Australian Parents ‘Pimp’ Their Kids For Flu Trial?
28 CommentsBy Ed Silverman // May 17th, 2010 // 9:36 am
A controversy appears to be emerging in Australia over payments made to parents who have enrolled children as young as six months old in H1N1 flu vaccine trials sponsored by GlaxoSmithKline. In some instances, parents were enrolling three children at a time and receiving $900, according to The Herald Sun, which notes the payments may breach national ethical guidelines.
Parents of healthy children up to 10 years old are receiving $300 for each child to participate in the trial, which involves two needles, two blood tests and medical monitoring for each child. A spokeswoman for AusTrials, which runs the trials for Glaxo, confirmed to the paper that the payments were made and that, so far, 110 children participated. However, an anonymous critic complained to the Sun that parents were, effectively, exploiting their children for hundreds of dollars.
And so the paper canvassed several oversight bodies, which offered some stern advice. The National Health and Medical Research Council told the Sun that offfering inducements to encourage people to take part in a clinical trial is “ethically unacceptable.” The Royal Australasian College of Physicians says it is “inadvisable” for a child to participate in a trial unless there is some benefit or the parent is making a decision in their best interest. The decision must also be free of “inappropriate incentives.” And the Australian Medical Association ethics committee chair Peter Ford tells the paper that parents whose children took part in trials should not be motivated by money.
Tom McCollum
This article really touches on the short-sighted nature of the media. Unfortunately, the media gets to play both sides of the story.
Glaxo will be demonized for testing the safety of the vaccine in healthy patients by offering an incentive to participate. (Why else would a healthy person participate in a study for pediatric patients?)
I can just imagine the same media outlets when the next flu outbreak occurs “Why hasn’t Glaxo prepared to protect our children?”
In my opinion, the $300 per child payment is not excessive or inducing. This child must endure two blood draws, two vaccinations, and how many trips to the office.
I do agree that pediatric patients should not be “purchased”. In this case, it does not appear to be the case.
pharmavet
$300 payment for reasonable and customary out-of-pocket expenses, such as mileage, parking and meals is not outrageous. In fact, if this were a Phase I trial I would offer quintuple that amount, which is closer to the going rate that is paid in this country.
Ed Silverman
Hi Tom,
Thanks for your note and sorry for belated reply. I agree that there are two sides to this issue in that failing to run a trial will leave a company open for criticism.
To what extent is the payment, in this case, appropriate is unclear - there are different economies, of course, in each country, and some families need the money more than the others.
Presumably, the organizations contacted were issuing cautionary notes about the fact that some parents were, perhaps, exploiting their children and that is something that AusTrials should be watching.
I’m not on the ground in Australia and have not taken a position. That’s why I used a quesetion mark in the headline. In any event, it seems to raise a thorny issue.
Regards
ed
JaT
To be decent (and not classist or elitist)- trials should have to be done equally on children and adults from families of all financial situations, or not at all. You can bet the $300.00 limit would be hiked. Let the compensation equal the risk.
Former Pharma Marketing Director
Pharmavet - c’mon, it is never OK to advertise a trial stating that a participant could be paid. Yes, it usually does state somewhere in the consent form that there are certain expenses being paid that would not otherwise have occurred were it not for the participation of the patient in the trial.
This appears to be a shameful tactic. Tom McCollum, you are missing two issues. Of course Pharma needs to accrue patients for trials, but this is advertising the trial to entice participation in exchange for money is never alright.
Shame on the parents who agreed to this.
What about providing the vaccine for free, paying for lab tests and parking and transportation? I haven’t read the protocol, but how about long term follow up i.e. tracking for the occurrence of chronic diseases in this patient group?
Anyway, not surprising that some parents would “sell out” their children’s after all, it is fellow human beings who actually thought up this ludicrous scenario in the first place!!!
pharmavet
Dear FPMD, go to any journal or newspaper recruiting subjects for a Phase I study. The exact amount to be paid may not be stated specifically, since this will vary by study, but a simple call to the study site will provide the required information. Clinics often compete for patients by offering lucrative compensation. In Phase II and Phase III trials subjects are incentivized to participate by being offered, for example, one year’s woth of free drug post NDA approval.
Basically because there is a finite number of potential study subjects and an almost infinite number of drug candidates competing for subjects, this is all SOP. As long as everything is spelled out beforehand, this is really pretty much business as usual, at least during the 27 years I’ve been doing trials. If we find ourselves at a competitive disadvantage we call up you guys in Marketing, dialing for more dollars.
Study subjects themselves know how the game is played, and at least in the Phase I world will shop one protocol versus another, looking for the best deal, just like shopping for a new car. I hope this does not shock anyone to state that the average full time “professional” subject can earn anywhere from $50,000-$75,000/year, even more if he/she is willing to participate in an ICU-type setting study withn multiple invasive monitoring procedures.
JaT
It is shocking, pharmavet, especially in pediatric studies. I wonder if there are limits to how many trials a baby can be enrolled in? What do you win for making your kid a guinae pig? A new car! How sad. Childrens Protective Services should be notified.
I stand by the anti-classism suggestion of trials having to involve patricipants from all financial situations. Yes that would make it more difficult for the right mix of people to be found- but it would also reduce children of poor families from taking risks for compensation. It isn’t a child’s fault if his parent needs to find ways to pay for life’s necessities.
Evelyn Pringle
This isn’t too surprising. Look how many parents in this country are willing to feed their kids daily cocktails of psychiatric drugs and have them declared disabled by mental disorders in order to collect $600 and some a month, per child, in disability payments (or so-called crazy checks).
Justice in MI
“The National Health and Medical Research Council told the Sun that offfering inducements to encourage people to take part in a clinical trial is “ethically unacceptable.”
Wow. My dermatologist does this all the time. Last time, I asked him how much he gets to sign me up and offered to split the difference.
Evelyn Pringle
Ha.ha.ha. Justice you’re too funny.
Former Pharma Marketing Director
Pharmavet, The drugs are provided free of charge because the drugs are not yet approved to be commercially available. It is completely acceptable in Phase, I and Phase II. I do not know of any protocol that pays participants as you are suggesting. With the exception the “Paid volunteer - normal healthy subject”. Send me the add - let me call someone directly, and let me assure you I would make a great deal of noise.
That being said, I sadly have to agree with JIM - doctors are paid for each patient they recruit.
Anyway, glad I am not one of those kind of parent, nor were my parents…
Which IRB board approved this trial in Australia anyway?
Justice in MI
Weird thing is that the dermo actually told me how much he’d get for signing me on, admitted that I didn’t actually fit the trial protocol, but he needed one more pelt to go forward.
He did not agree, however, to split the difference.
harpy
“Parents are giving consent on their children’s behalf,” the source said.
isn’t that a legal definition of a parent? don’t parents consent on their child’s behalf all the time?
I don’t have a problem with this. They should be compensated for their time. and kudos to your high-minded ideals, JaT, but if you’ve never been poor then just shut up. a new car? how about food on the table for a few weeks? maybe a roof over your head for another month? would that change your opinion? why do you think so many clinical trials are done in 3rd world countries? ‘cos middle-class Americans are begging to participate?
I don’t know what the welfare system is like in Australia, but the last thing poor people with kids need is another do-gooder telling them how badly they’re raising their children. take a look around - it’s a hard world and sometimes there are no good options.
Justice in MI
I rarely disagree with harpy, but I do on this one. Nor do I think we need reminders about what a “hard world” it is.
There are lots of ways to respond to the world’s hardness besides exploiting it.
Question for harpy would be: Why all those folks in Australia who themselves condemn the practice? Are they all insensitive to the families’ needs? Anything to be said for their position?
Former Pharma Marketing Director
Harpy,
Australian health care system is one of the tops in the world, these vaccines are usually taken care of within the government (i.e. taxpayers) programs. That is why this is so surprising….
You have a point about holding these trials in third world countries, but (1) Australia is definitely not in that category and (2) Constant Gardner….
patrons99
FPMD -
I’d add (3) The Shaman’s Apprentice.
Australia’s flu season generally preceeds ours in the U.S. The Australian flu season may be instructive as to how severe the flu season and the flu “preventives” will be for us, ca. 6 - 9 months from now.
I am curious to know how GSK already knows what “strains” of influenza their vaccine will “prevent”. What about viral mutation and viral evolution?
I doubt that the WHO has changed their latest definition of “pandemic” back to what it had been before the H1N1 “pandemic” of 2009. I doubt that safety waivers for pharma have been removed for their H1N1 cocktails.
I suspect that advanced market commitments are already in place for the “pandemic(s)” of 2010. Maybe it will only be another 3 shot series in 2010, i.e. seasonal plus “pandemic(s)” strain(s).
patrons99
What ever did the aborigines in the outback do to maintain their health prior to Big Pharma’s xenobiotics?
JaT
Harpy, you seemed to have missed that the new car comment was in reply to pharmavet’s comment:
“I hope this does not shock anyone to state that the average full time “professional” subject can earn anywhere from $50,000-$75,000/year, even more if he/she is willing to participate in an ICU-type setting study withn multiple invasive monitoring procedures.”
I am sad that people would do this for grocery money ($300.00). And just enough money to keep them coming back for more. It is as if poor kids are taking all the hits so things will be safer for children from wealthier families- thus my thinking that trials should have to include an equal number of people from all financial situations. I don’t think feeling it is wrong to test on poor children makes my ideals particularly high.
I have recently lost my house and am living in a fifth wheel, if you must know. I partly attribute that to the drug industry and expenses incurred from their reckless behavior. So please don’t think I am unable to comprehend anyone’s plight. I don’t collect SSDI by my own choice. I don’t take anything from anyone, refuse to be a drain on the system, and I’ll bet that my opinions here (while critical of pharma for obvious reasons) are more objective than many- as someone that needs and hates pharma at the same time.
If you still want me to shut up then say the word.
Josh
Patrons….comparing aborigines health maintenance and heavily populated city’s health has nothing to do with pharmaceutics. It is more about lifestyle and interactions between groups (aborigines don’t intermingle a whole lot since they are isolated). And I am not sure how the Shaman’s Apprentice has anything to do with this…as the book is centered around ethnobotany and the usage of those plants in making medicine.
patrons99
Josh -
I beg to differ. The book relates to the nearly polar opposite parallel health paradigms: natural versus xenobiotic. Using kids as “guinea pigs” for pharma’s latest portfolio of drugs and jabs, with or without their parent’s consent, is outrageous. I’d love to see the informed consent that provided with the H1N1 jab. It is the beginning of a pathologically co-dependent relationship between pharma and their “study buddies”. I’m sure that the money is “good”. In a way, though, it’s “blood money”. It’s business as usual to pharma.
It would certainly be worth asking whether this year’s H1N1 vaccines have aluminum adjuvants? Why bother asking? Aluminum adjuvants have been shown to be neurotoxic. Do this year’s H1N1 vaccines come in multidose vials with thimerosal, an organomercurial preservative? Aluminum has been identified in neurofibrillary tangles from post mortem brain specimens in Alzheimer’s patients. How does it get there?
I hope that these Australian study subjects are educating themselves thoroughly as to these questions. Let’s try to get a copy of the informed consent for study participation.
Over the last century Pharma has sought to restrict, if not actually eliminate, natural health practices globally, so that they have a constant supply of generally sickly, chronically-ill, malnourished, and debilitated customers for their toxic cocktails.
Here’s a fairly recent example. There are hundreds of such examples.
http://pharmagossip.blogspot.com/2010/01/fdas-new-warning-on-atypical.html
Former Pharma Marketing Director
Good points Patrons. I particularly like your comment on “Study Buddies”
JaT, I am sorry about your predicament. Some people in Pharma will just say, well be thankful you are alive. My response to them would be, alive for what? To watch these unspeakable cruelties being heaped upon innocent people, suffer the torture of trying to figure out on a daily/weekly/monthly/yearly basis where the money is going to come from to extend your life a bit longer? What life is being extended anyway? Whose definition of a life? If only people would stop and think…..
I am pretty much coming to the conclusion that much of what we need to be healthy and stay healthy is around us and free - for now…
JaT
Thanks Former, I am on a long camping trip is all. Not miserable in my new situation. You do what you can with what you have. Though the transition process stinks. My situation probably isn’t all that different from the people who are losing their jobs. It’s a relief when it’s over no matter where you land.
I wonder if the people enrolling their kids these in studies have all the latest gadgets and 500 satellite tv channels. Perspective.
Harpy, didn’t mean to offend you. No Harm - No Foul. I do know that boat.
Peace
patrons99
I’d be willing to wager that Pharma and their various cronies push VERY hard for mandated pandemic “flu” jabs this year. They can’t afford to lose on their investment ($$$) this time around…not that they lost any last year. They will point to ghostwritten studies showing effectiveness and “safety”. Then they will use public FEAR of pandemics and persuasion ($$$) to gain government “endorsements” for mandated jabs, worldwide. Two worlds are about to collide, natural health and xenobiotic “health”. Can’t you see it coming?
A speech titled “Will the Law Protect Health Freedom” by Jonathan Emord, Esq. in October 2009, addresses a VERY important topic which directly affects us all.
http://www.emord.com/media/PDF/Emord_Jonathan_-_Will_the_Law_Protect_Health_Freedom.pdf
Josh
Patrons, many of our drugs today come from these natural products. Some of the natural products have toxicities too, thus why FDA should regulate them.
patrons99
Josh -
A transcript of a talk given in October 2007, by Ian R. Crane, who describes himself as “a student of the Ancient Traditions and the passage of Ancient Wisdom”, provides a very interesting overview of the origin homeopathy and natural medicine, along with a description of the distinctly inglorious origins of Codex Alimentarius.
http://xcodex.wikidot.com/iancranelecture-en
To me, Codex is a predictable biproduct of Western (xenobiotic) medicine. No, I don’t agree that natural products should be regulated by FDA. FDA is itself another predictable biproduct of Western (xenobiotic) medicine.
‘Every time a Shaman dies, it’s as if a library burned down.’
“…and what he [Mark Plotkin, PhD] realised was that these guys had medicines, natural medicines, natural potions that they were mixing together that basically cured their diseases and their illnesses and they really, you know, had a very long-life expectancy.”
“…he [the Shaman] said “Well the [American] missionaries told us that to use our natural medicines is the work of the devil and that we have to use these bottled medicines.”
In a way, what happened to the tribes in the Amazon Rain Forest can be analogized to what is happening to us today, globally. If Codex is implemented, Pharma and FDA will basically tell us to use ONLY their bottled medicines and that our natural medicines are the “work of the devil”.
harpy
I’m sorry, JaT. I should’ve thought a bit more before striking out. and perhaps done some more research. the whole article just hit me wrong and I reacted before reflecting. mea culpa.
Just ME in T
Our Babies are used as guinea pigs?
Our babies and children are full of poisons given to them by government agencies
We are killing our children and all in the name of medical science!
Shame on those who like JUDAS sell the ones they purport to love!
Chris Pickard
Funny, when Dr Andrew Wakefield was struck off in the UK recently, one of the reasons was that he ‘bribed’ kids by offering them £5 to do something that the kids’ parents wanted anyway.
If he had been doing a trial to prove vaccine safety he would still be able to work in the UK. But as he found that vaccines are maybe not as safe as the drug companies claim he gets the boot.
Same thing happened with the Australian doctor that first said thalidomide caused birth defects.