How Many Die From Medical Mistakes in U.S. Hospitals?
An updated estimate says at least 210,000 patients die
from medical mistakes in U.S. hospitals a year.
by Marshall Allen
ProPublica
Sep. 19, 2013
It seems that every time researchers estimate how often a medical mistake contributes to a hospital patient’s death, the numbers come out worse.
In 1999, the Institute of Medicine published the famous “To Err Is Human” report, which dropped a bombshell on the medical community by reporting that up to 98,000 people a year die because of mistakes in hospitals. The number was initially disputed, but is now widely accepted by doctors and hospital officials — and quoted ubiquitously in the media.
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.
Asked about the higher estimates, a spokesman for the American Hospital Association said the group has more confidence in the IOM’s estimate of 98,000 deaths. ProPublica asked three prominent patient safety researchers to review James’ study, however, and all said his methods and findings were credible.
What’s the right number? Nobody knows for sure. There’s never been an actual count of how many patients experience preventable harm. So we’re left with approximations, which are imperfect in part because of inaccuracies in medical records and the reluctance of some providers to report mistakes.
Patient safety experts say measuring the problem is nonetheless important because estimates bring awareness and research dollars to a major public health problem that persists despite decades of improvement efforts.
“We need to get a sense of the magnitude of this,” James said in an interview.
James based his estimates on the findings of four recent studies that identified preventable harm suffered by patients – known as “adverse events” in the medical vernacular – using use a screening method called the Global Trigger Tool, which guides reviewers through medical records, searching for signs of infection, injury or error. Medical records flagged during the initial screening are reviewed by a doctor, who determines the extent of the harm.
In the four studies, which examined records of more than 4,200 patients hospitalized between 2002 and 2008, researchers found serious adverse events in as many as 21 percent of cases reviewed and rates of lethal adverse events as high as 1.4 percent of cases.
By combining the findings and extrapolating across 34 million hospitalizations in 2007, James concluded that preventable errors contribute to the deaths of 210,000 hospital patients annually.
That is the baseline. The actual number more than doubles, James reasoned, because the trigger tool doesn’t catch errors in which treatment should have been provided but wasn’t, because it’s known that medical records are missing some evidence of harm, and because diagnostic errors aren’t captured.
An estimate of 440,000 deaths from care in hospitals “is roughly one-sixth of all deaths that occur in the United States each year,” James wrote in his study. He also cited other research that’s shown hospital reporting systems and peer-review capture only a fraction of patient harm or negligent care.
“Perhaps it is time for a national patient bill of rights for hospitalized patients,” James wrote. “All evidence points to the need for much more patient involvement in identifying harmful events and participating in rigorous follow-up investigations to identify root causes.”
Dr. Lucian Leape, a Harvard pediatrician who is referred to the “father of patient safety,” was on the committee that wrote the “To Err Is Human” report. He told ProPublica that he has confidence in the four studies and the estimate by James.
Members of the Institute of Medicine committee knew at the time that their estimate of medical errors was low, he said. “It was based on a rather crude method compared to what we do now,” Leape said. Plus, medicine has become much more complex in recent decades, which leads to more mistakes, he said.
Dr. David Classen, one of the leading developers of the Global Trigger Tool, said the James study is a sound use of the tool and a “great contribution.” He said it’s important to update the numbers from the “To Err Is Human” report because in addition to the obvious suffering, preventable harm leads to enormous financial costs.
Dr. Marty Makary, a surgeon at The Johns Hopkins Hospital whose book “Unaccountable” calls for greater transparency in health care, said the James estimate shows that eliminating medical errors must become a national priority. He said it’s also important to increase the awareness of the potential of unintended consequences when doctors perform procedure and tests. The risk of harm needs to be factored into conversations with patients, he said.
Leape, Classen and Makary all said it’s time to stop citing the 98,000 number.
Still, hospital association spokesman Akin Demehin said the group is sticking with the Institute of Medicine’s estimate. Demehin said the IOM figure is based on a larger sampling of medical charts and that there’s no consensus the Global Trigger Tool can be used to make a nationwide estimate. He said the tool is better suited for use in individual hospitals.
The AHA is not attempting to come up with its own estimate, Demehin said.
Dr. David Mayer, the vice president of quality and safety at Maryland-based MedStar Health, said people can make arguments about how many patient deaths are hastened by poor hospital care, but that’s not really the point. All the estimates, even on the low end, expose a crisis, he said.
“Way too many people are being harmed by unintentional medical error,” Mayer said, “and it needs to be corrected.”
Wednesday, June 11, 2014
Tuesday, June 10, 2014
Do you want a souvenir DVD of your colonoscopy? So did I.
See all posts re UCSD.
I was scheduled for a routine colonoscopy at UCSD last month. Nothing controversial about that, right?
I had had a bizarre experience at Kaiser three years ago when I paid Kaiser $10 for a DVD of the digital video of my VUCG (or "VCUG"). Then suddenly the radiology imaging department claimed that there were no digital images of the procedure--even though the X-rays were done at the brand new Garfield Specialty Center advertised as having all-digital X-rays. Kaiser said that it only had a few odd thermal paper images of the June 15, 2011 procedure.
So naturally I wanted to make sure that the same thing wouldn't happen at UCSD. A couple of days before my colonoscopy I called to make sure that I would be able to get a DVD of the procedure.
UCSD's gastroenterology department told me that they don't save any of the digital data generated during colonoscopies.
This is what UCSD claims:
1. The patient can't get a second opinion from any doctor who wasn't watching the computer monitor during the procedure.
2. UCSD is very vulnerable to lawsuits; it can't prove that it wasn't negligent if the patient develops colon cancer that was missed.
3. UCSD can't learn from its mistakes. It can't go back and see what it was they missed so they can do a better job in the future.
4. A few seconds after the patient leaves, the doctor (and patient) are out of luck if the doctor suddenly thinks, "Hey, what was that I was looking at? Maybe that was something important. I'd like to see that again." Nope. No chance. According to UCSD, the images have been flushed from its computers.
5. UCSD says they don't save the images because it takes up too much space on the hard drive.
Yeah, right. Digital memory is getting cheaper by the month, so why would UCSD have suddenly stopped saving digital data recently? They used to give patients DVDs, and before that they gave VHS tapes of colonoscopies. Those tapes were a lot more expensive and bulky than digital memory.
I asked if I could pay extra to get my procedure saved, but they said NO. The procedure costs $1300 minimum. You'd think that would cover a bit of space on the hard drive, wouldn't you? Well, of course it does. They just don't want patients to see the images.
These days many doctors in the US are so dead set against patients seeing the images that they sedate everybody, even people who've had colonoscopies before without sedation and didn't have any problem. They'd rather take the risk of a bad reaction to drugs than to let patients see the video. I watched doctors on You Tube showing the whole process, and the first thing they asked patients when they woke up was, "Do you remember anything?" The patients all said NO.
When I suggested that I didn't believe that UCSD flushed the digital data, UCSD suggested that I go somewhere else if I wanted a DVD.
So I found a doctor who would give me a DVD of my colonoscopy.
The new doctor wants me to get some lab work done, so I went to UCSD today to get blood drawn.
The nurse who drew my blood was very sweet, but it quickly became clear that she had been tasked with finding out who had agreed to give me a DVD of a colonoscopy. Why would UCSD want to know that?
"Where are you going for your colonoscopy?" she asked.
I didn't want UCSD calling up the doctor and demanding that he not give me a DVD.
"I don't think I should say, since UCSD doesn't approve of patients getting DVDs," I told her.
"Oh, no," she said. "It's not that. It's just that we don't do DVDs."
Fine, I thought. So we're all happy and relaxed about this situation. I sat back in my chair and the nurse put a pillow on my lap.
"So are you getting it done at a hospital?" she asked. It seemed that my nurse was not so happy and relaxed about the situation after all.
I didn't want to say YES and I didn't want to say NO. I didn't want to tell the truth or tell a lie. So I didn't say anything.
I was afraid she'd be mad at me and poke me painfully with the needle, but she was very careful. I only felt a tiny pinch. And then we said friendly good byes.
Message to UCSD: she tried. She really did try. But I had planned ahead of time that I wouldn't spill the beans. So don't blame the very sweet girl who couldn't get the information out of me.
I was scheduled for a routine colonoscopy at UCSD last month. Nothing controversial about that, right?
I had had a bizarre experience at Kaiser three years ago when I paid Kaiser $10 for a DVD of the digital video of my VUCG (or "VCUG"). Then suddenly the radiology imaging department claimed that there were no digital images of the procedure--even though the X-rays were done at the brand new Garfield Specialty Center advertised as having all-digital X-rays. Kaiser said that it only had a few odd thermal paper images of the June 15, 2011 procedure.
So naturally I wanted to make sure that the same thing wouldn't happen at UCSD. A couple of days before my colonoscopy I called to make sure that I would be able to get a DVD of the procedure.
UCSD's gastroenterology department told me that they don't save any of the digital data generated during colonoscopies.
This is what UCSD claims:
1. The patient can't get a second opinion from any doctor who wasn't watching the computer monitor during the procedure.
2. UCSD is very vulnerable to lawsuits; it can't prove that it wasn't negligent if the patient develops colon cancer that was missed.
3. UCSD can't learn from its mistakes. It can't go back and see what it was they missed so they can do a better job in the future.
4. A few seconds after the patient leaves, the doctor (and patient) are out of luck if the doctor suddenly thinks, "Hey, what was that I was looking at? Maybe that was something important. I'd like to see that again." Nope. No chance. According to UCSD, the images have been flushed from its computers.
5. UCSD says they don't save the images because it takes up too much space on the hard drive.
Yeah, right. Digital memory is getting cheaper by the month, so why would UCSD have suddenly stopped saving digital data recently? They used to give patients DVDs, and before that they gave VHS tapes of colonoscopies. Those tapes were a lot more expensive and bulky than digital memory.
I asked if I could pay extra to get my procedure saved, but they said NO. The procedure costs $1300 minimum. You'd think that would cover a bit of space on the hard drive, wouldn't you? Well, of course it does. They just don't want patients to see the images.
These days many doctors in the US are so dead set against patients seeing the images that they sedate everybody, even people who've had colonoscopies before without sedation and didn't have any problem. They'd rather take the risk of a bad reaction to drugs than to let patients see the video. I watched doctors on You Tube showing the whole process, and the first thing they asked patients when they woke up was, "Do you remember anything?" The patients all said NO.
When I suggested that I didn't believe that UCSD flushed the digital data, UCSD suggested that I go somewhere else if I wanted a DVD.
So I found a doctor who would give me a DVD of my colonoscopy.
The new doctor wants me to get some lab work done, so I went to UCSD today to get blood drawn.
The nurse who drew my blood was very sweet, but it quickly became clear that she had been tasked with finding out who had agreed to give me a DVD of a colonoscopy. Why would UCSD want to know that?
"Where are you going for your colonoscopy?" she asked.
I didn't want UCSD calling up the doctor and demanding that he not give me a DVD.
"I don't think I should say, since UCSD doesn't approve of patients getting DVDs," I told her.
"Oh, no," she said. "It's not that. It's just that we don't do DVDs."
Fine, I thought. So we're all happy and relaxed about this situation. I sat back in my chair and the nurse put a pillow on my lap.
"So are you getting it done at a hospital?" she asked. It seemed that my nurse was not so happy and relaxed about the situation after all.
I didn't want to say YES and I didn't want to say NO. I didn't want to tell the truth or tell a lie. So I didn't say anything.
I was afraid she'd be mad at me and poke me painfully with the needle, but she was very careful. I only felt a tiny pinch. And then we said friendly good byes.
Message to UCSD: she tried. She really did try. But I had planned ahead of time that I wouldn't spill the beans. So don't blame the very sweet girl who couldn't get the information out of me.
Monday, June 9, 2014
UCSD Researchers Find Protein That Triggers Diabetes
UCSD Researchers Find Protein That Triggers Diabetes
The origins and steps of obesity-related
diabetes have been established for the first time, according to a
significant set of findings just published by researchers at the UCSD School of Medicine.
The researchers concentrated on a protein, called ANT2, that they believe causes diabetes in fat people.
“We’ve pinpointed the steps, the way the
whole thing happens,” said Jerrold M. Olefsky, associate dean for
Scientific Affairs and Distinguished Professor of Medicine at UCSD.
“The research is in mice, but the evidence
suggests that the processes are comparable in humans and these findings
are important to not just understanding how diabetes begins, but how
better to treat it and prevent it.”
In a study published this weekend in the medical journal Cell,
the UCSD researchers described a sequence that begins at the cellular
level, as cells react to high-fat diets. These high-fat diets can then
result in obesity- induced insulin resistance, and then diabetes.
Olefsky and others have previously shown that
obesity is characterized by low-grade inflammation in fat tissue, and
that this inflammation can become chronic and result in insulin
resistance and diabetes. In their most recent findings, the scientists
describe the earliest stages of the process which begin before obesity
manifests itself.
The scientists began by feeding mice a
high-fat diet. They noticed that the high levels of saturated fatty
acids in the diet activated a protein in the fat cell membranes, which
in turn caused increased oxygen consumption in the cells.
The increased oxygen consumption by the ANT2 protein left less oxygen for the rest of the cell.
Without an adequate oxygen supply, the cells
go through a process that ultimately launches the immune system’s
inflammatory response system. A sustained high-fat diet ensured that the
process continued unimpeded, and that led to obesity, chronic tissue
inflammation and insulin resistance in the mice.
The researches found that by controlling
certain aspects of the process, they could protect the mice from
inflammation, insulin resistance and elevated glucose levels that were
caused by the high-fat diet.
The researches suggest that by impeding two
specific steps in the sequence, they could blunt or even reverse the
damaging cellular sequence.
— City News Service
Friday, June 6, 2014
CDC confirms 4th U.S. case of mad cow disease after Texas man dies
Mad cow disease is still here, it turns out.
Los Angeles Times
June 6, 2014
Mad
cow disease -- the fourth confirmed case in the U.S. -- is responsible
for the death of a Texas man, the Centers for Disease Control and
Prevention said Friday.
The variant CJD, as it’s medically known, was confirmed by experts after a sample of the man’s brain tissue was analyzed.
No specifics on the victim or when he died were released.
“The history of this fourth patient, including extensive travel to Europe and the Middle East, supports the likelihood that infection occurred outside the United States,” the CDC said in a statement.
The disease is a rare, degenerative fatal brain disorder in humans that is believed to be caused by eating the meat of cows with the disease bovine spongiform encephalopathy, according to the CDC.
The disease in humans is more prevalent in Europe. The majority are in Britain, which has had 177 confirmed cases since the disease was discovered there in 1996, and France, with 27, the CDC reports.
CDC confirms 4th U.S. case of mad cow disease after Texas man dies
by Ryan ParkerLos Angeles Times
June 6, 2014
The variant CJD, as it’s medically known, was confirmed by experts after a sample of the man’s brain tissue was analyzed.
No specifics on the victim or when he died were released.
“The history of this fourth patient, including extensive travel to Europe and the Middle East, supports the likelihood that infection occurred outside the United States,” the CDC said in a statement.
The disease is a rare, degenerative fatal brain disorder in humans that is believed to be caused by eating the meat of cows with the disease bovine spongiform encephalopathy, according to the CDC.
The disease in humans is more prevalent in Europe. The majority are in Britain, which has had 177 confirmed cases since the disease was discovered there in 1996, and France, with 27, the CDC reports.
Saturday, May 31, 2014
UCSD gives consent for sharing medical records without patient approval
I got an interesting letter from UCSD three days ago. It told me that I had consented to share my electronic medical records.
The trouble is--I had NOT given my consent. I never signed a consent form. I never clicked a box on the Internet agreeing to share my records.
And the letter from UCSD did NOT arrive in my home mailbox or even in my email. It was purely by chance that I found it on MyUCSDChart—NOT among the MyChart emails. If it had been among the MyChart emails, I would have received an alert about it in my regular email.
UCSD was definitely NOT trying to make sure that I found out about my “consent”.
Today, each time I have clicked on the link about sharing electronic medical records on MyUCSDChart, I found myself unceremoniously thrown back to the sign-in page. Automatically signed out. They really don't like it when I click on the link!
UCSD seems to be remarkably fond of both signing me in and signing me out--without my involvement--whenever it feels like it.
I found this page on the UCSD site about sharing electronic records. It seems that I am now part of two databases: The San Diego Beacon Health Information Exchange, and something called Care Everywhere.
It's not that I want to keep my records secret. In fact, I think sharing electronic records is basically a good idea. It's just that I've had problems with health providers hiding my own test results from me, so I'm sensitive about doctors violating the law regarding medical records.
Apparently the VA is also part of this system, but the VA has a more transparent consent process.
I've heard of falsified medical records, but this is the first time I heard of a falsified consent for release of medical records.
See all posts regarding UCSD on Thank Heaven for Insurance Companies blog.
See all posts on medical records on Thank Heaven blog.
I found some interesting stuff about UCSD's informed consent process for patients in research projects:
Tufts Medical Center sued for faxing patient records without consent
July 15, 2011
By Karen Cheung-Larivee
FierceHealthcare
Tufts Medical Center in Boston faces a lawsuit after a patient said the hospital faxed her medical records to her workplace without her consent, causing her embarrassment, reports The Boston Globe yesterday.
"I feel like I might have walked in (the office) naked," said patient Kimberly White.
White requested Tufts to send a form for a disability claim, but instead the hospital allegedly sent four pages of medical records about her hysterectomy to a shared fax machine at her workplace.
White filed a complaint in Plymouth County Superior Court. The hospital denies any wrongdoing, according to the article.
Tufts spokeswoman Julie Jette said, "In this matter, we complied with a patient's request to share information. We firmly believe we responded to the patient's request appropriately."
"I can't go back there," White said. "I am so embarrassed. ... I couldn't live with knowing what these people knew about me."
Earlier this year, another Boston hospital, Massachusetts General Hospital, faced accusations that an employee lost records of 192 patients on the subway. The hospital in February settled the federal case for $1 million, according to the article.
UCLA HIPAA VIOLATIONS
UCLA Health System pays $865G to settle HIPAA violation charges
July 8, 2011
FierceHealthIT
By Ken Terry
UCLA Health System has agreed to pay a fine of $865,000 and to develop a correction action plan to settle potential HIPAA privacy violations involving improper disclosures of medical records at its three hospitals, the federal Office of Civil Rights (OCR) reports.
OCR launched the investigation in 2009, following complaints by two unnamed celebrities that their medical records had been compromised. The government probe revealed that from 2005 to 2008, "unauthorized employees repeatedly looked at the electronic protected health information of numerous other UCLAHS patients," according to an OCR press release.
The Los Angeles Times reports that violations allegedly occurred at all three UCLAHS hospitals: Ronald Reagan UCLA Medical Center, Santa Monica UCLA Medical Center, and Orthopaedic Hospital and Resnick Neuropsychiatric Hospital, which are regarded as a single unit.
The hospital had disclosed in April 2008 that it had discovered that several employees had snooped into the patient records of dozens of celebrities, including Britney Spears, Tom Cruise and Maria Shriver.
When the alleged violations came to light in 2008, the California legislature passed a law that imposed escalating fines on hospitals for patient privacy breaches. The state fined UCLAHS $95,000 in 2009, reportedly in connection with the medical records of the late Michael Jackson.
The UCLAHS settlement with OCR is much smaller than previous HIPAA settlements, including those involving CVS Caremark ($2.25 million) and Rite Aid ($1 million).
As part of its settlement, UCLAHS agreed to institute new security and privacy policies, improve employee training, take action against employees who violate privacy rules, and designate an independent monitor to oversee compliance.
In a statement, UCLAHS said, "The UCLA Health System considers patient confidentiality a critical part of our mission of patient care, teaching and research. Over the past three years, we have worked diligently to strengthen our staff training, implement enhanced data security systems and increase our auditing capabilities."
MEDICAL ETHICS--RESEARCH ON MEDICAL RECORDS WITHOUT INFORMED CONSENT
J Law Med Ethics. 2008 Fall;36(3):560-6. doi: 10.1111/j.1748-720X.2008.304.x.
Research on medical records without informed consent.
Miller FG.
Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.
PMID: 18840249 [PubMed - indexed for MEDLINE]
The trouble is--I had NOT given my consent. I never signed a consent form. I never clicked a box on the Internet agreeing to share my records.
And the letter from UCSD did NOT arrive in my home mailbox or even in my email. It was purely by chance that I found it on MyUCSDChart—NOT among the MyChart emails. If it had been among the MyChart emails, I would have received an alert about it in my regular email.
UCSD was definitely NOT trying to make sure that I found out about my “consent”.
Today, each time I have clicked on the link about sharing electronic medical records on MyUCSDChart, I found myself unceremoniously thrown back to the sign-in page. Automatically signed out. They really don't like it when I click on the link!
UCSD seems to be remarkably fond of both signing me in and signing me out--without my involvement--whenever it feels like it.
I found this page on the UCSD site about sharing electronic records. It seems that I am now part of two databases: The San Diego Beacon Health Information Exchange, and something called Care Everywhere.
It's not that I want to keep my records secret. In fact, I think sharing electronic records is basically a good idea. It's just that I've had problems with health providers hiding my own test results from me, so I'm sensitive about doctors violating the law regarding medical records.
Apparently the VA is also part of this system, but the VA has a more transparent consent process.
I've heard of falsified medical records, but this is the first time I heard of a falsified consent for release of medical records.
See all posts regarding UCSD on Thank Heaven for Insurance Companies blog.
See all posts on medical records on Thank Heaven blog.
I found some interesting stuff about UCSD's informed consent process for patients in research projects:
iDASH Integrating Data for Analysis, Anonymization and SHaringHOSPITAL FAXED MEDICAL RECORDS TO PATIENT'S WORKPLACE
Informed Consent
Paper Consent versus Electronic Consent
Traditionally, paper-based consent has been the medium through which researchers and physicians conducted the informed consent process. The paper-based process consists of giving a hard copy consent form to a patient for him or her to review. Then a care provider answers any questions from the patient and in some cases assists the patient in reviewing the paper consent forms. The issues surrounding this procedure are that the paper-based consent form tends to be long and monotonous, and the retrieval of paper forms are often time consuming.
The new electronic consent forms use tablets or computers as the medium for communicating information and seeking consent from the patient...The iDASH team is also currently working on two systems, iCONS and iCONCUR, which are intended for such open source use in the future.
iDASH electronic informed consent management system
iCONS is a system currently being tested in a clinical trials environment at Moores Cancer Center Biorepository. The system supports informed consent electronically by enhancing the consent process for patients and researchers by acting as a consent broker and by adding multimedia aspects to the process. This consent process is opt-in, meaning no patient information is shared with researchers until the patient specifies what specific information he or she would like to share with researchers. The iCONS system creates a permission ontology to model the consent choices of the patient to assist in the process of releasing data and specimens to researchers for their consented uses.
iCONCUR is a pilot study within the University of California - San Diego Health System. This system transforms the sharing of electronic records from the opt-out system that is currently in place, meaning a patient’s record is automatically entered into the system unless the patient specifically requests to have their records taken out, to an opt-in system. The tool presents the patient with a taxonomy of his or her medical record allowing the patient to dictate what parts of the medical record to share and with whom it may be shared with.
Tufts Medical Center sued for faxing patient records without consent
July 15, 2011
By Karen Cheung-Larivee
FierceHealthcare
Tufts Medical Center in Boston faces a lawsuit after a patient said the hospital faxed her medical records to her workplace without her consent, causing her embarrassment, reports The Boston Globe yesterday.
"I feel like I might have walked in (the office) naked," said patient Kimberly White.
White requested Tufts to send a form for a disability claim, but instead the hospital allegedly sent four pages of medical records about her hysterectomy to a shared fax machine at her workplace.
White filed a complaint in Plymouth County Superior Court. The hospital denies any wrongdoing, according to the article.
Tufts spokeswoman Julie Jette said, "In this matter, we complied with a patient's request to share information. We firmly believe we responded to the patient's request appropriately."
"I can't go back there," White said. "I am so embarrassed. ... I couldn't live with knowing what these people knew about me."
Earlier this year, another Boston hospital, Massachusetts General Hospital, faced accusations that an employee lost records of 192 patients on the subway. The hospital in February settled the federal case for $1 million, according to the article.
UCLA HIPAA VIOLATIONS
UCLA Health System pays $865G to settle HIPAA violation charges
July 8, 2011
FierceHealthIT
By Ken Terry
UCLA Health System has agreed to pay a fine of $865,000 and to develop a correction action plan to settle potential HIPAA privacy violations involving improper disclosures of medical records at its three hospitals, the federal Office of Civil Rights (OCR) reports.
OCR launched the investigation in 2009, following complaints by two unnamed celebrities that their medical records had been compromised. The government probe revealed that from 2005 to 2008, "unauthorized employees repeatedly looked at the electronic protected health information of numerous other UCLAHS patients," according to an OCR press release.
The Los Angeles Times reports that violations allegedly occurred at all three UCLAHS hospitals: Ronald Reagan UCLA Medical Center, Santa Monica UCLA Medical Center, and Orthopaedic Hospital and Resnick Neuropsychiatric Hospital, which are regarded as a single unit.
The hospital had disclosed in April 2008 that it had discovered that several employees had snooped into the patient records of dozens of celebrities, including Britney Spears, Tom Cruise and Maria Shriver.
When the alleged violations came to light in 2008, the California legislature passed a law that imposed escalating fines on hospitals for patient privacy breaches. The state fined UCLAHS $95,000 in 2009, reportedly in connection with the medical records of the late Michael Jackson.
The UCLAHS settlement with OCR is much smaller than previous HIPAA settlements, including those involving CVS Caremark ($2.25 million) and Rite Aid ($1 million).
As part of its settlement, UCLAHS agreed to institute new security and privacy policies, improve employee training, take action against employees who violate privacy rules, and designate an independent monitor to oversee compliance.
In a statement, UCLAHS said, "The UCLA Health System considers patient confidentiality a critical part of our mission of patient care, teaching and research. Over the past three years, we have worked diligently to strengthen our staff training, implement enhanced data security systems and increase our auditing capabilities."
MEDICAL ETHICS--RESEARCH ON MEDICAL RECORDS WITHOUT INFORMED CONSENT
J Law Med Ethics. 2008 Fall;36(3):560-6. doi: 10.1111/j.1748-720X.2008.304.x.
Research on medical records without informed consent.
Miller FG.
Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.
PMID: 18840249 [PubMed - indexed for MEDLINE]
Monday, May 26, 2014
UCSD doctor concealed six-figure pay from medical device company and used that company's products on his patient did nothing wrong; UCSD says he did nothing wrong
Dr. William Taylor, UCSD, implanted screws from a company that paid him a six-figure income and in which he owned hundreds of thousands of dollars in stock options. UCSD paid for his legal defense, saying he did nothing wrong. UCSD paid $1.75 million settlement to avoid trial.
It took longer to uncover some critical details that Dr. William Taylor, the surgeon, had not told the retired special education teacher or the university: He owned stock options worth hundreds of thousands of dollars in the company selling the spinal devices and had also collected six-figure annual fees from the same firm, the lawsuit said. Disclosure of such corporate payments is required by state law and university policy.
A lawyer for UCSD said Taylor did nothing wrong and denied that any patients were harmed. But the university last year paid Kitrosser $1.75 million to settle the case.
Dr. William Taylor got his medical degree from UCLA, whose medical school seems have particular problems with conflicts of interest.
UC system struggles with professors' outside earnings
Failing to report compensation from other sources leads to concerns about conflicts.
BY MELODY PETERSEN
OC Register
May 25, 2014
Doctors eventually solved the mystery of why Brenda Kitrosser suffered from unrelenting pain after her back surgery at a University of California hospital in San Diego.
A UCSD surgeon had implanted experimental screws and other hardware into her back, promising this would relieve her pain. Instead the devices pressed on her nerves endlessly, according to a lawsuit she filed later.
It took longer to uncover some critical details that Dr. William Taylor, the surgeon, had not told the retired special education teacher or the university: He owned stock options worth hundreds of thousands of dollars in the company selling the spinal devices and had also collected six-figure annual fees from the same firm, the lawsuit said. Disclosure of such corporate payments is required by state law and university policy.
A lawyer for UCSD said Taylor did nothing wrong and denied that any patients were harmed. But the university last year paid Kitrosser $1.75 million to settle the case.
The controversy over Taylor’s undisclosed compensation is not an isolated case. The University of California has repeatedly failed to discipline medical professors who did not disclose payments from drugmakers and medical companies.
Last month, after UCLA paid $10 million to settle a lawsuit that centered on undisclosed corporate compensation, the non-profit group Consumer Watchdog called on state Attorney General Kamala Harris to investigate how widespread the unreported payments have become.
In a letter to Harris, the Santa Monica-based consumer group said that evidence presented in the case had shown that the university’s policies were “either inadequate or unenforced.”
“Patients in UC hospitals deserve the most reliable surgical devices and medication,” the group wrote, “and they shouldn’t be treated as subjects in expensive experiments.”
Officials at UCLA and UCI said they have recently increased efforts to make sure professors comply with the rules. UCLA doubled its compliance staff and hired a chief compliance officer. UCI’s chancellor directed all medical faculty to certify they were in compliance with reporting requirements and not engaging in unauthorized outside activities.
Those changes came after a series of undisclosed compensation cases involving professors from across the UC system. In each case, the professors who received the payments were involved in promoting or encouraging the use of a company’s product at the same time they were treating patients. In all the cases except one, it was people from outside the university who discovered the undisclosed payments.
• In a Los Angeles courtroom last month, Dr. Robert Pedowitz, the former chair of UCLA’s orthopedic surgery department, testified that administrators retaliated against him after he tried to get surgeons to report their corporate payments – including one doctor who said he had received $250,000 from a device maker for just 20 days of work. Just before closing arguments, UCLA agreed to pay Pedowitz $10 million to settle the case. The university said administrators did nothing wrong.
Dr. Thomas Ahlering
FILE PHOTO: MARK RIGHTMIRE, ORANGE COUNTY REGISTER
• At UC Irvine, Dr. Thomas Ahlering received more than $100,000 since 2002 from a company selling a surgical robot, but put most of that money in his nonprofit foundation without disclosing it, the Register reported last year. University officials say they have since required Ahlering to turn over $4,000 of that money to the school.
• An investigation by U.S. Sen. Charles Grassley in 2009 found that UCLA spinal surgeon Dr. Jeffrey Wang had failed to report almost a half million dollars in compensation he had received from several companies. UCLA officials say Wang was required to turn over an undisclosed portion of that to the university.
Although some of the professors were required to return a portion of their undisclosed pay to the university, it’s not clear whether the universities disciplined them in any other way.
In Oakland, UC administrators said they have an obligation to encourage faculty to work with companies to develop new medicines and medical devices that can help the public. And they pointed to the policies that the university has long had in place to require faculty to disclose payments.
“We also recognize that more can be done to increase transparency and oversight,” said Steve Montiel, a spokesperson at UC’s Office of the President, “and we are reviewing our policies to determine how best to achieve these goals.”
* * *
Under state law, UC faculty who are leading research must disclose publicly any payments or gifts they receive from the companies or other parties involved in those studies. They must also disclose how much stock or stock options they hold in that company.
According to university policy, all faculty also must disclose on internal annual reports how much time they are spending on outside activities, as well as how much they were paid for that work.
Friday, May 23, 2014
Even Moderate Drinking Increases the Risk for Cancer
Even Moderate Drinking Increases the Risk for Cancer
Zosia Chustecka
Medscape
April 08, 2011
April 8, 2011 — "A considerable proportion of the most common and most lethal cancers is attributable to former and current alcohol consumption," concludes a large European study published online April 8 in BMJ.
The researchers attribute about 10% of all cancers in men and about 3% of all cancers in women to previous and current alcohol consumption.
The estimates come from an analysis of data from the huge ongoing European Prospective Investigation Into Cancer (EPIC) and from representative data on alcohol consumption compiled by the World Health Organization (WHO).
The risk increases even with drinking moderate amounts.
"This research supports existing evidence that alcohol causes cancer and that the risk increases even with drinking moderate amounts," coauthor Naomi Allen, DPhil, an epidemiologist at Oxford University, United Kingdom, said in a statement.
The original data in the EPIC study were collected from 1992 to 2000, so "the results from this study reflect the impact of people's drinking habits about 10 years ago," Dr. Allen noted.
"People are drinking even more now than they were then, and this could lead to more people developing cancer because of alcohol in the future," she added.
Data From 8 Countries
The EPIC study, which is still ongoing, is one of the largest studies of diet and cancer ever conducted. It involved more than half a million people in Europe. For this analysis of alcohol and cancer, the researchers used EPIC data from 363,988 participants from 8 European countries — France, Italy, Spain, the Netherlands, United Kingdom, Greece, Germany, and Denmark. Two of these centers (France and the Netherlands) recruited only women, so the total cohort was about two thirds female (254,870 women; 109,118 men). Data on the incidence of cancer was obtained through record linkage with national cancer centers and from sources such as death certificates, health insurance records, and pathology reports. Information on alcohol consumption was collected using a detailed questionnaire about the frequency and amount of drinking and the type of beverages consumed during the previous year. The researchers also computed data on alcohol exposure in the general population using data from a WHO survey. Cancer Attributable to Alcohol The researchers assumed a causal association between alcohol and cancer of the upper aerodigestive tract (which includes the oral cavity, pharynx, larynx, and esophagus), liver cancer, female breast cancer, and colorectal cancer (as decreed by the WHO's International Agency for Research on Cancer). The team then calculated the proportion of these specific cancers that could be attributable to previous and current alcohol consumption. They estimated that, in 2008, alcohol was responsible for 44% of the upper aerodigestive tract cancers in men and 25% in women, 33% of liver cancer in men and 18% in women, 17% of colorectal cancer in men and 4% in women, and 5% of breast cancer in women. A substantial portion of these cancers attributable to alcohol consumption was linked to drinking more than the currently recommended upper limit, the researchers note. The World Cancer Research Fund and the American Institute for Cancer Research recommend a maximum of 2 drinks per day (about 28 g of alcohol) for men and 1 drink (about 12 g) for women. The team calculated that drinking more than this was responsible for 57% to 87% of the cancers attributable to alcohol (i.e., upper aerodigestive tract, liver, colorectal, and female breast cancer) in men and from 40% to 98% in women. "Our data show that many cancer cases could have been avoided if alcohol consumption is limited to 2 alcoholic drinks per day in men and 1 alcoholic drink per day in women, which are the recommendations of many health organizations," said lead author Madlen Schütze, PhD student and epidemiologist at the German Institute of Human Nutrition in Potsdam-Rehbrücke, Nuthetal, Germany. "Even more cancer cases could be prevented if people reduced their alcohol intake to below recommended guidelines or stopped drinking alcohol altogether," she said in a statement. Although a substantial portion of the cancers were attributable to high alcohol intake, the remaining cancers were attributable to drinking alcohol at or under the currently recommended levels. Risk Increases With Every Drink "The cancer risk increases with every drink, so even moderate amounts of alcohol — such as a small drink each day — increases the risk of these cancers," according to a press release from Cancer Research UK, which cosponsors the ongoing EPIC study, along with several European agencies. "Many people just don't know that drinking alcohol can increase their cancer risk," said Sara Hiom, director of health information at Cancer Research UK. "Cutting back on alcohol is one of the most important ways of lowering your cancer risk," along with not smoking and maintaining a healthy bodyweight, she said. The researchers touch on this point in their discussion. They refer back to studies that have shown a beneficial effect of alcohol on death from cardiovascular disease, especially coronary heart disease and ischemic stroke, which have in the past led to recommendations to enjoy a drink to benefit the heart. But they point out that "even though light to moderate alcohol consumption might decrease the risk for cardiovascular disease, and mortality, the net effect is harmful." "Thus, alcohol consumption should not be recommended to prevent cardiovascular disease or all-cause mortality," they write. No Sensible Limit The researchers also emphasize that this latest study, in addition to several others, shows that "there is no sensible limit below which the risk of cancer is decreased." This point was also made recently in an editorial in the Journal of the National Cancer Institute (2009;101:282-283), which accompanied findings from the British Million Women Study showing that even 1 drink a day significantly increased the risk for cancer (J Natl Cancer Inst. 2009;101:296-305). There is no level of alcohol than can be considered safe. At that time, editorialists Michael Lauer, MD, and Paul Sorlie, PhD, from the division of prevention and population sciences at the National Heart, Lung and Blood Institute in Bethesda, Maryland, wrote: "From a standpoint of cancer risk, the message of this report could not be clearer. There is no level of alcohol that can be considered safe." BMJ. Published online April 8, 2011. Full text
Zosia Chustecka
Medscape
April 08, 2011
April 8, 2011 — "A considerable proportion of the most common and most lethal cancers is attributable to former and current alcohol consumption," concludes a large European study published online April 8 in BMJ.
The researchers attribute about 10% of all cancers in men and about 3% of all cancers in women to previous and current alcohol consumption.
The estimates come from an analysis of data from the huge ongoing European Prospective Investigation Into Cancer (EPIC) and from representative data on alcohol consumption compiled by the World Health Organization (WHO).
The risk increases even with drinking moderate amounts.
"This research supports existing evidence that alcohol causes cancer and that the risk increases even with drinking moderate amounts," coauthor Naomi Allen, DPhil, an epidemiologist at Oxford University, United Kingdom, said in a statement.
The original data in the EPIC study were collected from 1992 to 2000, so "the results from this study reflect the impact of people's drinking habits about 10 years ago," Dr. Allen noted.
"People are drinking even more now than they were then, and this could lead to more people developing cancer because of alcohol in the future," she added.
Data From 8 Countries
The EPIC study, which is still ongoing, is one of the largest studies of diet and cancer ever conducted. It involved more than half a million people in Europe. For this analysis of alcohol and cancer, the researchers used EPIC data from 363,988 participants from 8 European countries — France, Italy, Spain, the Netherlands, United Kingdom, Greece, Germany, and Denmark. Two of these centers (France and the Netherlands) recruited only women, so the total cohort was about two thirds female (254,870 women; 109,118 men). Data on the incidence of cancer was obtained through record linkage with national cancer centers and from sources such as death certificates, health insurance records, and pathology reports. Information on alcohol consumption was collected using a detailed questionnaire about the frequency and amount of drinking and the type of beverages consumed during the previous year. The researchers also computed data on alcohol exposure in the general population using data from a WHO survey. Cancer Attributable to Alcohol The researchers assumed a causal association between alcohol and cancer of the upper aerodigestive tract (which includes the oral cavity, pharynx, larynx, and esophagus), liver cancer, female breast cancer, and colorectal cancer (as decreed by the WHO's International Agency for Research on Cancer). The team then calculated the proportion of these specific cancers that could be attributable to previous and current alcohol consumption. They estimated that, in 2008, alcohol was responsible for 44% of the upper aerodigestive tract cancers in men and 25% in women, 33% of liver cancer in men and 18% in women, 17% of colorectal cancer in men and 4% in women, and 5% of breast cancer in women. A substantial portion of these cancers attributable to alcohol consumption was linked to drinking more than the currently recommended upper limit, the researchers note. The World Cancer Research Fund and the American Institute for Cancer Research recommend a maximum of 2 drinks per day (about 28 g of alcohol) for men and 1 drink (about 12 g) for women. The team calculated that drinking more than this was responsible for 57% to 87% of the cancers attributable to alcohol (i.e., upper aerodigestive tract, liver, colorectal, and female breast cancer) in men and from 40% to 98% in women. "Our data show that many cancer cases could have been avoided if alcohol consumption is limited to 2 alcoholic drinks per day in men and 1 alcoholic drink per day in women, which are the recommendations of many health organizations," said lead author Madlen Schütze, PhD student and epidemiologist at the German Institute of Human Nutrition in Potsdam-Rehbrücke, Nuthetal, Germany. "Even more cancer cases could be prevented if people reduced their alcohol intake to below recommended guidelines or stopped drinking alcohol altogether," she said in a statement. Although a substantial portion of the cancers were attributable to high alcohol intake, the remaining cancers were attributable to drinking alcohol at or under the currently recommended levels. Risk Increases With Every Drink "The cancer risk increases with every drink, so even moderate amounts of alcohol — such as a small drink each day — increases the risk of these cancers," according to a press release from Cancer Research UK, which cosponsors the ongoing EPIC study, along with several European agencies. "Many people just don't know that drinking alcohol can increase their cancer risk," said Sara Hiom, director of health information at Cancer Research UK. "Cutting back on alcohol is one of the most important ways of lowering your cancer risk," along with not smoking and maintaining a healthy bodyweight, she said. The researchers touch on this point in their discussion. They refer back to studies that have shown a beneficial effect of alcohol on death from cardiovascular disease, especially coronary heart disease and ischemic stroke, which have in the past led to recommendations to enjoy a drink to benefit the heart. But they point out that "even though light to moderate alcohol consumption might decrease the risk for cardiovascular disease, and mortality, the net effect is harmful." "Thus, alcohol consumption should not be recommended to prevent cardiovascular disease or all-cause mortality," they write. No Sensible Limit The researchers also emphasize that this latest study, in addition to several others, shows that "there is no sensible limit below which the risk of cancer is decreased." This point was also made recently in an editorial in the Journal of the National Cancer Institute (2009;101:282-283), which accompanied findings from the British Million Women Study showing that even 1 drink a day significantly increased the risk for cancer (J Natl Cancer Inst. 2009;101:296-305). There is no level of alcohol than can be considered safe. At that time, editorialists Michael Lauer, MD, and Paul Sorlie, PhD, from the division of prevention and population sciences at the National Heart, Lung and Blood Institute in Bethesda, Maryland, wrote: "From a standpoint of cancer risk, the message of this report could not be clearer. There is no level of alcohol that can be considered safe." BMJ. Published online April 8, 2011. Full text
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