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FDA warns on anemia drugs after test deaths
Headline News | 2007/03/10 18:47

Responding to a spate of deaths in clinical trials, the Food and Drug Administration yesterday issued its most severe warning possible for drugs widely used to treat anemia in kidney disease patients and cancer patients undergoing chemotherapy.

The "black box" warnings placed on the prescribing label for Amgen Inc.'s Epogen and Aranesp and Johnson & Johnson's Procrit are expected to result in more cautious dosing by doctors.

Use of the drugs has escalated as physicians have sought to improve the quality of life of anemic patients by using them to stimulate creation of energy-boosting red blood cells. Marketing by manufacturers has reinforced the trend. But the FDA said yesterday that recent clinical trials have shown treatment beyond recommended limits increases the risk of death from heart attack and stroke in kidney patients, and of tumor growth and death in some cancer patients.

The agency advised doctors to give patients the minimum dose required to reduce the need for blood transfusions. It said antianemia drugs should not be used in an attempt to improve the quality of life of cancer patients because those claims are unproven. The FDA allowed claims of lifestyle benefits to remain for kidney patients, but said it is re-examining the validity of patient questionnaires about factors used to support the claims.

Recent concerns about the potential dangers of antianemia drugs and their overuse have been heightened by Medicare reimbursement policies for kidney dialysis treatment, which provide a profit incentive for clinics to administer more Epogen.

Medicare loosened its policy last year to let clinics get paid even if patients exceed the FDA's recommended red blood cell limits. The National Kidney Foundation -- in a set of guidelines paid for by Amgen -- suggested last year that higher targets for red blood cell counts are appropriate, citing statistical studies that showed lower mortality. The foundation is revisiting those guidelines.

The new warnings would effectively reduce the red blood cell target to about 10 grams per deciliter, compared with the upper limit of 12 grams that remains on the label, and the 13 grams permitted under last year's updated Medicare policy. The warnings are advisory, and the targets are still left up to the discretion of physicians, the FDA said.

The FDA said it has alerted Medicare to its latest findings. A spokesman at Medicare, which spends about $2 billion annually on Epogen for dialysis patients, did not respond to a phone message yesterday.

Black box warnings, said Dr. Eric P. Winer, chief of the breast cancer center at Dana-Farber Cancer Institute in Boston, will likely make doctors more cautious about prescribing antianemia drugs.

"These are drugs that have been somewhat overused. I don't think it's been without some effort on the marketing end," he said. "There has been a tendency, I think, for patients, and to some extent health providers, to attribute more fatigue to anemia than deserves to be attributed."

The warnings tarnished the image of a class of drugs that was among the biopharmaceutical industry's first big triumphs and has generated billions of dollars for Amgen and Johnson & Johnson.

Aranesp, which accounted for $4.1 billion in sales last year, is Amgen's second-generation version of the drug. Epogen, its original form, generated $2.5 billion in revenue last year, most of it in federal Medicare reimbursements for its use in dialysis treatment. Amgen makes Procrit, which is identical to Epogen, and licenses Johnson & Johnson to sell it. Procrit sales last year totaled $3.1 billion.

Amgen's stock dropped 2.1 percent to $60.86 yesterday. Johnson & Johnson stock slipped 0.7 percent to $62.14.

In November, an article in New England Journal of Medicine described a clinical trial of Procrit called CHOIR that was cut short because of higher rates of death from heart attack and stroke in kidney patients receiving larger doses. The dosing regimen in the trial pushed red blood cell counts higher than is recommended by the FDA. The results echoed a study of Epogen in kidney dialysis patients that was suspended in 1996, also due to an unexpectedly high death rate during testing.

In October, a trial of Aranesp in Danish patients with head and neck cancers was halted early because of apparent increases in tumor growth. Amgen said it told the FDA about the trial immediately, but it did not alert investors, leading to an informal review disclosed last week by the Securities and Exchange Commission . News of the suspended study was not known until it was reported in February by The Cancer Letter , a trade publication in Washington.

In February, Amgen reported on another study of Aranesp in cancer patients not undergoing chemotherapy treatment, which resulted in a higher percentage of deaths. The causes of death have not been disclosed. The FDA has scheduled a May meeting of its Oncologic Drugs Advisory Committee to discuss the new data.



Clifford takes shots at Ziegler during debate
Legal Career News | 2007/03/10 18:35

After a week of news reports questioning Supreme Court candidate Annette Ziegler's judicial ethics, opponent Linda Clifford wasted no time in firing the opening salvo at a debate, charging that Ziegler's record in this regard was "lacking."

After Clifford, a Madison attorney, alleged several times during Friday's debate that Ziegler likely violated the state's code of judicial ethics by hearing, as a judge, cases involving West Bend Savings - where her husband is on the board of directors and the couple have more than $3.1 million in loans from the bank - Ziegler responded.

"My family doesn't have a financial stake in any case I've served," she said. "I don't think it's my job to get out of cases on which I serve." She said she welcomed any investigation of those charges.

Ziegler also tried to turn the tables, asking whether Clifford, if elected, would recuse herself from any cases involving negligence or malpractice because Clifford's husband is a personal injury lawyer.

Clifford called Ziegler's comments a "desperate attempt to confuse the laws of conflict of interest and recusal."

Clifford stayed on the offense during the hour-long debate Friday, which was sponsored by the State Bar of Wisconsin, WisPolitics.com and others. When Ziegler, a Washington County judge, said she held all the sitting Wisconsin Supreme Court justices with "high regard," Clifford cited a fundraising letter sent out on Ziegler's behalf in January that referred to the court as an "activist arm of liberal special-interest groups."

Ziegler fought back, charging that Clifford had longtime ties to the Democratic Party and hired a private investigator to "dig up dirt" on her.

But for the most part, Ziegler sought to portray herself as the logical choice for the seat by touting her 10 years of judicial experience as a circuit court judge in Washington County while pointing out, repeatedly, that Clifford has never been a judge.

Clifford, who has practiced law for 32 years, countered that practicing attorneys and non-judges have always had a presence on the Supreme Court.

"It's experience the court now lacks but needs," she said.

Ziegler and Clifford are vying to fill the seat being vacated by Justice Jon Wilcox, who is retiring. The election is April 3.

Court observers say the court is basically split now between liberals and conservatives, with Wilcox being among the conservatives.

When asked during the debate whether such designations had any place in the courtroom, both candidates said no.

"Using terms like conservative or liberal are not appropriate," Ziegler said. "I think judicial races should be non-partisan."

Ziegler said she lives a non-partisan life, but noted Clifford's Democratic affiliations.

Clifford, in turn, said Ziegler's campaign staff is comprised of "Republican operatives and Republican-identified individuals."

Clifford said she eschews political designations because they tend to affect a judge's ability to be independent and creates a public perception about how a judge will rule.

Clifford's closing remarks included another attack on Ziegler's ethics and a reiteration of her legal experience. Ziegler offered a more homey touch, harking back to her parents' hardware store and her desire as a young girl to work the cash register.

She said her parents made her earn that role by doing less glamorous work around the store first.

In a not-so-subtle reference to Clifford's lack of judicial experience, Ziegler said: "I think you do need to work your way up."



Ecuador president demands lawmakers accept firing
Legal World News | 2007/03/10 04:41
Ecuadorean President Rafael Correa ordered 57 lawmakers on Friday to accept a court ruling that fired them, intensifying a power struggle with Congress in the politically unstable Andean country.

Ecuador's electoral court ruled this week that the 57 must step down for trying to oust the court's president in legal wrangling over proposed changes to the constitution that could weaken Congress.

The popular leftist president stepped into the fight with a speech from a balcony of the presidential palace to student supporters, who like many Ecuadoreans back his efforts to use reforms to cut the power of traditional political elites.

"Those 57 lawmakers should comply with the law for their actions and they should be replaced by their substitutes. That is the way it should be," Correa told the cheering crowd.

If the lawmakers step down, they will be replaced by members of their own parties, ensuring Congress remains an opposition body.

But the removal of more than half of the elected legislature would strip power from influential Correa opponents in a Congress which has been pivotal in ousting three presidents in the last decade.

Despite lacking support from a traditional party, Correa won power last November with a pledge to rewrite the constitution to strip Congress of much of its power.

He is a close ally of Venezuelan President Hugo Chavez, whose supporters rewrote the constitution to boost his powers soon after he was first elected.

Congress has at times accepted Correa's moves against it. But in recent weeks lawmakers have increased their opposition to a referendum on the constitution scheduled for April 15.

Congress suspended its session on Thursday after police surrounded it to enforce the court ruling.

The feud highlights the charismatic Correa's troubles governing a nation which has had eight presidents in a decade.

Still, the U.S.-educated economist is highly popular as many blame lawmakers for chronic instability in the world's top banana exporter and South America's No. 5 oil producer.


Court Calls District Gun Laws Unconstitutional
Court Feed News | 2007/03/09 21:45

The US DC Circuit Court of Appeals Friday invoked the Second Amendment to reverse a lower court ruling and strike down a three-decades old ban on individuals in the District of Columbia having handguns in their homes. The 2-1 ruling is likely to be appealed to the US Supreme Court.

The Second Amendment to the US Constitution provides: "A well regulated Militia, being necessary to the security of a free State, the right of the people to keep and bear Arms shall not be infringed." Senior Judge Laurence Silberman wrote for the majority:

...the Second Amendment protects an individual right to keep and bear arms. That right existed prior to the formation of the new government under the Constitution and was premised on the private use of arms for activities such as hunting and self-defense, the latter being understood as resistance to either private lawlessness or the depredations of a tyrannical government. In addition, the right to keep and bear arms had the important and salutary civic purpose of helping to preserve the citizen militia. The civic purpose was also a political expedient for the Federalists in the First Congress as it served, in part, to placate their Antifederalist opponents. The individual right facilitated militia service by ensuring that citizens would not be barred from keeping the arms they would need when called forth for militia duty. Despite the importance of the Second Amendment’s civic purpose, however, the activities it protects are not limited to militia service, nor is an individual’s enjoyment of the right contingent upon his or her continued or intermittent enrollment in the militia.

In dissent Judge Karen Henderson, a Reagan appointee, countered that the Second Amendment did not properly apply to the case, as prior caselaw, statute, and the Constitution itself recognized that the District of Columbia is not a state subject to the jurisdiction of the Bill.



Mayor Frank Melton Released From Jail
Headline News | 2007/03/09 21:44

Mayor Frank Melton was released from jail Thursday after the Mississippi Supreme Court vacated his arrest and recused Judge Tomie Green from the case, according to court documents provided to The Associated Press.

Presiding Justice William Waller Jr. issued the orders without further comment.

Melton spoke to reporters at an impromptu news conference in front of the gates of his Jackson home after he arrived there from jail.

"It was quite a humbling experience," Melton said on Jackson news channel WAPT, noting he cleaned three bathrooms Thursday alongside other inmates.

"We're going to make this a great, great city," the 57-year-old mayor said. "I'm back on the job as of right now."

Melton had appointed Jackson City Councilman Frank Bluntson to be the city's interim mayor in an executive order late Wednesday.

The mayor turned himself in at the county jail Wednesday and was booked into the medical ward to await a hearing on whether he violated his probation on a misdemeanor weapons conviction.

Melton, who recently had heart surgery, checked himself into a hospital with chest pains a week earlier, the day Green issued a warrant for his arrest.

The mayor pleaded no-contest in November to a misdemeanor charge of carrying a pistol on a college campus and guilty to two other misdemeanor weapons violations. The plea deal spared him a felony conviction that would have forced him from office.

Melton was given a six-month suspended sentence on each count, one year of probation and fined $1,500.

Melton is a wealthy former TV executive and one-time state drug enforcement agency chief. He won a landslide election in 2005 on the promise of rooting out crime in Jackson.

He became a fixture on nightly newscasts, wearing fatigues, carrying guns and criticizing the district attorney's office for not putting away enough criminals. He cruised the inner city with police and often took troubled children back to his home in a gated community.

Separately, the mayor and his two former bodyguards are to stand trial April 23 on allegations they had roles in the use of sledge hammers to damage a building the mayor considered a drug haven.



China criticizes US human rights record
Legal World News | 2007/03/09 17:05

China accused the US of numerous human rights abuses on Thursday in its Human Rights Record of the US in 2006, the Chinese state response to US criticism in Tuesday's publication of the 2006 US State Department Country Reports. The Chinese report, its eighth consecutive annual rebuttal to the US report, cites news stories from around the world as examples of US rights abuses both within the US and in other countries. China said the US uses its strong military to trespass on the sovereignty of other countries and violate the rights of those countries' citizens, drawing from sources such as a John Hopkins University study that estimates more than 655,000 Iraqi deaths since the Iraq war began in early 2003, and US troop actions in Haditha and Mahmudiya .

The report also cited alleged Geneva Convention violations, including the detention and alleged torture of prisoners both in Iraq and Guantanamo Bay. On the situation within the US, the Chinese report looked at racial and gender inequality, overcrowding in the prison system, poverty, post September 11 government surveillance, political corruption including discussion of former lobbyist Jack Abramoff, and the crime rate in general. US Secretary of State Condoleezza Rice acknowledged that the US has an imperfect human rights record when introducing the State Department's report Tuesday, saying "We do not issue these reports because we think ourselves perfect, but rather because we know ourselves to be deeply imperfect, like all human beings and the endeavors that they make. Our democratic system of governance is accountable, but it is not infallible. We are nonetheless guided by enduring ideals: the inalienable rights of humankind and the principles of democracy toward which all people and all governments must continue striving. And that includes us here in America."

The US State Department report on China was just as detailed as the Chinese response, saying that China's human rights record has been steadily declining over the years. The US report looked at China's restrictions on press and speech, Internet censorship, governmental corruption, racial and gender discrimination, and limitations on religious freedom, including the state crackdown on Falun Gong.



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