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NYU Professor Uncovers How The FDA Systematically Covers Up Fraud & Misconduct In Drug Trials

Tyler Durden's picture




 

Submitted by Mike Krieger via Liberty Blitzkrieg blog,

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

 

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

 

From the Slate article: Are Your Medications Safe?

In the past week or so, I’ve come across several important articles that will leave any rational observer increasingly skeptical of the entire medial industry in the U.S. This isn’t something I say lightly, and I think it’s an absolutely horrific development for our society.

Just last week, Liberty Blitzkrieg published an article titled, Introducing “Physician Dispensing” – The Latest Troubling Medical Industry Scam, which expounded on why an erosion of trust in doctors is so troubling. If you missed that piece, I suggest going back and reading it. Here’s an excerpt:

Once the corruption reaches a certain level of societal saturation, you create a culture in which people simply stop trusting everyone and everything. For obvious reasons, this is a very dangerous development. There are people whom you need to trust for any civilization to function reasonably well. Police are one, but doctors are another. I can speak for myself when I say that I am not convinced that any medical professional I see has only my best interests at heart. I seriously wonder how he or she is balancing my health with the ability to earn more money. From conversations with friends and family, I have found that this is much more widespread than we would like to admit. This is incredibly bad and incredibly sad.

While that article was bad enough, it is nothing compared to what I just read by Charles Seife, a journalism professor at New York University. He and his students set out to research the FDA and how it deals with evidence of fraud and misconduct in pharmaceutical drug trials. What he found will shock and disturb even the most hardened cynic. If you are one of the 70% of Americans that take at least one prescription drug, brace yourself…

From Slate:

Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wildvideo. It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing. Faked X-ray reportsForged retinal scansPhony lab testsSecretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.

 

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

 

We didn’t have to search very hard to find FDA burying evidence of research misconduct. Just look at any document related to an FDA inspection. As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted. My students and I looked at FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only roughly 100 cases were we able to figure out which study, which drug, and which pharmaceutical company were involved. (We cracked a bunch of the redactions by cross-referencing the documents with clinical trials data, checking various other databases, and using carefully crafted Google searches.) For the other 500, the FDA was successfully able to shield the drugmaker (and the study sponsor) from public exposure.

Think about that. Despite all that digging, they were able to link questionable data to specific drugs in only 20% of the cases examined.

It’s not just the public that’s in the dark. It’s researchers, too. And your doctor. As I describe in the current issue of JAMA Internal Medicine, my students and I were able to track down some 78 scientific publications resulting from a tainted study—a clinical trial in which FDA inspectors found significant problems with the conduct of the trial, up to and including fraud. In only three cases did we find any hint in the peer-reviewed literature of problems found by the FDA inspection. The other publications were not retracted, corrected, or highlighted in any way. In other words, the FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware. The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct in a clinical trial.

 

Such was the case with the so-called RECORD 4 study. RECORD 4 was one of four large clinical trials that involved thousands of patients who were recruited at scores of clinical sites in more than a dozen countries around the world. The trial was used as evidence that a new anti-blood-clotting agent, rivaroxaban, was safe and effective. The FDA inspected or had access to external audits of 16 of the RECORD 4 sites. The trial was a fiasco. At Dr. Craig Loucks’ site in Colorado, the FDA found falsified data. At Dr. Ricardo Esquivel’s site in Mexico, there was “systematic discarding of medical records” that made it impossible to tell whether the study drug was given to the patients. At half of the sites that drew FDA scrutiny—eight out of 16—there was misconduct, fraud, fishy behavior, or other practices so objectionable that the data had to be thrown out. The problems were so bad and so widespread that, contrary to its usual practice, the FDA declared the entire study to be “unreliable.” Yet if you look in the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.

 

It’s not just one study, either. The FDA found major problems with sites involved in the other three clinical trials that were used to demonstrate rivaroxaban’s safety and effectiveness. RECORD 2, for example, was nearly as awful as RECORD 4: Four out of 10 sites that the FDA inspected showed evidence of misconduct, or other issues grave enough to render the site’s data worthless—including clear evidence of data falsification at one site. In aggregate, these problems raise serious doubts about the quality of all four key rivaroxaban studies—and, by extension, doubts about how seriously we should take the claim that rivaroxaban is safe and effective. The FDA is keeping mum, even as wrongful-death lawsuits begin to multiply.

 

In the decade since the Ketek affair, it’s hard to see any change in behavior by the agency. On occasion, the FDA has even actively approved and promoted statements about drugs that, according to its own inspectors, are based upon falsehoods. At the end of 2011, the FDA learned that an audit of a Chinese site involved in a key clinical trial of a different anti-clotting agent, apixaban, had turned up evidence of fraud: Personnel had apparently been fiddling with patient records. Worse yet, the fraud appeared to invalidate one key finding of the study. Just three months earlier, the researchers running the trial proudly announced in the New England Journal of Medicine that there was a “significant reduction in mortality” among patients who took apixaban compared with those who took the old standby, warfarin. Alas, the moment you exclude the data from the Chinese fraud site, as per standard FDA procedure, that statement went out the window. Yet look at the label for apixaban—the one approved by the FDA after the fraud was discovered—and you read that “treatment resulted in a significantly lower rate of all-cause death … than did treatment with warfarin,” backed up by the data set with the Chinese site included. In other words, the label is carrying a claim that the FDA knows is based upon fraud. In a written response to my questions on this subject, the FDA stated that, “The FDA extended the drug’s review period to address the concerns. However, the review team did conclude concluded [sic] that the data at that site and other sites in China did reflect meaningful clinical information; that was not what was considered unreliable.”

 

Again, this isn’t an isolated incident. I had previously encountered bogus data on FDA-approved labels when a colleague and I were looking into a massive case of scientific misconduct —a research firm named Cetero had been caught faking data from more than 1,400 drug trials. That suddenly worthless data had been used to establish the safety or effectiveness of roughly 100 drugs, mostly generics, that were being sold in the United States. But even after the agency exposed the problem, we found fraud-tainted data on FDA-approved drug labels. (The FDA still maintains its silence about the Cetero affair. To this day, the agency refuses to release the names of the 100-odd drugs whose approval data were undermined by fraud.)

 

The most common excuse the agency gives is that exposing the details about scientific wrongdoing—naming the trials that were undermined by research misconduct, or revealing which drugs’ approvals relied upon tainted data—would compromise “confidential commercial information” that would hurt drug companies if revealed. This claim falls apart under scrutiny. The courts have ruled that when information is provided by companies involuntarily, such as the information that an FDA inspector finds, “commercial confidential information” refers to proprietary material that causes substantial, specific harm when it falls into the hands of a competitor. It doesn’t cover embarrassing peccadilloes—or misconduct that might cause bad publicity when word gets out.

As usual, it’s all about protecting corporate profits.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

America’s new religion.

*  *  *

For related articles, see:

First is a MUST WATCH hilarious video by John Oliver: Video of the Day – John Oliver on Pharma Company “Marketing to Doctors”

Fraud Alert: FDA Allowed Drugs with Fraudulent Testing to Remain on the Market

The FDA is Caught Spying on its Employees and Creating an “Enemies List”

Introducing “Physician Dispensing” – The Latest Troubling Medical Industry Scam

 

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Wed, 02/18/2015 - 19:32 | 5801238 Dungholio
Dungholio's picture

Say it ain't so...

Wed, 02/18/2015 - 19:46 | 5801293 whotookmyalias
whotookmyalias's picture

What isn't full of fraud and misconduct if the government, banksters, or some other military-industrial complex type monster is involved? 

Wed, 02/18/2015 - 19:54 | 5801311 Steroid
Steroid's picture

According to studies the FDA kills four times more people than it saves.

End the FDA!

Wed, 02/18/2015 - 20:01 | 5801325 CH1
CH1's picture

FDA is utterly corrput, and has been for at least two decades. Knew a biochemist who had to deal with the crooks.

Wed, 02/18/2015 - 20:20 | 5801369 weburke
weburke's picture

"utterly corrput" 

well, I do have a freind who is a long term fda employee, and he went from being a eat anything guy, to eating organic and buying vegs from farmers collectives ect. I asked if this had anything to do with his job, and he said "yes". 

He says there are fine laws in place, but they dont fund anything more than an office and phone and limited agents to do any real work. We didnt get into any industry influences, that was assumed. 

Wed, 02/18/2015 - 22:29 | 5801763 TruthInSunshine
TruthInSunshine's picture

Anyone who has been in a physician's office sees the BIG PHARMA WHORE REPS, many sultry women, ready to bend & blow the good doctor if it leads to increased RXs being written, more $$$ for the Pharma Co., more $$ for the pharma whore (working on commission), and the good doctor gets all kinds of Swag, tickets, junkets, etc.

Fucking corrupt prostitution inside and out.

Every gov't agency and "regulator" is corrupt, as is the money-is-our-god Big Pharma Industrial Complex, along with their slaves, the doctors themselves, etc.

Wed, 02/18/2015 - 23:42 | 5802037 zhandax
zhandax's picture

"We can no longer hope that the situation will get better without firm action from the legislature."

We can no longer hope that the situation will get better with firm action from the legislature.  They are all bought off as well.

Wed, 02/18/2015 - 20:22 | 5801374 chunga
chunga's picture

These fucking FDA cunts banned Primatene Mist because it's bad for the environment and ozone layer or some bullshit. Instead they want you to got get an RX for some super expensive steroidal bullshit. There is an OTC alternative now for people who used to use primatene mist...but it's way more expensive and guess what?

Not only does it take batteries that are thrown in the landfill, but it must be rinsed daily with distilled water and vinegar. So much for you concern for the enviromnent you fraudulent FDA scumbags. Go to hell you dangerous .gov pricks.

Thu, 02/19/2015 - 07:13 | 5802591 Hobbleknee
Hobbleknee's picture

What percentage of the atmosphere was Primatene Mist?  It must've been microscopic compared to cigarette smoke, which is also microscopic.

Wed, 02/18/2015 - 20:56 | 5801429 Harbanger
Harbanger's picture

We have a "study" to prove anything we say dude.  GET IT? Perception management means covering all bases.  I love this game, why wasn't I born a few decades earlier?  I can't wait for my spin at this wheel.

Wed, 02/18/2015 - 21:33 | 5801566 BlindMonkey
BlindMonkey's picture

Have we hit peak .gov trust?  I sure hope so.

Wed, 02/18/2015 - 20:05 | 5801337 overmedicatedun...
overmedicatedundersexed's picture

as a seller of poisons, I wish I could refute this author, in fact things are even worse..man has been given tools which much like the atom, we might not be intelligent enough to use. or moral enough or ethical enough.

think of joe biden and his delemma : do something horribly wrong and get paid, or do the right thing- I think we know what mr biden will choose each time..and he might be one of the better ones in DC.

Wed, 02/18/2015 - 21:00 | 5801462 NotApplicable
NotApplicable's picture

 

"I'mma gonna fuck you later. Yeah, there too." -- Uncle Joe

Thu, 02/19/2015 - 02:54 | 5802369 TruthInSunshine
TruthInSunshine's picture

Uncle Joe Dirt, with the Trans-Am Firebird.

Thu, 02/19/2015 - 09:38 | 5802944 Refuse-Resist
Refuse-Resist's picture

With T-Tops and the screaming firechicken on the hood, 6.6 Liter 4 on the floor!

 

It'd be better with an SD455 in it, but it's what we've got.

Wed, 02/18/2015 - 23:10 | 5801917 spooz
spooz's picture

The fact that the FDA, like many other agencies that are supposed to protect us, has been captured by Big PHARMA and Big AG doesn't mean we don't NEED those agencies.  If our government hadn't been captured by corporate interests who are more interested in profits than people, the government could do the job its supposed to do for us.  

What we need to do is get corporate influence and lobbyists out of our political system. Lobbyists have made a mockery out of the whole democratic process.

Thu, 02/19/2015 - 04:08 | 5802400 zhandax
zhandax's picture

If our government didn't have all these useless unconstitutional agencies, the corporations and their lobbyists couldn't capture it so easily.  Name one thing the FDA has 'protected' you from.  Or any other worthless government agency, for that matter.  I will cite a few,  It has 'protected' you from opening your own business.  It has obviously 'protected' you from getting a useful education.  It has 'protected' you from getting an inflation adjusted income anywhere close to the equivalent 30 years ago.  Wake up and smell what you are stepping in.

You ever listen to the legal disclaimers for the drugs advertised on late night tv?  Do you even realize that is a feeble attempt to limit liability for the corporations who peddle these poisons?  I think my odds are better on a month-long bender banging whores in Bangkok with no latex than taking any of that shit.

And right behind those ads are the ads for the PI lawyers who sue those same FDA-approved drug dealers for damages when it is proven that their poisons wreck lives.

Thu, 02/19/2015 - 06:42 | 5802569 FMOTL
FMOTL's picture

Er, the "government" is a corporation . The UNITED STATES OF AMERICA CORPORATION. It also has owners like any other corp, the senior bond holders.

Wed, 02/18/2015 - 19:47 | 5801294 whotookmyalias
whotookmyalias's picture

Double post.

Wed, 02/18/2015 - 20:28 | 5801353 Richard Chesler
Richard Chesler's picture

This is precisely why President Obama pushed so hard to pass Obamacare. His signature bill will put an end to all these schemes and make drugs safe and affordable for all Americans.

 

 

 

PS: This post is dedicated to MDB. While nowhere near as clever or eloquent, I think I'm starting to grasp the hang of it.

Wed, 02/18/2015 - 20:39 | 5801412 MeelionDollerBogus
MeelionDollerBogus's picture

It was pretty good - all it needed was references to right-wing thugs pushing hill-billy home-schooling, anti-vaccination medical terrorism and hoarding gold to help communist red Russia instead of America, the greatest, free-est nation on Earth

Wed, 02/18/2015 - 20:23 | 5801379 RaceToTheBottom
RaceToTheBottom's picture

When humans say they are god, they end up acting like the devil.

Wed, 02/18/2015 - 19:34 | 5801249 davidalan1
davidalan1's picture

"The sworn purpose of the FDA is to protect the public health" ??

 

Seems being "sworn" these days at ALL levels of Gov is fucking meaningless...

 

I know at my ripe old age, I cannot touch my fathers (god rest his soul) integrity and he worked for the FDA for thirty plus years..

Wed, 02/18/2015 - 19:58 | 5801321 Blood Spattered...
Blood Spattered Banner's picture

LOL, cut the nostalgia bullshit.

The proliferation of using opiates to treat pain started under your old man's watch.

So much for that integrity huh?

Wed, 02/18/2015 - 20:37 | 5801408 MeelionDollerBogus
MeelionDollerBogus's picture

Pretty sure opiates for treating pain has been around a lot longer than that.

Thu, 02/19/2015 - 06:49 | 5802571 FMOTL
FMOTL's picture

Yeah and you used to be able to get the pure uncut and very affordable product over the counter from your local pharmacist back in the day before it was a "problem" what other people chose to medicate their bodies with or have fun with .

Wed, 02/18/2015 - 21:30 | 5801559 davidalan1
davidalan1's picture

It would be one thing to debate the years and times of using opiates, but you crossed the line when you made the comment

 

"my old mans watch"-  so good sir...God fuck you, your mother, your father, you kids, you uncle, your aunt, your fav teachers, your dog, your cat, your monkey, your wife, your boyfriend... your future

A paux on your house for insulting the most Honest man who EVER LIVED-- you dick head douche fuck face mother fucking cunt-- got it?

 

Thu, 02/19/2015 - 14:20 | 5804272 Blood Spattered...
Blood Spattered Banner's picture

Wow.  Maybe Zero Hedge isn't the website for you.  Don't come here to Fight Club and start talking about your Daddy who worked for the FDA, or shit like this happens.

Get a grip.  

Thu, 02/19/2015 - 18:58 | 5805681 mkkby
mkkby's picture

Making a false claim is where you crossed the line, and will never get respected at the fight club.  So congrats on that, fuck tard.  Now you can go back to that bag of goat dicks you enjoy so much.

Wed, 02/18/2015 - 19:35 | 5801250 LawsofPhysics
LawsofPhysics's picture

Science is very dogmatic and just like everything else, drugs must be approved by certain powers that be in washington.  That absolute power corrupts absolutely should come as no surprise to anyone.

Wed, 02/18/2015 - 19:55 | 5801306 Steroid
Steroid's picture

Please keep language clean!

Science by definition is anything but dogmatic.

Scientistic bureaucracies pretend to be scientific are dogmatic indeed.

Wed, 02/18/2015 - 20:51 | 5801441 Harbanger
Harbanger's picture

BS! We have studies to prove anything dude.  And it ain't cheap.

Wed, 02/18/2015 - 19:46 | 5801253 Thirst Mutilator
Thirst Mutilator's picture

The only hypothesis which makes sense to me would be one where if the manufacturer of a certain drug was on a certain "GO" list, it automatically gets approved. If you're not on the "GO" list, then it gets approved anyway, but red flagged.

 

Drugs that are red flagged immediately get sent to the Law firm of "Haifowitz, Davis, & Stern", where, after a 3 year waiting period, a class action lawsuit is initiated. HD&S take their cut of the damages recovery. The money paid to the victims comes from some Hank Greenberg run insurer, who also holds a re-insurance policy for these types of things through a shell company that nobody knows who operates, but whose shares trade publicly, and are bought by Josh Silverstein [who happens to be the MOMO of what used to be your 401k]

EVERYTHING IS AWESOME!

 

Wed, 02/18/2015 - 19:37 | 5801259 cigarEngineer
cigarEngineer's picture

Relax. I heard Holder is on it.

Wed, 02/18/2015 - 19:37 | 5801262 Chupacabra-322
Chupacabra-322's picture

CDC = Center for Disease Creation.

Wed, 02/18/2015 - 20:19 | 5801366 Galahad Threepwood
Galahad Threepwood's picture

FDA - Fraud and Death Association

Wed, 02/18/2015 - 21:02 | 5801470 NotApplicable
NotApplicable's picture

I'm stealing both of these.

Wed, 02/18/2015 - 19:39 | 5801271 Antifaschistische
Antifaschistische's picture

this whole subject makes me sick...

yah, look at the "cause of death" on those certificates.   How many times do they actually say "dude took way too many prescriptions drugs".  NEEEVVVVEEERRRR

Wed, 02/18/2015 - 20:09 | 5801305 Chupacabra-322
Chupacabra-322's picture

And, the Criminal FDA, CDC & Courts have given blanket immunity form prosecution or damages should any child or adult suffer Neurological damage due to the Adjuvents / Perservatives Mercury, Themerisol, Cancer in the Vaccines.

Your virtually left to pick up the pieces of your damaged love one with no recourse. Depopulation, all done by design, all done by agenda at its finest..

Wed, 02/18/2015 - 20:36 | 5801405 MeelionDollerBogus
MeelionDollerBogus's picture

Never de-population.

 

To make slaves stronger, stop diluting their power - stop making them replacable - depopulate.

 

To make the elites stronger ensure the fastest population bubble possible - which is today. Slaves are always replaced with zero effort as they are too broke/starving to complain.

Wed, 02/18/2015 - 20:02 | 5801274 mrpxsytin
mrpxsytin's picture

Vitamin A and proper hygiene will solve most medical problems.

 

Thu, 02/19/2015 - 09:17 | 5802886 N2OJoe
N2OJoe's picture

Diet is a major, if not the biggest, factor in overall health. Eat pesticides, GMOs, poison pills, etc. and how can you NOT expect to become a zombified, shambling wreck of a creature?

You don't have to go cold-turkey, just learn what you can and phase it in as you go. It's hard because just about EVERYTHING you'd buy from a supermarket is poisoned in one way or another.

Wed, 02/18/2015 - 20:01 | 5801277 Normalcy Bias
Normalcy Bias's picture

I'm confused, as I thought everyone already knew that the FDA is wholly captured by the corporatocracy.

How many 'bad drugs' have made it into the marketplace in the last 30 years? And now, we're all GMO guinea pigs.

Wed, 02/18/2015 - 20:09 | 5801346 trader1
trader1's picture

Solution 1: Higher Corporation Tax for Pharma/Healthcare Companies

Solution 2: Higher Fines for Breaking the Rules/Law for Pharma/Healthcare Companies

Solution 3: Do nothing / Status Quo

Solution 4: Other

Wed, 02/18/2015 - 22:38 | 5801793 Fred Hayek
Fred Hayek's picture

I don't like #1 because there may be some fairly honest pharma companies that would have to pay bigger tax because of the malfeasance of others.

#2 is misdirected. I'm sure there are real, serious penalties on the books now for fraud and knowingly endangering the public's health. Just like there were plently of laws already on the books to deal with the fraud of Wall Street and the big banks. The problem is that none of these laws are being enforced. Put Jamie Dimon or the head of Merck in a piss soaked cell for a few nights before arraigning them. And then put them on trial for real. See how J.P. Morgan and Merck behave after that.

Thu, 02/19/2015 - 07:21 | 5802607 Hobbleknee
Hobbleknee's picture

Erase the concept of corporations, which is just a tool to avoid liability. Everyone should be liable for their actions. You should not be able to sell poison and hide behind the shield of a corporation.

Wed, 02/18/2015 - 19:44 | 5801285 Chupacabra-322
Chupacabra-322's picture

Whistleblower Says CDC Knew in 2003 of Higher Autism Rate Among African-American Boys Receiving MMR Shot Earlier Than 36 Months

by Focus Autism
MarketWired

Excerpts:

A top research scientist working for the Centers for Disease Control and Prevention (CDC) played a key role in helping Dr. Brian Hooker of the Focus Autism Foundation uncover data manipulation by the CDC that obscured a higher incidence of autism in African-American boys. The whistleblower came to the attention of Hooker, a PhD in biochemical engineering, after he had made a Freedom of Information Act (FOIA) request for original data on the DeStefano et al MMR (measles, mumps, rubella) and autism study.

Dr. Hooker’s study, published August 8 in the peer-reviewed scientific journal Translational Neurodegeneration, shows that African-American boys receiving their first MMR vaccine before 36 months of age are 3.4 times more likely to develop autism vs. after 36 months.

According to Dr. Hooker, the CDC whistleblower informant — who wishes to remain anonymous — guided him to evidence that a statistically significant relationship between the age the MMR vaccine was first given and autism incidence in African-American boys was hidden by CDC researchers.

Dr. Hooker has worked closely with the CDC whistleblower, and he viewed highly sensitive documents related to the study via Congressional request from U.S. Representative Darrell Issa, Chairman of the House Oversight and Government Reform Committee. The CDC documents from Congress and discussions that Hooker had with the whistleblower reveal widespread manipulation of scientific data and top-down pressure on CDC scientists to support fraudulent application of government policies on vaccine safety. Based on raw data used in the 2004 DeStefano et al study obtained under FOIA, Dr. Hooker found that the link between MMR vaccination and autism in African-American boys was obscured by the introduction of irrelevant and unnecessary birth certificate criteria — ostensibly to reduce the size of the study.

The results of the original study first appeared in the journal Pediatrics which receives financial support from vaccine makers via advertising and direct donations, according to a CBS News report. The DeStefano et al study is widely used by the CDC and other public health organizations to dismiss any link between vaccines and autism — a neurological disorder on the rise. Dr. Hooker stated “The CDC knew about the relationship between the age of first MMR vaccine and autism incidence in African-American boys as early as 2003, but chose to cover it up.”

The whistleblower confirmed this.

“We’ve missed ten years of research because the CDC is so paralyzed right now by anything related to autism. They’re not doing what they should be doing because they’re afraid to look for things that might be associated.” The whistleblower alleges criminal wrongdoing of his supervisors, and he expressed deep regret about his role in helping the CDC hide data.

- See more at: http://healthimpactnews.com/2014/cdc-whistleblower-cdc-covered-up-mmr-va...

Thu, 02/19/2015 - 09:40 | 5802953 Refuse-Resist
Refuse-Resist's picture

Eugenics?

 

Could some small tribe be working to destroy the one tribe that it could never defeat, through covert means such as usury and propaganda brainwashing?

Nah... that could never happen.

 

 

Wed, 02/18/2015 - 19:46 | 5801292 kchrisc
kchrisc's picture

"Up for bidding is one 'FDA Approved' status. Do I hear $1,000,000? $1,000,000! Do I hear $2,000,000?..."

The banksters need to repay us.

 

Government, being nothing more than a criminal syndicate of theft and violence, always accomplishes the opposite of the stated goal. Always.

 

Wed, 02/18/2015 - 19:53 | 5801307 kchrisc
kchrisc's picture

Non "FDA Approved" drugs are bad for your health. You may get a case of gun and badge thugs along with a bad rash of plundering, and a chronic caging.

You could catch this even if you do not utilize non "FDA Approved" drugs: http://libertyblitzkrieg.com/2015/02/18/protecting-and-serving-florida-p...

The banksters need to repay us.

 

"Sir, do you know why I pulled you over? Yes, you desired to be put on my treason list for future prosecution."

Wed, 02/18/2015 - 20:06 | 5801338 JR
JR's picture

Our high drug prices are all about research and development, right? Wrong. They’re in large part about marketing.

HOW MUCH DOES BIG PHARMA SPEND ON: SALES & MARKETING vs. RESEARCH AND DEVELOPMENT

Johnson& Johnson - 17.5 vs 8.2

Novartis - 14.6 vs 9.9

Pfizer - 11.4 vs 6.6

GSK - 9.9 vs 5.3

Merck - 9.5 vs 7.5

Sanofi -  9.1 vs 6.3

Roche - 9 vs 9.3

AstraZeneca - 7.3 vs 4.3

Lilly - 5.7 vs 5.5

AbbVie - 4.3 vs 2.9

*In US $ billion for 2013

http://www.ritholtz.com/blog/wp-content/uploads/2015/02/big-pharma.png

Wed, 02/18/2015 - 20:23 | 5801360 Deathstar
Deathstar's picture

USA! USA! USA!

The carnival of fraud where every "trusted" institution is its own fun-house of deception, the entire GOV are clowns in a 3 ring show, the cops will shake you down in the parking lot, all of the markets are carnie games designed to steal your money and the Master Of Ceremonies the HNIC is ushering the trojan horse (all the illegals and sand n1ggers) right in the back of the big top while no one is looking.

USA! USA! USA!

Wed, 02/18/2015 - 21:39 | 5801584 L Bean
L Bean's picture

I was with you until the ubiquitous 'illegals and sand n1ggers'.

Meh.

Wed, 02/18/2015 - 22:20 | 5801660 Deathstar
Deathstar's picture

Typical display the typical ignorance of those who lack forward thinking skills that are stark characteristics of a libtard.

Lest we forget, the illegals are breeding like rats to increase their voting base.(admitted on many videos) There are already candidates out west that are waiting in the wings to complete the movement to remerge those SW states back with mexico. You really should catch up with current events, the "la raza" movement and others have been working at this for well over 10 years.

Lest we forget the sand niggers that libtard europe welcomed with open arms. They start breeding like rodents then change the political atmosphere to their likening and the chaos ensues. Have you read about the muslim "no go" zones un the UK and france where it is very dangerous for even the cops to go into??? Ooooo now the HNIC wants to import more jihadists wight into our country and give them jobs. (YES there will be terrorists mixed in).

You've obviously eaten too much of the libtard cheese. It has lobotomized you from thinking ahead, as with most libtards. Just do what feels good and don't think ahead. Total dumbass.

Really, are you liberals that doltish not to correctly think things out? NO you are not and it is showing in the tearing apart of this republic week by week through incrementation.

Wed, 02/18/2015 - 20:18 | 5801361 Lumberjack
Lumberjack's picture

Just so happens I know about a Doctor (female) who has Multiple Sclerosis who was interviewed by a pharma firm that specialized is MS drugs. She is a really sharp cookie and was NOT hired for a position in that company. She was very qualified and enough said. 

I recall that another commenter here who had, (pretty good credentials and can't recall with apologies), touched upon the basic subject some time ago regarding hiring financialists instead of the real pro's who know their shit.  

Wed, 02/18/2015 - 20:18 | 5801362 Atomizer
Atomizer's picture

‘Pink slime' eliminated from fast food, but not school lunches That problem is gone. Look at this..

http://www.fda.gov/  No comment. You can see with your own eyes.

 

Wed, 02/18/2015 - 20:20 | 5801368 monkman
monkman's picture

Fascist Duplicitous Assholes - where's the surprise?

Wed, 02/18/2015 - 20:23 | 5801380 Reaper
Reaper's picture

Doctors or judges or lawyers or used car salesmen are all further corrupted, when we substitute trust for careful scrutiny. Lord Acton's "The greatest heresy is that the office sanctifies the holder thereof." was said of the Pope, but applies equally to doctors or the FDA.
Trust is an opiate calming thoughtful doubt.

Wed, 02/18/2015 - 20:33 | 5801402 overmedicatedun...
overmedicatedundersexed's picture

I would bet most negative FDA posters are also socialists and big gov supporters ..cog dis ring a bell?

just pointing something out, I agree the FDA is captured .gov

Wed, 02/18/2015 - 20:31 | 5801395 sschu
sschu's picture

I have come to the conclusion that if you agree to put these substances in your body over a long period you are just rolling the dice.  Many have been saying this for years, so no surprise here.  It is impossible for the authorities to know what will happen.  This is especially so if you take more than one pill.  

I would rather die of hi cholesterol than take that pill for years where no one knows the real effect on your body.

If you are sick, get healthy, diet, exercise etal.  If possible, get off the meds ASAP, but minimize the number and dose of each if you have to.

 

sschu

Thu, 02/19/2015 - 00:43 | 5802217 Carpenter1
Wed, 02/18/2015 - 20:33 | 5801399 MeelionDollerBogus
MeelionDollerBogus's picture

This will be solved by having a new head of the FDA! http://media1.giphy.com/media/3ww3PIW5xLFEQ/giphy.gif

Wed, 02/18/2015 - 20:39 | 5801413 2muchtax
2muchtax's picture

I think they come up with a new compound then make up a disorder based on the side effects of the human monkeys they tested, (I.e. Shaky leg syndrome). A syndrome that didn't exist before they solved it.

 

Wed, 02/18/2015 - 20:41 | 5801419 cn13
cn13's picture

Integrity is absolutely dead.

 

The U.S. government is corrupt from top to bottom.

 

Sad days for Amerika.

Wed, 02/18/2015 - 21:06 | 5801422 Miss Expectations
Miss Expectations's picture

Glyphosate is a key ingredient in the herbicide Roundup. It's getting applied on crops at an alarming rate, but how big is the health risk of this increased application? Dr. Stephanie Seneff discusses the many issues that are now being connected to glyphosate exposure.

https://www.youtube.com/watch?v=jthp2HNnriI

 

Published on Jan 19, 2015

Dr. Stephanie Seneff discusses the potential connection between vaccines and autism. It's a hotly-debated topic. Here she gets specific into what ingredient in the vaccine may be linked to autism and other conditions. Find out what her research has found. You may think differently after watching this!

https://www.youtube.com/watch?v=o3P6wVUH0pc

 

 

 

Wed, 02/18/2015 - 20:50 | 5801436 2muchtax
2muchtax's picture

Keep in mind that the goobernment knew about lead paint for 43 years and asbestos for 30+ years before taking action.

However the kids that chewed on lead toys went on to build the computer and space shuttle, etc. Today's sterile environment kids don't show as much promise.

Wed, 02/18/2015 - 20:57 | 5801457 Atomizer
Atomizer's picture

Asbestos lawsuits and two planes on World Trade Center. Pull it.

Wed, 02/18/2015 - 20:54 | 5801449 Max Cynical
Max Cynical's picture

http://retractionwatch.com/

Tracking retractions as a window into the scientific process

Wed, 02/18/2015 - 20:59 | 5801463 Gunga
Gunga's picture

When government and industry combine to extract the fruits of the peoples labor ..it s fascism.

Wed, 02/18/2015 - 21:06 | 5801478 kenny500c
kenny500c's picture

The science is unsettling.

Wed, 02/18/2015 - 21:18 | 5801510 bytebank
bytebank's picture

Gardasil is the poster girl for this fraud. Girls are dying and becoming deathly ill after getting "immunized " but parents who refuse the shots to be given to their kids are demonized as anti sex etc.

I read a lot of the literature on this and still cannot understand why this is deemed effective when it only covers a small spectrum of HPV and side effects can be deadly? Somebody got paid off big time.

We can no longer trust anything. Not the police, the courts, the FDA, the press, the gov., the anything. All lies.

Wed, 02/18/2015 - 21:26 | 5801543 Its_the_economy...
Its_the_economy_stupid's picture

if you are onboard the "poison" train, youj aren 'thinking clearly

Wed, 02/18/2015 - 21:40 | 5801591 Lumberjack
Lumberjack's picture

 

Publishing: The peer-review scam

When a handful of authors were caught reviewing their own papers, it exposed weaknesses in modern publishing systems. Editors are trying to plug the holes.

http://www.nature.com/news/publishing-the-peer-review-scam-1.16400

 

...Moon's was not an isolated case. In the past 2 years, journals have been forced to retract more than 110 papers in at least 6 instances of peer-review rigging. What all these cases had in common was that researchers exploited vulnerabilities in the publishers' computerized systems to dupe editors into accepting manuscripts, often by doing their own reviews. The cases involved publishing behemoths Elsevier, Springer, Taylor & Francis, SAGE and Wiley, as well as Informa, and they exploited security flaws that — in at least one of the systems — could make researchers vulnerable to even more serious identity theft. “For a piece of software that's used by hundreds of thousands of academics worldwide, it really is appalling,” says Mark Dingemanse, a linguist at the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who has used some of these programs to publish and review papers.

 

But even the most secure software could be compromised. That is why some observers argue for changes to the way that editors assign papers to reviewers, particularly to end the use of reviewers suggested by a manuscript's authors. Even Moon, who accepts the sole blame for nominating himself and his friends to review his papers, argues that editors should police the system against people like him. “Of course authors will ask for their friends,” he said in August 2012, “but editors are supposed to check they are not from the same institution or co-authors on previous papers.”...

Wed, 02/18/2015 - 22:57 | 5801866 Fred Hayek
Fred Hayek's picture

Perhaps less in your face but more unsettling were all those climate science researchers. Remember about 4 years ago we all got to peek behind the curtain of their facade of rigorous peer review and found that they were a gossipy little clique, worse than middle school girls, conspiring to work to prevent the papers of scientists not in the club or not completely like minded from ever being published if possible but panning them if they were. And then we found that these guys were faking their studies. When Steve McIntyre, the canadian mining engineer who destroyed the famous hockey stick graph so beloved of Al Gore, got to review a couple papers he asked for copies of the code the paper writers had used to analyze the raw data. The magazine editors told McIntyre no one had ever asked for that before.

"Rigorous" peer review.

Wed, 02/18/2015 - 21:43 | 5801599 Oath_Keeper
Oath_Keeper's picture

This author was apparently jilted by some drug company and is on some vandetta. As a thirty-year-long drug researcher (who knows ass about finance) I can tell you that there is nothing more important, in the researcher's mind, that the patient is the priority.

 

I will also say that 95 if not 99 percent of medications are prescribed for self-inflicted diseases or problems. There exceptions clearly, but the norm is that.

 

People are unbelievably lazy, were that not so we wouldn't be having this discussion..diet and exercise work people.. do that and drugs aren't in your future, at least not as early and as many.

 

That being said, its not the FDA's problem; its just what effing MD wants to work for the government unless they are a social reject that cannot deal with patients. This is why shit slides-not the researchers in the field, but the incompetents that we as taxpayers fund to peruse the data. Were it not a mandate that drugs are sent through the FDA and not some private company none of this would be even possible. They would weed out the crap candidates for satellite study. The simple fact that the FDA does not allow drug studies conducted in other countries should signal that they do not have your best interests in mind, why rely on years of clinical data in another country to decide if a drug is viable here. The gov't simply doesn't care.

 

The drug companies do.

Wed, 02/18/2015 - 22:08 | 5801667 Rikeska
Rikeska's picture

I'm with you Oath.

In a situation where you can study a drug with a properly designed trial, (ethics not prohibiting blinding, placebo, etc....) the potential for shenanigans with data is impossible.

You could obviously fake the results, but that would be too risky.

If the condition being studied required all subjects to be treated with active compounds, procedures, etc... . the door is ajar for hijinks of course , but the author paints with a hysterically wide brush.

The stakes are too high.

Wed, 02/18/2015 - 22:20 | 5801727 Bazza McKenzie
Bazza McKenzie's picture

No doubt you're right.

We know the finance sector and the political and government classes are riddled with crooks.  AGW "scientists" have been found fiddling their numbers and conspiring with one another.  Big car companies have been found to have suppressed info on safety defects in their cars.  But all of us can rely on the integrity of big pharma, which would never, ever be involved in such unethical behaviour.

Wed, 02/18/2015 - 23:10 | 5801916 Fred Hayek
Fred Hayek's picture

Jesus, what a weird, rambling reply. So the patient is the priority, huh? Elves and gremlins didn't conduct those fraudulent trials. Those were "researchers" and "scientists" just like you. Their priorities were money.

What the hell does it have to do with the fraudulence of the research in question and the corruption of the FDA that, often, people could avoid needing the drug in the first place? That's a separate issue. Do you desperately want to avoid the issue of this article?

Your last paragraph is just a frigging joke. The same thing could be said of bank regulating and financial industry regulating. Your little whine is the same excuse that we hear now to excuse the CFTC and SEC not doing their job. "Oh, but all the really cool kids will be on the other team!". But 30 or so years back SEC enforcement was real because a guy named Stanley Sporkin headed the enforcement division and he took his job seriously. It wasn't magically cool to be on that side. It wasn't somehow better pay than working at the banks back then. He just took his job seriously.

Some people deserve the world described in their excuses, yours clash with your posting name.

Wed, 02/18/2015 - 22:27 | 5801751 q99x2
q99x2's picture

FDA doing what jihadists cannot do.

Thu, 02/19/2015 - 00:22 | 5802171 Bumbu Sauce
Bumbu Sauce's picture

People put trust in institutions and experts and are perpetually disappointed when they fail...news at 11.

 

But jews rule the world and chemtrails are real.  

Thu, 02/19/2015 - 00:43 | 5802219 Joe A
Joe A's picture

FDA'a approval of GMO is based on 'evidence' provided by biotech itself. FDA does not conduct research into the safety of GMO because they were 'deregulated'. This all started under Bush the senior. Besides that, there is a revolving door between the FDA and biotech industry. Rotten to the core.

Thu, 02/19/2015 - 01:02 | 5802250 Tellum Likitis
Tellum Likitis's picture

Check out www.ctmginc to learn about a company that has a fool proof way to prevent fraudulent data entry at the physician investigator site. This is where most fraudulent data is entered. If you stop fraud at that level it eliminates fraud and coverup at the fda. Unfortunately CTMG is a small company fighting an uphill battle against entrenched pharma and cro interests that cannot or do not wish to change.

Do NOT follow this link or you will be banned from the site!