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What We’re Reading: Maintaining Peak Flu Surveillance; Drug Industry Lobbyists Questioned; CRC Test Concerns

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The CDC has asked local and state health officials to maintain peak-season flu surveillance operation levels over the summer to watch for any signs of human-to-human spread of the H5N1 bird flu virus; the drug industry’s top lobbying group faced thorough questioning at a Senate Judiciary Committee hearing about the impact of patent system abuse on high prescription drug prices; FDA staff reviewers have raised concerns that Guardant Health’s colorectal cancer (CRC) blood test may fail to detect precancerous tumors.

CDC Asks States, Cities to Maintain Peak Flu Surveillance Levels Due to Bird Flu Threat

The CDC recently asked local and state health officials to maintain peak-season flu surveillance operation levels over the summer to watch for any signs of human-to-human spread of the H5N1 bird flu virus, according to Stat. Typically, flu surveillance activity is conducted at low levels during the late spring and summer months since the transmission of flu viruses drops to minimal levels as temperatures rise. However, Nirav Shah, MD, JD, the CDC’s principal deputy director, told health authorities that surveillance efforts should not go into off-season mode this summer due to the need to detect human infections of H5N1. Shah asked jurisdictions to increase the number of positive influenza virus samples submitted to public health laboratories for subtyping; he estimated that about 600 to 700 positive samples a week could be collected nationally. In addition, the CDC will continue to be testing wastewater to identify places where the H5N1 virus may be spreading.

Senators Blame Patent System Abuse for High Drug Prices

The drug industry’s top lobbying group faced thorough questioning on Tuesday at a Senate Judiciary Committee hearing that explored whether patent system abuse is responsible for high prescription drug prices in the US, according to NBC News. The patent system typically allows drugmakers to exclusively sell new medications on the market for 20 years, meaning other companies cannot make generic versions during this time. Senators accused drug companies of abusing this system on Tuesday, as some partake in “evergreening,” where drugmakers extend a drug’s patent by making small tweaks to the drug or the device used to deliver the medication. Although this practice is not illegal, the federal government has tried to limit it to promote more competition; last month, the Federal Trade Commission challenged hundreds of patent listings it felt were intended to prevent generic drugs from reaching the market.

FDA Warns Guardant Test May Fail to Detect Some Precancerous Tumors

FDA staff reviewers raised concerns on Tuesday that Guardant Health’s colorectal cancer (CRC) blood test may fail to detect precancerous tumors, according to Reuters. However, the test, Shield, may increase CRC screening compliance and help detect it in earlier stages, potentially helping cure patients and prolong survival. The FDA's comments came ahead of its meeting with outside advisors on Thursday; although the FDA typically makes decisions based on advisers’ recommendations, it does not have to. Guardant’s application for Shield was based on a study that found that the test detected 83% of CRC and 13% of advanced adenomas, or precancerous tumors; the low performance of detecting advanced adenomas could be a focus during the upcoming meeting. Ultimately, if approved, Shield would become the second US blood-based CRC cancer test.

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