Medical System – APRA https://www.americanpatient.org American Patient Rights Association Sun, 09 Feb 2025 17:22:46 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://www.americanpatient.org/wp-content/uploads/2018/07/favicon-APRA1-150x150.png Medical System – APRA https://www.americanpatient.org 32 32 US spends most on health care but continues to have worst health outcomes among high-income countries, new report finds https://www.americanpatient.org/us-spends-most-on-health-care-but-has-worst-health-outcomes-among-high-income-countries-new-report-finds/?utm_source=rss&utm_medium=rss&utm_campaign=us-spends-most-on-health-care-but-has-worst-health-outcomes-among-high-income-countries-new-report-finds Thu, 09 Feb 2023 21:53:48 +0000 https://www.americanpatient.org/?p=59605 Why the US healthcare system ranks last among 11 wealthy countries https://www.americanpatient.org/why-the-us-healthcare-system-ranks-last-among-11-wealthy-countries/?utm_source=rss&utm_medium=rss&utm_campaign=why-the-us-healthcare-system-ranks-last-among-11-wealthy-countries https://www.americanpatient.org/why-the-us-healthcare-system-ranks-last-among-11-wealthy-countries/#respond Tue, 31 Aug 2021 21:01:17 +0000 https://www.americanpatient.org/?p=56695 Read More]]>

By Katie Adams, Becker’s Hospital Review, August 4th, 2021.

The performance of the U.S. healthcare system ranked last among 11 high-income countries, according to a report released Aug. 4 by the Commonwealth Fund.

To compare the performance of the healthcare systems in 11 high-income countries, the Commonwealth Fund analyzed 71 performance measures across five domains: access to care, care process, administrative efficiency, equity and patient outcomes.

Despite spending far more of its gross domestic product on healthcare than the other nations included in the report, the U.S. ranked last overall, as well as last for access to care, administrative efficiency, equity and patient outcomes. However, the U.S. ranked second on measures of care process, trailing only New Zealand.

Norway, the Netherlands and Australia had the best healthcare system performance, according to the report. In all seven iterations of the study conducted by the Commonwealth Fund since 2004, the U.S. has ranked last. It is the only country included in the study that does not provide its citizens with universal health insurance coverage.

Four features separate the top performing countries from the U.S., according to the report: universal health insurance coverage and removal of cost barriers; investment in primary care systems to ensure equitable healthcare access; reduction of administrative burdens that divert time and spending from health improvement efforts; and investment in social services, particularly for children and working-age adults.

Link to the original article.

Link to the Commonwealth Fund article

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Our Broken Medical System Threatens Patients https://www.americanpatient.org/our-broken-medical-system/?utm_source=rss&utm_medium=rss&utm_campaign=our-broken-medical-system Tue, 01 Dec 2020 18:20:21 +0000 https://www.americanpatient.org/?p=12393 Read More]]> Our profit-driven healthcare system is broken and your life, as well as your savings, are at risk.

Unexpected medical bills, such as from out-of-network doctors who people thought were in-network, visits to the ER, hospital stays, or ambulance rides are resulting in over 500,000 people a year declaring bankruptcy (62% of all bankruptcies*). One in five Americans has medical debt in collections. And it’s not just the poor who are at risk. It’s also the middle class and even some who may be considered wealthy.

Even people with health insurance, including Medicare, can be threatened with bankruptcy because of doctors’ fees, operations, procedures, tests, and medications that their insurance doesn’t cover or their insurer refuses to pay for. 72% of patients bankrupted by medical bills have health insurance*.

And a growing, hidden epidemic of preventable medical errors in our hospitals, the 3rd leading cause of death, is killing between 250,000 and 400,000 people a year and injuring millions more. This is mainly the result of a misguided effort by hospitals, even “nonprofit” hospitals, to put profit before patient safety. And they’re not alone. Drug and medical device manufacturers, health insurers, and nursing homes are also guilty. Even the FDA puts patient’s lives at risk when it approves medications based on the influence of special interests and most medical devices without any testing at all.

Our broken medical system:

  • puts profit before patients’ lives
  • does not regulate health care prices
  • allows the cost of medical services to be hidden
  • bankrupts people who can’t pay their medical bills, even if the costs were hidden, the bills are inflated, unreasonable, predatory, fraudulent, or error-filled (80% of hospital bills contain errors).
  • won’t reveal dangerous doctors
  • threatens whistleblowers, including those who expose patient safety issues
  • won’t accept medical error as a cause of death
  • allows hospitals to pay the organization that inspects them
  • is secretive and hides serious harm and threats to patients
  • won’t make patient safety a priority.

APRA is fighting for fair, safe, transparent, affordable health care. 

Join Today for Free

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A New Hippocratic Oath Asks Doctors To Fight Racial Injustice And Misinformation https://www.americanpatient.org/a-new-hippocratic-oath-asks-doctors-to-fight-racial-injustice-and-misinformation/?utm_source=rss&utm_medium=rss&utm_campaign=a-new-hippocratic-oath-asks-doctors-to-fight-racial-injustice-and-misinformation Wed, 04 Nov 2020 17:25:24 +0000 https://www.americanpatient.org/?p=12194 Read More]]> By SARAH BODEN, for WESA-FM, November 4, 2020.

First-year medical student Sean Sweat “didn’t want to tiptoe around” issues of race when she sat down with 11 of her classmates to write a new version of the medical profession’s venerable Hippocratic oath.

“We start our medical journey amidst the COVID-19 pandemic, and a national civil rights movement reinvigorated by the killings of Breonna Taylor, George Floyd and Ahmaud Arbery,” begins the alternate version of the oath, rewritten for the class of 2024 at the University of Pittsburgh School of Medicine.

It continues: “We honor the 700,000+ lives lost to COVID-19, despite the sacrifices of health care workers.”

Sweat and the other incoming first-year medical students recited this newly penned pledge, along with a traditional version of the Hippocratic oath, as part of orientation activities during their first week of medical school this fall.

The earliest known version of the Hippocratic oath dates back to the fifth century B.C. Many iterations exist, and in many U.S. medical schools it’s become customary for incoming medical students to write and even recite their own versions; many of the variants include language that prohibits discrimination or bias in the practice of medicine.

What’s distinctive about the University of Pittsburgh version is that it specifically names people who have died recently at the hands of police and thereby addresses events that are still unfolding.

“Our oath can be both timely and timeless,” Sweat says.

Increasingly, medical professionals are joining protests for racial justice and acknowledging racism’s impact on public health. For example, Black residents of Allegheny County, where Pittsburgh is the county seat, have been disproportionately hurt by the coronavirus, like Blacks in other parts of the United States. Though 13% of Allegheny County is Black, Black residents make up nearly 19% of cases and 30% of COVID-19 hospitalizations.

“This pandemic has wreaked havoc on minority populations,” Sweat says. “It has revealed the many gaps within the medical field. … A lot of those gaps that this pandemic has revealed, those are things we need to go after to fix.”

Bioethicist Laura Guidry-Grimes agrees this year has been a “paradigm-shifting time” that has brought a “reckoning” for medicine, and therefore she likes that the University of Pittsburgh version of the Hippocratic oath discusses COVID-19.

“[It acknowledges] that we have been challenged and learned the hard way … that what we’ve been doing is not enough,” says Guidry-Grimes, an assistant professor in the Department of Medical Humanities and Bioethics at the University of Arkansas.

The new oath asks physicians to eliminate their personal biases, combat disinformation to improve health literacy and be an ally to minorities and other underserved groups in society.
It also calls on doctors to learn about the social determinants of health “to use my voice as a physician to advocate for a more equitable health care system from the local to the global level.”

But some worry that the proliferation of different versions of physician oaths could weaken their intended effect on the profession. A 2004 paper in Academic Medicine suggested that the trend might even lead to “fragmentation and confusion about the ethical values of the medical profession.”

But Guidry-Grimes says she thinks that concern is misplaced. If anything, she worries that physician oaths have lost relevance: “My fear is that too often that the oath taking is a ritual for the sake of ritual,” she says. “You have words washing over everything without meaning or impact.” If that is the case, exercises such as rewriting the oaths are helpful in that they may spur medical students to consider more deeply professional ethics and their sense of mission.
For Sweat, the oath she helped write has meaning and will continue to guide her as she launches her career. “Patients entrust us to take care of their health,” she says. “In my opinion we’re more than just physicians. We’re leaders in this society. With that comes a responsibility.”

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Lack of darker skin in textbooks and journals harms care for patients of color https://www.americanpatient.org/lack-of-darker-skin-in-textbooks-and-journals-harms-care-for-patients-of-color/?utm_source=rss&utm_medium=rss&utm_campaign=lack-of-darker-skin-in-textbooks-and-journals-harms-care-for-patients-of-color Fri, 23 Oct 2020 00:44:30 +0000 https://www.americanpatient.org/?p=12082 Read More]]> By Usha Lee McFarling, STAT News, Jul 21, 2020.

When dermatologist Jenna Lester learned that rashes on skin and toes were a symptom of Covid-19, she started searching the medical literature for images of what the rashes looked like on Black skin, so she’d recognize it in her Black patients. She couldn’t find a single picture.

“I was frustrated because we know Covid-19 is disproportionately impacting communities of color,” said Lester, an assistant professor of dermatology at the University of California, San Francisco who recently published her analysis. “I felt like I was seeing a disparity being built right before my eyes.”

The dearth of images in the Covid-19 literature is just the newest example of the glaring lack of representation of Black and brown skin that has persisted in dermatology research journals and textbooks for decades. The issue is coming under closer scrutiny now as dermatologists, like many physicians, grapple more openly with systemic racism and the health disparities it is causing in their field.

“Black Lives Matter is forcing a lot of people to look inward and say, ‘Where are our shortcomings?’” said Nada Elbuluk, an associate professor of clinical dermatology at the University of Southern California and the founder of a diversity and inclusion program in her department. “Dermatology is no different.”

The discrimination in her specialty extends beyond images and gaps in training, to restrictive insurance coverage for skin conditions that affect people with heavily pigmented skin, and to the many dermatologists who don’t accept patients with Medicaid.

It may be no surprise that a field that focuses on skin is now reckoning with skin color. In dermatology, where images are critical for diagnoses, the lack of images of darker skin poses a roadblock to proper treatment and medical education. Skin conditions that involve redness or pinkness in light skin can be subtler or harder to see in dark skin, and physicians who haven’t been adequately trained with such images are prone to misdiagnose people of color. “We absolutely need a diversity of images,” said Elbuluk.

An analysis of textbooks by Jules Lipoff, an assistant professor of clinical dermatology at the University of Pennsylvania, showed the percentage of images of dark skin ranged from 4% to 18%. “We are not teaching (and possibly not learning) skin of color,” Lester wrote in a separate analysis she conducted. Many worry the field’s shift toward using artificial intelligence to aid diagnosis of disease will further deepen the divide, because the machine learning algorithms are trained with datasets consisting primarily of fair-skinned images.

It gets worse. While many textbooks depict the vast majority of skin diseases using light skin, there is one notable exception: Black skin is more often used to depict sexually transmitted diseases, a glaring example of stereotyping that is all the more painful given the U.S. government’s complicity in the notorious Tuskegee experiments that left syphilis untreated for decades in a group of poor, Black men.

Lipoff’s analysis, published this year, showed many dermatology textbooks had zero images of dark skin with acne, psoriasis, or dermatitis. When it came to syphilis, however, many books relied heavily on images of dark skin. Lester’s analysis found that while 28% of images of infectious diseases used images of darker skin, the number of depictions of dark skin was twice as high for infections that were sexually transmitted.
“In the textbooks I used in medical school, every penis was a Black penis showing an STD. We’ve got to stop that,” said Susan Taylor, a pioneer in the push for better dermatologic care for patients with dark skin and the Sandra Lazarus professor of dermatology at the Perelman School of Medicine at the University of Pennsylvania.

Considered a trailblazer in the field of dermatology, Taylor established the nation’s first “Skin of Color” dermatology clinic at Mount Sinai in New York in the late 1990s. In 2004, she founded the Skin of Color Society to help educate fellow dermatologists about how to treat patients of color, push for research and clinical trials to include people with darker skin, and mentor and encourage medical students of color to enter dermatology, where only 3% of practitioners are Black and 4% are Hispanic. “These are really abysmal numbers,” Taylor said. “That’s got to change.”

Taylor is also the lead author of the textbook Dermatology for Skin of Color, a guide considered invaluable by many dermatologists. But even those who rely on the book say it’s frustrating that a separate book on dark skin is still required — when as a nation we are just a few decades away from a majority of residents having skin of color.

“This is the white patient treated as the default and the Black patient as the asterisk,” said Lipoff. “You can’t make skin of color a lecture that students get once a year. It can’t be ‘otherized’ or put in a separate textbook.”

Taylor agrees. “Nothing would make me happier than to not have to publish another edition of that book,” she said.

Dermatologists say the lack of images is one reason why many conditions, including Lyme disease, spider bites, and cancers can go misdiagnosed or underdiagnosed in darker skinned patients, sometimes with dangerous results. The five-year melanoma survival rate for Black patients is just 70% compared with 94% for white patients.

The mother of a mixed-race 13-year-old from Connecticut said she was told by her child’s pediatrician when she was 8 that the white patches on her skin were pityriasis alba, a skin rash that’s usually not considered a serious condition. She was given a lotion, but the skin patches never went away. “I kept going online and looking at things, but I couldn’t see anyone with issues that looked like hers,” said the mother, who didn’t want her name used to protect the girl’s privacy. “And the doctor was casual about it.”

Partly because of insurance issues, and partly because the mother thought there was nothing to worry about, it took five years before her daughter’s white patches were properly diagnosed: She had T-cell lymphoma, a cancer. While she will require maintenance light therapy for life, her overall prognosis is good. But her case highlights the difficult and sometimes frightening challenge many patients of color face to get a proper dermatologic diagnosis.

When Ellen Buchanan Weiss noticed patches on the dark brown skin of her toddler son, she wondered if it was eczema, or something more serious. “I Googled it and noticed immediately the pictures were all of white skin,” she said. “I Googled other conditions and it was the same. No matter what I searched, there were almost no images of dark skin.”

The patches did turn out to be eczema and were easily treated. Still, the disparity bothered her for months. About a year ago, Weiss, a stay-at-home mom in Raleigh, N.C., decided to create an Instagram account called “Brown Skin Matters.” She posted images of skin conditions in darker skin next to images of the same condition in white skin and asked followers to send in more photos. The account exploded almost immediately.

“I’ve had tons of medical schools, physicians, nurses, and pharmacists all contact me saying this was useful,” she said. “I never thought this was going to become a diagnostic tool.”

Instagram is not exactly the best platform for making medical diagnoses, so Weiss is now working with medical experts to help create a more rigorous and searchable web-based tool for diagnosis of skin diseases in darker skin. It still floors Weiss that she, a person with no medical background, is at the center of it. “It’s curious to me, and troubling, that this is 2020 and this gap is still here,” she said. “Some large medical institution should have been taking care of this, not me.”

The issue of textbooks failing to adequately represent skin of color is not a new one. Yet Lipoff’s study compared today’s textbooks with those of 15 years ago and found little has changed. Jean Bolognia, a professor of dermatology at the Yale School of Medicine, has spent more than two decades editing the widely used textbook, Dermatology; she said providing a wide spectrum of skin tones is critical and something she’s worked hard to include, though she acknowledged there’s more work to do.

“I’m not saying it’s perfect, but we’ve been working really hard for over 15 years to show the whole spectrum,” said Bolognia, who is now working on the fifth edition of the textbook. “I feel you can always do better and I realize I don’t have enough images of Asian skin, so that is something I’m addressing.”

Bolognia said she tries to include photos of the same condition in darkly pigmented and lightly pigmented skin, cropped exactly the same way and side-by-side for comparison so readers can see how the same condition can appear significantly different on darker skin. She also includes many more images of dark skin of conditions, like cutaneous lupus or scarring folliculitis, that are more likely to affect Black people.

Bolognia said she is extremely sensitive about not stigmatizing people of color by using only images of darkly pigmented skin to illustrate sexually transmitted diseases or drug users. “I noticed this as a student, the images of STDs were nearly all of patients with darkly pigmented skin, but the people I saw with syphilis were often fair-skinned,” she said. “I wondered about the possibility that pictures were being taken of individuals who were less likely to say no.”

The field’s other widely used textbook is Andrews’ Diseases of the Skin. That book’s lead author, William James, is a longtime champion of diversity in dermatology, according to his colleagues at Penn, who include Taylor and Lipoff. James said representing a variety of skin tones was an important issue, but said authors were challenged by limits placed on the number of photos by textbook publishers and because findings of redness or pinkness can be hard to see in images of darker skin. “Deciding if an entity is represented at all, or more than once, is always difficult,” he said in an email.

James said his textbook includes more photos of Black skin than white skin in conditions that are more common in Black patients, and noted that eight of 14 photos of syphilis are in lighter skin.
A growing number of dermatologists are following Taylor’s lead and opening skin of color clinics that provide care for darker-skinned patients. Lester opened one at UCSF last year. Elbuluk has worked at or founded three skin of color clinics throughout her training and early career, including at Penn, NYU Medical School, and, in 2018, at USC, where she hopes to also spur much-needed clinical research on darker skin. “It’s surprising to me when large cities don’t have these,” Elbuluk said.

There are many reasons why people of color, particularly those who do not have private health insurance, lack access to dermatologists. Lipoff, who has examined the issue, said many dermatologists do not take Medicaid. Racial bias that discourages the treatment of Black patients, he said, is literally built into the physician reimbursement system. Many conditions that affect darker skin are often not covered by insurance because they are considered cosmetic.

Meanwhile, the highest revenue procedures, Lipoff said, include those for the diagnosis and treatment of skin cancer, which is more likely to occur in white patients. This difference in how procedures are valued and reimbursed, he said, is a perfect example of structural racism that drives practices to directly and indirectly focus on white patients and marginalize Black patients. “If Black patients earned practices three times the revenue,” he said, “the disparity would disappear overnight.”

Until it does, physicians who run skin of color clinics are hoping to address the lack of care, and poor care, Black and brown patients have received. The clinics are a welcome addition to people like Dar Bray, a 45-year-old behavioral therapist and darker-skinned Black man from Los Angeles.

Bray had dealt for years with deep and persistent scars caused by acne, trying bleaching creams and expensive cosmetic products, all with no success. “I went to so many doctors who didn’t know what to do with my skin. All the pictures they had on their wall were fair-skinned people,” Bray said. “It didn’t feel like racism, it felt like just plain ignorance.”

Seeing Elbuluk, he said, was immediately different. Bray is now undergoing chemical peels to remove scarring and using simple (and inexpensive) cleansers and moisturizers, and says he sees a huge improvement in his skin. He’s also wearing sunscreen, something no physician had ever told him was necessary; like many, he had believed the myth “Black don’t crack.” “When I went to the beach, I never wore sunscreen,” he said. “Now I have years of sun damage.”

Mistrust of white physicians led Gregory Hines, a 63-year-old longshoreman who lives in Oakland, to go years without seeing a doctor about growths under his arm, on his back, and on his neck, even as they puffed up and became, in his words “kind of weird and ugly.”

“I experience it a lot, going to doctors — especially white, male doctors — they assume they know more than you. They assume they already know what your problem is the minute you walk through the door,” he said.

When he heard UCSF’s Skin of Color clinic had opened, he was willing to give it a try. “When Dr. Lester walked in, I said, ‘Whoa, this is great,’” he said. “I wanted a Black doctor who understands Black skin.”

Lester ended up removing the masses, one of which was nearly as large as a golf ball and sent them for tests to see if they were cancerous. Fortunately, they were not.

Lester is the only Black dermatologist in San Francisco. She’s hoping that will change after her current crop of residents decides where they will establish their practices. Her Black patients, she said, are often shocked when she walks in the door.

“I’ve had patients ask if they can take a picture with me to show their grandkids,” she said. “They want to talk all about me and how I got here, and I have to say, ‘No, this time is for you.’”

Article link: https://www.statnews.com/2020/07/21/dermatology-faces-reckoning-lack-of-darker-skin-in-textbooks-journals-harms-patients-of-color/

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2020 Scorecard on Health System Performance by State https://www.americanpatient.org/2020-scorecard-on-health-system-performance-by-state/?utm_source=rss&utm_medium=rss&utm_campaign=2020-scorecard-on-health-system-performance-by-state Fri, 18 Sep 2020 20:17:06 +0000 https://www.americanpatient.org/?p=11504 State Medical Boards and Health Department Websites https://www.americanpatient.org/state-territorial-health-department-websites/?utm_source=rss&utm_medium=rss&utm_campaign=state-territorial-health-department-websites Wed, 11 Mar 2020 21:00:11 +0000 https://www.americanpatient.org/?p=10043 State Medical Records Laws https://www.americanpatient.org/state-medical-records-laws/?utm_source=rss&utm_medium=rss&utm_campaign=state-medical-records-laws Wed, 11 Mar 2020 20:53:54 +0000 https://www.americanpatient.org/?p=10041 Health System Grinding Good Docs Out of Existence, Harming Patients https://www.americanpatient.org/health-system-grinding-good-docs-out-of-existence-harming-patients/?utm_source=rss&utm_medium=rss&utm_campaign=health-system-grinding-good-docs-out-of-existence-harming-patients Thu, 06 Feb 2020 18:50:12 +0000 https://www.americanpatient.org/?p=9820 Read More]]> By Melissa Bailey, KHN.org, FEBRUARY 4, 2020.  Excerpts from the original article.

Dr. Keith Corl was working in a Las Vegas emergency room when a patient arrived with chest pain. The patient, wearing his street clothes, had a two-minute exam in the triage area with a doctor, who ordered an X-ray and several other tests. But later, in the treatment area, when Corl met the man and lifted his shirt, it was clear the patient had shingles. Corl didn’t need any tests to diagnose the viral infection that causes a rash and searing pain.

All those tests? They turned out to be unnecessary and left the patient with over $1,000 in extra charges.

The excessive testing, Corl said, stemmed from a model of emergency care that forces doctors to practice “fast and loose medicine.” Patients get a battery of tests before a doctor even has time to hear their story or give them a proper exam.

“We’re just shotgunning,” Corl said.

Corl said he has been especially frustrated by a model of emergency medicine called “provider-in-triage.” It aims to improve efficiency but, he said, prioritizes speed at the cost of quality care. In this system, a patient who shows up to an ER is seen by a doctor in a triage area for a rapid exam lasting less than two minutes. In theory, a doctor in triage can more quickly identify patients’ ailments and get a head start on solving them. The patient is usually wearing street clothes and sitting in a chair.

These brief encounters may be good for business: They reduce the “door to doc” time — how long it takes to see a doctor — that hospitals sometimes boast about on billboards and websites. They enable hospitals to charge a facility fee much earlier, the minute a patient sees a doctor. And they reduce the number of people who leave the ER without “being seen,” which is another quality measure.

But “the real priority is speed and money and not our patients’ care,” Corl said. “That makes it tough for doctors who know they could be doing better for their patients.”

Emergency physician Dr. Angela Jarman sees similar challenges in California, including ER overcrowding and bureaucratic hurdles to discharging patients. As a result, she said, she must treat patients in the hallways, with noise, bright lights and a lack of privacy — a recipe for hospital-acquired delirium.

“Hallway medicine is such a [big] part of emergency medicine these days,” said Jarman, 35, an assistant professor of emergency medicine at UC-Davis. Patients are “literally stuck in the hallway. Everyone’s walking by. I know it must be embarrassing and dehumanizing.”

For example, when an older patient breaks an arm and cannot be released to their own care at home, they may stay in the ER for days as they await evaluation from a physical therapist and approval to transfer to rehab or a nursing home, she said. Meanwhile, the patient gets bumped into a bed in the hallway to make room for new patients who keep streaming in the door.

Also at UC-Davis, Dr. Nick Sawyer, an assistant professor of emergency medicine, has been working with medical students to analyze systemic problems. Among those they’ve identified: patients stuck in the ER for up to 1,000 hours while awaiting transfer to a psychiatric facility; patients who are not initially suicidal, but become suicidal while awaiting mental health care; patients who rely on the ER for primary care.

Sawyer, 38, said he has suffered moral injury from treating patients like this one: A Latina had a large kidney stone and a “huge amount of pain” but could not get surgery because the stone was not infected and therefore her case wasn’t deemed an “emergency” by her insurance plan.

“The health system is not set up to help patients. It’s set up to make money,” he said.

In Cumberland County, Pennsylvania, Mary Franco, who is now 65, retired early from her job as a nurse practitioner after a large corporation bought out the private practice she worked in. She said she saw “a dramatic shift” in the culture there, where “revenue became all-important.” The company cut in half the time for each patient’s annual exam, she said, down to 20 minutes. She spent much of that time clicking through electronic health records, she said, instead of looking the patient in the face. “I felt I short-shrifted them.”

In Chambersburg, Pennsylvania, Dr. Tate Kauffman left primary care for urgent care because he found himself spending half of each visit doing administrative tasks unrelated to a patient’s ailment — and spending nights and weekends slogging through paperwork required by insurers.

Corl said he was so fed up with the provider-in-triage model of emergency medicine that he moved his ER clinical work to smaller, community hospitals that don’t use that method.

“The system is flawed,” he said. “It’s grinding us. It’s grinding good docs and providers out of existence.”

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FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find  https://www.americanpatient.org/fda-approves-drugs-faster-than-ever-but-relies-on-weaker-evidence-researchers-find/?utm_source=rss&utm_medium=rss&utm_campaign=fda-approves-drugs-faster-than-ever-but-relies-on-weaker-evidence-researchers-find Thu, 30 Jan 2020 20:13:11 +0000 https://www.americanpatient.org/?p=9752 Read More]]> By Sydney Lupkin, NPR Shots, Jan 14, 2020.

The Food and Drug Administration has gotten faster at approving new prescription drugs over the past four decades, but the evidence it relies on in making those decisions is getting weaker, according to new research published Tuesday.

As a result, there are more cures and treatments on the market but less proof that they are safe and effective.

“There has been a gradual erosion of the evidence that’s required for FDA approval,” says lead study author Jonathan Darrow, a lawyer with Harvard Medical School’s Program on Regulation, Therapeutics and Law. As a result, patients and physicians “should not expect that new drugs will be dramatically better than older ones.”

Almost half of recent new drug approvals were based on only one pivotal clinical trial instead of the two or more that used to be the norm, according to the study published Tuesday in JAMA, the journal of the American Medical Association. And the reliance on surrogate measures — stand-ins for presumed patient benefits — has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment.

Darrow and his colleagues analyzed FDA drug approvals, changes in laws and regulations and the rise in industry funding of the agency’s reviews from 1983 through 2018.

The researchers found that the average number of new drug approvals per year increased from 34 in the 1990s to 41 in the 2010s, after a dip to 25 a year in the 2000s.

New drugs are getting through the FDA process faster. In 2018, the median review time for standard drug applications was 10.1 months compared with 2.8 years for standard and priority applications for the period from 1986 and 1992.

Faster approval was the goal of many legislative and regulatory changes starting in the 1980s. For instance, in 1983, Congress passed the Orphan Drug Act to encourage drugmakers toward developing rare disease treatments that otherwise might not be profitable. The FDA allowed approval for these drugs based on smaller trials with more flexible evidence standards, and it offered more time on the market for the medicines without generic competition.

Drugmakers also began paying the FDA fees to fund the review process after AIDS activists protested the agency’s sluggishness in the 1980s.

The FDA collected $29 million in fees in 1993, the year after Congress passed the Prescription Drug User Fee Act for the first time. The fees rose to $908 million in 2018. That year, industry fees amounted to about 80% of the money spent on FDA employee salaries for drug reviews, according to the study.

“There is some concern about the incentives that this is created within the FDA,” Darrow says. “And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry.”

Former FDA Principal Deputy Commissioner Dr. Joshua Sharfstein says the FDA has succeeded in approving more drugs, but he also says that more changes are needed to make sure the medicines are worthwhile for patients.

“Some of them are really great, and some of them [are] not so great,” says Sharfstein, now a professor at the Johns Hopkins Bloomberg School of Public Health. “And a lot of them are very expensive.”

In an accompanying editorial in JAMA, Sharfstein offers several suggestions for change, including a reevaluation of the FDA’s expedited approval programs to see which ones are working and which ones are mainly driving up health care costs.

“We’ve kind of reached a point where it makes sense to pause and see whether we can do things better,” Sharfstein says. “And I think we can.”

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