Category Archives: We’re In the News

‘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.

 

[…]

Read the full article here

‘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.

[…]

Read the full the article here

Celebrities Are Getting Coronavirus Tests Faster Than Everyone Else

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.

The US has fallen far behind other countries when it comes to testing, plagued by delays, errors, and limited testing supplies. Finally, on Thursday, the FDA approved Roche’s test to be rolled out free. There are now also testing drive-thrus in Colorado and California. To speed things up, private labs like Quest Diagnostics have begun offering their own coronavirus tests for people with the money or insurance to pay for it.

“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.

Read the full article here

FDA considers black box warning for all breast implants

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.

[…]

Currently, the black box warning exists only as a draft while the FDA continues to consider its implementation.

The draft warning outlines three main concerns.

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.”

Read the original story here.

Artificial Intelligence Is Rushing Into Patient Care – And Could Raise Risks

Liz Szabo, Kaiser Health News,


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 heartCT 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.

Even the U.S. Food and Drug Administration—which has approved more than 40 AI products in the past five years—says “the potential of digital health is nothing short of revolutionary.”

Yet many health industry experts fear AI-based products won’t be able to match the hype. Many doctors and consumer advocates fear that the tech industry, which lives by the mantra “fail fast and fix it later,” is putting patients at risk—and that regulators aren’t doing enough to keep consumers safe.

[…]

Relaxed AI Standards At The FDA

The FDA has come under fire in recent years for allowing the sale of dangerous medical devices, which have been linked by the International Consortium of Investigative Journalists to 80,000 deaths and 1.7 million injuries over the past decade.

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.”

Johnson & Johnson, for example, has recalled hip implants and surgical mesh.

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.”

[…]

Read original story here.

No Shortage of Controversies for New FDA Commissioner

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.

[…]

Read the original story here.

Everything is designed for men, even drugs

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.

https://www.youtube.com/watch?v=CVdn-2KE2bs