Archive for March 3rd, 2008

Omni Postings of 3/3/08

There has been a recall of Meijer’s frozen chicken entrees because of a potential of Listeria contamination.  As far as I’m concerned, Listeria could only help the taste.  Anyway, they have been distributed in Ohio and Michigan.  Exactly what chicken product are being recalled is included in the posting.
http://omniphysicians.com/2008/03/03/frozen-chicken-entrees-recalled/
This is a reminder from FDA that a patient with osteoporosis may come to you complaining of new onset of “bone” pain.  It may be the osteoporosis.  It may be an occult fracture.  But it may be the result of the medication like Actonel and Fosfamax which are being given to treat the disease.
http://omniphysicians.com/2008/03/03/fda-medwatch-bone-pain-with-osteoporosis-drugs/
There will be a new drug on the market for depression called Pristiq.  It’s an Effexor-like drug that can be started at therapetic dosages and is not metabolized by the liver.  And it’ll probably cost $1000.00 a month.
http://omniphysicians.com/2008/03/03/pristiq-approved-as-new-antidepressant/
Studies are coming out that a simple blow to the head resulting in LOC can also cause neuronal death and loss of brain volume.  This was reported from the journal, Neurology.  So even if the CT is negative, patients should be made aware of possible long-term sequelae as they stumble out of the ER and into a cab on the long and winding road to oblivion.
http://omniphysicians.com/2008/03/03/punchdrunk-for-a-reason/
You may have read this already in Annals.  Trauma patients at Level 1 trauma centers get enough radiation from all their x-rays to raise a significant concern about contracting cancer down the line.  Of course, no one mentions the possibility that if they didn’t get all those x-rays, they may not have lived long enough to get cancer.  
http://omniphysicians.com/2008/03/03/trauma-patients-iatrogenic-ca/

Frozen chicken entrees recalled

CDC, 3/2/08:  Meijer Distribution Center (Grand Rapids, Michigan) is voluntarily recalling ~2,184 pounds of frozen chicken entrées that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today. The following product is subject to recall: 12-ounce packages of “Discover Cuisine ™ Red Curry Chicken & Jasmine Rice.”

Each package bears the Canadian establishment number “Est. 302″ inside the Canadian Food Inspection Agency mark of inspection as well as a “Best By” date of “12 18 08.” The frozen chicken entrées were produced on October 18, 2007, and were sent to distributors and retail establishments in Illinois, Indiana, Michigan, and Ohio.
USDA Recall Release

British nurse convicted of killing patients

BBC, 3/3/08: 

Colin Norris outside Newcastle Crown Court
Colin Norris killed four patients at two hospitals in Leeds

A nurse has been found guilty of murdering elderly patients in his care at two Leeds hospitals.Colin Norris, 32, had denied killing the four women at Leeds General Infirmary and St James’s Hospital in 2002 by injecting them with insulin.

Norris, of Egilsay Terrace, Glasgow, was also convicted of the attempted murder of another patient.

The family of one of his victims, Ethel Hall, has called for an inquiry into Norris’s killing spree.

The trial heard suspicions were raised when Norris predicted the death of Mrs Hall who soon afterwards slipped into a fatal coma.

Mrs Hall, 86, from Calverley, Leeds, was recovering after hip surgery at Leeds General Infirmary (LGI) at the time of her death.

I just hope that he isn’t let out so he can do it again
Ethel Hall’s son Stuart

Tests later showed about 12 times the normal level of insulin in her blood, which the prosecution claimed was caused by injections from Norris.

Police then looked into other patients’ deaths and discovered that three more elderly women had slipped into hypoglycaemic comas and died while under Norris’s care.

The staff nurse has been found guilty of the murders of Mrs Hall, Doris Ludlum, 80, of Pudsey, and Bridget Bourke, 88, of Holbeck, at LGI.

He was also convicted of the murder of Irene Crooks, 79, of Leeds, at St James’s Hospital and the attempted murder of Vera Wilby, 90, of Rawdon, at the infirmary.

‘Opportunity to poison’

Mrs Hall’s son Stuart told the BBC he was “happy” that Norris had been convicted, and hoped he would receive a lengthy prison sentence.

He said: “I just hope that he isn’t let out so he can do it again.

“I would like an inquiry to find out what mistakes were made, what the trust could have done to the better and what they have done to rectify it so it can’t happen again.”

Ethel Hall
The nurse gave Ethel Hall a lethal dose of insulin

After the verdict, Leeds Teaching Hospitals NHS Trust apologised to the victims’ families for Norris’s “disturbing” crimes and described him as an “extremely dangerous criminal”.

Medical director, Dr Hugo Mascie-Taylor, said changes implemented at the trust’s hospitals included the wider use of CCTV, card entry to parts of the hospital and a permanent police presence on site.

But he said the trust believed none of those actions would have prevented Norris from killing.

West Yorkshire Police said that during their investigation more than 7,000 statements had been taken and more than 3,000 exhibits seized.

Speaking outside the court, Det Ch Supt Chris Gregg said: “What has shone through during this investigation and the trial is the absolute professionalism of the medical and nursing staff and the hospitals we’ve been working in.

“That’s with one clear exception - Colin Norris.

“Whilst other people at those hospitals were duly caring for the patients, Colin Norris was doing the opposite.

“He was looking for opportunities to poison them by insulin.”

Norris, who was convicted on a majority verdict, will be sentenced on Tuesday.

FDA MedWatch: Bone Pain with Osteoporosis Drugs

FDA is alerting healthcare professionals that severe bone, joint, or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel (risedronate sodium), Reclast (zoledronic acid) and Boniva (ibandronate sodium). These drugs are used to treat osteoporosis and certain other diseases.

This severe, sometimes incapacitating musculoskeletal pain has occurred within days, months, or even years after starting bisphosphonates. In the most serious cases, the pain was so severe that patients could not continue their normal activities. Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.

Note that these events are different from the acute phase response some patients experience after the first treatment with IV bisphosphonates, and occasionally after the first dose of oral bisphosphonates.

Although severe musculoskeletal pain is described in the labeling for all bisphosphonates, this association may be overlooked by practitioners because they may assume that the patient’s pain can be attributed to osteoporosis itself.

Practitioners should consider whether musculoskeletal pain in patients on bisphosphonates might be caused by the drug, and consider discontinuing it either temporarily or permanently.

Additional Information:

FDA MedWatch Safety Alert. Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). January 7, 2007.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates

Pristiq approved as new antidepressant

Wall St. Journal (3/3, B5, Wang) reports that drugmaker Wyeth “received Food and Drug Administration (FDA) approval for its antidepressant Pristiq (desvenlafaxine),” which is “a ‘refinement’ of the company’s hugely successful Effexor XR (venlafaxine), rather than a medication based on a new mechanism, said Geno Germano, Wyeth’s president of U.S. pharmaceuticals.” The drug “is the third antidepressant on the market in a class known as serotonin-norepinephrine reuptake inhibitors (SNRIs), along with Effexor and Eli Lilly’s Cymbalta (duloxetine).”

        According to the New York Times (3/1, C3, Saul), Philip Ninan, M.D., a Wyeth vice president for neuroscience, said that “he thought that Pristiq, which is chemically similar to Effexor, would have similar benefits in treating major depression,” as well as “distinct advantages over its existing product.” Patients taking desvenlafaxine can start with “the therapeutic dose of 50 milligrams,” instead of starting the antidepressant “at a low dose,” and “then ramp up.” Moreover, the drug “does not have to be broken down by the liver,” Dr. Ninan said. Therefore, “it is not likely to interact with other medications metabolized” by that organ.

Punchdrunk for a reason

Reuters, 3/4/08:  A blow to the head that knocks a person unconscious can result in widespread loss of brain tissue, Canadian researchers said on Monday, explaining why some people who suffer head injuries are never quite the same.

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The more severe the injury, the more brain tissue is lost, they said.

“There is more damage and it is more widespread than we had expected,” said Dr. Brian Levine of the Rotman Research Institute and the University of Toronto, whose study appears in the journal Neurology.

Levine studied brain scans taken from 69 traumatic brain injury patients whose head injuries ranged from mild to moderate or severe. The researchers used high-resolution magnetic resonance imaging or MRI to study changes in brain volume a year after the injury.

They ran a computer analysis of these images and found that even patients with mild brain injuries with no apparent scarring had less brain volume.

“When you have a blow to the head, it causes a neurochemical reaction in the brain cells that lead to cell death,” Levine said in a telephone interview. “The more cells that die, the less tissue you have.”

All the patients in the study had injuries severe enough that they needed to be hospitalized. “The amount of tissue loss seems to be related to the severity of the injury — how long was the person was knocked out,” Levine said.

He said the study helps to explain why some people with brain injuries often struggle with memory problems, mood changes, confusion and reduced information processing speed.

“What this study does is it gives us a window into the underlying brain structure changes that might relate to that disability,” he said.

Levine said the brain volume lost involved both frontal and posterior brain regions, and the damage was greatest to white matter, tissue that makes up the brain’s communication network.

“What you have basically is a loss of brain connectivity. That is essential for the efficient processing in the brain,” he said. “When you have a subtle loss of that, even if it is 5 to 10 percent, it will have a large effect on behavior.”

Levine said the study does not mean that people who have had mild head injuries will have a disability, but it might help to explain why some people never quite recover from their head injury.

“You hear this all the time from people, that they’re not the same. A lot of times doctors don’t know why,” Levine said.

According the U.S. Centers for Disease Control and Prevention, at least, 1.4 million people in the United States suffer a traumatic brain injury each year.

At least 5.3 million Americans, or about 2 percent of the U.S. population, need help to perform activities of daily living as a result of their brain injuries.

Trauma Patients & Iatrogenic CA

Reuters, 3/4/08:  Trauma patients treated in U.S. emergency rooms on average are exposed to radiation equivalent to 1,005 chest X-rays each, enough to raise their risk of cancer, researchers reported on Monday.

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Doctors should think about the total dose of radiation given patients, especially younger ones, Dr. James Winslow of Wake Forest University in North Carolina and colleagues said.

Writing in the Annals of Emergency Medicine, they said they analyzed the records of 86 patients who came to a level one trauma center over a three-month period in 2006.

More than half had been in car accidents.

These patients got many X-rays and computed tomography or CT scans, which provide a better image but which can deliver high amounts of radiation.

“Multi-trauma patients are at high risk of life-threatening injuries, which clearly justifies aggressive testing to determine the best course of treatment using all the tools available in the emergency department,” Winslow said in a statement.

“However, physicians should consider the long-term risks and benefits of exposing their patients to the high levels of radiation emitted by the series of studies informally referred to as the ‘pan scan,’ or computed tomography of the head, neck, chest, abdomen and pelvis.”

X-rays have long been known to raise the risk of cancer. Heavier doses raise the risk more, and younger people have a worse risk as they have many more years ahead of them in which to develop a tumor.

Winslow’s team said the average person living in the United States receives about 3 millisieverts of background radiation every year. The trauma patients got on average 40 millisieverts.

“Possible options for reducing radiation exposure may include ordering fewer repeated imaging studies, using lower dose radiological imaging techniques and using alternative imaging methods that do not use radiation, such as ultrasound and magnetic resonance imaging,” Winslow said.

Vitamin Supplements & Lung CA

Reuterts, 2/29/08:  People who take vitamin supplements are just as likely as those who don’t to develop lung cancer, and vitamin E supplements may actually slightly raise the risk, researchers said on Friday.Their study involved 77,721 people in Washington state ages 50 to 76, tracking their use over the prior decade of supplemental multivitamins, vitamin C, vitamin E and folate to see if this would offer protection from lung cancer.

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None of the vitamins looked at in the study was tied to a reduced risk of lung cancer. In fact, people who took high doses of vitamin E, especially smokers, had a small but statistically significant elevated risk, the researchers said.

“If you could find some sort of magic pill — a pill you could take once a day to decrease your risk — that would be ideal. But we obviously, unfortunately, didn’t find that in our study,” lead researcher Dr. Christopher Slatore of the University of Washington in Seattle said in a telephone interview.

The people in the study were followed for four years and 521 developed lung cancer, the vast majority of them smokers or former smokers, Slatore’s team reported in the American Journal of Respiratory and Critical Care Medicine.

“Some estimates are that around 50 percent of the American public takes supplemental vitamins of some sort. There’s been a lot of thought about: ‘do these supplements actually prevent chronic diseases like lung cancer, other cancers, heart disease?’” Slatore said.

VALIDATING OTHER STUDIES

The research did not look at beta-carotene, but previous work showed that people taking beta-carotene supplements, particularly smokers, had a higher risk of developing lung cancer than those who did not.

In those in the new study who developed lung cancer, the researchers saw a small increased risk associated with vitamin E supplements in addition to the expected links to smoking, family history and age.

This amounted to a 28 percent increased risk of developing lung cancer for those taking vitamin E supplements at a dose of 400 mg daily for 10 years, the researchers said.

Vitamin E is an antioxidant, thought to protect body tissue from damage caused by so-called free radicals, which are unstable substances that can harm cells, tissues and organs. It also is important in the formation of red blood cells.

“For folks — especially smokers — I would definitely recommend that they not take vitamin E (as a supplement) unless they have a very strong reason to take it,” Slatore said.

The notion that vitamin supplements are healthful, or at least not harmful, arises from the desire of many people to match the benefits of a healthful diet with a convenient pill, Dr. Tim Byers of the University of Colorado School of Medicine wrote in an editorial accompanying the study.

“Over the past two decades, we have been repeatedly disappointed in the ability of vitamin supplements to reduce risk for cancers at several sites, including the stomach, colorectum, breast and lung,” Byers wrote.

“Foods that are rich in vitamins seem to be associated with reduced risk of cancer, but vitamins packaged as pills clearly do not have the same effect,” Byers added.

FDA wants more power

Washington Post, 2/29/08: The chief of the embattled Food and Drug Administration challenged Congress on Friday to quickly give his agency more teeth to regulate food safety.

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“This is a time to not just be critical about what is not being done, but to collaborate on what must be done,” FDA Commissioner Andrew von Eschenbach said in a speech at the National Press Club. “We can’t transform this agency ourselves.”

The Bush administration last fall proposed that Congress give the FDA additional powers, including the ability to order mandatory recalls of unsafe foods, something the agency cannot do now. Von Eschenbach urged Congress to grant those new authorities by Memorial Day.

Von Eschenbach acknowledged the FDA must make some major changes to keep up with fast-moving scientific discoveries and complex global markets that mean more and more U.S. food and medicine is produced abroad, including in countries like China that provide far less product oversight.

But among the harshest criticisms of the FDA is its lack of speed in identifying and dealing with drug safety problems that don’t appear until the medicines have begun widespread sales.

On that front, von Eschenbach said the FDA soon would begin a long-awaited program called the “sentinel initiative.” Partnering with other health organizations, the program will create a national electronic database of records showing how medical products are used, potentially enabling FDA to spot signs of trouble faster.

Is FDA overreacting?

Wall Street Journal, 2/29/08:  Top Food and Drug Administration officials said this week consumers should expect to see more advisories and warnings from the agency about drug-side effects.

For years, the agency has issued dozens of so-called Medwatch safety alerts reports each year, aimed at health-care professionals, to inform them of changes to drug labels, and that practice still continues. But since Merck & Co.’s Vioxx was pulled off the market more than three years ago, the agency has stepped up the number of public-health advisories aimed at consumers and more recently has started issuing so called “early communications,” informing the public that the agency is looking at a possible problem.

Previously, the agency wouldn’t inform doctors or consumers about a problem until it was fairly certain it was linked to a particular product.

“I feel strongly it’s important for us to communicate early, but in communicating early we are acting with a much smaller degree of certainty,” FDA Commissioner Andrew von Eschenbach told the agency’s new risk-communication advisory committee Thursday, which wraps up its first two-day meeting later Friday. But, “we are trying to get people to understand that we haven’t said there’s a problem, only that we are concerned there’s a problem.”

The advisory panel, which is made up of outside academic and industry experts, has been established to help the FDA better communicate risks and benefits to the products the agency regulates; chiefly drugs, medical devices and certain foods.

“It’s a time in which, quite frankly, if you look at external data there has been an erosion of trust,” Mr. von Eschenbach said. “Perhaps because they need to better understand and appreciate what we are doing people’s confidence has been eroded.”

Indeed, Janet Woodcock, an FDA deputy commissioner and acting head of the agency’s drug center, told reporters this week that the agency is finding more drug side effects, mostly because the agency is looking for them after drugs are put on the market. Until Congress approved new legislation last year giving the FDA additional money and authority, much of FDA’s drug-center budget was aimed at reviewing drugs to get them on the market rather than continuing to monitor drugs once they are on the market.

“Consumers will know we are on the case,” she said. However, she explained that the agency’s goal is to find out which consumers benefit the most from a particular drug and which ones should avoid it, rather than pulling drugs off the market, a notion that’s becoming more of a reality with increased use of genetic testing.

Ms. Woodcock said the agency is continuing work on a public-private network that will allow the agency to more quickly track drug-side effects by tapping into medical databases as well as updating the computer software that runs the agency’s own adverse-event reporting system to make it easier for FDA staff to track problems.

So far this year the FDA has issued four public-health advisories, which are aimed at warning the public about a particular health problem, and at least three so-called “early communications” after issuing 11 public health advisories involving drugs for all of 2007. The agency also highlighted a warning about suicides associated with epilepsy drugs that was aimed at doctors. According to agency’s Web site, 16 drug-related public health advisories were issued in both 2006 and 2005 compared to five in 2004, two in 2003 and one in 2002.

One of the advisories, issued Feb. 1, involved Pfizer Inc.’s smoking-cessation drug Chantix and warned about severe changes in mood and behavior in patients taking the drug. It followed a previous “early communication” issued in November that said the agency evaluating reports of suicidal thoughts and aggressive and erratic behavior in patients who had taken Chantix.

On the flip side the FDA has cleared drugs after previously stating it was looking at a problem. In January the agency said a review of clinical studies involving AstraZeneca PLC’s reflux drugs Nexium and Prilosec don’t show an increase in heart attacks and sudden death.