Before meningitis outbreak, firm avoided sanctions

A good argument as to why government oversight and regulation is so critical for the welfare of society . . . left in the hands of the private sector, too often corporations cut corners for the benefit of their bottom line which could lead to massive problems, including death, in this case.

The pharmacy tied to a deadly U.S. meningitis outbreak escaped harsh punishment from health regulators several times in the years leading up to the health crisis that has raised questions about oversight of the customized drug mixing industry, newly released state records show.

Problems at the New England Compounding Center (NECC) in Framingham, Massachusetts, date as far back as 1999, the year after it began operations, according to hundreds of pages of documents obtained under a Freedom of Information Act request.

And the documents show regulators refraining from the harshest sanctions available to them, even as the list of complaints against NECC continued to grow.

The documents come to light after 23 people have died and close to 300 have become ill with fungal meningitis linked to steroid shots from NECC given to thousands of patients across the country. A top medical expert says the outbreak is not over and there will be more cases in the coming weeks.

Among the reported problems was a company official handing out blank prescriptions. And an outside evaluation firm found inadequate documentation and inadequate process controls involving sterilization at NECC in 2006, the documents show.

"Although your facility has seen significant upgrades in facility design for the sterile compounding operation, there were numerous significant gaps identified during the assessment," according to a 2006 letter to NECC from Pharmacy Support Inc, an outside evaluation firm.

Summing up the violations and concerns, one state inspector in 2004 recommended the company be given a formal reprimand, a sanction that would be made public and potentially hurt business.

The complaints hinted at bigger problems emerging at NECC as it grew from a tiny family business owned by chief pharmacist Barry Cadden and his brother-in-law, Gregory Conigliaro, into a company selling products in bulk to hospitals and clinics in nearly 50 states.

"New England Compounding Center worked cooperatively with the Massachusetts Board of Registration in Pharmacy to resolve to the Board's satisfaction any issues brought to the company's attention," NECC said in a statement on Monday.

NECC's improvements drew praise from George Cayer, president of the pharmacy board at the time.
"The board commends NECC on the progress to date," Cayer said in an April 12, 2006 letter. Cayer is currently a member of the pharmacy board.

Asked about the documents' content on Monday evening, the Massachusetts Executive Office of Health and Human Services said it is investigating the 2006 settlement.

"As part of our active investigation into NECC, we are looking at the events surrounding the signing of the consent agreement," Alec Loftus, a spokesman for the department said. "This consent agreement was signed under the previous administration and it is troubling to say the least."

HISTORY OF COMPLAINTS

The pharmacy board initially proposed sanctioning NECC in 2004 with three years of probation and a public reprimand amid allegations that the pharmacy violated accepted standards for compounding methylprednisolone acetate, the same steroid that is linked to the current fungal meningitis outbreak.
But two years later, the board agreed to a nondisciplinary settlement. It also agreed not to report the agreement to the National Association of State Boards of Pharmacy or other outside agencies.

NECC's lawyer had pleaded with the board not to issue a public reprimand because it could put the company out of business.

In 2004, pharmacists in Iowa and Wisconsin complained to the board that NECC and its chief pharmacist, Barry Cadden, were soliciting out-of-state prescriptions for office use and using a form unapproved by the Massachusetts Department of Public Health.

That same year, the board issued another advisory letter to NECC noting that it had received a complaint from a "concerned Texas pharmacist about products being solicited by Barry Cadden." An investigation revealed that NECC was offering an eye treatment and improperly included promotional material and terminology in the advertisements.

Pharmacies such as NECC are typically allowed only to compound drugs based on a specific prescription written by a physician for an individual patient. They are not generally allowed to solicit business or to promote products that have not been requested by physicians.

Heating Costs to Rise This Winter as Cold Returns

Let's add insult to injury... just what we need to make the economy stronger - higher heat bills!!

Americans will pay more to heat their homes this winter as they feel something they didn’t feel much of last year: cold.

Fuel prices will be relatively stable, but customers will have to use more energy to keep warm than they did a year ago, according to the annual Winter Fuels Outlook from the Energy Department’s Energy Information Administration.

Last winter was the warmest on record. This year temperatures are expected to be close to normal.
Heating bills will rise 20 percent for heating oil customers, 15 percent for natural gas customers, 13 percent for propane customers and 5 percent for electricity customers, the EIA announced Wednesday.

Heating oil customers are expected to pay the highest heating oil prices ever. That will result in record heating bills, with an average of $2,494. That’s nearly $200 more than the previous high, set in the winter of 2010-2011.

Customers who use natural gas, electricity or propane will see lower bills than they have in previous typical winters – even with the increase over last year – because prices are relatively low.

“It’s two different worlds. For most families this is still going to be an affordable year, except for those who use oil heat,” says Mark Wolfe, the Executive Director of the National Energy Assistance Director’s Association. “For them, it’s going to be very difficult.”

Just 6 percent of the nation’s households use heating oil, but they tend to be in some of the coldest parts of the country where heating needs are high, mainly in the Northeast. About half use natural gas for heat and 38 percent use electricity. Five percent of households use propane and 2 percent use wood.

Natural gas prices will average $10.32 per thousand cubic feet. That’s 0.8 percent higher than last year but 13 percent lower than the five-year average. Electricity prices will fall 2.3 percent to 11.4 cents per kilowatt hour. Propane prices will fall 8 percent in the Midwest to $2.02 per gallon and 13 percent in the Northeast to $2.95 per gallon.

Natural gas, propane and electricity prices are relatively low because of a dramatic increase in domestic natural gas production over the last five years. Natural gas is used to generate about one-third of the nation’s electricity and it is instrumental in setting the price of electricity. Recently drillers have been increasing production of so-called natural gas liquids, including propane.

Heating oil will average a record high of $3.80 per gallon because it is made from crude oil. Crude is priced globally, and has stayed high because of increasing world demand, worries about supply disruptions in the Middle East, and stimulus programs from central banks around the world that encourage investment in oil and other commodities.

But most of this year’s increase is because forecasters expect a more typical winter. East of the Rockies, weather is expected to be about 2 percent warmer than normal but 20 percent to 27 percent colder than last year. In the West, temperatures were closer to normal last year, so the expected increase for this winter is just 1 percent.

Did a Distant Solar System Send Life to Earth?

Digital Vision

The inner solar system with a visiting comet

I love science, as you know, and especially anything having to do with space intrigues me so much!

Time was, the solar system was raining rocks. You only need to look at the cratered face of airless bodies like Mercury and the moon to get a sense of the cosmic crossfire that took place back when the local worlds were just forming and much of the debris that helped make them up was still flying free. Even now, planets and moons occasionally swap rubble, with odd bits of, say Mars, blasted into space by a long-ago meteor spiraling slowly in to get snagged by Earth.

This kind of planetary tissue exchange long ago gave rise to the concept of panspermia — the idea that life on Earth may not have originated here at all, but rather was imported in the form of organic building blocks or even microorganisms from far away. Earth, in turn, may have similarly seeded other worlds. The catch is that the solar system is a limited place, with Earth the only place we know of that’s currently capable of supporting wandering biology.

Things get a lot more interesting if you expand the pool of candidate worlds to include those in other solar systems. This idea, called lithopanspermia, has always seemed like a nifty possibility, but not one worth much thought. The physics of interstellar transfer are so complex that it would, for practical purposes, be impossible for any debris to make such a journey. Or that was the belief. But a new paper published in the journal Astrobiology gives new energy to the lithospermia idea — concluding that interstellar transfer of life might be a whole lot more possible than anyone expected.

For astrophysicists, the easiest part of both panspermia and lithopanspermia has paradoxically been the biology itself. The universe is fairly awash in water, hydrocarbons and even amino acids — and all of them can be carried aboard free-flying space rubble. In 2011, geologists announced that a meteorite that landed on Earth in 2000 not only contained amino acids and other prebiotic materials, but that all of them existed in different stages of complexity — meaning that the meteor had actually been cooking them up en route, probably with the help of traces of on-board water and heat released by radioactive material.

But if organic cargo can survive — and even thrive — on such a long journey, there’s still the matter of how you ship it from sender to receiver, and here’s where lithopanspermia ran into trouble. Old models of interstellar transfer relied on the idea of rubble being flung out of a solar system by gravitational encounters with large bodies like Jupiter, meaning that they’d be traveling at speeds of about 8 km per second — or nearly 18,000 mph. That’s way too fast for the rocks ever to be captured by the gravity of another star system, even if they did reach one. “It is very unlikely that even a single meteorite originating on a terrestrial planet in our solar system has fallen onto a terrestrial planet in another solar system, over the entire period of our solar system’s existence,” wrote astrophysicist H. Jay Melosh of the University of Arizona in a 2003 paper that attempted to put the lithopanspermia idea to rest once and for all. If our rocks can’t get out, other rocks have no greater chance of getting in.

That, however, is only if you stick with the old model for how the debris was set free in the first place. A team of researchers from Princeton University, the University of Arizona and Centro de Astrobiologia in Spain took a different approach, developing computer models of a slow-boat transit method known as weak transfer. Under this process, rubble spirals slowly outward through a solar system until it reaches a spot so far from its parent sun that it requires only a slight perturbation to nudge it into interstellar space. “At this point,” says Princeton astrophysicist Edward Belbruno, one of the authors of the paper, “you’re escaping so slowly that randomness and chaos theory is involved in getting you out.”

The problem is that low speed can also mean slow transit time to the next solar system, with a trip lasting 1.5 billion years or more, longer than even the toughest organic material could survive. About 4.5 billion years ago, however, when the sun was just being born, it was part of a tight grouping of nascent stars known as the local cluster that was comparatively densely packed — and that could have cut transit times dramatically.

“After about 100 to 200 million years, the stars scattered, and the transfer likelihood went dramatically down,” says Belbruno. “But you do have a window.” Encouragingly, analyses of terrestrial rocks reveal that Earthly organics may indeed have formed in the solar system’s comparative babyhood, directly within the departure window.

On its face, the number of rocks that would reach another solar system seems small — 5 to 12 out of every 10,000. But since trillions of rocks per year make the low-speed escape, that means a whopping one billion in that same year might be captured by neighboring worlds — and we could be on the receiving end of similar numbers from elsewhere. It may still be unlikely that anyone alive today will ever meet an alien— but the odds just went up a little that we all could be the aliens.

The First Presidential Debate: A Test of Character, Not Necessarily Substance

University of Denver students stand in for President Obama and Mitt Romney during a presidential-debate dress rehearsal in Denver on Oct. 2, 2012

 

I'm set to watch the show-down tonight! I hope everyone tunes in...

When Barack Obama met John McCain in their first debate, on Sept. 26, 2008, Obama promised to free the U.S. from dependence on Middle East oil within a decade. He said he would “deal with” Pakistan to force more action against Taliban safe havens. And he decried McCain’s proposal to tax health care benefits “for the first time in history.”

Four years later, Middle East energy independence is still a distant goal. Pakistan’s government is as two-faced — and handsomely subsidized by the U.S. — as ever. When it came time to fight for his health care plan in Congress, Obama supported taxing health benefits. For the first time in history, apparently.

This isn’t to pick on Obama, who happens to be the man in a position to deliver on his pledges. McCain would surely have fallen short himself. (His incorrectly predicted that Obama would meet with, and get rolled by, the likes of Hugo Chávez and Mahmoud Ahmadinejad.) The point is to follow Wednesday’s debate between Obama and Mitt Romney with a decidedly skeptical ear.

It’s not that the debates are all empty talk. In his 2008 sessions with McCain, Obama also vowed to reform the country’s health care system. He promised a new push to support renewable energy. He called for Wall Street reform, pledged middle-class tax cuts and said he’d leave Iraq and send more troops to Afghanistan. He delivered on all those things, and fought unsuccessfully for others.

But such detailed plans rarely make it past the Inauguration intact. The world changes. Congress has its say. The political winds shift. Obama may have meant it in his second debate with McCain when he said, “We’re going to have to take on entitlements, and I think we’ve got to do it quickly.” But he hardly charged into that breach. And although liberals are understandably ridiculing Paul Ryan for dodging the details of the Romney-Ryan budget plan — whose basic math seems not to add up — Ryan also has a point when he says the specifics depend on the whims of an unpredictable  Congress (whose partisan makeup remains uncertain, no less).

Unfortunately, the substance of the debates is often secondary anyway. By the time they roll around, the candidates’ agendas are familiar to all but the most checked-out voters. (Yes, there are surely some people who have ignored most of the campaign to date and are willing to tune in for 90 minutes of policy talk. But probably not many.) The result can be tedium. Do you remember that first Obama-McCain debate? Do you clearly remember any of them? Probably not.

The exception proves the rule: it’s easy to remember 2008′s one vice-presidential debate, between Joe Biden and Sarah Palin, forever famous for her multiple winks at the camera. That’s because we process these debates with our reptilian brain. We watch for moments of conflict, wit, fallibility. In theory, debates are edifying exchanges and arguments. In reality, they often wind up being a form of jousting that helps viewers form judgments about the candidates’ true nature and character.

Whom does that favor? It’s difficult to say. Obama has the quicker wit, but also four pretty rough years to explain away. Romney survived more than one “do or die” debate in the primaries, but he was helped by his opponents’ ineptitude.

But remember: this is only the first of three presidential debates. As Gallup has noted, several recent “winners” of the first debate, as measured by quick reaction polls, went on to lose the election — sparing them the burden of making good on all those bold promises.