番茄社区

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Company Remotely Switches Off Robot Mid-Surgery

Intuitive Surgical shut down a da Vinci robot in the middle of a procedure, forcing the surgeon to switch to open surgery with the patient on the table -- so alleges a new lawsuit, .

Several hospitals are bringing class-action lawsuits against the surgical devicemaker, charging that the company's monopoly position forces them into expensive, inflated contracts for its maintenance services and replacement parts.

In the case above, the hospital had been considering a service contract with a third party, according to the suit.

Franciscan Health in Indiana, Valley Medical Center in Washington, and Kaleida Health in New York all filed class-action lawsuits against Intuitive Surgical. In addition to claims about being forced to sign multi-year, exclusive servicing contracts, they also charge that the company forces them to buy new, expensive instruments and attachments after just 10 uses even if the part is in good condition. (However, the company launched a program last year allowing for 12-18 uses for some instruments.)

The hospitals also allege that Intuitive Surgical has threatened to turn the machines into "paperweights" if they use outside vendors for repairs or new parts.

A spokesperson for Intuitive Surgical told 番茄社区 via email that the company "does not have the ability to remotely shut down a da Vinci system during a surgical procedure underway at hospital."

"There is risk associated with deviating from the validated processes cleared by regulatory authorities," the spokesperson added. "Continued use beyond an instrument's determined useful life may reduce safety, precision, and dexterity. Further, third parties may use incompatible or unvalidated parts or processes in servicing or repairing the systems, which could cause damage and put patient safety at risk."

Hotel Quarantine Not Good Enough With More Transmissible Variants

With rising concerns that hotel-based quarantines are no longer sufficient to prevent the spread of more infectious COVID-19 variants, some countries are planning to build specific quarantine structures, .

In one instance in Australia, it appears the virus transmitted simply when two individuals opened their hotel room doors, which were adjacent to each other, to collect meals within just seconds of each other. The person infected at the hotel then ignited an outbreak in Melbourne, authorities suspect.

In that case, it was the Kappa variant -- the initial B.1.617.1 first detected in India -- that appeared to have transmitted so readily.

Similarly, an outbreak of the Delta variant in the country's Northern Territory appears to have originated with a mine worker who picked up the virus during his stay at a quarantine hotel in Queensland, according to WSJ.

Australia and China are now planning new, specially designed quarantine centers that will be better at blocking transmission, and other countries, including New Zealand, are looking to take similar actions, the paper reported.

Australia already has one structure where each room has its own air supply and opens to an outdoor passageway instead of an inside hallway. The country will now build a similar but smaller facility near Melbourne, and is planning additional sites in Queensland and Western Australia.

China is planning to build large quarantine facilities in two southern cities. One center will be 2.7 million square feet, with rooms for 5,000 travelers and another 2,000 beds for logistics personnel.

The emergence of more infectious variants "does make us regret tremendously that we hadn't built a heap of purpose-built facilities eight months ago," Tony Blakely, an epidemiologist at the University of Melbourne, told WSJ.

Calls for Aduhelm Investigation Grow Louder

Calls for an investigation of the FDA's controversial approval of the Alzheimer's drug aducanumab (Aduhelm) are growing louder, with several voices insisting on further exploration -- , Janet Woodcock, MD.

Last Friday, to investigate the ties and interactions between agency staff and drugmaker Biogen.

"We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency's review staff were inconsistent with FDA's policies and procedures," .

Woodcock's request follows similar queries from lawmakers regarding a deeper look into ties between the drug company and the agency regarding this decision.

The House Committee on Oversight and Reform announced on June 25 that it would into the drug's approval and pricing. The group, led by Carolyn Maloney (D-N.Y.) and Frank Pallone (D-N.J.), also sent a requesting scores of documents and answers to questions.

In addition, Sens. Elizabeth Warren (D-Mass.) and Bill Cassidy, MD (R-La.) calling for a hearing on how the drug's $56,000 annual price tag will affect Medicare and other health programs.

Rep. Katie Porter (D-Calif.) also : "Patients should have confidence that their treatment plans are based on science, not cozy relationships between Big Pharma and [FDA]," she tweeted.

But at least one advocate wants to make sure any investigation includes a look at Woodcock herself. Public Citizen put out a press release last week that noted: "Such an investigation must be broad and determine when Dr. Woodcock first became aware of this collaboration and whether she ever specifically endorsed or facilitated it in any way."

"The IG also must examine how Dr. Woodcock fostered a culture within the FDA's Center for Drug Evaluation and Research that permitted and encouraged such an inappropriate collaboration with regulated industry," .

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