Archive for November, 2008

Global Warming Rocks

November 28th, 2008 | No Comments | Source: Economist, PNAS

Geologists know that when carbon dioxide contacts the igneous rock peridotite, a spontaneous chemical reaction results. The reaction produces limestone and eliminates carbon dioxide.

Carbon dioxide is a greenhouse gas, so people thought why not grind up some peridotite, transport it to power plants and line smokestacks with the stuff to trap CO2 before it’s released into the atmosphere?

A good thought, but one that proved too costly and energy intensive.

miraclerock 300x299 Global Warming RocksNow, a study published in the Proceedings of the National Academy of Sciences concludes that the miracle stone’s gas trapping abilities can be enhanced a million-fold by simple methods, and the whole CO2 sink idea suddenly has legs.

Peridotite normally resides in the Earth’s mantle 15 miles below the surface. Sometimes though, plate tectonic collisions push peridotite to the surface. That’s what happened eons ago in Oman which is now home to an exposed patch of peridotite the size of Massachusetts.

After 5 years of field work in the Omani desert, Peter Kelemen and Juerg Matter concluded that its peridotite patch is naturally absorbing 10,000 to 100,000 tons of carbon a year–far more than previously thought.

This means it may be feasible to pump CO2 from regional power plants to specially prepared peridotite fields resulting in “a low-cost, safe and permanent method to capture and store atmospheric CO2,” according to Kelemen.

The process would involve boring holes into the rock and injecting warm water containing pressurized CO2. Once started, the reaction would generate heat that would further accelerate the reaction. Fractures would form exposing new peridotite to the soda. The man-made gas trap would keep going as long as fresh CO2 was supplied.

The scientists assert that Omani peridotite alone can absorb some 4 billion tons of carbon a year—that’s 13% of the total spewed into the atmosphere each year.

Peridotite fields also exist in Papua New Guinea, Greece and Croatia. There are small deposits in the western United States as well.

And it turns out that ubiquitous basalt may have similar greenhouse gas gobbling characteristics. Scientists in Iceland are pursuing that lovely possibility right now.

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Road Trip for the FDA

November 28th, 2008 | No Comments | Source: Washington Post

In response to a downpour of lead-laced toys, contaminated food and counterfeit drugs that have been exported to the US in recent years, the FDA is deploying staff overseas. The FDA staff will work with foreign regulatory agencies, importers and whoever else they can find.

fdakeepingyousafe 300x199 Road Trip for the FDAThis week in fact, the FDA opened a foreign bureau in China, the country that exported tainted pet food to the US killing thousands of dogs and cats, and couldn’t prevent melamine-laced milk from sickening 54,000 of its own children.

The FDA’s China bureau will have 8 US employees and a Chinese staff. Its job is to certify inspections of Chinese exports headed for the US. The bureau will subcontract the work to private and commercial labs and liaise with several Chinese government agencies, where it hopes to establish quality standards.

Which raises the question, how does the FDA plan to assure that all items in a $320 billion stream of products are safe and fit for use?

Secretary of Health and Human Services Mike Leavitt seemed realistic when he told the Washington Post, “we…cannot inspect everything (but) we believe very strongly that we can, through independent certification, assure that someone we trust is overseeing products that come into the United States.”

But Jiang Weibo is circumspect.  The professor at China Agriculture University’s School of Food Sciences told the Post, “The FDA can never find all the potential poisons in Chinese-exported food products. There are dozens of pesticides used. Each product might have more than a thousand different poisonous possibilities.”

Oh great.

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Gulf War Syndrome

November 26th, 2008 | No Comments | Source: Reuters

Gulf War syndrome is legit and 175,000 US veterans of the first Gulf War suffer its effects.

That’s the conclusion of the Research Advisory Committee on Gulf War Veterans’ Illnesses, a group of scientists and veterans appointed in 2002 by Congress to evaluate the cornucopia of neurological and other symptoms that have struck our soldiers in the years since the war.

theresnoplacelikehome Gulf War SyndromeSeveral earlier studies concluded that combat stress had caused the syndrome.

“Scientific evidence leaves no question that Gulf War illness is a real condition with real causes and serious consequences for affected veterans,” committee spokespeople told Reuters.

The committee added that Congress should increase research funding on Gulf War syndrome to $60 million per year.

“This is a national obligation, made especially urgent by the many years that Gulf War veterans have waited for answers and assistance,” the committee said.

The veterans that contracted Gulf War syndrome represent one quarter of all US troops that served in the effort to repel Iraq’s invasion of Kuwait. The most common symptoms include diffuse pain, memory and concentration problems, fatigue, headaches, diarrhea, skin rashes and respiratory difficulties. Few vets report that their symptoms have improved since initial onset.

“Today’s report brings to a close one of the darkest chapters of the 1991 Gulf War, and that is the legacy of Gulf War illness. For those who ever doubted that Gulf War veterans are ill, this report is definitive and exhaustive,” said Anthony Hardie, who was a 23-year-old sergeant during the war.

The panel was unable to determine what causes the syndrome, but it suggested the 2 most likely factors were pyridostigmine, a drug given to the troops to protect against nerve gas, and pesticides that were used against sand flies and other bugs during the war.

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Facing the Music

November 26th, 2008 | No Comments | Source: Wall Street Journal

Facebook chief executive Mark Zuckerberg wants his company to focus on growing user base rather than revenues, but former Twitter CEO Jack Dorsey will attest that strategy doesn’t always work even in good times and these aren’t good times.

facebook Facing the MusicAnd no matter what the 24 year-old may say publicly, Zuckerberg and his COO and new BFF Sheryl Sandberg know the time has come to focus on revenue and prove once and for all their business deserves its astronomical valuation.

If they can, that is.

It’s not like Facebook hasn’t tried already. The Palo Alto-based company claims for example that in the last 2 years, 70 of the top 100 US advertisers have run ads on its site. But according to comScore, that has translated into a modest 1.1% share of US online display ad views.

By contrast, News Corp.’s Fox Interactive Media Unit, which owns MySpace, captured 15.9% of display-ad views in the same period.

So now Facebook is introducing a new revenue scheme called “engagement ads.” These things appear on the main log-on screen and encourage users to do something on the ad, like commenting on a TV show trailer or adding movies to a favorites list.

Completed actions are then shared with friends along with the implied recommendation.

The scheme may or may not work, but when Nashville resident Heather Watson came across an engagement ad for Bravo TV’s “Project Runway,” she clicked “not attending” which erased the ad from view. These ads “detract from the [Facebook] experience,” she scoffed to the Wall Street Journal.

And the Great Economic Crisis of 2008 isn’t going to help Facebook any. eMarketer predicts in fact that ad growth on the Internet will drop from 17% this year to 14.5% on 2009, and social-networking site ads are likely to be hit hardest because there’s no good way to assess effectiveness of these ads.

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Cephalon’s Pricing Shenanigans

November 26th, 2008 | No Comments | Source: Wall Street Journal

Cephalon has a great story. Founded 20 years ago, the Frazer, Pennsylvania-based biotech start-up has grown to become one of the top ten biopharmaceutical companies in the world. It has 9 products on the US market, a reputation for creativity, a prodigious pipeline, and revenues exceeding $1.4 billion.

And now that Provigil—the drug responsible for half its revenue is due to lose patent protection in 4 years—Cephalon has begun the next chapter in its story.

We’ve heard this one before. It’s about pricing schemes that wring every red cent out of Provigil and its long-acting offspring, Nuvigil.

Provigil has FDA approval for narcolepsy, obstructive sleep apnea and shift-work sleep disorder. It has also become a popular lifestyle drug that people use to stay sharp at work or wherever.

Twice already this year, Cephalon jacked-up the price of Provigil. It now costs 28% more than it did this spring and 74% more than 4 years ago.

It has done so in anticipation of the spring, 2009 launch of Nuvigil, which had received FDA approval 2 years ago but was shelved by Cephalon as part of its now-unfolding revenue-maximization strategy.

See, Nuvigil will come out cheaper than the now jacked Provigil, so everyone will switch to the new product which enjoys patent protection until 2023. Then, when the generics hit the market, patients and physicians will not be inclined to switch from the convenient long-acting drug to the short-acting generic.

Cephalon talks openly about its perfectly legal scheme. Its VP of investor relations Chip Merritt recently told those attending a conference last month, “you should expect that we will…raise Provigil prices to…create an incentive for the reimbursers to preferentially move to Nuvigil.”

Most insured patients taking Provigil for FDA-approved uses won’t be directly impacted by the price increase, but those who take the stuff for recreational purposes may be left out to dry.

That’s when we learn about price-elasticity for a wakefulness drug that you can’t order with extra foam, whipped cream and caramel drizzle.

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Kids, Antipsychotics Don’t Mix

November 25th, 2008 | No Comments | Source: NY Times

Last Tuesday, the FDA convened an expert panel for a routine review and approval of the agency’s monitoring practices for antipsychotic medications in children.

Apparently, panel members didn’t get the memo.

The experts unanimously rejected the FDA proposals and implored the agency to step up efforts to curb overutilization of the drugs for safety reasons.

dontlookatme 300x229 Kids, Antipsychotics Dont MixThe drugs in question are known as atypical antipsychotics. They include Risperdal, Zyprexa, Seroquel, Abilify and Geodon, although much of the meeting focused on Johnson & Johnson’s Risperdal.

Nearly 400,000 children and teens took Risperdal last year, 60% of which were 12 years old or younger. Many received the drug for attention deficit disorders, pediatric bipolar disorder and non-specific aggressive behavior or emotional outbursts. The drug is not approved for these purposes.

And side effects of Risperdal and other atypical antipsychotics are profound, including marked weight gain, metabolic abnormalities and tics that can become permanent. More than 1,200 children have suffered serious problems attributable to Risperdal, including 31 who died.

Prescriptions for atypical antipsychotics increased 500% in the last 15 years. Psychiatrists pen most of the pediatric prescriptions for these drugs.

“The committee is frustrated,” Leon Dure told the New York Times. The pediatric neurologist and panel member added, “We need to find a way to accommodate this concern of ours.”

But the FDA’s Dr. Thomas Laughgren said the agency had already affixed stern warnings to the drugs’ labels and there was little more it could do. Maybe the medical professional societies can do more to educate prescribers, he suggested.

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Brown Clouds and Global Warming

November 25th, 2008 | No Comments | Source: Wall Street Journal

Last week’s UN Environment Program Report concluded that Atmospheric Brown Clouds are darkening cities on several continents, destroying crops and killing hundreds of thousands of people.

The report also warned that brown clouds are enormously important climate changers and that poorly planned efforts to eliminate the clouds would accelerate global warming. 

goinggoinggone1 300x299 Brown Clouds and Global WarmingIn the Himalayan-Tibetan plateau, brown clouds enhance greenhouse warming and are thus accelerating the retreat of the Hindu Kush-Himalayan-Tibetan glaciers. These glaciers feed the four great rivers of Asia which provide water to 2.5 billion people. The matter carries “serious implications for the water and food security of Asia,” said Professor Veerabhadran Ramanathan, head of the UNEP scientific panel.

But warming of the Himalayas is an unfortunate regional anomaly. The UNEP scientific panel in fact concludes that brown clouds dampen the pace of global warming by 20-80% by reducing the amount of sunlight that reaches the Earth’s surface.

This means that tackling the pollution linked with brown cloud formation without simultaneously delivering big cuts in greenhouse gases may increase global temperatures 2 degrees Celsius, which is nearly three times the rise in world temperatures measured during the entire 20th century.

Professor Veerabhadran Ramanathan, head of the UNEP panel said, “Our preliminary assessment, published in 2002, triggered a great deal of awareness but also skepticism. That has often been the initial reaction to new, novel and far reaching, counter-intuitive scientific research.

“We believe today’s report brings ever more clarity to the ABC phenomena and in doing so must trigger an international response – one that tackles the twin threats of greenhouse gases and brown clouds and the unsustainable development that underpins both.”

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PCPs Need Some Love

November 25th, 2008 | No Comments | Source: CNN

andthiswasmyeasyday 240x300 PCPs Need Some LoveJust when it starts to look like we might finally expand health coverage and access in this country, we get word that 49% of physicians responding to a recent survey say they plan to reduce their panel sizes or quit practice altogether due to poor working conditions.

The Physician’s Foundation sent the survey to 250,000 primary care physicians and 50,000 specialists. It received 12,000 responses.

The results showed widespread frustration—particularly among primary care physicians—due to burdensome administrative responsibilities, reimbursement delays and governmental regulations.

- 94% said time spent on clerical duties increased in the last 3 years
- 63% said this caused them to spend less time with patients
- 82% said their practices would be unsustainable with further Medicare cuts
- 60% said they would not recommend medicine as a career
- 17% said their practices’ financial position was healthy and profitable
- 45% said they would retire today if they could

“Going into this project we generally knew about the shortage of physicians; what we didn’t know is how much worse it could get over the next few years,” said Lou Goodman, President of the Physicians’ Foundation. 

News of PCP dissatisfaction is not lost on students preparing to graduate US medical schools, where only 2% have indicated plans to enter primary care. That’s down from 9% in 1990.

The American Medical Association used this and other data to estimate that the US will be 35,000 PCPs short by 2025.

And strung-out PCPs don’t want to hear it but we’re more likely to empower nurse practitioners, utilize new provider venues like retail clinics and recruit more foreign medical graduates than we are to fix the fundamental issues raised by the surveys.

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Bag the Ginkgo Biloba

November 24th, 2008 | No Comments | Source: JAMA, MedPageToday

Honey, what should we do with the Ginkgo biloba?

How many people are asking that question after scientists at the University of Virginia proved the popular plant supplement does not reduce the risk of developing dementia of any kind nor Alzheimer’s disease specifically.

cantrememberwhatthisis1 200x300 Bag the Ginkgo BilobaGinkgo also did not impede progression to dementia in those having mild cognitive difficulties to begin with.

Subgroup analyses of younger patients, older patients, both sexes and those with all degrees of baseline cognitive impairment all came up dry, and there was no impact on overall mortality.

Pretty much, the stuff didn’t work.

Steven T. DeKosky and colleagues randomized 3,069 community-dwelling people who were at least 75 years of age to receive either 120 mg Ginkgo twice a day or a placebo. 482 study participants had mildly impaired cognition at study onset. Participants were evaluated twice yearly during the 6-year study.

The results were just published in the Journal of the American Medical Association. 

Annual US sales of Ginkgo products are $250 million, driven by some bench research showing neuroprotective effects that have been attributed to flavonoids contained in Ginkgo, an animal study showing mild protective effects during a stroke, and good old-fashioned hope that it could improve or at least maintain memory.

The present study did not exclude the possibilities that starting the extract at a younger age or continuing it longer than 6 years might have beneficial effects, though these seem unlikely.

A second large, randomized trial of Ginkgo biloba is nearing completion. We’ll try to remember to look for it.

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FDA Scientists Allege Misconduct

November 24th, 2008 | 1 Comment | Source: kaisernetwork.org, NY Times

In a letter to Congress, 8 FDA scientists accuse senior FDA officials of “serious misconduct” in squelching their opinions and approving ineffective and potentially unsafe medical devices.

The letter was sent a month ago and made public in redacted form last week. It says the scientists can prove that FDA managers “corrupted the scientific review of medical devices” by coercing experts to alter conclusions about certain devices, according to the New York Times.

fda FDA Scientists Allege MisconductThe scientists claim that top officials in the Center for Devices and Radiological Health told them they might be fired or given poor performance reviews if they did not alter their reports to hide unfavorable data and legal violations such as not obtaining informed consent from participants.

Public information on the matter does not specify which devices are being called into question.

“This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation,” according to the letter received by Congress.

The FDA scientists initially raised the matter with FDA Commissioner Andrew von Eschenbach in May. Eschenbach asked Assistant Commissioner William McConagha to investigate. The FDA scientists say McConagha concurred that the evidence was “’sufficient’ to justify curative and disciplinary actions” according to the letter received by Congress.

The matter was then referred to the CDRH Director who concluded there was no cause for disciplinary action. He told the FDA scientists to “move forward.”

Indeed they have.

 “These allegations are deeply concerning,” Representative John Dingell (D-Mich) told the New York Times. The chairman of the House Committee on Energy and Commerce added, “We intend to uncover whether any FDA activity has compromised the health and safety of American consumers.”

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