Saturday, July 24, 2004

In a Shift, Bush Moves to Block Medical Suits

WASHINGTON, July 24 — The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.

The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. In court papers, the Justice Department acknowledges that this position reflects a "change in governmental policy," and it has persuaded some judges to accept its arguments, most recently scoring a victory in the federal appeals court in Philadelphia.

Allowing consumers to sue manufacturers would "undermine public health" and interfere with federal regulation of drugs and devices, by encouraging "lay judges and juries to second-guess" experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.

In 2002, at a legal symposium, the Bush administration outlined plans for "F.D.A. involvement in product liability lawsuits," and it has been methodically pursuing that strategy.

The administration's participation in the cases is consistent with President Bush's position on "tort reform."

Mr. Bush often attacks trial lawyers, saying their lawsuits impose a huge burden on the economy and drive up health costs. The Democrats' vice-presidential candidate, Senator John Edwards, a longtime plaintiffs' lawyer, says his proudest accomplishment in Washington was to help win Senate passage of a bill defining patients' rights, including the right to sue. (The bill never became law.)

Jay P. Lefkowitz, former director of Mr. Bush's Domestic Policy Council, said the F.D.A.'s litigation strategy embodied "good health policy and good tort reform."

But Representative Maurice D. Hinchey, Democrat of New York, said the administration had "taken the F.D.A. in a radical new direction, seeking to protect drug companies instead of the public." Mr. Hinchey recently persuaded the House to cut $500,000 from the budget of the agency's chief counsel as a penalty for its aggressive opposition to consumer lawsuits.

In the Pennsylvania ruling, issued Tuesday, the appeals court threw out a lawsuit filed by Barbara E. Horn, who said her husband had died because of defects in the design and manufacture of his heart pump. The Bush administration argued that federal law barred such claims because the device had been produced according to federal specifications. In its briefs, the administration conceded that "the views stated here differ from the views that the government advanced in 1997," in the United States Supreme Court.

At that time, the government said that F.D.A. approval of a medical device set the minimum standard, and that states could provide "additional protection to consumers." Now the Bush administration argues that the agency's approval of a device "sets a ceiling as well as a floor."

The administration said its position, holding that individual consumers have no right to sue, actually benefited consumers.

The threat of lawsuits, it said, "can harm the public health" by encouraging manufacturers to withdraw products from the market or to issue new warnings that overemphasize the risks and lead to "underutilization of beneficial treatments."

Allison M. Zieve, a lawyer at the Public Citizen Litigation Group who represented the plaintiff in the Pennsylvania case, said, "The government has done an about-face on this issue." If courts accept the administration's position, Ms. Zieve said, it would amount to a backdoor type of "tort reform" that would shield manufacturers from damage suits.

In the Pennsylvania case, the federal appeals court quoted extensively from the administration's brief and said the views of the F.D.A. were entitled to great deference because the agency was "uniquely qualified" to determine when federal law should take precedence over state law.

Bush administration officials said their goal was not to shield drug companies, but to vindicate the federal government's authority to regulate drug products.

Patients and their families said they felt betrayed.

Kimberley K. Witczakof Minneapolis said her husband, Timothy, 37, committed suicide last year after taking the antidepressant drug Zoloft for five weeks. "I do not believe in frivolous lawsuits," Ms. Witczak said, "but it's ridiculous that the government is filing legal briefs on the side of drug companies when it's supposed to be protecting the public. My husband would be alive today if he had received adequate warnings about the risk of self-harm." Ms. Witczak sued Pfizer, the maker of Zoloft, in May. The government has not intervened in her case.

Thomas W. Woodward of North Wales, Pa., whose 17-year-old daughter committed suicide last year after taking Zoloft for a week, said, "I've been sickened to see the government taking the side of pharmaceutical companies in court." Mr. Woodward has not filed a suit.

Mr. Hinchey said that F.D.A. lawyers, led by the agency's chief counsel, Daniel E. Troy, had "repeatedly interceded in civil suits on behalf of drug and medical device manufacturers."

Ms. Witczak, Mr. Woodward and Mr. Hinchey said Mr. Troy had a potential conflict of interest because Pfizer was one of his clients when he was a lawyer in private practice.

Mr. Troy refused to discuss the agency's legal arguments or the criticism of his role. Dr. Lester M. Crawford, the acting commissioner of food and drugs, said Mr. Troy had "complied with the ethical requirement to recuse himself from any matter involving a past client for a year" after he joined the government in August 2001.

In its court filings, the Bush administration argues that private lawsuits threaten to disrupt a comprehensive nationwide system of drug regulation, and that federal standards pre-empt requirements established by state judges and legislators. In effect, the administration says, if a local judge or jury finds that a drug or device is unsafe, it is in direct conflict with the conclusion reached by the F.D.A. after years of rigorous testing and evaluation.

Five of Mr. Troy's predecessors sent a letter to Congress dated July 15 endorsing his position. The government occasionally filed such briefs in the last 25 years, they said, but "there is a greater need for F.D.A. intervention today because plaintiffs are intruding more heavily on F.D.A.'s primary jurisdiction than ever before."

Some judges and legal experts disagree. Erwin Chemerinsky,a constitutional scholar at the University of Southern California Law School, said, "The Supreme Court has expressly ruled that F.D.A. regulation does not pre-empt state law and local regulation" in all cases.

In a Tennessee case involving a cardiac pacemaker, the Bush administration told a state trial court, "It is inappropriate for a jury to second-guess F.D.A.'s scientific judgment on a matter that is within F.D.A.'s particular expertise."

If juries in different states reach different conclusions about the risks and benefits of a medical device, they will cause "chaos for the regulated industry and F.D.A.," the administration said.

The administration has also joined Pfizer in opposing a lawsuit filed by Flora Motus, a California woman who said her husband had committed suicide after taking Zoloft. Mrs. Motus argued that Pfizer had not adequately warned doctors and patients that the drug could increase the risk of suicide.

But the Bush administration said that when federal officials approved Zoloft, they saw no need for such a warning, and that a false or unnecessary warning could "deprive patients of beneficial, possibly life-saving treatment." Susan B. Bro, a spokeswoman for Pfizer, said this week, "There is no scientific evidence of a causal relationship between Zoloft and suicide."

Likewise, the administration intervened in a California case to help GlaxoSmithKline fend off consumer demands for restrictions on the advertising of Paxil. The government said the restrictions "would overly deter use of a life-improving medication."

Patients had persuaded a federal district judge to order a halt to television advertisements that declared, "Paxil is non-habit forming." The administration joined the manufacturer in challenging that order. The judge, Mariana R. Pfaelzer,lifted the injunction in 2002 for other reasons, but said the administration's arguments were unpersuasive and contrary to the public interest.


NYT, July 25

"We find that if we don't go there, they won't shoot us."

In the face of stubborn insurgency, troops scale back Anbar patrols

By Tom Lasseter

Knight Ridder Newspapers



RAMADI, Iraq - After more than a year of fighting, U.S. troops have stopped patrolling large swaths of Iraq's restive Anbar province, according to the top American military intelligence officer in the area.


Most U.S. Army officers interviewed this week said the patrols in and around the province's capital, Ramadi - home to many Iraqi military and intelligence officers under Saddam Hussein - have stopped largely because the soldiers and commanders there were tired of being shot at by insurgents who've refused to back down under heavy American military pressure.


Asked for comment, officials from the 2nd Battalion 4th Marines in Ramadi - which makes up about one-fifth of the forces there - provided a 21-year-old corporal, who confirmed that the Marines have discontinued patrols, but said it was because of the hand-over of sovereignty to the interim Iraqi government.


While American officials in Ramadi wouldn't provide exact figures for the change in numbers of patrols, there's obviously been a significant drop.


After losing dozens of men to a "voiceless, faceless mass of people" with no clear leadership or political aim other than killing American soldiers, the U.S. military has had to re-evaluate the situation, said Army Maj. Thomas Neemeyer, the head American intelligence officer for the 1st Brigade of the 1st Infantry Division, the main military force in the Ramadi area and from there to Fallujah.


"They cannot militarily overwhelm us, but we cannot deliver a knockout blow, either," he said. "It creates a form of stalemate."


In the wreckage of the security situation, Neemeyer said, U.S. officials have all but given up on plans to install a democratic government in the city, and are hoping instead that Islamic extremists and other insurgent groups don't overrun the province in the same way that they've seized the region's most infamous town, Fallujah.


"Since Ramadi is the seat of the governate, we worry that if they could unsettle the government center here they could destabilize the al Anbar province," said Capt. Joe Jasper, a spokesman for the 1st Brigade.


The apparent failure of a long line of Army and Marine units to bring peace to the province, which makes up about 40 percent of Iraq's landmass, will be a major challenge for Iraq's new government and could prove to be a tipping point for the nation as a whole. Increasingly, Iraq is a place in which cities or part of cities have been taken over by insurgents and radicals.


U.S. officers in Ramadi openly acknowledge that the Iraqi security force trained to take over the hunt for insurgents, the national guard, has become a site-protection service that so far is incapable and unwilling to conduct offensive operations.


When the governor of Anbar left town last month, the head of the national guard, who since has been replaced, took part in an attempt to overthrow him. National guardsmen in town have refused to go on patrols either alone or with the Americans. The 2,886 national guardsmen in Ramadi so far have detained just one person.


To show how operations in Anbar have changed, Jasper sketched a map on a piece of paper.


Pointing to a neighborhood outside the town of Habbaniyah, between Fallujah and Ramadi, he said, "We've lost a lot of Marines there and we don't ever go in anymore. If they want it that bad, they can have it."


And then to a spot on the western edge of Fallujah: "We find that if we don't go there, they won't shoot us."


Marine Cpl. Charles Laversdorf, who works in his battalion's intelligence unit, said the Marines averaged just five raids a month and no longer were running any patrols other than those to observation posts.


The sharp reduction in patrols flies in the face of comments made recently by a top military official in Baghdad, who spoke on condition of anonymity.


"Any insurgent that ... somehow thinks that after June 28 we'll be pulling back into base camps will be disappointed," he said. "This is a long-term program of handing over responsibility. ... It's not going to take days nor weeks, it's going to be months and years."




More than 124 U.S. troops have died in Anbar since President Bush declared major combat operations over in Iraq on May 1, 2003.


Between the 1st Brigade's 4,000 soldiers, who arrived in Ramadi last September, and a battalion of 1,000 Marines, who came in February, more than 80 have been killed and more than 450 injured.


Since the hand-over of sovereignty June 28, 25 U.S. soldiers have been killed. Fifteen of them were in Anbar.


The numbers grow more striking at smaller unit levels.


Capt. Mike Taylor, for example, commands a company of men in nearby Khaldiya. Out of his 76 troops, 18 now have purple hearts, awarded for combat wounds.


The Marines' Echo company, with 185 members, has had 22 killed.


"There's a possibility that we'll say we'll protect the government and keep travel routes open, and for the rest of them, to hell with 'em," said Neemeyer, the intelligence officer. "To a certain degree we've already done it; we've reduced our presence."


Neemeyer continued: "I'm sure they are beating their chests and saying they drove us out, but what have they driven us out of? Rural farmland that's not tactically important. ... If they want to call that victory, that's fine."


Looking up at a map on the wall, Neemeyer flicked his laser pointer across a large piece of land between Ramadi and Fallujah. "We don't go into that area anymore," he said. "Why go there when all that happens is we get hit?"


The U.S. military has poured about $18 million into reconstruction projects in Ramadi, but Neemeyer said the projects hadn't done much in the way of winning people over.


"The only way to stomp out the insurgency of the mind," he said, "would be to kill the entire population."


The commander of one of the local national guard battalions, Col. Adnan Allawi, said he thought the security situation in Ramadi and Anbar in general would only get worse.


"If the Americans stay here, the same thing that happened in Fallujah will happen in Ramadi," he said. "If the situation stays the way it is now, the Americans will begin losing one city after the next."


Residents in Ramadi had long said the U.S. military underestimated the resolve of fighters in the area. Also, residents said, soldiers made community support for the resistance stronger with each cultural misstep, such as brusque house raids and cultural slights toward important tribal sheiks.


Many of those interviewed in Ramadi recently said they'd welcome a Fallujah-like rule by insurgents.


Bashar Hamid, a stationery store owner, said "only the mujahedeen (holy warriors) can provide stability."


Muhanad Muhammed, a pharmacist, agreed: "The Americans misbehave ... that's why I do not blame the mujahedeen when they attack them."


Capt. John Mountford, who oversees a central command office in Ramadi for local police, national guard and U.S. military officials, said that in retrospect the military should've paid more attention to what the Iraqis were saying.


"We should have worked with the tribal leaders earlier," he said. "I just wonder what would have happened if we had worked a little more with the locals."

 

 



Some of the quotes in this article demonstrate clearly that it's all over but the leavin', and the killing and dying on the way out:

"We've lost a lot of Marines there and we don't ever go in anymore. If they want it that bad, they can have it."
"The only way to stomp out the insurgency of the mind," he said, "would be to kill the entire population."
"Why go there when all that happens is we get hit?"

And the one that should become symbolic of this entire Cheneyed-up War:

"We find that if we don't go there, they won't shoot us."



Wednesday, July 21, 2004

Flip-Flopper in Chief

On "Meet the Press", Feb. 7...

"I'm a war president. I make decisions here in the Oval Office in foreign-policy matters with war on my mind."


In a speech in Cedar Rapids, July 20...
"Nobody wants to be the war president. I want to be the peace president."


Against a 9/11 Commission, then for it.

Against a Department of Homeland Security, then for it.

Decisive, my ass.

Monday, July 19, 2004

Halliburton, Again

HOUSTON (Reuters) - A grand jury issued a subpoena to oil field services company Halliburton Co. seeking information about its Cayman Islands unit's work in Iran, where it is illegal for U.S. companies to operate, Halliburton said on Monday.

The company, formerly headed by Vice President Dick Cheney, said it understood the investigation of its subsidiary's work in Iran had been transferred to the U.S. Department of Justice from the Treasury Department, which first initiated an inquiry in 2001.

"In July 2004, Halliburton received from an Assistant U.S. Attorney for the Southern District of Texas a grand jury subpoena requesting the production of documents. We intend to cooperate with the government's investigation," Halliburton said in a filing to the U.S. Securities and Exchange Commission.
Halliburton Subpoenaed Over Unit's Iran Work

This is for stuff done while Ol' "Fuck Yourself" was still in charge. Trading with the enemy doesn't even make these thugs raise an eyebrow, but the timing is interesting, coming as it does when the attempt to tie Iran to 9/11 is gearing up...

Foreign Leaders for Kerry

The Repugnicans have lambasted John Kerry for months over his "Foreign Leaders" remark, and saying, in effect, "So What?" Well...

NEW YORK, July 18 /PRNewswire/ -- The Bush administration is finding few volunteers abroad who will offer troops to secure the critical U.N. mission to set up Iraqi elections, Newsweek has learned. As of last week just two nations had indicated interest, though "I don't think anyone's said yes yet," says a senior U.S. official. Washington is so nervous it has even enlisted Pakistan, although President Pervez Musharraf has his hands full with Al Qaeda and the Taliban in his backyard. Iraqi Foreign Minister Hoshyar Zebari also pleaded for NATO to provide the United Nations with protection. But NATO refuses to do more than train Iraqi troops. On other key issues, too, like the resolution of Iraqi debt, the Europeans have reduced talks to a "slow roll," as one Bush official puts it.

With the U.S. presidential election only four months away, "governments in Europe and elsewhere are waiting [it] out," a former senior foreign-policy official in the Clinton administration tells Newsweek. "They don't want to do anything to help Bush." That may be a partisan view, but it is endorsed by several foreign diplomats, reports Senior Editor Michael Hirsh in the July 26 issue of Newsweek (on newsstands Monday, July 19). Very few will admit, even off the record, that they want to sway the election toward Kerry. But one senior European diplomat, in an interview with Newsweek, comes close. "Some countries in the European Union will not do anything to prevent a regime change in Washington," he says.
More

Sure, folks overseas can't vote in our elections, but they certainly aren't obligated to make anything easier for Bush*...

Sunday, July 18, 2004

MORE Lies Exposed!!

Downing Street has admitted to The Observer that repeated claims by Tony Blair that '400,000 bodies had been found in Iraqi mass graves' is untrue, and only about 5,000 corpses have so far been uncovered.
The claims by Blair in November and December of last year, were given widespread credence, quoted by MPs and widely published, including in the introduction to a US government pamphlet on Iraq's mass graves.
In that publication - Iraq's Legacy of Terror: Mass Graves produced by USAID, the US government aid distribution agency, Blair is quoted from 20 November last year: 'We've already discovered, just so far, the remains of 400,000 people in mass graves.'
On 14 December Blair repeated the claim in a statement issued by Downing Street in response to the arrest of Saddam Hussein and posted on the Labour party website that: 'The remains of 400,000 human beings [have] already [been] found in mass graves.'
More

Christ on a Handrail WE have killed more Iraqi civilians than that. Is anything these thugs claimed about Saddam and Iraq actually true??

The next thing than pans out will be the first...