Meningitis outbreak illustrates absent oversight in drug production

Recall includes 17,000+ vials of a steroid from the New England Compounding Center

The rising toll — 7 dead, 57 ill and thousands potentially exposed — has cast a harsh light on the loose regulations that legal experts say allowed a company to sell 17,676 vials of an unsafe drug to pain clinics in 23 states. Federal health officials said Friday that all patients injected with the steroid drug made by that company, the New England Compounding Center in Framingham, Mass., which has a troubled history, needed to be tracked down immediately and informed of the danger.

“This wasn’t some obscure procedure being done in some obscure hospital,” said Tom Carroll, a close friend to the Lovelace family, and their lawyer. “They had sought out a respected neurosurgeon who had been referred by their family doctor, at a respected hospital,” he said, referring to the St. Thomas Outpatient Neurosurgery Center. “How does this happen?”

The answer, at least in part, is that some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies.

“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” said Kevin Outterson, an associate professor of law at Boston University…

To be sure, many compounding pharmacies perform well, producing formulations of drugs for specialized needs. Compounders have also provided hospitals and doctors with cheaper alternatives to F.D.A.-approved drugs…

In recent years, compounding pharmacies have sometimes filled gaps left by shortages of drugs made by pharmaceutical companies.

“As drug shortages have become more complex and common, pharmacies are turning to external compounding companies to help them,” said Cynthia Reilly, of the American Society of Health-System Pharmacists, referring to hospital pharmacies…

There certainly is need for production of generic alternatives of some of the more specialized drugs produced by these hospital pharmacies. The article notes a product from one pharmaceutical company that had the price increased 100 x previous charge – after it was approved by the FDA. Another definition of “care” in our current healthcare system.

Stirring win at World Porridge Making Championships

Benedict Horbrugh in the middle – with the Golden Spirtle

British expat Benedict Horsbrugh has won the 19th annual World Porridge Making Championships at Carrbridge in the Highlands.

The 45-year old, originally from London but now living in Germany, took home the Golden Spurtle award for making a perfect bowl of porridge.

Last year’s champion, John Boa from Edinburgh, failed to retain his title but did win the People’s Choice award…

The Golden Spurtle is awarded to the porridge maker deemed to have made the best traditional porridge using oatmeal, salt and water.

A spurtle is a spatula-like tool, traditionally used to stir porridge.

Mr Horsbrugh, originally from Twickenham, said he started making porridge to provide a “good and solid” breakfast for his three daughters, who then encouraged him to enter the competition.

The yearly event is held in the village hall in Carrbridge, and past recipes have included the use of curry powder, sausages and seafood.

The competition precedes World Porridge Day, an international day to celebrate the breakfast favourite.

My wife and our dog have oatmeal for breakfast every day. I dearly love it; but, rarely have it – usually starting the day off with a bit more animal protein.

I know, I know. It’s the troglodyte portion of my Highland genes.

Republican Congressman declares evolution, embryology are lies straight from the Pit of Hell

Georgia Republican congressman Paul Broun tore into scientists as tools of the devil in a speech at the Liberty Baptist Church Sportsman’s Banquet last month.

“All that stuff I was taught about evolution and embryology and the Big Bang Theory, all that is lies straight from the pit of Hell,” Broun said. “And it’s lies to try to keep me and all the folks who were taught that from understanding that they need a savior.”

According to Broun, the scientific plot was primarily concerned with hiding the true age of the Earth. Broun serves on the House Science Committee, which came under scrutiny recently after another one of its Republican members, Rep. Todd Akin (R-MO), suggested that victims of “legitimate rape” have unnamed biological defenses against pregnancy.

These are the people the Party-formerly-known-as-Republican charges with supporting and providing government oversight of science.

“You see, there are a lot of scientific data that I’ve found out as a scientist that actually show that this is really a young Earth,” he said. “I don’t believe that the Earth’s but about 9,000 years old. I believe it was created in six days as we know them. That’s what the Bible says…”

…Broun credited his literal Biblical interpretation with driving his approach to government…“What I’ve come to learn is that it’s the manufacturer’s handbook, is what I call it,” he said. “It teaches us how to run our lives individually, how to run our families, how to run our churches. But it teaches us how to run all of public policy and everything in society. And that’s the reason as your congressman I hold the holy Bible as being the major directions to me of how I vote in Washington, D.C., and I’ll continue to do that.”

It sickens me that an ideologue dedicated to superstition, opposing science as part of governance in this land, holds office in Congress. We can hold a separate discussion about whether some of these loonies need to be institutionalized. The core of my concern is the quantity of ignorant people who vote a clown like this into office – and why they do – believing a fundamentalist interpretation of a book written seven centuries ago by a monarchy’s church committee as holding sway over the breadth of modern science and knowledge.

The man’s a fool. I feel sorry for the people ignorant enough to vote for him. He probably expects to cure our economic problems by having Ron Paul or Mitt Romney lay hands on the door to the US Treasury and pray.

Should you worry about giving the flu to your dog or cat?

As autumn arrives, the approach of flu season is a real concern. Last year, thousands of people suffered from symptoms including a high fever, chills and fatigue—classic signs of the flu. Some 2,374 people in the United States were hospitalized for influenza during the last flu season — an incentive for many of us to get an annual flu vaccine, to avoid both getting sick and potentially passing on the flu to family members.

A group of veterinarians at Oregon State and Iowa State Universities is now looking into the risk of flu for an unexpected population that doesn’t have access to flu shots: dogs, cats and other household pets. “We worry a lot about zoonoses, the transmission of diseases from animals to people,” said Christiane Loehr, a professor at the OSU College of Veterinary Medicine. “But most people don’t realize that humans can also pass diseases to animals, and this raises questions and concerns about mutations, new viral forms and evolving diseases that may potentially be zoonotic. And, of course, there is concern about the health of the animals.”

We’re pretty well acquainted with zoonoses—diseases that can move from animals to humans—because of the high profile transmissions of the influenza strains H1N1 (“swine flu“) and H5N1 (“bird flu”) from animals in recent years. But, as it turns out, many diseases can also act as so-called reverse zoonoses, or anthroponoses, contagiously jumping from humans to other animals. This appears to be the case for H1N1: The researchers have discovered 13 cases in which H1N1 seems to have been passed from humans to pet cats, some of which ultimately died from the disease.

The first recorded instance, described in an article published by the team in Veterinary Pathology, took place in Oregon in 2009. While a cat owner was hospitalized with H1N1, both of her cats (which stayed indoors and had no contact with other sick people or animals) came down with flu-like symptoms and eventually died. A postmortem analysis of their lungs and nasal cavities turned up the H1N1 virus.

In the years since, the research team has turned up 11 more cats, one dog and even some ferrets that seem to have been infected with H1N1 due to human contact. The animals’ flu symptoms—respiratory disease and, for some, eventual death—resemble the same symptoms suffered by humans who encounter severe strains of the flu…

Realistically, though, the actual number of animals infected is quite small when compared to the population at large. The bigger worry is that the flu virus could mutate into a more dangerous form as it is transmitted from humans to animals. “Any time you have infection of a virus into a new species, it’s a concern, a black box of uncertainty,” Loehr noted.

If your companion animal is close to you, emotionally as well as physically, you would be irresponsible to ignore the possibility, albeit small. Even if your cat or dog doesn’t care – for example – about sneezing on you, you needn’t be so thoughtless. The thought doesn’t occur to them. It certainly should pop up in your own brain box. 🙂

So – if you’re struggling your way through the flu – wash your hands before you pet and hug your companion critter. As you would or should with your other kids.

Weather-making high-pressure systems predicted to intensify

High-pressure systems over oceans, which largely determine the tracks of tropical cyclones and hydrological extremes in much of the northern hemisphere, are likely to intensify this century, according to a Duke University-led study…

The study’s findings suggest that as summertime near-surface high-pressure systems over the northern Pacific and Atlantic oceans strengthen, they could play an increasingly important role in shaping regional climate, particularly the occurrence of drought and extreme summer rainfall, in coming years.

Wenhong Li…and colleagues used climate model simulations to predict future changes in the strength of the annually occurring North Atlantic Subtropical High, also known as the Bermuda High, and the North Pacific Subtropical High.

According to the simulations, these high-pressure systems will intensify over the 21st century as a result of increasing greenhouse-gas concentrations. The simulations suggest that an increase in the land-sea thermal contrast – the difference between ocean and land heating, as Earth’s climate warms – will fuel the systems’ intensification.

Just in case you thought summer weather where you live in the northern hemisphere was as crappy as it can get..?

I can see the smile on the face of my mate in Melbourne – Mark – from here. The only one in our extended group of editors and bloggers in the southern hemisphere.

Modern Meadow and their plans for producing lab-grown leather

For many people, meat and leather are an ethical and environmental nightmare, causing misery to billions of animals and wreaking havoc on the planet’s ecosystems. While mankind is unlikely to turn entirely vegan in the next generation, a more humane and cleaner type of leather could become available in the near future (and meat a few years later) thanks to the development of an in-vitro version of the material being developed by Modern Meadow.

The company’s founder and CEO Andras Forgacs recently revealed to Txchnologist, a GE-sponsored technology online magazine, that Modern Meadow has focused on leather because it is a simpler structure than meat, although he’s also working on the latter (and he’s not alone there)…

In reality, the process would not be completely animal-free, since it would start with a puncture biopsy of an animal. The extracted cells would be isolated and possibly genetically modified (not for meat, though). They would then be reproduced by the billions in a bioreactor and centrifuged to eliminate the agent that supports cell growth. Next, they would be lumped together to create aggregated spheres of cells, which would be then layered and fused together in a process called bioassembly.

The layered and fused cells would subsequently be placed in a bioreactor to mature, where they would be fed for a few weeks. The skin tissue would evolve into hide, and muscle and fat would be harvested for food. Here comes the good news for environmentalists: because the hide would not have hair or a tough outer skin, the tanning process would be shorter and require fewer chemicals…

Livestock accounts for nearly 20 percent of global greenhouse gas emissions, besides polluting waterways, causing soil erosion and being the main driver of deforestation of the Amazon forest, not to mention the immense suffering it causes to animals. Leather is also the source of massive pollution by chemicals, especially in India, and the production cycle involves a great deal of waste.

Global demand for meat is expected to double by 2050 and considering that currently we farm, feed, transport and slaughter around 70 billion land animals per year, the topic has gained momentum amongst the international environmental community. True, in-vitro meat and leather have an ecological footprint as well, but it’s insignificant compared with the devastation caused by livestock. And there’s no slaughtering involved.

The decades I’ve lived in the American Southwest have mostly been spent in regions differentiated into two categories: areas where the landscape has been negatively affected by grazing and overgrazing – and areas where the landscape has been to all intents and purposes destroyed by overgrazing.

There is a fair piece of terrain in New Mexico absent the ravages of cattle grazing and the ideology of those who profit from that traditional business. It is a constant political battle trying to maintain and defend that land.