Wednesday, April 30, 2008

Hematology - heparin contaminant may have been deliberate

A US Congressional hearing was held on Tuesday to discuss the recent heparin contamination issue. The hearing was dubbed, "The Heparin Disaster: Chinese Counterfeits and American Failures".

Baxter, which supplied half of the US market, issued a voluntary recall of the drug in January 2008 and again in February after multiple patients starting experiencing severe side effects like abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, loss of consciousness and vomiting. The drug eventually caused more than 80 deaths.

The company denied that it was responsible for contaminated batches of Heparin, an anticoagulant used mostly in hospitals, and that it may have been a deliberate contamination. It's CEO, Robert Parkinson, said that, CEO Parkinson said, "We're alarmed that one of our products was used, in what appears to have been a deliberate scheme, to adulterate a life-saving medication, and that people have suffered as a result".

The contaminant was an altered form of chondroitin sulfate, a drug that mimics the affects of Heparin. The company said during the hearing that the drug was in the batches before it reached Baxter's supplier, Scientific Protein Laboratories. Several other companies in multiple other countries found traces of the contaminant in their supplies of Heparin, as well. Parkinson testified that the company is still trying to understand where in the supply chain the contaminant was introduced, but the company believes it was in the raw material.

Heparin is one of several products coming out of China that have been recalled because of problems with production. Last year, there were recalls concerning toys and toothpaste made in China. The Chinese government has maintained that the contaminated Heparin was not associated with the adverse affects and deaths. This theory was debunked by Kishimoto et al., who provided a scientific rationale for a potential biologic link between the presence of over-sulphated condroitin in suspect lots of heparin and the observed clinical adverse events. They reported their findings in the NEJM earlier this year.

Heparin is a generic that has been around for more than 70 years. It is made from pig intestines. At the hearing, members of Congress discussed the rising cost of hogs as a potential reason for someone substituting the Heparin with the lower-cost chondroitin sulfate. The contaminant is an unnatural substance that was highly processed, pointing to the likelihood that the substance was deliberately added.

The committee appeared to be laying blame with the US FDA inspectors; the FDA only inspects foreign drug makers every 13 years. Baxter relied on inspections and audits of the SLP factory done by its predecessor, Wyeth, and did not conduct audits of the Chinese factory itself.

In short, it was a disaster waiting to happen; no one took responsibility or accountablity for the quality of either the raw materials or the final product, ultimately compromising patient safety.

Tuesday, April 29, 2008

Oncology news - lowering risk for leukemia

A new analysis of published studies has found that children who attended day care or playgroups had about a 30% lower risk of developing acute lymphoblastic leukemia (ALL) than children who did not.

ALL is the most common type of childhood leukemia, accounting for more than 80% of cases, and typically occurs in infants between the ages of 2 and 5 years. It is one of the most common cancers in children in the industrialized world, affecting about 1 in 2000 children.

One theory about how the disease develops focuses on early infection. Some proponents of this theory believe that if the immune system is not challenged early in life and does not develop normally, then it mounts an inappropriate response to infections encountered later in childhood, the charity explains. This could provoke the development of leukemia in children who are susceptible, for example, because of a genetic mutation.

Children who attend day care and playgroups are likely to be exposed to common infections early in life; such environments are known to increase the spreading of infection. The latest finding supports the theory that early exposure to infection offers some protection against the disease.

The analysis included 14 published studies and involved 6108 children with and 13,704 without leukemia. Parents were asked about day care and playgroup attendance and other forms of social interaction. Twelve of the studies showed that social interaction had a protective effect against leukemia and 2 showed no effect. Overall, the risk for leukemia was lowered by about 30%. This remained the case when the researchers re-analysed the data and considered only children who had attended day care before the age of 2 years. When 5 studies were excluded because of concerns about the methodology that had been used, analysis of the remaining 9 studies found that the risk for leukemia was lowered by 40%.

Source: 2nd Children with Leukaemia Causes and Prevention of Childhood Leukemia Conference. Presented April 29, 2008.

Monday, April 28, 2008

Market intelligence - hematology insights

An artificial blood substitute that has a long shelf life and does not need refrigeration could save untold lives by providing an alternative to trauma patients in emergencies, especially in rural areas and in combat settings.

A new analysis reported in JAMA, however, concluded that the FDA approved experiments with artificial blood substitutes even after studies showed that the controversial products posed a clear risk of causing heart attacks and death.

The review of combined data from more than 3,711 patients who participated in 16 studies testing five different types of artificial blood, released today, found the products nearly tripled the risk for heart attacks and increased the chances of dying by 30 percent. Based on the findings, the researchers questioned why the FDA allowed additional testing of the products to go forward and why the agency is considering letting yet another study proceed.

An FDA official declared that the risks and benefits of each study had been carefully weighed and a two-day meeting had been convened this week to address the new concerns raised by the analysis.


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