Daily Archives: April 17, 2008

Vioxx makers knew of drug’s dangers three years before recall

Seattle Times | Apr 15, 2008

By Kyung M. Song

The maker of the controversial arthritis drug Vioxx knew of dangers associated with it for as many as three years before a massive nationwide recall, but withheld the information from federal officials and played down the number of deaths associated with the pain medication, according to an analysis published today by University of Washington professors.

The article, which appears today in the prominent Journal of the American Medical Association (JAMA), contends that Merck, which pulled Vioxx from the market in 2004, knew internally as early as 2001 that people at risk of Alzheimer’s disease who were enrolled in two Vioxx clinical trials were dying at three times the rate of those taking a placebo.

The article, which examined previously secret Merck documents, contends the company switched calculations to minimize the number of deaths.

A Merck attorney, Jim Fitzpatrick of New York, countered today that the company disclosed all its clinical results thoroughly and that “we completely disagree” with allegations that Merck misrepresented its findings.

The article is one of two papers in this week’s issue of JAMA investigating the clash of corporate interests and scientific integrity involving Vioxx, the subject of the most expensive drug recall in history.

In an accompanying editorial, JAMA’s top editors call for “drastic actions” against corporate manipulation of clinical research and the practice of ghostwriting medical articles by unnamed authors on corporate payroll. It argues that researchers, regulators and even editors of medical journals such as JAMA are complicit. It singled out doctors who lend their names as authors on research papers for money for behavior “that is unprofessional and demeaning to the medical profession.”

Both the article by UW professors and the companion paper on hidden authorship of articles on clinical trials rely on documents disclosed through some of the 27,000 Vioxx lawsuits against Merck. In November, the New Jersey company agreed to settle a majority of those suits for $4.85 billion without admitting guilt.

The co-author of the UW paper, Richard Kronmal, professor of statistics at UW, is a paid expert witness for Vioxx plaintiffs. The lead author is Bruce Psaty, UW professor of medicine.

Vioxx is a prescription arthritis drug and painkiller that was promoted as a gentler alternative to other drugs such as aspirin. Merck withdrew it in September 2004 after disclosing that a study found it doubled the risk of heart attacks and strokes.

But information was available well before 2004 that showed that Vioxx posed serious potential harm to subjects in clinical trials. As early as June 2000, unpublished data submitted to the Food and Drug Administration showed that taking Vioxx significantly raised the rate of heart attacks and strokes, as well as edema and hypertension, according to subsequent analysis by independent researchers.

Some of the same early evidence prompted pharmacists from Seattle’s Group Health Cooperative to decide against adding Vioxx to its formulary. As a result, Group Health has never covered Vioxx for its members, said Jim Carlson, the co-op’s director of pharmacy.

In the latest JAMA article, the UW researchers compared internal Merck memos about two Vioxx studies involving patients at risk of dementia against information the company submitted to the FDA and published later in two clinical papers.

In April 2001, a Merck statistician concluded that 34 people in the Vioxx groups had died, compared with 12 in the two placebo groups. But in its submissions to the FDA three months later, Merck used different methods to reduce the mortality risk, coming up with 29 deaths among Vioxx takers and 17 in the placebo groups.

Merck apparently did this in part by omitting some of the deaths that occurred after the subjects had stopped taking the drug, said Psaty.

“They were not being forthright,” he said in an interview today. “They minimized the appearance of risk.”

Related

Merck Masked Vioxx Risk, Hired Study Ghostwriters

Advertisements

A Catholic Wind in the White House

pope-bush

Pope Benedict XVI and U.S. President George W. Bush attend the arrival ceremony for the pope on the South Lawn of the White House in Washington, April 16, 2008.

George W. Bush could well be the nation’s first Catholic president.

“Certainly much more Catholic than Kennedy.”

Washington Post | Apr 13, 2008

The key to understanding Bush’s domestic policy is to view it through the lens of Rome.

By Daniel Burke

Shortly after Pope Benedict XVI’s election in 2005, President Bush met with a small circle of advisers in the Oval Office. As some mentioned their own religious backgrounds, the president remarked that he had read one of the new pontiff’s books about faith and culture in Western Europe.

Save for one other soul, Bush was the only non-Catholic in the room. But his interest in the pope’s writings was no surprise to those around him. As the White House prepares to welcome Benedict on Tuesday, many in Bush’s inner circle expect the pontiff to find a kindred spirit in the president. Because if Bill Clinton can be called America’s first black president, some say, then George W. Bush could well be the nation’s first Catholic president.

This isn’t as strange a notion as it sounds. Yes, there was John F. Kennedy. But where Kennedy sought to divorce his religion from his office, Bush has welcomed Roman Catholic doctrine and teachings into the White House and based many important domestic policy decisions on them.

“I don’t think there’s any question about it,” says Rick Santorum, former U.S. senator from Pennsylvania and a devout Catholic, who was the first to give Bush the “Catholic president” label. “He’s certainly much more Catholic than Kennedy.”

Bush attends an Episcopal church in Washington and belongs to a Methodist church in Texas, and his political base is solidly evangelical. Yet this Protestant president has surrounded himself with Roman Catholic intellectuals, speechwriters, professors, priests, bishops and politicians. These Catholics — and thus Catholic social teaching — have for the past eight years been shaping Bush’s speeches, policies and legacy to a degree perhaps unprecedented in U.S. history.

“I used to say that there are more Catholics on President Bush’s speechwriting team than on any Notre Dame starting lineup in the past half-century,” said former Bush scribe — and Catholic — William McGurn.

Bush has also placed Catholics in prominent roles in the federal government and relied on Catholic tradition to make a public case for everything from his faith-based initiative to antiabortion legislation. He has wedded Catholic intellectualism with evangelical political savvy to forge a powerful electoral coalition.

“There is an awareness in the White House that the rich Catholic intellectual tradition is a resource for making the links between Christian faith, religiously grounded moral judgments and public policy,” says Richard John Neuhaus, a Catholic priest and editor of the journal First Things who has tutored Bush in the church’s social doctrines for nearly a decade.

In the late 1950s, Kennedy’s Catholicism was a political albatross, and he labored to distance himself from his church. Accepting the Democratic nomination in 1960, he declared his religion “not relevant.”

Bush and his administration, by contrast, have had no such qualms about their Catholic connections. At times, they’ve even seemed to brandish them for political purposes. Even before he got to the White House, Bush and his political guru Karl Rove invited Catholic intellectuals to Texas to instruct the candidate on the church’s social teachings. In January 2001, Bush’s first public outing as president in the nation’s capital was a dinner with Washington’s then-archbishop, Theodore McCarrick. A few months later, Rove (an Episcopalian) asked former White House Catholic adviser Deal Hudson to find a priest to bless his West Wing office.

“There was a very self-conscious awareness that religious conservatives had brought Bush into the White House and that [the administration] wanted to do what they had been mandated to do,” says Hudson.

To conservative Catholics, that meant holding the line on same-sex marriage, euthanasia and embryonic stem cell research, and working to limit abortion in the United States and abroad while nominating judges who would eventually outlaw it. To make the case, Bush has often borrowed Pope John Paul II’s mantra of promoting a “culture of life.” Many Catholics close to him believe that the approximately 300 judges he has seated on the federal bench — most notably Catholics John Roberts and Samuel Alito on the Supreme Court — may yet be his greatest legacy.

Bush also used Catholic doctrine and rhetoric to push his faith-based initiative, a movement to open federal funding to grass-roots religious groups that provide social services to their communities. Much of that initiative is based on the Catholic principle of “subsidiarity” — the idea that local people are in the best position to solve local problems. “The president probably knows absolutely nothing about the Catholic catechism, but he’s very familiar with the principle of subsidiarity,” said H. James Towey, former director of the White House Office of Faith-Based and Community Initiatives who is now the president of a Catholic college in southwestern Pennsylvania. “It’s the sense that the government is not the savior and that problems like poverty have spiritual roots.”

Nonetheless, Bush is not without his Catholic critics. Some contend that his faith-based rhetoric is just small-government conservatism dressed up in religious vestments, and that his economic policies, including tax cuts for the rich, have created a wealth gap that clearly upends the Catholic principle of solidarity with the poor.

John Carr, a top public policy director for the U.S. Conference of Catholic Bishops, calls the Bush administration’s legacy a “tale of two policies.”

“The best of the Bush administration can be seen in their work in development assistance on HIV/AIDS in Africa,” says Carr. “In domestic policy, the conservatism trumps the compassion.”

And other prominent Catholics charge the president with disregarding Rome’s teachings on the Iraq war and torture. But even when he has taken actions that the Vatican opposes, such as invading Iraq, Bush has shown deference to church teachings. Before he sent U.S. troops into Baghdad to topple Saddam Hussein, he met with Catholic “theocons” to discuss just-war theory. White House adviser Leonard Leo, who heads Catholic outreach for the Republican National Committee, says that Bush “has engaged in dialogue with Catholics and shared perspectives with Catholics in a way I think is fairly unique in American politics.”

Moreover, people close to Bush say that he has professed a not-so-secret admiration for the church’s discipline and is personally attracted to the breadth and unity of its teachings. A New York priest who has befriended the president said that Bush respects the way Catholicism starts at the foundation — with the notion that the papacy is willed by God and that the pope is Peter’s successor. “I think what fascinates him about Catholicism is its historical plausibility,” says this priest. “He does appreciate the systematic theology of the church, its intellectual cogency and stability.” The priest also says that Bush “is not unaware of how evangelicalism — by comparison with Catholicism — may seem more limited both theologically and historically.”

Former Bush speechwriter Michael Gerson, another evangelical with an affinity for Catholic teaching, says that the key to understanding Bush’s domestic policy is to view it through the lens of Rome. Others go a step further.

Paul Weyrich, an architect of the religious right, detects in Bush shades of former British prime minister Tony Blair, who converted to Catholicism last year. “I think he is a secret believer,” Weyrich says of Bush. Similarly, John DiIulio, Bush’s first director of faith-based initiatives, has called the president a “closet Catholic.” And he was only half-kidding.

Trenches filled with lime found at ‘house of horrors’ children’s home

This Is London | Apr 17, 2008

Two secret pits filled with a substance that can be used to decompose bodies have been found in the grounds of the Jersey care home where child remains were found.

The mysterious trenches – one measuring 5ft deep – were filled with lime, which destroys flesh and bones.

The two pits are being excavated near the boy’s dormitory at a former Jersey children’s home where the remains of a child’s skull were uncovered.

Police have been searching the Haut de la Garenne care home since a fragment of a child’s skull was found in February.

The inquiry team at Haut de la Garenne, the home where more than 100 people claim they were abused, were contacted by a man claiming he was asked to dig the pits during the 1970s or 1980s.

The man told police that, when he asked what they were for, care staff told him “it was none of his concern”.

When he returned the following day he was ordered to fill in the pits.
A police spokeswoman said forensic teams have excavated one pit and are working on the second.

She said: “The team excavated the first pit and found it to be about 1.5 metres deep.

“At the bottom of the pit was a large quantity of lime. There was nothing else in the hole.

“The inquiry team can think of no reason why this pit would have been created, nor why it was filled with lime.

“We would emphasise that we have no evidence of any motive. We are currently excavating the second pit which is very close to what was the boys’ dormitory.”

More then 100 people have come forward to say they were victims of abuse at the care home.

Haut de la Garenne was dubbed the “house of horrors” after fragments of a child’s skull were found in February.

Tests on the skull, which was buried under a stairwell, were unable to identify the child but revealed that the bone was placed at that location no earlier than the 1920s.

The home is at the centre of one of Britain’s biggest ever abuse investigations with more than 100 people claiming they were assaulted there since the 1960s.

Some of the victims claim they were kept in solitary confinement and attacked in secret underground chambers known as “punishment rooms”.
There was also a large quantity of lime found in the stairwell where the skull fragment was found.

Archaeologists who carried out tests said this meant it could not have been buried “in a much less favourable environment” and the protein collagen had been completely destroyed in the bone.

Police have also found and excavated a network of four underground rooms. They have found a number of items, including shackles and a bath, which they say corroborate claims from victims.

The police spokeswoman said: “The forensic examination of the third and fourth rooms of the cellars continues.

“A number of finds have been made and are being studied. They have the potential to further corroborate the versions of events given to us by victims who have come forward.”

So far only one man has been charged in connection with the abuse inquiry, which focuses on Haut de la Garenne but involves other care homes on Jersey.

Gordon Claude Wateridge is charged with three offences of indecent assault on girls under 16 between 1969 and 1979 when he was warder at the home.
The 76-year-old is on conditional bail and will next appear before St Helier Magistrates’ Court on May 12 at 10am.

Wateridge, who is originally from Croydon, south London, has not entered a plea. There are more than 40 suspects in the inquiry as a whole.
Haut de la Garenne closed as a children’s home in 1986.
It is expected that this work will continue into next week.

Netanyahu says 9/11 terror attacks good for Israel

netanyahoo

“We are benefiting from one thing, and that is the attack on the Twin Towers and Pentagon.”

– Former Israeli Prime Minister and current Likud chairman Benjamin Netanyahu

Haaretz | Apr 16, 2008

The Israeli newspaper Ma’ariv on Wednesday reported that Likud leader Benjamin Netanyahu told an audience at Bar Ilan university that the September 11, 2001 terror attacks had been beneficial for Israel.

“We are benefiting from one thing, and that is the attack on the Twin Towers and Pentagon, and the American struggle in Iraq,” Ma’ariv quoted the former prime minister as saying. He reportedly added that these events “swung American public opinion in our favor.”

Netanyahu reportedly made the comments during a conference at Bar-Ilan University on the division of Jerusalem as part of a peace deal with the Palestinians.

Meanwhile, Iran’s President Mahmoud Ahmadinejad cast doubt over the veracity of the September 11 attacks Thursday, calling it a pretext to invade Afghanistan and Iraq.

“Four or five years ago, a suspicious event occurred in New York. A building collapsed and they said that 3,000 people had been killed but never published their names,” Ahmadinejad told Iranians in the holy city of Qom.

“Under this pretext, they [the U.S.] attacked Afghanistan and Iraq and since then, a million people have been killed only in Iraq.”

Speaking Wednesday at a news conference on the Iran threat, Netanyahu compared Ahmadinejad to Adolf Hitler and likened Tehran’s nuclear program to the threat the Nazis posed to Europe in the late 1930s.

Netanyahu said Iran differed from the Nazis in one vital respect, explaining that “where that [Nazi] regime embarked on a global conflict before it developed nuclear weapons,” he said. “This regime [Iran] is developing nuclear weapons before it embarks on a global conflict.”