watch out EU and US--clinical trials regulation new hot topic!

[Lani]

on the website for the ECCO european cancer association which is currently meeting there is a reference to a new EU directive (ouch!?) on clinical trials


After the EU directive on MRIs I was hesitant to click on it, for fear of being further outraged.

I TOTALLY AGREE THAT CLINICAL TRIALS NEED TO BE REGULATED DIFFERENTLY and better (although I am sure I don't know a billionth of what I should know about the subject), but hate to see directives handed down from
people who do not have the medical qualifications or background to evaluate things thoughtfully, with money and politics too far in the foreground and not, even necessarily democratically elected. Some countries may feel differently about things, but can't opt out.

Here is something re clinical trials regulation (or lack of it) in the US. I hope professional organisations get together and get their act together so that Washington lobbyists (insurance companies, drug companies, etc)do not
get to dictate something in an area in which experts in the area--researchers doing the research, participating MDs, ALSO nonparticipating MDs, AND NONPARTICIPATING scientists in basic research who are not under the pay/influence of the powers in the area--should be providing leadership and paving the way.

[Lani]

Report Assails FDA Oversight of Clinical Trials [New York Times; Subscribe]
WASHINGTON, Sept. 27 — The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.
The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.
"In many ways, rats and mice get greater protection as research subjects in the United States than do humans," said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.
Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said.
Because no one collects the data systematically, there is no way to tell how safe the nation's clinical research is or ever has been.

[AlaskaAngel]

One book that makes some positive logical suggestions about how to push for more logical regulation of clinical trials and drug development is The Truth About Drug Companies; How They Deceive Us and What to do About It, by Marcia Angell, M.D.

[fullofbeans]

Hi Lani,

I undestand that companies are very reluctant to carry out clinical trial because it is v. time consuming+ extremely costly, surely adding more regulations to this is not going to help our cause.

From a (happy) guinea pig point of view for example I am annoyed that FDA could stop me from having Trovax (another vaccine) because I already have had the peptide UW vaccine. When I understand that UW would be quite keen on me having it aswell since they are hypothetising that it may confer better protection.

I do not know exactly how clinical reseach operates here or in the EU, however my instinct is to say that ( for life threatening conditions) I am very much in favour of relaxing the regulations as oppose to go the other way! I am very much in favour also to have compationate access to trials. If you are a stage 4 you know what true desesperation taste like, and this feeling is, in my opinion, the most inhumane aspect of closing off research access and or making it difficult and costly.

I am doubdful that rats and mice get better protection than human..sounds rather ludicrous comment made to shock people and get media attention.

Thanks AA for the book reference I will order it.

Lani I really respect your views and comments on this. And once again thank you once more for your interesting post as always.