President Donald Trump said he will “slash red tape like nobody has even done it before” in a bid to get unapproved coronavirus treatments to patients faster and identify effective drugs.
The president said Thursday he directed the Food and Drug Administration to “eliminate out-of-date rules and bureaucracy so this can go forward fast” — but he did not offer any details. Instead, Trump and top health officials highlighted steps the government has taken in recent weeks to launch clinical trials of potential coronavirus treatments.
Trump’s remarkscame one day after he teased that an“exciting FDA announcement” was on the way —news that reportedly caught some in the health agency by surprise as they scrambled to finalize details, saidthree HHS officials.
Food and Drug Administration Commissioner Stephen Hahn appeared to downplay the president’s optimism about speeding up access to three drugs in particular. “What’s important is not to provide falsehood but provide hope,” Hahn said.
“We need to make sure the sea of new treatments will get the right drug to the right patients, at the right dosage, at the right time,” he added. “That’s why it is important we have our professionals looking at these therapeutics in development.”
Trump suggested certainprograms that the administration could use to get experimental drugs to people quickly outside of clinical trials. One such route, known as “Right to Try,” was established by a 2018 law that Trump and Vice President Mike Pence supported to help people who are seriously ill and have no other treatment options.
“What we’re talking about today is beyond Right to Try,” Trump said, adding that the law “has been a tremendous success.”
But outside researchers were quick to sound the alarm.
“Wow, that is bad advice from President Trump,” said Diana Zuckerman, a drug safety expert at the National Center for Health Research. “Lives can be saved if red tape is cut in terms of making tests, respirators, and hospital beds more available. Making untested antivirals available is not a good strategy.”
The Right to Try program allows patients to appeal directly to drugmakers to use medicines that are still being developed and tested. Bioethicists and drug policy experts argue there are other ways to help people access experimental medicine — like the FDA’s compassionate use route, also name checked by the president — and that Right to Try fuels false hope, while making it difficult to collect data on how well the drugs work.
Shira Feder and Julia Naftulin, Insider: March 13, 2020
When news broke that Tom Hanks and his wife Rita Wilson had become the first celebrities diagnosed with the coronavirus, it was a moment that struck fans — particularly in countries that have yet to feel the brunt of the virus — just how far and fast it is spreading.
But amid the praise for how Hanks and Wilson are handling the situation, many people have also called into question how quickly the couple were tested and diagnosed, while most of the general public in the US and many European countries struggle to even find out where to get a test.
[…]
It was a dramatic moment when medical officials raced onto the Chesapeake Energy Arena basketball court in Oklahoma City on Wednesday night to prematurely shut down the game the Jazz and Oklahoma City Thunder teams were playing. They’d received a tip that Rudy Gobert, a basketball player for Utah Jazz, had tested positive for the new coronavirus.
Up until that point, testing had been sluggish. On Tuesday, 2,728 people were tested across the US — just over 50 people for each state. On Wednesday night, 58 tests were performed on athletes and team staff.
That day, the same day the World Health Organisation declared COVID-19 a pandemic, new stats emerged showing the US had done a total of five tests for every one million people, compared to with almost 4,000 tests per million people in South Korea.
“Other countries are testing much more broadly than we are,” William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine, previously told Business Insider. “We are trotting along while they’re racing along.”
The only other people who were tested nearly as quickly appeared to be political officials, like Ted Cruz, Paul Gosar, and Matt Gaetz, who were exposed at conservative conference CPAC.
According to Diana Zuckerman, the president of the National Center for Health Research in Washington, DC, it makes sense that high-profile celebrities and athletes have more access to COVID-19 testing than the general public.
“I think there’s a lot of benefit for a physician to have celebrity patients, and that means that those physicians are going to do their very best to please their patients in ways that they might not work quite so hard for in a non-celebrity patient,” Zuckerman told Insider. “When something is available but limited, and there’s limited access but it exists, people with more fame are and more money are more likely to get it.”
America is lagging behind every other country when it comes to coronavirus testing
Without testing widely, it is impossible for public health officials to measure exactly how dangerous this outbreak is. As of Friday, CDC criteria states that anyone who had close contact with a confirmed COVID-19 patient within the past 14 days should get tested, as should people who traveled from a high-risk area within the past 14 days.
But many people who may have coronavirus do not fit this criteria.
“We’re certainly in a situation where there’s such a limit to the number of tests available. We hope the situation will change soon, but currently it’s a big problem,” Zuckerman said.
Regardless, she hopes there will be less favorable treatment.
“It’s a little bit hard to make the case that celebrities deserve to be tested before people who actually have symptoms,” said Zuckerman. “It isn’t just the celebrities, it’s also the people taking the subway to work.”
There’s another problem: tests are free for Americans, but ambulances and treatment are not
Those that have sought treatment for the coronavirus have faced another conundrum: some have gotten stuck with hefty bills.
The Miami Herald reported that one man was charged $3,270 for a test at the hospital. The New York Times reported that one man left a mandatory quarantine and received a bill for thousands. Another uninsured person was issued a $1,295 bill out-of-pocket.
“Anybody that wants a test can get a test,” Trump announced to reporters on March 6. But testing supplies are limited and to-test-or-not-to-test is a decision that has been left up to individual clinicians and healthcare provider’s judgments.
Trump also announced that insurers will pay for coronavirus treatments. The next day vice president Mike Pence clarified that insurers have waived copays for the coronavirus tests — not the coronavirus treatment, which may require respirators and hospital stays and can quickly get expensive.
Mariel Carbone, WCPO Cincinnati: February 09, 2020
Although many other survivors choose implants after their mastectomies, [Lily McBreen is] adamant that she won’t. Having almost lost her life once, she’s worried the side effects of receiving breast implants could endanger it again.
[…]
“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades,” she said. “There has been so many accounts of women complaining of problems with them.”
Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.
First, “breast implants are not considered life time devices” and women may require more surgery if complications occur.
It also states that implants have been associated with BIA-ALCL.
[…]
Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”
The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.
Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.
“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”
Health products powered by artificial intelligence, or AI, are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots.
IBM boasted that its AI could “outthink cancer.” Others say computer systems that read X-rays will make radiologists obsolete.
“There’s nothing that I’ve seen in my 30-plus years studying medicine that could be as impactful and transformative” as AI, said Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heart, CT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said.
Many of these devices were cleared for use through a controversial process called the 510(k) pathway, which allows companies to market “moderate-risk” products with no clinical testing as long as they’re deemed similar to existing devices.
In 2011, a committee of the National Academy of Medicine concluded the 510(k) process is so fundamentally flawed that the FDA should throw it out and start over.
Instead, the FDA is using the process to greenlight AI devices.
Of the 14 AI products authorized by the FDA in 2017 and 2018, 11 were cleared through the 510(k) process, according to a November article in JAMA. None of these appear to have had new clinical testing, the study said. The FDA cleared an AI device designed to help diagnose liver and lung cancer in 2018 based on its similarity to imaging software approved 20 years earlier. That software had itself been cleared because it was deemed “substantially equivalent” to products marketed before 1976.
AI products cleared by the FDA today are largely “locked,” so that their calculations and results will not change after they enter the market, said Bakul Patel, director for digital health at the FDA’s Center for Devices and Radiological Health. The FDA has not yet authorized “unlocked” AI devices, whose results could vary from month to month in ways that developers cannot predict.
To deal with the flood of AI products, the FDA is testing a radically different approach to digital device regulation, focusing on evaluating companies, not products.
The FDA’s pilot “pre-certification” program, launched in 2017, is designed to “reduce the time and cost of market entry for software developers,” imposing the “least burdensome” system possible. FDA officials say they want to keep pace with AI software developers, who update their products much more frequently than makers of traditional devices, such as X-ray machines.
Scott Gottlieb said in 2017 while he was FDA commissioner that government regulators need to make sure its approach to innovative products “is efficient and that it fosters, not impedes, innovation.”
Under the plan, the FDA would pre-certify companies that “demonstrate a culture of quality and organizational excellence,” which would allow them to provide less upfront data about devices.
Pre-certified companies could then release devices with a “streamlined” review—or no FDA review at all. Once products are on the market, companies will be responsible for monitoring their own products’ safety and reporting back to the FDA. Nine companies have been selected for the pilot: Apple, FitBit, Samsung, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool and Verily Life Sciences.
High-risk products, such as software used in pacemakers, will still get a comprehensive FDA evaluation. “We definitely don’t want patients to be hurt,” said Patel, who noted that devices cleared through pre-certification can be recalled if needed. “There are a lot of guardrails still in place.”
But research shows that even low- and moderate-risk devices have been recalled due to serious risks to patients, said Diana Zuckerman, president of the National Center for Health Research. “People could be harmed because something wasn’t required to be proven accurate or safe before it is widely used.”
In a series of letters to the FDA, the American Medical Association and others have questioned the wisdom of allowing companies to monitor their own performance and product safety.
“The honor system is not a regulatory regime,” said Jesse Ehrenfeld, who chairs the physician group’s board of trustees. In an October letter to the FDA, Sens. Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.) and Patty Murray (D-Wash.) questioned the agency’s ability to ensure company safety reports are “accurate, timely and based on all available information.”
Thomas M. Burton, The Wall Street Journal: January 29, 2020
New Food and Drug Administration commissioner Stephen M. Hahn rises at 4 a.m. each day for an hour of intensive strength and stamina training. On stressful days, he fits a second workout in during the late afternoon.
Dr. Hahn, 60, takes over an FDA under fire for failing to adequately respond to the health threat from growing use of e-cigarettes and vaping products. This spring, he and the agency will face applications from e-cigarette companies and have to decide what e-cigarette products can qualify to stay on the market.
[…]
Dr. Hahn also faces thorny decisions on stem-cell research and use of cannabidiol, or CBD, that will likely put him in the hot seat between rival advocacy groups.
The man taking on these challenges comes to the FDA with a sterling reputation in medicine and management, but with no previous government experience, unlike his predecessor Scott Gottlieb. That has some concerned about his ability to tackle the issues ahead.
“Always we have concerns when someone comes in who doesn’t know the FDA, which is a complex organization,” said Diana Zuckerman, president of the public-interest research group National Center for Health Research in Washington. “I never think it’s a good idea.”
What’s more, Dr. Hahn may not have long to make his mark if Mr. Trump fails to win re-election Nov. 3. “It’s a hard thing to come in with so little time [in the president’s term] and so little government experience,” said a former FDA commissioner, Robert Califf, who served under President Obama. “It’s so difficult to change policy with so little time.”
Dr. Hahn didn’t immediately comment for this article.
Producers Kim Mas and Ranjani Chakraborty, Vox: January 16, 2020
This short video explains why designing medicine around the “average man” is so dangerous. Most things in society are built for, and designed around, a specific “reference man.” This “standard human” is usually a white male in his 30s who weighs around 155 pounds. When we design everything from cars, to air-conditioned offices, to city streets, reference man is the default user. And when it comes to healthcare, that can mean deadly effects for women. Watch the video above to find out how dosages are determined with “reference man” in mind. After dozens of women got into car accidents under the influence of sleeping pills they’d taken the night before, the FDA had to tell women to cut their dose in half; it turned out, women metabolize Ambien’s active ingredient twice as slowly as men. What was supposed to be a “gender-neutral” dose was anything but. Diana Zuckerman, president of the National Center for Health Research, explains why we need more inclusivity in clinical trials — for women, for people over 65, and for people of color.
FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020, according to device center Associate Director for Compliance and Quality Erin Keith. Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency.
Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency.
The downturn in Center for Devices and Radiological Health warning letters from 81 in fiscal year 2015 to nine in 2019 comes amid a major effort to reorganize the FDA device center that proved “very disruptive to the compliance office,” Keith said.
“It is organized in a different way now than it was in the past, so the processes have had to be worked out,” Keith told the Food and Drug Law Institute’s annual compliance conference in December. “We can’t issue a warning letter if we don’t do it timely, according to the evidential requirements.”
[…]
Still, some patient safety advocates are concerned the drop in warning letters cannot be entirely attributed to the restructuring changes at the agency.
“I don’t think that downward trend can adequately be explained by the reorganization that is taking place,” Public Citizen Health Research Group Director Mike Carome said.
Diana Zuckerman, president of the National Center for Health Research, said the trend is emblematic of a regulator that is overly focused on pleasing industry.
“It could have several different causes, reorganization could be one. [Medical Device User Fee Amendments] regulations could be part of it, which requires more meetings. But there is this emphasis on customer service, which is defined as making life easier for the industry. Industry is an important customer, but so is the American taxpayer,” Zuckerman said.
Over the past decade, the device center has also focused on shifting how it communicates with manufacturers, focusing on pushing companies to prioritize making decisions that improve quality and patient outcomes rather than simply achieving compliance with regulatory requirements. The goal, Keith said, is to have companies address potential issues before they rise to the warning letter stage.
“We as a philosophy for the center don’t want to have to go to enforcement,” Keith said. “We want to get to problems when they are smaller and easier to fix.”
Another method FDA has utilized is increasing the number of alternative methods of disseminating information, such as issuing Letters to Health Care Providers and Safety Communications. For example, in April 2019, the agency issued a safety communication alerting patients and providers of mammography problems at a medical clinic in Ohio, noting the facility “was unable to meet the parameters for a key quality control test on the day of the 2018 annual inspection.” FDA noted in the safety communication quality problems at East Palestine Family Medical Clinic dated back to October 2017, and recommended patients screened at the facility receive an additional mammography.
“I think it’s important that we won’t wait to let people know that there is an issue patients and providers need to know about by letting a compliance process catch up to documentation,” Keith told MedTech Dive. “Sometimes we can get what we need, have the public know what’s going on and get a change by sharing information. When it’s more appropriate to use a more traditional compliance activity, we will do that.”
Tawnell D. Hobbs, The Wall Street Journal: January 6, 2020
[…]
An estimated 5.4 million middle- and high-school students in the U.S. recently used e-cigarettes, a vaping device, according to a federal survey released in December. That is 20% of all students, far more than the 4.3% that used cigarettes.
The Centers for Disease Control and Prevention reported 2,561 cases of hospitalizations for lung injury involving e-cigarettes, and 55 deaths, as of Dec. 27. The majority of cases are linked to products containing THC, the psychoactive ingredient in marijuana.
School administrators say vaping is more challenging to tackle on campus than regular cigarettes. Vape devices are typically battery-powered and made to look like everyday items, such as pens, lipstick cases and USB drives.
They come in child-friendly flavors, from bubble gum to strawberry cheesecake, and have pleasant smells. Students can take quick whiffs undetected while sitting in class or walking down a hallway, with exhaled vapor dissolving quickly into the air or held in to be absorbed, unlike lingering smoke from lit cigarettes.
School resource officers in Chico, Calif., use 18-years-olds, under the nicotine purchasing age of 21, as decoys to bust businesses selling tobacco products used for vaping; officials said eight clerks have been cited. The officers also allow students to trade vape devices for coupons for pizza and smoothies, with no questions asked. In four weeks, about 50 vapes were turned in, said Sgt. Greg Rogers.
“We’re just trying something different,” Sgt. Rogers said. “We wanted it to not be punitive.”
Jupiter Community High School in Palm Beach County, Fla., in October banned students from using the restroom during class periods unless for emergencies and with an administrative escort. The rule has since been lifted.
“Parents were frustrated with the fact that their children weren’t just allowed to go to the restroom,” said June Eassa, a Palm Beach school assistant superintendent.
Plainwell Community Schools in Michigan is starting random nicotine testing of high-school students in extracurricular activities in January. Students testing positive are restricted in participating in their activity.
[…]
Juul Labs said that it has suspended broadcast, print and digital product advertising in the U.S. “We are focused on resetting the vapor category in the U.S. and earning the trust of society by working cooperatively with regulators, public health officials, and other stakeholders to combat underage use,” the company said.
According to Juul’s website, “one 5% strength JUUL pod is designed to replace one pack of cigarettes in nicotine strength,” and saves money.
Researchers are concerned that there doesn’t seem to be a standard of what should be a normal vape dose, leaving students to grossly overuse the product.
“There’s a certain understanding that you don’t smoke more than a pack a day,” said Diana Zuckerman, president of the National Center for Health Research. “With vaping, because it’s new and because all these products vary, there aren’t the sorts of standards that help people restrict what they’re doing.”
It was a busy year for FDA’s expert advisory committees, called on to tackle many of its biggest medical device questions in 2019, new and old.
The Circulatory System Devices Panel met in June in reaction to a concern that emerged in late 2018 after a meta-analysis found a late mortality signal in patients receiving paclitaxel-coated devices. Other topics, like the benefit-risk profile of transvaginal mesh, had been hashed out in numerous meetings over the past few decades.
Repeated meetings aren’t necessarily a negative, said Diana Zuckerman, president at the National Center for Health Research since 1999.
“We can’t think of these public meetings as a bad outcome … We wish that people weren’t being harmed by breast implants, by mesh, by Essure, and so on. But if they are being harmed, then I’d much rather there be a public meeting about it then to have it covered up,” Zuckerman said. “For breast implants especially, it’s made an enormous difference in terms of public awareness.”
Of all the device meetings this year, none seemed to draw as much attention as a March meeting on breast implant safety. It came amid growing recognition of a type of lymphoma that can develop around the devices called breast implant associated anaplastic large cell lymphoma, or BIA-ALCL, as well as a vast collection of potentially related symptoms called breast implant illness.
In one of the clearer impacts from an advisory panel this year, FDA followed up months later by asking Allergan to initiate a worldwide recall of certain textured implants, and issuing a draft guidance outlining a black box warning and patient safety informed consent checklist to be included with the implants.
Raylene Hollrah, a breast cancer and BIA-ALCL survivor who has advocated that FDA improve breast implant safety, said that while the advocacy community has made significant strides with regulators and plastic surgeons this year, language in FDA’s draft guidance regarding breast implants’ risks is “way too vague.” Comments on that proposal are due Monday.
“I am definitely not anti-implant,” she said. “I want women to have a choice but I want it to be a safe one.”
Better transparency on the chemicals and metals contained in breast implants remain at the top of advocates’ list, Hollrah said.
Eight months after the breast implants meeting, FDA asked its Immunology Devices Panel to weigh immunological responses to devices based on different metal elements in implants.
Zuckerman said that meeting represented the first time she’d heard high-level FDA scientists and officials link certain immunological responses to devices and vocalize a need to better understand what causes that link, and which patient and product factors increase risk.
“It was very interesting because it wasn’t specific to any particular product,” Zuckerman said. “[When] there’s an advisory committee on one product, there always seems to be a lot of caution about suggesting immunological responses to implants,” adding that panelists seemed “much more open-minded about these issues than they usually are.”
One undercurrent across many meetings was inadequacy of post-approval studies and spotty adverse event reporting, leading to incomplete data with which panelists could form opinions. Once a device is commercialized, it’s very difficult to complete postmarket studies, Zuckerman said.
Even if those postmarket studies and other forms of surveillance are happening, “it’s too late for the patients being harmed,” Zuckerman said. “Most of us would much rather know that some implant that’s going into our body was adequately tested before it was put in our body. Not that it might be tested a year or two later.”
In the shadow of the World Trade Center in downtown Manhattan, right down the block from a Target store, there’s a secret emergency room, tucked away on the fifth floor of an office tower.
Here, Sollis Health is staffed 24/7 with doctors who are trained in emergency medicine. They’re on-call for an elite membership of hundreds of wealthy clients who pay to skip dealing with their local ERs, where staff say conditions are like a “war zone.”
“The ER system is broken, I think everybody agrees to that,” Diana Zuckerman, president of the National Center for Health Research, told Insider, saying the country’s emergency medicine system is misused, overused, and wildly expensive.
Patients often wait more than five hours to see a doctor in a regular New York City ER. But at Sollis Health, patients can spend as little or as long with their doctors as they want, and get most of the same type of emergency care they’d receive at a hospital in a fraction of the time.
[…]
On the Upper East Side Sollis also has an MRI machine on hand, but not here. (MRIs give more detailed images of organs and soft tissue than X-rays or CT scans can.)
“Those are very, very expensive,” Zuckerman said of the MRI, X-ray, and other imaging machines. “Unless you have a lot of patients, you’re going to have to charge an enormous amount of money for each one.”
In Tribeca, Sollis shares space with a few different health companies, including one that does “executive health exams” which include lots of testing, imaging, and blood work.
[…]
Concierge services can make managing healthcare easier for patients with chronic health issues, young children, and older people.
Estimates suggest there are about 10,000 concierge doctors at work across the country.
“We can give care in the sort of one-to-one fashion that we think we would want for ourselves or we would want for our parents, when they’re sick,” Olanow said. “Basically, have the entire experience led by a physician.”
Ranging between $250 and upwards of $400 a month, the price of this kind of private care (which is billed as out of network) isn’t exactly a bargain, nor is it a particularly fair solution to the nation’s ER crisis.
“I can’t imagine this is the best solution, because it’s obviously only for people who can afford it,” Zuckerman said. “If you’re willing to spend a few thousand dollars to participate in this program, you have the money to make sure that you don’t have to wait very long for whatever it is you need.”
[…]
Here, Sollis Health is staffed 24/7 with doctors who are trained in emergency medicine. They’re on-call for an elite membership of hundreds of wealthy clients who pay to skip dealing with their local ERs, where staff say conditions are like a “war zone.”
“The ER system is broken, I think everybody agrees to that,” Diana Zuckerman, president of the National Center for Health Research, told Insider, saying the country’s emergency medicine system is misused, overused, and wildly expensive.
