Cops: Hospital worker accused of rape kept working
Seattle PI
November 26, 2014
BRIDGEPORT,
Conn. (AP) — Connecticut police say a hospital allowed a nursing
assistant to continue working there for three months after a patient
reported being raped by him.
The Connecticut Post reports (http://bit.ly/1uG3Bi9 ) that Gonzalo Flores was charged Tuesday with raping a paralyzed male patient in March at St. Vincent's Medical Center. He was already awaiting trial on charges he sexually assaulted another patient in June.
An arrest warrant says Flores admitted having other sexual encounters with patients.
The
affidavit says the hospital's director of safety and security told
police he knew about the allegation in March but could not
substantiate it.
Flores' lawyer declined to comment.
Hospital spokeswoman Caryn S. Kaufman said Tuesday that St. Vincent's takes complaints by patients and staff very seriously and investigates all claims.
Wednesday, November 26, 2014
Thursday, October 30, 2014
Dr. Hooman Noorchashm calls for FDA Deputy Director resignation over power morcellation conflicts
American Recall Center
Oct. 30, 2014
Dr. Hooman Noorchashm, an outspoken critic of the use of power morcellators in gynecological operations, recently published an open letter calling for the resignation of Dr. William Maisel, the deputy director and chief scientist at the FDA’s Center for Devices and Radiological Health (CDRH). Dr. Noorchashm, a cardiothoracic surgeon at Brigham & Women’s Hospital and surgical lecturer at Harvard University, accuses Dr. Maisel of a conflict of interest.
As it pertains to the deadly hazard of gynecological morcellators in the United States and abroad, your primary stated mission as a strong industry advocate represents a clear conflict of ethical interest in guaranteeing patient safety. Under your leadership, the CDRH has failed to call for a ban on power morcellators, nearly two months after the data was clearly delineated and the victims presented at the FDA advisory – nearly one year after we raised an alarm from Boston, MA.1Dr. Noorchashm has been a central figure in the fight to ban power morcellation. When the FDA issued a safety communication recommending that patients talk with their doctors about power morcellation, Dr. Noorchashm criticized the FDA for not going far enough, arguing that a forced recall of power morcellators should be issued rather than simply advising people to talk with their doctors. To date the FDA has not issued such a mandatory recall, although Johnson & Johnson did voluntarily withdraw its Ethicon morcellation devices from the market, and several insurance providers have stopped covering morcellators as a surgical tool.
In his latest communication, Dr. Noorchashm accused the FDA of deliberately dragging its feet on a potential power morcellator ban.
It is now our understanding that the FDA may be delaying a final statement. This delay in a ban on power morcellators by the FDA is occurring despite the overwhelming evidence of deadly hazard. And many industry advocates appear to have been assured that FDA will not be banning the power morcellators from market.Dr. Noochashm has called for Dr. Maisel “to do right by all those women harmed, resign from the CDRH and relinquish the responsibility to protect the public’s health to those of your colleagues at FDA with capacity and patient safety foremost in their highest priority.” The letter appeared as part of Dr. Noorchashm’s larger effort to build awareness about health risks related to power morcellation, which includes a petition on Change.org.
[It seems] increasingly clear that this lethargy in FDA action to protect the public is directly related to industry lobby to which you, as a CDRH leader, have clearly stated your loyalty in the press.
For Dr. Noorchashm, the power morcellation issue is both a matter of public health and one of personal interest. His wife, Amy Reed, an anesthesiologist at Beth Israel Hospital in Boston, received a morcellator-assisted hysterectomy in October 2013. A few days later, Dr. Reed learned that she had leiomyosarcoma, a rare form of soft-tissue cancer, and that the morcellation procedure may have worsened her prognosis. Since then, Dr. Noorchashm has been on a campaign to ban the use of power morcellators altogether.
Although it’s hard to predict how the FDA will respond to Dr. Nooschashm’s latest call for Dr. Maisel’s resignation—if the agency responds at all—the letter does seem to have drawn some attention to this important issue. Power morcellation has been discussed in recent days on popular shows like The Dr. Oz Show, and a number of articles have appeared in reputable publications like The Wall Street Journal and various health news outlets. Even if Dr. Maisel does not resign as Dr. Noorchashm wishes, at least more people are now talking about the potential problems of power morcellators.
Tuesday, September 16, 2014
Broken Bed Alarm Blamed for UCSD Walkaway Patient's Death
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. 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...
A QUESTION OF PRIORITIES: Profits, Short Staffing, and the Shortchanging of Patient Care at UC Medical Centers
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...
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.]
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. 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...
A QUESTION OF PRIORITIES: Profits, Short Staffing, and the Shortchanging of Patient Care at UC Medical Centers
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...
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.]
Wednesday, September 10, 2014
Xanax, Valium Raise Alzheimer's Risk: Study
Xanax, Valium Raise Alzheimer's Risk: Study
NewsMaxx
10 Sep 2014
Older adults who habitually use sedatives for anxiety or insomnia may have a heightened risk of developing Alzheimer's disease, a new study suggests.
The drugs in question are benzodiazepines, a widely prescribed group of sedatives that include lorazepam (Ativan), diazepam (Valium) and alprazolam (Xanax). Older adults commonly take the drugs for anxiety or insomnia, often long-term, according to background information in the study.
That's despite the fact that guidelines call for only short-term use of the drugs, at most. In 2012, the American Geriatrics Society (AGS) put benzodiazepines on its list of drugs considered "potentially inappropriate" for seniors, because of risks like confusion, dizziness and falls.
The current study isn't the first to link benzodiazepines to Alzheimer's risk, but it adds to evidence that longer-term use of the drugs -- beyond three months -- might be a risk factor, according to lead researcher Sophie Billioti de Gage, a Ph.D. candidate at the University of Bordeaux, in France.
"For people needing or using benzodiazepines, it seems crucial to encourage physicians to carefully balance the benefits and risks when renewing the prescription," Billioti de Gage said.
But the study was only able to find an association between the drugs and Alzheimer's risk.
It wasn't designed to definitively prove that the drugs caused the memory-robbing condition, according to geriatrics specialist Dr. Gisele Wolf-Klein, who was not involved in the research.
One reason is that the findings are based on prescription records. "We know the drugs were prescribed, but we don't know how often people took them, or if they took them at all," said Wolf-Klein, director of geriatric education at North Shore-LIJ Health System in New Hyde Park, N.Y.
Regardless, she said, benzodiazepines have enough known risks to warrant concern.
"There is absolutely no doubt these drugs have dangerous side effects," Wolf-Klein said. "It's important for people to understand that they can be addictive, and increase the risk of confusion and falls."
The study was published online Sept. 9 in BMJ.
For the study, Billioti de Gage's team examined the histories of nearly 1,800 older adults with Alzheimer's, comparing each one with four dementia-free people of the same age and sex.
They found that people who'd been prescribed benzodiazepines for more than three months were 51 percent more likely to develop Alzheimer's, versus people who'd never used the drugs.
The risk was almost doubled if they'd taken the medications for more than six months. According to Billioti de Gage, people in the early stages of Alzheimer's can have symptoms like sleep problems and anxiety. That raises the possibility that benzodiazepine use is the result of Alzheimer's, and not the cause of the disease.
But she said her study was designed to counter this possibility. They only considered prescriptions that were started at least five years before a person's Alzheimer's diagnosis.
Billioti de Gage said the medications can be useful short-term. And, she pointed out, the study found no increased Alzheimer's risk among older adults who were prescribed the drugs according to international guidelines; that means using them no longer than one month for insomnia, and no more than three months for anxiety symptoms.
Read more http://www.NewsmaxHealth.com/Health-News/sedatives-alzheimers-xanax-valium/2014/09/10/id/593712/#ixzz3CyTC3GUJ
NewsMaxx
10 Sep 2014
Older adults who habitually use sedatives for anxiety or insomnia may have a heightened risk of developing Alzheimer's disease, a new study suggests.
The drugs in question are benzodiazepines, a widely prescribed group of sedatives that include lorazepam (Ativan), diazepam (Valium) and alprazolam (Xanax). Older adults commonly take the drugs for anxiety or insomnia, often long-term, according to background information in the study.
That's despite the fact that guidelines call for only short-term use of the drugs, at most. In 2012, the American Geriatrics Society (AGS) put benzodiazepines on its list of drugs considered "potentially inappropriate" for seniors, because of risks like confusion, dizziness and falls.
The current study isn't the first to link benzodiazepines to Alzheimer's risk, but it adds to evidence that longer-term use of the drugs -- beyond three months -- might be a risk factor, according to lead researcher Sophie Billioti de Gage, a Ph.D. candidate at the University of Bordeaux, in France.
"For people needing or using benzodiazepines, it seems crucial to encourage physicians to carefully balance the benefits and risks when renewing the prescription," Billioti de Gage said.
But the study was only able to find an association between the drugs and Alzheimer's risk.
It wasn't designed to definitively prove that the drugs caused the memory-robbing condition, according to geriatrics specialist Dr. Gisele Wolf-Klein, who was not involved in the research.
One reason is that the findings are based on prescription records. "We know the drugs were prescribed, but we don't know how often people took them, or if they took them at all," said Wolf-Klein, director of geriatric education at North Shore-LIJ Health System in New Hyde Park, N.Y.
Regardless, she said, benzodiazepines have enough known risks to warrant concern.
"There is absolutely no doubt these drugs have dangerous side effects," Wolf-Klein said. "It's important for people to understand that they can be addictive, and increase the risk of confusion and falls."
The study was published online Sept. 9 in BMJ.
For the study, Billioti de Gage's team examined the histories of nearly 1,800 older adults with Alzheimer's, comparing each one with four dementia-free people of the same age and sex.
They found that people who'd been prescribed benzodiazepines for more than three months were 51 percent more likely to develop Alzheimer's, versus people who'd never used the drugs.
The risk was almost doubled if they'd taken the medications for more than six months. According to Billioti de Gage, people in the early stages of Alzheimer's can have symptoms like sleep problems and anxiety. That raises the possibility that benzodiazepine use is the result of Alzheimer's, and not the cause of the disease.
But she said her study was designed to counter this possibility. They only considered prescriptions that were started at least five years before a person's Alzheimer's diagnosis.
Billioti de Gage said the medications can be useful short-term. And, she pointed out, the study found no increased Alzheimer's risk among older adults who were prescribed the drugs according to international guidelines; that means using them no longer than one month for insomnia, and no more than three months for anxiety symptoms.
Read more http://www.NewsmaxHealth.com/Health-News/sedatives-alzheimers-xanax-valium/2014/09/10/id/593712/#ixzz3CyTC3GUJ
Saturday, September 6, 2014
Potassium-rich Foods Reduce Risk of Death and Stroke in Older Women, Study Finds
Potassium-rich Foods Reduce Risk of Death and Stroke in Older Women, Study Finds
Sep 05, 2014
..."Previous studies have shown that potassium consumption may lower
blood pressure. But whether potassium intake could prevent stroke or
death wasn't clear," said Sylvia Wassertheil-Smoller, the study's senior
author and distinguished university professor emerita, department of
epidemiology and population health, at Albert Einstein College of
Medicine, in a press statement...
At the end of the study, researchers found that women who ate more potassium-rich food were 12 percent less likely to suffer a stroke compared to those that ate lower amounts of potassium. They were also 16 percent less likely to suffer an ischemic stroke and 10 percent less likely to die than those who ate the least amount of potassium-rich food. Among the hypertension-free participants, those that ate more potassium had a 27 percent lower ischemic stroke risk and 21 percent reduced risk for all stroke types.
"Only 2.8 percent of women in our study met or exceeded this level. The World Health Organization's daily potassium recommendation for women is lower, at 3,510 mg or more. Still, only 16.6 percent of women we studied met or exceeded that," said Wassertheil-Smoller. "... Some foods high in potassium include white and sweet potatoes, bananas and white beans."
...
Previous studies have found that potassium-rich food blunts the effects of salt on blood pressure, which reduces the risk of developing kidney stones, and possibly decrease bone loss with age.
The current study was published online in the American Heart Association's journal Stroke. The National Heart, Lung and Blood Institute funded the study.
Saturday, August 30, 2014
Many Women Have Died Unnecessarily Because of surgery with MORCELLATORS
Why does Morcellation surgery continue when we know it kills
women? Why do doctors continue to do the surgery? The answer: profits
for medical device companies, profits for doctors.
How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
By Harriet Brown
Prevention Magazine
May 2014
"...Noorchashm stayed up nights writing strongly worded letters, posting comments on every website remotely relevant to the cause, and having strategic conversations with anyone who would talk to him. The only resulting change he saw was in his own reputation. He'd gone from star surgeon to social leper, shut out of the operating room at his own hospital (though he can't prove it was because of the campaign) and avoided by colleagues and former friends. "They closed ranks on me," he says now, with sadness in his voice. "I broke the white code of silence; I hung out our dirty laundry."..."
Dr. Noorchashm asks: "When new technology makes
medicine cheaper and more convenient, how many
patients have to die to prove it's not worth it?"
Petition by Hooman Noorchashm, MD, PhD:
My wife [Dr. Amy Reed] had a surgical procedure that spread cancerous cells throughout her body. She now has stage 4 cancer. Please sign my petition demanding the FDA stop a procedure that has spread cancer in thousands of women.
My wife Amy is a mother of six, and an accomplished anesthesiologist who helped treat victims of the Boston Marathon bombing last year.
How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
By Harriet Brown
Prevention Magazine
May 2014
"...Noorchashm stayed up nights writing strongly worded letters, posting comments on every website remotely relevant to the cause, and having strategic conversations with anyone who would talk to him. The only resulting change he saw was in his own reputation. He'd gone from star surgeon to social leper, shut out of the operating room at his own hospital (though he can't prove it was because of the campaign) and avoided by colleagues and former friends. "They closed ranks on me," he says now, with sadness in his voice. "I broke the white code of silence; I hung out our dirty laundry."..."
Dr. Noorchashm asks: "When new technology makes
medicine cheaper and more convenient, how many
patients have to die to prove it's not worth it?"
Petition by Hooman Noorchashm, MD, PhD:
My wife [Dr. Amy Reed] had a surgical procedure that spread cancerous cells throughout her body. She now has stage 4 cancer. Please sign my petition demanding the FDA stop a procedure that has spread cancer in thousands of women.
My wife Amy is a mother of six, and an accomplished anesthesiologist who helped treat victims of the Boston Marathon bombing last year.
Now, because of a dangerous, but standard, gynecological
procedure her early stage cancer was spread -- causing stage 4 cancer.
Last Fall, Amy went in for a routine hysterectomy to treat what
we thought were benign fibroids, and had a minimally invasive “morcellation”
procedure to remove her uterus. Little did we know that this procedure would
end up spreading malignant cancer cells throughout Amy’s belly. What's more is
that “morcellation” is totally avoidable and it has devastated thousands of
women and families by spreading and upstaging dangerous cancers of the uterus
and ovaries.
Now we’re taking a stand in hopes of banning this surgery for
good, and saving the lives of countless women and mothers. And the momentum is
on our side.
Because of the momentum of this petition,
numerous hospitals around the country have stopped performing this type of
hysterectomy. Last week, a major health insurer -- Blue Cross Blue Shield --
announced that they would no longer cover the procedure. And Johnson &
Johnson, which manufactures some of the surgical tools used in this procedure,
issued a worldwide voluntary recall of the tools called "power
morcellators," saying that they couldn’t guarantee that the procedure was
safe for women to undergo.
The reason this surgical procedure is so controversial is that doctors
have no reliable way of testing whether patients are at risk of having
cancerous cells spread throughout their body during the surgery. That was
the case with Amy -- in the process of removing her uterus, undetected cancer
cells were spread throughout her abdomen region, and stage 4 cancer developed.
The same has happened to scores of other women, globally. Women who went in
thinking they were having a “minimally invasive” procedure, left the operating
room with an advanced stage of cancer.
Last month, the FDA held public hearings on this surgical
procedure. Amy and I traveled down to Washington, D.C., to talk about this
petition and to bring Amy’s story to the attention of FDA and congressional
regulators. They are currently debating whether to ban this procedure or not,
and that’s why I need your help today.
I cannot tell you what this means to my wife, to me, and to our
family. Together, we can help potentially save the lives of thousands of women
moving forward. No other woman should ever have her uterine cancer upstaged to
an advanced stage by a gynecologist practicing this totally avoidable procedure
they call "morcellation."
Thank you,
Hooman Noorchashm, MD, PhD
Boston, MA
Boston, MA
Health Alert: Many Women Have Died Unnecessarily Because Dangerous Cancers of the Uterus and Ovaries Are Being Spread using MORCELLATORS. Stop MORCELLATION in Minimally Invasive Gynecological Surgery.
Friends of the Public,
Many women have been harmed and have died prematurely or unnecessarily because of a routine but avoidable gynecological practice known as MORCELLATION. This world-wide practice has devastated many families for well over two decades now.
More than 600,000 hysterectomies are done in the US every year. By the age of 70, one out of every three American women will have had a hysterectomy. About 90% of these surgeries are done for what is presumed to be a benign condition called fibroids. More and more of these surgeries are done with minimally invasive techniques. Usually, to get the uterus out of the body using the "minimally invasive" technique, it is cut into small pieces with a machine called a morcellator. However, a devastating problem happens if in fact the woman did NOT have fibroids – but if she actually had cancer. Unfortunately, the tests that are done before a hysterectomy do not identify these cancers well. Many gynecologists don't even bother getting any tests. In fact, morcellating cancer spreads the cancer inside the woman’s body.
This is called ‘up staging’ the cancer.
It is important to understand:
1) The average life span following accidental morcellation of sarcoma is only 24-36 months.
2) Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.
3) Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated.
This is an avoidable disaster.
This problem has been recognized for more than two decades. A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma. This means that everyday 2-5 women in the US – and more around the world will have a deadly cancer spread because of morcellation.
This catastrophic problem has happened in our own family and we are fighting to stop this dangerous activity called morcellation. A chance of 1 in 415 for such a devastating outcome is much too high to accept. Women should be told the truth and the practice should stop.
Please help us bring an end to spreading cancer with morcellation. There are alternatives. Some surgeons have begun using a special bag to avoid spreading cancer cells. Several of the reasons why this has not yet become commonplace are the fact that: a) bag morcellation takes more time – and time is money; b) lack of training; and c) lack of awareness. Other people opt for a traditional open hysterectomy. People need to understand their options – but – currently, most women never hear anything about morcellation or about the possibility of cancer upstaging. We need your help.
Please sign our petition so we can get the word out. We want the American Congress of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this "standard of care" by ending the needless waste of life caused by spreading cancer with morcellation.
For more information and original references see: http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=188 ) (also see:http://www.ncbi.nlm.nih.gov/pubmed/23189178) (also see:http://www.ncbi.nlm.nih.gov/pubmed/21565389).
The attached video below shows an example of morcellation http://www.youtube.com/watch?v=fMnzQbRMWJ8
The following companies manufacture and distribute uterine morcellator devices:
1) ETHICON: Gynecare morcellator
2) Storz: Rotocut Morcellator
3) Richard Wolf Medical Instrumentation Company
4) LiNA: LiNA Xcise Cordless Laparoscopic Morcellator
5) Blue Endo MOREsolution Tissue Morcellator
Intuitive Surgical's Da Vinci Robot deserves special mention, as the frequency of robotic hysterectomies performed by minimally invasive gynecologists is currently on the rise across the United States. Note that Intuitive Surgical builds and markets the DaVinci robot, which is not itself a "morcellator". However, use of the DaVinci robot almost invariably appears to require that the uterus be minced up, or morcellated, into smaller pieces inside the woman's belly cavity in order to extract from the abdomen. A clear example is shown in the following YouTube video of DaVinci being used to perform a robotic hysterectomy and manually morcellating the uterus using the endo-wrist component of the robot (morcellation is being performed at minute 5:30 of the video).
https://www.youtube.com/watch?v=f6luiX6UQmg
Without morcellation using equipment manufactured by Intuitive Surgical, robotic hysterectomies would, likely, not be possible using the DaVinci Robot. It is noteworthy that the DaVinci robot does not appear to have a readily available warning label advising against its use to morcellate tumors with malignant potential inside the body. The company's Chief Medical Advisor, Dr. Myriam Curet, a surgeon herself, has been informed and advised of this severe hazard in the use of DaVinci for robotic hysterectomy and the absence of a readily available warning label.
Many women have been harmed and have died prematurely or unnecessarily because of a routine but avoidable gynecological practice known as MORCELLATION. This world-wide practice has devastated many families for well over two decades now.
More than 600,000 hysterectomies are done in the US every year. By the age of 70, one out of every three American women will have had a hysterectomy. About 90% of these surgeries are done for what is presumed to be a benign condition called fibroids. More and more of these surgeries are done with minimally invasive techniques. Usually, to get the uterus out of the body using the "minimally invasive" technique, it is cut into small pieces with a machine called a morcellator. However, a devastating problem happens if in fact the woman did NOT have fibroids – but if she actually had cancer. Unfortunately, the tests that are done before a hysterectomy do not identify these cancers well. Many gynecologists don't even bother getting any tests. In fact, morcellating cancer spreads the cancer inside the woman’s body.
This is called ‘up staging’ the cancer.
It is important to understand:
1) The average life span following accidental morcellation of sarcoma is only 24-36 months.
2) Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.
3) Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated.
This is an avoidable disaster.
This problem has been recognized for more than two decades. A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma. This means that everyday 2-5 women in the US – and more around the world will have a deadly cancer spread because of morcellation.
This catastrophic problem has happened in our own family and we are fighting to stop this dangerous activity called morcellation. A chance of 1 in 415 for such a devastating outcome is much too high to accept. Women should be told the truth and the practice should stop.
Please help us bring an end to spreading cancer with morcellation. There are alternatives. Some surgeons have begun using a special bag to avoid spreading cancer cells. Several of the reasons why this has not yet become commonplace are the fact that: a) bag morcellation takes more time – and time is money; b) lack of training; and c) lack of awareness. Other people opt for a traditional open hysterectomy. People need to understand their options – but – currently, most women never hear anything about morcellation or about the possibility of cancer upstaging. We need your help.
Please sign our petition so we can get the word out. We want the American Congress of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this "standard of care" by ending the needless waste of life caused by spreading cancer with morcellation.
For more information and original references see: http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=188 ) (also see:http://www.ncbi.nlm.nih.gov/pubmed/23189178) (also see:http://www.ncbi.nlm.nih.gov/pubmed/21565389).
The attached video below shows an example of morcellation http://www.youtube.com/watch?v=fMnzQbRMWJ8
The following companies manufacture and distribute uterine morcellator devices:
1) ETHICON: Gynecare morcellator
2) Storz: Rotocut Morcellator
3) Richard Wolf Medical Instrumentation Company
4) LiNA: LiNA Xcise Cordless Laparoscopic Morcellator
5) Blue Endo MOREsolution Tissue Morcellator
Intuitive Surgical's Da Vinci Robot deserves special mention, as the frequency of robotic hysterectomies performed by minimally invasive gynecologists is currently on the rise across the United States. Note that Intuitive Surgical builds and markets the DaVinci robot, which is not itself a "morcellator". However, use of the DaVinci robot almost invariably appears to require that the uterus be minced up, or morcellated, into smaller pieces inside the woman's belly cavity in order to extract from the abdomen. A clear example is shown in the following YouTube video of DaVinci being used to perform a robotic hysterectomy and manually morcellating the uterus using the endo-wrist component of the robot (morcellation is being performed at minute 5:30 of the video).
https://www.youtube.com/watch?v=f6luiX6UQmg
Without morcellation using equipment manufactured by Intuitive Surgical, robotic hysterectomies would, likely, not be possible using the DaVinci Robot. It is noteworthy that the DaVinci robot does not appear to have a readily available warning label advising against its use to morcellate tumors with malignant potential inside the body. The company's Chief Medical Advisor, Dr. Myriam Curet, a surgeon herself, has been informed and advised of this severe hazard in the use of DaVinci for robotic hysterectomy and the absence of a readily available warning label.
Sunday, August 17, 2014
China watchdogs are going after rampant corruption in healthcare, among other enterprises
Tread carefully, Dr. Binder! Make sure the people you do business with in China aren't part of the "rampant graft" in healthcare there. The anti-corruption watchdog in China has announced five more years of cracking-down on corruption.
UCLA is involved with healthcare company in China:
ADICON, UCLA, and Second Affiliated Hospital of Zhejiang University form Triangle Telepathology services
Adicon
7.11.2012
UCLA Doctor Scott Binder and friends
In the morning of Apr. 23, ADICON’s COO Janny Yang, the head of UCLA pathology outreach service Scott Binder, and the chair of second affiliated hospital Jianan Wang, signed the telepathology service contract. Three parties will utilize their own resources and advantages to provide high-end diagnosis to the clients. The trilateral leaders attending the signing ceremony included ADICON’s COO Janny Yang, international cooperation manager Ti He; UCLA’s vice director of pathology department and supervisor of dermal pathology discipline Scott Binder, supervisor of gynecological pathology and cellular pathology discipline Professor Qian JianYu; the second affiliated hospital Zhejiang university medical school’s president Wang Jian’an, vice president You Xiangdong, admin office director Wang Kai, medical department vice director Xu Hangdong, medical lab director Chen Gongxiang, pathology department director Chen Derong, International affairs office vice director Yang Mingli.
Each party expressed their good wishes for the collaboration. Dr. Binder hopes to deliver better service capacities, as well as more chances of health education and research. Mr. Wang hopes that the participation of ADICON can reach more patients who need such services. The head of pathology, Derong Chen reiterates that the digital pathology is the trend of pathology services and communications. The involvement of three parties gives this service much more chances to enjoy the high-end resources not only in China, but also abroad. Janny mentioned that much more pathologists and patients can get access of the diagnosis through ADICON’s network and logistics. It will give the final result much bigger than we thought. ADICON expected to realize a “1+1+1>3” everyone-win situation through the collaboration.
UCLA is a leading medical center in US. From the ranking by USNews, multiple areas, such as GI, urology, ophthalmology are in top 5. Through this partnership, UCLA will deliver dermatology, gastrointestinal pathology, hematology, cytology services in China. Consisting of 47 clinical or medical departments, the second affiliated hospital Zhejiang university medical school is a renowned “AAA” hospital with a history of over 100 years. It will combine the existing strong capacities of Second affiliated hospital pathology team and ADICON pathology team to serve the patients.
This partnership also includes the technical training program and quality control program, in order to improve ADICON’s pathology team. ADICON will utilize this contract to solve the difficult-to-diagnosis cases, as well as to provide research chances. It will be a comprehensive platform of “diagnosis, education, research, and service”.
China warns again of dark side of the mooncakes
SHANGHAI(Reuters)
China's crackdown on corruption, a scourge Communist Party leaders fear threatens their hold on power, is likely to last at least another five years, an official said, warning also against the mid-autumn tradition of handing out mooncakes as gifts.
President Xi Jinping has promised to go after "tigers and flies" in rooting out rampant graft, a campaign that has brought down politicians and company executives in industries including oil, cars and healthcare.
UCLA is involved with healthcare company in China:
ADICON, UCLA, and Second Affiliated Hospital of Zhejiang University form Triangle Telepathology services
Adicon
7.11.2012
UCLA Doctor Scott Binder and friends
In the morning of Apr. 23, ADICON’s COO Janny Yang, the head of UCLA pathology outreach service Scott Binder, and the chair of second affiliated hospital Jianan Wang, signed the telepathology service contract. Three parties will utilize their own resources and advantages to provide high-end diagnosis to the clients. The trilateral leaders attending the signing ceremony included ADICON’s COO Janny Yang, international cooperation manager Ti He; UCLA’s vice director of pathology department and supervisor of dermal pathology discipline Scott Binder, supervisor of gynecological pathology and cellular pathology discipline Professor Qian JianYu; the second affiliated hospital Zhejiang university medical school’s president Wang Jian’an, vice president You Xiangdong, admin office director Wang Kai, medical department vice director Xu Hangdong, medical lab director Chen Gongxiang, pathology department director Chen Derong, International affairs office vice director Yang Mingli.
Each party expressed their good wishes for the collaboration. Dr. Binder hopes to deliver better service capacities, as well as more chances of health education and research. Mr. Wang hopes that the participation of ADICON can reach more patients who need such services. The head of pathology, Derong Chen reiterates that the digital pathology is the trend of pathology services and communications. The involvement of three parties gives this service much more chances to enjoy the high-end resources not only in China, but also abroad. Janny mentioned that much more pathologists and patients can get access of the diagnosis through ADICON’s network and logistics. It will give the final result much bigger than we thought. ADICON expected to realize a “1+1+1>3” everyone-win situation through the collaboration.
UCLA is a leading medical center in US. From the ranking by USNews, multiple areas, such as GI, urology, ophthalmology are in top 5. Through this partnership, UCLA will deliver dermatology, gastrointestinal pathology, hematology, cytology services in China. Consisting of 47 clinical or medical departments, the second affiliated hospital Zhejiang university medical school is a renowned “AAA” hospital with a history of over 100 years. It will combine the existing strong capacities of Second affiliated hospital pathology team and ADICON pathology team to serve the patients.
This partnership also includes the technical training program and quality control program, in order to improve ADICON’s pathology team. ADICON will utilize this contract to solve the difficult-to-diagnosis cases, as well as to provide research chances. It will be a comprehensive platform of “diagnosis, education, research, and service”.
Thursday, August 14, 2014
Ever since Kaiser left its Northern California patients off the list to receive kidney transplants, the evidence seems to be mounting that Kaiser is a particularly bad place for kidney patients.
Kaiser Death Blamed on Recalled Dialysis Fluid
By TISH KRAFT
Courthouse News
August 14, 2014
ALAMEDA, Calif. (CN) - A patient died because Kaiser used recalled dialysis fluid, her distraught daughter claims in an Alameda County Superior Court complaint.
The fluid, made by Fresenius Medical Care, was recalled "after it was found that the products could put patients at risk for cardiac arrest," the complaint states.
v Janal Watkins, individually and as personal representative of the Estate of Janice Rose Watkins sued Kaiser Foundation Health Plan Inc.; Kaiser Foundation Hospitals; Northern California Permanente Medical Group; Fresenius Medical Care; DaVita; Wesley Lesker; Kim Hadley and Satellite Healthcare.
Defendants used Fresenius' GranuFlo and Naturalyte products when they put Janal's mother on dialysis.
After several treatments, Janice had a cardiac arrest due to a condition caused by the high acid concentrates in the products, and died the same day.
The Food and Drug Administration had issued a Class 1 recall on dialysis concentrates GranuFlo and Naturalyte but did not warn outside clinics, which used the products, until an internal memo was leaked, according to the complaint.
A Class I recall indicates that "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death," according to the complaint.
Janice was not warned of the risks, the complaint states.
Defendants "knew or should have known of the recall or inherent dangers of using the Fresenius Medical Products. Defendants collectively continued to administer such products to decedent, which placed her at increased and greater risk for cardiac arrest. Defendants also used unsafe doses" of the products," according to the complaint.
Prior to Janice's hospitalization, she had "lived at her own home, drove her own vehicle, and performed her own activities of daily living. She controlled her own finances. She functioned independent of others. She was in no way nearing death, an irreversible coma, or a persistent vegetative state," according to the complaint.
Mother and daughter had had an extremely close relationship, spending much of their time with each other and seeing or speaking to each other each day, as they have most of their lives, the complaint states.
Janal seeks punitive damages for negligence, medical negligence failure to warn, willful misconduct and wrongful death.
She is represented by Stephen M. Sirota of the Law Offices of Allan R Frumkin in San Ramon.
Kaiser Death Blamed on Recalled Dialysis Fluid
By TISH KRAFT
Courthouse News
August 14, 2014
ALAMEDA, Calif. (CN) - A patient died because Kaiser used recalled dialysis fluid, her distraught daughter claims in an Alameda County Superior Court complaint.
The fluid, made by Fresenius Medical Care, was recalled "after it was found that the products could put patients at risk for cardiac arrest," the complaint states.
v Janal Watkins, individually and as personal representative of the Estate of Janice Rose Watkins sued Kaiser Foundation Health Plan Inc.; Kaiser Foundation Hospitals; Northern California Permanente Medical Group; Fresenius Medical Care; DaVita; Wesley Lesker; Kim Hadley and Satellite Healthcare.
Defendants used Fresenius' GranuFlo and Naturalyte products when they put Janal's mother on dialysis.
After several treatments, Janice had a cardiac arrest due to a condition caused by the high acid concentrates in the products, and died the same day.
The Food and Drug Administration had issued a Class 1 recall on dialysis concentrates GranuFlo and Naturalyte but did not warn outside clinics, which used the products, until an internal memo was leaked, according to the complaint.
A Class I recall indicates that "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death," according to the complaint.
Janice was not warned of the risks, the complaint states.
Defendants "knew or should have known of the recall or inherent dangers of using the Fresenius Medical Products. Defendants collectively continued to administer such products to decedent, which placed her at increased and greater risk for cardiac arrest. Defendants also used unsafe doses" of the products," according to the complaint.
Prior to Janice's hospitalization, she had "lived at her own home, drove her own vehicle, and performed her own activities of daily living. She controlled her own finances. She functioned independent of others. She was in no way nearing death, an irreversible coma, or a persistent vegetative state," according to the complaint.
Mother and daughter had had an extremely close relationship, spending much of their time with each other and seeing or speaking to each other each day, as they have most of their lives, the complaint states.
Janal seeks punitive damages for negligence, medical negligence failure to warn, willful misconduct and wrongful death.
She is represented by Stephen M. Sirota of the Law Offices of Allan R Frumkin in San Ramon.
Wednesday, June 11, 2014
Unconscious patient's cell phone captures doctors mocking him during colonoscopy
See all posts on colonoscopies.
Unconscious patient's cell phone captures doctors mocking him during colonoscopy.
Sarah Fruchtnicht
Opposingviews.com
22 Apr 2014
A Virginia man is suing after his cell phone captured audio of doctors allegedly mocking him while he was under anesthesia for a colonoscopy.
The plaintiff, D.B., says doctors joked about firing a gun up his rectum and accused him of having STDs during his medical procedure.
"On April 18, 2013, during a colonoscopy, plaintiff was verbally brutalized and defamed by the very doctors to whom he entrusted his life while under anesthesia," the complaint says.
D.B. sued Safe Sedation LLC and Safe Sedation Management in Fairfax County Court for defamation, infliction of emotional distress and illegally disclosing his health records.
The patient said he left his phone on and recorded everything on accident. When he later drove home with his wife, they discovered the recording.
The doctors, Tiffany Ingham and Soloman Shah, are not named as defendants but are accused of mocking D.B. as soon as the anesthetic knocked him out.
"Tiffany Ingham, M.D. started to mock, and then continued to mock, the amount of medicine required to anesthetize plaintiffs," the complaint states. "Referring to plaintiff, Soloman Shah, M.D. commented that a teaching physician known to both him and Tiffany Ingham, M.D. 'would eat him for lunch.'
"Tiffany Ingham, M.D. agreed that plaintiff would be 'eaten alive' and also jokingly discussed a hypothetical of firing a gun up a rectum," it says.
"And really, after five minutes of talking to you in pre-op I wanted to punch you in the face and man you up a little bit," Ingham allegedly said to the patient while he was under.
Doctors allegedly discussed D.B.'s prescription medication and an irritation he had on his penis. v "A medical assistant at GMA touched plaintiff's penis during the colonoscopy," the complaint states. "Although plaintiff's penis is not involved in a colonoscopy, the medical assistant noted there was not 'much of a penile rash.' Tiffany Ingham, M.D. responded, 'No, you'll accidentally rub up against it. Some syphilis on your arm or something.' Solomon Shah, M.D. responded, 'That would be bad. That would be real bad.'"
"Tiffany Ingham, M.D. then stated to all present in the operating suite that, 'It's probably tuberculosis in the penis, so you'll be all right.'"
The lawsuit notes that the plaintiff has neither disease.
In a final remark on tape, Ingham allegedly said she would make a note in D.B.'s file that he had hemorrhoids even though he didn't.
He's seeking $1 million in compensatory damages and $350,000 in punitive damages. COMMENTS
No need to anesthetize everyone
By: Publicgood
I did just fine during my colonoscopy with no anesthesia at all. I think doctors who anesthetize all patients are doing it for the same reason that they refuse to allow patients to have a DVD of the procedure: they don't want to listen to patient's questions either during the procedure or later on.
Colonoscopy souvenir DVDs
By: Publicgood
I am shocked that doctors across the US have stopped providing DVDs of colonoscopies in response to medical records requests. It's okay that they don't automatically give souvenir DVDs, but it's not okay to violate the law regarding patient's rights to access to their medical records. Doctors even claim that it's a cost-cutting measure; this is obviously false since digital memory is getting cheaper by the month and has always been cheaper and more compact than the VHS tapes on which colonoscopies used to be saved.
Unconscious patient's cell phone captures doctors mocking him during colonoscopy.
Sarah Fruchtnicht
Opposingviews.com
22 Apr 2014
A Virginia man is suing after his cell phone captured audio of doctors allegedly mocking him while he was under anesthesia for a colonoscopy.
The plaintiff, D.B., says doctors joked about firing a gun up his rectum and accused him of having STDs during his medical procedure.
"On April 18, 2013, during a colonoscopy, plaintiff was verbally brutalized and defamed by the very doctors to whom he entrusted his life while under anesthesia," the complaint says.
D.B. sued Safe Sedation LLC and Safe Sedation Management in Fairfax County Court for defamation, infliction of emotional distress and illegally disclosing his health records.
The patient said he left his phone on and recorded everything on accident. When he later drove home with his wife, they discovered the recording.
The doctors, Tiffany Ingham and Soloman Shah, are not named as defendants but are accused of mocking D.B. as soon as the anesthetic knocked him out.
"Tiffany Ingham, M.D. started to mock, and then continued to mock, the amount of medicine required to anesthetize plaintiffs," the complaint states. "Referring to plaintiff, Soloman Shah, M.D. commented that a teaching physician known to both him and Tiffany Ingham, M.D. 'would eat him for lunch.'
"Tiffany Ingham, M.D. agreed that plaintiff would be 'eaten alive' and also jokingly discussed a hypothetical of firing a gun up a rectum," it says.
"And really, after five minutes of talking to you in pre-op I wanted to punch you in the face and man you up a little bit," Ingham allegedly said to the patient while he was under.
Doctors allegedly discussed D.B.'s prescription medication and an irritation he had on his penis. v "A medical assistant at GMA touched plaintiff's penis during the colonoscopy," the complaint states. "Although plaintiff's penis is not involved in a colonoscopy, the medical assistant noted there was not 'much of a penile rash.' Tiffany Ingham, M.D. responded, 'No, you'll accidentally rub up against it. Some syphilis on your arm or something.' Solomon Shah, M.D. responded, 'That would be bad. That would be real bad.'"
"Tiffany Ingham, M.D. then stated to all present in the operating suite that, 'It's probably tuberculosis in the penis, so you'll be all right.'"
The lawsuit notes that the plaintiff has neither disease.
In a final remark on tape, Ingham allegedly said she would make a note in D.B.'s file that he had hemorrhoids even though he didn't.
He's seeking $1 million in compensatory damages and $350,000 in punitive damages. COMMENTS
No need to anesthetize everyone
By: Publicgood
I did just fine during my colonoscopy with no anesthesia at all. I think doctors who anesthetize all patients are doing it for the same reason that they refuse to allow patients to have a DVD of the procedure: they don't want to listen to patient's questions either during the procedure or later on.
Colonoscopy souvenir DVDs
By: Publicgood
I am shocked that doctors across the US have stopped providing DVDs of colonoscopies in response to medical records requests. It's okay that they don't automatically give souvenir DVDs, but it's not okay to violate the law regarding patient's rights to access to their medical records. Doctors even claim that it's a cost-cutting measure; this is obviously false since digital memory is getting cheaper by the month and has always been cheaper and more compact than the VHS tapes on which colonoscopies used to be saved.
How Many Die From Medical Mistakes in U.S. Hospitals?
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.”
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.”
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
Wednesday, May 21, 2014
YOU MUST FILE A TORT CLAIM AT UCLA MEDICAL CENTER RATHER THAN THE STATE OF CALIFORNIA
YOU MUST FILE A TORT CLAIM AT UCLA MEDICAL CENTER RATHER THAN THE STATE OF CALIFORNIA
The University of California works hard to conceal the tort claim process.
You can't sue if you don't file a tort claim within 6 months, so the Regents try to prevent those who have been harmed from filing a tort claim.
At first I was duped by the following document published by the Regents of the University of California:
[Maura Larkins' warning: the following is deceptive, produced by the Regents to avoid tort claims.]
"The Office of The General Counsel of The Regents (“OGC”)... THE REGENTS IS NOT SUBJECT TO CLAIM-FILING PROVISIONS OF THE TORT CLAIMS ACT California Government Code section 905.6 exempts The Regents of the University of California from claim-filing provisions of the Tort Claims Act. A claimant who wishes to file suit against The Regents may serve OGC as specified in section 1 above."
But if you go to "section 1 above", you see an address in San Francisco. It's the wrong address for filing a tort claim. Clearly, the Regents want you to come to them for health care, but if they harm you, they don't want to repair the damage.
I did more research and deciphered the truth with much difficulty. You have to present a tort claim to the specific campus medical center that is involved.
The University of California works hard to conceal the tort claim process.
You can't sue if you don't file a tort claim within 6 months, so the Regents try to prevent those who have been harmed from filing a tort claim.
At first I was duped by the following document published by the Regents of the University of California:
[Maura Larkins' warning: the following is deceptive, produced by the Regents to avoid tort claims.]
"The Office of The General Counsel of The Regents (“OGC”)... THE REGENTS IS NOT SUBJECT TO CLAIM-FILING PROVISIONS OF THE TORT CLAIMS ACT California Government Code section 905.6 exempts The Regents of the University of California from claim-filing provisions of the Tort Claims Act. A claimant who wishes to file suit against The Regents may serve OGC as specified in section 1 above."
But if you go to "section 1 above", you see an address in San Francisco. It's the wrong address for filing a tort claim. Clearly, the Regents want you to come to them for health care, but if they harm you, they don't want to repair the damage.
I did more research and deciphered the truth with much difficulty. You have to present a tort claim to the specific campus medical center that is involved.
Tuesday, April 29, 2014
Amicus Therapeutics Inc. Conducts Successful Trial For Fabry Genetic Disorder (excess fat in cells) Drug
Amicus Therapeutics Inc. Conducts Successful Trial For Fabry Genetic Disorder Drug
By Rebekah Marcarelli r.marcarelli@hngn.com
HNGN
Apr 29, 2014
An Amicus Therapeutics Inc. drug that would reduce abnormal fat that accumulates in cells when a rare genetic disorder is present proved succeeded in trials. The condition can lead to "heart attack, stroke and kidney failure," Reuters reported. The company plans to file for U.S. marketing approval in the wake of these results. The drug, dubbed migalastat, could be an effective monotherapy for Fabry disease patients who have endure a year of previous treatment. Share This Story The researchers conducted a 24-month study in which for the first six months participants either received the fat-fighting drug or a placebo. All of the patients were then treated with migalastat for a six-month follow up period and 12-month extension phase, Reuters reported. The drug is administered intravenously. The drug did not show a significant reduction after six months, but the compant plans to report the results at 12 months. "It may be that (the drug) needs more time to work, as shown by today's results," Janney Montgomery Scott analyst Kimberly Lee told Reuters. The drug is also being tested as a combination treatment to be used with other common treatment methods for the condition. Fabry disease is genetic; it causes a type of fat called "globotriaosylceramide, or GL-3," to build up in cells, especially in the kidney. This lipid accumulation is accompanied by a reduction in the enzyme α-galactosidase A (α-Gal A), which can lead to "cell damage, leading to pain, hearing loss, kidney failure, heart attacks and strokes," Reuters reported. Migalastat could combat these devastating effects by binding to the α-Gal A enzyme and helping it to break down the accumulating lipids. Lee believes the new drug could generate $250 million globally if used as a monotherapy; if the drug is used as a combination therapy it could be worth up to twice as much, Reuters reported.
By Rebekah Marcarelli r.marcarelli@hngn.com
HNGN
Apr 29, 2014
An Amicus Therapeutics Inc. drug that would reduce abnormal fat that accumulates in cells when a rare genetic disorder is present proved succeeded in trials. The condition can lead to "heart attack, stroke and kidney failure," Reuters reported. The company plans to file for U.S. marketing approval in the wake of these results. The drug, dubbed migalastat, could be an effective monotherapy for Fabry disease patients who have endure a year of previous treatment. Share This Story The researchers conducted a 24-month study in which for the first six months participants either received the fat-fighting drug or a placebo. All of the patients were then treated with migalastat for a six-month follow up period and 12-month extension phase, Reuters reported. The drug is administered intravenously. The drug did not show a significant reduction after six months, but the compant plans to report the results at 12 months. "It may be that (the drug) needs more time to work, as shown by today's results," Janney Montgomery Scott analyst Kimberly Lee told Reuters. The drug is also being tested as a combination treatment to be used with other common treatment methods for the condition. Fabry disease is genetic; it causes a type of fat called "globotriaosylceramide, or GL-3," to build up in cells, especially in the kidney. This lipid accumulation is accompanied by a reduction in the enzyme α-galactosidase A (α-Gal A), which can lead to "cell damage, leading to pain, hearing loss, kidney failure, heart attacks and strokes," Reuters reported. Migalastat could combat these devastating effects by binding to the α-Gal A enzyme and helping it to break down the accumulating lipids. Lee believes the new drug could generate $250 million globally if used as a monotherapy; if the drug is used as a combination therapy it could be worth up to twice as much, Reuters reported.
Monday, April 28, 2014
Why Chocolate Is Good for Us
Why Chocolate Is Good for Us
By GRETCHEN REYNOLDS
New York Times
April 24, 2014
This column appears in the April 27, 2014, issue of The New York Times Magazine.
In recent years, large-scale epidemiological studies have found that people whose diets include dark chocolate have a lower risk of heart disease than those whose diets do not. Other research has shown that chocolate includes flavonols, natural substances that can reduce the risk of disease. But it hasn’t been clear how these flavonols could be affecting the human body, especially the heart. New findings from Virginia Tech and Louisiana State University, however, suggest an odd explanation for chocolate’s goodness: It improves health largely by being indigestible.
Researchers at Louisiana State reached this conclusion after simulating the human digestive system in glass vessels. One represented the stomach and the small intestine, with their digestive enzymes, and a second reproduced a large-intestine-like environment, with gut microbes from human volunteers. The scientists then added cocoa powder to the stomach vessel.
The “stomach” and “small intestine” broke down and absorbed some of the cocoa. But while many of the flavonols previously identified in chocolate were digested in this way, there was still plenty of undigested cocoa matter. Gut bacteria in the simulated colon then broke that down further into metabolites, small enough to be absorbed into the bloodstream and known to reduce cardiac inflammation. Finally, the last undigested cocoa matter, now mostly fiber, began to ferment, releasing substances that improve cholesterol levels. And there was another health-giving twist to this entire process: The gut microbes that digested the cocoa were desirable probiotics like lactobacillus. Their numbers appeared to increase after the introduction of the cocoa, while less-salutary microbes like staphylococcus declined in number.
These findings are broadly consistent with those from Virginia Tech, published in March in The Journal of Agricultural and Food Chemistry. Researchers there began by feeding healthy lab mice a high-fat diet. Some of the mice were also given unsweetened cocoa extract; others were fed various types of flavonols extracted from the cocoa. After 12 weeks, most of the mice had grown fat and unwell, characterized by insulin resistance, high blood sugar and incipient diabetes. A few, however, had not gained weight. These animals had ingested one of the flavonol groups whose chemical structure seems to be too large to be absorbed by the small intestine.
What the results suggest, says Andrew Neilson, an assistant professor at Virginia Tech and the senior author of the mouse study, is that “there is something going on with cocoa in the colon,” but what that means for chocolate lovers is not clear. Future experiments, he hopes, will tease out why one flavonol group impeded weight gain and the others did not. Do not hold your breath for a cocoa-based diet pill anytime soon, though. Cocoa’s biochemical impacts are “extremely complex,” he says.
Sadly, Dr. Neilson also points out that cocoa is not a chocolate bar, something whose added ingredients and processing reduce the number and type of flavonols, increase calories (cocoa itself has very few) and possibly change the response of gut bacteria to the cocoa. “The evidence does not show that you can eat a chocolate bar every day and expect to improve your health,” he says. A few tablespoons of unsweetened cocoa powder sprinkled onto oatmeal or a handful of cocoa nibs — bits of the cacao bean, availab
le at natural-food stores — would be better, he says less than sweetly.
By GRETCHEN REYNOLDS
New York Times
April 24, 2014
This column appears in the April 27, 2014, issue of The New York Times Magazine.
In recent years, large-scale epidemiological studies have found that people whose diets include dark chocolate have a lower risk of heart disease than those whose diets do not. Other research has shown that chocolate includes flavonols, natural substances that can reduce the risk of disease. But it hasn’t been clear how these flavonols could be affecting the human body, especially the heart. New findings from Virginia Tech and Louisiana State University, however, suggest an odd explanation for chocolate’s goodness: It improves health largely by being indigestible.
Researchers at Louisiana State reached this conclusion after simulating the human digestive system in glass vessels. One represented the stomach and the small intestine, with their digestive enzymes, and a second reproduced a large-intestine-like environment, with gut microbes from human volunteers. The scientists then added cocoa powder to the stomach vessel.
The “stomach” and “small intestine” broke down and absorbed some of the cocoa. But while many of the flavonols previously identified in chocolate were digested in this way, there was still plenty of undigested cocoa matter. Gut bacteria in the simulated colon then broke that down further into metabolites, small enough to be absorbed into the bloodstream and known to reduce cardiac inflammation. Finally, the last undigested cocoa matter, now mostly fiber, began to ferment, releasing substances that improve cholesterol levels. And there was another health-giving twist to this entire process: The gut microbes that digested the cocoa were desirable probiotics like lactobacillus. Their numbers appeared to increase after the introduction of the cocoa, while less-salutary microbes like staphylococcus declined in number.
These findings are broadly consistent with those from Virginia Tech, published in March in The Journal of Agricultural and Food Chemistry. Researchers there began by feeding healthy lab mice a high-fat diet. Some of the mice were also given unsweetened cocoa extract; others were fed various types of flavonols extracted from the cocoa. After 12 weeks, most of the mice had grown fat and unwell, characterized by insulin resistance, high blood sugar and incipient diabetes. A few, however, had not gained weight. These animals had ingested one of the flavonol groups whose chemical structure seems to be too large to be absorbed by the small intestine.
What the results suggest, says Andrew Neilson, an assistant professor at Virginia Tech and the senior author of the mouse study, is that “there is something going on with cocoa in the colon,” but what that means for chocolate lovers is not clear. Future experiments, he hopes, will tease out why one flavonol group impeded weight gain and the others did not. Do not hold your breath for a cocoa-based diet pill anytime soon, though. Cocoa’s biochemical impacts are “extremely complex,” he says.
Sadly, Dr. Neilson also points out that cocoa is not a chocolate bar, something whose added ingredients and processing reduce the number and type of flavonols, increase calories (cocoa itself has very few) and possibly change the response of gut bacteria to the cocoa. “The evidence does not show that you can eat a chocolate bar every day and expect to improve your health,” he says. A few tablespoons of unsweetened cocoa powder sprinkled onto oatmeal or a handful of cocoa nibs — bits of the cacao bean, availab
le at natural-food stores — would be better, he says less than sweetly.
Friday, April 25, 2014
Scientists reverse memory loss in mice with Alzheimer's
Scientists reverse memory loss in mice with Alzheimer's
April 24, 2014
Relaxnews
Spanish scientists have for the first time used gene therapy to reverse memory loss in mice with Alzheimer's, an advance that could lead to new drugs to treat the disease, they said Wednesday. The Autonomous University of Barcelona team injected a gene which causes the production of a protein that is blocked in patients with Alzheimer's into the hippocampus -- a region of the brian essential to memory processing -- in mice that were in the initial stages of the disease. "The protein that was reinstated by the gene therapy triggers the signals needed to activate the genes involved in long-term memory consolidation," the university said in a statement. Gene therapy involves transplanting genes into a patient's cells to correct an otherwise incurable disease caused by a failure of one or another gene. The finding was published in The Journal of Neuroscience and it follows four years of research. "The hope is that this study could lead to the development of pharmaceutical drugs that can activate these genes in humans and allow for the recovery of memory," the head of the research team, Carlos Saura, told AFP. Alzheimer's, caused by toxic proteins that destroy brain cells, is the most common form of dementia. Worldwide, 35.6 million people suffer from the fatal degenerative disease, which is currently incurable, and there are 7.7 million new cases every year, according to a 2012 report from the World Health Organisation. In 2010 the total global societal cost of dementia was estimated to be $604 billion, according to Alzheimer's Disease International, a federation of Alzheimer associations around the world.
April 24, 2014
Relaxnews
Spanish scientists have for the first time used gene therapy to reverse memory loss in mice with Alzheimer's, an advance that could lead to new drugs to treat the disease, they said Wednesday. The Autonomous University of Barcelona team injected a gene which causes the production of a protein that is blocked in patients with Alzheimer's into the hippocampus -- a region of the brian essential to memory processing -- in mice that were in the initial stages of the disease. "The protein that was reinstated by the gene therapy triggers the signals needed to activate the genes involved in long-term memory consolidation," the university said in a statement. Gene therapy involves transplanting genes into a patient's cells to correct an otherwise incurable disease caused by a failure of one or another gene. The finding was published in The Journal of Neuroscience and it follows four years of research. "The hope is that this study could lead to the development of pharmaceutical drugs that can activate these genes in humans and allow for the recovery of memory," the head of the research team, Carlos Saura, told AFP. Alzheimer's, caused by toxic proteins that destroy brain cells, is the most common form of dementia. Worldwide, 35.6 million people suffer from the fatal degenerative disease, which is currently incurable, and there are 7.7 million new cases every year, according to a 2012 report from the World Health Organisation. In 2010 the total global societal cost of dementia was estimated to be $604 billion, according to Alzheimer's Disease International, a federation of Alzheimer associations around the world.
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