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Pharma giant failed to report 80,000 drug files

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posted on Jun, 29 2012 @ 01:52 PM
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Pharma giant failed to report 80,000 drug files


www.newscientist.com

An investigation is under way after the discovery that 80,000 reports of patient reactions to drugs were not passed on to regulatory authorities by the Swiss-based pharmaceutical giant Roche and its US affiliate, Genentech.

The focus of the probe, by the European Medicines Agency, is to find out whether patient safety has been compromised by the unreported information....
(visit the link for the full news article)


Related News Links:
www.pharmalot.com




posted on Jun, 29 2012 @ 01:52 PM
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...which includes 15,000 reports of patients who ultimately died of their illnesses – although there is no evidence that their deaths were a result of the drugs they took.


Even if the drugs weren't "responsible" for the patients death as the media so diligently implies... they were treated with a drug whose "reactions" on 80,000 patients were excluded from oversight by the appropriate authority....

Why?

A Spokeswoman for the agency said it's not clear how many of the 80,000 reports were of adverse reactions. "They are not necessarily [adverse reaction reports]" A diligent soldier of the Chem/Pharma cartel knows not to ruin her career by stating that the situation is worse NOT knowing....

Roche's rebuttal..... (see additional link)


Based on our assessments to date, no impact on the safety profile of any of its products has been found. Our products have a well-characterised benefit-risk profile based on all available safety information, such as the clinical trials on which their approval by health authorities was based on, extensive programs of post-approval clinical studies, scientific publications, pre-clinical data and epidemiologic publications. This information is complemented throughout the life-cycle of the product with spontaneous safety reports coming from doctors and patients.


Saved by the boilerplate press release.....

www.newscientist.com
(visit the link for the full news article)



posted on Jun, 29 2012 @ 01:59 PM
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Today big pharma is as corrupt as the banks. This does not surprise me because it is well known that companies contract out much of their drug studies to industry friendly researcher who have a vested financial interests in getting the results need by the company who asked for the research.

I was reading on www.naturalnews about something related to cancer studies... here is the link....

www.naturalnews.com...



posted on Jun, 29 2012 @ 02:04 PM
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I remember when aspartame was coming in to the marketplace and the fraud that was found ... here is a good story about more big pharma lies!

www.mercola.com...



posted on Jun, 29 2012 @ 02:08 PM
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reply to post by Maxmars
 


These drug companies make me sick, so do the people in power who assist them in covering up their crimes and deceptions. I currently have a family member who has recently been diagnosed with an auto-immune disease and her symptoms have worsened ever since she has been taking the drug cocktails they have prescribed.

It would be nice if there was accountability but since they do their testing on poor people in poor nations it's easy for them to cover their tracks. In fact, they can even get away with it in North America as they have everyone in their wallet.

All these entities are guilty of these practices and deserve to receive the karma they have brought upon themselves.



posted on Jun, 29 2012 @ 02:19 PM
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reply to post by Maxmars
 


looks like the nazis are still killing people
who says they lost the war?



posted on Jun, 29 2012 @ 02:28 PM
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And when a promising potential cancer cure comes along like antineoplastons, the FDA try their hardest to shut it down with the most petty of reasons, numerous court appearances over many years and no indictments. Now I know how an ant feels as these corporate giants walk among us. Heads up people.



posted on Jun, 29 2012 @ 04:13 PM
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All I can say is that it is our responsibility as intelligent humans to take our health into our own hands. We need to become informed. Knowledge is power and what a great place to share information with such open minded individuals. We are powerful as a collective. Also eating the right food that is organic preferably home gown or local. Also exercise is a great way to stay healthy, strong, and become empowered. We really have a social problem on our hands though. Socialization is a very powerful form of interaction which helps even with healing or maintaining ones health. We have a lack of community these days. Their are people in my neighborhood i don't even know or have anyway of connecting with. The departmentalization of American communities and worldwide has disabled us as citizens to have our voices heard with appropriate action taken. Here at ATS we have formed a sort of artificial community. It is great, but building our communities is something i think we need to take seriously. We are dependent on so many things from the system food, water, energy, ect. we are consumers. If we transitioned to a more independent community were we are instead producers sustainably of our food, water, and energy than we would not be pushed around by this out of control system. This is how we can create a healthier society and environment. Start with yourself and bring in others along the way. Look up permaculture design and natural building for more info.



posted on Jun, 30 2012 @ 12:26 AM
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Originally posted by Maxmars
Even if the drugs weren't "responsible" for the patients death as the media so diligently implies... they were treated with a drug whose "reactions" on 80,000 patients were excluded




Rather than rely on second hand reporting, the original news release from the European Medicines Agency is in this pdf.

Its not the media who are reporting that the drugs were not responsible for the deaths, it is the European Medicines Agency who say that...

There is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action.


Looking through the thread, people seem to be under the false impression that there were 80000 "reactions" from the drugs. Not so.
To use an analogy, imagine a law where any and every car accident must have the fuel manufacturer notified so they can determine if the gasolene was in any way to blame for the car accident.
Its like that in the pharmaceutical world.



posted on Jun, 30 2012 @ 01:45 AM
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reply to post by alfa1
 

thanks for the link but since i cannot view a pdf, perhaps you can answer this question.
how many total patient accounts/reactions were reported ?
80,000 unreported reactions out of how many ??
does the 80,000 represent 2% or 80% of total reactions reported ??

good reactions or bad, withholding that many reports would appear to skew the results along the way.



posted on Jun, 30 2012 @ 03:02 AM
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reply to post by Maxmars
 

These drug companies are a force unto themselves.....and the bottom line of the matter, for them, it's all about the dollar$$$$$

The pharma company GlaxoSmithKline, who produced a certain controversial diabetes drug, finally had it pulled off the market and is only allowed to be given to special patients. For years the FDA and the company went back and forth, over the safety of the drug, even found that they had altered some of the results from the study.

Finally, after billions of dollars later that they made off the drug, they re-called it.

I remember a test trial used to be approx. 10- 15 years or so before it was put on the market.

Not so today......After 2 or 3 years, they put it out on the market, while still doing trial tests, and haven't got a care in the world whether or not people have reactions to it or not. Maybe after years of stone walling the FDA, after raking in the money, if it's to be determined not safe, then it gets re-called. All at the expense of the patients health.

All one has to do is watch all the commercials on TV for "bad drugs"......

Seems as though they are trying to get people addicted to pharma drugs...... legalized drug dealers.

What a sham...



posted on Jun, 30 2012 @ 06:08 AM
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Originally posted by Honor93
how many total patient accounts/reactions were reported ?
80,000 unreported reactions out of how many ??



The EMA pdf says there were 80000 files that were not examined, but this is not the same as there being 80000 patient reactions.


...some 80,000 reports for medicines marketed by Roche in the USA that had been collected through a Roche-sponsored patient support programme, but which had not been evaluated to determine whether or not they should be reported as suspected adverse reactions to the EU authorities.


The pdf doesnt say what was in these "reports".

Note also that in the pharmaceutical industry, reports are also gathered for a wide range of things other than "reactions".
Efficacy (if it works as well as it should) is one that is closely monitored.
Anything notable about the drug in any way. eg. A liquid drug that is supposed to be clear, but has a cloudy appearance would generate a report. A tablet that is supposed to dissolve in water, but doesnt, would generate a report. An error in the instructions or labelling would generate a report.
And that "reactions" is a very wide term that can include such minor things as a dry mouth or wakefullness and people shouldnt jump to the conclusion that a "reaction" meant the patient suffered a dramatic traumatic near death (or death) situation.

How was this discovered?

The deficiencies are identified in a May 2012 report from the UK medicines regulatory agency (MHRA) following an inspection at Roche. This was part of a coordinated European programme of routine inspection of safety reporting systems.


From time to time, the various pharmaceutrical industry regulatory bodies around the world (FDA in the USA, for example) inspect the pharmaceutical companies. They have great power and can demand inspections of anything anytime, random or forewarned, and the drug conpanies are nearly scared to death of the continual sword of damocles that the regulatory bodies represent.
At any time, these regulatory bodies can say "not good enough, you are shut down".

edit on 30-6-2012 by alfa1 because: (no reason given)



posted on Jun, 30 2012 @ 07:03 AM
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reply to post by alfa1
 


You can write what you want but 80,000 not overseen files are something to be worried about, if they are drug related or not!



posted on Jun, 30 2012 @ 01:07 PM
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reply to post by Maxmars
 


Prescription drugs killed more Americans that street drugs last year.

I've read different studies that suggest the average 65 year old takes 3-5 Rx drugs a day that either do nothing or actually cause harm.

We're talking about billions of dollars being wasted.


The only way America will ever have medical reform is if BigPharma gets out of the way.



posted on Jul, 1 2012 @ 11:28 PM
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reply to post by alfa1
 
thanks for answering my questions, i still can't read it. (pdf)


The EMA pdf says there were 80000 files that were not examined, but this is not the same as there being 80000 patient reactions
now this is pc speak and BS at that.

80,000 unreported treatments EQUALS 80,000 unreported reactions.
(good or bad, every action has a reaction - don't even try to re-write that one)

i question the balance of the overall results, not the evaluation results of the unreported.

80,000 unreported, unexamined cases could seriously sway the overall results in either direction, if total participants were, say 100,00 or even 500,000.
failing to provide such info (not you but them) is suspicious at minimum.

yes, i'm aware there are a multitude of reports in the pharm industry, what does that have to do with this investigation?

the OP states the investigation results from the discovery of 80,000 reports of patient reactions to drugs ... etc ... not, drug reactions reported by patients.
to me, it's just one more case of ... (whatever the cause or product) casestudy = manipulated results. which is very sad indeed.

no offense intended, but if they were not skirting the regulations, they wouldn't have to worry so much.
If these "regulatory bodies" were either scary or effective, why then, do we have so many marketed drugs, re-called, annually?

just a observation here but it sure seems like there are more snake-oil salesman now, than there ever was in the early 1900s ... and, if this observation be true, what good are these "regulatory bodies" anyway?



posted on Jul, 1 2012 @ 11:40 PM
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Originally posted by Honor93
the OP states the investigation results from the discovery of 80,000 reports of patient reactions to drugs ... etc ... .


The OP says that, yes, but thats a reporter making a story from the material in the pdf.
The pdf does not say that it was 80000 reactions, and goes out of its way to say that it in fact wasnt the case.

...had not been evaluated to determine whether or not they should be reported as suspected adverse reactions...





Originally posted by Honor93
...no offense intended, but if they were not skirting the regulations, they wouldn't have to worry so much.


Agreed.
I have some slight connection to the industry, and yes, its all about the Benjamins.

edit on 1-7-2012 by alfa1 because: (no reason given)



posted on Jul, 1 2012 @ 11:42 PM
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The head of the FDA is always somebody high up in the pharmaceutical industry. They do not work for you and I. They work for the pharmaceutical industry.



posted on Jul, 2 2012 @ 02:53 AM
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reply to post by alfa1
 

i understand reporter slant, that's why i asked for details in the pdf.
which btw, don't seem to be forthcoming.

i read that quote last post ... it says the same thing now as it did then.

had not been evaluated to determine whether or not they should be reported as suspected adverse reactions...

doesn't change the fact that they were not reported at all.
i told you then and i'll say again, the results of the non-evaluated reports are not the topic.

i will also say, as the results still aren't available, they may be adverse just as easily as not.
that information wasn't provided and is irrelevant to the investigation, agreed ?

now for a "what if"
what if all 80,000 results indicate adverse reaction to the drug(s) in question.
are you implying that the results, may somehow, absolve the act of withholding them ?
or can we agree that the withholding (if intentional) was just plain wrong if not illegal ?

thanks for admitting the industry affiliation, although, that doesn't relieve you from answering my "what ifs" honestly.

i fully accept the results could be equally benign [we don't know] but does that make the act of withholding the information better, worse or what exactly ??



posted on Jul, 2 2012 @ 06:16 AM
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Originally posted by Honor93
i understand reporter slant, that's why i asked for details in the pdf.
which btw, don't seem to be forthcoming.


Google has a "quick view" function that might work.
Edit - the link is too long to post here, but if you a google search for the pdf report you can view it with "quick view".



Originally posted by Honor93
...although, that doesn't relieve you from answering my "what ifs" honestly.


There are no answers to "what if"s.
All 80000 reports may be related to reactions. Or none. Or 32 percent. What if it is 19 percent? Either way we both agree it is a serious lapse in reporting.

According to something I read somewhere earlier but cant find now, Roche have promised to come back with results of an investigation into those reports by 27 June. (A few days ago).
If the EMA place a news article about that on their page, it will be here

And if anyone cares, a Roche representative has spun some words in response to questions on this matter.
The blah blah blah is to be found here.


edit on 2-7-2012 by alfa1 because: (no reason given)




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