First Edition: May 18, 2018

Kaiser Health News: Vermont Legislators Pass A Drug Importation Law. So What?
This week, Vermont passed a first-in-the-nation law that would facilitate the state’s importation of prescription drugs wholesale from Canada. It represents the state’s effort to tackle head-on the issue of constantly climbing drug prices. Other states, including Louisiana and Utah, have debated similar legislation and are watching Vermont’s progress closely. (Luthra, 5/18)

Kaiser Health News: Podcast: KHN’s ‘What The Health?’ Much Ado About Drug Prices
President Donald Trump’s blueprint to reduce drug prices frames almost as many questions as answers, but it does shine light on a vexing and complicated problem. Meanwhile, Vermont passed a law to do something that’s not in the president’s plan: import cheaper prescription drugs from Canada. The state will need federal permission to do that, which is unlikely to be granted. And Timothy Jost, emeritus professor of law at Washington and Lee University in Virginia, discusses the state of the Affordable Care Act and what might be in the health law’s immediate future. (5/17)

Kaiser Health News: Between Death And Deportation
“Dear the most highly respected judge and court, I’m writing this because I love my mom. My mom is very important to me. I have no idea what to do without her. Even though my mom’s afraid, she’s not giving up.” This is the beginning of a plea written by a 13-year-old girl to the Department of Homeland Security. The goal: to get her mother the insurance coverage she would need to enter a clinical trial. (Gorenstein, 5/18)

The Associated Press: Trump To Deny Funds To Clinics That Discuss Abortion
The Trump administration will resurrect a Reagan-era rule that would ban federally funded family planning clinics from discussing abortion with women, or sharing space with abortion providers. The Department of Health and Human Services will announce its proposal Friday, a senior White House official said Thursday, speaking on condition of anonymity because the official was not authorized to confirm the plans before the announcement. (Alonso-Zaldivar, 5/18)

The New York Times: Trump Administration To Tie Health Facilities’ Funding To Abortion Restrictions
The rule, which is to be announced Friday, is a top priority of social conservatives and is the latest move by President Trump to impose curbs on abortion rights, in this case by withholding money from any facility or program that promotes abortion or refers patients to a caregiver that will provide one. The policy would be a return to one instituted in 1988 by President Ronald Reagan that required abortion services to have a “physical separation” and “separate personnel” from other family planning activities. That policy is often described as a domestic gag rule because it barred caregivers at facilities that received family planning funds from providing any information to patients about an abortion or where to receive one. (Davis and Haberman, 5/17)

The Associated Press: FDA Names Drugmakers Accused Of Blocking Cheaper Generics
U.S. drug regulators are publicizing information on brand-name drugmakers that use what government officials call "gaming tactics" to block cheaper copycat versions. The Food and Drug Administration's new webpage names the makers of more than 50 brand-name drugs, many carrying five- or six-figure annual price tags, who are under scrutiny. The agency also lists inquiries it has received from generic drugmakers requesting FDA's help in getting access to the brand-name drugs though not all the complaints have been verified. (Johnson, 5/17)

The New York Times: F.D.A. Names And Shames Drug Makers To Encourage Generic Competition
Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, calls this “gaming the system,” and has vowed to stop it as part of the government’s campaign to lower drug prices. On Thursday, the F.D.A. took a new tack and began posting a list of makers of brand-name drugs that have been the target of complaints, to persuade them to “end the shenanigans,” in the commissioner’s words. Dr. Gottlieb calls it transparency, but this approach is better known among ethicists as naming and shaming. (Kaplan, 5/17)

The Wall Street Journal: FDA Calls Out Drug Makers That Improperly Block Generic Competition
“We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval,” Dr. Gottlieb said in a statement. The FDA plans to update the list twice a year. Companies on the FDA’s list include midsize and larger drugmakers like AstraZeneca PLC and its heart drug Brilinta, Biogen Inc. and its multiple sclerosis drug Tecfidera, and Bayer AG’s cancer drug Nexavar. Biogen said it is the company’s practice to comply with requests from generic companies for drug samples. Bayer also said its practice is to “provide samples upon request, in full accordance with applicable laws and regulations.” AstraZeneca said it wasn’t aware of any outstanding requests for samples of Brilinta by any generic manufacturers. (Burton, 5/17)

Stat: Right-To-Try Bill Headed For Vote Puts Bigger Burden On FDA, Gottlieb Says
The House is set to take up a controversial “right-to-try” bill next week — and if it passes, the Food and Drug Administration will have to work harder to protect patients than it would if a different version of the legislation were advancing, Commissioner Scott Gottlieb told STAT in an interview. Gottlieb’s comments, made at FDA headquarters on Thursday, indicate that one of President Trump’s top lieutenants believes Congress is moving forward with a bill that contains less of his agency’s input than an alternative version of the bill — a more recent, updated bill that passed the House in March but ultimately stalled in the Senate. (Swetlitz and Mershon, 5/17)

The Hill: House To Vote To Send 'Right To Try' Bill To Trump’s Desk Next Week 
“This will not only offer a chance for the patient to possibly find treatment but could open possibilities to help others do the same,” House Majority Leader Kevin McCarthy (R-Calif.) said in a statement. “I am proud we will send this historic legislation to President Trump and offer hope to individuals and families facing dire circumstances.” In August, the Senate passed Right to Try by unanimous consent. The bill, which Sen. Ron Johnson (R-Wis.) championed, lets sick patients request access to treatments the Food and Drug Administration (FDA) hasn’t yet approved. (Roubein, 5/17)

Stat: FDA Looks At Ways To Include Price Info In Drug Ads, As Questions Loom
The commissioner of the Food and Drug Administration, Scott Gottlieb, said a proposal to have pharmaceutical companies include drug prices in advertisements has prompted a series of questions, including exactly how consumers would benefit and whether the government can legally require the disclosures. In an interview with STAT, Gottlieb said an agency working group would consider questions like those as it seeks to implement one of the Trump administration’s top proposals for lowering drug prices. (Swetlitz, 5/18)

The Hill: Ryan: 'Compromise' In The Works For Controversial Drug Pricing Bill 
Speaker Paul Ryan (R-Wis.) said Thursday that a compromise is being worked out on a controversial bill aimed at lowering drug prices, boosting hopes from supporters that the bill could move forward. Ryan said the Energy and Commerce Committee and the Judiciary Committee are working out a compromise on the legislation, known as the Creates Act. (Sullivan, 5/17)

Politico: Pulse Check: Azar To Drug Plan Critics: Bring On The Fight
HHS Secretary Alex Azar has a message for critics of the Trump administration's plan to lower drug prices: Bring it on. Drugmakers, pharmacy benefit managers and some physician groups have spent a week taking shots at the new effort — a reprise of how the industries banded together to stop a similar Obama-era initiative in 2016. On POLITICO’s “Pulse Check” podcast, Azar encouraged the players to engage with the administration. (Diamond, 5/17)

The New York Times: N.I.H. Halts Enrollment In A Study Of Drinking Now Under Scrutiny
The National Institutes of Health has suspended enrollment in a huge clinical trial on the health benefits of moderate drinking while officials review whether its employees inappropriately solicited funding from the alcohol industry. Five liquor and beer companies are providing about $67 million of the $100 million cost of the 10-year study. In March, The New York Times reported that scientists and officials with the N.I.H.’s National Institute on Alcohol Abuse and Alcoholism met with alcohol industry groups on several occasions in 2013 and 2014 to discuss funding. (Rabin, 5/17)

The Washington Post: NIH Halts $100 Million Study Of Moderate Drinking That Is Funded By Alcohol Industry
Thursday morning’s announcement by NIH Director Francis Collins reflects the seriousness of allegations that surfaced in news reports in recent months, including a story in March in the New York Times that described two scientists and a federal health official pitching the idea for the study to liquor company executives at a 2014 gathering in Palm Beach, Fla. The alcohol industry agreed to fund the research via a private foundation that supports NIH. The goal of the study, which involves 7,000 individuals, is to assess whether moderate drinking — a single drink a day — has a health benefit. Some research has suggested such a benefit, but the conclusion remains controversial, and the U.S. dietary guidelines recommend that people who do not drink alcohol should not start. (Achenbach, 5/17)

The New York Times: Veterans Go Back To Court Over Burn Pits. Do They Have A Chance?
On May 9, a federal appeals court heard oral arguments in a case about an explosive issue among U.S. veterans: the widespread use of burn pits in Iraq and Afghanistan, and the potential health consequences they suffered as a result. The case, which dates back to 2008, consolidated dozens of lawsuits by hundreds of veterans and their families seeking to recover damages from the military contractor KBR Inc., but a trial court dismissed it in July 2017. It could be at a legal dead end unless the panel of judges, the Fourth Circuit Court of Appeals in Richmond, Va., overturns the dismissal. (Harp, 5/17)

The Associated Press: Gov't Approves $10B Deal To Overhaul VA Medical Records
The government approved a $10 billion deal Thursday to overhaul the electronic health records of millions of veterans, part of a bid to improve wait times and expand access to doctors outside the Veterans Affairs system. The aim of the contract with Cerner Corp. is to provide veterans easy access to their health records upon leaving active-duty service and when they receive medical treatment at a VA facility or a private doctor referred under the VA's Choice private-sector program. (Yen, 5/17)

Politico: VA Joins Military In Fraught Multibillion-Dollar Health IT Contract
Former VA Secretary David Shulkin announced his intention to sign the single-source contract last June after consultation with Jared Kushner, but then revealed in December that he had put it on hold as the implementation of a related Pentagon contract experienced grave difficulties, including critical safety concerns at four Pacific Northwest treatment centers. Kushner and others argued the best way to assure seamless health care records was for both the VA and DoD to use the same technology. Others pointed out that since the majority of vets leave the military system after retiring, most of the data sharing would take place between the VA and private doctors and hospitals where 70 percent of veterans’ care takes place. Many of the big academic health centers that treat veterans use Cerner’s biggest competitor, Epic. (Allen, 5/17)

NPR: Army Takes Steps To Protect A Shooter's Brain From The Weapon's Blast
For the first time, the U.S. military is speaking publicly about what it's doing to address potential health risks to troops who operate certain powerful shoulder-mounted weapons. These bazooka-like weapons produce forceful explosions just inches from the operator's head. Though several scientific reports over the past year have noted the possible risk, until now military officials have been reluctant to speak publicly about whether repeated exposure to these blasts might result in injury to a shooter's brain. (Hamilton, 5/17)

Politico: Trump Donates First-Quarter 2018 Salary To VA
President Donald Trump will donate his salary for the first quarter of 2018 to the Department of Veterans Affairs, the White House announced Thursday. Acting VA Secretary Robert Wilkie said at a press briefing that the money would go toward caregiver support programs, including mental health, peer support, research, education, training and financial aid. (Okun, 5/17)

The New York Times: New Drug Offers Hope To Millions With Severe Migraines
The drug, Aimovig, made by Amgen and Novartis, is a monthly injection with a device similar to an insulin pen. The list price will be $6,900 a year, and Amgen said the drug will be available to patients within a week. Aimovig blocks a protein fragment, CGRP, that instigates and perpetuates migraines. Three other companies — Lilly, Teva and Alder — have similar medicines in the final stages of study or awaiting F.D.A. approval. “The drugs will have a huge impact,” said Dr. Amaal Starling, a neurologist and migraine specialist at the Mayo Clinic in Phoenix. “This is really an amazing time for my patient population and for general neurologists treating patients with migraine.” (Kolata, 5/17)

The Associated Press: US Approves 1st Drug Developed To Prevent Chronic Migraines
U.S. regulators Thursday approved the first drug designed to prevent chronic migraines. The Food and Drug Administration's action clears the monthly shot Aimovig for sale. It's the first in a new class of long-acting drugs for preventing migraines. Three other shots are expected to win approval by next year, and several pills for preventing migraines are being tested. (Johnson, 5/17)

The Wall Street Journal: FDA Approves Migraine Medicine
Currently, said Dr. Kadrie, clinicians tend to use drugs such as blood-pressure medicine and drugs for seizures that “happen to prevent migraines.” It is estimated that in the U.S., more than 37 million people suffer from migraines, and there are studies suggesting that as many as 13% of the adult U.S. population have them, including two million to three million who are chronic sufferers. The condition tends to be about three times as frequent in women as in men, and is especially prevalent in the age group between 35 and 55 years old. (Burton, 5/17)

Stat: Amgen's New Migraine Drug Will Cost 30 Percent Less Than Wall Street Expected
Amgen will charge $6,900 a year for a new drug that can spare migraine sufferers a few headaches each month, a price that comes in well below Wall Street expectations as the company hopes to avoid the payer backlash that has hamstrung recent drug launches. In clinical trials, patients who took Amgen’s drug experienced about two fewer migraines per month compared to those who got placebo. Doctors have described the effect as modest, but the difference was enough to convince the Food and Drug Administration, which approved the treatment Thursday. (Garde, 5/17)

The Associated Press: Surgeon General: Most In US Think Opioid Abuse Is Not Local
The U.S. surgeon general, Dr. Jerome Adams, said Thursday that opioid abuse occurs nationwide, but only a small percentage of Americans think it's an emergency in their own communities. "Most of us feel that the opioid epidemic is a problem," Adams said during a panel discussion at the University of Mississippi Medical Center. "But when you look at surveys, less than half of the people in the United States feel that it rises to the level of an emergency. And less than half of that — less than a quarter of the people — feel it's an emergency in their community. Everyone thinks there's a problem somewhere else." (5/17)

Stat: FDA Admonishes Big Data Provider Over Error Concerning Opioid Prescriptions
In an unusual development, the Food and Drug Administration has sternly criticized a big provider of prescription data to the federal government after discovering an “inaccuracy” concerning the amount of fentanyl that was prescribed over the past year, as well as “data quality issues” regarding several other controlled substances. The mistakes occurred as the agency attempts to manage and develop policies for coping with the opioid crisis, a task that can be accomplished only with the help of accurate prescribing data that is dissected for usage trends. For this reason, the FDA plans to brief members of Congress for potential public health implications and convene with other federal agencies, such as the Drug Enforcement Agency. (Silverman, 5/17)

ProPublica: At St. Luke’s In Houston, Patients Suffer As A Renowned Heart Transplant Program Loses Its Luster
The anonymous letter reached Judy Kveton in March 2017. Nearly two months earlier, her husband’s failed heart transplant at Baylor St. Luke’s Medical Center had led to a week of follow-up surgeries, a pair of devastating strokes and then, his death. The donor heart that doctors had implanted in David Kveton was “just not acting right,” Judy remembers the surgeon, Dr. Jeffrey Morgan, telling her hours before she decided to remove her husband from life support. (Ornstein and Hixenbaugh, 5/16)

The New York Times: ‘Will You Be My Emergency Contact?’ Takes On A Whole New Meaning
Will you be my emergency contact? When you’re dating, the question is a sign that you’ve made it to the this-is-really-serious category. When you’re friends, it’s a sign that you’re truly beloved or truly responsible. And if you’re related, it may mean that you will now be entered into a medical study together so scientists can figure out if sinus infections or anxiety run in your family. (Murphy, 5/17)

Los Angeles Times: To Prevent Recurrent Strokes, Should Aspirin Have A Wingman? Maybe Not
When it comes to preventing the formation of potentially deadly blood clots in people at elevated risk for them, there are no easy answers. That's the upshot of a clinical trial involving patients who suffered a stroke that resolved quickly and caused no lasting damage. For these patients, adding the anti-platelet drug Plavix to usual aspirin therapy drove down some serious risks, but increased the chances of bleeding events. A second study found that an anticoagulant drug known as Xarelto performed no better than aspirin alone in heading off strokes and heart attacks after a small stroke, and also drove up subjects' risk of bleeding. (Healy, 5/17)

Stat: Patients Are Taking Home Recordings Of Doctor Visits. Who Else Could Listen?
Doctors across the U.S. have begun doing what once seemed unthinkable in a litigious health care environment: recording their medical conversations with patients and encouraging them to review the audio at home. The rationale for the practice is as simple as the smartphone technology that enables it: having a recording improves patients’ understanding and recall of their doctor visits and helps them adhere to treatment regimens. (Ross, 5/18)

The New York Times: Netflix Counts The Reasons Teens Should Watch ‘13 Reasons Why’
In the second episode of the new season of Netflix’s “13 Reasons Why,” the high school student Courtney Crimsen publicly reveals that she is a lesbian. Wanting to be understanding, caring parents as the news ripples through town, her two fathers hold a family movie night. They flip through a stack of DVDs — all about lesbian relationships. “Movies and shows are a wonderful way to open up a dialogue,” one of the dads says to the other, as Courtney sighs, annoyed. (Rosman, 5/17)

The New York Times: Inducing Labor At Full Term May Be Best Bet
Whether to induce labor for babies at or beyond full term is a difficult decision. Waiting to give birth after 41 weeks’ gestation may slightly increase the risk that the baby will die before or shortly after birth. But there are also risks in inducing labor, including lowering the baby’s heart rate and an increased likelihood of infection for both mother and baby. (Bakalar, 5/17)

The New York Times: Acupuncture Does Not Improve Pregnancy Rates
Acupuncture is sometimes recommended as a complementary treatment for women undergoing in vitro fertilization. But a randomized clinical trial has found that the procedure does not improve pregnancy rates. The Australian study, published in JAMA, included 824 women planning to undergo I.V.F. Half received acupuncture and half sham acupuncture a week before follicle stimulation and then again before and after transfer of the embryo. The acupuncture treatment technique was based on traditional Chinese medicine, and the sham acupuncture used a non-inserted needle placed away from the true acupuncture points. (Bakalar, 5/17)

The New York Times: Hail Caesar Salad! Romaine Is Safe To Eat Again
Attention Caesar salad fans: You may now safely rekindle your romance with romaine. Federal health officials have concluded that the tainted lettuce that sickened 172 people across 32 states, and killed one, is no longer available for sale. Both the Food and Drug Administration and Centers for Disease Control and Prevention announced this week that the danger had passed. (Hoffman, 5/17)

The Associated Press: Health Officials: Stay Out Of The Pool If You Have Diarrhea
Health officials say hotel pools and hot tubs are a major source of the stomach bugs people get from swimming. And they're reminding people with diarrhea to stay out of pools, hot tubs and water playgrounds. U.S. public health officials report on safe swimming every year. Thursday's version from the Centers for Disease Control and Prevention focused on outbreaks in 2000 through 2014 that were tied to swimming or bathing in treated recreational water spots. (Stobbe, 5/17)

KQED: In The Land Of Legal Weed, Drug Education Moves From ‘Don’t’ To ‘Delay’ 
Public schools in California are required by law to provide anti-drug abuse education, although experts say the quality of the instruction varies widely from district to district, and there’s little enforcement. ... Today, drug abuse education is an advanced pedagogy, drawing on decades of rigorous effectiveness research and the newest teaching techniques. (Feibel, 5/16)

The New York Times: ‘Just The Grossest Thing’: Women Recall Interactions With U.S.C. Doctor
Former students at the University of Southern California are coming forward by the dozens, re-examining years-old interactions with Dr. George Tyndall, the longtime gynecologist at the student health center who is now at the center of a growing scandal. What they considered inappropriate and humiliating at the time, they are now reporting to a special university hotline as signs of the doctor’s trail of abuse. (Medina, 5/17)

Los Angeles Times: USC's Aggressive Recruiting Of Chinese Students Faces Challenge Amid Gynecologist Scandal
USC has relied on bright young minds from across the Pacific to propel itself from prominent Southern California commuter school to international research university. Aggressive recruitment of Chinese students has delivered high-quality students and tuition dollars to the university and given scholars from rural provinces access to top professors and the bright lights of Hollywood. But the unique bond forged in recent decades between USC and the world's most populous nation was shaken this week amid allegations of misconduct on the part of a longtime campus gynecologist. (Etehd, Pringle, Xia and Hamilton, 5/17)

The Washington Post: Jorge Zamora-Quezada Gave Unnecessary Chemo Injections To His Patients In $240 Million Fraud Scheme, Authorities Say
The business of chemotherapy treatment for arthritis has been good to Jorge Zamora-Quezada. The Texas doctor took to the air on his six-seat Eclipse 500 business jet, bought with some of the $50 million he was paid since 2000 administering a host of treatments to countless patients. And on land, Zamora-Quezada, 61, roared between various homes and properties in South Texas in his blue 2017 Maserati Granturismo Coupe. (Horton, 5/17)

The Associated Press: Doctor Accused Of Keeping Human Fat In Closet Back At Work
The North Carolina doctor accused of reusing syringes and storing human fat in plastic bags can practice medicine again, even though her license was suspended. The Winston-Salem Journal reports a Wake County judge granted a temporary restraining order Tuesday against the N.C. Medical Board, saying it violated due process by summarily suspending Dr. Anne Litton White’s license ahead of a June 21 board hearing where she can defend her medical actions. (5/17)

The Associated Press: Virginia House To Reconvene In Hopes Of Passing Budget
The Virginia House of Delegates plans to reconvene next week in hopes of being able to finalize a state budget. GOP Speaker Kirk Cox announced Thursday that the House would gavel in on May 23. Cox said he expects the Senate to have passed a state budget by then for the House to consider. The Senate is set to meet on May 22, but it’s unclear whether it will pass a budget that day. (5/18)

The Associated Press: Report Faults Response To San Diego's Hepatitis A Outbreak
A grand jury report following the worst outbreak of Hepatitis A in the United States in 20 years faulted the response of San Diego city and county officials on Thursday and recommended improving communications to prepare for future health emergencies. The outbreak killed 20 and sickened 577 people between November 2016 and October 2017. (5/17)

The Associated Press: Walgreens Offers Free Hepatitis C Testing At 10 Pharmacies
The Virginia Department of Health is partnering with Walgreens to offer no-cost Hepatitis C testing at 10 pharmacies across the state. The health department announced the development Thursday.The testing offer comes as Virginia’s opioid epidemic has contributed to an increasing number of Hepatitis C cases in the state. The health department says people who share needles when they inject drugs are most at risk for acquiring the virus. (5/18)