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Updated: 8 hours 15 min ago

FDA approves Amarin fish-oil-derived drug to prevent heart attacks and strokes

Fri, 12/13/2019 - 14:47

The Food and Drug Administration on Friday expanded the approval of Vascepa, a fish-oil-derived medicine, to allow the drug’s maker to say it prevents heart attacks, strokes, and related health problems in people who are at high cardiovascular risk.

The approval reverses decades of mixed results for fish-oil-based drugs and could result in Vascepa being prescribed to millions of patients, potentially resulting in a windfall for the drug’s maker, Amarin Pharmaceuticals, which sells no other products.

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Opinion: Deadline looms to stop the Health Insurance Tax — but Congress has been there before

Fri, 12/13/2019 - 11:12

It has become something of an unintentional tradition in Congress to allow key votes to wait until days or hours before a pressing deadline, regardless of which party holds power.

More than once during my 10 years as a member of Congress, I spent much of the holiday season in Washington alongside my colleagues on an essential piece of legislation. In late 2012, for example, action was needed to avert the so-called “fiscal cliff” — a perfect storm created by a series of automatic tax increases and indiscriminate spending cuts set to take effect on New Year’s Day 2013.

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STAT Plus: Amid fears of superbugs, sales of antibiotics used in food-producing livestock rose last year

Fri, 12/13/2019 - 09:55

In a surprise showing, the sale of medically important antibiotics given to food-producing livestock rose last year, reversing a trend amid concerns such usage can cause antibiotic resistance in humans.

Sales rose 9% in 2018, compared with a 33% drop the year before, according to the latest annual report from the Food and Drug Administration. In particular, sales for tetracycline, which is used to treat a number infections in humans, rose 12%. The medicine was the most widely used antibiotic in livestock, accounting for 66% of all such medicines given to food-producing animals last year.

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STAT Plus: Up and down the ladder: The latest comings and goings

Fri, 12/13/2019 - 07:09

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Alector hired Dr. Shehnaaz Suliman as president and chief operating officer. She previously worked at Theravance Biopharma (TBPH), where she was senior vice president, corporate development and strategy.

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STAT Plus: Pharmalittle: FDA does about-face on rare disease drug; patent office pulls lawyer from Gilead case

Fri, 12/13/2019 - 06:26

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is notably modest this time around. We plan to catch up on a thick pile of reading, take a few naps, and perhaps binge-watch a show on the telly, a rare indulgence. And what about you? The holiday season is fast approaching, but there is still time to make getaway plans. This is also an opportunity to stimulate the economy and purchase some gifts. You might consider a year-end charitable donation (but do try to avoid those that serve as piggy banks for their namesakes). Or you could simply take stock of life, such as it is. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon.

House Democrats passed sweeping legislation to lower prescription drug prices, marking the latest volley in a health care debate that has animated progressives, Republican lawmakers, drug makers, and the Trump administration all year, STAT explains. But the high-stakes showdown over drug prices is far from over. President Trump has vowed to veto the bill, which passed on a 230-192 vote, largely along party lines. And the Republican-controlled Senate is still considering a separate, less aggressive bipartisan drug pricing package.

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STAT Plus: The good, the bad, and the really, really ugly behind Sarepta’s drug approval

Fri, 12/13/2019 - 04:58

What does it all mean now that the Food and Drug Administration has issued a surprise decision to approve Sarepta Therapeutics’ Duchenne muscular dystrophy drug Vyondys 53, reversing its surprise decision to reject the drug in August?

Here are some thoughts and observations about the latest twist in the always twisty Sarepta story, including potential implications for Biogen and its controversial Alzheimer’s drug.

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STAT Plus: U.S. Patent Office removes lawyer from high-profile case involving a Gilead HIV medicine

Fri, 12/13/2019 - 02:55

The U.S. Patent and Trademark Office has removed a senior legal adviser from a high-profile case after she tweeted contentious remarks about the right of AIDS activists to challenge a patent-term extension sought by Gilead Sciences (GILD) for an HIV medicine.

A spokesman for the federal agency told us that Mary Till, a 14-year employee who reviews extension requests, is “no longer working on the matter.”

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Opinion: Integrated care opens new doors to mental health, addiction care

Fri, 12/13/2019 - 01:50

In every American community — wealthy or poor, rural or urban, young or old — at least 1 in 5 people live with mental health disorders. And yet no American community has an adequate supply of mental health clinicians who can provide timely, affordable, high-quality care for the people who need it.

Untreated mental illness has a profound toll: poor health outcomes, missed work, high costs of care, and premature death. Only half of individuals referred for treatment are actually seen by a mental health care provider and, when they are, the average number of visits is just two. Only half of psychiatrists accept insurance, and less than half of U.S. counties have any psychiatrists at all.

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Opinion: BMJ should retract flawed research paper on chronic fatigue syndrome

Fri, 12/13/2019 - 01:40

Few journals have been more admirable than The BMJ (formerly the British Medical Journal) and some of its sister publications under the BMJ brand in highlighting issues of direct significance to health care consumers. So it is baffling — and troubling — when BMJ editors fail to take appropriate action to address unacceptable lapses in high-profile research they have published.

For years, the reading list for my journalism class on public health and medicine at the University of California, Berkeley, included groundbreaking articles in The BMJ on “disease-mongering” — how pharmaceutical companies have manipulated and misrepresented research data to expand existing diagnostic categories and create new ones. I have also appreciated BMJ’s campaign for open access to trial data and its forays into investigative journalism.

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My baby needed expensive intensive care, but my insurer was taking a long weekend. How can this be?

Fri, 12/13/2019 - 01:35

On Thanksgiving evening my baby spiked a high fever. By Friday morning her little head started bobbing up and down as it became hard for her to breathe. My daughter had an infection and she was in respiratory distress.

We rushed to a pediatric emergency room where the doctors recommended that she be admitted to their hospital’s intensive care unit. Because we ended up at a hospital that was considered “out of network” by my insurance plan, I called the number on the back of my insurance card to make sure the emergency admission was OK. To my horror, the office was closed and would not re-open until Monday. 

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STAT Plus: Biotech veteran Chris Garabedian on Sarepta’s legacy and Biogen’s future at the FDA

Fri, 12/13/2019 - 01:30

This September marked the third anniversary of a pivotal moment in biotech. Back in 2016, Sarepta Therapeutics convinced the Food and Drug Administration to approve a treatment for Duchenne muscular dystrophy based on preliminary evidence from a tiny clinical trial.

Critics — and there were many — argued that Sarepta hadn’t done enough to prove that its drug could actually help patients. And there were countless tweets and editorials claiming that the FDA had set a dangerous precedent by approving the company’s medicine.

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FDA changes course on Sarepta’s once-rejected muscular dystrophy drug

Thu, 12/12/2019 - 15:47

The Food and Drug Administration reversed its decision on a treatment for Duchenne muscular dystrophy from Sarepta Therapeutics, approving a previously rejected drug without explaining what the problem was in the first place.

The therapy, called Vyondys 53, is approved to treat the roughly 8% of Duchenne patients whose disease results from a specific DNA error. In a clinical trial, Sarepta’s drug produced a small increase in an important muscle protein called dystrophin that is normally missing in children with Duchenne. The company has yet to demonstrate that Vyondys 53 can improve muscle function or slow the progression of the disease.

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Listen: The future of CAR-T, an alarming cancer trend, and Sarepta’s FDA legacy

Thu, 12/12/2019 - 13:28

Has CAR-T lost its luster? Why is colorectal cancer on the rise? And did the FDA forever change in 2016?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. First, we dig into the news out of this week’s big hematology conference, where novel treatments for blood cancer threatened the future of genetically engineered CAR-T therapies. Then, former Sarepta Therapeutics CEO Chris Garabedian joins us to talk about the company’s regulatory legacy and what he’s been up to since leaving it. Finally, we talk to Manju George, a patient activist working to spread the word about the alarming increase of colorectal cancer among young people.

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STAT Plus: PhRMA sues Oregon over drug pricing transparency laws, calling them ‘unconstitutional’

Thu, 12/12/2019 - 12:52

The trade group for the pharmaceutical industry has filed a lawsuit alleging a pair of Oregon laws is unconstitutional, the latest bid to push back against state efforts to shed more light on the rising cost of prescription medicines.

One law required drug makers to notify the state when list prices rise by at least 10% or a new medicine is introduced that costs more than $670 for a month’s supply. In addition, the drug companies must explain why prices rose and provide detailed information about manufacturing, marketing, and distribution costs. Known as the Disclosure Law, the measure went into effect earlier this year.

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Senate confirms Stephen Hahn, oncologist and political newcomer, as FDA commissioner

Thu, 12/12/2019 - 11:15

WASHINGTON — Dr. Stephen Hahn will now be the man in charge of regulating e-cigarettes, ultra-expensive drugs, and medical cannabis products — at a time of increased political focus on all fronts.

The Senate on Thursday voted to confirm Hahn, who has no previous political experience in Washington, as the next head of the Food and Drug Administration, the agency charged with regulating countless other food and drug products.

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House passes major drug-pricing bill, a Democratic salvo in a showdown far from over

Thu, 12/12/2019 - 11:12

WASHINGTON — House Democrats on Thursday passed sweeping legislation to lower prescription drug prices, marking the latest volley in a health care debate that has animated progressives, Republican lawmakers, pharmaceutical industry groups, and the Trump administration throughout the year. With the GOP-majority Senate certain to ignore Democrats’ bill, however, the high-stakes showdown over drug prices is far from over.

Democrats project that their bill, which would require Medicare to negotiate the price of between 50 and 250 prescription drugs, would lower consumer drug spending by 55%, save the federal government nearly $400 billion, and slash drug industry revenues by $1 trillion in the coming decade. Democrats plan to invest those funds in a historic Medicare expansion that would allow the program to fund hearing, vision, and dental benefits for the first time.

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STAT Plus: Activists say a patent office lawyer’s tweets showed ‘bias’ in favor of Gilead in HIV drug case

Thu, 12/12/2019 - 10:13

One day after AIDS activists petitioned the U.S. Patent and Trademark Office last week to reject a request by Gilead Sciences (GILD) for a patent extension on an HIV drug, a senior legal adviser at the federal agency tweeted contentious remarks about their right to take such a step. She also challenged a key point in their filing.

Now, the activists have filed yet another petition with the USPTO and accused the legal adviser of making inappropriate remarks and displaying favoritism toward Gilead. And the activists, known as the PrEP4All Collaboration, have also asked the USPTO to reassign the adviser — a 14-year-employee named Mary Till — while their petition remains active.

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STAT Plus: Pharmalittle: Pharma ad spend skyrockets to defeat drug pricing bill; many antibiotic prescriptions are inappropriate

Thu, 12/12/2019 - 06:33

Top of the morning to you, and a fine one it is. After a quick out-of-town speaking engagement, we have happily returned to the Pharmalot campus, where we awoke to sunny skies and a bit of a nip in the air. Certainly nice to be back in the groove, as they say, and to celebrate, we have fired up the coffee kettle to enjoy a cup or three of stimulation. Feel free to join us. After all, no prescription is required. So no need to fuss over rebates or authorization to try a different flavor. Meanwhile, here are some tidbits. Hope all goes well and do keep in touch.

As voting neared on the House drug pricing bill, the legislation has prompted a barrage of advertising from the pharmaceutical industry in newspapers that circulate in Washington, D.C., STAT reports. The ads are unlikely to prevent the House from passing the bill, but are emblematic of a larger truth in Washington: Never underestimate deep industry pockets when it comes to drug pricing legislation. And the last-minute blitz is already being decried by drug pricing advocates.

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Opinion: Congress: Don’t eliminate funding for the diversity creating Health Career Opportunity Program

Thu, 12/12/2019 - 01:45

The Senate is preparing to make a big mistake with a small budget item.

On Dec. 20, it will vote on its proposed budget for the 2020 fiscal year. If approved in its current form, the new budget will completely eliminate the Health Career Opportunity Program (HCOP), a nearly $15 million national pipeline program for diversifying the U.S. health care workforce. Enacted in 1972, HCOP is a federally funded grant program that helps students from economically and/or educationally disadvantaged backgrounds develop the skills needed to successfully compete for, enter, and graduate from medical, nursing, and other health professional schools.

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Opinion: Machine learning for clinical decision-making: pay attention to what you don’t see

Thu, 12/12/2019 - 01:40

Even as machine learning and artificial intelligence are drawing substantial attention in health care, overzealousness for these technologies has created an environment in which other critical aspects of the research are often overlooked.

There’s no question that the increasing availability of large data sources and off-the-shelf machine learning tools offer tremendous resources to researchers. Yet a lack of understanding about the limitations of both the data and the algorithms can lead to erroneous or unsupported conclusions.

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