2008 March 15

John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote an e-mail message in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators.

Mr. Lechleiter’s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.

The e-mail message was discussed this week in an Anchorage courtroom in a lawsuit against Lilly by the State of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa.

The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.

Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it “off label” for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug.

The federal government has investigated drug companies before for off-label promotion of their medicines, but Mr. Lechleiter’s note provides rare documentation of a senior drug executive’s openly discussing the practice.

A spokeswoman for Eli Lilly said Mr. Lechleiter was not advocating off-label promotion in his note but simply wanted the company to respond to physicians’ requests for information.

In his e-mail message, Mr. Lechleiter discusses the use of Zyprexa by children and teenagers.

Mr. Lechleiter, who was then the company’s executive vice president for pharmaceutical products, noted to other Lilly officials that company representatives were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, he said.

“The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,” Mr. Lechleiter wrote in the message.

He also encouraged Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase the drug’s sales.

Because of Zyprexa’s physical side effects, many psychiatrists now say it is appropriate only for severely mentally ill patients. Clinical trials have shown that its tendency to cause dangerous weight gain appears to be especially pronounced in younger patients. The Food and Drug Administration has for more than a year declined to act upon an application by Lilly to broaden the drug’s label to allow its use in people under 18.

Mr. Lechleiter’s e-mail message has not previously been discussed publicly. In the Alaska trial, after plaintiff lawyers presented it without the jury present, Judge Mark Rindner said it could not be admitted into evidence in the trial because off-label use was not at issue in the case.

Its disclosure nonetheless comes at a sensitive moment for Lilly, which is also under federal criminal investigation for the way it promoted Zyprexa and played down the drug’s risks to doctors.

From 2000 to 2002, internal Lilly documents show that the company tried aggressively to expand Zyprexa’s sales into markets for which the drug was never approved, including elderly patients with dementia.

To settle that investigation, and related investigations by several states, Lilly is negotiating with federal prosecutors in Pennsylvania on a deal that could result in the company’s paying $1 billion to $2 billion in fines and restitution, according to people involved in the investigation. The prosecutors declined to comment on Friday.

Because Mr. Lechleiter, an organic chemist who is Lilly’s president and chief operating officer, is a senior official about to become the chief executive, the public disclosure of an e-mail message in which he appears to have encouraged off-label promotion of Zyprexa could complicate the talks.

He is scheduled to become chief executive on April 1, succeeding Sidney Taurel, and is to succeed Mr. Taurel as Lilly’s chairman at the end of the year.

Since 2003, as information about the drug’s risks has spread, prescriptions for Zyprexa have fallen sharply in the United States. But Lilly has repeatedly increased the drug’s price to counteract the slumping prescriptions, and Zyprexa remains by far Lilly’s best-selling product, with worldwide sales of $4.8 billion last year, about half in the United States. Zyprexa now costs about $8,000 a year at commonly prescribed doses.

Marni Lemons, a spokeswoman for Eli Lilly, said Mr. Lechleiter’s e-mail message was meant to encourage Lilly representatives to answer questions from doctors who were already prescribing Zyprexa off label to children and teenagers.

“Rather than driving physician demand, what he was doing was responding to demand from physicians, which we are allowed to do,” Ms. Lemons said.

Federal law does let companies send “medical letters” with additional information about off-label uses to physicians who request the information, although sales representatives are not supposed to discuss it.

In the e-mail message, Mr. Lechleiter made several other references to off-label use of Zyprexa. He wrote, “We are losing scripts to Risperdal for treatment of disruptive kids, because Johnson & Johnson has the data and we don’t.”

Risperdal, made by Johnson & Johnson, is another drug for schizophrenia and bipolar disorder. Unlike Zyprexa, it has been approved for pediatric use.

Mr. Lechleiter also wrote that “Zyprexa is getting traction with some neurologists for treatment of pain,” another off-label use of Zyprexa, which has never been approved for pain relief.

The Alaska trial over Zyprexa began March 5 in Anchorage and is expected to last until late this month.

In its initial complaint, the state tried to recover costs associated with Lilly’s off-label promotion of Zyprexa. But just before the jury was chosen, Judge Rindner dismissed that claim. As a result, jurors have not been permitted to hear any evidence relating to off-label promotion in the case.

But lawyers for the state tried on Tuesday to introduce the e-mail message into evidence anyway. Although the judge ruled against them, the message became part of the court record.

Anti-war demo draws thousands

Thousands of anti-war protesters rallied to demand Britain withdraw its troops from Iraq and Afghanistan.

Activists urging an end to Britain’s role in overseas’ wars gathered in Trafalgar Square, central London, for a march on parliament.

The protest, organised by the Stop the War Coalition, was called to mark the fifth anniversary of the invasion of Iraq. Demonstrators called for no US attack on Iran and for an end to the “siege” of Gaza.

Organisers in London estimated up to 40,000 people joined the protest. Police said no arrests were made. They estimated numbers at 10,000.

The London protest was one of a number taking place in countries around the world on Saturday, organisers said. Protesters heard speeches from the leaders of a range of groups including CND, and the Palestinian Solidarity Campaign.

Former Labour cabinet minister Tony Benn said: “The troops in Iraq have caused devastation. It’s the same in Afghanistan.”

Green MEP Caroline Lucas called for the Prime Minister and his predecessor to be prosecuted for war crimes. She said: “Tony Blair and Gordon Brown should be tried for war crimes at the international court in the Hague.

Former CND leader Bruce Kent described the protest as an “orchestra of peace”.

“I think the common agreement is for a peaceful and just world. I am speaking about nuclear weapons but the war in Iraq is part of the same campaign.”

Chavez: I dare Bush to call us terrorist

President Hugo Chavez says that Washington does not dare to list Venezuela as one of the countries allegedly supporting terrorism.

Republican lawmakers including Reps. Connie Mack and Ileana Ros-Lehtinen have urged the State Department to add Venezuela to the list of terror sponsors.

In a Friday televised speech, Chavez said the threat to label Venezuela as a ‘terror sponsor’ is yet another politically motivated attempt to undermine the regional success of Caracas.

“Let them make that list and shove it in their pocket, we shouldn’t forget for an instant that we’re in a battle against North American imperialism. On this continent, they have us as enemy No. 1,” said Chavez.

The heated comments come as Ecuadorian leader Rafael Correa hammered US President George W. Bush for supporting Columbia’s assault on Ecuador.

“Bring your soldiers Mr. Bush. Let it be your soldiers who die along the southern border with Colombia. We’ll see if the Americans, the citizens of the United States will accept tremendous atrocity,” said Correa.

“If not, shut your mouth and understand what is happening in Latin America,” he concluded.

VIDEO: Police caught inciting violence

For over ten years now, I’ve been writing about and documenting police riots at protests.

Note: New Orleans police have coincidentally been given a “grant” of assault weapons and riot gear recently. Also, an article recently appeared in New Orleans Magazine praising the local SWAT team for brutalizing local affordable housing protesters. How subtle.

Yemeni man accuses CIA of torture

A Yemeni national accused American secret agents of subjecting him to various forms of torture during nearly three years of CIA detention, in a statement released by Amnesty International yesterday. Khaled Abdu Ahmed Saleh Al Maqtari was arrested by American soldiers in Fallujah, Iraq, in January 2004, along with around 60 other people, he told the London-based human rights group. He said he was transferred to the Abu Ghraib prison in Iraq where he was held as a “ghost detainee”, where he experienced violent beatings, intimidation by dogs, sleep deprivation, induced hypothermia, and other forms of torture. Al Maqtari described one occasion when he was beaten by three men and then made to stand naked on a chair in front of an air conditioner while holding up a large bottle of water. During this time, he was periodically doused in water, making him feel so cold he had trouble standing.

The 31-year-old added that he was also suspended by his feet with his arms cuffed behind his back while he was lowered up and down over a water crate with a pulley. After nine days of interrogation at Abu Ghraib, Al Maqtari was transferred to Afghanistan in a secret CIA flight, Amnesty said. The organisation added that flight records it obtained showed a plane operated by the CIA left Baghdad for Kabul nine days after the Yemeni national’s arrest.

In Afghanistan, Al Maqtari was again subjected to torture, including prolonged isolation, sleep deprivation, exposure to extreme heat and cold, and sensory deprivation with bright lighting and loud music or sounds channeled into his cell, among other forms of ill-treatment, it said. At the end of April 2004, Al Maqtari was transferred to another secret CIA detention centre, according to Amnesty, possibly in eastern Europe, where he was held for nearly two and a half years, before eventually being transferred to Yemen, where he was detained until May 2007.

“At no point during his 32-month confinement was Khaled al-Maqtari told where he was or why,” said Anne FitzGerald, an Amnesty senior adviser. “He did not have access to lawyers, relatives, the International Committee of the Red Cross or any person other than his interrogators and the personnel involved in his detention and transfer. This clearly violates the US’s international obligations.”

Guantanamo detainee’s request for key witness OKd

Prosecutors must make available a military commander who allegedly altered a report to cast blame on their client for the killing of a U.S. soldier.

GUANTANAMO BAY, CUBA — The Army judge presiding over the war-crimes trial of Canadian Omar Khadr ordered prosecutors to turn over to defense lawyers documents and interrogation notes, and to make available a key witness.

The judge, Col. Peter E. Brownback III, issued his rulings a day after hearing defense appeals for more disclosure from prosecutors in the case against Khadr, 21, who is charged with killing a U.S. Army special forces soldier during a 2002 firefight in Afghanistan.

Among the witnesses who will be made available by April 4 to Khadr’s attorneys is an Army commander identified only as Lt. Col. W.

Khadr’s Navy lawyer, Lt. Cmdr. William C. Kuebler, has accused military authorities of doctoring evidence to make his client appear guilty. He said in pretrial motions that the Army commander for the Khost region of eastern Afghanistan, Lt. Col. W, reported in July 2002 that the person who threw a grenade that killed Sgt. 1st Class Christopher J. Speer also died in the firefight.

But two months later, Kuebler said, the commander altered his account to say Speer’s attacker was “engaged” by U.S. forces, suggesting that he might still be alive. Defense attorneys now will be able to question the commander about why he changed his account of the incident.

The government contends that Khadr was the only enemy combatant to survive the clash in which Speer suffered wounds that led to his death eight days later.

Defense attorneys also on Friday won access to documents and notes that they hope will reveal the harsh treatment Khadr has endured as a prisoner, and the conditions under which he may have provided statements to U.S. authorities.

Khadr, who was 15 at the time of the clash, was wounded and captured in the confrontation. As a 9- or 10-year-old, he was taken by his militant father from Canada to Afghanistan to visit Al Qaeda training sites.

Kuebler and the other military lawyers assigned to defend Khadr in an earlier commissions process have argued that the suspect should have been treated as a juvenile, in accordance with the Geneva Conventions.

Khadr was taken from the battlefield to the U.S. military base at Bagram, north of Kabul, where Kuebler said Khadr was exposed to weeks of harsh treatment by military interrogators before being sent to Guantanamo.

Khadr’s attorneys on Friday also were granted a request to delay the trial because of the protracted dispute over what could be disclosed to the defense team. The judge set no date, but the proceedings will be delayed until at least June.

MPs raise fears over data protection for ID register

Repeated breaches of data protection laws by government departments raise huge question marks over plans for the national identity register required for ID cards and biometric passport, an influential parliamentary human rights watchdog has warned.

MPs and peers on the Lords and Commons Joint Committee on Human Rights said repeated losses of personal information by departments had increased their concern, and announced they ” intend to take a close interest in the government’s detailed proposals for the national identity register as and when they emerge.”

In a hard-hitting report the committee insisted the privacy of personal data is guaranteed under the European Convention on Human Rights as well as the Data Protection Act. The report demands that detailed rules must in future be written in to all relevant primary legislation to “help ensure that data protection becomes a primary concern of managers and frontline staff in the public sector.”

The committee questioned the role of justice minister Michael Wills, responsible for data protection and human rights issues - who said he was not personally responsible for ensuring other departments obey the law - insisting he must be more proactive.

The MPs were also surprised to discover government departments have senior officials designated as “human rights champions” about whom it had never heard.

Committee chairman Andrew Dismore said people had been shocked at the loss of child benefit data and demanded individual information should be treated “as sensitively and carefully as hard cash”.

“The government must demonstrate that it appreciates the seriousness of what needs to be done,” he said.

“The fundamental problem is a cultural one. There has been a rapid increase in the amount of data sharing in the public sector, which can be useful, important and necessary, but this has not been matched by the even more necessary strong commitment to safeguard the right to respect for privacy.”

Call to scrap ID cards plan

A critical report today should be the last nail in the coffin of the government’s proposed ID cards, said Jenny Willott, Welsh Liberal Democrat MP for Cardiff Central.

The report by the Joint Committee on Human Rights, comes as details, released through the Freedom of Information Act revealed how many of those departments lack basic systems to comply with the Data Protection Act.

A survey of 14 departments by the British Computer Society published today shower that none of them had statistics of how many errors were on their database, nor had a budget to correct them.

The loss of 25m child benefit records by the HM Revenue & Customs last year when computer discs were mislaid has hugely dented trust in the government’s ability to look after personal data.

The Ministry of Defence has admitted that more than 11,000 military ID cards have been lost or stolen in the past two years.

Defence minister Bob Ainsworth admitted that 4,433 ID cards disappeared in 2006 and a further 6,812 went missing from July 2006 to December 2007.

Commenting on today’s Joint Committee on Human Rights critical report
into ‘Data Protection and Human Rights’, Ms Willott sid: “This report should be the last nail in the coffin for ID cards. Why should the public trust this Government with the quantity of personal data they would load on to the ID card system, when it has utterly failed to protect far less?

“Over the last 10 years, the Labour government has combined a drive to gather up ever more information on the public with a cavalier attitude to people’s basic human right for their personal data to be properly
protected.

“Why has it taken the loss of data affecting 1 in every 3 people for the Government to look again at their security procedures? Whatever the outcome of the ongoing review into personal information safeguards, the Government will have to do the miraculous to convince anyone that they know how to fix this systematic problem.”

DNA bill expected to pass key committee

A bill that would expand the criminal DNA database to include suspects of every violent crime appeared likely to pass a key House committee late Friday, despite a request from black lawmakers to postpone discussion.Members of the House judiciary committee debated potential changes to Gov. Martin O’Malley’s proposal to collect DNA from all suspects in violent crimes. His administration is offering significant amendments to alleviate resistance from the legislature’s black caucus who say the proposal encourages racial profiling.

Some members of the caucus asked House leaders to delay the committee vote to discuss the changes. The request was denied.

“It was a proper, reasonable request,” said Del. Jill Carter, a Baltimore City Democrat. “The impact it has on black people is going to be different and more significant that it will be to other people.”

The state currently collects DNA samples from those convicted of felonies or child sex abuse. Under the amended proposal, the state will collect samples from those charged with violent crimes and will automatically destroy samples if a suspect is arrested but not indicted. The governor’s proposal also adds about 15 crimes including arson, rape and manslaughter.

Committee members indicated they would have passed the bill as O’Malley originally proposed. Several Republican members supported the request to delay a vote until after Monday, when the black caucus is scheduled to meet next.

“I would hope that if my caucus made that request it would be honored,” said Minority Whip Christopher Shank, a sponsor of the legislation. “I think we should give the black caucus the ability to work this out.”

Not all black lawmakers oppose the bill. Del. Gerron Levi, a Prince George’s County Democrat, suggested the delay was a strategy to ultimately kill the proposal before next week’s deadline for bills to cross to opposite General Assembly chambers.

“I do not think it’s fair to say there is one black side of the equation or another,” Levi said “I think it’s split at best.”