Senate Votes to Give F.D.A. Sweeping New Powers

nytimes
WASHINGTON, May 9 — By a vote of 93 to 1, the Senate passed a bill this afternoon that gives the Food and Drug Administration sweeping new power to police drug safety, order changes in drug labels, and restrict the use and distribution of medicines found to pose serious risks to consumers.

The bill calls for a fundamental change in the philosophy and operations of the F.D.A., requiring the agency to focus on the entire life cycle of a drug — not just the years prior to its approval, but also the experience of patients who later take it.

Senators said the bill was a response to a widespread loss of confidence in the ability of the F.D.A. to protect consumers against the dangers of drugs like Vioxx, a popular painkiller withdrawn from the market in 2004. The bill would carry out many recommendations from the National Academy of Sciences and appears broadly acceptable to the House. The Bush administration has not actively opposed the measure and many drug manufacturers support it.

The bill is widely seen as “must pass” legislation because it renews authority for the government to collect fees from drug companies to speed the review of their products. Without action by Congress, the authority would expire Sept. 30.

“This legislation will make a major difference for families in America, ensuring the safety of our prescription drug system,” said the chief sponsor of the bill, Senator Edward M. Kennedy, Democrat of Massachusetts. “We will also have safer food for families and for pets.”

Senator Michael B. Enzi, Republican of Wyoming, said the bill was the “most comprehensive drug safety overhaul in more than a decade.”

The no vote was cast by Senator Bernard Sanders, the Vermont independent who is an outspoken critic of the pharmaceutical industry.

Work on the bill began long before Democrats took control of Congress. At a time when bills often pass or fail on party-line votes, the Senate drug bill was a triumph of bipartisan cooperation. Republicans were full partners in drafting it.

The bill sidestepped a multibillion-dollar question: how to give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year. But lawmakers from both parties said they intended to create a procedure for federal approval of such copycat drugs, sometimes called generic biologics.

Just minutes before passage of the bill this afternoon, the Senate voted, 64 to 30, to double the maximum civil fine that could be imposed on a drug company for violations of a drug safety plan approved by the F.D.A. The maximum fine would now be $2 million.

“If fines are nothing more than the cost of doing business, you cannot deter bad behavior,” said Senator Charles E. Grassley, Republican of Iowa, who proposed the increase.

Under the bill, the government would analyze data on tens of millions of patients, looking for signals that particular drugs posed serious risks.

To minimize those risks, the government could order changes in a drug’s label and could require the manufacturer to conduct more studies and clinical trials of a drug already on the market.

Under current law, the government and drug companies sometimes haggle for months over changes in drug labeling, and the F.D.A. can request but not compel manufacturers to perform studies.

“For Vioxx, it took 14 months to change the drug’s label to warn doctors and patients of the danger,” Mr. Kennedy said. “Companies routinely promise to conduct studies that are never even started, much less completed.”

The bill would require the government to establish a public database of all clinical trials and their results. Lawmakers said the database would make it difficult for drug companies to hide evidence of safety problems, as some have done in the past. The database would also make it easier for patients to learn of clinical trials testing experimental drugs that could save their lives.

Senator Enzi said the bill could speed the approval of new drugs, by giving the F.D.A. more tools to protect patients after treatments were approved. The agency would no longer have to rely on “the nuclear option, which is pulling a drug completely off the market” — an extreme step that may disrupt the care of patients, Mr. Enzi said.

The F.D.A. could instead require a manufacturer to adopt a “risk evaluation and mitigation strategy” for any drug that posed a serious risk to patients.

As part of its risk-management plan, a drug maker might have to notify doctors and patients of a drug’s risks. In exceptional cases, the F.D.A. could restrict the use and distribution of a drug that posed extraordinary risks.

The agency could, for example, require special training for doctors who prescribe a particular drug, certification of drugstores that dispense it and monitoring of patients who take it.

Senator Judd Gregg, Republican of New Hampshire, said that any restrictions on the use or marketing of a drug would have to be based on “sound science.”

David Rockefeller met with Saddam

David Rockefeller, founder of the Council on Foreign Relations and the Trilateral Commission, discusses his meeting with Saddam Hussein. The meeting was held at the request of Henry Kissinger. Rockefeller comments that their meeting is "all the more interesting" due to the role that Saddam would play after their meeting. In case you don't know David Rockefeller is one of the leaders of the world government movement. They create and fund "threats" like Saddam to generate fear among the general population. Fear leads to control.


http://www.youtube.com/watch?v=08TV7MabJw0

Verizon says phone record disclosure is protected free speech

ARS TECHNICA
Verizon is one of the phone companies currently being sued over its alleged disclosure of customer phone records to the NSA. In a response to the court last week, the company asked for the entire consolidated case against it to be thrown out—on free speech grounds.

The response also alleges that the case should be thrown out because even looking into the issue could violate state secrets, of course, but a much longer section of the response tries to make the case that Verizon has a First Amendment right to "petition" the government. "Based on plaintiffs' own allegations, defendants' right to communicate such information to the government is fully protected by the Free Speech and Petition Clauses of the First Amendment," argue Verizon's lawyers.

Essentially, the argument is that turning over truthful information to the government is free speech, and the EFF and ACLU can't do anything about it. In fact, Verizon basically argues that the entire lawsuit is a giant SLAPP (Strategic Lawsuit Against Public Participation) suit, and that the case is an attempt to deter the company from exercising its First Amendment right to turn over customer calling information to government security services.

"Communicating facts to the government is protected petitioning activity," says the response, even when the communication of those facts would normally be illegal or would violate a company's owner promises to its customers. Verizon argues that, if the EFF and other groups have concerns about customer call records, the only proper remedy "is to impose restrictions on the government, not on the speaker's right to communicate."

With all of the phone company cases consolidated into one master case, Verizon is hoping to have the case thrown out on free-speech grounds, putting an end to its legal troubles over the issue. Should it fail, the Bush administration is already preparing to ask Congress for retroactive immunity for all telecommunications companies that assisted the government after September 11, 2001. The government is also fighting hard in court on behalf of the phone companies, filing repeated briefs which claim that "state secrets" trump even the legality of the alleged security programs.

Police Are Using Armored Vehicles

AP


PITTSBURGH -- After six people were shot in the city's Homewood neighborhood in less than 24 hours, Pittsburgh police rolled in with a 20-ton armored truck with a blast-resistant body, armored rotating roof hatch and gunports.

No guns or drugs were seized and no arrests made during the sweep in the $250,000 armored vehicle, paid for with Homeland Security money. But the show of force sent a message.

Whether it was the right message is a matter of debate.

With scores of police agencies large and small, from Lexington, Ky., to Austin, Texas, buying armored vehicles at Homeland Security expense, some criminal justice experts warn that their use in fighting everyday crime could do more harm than good and represents a post-9/11, militaristic turn away from the more cooperative community-policing approach promoted in the 1990s.

When the armored truck moved through the Homewood neighborhood late last year, residents came out of their homes to take a look. Some were offended.

"This is really the containment of crime, not the elimination, because to eliminate it you have to address some of the social problems," complained Rashad Byrdsong, a community activist.

Law enforcement agencies say the growing use of the vehicles, a practice that also has its defenders in the academic field of criminal justice, helps ensure police have the tools they need to deal with hostage situations, heavy gunfire and acts of terrorism.

But police are also putting the equipment to more routine use, such as the delivering to warrants to suspects believed to be armed.

"We live on being prepared for `what if?'" said Pittsburgh Sgt. Barry Budd, a memer of the SWAT team.

Critics say that the appearance of armored vehicles in high-crime neighborhoods may only increase tensions by making residents feel as if they are under siege.

Most departments do not have "a credible, justifiable reason for buying these kinds of vehicles," but find them appealing because they "tap into that subculture within policing that finds the whole military special-operations model culturally intoxicating," said Peter Kraska, a professor at Eastern Kentucky University and an expert on police militarization. The military-style approach "runs a high risk of being very counterproductive."

Peter Moskos, a criminologist at the John Jay College of Criminal Justice in New York, said police departments would be better off hiring people with different language skills if the goal is to root out terrorism.

"It does worry me when cops try to be more military-like because an armored car is not going to stop a terrorist," he said.

In Pittsburgh, a city of about 370,000 with pockets of mostly drug- or gang-related crime, the armored truck made by Lenco Industries Inc. of Pittsfield, Mass., has been used about four times a month, Budd said.

He said the Lenco B.E.A.R., or Ballistic Engineered Armored Response and Rescue vehicle, was bought primarily to be used in hostage situations and when officers are wounded. On Sunday, the truck was deployed when Pittsburgh's SWAT team responded to a report of an armed man holed up in a home. The standoff ended peacefully.

Since the Sept. 11 attacks, police in Lexington, Ky., a city of about 280,000, have obtained two armored vehicles, including a Lenco B.E.A.R. paid for with Homeland Security money, and two military helicopters acquired from the Pentagon.

Police Chief Anthany Beatty said the equipment is used mostly to fight daily crime but is also meant to protect the area's "significant military assets" from terrorists. Lexington's SWAT team takes its armored truck out on every call, including the serving of warrants to heavily armed suspects.

Police in Austin -- home to about 720,000 -- bought Lenco's smaller armored vehicle, the BearCat, with a $250,000 Homeland Security grant. Lt. Vic White, who heads the department's tactical operations, said it is deployed every time the SWAT team is called out, including instances in which officers need to be taken into an area where armed suspects could be holed up.

Robert J. Castelli, chairman of criminal justice at Iona College in New Rochelle, N.Y., said if he were a police chief of a force with an armored vehicle, he would order it sent out on every SWAT call.

"Things can go pretty bad pretty quick in police work," said Castelli, a former member of the New York State Police.

Castelli said armored vehicles can send a positive message -- that police are in control of the situation -- and make police better prepared to deal with more heavily armed criminals, as well as terrorists.

Lenco Industries president Len Light said Homeland Security grants have significantly boosted sales but would not provide precise figures. He said the company has sold hundreds of armored vehicles to police nationwide, and has annual sales of about $40 million.

The Homeland Security Department has said it may have been too free in giving out money.

Until recently, little scrutiny was given to whether grants served a national purpose, said Larry Orluskie, a Homeland Security spokesman. In March, grant-giving was handed over to the Federal Emergency Management Agency.

"Now, states have to propose a plan and how the money will be used to support Homeland Security missions," he said.

Cheney in Baghdad to put pressure on Maliki

LATIMES

BAGHDAD -- A truck bomb exploded in midtown Irbil in the semi-autonomous region of Kurdistan today, killing 19 people, injuring 70 and illustrating the worsening violence in areas of Iraq previously considered to be relatively safe.

The violence came on the day that Vice President Dick Cheney made a surprise trip to Iraq. The visit was part of the Bush administration's campaign to keep pressure on Prime Minister Nouri Maliki's government to forge ahead with legislation to mend sectarian rifts.

Cheney met with Maliki and other senior government officials, as well as with the commander of U.S. troops in Iraq, Gen. David Petraeus. His message to the Iraqi leaders, according to a senior administration official who briefed reporters, is: "We've all got challenges together. We've got to pull together. We've got to get this work done. It's game time."

But Iraq's parliament met without taking up any of the so-called benchmark laws that the United States is counting on them passing, such as an oil law that is designed to boost production and share oil profits among Iraq's different regions.

Militant cleric Muqtada Sadr called for Iraqis to protest the visit and about 1,000 demonstrated in the holy city of Kadhimiya, northwest of Baghdad.

"Kick out the leaders of evil," one of their signs read. Sadr's Mahdi army oversaw the protest and limited participation for security concerns.

The bombing in Irbil, 300 miles north of Baghdad, targeted the Interior Ministry, which oversees Iraqi police, and could be another sign of insurgents taking their operations into new areas after being targeted by the security plan in Baghdad, Al Anbar and Diyala provinces.

Additionally, the conflict between Kurdistan and Sunni insurgents has sharpened from the deployment of several thousand Kurdish Peshmerga troops in Baghdad as part of the security plan.

In the capital city, at least four people were killed in mortar, gunshot and roadside bomb attacks. They included one laborer working on construction of a controversial barrier designed to quell violence in the Sunni stronghold of Adhamiya, in northeastern Baghdad.

He was killed when gunmen opened fire on workers erecting what the U.S. and Iraqi military have portrayed as a temporary security barrier that will prevent Adhamiya's Sunni population from clashing with Shiites in the surrounding neighborhoods.

Last week, a senior U.S. Army officer was shot and injured as he surveyed progress on the barrier. Local residents have denounced the structure as inhumane and say it will cage them into their neighborhood.

Also today, a car bomb exploded a few hundred feet from an Iraqi army checkpoint on a busy street in Baghdad, killing one person and damaging nearby shops and cars.

Two people were killed in Musayyib, about 40 miles south of Baghdad, when a bomb exploded in front of a shop. Two more Iraqis died when mortars crashed into a neighborhood in Haswa, 30 miles south of the capital.

In the city of Samarra, local residents were chafing after a week under curfew, which was imposed after leaflets signed by the Al Qaeda-linked group, Islamic State of Iraq, were distributed warning of attacks on police and the army.

Last Sunday, 12 police officers in Samarra, 12 miles north of Baghdad, died when a suicide bomber rammed his car into a police station.

Locals say the curfew and road closures, preventing traffic in and out of the city, has led to shortages of supplies. It also has made it difficult for people to keep their homes powered because of their inability to get fuel for generators.

Dr. Mustafa Abdul Kareem, head of the pediatrics ward in a Samarra hospital, said two newborns in incubators had died because of the power shortage. They could not be transferred to other cities because ambulances have been prevented from entering and leaving the city.

4 Arrested in 2005 London Transit Bombings

NEW YORK TIMES

LONDON, May 9 — British police today arrested three men and the widow of a suicide bomber involved in the terror attack on the London transit system in 2005 on suspicion they helped in the atrocity that killed 52 people.

Three of the early morning arrests, the second round of arrests in six weeks in connection with the attack, were in the West Yorkshire region of Britain where three of the four suicide bombers lived, and the fourth was in the West Midlands region.

The arrests suggested that after a long period of investigation, with little early success, the police were beginning to piece together how the plot worked and who else, aside from the four suicide bombers, was responsible.

In a stern message last month, Peter Clarke, the chief of counterterrorism at Scotland Yard, said that his investigators would soon catch up with others who, he said, had been aware of the planning of the 2005 attack.

The arrests today appeared to be the result of the investigations that Mr. Clarke referred to.

For a long time, it seemed the authorities would be unable to charge anyone with the transit attacks, which caused the worst peace-time casualty toll in Britain’s history.

But the latest arrests, together with the arrests of three men in late March, are changing the presumption that the bombers took the secrets of their plan with them.

Now, the details of the organization behind the attack, both in Britain and in Pakistan where two of the suicide bombers traveled, could be publicized at a trial. It is unlikely, however, that those arrested today masterminded the plot, analysts said.

For the British authorities, the arrests presented a respite from the furor surrounding disclosures last week that the security services knew about two of the suicide bombers in the 2005 attack — Mohammed Sidique Khan and Shehzad Tanweer — more than a year before they unleashed their bombs.

Those arrested today included Hasina Patel, 29, who was married to the suicide bomber, Mr. Khan, and Khalid Khaliq, who lived in the same street as Mr. Tanweer.

Police did not release the names of two other men, who were described as being in their 20s and 30s. They, together with Ms. Patel and Mr. Khaliq, are suspected of commissioning, preparing or instigating acts of terror, a spokesman for the Metropolitan Police in London, said. They were being held at a central London police station for questioning, he said.

Analysts said Ms. Patel was being questioned as to what knowledge she had before the attack took place.

Under a British terrorism law enacted in the wake of the Sept. 11 terrorist attacks, people who know about a planned terror attack are obliged to tell the authorities or face prosecution.

But successfully prosecuting such cases has proven difficult. When a British citizen of Pakistani background, Asif Mohammed Hanif, blew himself up in an attack outside a café in Tel Aviv in 2003, his sister, wife and brother were arrested in Britain and charged for not telling the authorities what they knew about Mr. Hanif’s plans. In a landmark trial, all three were found not guilty.

In contrast to earlier arrests, the West Yorkshire police made the morning arrests in a low key way, using local officers and fewer officers than in similar arrests in the past.

During earlier arrests connected with terror cases that have involved British suspects of Pakistani descent, there have been complaints from communities of overbearing police operations.

The arrests today took place in Dewsbury; Beeston, an area near Leeds where several of the 2005 suicide bombers lived; and Birmingham.

Police said searches were continuing in connection with the arrests at five addresses in West Yorkshire and one place in Birmingham.

The three British men of Pakistani origin arrested in late March in the Beeston area of West Yorkshire were charged in early April with conspiring to help in the transit attacks. They are Mohammed Shakil, 30; Sadeer Saleem, 26; and Shipon Ullah, 23.

Mr. Shakil and Mr. Ullah were arrested at Manchester airport moments before boarding a plane for Pakistan.