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D.C. spending standoff ahead as U.S. House Republicans demand $130 billion in cuts 

2 years 2 months ago

WASHINGTON — U.S. House Republicans outlined Wednesday how they would cut $130 billion from the dozen annual government funding bills — producing a plan with significantly lower spending than the level both parties agreed to in the debt limit deal just two weeks ago. The spending levels likely set up a stalemate later this year […]

The post D.C. spending standoff ahead as U.S. House Republicans demand $130 billion in cuts  appeared first on Missouri Independent.

Jennifer Shutt

Music Label Demands Google Delist A Wikipedia Page With Info It Doesn’t Like

2 years 2 months ago
In Walled Culture the book (free digital versions available) there’s a chapter about the widely-used “notice and takedown” system, and its many abuses. One indicator of how bad things are, and how they are still getting worse, is the number of requests that Google receives to de-list links from its search results. Last year, Google […]
Mike Masnick

Scores of Critical Lab Tests Fall Into a Regulatory Void. The FDA Is Trying to Close It.

2 years 2 months ago

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

After decades of intense debate and stalled legislation, the Food and Drug Administration has taken a critical step in overseeing a vast category of lab tests that reach patients without any federal agency checking to ensure they work the way their makers claim.

Among the tests that are not reviewed by the FDA: popular prenatal genetic screenings that ProPublica recently reported on, as well as certain cancer screenings and tests for rare diseases.

On Wednesday, a notice of the proposed rule was posted. This is the first concrete evidence that the FDA is preparing to apply its regulatory powers to these lab tests.

“A modern oversight framework that is specifically tailored to assuring tests work is critical to position ourselves for the future — whether it is preparing for the next pandemic or realizing the full potential of diagnostic innovation,” an FDA press officer said in a statement to ProPublica.

Peter Lurie, president and executive director of the Center for Science in the Public Interest, applauded the move. “It’s exciting to see the agency taking concrete steps to address this long-standing hole in the public health safety net,” he said.

The agency’s hands-off approach to lab-developed tests — which are designed, manufactured and used by a single lab — traced back to a time when they were deployed at a small scale. The idea was to spare hospital labs, for example, from the time, money and hassle of getting approval in Washington whenever they needed to create a simple test for their own patients.

Nowadays, so-called LDTs are an enormous part of the health care system, including a number of high-stakes tests made by commercial companies. Because they aren’t registered with the federal government, nobody knows how many exist. A 2021 study by Pew Charitable Trusts estimates that 12,000 labs are likely to use such tests, many of which process thousands of patient samples each day. Currently, the Centers for Medicare and Medicaid Services reviews lab operations, but it doesn’t check whether the tests themselves are clinically valid.

While these tests “play an important role in our health care system,” said the FDA press officer, the agency “is very concerned about problematic LDTs currently used in the U.S. that might not provide patients with accurate and reliable results.”

ProPublica’s investigation of prenatal genetic screenings detailed how the FDA doesn’t review the tests before they reach patients, nor does it verify marketing claims made by companies that sell them. False positives, false negatives and uncertain results about genetic anomalies have sometimes led to devastating consequences for families, the investigation found. Companies aren’t required to publicly report instances of when the test gets it wrong, and no federal agency is able to recall faulty tests. (We also made a guide to prenatal screening tests for expectant parents.)

The next step for the FDA is to publish a draft of the proposed rule, which seems likely to happen in August. It will go through a public comment period, and then the agency will develop a final rule. Both the proposed and final rules need to be cleared by the Department of Health and Human Services and the Office of Management and Budget. Experts said this process could go relatively quickly, or it could take a year or more, pushing up against a 2024 election that might change priorities in Washington.

Over the years, a large coalition of labs, professional associations and academic medical centers have argued that FDA oversight over the lab tests would be overly burdensome and inflexible — so much so that it would stunt critical innovations and limit patient access to quality health care. Opponents also express concern about the FDA’s capacity to oversee the tests.

Mary Steele Williams, executive director of the Association for Molecular Pathology, said in a statement to ProPublica that AMP is updating its proposal for an alternative approach to lab testing reform, one that doesn’t rely on the FDA. Instead, it recommends modernizing existing regulations through CMS, “which we believe to be the most effective and streamlined approach.”

Williams also said that AMP intends to continue working with other institutions to “raise our shared concerns with FDA regulation” over lab-developed tests. It remains committed, she said, “to working with Congress and other stakeholders to establish a more efficient regulatory framework that ensures high-quality patient care while continuing to foster the rapid innovation and promise of new diagnostic technologies.”

An earlier effort by the FDA to rein in LDTs came in 2014, when the agency issued draft guidance. But after facing nearly two years of stiff opposition, the agency pulled it. One of the strongest critics was the American Clinical Laboratory Association, a national trade group. It challenged the FDA’s authority over the tests by filing a citizen petition and making clear its intent to sue if necessary.

In a statement on Wednesday to ProPublica, an ACLA spokesperson said the association has long taken the position that any regulation of LDTs must be done through legislation. It should be a framework “that recognizes the essential role of clinical laboratories in advancing public health, preserving and fostering innovation and maintaining access to critical testing services,” the spokesperson said, adding: “We stand ready to provide expertise and technical assistance to Congress.”

There have been several efforts to reform lab testing through Congress over the years, and the FDA has signaled that it welcomes legislative action that would create a modern framework specifically tailored to clinical testing.

In 2022, a bipartisan bill known as the VALID Act seemed to have its best shot at passing, having gathered momentum after the scandal over fraudulent Theranos blood tests and the coronavirus pandemic. But, facing pushback, it was dropped from a must-pass bill at the end of the year. While ACLA’s spokesperson said the association worked with the bill’s sponsors to help shape it, in the end, ACLA didn’t endorse it. The act was reintroduced in the House in March.

If the FDA enacts a new rule, supporters anticipate legal challenges, said Cara Tenenbaum, a former policy adviser for the agency whose consultancy signed onto a recent letter urging it to assert oversight.

But over the past decade, the FDA tried every alternative to address what it sees as a public health problem, she said.

“All they have left is their existing device authority,” Tenenbaum said. “They’ve been backed into a corner, if you ask me.”

The FDA pushing ahead with a proposed rule, even while legislation is on the table, makes sense because “the clock is ticking on the administration,” said Lurie, a former top FDA official who worked on lab testing reform.

At the same time, he said, “the problem is long-standing and, frankly, in fact, growing. More and more products come to market every day, and very few of them get regulated.”

by Anna Clark

Brown Bag Bistro Recognized by America's Best Restaurants

2 years 2 months ago
ALTON - The Brown Bag Bistro has gained acclaim across the Riverbend. Now, they’re taking on the rest of the country. America’s Best Restaurants , a media company that highlights independently-owned restaurants across the U.S., is coming to Alton. The Brown Bag Bistro will be featured on their ABR Roadshow series. The Bistro was opened in 2018 by mother-daughter duo Christine and Erin Velloff. As Christine explained, they found success as a “small, quaint little lunch spot.” “It’s just turned out to be incredible,” Christine added. “We really have consistent food.” The Bistro offers sandwiches, salads, soups and desserts, among other beloved menu items. Several of the sandwiches have unique names that nod to Alton history or the Velloff family, including “The Wadlow” and “The Sammy Roo.” The Bistro’s full menu can be found on their website . America’s Best Restaurants will film i

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ISP, Mitchell Fire Respond To Ravaging Car Blaze

2 years 2 months ago
MITCHELL - One of the most dramatic car fires in recent memory occurred this past weekend on Illinois Route 270 just over the Mitchell border. The Illinois State Police explained today what happened in the fiery incident: "At 6:36 p.m. on June 9, 2023, Troop 8 responded to a vehicle fire on I-270 westbound at the intersection with I-255 southbound in Madison County," ISP said. "Unit 1, a 2021 Chrysler Voyager, struck an unknown piece of debris in the roadway. The driver of Unit 1 pulled onto the shoulder and noticed that Unit 1 was on fire. "The driver and five occupants safely exited the vehicle and Unit 1 became fully engulfed in flames. Mitchell Fire arrived on the scene and extinguished the flames. " The State Police said no further information is available about the incident.

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Tougher ethics rules for U.S. Supreme Court justices advocated in Senate hearing

2 years 2 months ago

WASHINGTON — Senate Democrats for the third time this year made their case that U.S. Supreme Court justices must follow stronger ethics rules, including recusing themselves from cases where they have a financial stake or other connection to a case. The series of hearings by the Senate Committee on the Judiciary and its subcommittees came […]

The post Tougher ethics rules for U.S. Supreme Court justices advocated in Senate hearing appeared first on Missouri Independent.

Ashley Murray

St. Louis to celebrate Juneteenth in style

2 years 2 months ago
A year ago, 22nd Circuit Court Judge David Mason was joined by hundreds of St. Louisans as he unveiled the Freedom Suits Memorial, located at the Civil Courts Building on 10 N. Tucker Street in St. Louis, Missouri.
Alvin A. Reid | The St. Louis American

New Alton Starbucks Takes Shape

2 years 2 months ago
ALTON - Each day, the new Starbucks in Alton gets closer to being a reality. Much progress has been made at the location, which is fenced off just off Homer Adams Parkway in Alton. The shell of the new structure is in a place where the old Shop 'n Save gas station was once located. Alton Mayor David Goins said he believes the new location will open soon. He hopes to see doors open sometime in July or in the summer. Mayor Goins said he knows the new Starbucks will provide a boost in tax revenues because it is such a popular coffee house and it has been sought for many years. Starbucks is an American chain of coffeehouses and roasters reserves headquartered in Seattle, Wash., and is the nation's largest coffeehouse chain. Starbucks has hot and cold drinks, whole-bean coffee, espresso, coffee latte, full and loose-leaf teas, juices, Frappuccino beverages, pastries and snacks with free Wi-Fi internet service. "We are really excited to see the progress on the Starbucks," the mayor said.

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