Showing posts with label patient deaths. Show all posts
Showing posts with label patient deaths. Show all posts

Sunday, November 9, 2014

Power morcellation ban unlikely, but other FDA restrictions coming soon

Power morcellation ban unlikely, but other FDA restrictions coming soon
The doc spearheading the antimorcellation campaign says FDA is divided, as are gynecologists

Johnson & Johnson's Ethicon division's power morcellation device, which has been recalled since the controversy errupted--Courtesy of Johnson & Johnson
The doctor who brought the cancer risks posed by power morcellation to the attention of the public and the FDA protested what he described as "imminent plans to use legal mechanisms to functionally institute a 'registry of outcomes' or a 'probationary period' in order to avoid banning power morcellators from the marketplace," in an email to Commissioner Hamburg, various U.S. senators, White House officials and others obtained by FierceMedicalDevices.
Cardiac surgeon Hooman Noorchashm and wife, Amy Reed, an anesthesiologist, have led the charge against the controversial surgical technique performed using the drill-like power morcellator. Power morcellation can upstage preexisting uterine cancers like uterine sarcoma to fatal levels.
Noorchashm and Reed have sparked public outcry, an FDA safety notice and a recall of power morcellators by former market leader Johnson & Johnson ($JNJ) via efforts like a petition on Change.org. Now they are aiming to take the campaign to its logical conclusion by securing an FDA ban of the device. That does not appear likely, according to information Noorchashm has received from a source within the FDA, who he wouldn't name during an interview.

The Biotech Primer: An insider's guide to the science driving the biotech and pharma industries

This 200-page book takes an in-depth look at the biotech industry and the science that drives it. Although the industry itself is constantly changing, these fundamental concepts upon which it is built will remain important for years to come - and decision-makers who understand these fundamentals will be better able to evaluate and predict new trends. Click here to buy today!
Sign up for our FREE newsletter for more news like this sent to your inbox! Noorchashm described a power struggle within the FDA in the interview, saying, "My impression is that inside the FDA there are two groups of individuals: individuals who are more interested in advocating for industry interests and individuals who understand that the position of the FDA should be to protect patient safety and ensure patient safety. Those two groups of people are basically struggling."
The FDA's Office of Policy and Planning favors stricter action, but the agency's device arm, the Center for Devices and Radiological Health (CDRH) is spearheading a plan to put the device on probation instead, he said.
"The imminent plan that the CDRH has is to sugarcoat this thing using a probationary mechanism. That would deflect any sort of criticism away from 510(k). It would deflect public criticism of anyone who says FDA didn't do anything. CDRH can comes out and says, 'Well we did something. We put out an FDA advisory and we put the device under probation.' That basically will give industry a chance to recover from an absolute medical atrocity," he said.
It is unclear what a probation would entail. During the FDA's public hearing on power morcellation, the agency discussed solutions such as enhanced informed consent requirements, the use of a surgical bag during morcellation and the need for improved testing of uterine sarcoma prior to surgery. A ban of power morcellators was also on the table, although agency officials didn't seem too intent on that option.
Central to the debate is the prevalence ratio of uterine sarcoma prior to power morcellation. The FDA estimates that the ratio is one women in 350.
A well-publicized paper in the Journal of the American Medical Association estimated that the rate of uterine cancer in women who underwent morcellation was one in 370. However, uterine sarcoma is a rare subset of uterine cancer that is more difficult to detect prior to surgery than other cancers of the uterus. Uterine sarcoma specifically is the main cause of concern among the FDA and other public health experts.
The paper's author, Dr. Jason Wright of the Columbia University College of Physicians and Surgeons, said in an email to FierceMedicalDevices that he is unable to separate sarcomas or other subtypes of uterine cancer based on the insurance database. But he added, "I would assume that most cancers (in the sample) were not known preoperatively in women who underwent morcellation."
"Physicians who are defending this are saying the incidence (of uterine sarcoma in women undergoing morcellation) is one in 7,500," Noorchashm said, referring to research by obstetrician-gynecologist Elizabeth Pritts of the Wisconsin Fertility Institute.
Pritts spoke at the FDA public hearing and believes the agency is wildly overestimating the prevalence of uterine sarcoma because the agency used confirmation bias in its literature review used to arrive at its estimate of one in 350 women.
To add to the complexity, most experts assume that power morcellation poses a great chance of upstaging preexisting uterine sarcoma to fatal levels because it shreds and spreads the cancerous tissue to new parts of the body. However, in October Pritts and medical colleagues published a paper in the Journal of Minimally Invasive Gynecology concluding "there is no reliable evidence that morcellation (power or otherwise) significantly results in tumor upstaging."
"The new data by Dr. Pritts et al reveal that there is no proof that uterine morcellation upstages cancer. This is a critical discovery and changes the framework for discussion of how to care for the 31 million women with symptomatic fibroids," said gynecologic surgeon Antonio Pizarro in Shreveport, LA in an email. "Dr. Wright has issued a report of lapses in preoperative diagnosis for women with detectable cancers, not a report on sarcoma on women with fibroids."
Other members of the field favor strict action against power morcellators. "What you do about it is: you stop," said Robert Graebe, chairman and program director of the Department of Obstetrics and Gynecology at NJ-based Monmouth Medical Center in a prior article in The Wall Street Journal, adding "it's not worth playing Russian roulette with the patient."
So far the FDA has only banned one device. In 1983 it outlawed prosthetic hair fibers.
"The FDA is considering a great deal of information, including the panel's input, all comments from the public docket, and all relevant available data, in determining any future regulatory action. If the FDA decides to take further action, we will issue communication to inform manufacturers and the public, including notice in the Federal Register," said an FDA spokeswoman in an email to FierceMedicalDevices.
Meanwhile, the Democrat & Chronicle reports that a third Rochester, NY, woman has recently died of an undetected cancer two years after undergoing power morcellation.
- here is the email
- here's the article in the Democrat & Chronicle
- here's Dr. Pritt's paper abstract
Related Articles:
Physicians defend power morcellator devices amid industry fallout
Johnson & Johnson pulls power morcellator devices amid industry and regulatory backlash
Upcoming study to dispute FDA's data on power morcellation risk
FDA panel recommends stronger labeling, limiting use of power morcellation--agency may go further
Power morcellator fallout continues after FDA advisory warning

Tuesday, September 16, 2014

One-fourth of bed alarms were broken before UCSD patient wandered away to his death

When Thomas Vera wandered away from UCSD to die in a nearby canyon in May 2013, executives across the University of California Health System were cutting positions of staff members who dealt directly with patients.

But those positions weren't cut because there was no money. The money was being shifted to administrators. It seems that the University of California's priorities have been shifting away from patient care to profit over the past several years.

But the greed of the executives and doctors at UC isn't the only factor at play in tragic patient deaths. I see another problem here, and we're all to blame for it. It's our refusal to talk about what should be done for terminally ill or injured patients. Sometimes hospitals are held hostage by families who demand miracles for their dying relatives. Losing a loved one is difficult, and some people can't accept the inevitable. They demand every test and treatment that might possibly give some short term benefit, and they even threaten to sue when their 95-year-old grandmother dies.

Few people want to talk about how to apportion health care dollars. The major exceptions to this are the vocal advocates of leaving large numbers of Americans without health coverage. In other words, these individuals want to let economics decide who should live and who should die. The advantage of this position is that it insulates its adherents from making specific choices about who should suffer or die. They want to let the market choose. Of course, the market is increasingly controlled by wealthy corporations and individuals who are taking a bigger and bigger share of the economy each year. The wealthy and their advocates apparently believe that fewer and fewer people should have health care.

Currently we spend an inordinate amount of money on the elderly during their last year of life, and, in particular, their last month of life. The truly disturbing aspect of this enormous outlay of healthcare dollars is that those who receive expensive hospital care during their final months have a lower quality of life than those who receive hospice or home care.

In the Archives of Internal Medicine, a study asked if a better quality of death takes place when per capital cost rise. In lay terms...the study found that the less money spent in this time period, the better the death experience is for the patient.

--Why 5% of Patients Create 50% of Health Care Costs?
Michael Bell
Forbes
1/10/2013


Obviously, if UCSD can keep the latest high-priced medical equipment in good repair, then it's perfectly capable of keeping bed alarms working. The California DHHS recently revealed some facts about the case of Thomas Vera, a UCSD patient who wandered into a nearby canyon and was found dead several days later:

State inspectors said the hospital failed to routinely test the buttons and failed to repair them when broken.

Prior to Vera’s disappearance, the most recent test had revealed more than 1 out of every 4 panic buttons at UCSD’s two main hospitals didn’t work.

--Broken Bed Alarm Blamed for Walkaway Patient's Death
By Steven Luke
NBC 7 San Diego
Sep 15, 2014


Is this the best that all these high-priced UC administrators can come up with? A patient dying of hunger, thirst and exposure in a nearby canyon? Obviously, UCSD can do better than this. AFSCME notes: "Care providers are forced to give special treatment to VIPs—so-called because of their wealth or relationship to UC administrators—at the expense of other patients."

It seems quite possible that Thomas Vera might not have recovered from his head injury even if he hadn't wandered away. He had apparently been in the hospital for weeks, too ill for surgery, and suffering from the delusion that he was being held captive in a garage in Texas. Perhaps he would never have become a good candidate for surgery. Would this man have had a better quality of life in his last days if he'd been in hospice care, or at home? It seems clear that he would have.

And would another person have benefited more from being in that hospital bed? It's hard to see how anyone could have benefited less than Thomas Vera did.

Perhaps UCSD administrators engaged in a chain of thought similar to these musings of mine when they created the situation that allowed Thomas Vera to wander off and die of exposure in a canyon. Did UCSD make a conscious decision to maintain expensive medical technology while neglecting low-tech life-saving gadgets for certain rooms?

The University of California has an enormous amount of political clout. Why not use that power for something besides making billions in profits from its health care system? Why not lead the discussion about how much of our health care resources should go to the terminally ill or injured?



A QUESTION OF PRIORITIES: Profits, Short Staffing, and the Shortchanging of Patient Care at UC Medical Centers
This report was written by AFSCME Local 3299 over the course of several months in 2012 and 2013. It is based on interviews with Local 3299 members employed at UC Medical Centers, reports by the California Department of Public Health, inpatient discharge data from the State of California’s Office of Statewide Health Planning and Development, as well as additional sources.

The public sees University of California Medical Centers as premier, world-class facilities. We rely upon them when our loved ones face the most serious illnesses because we expect them to provide the highest level of care. With the UC Medical System earning $6.9 billion in operating revenues and hundreds of millions in profits, it has the resources to do just that.

But recently, patient care advocates have witnessed something else: administrative decisions that prioritize UC’s profit margins over patients’ health. These decisions reflect a shift in values that reached a tipping point with a system-wide policy in 2011 that decentralized UC budget practices, and turned each medical center into an independent profit center.

This culture change is evidenced by a sharp rise in management salaries and compensation, excessive management costs, and unprecedented borrowing to construct new buildings.

Since 2009, management at UC Medical Centers has grown by 38 percent, adding $100 million to the annual payroll cost of management.

Debt service payments have almost quadrupled since 2006.

This diversion of patient care dollars results in management’s need to capture “efficiencies” to bolster profit margins.

While “efficiencies” can be positive, they can also have serious negative consequences. Often taking the form of aggressive cost-cutting measures, some translate into chronic short staffing, over scheduling of operating rooms, prioritizing “VIP” patients over everyone else, shortchanging charity care, and outsourcing essential services.

These degrade the medical centers’ core mission.

Care providers are painfully aware of administrative priorities that too often leave them unable to provide the care that patients deserve. Patient care workers suffer unnecessary stress and fatigue, and at times work without adequate training on the use of hazardous materials used to sterilize patient care areas. Some report being so rushed in their work that dirty patient care areas may not be properly sanitized before new patients arrive.

While workers are already feeling squeezed, the University is threatening to cut staff. At UCSF Medical Center, management recently announced its plan to reduce 300 hospital workers, or 4 percent of its full-time workforce. These reductions are being proposed at a time when the medical center is only just recovering from having to ration respiratory care services in January 2013 because of inadequate staffing levels. To make matters worse, the hospital’s CEO admits that, in his view, these cuts are needed, at least in part, to free up resources for new construction...

Frontline care providers give examples of how UC policies degrade safe staffing and patient care.

Patients often fall trying to go to the bathroom by themselves because short staffing delays staff response times. In one instance, a patient classified with “altered mental status” did not receive one-on-one attention and was found standing on a windowsill.

Chronic short staffing creates excessive workloads and stress. One nurse’s aide reports being afraid to take breaks because it would increase the ratio of patients to CNAs from 10:1 to 20:1.

The UC health system seeks to “re-align” Medicare and Medicaid patients to non-UC hospitals under the assumption that they often do not require the level of care UC provides.

Care providers complain about dirty patient care areas. An operating room assistant sees dried blood and fluids in the crevices of an operating table month after month...

Profitable high-level procedures get overscheduled, causing stress and exhaustion for care providers and delays for patients.

The State of California provides significant funding for the University’s Health System. In the fiscal year 2012-2013, it will provide approximately $300 million in public dollars for health sciences instruction....[Read more here.]


Broken Bed Alarm Blamed for Walkaway Patient's Death
Thomas Vera died after he became disoriented and walked away from his hospital room at UCSD Medical Center in May
By Steven Luke
NBC 7 San Diego
Sep 15, 2014

California Department of Health and Human Services records obtained by NBC 7 shed new light on what went wrong inside UCSD Medical Center when a disoriented patient walked away from his supervised room into a nearby canyon.

The [May 2013] lapse in hospital security led to a tragic search which ended when ...Thomas Vera’s body was found [several] days later less than a mile from the hospital entrance in Palm Canyon.

Family blames the hospital for allowing 58-year-old Thomas Vera, suffering severe head and neck injuries as well as [delusions], to leave the facility...

According to the CHHS investigation, Vera’s bed alarm never sounded. Vera was under video surveillance, and when nurses were notified, the report states they “attempted to contact security by paging security twice with no response and then pushing the panic button twice with no response.”

The panic button was “broken for 8 days,” according to the report.

State inspectors said the hospital failed to routinely test the buttons and failed to repair them when broken.

Prior to Vera’s disappearance, the most recent test had revealed more than 1 out of every 4 panic buttons at UCSD’s two main hospitals didn’t work.


“That’s incomprehensible to me. This is a big time, generally well thought of medical facility, and it’s like clown school” said legal expert Joel Brant, an attorney who specialized in elder care law.

[Maura Larkins comment: I don't believe they're clowns. They're clever, and they're calculating. The buttons were not a priority. UCSD pays huge amounts of money to maintain the equipment it wants to keep maintained. Were the walkaway patients paying full price? Were they a drain on UCSD financially?]

UC San Diego Health Sciences director of communications Jacqueline Carr released this statement in response to the incident:

“UC San Diego Health System underwent extensive internal and external investigations to identify the reasons that led to this tragic event...”

Fifteen months after the incident, CHHS says no fine or penalty has been issued as a result of the mishap...

Read more here.


Missing Hospital Patient's Body Found in Canyon: Officials
By Monica Garske and Dave Summers
NBCSanDiego
Jun 1, 2013

The body of a missing hospital patient was discovered by search and rescue officials in a canyon Friday evening after an extensive search.

Chula Vista resident Thomas Vera, 58, had been missing since Monday. For the last several weeks, he had been a patient at the UCSD Medical Center.

Vera was admitted to the hospital after falling down the stairs at his home. He suffered a concussion and broken collar bone, according to his family, and was awaiting surgery...


Family, Cops Search for Missing Hospital Patient
By Brandi Powell, R. Stickney and Monica Garske
NBC 7 San Diego
May 31, 2013

A Chula Vista man, suffering from a head injury and broken bones, walked away from a San Diego hospital wearing only a hospital gown four days ago.

On Friday, San Diego police officers and family members spent all day searching canyons near Mission Valley for any sign of the man who officials say was likely disoriented and confused...

His daughter Tanya said Thomas last spoke with his wife on Sunday night.

"These are his words - he was being held in a garage in Texas - we're from Texas so he's thinking he's in Texas - that people were holding him against his will and drugging him, and so he was crying and telling my mom he was very scared," she said...

Wednesday, June 11, 2014

How Many Die From Medical Mistakes in U.S. Hospitals?

How Many Die From Medical Mistakes in U.S. Hospitals?
by Marshall Allen
ProPublica
Sep. 19, 2013

...In 2010, the Office of Inspector General for Health and Human Services said that bad hospital care contributed to the deaths of 180,000 patients in Medicare alone in a given year. Now comes a study in the current issue of the Journal of Patient Safety that says the numbers may be much higher — between 210,000 and 440,000 patients each year who go to the hospital for care suffer some type of preventable harm that contributes to their death, the study says.

That would make medical errors the third-leading cause of death in America, behind heart disease, which is the first, and cancer, which is second.

The new estimates were developed by John T. James, a toxicologist at NASA’s space center in Houston who runs an advocacy organization called Patient Safety America. James has also written a book about the death of his 19-year-old son after what James maintains was negligent hospital care...

Friday, May 30, 2014

Napolitano’s newest headache: “Outright bullying” and “patient deaths”

Napolitano’s newest headache: “Outright bullying” and “patient deaths”
Josh Eidelson
Salon
Nov 20, 2013

Four months after former Obama Homeland Security head Janet Napolitano took the helm of the massive University of California system, unions representing 35,000 U.C. employees are staging a one-day strike over alleged illegal intimidation.

“She is the president, and she has the power to make change,” said Tim Thrush, a diagnostic stenographer and a vice president of the 21,000-member American Federation of State County and Municipal Employees Local 3299, which instigated the strike. “Ultimately it all comes back to her,” said Marco Rosales, a head steward in the 13,000-member United Auto Workers Local 2865, a student-worker union that is joining the strike.

At issue in today’s walkout is AFSCME’s allegation that U.C. management repeatedly violated state labor law in efforts to discourage the union’s members — patient care technical and service workers employed in medical centers – from mounting an unprecedented work stoppage last May. In charges filed with the government, AFSCME charges that administrators violated the state Higher Education Employer-Employee Relations Act through a battery of fear tactics: repeated statements by top officials promising or implying potential punishment for strikes; threatening postings and letters; and interrogations by individual managers.

“It’s a little disturbing that, you know, as we are fighting for patient safety in the workplace, and just being advocates for what’s right for the patients and their families, that management would act so aggressively to try to shut us up,” said AFSCME’s Thrush.

Thrush is among the AFSCME members who say they were personally intimidated by management in the lead-up to last May’s strike, before Napolitano took over for then-president Mark Yudof. He told Salon that his manager gave him a list of supplies to fetch from a supply room, and then “proceeded to pursue me” there, “blocking the door, and very aggressively began to interrogate me.” Thrush added, “Her hands were on her hips and she was roughly maybe two feet from my face, and was telling me that I was acting illegally, that I shouldn’t be doing what I’m doing, that I would be hurting patients and she didn’t think it was right that I told the other employees what their legal rights were when she was interrogating them.” He called the tactic “outright bullying,” and said he found it “pretty The evidence presented by AFSCME also includes a message from U.C. labor relations director Peter Chester stating that “Service Unit employees at any location who engage in an unlawful sympathy strike face the possibility of disciplinary action,” and notices posted throughout the U.C. Davis Medical Center warning that “If an employee fails to report to work on one or more days between May 20 and 23, their absence will be considered unauthorized, they will not be paid, and they may be subject to disciplinary action.” (The union alleges the university espoused specious arguments that strikes would be illegal as a way to intimidate workers out of participating, and then withdrew its legal charges to that effect because they were bogus.)

Asked about the allegations, the strike and Napolitano’s role, the university referred Salon to a series of recent statements, one of which charged that “even the threat of an AFSCME strike has already affected patients,” including the rescheduling of elective surgeries, and said that it had “proposed several packages that showed significant movement in response to the union’s concerns and offered multi-year wage increases, affordable healthcare and quality pension benefits, which AFSCME rejected.” AFSCME countered that as in May, certain critical employees would voluntarily stay on the job under the union’s Patient Protection Task Force. In another statement, U.C. vice president Dwaine Duckett said that the university “asked AFSCME-represented employees if they planned to come to work, as is our a normal procedure, so we could adjust staffing as needed and ensure we could still care for patients during the strike.” AFSCME contends that the university violated several legal limitations on such conversations.

AFSCME and U.C. administrators have been in negotiations for over a year and a half. The university has blamed the lack of an agreement on AFSCME’s resistance to pension changes, while AFSCME has blamed the university’s rejection of proposals it says would improve patient safety. “We have made major concessions on many of our proposals, including wages and retirement benefits, in hopes that they would respond to our safety proposals,” said Thrush. “And they have not.” He cited AFSCME proposals regarding training and staffing. Noting fines assessed by government agencies, he charged, “There’s been patient deaths as a result of staffing issues and neglect of the safety” of patients.

Thrush offered some praise for Napolitano’s record to date, saying, “We find her to be much more open and receptive to working with the unions and our right to advocate with patients” and “we would hope that she would carry that new attitude on to her management group and get them to actually give us a workplace that’s safe and free of the intimidation tactics that they apply to quiet our voice.” The UAW’s Rosales was less optimistic, charging Napolitano has tried to “take the wind out of our sails” by publicly committing to invest funds that are “actually the amount of money that we would get in raises each year,” and thus “trying to co-opt the pressure that is being put on the university.” Rosales added, “I don’t think she’s done a good job of responding to these issues in earnest. It seems not very genuine.” The striking AFSCME and UAW locals are both helmed by leaders who ran on reform platforms and ousted incumbent union officials in bitter 2011 contests...