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Art. I. Kate Scannell: The Avandia story -- science at the wounded heart of medicine 07/24/2010 12:00:00 AM PDT
THE TROUBLING story about the diabetes drug Avandia concerns everyone not "just" the millions of diabetic patients who have taken it. It concerns everyone because it provides an instructive and cautionary tale about prescription drug evaluation and marketing in general. And, importantly, the Avandia story adds to the awesome burden of uncertainty and mistrust that already weighs down our health care system and drives up its costs.
Telling the Avandia story is difficult for many reasons it is depressing, convoluted, and disappointing. But it is also difficult to tell because it makes me want to use millions of exclamation marks, which would consume too much limited column space. It makes me want to punctuate the ends of too many sentences with sad emotions like this: It makes me feel outraged, like an incredulous "Saturday Night Live" reporter on the "Really?!?" segment of Weekend Update News. But I will try to resist these emotional tides and undertows! Really. We begin with these three cold facts:
1. In 1999, the FDA approved Avandia's use for type-2 diabetes the type often referred to as "adult- onset diabetes" and generally characterized by an impaired ability of cells to interact appropriately with insulin and drive down blood glucose levels. In contrast, type-1 diabetes is commonly referred to as "juvenile onset" and generally characterized by an actual deficiency of insulin.
2. Avandia is the drug manufacturer's trade name for "rosiglitazone," which belongs to a class of anti- diabetes drugs that tweak cells to increase their sensitivity to insulin. Hence, this drug class should help to lower blood glucose levels for many patients with type-2 diabetes. Made by a rival drug company, Actos is Avandia's main competitor within its class.
3. Avandia is manufactured by GlaxoSmithKline, Britain's largest pharmaceutical company. "GSK" in 2009 had total profits of $8.4 million, helped by $1.1 million in revenues from Avandia.
The Avandia story began to heat up in 2007 when a Cleveland Clinic cardiologist noted that 42 available studies about Avandia appeared to show a 43 percent increased risk of heart attacks from the drug! He published those findings in the New England Journal of Medicine in May 2007. But lo and behold, one of the journal's reviewers had faxed the confidential manuscript to GSK before its publication. Really!!! Additionally, that reviewer not only had financial ties to GSK, but he had also served on the steering committee for GSK-sponsored research on Avandia.
This outrageously unethical heads-up helped explain why GSK was able to publish a rebuttal study in the same journal within one short month. Oh, and that GSK study showed that Avandia did not cause heart problems! Really!?! What a conundrum. Diabetes was already associated with a heightened risk of debilitating and fatal cardiovascular problems. And there were plenty of other medications on the market without the risks that some associated with Avandia. Who and what should diabetic patients and doctors believe about taking or continuing Avandia?
Re-enter the FDA in July 2007. An advisory panel convened and concluded that Avandia was associated with a definite increased risk of heart disease. Really, definitely, they meant it! And, by a whopping 22-to-1 vote, the panel recommended that Avandia should remain on the market because it "... it controlled blood sugar. Presumably, that was meant to offer "the good news" for diabetic patients clutching their chests in emergency rooms.
Years pass. It is February 2010, and Congress is involved again. Now it accuses GSK of conspiring to cover-up evidence of Avandia's heart risk. The New York Times reported that as far back as 2001, an executive of SmithKline (a precursor of GlaxoSmithKline) withheld data that not only suggested that Avandia was "no better than Actos," but that it also was "riskier to the heart." An internal GSK e-mail message read: "Per Sr. Mgmt. request, these data should not see the light of day to anyone outside of GSK."
In May of this year, two studies again demonstrated that Avandia increased the risk of cardio-vascular problems. One of them came from the FDA and included data from over 220,000 patients; it claimed that, for every 60 people on Avandia for a year, there occurred an extra heart attack, stroke, heart failure, or death. Really. This month, the FDA convened another advisory committee to discuss the cardiovascular risks relating to Avandia again. The 33 committee members listened to conflicting reports and opinions by FDA staff, GSK researchers, and independent scientists.
The committee determined again that Avandia's risk for heart attacks was worse than that for its sister drug, Actos. And, by a 20-12 vote, with one abstention, it decided to keep Avandia on the market again!!! This mixed message was further complicated by the fact that the majority of the 20 members who voted to keep Avandia on the market also advocated for stronger warnings or restricted use for the drug, while 12 members urged an Avandia recall, and three members one of whom was on GSK's paid speakers' bureau (Really !?!) voted to maintain the status quo. So, what to do now?
The FDA will make its final decision about Avandia in the coming weeks or months. But clearly, its decision will rest upon information that no one can reliably interpret or trust. The decision will be made within an atmosphere of blatant confusion and explicit deception that GSK helped to create. All the while, GSK advises concerned patients taking Avandia to "speak with their physician about their treatment and any questions they may have regarding the safety of the medicine."
Well, this physician would answer that GSK has inflicted a remarkable amount of uncertainty, suffering, and anxiety on patients and their doctors. Heart attacks and strokes that conceivably may have been prevented if patients and doctors had known about concealed risk data that took years "to see the light of day." Heightened mistrust of the pharmaceutical, research and medical establishments. And an incredible waste of our health care dollars lost to expensive and faulty research, repetitive costly "meetings," paid undercover professional salaries, and lawsuits. (Already this month, according to Bloomberg News, GSK settled a $460 million lawsuit involving about 10,000 people alleging harm from Avandia.) Meanwhile, another research question looms unanswered and urgent: Has Avandia ever been shown to actually improve real-life clinical outcomes for diabetic patients? Really.
Kate Scannell is a Bay Area physician and syndicated columnist. Her new novel is "Flood Stage."
Art. II. Pay czar will not fight banks on $1.6B in exec pay
By DANIEL WAGNER AP Business Writer Updated: 07/23/2010 03:22:52 PM PDT
WASHINGTONFor all his tough talk about excessive pay for bankers, the Obama administration's pay czar let the executives go without a fight. Kenneth Feinberg announced Friday that he would not try to recoup $1.6 billion in compensation given to top executives at bailed-out banks because he thought shaming them was punishment enough. His decision to go easy on 17 banks that made "ill-advised" payments to their executives is likely to fuel concerns about how he will oversee the $20 billion oil spill compensation fund created by BP.
"I'm not suggesting we should blink or turn the other cheek," Feinberg said later in an interview with The Associated Press. "These 17 companies were singled out for obviously bad behavior. The question is: At what point are you piling on and going beyond what is warranted?" He could not force the banks to repay the money, but the law instructed him to negotiate with banks to return money if he determined that the pay packages were "contrary to the public interest"language that he opted not to use.
Still, his leniency is a far cry from the bravado he displayed in the months leading up to his final act as pay czar. In February, he spoke with confidence about his ability to get companies that received taxpayer help to accept less. In an interview with The Hill newspaper, Feinberg said he had been "fairly successful in convincing the companies that it is in their best interests to seek an accommodation on compensation." Among the companies Feinberg did not pursue were two whose bailouts are expected to cost taxpayers more than $38 billion: American International Group Inc. and CIT Group Inc. He also ignored excessive pay at Wall Street powerhouses such as Goldman Sachs Group Inc. and JPMorgan Chase & Co., which reaped massive profits from government efforts to stabilize the financial system. They had no trouble repaying their bailouts. He said a fight with those banks could have exposed them to lawsuits from shareholders trying to recapture the executives' money, and he did not think that would be fair.
Sen. Bernie Sanders, a Vermont independent, said he was disappointed that Feinberg decided there was no way to force the banks to return the bonus payments. "These people's jobs were saved by the taxpayers of this country, and their response was to give themselves these huge bonuses," Sanders said. "Many Americans lost their jobs because of this Wall Street greed. It is one of the reasons the American people are as angry as they are."
Many Gulf Coast fishermen are angry, too, at the way BP and the government have handled the legal claims of those whose earnings have been hurt by the oil spill. Paul Nelson, a fisherman in Coden, Ala., who leads the South Bay Communities Alliance on the Alabama coast, said the fishermen he represents feel they have no voice in the claims process. "Where is the citizen input?" he said.
It's not the first time Feinberg has talked tough but taken a light touch with bankers. He clashed publicly with AIG CEO Robert Benmoschewhile quietly approving a pay package worth more than $10 million. He announced in October 2009 that he had cut cash pay by 90 percent at the handful of companies that got the biggest bailouts. Yet the changes were not retroactive; they only applied to the final six weeks of that year.
That track record concerns some Gulf state officials. Alabama Attorney General Troy King announced Thursday he will file suit against BP to recover tax revenues lost because of the oil spill and to recoup cleanup costs. At the news conference, he said Feinberg seems to be working more for BP than for the people harmed.
Feinberg strongly defended his independence from BP, saying his actions "speak for themselves." "I think both the administration and BP will acknowledge my absolute independence," Feinberg said. He added that anyone who believes he "went easy on the banks hasn't carefully read what I did over the past 16 months, and what I did today regarding these 17." Rather than demanding they return the money, Feinberg invited the 17 banks that overpaid workers to give their boards of directors more power to withhold pay during future crises. The request was voluntary.
Feinberg reviewed 419 companies that received bailout money before pay curbs were enacted by Congress in February 2009. The review covered the period from October 2008 to February 2009. The starting point was when banks began receiving bailout money under the Troubled Asset Relief Program. The ending point was when Congress enacted pay curbs on institutions receiving government support.
Feinberg determined that a total of $1.7 billion in payments were made during that period that would have violated the guidelines adopted later. And $1.6 billion of that amount was paid out by 17 of the country's largest financial institutions. In addition to AIG, CIT Group, Goldman and JPMorgan, Feinberg criticized pay at the following banks: American Express Co., Bank of America Corp., Boston Private Financial Holdings Inc., Capital One Financial Corp., Citigroup Inc., M&T Bank Corp., Morgan Stanley, Regions Financial Corp., SunTrust Banks Inc., Bank of New York Mellon Corp., PNC Financial Services Group Inc., US Bancorp and Wells Fargo & Co.
Art. III. The Middle Class in America Is Radically Shrinking. Here Are the Stats to Prove it Jul 15, 2010 02:25pm EDT in Recession From Business Insider Michael Snyder is the economiccollapseblog.com editor
The 22 statistics detailed here prove beyond a shadow of a doubt that the middle class is being systematically wiped out of existence in America.
The rich are getting richer and the poor are getting poorer at a staggering rate. Once upon a time, the United States had the largest and most prosperous middle class in the history of the world, but now that is changing at a blinding pace. So why are we witnessing such fundamental changes? Well, the globalism and "free trade"
that our politicians and business leaders insisted would be so good for us have had some rather nasty side effects. It turns out that they didn't tell us that the "global economy" would mean that middle class American workers would eventually have to directly compete for jobs with people on the other side of the world where there is no minimum wage and very few regulations. The big global corporations have greatly benefited by
exploiting third world labor pools over the last several decades, but middle class USA workers have increasingly found things to be very tough. Here are the statistics:
83 percent of all U.S. stocks are in the hands of 1 percent of the people.
61 percent of Americans "always or usually" live paycheck to paycheck, which was up from 49 percent in 2008 and 43 percent in 2007.
66 percent of the income growth between 2001 and 2007 went to the top 1% of all Americans.
36 percent of Americans say that they don't contribute anything to retirement savings.
A staggering 43 percent of Americans have less than $10,000 saved up for retirement.
24 percent of American workers say that they have postponed their planned retirement age in the past year.
Over 1.4 million Americans filed for personal bankruptcy in 2009, which represented a 32 percent increase over 2008.
Only the top 5 percent of U.S. households have earned enough additional income to match the rise in housing costs since 1975.
For the first time in U.S. history, banks own a greater share of residential housing net worth in the United States than all individual Americans put together.
In 1950, the ratio of the average executive's paycheck to the average worker's paycheck was about 30 to 1. Since the year 2000, that ratio has exploded to between 300 to 500 to one.
As of 2007, the bottom 80 percent of American households held about 7% of the liquid financial assets.
The bottom 50 percent of income earners in the United States now collectively own less than 1 percent of the nation's wealth.
Average Wall Street bonuses for 2009 were up 17 percent when compared with 2008.
In the US, the average federal worker now earns 60% MORE than the average worker in the private sector.
The top 1 percent of U.S. households own nearly twice as much of America's corporate wealth as they did just 15 years ago.
In America today, the average time needed to find a job has risen to a record 35.2 weeks.
More than 40 percent of Americans who actually are employed are now working in service jobs, which are often very low paying.
For the first time in U.S. history, more than 40 million Americans are on food stamps, and the U.S. Department of Agriculture projects that number will go up to 43 million Americans in 2011.
US workers compete in China: garment worker makes 86 cents, in Cambodia about 22 cents an hour.
In US, 21 percent of all children are living below the poverty line in 2010 - the highest rate in 20 years.
Despite the financial crisis, the number of millionaires in the United States rose 16 %, to 7.8 million in 2009.
The top 10 percent of Americans now earn around 50 percent of ALL our national income.
Art. IV. Giant Sucking Sound
The reality is that no matter how smart, how strong, how educated or how hard working US workers are, they just cannot compete with people who are desperate to put in 10 to 12 hour days at less than a dollar an hour on the other side of the world. After all, what corporation in their right mind is going to pay an American worker 10 times more (plus benefits) to do the same job? The world is fundamentally changing. Wealth and power are rapidly becoming concentrated at the top and the big global corporations are making massive amounts of money. Meanwhile, the American middle class is being systematically wiped out of existence as U.S. workers are slowly being merged into the new "global" labor pool.
What do most Americans have to offer in the marketplace other than their labor? Not much.
The truth is that most Americans are absolutely dependent on someone else giving them a job. But today, U.S. workers are "less attractive" than ever. Compared to the rest of the world, American workers are extremely expensive, and the government keeps passing more rules and regulations seemingly on a monthly basis that makes it even more difficult to conduct business in the United States. So corporations are moving operations out of the U.S. at breathtaking speed. Since the U.S. government does not penalize them for doing so, there really is no incentive for them to stay.
What has developed is a situation where the people at the top are doing quite well, while most Americans are finding it increasingly difficult to make it. There are now about six unemployed Americans for every new job opening in the United States, and the number of "chronically unemployed" is absolutely soaring.
There simply are not nearly enough jobs for everyone. Many of those who are able to get jobs are finding that they are making less money than they used to. In fact, an increasingly large percentage of Americans are working at low wage retail and service jobs. But you can't raise a family on what you make flipping burgers at McDonald's or on what you bring in from greeting customers down at the local Wal-Mart. The truth is that the middle class in America is dying -- and once it is gone it will be incredibly difficult to rebuild.
V. India unveils prototype of $35 tablet computer
By ERIKA KINETZ AP Business Writer Posted: 07/23/2010 03:19:23 AM PDT
MUMBAI, IndiaIt looks like an iPad, only it's 1/14th the cost: India has unveiled the prototype of a $35 basic touchscreen tablet aimed at students, which it hopes to bring into production by 2011. If the government can find a manufacturer, the Linux operating system-based computer would be the latest in a string of "world's cheapest" innovations to hit the market out of India, which is home to the 100,000 rupee ($2,127) compact Nano car, the 749 rupees ($16) water purifier and the $2,000 open-heart surgery.
The tablet can be used for functions like word processing, web browsing and video-conferencing. It has a solar power option tooimportant for India's energy-starved hinterlandsthough that add-on costs extra. "This is our answer to MIT's $100 computer," human resource development minister Kapil Sibal told the Economic Times when he unveiled the device Thursday.
In 2005, Nicholas Negroponteco-founder of the Massachusetts Institute of Technology's Media Lab unveiled a prototype of a $100 laptop for children in the developing world.
India rejected that as too expensive and embarked on a multiyear effort to develop a cheaper option of its own. Negroponte's laptop ended up costing about $200, but in May his nonprofit association, One Laptop Per Child, said it plans to launch a basic tablet computer for $99.
Sibal turned to students and professors at India's elite technical universities to develop the $35 tablet after receiving a "lukewarm" response from private sector players. He hopes to get the cost down to $10 eventually. Mamta Varma, a ministry spokeswoman, said falling hardware costs and intelligent design make the price tag plausible. The tablet doesn't have a hard disk, but instead uses a memory card, much like a mobile phone. The tablet design cuts hardware costs, and the use of open-source software also adds to savings, she said.
Varma said several global manufacturers, including at least one from Taiwan, have shown interest in making the low-cost device, but no manufacturing or distribution deals have been finalized. She declined to name any of the companies. India plans to subsidize the cost of the tablet for its students, bringing the purchase price down to around $20. "Depending on the quality of material they are using, certainly it's plausible," said Sarah Rotman Epps, an analyst at Forrester Research. "The question is, is it good enough for students?" Profitability is also a question for the $35 machine. Epps said government subsidies or dual marketingwhere higher- priced sales in the developed world are used to subside low-cost sales in markets like Indiacould convince a
manufacturer to come on board. This and similar effortslike the Kakai Kno and the Entourage Edge tabletsshow that there is global demand for an affordable device to trim high textbook costs, she said.
If it works, Epps predicts the device could send a shiver of cost-consciousness through the industry. "It puts pressure on all device manufacturers to keep costs down and innovate," she said. The project is part of an ambitious education technology initiative by the Indian government, which also aims to bring broadband connectivity to India's 25,000 colleges and 504 universities and make study materials available online.
So far nearly 8,500 colleges have been connected and nearly 500 web and video-based courses have been uploaded on YouTube and other portals, the Ministry said.
Art. V. US brushes off NKorean warning on military drills
07/22/2010 - WASHINGTONAmerican officials on Thursday brushed aside North Korea's warning that new U.S. financial sanctions against the communist regime and the staging of military maneuvers off the Korean coast this weekend raises the risk of war.
By ROBERT BURNS AP National Security Writer