WASHINGTON — Senators pressed pharmaceutical executives to justify raising drug prices, and healthcare workers urged members of a House subcommittee to pass legislation mandating workplace violence protections.
Senators Grill Drugmakers Over High Prices
Stopping rebates, using value-based purchasing, and making drug prices more transparent were the phrases of the day at Tuesday’s Senate Finance Committee hearing on high drug prices, where neither the senators nor their witnesses seemed to score any major public relations victories.
“Today we expect open, honest answers from the pharmaceutical industry,” committee chairman Chuck Grassley (R-Iowa) said to the panel, comprising top executives from seven large drugmakers. “One of the first things to talk about is pretty simple: list price. … You folks are probably going to tell us that it’s not that simple.”
And although some drugmakers may believe that list price is meaningless, said Grassley, “for seniors on Part D [Medicare drug plans] who are paying co-insurance as a percentage of the list price … list price is very meaningful.”
Sen. Ron Wyden (D-Ore.), the committee’s ranking member, zeroed in on the companies’ prior actions. “Prescription drugs didn’t become expensive by accident,” he said. “Drug prices are astronomically high because that’s where pharmaceutical companies and their investors want them. The brakes have come off pharmaceutical pricing and American families are hurtling along in the passenger seat, terrified about what comes next.”
Nurses, Social Workers Demand Action on Workplace Violence
House members discussed legislation aimed at protecting healthcare workers from violent patients during a hearing on Wednesday.
The purpose of Wednesday’s hearing by the House Education and Labor Committee’s Workforce Protections subcommittee was to examine the Workplace Violence Prevention for Health Care and Social Service Workers Act , recently re-introduced by Rep. Joe Courtney (D-Conn.)
Witnesses told of threats and injuries on the job. Some said the incidents ended their careers and shattered their health.
“My head snapped backwards, and I heard a bang and a pop and all of the air rushed out of me,” said Patricia Moon-Updike, RN, of the Wisconsin Federation of Nurses and Health Professionals, recalling the moment in June 2015 when a large, agitated teenage boy kicked her in the throat.
At the time, Moon-Updike and the patient’s assigned nurse had been trying to bring the teenager “screaming and thrashing” into a seclusion room. One of her colleagues called security and Moon-Updike believed that four guards were on their way — one to hold each of the teenager’s four limbs, as Moon-Updike noted in written testimony.
Subcutaneous Herceptin OK’d for Breast Cancer
The FDA approved a subcutaneous version of trastuzumab (Herceptin) for treating HER2-positive breast cancer on Thursday.
Two randomized trials confirmed the safety and efficacy of the new formulation, which combines the anti-HER2 targeted agent with hyaluronidase, an endoglycosidase, and will be branded Herceptin Hylecta.
In the HannaH trial, 596 operable, HER2-positive breast cancer patients with locally advanced or inflammatory disease were randomized to 8 cycles of chemotherapy plus either subcutaneous or intravenous trastuzumab. Following surgery, they received another 10 cycles of their respective trastuzumab therapy.
The study met both primary endpoints, demonstrating that subcutaneous trastuzumab’s pharmacokinetics and rates of pathological complete response (pCR) were noninferior to standard IV therapy. Rates of pCR were 45.4% in the subcutaneous arm compared with 40.7% in the IV arm (4.7% difference, 95% CI -4.0% to 13.4%).
Big Pharma Targeted at Senate Hearing on Opioid Crisis
Sen. Dick Durbin (D-Ill.) took aim at Big Pharma during a Senate hearing Thursday on the opioid crisis.
“A few years ago there was a committee hearing, and they dislcosed that the pharmaceutical industry asked for permission to produce 14 billion opioid doses a year … so that every adult in America could then fill a prescription for 3 weeks,” he said at the hearing held by the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. “They came up with 14 billion because they thought they could make money selling [that amount], and it was approved by the Drug Enforcement Administration. Think of that — at a time when we’re facing the worst drug epidemic in our history, a government agency is giving this industry permission to make 14 billion tablets!”
“How does that fit with what the CDC sends out as a notice to doctors?” Durbin asked, then read from a CDC flyer: “‘Start low and go slow — for acute pain, prescribe fewer than a 3-day supply — more than 7 days rarely required.’ And here the pharmaceutical industry asks for 14 billion opioid doses despite another agency of the government saying, ‘This is preposterous.'”
“So, being a senator, I decided to raise hell about 14 billion and boy, did we make progress,” he said. “You know what we have now as an annual production quota? 13 billion.”
‘We Need to Get to Zero’ on Measles: NIAID Chief to House Panel
The views that some House committee members expressed Wednesday in favor of vaccination brought to mind a line from a character on a British television show: “I am unanimous in this.”
“It wasn’t until the development of the MMR [measles, mumps, and rubella] vaccine that we as a country were able to stop this horrific illness,” said Rep. Diana DeGette (D-Colo.), chairman of the House Energy & Commerce Subcommittee on Oversight and Investigations, at a hearing on recent measles outbreaks in the U.S. “But despite that success, here we are again 20 years later.”
Rep. Greg Walden (R-Ore.), ranking member of the full Energy & Commerce Committee, noted that one in four people diagnosed with measles will end up being hospitalized. “If we don’t reverse the downward trend in vaccination, we risk bringing back measles in full force,” he said.
DeGette called the recent measles outbreaks “a real cause for national concern” and pointed out that the national measles vaccination rate for children stands at 91%.
FDA Expresses Concern Over Device Sterilizing Facility Shutdown, Robotic Surgeries
The closure of an Illinois facility that sterilizes medical devices could create an unusual shortage situation, the FDA warned Wednesday.
Sterigenics’ operation in Willowbrook, Illinois, closed Feb. 15 under a state order related to emissions of ethylene oxide, a common sterilant used to disinfect devices such as endoscopes used in gastrointestinal procedures. It’s also a known carcinogen. Air monitoring had detected potentially hazardous levels of ethylene oxide outside the facility beginning in the spring of 2018. (The company denied any problems.)
Also, patients and providers considering robotic surgery for cancer-related procedures such as mastectomy should be aware that currently available devices are not necessarily as safe or effective as conventional surgery, the FDA said Thursday.
“The relative benefits and risks of surgery using robotically-assisted surgical devices compared to conventional surgical approaches in cancer treatment have not been established,” the agency stated in a Safety Communication.
On Tuesday, Health Affairs hosts a briefing focused on consumers’ perspective of the healthcare system.
And the Senate Health, Education, Labor and Pensions committee will examine the role of vaccines in preventing disease outbreaks.
On Wednesday, a subcommittee for the House Committee on Appropriations will explore the issue of Electronic Health Record modernization.
On Wednesday and Thursday, the Senate Special Committee on Aging will examine the rising costs of prescription drugs.
Also on Wednesday and Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee will discuss and then make recommendations regarding which strains to include in the influenza virus vaccines for the 2019 to 2020 season.
And on Thursday, a different subcommittee for the House Committee on Appropriations will address gun violence as a public health emergency.