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/

22 THOUSAND Women File Lawsuit in Federal Court in West Virginia: FDA Covers Butt!

FDA Kicks Off Women’sHealth Program With Surgical Mesh Registry

by Stephanie Beasley  FiDA highlight

Posted in FDA Week, June 27, 2013

 FDA’s launch of a new registry for controversial surgical transvaginal mesh products as part of a new program focusing on women’s health could signal the agency is planning to prioritize sex-specific device concerns, a consumer advocate said. However, sources said it is still unclear how FDA will tackle other women-specific issues, like a lack of women in device clinical trials, and suggested the agency could examine criteria used to exclude subjects from clinical trials that could be reducing the number of women able to participate in these studies.

FDA device center officials announced Tuesday (June 25) during a two-day workshop for the Improve the Health of Women program that the agency plans to launch a new transvaginal mesh registry that will monitor patient outcomes and collect data on the safety and effectiveness of the products. The agency partnered with the National Institutes of Health, the American Urogynecological Society and the American College of Obstetricians and Gynecologists on the initiative, which will begin enrolling patients later this summer.

“I’m happy to announce that the registry is ironing out its final kinks and will register its first patient in August of this year,” said Colin Anderson-Smits, an epidemiologist at the Office of Surveillance and Biometrics in FDA’s device center.

The Pelvic Floor Disorders Outcomes Registry will begin by collecting information on pelvic organ prolapse (POP) devices but could expand to other types of mesh products, he said. Enrolled patients will be contacted by the system every six months to complete patient-reported outcomes. The registry will also collect real-time safety reports.

Transvaginal mesh, which is used to repair weakened or damaged tissue, was approved as a class II low-risk device but an advisory panel recommended FDA upclassify the products in 2011 after the agency received a number of adverse event reports citing serious complications. The panel also said FDA should require manufacturers to conduct post-market studies of currently marketed products and pre-market studies for new transvaginal mesh products.

A consumer safety advocate called the registry “a step in the right direction” toward prioritizing sex-specific device concerns but said she was concerned that it will only collect data from new patients and not those already using the devices.

“If they start with new patients, it will take years before we get the information that we need,” said Diana Zuckerman, president of the National Research Center for Women & Families.

Data from new patients will allow researchers to have better information about the patient’s health before the device was implanted, which can be compared with later outcomes from the procedure, she said. But the registry would generate information about possible health outcomes much sooner if patients already using the devices were included in the registry. It will be at least five years before there will be any useful information from the registry, she noted.

Further, Zuckerman said she was concerned that no consumer safety or public health advocates had been asked to weigh in on the design of the registry.

“The fact that we were not included suggests that consumer groups and public health groups probably weren’t asked to participate,” she said.

Stakeholders said they would also like the new women’s health program to address the lack of pre- and post-market data for women in device clinical trials.

One researcher said strict clinical trial criteria for orthopedic devices that excludes patients over a certain body mass index could be detrimental to obese women seeking more orthopedic surgeries, and who are also at greater risk for complications and poor outcomes.

Nancy Lynch, founder of the consultancy service Advisorthopaedics Inc., said although women are more likely to undergo orthopedic procedures, and twice as likely to receive joint replacements as men, they are being excluded from clinical trials for the devices because of rigid exclusion criteria like body mass index.

Obese people are at greater risk for adverse events resulting from orthopedic surgeries and generally experience fewer long-term benefits from the devices, she said. That risk has been mitigated by using BMI to exclude patients from clinical trials, but by doing so researchers are also excluding large numbers of women and and some racial groups like blacks and Hispanics.

“Eighteen percent of women have a body mass index of 35 and greater and only 12 percent of men do,” she said. “Let’s overlap race on top of that. Twenty-nine percent of African-American women would not qualify for a trial. That’s pretty significant.”

Lynch said although body weight should be a consideration for orthopedic device trials, overweight patients are more likely to have musculoskeletal conditions like arthritis and utilize orthopedic devices more frequently. Obese patients seek orthopedic treatments ten years earlier and undergo joint replacement surgeries seven years earlier than patients of normal weight, she said.

Lynch also said women of childbearing age are underrepresented in orthopedic device trials because of restrictive, long-term imaging requirements, which is a concern because 43 percent of the U.S. population is between the ages of 21 and 44 and women make up half of that number.

Zuckerman, who has long pushed for the inclusion of more women in clinical trials, said the issue was another example of how FDA has lagged behind other federal agencies like NIH that already require diversity in clinical trials. FDA should require the inclusion of women, people of various ages and obese people in these studies, she said.

“This is a bigger issue, ” she said. “It’s an issue of FDA being reluctant to require the kind of diversity that they need in these trials. FDA needs to be forceful and clear about who they expect to be in these clinical trials.” – Stephanie Beasley

Tort reform: dangerous and costly

http://www.cnn.com/2012/10/12/health/medical-malpractice/index.html

Opinion: Protect patients'rights, protect patients' lives

By Mary Alice McLarty, Special to CNN

updated 8:53 AM EDT, Fri October 12, 2012

Editor's note: Mary Alice McLarty is president of the American Association for Justice and a partner in McLarty Pope LLP in Dallas. She practices personal injury and civil trial law, concentrating on catastrophic injury cases.

(CNN) -- We are facing a medical malpractice crisis in our country.

More than 98,000 people die every year because of preventable medical errors. That is equivalent to two 737s crashing every day for a whole year. Preventable medical errors are the sixth leading cause of death in the United States and cost our country $29 billion a year.

Lawsuits are only a symptom of the disease. The root of the medical malpractice problem is medical malpractice itself.

The civil justice system gives families of patients who have died or have been injured by medical negligence an avenue to seek accountability. It also provides an incentive to health care providers to improve patient care. Removing that accountability and incentive leaves people at risk for more injures from negligent care.

The calls for medical malpractice reform are misguided because they center on stripping away patients' rights when they should be focused on preventing the deaths and injuries from occurring in the first place.

In his October 5 piece, Dr. Anthony Youn states that the American Association for Justice "is opposed to malpractice tort reform."

We absolutely are. Not just because it violates the Constitution and is an infringement on patients' rights but, more important, because when no one is accountable, no one is safe.

Let's use my home state of Texas to see how eliminating the rights of patients -- or "tort reform" -- does not work for patients or doctors, or consumers.

In 2003, Texas passed Proposition 12, which severely limited the rights of patients by placing a $250,000 cap on non-economic damages and giving extensive immunity to emergency room doctors.

Children, stay-at-home moms and the elderly have been disproportionately impacted by this law because often they do not have substantial economic losses (i.e., lost wages or salary) from medical injuries, but their quality of life has been substantially, even permanently, diminished.

If limiting injured patients' rights actually reduced unnecessary tests and costs, Texas should have significantly lower health care costs than other states. But Texas has some of the highest health care costs and highest number of uninsured people in the country.

In fact, health care costs in Texas have increased at a higher rate than anywhere else in the country, according to a study from the University of Illinois and the University of Texas.

Not only has the cost of health care not decreased, but the quality of care has not improved, either. In July 2011, the federal Agency for Health Care Research and Quality ranked Texas health care the worst in the nation.

Lastly, one of the biggest myths of all is that doctors have flocked to Texas because of the cap on damages. It is simply not true. The number of practicing physicians in Texas was actually increasing at a faster rate before this law was passed.

This applies nationwide. The Government Accountability Office and Congressional Budget Office have both said that taking away patients' rights will not significantly lower health care costs and found no evidence of doctors running unnecessary tests to avoid lawsuits, or "defensive medicine."

Patients will not see the savings and neither will doctors. The Center for Progressive Reform, a regulatory think tank, found that "restricting lawsuits might save doctors a negligible amount on malpractice premiums but the vast majority of any savings will most certainly line the pockets of the insurance companies demanding these restrictions."

This is little more than a handout to medical malpractice insurers whose average profit margin is twice as high as 50 of the most profitable Fortune 500 companies (PDF).

Eliminating patients' rights is not the answer to our nation's health care problems. Instead, we must focus on patient safety efforts. That will undoubtedly lower costs, prevent lawsuits and save Americans' lives each year.