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Capitol Checkup: Anemic flu shot probe; kratom alert widens; poorly hatched joke


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Capitol Checkup: Anemic flu shot probe; kratom alert widens; poorly hatched joke

The Centers for Disease Control and Prevention had some fairly good news about the influenza outbreak that has hit the U.S. hard during the 2017-2018 season — reporting that for the second week in a row, the number of people visiting the doctor to seek treatment for the flu had dropped.

But lawmakers have summoned the acting head of the agency, Anne Schuchat, along with other government agency leaders — National Institute of Allergy and Infectious Diseases Director Anthony Fauci, Food and Drug Administration Commissioner Scott Gottlieb and Biomedical Advanced Research and Development Authority Director Rick Bright — to Capitol Hill for a March 8 hearing to explain why this year's flu vaccine was largely ineffective, demonstrating only 36% protection overall.

Schuchat and Fauci, along with other government officials, faced the same panel — the House Energy and Commerce Subcommittee on Oversight and Investigations — in February 2015, the last time the flu shot was a dud, and were grilled about why after recognizing the vaccine was likely not going to work against the H3N2 strain they did not urge the biopharmaceutical industry in summer 2014 to quickly produce a new product before the virus spread.

Like the current season, the H3N2 virus — the predominant strain in the 2014-2015 and 2017-2018 seasons — had mutated between the time the U.S. selected its strains for the vaccine and when manufacturers started producing their products. The 2014-2015 vaccine was only 23% effective.

"Influenza viruses present us with unique challenges. Unlike other vaccine-preventable diseases, influenza is constantly changing," Schuchat had explained during the February 2015 hearing.

She admitted the CDC first detected the H3N2 virus had started to "drift," or mutate, in March 2014.

Members of the subcommittee in 2015 demanded to know why manufacturers could not have shifted gears and produced a new vaccine, even in limited doses, specifically to prevent the mutated H3N2 strain.

"The American people were stuck with a vaccine that wasn't going to work for nearly four out of five people and nearly nine out of 10 seniors," declared now-former Rep. Tim Murphy, R-Pa., who was the chairman of the subcommittee at that time.

Fauci and Schuchat explained that it typically takes up to six months to produce a vaccine and even if drugmakers had started producing a separate vaccine in summer to protect against the mutated H3N2 strain — supplementing the vaccine that was already being shipped to pharmacies, hospitals and doctors' offices — it was doubtful all Americans would get the second shot, given many in the U.S. take getting protected against the virus for granted.

Advisers to the FDA hoped they made a more accurate prediction for 2018-2019, recommending at a March 1 meeting that the agency select the same four strains for next season's U.S. vaccine that advisers to the World Health Organization proposed for the southern hemisphere, which involved a different H3N2 virus and a tweak to one of the B strains.

Fauci is likely to use the March 8 hearing session as another opportunity to promote the need for a universal flu vaccine and more funding to speed the effort — something he had tried to convince lawmakers to support more boldly in 2015.

But three years later, the universal flu shot has remained without the big money, initiative-type funding that lawmakers have approved for other government-supported projects like cancer, precision medicine and brain research.

In a Feb. 28 interview with S&P Global Market Intelligence, Fauci insisted the time is ripe now for a "full-court press" in investment and resources from all stakeholders to make a universal flu vaccine a reality.

He said scientists now have a better understanding about the potential ability to induce a response against the part of the flu virus that does not change from year to year — knowledge that was lacking until recently.

Last week, Rep. Rosa DeLauro, D-Conn., introduced legislation in the House meant to be a companion to a February bill from Sen. Ed Markey, D-Mass., that calls for $1 billion — $200 million each year over five years — to be invested in a universal flu vaccine.

DeLauro noted that the CDC reported on Feb. 9 that essentially 4,000 Americans were dying per week of the flu or related pneumonia.

But the 2017-2018 U.S. flu epidemic has started showing signs of easing, with the proportion of outpatient visits for influenza-like illness falling to 5% from 6.4% a week earlier, the CDC said on March 2.

Hospitalizations, however, rose to 81.7 per 100,000 versus the 74.5 per 100,000 reported by the CDC on Feb. 23.

Another 17 children have also died of the flu, bringing the total number of pediatric deaths for the 2017-2018 season to 114.

Based on the most recent data, the CDC has determined the flu peaked in the U.S. in early February, spokeswoman Kristen Nordlund told S&P Global Market Intelligence.

But even though flu activity has peaked and declined significantly for second consecutive week, "there are still several weeks of elevated flu activity to come," Schuchat warned on Twitter.

FDA warns about fake flu meds

Meanwhile, the FDA warned Americans to be on the lookout for fake anti-flu products sold online and in certain retail settings, noting that bad flu seasons are a prime time for fraudsters to try to take advantage of consumers.

"Consumers should be aware that there are no legally marketed over-the-counter drugs to prevent or cure the flu," the FDA said March 2.

Americans cannot buy antivirals like Roche Holding AG's Tamiflu without a prescription, FDA chief Gottlieb emphasized on Twitter.

Antivirals offered online without a prescription "may be counterfeit, ineffective or may make you sick," he said.

The FDA recommended that consumers buy prescription drugs from their local pharmacy or only through an online pharmacy that requires a valid prescription from a doctor or other authorized healthcare professional and is licensed by the state board of pharmacy where the patient is located.

CDC, FDA broaden kratom alert

The FDA and the CDC last week broadened their alert about a multistate outbreak of salmonella infections linked to the botanical substance kratom, which Gottlieb declared to be an opioid Feb. 6.

The agencies said that 12 more people from seven states had been linked to the outbreak since the government first announced the federal investigation Feb. 20. A total of 40 people from 27 states have been identified as being infected with salmonella from the contaminated kratom, they said.

The agencies said there had been no reported deaths linked to the outbreak, but nearly half of the people infected have been hospitalized.

Last month, Gottlieb said kratom has helped to fuel the opioid crisis. He said the epidemic has increasingly started to migrate to substances like kratom and the over-the-counter anti-diarrhea drug Imodium, also known as loperamide.

Last week, the FDA chief asked certain online retailers, like Inc. and Walmart Inc., to stop selling bundled packages of Imodium and to provide only one package at a time per customer.

Gottlieb noted the FDA was working with Imodium manufacturers to limit the number of pills by putting the product into unit-dose packaging, such as "blister packs" of eight tablets.

Utah senator's poorly hatched ACA 'joke'

In a March 2 tweet, Sen. Orrin Hatch, R-Utah, said his description of supporters of the Affordable Care Act as "the stupidest, dumbass people I've ever met" was a "poorly worded joke" that was "not reflective of my actual feelings towards my friends on the other side."

The outgoing Utah senator, who plans to end his time on Capitol Hill in January 2019 — a seat now being sought by failed 2012 Republican presidential candidate Mitt Romney — made the remark about the ACA supporters during a March 1 speech at a forum hosted by conservative-leaning Washington think tank the American Enterprise Institute.

Hatch's criticism came on the same day the Kaiser Family Foundation reported that 54% of Americans now hold a favorable view of the ACA — the highest share in more than 80 tracking polls since the 2010 law was enacted.

During his speech, Hatch had talked about leading his Republican colleagues in repealing the ACA's individual mandate tax penalty in December 2017. But the Kaiser poll found that the majority of the public were either unaware of that action or were aware but did not know the penalty is not lifted until 2019.