The Massachusetts anesthesiologist accused of cooking up data for use in trials of pain medications has agreed to plead guilty to criminal charges in a deal with federal prosecutors.

Scott Reuben, who had been among the nation’s most respected investigators on the subject, had been charged with one count of healthcare fraud.

Reuben’s trouble began last year, when an internal audit conducted by Baystate Medical Center in Springfield, Mass., revealed he fabricated data for 21 studies he had conducted during the last 15 years.

The criminal charge had focused on one of these, a trial of Celebrex as part of a “multimodal” pain regimen for knee surgery. The study showed the drug was effective and was published in 2007 in Anesthesia & Analgesia.

“In fact,” the prosecution wrote in a court filing, “Reuben had not enrolled any patients into that study, and the results reported…to Anesthesia & Analgesia were wholly made up by Reuben .”

Had he not copped a plea, Reuben could have spent 10 years behind bars and been fined $250,000. The plea convinced prosecutors to recommend lighter penalties.

After Baystate spilled the beans, journals that had published his tainted articles retracted them.

Baystate terminated its contract with Reuben last spring. At the same time, he reportedly agreed to suspend his practice and was stripped of a professorship at Tufts.

Several widely accepted medical beliefs need to be re-examined in light of the scandal. Topping the list are the effect of COX-2 inhibitors on bone healing and the role of multimodal analgesic regimens in managing chronic pain.

With respect to the former, Reuben’s studies suggested the drugs had no effect on bone fusion, a finding that was contrary to the results of several animal studies.

A federal judge has told the FDA to quit blocking the importation of electronic cigarettes from China and ruled the devices should be regulated like tobacco products rather than as drugs or medical devices.

Judge Richard Leon of Federal District Court in Washington issued the order in a lawsuit brought by e-cigarette distributors.

e-Cigarettes are battery-powered tubes that heat liquid nicotine into a vapor which is subsequently inhaled. The devices also add ingredients that give the vapor a taste and smell just like cigarette smoke.

According to e-cigarette distributors, the inhaled mix does not contain cancer-causing chemicals. The FDA argues they have not been proven safe.

Judge Leon ruled that last year’s tobacco legislation gave the FDA power to regulate the contents and marketing claims of e-cigarettes just like traditional tobacco products, but not to ban them.

The FDA released a statement in response: “The public health issues surrounding electronic cigarettes are of serious concern to the FDA. The agency is reviewing Judge Leon’s opinion and will decide the appropriate action to take.”

Ray Story, a VP at Smoking Everywhere, the plaintiff in the suit, claimed the ruling was a victory for people who want a safer cigarette. “The public will have a less harmful alternative to tobacco products,” Story said. “Wherever they’re sold, we are going to be sold.”

Matthew Myers, president of the antismoking advocacy group Campaign for Tobacco-Free Kids, decried the ruling. “These products could serve as a pathway to nicotine addiction for children,” Meyers told the New York Times.

People have estimated e-cigarettes could grow to become a $100 million business nationwide. Traditional cigarette makers are not involved in the e-cigarette business.

The Obama administration has announced a new policy that makes it harder for the government to claim “state secrets”—a phrase we thought had become George W. Bush’s middle name—in an effort to hide shady national security tactics like rendition and warrantless wiretapping from the public. 

The new policy requires the CIA, FBI, NSA and the US military to convince the attorney general and a team of lawyers at Justice that the release of information regarding such tactics presents a significant risk to “national defense or foreign relations,” according to the Washington Post.

The legislation raises the standard for “state secrets” to instances when the release of material “would be reasonably likely to cause significant harm to the national defense or the diplomatic relations of the United States.”

Under Bush, a claim of “state secrets” required approval of a mid-level official using a much lower standard of proof that disclosure would harm national security.

Bush asserted “state secrets” dozens of times, according to legal scholars.

“What we’re trying to do is . . . improve public confidence that this privilege is invoked very rarely and only when it’s well supported,” a senior department official confided to the Post. “We’re not following a ‘just trust us’ approach.”

Gary Bass, executive director of OMB Watch, a nonprofit that promotes government transparency welcomed the change. It is “enormously consistent with open-government recommendations” that he and other advocates have made for years.

Last February, in anticipation of the policy shift, Justice began reviewing about a dozen cases in which “state secrets” had been invoked.

Surprisingly, it reversed course in just one instance—a bizarre case in which a former DEA operative has accused the CIA and the State Department of wiretapping his home.

Boston Scientific Corp. has agreed to cut a $716 million check to Johnson & Johnson to settle more than a dozen patent infringement lawsuits, including one in which a judge had already ruled in favor of J&J.

The settlement wraps up all but 3 stent-related lawsuits involving the two companies. Stents are cage-like metal struts that prop open partially blocked arteries.

Stents are most frequently used in the coronary arteries, but they can be used in other arteries as well.

The market for cardiac stents now exceeds $4 billion. Boston Scientific leads the pack in this field, but J&J owns the original patents on the medical devices after acquiring them from Julio Palmaz, the radiologist who invented them.

Nine years ago, a judge ruled that a Boston Scientific stent known as the NIR infringed on one of J&J’s patents. Boston Scientific appealed, but announced last year that it expected to fork over more than $700 million to settle the claim. That includes interest dating from the original verdict.

Boston Scientific announced it will pay the settlement from cash holdings, which amounted to $1.2 billion as of last June.

The market for stents has leveled off in recent years after studies showed they weren’t that effective in many instances, and other studies raised concerns about bleeding from the anti-platelet therapy that is normally prescribed after stents are placed.

The J&J settlement comes shortly after Boston Scientific settled separate stent-related claims with Medtronic. For its part, Medtronic recently paid $400 million to Abbott Laboratories to settle a patent infringement case regarding…you guessed it, stents.

Last June, Internet radio host Hal Turner disagreed with a decision by 3 Chicago-based federal judges, in which they rejected the National Rifle Association’s lawsuit designed to overturn a pair of bans on handguns.

So he shared his opinions on his blog. “Let me be the first to say this plainly: these judges deserve to be killed,” he wrote. “Their blood will replenish the tree of liberty. A small price to pay to assure freedom for millions.”

A day later, Turner posted photos of the judges and a map showing routes to the courthouse where they presided.

He appended details regarding the location of “anti-truck bomb barriers” in front of the courthouse.

Not too long thereafter, US Attorney Patrick Fitzgerald charged Turner, whose blog is followed by white supremacists, with threatening the lives of the judges. Turner was sent to prison, and his bail request was denied.

Turner’s attorney, Michael Orozco claims the Feds overreacted. “He gave an opinion. He did not say go out and kill,” he told the Washington Post. “This is political hyperbole, nothing more. He’s a shock jock.”

Turner’s blog has been taken down. On it, Turner called the judges, who are generally felt to be conservative, “unpatriotic, deceitful scum.” He added that the only thing preventing judges and “the government” from achieving ultimate power “is the fact that We The People have guns. Now, that is very much in jeopardy.”

Turner then quoted Thomas Jefferson: “The tree of liberty must be replenished from time to time with the blood of tyrants and patriots.” To this, Turner added an exhortation of his own: “It is time to replenish the tree!”

Timothy McVeigh, the Oklahoma City bomber, was wearing a T-shirt emblazoned with that very Jefferson quote when he was nabbed.

According to First Amendment scholar Martin Redish, most of Turner’s rants are protected by the Constitution, including his statements that the judges should be cut down.

But Turner probably crossed the line by printing information about the judges’ whereabouts and a map of the courthouse.

“I would give very strong odds that once he said that stuff, it takes it out of any kind of hyperbole range,” Redish told the Post.

New York-based Pfizer Inc. has agreed to plead guilty to criminal charges of illegally promoting the sale of its painkiller, Bextra and other drugs for non-FDA approved uses.

Terms of the agreement call for the drug giant to fork over $2.3 billion in fines. That’s the largest penalty ever assessed for such marketing shenanigans.

Pfizer announced last winter that it had taken a $2.3 billion settlement-related charge for Q4, 2009, but details of the agreement hadn’t been made public until now.

The details are that Pfizer encouraged physicians to prescribe Bextra for off-label uses like acute pain, its atypical antipsychotic Geodon for off-label use by children, and similar behavior involving Zyvox, an antibiotic, and Lyrica, an epilepsy drug.

US physicians are permitted to prescribe FDA-approved drugs for anything they want,  but drug companies are not allowed to market drugs for unapproved uses.

The settlement involved Pfizer’s Pharmacia & Upjohn unit and the Departments of Justice and Health and Human Services.

Pfizer yanked Bextra in 2005, shortly after Merck had pulled the plug on its painkiller, Vioxx, after the latterwas shown to increase the risk of heart attacks.

Terms of the settlement also resolve allegations that Pfizer comped doctors for meals, subsidized their travel and paid honoraria for speaking engagements to induce them to prescribe these drugs for off-label uses.

Remarkably, the settlement represents the third time in which Pfizer has been required to sign a “corporate integrity” agreement pledging to clean up its act. It signed similar agreements in 2002 regarding Lipitor and in 2004 for Neurontin.

Three times in the recent past, the Feds have fired fastballs at Google in the form of antitrust reviews. And they have very little to show for it.

First, the Feds gave a look-see at Google’s pending book-scanning settlement — a deal aimed at protecting book publishers which the Feds ardently believe have been rendered an endangered species by the search giant.

Then, government officials questioned the overlapping board membership involving the Google and another somewhat popular company, Apple.

Most recently, they’ve questioned why Google and other normally business-aggressive tech companies suddenly get all Shirley Temple-like when it comes to snapping up each other’s prized employees.

All the attention has turned Dana Wagner, a former antitrust lawyer at the DOJ who joined Google last year, into a veritable spokesperson for the company. Wagner has been talking up public officials, academics and reporters pretty much non-stop in an attempt to quiet the storm. 

After highlighting the company’s foundation and “don’t be evil” corporate philosophy, Wagner’s mantra is that his company actually owns a 2.66% share of the advertising market.

Say what?

Wagner insists Google’s market is not search advertising, where it owns a 70% market share, but the entire advertising arena which includes everything from highway billboards to Oxyclean pitchmen. 

“We need to move past intuitive market definitions and actually look at how consumers, advertisers and publishers are shifting their spending,” Wagner told the Washington Post. “Market definition is job one, and hopefully people aren’t bringing too many preconceived notions to that.”

Never mind that Google maintains a 30% operating margin, which is all but impossible if the playing field were actually level. Or that when old friend Microsoft tried a similar tactic in the 1990s, the strategy was dismissed as disingenuous. (more…)

After being diagnosed with breast cancer 3 years ago, Genae Girard knew she faced medical travails and steep costs, but she didn’t necessarily expect to encounter a patent problem.

Still, that’s what happened after the 39 year-old Austin, Texas native underwent BRCA gene testing to determine whether she was at increased risk for ovarian cancer, perhaps necessitating that her ovaries be removed as well.

The test was positive.

She requested confirmation using another test, but was stoned by a decade-old Patent Office ruling that granted Myriad Genetics a patent on BRCA genes and the related testing procedures that determine ovarian cancer risk.

Now Girard is suing Myriad and the Patent Office. She has been joined by other cancer patients, professional organizations representing 100,000 pathologists, and a raft of genetic researchers. The ACLU organized the case and filed it in a federal court in New York. 

The coalition does not plan to accuse Myriad of being a poor steward of the information concerning the BRCA genes, but rather that BRCA testing could improve and costs could be reduced in the absence the monopoly held by Myriad as a result of the Patent Office’s decision.

“With a sole provider, there’s mediocrity,” Wendy Chung told the New York Times. Chung is a plaintiff in the case and directs clinical genetics at Columbia.

Companies like Myriad have contended in similar cases that the patent system fosters innovation by rewarding risky investments in research and development.

The Patent Office has already granted patents to single companies for genetic testing on long QT syndrome, a condition associated with cardiac arrhythmias and sudden death, and testing for the gene that causes hemochromatosis, a rare condition characterized by excessive iron accumulation.

A jury has acquitted W.R. Grace & Company and its former executives of knowingly exposing mine workers and the residents of Libby, Montana to asbestos.

“We at Grace are gratified by today’s verdict and thank the men and women of the jury who were open to hearing the facts,” said Fred Festa, the company’s CEO in a statement obtained by CNN.

Prosecutors had alleged the mining company conspired to “knowingly release” asbestos for decades. “It was a purpose of the conspiracy to conceal and misrepresent the hazardous nature of the…asbestos contaminated vermiculite, thereby enriching defendants and others,” read the indictment.

Best estimates are that Libby residents suffered 200 excess deaths and 1,000 illnesses due to asbestos exposure.

The fine, dusty stuff had blanketed everything in town from big rigs to baseball fields. Libby residents testified that Grace never told them about health risks associated with the stuff.

Grace never denied that asbestos came from its vermiculite mine in town, nor that it had sickened and killed many, but it vigorously denied a conspiracy.

In fact, it claimed that it acted responsibly once it became aware of the problem, and that it paid millions to cover the asbestos-related medical bills of Libby residents.

Asbestosis causes numerous illnesses including mesothelioma, a rare cancer that originates in the lining of the lungs, abdomen and heart.

Grace faced fines of up to $280 million, and certain Grace executives were looking at jail time had the verdict gone the other way.

“I don’t see how they could have gotten out of it,” said Steven Schnetter, who worked at the mine for 17 years before developing asbestosis, a lung disease caused by exposure to asbestos fibers.

Six years after Savana Redding was strip-searched by school officials in a frutiless hunt for Motrin (yes, Motrin), her case is going to the Supreme Court. Savana was 13 years old back then, an honor roll student with a spotless discipline record.

Safford Middle School officials claim they had to take seriously all allegations of prescription drug misuse at the time, because in the previous school year a student almost died after ingesting such medication.

They also claim that on the day Redding was searched, another student was discovered to be in possession of prescription drugs that she claimed to have obtained from Redding.

Redding denies this.

Neither side disputes that Redding was strip searched. After a male Vice Principal searched Redding’s backpack, he instructed the girl to go to the nurse’s office with 2 female employees. These people told her to take off her shoes, socks, pants and T-shirt.

Then they asked her to move her bra around in a way that exposed her breasts, and pull upward on her underwear. The search turned up nothing.

She never returned to Safford Middle School — “I just couldn’t go back,” she told the Washington Post.

Earlier court rulings on the case have split down the middle. The first judge sided with the school, saying the search was justified in light of the accusations that had been made against Savana.  That finding was upheld by a divided 3-judge panel of the 9th Circuit of the US Court of Appeals.

But these decisions were subsequently overruled by the full bench of the 9th Circuit, which found that the search violated the girl’s Fourth Amendment protections against unreasonable search.

The Supreme Court’s ruling is expected later this spring.

With apologies to GE, Disney and the 8 US citizens who remain optimistic about prospects for our health care system.

Welcome to the US Health Care Carousel of Progress!

Normal carousels just spin ’round and ’round and don’t get you anywhere, but ours is different.

The Health Care Carousel makes progress every year.

And progress isn’t simply moving forward, it’s working together and dreaming and assuring better health care for all.

Progress is the whiz-BANG of an MRI machine in use for the evaluation of a 22 year old with a headache. It’s the drug-induced smile on the face of a woman that became depressed after losing her home to foreclosure.

Progress is the rhythmic lub-dupp of a heart beating normally following a transplant for preventable cardiac disease. It’s the sound of an uninsured child wheezing in a crowded emergency room.

Why, you can hardly imagine all the amazing gadgets they’ve got in ERs nowadays!

Remember the sixties when folks got their exercise doing the Twist? Well, today we keep our cholesterol down with pills!

And our food safety system has never been better.

Our generation may be the first in 300 years to experience a decrease in life expectancy, but think how much worse it would be without $10,000 cancer drugs and blood thinners that prevent complications from hardware we’ve inserted into people’s bodies.

It’s never been easier to find a PCP, and would you believe it? They’re building our city’s 17th PET scanner right where that run-down urban health clinic used to be.

You should hear physicians rave about how those newfangled EMRs save them time.

And progress even has a smell! It’s the smell of money lining the pockets of a hundred-thousand physicians that have been bought off by Big Pharma.

With all these marvels, it’s hard to believe things could get better than they are right now. But as you join us for a spin around our Carousel of Progress, you’ll surely agree. Anything’s possible.

Ethics
In a referenced essay titled, Transparency in the Pharmaceutical Industry, Brain Blogger’s Jennifer Gibson describes how the impending passage of the Physician Payments Sunshine Act has motivated Big Pharma to disclose financial relationships with physicians. She warns there may be adverse consequences from this otherwise laudable development: some physicians will be discouraged from forging socially beneficial collaborations with the private sector.

Last week, the FDA’s Psychopharmacologic Drug Advisory Committee unanimously rejected AstraZeneca’s application to market its atypical anti-psychotic drug Seroquel for generalized anxiety disorder and major depression.

Merrill Goozner at GoozNews applauds the decision, but wonders whether the agency may have left itself open to charges of bias by seating a patient representative on the panel who had lost a son to cardiac arrest while taking the drug. 

Health Care Renewal contributor Roy Poses has reviewed an unseemly side show to the Madoff scandal. The antagonist is Ezra Merkin, a hedge fund director charged with fraud for misrepresenting his investment strategies.

Merkin and Madoff had served on the board of Yeshiva University, which lost $110 million to the Ponzi scheme. Their unholy alliance leads Poses to consider possible negative consequences of having too many financial types on the boards of academic institutions.

Insurance
In the latest chapter of her neverending odyssey to navigate Big Insurance and the health care system generally, Colorado Health Insurance Insider’s Louise Norris describes what happened when her husband needed knee surgery. The savvy couple planned for every contingency, yet still they encountered a system failure in the form of an out of network charge.

Jaan Sidorov at Disease Management Care Blog has proposed a frightening, unintended consequence of health care reform which is that private health insurers might, like AIG, become too big to fail.

Sidorov thinks creation of a new public insurer will prompt a wave of consolidation in Big Insurance, and the remaining behemoths will seek cover in the form of regulatory oversight from the Feds.

Over at The Health Care Blog, Brian Klepper has contributed a wide-ranging historical perspective on efforts by Big Insurance to control health care cost escalation.

After characterizing utilization review and PCP gatekeeper systems as well-intentioned but poorly executed efforts, he proposes that tricked-out workplace-based clinics (“onsite clinics”) may be a solution, and cites facilities on the premises of Cigna as shining examples.

He concludes however, that the proof will be in the pudding. After all, everyone thought UR and gatekeepers were good ideas, too.

There’s a great, big, beautiful tomorrow,
Shining at the end of every day

There’s a great, big, beautiful tomorrow
And tomorrow’s just a dream away

Man has a dream and that’s the start
He follows his dream with mind and heart

When it becomes a reality
It’s a dream come true for you and me

Access, Cost Escalation
InsureBlog’s Bob Vineyard reviews interim results from Massachusetts’ much publicized universal health care plan, which many believe should be a model for national health care reform.  The plan has left at least 200,000 state residents uninsured while utterly failing to rein in costs. And to make it right Vineyard warns, Bay state lawmakers are either going to have to squeeze providers even more or (gasp!) ration care.

At Managed Care Matters, Joe Paduda has posted a dispassionate, fact-based treatise designed to calm the knee-jerk anxiety that normally surrounds concepts like universal health care and rationing.

He points out for example that Big Insurance already engages in rationing through pre-certification processes, provider agreements and so forth.

He then dismantles the claim that universal health care leads to longer waiting times for care. Paduda concludes that if we manage to institute such programs, “access will go up and waiting times may well go down.”

Amid a fusillade of jabs and an occasional uppercut to the jaws of the Big O and his admirers, JD Bell reveals over at It Takes Work that Howard Dean has launched a web site to promote his own vision for health care reform.

According to Bell, Dean is concerned the Big O is waffling on his campaign promises, and wants nothing more for the American people than what Obama promised them prior to November 4.

Writing for Workers’ Comp Insider, Jon Coppelmen observes that employers’ most effective tools for managing comp losses vanish after they lay off employees. The trust, indeed the entire relationship between employer and former employee, is lost. This leaves claims adjusters, who are typically overworked and not properly incented, to manage workers’ compensation costs.

With unemployment approaching historical levels, Copplemen’s antidote, three proactive steps employers can take to manage the regrettable situation, is timely indeed.

Quality and Safety
A recent NEJM article on the cost and quality implications of readmissions has prompted Maggie Mahar to review the subject over at Health Beat. Mahar summarizes the views of White House budget director Peter Orszag and others on the matter, and then offers several home-grown suggestions about how to tackle the problem.

Mahar explores for example, the concept of bundling payments to hospitals and physicians who are responsible for care immediately following discharge, and directing special attention towards states in which the readmission problem is particularly severe.

Novo Nordisk had been prepared to discuss cardiovascular complications at last week’s FDA advisory panel meeting regarding liraglutide, its new diabetes drug, but instead the drug’s association with rare tumors of the thyroid drove the discussion.

Jeffrey Seguritan at Nuts for Healthcare summarizes the surprising development then expands into an informative discussion of the efficacy with which drug trials assess cancer risk.

There’s a great, big, beautiful tomorrow,
Shining at the end of every day

There’s a great, big, beautiful tomorrow
And tomorrow’s just a dream away

Man has a dream and that’s the start
He follows his dream with mind and heart

When it becomes a reality
It’s a dream come true for you and me

Legal
HealthBlawg’s David Harlow is generally supportive of the deal struck by CVS and Google, in which prescription data from the retail pharmacy giant can now be directly imported into Google Health, the search giant’s personal health record. On balance Harlow says, the gains in patient safety and quality outweigh the increased risk of breaches in patient confidentiality, at least for people who have not recently given birth to octuplets or are named Britney Spears.

Health IT
When a healthcare journalist came down with a touch of bronchitis, he blew off the last vendor meeting at HIMSS and went to the doctor.

His encounter underscored a yawning gap between today’s reality of spotty EMR adoption and a future-state of nirvana that has been promised by so many. 

The real-life story appears at Niel Versel’s Healthcare IT Blog.

We hope Neil feels better, by the way.

At the Health Business Blog, David Williams has posted a transcript of his interview with Wayne Guerra, the co-founder and chief medical officer of Healthagen, the maker of a way-cool iPhone application known as iTriage.

In the interview, Guerra explains how his mobile triage and health information tool can be used, the types of people most likely to benefit from it, and how he hopes to monetize the idea.

The Healthcare IT Guy invited Paul Nuschke, a software design expert at the IT consultancy Electronic Link to comment on the subject of EMR usability. Nuschke asserts there are three keys: the EMR should be easy to learn, efficient, and prevent errors automatically.

Nuschke appends a series of baffling screen shots which make it laughably clear that some of the mainstream players in the space aren’t quite there yet.

Policy
Over at the Healthcare Economist, Jason Shafrin asks, “Why have disability rates decreased?” To answer the question, Shafrin reviews a scholarly piece from the National Bureau of Economic Research. He notes that the apparently heartening trend has occurred despite an increasing burden of illness in the general population. The beneficial trends, he concludes, are attributable primarily to non-medical advances like “internet shopping, amplifying devices for phones and street ramps” rather than health care-specific interventions.

Damn, we thought we had something there for a moment.

Actual US Health Care Carousel of Progress:

Seattle Semi-Pro Wrestling has entertained bar patrons in the Pacific Northwest for 6 years with its lampoons of World Wrestling Entertainment.

The cast includes Ronald McFondle, a raunchy rendition of a the iconic hamburger peddler who finishes off opponents with a lewd gesture and a vainglorious fellow named Deevious Silvertongue who looks like a cross between David Bowie and Liberace.

The characters grapple on foam padded stages, or at least they did until the Washington State  Department of Licensing classified the show as “sports entertainment,” meaning the SSP had to post a $10,000 bond, hire medical personnel to monitor events, and buy a regulation wrestling ring.

The SSP, which has no money to speak of, plans to appeal the ruling but has halted matches in the meantime.

“It’s a bunch of grown men and women in costumes pretending to be professional wrestlers,” David Osgood, the league’s lawyer told the Wall Street Journal. “It is to wrestling as ‘West Side Story’ is to actual gang relations.”

To which department spokesperson Christine Anthony countered that pro wrestling “is just as much theater as these guys claim to be.” The department considers the WWE to be sports entertainment and requires it to have a license to perform in the state.

The smackdown was prompted by a fallout involving the league and The Banana, one of its characters. Apparently, Paul Richards, who played The Banana, left the league upon hearing of plans to sideline his character.

The league had named Lucas Keyes to be The Second Banana, a sidekick to The Banana, and planned to have The Second Banana betray and then defeat The Banana.

Richards stormed off rather than lose his status as the top banana, according to the Journal.

That might have been the end of it, but then Richards found out that SSP members were ridiculing him behind his back, so he notified the licensing department that he believed SSP was violating the law.

In his appeal, Osgood will argue the ruling threatens everything from jello wrestlers to actors engaging in a sword fight in “Hamlet.”

“We’re in ‘Looney Tunes’ territory here,” he told the Journal.

During his campaign to “change Washington,” the Big O frequently accused Bush of wantonly ignoring public disclosure rules and flaunting the state-secrets privilege at will.

Now it appears The Coronated One is doing a bit of that himself.

Obama’s Justice Team is seeking to dismiss a US District court case filed by an Oregon charity accused of funding terrorism on grounds that it threatens state secrets and national security.

It has even intimated it might abscond with classified documents currently in the court’s custody to prevent the charity’s lawyers from perusing them.

The Bush Justice Team regularly invoked “state secrets” to prevent civil liberties groups from accessing sensitive documents regarding offshore prisons for terrorism suspects, warrantless wiretapping of US citizens and other questionable behavior.

The charity, al-Haramain wants damages from the FBI and National Security Agency, alleging the Feds’ illegal eavesdropping of its board members and lawyers violated its freedom of speech and due process rights.

The charity is no longer in business. It claims its purpose was philanthropic and that the Feds have no evidence to support assertions against it.

“There has to be other ways to protect secret information without having to block accountability,” Erwin Chemerinsky, a law professor at UC Irvine told the Washington Post.

Justice Department spokesman Matthew Miller responded that it “has already moved on a number of fronts to ensure Americans have access to information about their government’s actions. With respect to state secrets, the attorney general has ordered a review of pending cases to ensure the privilege is only invoked when absolutely necessary.”

“At this point,” said Jon Eisenberg, the al-Haramain attorney, “I don’t feel like I need to do anything. The outrage speaks for itself.”

Years ago, Vermont guitarist Diana Levine lost her arm and her livelihood to gangrene after a health provider administered a nausea drug improperly.

Levine argued in state court that drug maker Wyeth should have affixed stronger warnings to the drug’s label.

Wyeth countered that the FDA approved the drug label and that should preempt state law.

The jury awarded Levine $7 million.

Wyeth appealed to the Supreme Court and last week, the Court ruled for Levine by a score of 6-3.

Writing for the majority, John Paul Stevens said that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”

He added the FDA has “limited resources” with which to regulate the 11,000 or so drugs on the market.

“State tort suits…provide incentives for drug manufacturers to disclose safety risks promptly,” he added.

The decision amounted to a righteous whuppin’ for Big Pharma, which knew a positive ruling could short circuit a world of trouble in state courts where thousands of patients allege they have been harmed by more drugs than most can count.

In a conference call, Levine said the verdict brought her “unrestrained joy,” according to the Washington Post. “Next to getting my hand back, it’s the best they could do.”

Joining Stevens in support of Levine were Stephen Breyer, Ruth Bader Ginsburg, Anthony Kennedy, David Souter and Clarence Thomas.

Samuel Alito dissented, saying the case, “illustrates that tragic facts make bad law. The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.”

“And the FDA conveys its warnings with one voice, rather than whipsawing the medical community with 50 (or more) potentially conflicting ones.”

“After today’s ruling, parochialism may prevail,” Alito predicted.

For decades, folks in Libby, Montana knew the fine dusty stuff that covered everything in town from big rigs to baseball fields was asbestos.
 
They knew where it was coming from, too. Right over there, wafting out of the W. R. Grace mine on the other side of town.

NBD. Just part of life, they assumed. No one told them otherwise.

Lifetime resident Helen Bundrock remembers Grace “called it a nuisance dust, (they) did.”

Helen, her husband and 4 of their 5 children have been diagnosed with asbestosis, a slowly progressive lung disease that is associated with mesothelioma and premature death.

Turns out the medical community and who knows, maybe some mining companies knew about the risks of asbestos for decades.

Now, Federal prosecutors have put the mining company on trial. They claim asbestosis sickened at least 1,000 residents of Libby Montana, and killed 200 more.

“There’s never been a case where so many people were sickened or killed by environmental crime,” says David Uhlmann, said the Justice Department’s former top prosecutor.

The Feds allege that until 1990, the company conspired to “knowingly release” asbestos and that it failed to reveal the risks to employees and residents, leaving them “in imminent danger of death or serious bodily injury.”

Grace faces fines of up to $280 million if convicted. Several executives could end up in jail.

Grace doesn’t deny that asbestos emanated from the mine nor that some were sickened and died. But it “categorically denies any criminal wrongdoing.” In fact Grace says, as information about the problem became known, it acted to mitigate the risk and communicate openly about it.

The trial is expected to last four months.

In the summer of 2005, physicians were growing concerned that Seroquel, AstraZeneca’s $4.4 billion antipsychotic drug was causing their patients to gain weight, so AZ employee Christine Nee instructed her sales force to assure physicians there was no evidence its drug did that.

“Our objective is to neutralize customer objections to Seroquel’s weight and diabetes profile…(and to then) refocus the call” Ney said.

The problem AZ’s got is that 5 years earlier, its drug-safety expert Wayne Geller told Dutch regulatory authorities there was “reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes mellitus in certain individuals.”

These tidbits were culled from 100 evidentiary documents unsealed last week as part of an agreement between the Swedish/British giant and thousands of plaintiffs who believe they’ve been harmed by Seroquel.

It was not immediately clear how the new developments would affect the progress of the long, multi-theater legal battle, in which AZ had actually been doing pretty well for itself, thank you very much.

After many of the cases were consolidated in Florida’s US District Court, AZ scored a big win when the first 2 test cases were thrown out because the judge felt the evidence failed to prove Seroquel caused the plaintiff’s diabetes.

Next thing you know, 2,300 more cases were dismissed on similar grounds.

But AZ still faces battles in Delaware, Pennsylvania, Montana, Arkansas and South Carolina state courts, where among other things, states are claiming the drug giant bilked them into paying for off-label use of Seroquel.

AZ spokesperson Tony Jewell told the Wall Street Journal that, “from the time it was first approved, the Seroquel labeling alerted physicians that diabetes mellitus, hyperglycemia and weight gain had been observed in clinical trials. We’ve continued to update the label as the findings have developed.”

Jewell added that Geller’s document didn’t reflect AZ’s position when he wrote it. “In fact,” Jewell clarified, “it was not Dr. Geller’s ultimate view either. It was an initial draft for discussion purposes.”