Category Archives: We’re In the News

Hahn Defends Using Less ‘Robust’ Data During COVID, But Critics Contend It Has Gone Too Far

Sarah Karlin-Smith, Informa Pharma Intelligence: June 04, 2020


[…]

Anecdotes Are Not Data Sets

The regulatory flexibility touted by Hahn was embraced to some degree by even some of the agency’s most notable critics, who agreed that the nature of the COVID-19 pandemic should allow for a different pace of decision making than under normal circumstances. However, they said they were concerned that FDA is misusing such flexibility, particularly when it came to the emergency use authorization (EUA) for hydroxychloroquine and chloroquine.

“I agree with Dr. Hahn that in emergency situations it makes sense to move quickly and change course quickly if the evidence is different from what was hoped for. But the only justification for making [hydroxychloroquine] immediately widely available was that President Trump had ‘a good feeling about it,” said Diana Zuckerman, president of the National Center for Health Research.

The EUA was granted based on laboratory data and anecdotal clinical reports. (Also see “FDA’s Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments” – Pink Sheet, 30 Mar, 2020.)

Zuckerman described this not as datasets but as anecdotal evidence. “Scientists don’t call anecdotal evidence datasets. As any scientist can tell you, the plural of anecdote is ‘anecdotes’ not ‘data,”” Zuckerman said.

In an emergency situation “making decisions on the fly and using the best data that you have is inevitable,” but the agency should follow certain principles when it does this, said Aaron Kesselheim, the director of the Program on Regulation, Therapeutics and Law at Harvard Medical School and Brigham and Women’s Hospital.

Kesselheim’s third principle was that the FDA should revisit or revise these decisions just as quickly as they made them when new information emerges. He said the FDA has done a good job in some circumstances of adhering to these principles and done less well in others.

As Hahn mentioned in his speech, the agency has reversed some of its early EUAs for COVID-19 tests. (Also see “FDA Yanks Potentially Faulty COVID-19 Antibody Tests – And More May Be On The Chopping Block” – Medtech Insight, 22 May, 2020.)

[…]

Read the full article here.

Allergan is trying to track down women with breast implants it recalled nearly a year ago

Maria Aspan, Fortune: June 03, 2020


More than 10 months after recalling some of its breast implants, Allergan is making a new effort to find tens of thousands of women who still have the dangerous devices.

The pharmaceutical company, now owned by AbbViesaid this week that it will launch a digital and social media ad campaign to alert patients about the July 2019 recall of its textured Biocell implants. Those implants have been linked in academic studies to a sometimes-fatal cancer known as BIA-ALCL, for “breast implant–associated anaplastic large cell lymphoma.” More than 33 women have now died from BIA-ALCL.

Allergan’s announcement comes two weeks after Fortune published an investigation into the persistent problems with breast implants and the health risks, including BIA-ALCL, they have created for millions of women worldwide. These risks have been amplified by decades of inadequate study and problems that were hidden by breast implant manufacturers, as well as the generally poor tracking of medical devices, our investigation found.

Many women affected by Allergan’s Biocell recall told Fortune that they found out about it through social media or news reports, rather than directly from the company or the U.S. Food and Drug Administration, which requested the recall.

On Monday, Allergan acknowledged that it does not have device-tracking information for some 52,000 Biocell breast implants. Despite “robust efforts” to reach patients since last July, “the company is still seeking to directly contact all U.S. Biocell patients that have not yet been notified,” Allergan said in a press release.

“We are continuing to make every effort to make sure that each and every patient is made aware of the Biocell recall, and knows their implant type and implant history,” John Maltman, Allergan’s vice president of medical affairs, said in the release.

A company spokesperson did not respond to a request for more specifics about when the ad campaign would launch, or what exactly it would entail. And longtime critics of breast implant safety greeted Allergan’s announced plans with skepticism.

“I don’t know how visible it’s going to be,” says Diana Zuckerman, president of the National Center for Health Research. “Will the kind of money and effort be put into this in a way that’s comparable to ad campaigns when they’re selling something?

The new ad campaign appears to be at the behest of the FDA, which “asked Allergan to develop a strategy to contact patients who may not have heard about the recall,” an agency spokesperson told Fortune by email on Tuesday, adding that the FDA “is working with Allergan to amplify the message and outreach related to its July 2019 voluntary recall of certain breast implants.”

This is the latest of several actions the FDA has taken on breast implant safety in the wake of Fortune’s investigation. Last month, after speaking with Fortune, the FDA sent a warning letter to Allergan over its longtime failure to comply with regulatory requirements for selling its implants. At the same time, the agency also sent a letter to a smaller manufacturer warning about manufacturing and quality-control issues.

[…]

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A Patient’s Guide to Telemedicine

Michelle Llamas, Drugwatch: May 20, 2020


Telemedicine allows patients to have a remote, non-emergency office visit with their health care provider by using a smartphone, computer or tablet. Research shows most patients are highly satisfied with telemedicine visits, and in most instances these visits are as good as in-person visits.

Telemedicine has been growing in popularity in recent years. As more states are implementing laws to facilitate telemedicine, more Americans are embracing remote visits with their health care providers.

From 2016 to 2017, health insurance claims for telemedicine grew by 53 percent, according to FAIR Health’s FH Healthcare Indicators and FH Medical Price Index 2019. It grew more than claims for urgent care centers, retail clinics and emergency departments.

By 2017, about 76 percent of hospitals in the United States connected with patients and other practitioners virtually through video or other technology, according to the American Hospital Association.

Because of the COVID-19 pandemic, analysts for Forrester Research predicted virtual health care interactions could top one billion by the end of 2020, CNBC reported.

Telemedicine vs. Telehealth

Telemedicine is a component of a larger group of remote health care services called telehealth, though sometimes people use the terms interchangeably.

The main difference between the two is that telemedicine specifically refers to medical information exchanged remotely to improve a patient’s health. Information can be exchanged through email, two-way video, smartphones and other wireless tools.

Telehealth encompasses telemedicine and other types of remote health care information exchanges, such as health education, medical provider training, administrative meetings and more.

[…]

Is Telemedicine as Good as an In-Person Visit?

The majority of telemedicine uses are just as good as in-person visits, according to research by the American Telemedicine Association (ATA). They may also be less expensive than in-person visits.

There has been over 40 years of research and thousands of studies related to telemedicine, and ATA reviewed these for cost effectiveness and quality of care in its 2013 report, Telemedicine’s Impact on Healthcare Quality and Cost.

“For most telemedicine applications, studies have shown that there is no difference in the ability of the provider to obtain clinical information, make an accurate diagnosis, and develop a treatment plan that produces the same desired clinical outcomes as compared to in-person care when used appropriately,” the ATA said.

Eighty-three percent of the time, patients can resolve their health issues during the first telemedicine visit, according to Red Quill Consulting.

One key thing to consider is preparing ahead of time, according to Diana Zuckerman, president of the National Center for Health Research.

“It’s important to make a list in advance of every question and comment before the [telemedicine] doctor’s visit,” Zuckerman told Drugwatch. “Being organized with anything that concerns you is even more important when the doctor doesn’t see you in person and can’t notice health issues that might be more obvious in person.”

Zuckerman advises consumers to write down and keep track of their medical provider’s answers during a telemedicine visit.

Getting Started

Patients who want to conduct a telemedicine visit with a provider will first need to confirm that the provider offers this option. Second, they will need a reliable internet connection and a smartphone, computer, laptop or tablet.

If you don’t have a preferred medical provider, you can check with your insurance company for providers that participate in their telemedicine program. You’ll also want to check with your insurance company’s policies on paying for these visits.

Ask your HR department if your employer has a preferred telemedicine provider.

[…]

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FDA Warns Allergan Over Breast Implant Studies

Sasha Chavkin, International Consortium of Investigative Journalists: May 19, 2020


United States health authorities issued a warning letter to leading global breast implant manufacturer Allergan for failing to properly carry out post-market safety studies.

The U.S. Food and Drug Administration found that Allergan did not meet its standards for recruiting and following up with participants in studies that included several styles of implants withdrawn from sale worldwide last year due to cancer risks.

Another company, Ideal Implant Incorporated, was rebuked for failing to properly track complaints by customers or take adequate corrective actions for problems identified during a site inspection.

“The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations,” Dr. Binita Ashar of the FDA’s Center for Devices and Radiological Health said in an agency statement announcing the warning letters.

In November 2018, the International Consortium of Investigative Journalists revealed that thousands of women around the world were suffering from serious illnesses after receiving breast implants, a finding that was part of its global Implant Files investigation.

In the months after the Implant Files’ publication, regulators around the world took action to better protect patients. Authorities in France, Canada, and the United States announced bans on Allergan Biocell implants, which were associated with increased risk of a rare form of cancer.

The moves prompted Allergan to announce a global recall of Biocell products last July. (Earlier this month, Allergan was acquired by global pharmaceutical giant AbbVie.)

The recalled implants are among the ones that Allergan was failing to properly study, the FDA found. The agency noted that the studies were crucial to identifying the risks for patients already implanted with Biocells.

“Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market,” Ashar said in the FDA’s statement.

The agency touted the warning letters as a part of its “ongoing efforts” to better protect breast implant patients, also citing its Medical Device Safety Action Plan and the development of a National Breast Implant Registry to collect data on breast implant safety.

But Dr. Diana Zuckerman, the director of the National Center for Health Research, a health policy think tank, said the agency must also be willing to take tough measures against companies that fail to follow its rules.

Zuckerman noted that breast implant makers have a history of poor compliance with safety studies mandated by the FDA, which approved silicone breast implants for the U.S. market in 2006 despite scant data on their long-term safety.

Instead, the agency allowed manufacturers Allergan and Mentor to conduct long-term safety studies after their products were already on the market. Within three years, Allergan and Mentor lost touch with 40% and 80% of the patients, respectively, in key sections of these post-approval studies, torpedoing the FDA’s demand that they collect reliable long-term data.

Nonetheless, the agency permitted the implants to remain on the market.

Zuckerman was skeptical that the warning letters would have much effect unless the FDA showed it was willing to take products that violated its rules for safety studies off the market.

“It absolutely should be possible to take off the ones that aren’t studied properly,” Zuckerman said. “I guarantee if they did that the ones that are still on the market would finish their studies.”

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How MLB is navigating the coronavirus pandemic to play ball

ESPN staff, ESPN: May 19, 2020


MAJOR LEAGUE BASEBALL’S plan to start the season by July 4 relies on a dizzying array of moving parts, including the cooperation of 27 U.S. cities and a foreign country, the availability of more than 200,000 reliable coronavirus tests and a promise not to interfere with the nationwide fight to contain the pandemic.

ESPN examined the challenges facing MLB as it struggles to get back on the field. What emerges is like nothing that has been attempted in the history of American sport, less a baseball season than a military-style operation in which any number of variables could derail the plan, or, worse, contribute to the spread of the deadly disease.

[…]

WHEN MLB ABANDONED the idea to play the season under a bubble-like quarantine, it eased the restrictions that players would face but also created a riskier and more complicated scenario, according to health experts.

Even if teams are limited to regions — reducing travel, as the plan anticipates — players and other personnel will still travel between cities where people are living under different health orders and the virus may be spreading at different rates. Some states have reopened more than others and are projected to see a spike in cases, while others remain all but closed. Georgia, for example, partially ended its stay-at-home order on April 24, lifting restrictions on gyms, bowling alleys, hair salons and other businesses. In Cobb County, where the Braves play, new cases have been averaging about 50 a day. Some models and experts predict Georgia will soon see an increase in deaths because of the reopening.

“I wouldn’t want to put players in Atlanta’s ballpark,” said Beth Blauer, the executive director of the Johns Hopkins Center for Civic Impact, which specializes in the use of data to advise governments and nonprofits on best practices. “You have to determine where to play based on that modeling. You can’t bring players into hot spots. … You’ll know between mid-May and June how devastating the decisions are and where the new hot spots are, potentially.”

Alex Fairly, CEO of Fairly Group, an Amarillo, Texas-based risk management firm whose clients include MLB and the NFL, served as chairman of Lt. Gov. Dan Patrick’s Back to Work Task Force on Sports and Entertainment, which included representatives of the Astros and Houston Texans. The challenge of figuring how sports will be staged safely “fried my brain,” said Fairly, adding that the process caused him to lose sleep. “There are 8,000 issues. No one knows exactly what to do because this has never happened. It’s a true black swan moment.”

Baseball’s plan designates about 100 essential employees per team — players and other on-field personnel and “a limited number of essential staff who come in close proximity to the players.” These “Tier 1” and “Tier 2” individuals will be tested multiple times per week, though the plan doesn’t specify how many times that would be. The plan says nothing about regular testing for 150 “Tier 3” individuals who are involved in “essential event services” but will be separated from the others. If those people come into contact with someone who has the virus, they will be tested.

Beyond their families, teammates, managers and other baseball personnel, players still will be exposed to a broad range of people — from hotel staff to security personnel; from bus drivers to flight attendants. All will be traveling in their own circles when not working; MLB’s plan does not say anything about testing those workers. That creates added potential for an outbreak, experts said.

“One of the things I try to explain to people is that whatever other people are doing who live anywhere near you, is gonna affect you,” said Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C., a nonprofit independent think tank. “Just because you’re not going to get a tattoo when you’re in Georgia when your team is playing the Braves, if the person serving you at the restaurant is married to a person who got a tattoo or married to the person who is the tattoo artist, then you as a customer at that restaurant or even picking up carryout has the potential for being contaminated by those people who are doing those things.”

Keeping stadiums and other areas sterile will be a perpetual ordeal. It will involve perimeter security to keep fans away, both at the ballpark and hotels, where autograph seekers often congregate.

[…]

IN INTERVIEWS WITH dozens of health care experts — doctors, epidemiologists, immunologists, policy specialists, government authorities — there was consensus that the main component to keeping baseball safe will be diagnostic testing. That’s the same issue that has bedeviled the national effort to combat the coronavirus.

The goal of testing is to weed out and isolate those who test positive and prevent outbreaks. The risks of insufficient testing are incalculable. Clusters of the coronavirus have erupted in group and travel environments. In early March, more than 100 people became infected at a Boston leadership conference of Biogen, turning the drug company into an unwitting spreader of the disease to other states.

With that nightmare scenario for baseball in mind, and players and staff traveling in and out of their communities, it’s imperative for MLB to ferret out positive cases before they spread, the experts said. MLB’s plan calls for testing players and personnel “multiple times” per week, but not daily, as some experts suggest.

“If you were doing daily testing, you’d have the ability to pick up very low numbers on the virus, pick it up as soon as somebody has the ability to transmit,” said Dr. Melissa Nolan, an infectious disease expert at the University of South Carolina.

Nolan described MLB’s testing plan as a B-minus — compared to an A-plus if you were testing daily — but said she believed it could be effective, particularly if players are diligent about social distancing and limit their exposure away from the ballpark.

Trout told ESPN: “I don’t see us playing without testing every day.”

Dr. Howard Forman, a Yale professor of health policy who has offered guidance to some sports leagues and teams, said he believes baseball’s plan should work. He noted that data suggest the prevalence of the virus among top-level athletes is likely to be extremely low, plus it will be easier to limit exposure without fans and other workers at the ballparks. Forman wouldn’t say which leagues he had spoken with.

Under MLB’s plan, only the person who tests positive will be quarantined. That policy conflicts with current Centers for Disease Control and Prevention guidelines, which call for anyone who has had close contact with a confirmed case to quarantine for 14 days. “Our experts are advising us that we don’t need a 14-day quarantine [in such cases],” Manfred told CNN. The plan says baseball is following rules established by “health care institutions and governmental entities” but does not specify which entities.

Baseball is in a difficult position: Quarantining players who come in contact with infected individuals could force MLB to shut down entire teams.

Most health experts interviewed by ESPN said they believe MLB would be increasing the risk of an outbreak by not quarantining more extensively, if only for a few days.

“CDC guidelines are pretty clear that anybody who makes substantial contact with somebody who has the virus needs to be quarantined,” Dr. Ashish Jha, director of the Harvard Health Institute, told ESPN. “I think baseball has to ask themselves on what basis are they going against the CDC guidelines. How confident are they gonna be that another player on another team didn’t have substantial contact with that player? It just strikes me as risky. My feeling is it just depends on how lucky you feel.”

Zuckerman, who runs the nonprofit think tank in D.C., said, “I could understand not quarantining for 14 days, because potentially you’d end up never being able to play. But not quarantining at all seems dangerous.” But Humble, the former Arizona health director, said MLB developed “a reasonable plan. The idea of the CDC guidance is to minimize risk, so if you find another way, that’s OK. Guidance shouldn’t be one-size-fits-all. This may even be better, because of the frequency of testing, which is robust.”

After a positive test, clubs are required to work with local health officials to trace those who came in contact with the infected individual. Those people will receive an expedited test and, if negative, will be allowed to remain active — raising the possibility that people exposed to the virus could return to baseball within minutes. Baseball’s plan calls for additional testing of those individuals every day for one week, with results returned within 24 hours. “That’s time someone could be infecting other players, staff, their families,” one union source said.

Experts told ESPN that it can take several days for someone to test positive after contracting the virus.

[…]

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‘They killed her’: Why are breast implants still putting millions of women at risk?

Maria Aspan, Fortune: May 18, 2020


Thirty-three years before her death, Paulette Parr visited her doctor for a popular and relatively routine procedure. It was 1986, and Parr was 35, working in human resources at the local hospital in Sikeston, a 16,000-person Missouri enclave midway between St. Louis and Memphis. A married mother of two young boys, she was interested in what plastic surgeons still call a “mommy makeover,” a catchall for the various procedures that nip, tuck, and lift women back to a pre-childbirth shape. For Parr, that meant getting her first set of breast implants.

For the next 15 years, through losing her first husband and remarrying and getting promoted to her hospital’s purchasing department, Parr was mostly happy with her implants, and with how they made her look and feel. But they were silicone-based, a type the U.S. Food and Drug Administration banned in 1992 over concerns that they were causing autoimmune and safety problems, and Parr eventually started to worry about them. So by 2002, when she learned that one of her implants had ruptured and was leaking silicone into her body, Parr’s surgeon replaced them with saline-filled versions. Her new Biocell implants were covered in a roughly textured silicone shell, designed to reduce movement of the device.

That’s when Parr’s implant-related health problems really began, according to a lawsuit her husband has filed against pharmaceutical company Allergan, the maker of Biocell products and one of three major manufacturers of American breast implants. In 2010, after one of her saline implants started leaking, her plastic surgeon replaced them with yet another set of Biocell textured implants, this time filled with silicone, which the FDA had allowed back onto the market in 2006.

“They were gorgeous, and they were put in by a reputable doctor,” says Paulette’s widower, Calvin Parr, months after her death. “We never gave it a second thought.”

Breast implants have long been a punch line, mocked as frivolous markers of female vanity. But that dismissive attitude overlooks a business with a serious and sometimes deadly impact on the health of its overwhelmingly female customer base. More than 8 million American women have undergone breast-related plastic surgeries since 2000; in 2018 alone, more than 400,000 women chose one for either cosmetic or reconstructive reasons. Breast augmentation is the most popular cosmetic procedure tracked by the American Society of Plastic Surgeons.

Many women, especially those affected by breast cancer, say they are grateful to have implants as an option. “It’s a decision that’s personal,” says Lynn Jeffers, the society’s current president, a plastic surgeon, and a cancer survivor who’s getting post-mastectomy reconstruction. “With the data that I have now, I’m comfortable having implants.”

And pharmaceutical companies have been very comfortable selling them, despite a long history of government recalls and product-liability lawsuits. Allergan, which was acquired by AbbVie in May, sold $399.5 million worth of implants in 2017, before regulators around the globe started banning some of its products. Its main rival, Johnson & Johnson, doesn’t break out results for its Mentor Worldwide breast implant business. Smaller specialist Sientra reported annual “breast products” revenues of $46.4 million in 2019.

Those numbers pale in comparison to blockbusters like Allergan bestseller Botox, which raked in $3.8 billion last year. But like Botox, breast implants can have attractive recurring revenue built in for manufacturers and the doctors who use their products. Even under ideal circumstances, breast implants “are not lifetime devices,” the FDA warns, and will likely need to be replaced every 10 to 15 years, for a cost of up to $12,000 per cosmetic procedure.

Yet as doctors, patients, lawyers, and public health experts tell Fortune, breast implants have remained on the market despite decades of inadequate testing and study, recurrent safety concerns, and poor regulatory oversight. Those problems plague many medical devices, which range from machines used outside the body to artificial parts implanted within it. But breast implants are unique in their affiliation with female sexuality and physical appearance, their intersecting roles as elective beauty products and clinical tools that can help cancer survivors feel more like themselves—and the degree to which patients’ mounting concerns about them have been dismissed for decades. Now, that accumulated failure of oversight has created sweeping, sometimes tragic crises for potentially millions of women.

“There are a lot of women who are really suffering,” says Diana Zuckerman, president of the National Center for Health Research. “You have these products that are widely, widely sold, and every few years we learn something new about the problems they cause.”

Breast implant makers walk a particularly fine line when it comes to creating a product that is both safe and “realistic.” Today’s implants are either filled with saline (more likely to break) or silicone (more natural looking and feeling but plagued by a history of safety concerns). Their exteriors can be either smooth or made of a “textured” silicone shell. Smooth implants are more popular in the U.S., but surgeons working with mastectomy patients sometimes prefer textured versions, because the products’ rougher surface enables tissue to grow onto the implant more easily.

All of these variations are prone to malfunctions or side effects, which can include ruptured implants; a buildup of scar tissue that can cause pain and tissue hardening; a large collection of symptoms often known as “breast implant illness,” which can include joint pain, migraines, and chronic fatigue; and, increasingly, a sometimes fatal cancer of the immune system known as ­BIA-ALCL, for “breast implant–­associated anaplastic large cell lymphoma.”

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

The causes of the various problems with breast implants are still poorly understood, which public health experts blame on a lack of testing or objective, long-term studies that do not rely on manufacturer-provided data or funding. Device makers also have yet to fully report the data the FDA required as a condition of allowing silicone implants back on the market in 2006.

[…]

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You Can’t Travel, but You Can Vacation at Home

Hilary Nangle, AARP, May 12, 2020


In a pre-Covid-19 world, the freedom to be at home without obligations would have seemed like a vacation. But isolating for the coronavirus has changed that perspective. The American belief in productivity may make some feel guilty for taking a vacation day at home, but experts say that it’s no less important to do so now than it was before the pandemic.

“It’s important because it seems like something that we shouldn’t do, because with no place to go, it feels like a waste of time,” says Andrea Bonior, a clinical psychologist in Bethesda, Maryland, and author of Detox Your Thoughts. “We have this big blurring between working and home, and taking a day off is a way to reclaim that boundary.”

Home should be a place for pausing, resting and healing, Bonior says, and she recommends doing something creative, social or nourishing with an “off” day at home — even watching TV without guilt. It may seem silly, because you may be working at home anyway, but it’s important to reclaim some space emotionally, and time off — without commitment or obligation — is key to helping lower overall stress levels.

Over the past few years, it has become “harder to distinguish vacation days from other ones,” says Diana Zuckerman, a psychologist and epidemiologist and president of the National Center for Health Research in Washington, D.C. But, “it’s important to have at least a day or two when you don’t work.”

How to plan a ‘home-cation’

But how does one vacation, literally, in the home? Bonior recommends starting by thinking about where, if you could travel, you would go. “That’s a clue to your values right now. If you would choose to spend time with other people, maybe spend time connecting digitally with others.” You might play a game, host a watch party for a movie, or start a book group online.

If you’re thinking about nature, you’re probably craving fresh air and sunshine. Depending upon your circumstances, maybe find a safe place to take a long walk. Or, if you have a backyard, sit outside and read or enjoy a garden. “Don’t dismiss the importance of sunshine, even through a window,” Bonior says. Pair that with watching nature documentaries or travel shows or simply looking at pictures of trees. “There’s research literature on how even looking at pictures of trees makes people feel better,” Zuckerman says. “For a lot of people, nature really does make a difference. Looking at the natural world can be uplifting.”

Some “home-cation” ideas require a bit of advance planning, others can be as easy as allowing yourself to make popcorn and watch movies. Speaking of movies, why not create a daylong film festival? Pick a genre, location or actor and queue up related movies. Or, create a music or dance festival.

Whether you’re pining for France, coastal Maine, a spa escape, or a camping getaway, you can recreate a semblance of your dream trip by using your senses to help evoke the experience. Think about typical food and drink, not only the flavors but also the aromas and textures; think about what you’d see and hear; and think about what you would do. Now set about recreating that at home. Here, a few examples to get you started.

Vacation in France without leaving home

If France is calling to you, spend a day there. Let technology aid your imagination and help you travel faster than the old Concorde. First, listen to Edith Piaf or other typical French music to set the mood. Then get ready for some virtual tours. Go up into the Parisian signature Eiffel Tower, built for the 1889 World’s Fair; descend into the Lascaux Caves in southwestern France to see the prehistoric cave paintings; discover the Mona Lisa without a hint of crowds at the Louvre or browse the paintings in Museé d’Orsay.

You may not be able to stroll the incredible Champs d’Elysses, but you might tantalize your taste buds with the flavors of France you would find along that avenue; perhaps a green salad with bread and a cheese and charcuterie plate. Or maybe make a delicious croque monsieur (a fancy-pants broiled ham and cheese).

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Tests for COVID-19: Has the FDA said yes too many times?

By Robert M. Kaplan and Diana Zuckerman, The Hill Opinion Contributors, May 6, 2020


There are many controversies about the coronavirus, but there is one point of consensus: We need testing, testing, and then more testing. But yesterday, in response to criticisms from chairs of two House health subcommittees, the FDA tightened their standards for antibody tests intended to identify people who were previously exposed to the coronavirus. Why?

Typically, the FDA approves tests based on evidence of accuracy. But, under the urgency of the pandemic, the FDA temporarily lifted the requirement that tests be validated before they are marketed. Until the new policy was announced, it was not clear when or if the FDA would review the accuracy of each test.

The FDA website shows that, to date, the FDA has temporarily approved coronavirus testing for 84 different labs and companies. There were 14 new approvals in the last week alone and more than 400 more applications are waiting for FDA’s review. Unfortunately, none of the tests currently available – not the 84 and not the other 400 — have a record of proven accuracy that can be independently verified.

[….]

What happens when hundreds of unvalidated tests flood the market? Monitoring a pandemic requires accurate, consistent information. With so many tests, we can’t know when cases are peaking, stabilizing, or decreasing in different communities — and therefore, when it is possible to loosen restrictions on social distancing.

Read the article here https://thehill.com/opinion/healthcare/496403-tests-for-covid-19-has-the-fda-said-yes-too-many-times

 

Coronavirus Relief Act Gives Drug Makers New Sway Over FDA

By David S. Hilzenrath, Project on Government Oversight:


Last year, based on growing concerns about the safety of certain sunscreens, the Food and Drug Administration (FDA) published a plan of action.

It proposed concluding that, for two sunscreen ingredients, the risks outweigh the benefits, and it proposed declaring that there was insufficient data to support the safety of a dozen others—for example, one that has shown up in blood plasma, amniotic fluid, urine, and breast milk.

It proposed restricting properties of spray sunscreens to reduce the risk of inhaling them and suffering lung disease, and it proposed requiring that many sunscreens meet a stricter standard for protection against ultraviolet radiation.

It said it wanted to eliminate “potential confusion permitted by the current labeling regime,” under which a product labeled with a higher sun protection factor or SPF can provide “inferior protection” than one with a lower SPF because it filters a narrower spectrum of ultraviolet radiation.

The FDA’s proposal was apparently derailed by the coronavirus.

More specifically, by part of Congress’s response to the pandemic: the economic relief legislation known as the CARES Act, passed in late March.

While Americans were focused on a deadly plague and its devastating fallout, Congress fundamentally altered FDA oversight of thousands of drugstore items.

Little-noticed provisions of the CARES Act gave manufacturers new sway over the consumer protection agency and streamlined the process by which the FDA makes decisions about so-called over-the-counter or OTC drugs—products marketed for personal health and sold without a prescription.

[…]

“User Fees”

[…]

While the CARES Act requires the FDA to negotiate with industry, it requires the agency to “consult” with others, such as “representatives of patient and consumer advocacy groups.” In the realm of prescription drugs, the so-called patient advocacy groups the FDA consulted the last time user fees came up for renewal generally had ties to the pharmaceutical industry, POGO’s 2016 “Drug Money” investigation found.

The FDA and manufacturers have for years been laying the groundwork for adoption of user fees for over-the-counter products. In 2016 and 2017, they held a series of meetings on the subject. Industry participants included Procter & Gamble, Bayer, Sanofi, Johnson & Johnson, and a trade association, the Consumer Healthcare Products Association.

The plan the FDA and industry developed set out “performance goals” for the agency to meet under an anticipated user fee regime, including what the document describes as “substantially shortened timeframes” for the FDA to act on requests from manufacturers of over-the-counter drugs.

“This goals document represents the product of FDA’s discussions with the regulated Industry, and consideration of input by public stakeholders,” the document, called a “commitment letter,” says.

The performance goals “are important for facilitating timely access to safe and effective medicines,” the document says.

The plan the FDA and industry developed was contingent on action by Congress. Now that Congress has acted, the FDA plans to follow the performance goals in that document, FDA spokesman Charlie Kohler said in an email to POGO.

Diana Zuckerman, president of the National Center for Health Research, said the commitment letter “does not seem appropriate.”

“Performance goals should include at least as much attention regarding evidence of safety or effectiveness as it does to the issues that industry cares the most about,” Zuckerman said by email.

Historically, industries have embraced user fees as a means of reducing regulatory delays. For Congress, getting companies to pay for regulators’ salaries has been an easier pill to swallow than spending taxpayer dollars or adding to federal budget deficits.

The new user fees will enable the FDA to increase its budget and staffing for overseeing nonprescription drugs.

In the 2016 slide presentation, the FDA said it was spending just $8.2 million a year and had the equivalent of only about 30 full-time employees to oversee “hundreds of thousands of products consumed – in many cases, on a daily basis – by millions of Americans.”

The FDA compared the $8.2 million to what it said was the $8 million cost of producing “the ‘Blackwater’ episode of the hit TV series Game of Thrones.”

According to the industry’s Consumer Healthcare Products Association, over a five-year period, the user fee program will generate more than $130 million in fee revenue for the FDA.

 

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‘Bad advice from the president’: Trump touts unproven coronavirus drugs

Sarah Owermohle, Politico: March 20, 2020.


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 remarks came 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, said three 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.

[…]

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