Tagged HHS

Podcast: KHN’s ‘What The Health?’ Is Health Spending The Next Big Political Issue?

The Republican-led Congress was unable to repeal the Affordable Care Act in 2017, but the Trump administration continues to implement elements of the failed GOP bill using executive authority. The latest change would make it easier for states to waive some major parts of the health law, including allowing subsidies for people to buy insurance plans that don’t meet all the law’s requirements.

Meanwhile, in states that are transitioning from Republican governors to Democrats, GOP legislators are using lame-duck sessions to try to scale back executive power and lock in some key health changes, such as work requirements for Medicaid enrollees.

And there is growing evidence that even with health insurance, patients who use significant amounts of medical care are increasingly unable to afford their share.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Joanne Kenen of Politico and Rebecca Adams of CQ Roll Call.

Among the takeaways from this week’s podcast:

  • The Trump administration outlined last week what type of waivers it is willing to consider for states’ ACA markets. Options include changes in who gets premium subsidies and how much they receive, and making short-term insurance plans that are not as comprehensive as current marketplace plans eligible for subsidies.
  • Any changes are likely to end up in court, as have most of the revisions that the Trump administration has proposed.
  • In Wisconsin and Michigan, Republican legislatures are seeking to restrict what the new Democratic governors can do to change GOP policies on Medicaid and challenges to the ACA.
  • A recent study has highlighted that health problems can create financial hardships well beyond the illness. For example, loss of income from a debilitating illness can make paying other bills very difficult and sometimes other family members must give up their jobs to be caregivers.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: NBC News.com’s “FDA Approves Drug for Dogs Scared by Noise,” by Maggie Fox

Margot Sanger-Katz: The Washington Post’s “An Experiment Requiring Work for Food Stamps Is a Trump Administration Model,” by Amy Goldstein

Joanne Kenen: The Atlantic’s “The CRISPR Baby Scandal Gets Worse by the Day,” by Ed Yong

Rebecca Adams: The New York Times’ “Why Hospitals Should Let You Sleep,” by Austin Frakt

Also mentioned in this episode:

The New York Times: “1,495 Americans Describe the Financial Reality of Being Really Sick,” by Margot Sanger Katz

Kaiser Health News: “No Cash, No Heart. Transplant Centers Require Proof of Payment,” by JoNel Aleccia

CBS News: “High Cost Has Many Diabetics Cutting Back on Insulin,” by Serena Gordon

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report today.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it is “streamlining our processes” and declined requests for interviews. Officials at the Department of Health and Human Services, which oversees the FDA, said they agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO investigators examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat the disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start off treating rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $147,308 in 2017 compared with $30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the U.S. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $5.4 billion in sales and $184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $10 billion drugs, even though they are for rare diseases,” he added.

From 2008 to 2017, more than 50 percent of the drugs granted orphan status were for oncology or hematology, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report today.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it is “streamlining our processes” and declined requests for interviews. Officials at the Department of Health and Human Services, which oversees the FDA, said they agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO investigators examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat the disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start off treating rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $147,308 in 2017 compared with $30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the U.S. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $5.4 billion in sales and $184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $10 billion drugs, even though they are for rare diseases,” he added.

From 2008 to 2017, more than 50 percent of the drugs granted orphan status were for oncology or hematology, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! I don’t know about you, but I have been absolutely riveted by the ethics controversy that has sent the scientific community into a shocked-and-appalled, pearl-clutching frenzy this week. I’ll get to that in a second. First, another too-frequent example of the current pitfalls in our health system: A hospital turned down a woman’s heart transplant request because she lacked a secure source of financing for the drugs necessary for the procedure. The hospital’s suggestion for her? Use crowdfunding to raise the $10,000.

Now here’s what you may have missed as we enter that strange lull between holidays (though there certainly wasn’t a dearth of health news).

New guidelines released by the administration on Thursday, among other things, encourage states to flex their creative muscles on how to spend the subsidy money they get under the health law.

Currently, the subsidies are tied to income, and can be used only for insurance that meets federal standards and is purchased through public marketplaces. But the Centers for Medicare & Medicaid Services wants to lift those restrictions and let states do what they will with the pot of money. That could include: allowing the use of subsidies for short-term “junk insurance” plans; offering subsidies as incentive to woo in younger consumers; setting different income limitations; letting people with employer-based plans set up accounts to use the money, etc., etc.

If states acted on these options, that could steer the marketplace toward the geographical disparity that ran rampant before the health law. But it’s doubtful any state would want to take advantage of this offer in the first place. For one, it would be expensive for states to manage the pot of money. Secondly, even if a state received a waiver for the regulations, court challenges likely would follow. That could be more of a headache than it’s worth.

The Washington Post: New Insurance Guidelines Would Undermine Rules of the Affordable Care Act

Modern Healthcare: CMS Allows States to Get Creative With Federal Exchange Funds Under 1332 Waivers


The lagging numbers for this open-enrollment season are a bit at odds with what experts had seen as a stabilizing, if not quite flourishing, marketplace. While no one is Chicken Little-ing yet (there is still time left to see a boost, and the early weeks of November were busy ones for Americans), health law supporters are concerned that what they see as the administration’s attempts to “sabotage” the Affordable Care Act are coming to fruition.

Politico: Trump May Finally Be Undermining Obamacare

One statistic from the week that experts found “very troubling” was that for the first time in a decade the number of uninsured children rose, despite the improving economy and the low unemployment rate. Rural areas were particularly affected.

Los Angeles Times: Number of Uninsured Children Climbs, Reversing More Than a Decade of Progress, Report Finds


In what is certain to draw fierce pushback from patient advocacy groups and pharma alike, President Donald Trump is expanding Medicare’s negotiating power when certain drug prices rise faster than inflation. The idea has been kicking around for a while as both parties have been trying to come up with the silver bullet for high costs, but the political ramifications are unappetizing. Potentially cutting seniors off from needed drugs — whether it would play out that way or not — has always kept the idea on the back burner.

The New York Times: Trump Moves to Lower Medicare Drug Costs by Relaxing Some Patient Protections

File this under “I’m not sure that’s how it’s supposed to work”: A generic EpiPen is now available. The catch? It’s the exact same price as the one already out there.

The Hill: Generic EpiPen Not Any Cheaper Than Existing Version


FBI background checks were waived for caregivers and mental health workers who were in charge of caring for teens at an immigration detention center in Texas. The revelation ignited outrage, and the Department of Health and Human Services was quick to promise it would fingerprint the employees (officials warned it could take a while, though).

The government also allowed the company who is overseeing the operation of the facility to sidestep mental health requirements — youth shelters generally must have one mental health clinician for every 12 kids, but the contractor was allowed to staff the Texas facility with just one clinician for every 100 children.

The Associated Press: Lawmakers Press for Fingerprinting of Detention Camp Staff

Very quietly, family separations at the border have resumed.

ProPublica: Family Separations Are Still Happening at the Texas Border

Also, Baltimore is suing the Trump administration over its “public charge” policy that lets immigration officials use the acceptance of government aid, such as Medicaid, against those seeking green cards. The lawsuit might be the first of its kind, but it’s doubtful it will be the last.

The Associated Press: Baltimore Sues Trump Administration Over Immigration Policy


It is indicative of just how busy this week was that I haven’t gotten to the (aforementioned) ethics scandal rocking the scientific community yet, but we got here eventually. Chinese scientist He Jiankui dropped a bombshell (unverified and un-peer reviewed) on everyone that he gene-edited human embryos to make designer babies resistant to HIV infections.

This practice crosses an ethical line that many researchers had dug deep, deep, deep in the sand. “Deeply unethical,” “crazy,” “driven by hubris,” were just a few of the reactions from fellow scientists at the shocking news. One consensus that has come out of it, though, seems to be that there’s a crucial need for binding and international guidance on editing human genes. (Oh, and this isn’t over. He says there’s another pregnancy with gene-edited embryos underway.)

Los Angeles Times: Why Geneticists Say It’s Wrong to Edit the DNA of Embryos to Protect Them Against HIV

Stat: He Took a Crash Course in Bioethics, Then Created CRISPR Babies

NPR: Science Summit Denounces Gene-Edited Babies Claim, But Rejects Moratorium

Stat: NIH Director Says There’s Work to Do on Regulating Genome Editing


Medical device policy usually flies a bit under the radar, but it was a hot topic this week. Following a damning report on spinal implants causing severe injury to some patients, the Food and Drug Administration announced that it wants to revamp its (long-criticized and decades-old) approval system.

The Associated Press: FDA Says It Will Overhaul Criticized Medical Device System

And a look at whether the agency’s “first in the world” ambition contributed to a series of high-profile malfunctions.

The Associated Press: At FDA, a New Goal, Then a Push for Speedy Device Reviews


In the miscellaneous file this week:

• The combined suicide and opioid crises are taking a particularly grim toll on the country, sending us into our longest period of generally declining life expectancy since the slice of time that includes a little thing called World War I and the worst flu pandemic in modern history. I’m not going to lie, that’s not a great comparison.

The Associated Press: Suicide, at 50-Year Peak, Pushes Down US Life Expectancy

• A gut-wrenching personal story offers insight into the loved ones left behind in cases of suicides, and how they’re plagued with a forever-unanswerable question of “why”? The entire series is worth a deep read.

USA Today: Suicide: My Mom Took Her Life at The Grand Canyon

• An epidemic of extensive backlog of rape kits languishing on shelves in police departments recently drew a lot of attention. But an even more fundamental and low-profile issue? Those departments that trash them completely before the statute of limitations is up.

CNN: Destroyed: How the Trashing of Rape Kits Failed Victims and Jeopardizes Public Safety

• Johns Hopkins vowed to transform a Florida hospital’s heart surgery unit. Then patients started dying at an alarming rate.

Tampa Bay Times: Heartbroken

• Despite changes in policy, federal prisons are still failing to offer inmates proper mental health care.

The Washington Post/The Marshall Project: Federal Prisons Are Failing Inmates With Mental Health Disorders


As you can tell, it’s a good thing I started drinking coffee (for the first time ever, cue shocked faces) this week! No, I have not been spending my time Googling its health benefits. (OK, I have.) Have a lovely, possibly caffeine-fueled weekend!

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! I don’t know about you, but I have been absolutely riveted by the ethics controversy that has sent the scientific community into a shocked-and-appalled, pearl-clutching frenzy this week. I’ll get to that in a second. First, another too-frequent example of the current pitfalls in our health system: A hospital turned down a woman’s heart transplant request because she lacked a secure source of financing for the drugs necessary for the procedure. The hospital’s suggestion for her? Use crowdfunding to raise the $10,000.

Now here’s what you may have missed as we enter that strange lull between holidays (though there certainly wasn’t a dearth of health news).

New guidelines released by the administration on Thursday, among other things, encourage states to flex their creative muscles on how to spend the subsidy money they get under the health law.

Currently, the subsidies are tied to income, and can be used only for insurance that meets federal standards and is purchased through public marketplaces. But the Centers for Medicare & Medicaid Services wants to lift those restrictions and let states do what they will with the pot of money. That could include: allowing the use of subsidies for short-term “junk insurance” plans; offering subsidies as incentive to woo in younger consumers; setting different income limitations; letting people with employer-based plans set up accounts to use the money, etc., etc.

If states acted on these options, that could steer the marketplace toward the geographical disparity that ran rampant before the health law. But it’s doubtful any state would want to take advantage of this offer in the first place. For one, it would be expensive for states to manage the pot of money. Secondly, even if a state received a waiver for the regulations, court challenges likely would follow. That could be more of a headache than it’s worth.

The Washington Post: New Insurance Guidelines Would Undermine Rules of the Affordable Care Act

Modern Healthcare: CMS Allows States to Get Creative With Federal Exchange Funds Under 1332 Waivers


The lagging numbers for this open-enrollment season are a bit at odds with what experts had seen as a stabilizing, if not quite flourishing, marketplace. While no one is Chicken Little-ing yet (there is still time left to see a boost, and the early weeks of November were busy ones for Americans), health law supporters are concerned that what they see as the administration’s attempts to “sabotage” the Affordable Care Act are coming to fruition.

Politico: Trump May Finally Be Undermining Obamacare

One statistic from the week that experts found “very troubling” was that for the first time in a decade the number of uninsured children rose, despite the improving economy and the low unemployment rate. Rural areas were particularly affected.

Los Angeles Times: Number of Uninsured Children Climbs, Reversing More Than a Decade of Progress, Report Finds


In what is certain to draw fierce pushback from patient advocacy groups and pharma alike, President Donald Trump is expanding Medicare’s negotiating power when certain drug prices rise faster than inflation. The idea has been kicking around for a while as both parties have been trying to come up with the silver bullet for high costs, but the political ramifications are unappetizing. Potentially cutting seniors off from needed drugs — whether it would play out that way or not — has always kept the idea on the back burner.

The New York Times: Trump Moves to Lower Medicare Drug Costs by Relaxing Some Patient Protections

File this under “I’m not sure that’s how it’s supposed to work”: A generic EpiPen is now available. The catch? It’s the exact same price as the one already out there.

The Hill: Generic EpiPen Not Any Cheaper Than Existing Version


FBI background checks were waived for caregivers and mental health workers who were in charge of caring for teens at an immigration detention center in Texas. The revelation ignited outrage, and the Department of Health and Human Services was quick to promise it would fingerprint the employees (officials warned it could take a while, though).

The government also allowed the company who is overseeing the operation of the facility to sidestep mental health requirements — youth shelters generally must have one mental health clinician for every 12 kids, but the contractor was allowed to staff the Texas facility with just one clinician for every 100 children.

The Associated Press: Lawmakers Press for Fingerprinting of Detention Camp Staff

Very quietly, family separations at the border have resumed.

ProPublica: Family Separations Are Still Happening at the Texas Border

Also, Baltimore is suing the Trump administration over its “public charge” policy that lets immigration officials use the acceptance of government aid, such as Medicaid, against those seeking green cards. The lawsuit might be the first of its kind, but it’s doubtful it will be the last.

The Associated Press: Baltimore Sues Trump Administration Over Immigration Policy


It is indicative of just how busy this week was that I haven’t gotten to the (aforementioned) ethics scandal rocking the scientific community yet, but we got here eventually. Chinese scientist He Jiankui dropped a bombshell (unverified and un-peer reviewed) on everyone that he gene-edited human embryos to make designer babies resistant to HIV infections.

This practice crosses an ethical line that many researchers had dug deep, deep, deep in the sand. “Deeply unethical,” “crazy,” “driven by hubris,” were just a few of the reactions from fellow scientists at the shocking news. One consensus that has come out of it, though, seems to be that there’s a crucial need for binding and international guidance on editing human genes. (Oh, and this isn’t over. He says there’s another pregnancy with gene-edited embryos underway.)

Los Angeles Times: Why Geneticists Say It’s Wrong to Edit the DNA of Embryos to Protect Them Against HIV

Stat: He Took a Crash Course in Bioethics, Then Created CRISPR Babies

NPR: Science Summit Denounces Gene-Edited Babies Claim, But Rejects Moratorium

Stat: NIH Director Says There’s Work to Do on Regulating Genome Editing


Medical device policy usually flies a bit under the radar, but it was a hot topic this week. Following a damning report on spinal implants causing severe injury to some patients, the Food and Drug Administration announced that it wants to revamp its (long-criticized and decades-old) approval system.

The Associated Press: FDA Says It Will Overhaul Criticized Medical Device System

And a look at whether the agency’s “first in the world” ambition contributed to a series of high-profile malfunctions.

The Associated Press: At FDA, a New Goal, Then a Push for Speedy Device Reviews


In the miscellaneous file this week:

• The combined suicide and opioid crises are taking a particularly grim toll on the country, sending us into our longest period of generally declining life expectancy since the slice of time that includes a little thing called World War I and the worst flu pandemic in modern history. I’m not going to lie, that’s not a great comparison.

The Associated Press: Suicide, at 50-Year Peak, Pushes Down US Life Expectancy

• A gut-wrenching personal story offers insight into the loved ones left behind in cases of suicides, and how they’re plagued with a forever-unanswerable question of “why”? The entire series is worth a deep read.

USA Today: Suicide: My Mom Took Her Life at The Grand Canyon

• An epidemic of extensive backlog of rape kits languishing on shelves in police departments recently drew a lot of attention. But an even more fundamental and low-profile issue? Those departments that trash them completely before the statute of limitations is up.

CNN: Destroyed: How the Trashing of Rape Kits Failed Victims and Jeopardizes Public Safety

• Johns Hopkins vowed to transform a Florida hospital’s heart surgery unit. Then patients started dying at an alarming rate.

Tampa Bay Times: Heartbroken

• Despite changes in policy, federal prisons are still failing to offer inmates proper mental health care.

The Washington Post/The Marshall Project: Federal Prisons Are Failing Inmates With Mental Health Disorders


As you can tell, it’s a good thing I started drinking coffee (for the first time ever, cue shocked faces) this week! No, I have not been spending my time Googling its health benefits. (OK, I have.) Have a lovely, possibly caffeine-fueled weekend!