Tagged Public Health

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! We have officially made it through the dog days of summer. (Fun fact: Apparently those are set dates and not just … a vague concept of “sometime in August when it’s hot.” I was today-years-old when I learned that.) But that doesn’t mean we’ve had even close to a dearth of health care news. So buckle up, here’s what you may have missed this week.

Planned Parenthood officially rejected Title X funding rather than comply with what it deemed a “gag rule” on its providers. The price tag on that decision? About $60 million annually. Clinics across the country are bracing for the financial hit, and the organization is leaning heavily on donors to try to stanch the wound.

The New York Times: Planned Parenthood Refuses Federal Funds Over Abortion Restrictions

The Associated Press: Planned Parenthood Sees Swift Fallout From Quitting Program

Meanwhile, it was a bit of a roller-coaster week in terms of whether President Donald Trump would be pushing for background checks in his proposal to stem gun violence. After the dual mass shootings in El Paso, Texas, and Dayton, Ohio, Trump seemed open to the strategy, despite it being less than popular with his party. Then The Atlantic reported that following a phone call with NRA chief Wayne LaPierre, Trump softened that stance. Then Trump claimed the media reports were inaccurate and that some kinds of background checks were still on the table.

Pretty much nothing seems set in stone yet (at least publicly), and we should all just wait to see what comes in the official proposal likely to coincide with Congress’ return in September.

The Atlantic: Trump’s Phone Calls With Wayne LaPierre Reveal NRA’s Influence

Politico: Trump to Release Gun Control Proposals, Including Background Check Updates

We did find out this week exactly what was in the Parkland students’ plan, though. And let me tell you, they swung for the fences with it. Included in the roadmap: a national licensing and gun registry; a mandatory gun buyback program for assault-style weapons; a limit of one firearm purchase a month per person; the establishment of a national director of gun violence prevention; and a new multistep gun licensing system that would include in-person interviews and a 10-day waiting period before gun purchases are approved.

USA Today: Parkland Students Announce Gun Control Plan, Aim to Halve Gun Violence Rate in 10 Years

The Trump administration (and the Obama administration, as well) has long chafed at the restrictions that come with the Flores Settlement Agreement, which offers protection to detained immigrant children in U.S. custody. So, this week it released a new set of rules that effectively replace those regulations. Among other things, the new standards allow the government to detain children indefinitely instead of for 20 days, as laid out in the Flores agreement.

Reuters: Trump Imposes Rule Allowing U.S. to Detain Migrant Families Indefinitely

What’s definitely worth a read: the history behind the agreement and the story of the lawyers who have been defending it for decades. (“If someone had told me in 1985 that our work to protect children would continue into 2019, there is no way I would have believed it,” says Carlos Holguin, one of those original lawyers.)

The New York Times: The Flores Agreement Protected Migrant Children for Decades. It’s Under Threat.

Thirteen years ago, then-U.S. Surgeon General Richard Carmona was warned about some “disturbing” data that top federal scientists had discovered. It turned out that opioids were addictive and dangerous. The scientists recommended urgent action be taken to address the startling statistics, which hinted at a brewing crisis. Carmona agreed.

Yet the public was never told, and the momentum to do so fizzled. So what happened?

Politico: Federal Scientists Warned of Coming Opioid Crisis in 2006

Seemingly to further emphasize that the opioid epidemic’s early days were marked by (in retrospect) devastating missed opportunities and deep regret, another story looks at a little town in Appalachia in the late 1990s. There, a nun, a doctor and a lawyer were among the nation’s first activists to sound the alarm. Their efforts were ultimately crushed by Purdue Pharma.

The New York Times: A Nun, a Doctor and a Lawyer — and Deep Regret Over the Nation’s Handling of Opioids

Meanwhile, a study links states’ expansion of Medicaid and the uptick of opioid treatment prescription rates.

The New York Times: Opioid Treatment Is Used Vastly More in States That Expanded Medicaid

And HHS is going to relax privacy regulations around how patients’ history with addiction is noted in their charts. The rules were put in place so that patients felt comfortable seeking medical help without law enforcement being alerted, but HHS Secretary Alex Azar said they’ve become a barrier to proper care.

The Associated Press: Feds to Revamp Confidentiality Rules for Addiction Treatment

The FDA is stepping in to join the CDC’s investigation into cases of lung disease across the country that seem linked to vaping.

The New York Times: Vaping Sicknesses Rising: 153 Cases Reported in 16 States

And don’t miss the story from KHN’s own Victoria Knight about a West Virginia physician who all the way back in 2015 filed a paper on a patient with a lung disease he suspected was tied to vaping.

Years Ago, This Doctor Linked a Mysterious Lung Disease to Vaping

In this week’s miscellaneous file:

  • Emergency care in financially depressed areas has become a standoff between insolvent rural hospitals and patients who don’t have the money to pay their ER bills. That fight is ending up in court so often that locals in a small Missouri town call it the “follow-up appointment.”

The Washington Post: The ‘Follow-Up Appointment’

  • One of the side effects of the growing popularity of at-home DNA tests? More and more, people who were born using artificial insemination are finding out that their fathers aren’t the sperm donors their mothers chose but rather the doctor who performed the procedure.

The New York Times: Their Mothers Chose Donor Sperm. The Doctors Used Their Own.

Also, be sure to check out the Dallas Morning News’ original reporting from April on one of the women featured in the story.

Dallas Morning News: ABC’s ’20/20′ Features Dallas Woman Who Found Out Her Mother’s Fertility Doctor Is Her Father

  • The patient suffers from tremors, difficulty walking and loss of balance. If the patient is a man, his symptoms would be enough to have doctors start wondering if it’s Parkinson’s. But if it’s a woman, it’s chalked up to the modern-day version of what Victorians called female “hysteria.”

ProPublica: In Men, It’s Parkinson’s. In Women, It’s Hysteria.

  • For years, residents of a Newark neighborhood have been saying their water tastes funny because of the dangerous levels of lead. And yet little has been done to fix it.

The New York Times: ‘Tasting Funny for Years’: Lead in the Water and a City in Crisis

That’s it for me, and have a great weekend!

The Opioid Reckoning: It’s Rare To Hold Directors Liable For Corporate Conduct, But Sacklers May Prove To Be Exception

As court cases against Purdue Pharma progress, details continue to be revealed about the extent the Sackler family was involved in making decisions about the company’s strategy. In other news on the crisis: lawyers fight to give newborns suffering from opioid epidemic a voice in the upcoming legal battles; Ohio’s attorney general warns Endo and Allergan that their settlements don’t resolve all the claims against them; a look at how journalists dug into DEA records on the root of the crisis; and more.

Years Ago, This Doctor Linked A Mysterious Lung Disease To Vaping

Dr. John E. Parker was working at a West Virginia hospital in 2015 when a 31-year-old female patient was admitted with acute respiratory problems. A team of doctors ultimately suspected that her mysterious case of lipoid pneumonia might be related to vaping and weren’t sure they had seen anything like it before. They were intrigued enough to publish a case report — a type of medical paper on unusual or provocative patient findings. Such reports can serve as a call to the medical community to be on the lookout, though they sometimes raise more questions than they provide answers.

This summer, almost four years later, federal officials began investigating a national outbreak of severe lung illnesses linked to vaping that has struck more than 150 patients in 16 states. In an interview, Parker, a professor of pulmonary critical care and sleep medicine at West Virginia University, described what happened.

Q: Can you describe what the patient’s symptoms were when she arrived?

We would view them as classic for what is getting to be called vaping-associated lung disease. She was very, very short of breath and had a cough, and we were, of course, very worried that she might have pneumonia or some other acute respiratory illness. And then she was so sick she needed to be intubated.

Q: What happens next in cases like this?  

We look for things like a [hemorrhage] or an active infection. And then for lipid-containing macrophages. And then we usually start some antibiotics [and a] low-dose steroid and then support the patient with a ventilator and oxygen and nutrition. And then just kind of wait and see if any other cultures come back to prove anything different than what you might be thinking.

Early on, we just felt like it was an unusual case and may not be a common viral or bacterial infection.

Q: How did you figure out the cause of her lipoid pneumonia was e-cigarettes?

It’s a diagnosis of exclusion. We excluded other [options], and it became the most likely cause.

We were convinced enough that the case was submitted for publication [in the medical journal Chest] and was accepted.

Q: Once you figured out the cause could be e-cigarettes, did you contact the Centers for Disease Control and Prevention or the Food and Drug Administration or any other regulatory agency to tell them about this?

We did not. We felt at the time that putting it in the medical literature was appropriate. And if other case reports from other parts of the country came forward, then we’d have more of a clustering of findings that might then warrant research agencies [getting a] better understanding [about] the cause of the disease.

Q:Which federal agency would you report it to, if you did?

Dr. John E. Parker(Courtesy of the West Virginia University Health Sciences Center)

In 2015, the FDA, of course, was still regulating cigarettes, but I don’t think the government had yet decided who would regulate vaping products. So I’m sure it was unclear who we should call.

Q: So did you or your team think this was a one-off event when you witnessed it?

We really felt that it wasn’t going to be a one-off event and that it was what we usually called in public health a “sentinel” health event … that it was an example of a respiratory illness that can be caused by this exposure and that it probably wasn’t the first case ever seen nor would it be the last.

Q: Was it the first case that you had seen at your institution?

To our knowledge it was our first case, but we are humble enough clinicians to realize we may have missed some other cases that we interpreted [as] viral pneumonia or bacterial pneumonia.

Q: Have you seen more cases since then?

I know we’ve seen a case [of alveolar hemorrhage syndrome] that we published, and in polling some colleagues we think we’ve probably also seen [cases of] cryptogenic organizing pneumonia as well as lipoid pneumonia and acute eosinophilic pneumonia. Yeah, we’ve certainly seen at least probably four forms of lung disease from vaping.

Q: If your team was seeing this back in 2015, is it possible that it’s been happening in the four years since then and people just don’t know about it?

I really have every reason to think we were not the first ones to see it, by any means.

And I don’t think we were even the first ones to report it. I think that there were some clusters in Wisconsin and some other places in the U.S. I also know that the Japanese have been very interested. They’ve probably got four or five papers at least in the medical literature about vaping related lung injury.

Q: Do you have a theory of what might be causing the lipoid pneumonia cases? Do you think there may be certain chemicals that are irritants?

We need a strong multidisciplinary team to understand the real etiology and cause of lung injury from inhalation. I think it could be any number of components in the mixtures. Lungs don’t like oil, in general, and probably the most specific agent that’s been studied recently is diacetyl, which was studied in popcorn-flavoring lung disease.

Q: Have these kinds of cases changed the way you approach patients?

Yeah, we search very carefully for a history of vaping. … I think it’s quite important to understand if they might be using inhaled agents or vaping that might present new toxicities to the lung.

Q: Will these illnesses have long-term health effects?

An inhalational injury may cause an acute lung injury that’s life-threatening and that someone may survive from and have no long-term sequelae [condition]. But there also is the possibility that long-term [e-cigarette] use may cause more insidious or chronic diseases from which there may not be a full recovery.

Readers And Tweeters Take Dialysis Providers To Task: Nowhere But In The USA

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

The Undue Strain Of Dialysis

This is criminal, and the dialysis companies are not the only ones plundering the public (“Bill Of The Month: First Kidney Failure, Then A $540,842 Bill For Dialysis,” July 25). If you have no medical insurance and go to a doctor or hospital for medical care, you get charged tenfold what they accept from insurance companies. No properly run health care facility or doctor is losing money by accepting the agreed fees that the insurance companies pay. It’s absolutely outrageous to charge people who can least afford to pay up to 10 times the insurance charges. This scam has existed for decades and Congress has done nothing to protect consumers. My understanding is that no other country allows this discrimination against the poor. It’s time this outrageous exploitation of consumers be terminated.

— Jorg Meister, Middlegrove, N.Y.

— David W.S. Lieberman, Somerville, Mass.

This is in response to the bill of Sovereign and Jessica Valentine. It is ridiculous that Fresenius can charge them $14,000 per session when dialysis in Mexico using the same dialysis machines and procedures runs $400 USD per session. I take my mother there frequently for vacation, and we pay cash for her dialysis sessions.

—Martina Patella, Oakland, Calif.

— Andrea Hilderman, Manitoba, Canada

I was appalled to read your article on dialysis. I have a dear friend who built, opened and now operates a dialysis center in Thessaloniki, Greece. His father is a kidney specialist of 30+ years. He wrote the string below about dialysis in Greece when I forwarded the story to him:

“If you have insurance dialysis is free
The average price that dialysis facilities in Greece charge the Greek NHS is around 136 euros.

If a patient who does not have insurance goes to a dialysis facility, he will be charged around 200 euros [about $223 in the United States]. That will be a great day for the facility.”

— Jerry Efremides, New York City

PBMs Put Patients In A Pickle

Besides the delay of generic drugs to market (“California Bill Would Fight Deals That Delay Generic Drugs,” Aug. 1), the pharmacy benefit managers (PBMs) have deals with the manufacturers, and pharmacies are not allowed to dispense a new generic because the PBM will not allow it to happen. Currently, there are Medicare plans that will not pay for generic Ventolin or Advair and demand that we dispense the brand name. It costs patients more, the plan more, and pharmacies lose by dispensing the brand-name drugs.

— David Smith, A & O Clinic Pharmacy, Salinas, Calif.

Winning The Match Game

This is not news (“American Medical Students Less Likely To Choose To Become Primary Care Doctors,” July 3). Medical students have been choosing the higher-end specialties over primary care for decades. I have been in the health care industry for over 40 years and have worked with literally thousands of physicians as an executive at Cedars-Sinai Medical Center and at my two companies, Practice Management Information Corp. and Flash Code Solutions LLC. My daughter and her husband are both radiation oncologists. Board certification in a higher specialty results in higher income and better career choices. Why settle for family practice if you can be an orthopedic surgeon?

— James B. Davis, president and CEO of Practice Management Information Corp., Beverly Hills, Calif.

— Dr. Jacqueline Ivey-Brown, Chicago

Meds And Momentary Mental Lapses

I read your Navigating Aging column about how many medications affect older adults (“Common Medications Can Masquerade As Dementia In Seniors,” July 18). I am 85 and had two knee replacement surgeries. Every time I have to go to the dentist, I must take four amoxicillin antibiotic tablets one hour before the dentist appointment. I noticed that after I took these antibiotics, my memory became very bad. After a few days, I felt like myself again.

— Janet Gileno, Bomoseen, Vt.

— Dr. James P. Richardson, Baltimore

Weighing Costs And Benefits Of Intravenous Iron

I feel your article about iron infusions (“Infusion Treatments — Needed or Not — Can Deplete Patients’ Wallets” Aug. 2) was biased. The article did not discuss the reasons a physician might choose to use IV iron to treat a patient versus oral iron – oral iron is not well tolerated and in the presence of inflammation in the body is not well absorbed. There are blood management programs in the United States that regularly use IV iron to treat anemia to decrease the patient’s risk for a blood transfusion. Although the cost of IV iron differs from one drug to another (the less expensive drugs, such as Ferrlecit, require multiple infusions), when you add up the cost, it includes not only the administration of the drug, but the nursing time and pharmacy preparation time for the medication.

One also must consider the risk for reaction when choosing a particular form of IV iron. Anaphylactic reactions can occur in patients receiving IV iron. Injectafer is one of the drugs we use on a regular basis because other forms of IV iron have a greater risk for reaction. One must consider the added cost of treating an anaphylactic reaction in a patient. Injectafer is a longer-acting form of IV iron; slow-release preparations such as ferric carboxymaltose (Injectafer) are first taken up by macrophages, the shell is digested, and the iron is released slowly over few days as opposed to near-immediate iron release found in other preparations that lead to more adverse reactions.

Although your story provided the experience of a single patient, it did not report the “whole” story about why physicians use IV iron. I receive no incentive for using one drug over another and must consider the patient’s clinical condition and the risks associated with giving IV iron. IV iron will correct iron levels more rapidly in patients because you can give a higher concentration of the drug, versus oral iron, which can take upward of a couple months to improve iron levels. Without really knowing the physician’s rationale for using IV iron in the case of the patient in the article, the author drew conclusions without having all the facts. I agree that we really need to look at health care costs, but the author of the article also failed to mention Big Pharma’s role in driving up the cost of health care.

— David J. Sterken, Grand Rapids, Mich.

— Jim McMullen, Kansas City. Mo.

As a Board Certified Oncology Pharmacist (BCOP), hematology/oncology is my field. Our institution used the cheaper iron (Venofer, which, at a low dose of 100 mg, needs to be given more often) for years. Medicare stopped paying for it because the charge was less than $100 — for some reason, the federal insurance program will not bother to pay for lower-cost IV drugs. Seriously. We switched our formulary iron to Injectafer, 750 mg per vial (cost to us ~$100-$750/vial, and the charge to patients per vial is about $1,000 and up), because we were reimbursed by Medicare for the Injectafer (because it is more than $100).

You are spot-on: The USA does not give our healthy iron-deficient patients enough time to benefit from oral iron. We inject IV iron for iron-deficiency anemia even when the patient does not suffer from anything other than bad lab tests.

Most hospitals and ambulatory care centers base their formulary decisions in large part on reimbursement. Medicare cannot bid for drug pricing and does not have a national formulary. This is a serious error on the part of the legislature and costs billions of dollars or more in taxpayer money that goes directly into the pocket of the pharmaceutical industry. Not paying for lower-cost IV drugs is just one very small example. It is terrible for the patients who must bear the cost of this discrepancy.

Reimbursement is a complex issue these days in no small part to the waste of the government.

— Mary Davis, Bellingham, Wash.

— Dr. Nicolas Argy, Boston

Shefali Luthra’s article on intravenous iron is rife with error. The pricing is not close, relative costs are wrong, and the implication of inappropriate use may be correct only based on utterly usurious prices listed.

More than 70% of those prescribed oral iron (PO) report significant gastrointestinal (GI) perturbation, intolerance and non-adherence. PO iron causes diarrhea and constipation, gastric cramping, metallic taste and thick, green tenacious stool. A year of therapy is required to replace stores and correct hemoglobin concentrations, all of which can be done with IV iron in 30 minutes. For people with hereditary bleeding disorders, there is zero credible expectation oral iron can keep up with losses since 10% (maximum) of PO is absorbed and PO raises a protein, hepcidin, which blocks iron absorption for 24 to 48 hours, making adequate repletion unrealistic.

InjectaFer is the most expensive iron. It costs $843 for 750 milligrams. Based on the preponderance of published evidence, a gram of iron in a single dose is about all we can utilize. The recommended dose of InjectaFer is 1,500 mg, $1,686 for a course (not vial) of iron. I think that wastes 500 mg, and there is double-blind, prospective evidence supporting that conclusion. It costs $100 for an office visit, chair time nursing and IVs, which takes 15 minutes. If you visit twice, that’s an additional $100.The charges you mentioned suggest that an institution in New York is fleecing its clients or insurance companies. This is usury and should be investigated and stopped.

The health economist Richard Pollock is mistaken. IV iron is widely used in Great Britain and it is extremely likely, not unlikely, a patient with chronic blood loss would get IV iron, irrespective of symptoms. That being said, Ferinject, the European name for InjectaFer, costs $140 per gram and health providers don’t have to deal with the ridiculous 750 mg vial we do. Feraheme costs $466 for 510 mg and requires two vials for a gram (1,020 mg). Four insurers allow me to give 1,020 mg in a single 30-minute infusion: the Blues, MedStar, Priority Partners and Cigna. The rest, including Medicare and Medicaid, require two visits. The only benefit is to our practice, which gets $100 for the completely unnecessary second visit. Despite making it clear the single 1,020 mg infusion is just as safe and effective, you halve the number of IVs and chances for minor reactions. It’s not covered, I have no choice. A third get it once; two-thirds, twice. We charge $932 plus a 6% markup to cover nursing costs and paraphernalia.

INFeD, or low molecular weight iron dextran, costs $243 per gram, comes as 100 mg vials and requires 10 vials for 1 gram. It takes an hour and is just as safe and efficacious.

The author is mistaken about Venofer, iron sucrose and Ferrlecit, ferric gluconate. You can’t give more than 200-250 mg because the sugar that carries iron does so much less tightly than the carbohydrate cores of InjectaFer, Feraheme and INFeD. To give a gram takes four to five visits. I never use these drugs for that reason, but I have no criticism of nephrologists who use them in dialysis with thrice-weekly visits. Venofer is $600 per gram (definitely more than INFeD) and Ferrlecit $1,000 per gram.

The medical system you wrote is screwing the community. IV iron is an unmet need. Oral iron cannot keep up with losses in abnormal uterine bleeding, be absorbed after bariatric surgery, makes inflammatory bowel disease worse because it is directly toxic to the intestinal epithelium and makes the wrong bacteria grow, and most of all doesn’t get to babies in the third trimester when the fetal brain needs iron for normal development. IV iron is a godsend for millions.

— Dr. Michael Auerbach, Baltimore

Correct By Degrees

The article “‘Climate Grief’: Fears About The Planet’s Future Weigh On Americans’ Mental Health” (July 18) said a recent report by the Intergovernmental Panel on Climate Change predicts that “by 2040 the Earth will warm by 2.7 degrees Fahrenheit (1.5 degrees Celsius).” As the report’s opening page (to which you link) says, by 2040 the Earth will have warmed by 2.7F above preindustrial levels. That’s total warming over 200 years, not future warming in the next 22 years.

The report also provides little support for the extreme claims that have terrified so many people — and, even less excusably, terrified so many children. This is also true of many reports by the major climate agencies.

The IPCC is the largest and best-run project of its kind, ever — an assessment of current science, which is then summarized for non-scientists. The tragedy is that its work has been largely abandoned for propaganda that exaggerates or even ignores the findings. I believe this has caused the gridlock in U.S. climate policy, so that we are not only unprepared for future extreme weather, but for the inevitable repeat of past extreme weather.

— Larry Kummer, editor of the Fabius Maximus website, Davenport, Iowa

Editor’s note: Warm thanks for pointing out the error. Our article has been updated.

— Michelle Mills, Chicago

— James C. Coyne, Philadelphia

Incrementally Exploited By Politicians

My copay requirement of $7,500 plus a monthly payment must be paid before my insurance pays any expenses. This is not health care. On paper I have health care; but the reality is I can’t afford to use it. It simply would stop me from bankruptcy in case of an emergency. However, these politicians and attorneys are making millions and getting a lot of publicity with every petition they file (“Biden’s ‘Incremental’ Health Plan Still Would Be A Heavy Lift,” July 22).

I feel the politicians should have the same health care choices as the American people. This would help them make better choices. Democrats and Republicans know health care in the U.S. is unaffordable. They should all be fired for not doing their job.

I also believe they should be able to serve only two terms, just like the presidential office. Politicians treat their position as a lifestyle instead of a job.

— Catherine Mossner, Gladwin, Mich.

The Battle For Uniform Excellence In Tribal Care

I’m part Inupiaq Eskimo from northwestern Arctic Alaska. The article “How The Eastern Cherokee Took Control Of Their Health Care”(July 22) states that the Cherokee benchmarked a program developed by Southcentral Foundation, a Tribal Health Organization originally created by an ANCSA (Alaska Native Claims Settlement Act) corporation but allowed to operate as a Public Law 93-638 entity. Awarded largely no-bid contracts through the Indian Health Service, Southcentral Foundation legally represents only shareholders of Cook Inlet Region Inc. — not all Alaska Native peoples.

To say SCF and other Alaska Natives run the program may be partly accurate, but it does not give credit to valuable contributors who served for decades ensuring we understood and implemented programs designed for all cultures — even families related to non-Indian Health Service beneficiaries.

Augusta Reimer is one of those deserving credit for this program. She was the first female Alaska Native/American Indian chief of an Indian Health Service department and was largely responsible for creating an atmosphere of wellness and creativity. Reimer, from IHS, and Mike McKeown from the University of Alaska-Anchorage designed my degree in human services; she spent hours working with interns and volunteers educating them on laws impacting us. Everyone who contributed deserves to be cited accurately and not just in a side note as other “Alaska Natives.”

The government has been pretty decent about encouraging native peoples’ self-determination, but it does not come without responsibility to follow the standards of care and communication and the law to ensure the quality and longevity of our programs.

The Indian Health Service was not approved to provide care to non-Indian health service beneficiaries. So the Nuka system of care — originally called Nutuqsiivik, which means “new beginnings” — was created to help identify gaps in data that were barriers to providing care to families with multiple health care providers and health and socioeconomic issues.

Indian Health Service programs have come a long way, but consistency and uniformity among tribal areas is highly concerning. In the age of a one-payer review, transparency is critically important. So is accuracy. Data and the lack thereof can cause a myriad of health and economic issues the patient or customer may have to deal with while their tribal organization isn’t monitored or corrected when needed. Without competition, I fear, these programs do not adequately respect patient needs, desires and have no real incentive to improve the quality of their care in order to keep their customers.

The Alaska legislature has created a committee specifically designed to educate lawmakers and the public on issues affecting the public and the tribes because there are so many of us. These programs do not live in a vacuum, but rather impact local economic development and regulatory control over your community. I encourage accountability among all parties and the mirroring of the U.S. Constitution and laws, so we have a legal template to follow.

— Cheryl Bowie, Anchorage, Alaska

Patient Privacy Continues To Be A Priority When Working On Increasing Access To Health Data, Federal Official Says

Dr. Donald Rucker, the chief of the Office of the National Coordinator for Health Information Technology, said balancing privacy and patients’ rights is a “delicate balancing act.” In other news at the intersection of health and technology: robotic nurses and artificial intelligence’s role in drug development.

Scores Of People Born Through Artificial Insemination Are Finding Out Their Fathers Are The Doctors Who Performed Procedure

With the growing use of consumer DNA tests, many have been left reeling by the news that the sperm donors that their mothers selected are not their fathers. “You build your whole life on your genetic identity, and that’s the foundation,” said one woman. “But when those bottom bricks have been removed or altered, it can be devastating.” In other public health news: Lyme disease, gene editing, a blood test for Alzheimer’s, employee wellness programs and more.

Planned Parenthood Braces For Fallout From Title X Decision With Fundraisers, New Fees And Warnings

Clinics across the country are expecting to lose millions in federal funding after Planned Parenthood rejected money that came with a condition the organization deemed a “gag rule.” The women’s reproductive health care provider plans to lean heavily on donors to make up the funding gap while staff members assess how they’ll cope. Other news on abortion comes out of Ohio and Tennessee, as well.

Lung Illnesses Among Vapers Is Growing: FDA Joins CDC’s Investigation As 153 Cases In 16 States Are Identified

Federal and state officials say it does not appear that an infectious disease is responsible for the illnesses, while noting numerous ingredients in e-cigarette aerosol could harm the lungs. News on e-cigarettes also looks at bans against vaping in public places, a new industry probe over health concerns and more.

Texas Touch Football Group Requires All Players Wear Soft-Shell Helmets After Serious Head Injuries Occur

Researchers have found that flag football players receive many smaller hits to the head than those playing contact football, and they’re falling down on nearly every play. “This idea that there is no contact at all is fairly naïve,” said Robert C. Lynall, co-author of a study done at Georgia. Public health stories focus on artificial intelligence, vaping, PTSD treatments, a dehydration patch, e-cig TV ads, state fairs and cannabis research, as well.

FDA Officials: Stakes Were Too High In Novartis Data Manipulation Case To Do Anything But Publicly Drop The Hammer

The FDA came down hard on Novartis, subjecting the company to a public flogging over the data manipulation that, at the end of the day, didn’t effect patients’ safety. But the issue is too important to give anyone a pass, officials say. “It may sound like we’re kind of bureaucratic paper-pushers, but it’s more than that,” said FDA’s Dr. Peter Marks. “It’s making sure that the whole ecosystem understands that when people are working on these things that are highly technically complex, that they have to work truthfully and accurately.”

Former FDA Chief Urges Agency To Loosen Restrictions On Drugs To End Early Pregnancy

Former FDA Commissioner Dr. Jane Henney says Mifepristone is still heavily regulated despite having been proven safe and effective. “I think the FDA has shown a willingness to … take action,” Henney said. “I believe it’s important for them to do another review in light of the safety information we know about this drug.” In other news, clinics react to the Planned Parenthood’s decision to forgo Title X funds and ousted Planned Parenthood head Leana Wen announces her new job.

Government Was On Cusp Of Alerting Public About Opioid Crisis 13 Years Ago. Why It Didn’t Remains A Mystery.

Top government officials flagged “disturbing” data around opioids and addiction back in 2006 and requested urgent action be taken. Then-U.S. Surgeon General Richard Carmona agreed to issue a call to action. But then the momentum fizzled after a new surgeon general came on and 13 years later, the crisis continues to grip the country.

Joe Camel Was Forced Out Of Ads. So Why Is Juul Allowed On TV?

Why does e-cigarette maker Juul advertise its product on TV when cigarette ads are banned? The short answer: Because it can.

For nearly 50 years, cigarette advertising has been banned from TV and radio. But electronic cigarettes — those battery-operated devices that often resemble oversized USB flash drives with flavored nicotine “pods” that clip in on the end — aren’t addressed in the law.

Since launching its product in 2015, Juul Labs, based in San Francisco, has taken the e-cigarette market by storm, and now accounts for roughly 75% of e-cigarette sales at convenience stores and mass retail outlets. Until recently, TV ads haven’t played a role in Juul’s marketing, which relied primarily on social media.

But this year, the company launched a $10 million TV advertising campaign, “Make the Switch,” that it said was aimed at helping adults find a healthier alternative to smoking cigarettes. The campaign also features print and radio ads.

Many public health advocates are skeptical of the company’s repeated assertions that adult smokers are its target audience. When the company launched its sleek e-cigarette four years ago, it relied on social media outlets such as Facebook, Instagram and Twitter to promote its product in ads that, especially at the beginning, featured playful, partying 20-somethings.

As the product caught on, young people helped spread the word to other young people using hashtags like #juul. Social media influencers who posted content praising Juul amplified the message.

“There’s overwhelming evidence that the behavior of Juul contributed to the product being sold to youth,” said Dr. Robert Jackler, a professor and the principal investigator at Stanford Research Into the Impact of Tobacco Advertising (SRITA) at the university’s medical school.

Juul said it is not targeting children and teens and supports efforts to limit tobacco products to people under age 21. “We recognize that youth use of vapor products is a problem that requires an effective and appropriate response from industry and regulatory bodies,” said Ted Kwong, a Juul Labs spokesman. “We strongly support restrictions on social media marketing of vapor products.”

In recent years, the number of high schoolers and even younger kids who say they’ve used e-cigarettes has grown rapidly, alarming parents and public health advocates.

Last year, almost 21% of high school students reported using e-cigarettes in the previous 30 days, according to an analysis of National Youth Tobacco Survey data published by the federal Centers for Disease Control and Prevention. In 2011, the proportion was just 1.5%. Between 2017 and 2018 alone, the number of high school students who said they were current e-cigarette users grew by 78%, to more than 3 million students overall. The CDC said 1 in 20 middle school students, those in grades 6 through 8, reported vaping in the previous 30 days.

In contrast, 3% of adults said they used e-cigarettes in 2017, according to the CDC.

E-cigarettes, also called vapes, were introduced in the United States in the mid-2000s. Some early versions resembled actual cigarettes. Juul’s product can be plugged into a USB port to recharge and fits inconspicuously into the palm, often frustrating parents and teachers seeking to stop teens from using it.

There’s evidence that smoking e-cigarettes may act as a “gateway” that leads young people to try cigarette smoking. And cigarette smoking remains the leading cause of preventable death, killing more than 480,000 people in the United States every year.

E-cigarettes don’t produce tar, in which most of the cancer-causing and other harmful chemicals from tobacco smoke are found. But both products contain nicotine, which is highly addictive and can harm the developing brains of adolescents.

In addition, the vapor that people inhale when the liquid nicotine in e-cigarettes is heated may contain cancer-causing chemicals, heavy metals and other dangerous substances.

Nevertheless, e-cigarettes are often touted as a healthier alternative to cigarette smoking, and that’s the premise of Juul’s “Make the Switch” campaign. The testimonial ads feature adults describing the positive changes in their lives after they gave up smoking cigarettes to use Juul.

“We want adult smokers to hear directly from former adult smokers that Juul Labs provides a true alternative to combustible cigarettes and is showing unprecedented success, with studies showing 40 to 56 percent of adult smokers fully switching within 90 days of use,” said Kwong.

Although adolescents may be more likely to see ads in social media than traditional broadcast and print ads, the Juul TV ads probably have an impact on them, said Bonnie Halpern-Felsher, a professor of pediatrics at Stanford University School of Medicine who developed a tobacco prevention toolkit for teachers.

“When you say that a product is for an adult, the message is not ‘Don’t use,’ it’s ‘Use these products and you’ll appear to be adult or mature,’” Halpern-Felsher said.

Anti-smoking advocates would like to see the same marketing limits applied to e-cigarettes that apply to so-called combustible cigarettes, including banning them from advertising on TV and radio.

They would also like to see the changes that were put in place under the Master Settlement Agreement in 1998 between the largest cigarette manufacturers and the attorneys general of 46 states applied to e-cigarettes. The states had sued the cigarette makers to recover their costs for treating sick and dying smokers. Among other things, the agreement banned most transit and billboard advertising of cigarettes, branded merchandise, free product samples and sponsorships of events, such as concerts and sporting events.

E-cigarette makers, such as Juul, have used some of those advertising methods over the years.

Last year, after the federal Food and Drug Administration said it was cracking down on an “epidemic” of teen vaping, Juul announced changes to its marketing activities.

The company shut down its Facebook and Instagram accounts and limited Twitter communications to non-promotional posts, Kwong said.

That’s like closing the door to the barn after the horse has left, said public health advocates. Young people, they added, are continuing to post about Juul on those sites.

“It’s too late,” said Dave Dobbins, chief operating officer at the Truth Initiative, an anti-tobacco advocacy group. “The kids are doing their work for them.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

MDMA, Or Ecstasy, Shows Promise As A PTSD Treatment

The first time Lori Tipton tried MDMA, she was skeptical it would make a difference.

“I really was, at the beginning, very nervous,” Tipton said.

MDMA is the main ingredient in the club drug known as ecstasy or molly. But Tipton wasn’t taking pills sold on the street to get high. She was trying to treat her post-traumatic stress disorder by participating in a clinical trial.

After taking a dose of pure MDMA, Tipton lay in a quiet room with two specially trained psychotherapists. They sat next to her as she recalled some of her deepest traumas, such as discovering her mother’s body after Tipton’s mother killed two people and then herself in a murder-suicide.

“In the embrace of MDMA,” Tipton said, she could revisit that moment without the usual terror and panic. “I was able to find such empathy for myself.”

Scientists are testing how pharmaceutical-grade MDMA can be used in combination with psychotherapy to help patients with a severe form of PTSD that has not responded to other treatments. Unlike street drugs, which may be adulterated and unsafe, researchers use a pure, precisely dosed form of the drug.

MDMA is not yet available as a treatment for PTSD outside of clinical trials. But proponents are aiming for approval by the Food and Drug Administration, which granted breakthrough therapy status to MDMA-assisted psychotherapy in 2017.

Researchers are conducting Phase 3 clinical trials at more than a dozen sites. Clinicians who treat PTSD are hopeful the next round of trials will show that MDMA treatment is an effective option to relieve patient suffering.

“The problem is we haven’t had a new drug to treat PTSD in over 17 years,” said Dr. Sue Sisley, a physician and president of the Scottsdale Research Institute, based in Arizona. “There are certain illnesses that are just intractable and not responsive to traditional therapy, and we need to start thinking more broadly.”

But MDMA is a Schedule I controlled substance, which means it currently has no accepted medical use and has a “high potential for abuse” (something that MDMA’s therapeutic proponents dispute). Because of that designation, the current research trials are privately funded by the Multidisciplinary Association for Psychedelic Studies, or MAPS.

‘Anywhere I Would Feel Unsafe’

Tipton struggled for years with PTSD before she was treated with MDMA. She said life with PTSD was like “seeing the world through dirty goggles.”

“Anywhere I would feel unsafe,” the 40-year-old from New Orleans said. “I would feel like I had to always be vigilant because if I didn’t, something bad was going to happen.”

Tipton described her 20s as a catalog of tragedy and trauma. It began when her brother fatally overdosed in her home. After his death, she began caring for her mother, who struggled with mental illness. In 2005, Tipton’s mother killed two people and then herself. Tipton discovered their bodies.

“I completely just disassociated. I couldn’t believe what I was seeing,” Tipton said.

“When you have PTSD, you are living in this constantly triggered environment,” says patient Lori Tipton. More than a year after getting MDMA-assisted psychotherapy in a clinical trial, Tipton no longer qualifies as having PTSD.(Will Stone)

The traumas continued to pile up. The place she lived was destroyed when Hurricane Katrina hit New Orleans, and the following year, she was raped.

As the years went by, Tipton had panic attacks and terrible anxiety. She tried everything to treat her symptoms: talk therapy, antidepressants, hypnotherapy, meditation and yoga. Nothing worked. She went through life exhausted and apathetic, constantly triggered and struggling to be intimate with people close to her.

Then Tipton enrolled in the Phase 2 clinical trials for MDMA-assisted psychotherapy.

MDMA And Therapy Together

MDMA was first synthesized in 1912, and its therapeutic benefits were studied in the 1970s. But those efforts stalled when the U.S. federal government — in light of the growing popularity of ecstasy as a recreational drug — designated it a Schedule I drug in 1985.

In recent years, research has resumed, funded by private sponsors such as MAPS.

The treatment protocol in the current trial calls for a 12-week course of psychotherapy with specially trained therapists. During that time, there are two or three daylong sessions, which begin with the patient taking a calibrated dose of MDMA in pill form.

The treatment begins with patients swallowing a calibrated dose of MDMA in pill form.(Courtesy of the Multidisciplinary Association for Psychedelic Studies)

A team of two therapists, generally one man and one woman, then guide the patient through the eight-hour MDMA “session.” Later, there’s follow-up talk therapy, without the drug, to help the patient process feelings, thoughts or impressions that came up while under the influence of the drug.

“MDMA allows you to contact feelings and sensations in a much more direct way,” said Saj Razvi, a Colorado-based psychotherapist who was a clinical investigator in the Phase 2 trials.

How MDMA works in the brain is not completely understood. The psychoactive drug boosts chemicals like serotonin and oxytocin. It also tamps down activity in the amygdala, a part of the brain that processes fear. This may lead to a state characterized by heightened feelings of safety and social connection.

“Trauma happens in isolation,” Razvi said. “One of the things that MDMA does is, really, lets you know that you are not alone.”

PTSD In Remission

After the Phase 2 trials of MDMA-assisted treatments concluded in 2017, researchers found that 54% of the 72 patients who took MDMA had improved to the point that they no longer fit the diagnosis for PTSD (compared with 23% in the control group).

And the beneficial effects of the treatment appeared to increase over time. A year later, the number who no longer had PTSD had risen to 68%.

“That was astonishing,” Sisley said. “Even with the best pharmaceutical regimen, you rarely ever see patients go into remission.”

Dr. Sue Sisley, president of the Scottsdale Research Institute, has spent much of her career working with people who have severe PTSD.(Will Stone)

She said she hopes to offer her patients MDMA-assisted psychotherapy as soon as possible, maybe before the drug receives full FDA approval.

Brad Burge, a spokesman for MAPS, said that, beyond sponsoring the MDMA trial, the organization is working to get the FDA to include the drug in its expanded access program, which can allow individual patients to be approved to use drugs that are still being studied.

Burge said the goal is to make MDMA-assisted psychotherapy available as a prescription treatment in a specialty clinic to anyone with PTSD.

And MAPS is working to persuade public and private insurance plans to cover the treatment, Burge said. He estimates that for patients paying entirely out-of-pocket, a 12-week course of treatment would cost between $5,000 and $10,000.

Most of the cost is for the guided therapy, not the actual drug.

Transformative Treatment

Tipton describes her treatment with MDMA as transformative.

She was able to let go of the troubling feelings surrounding her mother’s death. And, she unearthed other memories, too, feelings of joy that had been sealed away.

By her last MDMA session, Tipton was even able to talk about her sexual assault.

A year later, she was reassessed and no longer qualified as having PTSD. Tipton said she believes the treatment saved her life.

“Everything is at my fingertips for me in a way that it never was before,” she said. “I want that for everybody.”

This story is part of a partnership that includes KJZZ, NPR and Kaiser Health News.

Long-Sought Safety Changes In Car Seats For Side Impact Crashes Hit Multiple Road Bumps. Federal Agency, Industry Can’t Agree On New Rules.

While car crashes are a leading killer of children, seats have only been tested for head-on crashes. Since the early 2000s, the National Highway Traffic Safety Administration has pushed for new seats that also protect children from side-impact crashes as well. ProPublica reports on what’s taking so long and how the industry is dragging its heals. Public health news looks at dementia, measles, vaccines, diets and telemedicine, as well.

Racketeering Lawsuit Alleges Juul, Philip Morris Adopted Big Tobacco’s Catchy Ad Campaigns Geared Toward Kids

A 19-year-old is suing the two companies using the Racketeer Influenced and Corrupt Organizations Act, claiming that “the defendants prey on youth for financial gain.” The suit is just the latest litigation over the e-cigarette maker’s marketing tactics. In other news: the prevalence of e-cigarettes in classrooms, legal smoking ages, and lung disease possibly linked to vaping.

Smaller Players In Sweeping Opioid Case Against Drugmakers Closing In On Potential Settlements

Drugmakers Endo International and Allergan are both in talks to settle over allegations about the role they played in the opioid crisis. The two companies have drawn less attention than bigger players like Purdue Pharma. The nationwide, consolidated lawsuit that will be heard in Ohio is being closely watched and likened to the Big Tobacco reckoning of the 1990s. Other opioid news focuses on supervised injection facilities, the effect of the drugs on the country’s life expectancy, and more.