Just like with Watergate: Follow the money.
In 2003, Mary’s 26-year-old son, Dan, was enrolled against her wishes in a psychiatric drug study at the University of Minnesota, where I teach medical ethics. Less than six months later, Dan was dead. I’d learned about his death from a deeply unsettling newspaper series by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto that suggested he was coerced into a pharmaceutical-industry study from which the university stood to profit, but which provided him with inadequate care. Over the next few months, I talked to several university colleagues and administrators, trying to learn what had happened. Many of them dismissed the story as slanted and incomplete. Yet the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.
The paragraph after is more interesting. The kid had a perfect SAT verbal score, and a degree in English from Michigan, and wanted to be an actor or a screenwriter and was working as a celebrity bus tour driver.
So they have trials for antipsychotic drugs, but are supposed to exclude people at risk of suicide or homicide… I’m not surprised that they have trouble finding enough people for these trials.
Even more hilarious as you read the article, you get popup ads from Mother Jones magazine, selling the Economist.
The article is wrenching. It’s also a perfect example of what the FDA is supposed to be doing, but isn’t.
Question to you Republican types….is this the sort of “innovation” that is hindered by onerous regulations? If so, then we unequivocally need more regulation and oversight of this industry. Fair studies and honest trials are critical, and clearly we’re not getting them.
Mike…the author’s conclusion about the trial being designed as nothing more than a marketing tool is key. They didn’t care if they had enough people. They had a study, and it said “our drug is ok compared to the other over-priced crap on the market.”
Marketing gold, and damn the human costs.
@#3 For Rep’ or Dem’ types: Read article and find that an adult (Dan) have signed valid contract which have disclosed risks. Fact that mother of 26 yrs old didn’t like it is irrelevant as he was not stripped of competence to care of himself by the Court.
No new regulation is needed. It is your own responsibility to analyze risk you are exposing yourself to and adhere to consequences of contracts you sign. Also to trust medications on market based on more than manufacturers claims/studies. Left, however wants to Nanny you in a utopian world with no risks where whatever you decide has no consequences. No consequences – no progress (and I am not speaking of what Anal Progressives peddle for progress).
dusanmal…brilliant. So a psychotic’s signature excuses the worst actions of a corp that has no ethics.
So as far as you’re concerned, the government’s responsibility to protect its citizens starts at conception and ends at birth. After that, fuck ’em, the corps will hire some, eat some, and pave the road with others.
I’m thinking that’s exactly what the founding fathers had in mind.
The author’s article struck me as using the same techniques as the drug trials he is criticizing. Just throwing together whatever complaints he can make that help his case.
>Many clinical studies place human subjects at risk—at a minimum, the risk of mild discomfort, and at worst, the risk of serious pain and death.
Many studies, and we’ll just throw out the possibility of death here.
I’m not surprised by scientists using tactics that help their case, such as suppression of studies that show results they don’t like rigged studies to get the results they want, etc.
@8 Considering one of the prime subjects of the articled died, (possibly as a result of the drug trial), isn’t it fair to mention, death as the result of trials, in the article. Also, should an ethicist be held to the same standards of neutrality as a reporter? Granted by writing the article he has become a reporter, but clearly he is wearing his ethics pants while writing this article.
Back in the day I tried a trail study at Quintiles for an “antibiotic”. A couple hours after taking it I got sick and puked. I told the staff I was leaving. The nurse told me I was supposed to save and measure the vomit. They let me after taking blood. I got a check for 24hrs of study time. Weird place.
That’s why we do most drug studies overseas nowadays.
Easier to hide the bodies.
Olo Baggins of Bywater, are you for real??
So, let me try to understand your incomprehensible insanity.
So you want an even bigger, more corrupt and inefficient government institution to police an already catastrophically massive, corrupt, and inefficient government institution?
Like a true liberal.
Try and learn something:
http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration
Why Baggins, I’m glad to see you have come around to the Republican way of thinking, instead of something insipid like “we unequivocally need more regulation”.
No, we don’t need more regulation, we need BETTER regulation. It’s not the same thing.
A leaner, meaner, smaller and more efficient FDA. Dare we say, a leaner, meaner, smaller and more efficient FEDERAL GOVERNMENT!
Why Baggins, you’re thinking true Republican now! Good for you!!
I get a kick out of the commercial for a drug that clears up toe nail fungus. It may cause stroke kidney failure, penis shrinkage and brain tumors. OK I might have exaggerated a bit but not by much.
This article is a hatchet job.
But then, Mother Jones, what do you expect?
Yes, why, yes I am. I may just go buy some TruckNutz for my Subaru Outback.
Not really, but I’ll agree about the better rather then bigger FDA. I think we might also agree that letting honest scientists run FDA is a good idea, too.
Yes, agreed.
So, bobbo. Let me guess, you didn’t read the link … again??
Typical. But then again, you don’t have to read the link because you know everything already.
Ah Yea–I love you when you are in your manic phase. Of course I didn’t read the article, but I usually get around to it as I will now. Lets see, is the article relevant to anything I posted? . . . . . . . . No. Ha, ha. More with the diverting attention with bs irrelevant issues?
I posted to criticize your reference to the FAILED Friedman. What does the credentials of the links author have to do with that?
But anyway, the problem with too many linked articles is that they never provide enough information so one is left to one’s own experiences anyway. I have participated in several clinical trials, their design and enforcement.
Amusing that when a commenter knows/shares “anything” they are critized for knowing “everything.” More rhetorical bs.
Well, before I go read the presumed insufficient link from the presumed very qualified author, let me posit that the “problem” with many trials is when the “POTENTIAL RISKS” become actual risks to a known subject. That is when the trial is supposed to end, at least to that subject and those similarly situated.
Its “hard” when the word RISK is used in two different sentences with two different meanings.
Imagine that. Context having some play in our understanding of the world?
Imagine that.
I almost enjoy your blather, but it does get old.
Let’s see, “Of course I didn’t read the article” yet you posted anyway.
Hummmm…
Then you say “is the article relevant to anything I posted?”
What?? Insane again? I didn’t post ANYTHING about anything you posted. My post came first, and then your insipid criticism!
OH WAIT, I FORGOT, YOU ARE BAGGINS OF BYWATER!!
One of your multiple personalities again.
Insanity is a virtue, right Baggins/Bobbo?
Young Depressed Son of Ah Yeah==get off your dad’s computer. You are making him look stupid and disrespectful again.
I’ve never seen Olo be anything except polite ((aka–too polite in my book)), reasonable ((aka–not having as much fun as I do)), and appropriately brief ((aka–not a blowhard like me)), in his postings on this blog. Neither one of us is retarded, but we are easy to tell apart. Quite consistent you can’t. What happens, do you black out/white out/or bleed out when you read anything that disagree’s with your LIEberTARDians informed world view?
you mentioned Milton (the FAILED economist) Friedman and I responded to it. No reason at all to read the linked article.
but prove me wrong: state what the linked article says that would inform/modify my post?
You can’t do it. Very universal that.
Ah Yea==not that it matters, but isn’t the author of the link Carl Elliott?
that was a creepy picture of the guy fondling his mothers breast. I stopped reading the article shortly thereafter. The human interest angle interfered too much.
Yea, a mentally ill patient kills himself. Stop the presses. Too many squeaky wheels getting the most attention/resources while kiddies with real potential are wasted on the wayside.
It is really too bad everyone can’t get everything they need and meanwhile our distribution decisions are totally corrupted.
I’m appalled at the lack of reading comprehension shown by some commenters.
Specifically: “@#3 For Rep’ or Dem’ types: Read article and find that an adult (Dan) have signed valid contract which have disclosed risks. Fact that mother of 26 yrs old didn’t like it is irrelevant as he was not stripped of competence to care of himself by the Court.”
FTA – “In Minnesota, patients who have been involuntarily committed are given another option: a “stay of commitment.” Patients can avoid being confined to a mental institution as long as they agree to comply with the treatment program laid out by their psychiatrist. On November 20, Olson [The Dr. in charge of his “care”] asked for a stay of commitment. The court granted the stay for six months, stipulating that Dan had to follow the recommendations of his treatment team. Olson, however, did not simply recommend standard medical treatment. Instead, he proposed that Dan take part in an industry-funded study of antipsychotic drugs. The university’s study coordinator, Jean Kenney, had Dan sign a consent form [NOTE: CONSENT not CONTRACT] when Mary wasn’t present, and on November 21, he was enrolled in the study.”
Nowhere does it state that the patient was COMPETENT, in fact SINCE HIS DOCTOR WAS THE ONE SEEKING THE STAY, there’s every indication that he wasn’t AND THE COURT KNEW IT.
This isn’t about Nannystate-ism, it IS about medical malfeasance and the subjugation of parental rights.
I wish this board had basic formatting functions so I didn’t need to resort to caps, but it doesn’t.
[Complain to WordPress. – ed.]
IMP, excellent and accurate summary, thank you.
Excellent and accurate summary?
Well, close, but no cigar.
iMP==you correct deride others for giving any weight to 26 yo Dan’s Mother not liking what was going on with her son but then later you complain about parental rights ((aka no rights at all)) being subjugated.
Thats inconsistent. What rights should a parent have over a 26 yo competent adult? And if incompetent, one who’s care/guardianship is not theirs? Its not the main point, just to the subsequent accolade.
I think too much time, money, and other resources are spent in unworthy pursuits, but even guinea pigs should be protected against malpractice-if any there was.
Can I ask a question?
Is it about time for a few corporations to be found dead?
Publius….yes, but they’re too big to die.
Well, it seems to me that corporations as “people” once convicted of felonies ((eg–BP oil spill killing 12-14 plus environment)) should no longer be eligible to vote–and by extension to “speak” in the market place?
Its all such a game.
bobbo snatched up his digital pen and scribed:
“iMP==you correct deride others for giving any weight to 26 yo Dan’s Mother not liking what was going on with her son…”
No bobbo, I was deriding dusanmal’s inability to parse both what was stated and what was implied in the article; i.e., that he was competent and signed a contract (neither of which were true), and that he in essence “got what he paid for”.
Ergo sum, “no new regulation is needed”.
I would go so far as to say that the statement above, in literal terms, is true; but that in fact there are plenty of salient regulations integral to this matter that need to be either amended or done away with.
You continued “… but then later you complain about parental rights ((aka no rights at all)) being subjugated. Thats inconsistent.”
Not really, but bear with me here.
“What rights should a parent have over a 26 yo competent adult?”
My choice of saying “parental rights” may have been misleading and given to misinterpretation, as there are no parental rights over an individual once they reach majority. There is ample case law to support that fact. However, I did not, at the time, have an opportunity to find a term that precisely fit.
“And if incompetent, one who’s care/guardianship is not theirs?”
Here we start getting close to the heart of the matter.
How is it that someone totally unconnected to the patient became the final arbiter of his fate?
“Its not the main point, just to the subsequent accolade.”
Au contraire, I feel that it *is* the main point.
Somehow we have abdicated the ability to decide what is best for those near and dear to us, instead allowing the courts, medical professionals, “the guv’mint” and others to have that power.
And once having gained it, those entities are loathe to relinquish it, no matter how grave the need or their error.
You don’t have to look far to find examples of government, corporate or individual examples of abuse. CPS, Enron, Jim Jones…but this is an exercise best left to the reader.
“I think too much time, money, and other resources are spent in unworthy pursuits,”
Unfortunately one person’s unworthy is another person’s holy grail, look no further than the health care debate, or climate change, or Don’t Ask Don’t Tell.
“but even guinea pigs should be protected against malpractice-if any there was.”
Malpractice? Probably not.
FTA: “…the CAFE study only prohibited patients at risk of suicide, not homicide. This meant that Dan—who had threatened to slit his mother’s throat, but had not threatened to harm himself—was a legitimate target…”
So, malpractice, no. But MALFEASANCE? Oh yeah. That’s what this is all about. Using people, discarding them, all to support an agenda, and in this case a profit based one at that.
Therein lies the need for change, for accountability, from those making these decisions.
Dan’s Mom, justifiably concerned and afraid, acted out of love, entrusting the care of her child to another; only to have that trust betrayed, and in the end have her child taken from her.
The FDA causes Global Warming.
iMP–you are correct that when you use the wrong word/concept other people are not going to follow your private intent but rather what you publicly post. Nothing “misleading” about it. When you miscommunicate, you initiate a different conversation than the one you intended but “you” are the only one mislead.
So–we can all look up what the reviewed elements are of court appointed guardians. In the main, I assume/hope they “have the best interests of the subject in mind” ((something that most parents have and most attending physicians do NOT have as they have a direct conflict of interest in such position)) AND they are in a position to and have the ability to weigh the pro’s and con’s of options available to the subject ((something that most attending physicians have and most parents do NOT have as they are uneducated and out of state)).
Of interest here is that the subject was not “risk free” to begin with as he was mentally ill so with a doc qualified to treat him, operating under a protocol ((strongly implies third party observation and review)) on balance it looks like the doc was an appropriate guardian even with the conflict of interest as there were no other more qualified people.
“Dan’s Mom, justifiably concerned and afraid, /// I see no justification–just mindless anxiety
acted out of love, entrusting the care of her child to another; /// she didn’t entrust, decision was not hers
only to have that trust betrayed, /// again, there was no trust.
and in the end have her child taken from her. /// true.
Sounds like a defective law in that it drew a line between two crazies that should be viewed as a package: danger to self/danger to others. Sick is sick. Was the drug meant to treat the one and not the other, or the illness so strongly on one condition and not the other? I think not. Humans are not so discrete in their behavior nor are the drugs to treat them.
I was tangential in my comment regarding the waste of societal resources. There are too many people, and too many crazy people. If research money and medical treatments could be made with an unlimited budget, then fine: treat everyone for everything. But the world is limited. I think in this limited world, a dollar spent on the mentally ill is a dollar not spent on others with real potential for a happy/productive life. Spend the money there and get rid of the Darwin failures. Just one chink in my empathetic morality? No, just empathetic towards those who will benefit.
in # 9 Olo Baggins of Bywater said: “why do a drug trial to make marketing points if there’s a possibility someone will die?”
But no one the marketers knows dies* so there’s no possible risk, now is there?
Of curse, the problem with that approach is that they eventually believe what they write, even though they KNOW is BS since they write it and then people die AND THE DEAD DON’T VOTE or PAY TAXES or WRITE LETTERS TO THEIR CONGRESS CRITTERS.
The sad fact is that Joe Schmoe dying gets no sympathy.
The media has to sexy it up otherwise it isn’t even a statistic.
Face it, you’re better assuming that they’re full if sh*t and carrying on as best you can by yourself**.
*The fact that they can’t apply sort of eliminates the possibility of that sort of unpleasant event ever happening. (Self fulfilling prophesy.)
**And having a chronic disease myself (MS) its not something I state lightly.