Wednesday, March 02, 2016

Endoscope Maker Olympus Agrees To $646 Million Settlement Over Kickbacks, while still ignoring the elephant in the room, CJD TSE PRIONS

Health Inc.

 

Endoscope Maker Olympus Agrees To $646 Million Settlement Over Kickbacks

 

March 2, 2016·11:03 AM ET

 

Medical device maker Olympus Corp., already under federal investigation for its role in superbug outbreaks, has agreed to pay $646 million to resolve criminal and civil probes into illegal kickbacks and bribes to doctors and hospitals.

 

Federal prosecutors said Tuesday that the company's settlement is the largest ever for violations of the U.S. Anti-Kickback Statute. A portion of the company's payout, $22.8 million, will resolve similar bribery allegations in Latin America.

 

U.S. investigators said the Tokyo-based company's "greed-fueled kickback scheme" from 2006 to 2011 used research grants, consulting deals, luxury trips, gifts of hot-air ballooning and spa treatments and free equipment to induce influential doctors to order more Olympus devices at prominent hospitals and help the company keep out competitors. The devices included gastrointestinal scopes, which have been tied to deadly outbreaks of drug-resistant bacteria.

 

In one case, according to the federal criminal complaint, senior Olympus executives agreed to pay for three doctors to spend a week in Japan "as a quid pro quo" for a prominent California institution to switch from a competitor's products to Olympus.

 

After the trip, one of the doctors thanked Olympus for "providing so much extra entertainment that we did not expect," according to the government's complaint.

 

Prosecutors declined to name any medical centers or doctors in their complaint.

 

In other instance, Olympus gave a doctor $400,000 worth of free endoscopes and other supplies for his private practice from 2006 to 2010, prosecutors said. Olympus believed this doctor could persuade a "leading New York medical center" to spend millions of dollars on devices, according to the government complaint.

 

This strategy appeared to pay off for Olympus. Prosecutors alleged that after a key doctor for a Midwest hospital system took a week-long trip to Japan and received a company grant, an Olympus vice president wrote an internal email in 2006 that said, "We have received all of the orders expected and have kept [a competitor] completely out of the [hospital] system. Hooray!"

 

As part of the settlement, Olympus agreed to a corporate-integrity agreement and the appointment of an independent monitor, Larry Mackey, a former prosecutor in the Oklahoma City bombing cases.

 

"Olympus leadership acknowledges the company's responsibility for the past conduct, which does not represent the values of Olympus or its employees," Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement. "Olympus is committed to complying with all laws and regulations and to adhering to our own rigorous code of conduct."

 

As a result of the kickbacks, Olympus generated more than $600 million in sales and reaped gross profits of $230 million, officials said. Olympus is the leading manufacturer of gastrointestinal scopes worldwide, and it boasts an 85 percent share of the U.S. market.

 

"Kickbacks are illegal because they taint buying decisions," said Paul Fishman, U.S. Attorney for the District of New Jersey, which spearheaded the investigation. "Doctors and hospitals should decide to purchase medical devices based solely on legitimate considerations, like quality and price. They shouldn't be tempted and swayed by free trips, free equipment, consulting agreements or research grant money."

 

Prosecutors credited the help of the former chief compliance officer at Olympus, John Slowik, who filed a whistleblower case against the company under seal in 2010.

 

In his whistleblower complaint, unsealed Tuesday after the government's announcement, he said he was fired by Olympus for trying to end improper practices. Slowik now stands to receive about $50 million from the settlement, in accordance with federal whistleblower law, prosecutors said.

 

Patrick Burns, acting president of the Taxpayers Against Fraud Education Fund, praised Slowik, saying he exposed illegal actions that wasted money and threatened patient safety.

 

"This is exactly why we need whistleblowers — because companies cannot be relied upon to put patients before profits," Burns said. Olympus was "funding a massive kickback scheme that channeled millions of dollars in payola to doctors and hospitals."

 

Well before Tuesday's announcement, Olympus was under fire for failing to alert U.S. regulators and hospitals sooner about the risks of infection from its duodenoscopes, a gastrointestinal scope that has proven difficult to clean of dangerous bacteria because of its intricate design.

 

A Senate investigation released in January identified 19 scope-related outbreaks at U.S. medical centers from 2012 to 2015 that sickened nearly 200 patients with drug-resistant infections. Thirteen of those outbreaks were associated with Olympus scopes.

 

Olympus announced in January it would recall its duodenoscopes nationwide and make repairs to better protect patients. Last year, the company disclosed it had received a subpoena from federal prosecutors seeking "information relating to duodenoscopes."

 

In the kickback case, federal officials said Olympus used a grants committee staffed by sales and marketing executives to dole out millions of dollars to key hospital and physician customers.

 

In 2007, Fishman said an Olympus vice president recommended a research grant of $100,000 to a hospital's foundation. "Why? Because that hospital was their '#1 account in the US' and they had, and I'm quoting, 'no intention of losing it' to a competitor," Fishman said Tuesday.

 

Although prosecutors didn't identify institutions, the whistleblower's complaint did mention some physicians and hospitals by name.

 

For instance, it recounted an October 2009 meeting between top Olympus executives and a prominent doctor at the University of Southern California's Keck School of Medicine, about the possibility of a company grant.

 

After the meeting, an Olympus executive in Japan emailed a counterpart in the U.S. about his opinion on the USC grant in light of "future business expansion (any future sales potential?)," according to the whistleblower's complaint.

 

A spokeswoman for USC said she couldn't immediately comment late Tuesday.

 

Olympus reported a general payment of $64,013 to USC's Keck Hospital in 2014 for "in-kind items and services," according to federal data on industry contributions to doctors and teaching hospitals.

 

Overall, for 2014, Olympus issued $5.25 million in general and research-related payments to physicians and hospitals, the federal database shows.

 

Slowik, the whistleblower, said the company ran a "sham physician consultant program" that paid some doctors more than $100,000 annually.

 

Prosecutors said Olympus paid one doctor $112,300 for consulting from 2006 to 2011 in order to influence the purchasing decisions of a "leading Southeastern medical institution."

 

The company also used "permanent loans" or "medical loaner scopes" to improperly give hospitals free equipment, inducing them to buy more products, according to federal investigators.

 

"This practice enabled Olympus America to acquire monopoly power in certain segments of the medical business, ultimately resulting in customers paying inflated prices," according to Slowik's amended complaint.

 

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

 

 health care fraud

 

Medical Devices

 


 

 I told Olympus 15 years ago about these risk factors from endoscopy equipment, disinfection, even spoke with the Doctor at Olympus, this was back in 1999. I tried to tell them that they were exposing patients to dangerous pathogens such as the CJD TSE prion, because they could not properly clean them. even presented my concern to a peer review journal GUT, that was going to publish, but then it was pulled by Professor Michael Farthing et al... see ;

 

some old history on Endoscopy equipment and CJD TSE Prion concerns ;

 

1999

 

Subject: CJD * Olympus Endoscope

 

Date: Sun, 10 Oct 1999 16:41:49 –0500

 

From: "Terry S. Singeltary Sr."

 

To: GOLDSS@...

 

Dear Dr. Goldstine,

 

Hello Sir, I understand that Olympus has issued a letter to the medical institutions and the CDC, about the dangers of _not_ being able to decontaminate the instruments (endoscope's) via modern autoclaving techniques (boil 3 minutes in 3% SDS or another ionic detergent and autoclave for 1 hour at 134 degrees C). I understand that; "Olympus" has issued a warning, _not_ to attempt to decontaminate the instrument, that they are instructed to destroy them.

 

(very very wise move);

 

Please Sir, it is imminent that I receive a copy of this letter, it is very important. This could lead to other company's following through, and lead to awareness of the potential health threats from human T.S.E.'s and the risks through surgery, and not just from endoscopes. It would be most appreciated, if you could send a copy of this document to;

 

Fax: xxxxx

 

I look forward, to hearing back from you....

 

Many Thanks,

 

Terry S. Singeltary Sr./ Mom DOD 12-14-97 hvCJD

 

Subject: Re: CJD * Olympus Endoscope

 

Date: Tue, 12 Oct 1999 15:57:03 –0500

 

From: "Terry S. Singeltary Sr."

 

To: GOLDSS@...

 

References: 1

 

Dear Mr. Goldstine, Hello again, I hope the CDC has not changed your mind, since our phone call, about sending me the information, in which we spoke of. I am still waiting for the information, re-fax. Someone had told me, you would not send me the information, but I told them you would, due to the importance of it pertaining to public safety, and the fact, you are a Doctor. I hope you don't disappoint me, and the rest of the public, and hide the facts, as the CDC and NIH have for years. Olympus can be part of the Truth, or you can be part of the cover-up. We are going to find out, sooner or later.

 

I already know, as do many more.

 


 

Still waiting,

 

Kind Regards,

 

Terry S. Singeltary Sr.

 

"Terry S. Singeltary Sr." wrote:

 

Dear Dr. Goldstine,

 

Hello Sir, I understand that Olympus has issued a letter to the medical institutions and the CDC, about the dangers of _not_ being able to decontaminate the instruments (endoscope's) via modern autoclaving techniques (boil 3 minutes in 3% SDS or another ionic detergent and autoclave for 1 hour at 134 degrees C). I understand that; "Olympus" has issued a warning, _not_ to attempt to decontaminate the instrument, that they are instructed to destroy them.

 

(very very wise move);

 

Please Sir, it is imminent that I receive a copy of this letter, it is very important. This could lead to other company's following through, and lead to awareness of the potential health threats from human T.S.E.'s and the risks through surgery, and not just from endoscopes. It would be most appreciated, if you could send a copy of this document to;

 

Fax: xxxxxxx

 

I look forward, to hearing back from you....

 

Many Thanks,

 

Terry S. Singeltary Sr./ Mom DOD 12-14-97 hvCJD

 

=================================================================

 

Something I submitted to GUT previously;

 

Subject: Re: gutjnl_el;21 Terry S. Singeltary Sr. (3 Jun 2002) "CJDs (all human TSEs) and Endoscopy Equipment"

 

Date: Thu, 20 Jun 2002 16:19:51 –0700

 

From: "Terry S. Singeltary Sr."

 

To: Professor Michael Farthing

 

CC: lcamp@BMJgroup.com

 

References: 001501c21099$5c8bc620$7c58d182@mfacdean1.cent.gla.ac.uk

 

Greetings again Professor Farthing and BMJ,

 

I was curious why my small rebuttal of the article described below was not listed in this month's journal of GUT? I had thought it was going to be published, but I do not have full text access. Will it be published in the future? Regardless, I thought would pass on a more lengthy rebuttal of mine on this topic, vCJD vs sCJDs and endoscopy equipment. I don't expect it to be published, but thought you might find it interesting, i hope you don't mind and hope to hear back from someone on the questions I posed...

 

Here is my short submission I speak of, lengthy one to follow below that:

 

Date submitted: 3 Jun 2002

 

>> eLetter ID: gutjnl_el;21

 

>> >> Gut eLetter for Bramble and Ironside 50 (6): 888

 

>> >>Name: Terry S. Singeltary Sr.

 

>>Email: flounder@wt.net

 

>>Title/position: disabled {neck injury}

 

>>Place of work: CJD WATCH

 

>>IP address: 216.119.162.85

 

>>Hostname: 216-119-162-85.ipset44.wt.net

 

>>Browser: Mozilla/5.0 (Windows; U; Win98; en-US; rv:0.9.4)

 

>>Gecko/20011019 Netscape6/6.2

 

>> >>Parent ID: 50/6/888

 

>>Citation:

 

>> Creutzfeldt-Jakob disease: implications for gastroenterology

 

>> M G Bramble and J W Ironside

 

>> Gut 2002; 50: 888-890 (Occasional viewpoint)

 


 


 

>>-----------------------------------------------------------------

 

>>"CJDs (all human TSEs) and Endoscopy Equipment"

 

>>-----------------------------------------------------------------

 

regarding your article;

 

Creutzfeldt-Jakob disease: implications for gastroenterology

 

>>I belong to several support groups for victims and relatives

 

>>of CJDs. Several years ago, I did a survey regarding

 

>>endoscopy equipment and how many victims of CJDs have

 

>>had any type of this procedure done. To my surprise, many

 

>>victims had some kind of endoscopy work done on them.

 

>>As this may not be a smoking gun, I think it should

 

>>warrant a 'red flag' of sorts, especially since data now

 

>>suggests a substantial TSE infectivity in the gut wall

 

>>of species infected with TSEs. If such transmissions

 

>>occur, the ramifications of spreading TSEs from

 

>>endoscopy equipment to the general public would be

 

>>horrible, and could potential amplify the transmission

 

>>of TSEs through other surgical procedures in that

 

>>persons life, due to long incubation and sub-clinical

 

>>infection. Science to date, has well established

 

>>transmission of sporadic CJDs with medical/surgical

 

>>procedures.

 

Terry S. Singeltary Sr. >>CJD WATCH

 

Again, many thanks, Kindest regards,

 

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 flounder@wt.net CJD WATCH

 

[scroll down past article for my comments]

 

snip...

 

were not all CJDs, even nvCJD, just sporadic, until proven otherwise?

 

Terry S. Singeltary Sr., P.O. BOX 42, Bacliff, Texas 77518 USA

 


 

Professor Michael Farthing wrote: Louise Send this to Bramble (author) for a comment before we post. Michael

 

=======================================================

 

snip... see full text ;

 

2003

 

Evidence For CJD TSE Transmission Via Endoscopes 1-24-3 re-Singeltary to Bramble et al

 

Evidence For CJD/TSE Transmission Via Endoscopes

 

From Terry S. Singletary, Sr flounder@wt.net 1-24-3

 


 

Monday, December 26, 2011

 

Prion Uptake in the Gut: Identification of the First Uptake and Replication Sites

 


 

snip...see full text ;

 

 Monday, August 17, 2015

 

FDA Says Endoscope Makers Failed to Report Superbug Problems OLYMPUS

 

I told Olympus 15 years ago about these risk factors from endoscopy equipment, disinfection, even spoke with the Doctor at Olympus, this was back in 1999. I tried to tell them that they were exposing patients to dangerous pathogens such as the CJD TSE prion, because they could not properly clean them. even presented my concern to a peer review journal GUT, that was going to publish, but then it was pulled by Professor Michael Farthing et al... see ;

 


 

Sunday, January 17, 2016

 

Of Grave Concern Heidenhain Variant Creutzfeldt Jakob Disease

 


 

Saturday, February 13, 2016

 

The Risk of Prion Infection through Bovine Grafting Materials in dentistry

 


 

Thursday, February 25, 2016

 

U.S. Food & Drug Administration (FDA) FDA/CFSAN Cosmetics Update: Cosmetics Program; Import and Domestic and Transmissible Spongiform Encephalopathy TSE Prion Disease Risk Factors

 

***WARNING TO ALL CONSUMERS AND COUNTRIES AROUND THE WORLD***

 

***Note: FDA labs do not conduct BSE analysis and thus no sampling guidance is issued for BSE. ***

 


 

Saturday, February 6, 2016

 

*** Secretary's Advisory Committee on Animal Health; Meeting [Docket No. APHIS-2016-0007] Singeltary Submission ***

 


 

Terry S. Singeltary Sr.

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