Category Archives: We’re In the News

MLB’s return plan mirrors the Bundesliga’s. The key difference? It’s in the U.S., not Germany.

Jesse Dougherty: The Washington Post, June 3, 2020


One season is ending, another is beginning, and the intersection of the two — Major League Baseball and Bundesliga soccer — shows how risky it is to restart sports in the United States right now.

On Saturday, Bayern Munich and Bayer Leverkusen will meet in the German Cup final in Berlin, capping a successful six-week schedule. Across the Atlantic Ocean and all over North America, MLB will begin summer camp during the novel coronavirus pandemic. The models for the two are similar in that, unlike the NBA, they are operating outside of a bubble, traveling between cities and having players, coaches and staff live at home.

But here’s a key difference: Germany’s response to the pandemic was much more successful — and much more proactive — than the United States’. It enabled the Bundesliga, the country’s top-tier soccer league, to resume in mid-May and handle sporadic coronavirus cases. Baseball, on the other hand, is about to make a similar attempt in a much different environment.

The United States topped 50,000 new daily cases for the first time Wednesday. That was more than a fourth of Germany’s total cases to date. Germany has had around 9,000 coronavirus deaths, and by mid-May, when soccer returned, it had almost completely flattened the curve.

“Germany was able to pull it off, but we are not Germany. Many of the markets that MLB wants to play in do not look like Germany,” said Zachary Binney, an epidemiologist at Oxford College of Emory University. “The baseline risk is much higher. So unfortunately, because of our response to covid-19, sports leagues need stricter return plans, and I don’t know that MLB has really wrestled with that yet.”

Both plans hinge on players, coaches, staff and their families being cautious and smart away from team facilities. That’s the reality of not playing inside a bubble, which the NBA will use in Florida to negate travel and limit exposure to the outside world. But MLB and the Bundesliga took near-opposite approaches for regulating off-site behavior.

MLB’s 113-page operations manual dedicated one paragraph to it, writing individuals “must exercise care,” adding that they should avoid restaurants, bars and other crowded areas. MLB left each team to craft and enforce its own policy. Four players, who spoke on the condition of anonymity to freely discuss a sensitive topic, said this is MLB’s way of avoiding responsibility should an outbreak occur.

[….]

Here is where baseball picks up this weekend, starting with testing. Before training begins, all players, coaches and staff have to take a coronavirus test and self-quarantine while awaiting results. After that, they will be tested every other day. A lab in suburban Salt Lake City will be tasked with fielding thousands of tests and turning around results in “approximately 24 hours,” according to MLB’s operations manual. There is, however, already skepticism within the sport that results will come that quickly.

Before training began in Germany, players, coaches and staff did a week-long quarantine at a hotel. They ate meals separately and, each morning, completed a questionnaire to check for possible symptoms. Testing was frequent during that period, then slowed to around twice a week during the season. The Bundesliga contracted five labs to process results and, according to news accounts, was comfortable doing so because the country wasn’t stretched for resources.

Since the Bundesliga was the first league to return, it provided a template for how to play outside of a bubble. But environmental influences serve as the trickiest element there. Baseball’s plan, while similar, is less detailed in critical areas, according to public health experts, and set to unfold where the virus is still rampant.

“The biggest risk for baseball is location,” said Diana Zuckerman, president of the nonprofit think tank National Center for Health Research. “The greatest weakness of the plan is sending teams and having teams in states where the governor is unwilling to have strict rules.”

Read the full article here

DOT Wants to Weaken Its Own Power to Penalize Airlines Over Consumer Complaints

Amy Marten: Fair Warning June 1, 2020


With enforcement against airlines for consumer violations already falling sharply, the Department of Transportation is pushing for a rule change that consumer groups and some lawmakers say would serve no other purpose than further protecting airlines from civil fines.

The proposed change, announced in February, would require the DOT to use a more rigid definition of “unfair and deceptive practices” when investigating consumer complaints against airlines. The rule would also allow airlines to call for additional hearings when defending complaints or when facing future regulations.

Under Transportation Secretary Elaine Chao, the agency already is taking a more hands-off approach to complaints by air travelers, with enforcement actions on a sharp downward trend. In 2019, the DOT’s Aviation Consumer Protection Division issued eight enforcement orders against airlines, a record low and half as many as it issued the previous year, an agency database shows. The previous record low was nine enforcement orders, set in 2000, according to The Washington Post.

This year has also seen few cases, with three civil penalties imposed on airlines so far in 2020 totalling $850,000.

The DOT acknowledges in its proposal that it could be “performing fewer enforcement and rulemaking actions” under the rule. The agency credits Airlines for America, the lobbying organization that represents the nation’s major airlines, for suggesting the change. The industry group had complained that it had been subject to aggressive regulatory activity over the years, even for “minor infractions, inadvertent errors, or isolated incidents,” according to the DOT’s summary of the request.

“The value of this proposal is that DOT will need to explain…the reasons why it believes a practice is ‘unfair’ or ‘deceptive,’” Airlines for America said in a statement to FairWarning.

Few outside the industry would argue that airlines are being burdened by excessive regulations, especially with the free-for-all that has characterized air travel during the Covid-19 crisis.

In a June 10 letter to Chao blasting the proposal, Senators Edward Markey, Maria Cantwell, Tammy Baldwin and Richard Blumenthal, all Democrats, cited the recent decline in enforcement and thousands of consumer complaints since the onset of the coronavirus pandemic, many about airlines’ refusal to pay refunds.

[…]

Even as infection rates are on the rise in the U.S., some carriers are starting to abandon voluntary measures to prevent the spread of disease, such as leaving the middle seat open to allow for social distancing. This week, American Airlines announced that it would resume selling planes at full capacity. The airline justified the plan by saying it would require enhanced cleaning and face coverings. “With all of these layers of protection, we are comfortable removing the load factor cap,” American Airlines said in an email to FairWarning.

But the airline refused to say whether the Centers for Disease Control and Prevention had vetted its plan to allow full planes. Instead, American Airlines said that its safety plan is accredited by ISSA, a trade group for corporations that sell cleaning products, such as 3M and Procter & Gamble.

“Having a certification from an industry group is not the same thing as having met the standards of the CDC or the NIH [National Institutes of Health] or any other objective agency,” Dr. Diana Zuckerman, president of the nonprofit National Center for Health Research, said in an interview. 

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We can’t ever go to the doctor with our guard down’: Why Black women are 40% more likely to die of breast cancer

Maria Aspan: Fortune Magazine June 30, 2020


Racism kills Black Americans, and has long before COVID-19. But its toxic combination with sexism has particularly vast and disastrous consequences for the health of Black women.

While Black people in the U.S. are dying from the COVID-19 pandemic at a disproportionately high rate, this national health crisis underlines an even grimmer status quo: Black Americans are also much more likely to die from far more common and longstanding health problems every day. Black women are at particularly high risk of heart disease and strokes, and are at least three times as likely to die as a result of childbirth as white women, contributing to the overall alarmingly high maternal mortality rate in the United States.

Then there are the shocking statistics around breast cancer, which affects one in every eight women and is the most common non-skin cancer affecting women. Black women are less likely to develop it—but 40% more likely to die from it than white women, according to the U.S. Centers for Disease Control and Prevention.

The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it. Now the disproportionately high toll of COVID-19 on the Black population in the U.S. and the simultaneous national reckoning over racism are drawing new attention to the racial inequities hurting Black women—and amplifying the voices of doctors, scientists, and public health experts who have long sounded the alarm.

[…]

Women of all races could be legally omitted from government-funded clinical trials before 1993, and are still often under-represented in most research studies of conditions that affect them. Pregnancy and menstrual cycles are thought to “complicate” the results of trials that are mostly conducted on white men, who are seen as the “norm.”

This can obviously backfire. In 2013, the U.S. Food and Drug Administration sharply cut its recommended dosages of Ambien for women, after years of complaints about grogginess and falling asleep while driving, when followup tests showed that women metabolized the active ingredient in sleeping aids much more slowly than men.

When it comes to clinical trials funded by pharmaceutical companies, “the FDA encourages but does not require diversity in clinical trials,” says Diana Zuckerman, a scientist and president of the National Center for Health Research. “Worse, the agency frequently approves drugs and devices for all adults, even if they were primarily studied on white adults.”

One treatment that the FDA approved in April, for the “triple-negative” type of breast cancer that disproportionately affects Black women, was approved after being tested on 108 patients. Eight of them, or 7%, were Black. Another breast-cancer treatment was approved last year after being tested on 234 patients; seven of them, or 3%, were Black.

[…]

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CRS: Congress Can Rein In FDA’s Flexible COVID-19 Vaccine Trial Policies

Beth Wang, Inside Health Policy: June 03, 2020


The Congressional Research Service says Congress could rein in FDA’s broad discretionary authority over vaccine clinical trial policies by legislating how the agency and Institutional Review Boards approach clinical trial designs and reviews for the current COVID-19 pandemic, as well as for future emergencies. In a Tuesday (June 2) report, CRS suggests Congress could provide more specific direction to FDA and IRBs on how to approach clinical trials in emergency situations, and also could appoint a neutral scientific body to consider ethical and scientific issues as well as general guidelines for trials. Congress also could fund global collaboration among regulators, and provide additional funding and resources to facilitate clinical trials, the report suggests, echoing recent calls from lawmakers who have said the United States should get involved with global efforts to fund and develop COVID-19 vaccines and treatments.

Diana Zuckerman, president of the National Center for Health Research, applauded CRS for explaining the vaccine approval process to Congress and for telling lawmakers what their options are so Congress can, in Zuckerman’s words, “ensure a better outcome than we’ve seen with the disastrous coronavirus testing situation (in terms of accuracy, transparency, and availability).” The document, she told Inside Health Policy, does a good job of explaining that FDA has authority to lower approval standards for any drug or vaccine unless Congress steps in. “[B]ased on FDA’s actions of the last 3 months, it seems likely that they will do so in ways that could create the free-for-all that currently exists for coronavirus testing,” Zuckerman wrote in an email. “So the CRS is telling Congress that legislation is the option they have if they want to ensure a better outcome.”

Existing law, CRS says, requires FDA and IRBs to weigh considerations about safety and effectiveness against the desire to bring products to market quickly when evaluating proposed clinical trial designs for vaccines.

[…]

Congress previously told FDA what to do in the drug trial and approval space through passage of the 21st Century Cures Act, but FDA was given leeway in how to interpret the law, Zuckerman explained. “It pushed FDA in a particular direction but still gave the FDA the authority to rely on the agency’s subjective judgment,” she said. If Congress were to step in and tell FDA what it should do, it would be a radical departure, Zuckerman added. “[But it’s] probably necessary given FDA’s response to the pandemic so far, and the Administration’s track record of ignoring Congress when it suits them,” she said.

Read the entire article here.

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.

[…]

Read the full article here.

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.

[…]

Read the full article here

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.”

Read the full article here

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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