Daily Archives: May 11, 2007

Giuliani represented Purdue Pharma which deceived public on OxyContin addiction

Associated Press| May 11, 2007

You know the dealer, the dealer is a man
With the love grass in his hand

Oh but the pusher is a monster
Good God, he’s not a natural man

The dealer for a nickel
Lord, will sell you lots of sweet dreams

Ah, but the pusher ruin your body
Lord, he’ll leave your, he’ll leave your mind to scream

– The Pusher – lyrics and music by Hoyt Axton

giuliani_kbe

Sir Giuliani proudly displaying his Knight Commander of the British Empire medal from the Queen

Giuliani and his consulting firm Giuliani Partners have represented Purdue since January 2002, the same month the former mayor left office and a time when both regulatory and public concerns were cresting over a drug that brought in more than $1 billion a year but also had been linked to hundreds of deaths and produced a plague of abuse and addiction.
 
In a case that could stoke unwelcome interest in one of presidential candidate Rudolph Giuliani’s first private consulting contracts, the maker of the controversial painkiller OxyContin and three top executives pleaded guilty yesterday to misleading the public about addiction risks.

In the plea deal, Purdue Pharma of Stamford, Conn., and the three current and former officials agreed to pay $634.5 million in fines for falsely claiming between 1995 and June 2001 that its drug was less addictive than other painkillers. Future marketing will be monitored.

“Purdue unleashed a highly abusable, addictive and potentially dangerous drug on an unsuspecting and unknowing public,” said Virginia U.S. Attorney John Brownlee at a news conference in Roanoke.

Giuliani and his consulting firm Giuliani Partners have represented Purdue since January 2002, the same month the former mayor left office and a time when both regulatory and public concerns were cresting over a drug that brought in more than $1 billion a year but also had been linked to hundreds of deaths and produced a plague of abuse and addiction.

As part of the deal, Giuliani agreed to help Purdue develop an early warning network to spot prescription abuse trends, develop education programs to help police and medical professionals prevent improper diversion of the drug, work on smuggling issues, and review plant and supply chain security.

Giuliani also helped the company fight on the public relations and regulatory front. He agreed to head up a group called Rx Action Alliance, which would publicly advocate for a “balance” between checking abuse and making sure painkillers were still available to everyone who needed them, and still is identified as chairman on the group’s Web site.

He also attended meetings Purdue executives had with Drug Enforcement Administration officials investigating illicit diversion of OxyContin, and put his post-Sept. 11 credibility behind the company with public statements. “Purdue has demonstrated its commitment to fighting this problem … ,” Giuliani said in a May 2002 press release.

A Giuliani aide pointed out yesterday that part of his firm’s business is helping companies in trouble, and he became involved six months after the illegal conduct that was part of yesterday’s guilty plea.

Even after Giuliani stepped in, however, Purdue’s commercial conduct continued to attract criticism. As late as January 2003, for example, the U.S. Food and Drug Administration warned Purdue that it was continuing to “grossly overstate the safety profile” of OxyContin in ads.

Giuliani’s political foes were publicly silent about his Purdue role, but some drug-safety watchdogs argued that years later the company’s distribution of OxyContin continues to raise questions.

“It’s still too widely used,” said Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group. “So I think there’s still a big problem out there.”

Oxycontin case

THE DRUG. OxyContin, a trade name for oxycodone, is a time-release painkiller that can be highly addictive. The pills can produce a heroinlike high if crushed and then swallowed, snorted or injected.

THE COVER-UP. Purdue Pharma learned from focus groups with physicians in 1995 that doctors were worried about the drug’s potential for abuse. The company then gave false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers.

THE PLEA DEAL. Purdue, its president, top lawyer and former chief medical officer will pay $634.5 million in fines. The plea agreement settled a national case and came two days after the company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe the drug.

OxyContin executives plead guilty to misleading public on addiction risk

Associated Press | May 11, 2007

You know the dealer, the dealer is a man
With the love grass in his hand

Oh but the pusher is a monster
Good God, he’s not a natural man

The dealer for a nickel
Lord, will sell you lots of sweet dreams

Ah, but the pusher ruin your body
Lord, he’ll leave your, he’ll leave your mind to scream

– The Pusher – lyrics and music by Hoyt Axton

The Connecticut maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty Thursday to misleading the public about the drug’s risk of addiction, a federal prosecutor and the company said.
 
Purdue Pharma L.P., as well as its president, top lawyer and former chief medical officer will pay $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said.
 
The plea agreement settled a national case and came two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.
 
“With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public,” Brownlee said. “For these misrepresentations and crimes, Purdue and its executives have been brought to justice.”
 
Purdue spokesman James Heins objected to the suggestion of a connection between the plea agreement and individuals’ abuse of OxyContin.
 
“We promoted the medicine only to health-care professionals, not to consumers,” he said in a statement.
 
Purdue learned from focus groups with physicians in 1995 that they were worried about the abuse potential of OxyContin. The company then gave false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers, the U.S. attorney said.
 
Ken Jost of the Justice Department’s Office of Consumer Litigation said this case should put pharmaceutical companies on notice that they won’t be able to get away with breaking the law to make a profit.
 
“The things that they plot in their boardrooms, the things that they do behind closed doors will not stay behind closed doors,” Jost said. “We have the people, we have the resources. We’ll take the time and we’ll take the effort to find out what they did and how they did it.”
 
Purdue Pharma said it accepted responsibility for its employees’ actions.
 
“During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again,” the company said in a news release.
 
OxyContin, a trade name for oxycodone, is a time-release painkiller that can be highly addictive. Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected.
 
From 1996 to 2001, the number of oxycodone-related deaths nationwide increased 400 percent while the annual number of OxyContin prescriptions increased nearly 20-fold, according to a report by the U.S. Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to another 318.
 
In western Virginia, the state medical examiner’s office listed oxycodone as the cause of death of 228 people from 1996 to 2005, a spokeswoman for Brownlee said.

Gas station owner told to raise prices

Boston Globe | May 9, 2007

A service station that offered discounted gas to senior citizens and people supporting youth sports has been ordered by the state to raise its prices.

Center City BP owner Raj Bhandari has been offering senior citizens a 2 cent per gallon price break and discount cards that let sports boosters pay 3 cents less per gallon.

But the state Department of Agriculture, Trade and Consumer Protection says those deals violate Wisconsin’s Unfair Sales Act, which requires stations to sell gas for about 9.2 percent more than the wholesale price.

Bhandari said he received a letter from the state auditor last month saying the state would sue him if he did not raise his prices. The state could penalize him for each discounted gallon he sold, with the fine determined by a judge.

Bhandari, who bought the station a year ago, said he worries customers will think he stopped the discounts because he wants to make more money. About 10 percent of his customers had used the discount cards.

Dale Van Camp said he bought a $50 card to support the local youth hockey program. It would have saved him about $100 per year on gas, he said.

White House cranks up hunt for war czar

Courier Press | May 7, 2007

Now that the White House is searching for a “war czar,” the question arises: just who has been coordinating U.S. involvement in Iraq and Afghanistan the past four years?

A team of West Wing players led by national security adviser Stephen Hadley has tried to keep turf-conscious agencies marching in the same direction on military, political and reconstruction fronts. A few Bush aides say privately, however, that the White House probably should have recruited someone to oversee the war effort a year ago.

Critics say the administration’s job of coordinating the war has never gone smooth enough or fast enough. And now two key members of the White House team focused on the war are leaving.

“The problem is not broad strategy and policy, it’s that the bureaucracy is so inefficient and there’s been so little follow-up that the machine doesn’t work,” former House Speaker Newt Gingrich said. He believes red tape in Washington is the biggest obstacle to winning in Iraq.

Gingrich has joined others in suggesting that a single person report directly to Bush and perhaps the next president and ask: “What are the choke points? What regulations do we need to fix?”

The new job comes as Bush’s combat troop buildup is trying to bring a degree of calm in Iraq so political reconciliation and rebuilding can take root.

“We’re at a point now where we’ve got a plan,” Hadley said. “Execution of that plan is now everything.”

Hadley said he wants to make sure that if any request from the war zone bogs down among agencies, there is someone who can speak for the president to get it solved quickly.

“That’s the kind of thing that I do, but I can’t do it full time,” said Hadley, who must monitor hot spots around the world.

Hadley interviewed several candidates in the past few days. He has contacted at least six retired military leaders either to learn what they think about the job or to try to persuade them to take it.

“This is really more of a head cracker than a czar a bureaucracy cracker,” said Michael O’Hanlon, a foreign policy analyst for the Brookings Institution who likes the idea.

“They want one point person to contact everyone else to tell them that we need these 17 things by Tuesday to comply with the president’s top foreign policy priority,” said O’Hanlon, a former adviser to the Iraq Study Group. The panel concluded that duplication and conflicting strategies at federal agencies were undermining confidence in U.S. policy.

So far, there have been no takers.

“It’s the nuttiest idea ever,” said James Carafano, a defense expert at Heritage Foundation.

“You’re too far from the battlefield. You’re in the wrong time zone. You can’t make timely decisions. You don’t have the staff,” he said. “The administration will be over before they even have the communications and everything in place to do this.”

War worsens Iraq’s soaring child death rate

Sydney Morning Herald | May 9, 2007

In 2005 about 122,000 Iraqi children died before their fifth birthday.

IRAQ has suffered the world’s worst increase in child mortality over the past 15 years, a report released by Save the Children says. Other countries with soaring rates were Botswana, Zimbabwe and Swaziland, which have been devastated by AIDS.

However, researchers also found progress in some of the world’s poorest nations.

Bangladesh has profoundly improved the chances that a child would survive by promoting family planning, a strategy that has enabled women to have fewer children, space births and strengthen their own health and that of their babies.

Nepal, despite a decade-long Maoist insurgency, has halved the death rate of children under the age of five. It has enlisted the help of 50,000 mothers, most of them illiterate, who have squeezed vitamin A drops into the mouths of every child, hauled laggards in for vaccinations and even diagnosed pneumonia and dispensed medicine to combat it.

And Malawi, which suffers from an extreme shortage of doctors and nurses, has made surprising gains by taking simple steps that require no professional skills, such as distributing nets that protect children from malarial mosquitoes.

“In 2007, when we know what to do and how little it costs, that 28,000 kids are still dying each day is just plain wrong,” said David Oot, a public health expert on the team that produced the Save the Children report, State of the World’s Mothers: Saving the Lives of Children Under 5.

Despite many hopeful stories, broad progress against infant and child mortality has flagged since international health agencies began a campaign to reduce deaths 25 years ago, the researchers concluded. By the end of the 1980s, global rates of child mortality had fallen 20 per cent, and the lives of 12 million children had been saved.

“Much of the momentum behind the child survival revolution has now been lost, and gains achieved in the 1980s and early 1990s have slowed or reversed,” the report says. “Under-five mortality declined by only 10 per cent from the early 1990s to 2000.”

Among the 60 developing countries where 94 per cent of the child deaths occurred, 20 have either made no progress or have regressed, while 24 have cut death rates of children under five by at least 20 per cent.

Iraq, hit hard by sanctions and war, experienced the most staggering rise in under-five mortality – 150 per cent over 15 years. Since the US-led invasion in 2003, deteriorating health services, rising inflation and electricity shortages have worsened living conditions, the report says. In 2005 about 122,000 Iraqi children died before their fifth birthday.

In countries that progressed, a focus on family planning was central to progress, the report says. In the five countries that made the greatest strides in reducing child deaths – Egypt, Indonesia, Bangladesh, Nepal and the Philippines – women’s use of contraceptives rose and fertility rates declined.

In those countries, mothers were less likely to be physically depleted by having too many babies in too short a time. With fewer children, families were also able to invest more in the care of each child.

Political will was also an essential ingredient of success – and in Malawi, Tanzania, Nepal and Bangladesh was even more important than national wealth, the report found. Egypt, which has cut the death rate of children under age five by 68 per cent since 1990, more than any other country, has shown a particular commitment to children’s health, the researchers say.

Chavez accused of censorship over threat to close TV station

Independent | May 10, 2007

All day and all evening the television in Florentino Santas’s busy grocery store in Venezuela’s capital city blares out the soaps and telenovelas broadcast by the Radio Caracas Television network.

Mr Santas, his son Juan and their friends who hang around the store drinking beer, are frequently transfixed by the television set upon a fridge, especially on Monday evenings when Radio Rochela – a comedy sketch show that has been entertaining Venezuelans for more than 40 years – is broadcast.

But his simple pleasures may be coming to an end. The broadcast licence of RCTV, the oldest and most popular channel in Venezuela, comes to an end later this month and the government of President Hugo Chavez has indicated that it will not be renewed.

The showdown between Mr Chavez and RCTV is emerging as the latest battlefront between supporters of the thrice-elected leader and his political opponents. His opponents say that the decision not to renew the licence is a blow to press freedom and evidence of what they say is President Chavez’s increasing authoritarianism.

His supporters, meanwhile, say that RCTV is responsible for promoting anti-government propaganda and that its news coverage does not represent real journalism. They point to the station’s behaviour during the 2002 coup that briefly unseated Mr Chavez.

The network initially urged people to take to the streets, and then enforced a news blackout as the coup started to fall apart. Mr Chavez’s supporters say that no other country would permit a broadcaster to behave in such a way.

“RCTV always show the bad side and then incite people to protest,” said José Salas, 59, an electrician. “I think it’s good that their licence is running out but the closure has nothing to do with politics. They put a lot of shows on that aren’t good for the public and they try to alter people’s viewpoints.”

RCTV’s director, Marcel Granier, recently met members of the European Parliament to seek support against the closure, due to take place on 27 May. He has also lobbied the Organisation of American States (OAS) which referred the matter to the Inter-American Court of Human Rights.

“The threat of Hugo Chavez’s decision to close the channel fully violates article 13 of the Inter-American Human Rights Treaty which prohibits discrimination or punishment of journalists based on their editorial position,” Mr Granier said last month.

But the Chavez government has hit back. Alejandro Fleming, Venezuela’s ambassador to the EU, said: “Europeans would never allow a channel on their televisions to incite violence, support coups, or break the constitutional order.”

When he was elected to a third term by a two-thirds majority last November, Mr Chavez vowed he would push forward with his vision of “socialism for the 21st century”. He has announced a decision to withdraw Venezuela from the World Bank and the International Monetary Fund, which has sees as tools of US influence.

Not all of Mr Chavez’s supporters agree with his decision not to renew RCTV’s licence. Gracy Lucela, 23, a streetseller in the Capitolio neighbourhood, said: “I’m a chavista but I don’t agree with this at all. The government already has enough channels with TeleSUR, Channel 8, Vive and the others. We need other points of view. ” She added: “I watch RCTV every night and I’ve grown up with it – it’s part of our culture.” Mr Santas agrees: “I just don’t agree with the closure of RCTV. They don’t have any reason to do it. There are going to be real problems with freedom of speech in Venezuela and people will be really unhappy if they shut it down.”

‘Channel Chavez’

* Mr Chavez is launching a television channel that will broadcast in Britain and Spain. Telesur, the channel he started to counter what he claims is biased US coverage of his country, will have offices in London and Madrid.

* From the outset the channel has been accused of simply espousing Mr Chavez’s left-wing populism. Telesur’s president, Andres Izarra, who was in Madrid yesterday for talks with Spanish partners, said the channel countered the “CNN vision” of Latin America.

* To underscore its independence, Mr Izarra said a deal had been signed with the BBC to exchange content that gave supervision of Telesur production to experts from the BBC.

* Telesur began broadcasting in 2005 in South America. It is planning to open an office in Brussels and then to expand into Africa and Asia.

FDA says farm-bred fish fed contaminated meal

Boston Globe | May 9, 2007

The smelt in question ate food tainted with chemicals the FDA traced to ingredients imported from China.

Alabama last month began rejecting all catfish imports from China , due to 14 samples that tested positive for an unapproved antibiotic.

Farm-raised fish in an undisclosed number of states ate meal contaminated with an unapproved industrial chemical, the Food and Drug Administration said yesterday, widening the scope of one of the nation’s largest pet food recalls. Farm-raised fish are bred for purchase at grocery stores and restaurants and to stock reservoirs and lakes for anglers. It is unclear how many fish ate the contaminated meal .

The disclosure comes following news that millions of domestic chickens and thousands of domestic hogs that ate pet food laced with industrial chemicals have entered the US food supply.

The livestock and smelt in question ate food tainted with chemicals the FDA traced to ingredients imported from China. Like the chicken and hogs, the FDA said, the smelt should pose no hazard to humans because only a small part of their diet included melamine , a chemical linked to the food imports.

A Canadian firm that manufactured the fish meal included contaminated wheat gluten imported from China and shipped the fish meal to the United States.

ChemNutra Inc.’s spokesman Steve Stern said the Las Vegas company told the FDA about three weeks ago about the container of wheat gluten, which was shipped directly to Canada from China . ChemNutra was the middleman between a Canadian broker and the Chinese supplier, Stern said.

The FDA did not rule out future testing of Chinese-imported wheat flour for chemical residues. The amount of fish affected, however, could expand.

Alabama last month began rejecting all catfish imports from China , due to 14 samples that tested positive for an unapproved antibiotic.

Dr. David Acheson , the FDA’s new food safety czar , said it will use a new test to determine whether remaining catfish samples contain melamine, the industrial chemical that triggered a pet food recall that since mid-March has pulled millions of cans, pouches, and bags of food from store shelves.