neither that widespread, nor complete, and most cities don't have a single hospital housing all medical records. In any emergency situation, how does it make any sense to say that checking someone's arm can be done as quickly as sending someone across the building or even across town for a chart? That these are emergency situations is the key point here - MUCH is going to be unknown, and so who knows if the CONVENTIONAL treatment is not going to do more harm than good?

"You can put a dot on a driver's license like the organ donor program, or set up a national opt-in database that a nurse or EMT can instantly bring up and query on a cheap Blackberry en route to the hospital or right in the surgery room."

I'm a BIG proponent of organ donation...but I don't have the dot on my driver's license. It slid off a long time ago, and I admit, I've been too lazy to go to the DMV for a new one. I'm sure I'm not the only one in this city, and that takes a lot less effort to do than to opt into a national database (which does not itself exist, let alone the means or resources to
 
  by: MomentOfClarity     06/09/2007 01:37 AM     
  Continued...  
 
...and abbreviated, since I lost the end of that submission.

"...let alone the means or resources to" connect it to every EMT).

Your banking example is flawed because it outlines wanton experimentation rather than that which occurs within narrow criteria such as in the topic at hand. However, the federal government DOES experiment with my dollar on a daily basis, which we allow because we hope to excel as a nation. Mostly, though, I don't know why anyone would care more about experimentation affecting their money than their life.

I do know, though, that even the most comprehensive set of rules will not be the best set of guidelines for every situation.
 
  by: MomentOfClarity     06/09/2007 01:43 AM     
  @MomentofClarity, Ouka  
 
Thank you, both of you. I appreciate both of you taking the time to talk about this. I also called my niece, who's a medical researcher in Seattle. She laughed and called me an idiot. I hope that means she'll still invite me over to dinner, but I'm afraid she's calling all her friends to get me enrolled in a study. Thank you for being more tactful than she was :-)

I'm still not sure I understand your views, as I haven't got your perspective or background, but it appears that many of my concerns may have been based in misunderstanding the details of what goes on with this research. If my niece does call all her friends, I'll enroll, if only for the opportunity to bombard them with questions about what they do.

I'm appalled to learn about the situation with the computers. I live and work in Silicon Valley, and my own home is crawling with computers. I visit my doctor, the receptionist makes a few taps and next thing I know, my doctor walks in with my updated chart and says "YOU again!" Even my vet is able to track back on everything that was ever inflicted on my cat, right in the exam room with the cat gnawing on her arm. Takes about three seconds or less to bring up a chart. I simply assumed that this was common practice. The technology to get this data quickly into the hands of doctors, nurses and EMT's exists and is cheap and durable; probably between $200 to $1500 retail per unit. As to the national database; if we can come up with a national Do Not Call registry, if we can come up with all sorts of other national databases (missing kids, sexual predators, etc. etc.), why can't we muster the resources to generate an opt-in or opt-out database?

My point with the banking analogy was not wanton experimentation, but the customer's experience of invasion when they discover what's happened after the fact, and then finding out they can't easily stop it. The banking experts know what they're about. That information doesn't necessarily get communicated to the customer in a timely or effective way, and the customer isn't given the opportunity to willingly participate.

I will still avoid this bracelet. I know of surgical steel, but too often, I've been assured something is made of this, only to soon discover it isn't. That's one thing that would be helpful to change; this requiring only one official bracelet. Not so much as a tattoo, or a bracelet of another material, or a dot someone can stick on a watch, something?

I'm with you on the organ donation. A friend of mine was murdered back in the 80's. It didn't take long for him to get divvied up, and while we weren't given any names, we were given numbers; his skin helped around 24 people, and so on. I slack about a lot of things, but not that.

Thanks again, you two.
 
  by: awhompbamboom     06/09/2007 12:25 PM     
  to quote  
 
terry pratchet
"well does he trust doctors?"
"absolutly not"
"well, at least he still retains some of his sanity"
 
  by: ganjaman22     06/12/2007 03:24 PM     
  @awhomp  
 
I agree that if technology were more widespread that an opt-in sort of system might work, like if they asked you to update the form every time you visit a doc for any reason.

However, even at "$200 to $1500 retail per unit" do you have any inkling to what that would cost? I live in silicon valley too so I'm used to high tech being all around, but consider the logistics -- all emergency vehciles would have to be outfitted with at least two of these devices. Each hospital would have to have hundreds. You have to assume that connection to the database would be instantaneous, that there would never be downtime, that internet congestion would not slow down access times, that the security would have to be as foolproof as it can be.

You'd have to install, maintain, and upgrade this infrastructure in about 6,000 hospitals around the country, the majority of which do not have any sort of universal documentation standard (fax is still a primary method of information sharing) and many have not even gone digital yet.

As for the ethics, we'll just have to agree to disagree. I have no problem with EMTs trying out new care procedures on me in life & death situations. You have to understand that even the *current* methods are a total shot in the dark. It's good to have options, and the only way those new options are going to be discovered is to try them out. And for me, the guidelines that oversee the testing of new procedures are more than sufficent.
 
  by: Ouka   06/13/2007 01:03 AM     
  part 2  
 
Sorry, copy/paste malfuntion.

Sorry, copy/paste malfunction.

Any "modern" or "approved" ER care standards can already be lethal. When you show up to an ER, they are working to keep you alive. Even in the most modern medical facility it's unlikely in the extreme that they have any of your medical history in front of them when they start working on you.

They are going to start injecting you with things to stabilize your heart rate, bring down your blood pressure, stave off infection, etc. Any of those substances can kill you if you have a bad reaction to it for some reason. Maybe that info was even in your medical history.

But when you are crashing in front of them there's literally no time to get that history even with instantaneous communication. ER docs and nurses make the best decisions they can, which is going to be incomplete no matter what sort of system you have in place, and those decisions are still regularly lethal.

As MoC said, visiting the ER is not like visiting the mechanic. There are overall guidelines and approaches in care based on cumulative medical knowledge but there are no guarantees in medicine. Even with all the medical equipment in the world at your disposal people are still going to die on the table. Not because the doctor screwed up or because they used an unconventional treatment, but because the human body is a fickle thing when it is in shock and is prone to shutting down despite everyone’s best efforts. This is the problem emergency consent wavier clause is trying to address.

They aren’t going to give you an experimental treatment for the sake of giving you an experimental treatment, they are going to do so if and when it appears that the experimental treatment might have an equivalent or better chance at keeping you alive or minimizing side effects/recovery time. Remember, by the time experimental treatments are even approved for use in this manner they have already been tested as best they can in animal or computer models. They are essentially Phase III tests.
 
  by: Ouka   06/13/2007 01:36 AM     
 
 
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