A promising drug with a small flaw – you might bleed to death


Walter Daumler with a photograph of his sister Doris Daumler – on Pradaxa and died in May

Dr. Bryan A. Cotton, a trauma surgeon in Houston, had not heard much about the new anticlotting drug Pradaxa other than the commercials he had seen during Sunday football games.

Then people using Pradaxa started showing up in his emergency room. One man in his 70s fell at home and arrived at the hospital alert and talking. But he rapidly declined. “We pretty much threw the whole kitchen sink at him,” recalled Dr. Cotton, who works at Memorial Hermann-Texas Medical Center. “But he still bled to death on the table.”

Unlike warfarin, an older drug, there is no antidote to reverse the blood-thinning effects of Pradaxa.

“You feel helpless,” Dr. Cotton said. The drug has contributed to the bleeding deaths of at least eight patients at the hospital. “And that’s a very bad feeling for us.”

Pradaxa has become a blockbuster drug in its two years on the market, bringing in more than $1 billion in sales for its maker, the privately held German drug maker Boehringer Ingelheim.

But Pradaxa has been linked to more than 500 deaths in the United States, and a chorus of complaints has risen from doctors, victims’ families and others in the medical community, who worry that the approval process was not sufficiently rigorous because it allowed a potentially dangerous drug to be sold without an option for reversing its effects.

Pradaxa is an example, some critics say, of what can happen when a drug that performs well in tightly controlled trials is released into the messy world of real-life medicine. Boehringer Ingelheim said it was working on developing an antidote but that even without one, patients in a large clinical trial died at roughly the same rate as those who were taking warfarin.

The Food and Drug Administration released a report on Friday that found that the drug did not show a higher risk of bleeding than for patients taking warfarin. The report did not address the lack of an antidote for Pradaxa.

Think that’s an oversight? Or perhaps the FDA deliberately didn’t address the question of an antidote publicly – because they don’t care to.

Either flavor, the report sucks. Allowing medication with significant benefits into the marketplace – if you never acquire a bleeding injury – is absurd. Guaranteeing death while increasing survival odds in another part of the equation is pure and simple madness. Madness driven by profits.

Canadian drugstore chain pulls the plug on early Xmas music

My favorite winter solstice song [Thanks, Om]

It’s a question most of us seem to have pondered at some point: When should stores start on the Christmas season..?

Shoppers Drug Mart pulled Christmas music from its almost 1,200 stores across Canada at midnight Friday after hearing complaints from customers that they weren’t quite ready for the season to be jolly.

“Hi everyone, due to recent complaints around the Christmas music being played in stores we want to advise you that as of midnight EST tonight, all Christmas music will be suspended until further notice. We do take customer feedback to heart, and it does lead to change,” the chain announced on its Facebook page.

The posting has drawn more than 7,300 “likes” and almost 6,000 comments as of Monday morning, the majority of them positive…

“This is awesome. Christmas has been rammed down consumer’s throats earlier and earlier each year. I will be shopping at your store more often to avoid it!” wrote Lori Anne Stoute.

James MacFarlane said Christmas music in stores makes him fell “like being trapped in an endless jukebox.”

“Thank you!” MacFarlane wrote. “It turns me off of even going into stores over the holiday season knowing it’s endless Christmas music everywhere. Having two months of it is insane.”

Wayne Gerand Martin said hearing the sounds of the season eight hours a day “would drive me nuts. It would take the Christmas spirit out of the employees.”

“Your employees probably are thanking you too — having to listen to Christmas music for 2 months is just too long,” wrote Janet Williams.

This will be reported on the nutball AM radio circuit as a Canadian Assault on Christmas. No doubt.

The million puppet march – fighting for public broadcasting

It might have been the friendliest rally to ever come to the Mall — especially three days before the election. Puppets and toddlers danced. Grown-ups in furry costumes sang. A girl dressed as Cookie Monster handed out Chips Ahoys to passersby. There was even a puppet-themed wedding.

The Million Puppet March — a political rally against Mitt Romney’s debate remarks about Big Bird and cutting funding to public television — may not have actually been a million puppets strong, but furry monsters came from far and near in a post-Halloween parade of support for PBS on Saturday…

“I am the way I am — I’m an artist — because of ‘Sesame Street’ and PBS,” said Michael Montgomery, who came up from Orlando, Fla., with puppet Eddie. “To even think that that could go away is sad, and I want to raise my support for it in any way that I can.”

“I used to work for Sesame Street, and not only did it change my life as a kid, it changed my life as an adult,” said Michael Schupbach, who came in from New York City with his puppet Malcolm. “I can speak for the people who work there, everyone there knows how important their job is, they know they’re reaching 17 million kids every day.”

Malcolm described himself as a distant cousin of Oscar the Grouch. “We’re friends on Facebook,” the furry green puppet said. “I believe we’ve endorsed each other on LinkedIn.”

Schupbach also brought an “Oven Mitt Romney” puppet — a green oven mitt with stern-looking eyes…

…Charlie Anderson and Lisa, who declined to give her last name, met on Match.com five years ago and came from North Kingstown, R.I., to get married in Lincoln Park before the rally. The groom dressed as Big Bird in a yellow tuxedo. The bride, in a green gown, dressed as Kermit…

Other fans and puppeteers, from Vermont’s professional Bread and Puppet Theater to amateur PBS enthusiasts with sock puppets, came from afar — even braving transportation obstacles caused by the hurricane…

Dana Cook brought her daughter, Emma, from Wilmington, N.C., for the rally, along with their puppets: Frederick, a sheepdog, and a penguin named Lucy. “I just made that up,” said Emma, who agreed that her mom was probably the coolest ever for letting her miss school Friday to travel to Washington to play with puppets.

It’s the perfect protest to teach my daughter about protests,” said Dana, who is a fan of NPR. “There wouldn’t be angry people — there would be puppets.”

If I had been there – it would have been out of anger. How dare these papier mache conservatives try to shut down nationwide educational TV? I’m too old to have ever watched the kiddies’ shows; but, the myriad of documentaries, Masterpiece theatre variants, history delivered to a public that hardly knows the realities of our Civil War – all have served to educate folks like me who don’t intend to stop learning. Especially since the worst political hacks in this land are the ones telling me to shut up and stop watching PBS.

Scumbags of the worst kind. Their hatred of education and the educated is characteristic of their breed throughout history.

CalmSpace pod for office power naps

The rejuvenating power of naps has been known about for some time, with various studies showing that even a short nap can increase alertness. While a nap of around two hours is of most benefit as it encompasses all stages of sleep, a power nap of up to 30 minutes is certainly better than nothing. It’s not long enough for you to enter deep sleep (and consequently risk feeling worse than before), but it’s long enough to take the edge off your need to actually go to bed. Whether such evidence would ever be enough to persuade a company to provide designated areas for workers to sleep is unclear, but CalmSpace exists for that very purpose.

CalmSpace was designed by Marie-Virginie Berbet, originally as a prototype for France Telecom, but is now a finished product for office furniture brand Haworth. It’s a self-contained, plug-and-play sleep capsule optimized to create the perfect environment for tired office workers to catch some shuteye…

As well as preventing people falling asleep at their desks or burning out, power naps boast some other alleged health benefits. They can reduce stress and raise brain power and productivity levels. While many forward-thinking companies are providing areas for employees to collectively relax and take time out, very few are providing environments for individuals to actually get some sleep in.

OK. Let’s examine what could go wrong with this idea:

1. Is there room for two inside…?

2…

Survivors of meningitis from contaminated steroid coming down with a 2nd serious illness

Just when they might have thought they were in the clear, people recovering from meningitis in an outbreak caused by a contaminated steroid drug have been struck by a second illness.

The new problem, called an epidural abscess, is an infection near the spine at the site where the drug — contaminated by a fungus — was injected to treat back or neck pain. The abscesses are a localized infection, different from meningitis, which affects the membranes covering the brain and spinal cord. But in some cases, an untreated abscess can cause meningitis. The abscesses have formed even while patients were taking powerful antifungal medicines, putting them back in the hospital for more treatment, often with surgery.

The problem has just begun to emerge, so far mostly in Michigan, which has had more people sickened by the drug — 112 out of 404 nationwide — than any other state…

In the last few days, about a third of the 53 patients treated for meningitis at St. Joseph Mercy Hospital in Ann Arbor, Mich., have returned with abscesses, said Dr. Lakshmi K. Halasyamani, the chief medical officer.

“This is a significant shift in the presentation of this fungal infection, and quite concerning,” she said. “An epidural abscess is very serious. It’s not something we expected…”

The main symptom is severe pain near the injection site. But the abscesses are internal, with no visible signs on the skin, so it takes an M.R.I. scan to make the diagnosis. Some patients have more than one abscess. In some cases, the infection can be drained or cleaned out by a neurosurgeon.

But sometimes fungal strands and abnormal tissue are wrapped around nerves and cannot be surgically removed, said Dr. Carol A. Kauffman, an expert on fungal diseases at the University of Michigan. In such cases, all doctors can do is give a combination of antifungal drugs and hope for the best. They have very little experience with this type of infection.

Some patients have had epidural abscesses without meningitis; St. Joseph Mercy Hospital has had 34 such cases.

The meningitis outbreak, first recognized in late September, is one of the worst public health disasters ever caused by a contaminated drug. So far, 29 people have died, often from strokes caused by the infection. The case count is continuing to rise

Compounding pharmacies, which mix their own drugs, have had little regulation from either states or the federal government, and several others have been shut down recently after inspections found sanitation problems.

And no one is surprised. No one.

As often as conservative politicians lecture voters on their theology – ranging from states’ rights to corporations relying on self-policing to prevent crimes and disasters – history proves them wrong.

Whether the market is poisoned by derivative investments based on phony real estate valuations or individuals trying to cure chronic ailments are given contaminated medication – an essential service provided by good government is oversight. Regulations based on common sense, oversight based on an honest assessment of criminal opportunity are both required for a nation that wants health, monetary security and accountability in public and private practices.

Salon du Chocolat

The 18th annual Salon du Chocolat has been running in Paris — it’s the world’s largest event dedicated to the art of chocolate, with some 130,000 visitors coming to meet cocoa farmers and artisan chocolatiers from around the world. One highlight, especially for anyone counting calories: a fashion show of chocolate couture. The show stays in Paris until November 4, is scheduled for New York November 9–11, and lands in Seoul and Tokyo in January 2013, but if you can’t make it to any of the festivities, click through our slideshow for an eyeful of the incredible dresses…

Enough to make your mouth water.