NEWS SCAN: New malaria guidelines, food additive safety, Supreme Court takes vaccine case

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Mar 9, 2010

WHO stresses testing in revised malaria guidelines
The World Health Organization today released new guidelines on malaria treatment that emphasize testing to target treatment properly and limit drug resistance. "The world now has the means to rapidly diagnose malaria and treat it effectively," said Dr. Robert Newman, director of the WHO Global Malaria Programme, in a news release. "WHO now recommends diagnostic testing in all cases of suspected malaria. Treatment based on symptoms alone should now be reserved for settings where diagnostic tests are not available." Most clinics have had to rely on microscopy for testing until now, but the development of rapid diagnostic tests using a dip stick and a drop of blood makes rapid testing possible at all levels of the healthcare system. Artemisinin-based combination therapy (ACT) has transformed malaria treatment in recent years, and testing makes it possible to reserve it for those who actually have malaria, the WHO said. This will reduce the spread of drug resistance and help identify patients who don't have malaria, so that their illnesses can be determined and appropriately treated. The new guidelines also recommend that oral artemisinin-based monotherapies should be removed from the market, because their use promotes drug resistance. The WHO also today released guidance on good practices for procuring artmesinin-based medicines, designed to help national authorities assess the quality of malaria drugs before buying them.
Mar 9 WHO press release on new malaria guidelines
Access to full 149-page text of malaria guidelines
Access to 108-page guidance on good procurement practices

GAO says spices, preservatives need more FDA oversight
Not only is the US Food and Drug Administration (FDA) not required to review certain food additives, such as spices and preservatives, that are generally recognized as safe (GRAS) for consumption, but producers of these ingredients are allowed to declare which of them are considered GRAS without notifying the FDA. And two such additives—peppers and the flavor enhancer hydrolyzed vegetable protein—have recently been involved in recalls due to Salmonella contamination. In this setting, a recent report from Congress's Government Accountability Office (GAO) reviewed the FDA's policies toward GRAS substances and found that more control over them is warranted. The report, released by the GAO Mar 5, recommends that the FDA:

  • Require any company that conducts a GRAS determination to provide FDA with basic information about it
  • Develop a strategy to minimize the potential for conflicts of interest in companies' GRAS determinations, including steps such as issuing guidance for companies
  • Monitor the appropriateness of companies' GRAS determinations through random audits or other means
  • Finalize its 1997 proposed rule that sets forth the framework and criteria for the voluntary GRAS notification program, incorporating public input
  • Systematically reconsider the safety of GRAS substances
  • Ensure the safety of engineered nanomaterials—materials manufactured on a tiny scale to take advantage of novel properties—that companies market as GRAS substances without the FDA's knowledge—unlike the Canadian and European practice of regulating them

The report states, "FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances."
Complete GAO report
Report highlights page
GAO report summary

Supreme Court to hear appeal involving vaccine maker
The US Supreme Court yesterday agreed to hear an appeal from parents who want to sue a vaccine company because their daughter, now a teen, allegedly suffered health problems after getting the diphtheria, tetanus, and pertussis vaccine, the Associated Press (AP) reported. A 1986 federal law, enacted to help ensure a reliable vaccine supply, bars most claims against vaccine makers. The law set up a special vaccine court to handle suits against vaccine makers, and the Third Circuit Court of Appeals in Philadelphia had previously ruled against the parents. The vaccine company the parents want to sue, Wyeth (now part of Pfizer), joined in asking the court to hear the case, saying it offers a chance to resolve a persistent legal issue. The Obama Administration had joined the call for a Supreme Court review, with the government supporting the vaccine manufacturer. The child at the center of the case received the third of five DTP vaccine doses as an infant in April 1992 and reportedly within hours had a series of debilitating seizures. According to the lawsuit, she still has a residual seizure disorder.
Mar 8 AP story

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