Archive for September, 2008

Taiwan finds melamine in biscuits imported from Malaysia

Taipei - A Taiwan company began Tuesday to recall a batch of cheese cracker sandwiches imported from Malaysia after finding the toxic chemical melamine in the biscuits. The Golden Kestrel Co Ltd ordered the recall after test results at two laboratori...

Taiwan demands apology, compensation from China over tainted milk

Taipei - Taiwan on Tuesday demanded an apology and possible compensation from China over imported milk tainted with the chemical melamine. Hereby, I make a formal request to demand China apologize to Taiwan, Premier Liu Chao-hsuan told parliament. ...

Thai food and drug agency finds melamine in Chinese milk powder

Bangkok - Thailand's Food and Drug Administration (FDA) has found traces of melamine in 20 tons of milk powder imported from China, where at least four children have died from excessive melamine intake, media reports said Tuesday. The chemical was fo...

The never-ending story: Flu vaccine season goes year-round

After several rocky seasons, this year's stock of influenza vaccine has been arriving on time, or even before physicians expected it. "This year was good news," said Stuart Sanders, MD, an internist and sports medicine physician in Demorest, Ga. "There was no problem getting our full shipment of flu vaccine."

His 1,350 doses arrived by the end of August, a far cry from previous years when supplies arrived late or not at all. Some 143 million to 146 million doses are expected before the season is done, and all five manufacturers have been shipping since early August.

"This is really quite a technical achievement that [manufacturers] are rising to this challenge and are on a faster timeline than in previous years," said Bruce Innis, MD, vice president for clinical research and development at GlaxoSmithKline.

Medical societies and public health agencies have long been working to stabilize the supply chain. The American Medical Association and the Centers for Disease Control and Prevention, for example, have organized the National Influenza Vaccine Summit, which meets annually and holds conference calls regularly during flu season. The AMA also advocates that physicians serving high-risk populations receive influenza vaccine in a timely and equitable manner.

Improvements in the supply chain are due to these efforts as well as a combination of business changes and scientific advancements that have made the vaccine's journey more efficient.

5 companies are making vaccine for the 2008-09 flu season.

On the business side, more companies are in the game, making a repeat of the 2004-05 season less likely. At that time, one company, Chiron Corp., had sterility problems in its manufacturing facility, and 46 million to 48 million doses -- nearly half of the total expected supply -- were lost. This left Sanofi Pasteur, then Aventis Pasteur, which initially planned to deliver 52 million doses, as the sole manufacturer of injectable vaccine. Production ramped up, and the company delivered about 58 million doses. MedImmune Inc. created 3 million doses of the intranasal version.

This season, five companies are involved. Sanofi Pasteur expects to ship 50 million doses, and CSL Limited is supplying 6 million. Novartis, which purchased Chiron in 2006, will manufacture 40 million shots, and GSK plans to provide 35 million to 38 million. MedImmune will make 12 million doses of the intranasal version.

Science also is speeding the process. Manufacturers increasingly are using reverse genetics to hasten production of seed viruses. They also are working to develop cell culture production, which is expected to increase capacity and make supplies more predictable. Cell culture would be particularly useful to deal with a pandemic in which the virus also affects birds, since chickens produce the eggs required to make the vaccine.

"The key thing is that it takes chickens out of the mix," said Matthew Stober, global head of technical operations for Novartis.

In the research world, investigators also are looking at vaccine formulations that would not need to be changed annually.

Data on a phase I study of a vaccine for all influenza A viruses will be presented at an October joint meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America, to be held in Washington, D.C. The findings suggest this vaccine creates a good immune response and is well tolerated.

"[This] has the potential to be a safe, highly effective and much-needed option to prevent seasonal and pandemic influenza," said Christine Turley, MD, the study's primary investigator and director of clinical trials and research at the Sealy Center for Vaccine Development at the University of Texas Medical Branch in Galveston.

This formula does not rely on cell- or egg-based production processes. Instead, vaccine antigens are produced more quickly by combining toll-like receptor-mediated immune enhancers and recombinant bacteria.

Surgeon general urges more vigilance on dangerous clots

Washington -- Deep vein thrombosis and pulmonary embolism affect 350,000 to 600,000 Americans each year, but often they are unrecognized at the earliest and most treatable stages.

With an eye toward elevating awareness of these potentially serious medical conditions, acting Surgeon General Steven K. Galson, MD, MPH, issued a "Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism." He introduced the publication Sept. 15 at the second annual meeting of the Venous Disease Coalition in Washington, D.C.

"DVT and PE are often referred to as 'silent' conditions -- they can occur suddenly and without symptoms. In nearly half of the cases, there are no apparent symptoms," he said. Although gains have been made in understanding how these dangerous clots develop and how to prevent, diagnose and treat them, that knowledge is not always applied systematically, he added.

The conditions generally keep a low profile, but they hit the headlines when they strike young, seemingly healthy individuals. NBC journalist David Bloom died in 2003 at age 39 of DVT and PE while covering the Iraq war, where he spent hours crouched in the close confines of a tank. His widow, Melanie, who attended the surgeon general's meeting, has since worked to spread the word about the dangers of DVT.

The two conditions may contribute to as many as 100,000 deaths each year, Dr. Galson said. That number is expected to rise as the population ages because patients older than 50 are at increased risk.

"It is clear that we are dealing with a major health problem," noted Elizabeth Nabel, MD, director of the National Heart Lung and Blood Institute, who spoke at the event.

The call also is intended to spell out certain warning signs to the primary care physician, who is often the first to detect a clot, Dr. Nabel said. Initial symptoms can be subtle.

Mistaken identity

Patients may have swelling or pain in an arm or leg, skin redness or a warm spot on a leg. Physicians first might consider diagnoses of skin infections or muscle strains instead of DVT. In the case of shortness of breath caused by a pulmonary embolism, the patient may be thought simply to be out of shape, Dr. Nabel said.

Le Keisha Ruffin, 32, described several fruitless trips to emergency departments when pain in her side and chest from an undiagnosed PE became so sharp "it felt like someone was literally stabbing me over and over again in the same spot." She was told the pain was from the birth of her daughter by cesarean section.

Patients older than 50 are at increased risk of pulmonary embolism and deep vein thrombosis.

The proper diagnosis was made weeks later after a hot bath at home resulted in massive swelling in her right leg and she was rushed back to the emergency department. A physician told Ruffin that the DVT in her leg had caused one of the largest blood clots the physician had ever seen. Plus, part of the clot had broken off and caused a PE. She was told she might not have lived through the night had she not received help.

To prevent such occurrences and speed recognition of these conditions, the Agency for Healthcare Research and Quality published a 12-page patient guide and a 60-page physician guide on preventing and treating dangerous blood clots, said AHRQ Director Carolyn Clancy, MD. "We know how to prevent many of these dangerous blood clots, and these guides will help patients and clinicians put that knowledge to work to improve care."

The clinician guide, "Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement," is intended to help hospitals and clinicians implement successful processes to prevent dangerous blood clots, Dr. Clancy said. It identifies such clots as the "most common, preventable cause of hospital deaths."

The document also points to additional triggers for DVT that include taking hormones, having a bad bump or bruise, having had a stroke, being obese, or taking a trip of more than an hour in a car, airplane, bus or train. Certain inherited blood disorders also can make clots more likely.

NHLBI also is funding new research on the two conditions. Studies are under way on treatment for damaged veins and valves following DVT and on improving the health and well-being of elderly patients at risk for dangerous blood clots.

The institute also is launching the first multicenter, randomized clinical trial of genotype-guided dosing of warfarin, the most common blood-thinning treatment for those with diagnosed clots. The study will examine whether the use of clinical plus genetic data during warfarin initiation can lead to better and safer treatment.

Meanwhile, the AMA and other groups have developed the brochure "Personalized health care report 2008: Warfarin and genetic testing." It is designed for physicians and other health care providers who commonly prescribe warfarin but who may not have had exposure to pharmacogenomics and genetic testing. It outlines the effects of variations in the genes CYP2C9 and VKORC1 on warfarin metabolism and response, and summarizes the genetic testing available to determine whether a patient carries such gene variations.