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Post by vark on Dec 14, 2015 17:49:07 GMT -5
www.statnews.com/2015/12/13/clinical-trials-investigation/article is about how sites usually dont post their results on time at clinicaltrials.gov as required by law, but there have been no fines issued to anybody. there is a form to fill out if you want to complain about a clinic or provide other feedback.
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tom
New Member
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Post by tom on Dec 15, 2015 12:59:44 GMT -5
Does anyone know if Spaulding does partial payments at checkout?
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Post by vark on Jan 12, 2016 4:48:43 GMT -5
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mike
Moderator
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Post by mike on Jan 12, 2016 13:57:17 GMT -5
Yeah I like how the author points out how Uber and Lyft actually underhandedly reduced how much you can make, AFTER lots of people had committed to working for them.
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Post by respect on Jan 15, 2016 13:26:56 GMT -5
Breaking News: Phase l started this January leaves one brain dead and three other permanently brain damaged! Ranks like Parexel are no stranger these outcomes.Just in the last year doctors have taken extra ordinary risk resulting in cardiac episodes. Other clinician seeing the risk would have made different decisions possible mitigating these events. It brings to question drug companies trying to save money by using Clnical Research Units. Often these profit centers are staffed with temps who are overworked and not as well trained as hospital or University staffs. This can lead to deadly mistakes. The cost can be human lives and possibly drugs that make it to market killing thousands.If this article makes you uncomfortable it should! nyti.ms/204MZ
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Post by vark on Jan 15, 2016 17:10:04 GMT -5
woah
By THE ASSOCIATED PRESS JANUARY 15, 2016 PARIS — One man was brain dead and three others faced possible permanent brain damage after volunteering to take part in a trial for a painkiller and anxiety medication based on a natural brain compound similar to the active ingredient in , French authorities said Friday.
The Paris prosecutor's office ed an investigation into what French Health Minister Marisol Touraine called "an accident of exceptional gravity" at a clinical trial lab in the western French city of Rennes.
The drug trial involved 90 healthy volunteers who were given the experimental drug in varying doses at different times, she told reporters at a news conference in Rennes.
Six male volunteers between 28 and 49 years old have since been hospitalized, including one man now classified as brain dead, Touraine said, adding that the other 83 volunteers were being contacted.
Calling the case "unprecedented," Touraine said she was "deeply moved" by the suffering of the victims, who she met with earlier Friday, along with their families. "We'll do everything to understand what happened," she said. "I don't know of any other event like this."
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mike
Moderator
Posts: 334
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Post by mike on Jan 15, 2016 21:47:24 GMT -5
Harsh, I wonder if France has less protections and safeguards than other countries. It's interesting to me that the only two really bad incidents in clinics that I have heard of were not in the US (the other was a few years ago in England); one has to figure that many more of these trials are done in the US than anywhere else.
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mike
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Posts: 334
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Post by mike on Jan 15, 2016 21:50:45 GMT -5
I'm positing that the US govt is sometimes criticized as being invasive and that America is considered overly litigious; maybe this is an area where it works in our favor.
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Post by vark on Jan 17, 2016 11:08:58 GMT -5
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mike
Moderator
Posts: 334
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Post by mike on Jan 17, 2016 16:06:12 GMT -5
I never googled the subject; but that gene therapy study was a very unusual study with a non-healthy subject, the treatment sounds inherently more unpredictable. And who knows with a suicide how much it had to do with the study drug.
The studies in France and England are a lot scarier to me because they sound just like studies that I could be doing.
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Post by vark on Mar 12, 2016 1:16:13 GMT -5
. Experts: Drug trial disaster followed several missteps; new rules needed
Thursday, March 10, 2016 | By John Carroll
French Health Minister Marisol Touraine Why did an experimental "me-too" drug tested in France kill one patient and leave 5 others hospitalized?
French health authorities gathered a committee of experts together to explore that question, and their first stab at an answer leaves the mystery largely unsolved. The committee, though, zeroed in on unexpected off-target effects of the drug as a likely culprit for the serious brain damage inflicted on trial subjects. And there were enough visible mistakes in the study--a poor preclinical evaluation of pharmacology, the use of maximum doses that were far higher than what was needed to achieve the desired effect, and erratic dose escalation in the human study--that the authors are calling for new trial rules that should be adopted globally.
The drug in question--a painkiller dubbed BIA 10-2474--is an FAAH inhibitor similar to others that have been abandoned; not because they were unsafe, but because they were ineffective. "Its originality is relative as it could appear to be a 'me-€ too' of several molecules previously developed as FAAH inhibitors such as PF-€ 3845 by and JNJ-€ 42165279 by Janssen (J&J)," the scientists report.
The Portuguese pharma company Bial had billed the compound as a reversible FAAH inhibitor, but the drug in fact appears to be irreversible. In addition, by blocking FAAH you increase levels of an endocannabinoid called anandamide, which in turn can spur the development of other compounds "which could have a harmful effect, especially on brain circulation."
"BIA 10†2474 would appear to be a lot less specific to FAAH than its predecessors," the experts also note, "making binding to other cerebral enzymes plausible."
Particularly perplexing for the experts was safety data from studies using the drug on four different species: rats, mice, dogs and monkeys. Several primates were "put down" in the study, but only after taking high doses of the drug. Cerebral damage was noted in rodents, but only after they were given doses more than 100 times stronger than what was planned for humans. In the dogs, though, there were changes in their lungs that raised questions, along with a query about why investigators in the study lowered the dose as they went along.
None of that, though, would prevent an investigator from trying the drug in humans, the report states. What was particularly troubling, they said, was that the drug didn't show the kind of efficacy as an analgesic that warranted a human study: "This seems too basic to justify uing development, a fortiori in humans." Better preclinical pharmacology studies should have been required.
The scientists raised questions about some of the patients recruited, including one with a head injury. Dose escalations were sometimes too sharp, and they once again singled out the fact that the investigators ued to dose patients even after one of the patients in the study was hospitalized.
Patients in only one of 14 cohorts in the study experienced severe adverse events; "serious central nervous system symptoms exclusively, only appeared in the exposed volunteers from MAD cohort 5 (50 mg).
So what could have happened? The scientists speculated that there could have been an interaction with other products; "anandamide†related toxic effects" could have been involved; toxicity from a metabolite of the drug may have played a role.
One favorite theory is that the drug had an off-target effect, hitting other cerebral enzymes, which may have been likely given the random nature of the FAAH inhibition they saw in the drug. And cohort 5 was given doses up to 40 times what was needed to achieve full inhibition of FAAH, raising additional questions about the trial design.
The group also wants new rules put in place that govern trial design, which they're recommending for international use.
First and foremost, they want to see stricter requirements on preclinical pharmacological studies to demonstrate that a drug has potential. Trial volunteers should be screened better for CNS studies, including a neuropsychological assessment. Maximum doses should be better evaluated and new, best practices rules on dose escalation need to be adopted.
- here's the report (PDF)
Related Articles: 'Molecule to blame' in fatal French drug study Report: Fatal French trial ignored preclinical warning signs French investigators to Biotrial: You should have stopped fatal study earlier
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Post by vark on Mar 12, 2016 1:43:11 GMT -5
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