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Reporting from the frontiers of health and medicine
Updated: 5 hours 43 min ago

STAT Plus: Our 9 biggest questions about Nancy Pelosi’s drug pricing bill

7 hours 42 min ago

WASHINGTON — Nancy Pelosi unveiled House Democrats’ long-rumored plan to lower drug prices on Thursday, following months of speculation and back-and-forth between House progressives and the speaker’s policy advisers.

It’s a comprehensive plan: The bill would allow the federal government to negotiate the price of up to 250 drugs under Medicare and extend that price to the commercial market. It would force drug companies to pay back price hikes above inflation, dating back to 2016, to the federal government. It would also enact a price cap for U.S. drugs based on an index of prices in six foreign countries.

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Number of vaping-related illnesses in U.S. has spiked, CDC says

8 hours 59 min ago

The number of serious lung injuries linked to vaping has jumped sharply, the Centers for Disease Control and Prevention said Thursday, with 38 states and one territory reporting 530 confirmed or probable cases of the illness.

That’s up from 380 reported earlier this week.

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U.S. awards $3 million to fill gaps in medical marijuana research

9 hours 26 min ago

The U.S. government will spend $3 million to find out if marijuana can relieve pain, but none of the money will be used to study the part of the plant that gets people high.

Nine research grants announced Thursday are for work on CBD, the trendy ingredient showing up in cosmetics and foods, and hundreds of less familiar chemicals. THC research was excluded.

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Amid privacy concerns, startup becomes first consumer DNA company to offer anonymous sequencing

10 hours 4 min ago

The upstart direct-to-consumer DNA-testing company Nebula Genomics announced on Thursday that it will offer anonymous genome sequencing, becoming the first to do so amid public concerns about the privacy of genetic data and law enforcement use of public DNA databases to identify suspects.

Customers will be able to purchase Nebula’s whole-genome sequencing “without sharing their name, address, or credit card information,” said Nebula co-founder and chief scientific officer Dennis Grishin.

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Opinion: Health care providers: canaries in the coal mines of American society?

10 hours 46 min ago

For hundreds of years, health care providers have been on the front lines of social change. Think Margaret Sanger, a nurse who championed women’s rights and started the organization that later became Planned Parenthood, or Max Recamier, one of the physician founders of Doctors Without Borders, who openly worked against governments fomenting violence.

As we lose more and more clinicians to burnout, our nation is losing some of its most effective agents for social change. And if medical schools choose to heed Dr. Stanley Goldfarb’s recent call to shun “social justice” in medical education (the quotes are Goldfarb’s), then we could very well lose a whole generation of them.

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STAT Plus: Pharmalittle: Pelosi unveils aggressive drug pricing plan; Novartis says baby death not related to gene therapy

11 hours 4 min ago

Good morning, everyone, and how are you today? We are doing just fine, thank you, courtesy of a warm and shiny sun and a delicious cool breeze wafting across the Pharmalot campus. Moreover, a soothing quietude has descended upon us now that our short person has left for the local schoolhouse and our official mascot has taken up his snoozing position in a faraway corner. As for us, yes, we are brewing our ritual cups of stimulation — we favor hot-buttered rum today, for those keeping track. Meanwhile, here is the latest menu of interesting items for you. Hope you have a wonderful day and do keep in touch. …

House Speaker Nancy Pelosi on Thursday formally unveiled her long-awaited plan to lower drug prices, giving Democrats an aggressive counter to the White House’s numerous and widely covered efforts to lower drug prices, STAT reports. The plan would enact an international price index, capping U.S. drug payments for Medicare at an average of foreign prices, and require the federal government to negotiate the cost of 250 prescription medicines, using the international price as a maximum price, and extend the negotiated price to insurers and the commercial market at large. The bill would also cap senior out-of-pocket drug expenses at $2,000 annually.

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Pelosi’s drug pricing plan would let Medicare negotiate prices for up to 250 drugs

11 hours 49 min ago

WASHINGTON — House Speaker Nancy Pelosi unveiled her long-awaited plan to lower drug prices Thursday.

The progressive plan gives Democrats an aggressive counter to the White House’s numerous and widely covered efforts to lower drug prices. But the plan also serves, in some ways, as an olive branch to President Trump: Pelosi included many of the administration’s own ideas in her document, in apparent hopes of gaining his support.

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STAT Plus: Ginkgo Bioworks scores an eye-popping valuation with latest fundraise

15 hours 5 min ago

Quick: What’s the most valuable venture-backed startup in Boston?

Hint: If you don’t follow biotech closely, you’ve probably never heard of it.

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STAT Plus: A biotech startup hopes to disarm cancer by targeting a genetic bandolier

16 hours 4 min ago

Cancer, with all its wiles, has figured out how to withstand science’s best efforts by tapping a secret genetic arsenal. One company aims to kill drug-resistant tumors by cutting off their resupply.

Scores of treatments work by targeting cancer-causing genes like EGFR and HER2. But the trickiest tumors have devised a way to replace the malignant genes by reaching into tiny circles of DNA floating inside cancer cells, allowing tumors to grow despite a pharmaceutical assault. At Boundless Bio, which just raised $46 million in venture funding, the idea is to knock out the backup DNA before cancer can reload.

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Opinion: Eliminating ‘tensions’ in health care: a litmus test for innovation

16 hours 29 min ago

The term “innovation,” once considered an insult in religious sectors, has garnered a cult following in health care. Dozens of health innovation accelerators, incubators, labs, and centers now exist in universities, nonprofit institutions, and corporations across the country, and new ones are emerging all the time.

It is easy to understand why: the promise of innovation is astounding. Innovation done well can improve health care outcomes, decrease costs, serve more people, create market share, and help institutions gain cutting-edge reputations. And as health care spending approaches 20% of the U.S. economy, it’s apparent why the concept holds so much appeal for decision-makers and innovators.

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Democrats still have questions about Nancy Pelosi’s drug pricing plan

16 hours 34 min ago

WASHINGTON — For months, Nancy Pelosi has kept even her fellow Democrats in the dark on her plan to lower drug prices.

The big reveal, for the lawmakers, came this week: Pelosi barnstormed the Capitol as if campaigning for office, pitching moderate, progressive, and middle-ground Democratic groups on her plan. But for many members of Congress, Pelosi’s presentation left more to be desired — even as she’s expected to publicly release it as soon as today.

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STAT Plus: Flawed trials supported half of recent approvals of cancer drugs in Europe, study says

Wed, 09/18/2019 - 15:30

As drug makers race to bring cancer treatments to market, a new study finds about half of the supporting clinical trials for cancer medicines recently approved in Europe had a high risk of bias, underscoring concerns about approval standards and exaggerated benefits for patients.

Concerned about potential flaws in design, analysis, and reporting of studies, the researchers examined randomized, controlled trials used to win approval in Europe for cancer drugs from 2014 to 2016. During that time, the European Medicines Agency approved 32 new cancer medicines based on 54 studies. Of these, 41, or 76%, were randomized and controlled, but publications were available for only 39.

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Opinion: Constant, rapid testing is key to creating the ‘learning health system’ of the future

Wed, 09/18/2019 - 14:00

In this era of evidence-based medicine, you’d be right to expect hospitals and doctor’s offices to base their operational interventions on evidence, too. The reality is, they don’t.

Instead, most try to encourage evidence-based care by doing things that seem like good ideas: sending mailers, putting up posters, calling patients, adding alerts to electronic health records, engaging community health workers, and involving care managers. Most of the time it’s impossible to tell whether such interventions actually improve outcomes like obtaining preventive care, preventing people from being readmitted to the hospital, or receiving evidence-based treatment.

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STAT Plus: Industry groups push back against ‘troubling’ FDA crackdown on genetic tests used to predict response to drugs

Wed, 09/18/2019 - 12:57

In recent weeks, the genetic testing world has been rattled by the Food and Drug Administration’s efforts to quietly pressure a number of companies to stop reporting results to patients about how their genes may interact with specific drugs. Now, increasingly, the industry is pushing back.

On Wednesday, a trade group that represents clinical laboratories sent a sharply worded letter to the agency calling its enforcement actions “troubling” and “inappropriate.” The letter, from the American Clinical Laboratory Association, warned that the agency’s actions could stifle the growth of a burgeoning industry and make it harder for patients to get the right types and doses of their medications.

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STAT Plus: FDA unveils new plan to modernize its technology — and make more efficient use of data

Wed, 09/18/2019 - 10:20

Dr. Amy Abernethy, the principal deputy commissioner at the Food and Drug Administration, is unveiling a three-point plan to radically redirect the agency’s efforts at using computer technology.

At a Wednesday meeting held by Friends of Cancer Research, a patient advocacy group, Abernethy, who is also the FDA’s acting chief information officer, plans to outline how regulators can move more of their work to “the cloud” — virtual servers – and automate work that is now done by hand. This, she said, could change the way that the agency interacts with the companies it regulates. She also expressed a desire to set up new lines of communication with the technology industry.

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STAT Plus: Sandoz halts global distribution of heartburn med over carcinogen link while Canada tells other manufacturers to stop

Wed, 09/18/2019 - 09:03

The Sandoz unit of Novartis (NVS) is halting worldwide distribution of heartburn medicines containing high levels of a carcinogen and also issued a recall in some European countries and Canada.

The move comes as regulators scramble to understand why an impurity known as NDMA was found in the medicines, which are sold over the counter and by prescription. The same carcinogen was also detected last year in a class of blood pressure pills, prompting a spate of ongoing recalls, and these episodes have sparked broader concerns over the quality of the pharmaceutical supply chain.

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Canada investigating a case of vaping-related illness

Wed, 09/18/2019 - 08:36

Health officials in London, Ontario, are investigating a case of vaping-related illness in a youth who suffered severe respiratory problems that have been linked to e-cigarette use.

Officials at the Middlesex-London Health Unit in London — a city southwest of Toronto — did not reveal many details about the individual.

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Opinion: Dreamers like me fill critical gaps in mental health care. The Dream and Promise Act will let us keep doing that

Wed, 09/18/2019 - 07:51

In 1993, when I was 3 years old, my family left Pakistan for the United States. My parents were searching for a brighter, safer future and better educational opportunities for their children. All of that came true for me, but now it is being threatened by President Trump’s decision to rescind the Deferred Action for Childhood Arrivals (DACA) program, which gives young undocumented immigrants — often called Dreamers — the right to live and work in the United States without fear of deportation.

I’m now working in my dream job as a psychiatrist in a hospital and Veterans Health Administration clinic just outside Chicago. It’s a career I chose after overcoming a great deal of hardship, including an impoverished childhood. It allows me to give back to the country I now call home. But though I’m filling a critical labor gap in the health care workforce, I worry that my days here may be numbered.

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STAT Plus: Pharmalittle: Senators ask FTC to probe pharma mergers; is the Purdue settlement blood money?

Wed, 09/18/2019 - 06:49

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is … pumpkin spice. Remember that no prescription is required. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day and please do stay in touch …

Lawyers for cities and counties suing drug companies over the opioid epidemic on Monday objected to a bid by pharmaceutical distributors and pharmacies to disqualify the federal judge overseeing the cases, saying it had no basis and came too late, Reuters reports. The lawyers for the plaintiffs argued the companies had waived their ability to seek the judge’s recusal, noting they were relying on statements he made more than a year ago to belatedly seek his disqualification.

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Opinion: Why didn’t nonprofits and the NIH require ‘reasonable’ pricing for Zolgensma? That may happen in France

Wed, 09/18/2019 - 01:40

When a new drug emerges from research largely funded by grants from charities and government agencies, who gets to set the price? In the U.S., that question seems to have been answered — the drug company that makes it. As I’ve learned from a poorly redacted filing with the Securities and Exchange Commission, the answer may be different in France.

In May, the FDA approved Zolgensma, a gene therapy for young children with spinal muscular atrophy (SMA). Its maker, Novartis, set the price at $2.1 million, roughly nine times the median sale price for a home in the U.S. and 33 times the national per capita income.

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