Conflicted FDA DEFENDS illegal Olympus, device, that killed 2

FDA: Manufacturer never had permission to sell device connected to superbug deaths

By Elizabeth Cohen, CNN Senior Medical Correspondent

Updated 1:04 AM ET, Wed March 4, 2015

Story highlights

1. FDA official says Olympus never got permission to sell its endoscope
2. Medical device is connected to CRE outbreak in California that's left two people dead

(CNN)CNN has learned that the manufacturer of the endoscope involved in two superbug deaths at UCLA never obtained permission to sell the device, according to an official at the Food and Drug Administration.

Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA's Office of External Affairs.

"Why didn't we notice it? I don't know," Riley said.

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"Can you imagine a prescription drug getting out on the market that didn't go through the approval process?" asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, who's testified to Congress about device safety problems. "Devices need to be regulated more vigorously. This is really disturbing."

Mark Miller, a spokesman for Olympus, did not respond to calls and emails from CNN seeking comment for this story.

Outbreak started at UCLA

Seven hospital patients at Ronald Reagan UCLA Medical Center were infected with the deadly superbug CRE -- also known as carbapenem-resistant Enterobacteriaceae -- between October and January, according to hospital officials. Two of those patients died.

The patients caught CRE after routine endoscopic treatments. Hospital officials believe two medical scopes that still carried the deadly bacteria even after disinfection guidelines were followed were the cause of the superbug outbreak.

The medical center has contacted 179 others who had endoscopic procedures between October and January and is offering them home tests to screen for the bacteria.

In a separate outbreak on the other side of the country, 18 people contracted CRE in North Carolina, and one of those died.

Not safer

According to FDA rules, a manufacturer must seek clearance for a new model if it includes changes that "could significantly affect the safety or effectiveness of the device."

The TJF-Q180V duodenoscope, used to check out ducts in the gastrointestinal system, includes a modification to the exact part of the device that's been implicated in the superbug outbreaks.

With this new model, Olympus sealed up that part of the device, known as the elevator channel, hoping to make it more impervious to infection.

"The company clearly made these modifications to make the device safer, but it seems to be that it wasn't safer," Riley said.

Last year, at the FDA's request, Olympus applied for permission to sell the scope. That application is still pending.

Riley emphasized that duodenoscope procedures can be lifesaving, so the agency doesn't want to take them off the market.

"More than 500,000 of these procedures are done every year in the U.S., and the risk of bacterial transmission is actually really very, very low," she said. "We believe the risks outweigh the benefits."

Riley noted that the other two duodenoscope manufacturers, Pentax and Fujifilm, did apply for and were granted clearance to market models similar to Olympus' TJF-Q180V.

Not clean enough

Now the FDA is asking all three companies to submit evidence that the scopes can be thoroughly cleaned -- and so far it's not going well.

Riley said twice the companies have submitted data that failed to show that cleaning could get rid of 99.9999% of all microbes on the scope -- the FDA's standard for disinfection.

"We're still working with them to get good data," she said.

Riley said she doesn't know if the FDA will penalize Olympus for selling the device without permission.

Diana Zuckerman, a device safety expert (National Center for Health Research), said they should.

"It's like with kids. How do you teach your children to behave if there are no consequences when they misbehave?" she said.

http://www.cnn.com/2015/03/04/us/superbug-endoscope-no-permission/

Questionable Benefit of Implanted Heart Device: Patient Outcomes Tracked by Registry!

 Clots Tied to Heart Pump Open Debate on RisksPatients Face in Trials

By BARRY MEIER

Published: December 9, 2013 The New York Times

                         

A new report showing an increase in blood clots associated with a popular heart device is dividing experts over whether a clinical trial of the implant is potentially too risky for patients.

The debate, which involves a heart pump called the HeartMate II, sheds light on how researchers calculate whether to expose patients to a trial’s risks.

Medical researchers say such decisions are based on objective evidence. But a look at their decisions about HeartMate II trial shows how subjective those choices can be.

The trial, which has already faced delays, is set to start soon, if it receives a final go-ahead. But at least two hospitals that originally agreed to recruit patients for the trial have now withdrawn because of the new findings, while others have decided to stay in.

Some experts contend other factors might also be in play in those decisions, including an investment of years by some researchers to set up the study. In addition, more than $13 million has been earmarked for the trial by the HeartMate II’s maker, Thoratec, and the federal National Heart Lung and Blood Institute.

“You could argue it both ways,” said Dr. Carmelo A. Milano, a cardiologist at Duke University, which has decided not to participate, as has the Cleveland Clinic. “It certainly would be better if we didn’t have this problem.

The HeartMate II is a small pump that continuously pushes blood through the heart. Patients who get the device now are those facing imminent death from heart failure. Even the researchers who put together the new report said they would continue to use the pump in those cases.

The trial, called Revive-It, is intended to determine whether a HeartMate II can also benefit patients who have not quite reached that stage of heart failure. Such patients, who take drugs for their condition, typically struggle to perform physical activities, like walking short distances.

Because heart failure is a progressive condition, the new blood clot study has complicated the question of how to weigh the device’s risks and benefits to less sick patients.

“I would not embark on a clinical study until this problem is understood and mitigated,” said Dr. Robert G. Hauser of the Minneapolis Heart Institute Foundation, who is not involved in the trial.

In the new study, three big hospitals, the Cleveland Clinic, Duke and Washington University in St. Louis, jointly reported that the rate of HeartMate II-related blood clots had increased by nearly fourfold in devices implanted after early 2011.

Some patients died and others underwent emergency operations to get new pumps or transplanted hearts, according to a report in The New England Journal of Medicine.

Experts have yet to find a reason for the increase. But they say it most likely involves factors like changes in the device and changes in how doctors use anti-clotting drugs with such patients.

Long before the new report, however, word of a growing problem with the HeartMate II had been circulating among device experts. And researchers involved with Revive-It had already begun scrambling to understand its potential impact on the trial.

The issue began to take shape in March, when the Cleveland Clinic reported to the Food and Drug Administration and Thoratec that it was seeing a rise in pump-related clots. Physicians at other hospitals were also seeing an increase and were discussing the problem with colleagues at medical meetings or privately.

“There is an incestuous nature to our field,” said Dr. Scott Silvestry, a cardiologist at Washington University

In May, the principal investigators leading the trial — Dr. Keith Aaronson and Dr. Frank D. Pagani of the University of Michigan and Dr. Robert Kormos of the University of Pittsburgh — decided to delay the start of patient recruitment to examine the problem.

At that time, doctors at the Cleveland Clinic were keeping their findings confidential because they hoped to publish them in a medical journal.

But another source of data was available. In recent years, a federally funded registry at the University of Alabama at Birmingham has been tracking the safety of heart pumps like the HeartMate II. Known as Intermacs, the registry was showing that pump-related blood clots associated with the HeartMate II had risen to about 5 percent since early 2011, compared with about 2 percent in previous years.

But the registry also showed a variation in clot rates at differing hospitals, raising the possibility that facilities such as the Cleveland Clinic were outliers.

The trial’s lead investigators, Dr. Aronson, Dr. Pagani and Dr. Kormos, declined to be interviewed. But in a statement, they said the added risk detected by Intermacs was “small” and did not alter the trial’s balance of benefits and risks.

Based on the Intermacs data, officials at the F.D.A. and the National Heart Lung and Blood Institute and a panel of experts appointed by the institute to monitor the study’s safety came to the same conclusion.

“F.D.A. reviewed the Intermacs data and supported the Revive-It team’s decision to move forward,” the three researchers said a statement.

As a result, about 18 major hospitals nationwide again prepared to enroll patients. But now, the recent New England Journal of Medicine study published late last month has raised questions about which blood clot data is more reliable.

In their study, the Cleveland Clinic, Duke and Washington University reported a pump-related clot rate of 8.4 percent, compared with 2.2 percent in earlier years. The increase was significantly higher than the 5 percent rate reported by Intermacs.

Dr. Randall Starling of the Cleveland Clinic said he thought that Intermacs’ data was understating the problem’s scope.

“We believe our data is more accurate,” Dr. Starling said.

However, the import of new report was quickly disputed by the three investigators heading Revive-It. In a statement, they described the hospitals as outliers and said the Intermacs data was more reliable.

Dr. Milano, the cardiologist at Duke, said he thought that the reaction of researchers, who have spent years setting up the Revive-It study, was understandable.

“They are more apt to look at the data that suggests there is less of a problem,” Dr. Milano said. Still, at this point, he cannot see asking less-sick patients to get a device. “Knowing what I know, I probably won’t sign up,” he said. The three researchers leading the trial said it was imperative, given the shortage of donor hearts to know whether the device worked in earlier stage patients.

Whatever the case, the National Heart Lung and Blood Institute said in a statement that the study’s safety panel would soon review the new journal report and its implication, if any, for the trial.

In the meantime, specialists are going their separate ways. For example, while Dr. Hauser, the device expert in Minneapolis, says he thinks that the trial should be delayed, cardiologists at the hospital where he works are going forward. And unlike Duke and the Cleveland Clinic, Dr. Silvestry said Washington University hospital was also staying in the trial because it thought that the device’s potential benefits still outweighed its risks.

“We feel our patients will be served by a possibility of enrollment,” Dr. Silvestry said.

Proprietary Silo for Medical Devices: PCORI Irrelevant?

Where Is the Patient Stakeholder?  FiDA highlight.

By Jaimy Lee  Modern Healthcare

Posted: April 9, 2013 - 8:00 am ET

Health insurer UnitedHealthcare and about 50 hospitals say they will conduct research comparing some of the costliest medical devices on the market and then use that data to inform their purchasing decisions as part of a joint venture.

UnitedHealthcare and Dignity Health, a 37-hospital system based in San Francisco, formed  SharedClarity last year.

Since then, the Phoenix-based venture has added Baylor Health Care System, which operates 11 hospitals in Texas, and Advocate Healthcare, a 10-hosptial system based in Oak Brook, Ill., as its newest members. There are plans to include up to seven other health systems over the next few months.

“Our members have a tremendous thirst for getting independent information about how medical devices perform,” said Mark West, SharedClarity's president and a former vice president of supply chain management for UnitedHealthcare.

Implantable medical devices are among a hospital's most expensive supply costs. The prices of these devices are also rising, making them a concern for hospitals and insurers seeking to better manage the costs of pricey procedures such as hip and knee implants. 

Many hospitals have implemented cost-cutting strategies for devices and other physician-preference items, and some have formed new ventures that aim to address the costs of these products. Earlier this year, the Cleveland Clinic and VHA announced a joint venture that aims to target the costs of physician preference items.

However, SharedClarity is unique in that the venture was formed between an insurer and a health system. SharedClarity said it will identify the best-performing devices in 30 categories by using clinical data gathered from member hospitals and claims information from UnitedHealthcare, West said. The device categories range from stents and defibrillators to pacemakers and knee and hip implants. 

The hospital systems then plan to pool their purchasing volume to negotiate better prices on what they find to be the best-performing devices. In addition, hospitals that are part of UnitedHealthcare's provider networks will have access to those devices at prices negotiated by SharedClarity, although the prices will be less favorable than what the member hospitals receive.

The studies are expected to begin this spring. Richard Roth, Dignity's vice president of strategic innovation, said he expects the first purchasing decisions to be made next fall.

“As Dignity is entering in accountable care organizations and we're doing bundled payments and we're continually demonstrating the tenets of reform, this is going to be a valuable intelligence tool as we're caring for patients,” Roth said.

Both providers and insurers have lamented a lack of independent data about how implants perform, as well as lack of transparency about how they are priced. As more hospitals and insurers are taking on risk-based reimbursement strategies, they say there is a need for better data.

The higher failure rates of metal-on-metal hip implants, which led to revision surgeries and thousands of lawsuits against Johnson & Johnson, would have been caught sooner if data about the performance of those devices had been captured, according to West. 

SharedClarity will not only compare types of device and how they perform, it will also research how some devices fare when compared to different types of treatments or therapies.

“Our goal is to shed a light on this and create transparency,” Roth said.