Archive for October, 2009

Preventable Deaths in the US

October 30th, 2009 | No Comments | Source: Health Affairs, Washington Post

Given that the US spends $2.4 trillion per year on health care, far more on a per capita basis than any other country, it’s hard to believe that we fare so poorly when it comes to “preventable deaths,” a smorgasbord  of illnesses that shouldn’t—but do—kill us before our time.

thistimeitsthebigone 200x300 Preventable Deaths in the USBut that’s the disheartening conclusion of a study by the Commonwealth Fund which recently appeared in Health Affairs.

The study looked first at death rates compiled by the World Health Organization regarding diabetes, epilepsy, influenza, pneumonia, stroke and ulcers during 1997-1998. It showed that Uncle Sam ranked 15th out of 19 industrialized countries in death rates from such “preventable” conditions.

A repeat analysis for the years 2002-2003 revealed that we had dropped to dead last, even though US health care costs rose nearly 30% in the intervening years.

According to the scientists leading the analysis, nearly 100,000 lives could have been spared if our health system performed as well those in Australia, France or Japan.

The scientists defined “preventable deaths” as those secondary to illnesses or injuries that need not happen or for which we have therapies proven to extend life through a certain age. Measles is an example, at least in developed countries. So are fatal cases of epilepsy, skin cancer, and certain surgical complications.

“These are conditions where early care and the right care should be able to prevent an early death,” Cathy Schoen, a Commonwealth Fund executive told the Washington Post. “We shouldn’t see people dying of diabetes before age 50.”

Or, as Mark Pearson, who chairs the health division at the Organization for Economic Cooperation and Development Pearson concluded succinctly, “the US doesn’t take primary care very seriously.”

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Beware of Healthy Foods

October 29th, 2009 | No Comments | Source: Washington Post

Tomatoes, leafy greens and berries have all sorts of beneficial effects on health and everybody from your mother to Mehmet Oz says you should eat them regularly. There’s one problem though—these delectables frequently make you sick.

yeabutIstilldontlikethestuff1 200x300 Beware of Healthy FoodsThat’s the depressing news from a study conducted by the Center for Science in the Public Interest, whose scientists reviewed FDA data from the past 20 years to identify the foods that were responsible for the greatest numbers of food-borne outbreaks.

In descending order, the top 10 riskiest foods were: leafy greens, eggs, tuna, oysters, potatoes, cheese, ice cream, tomatoes, sprouts and berries.

“These are products that people are eating every day,” Sarah Klein, an attorney for the Center told the Washington Post.

“We need the food industry and the FDA to make sure these products are arriving in our homes and restaurants in a way that’s safe for consumers.”

Bacteria and their byproducts were the main culprits, from spinach laced with E. coli O157:H7 to tuna marinated in scombrotoxin. The unfortunate people who consumed tainted foods suffered a range of symptoms from stomach discomfort to death.

The report did not account for poultry, meat and some egg products since they are regulated by the Department of Agriculture.

Potatoes were the most surprising entry on the list. Since many of the spud-associated outbreaks were traced to restaurants, the offending bacteria might have found their way there from other foods courtesy of food handlers or tainted equipment.

According to the CDC, nearly 25% of Americans are sickened and 5,000 die each year from food borne illnesses.

Last summer, the House passed a bill to increase FDA jurisdiction over the nation’s food producers. The Senate should get around to it this fall.

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The Plight of Winter Babies

October 28th, 2009 | No Comments | Source: Wall Street Journal

It had been known for decades that kids who are born during the winter test relatively poorly, drop out of school more frequently, earn less as adults and have a shorter life expectancy than those born at other times.

But no one knew why.

Brownfatexperiment1 200x300 The Plight of Winter BabiesThere were several theories, of course. One held that since winter babies reach age 16 earlier in the school year, they can legally drop out a bit earlier in their education. Another postulated that vitamin D played a role, since winter babies got less sunshine early in life. A third suggested that the cause was higher pesticide concentrations in the surface water during spring and summer, when winter babies were conceived.

These theories might have some validity, but Notre Dame economists Kasey Buckles and Daniel Hungerman have come up with another, more compelling explanation: winter babies are more likely to come from socioeconomically less-privileged families.

To reach this conclusion, the economists examined CDC birth-certificate data for 13 consecutive years beginning in 1989. In every year, winter babies were more likely to be born to teenage or unwed mothers, or mothers that hadn’t completed high school themselves.

For example, 13.2% of January babies are born to teen mothers, whereas the number is 12% for May babies, a statistically significant difference that, along with other findings like it, is large enough to explain at least 50% of the differences in earnings, education and mortality (according to Buckles and Hungerman).

nevershoudastoppedthemilk1 150x99 The Plight of Winter BabiesThe economists can’t explain the surprising link between socioeconomic status and the time of the year when babies are born.

Perhaps it’s related to seasonal variations in employment, since married women tend to conceive when they are unemployed, they say.  Or perhaps it is due to cooler springtime temperatures, since hot weather decreases fertility, but only for those who live in homes without air conditioning.

Then again…January is roughly 9 months after prom season!

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Chantix May Not Bump Suicide Risk

October 27th, 2009 | No Comments | Source: British Medical Journal, MedPageToday

Contrary to FDA warnings on the matter, a UK  study has found “no clear evidence” to support the claim that the cigarette cessation drug Chantix increases the risk of suicidal thoughts and suicide.

chantix Chantix May Not Bump Suicide RiskTo reach these conclusions, David Gunnell and colleagues at the University of Bristol reviewed the records of 80,660 men and women aged 18-95 years that had received a smoking cessation product (Chantix, Zyban or nicotine replacement therapy) between September 2006 and May 2008.

The scientists found 166 episodes of nonfatal self-harm and 2 suicides — both occurring in patients receiving nicotine replacement therapy. An additional 37 subjects reported having suicidal thoughts.

Chantix and Zyban did increase the risk of such phenomena by 12% and 17% compared with nicotine replacement products in the study, but this difference did not achieve statistical significance. The authors were left to conclude there was no clear evidence that Chantix was associated with an increased risk.

The limited study power “means we cannot rule out either a halving or a twofold increase in risk,” according to the authors.

squashed 200x300 Chantix May Not Bump Suicide RiskChantix also did not appear to increase the risk of depression or suicidal thoughts, confirming a report last March.

The FDA issued black box warnings for both Chantix and Zyban last July, and regulatory agencies around the world followed suit after adverse event reports raised the possibility of such a relationship.

The authors noted that smokers have a nearly threefold increased risk of suicide, probably because people with psychiatric illnesses are far more likely to be smokers.

It’s possible, they said, that smoking “has a beneficial effect on psychiatric symptoms, such as anxiety, that may be lost with smoking cessation.”

The write-up is in the British Medical Journal.

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People Worried about H1N1 Vaccine

October 26th, 2009 | No Comments | Source: Washington Post

Although Americans are increasingly worried about the H1N1 (swine) flu, they remain wary about getting the vaccine designed to protect them against it, according to a poll completed last week by Washington Post-ABC News.

oldschool 300x208 People Worried about H1N1 VaccineA majority of survey responders, 52%, claim to be worried “a great deal” or “somewhat” that they or another household member will come down with the infectious disease. That number was 39% in August.

Adults between the ages of 18 and 29, who are particularly vulnerable to the virus, exhibited markedly increased concern about the pandemic over the last 2 months. Forty-seven percent of the respondents in this group expressed concern about contracting the infection, up from 26% in August.

Yet despite this growing concern, only a shade over 60% of survey respondents indicate they intend to get vaccinated, and a measly 52% of parents plan to have their children get the jab.

This illustrates the twin challenges faced by the Feds in their effort to control the impact of the world’s first flu pandemic since man landed on the moon.

The CDC has allocated $2 billion to vaccinate more than half the US population and has made a commitment to immunize everyone that wants a shot.

Unfortunately, vaccine production has been slow out of the gate which has forced public health officials into triage mode, allocating limited supplies to those at greatest risk for fuliminant complications.

That said, the Feds have been largely ineffective in their efforts to convince people the vaccine is both safe and necessary.

For example, although 67% of survey respondents believe the spike is safe, only 22% claim to be “very” confident that it is. And among the one-third or so respondents who are not confident in its safety, only 6% plan to get the shot.

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Fatty Diets Cut Endurance, Cognition

October 23rd, 2009 | No Comments | Source: BurrillReport, FASEB Journal

Looking for another reason to avoid the Greasy Spoon on your lunch break?

Oxford University scientists have provided a doozy. In their study, rats receiving a fat-laden diet exhibited a 50% reduction in exercise capacity and diminished cognitive skills after just 9 days.

eatthisanddie 300x249 Fatty Diets Cut Endurance, CognitionThe findings could have implications for Average Joes who eat Sloppy Joes for lunch, athletes in search of an edge, and people at risk for metabolic syndrome and diabetes, say the authors who published their findings in the FASEB journal.
 
“We found that rats, when switched to a high-fat diet from their standard low-fat feed, showed a surprisingly quick reduction in their physical performance,” lead author Andrew Murray told BurrillReport.
 
The physiology behind the observations is fairly well understood. Exercise endurance is a function of the amount of oxygen that can be delivered to muscles and the efficiency with which muscles can extract the energy contained within the chemical bonds of the nutrients supplied to them (a process known as oxidation)

Fat oxidation is less efficient than the oxidation of simple carbohydrates like glucose.

For their study, Murray and Co. fed 42 rats a standard diet containing 7.5% fat, and measured exercise capacity as the maximal time they were able to run on a treadmill. They assessed short-term memory in the subjects using a maze task.

moregoodnews4him 150x112 Fatty Diets Cut Endurance, CognitionThe scientists then switched half the rats to a diet in which 55% of the calories were derived from fat and reassessed the rats’ endurance and cognitive abilities.

Junk food diets can easily approach the 55% fat content used by the scientists.
 
By day 9, rats on the high fat diet managed to run only half as far as their counterparts. They were also making mistakes about 17% earlier in the maze task, suggesting diminished cognitive skills.

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Female Surgeons are Happy Campers

October 22nd, 2009 | No Comments | Source: Archives of Surgery, MedPageToday

If given the opportunity, most female surgeons would choose the same career again, even though it had a major–and not altogether positive–impact on their lives, according to a study in the Archives of Surgery

greatbigbeautifultomorrow 150x99 Female Surgeons are Happy CampersFor the study, Kathrin Troppmann and colleagues from UC Davis mailed surveys to all 3507 surgeons that received certification from the American Board of Surgery in the years 1988, 1992, 1996, 2000 and 2004.

The scientists received 895 responses; 178 from women, and 698 from men.

Although both sexes reported they worked too much, more than 82% of female respondents and 77% of male respondents said they would choose their profession again. More than 75% of the female surgeons and 91% of the male surgeons were married

Female surgeons were less likely to have children (64% vs 91%) than their male counterparts, and tended to have their first child at an older age—after they had entered practice. Men tended to have their first child during residency.

For 27% of female surgeons, the spouse was their child’s primary caretaker. The spouse of male surgeons assumed these responsibilities nearly 80% of the time.

seaofjoy 200x300 Female Surgeons are Happy CampersFemale surgeons were more than twice as likely to assert that time-off for child-rearing was important after the birth of a child, and that child care should be available at work. Only 9% of females and 3% of males actually took time off after the birth of a child.

“A career in surgery has significant lifestyle implications: the profession is associated with high degrees of patient acuity, significant on-call responsibility, and irregular work hours, all requiring a significant commitment of personal time,” wrote the authors.

They concluded that strategies to increase recruitment and retention of female surgeons should include flexible work schedules and improved maternity leave and child care options.

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Feds Crack Down on H1N1 Fraud

October 21st, 2009 | No Comments | Source: FDA, Reuters

The FDA has been on a seek and destroy mission against Web sites that distribute products it has not approved for use in the fight against H1N1.

Since May in fact, the agency has warned at least 75 Web sites to stop selling more than 135 products with fraudulent claims of efficacy against H1N1.

newNYCfashion 300x199 Feds Crack Down on H1N1 FraudThe FDA’s latest move in this regard has been to issue a joint warning letter, along with the FTC, to a Web site that markets fraudulent supplements claiming to help prevent spread of the virus.

The letter advises the Web site owners to cease and desist within 48 hours or else face the heavy hand of the law, which could include an injunction by the FTC and seizure of products, an injunction or criminal prosecution by the FDA.

To date, the FDA has identified all sorts of bogus H1N1 products, including:
– A shampoo claiming to protect against H1N1,
– A dietary supplement claiming to protect infants and children from H1N1,
– A supplement claiming to cure H1N1 in 4-8 hours,
– A spray claiming to leave a layer of ionic silver on one’s hands that kills the virus
– Several tests claiming to detect the virus, and
– An electronic instrument costing thousands of dollars claiming to use “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1.

“Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said FDA Commissioner Margaret Hamburg. Such products can “make matters worse by providing consumers with a false sense of protection,” she added.

The FDA has approved 2 anti-viral drugs for treatment and prophylaxis of the 2009 H1N1: Tamiflu and Relenza.  It has also issued Emergency Use Authorizations that extend their approved labeling to additional, specific authorized uses as the pandemic spreads.

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Journals Aided Neurontin Marketing

October 20th, 2009 | No Comments | Source: MedPageToday

When Pfizer coughed up $2.3 billion to settle criminal allegations that it promoted off-label use of Bextra, it was the biggest such settlement in history. But Pfizer is not the only drug company to have been nabbed for such activities.

ParkeDavis Journals Aided Neurontin MarketingFive years ago, Parke-Davis forked over $430 million to settle a similar suit involving Neurontin.

Now it has come to light that Parke-Davis took advantage of the half-baked policies of certain journals regarding ghostwriting and disclosure of the financial ties of authors to promote off-label utilization of the latter drug.

Between 1997 and 2000, these journals published 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by Parke-Davis without disclosing such arrangements, according to Jenny White, a research analyst at UCSF, who spoke at last months’ Peer Review Congress.

The journals have beefed up their disclosure policies since that time, White added.

To reach these conclusions, White and colleagues reviewed internal industry documents regarding Neurontin that had been archived at her school’s Drug Industry Document Archive. They subsequently asked the journals to delineate current and former policies regarding ghostwriting, conflict of interest and so on.

whoknowstherightanswer 300x199 Journals Aided Neurontin MarketingWhite’s group identified 24 articles and correspondences with editors that had either been produced with support from grants that Parke-Davis or  by Parke-Davis ghostwriters.

At least 13 of these articles were published in journals that included no disclosure of the fact that Parke-Davis had a role in producing the paper. Only 2 of these articles revealed that the authors had received honoraria from Parke-Davis.

These journals “generally had less stringent requirements [regarding disclosures] than those where articles were not published,” according to White. None of them had a policy regarding disclosure of ghost authorship.

White recommended that peer-reviewed journals adopt uniform policies to prohibit such shenanigans in the future.

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Stent Suit Settled

October 19th, 2009 | No Comments | Source: Wall Street Journal

Boston Scientific Corp. has agreed to cut a $716 million check to Johnson & Johnson to settle more than a dozen patent infringement lawsuits, including one in which a judge had already ruled in favor of J&J.

Stent 300x200 Stent Suit SettledThe settlement wraps up all but 3 stent-related lawsuits involving the two companies. Stents are cage-like metal struts that prop open partially blocked arteries.

Stents are most frequently used in the coronary arteries, but they can be used in other arteries as well.

The market for cardiac stents now exceeds $4 billion. Boston Scientific leads the pack in this field, but J&J owns the original patents on the medical devices after acquiring them from Julio Palmaz, the radiologist who invented them.

Nine years ago, a judge ruled that a Boston Scientific stent known as the NIR infringed on one of J&J’s patents. Boston Scientific appealed, but announced last year that it expected to fork over more than $700 million to settle the claim. That includes interest dating from the original verdict.

Boston Scientific announced it will pay the settlement from cash holdings, which amounted to $1.2 billion as of last June.

The market for stents has leveled off in recent years after studies showed they weren’t that effective in many instances, and other studies raised concerns about bleeding from the anti-platelet therapy that is normally prescribed after stents are placed.

The J&J settlement comes shortly after Boston Scientific settled separate stent-related claims with Medtronic. For its part, Medtronic recently paid $400 million to Abbott Laboratories to settle a patent infringement case regarding…you guessed it, stents.

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