HEALTH

CDC: H1N1 surges on through the spring, possibly summer

BY Michael Johnsen

ATLANTA The novel H1N1 virus still is proliferating, even this late into the spring, the Centers for Disease Control and Prevention reported Thursday during a press conference.

“As the summer is approaching, influenza season has normally ended by now. However, the novel H1N1 influenza transmission continues in the United States,” said Daniel Jernigan, deputy director of the influenza division at the CDC. “There are two areas of the country that continue to see increased numbers of patients in the clinic with influenza-like illness, [and] both of those are in the northeast part of the United States.”

Although, overall, there continues to be influenza activity reported in 17 states.

“The United States will likely continue to see influenza activity through the summer, and at this point, we’re anticipating that we will see the novel H1N1 continue with activity probably all the way into our flu season in the fall and winter,” Jernigan said. “There is a potential for this fall that we might have multiple sub-types circulating,” he added, especially as the novel virus circulates through a typical flu season across the southern hemisphere. “In the past with pandemic strains, [there] has been a replacement [virus],” he said, such as the pandemics in 1918, 1957 and 1968. “But right now, we don’t have enough information to say that there is a replacement occurring. And at this point, we are expecting — at least planning — that there will be multiple sub-types that are circulating at the same time this fall.”

As of Friday, the CDC reported 21,449 confirmed cases throughout the states and United States territories, up some 20.2% from the number of confirmed cases reported last week, including 87 deaths. New York leads the nation with the number of deaths at 24, followed by Texas with 10.

“There are some surveys that indicate that the amount of disease in the areas that are having activity with H1N1 is perhaps around 7% of the population reporting symptoms due to influenza-like illness,” Jernigan reported, so the number of confirmed cases may still be significantly under-representative of the actual number of patients who have contracted the novel H1N1 virus. “The virus continues to impact mostly younger people. So far it is not causing significant illness and death in the elderly like we would see with seasonal influenza. And the symptoms that are being reported are consistent with influenza, [those] being predominantly fever, cough, some shortness of breath, fatigue and chills,” Jernigan said, as well as some vomiting and diarrhea.

In addition, some 81 healthcare professionals also have tested positive for the novel H1N1 virus, so far. The CDC successfully tracked 26 of those professionals prior to May 13, and determined that roughly half of them contracted the virus at their workplace.

“[One] point that’s made in this report is related to the infection control measures that are used to prevent exposure of healthcare personnel to influenza,” commented Mike Bell, associate director for infection control at the CDC. “Probably the single most important thing is that infectious patients be identified at the front door. Whether these patients are coming in through the emergency department or the ambulatory care clinic, identifying them up front is essential so healthcare personnel know that they should be doing the things that we recommend; that consistent application of precautions is important to make sure that there isn’t occupational exposure.”

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Schering-Plough teams up wih Tekscan

BY Michael Johnsen

BOSTON Schering-Plough Health Care Products and Tekscan on Thursday announced their partnership to develop a revolutionary new kiosk designed to assess a customer’s feet and recommend the optimal Dr. Scholl’s Custom Fit Orthotic.

The consumer steps up to the kiosk and onto the sensing platform and, within seconds, receives a Dr. Scholl’s Custom Fit Orthotic recommendation based on his or her foot pressure pattern, arch type and foot length. The orthotic, designed with special cushioning and support layers, offloads high-pressure areas with support and comfort in mind.

The Dr. Scholl’s Custom Fit Orthotics system uses the patented science of Tekscan’s pressure-sensing technology along with sophisticated algorithms to recommend a perfect fit.

Dr. Scholl’s Custom Fit Orthotic Kiosks can be found in Meijer, Kroger, CVS, Walmart and Walgreens retail stores in select markets, with further expansion planned.

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Zicam maker discusses FDA warning letter with analysts

BY Michael Johnsen

SCOTTSDALE, Ariz. The Food and Drug Administration’s warning letter issued Tuesday to Matrixx Initiatives was “quite honestly unprecedented,” commented Bill Hemelt, acting president of Matrixx Initiatives, during a conference call with analysts Tuesday morning.

“The letter we received Tuesday morning came as a complete surprise to us,” Hemelt said. There was no indication that the FDA was reviewing the matter, he said, and it was “surprising particularly because those reports [complaints around Zicam use and anosmia, or the loss of smell] have been declining in recent years.”

And while Matrixx plans to sit down with the agency and present its evidence that the products are safe in the next 15 days, Hemelt emphasized that “public safety is and will continue to be our No. 1 priority” during that conference call.

The FDA’s action is unprecedented across several fronts. The agency issued a warning letter without any prior indication to a company that’s been on the market with legally marketed and merchandised products for more than 10 years, and the agency had conducted a routine audit of Matrixx in the past three weeks, Hemelt said.

The agency based that warning letter on some 130 adverse events that it had compiled across those 10 years. Even if you add the 800 consumer complaints fielded by Matrixx in that time, and assumed every one of those complaints suggested a link between anosmia and Zicam use, that’s still less than 1,000 complaints over a 10-year period, as compared with the more than 35 million units sold in that time frame — less than 0.003% of complaints versus use.

The three most common causes of anosmia, according to epidemiological studies on the matter, are the common cold, sinusitis and nasal injury. Consumer complaints around anosmia and Zicam use are no more than would be expected in the number of anosmia incidences that you would find in the general public, Hemelt said.

Further, the peer-reviewed, published research on the subject would indicate that there is no causality link between Zicam swab or gel intranasal use and anosmia, Hemelt said, and since that research has been published, no additional research has suggested anything to the contrary. “The cumulative evidence does not support the allegation” that Zicam use is a root cause of anosmia, Hemelt said.

And there is legal precedent supporting that research — no fewer than 10 federal judges dismissed plaintiff experts attempting to establish such a link. “The FDA position does not introduce any new science in that situation,” Hemelt responded, when asked if the FDA warning letter would influence future court decisions.

The FDA action is expected to significantly impact Matrixx’ business. Preliminary cost estimates directly related to the recall are expected to run north of $10 million, but there also is the damage to the brand name and the necessity to defend the company against future lawsuits. Law firms that actively pursue product liability litigants already have been advertising around the issue, Hemelt noted. 

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