The Department of Justice Is Investigating LifePoint Hospitals

Modern Healthcare (2/13, Schencker, Subscription Publication, 246K) is reporting that in a Feb. 12 filing with the Securities and Exchange Commission, Tennessee-based LifePoint Hospitals “revealed” that it is “the target of federal investigations, more than twelve individual lawsuits and two class action suits alleging the performance of improper interventional heart procedures.” After conducting “an internal review,” LifePoint “identified two cardiologists who ‘independently elected to place cardiac stents that may not have been clinically appropriate,’ according to a LifePoint statement released” yesterday. LifePoint “then self-reported the matter to the Department of Justice.” The two physicians no longer practice at any facilities affiliated with LifePoint, according to a company statement. Currently, the only LifePoint Hospital in Georgia is Rockdale Medical Center.

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Senators Request FDA Investigate Dietary Supplements

According to The Hill (2/5, Wheeler, 224K) Senators are encouraging the FDA to launch a “nationwide investigation after four major retailers were accused of selling mislabeled and tainted dietary supplements in their New York stores” by the state’s Attorney General Eric Schneiderman. Sen. Dick Durbin (D-IL) said in a statement, “Today, Sen. [Richard] Blumenthal [D-CT] and I are calling on the FDA to…take steps to protect all American consumers from an industry shown to be selling products they know are at best, ineffective, and at worst, truly harmful.” Sen. Blumenthal said in a statement, “The apparent widespread sale of fraudulently-labeled dietary supplements by four major national retailers should be a major wake-up call that the industry is in desperate need of additional oversight.”
The need for increased oversight over dietary substances is substantiated by the fact that US consumers “are nuts” for products they believe help them “boost their health and lose weight,” despite a “series of studies and investigations that have cast serious doubt on the safety and reliability of” dietary supplements, the Washington Post (2/5, Millman, 5.17M) “Wonkblog” reported. The popularity of dietary supplements is maintained by the “common public misperception that these products face the same rigorous oversight that pharmaceuticals receive from the FDA.” A report from the HHS Inspector General in 2012 “found that 20 percent of the weight loss and immune system support supplements they purchased made illegal claims about their ability to treat and cure disease,” and just a year later, researchers from Harvard “found that between 2004 and 2012, there were 237 recalls of dietary supplements — accounting for more than half of FDA recalls of Class 1 drugs,” which signifies that “the products contain substances that can cause death or serious health problems.”

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The FDA’s Adverse Reporting System Includes Numerous Incomplete Reports

The New York Times (2/3, B3, Thomas, Subscription Publication, 9.97M) is reporting that “the main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the” FDA, “according to a new study by” the Institute for Safe Medicine Practices (ISMP), “a nonprofit group that tracks drug safety issues.” An FDA spokesman “acknowledged that adverse-event reports were often incomplete, and said improving the system was ‘of great interest’ to the agency.” But, “doing so ‘is challenging because of the voluntary nature of the reporting.’”
Similarly, The Wall Street Journal (2/2, Silverman, 5.67M) “Pharmalot” blog reports that although the ISMP says reports can only be considered reasonably complete when they include patient age, gender and event date, only 49% of reports contained that information. Additionally, the analysis found that 67% of death reports were of limited value due to incomplete information about the cause of death and the possible role of a medicine. Thomas Moore, an ISMP senior scientist, attributes the lack of completeness in reporting in part to the fact that the FDA’s adverse-alert system has not been updated since 2001 despite the fact that the pharmaceutical market has evolved immensely, yielding new interactions between drugmakers, patient, and consumers.

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Large Pharmaceutical Companies Are Outsourcing Drug Safety Monitoring Overseas

According to The Wall Street Journal (2/2, Mclain, Subscription Publication, 5.67M) more and more pharmaceutical companies are outsourcing their drug-monitoring operations to foreign countries like India. Outsourcing companies like Accenture are benefiting as major drug companies like AstraZeneca, Novartis, and Bristol-Myers Squibb contract out safety checks in order to lower costs and focus on R&D and marketing. The Journal goes on to explore in great depth the issues surrounding the practice, observing that some opponents of this type of work say that drug monitoring is hard to do, requiring significant experience, natural talent, and sufficient knowledge of biochemistry and pharmacology, and that the outsourcing trend brings greater risk that harmful side effects of drugs will be overlooked.

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Another Example of VA Neglect

The Los Angeles Times (1/28, Holland, 3.49M) is reporting that the U.S. government “has agreed to settle a lawsuit accusing the Department of Veterans Affairs of misusing its sprawling West Los Angeles health campus while veterans with brain injuries and mental impairment slept in the streets, people familiar with the agreement said Tuesday.” The settlement will require the VA “will develop a master land-use plan for the campus that identifies sites for housing homeless veterans.” The ACLU of Southern California brought the lawsuit contending “that the VA should develop housing for veterans on the 387-acre campus.” The ACLU of Southern California “accused the agency of illegally leasing land to UCLA for its baseball stadium, a television studio for set storage, a hotel laundry and a parking service.” In 2013 a Federal Judge “struck down the leases, saying they were ‘totally divorced from the provision of healthcare.’” More recently, US District Judge S. James Otero “halted construction of an amphitheater on the property.”

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Senator Charles Grassley: Nonprofit Hospitals Who Sue Poor Patients Over Unpaid Bills Could Be Breaking The Law

Fox News (1/25, 8.25M) reports that “Sen. Charles Grassley [R-IA] is calling out nonprofit hospitals who are suing poor patients over unpaid bills and says they could be breaking the law, according to a report by ProPublica and NPR.” Senator Grassley “sent a letter, dated January 16, 2015, to Heartland Regional Medical Center, a nonprofit hospital in St. Joseph, Mo., that has garnished the wages of low-income patients who were unable to pay their medical bills.” Sen. Grassley, “citing the ProPublica (1/26, 7K) and NPR (1/22, 1.58M) report…said the hospital, which recently changed its name to Mosaic Life Care, had stretched the law to the breaking point,” writing that the hospital, “may not be meeting the requirements to be a nonprofit, tax-exempt hospital.”

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NHTSA Scrutinizes Ford Recall

In an article appearing on the front page of its “Business Day” section, the New York Times (1/21, B1, Jensen, Ivory, Subscription Publication, 9.97M) reports that a week after NHTSA Administrator Mark R. Rosekind said he planned on being “more vigilant on safety,” the NHTSA has “taken the unusual move of revisiting the 2013 recall of Ford’s biggest pickup trucks.” The initial recall, which was issued to repair a stalling problem, was limited to nearly 3,000 trucks that were used as ambulances. However, citing several complaints from drivers, the NHTSA notified Ford that “it is now investigating whether that recall should be” expanded, to include almost “197,000 additional pickups that have similar engines but are not used as ambulances,” according to the report. The Times goes on to note that recall queries, such as the investigation into the Ford recall, are “unusual,” noting that there were only four recall queries in 2014.

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NHTSA Investigates Jeep Cherokee Vehicles After Reports Of Fires

Bloomberg News (1/17, Plungis, 2.94M) reports that NHTSA has begun “a defect investigation into the latest model of the Jeep Cherokee sport-utility vehicle after an owner reported 20-foot flames shot out of its engine compartment after being parked,” which spreads across 50,415 vehicles built for the 2015 model year. The article states that NHTSA routinely starts investigations “based on a single complaint” when the agency “believes the alleged defect is especially dangerous.”
Reuters (1/17) reports that Fiat Chrysler spokesperson Eric Mayne stated the company plans to cooperate to the fullest with NHTSA.
The Auto World News (1/16, 1K) reported that NHTSA Deputy Administrator David Friedman told the press back in November that Jeep has “to get their act in gear,” adding that “They’ve got to make sure that they are getting those parts in the hands of consumers.”

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Dietary Supplements Manufacturer Shuts Down After Federal Lawsuit

The Los Angeles Times (1/17, Panzar, 3.49M) reported that a pharmaceuticals manufacturer in Los Angeles “agreed to close its operations and to recall and destroy all the dietary supplements it has sold since 2011 as part of an agreement with” the FDA. According to a lawsuit filed by the DOJ and FDA, the manufacturer “distributed unapproved supplements that claimed to treat diabetes, allergies and cancer. “ The AP (1/16) and Medical Daily (1/18, Olson, 85K) also reported on the story.

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Auto Parts Suppliers Step Up Quality Control

The Wall Street Journal (1/14, Kubota, Subscription Publication, 5.62M) reports that parts suppliers for automakers are working to improve their quality control process following the record recalls in 2014, including the issues with Takata’s exploding air bags and Delphi Automotive’s faulty ignition switches in GM vehicles.

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