Wednesday, November 19, 2014

Deep sedation for colonoscopy might not be safe
Consumer Reports
Nov. 19, 2014

Getting knocked out during a colonoscopy might seem like a good idea. After all, being awake as your doctor uses a long, flexible tube to get an inside view of your lower intestines doesn't sound very appealing. To avoid that problem, many doctors now routinely use the drug propofol (Diprivan) during colonoscopy to cause deep sedation in their patients.
But beware: That drug, which was reportedly given to Joan Rivers  soon before she died, might not be the healthiest choice and could put you at risk for some serious complications.
Don’t get the wrong idea: Colonoscopies are usually safe (about 3 out of every 1,000 people suffer a serious complication). And the procedure is proved to prevent colon cancer deaths. So if you’re ages 50 to 75, you should be screened (see our guide, "The Cancer Tests You Really Need," to find out how often you should be screened). 
But deep sedation isn't necessary. Colonoscopy can be done using conscious sedation or even none at all. “You should always try to aim for the lightest level of sedation that you need,” says Consumer Reports' medical adviser, Orly Avitzur, M.D. “The trend toward deep sedation is worrisome because it increases risk.”
For example, propofol increases your risk of aspiration pneumonia (caused by inhaling particles such as vomit, mucus, or saliva) by almost 50 percent, according to a study by Gregory Cooper, M.D., in the journal JAMA Internal Medicine. And it can cause a host of other side effects, including confusion, seizures, irregular heart beats, and potentially deadly allergic reactions.  
“For the general population there’s not a lot of good data saying patients have a better outcome with propofol when there’s not a medical indication,” says Cooper, a professor of medicine at Case Western Reserve University in Cleveland. “It’s overkill.”
Instead, Cooper says he uses the narcotics fentanyl (Duragesic and others) or meperidine (Demerol) combined with midazolam (Versed) to induce light sedation during colonoscopies.  
And propofol is expensive. Colonoscopies using anesthesia cost about 20 percent more than those done without, according to Cooper. And a 2013 research letter in JAMA Internal Medicine titled, "Propofol for screening colonoscopy: Are we paying too much?" said that the use of propofol typically added $600 to $2,000 to the price tag.
Screening colonoscopies are covered by insurance plans, thanks to the Affordable Care Act, although you might have to pay for part of the anesthesiologist’s fees, bowel prep kit, pathology costs, and a facility fee. But even so, “Somebody’s got to pay for it, whether it’s the insurance company or the patients,” Cooper says, adding that the current system provides a financial motivation for using more anesthesia.
But the rising tide of propofol use could be about to ebb. Beginning Jan. 1, 2015, Medicare is changing how it pays anesthesia professionals for colonoscopy care. Gastroenterologists will be paid a set amount that will cover the anesthesia cost, even if an anesthesiologist, for example, administers it. Doctors will then have to decide whether to recommend expensive anesthesia, which could include hiring a nurse anesthetist or anesthesiologist and pay them out of the same pot, or choose a less pricey option. “There may be a financial disincentive for Medicare doctors to recommend deep sedation,” Avitzur says.
We’ll have to wait to find out if commercial insurers follow Medicare’s lead. If they do, says Cooper, “There will be less cost to the health care system since there won’t be another bill from the anesthesiologist.”
Until then, if you’re gearing up to have a colonoscopy, make sure you discuss your anesthesia options with your doctor before the procedure.

Tuesday, November 11, 2014

L.A. County Health Dept. Allegedly Falsified Nursing Home Records of Complaints

L.A. County Health Department Allegedly Falsified Nursing Home Probe Records

The Los Angeles County Public Health Department falsified the dates it received complaints about nursing homes as pressure rose to meet state deadlines for launching investigations, according to two employees.
In a letter last month to county, state and federal officials,  inspector Kimberly Nguyen cited 11 cases in which she said the dates typed into the computer system were later than the dates the complaints were actually received. The cases mentioned in the letter involve alleged abuse, falls and pressure sores, she said.
“In my belief, falsification is a serious matter and unlawful and our department should know better to not manipulate paperwork to mislead others and the public,” Nguyen wrote in the Oct. 7 letter.

...Meanwhile, the state, which directly oversees nursing homes in every district except Los Angeles County, has had its own history of problems with timely investigations. A lawsuit by California Advocates for Nursing Home Reform, or CANHR, resulted in a 2006 order by a Superior Court judge instructing public health officials to follow the law regarding investigation timelines.
Geraneo noted that order in her e-mail to administrators, referring to a case involving a non-working generator in which the complaint year had allegedly been changed from 2013 to 2014. “We cannot change the initiation dates of these complaints because of the CANHR lawsuit!”
Geraneo declined to be interviewed.
Since Kaiser Health News began writing about the department’s health facilities inspection division in March, administrators have sent e-mails to staff telling them not to speak to the media and to forward all requests. Reached by phone, several inspectors have declined to talk, saying they feared retaliation.
Nguyen said  she has been she has been targeted for retaliation as a result of raising questions since July 2013 about the quality of nursing home oversight.
In May 2014, Nguyen was suspended for five days without pay because she allegedly failed to renew her nursing license. A department letter said her license expired on November 30, 2013 and that she worked for six days without a valid license.
But as the Board of Nursing later confirmed in writing, her license actually had been renewed promptly. The Board simply hadn’t entered the renewal on its website.




L.A. County Health Dept. Allegedly Falsified Nursing Home Records

Two Los Angeles County Public Health Department employees allege that the department falsified the dates it received nursing home complaints in order to meet state deadlines for launching investigations, Kaiser Health News reports.


Under state law, investigations must be launched within 10 days of receiving a nursing home complaint -- or within 24 hours if the complaint involves the threat of death or serious harm.
The California Public Health Department requires inspectors to enter dates based on when the complaint was first received by phone, fax, email or letter.

Details of Falsified Records

In a letter sent last month to county, state and federal officials, Inspector Kimberly Nguyen cited 11 cases in which she found records with falsified dates.
The dates entered were much later -- as much as 79 days --than the dates the allegations actually had been submitted.
The cases involved complaints about:
  • Abuse;
  • Falls; and
  • Pressure sores.
According to KHN, Nguyen said she believes the date manipulation was deliberate (Gorman, Kaiser Health News, 11/10).
Nguyen said her supervisor, Adewole Adegoke, has been aware of the record falsification since July but has made no effort to stop the practice (Nguyen Letter, 10/7). She wrote, "In my belief, falsification is a serious matter and unlawful, and our department should know better to not manipulate paperwork to mislead others and the public."
Meanwhile, Sharon Geraneo, an assistant supervisor at the department, sent a separate email in August about the department allegedly falsifying records.

Response to Allegations

The county Department of Public Health said it has "zero tolerance for intentional document falsification" and is not aware of any deliberate falsification.
Officials said that they had identified a data entry error by one individual that affected 35 cases but that "swift and appropriate corrective actions" were taken.
The California Department of Public Health said it is investigating the allegations (Kaiser Health News, 11/10).

Sunday, November 9, 2014

Power morcellation ban unlikely, but other FDA restrictions coming soon

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

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

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

Sunday, November 2, 2014

Drinking a lot of milk doubled the risk of death for women, and increased hip fractures by 60%

Milk causes osteoporosis? How many trillions to we pay for medical care in the US? Why did we need to wait for a tiny country like Sweden to give us this information?

For years doctors prescribed large doses of Vitamin D and calcium that turned out to be no help at all with osteoporosis. All that time, our doctors never warned us against milk.

And the medical establishment moans about its helplessness in the face of Alzheimer's, but forgot to mention that D-galactose was associated with memory loss in animals in research going back to 2006. Certainly, my doctors never mentioned it.

Is our health being held hostage to the profits of politically-powerful groups like the milk lobby? It seems like every month I am presented with a new reason for not trusting the CDC (Center for Disease Control). It seems that the research done by the government too often involves increasing or protecting profits for some powerful, wealthy group of people. New drugs, new devices, new procedures keep coming down the pipeline. But of course, the people who repair broken hips aren't going to make as much money now that women have this information from Sweden.

Drinking a lot of milk may be shortening women’s lives
October 30, 2014
By Karen O’Shea
Irish Examiner

Drinking three or more glasses of milk per day may be harmful to women’s health, a study suggests.
Women in the study who drank at least three glasses of milk a day were nearly twice as likely to die over the next 20 years compared with their peers who drank less than a glass daily, researchers in Sweden found. In addition, the study, published in the British Medical Journal found that women’s risk of bone fracture climbed steadily as their milk intake increased.

The reason could be galactose, a simple sugar found in milk, said Karl Michaelsson, a professor at Uppsala University in Sweden and one of the study’s authors. “That compound might induce oxidative stress and low-grade inflammation, and that type of inflammation can affect mortality and fractures,” Michaelsson said. 

Many health bodies recommend that adults get the equivalent of three cups of milk daily, based on the idea that dairy is good for the bones, and may reduce heart disease risk. But there’s actually little scientific evidence to support these recommendations, the study authors said.

The study included 61,433 women who were ages 39 to 74 at the study’s start, and 45,339 men ages 45 to 79. The women were followed for 20 years, on average. During that time, 15,541 died and 17,252 had fractures, including 4,259 hip fractures. After the researchers took into account factors like age, body mass index and alcohol consumption, they found that women who drank three or more glasses of milk daily were 1.93 times more likely to die during the follow-up period than those who drank less than a glass of milk daily. 

Among the men, who were followed for an average of 11 years, there was no association between mortality or fractures and milk consumption. 

But dairy lovers need not despair. The researchers found that fermented milk products, like cheese and yogurt, which contain little or no galactose, had the opposite effect: women who ate or drank the most fermented milk products were less likely to die or sustain fractures during the study.

Milk intake and risk of mortality and fractures in women and men: cohort studies

  • Accepted 22 September 2014


Objective To examine whether high milk consumption is associated with mortality and fractures in women and men.
Design Cohort studies.
Setting Three counties in central Sweden.
Participants Two large Swedish cohorts, one with 61 433 women (39-74 years at baseline 1987-90) and one with 45 339 men (45-79 years at baseline 1997), were administered food frequency questionnaires. The women responded to a second food frequency questionnaire in 1997.
Main outcome measure Multivariable survival models were applied to determine the association between milk consumption and time to mortality or fracture.
Results During a mean follow-up of 20.1 years, 15 541 women died and 17 252 had a fracture, of whom 4259 had a hip fracture. In the male cohort with a mean follow-up of 11.2 years, 10 112 men died and 5066 had a fracture, with 1166 hip fracture cases. In women the adjusted mortality hazard ratio for three or more glasses of milk a day compared with less than one glass a day was 1.93 (95% confidence interval 1.80 to 2.06). For every glass of milk, the adjusted hazard ratio of all cause mortality was 1.15 (1.13 to 1.17) in women and 1.03 (1.01 to 1.04) in men. For every glass of milk in women no reduction was observed in fracture risk with higher milk consumption for any fracture (1.02, 1.00 to 1.04) or for hip fracture (1.09, 1.05 to 1.13). The corresponding adjusted hazard ratios in men were 1.01 (0.99 to 1.03) and 1.03 (0.99 to 1.07). In subsamples of two additional cohorts, one in males and one in females, a positive association was seen between milk intake and both urine 8-iso-PGF2α (a biomarker of oxidative stress) and serum interleukin 6 (a main inflammatory biomarker).

Conclusions High milk intake was associated with higher mortality in one cohort of women and in another cohort of men, and with higher fracture incidence in women. Given the observational study designs with the inherent possibility of residual confounding and reverse causation phenomena, a cautious interpretation of the results is recommended.


A diet rich in milk products is promoted to reduce the likelihood of osteoporotic fractures. Milk contains 18 of 22 essential nutrients, including calcium, phosphorus, and vitamin D of especial importance for the skeleton. Intestinal uptake of these nutrients is enhanced by the enzymatic capacity to digest lactose into D-glucose and D-galactose by mutation in the lactase gene, a variant common in those with northern European ancestry.1 2 An intake of dairy foods corresponding to three or four glasses of milk a day has been suggested to save at least 20% of healthcare costs related to osteoporosis.3

A high intake of milk might, however, have undesirable effects, because milk is the main dietary source of D-galactose. 

Experimental evidence in several animal species indicates that chronic exposure to D-galactose is deleterious to health and the addition of D-galactose by injections or in the diet is an established animal model of aging.4 5 6 7 Even a low dose of D-galactose induces changes that resemble natural aging in animals, including shortened life span caused by oxidative stress damage, chronic inflammation, neurodegeneration, decreased immune response, and gene transcriptional changes.5 7 A subcutaneous dose of 100 mg/kg D-galactose accelerates senescence in mice.5 This is equivalent to 6-10 g in humans, corresponding to 1-2 glasses of milk. Based on a concentration of lactose in cow’s milk of approximately 5%, one glass of milk comprises about 5 g of D-galactose. The increase of oxidative stress with aging and chronic low grade inflammation is not only a pathogenetic mechanism of cardiovascular disease and cancer in humans8 9 but also a mechanism of age related bone loss and sarcopenia.9 10 The high amount of lactose and therefore D-galactose in milk with theoretical influences on processes such as oxidative stress and inflammation makes the recommendations to increase milk intake for prevention of fractures a conceivable contradiction.

  1. Karl Michaëlsson, professor1,
  2. Alicja Wolk, professor2,
  3. Sophie Langenskiöld, senior lecturer3,
  4. Samar Basu, professor3,
  5. Eva Warensjö Lemming, researcher14,
  6. Håkan Melhus, professor5,
  7. Liisa Byberg, associate professor1
    Author affiliations
  1. Correspondence to: K Michaëlsson