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Monday, August 3, 2015

FRAUD, CORRUPTION CHARGES U.S. MEDICAL INDUSTRY

HOW MANY U.S. PHARMACEUTICAL COMPANIES HAVE EVER HAD  TO GO TO COURT AND DEFEND THEMSELVES ON CHARGES?

ALL OF THEM.


HOW MANY MAJOR U.S. DRUG-MAKERS HAVE BEEN "INVESTIGATED" BY CONGRESS?

ALL OF THEM.

WHAT WERE THE CHARGES?
MANY.

VARIOUS TYPES OF FRAUD.
SOME CAUSED THOUSANDS OF DEATHS.

WHO WENT TO JAIL?
NOBODY!

HOW MANY CASES OF FRAUDULENT MEDICAL/SCIENTIFIC RESEARCH AND "PEER REVIEW" IN THE PAST 10 YEARS?
ABOUT 33% OF ALL SUBMISSIONS OF RESEARCH, BUT ONLY ABOUT 2% TO 3% WERE RETRACTED.

"
There is no accurate data on the prevalence of research misconduct.
The first meta-analysis looking into the prevalence of research misconduct was performed 


by Fanelli.[] Examining “scientific behaviors that distort scientific knowledge” only, he 

showed that 2% of the scientists admitted to serious misconduct (falsification or

fabrication 
of data) at least once, and up to 34% admitted other questionable research

practices. When participants were asked about their colleagues’ practices, the results

were even higher (14% for falsification of data and 72% for other questionable practices).
However, Fanelli suggests these results may only represent a conservative estimate of 

the real prevalence of research misconduct, a similar argument put forward by Ranstam 
et al."

TYPES OF UNCOVERED FRAUD CAN BE SEEN IN THE TABLE <HERE>.

DRUG MAUFACTURERS, THE NEW 'AMERICAN MAFIA'?

A VERY SHORT LIST OF "COSTLIEST" FINES PAID BY MAJOR DRUG COMPANIES, NOT BY ANY MEANS ALL, FROM SEPTEMBER 17, 2012,  BEFORE THE MOST RECENT CHARGES WERE BROUGHT AGAINST MERCK, PFIZER AND GLAXOSMITHKLINE IS GIVEN BELOW.


TIME MAGAZINE, HEALTHLAND

"Record-breaking multibillion-dollar settlements against big drug companies have become routine in the U.S. In recent years, pharmaceutical companies seem to have been playing a game of one-upmanship, each surpassing yet a new milestone of wrongdoing — fraudulently marketing their drugs or making misleading claims about their safety — and the threat of massive payouts appears to have offered little deterrent.


Even the largest of settlements rarely dent the profits associated with the drugs involved: for example, the largest fine ever imposed on a drug company — July’s $3 billion judgment against GlaxoSmithKline (GSK) in part for illegally marketing the antidepressants Paxil and Wellbutrin and withholding data on the health risks of the diabetes medication Avandia — accounted for just 11% of associated revenue. Many other cases resulted in relatively smaller losses even when the fines were imposed as criminal penalties, as in the GSK case, and not just for civil law violations. Contrast such outcomes with those in most individual cases of fraud, in which all profits are typically confiscated as ill-gotten gains and the fraudster goes to prison.

A recent editorial in the New England Journal of Medicine calls for change: levy large enough fines against drug companies for illegal behavior, so that the payouts can’t be dismissed as merely “the cost of doing business”; offer more protections for whistleblowers; and perhaps most importantly, file criminal charges against drug company executives for misconduct that could put them in prison.   

Following are the 10 biggest pharma settlements since 2007, with details on companies’ illegal acts and the drugs involved, based on both the New England Journal editorial and other sources.

1~ Bristol Myers Squibb (BMS)
Settlement amount: $515 million
Year of settlement: 2007
Drugs involved: The atypical antipsychotic Abilify (aripiprazole); the antidepressant Serzone (nefazadone); several anticancer drugs
Criminal charges filed? No


2~ AstraZeneca
Settlement amount: $520 million
Year of settlement: 2010
Drugs involved: The atypical antipsychotic Seroquel (quetiapine)
Criminal charges filed? No

3~ 
Purdue Pharma

Settlement amount: $634 million
Year of settlement: 2007
Drugs involved: The painkiller Oxycontin (time-released oxycodone)
Criminal charges filed? Yes


4~ Amgen
Settlement amount: $760 million
Year of settlement: pending
Drugs involved: The anemia drugs Aranesp (darbepoetin alfa) and Epogen (epoetin alfa)
Criminal charges filed? Not yet determined


5~ MERCKSettlement amount: $950 million
Year of settlement: 2011
Drug involved: The painkiller Vioxx (rofecoxib)
Criminal charges filed? Yes

The drug is estimated to have contributed to between 88,000 and 140,000 heart attacks, about half of them fatal. 

6~  Eli Lilly
Settlement amount: $1.4 billion
Year of settlement: 2009
Drugs involved: The atypical antipsychotic Zyprexa (olanzapine) and others
Criminal charges filed? Yes

Zyprexa carries a risk of death, even at doses within the normal range.

7~ Abbott
Settlement amount: $1.5 billion
Year of settlement: 2012
Drugs involved: The mood stabilizer and antiepileptic Depakote (valproic acid)
Criminal charges filed? Yes


8~ JOHNSON & JOHNSONSettlement amount: $1.5 to $2 billion
Year of settlement: pending
Drugs involved: The atypical antipsychotics Risperdal (risperidone) and Invega (paliperidone); the heart medication Natrecor (nesiritide)
Criminal charges filed? Yes
The 
FDA never approved Risperdal for the treatment of ADHD, nor is there any evidence that it helps children with the condition.


9~ Pfizer
Settlement amount: $2.3 billion
Year of settlement: 2009
Drugs involved: The atypical antipsychotic Geodon (ziprasidone); the painkillers Bextra (valdecoxib) and Lyrica (pregabalin); and others
Criminal charges filed? Yes

The company’s fourth multimillion-dollar settlement in less than a decade.

10~ GlaxoSmithKline
Settlement amount: $3 billion
Year of settlement: 2012
Drugs involved: The antidepressants Paxil (paroxetine) and Wellbutrin (bupriopion); the antiepileptic Lamictal (lamotrigine); and others
Criminal charges filed? Yes


ADD TO THAT SHORT LIST THESE FEW OTHERS, BY NO MEANS ARE ALL CHARGES NOR DRUGS NOR PHARMACEUTICAL COMPANIES LISTED HERE...

TAP Pharmaceutical Products, formed in 1977 as a joint venture between the two global pharmaceutical companies,Abbott Laboratories and Takeda Pharmaceutical Co.

PAID $875 million FOR fraudulent drug pricing and marketing conduct with regard to Lupron.

Serono, S.A., together with its U.S. subsidiaries and related entities (INCLUDING MERCK]
Serono abused the system of testing and approval.$136.9 million criminal fine and its affiliate companies a total of $567 million to settle civil liabilities.

Teva Pharmaceuticals USA Inc. and a subsidiary, IVAX LLC, have agreed to pay the government and the state of Illinois $27.6 million for allegedly violating the False Claims Act by making payments to induce prescriptions of an anti-psychotic drug, Clozapine, for Medicare and Medicaid beneficiaries. 

Lannett and also Impax Laboratories, both generic drug makers, were each served in November, 2014, with a grand jury subpoena “relating to a federal investigation of the generic pharmaceutical industry into possible violations” of anti-trust laws.
Main drug, generic for Digoxin

Reckitt Benckiser’s offices in Richmond, Va., were raided by a team of IRS and Office of Inspector General (OIG) agents on December  3rd.  The raid comes only a few weeks after the New York Times published an article on November 16 about the incongruity of Reckitt Benckiser’s wonder drug, Suboxone.


WE TRUST THE DRUG MAKERS TO PROVIDE US WITH SAFE PRODUCTS.
THEY DO NOT DO THAT!

PARENTS, PLEASE BE AWARE OF THE FOLLOWING.
March 10, 2015, FROM REUTERS


Tylenol maker to pay $25 million for selling metal-contaminated children’s drugs 

A Johnson & Johnson subsidiary agreed to plead guilty late Tuesday to federal criminal charges of selling liquid drugs for children contaminated with metals.


Court documents unsealed Tuesday say McNeil Consumer Healthcare, of Fort Washington, Pennsylvania, will acknowledge selling adulterated bottles of Infants’ and Children’s Tylenol and Children’s Motrin. The company agreed to pay $25 million to resolve the case.
In the case involving metal particles, the troubles began in May 2009 when a consumer complained after noticing "black specks" in the bottom of a bottle of Infants' Tylenol. The specks were found to be nickel and chromium particles.
In 2010, the company launched mass recalls of certain children's over-the-counter-medicines, including Infants' Tylenol and Children's Motrin, made at its Fort Washington, Pennsylvania plant.
BIG PHARMA IS A TYPE OF "MAFIA ORGANIZATION" TO MANY WHO KNOW TOO WELL THEIR INNER WORKINGS, BUT THAT DOESN'T MEAN SMALL COMPANIES ARE ANY BETTER.

LITTLE LOCAL "DRUG COMPOUNDING" SHOPS CAN ALSO KILL PEOPLE!

Law enforcement agents swooped in during predawn raids Wednesday and arrested executives and former staffers of a Framingham compounding pharmacy blamed for producing tainted drugs that killed dozens in one of the deadliest medication contamination cases in US history.

In all, 14 people were charged in connection with the 2012 fungal meningitis outbreak linked to the shuttered New England Compounding Center. Contaminated drugs — produced with expired ingredients under unsterile conditions — have been tied to the deaths of 64 people and to illnesses in about 700 patients in 20 states.

BIG PHARMA PAYS BILLIONS FOR "SCIENTIFIC RESEARCH" THAT SHINES GLOWING LIGHTS ON THEIR PRODUCTS, AND PERHAPS JUST AS MANY BILLIONS TO PREVENT OR REFUTE NEGATIVE RESEARCH RESULTS, THE WHOLE TRUTH, OR ARTICLES OR RESEARCH THAT TOUT "NATURAL CURES".  

LET ME PUT IT ANOTHER WAY...THE OFTEN-USED COOKING 'SPICE' TURMERIC  HAS BEEN MOST DEFINITELY PROVEN TO BE AS EFFECTIVE AS MANUFACTURED DRUGS FOR MANY AILMENTS, INCLUDING CANCER TREATMENT...PROVEN FACTS.
IT COST LESS THAN $16 A POUND.
THE MANUFACTURED DRUGS THAT DO NOT DO AS WELL AS TURMERIC IN CLINICAL TRIALS ALL ARE PRICED IN THE $5.00 TO $3,OOO PER DOSE RANGE.

A PHYSICIAN MAY HAVE READ THOSE STUDIES, KNOWS THEY ARE FACTUAL, BUT HE IS FORBIDDEN TO EVEN SUGGEST SUCH A TREATMENT TO PATIENTS!

EVEN IF HE HAD SEEN WITH HIS OWN EYES THE CURES ACCOMPLISHED BY THE INEXPENSIVE, READILY AVAILABLE, WITHOUT PRESCRIPTION 'HERB', HE WOULD HAVE TO PRESCRIBE A MANUFACTURED DRUG.
THE VERY RECENT "NEWS" THAT RESEARCH DATA AND "PEER REVIEWED" ARTICLES WERE BOGUS, WORTHLESS, FALSIFIED AND MANIPULATED, THAT REAL DATA WERE TOSSED OUT, EXCLUDED AND "BOUGHT-OFF" HAS DONE LITTLE TO MAKE AMERICANS DEMAND CHANGE IN THE MEGA-INDUSTRY KNOWN AS "MEDICINE".

Cancer Research of 10 Years Useless: Fraudulent Studies, Says Mayo Clinic


JAMA’s editor calls fraudulent medical research a ‘scar on the moral body of science’.
But it’s really just part of an entire system of fraud in medicine.


Duke settles suit over flawed cancer research
Jul. 14, 2015
"A lawsuit against Duke University and one of its discredited former cancer researchers has been settled.

The suit, which was settled in May, was brought by the families of eight cancer patients treated in clinical trials based on allegedly falsified data by Anil Potti, a scientist at Duke who has retracted 11 research papers.

The lawsuit alleged that Potti falsified data about the use of genetic analysis for personalized cancer treatment, and that Duke tried to cover up questions about the research and performed unnecessary chemotherapy on patients in hopes of patenting a cancer-screening test.

Duke stopped the clinical trials in 2010 after learning that Potti exaggerated his credentials, including a claim that he was a Rhodes Scholar.

The American Cancer Society stopped paying Duke on a five-year grant totaling $729,000 after news reports surfaced about the faulty research."

PERHAPS WORST OF ALL TO HIDE FALSIFIED DATA AND FAKE RESULTS IS THE FDA, THE AGENCY THAT IS APPOINTED TO MAKE SURE THAT ALL WE CONSUME IS SAFE... FOOD, DRUGS, DRINK, EVERYTHING.

THE FDA INSTEAD HAS BEEN FOUND TO HELP DRUG COMPANIES AND THE MEDICAL/SCIENTIFIC COMMUNITIES STAY OUT OF TROUBLE, PRESENT FALSE RESULTS, MARKET UNSAFE PRODUCTS, EVEN IF THAT MEANS ENDANGERING OUR LIVES! 

The FDA buries evidence of fraud in medical trials.
FEB. 9 2015

"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.

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 FDA redactions make it all but impossible to figure out which study is tainted.

[We] 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.

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.

The FDA is keeping mum, even as wrongful-death lawsuits begin to multiply.

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.)"

MEDICINE SHOULD CURE, NOT TREAT SYMPTOMS!
REAL MEDICINE, GOOD MEDICINE RESOLVES THE UNDERLYING CAUSE OF ILLNESS AND DISEASE.


TO MERELY TREAT SYMPTOMS IS LIKE SHOUTING "GOOD LUCK!" TO A DROWNING MAN.  

WESTERN MEDICINE HAS BECOME SO SPECIALIZED THAT BY THE TIME A PATIENT FINDS THE RIGHT "SPECIALIST" IT IS JUST TOO LATE FOR CURE! 

AND WE MUST ASK, IS CURE THE GOAL?
I HONESTLY DO NOT BELIEVE IT IS, NOT HERE, NOT BY WESTERN MEDICINE, NOT ANYMORE, NOT FOR THE PAST 40 OR MORE YEARS!


I SAY THAT AS A RETIRED "MEDICAL PROFESSIONAL".
IN FACT, GIVEN WHAT I KNOW FROM DECADES INSIDE MEDICAL OFFICES WHERE MANY PHYSICIANS SHARE THE SAME FACILITY, IT'S MOSTLY ABOUT SCHEDULING AS MANY APPOINTMENTS AS POSSIBLE, GIVING A "QUICK FIX" IN 5 TO 10 MINUTES AT MOST, SCHEDULING "FOLLOW-UP" APPOINTMENTS AND "SMILING ALL THE WAY TO THE BANK".

GIVE THIS PILL (REMOVE INSERTS FROM "SAMPLE DRUGS"!) , THEN TWO OTHERS TO COUNTERACT THE FIRST PILL, THEN HOSPITALIZE WHEN THINGS REALLY SLIDE DOWNHILL, GET THE PATIENT BACK TO "SQUARE ONE" IF POSSIBLE, SEND PATIENT HOME WITH A NEW APPOINTMENT FOR A NEW FOLLOW-UP, REPEAT THE PROCESS UNTIL THE PATIENT EXPIRES, OR JUST GIVES UP AND DECIDES TO SEE ANOTHER "PHYSICIAN". 
MEANWHILE, PAY OUT THE NOSE FOR MALPRACTICE INSURANCE AND DO VERY LITTLE THAT MIGHT BRING ON A LAWSUIT...WHICH REALLY MEANS...DO VERY LITTLE, PERIOD.

OH, AND DO HIRE SOMEONE TO KEEP ABREAST OF THOSE NEW RULES AND REGULATIONS AND DON'T ROCK THE INDUSTRY BOAT.

THE FEDERAL GOVERNMENT HAS CRIMINALIZED NATURAL MEDICINE!
MOST PATIENTS ARE UNAWARE OF THAT.


IT IS ILLEGAL FOR A DOCTOR TO "PRESCRIBE" ANYTHING BUT FDA APPROVED TREATMENT, AND I AM OF THE OPINION THAT IS BECAUSE THE FDA KNOWS "NATURAL MEDICINE", IN MANY, MANY CASES CURES DISEASE!

IF CURED BY LESS EXPENSIVE, PURE, UNADULTERATED, BETTER TOLERATED "NATURAL" DRUGS, THINGS NATURE HERSELF HAS CREATED, THEN PATIENTS WOULD NOT BE KEPT IN THAT DISGUSTING CYCLE OF REPEAT VISITS THAT NEVER ELICIT CURE BUT JUST TREAT SYMPTOMS WITH EXPENSIVE, THOUGH MOSTLY WORTHLESS DRUGS.
IT WOULD NOT BE "GOOD FOR BUSINESS"!
THE PHARMACEUTICAL HOUSES WOULD GO BROKE, PEOPLE WOULD LIVE LONGER AND BECOME THAT "BURDEN TO SOCIETY" CONGRESSMEN WHISPER ABOUT WHEN THEY TRY TO COME UP WITH NEW WAYS TO GET RID OF SOCIAL SECURITY, MEDICARE, VETERANS "BENEFITS", NUTRITION PROGRAMS AND MEDICAID!

THIS FACT WAS DRIVEN HOME TO ME WHEN I INTRODUCED MYSELF TO A GROUP OF ASIAN PHYSICIANS WHO SET UP THEIR CLINIC IN THE SAME INDUSTRIAL CLINIC WHERE THE GROUP I WAS EMPLOYED BY HAD OFFICES.

THEIR HOURS EXTENDED TO 9 PM, 4 HOURS AFTER WE CLOSED.

IN 'HANGING OUT' WITH THEM, I SAW NOT ONE PRESCRIPTION WRITTEN FOR A MANUFACTURED DRUG, NOT ONE SINGLE SYMPTOM TREATED, AND PATIENTS WERE CURED!THOSE PHYSICIANS FOUND THE CAUSE OF ILLNESS, TREATED ALL THE BODY, NOT JUST BITS AND PIECES.
FOR ALMOST FOUR YEARS I WATCHED PATIENTS ACTUALLY BEING CURED WITHOUT FDA APPROVED PILLS!

[NO, THEY COULD NOT TREAT THOSE WHO HAD MEDICARE OR MEDICAID, BUT MANY ELDERLY, VETERANS, AND PEOPLE WITH LOWER INCOME DID GO TO THEM AND PAY CASH BECAUSE WORD SPREAD THAT THEY EFFECTED CURES!
CURE IS CHEAPER THAN LONG-TERM DRUGS AND CO-PAYS FOR ELABORATE TESTS!]

IT WAS AT THE END OF THAT FOUR YEARS THAT I RETIRED FROM THE "FIELD OF MEDICINE".
I COULD NO LONGER ETHICALLY CONTINUE TO BE A PARTY TO THE "BIG LIE".
WESTERN MEDICINE, FOR THE MOST PART, IS INDEED A LIE.

THE "CONVENTIONAL TREATMENTS" THE FEDERAL GOVERNMENT DEMANDS FROM ALL HEALTH CARE PROFESSIONALS WHO TREAT "FEDERALLY-FUNDED PATIENTS", PATIENTS USING MEDICARE, MEDICAID, OR COMING THROUGH THE VETERANS ADMINISTRATION ARE USUALLY "TREATMENTS" FOR VARIOUS SYMPTOMS, NOT DESIGNED TO  CURE.

YOU WILL DO WELL TO READ THE FACTS OF THIS MATTER OF GOVERNMENT CONTROL OVER YOUR PHYSICIANS.
<CLICK HERE TO READ>


MANY WHO HAVE SPENT HUNDREDS OF THOUSANDS OF DOLLARS ON THEIR MEDICAL EDUCATION AND OTHER THOUSANDS UPON THOUSANDS TO "SET UP SHOP" WILL AGREE TO FEDERAL REGULATIONS, TO HAVING THE U.S. GOVERNMENT AND GOVERNMENTS OF STATES AS WELL TELL THEM HOW THEY CAN PRACTICE.  



“Standard of Care” means whatever the State Medical Board says!

MANY WANT TO OFFER ALTERNATIVE TREATMENTS, BUT THE THREATS OF RUIN AND EVEN JAIL ARE "LEGION"...TOO MANY, TOO GREAT, TOO REAL.MEANWHILE, OTHER NATIONS ARE STARTING TO REALIZE THINGS ARE JUST NOT RIGHT.
The European Medicines Agency, the European equivalent of the FDA, examined more than 1,000 drugs in various dosages affected by GVK’s “data manipulations” and has 
suggested pulling 700 off the market. You can find the full list on the EMA website; to their credit, the Europeans are being relatively transparent as the crisis develops.
IT'S ALL BECOME AN INDUSTRY, MY FRIENDS.
IT'S ALL GONE TO HELL IN A LARGE HANDBASKET.





FURTHER READING:
The Tea Room recommends the book 'Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients' by Ben Goldacre.

~ "FORBIDDEN CURES", AN ARTICLE THAT EXPLAINS HOW MEDICINE BECAME A BUSINESS , AND HOW CURES BECAME FORBIDDEN BY LAWS.

THE TEA ROOM DISAGREES WITH CERTAIN PARTS OF THIS ARTICLE [ABOUT CERTAIN "THERAPIES"] QUITE VEHEMENTLY, BUT THE EXPLANATION OF HOW PHYSICIANS' HANDS BECAME TIED BEHIND THEIR BACKS IS SPOT-ON.

Forbidden words, and diagnosis



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