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.

Now, 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.

This 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.

Several 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.

And 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.

The 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. 

In 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

Just 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.

Ginkgo 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: NY Times, kaisernetwork.org

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.

The 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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TV Ads in the Age of DVRs

November 24th, 2008 | No Comments | Source: Economist

In the Jurassic period of the information age, otherwise known as the late 1970s, there were no cable-ready TVs, electronic games or cell phones and of course there was no Internet. Times were good for TV marketers. They could reach 90% of US households with prime-time ads on just 3 networks.

In 2008, they would be happy to reach 30% with such a strategy, and DVRs mean viewers can skip the ads anyway.

But now things might be looking up for TV ad sellers. Researchers from the Carroll School of Management at Boston College have found that TV advertisements can influence brand preferences even when viewed in fast forward mode.

James Gips and Adam Brasel tracked the eye-movements and subsequent brand selections of participants watching a nature documentary on TV. The scientists showed that viewers focus intensely on the screen while fast forwarding commercial sequences so they don’t miss the start of normal programming.

In fact they’re paying closer attention than when ads are displayed at normal speed.

This explains why fast-forwarded brand images displayed for just a third of a second influenced future preferences, but only if they were centered on the screen and surrounded by little clutter. 

The scientists had inserted ads for Flake and Aero, two UK chocolate bars unfamiliar to most US viewers. Study participants fast-forwarding though ads in which the brand logo was displayed simply and on center screen were twice as likely to choose that brand during follow-up. Such preferences were not observed when ad lay-out deviated from the centered, uncluttered presentation.

So get ready to see brand images parked squarely and simply in mid-screen next time you’re leaning on fast forward.

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Health Reform Starting to Quack

November 21st, 2008 | No Comments | Source: NY Times, Wall Street Journal

Shhhh! If you speak about it you’ll jinx it, but it’s all good right now because something might get done in health care.

On Wednesday, two main trade associations representing America’s health insurers indicated they were ready to cut a deal with the Big O: we’ll cover everyone regardless of pre-existing conditions if you require that everybody gets coverage.

That’s the biggest trade since A-Rod to the Yankees for Soriano and a player to be named.

In 93-94 when Hil tried to get this done, the mere suggestion that such hurdles could be overcome would have drawn guffaws.

And there are other reasons to be optimistic.

Tom Daschle knows his way around the yard.

The private sector wants out from employee health care costs which oh by the way, foreign competitors never had to pay.

Big Pharma has even nodded assent. A little. We think. Maybe. 

Yep! That was Montel Williams on TV this week saying, “Early diagnosis and preventative treatment can save lives and lower health-care costs…that’s why everyone should have affordable health insurance.”

Way to go Montel!

So who’s left, doctors? They could kvetch about reimbursement, working conditions and whatever but if they play their cards right they get tort reform out of this and besides, doctors have been emasculated for so long, this one isn’t even going to hurt.

It’s hard to imagine physicians, who are fed up like no other with their career choice, wouldn’t go for the ride just on the chance things could get better.

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SATs a Piece of Cake

November 21st, 2008 | No Comments | Source: Wall Street Journal

A lot of people in South Korea had November 13 circled on their calendars. That was College Entrance Exam Day, an annual event that affects and perhaps reflects modern South Korean society as much as any on the calendar.

In South Korea, 80% of high school seniors attend college, and the results of last week’s 9-hour mostly multiple choice test will strongly impact the college they attend. Years hence, it will impact their success in securing desirable entry positions in large companies and the public sector.

So it was a big deal for the 600,000 students that took the Exam this year, and practically the whole country rose up, as it does every year, to help them do their best.

Offices and the stock market opened an hour late to assure the roads were open just when students needed a stress-free trip to the Exam sites. Non test-taking school children were given the day off to minimize noise. The nations’ national utility had 4,000 people on standby in case the power went out. Airplane take-offs and landings were halted during listening comprehension.

By 6pm though, it was over. Newspapers had published every question and the correct answer. Poorly performing students could hope for a better showing next year. The test prep industry began a new cycle and media outlets shelved their tip lines which had helped students improve concentration, study habits and dietary intake in the days before the test.

Many colleges and government officials feel it’s not right to have so much riding on a single test. They want to add essays, recommendations and related subjective material to college acceptance criteria.

But others like things as they are. They like a system that gives every student the same chance to succeed and the objectivity with which grades are assigned. 

No matter, everybody’s holding the date in 2009.

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Big Pharma Follows the Money

November 21st, 2008 | No Comments | Source: Economist

Big Pharma always had a special place in its heart for America. Why wouldn’t it? Americans spent a ton on health. Americans valued innovation and minimized regulation. Americans even let Big Pharma price its products.

And America generated half of Big Pharma’s worldwide profit.

But things change. Now, Big Pharma thinks its future lies in the developing world. Pfizer just reorganized itself to reflect that as a matter of fact. That move came after Pfizer began cultivating a presence in 130 Chinese cities. Heck, Pfizer just established a JV with a bank to develop rural markets for basic drugs in Bangladesh of all places.

Jean-Michel Halfon was describing Pfizer’s strategy when he told the Economist, ‘serving customers in developing countries is now “a business not a charity,’” but he might have spoken for all Big Pharma.

Why the change? Follow the money. Annual drug sales are expected to grow by 34% per year in emerging markets compared with 9% in the US and Japan, and 14% in Europe.  In less than a decade, drug sales in emerging markets should top $300 million, which is equal to total current sales in America and the 5 top European countries combined.

And frankly, Big Pharma doesn’t know what it’s got in the Big O. What if he were to permit the import of cheap Canadian drugs? What about his threats to have Medicare negotiate tougher price discounts? That could cut American sales by 3-10% right there, according to the Boston Consulting Group.

Meanwhile just because it’s a good idea for Big Pharma to focus on developing countries doesn’t mean it can execute. New marketing and sales strategies will be needed, not just recycled riffs designed for the American, Japanese and European markets. It can expect some tough sledding with distribution partners and regulatory complexity as well.

And what will it do about pricing?

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Concern Grows for Obese Children

November 20th, 2008 | No Comments | Source: NY Times

The arteries of children that are obese or have high cholesterol look like they are 45 years old, according to the findings of a study presented last week at the American Heart Association meetings.

Dr. Geetha Raghuveer, a cardiologist at the University of Missouri Kansas City School of Medicine used a sensitive ultrasound device to measure carotid arterial inner wall thickness in such children, who were between the ages of 6-19.

Raghuveer found that the thickness of the inner 2 layers of these arteries (known as the intima and media) exceeded 0.5 mm in 52 of the 70 children tested. That’s what’s normally found in middle aged adults.

The ultrasound method used in this study is considered to be a more accurate measure of cardiac risk than cholesterol levels, blood pressure recordings and most other tests, but it is too expensive to be used in large populations.

“These findings are potentially consistent with predictions that obesity and its complications would result in cardiovascular disease becoming a pediatric illness,” David Ludwig told the New York Times. Ludwig is an associate professor of pediatrics at Harvard Medical School. He had published a study in 2005 predicting that obesity could cut short the lives of children by an average of 2-5 years.

“This is actually looking at the development of atherosclerosis, the process that we know will, if it is not dealt with, lead to heart attack or stroke,” Ludwig added.

About 16% of US children are obese, according to the CDC. Recently the epidemic had appeared to be stabilizing, but the Great Economic Crisis of 2008 may trigger a further expansion of kids’ waistlines, because inexpensive meals are often calorie-leaden.

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Beware the Brown Cloud

November 20th, 2008 | No Comments | Source: Wall Street Journal

Man-made Atmospheric Brown Clouds (ABCs or simply, brown clouds) are darkening Asian megacities from Tehran to Shanghai, reducing crop yields and killing hundreds of thousands of people each year, according to a report released last week by the United Nations Environment Program.

The report was compiled by a scientific team with research bases in China, India, Europe and the US.

Brown clouds are 2-mile thick layers of soot, black carbon, sulfates, toxic aerosols and carcinogens that result from burning fossil fuels and biomass. Coal-stoked power plants are the single biggest contributor.

Half the world’s population resides under one or another of the world’s 5 major regional brown clouds blanketing:
- East Asia, including eastern China
- South Asia including Pakistan, India, Bangladesh and Myanmar
- Southeast Asia including Cambodia, Indonesia, Thailand, and Vietnam
- Southern Africa from sub-Saharan Africa to Zimbabwe
- South America’s Amazon basin

Brown clouds reflect and absorb sunlight and have thus dimmed the skies over Tehran, Karachi, Beijing, Hanoi, Bangkok and hundreds of other major cities by 10-25% in just 30 years.

They also adversely affect food production, according to the UN report. In addition to the lost photosynthetic potential caused by dimming, brown clouds cut crop yields by 10-40% by trapping ground level ozone. Annual economic losses from crop damage exceed $5 billion in China, Japan and the Republic of Korea. 

In addition, the toxic components of brown clouds cause respiratory and cardiovascular disease. The UN report attributes 340,000 excess deaths per year in China and India to brown clouds, and estimates economic losses due to illness and disability at 3.6% of GDP in China and 2.2% in India.

And that’s not the half of it. It turns out that getting rid of the toxic clouds may accelerate global warming. Stay tuned for a post on this matter.

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