HEALTH

CDC study reveals face masks ineffective against spread of pandemic flu due to Americans’ lack of use

BY Michael Johnsen

ATLANTA Face masks may not be an effective barrier against the spread of pandemic influenza, the Centers for Disease Control and Prevention revealed in a study posted last week on its Web site.

But it’s not because the masks don’t work, it’s because Americans are not likely to wear them.

During the 2006 and 2007 winter seasons, CDC recruited 286 exposed adults from 143 households who had been exposed to a child with clinical respiratory illness. “We found that adherence to mask use significantly reduced the risk for ILI-associated [influenza-like illness] infection, but less than 50% of participants wore masks most of the time,” the CDC noted. “We concluded that household use of face masks is associated with low adherence and is ineffective for controlling seasonal respiratory disease. However, during a severe pandemic when use of face masks might be greater, pandemic transmission in households could be reduced.”

In fact, only 21% of household contacts in the face mask arm self reported wearing the mask often or always during the follow-up period. Adherence with treatments and preventive measures is well known to vary depending on perception of risk, the CDC noted, and that adherence would be expected to increase during an influenza pandemic. During the height of the SARS epidemic of April and May 2003 in Hong Kong, for example, adherence to infection control measures was high, the agency said — 76% of the population wore a face mask, 65% washed their hands after relevant contact and 78% covered their mouths when sneezing or coughing. In addition, adherence may vary depending on cultural context; Asian cultures are more accepting of mask use.

“Results of our study have global relevance to respiratory disease control planning, especially with regard to home care,” the agency noted. “During an influenza pandemic, supplies of antiviral drugs may be limited, and there will be unavoidable delays in the production of a matched pandemic vaccine. For new or emerging respiratory virus infections, no pharmaceutical interventions may be available. Even with seasonal influenza, widespread oseltamivir [Tamiflu] resistance in influenza virus A (H1N1) strains have recently been reported. Masks may therefore play an important role in reducing transmission.”

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CRA urges supplement and food companies to keep record of dietary supplement ingredients

BY Michael Johnsen

WASHINGTON Responding to a recent Food and Drug Administration decision that defines pyridoxamine dihydrochloride, a form of vitamin B6, as a new drug, the Council for Responsible Nutrition reiterated its position that vitamin B6 has a long history sold as a dietary supplement.

“FDA’s decision suggests that companies need to produce even more extensive evidence supporting an ingredient’s marketing as a dietary supplement, including catalog and business records from more than 15 years ago,” stated Andrew Shao, CRN’s VP scientific and regulatory affairs. “Demanding that industry maintain these records, but failing to work with industry to develop an agreed-upon list of ‘grandfathered ingredients,’ places more burden on dietary supplement companies to be sure that they can substantiate that an ingredient has in fact previously been marketed as a dietary supplement.”

The FDA’s decision precludes any dietary supplement manufacturer from marketing pyridoxamine without first obtaining FDA approval through a new drug application. CRN has argued that pyridoxamine has been on the market as a supplement even prior to the passing of the Dietary Supplement Health and Education Act. Under DSHEA provisions, an ingredient that has been sold as a supplement prior to being submitted as a new drug can continue to be sold as a supplement. Conversely, an ingredient cannot be marketed as a supplement following the submission of an NDA.

 “The Agency’s decision on pyridoxamine could set a precedent for the status of other dietary ingredients to be challenged,” Shao suggested. “As such, CRN strongly encourages supplement and food companies to keep careful records of ingredients and marketing materials to ensure that the ingredients that they are using and marketing can continue to be marketed as dietary supplement ingredients under the law.”

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Reps. introduce FDA Globalization Act of 2009 to earmark funding against increased inspections of int’l food and drug facilities

BY Michael Johnsen

WASHINGTON In an effort to better safeguard America’s food and drug supply, Reps. John Dingell, D-Mich., Frank Pallone Jr., D-N.J., and Bart Stupak, D-Mich., on Wednesday introduced the Food and Drug Administration Globalization Act of 2009, a piece of legislation that would earmark funding specifically against increased inspections of international food and drug facilities and improve information systems.

The legislation also would require food producers to have preventive food safety plans in place and subjects the plans to FDA inspection; require food imports to meet all U.S. standards; would close the loopholes in the FDA’s ability to trace the source of contaminated products; and would impose stiff penalties on companies that violate safety standards, according to a press release issued announcing introduction of the legislation.

“Antiquated authorities and years of starving the FDA of resources has put the public health at risk,” stated Dingell. “Every few months brings another crisis — E. Coli in spinach, contaminated heparin, tainted peppers and now salmonella in peanut butter — that has killed eight people and sickened more than 483 people. The time to act is now,” he said. “Americans shouldn’t have to worry about whether the food they serve their families and the medical products they use to improve their health might actually make them sick.”

“As witnessed by the latest salmonella outbreak, the Peanut Corp. of America’s outrageous actions show that food manufacturers cannot be trusted to self-regulate,” Pallone charged.

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