Foreign Medics Sentenced to Die in Libya HIV-Transmission Case

19 December 2006 (Reuters Health [Lamine Ghanmi])—A Libyan court sentenced 5 Bulgarian nurses and a Palestinian doctor to death for deliberately infecting hundreds of children with HIV, provoking a chorus of Western condemnation.

The ruling in a deeply politicized case could set back oil-producer Libya's hopes of better ties with the West, which meant a deal that saves the 6 from execution was still likely, analysts said.

The children's relatives broke down in tears and hailed the ruling that ended a 7-month retrial as a welcome act of defiance of the West. “Justice has been done. We are happy,” said Subhy Abdullah, whose daughter Mona, 7, died from AIDS contracted at the hospital in the town of Benghazi where the medics worked. “They should be executed quickly.”

The 6 deny infecting 426 children, 150 of whom have since died, with HIV at the hospital in the late 1990s.

The defendants sat calmly as their sentences were announced. “The verdicts will change nothing. We are innocent,” the Palestinian doctor, Ashraf Alhajouj, told Reuters from behind the bars of the dock.

Their lawyer said they planned to appeal against their latest conviction, which some analysts say Libya may use to strengthen its hand as it seeks foreign financial compensation in order to placate the families.

The 6 were first found guilty in a 2004 trial and sentenced to death by firing squad. But the supreme court quashed the ruling last year, citing unspecified failings in the case, and ordered a retrial.

Libyan leader Muammar Gaddafi has reason to free the 6 eventually, analysts say, because the case has slowed Tripoli's rapprochement with the West after decades of isolation. This moved up a gear when

Libya abandoned its pursuit of nuclear, chemical, and biological weapons in 2003.

Chorus of Criticism

Bulgaria, the European Union (which it joins next month), and Amnesty International were among swift critics of the verdict. Washington had also earlier said the medics were innocent.

The International Council of Nurses and World Medical Association said the ruling turned a blind eye to evidence— including that from Luc Montagnier— that the children were infected well before the medics arrived in Benghazi in 1998.

“How many children will go on dying in Libyan hospitals while the government ignores the root of the problem?” they said in a joint statement.

Some Western scientists say negligence and poor hospital hygiene are the real culprits and the 6 are scapegoats.

Analysts say the case is embroiled in power politics and a solution could take many more months, with Libya keeping the 6 as bargaining chips until talks yield a payout.

Libyan Justice Minister Ali Omar Hass-naoui said the 6 may appeal to the supreme court and, if that went against them, to a superior body called the high council of justice.

Tripoli has demanded 10 million euros ($13.11 million) for each infected child's family. Bulgaria and its allies reject this, saying it would admit guilt, but have offered a fund for treatment at European hospitals for the children.

“Now the real negotiations will begin, to find a way of either arranging compensation for the families of the infected children, or a pardon for the nurses,” said George Joffe, a North Africa expert at Cambridge University

“There will be a price to pay. It depends on what the international community is prepared to pay.”

(Additional reporting by Reuters in Sofia, Brussels)

Editor's comment. For those who may have missed earlier stories on this, it is a continuing demonstration of how politics can trump scientific evidence. Despite testimony from Luc Montagnier and other scientists that the exact same virus was present in children in the hospital prior to the alleged intentional infecting and, in fact, prior to the arrival of the accused in Libya, the Libyans preferred to blame foreigners and nefarious experimentation with the HIV virus rather than their own faulty hospital environment.

FDA Panel Urges Limits on Ketek Antibiotic

18 December 2006 (Reuters Health [Lisa Richwine])—Sanofi-Aventis antibiotic Ketek (telithromycin) should stay on the market, but use should be limited to treating pneumonia, United States advisers said after reviewing rare cases of liver failure and other problems.

The recommendations mean the French drugmaker likely will be allowed to keep selling Ketek for pneumonia but be barred from promoting the medicine for bronchitis and sinusitis. The drug currently is approved for all 3 uses.

Members of a Food and Drug Administration (FDA) panel said doctors needed Ketek as an option for treating pneumonia. Many said they were unsure, however, if the drug was truly effective for bronchitis and sinusitis.

Given that concern and recent reports of liver failure, blurred vision, and other problems, members voted 17 to 2 against continued marketing for the 2 less-serious conditions. They said the risks outweighed the benefits in those cases.

“I'm just not convinced the drug is effective given the clinical trials” on sinusitis and bronchitis, said panel member Louis Morris, a drug safety expert from Dix Hills, New York.

The FDA usually follows advice from its panels of outside experts. The panel voted 16 to 3 in favor of continued Ketek sales for community-acquired pneumonia.

Most panel members urged the FDA to consider a “black box” warning, the strongest type allowed for prescription drugs, to highlight the risks of Ketek. Some said the drug should be recommended only as a second choice.

The FDA approved Ketek in 2004, even though an investigation found a key safety study was tainted by fraud. Agency officials said other data provided adequate reassurance.

Senate Finance Committee Chairman Charles Grassley, an Iowa Republican who has been investigating the Ketek case, has criticized the FDA's actions. Some reviewers within the FDA also have questioned the basis for approval.

Recent reports of liver failure added to concerns. Agency staff said they had been told of 13 severe liver failure cases in Ketek users through September. Five of the patients died.

Some FDA reviewers said it was striking that potentially serious problems appeared soon after patients took Ketek. Half the liver failure cases started within 4 days. Blurred vision, loss of consciousness, and exacerbations of myasthenia gravis also were reported.

Investigational Drug for Hepatitis C Successful in Large Trial

13 December 2006 (Reuters Health [Rans-dell Pierson])—Vertex Pharmaceuticals Inc. reported the effectiveness of its experimental drug VX-950 for infection with hepatitis C virus (HCV) was as impressive in a trial involving hundreds of patients as it was in 2 smaller previous studies, according to an interim analysis.

“Although the latest results are preliminary, they are exciting and confirm findings from initial studies,” said study leader Dr. John McHutchison, a Duke University professor.

The trial involves 250 patients infected with HCV genotype 1, the most common but hardest-to-treat subtype. The treatment-naive patients received VX-950 for 12 weeks.

The United States study, 1 of 3 midstage trials either planned or already in progress, was designed to assess how well patients respond to the Vertex drug within 24 weeks after completing treatment. Patients were divided into 4 treatment groups.

Three groups received the Vertex drug for 12 weeks in combination with long-acting interferon and ribavirin. Another group received only interferon and riba-virin, along with a placebo.

Among 74 patients given VX-950 for whom data were available at the end of 12 weeks, 88% had undetectable levels of the virus, compared with 52% of those in the group that received only interferon and ribavirin.

“In effect, almost 90% of patients had undetectable virus after the first 12 weeks of triple therapy in this trial,” Dr. Mc-Hutchison said.

He said patients who became unde-tectable within 4 weeks of treatment, and continued to be undetectable at 12 weeks, will be allowed to stop taking all medicines, but will continue to be followed.

Others will take interferon and ribavirin alone for either an additional 12 or 36 weeks, but receive no additional VX-950.

“If the virus remains undetectable 24 weeks after treatment is stopped, you are considered to have cleared the virus,” Dr. McHutchison said.

With interferon and ribavirin alone, only one-half of patients typically clear the virus after a full year of treatment. And the dual therapy can cause severe flulike symptoms, as well as depression.

Although the Vertex medicine by itself has been shown to wipe out 199.99% of virus in the bloodstream, it is not a standalone cure because the virus rebounds.

Vertex is hoping that, by combining VX-950 with interferon and ribavirin— but for far shorter periods than the 2 older drugs are commonly used—it will deliver the final knockout punch.

Despite its apparent better potency, 9% of patients taking VX-950 dropped out of the latest study due to adverse events, including rash, gastrointestinal disorders, and anemia—compared with only 3% taking the standard dual therapy. Serious adverse events were seen in 3% of those taking the Vertex drug, compared with 1% taking just interferon and ribavirin.

While side effects were more pronounced among patients on VX-950, McHutchison said they should be weighed against the risks of continued HCV infection.