First Edition: May 23, 2018

Kaiser Health News: Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions
Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found. As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts. (Lupkin, 5/23)

California Healthline: California Hospitals Urge Moms To Favor Breast Milk Over Formula
Wendy Wan, 31, said American infant formula is advertised in her native China as the most nutritious food for a newborn.“It sounds like it’s premium,” said Wan, who gave birth in early May at Beverly Hospital here. Wan said she was skeptical of the ads and had planned to feed her baby son only breast milk. But when her milk failed to come in quickly, she didn’t hesitate to supplement it with formula. “I prefer breastfeeding, but I think it’s almost the same,” she said from her hospital bed the day after her son was born. (Gorman, 5/22)

The Associated Press: Congress OKs Letting Terminal Patients Try Unapproved Drugs
A bill helping people with deadly diseases try experimental treatments sailed through Congress on Tuesday, a victory for President Donald Trump and foes of regulation and a defeat for patients' groups and Democrats who argued the measure was dangerous and dangled false hope. After an emotional debate, the House gave the legislation final congressional approval by a largely party-line vote of 250-169, nine months after it passed the Senate. (Fram, 5/22)

The New York Times: Congress Approves Bill Giving Patients A ‘Right To Try’ Experimental Drugs
The bill would, in effect, allow dying patients to bypass the Food and Drug Administration and obtain an “investigational drug” with the approval of their doctors, if the drug manufacturer agrees to supply it. On at least three occasions in the past four months, Mr. Trump has urged Congress to pass the bill.“Patients with terminal conditions, and terminal illness, should have access to experimental treatment immediately” and “should not have to go from country to country to seek a cure,” he said in January in his State of the Union address. (Pear, 5/22)

The Washington Post: ‘Right To Try’ Legislation Heads To The White House
The Senate passed the bill in August, and the House approved its own version in March. That version was less objectionable to the medical groups, but then the legislation got bogged down. With the White House demanding action, House leaders in recent days decided to short-circuit the process by taking up the Senate-passed bill. The vote was 250 to 169. The measure, championed by Sen. Ron Johnson (R-Wis.), is designed to give patients an alternative way to obtain drugs not approved by the FDA. Currently, there are two options for patients seeking experimental medications: enrolling in clinical trials if they are eligible or participating in the FDA’s “expanded access” program. The agency has said that it approves almost all such requests to that program. (McGinley, 5/22)

The Wall Street Journal: House Approves Giving Terminally Ill Quicker Access To Experimental Drugs
Most patients already get access to unproven medicines under a compassionate-use program overseen by the Food and Drug Administration, agency officials say. But the bill would essentially skirt the FDA’s normal approval process to get trial medicines more rapidly to patients with life-threatening illnesses. Republicans pushed for the change, which Mr. Trump supported in his State of the Union address, saying it would give patients access to non-FDA-approved drugs before it is too late. Some Democrats and patient groups have argued it would usurp the FDA and leave patients vulnerable to dangerous and possibly sham treatments. (Armour, 5/22)

Politico: House Passes Trump-Backed Drug Bill, Letting Sick Patients Bypass FDA
Trump heard from Pence — who had passed a similar bill while governor of Indiana — many anecdotes about terminally ill people and their families who wanted access to new drugs, according to an administration source. The legislation took a winding path through Congress. The vote Tuesday was the third time the House attempted to pass a right-to-try measure, having failed once to get enough votes to fast-track the bill. The effort also got caught up in a standoff between the House and Senate, which had competing versions of the bill. Patient advocacy groups that opposed the bill’s passage this week didn’t raise much opposition when the bill quietly passed the Senate unanimously last year. A last-ditch effort to get a new version through the Senate in recent days failed. (Haberkorn, 5/22)

NPR: Right-To-Try Bill Heads To President Trump For Signature
FDA Commissioner Scott Gottlieb said on Twitter that he's "comfortable" with the bill and later that he is prepared to implement the law "in a way that achieves Congress' intent to promote access and protect patients." (Kodjak, 5/22)

The Wall Street Journal: Trump Administration To Advance Plan To Restrict Funding For Abortion Providers
The Trump administration will move ahead with restrictions on funding access for family planning providers that offer abortion services, the Department of Health and Human Services said Tuesday. The announcement came shortly before President Donald Trump was addressed the annual gala of the Susan B. Anthony List, a group that supports antiabortion candidates for federal office. There, Mr. Trump said his administration had made a “historic announcement” and “kept another promise.” (Radnofsky, 5/22)

The New York Times: Trump Rule Would Bar Some Abortion Advice At Federally Funded Clinics
The proposed rule submitted last week, a copy of which was posted on the Department of Health and Human Services website, would bar clinics or programs that receive federal family planning funds from providing abortions or referring women to places that do, imposing what it calls a “bright line” of separation. It takes direct aim at Planned Parenthood and reproductive health organizations like it, which provide a range of women’s health services, including abortions. Mr. Trump hailed the new proposal — a top priority of social conservatives who have been among his staunchest supporters — at a gala on Tuesday night for the Susan B. Anthony List, a leading anti-abortion organization. “For decades, American taxpayers have been wrongly forced to subsidize the abortion industry,” Mr. Trump said, describing the new policy to sustained applause from the audience of activists and Republican lawmakers. (Davis and Shear, 5/22)

The Hill: Trump Urges Anti-Abortion Advocates To Rally In November
President Trump on Tuesday encouraged anti-abortion advocates to turn out to the polls in November to help get more of his priorities through Congress, like a ban on abortion after 20 weeks of pregnancy. “If we work hard between now and November, every one of these states can be flipped to a senator who shares our values and votes our agenda,” Trump said at an annual gala held by the Susan B. Anthony List, an anti-abortion group based in Washington. (Hellmann, 5/22)

Politico: How Anti-Abortion Forces Learned To Love Trump
President Donald Trump on Tuesday night was feted by a leading anti-abortion group that called him the most "pro-life president" ever. It's the exact same group that just two years ago begged Iowa caucus voters to nominate “anyone” but Trump. “I’m totally eating my words,” said Susan B. Anthony List President Marjorie Dannenfelser, who praised Trump at the group's annual gala in Washington. “It’s the happiest wrong I’ve ever been." (Haberkorn and Cadelago, 5/22)

The Associated Press: Portrait Of Despair: Opioids Land More Women Behind Bars
On opposite sides of the county jail, a mother and her son chat about school, girls, birthday gifts — and their future together. They aren't allowed to see each other face-to-face, so the inmate and the fifth-grader connect by video. "Hi, Mommy," 10-year-old Robby says to Krystle Sweat, clutching a phone in the visiting room as he looks at his mother on a screen, sitting in her cell. (Cohen, 5/21)

The Associated Press: In The Addiction Battle, Is Forced Rehab The Solution?
The last thing Lizabeth Loud, a month from giving birth, wanted was to be forced into treatment for her heroin and prescription painkiller addiction. But her mother saw no other choice, and sought a judge's order to have her committed against her will. Three years later, Loud said her month in state prison, where Massachusetts sent civilly committed women until recent reforms, was the wake-up call she needed. (Marcelo, 5/23)

The New York Times: Overdoses From ‘Dangerous Batch’ Of K2 Grows To 56 In Brooklyn
The small, shiny packets that claim to hold only scented potpourri look harmless. One, a bubble gum variety of Scooby Doo Snax, bears a classically goofy image of the clue-sniffing dog. Another, Barely Legal, hints at naughtiness with a cartoon rendering of a woman’s torso. But the police and city health officials say that the contents, drugs known loosely as synthetic marijuana, or K2, is wholly illegal and dangerous. A particularly toxic batch was responsible for a mass overdose in Brooklyn over the weekend, sickening at least 56 people and leading to at least 15 arrests since Saturday. (Southall and Piccoli, 5/22)

The Associated Press: Alabama Doctor Acquitted In Rock Guitarist's Overdose Death
Jurors acquitted an Alabama physician accused of prescribing drugs that killed a former guitarist for rock band 3 Doors Down. The not guilty verdict was returned Monday in the case of Dr. Richard Snellgrove, court documents show. Snellgrove had been indicted on 13 counts of unlawful distribution of drugs and health care fraud tied to the 2016 death of Matthew Roberts. (5/22)

The Associated Press: Virginia Lawmakers Put Off Budget, Medicaid Debate
Virginia senators put off debate Tuesday on the state budget and whether to expand Medicaid, but pledged to settle the issue next week. Senate Republican Majority Leader Tommy Norment said he expects the upper chamber to pass a budget next week, and it is likely to include Medicaid expansion. “I think there’s a probability it will pass. The question is: In what form?” Norment said. (Suderman, 5/22)

The Washington Post: Va. Senate Puts Off Medicaid Vote With Democrats Unable To Pull Off 'Nuclear' Move
The Senate will return in a week, a delay billed as a way to give senators more time to study the latest Medicaid expansion plan, which was announced the day before by a key GOP senator and the House’s budget chief. “A last-ditch obstructionist effort,” state Sen. Janet D. Howell (D-Fairfax) called the development. In a rare outburst from the Senate gallery, two women shouted. “People are dying!” one of them called out. “Do your job!” The delay came with a change in tone from Senate Majority Leader Thomas K. Norment Jr. (R-James City), who for the first time publicly acknowledged that expansion is likely to pass the Senate. The House has already backed it. (Vozzella, 5/22)

The New York Times: 200 Professors Call For Ouster Of U.S.C. President, Citing Lack Of ‘Moral Authority’
Two hundred professors at the University of Southern California have demanded the resignation of the school’s president, C.L. Max Nikias, saying that he no longer had the “moral authority to lead” and had failed to protect students and staff from “repeated and pervasive sexual harassment and misconduct.” The letter was addressed to the board of trustees of the private university and signed by senior faculty members, who said they wanted to “express our outrage and disappointment” over how Mr. Nikias had handled reports that a gynecologist at the campus health center had mistreated students for decades. (Medina and Arango, 5/22)

The Associated Press: USC President Urged To Resign Over Response To Complaints
Dr. George Tyndall routinely made crude comments, took inappropriate photographs and forced plaintiffs to strip naked and groped them under the guise of medical treatment for his "sexual gratification," according to civil lawsuits filed this week. The latest complaint announced by attorney Gloria Allred was filed Tuesday on behalf of Daniella Mohazab, a USC student seeking a master's degree in communications management. Mohazab said Tyndall saw her at the clinic in 2016 for an STD test. Tyndall made comments about her Filipina heritage, including telling her that "Filipinas are good in bed," according to court documents. (5/22)

The Washington Post: Pressure Mounts On USC President To Resign After Scandals
The chairman of the school’s board of trustees expressed strong support for the school’s president Tuesday. The trustees’ executive committee has full confidence in the “leadership, ethics and values” of USC President C.L. Max Nikias, the board’s chairman John Mork said in a statement, “and is certain that he will successfully guide our community forward.” Nikias released an action plan Tuesday to change the campus culture. (Svrluga, 5/22)

Los Angeles Times: 200 USC Professors Demand Nikias Step Down; Trustees Express 'Full Confidence' In President
Nikias sent the campus community a 20-page "action plan" Tuesday that he said was prepared at the request of trustees. It called for a wide rethinking of university ethics that will include a rewrite of USC's Code of Ethics and a new presidential commission on improving campus culture. In a statement, Nikias said he understood "the faculty's anger and disappointment." "I am committed to working with them as we implement this wide-reaching plan and to rebuilding their trust," he said. (Ryan, Parvini and Hamilton, 5/22)

The Associated Press: Ohio State President Seeks Info About Alleged Misconduct
The president of Ohio State University has asked alumni for help with an investigation into reports of alleged sexual misconduct by a former university doctor. At issue are allegations against Richard Strauss, who died in 2005. To date, the university has received confidential reports alleging sexual misconduct from male athletes in eight sports. (5/22)

The New York Times: Ex-Valeant Executive Is Convicted Of Bilking Drugmaker In Kickback Scheme
A former executive at Valeant Pharmaceuticals International and the onetime head of a small mail-order pharmacy were convicted on Tuesday of using a secret kickback arrangement to defraud the drugmaker. A federal jury in Manhattan found Gary Tanner, the former Valeant executive, and Andrew Davenport, at one time the chief executive of Philidor Rx Services, guilty on all charges, including wire fraud and conspiracy to commit money laundering. (Thomas, 5/22)

The Wall Street Journal: Jury Finds Former Valeant Exec Guilty On Charges Related To Kickback Scheme
The former Valeant executive, Gary Tanner, and his co-defendant, Andrew Davenport —the former chief executive of Philidor Rx Services, a specialty mail-order pharmacy involved in the scheme—were both convicted Tuesday on all four criminal counts they faced, including honest services wire fraud and money-laundering conspiracy. “We are of course disappointed in the verdict, but we look forward to addressing the many legal and evidentiary issues on appeal,” said Brendan McGuire, a lawyer for Mr. Tanner. (O'Brien, 5/22)

Stat: Former Valeant Executive Is Found Guilty In Kickback Scheme 
The verdict comes nearly three years after the drug maker became enmeshed in scandals over its pricing and accounting practices, which led to congressional hearings, a loss of confidence among investors, and a subsequent turnover in management and the board. The Philidor episode was particularly explosive, though, because Valeant failed to properly disclose its relationship with the pharmacy. (Silverman, 5/22)

Stat: FDA Plans To Speed Path To Approval For Some Gene Therapies
The Food and Drug Administration will soon be alerting companies that certain gene therapies in development can qualify for less arduous review at the agency, Commissioner Scott Gottlieb said Tuesday. Specifically, gene therapies for hemophilia, a rare disease in which blood doesn’t clot properly because it lacks certain proteins, could be evaluated based on whether therapy increases those proteins in the blood, regardless of whether the therapy actually causes the patient to bleed less. (Swetlitz, 5/22)

Bloomberg: Gene Therapies That Could Transform Diseases Get Easier FDA Path 
Unlike traditional drugs, gene therapies are intended to be given once, transform the inner workings of the body and last for a lifetime. For regulators, the challenge is to find ways to get the new therapies to desperate patients while balancing the need to monitor their long-term safety for years after approval, FDA Commissioner Scott Gottlieb said Tuesday. “For some of these products, there’s going to be some uncertainty, even at the time of approval,” Gottlieb said in a speech at the Alliance for Regenerative Medicine’s annual board meeting. “But these products are initially being aimed at devastating diseases, many of which are fatal and lack available therapy. In these settings, we’ve traditionally been willing to accept more uncertainty to facilitate timely access to promising therapies.” (Cortez, 5/22)

Stat: The Drug Industry's Next Big Idea To Treat Alzheimer's Faces Fresh Doubts
After a generation of failures, the drug industry has pivoted to its next-best idea for treating Alzheimer’s disease. But a troubling string of clinical trial results suggests that the latest approach to the devastating disease might go the way of its forebears, continuing decades of frustration for patients and scientists. Over the past year, three clinical trials involving two similar medicines have been halted early, two because a drug was clearly not working and a third because the treatment came with worrying safety concerns. (Garde, 5/23)

The Associated Press: Many Cancer Patients Juggle Care Along With Financial Pain
Josephine Rizo survived chemotherapy, surgery and radiation, but breast cancer treatment wrecked her finances. Money was already tight when doctors told the Phoenix resident she had an aggressive form of the disease. Then she took a pay cut after going on disability leave, and eventually lost her job and insurance coverage. During treatment, Rizo got swamped with more than $50,000 in medical bills. "My concern was, 'Am I going to die?'" she said. "I had to kind of focus 100 percent on my health to make sure I was around for my kids." (Murphy, 5/22)

Los Angeles Times: The Death Rate From Cancer Is Falling For American Men, Women And Children Of All Backgrounds
Cancer is the No. 2 cause of death in the U.S., but a comprehensive new report says that it is affecting — and killing — fewer Americans with every passing year. The gains have been seen in men, women and children, as well as across racial and ethnic groups. However, depending on the type of cancer involved, some Americans benefited more than others. There are also some cancers that are becoming more common in the U.S., even as the overall incidence is declining. (Kaplan, 5/22)

Los Angeles Times: New 'Unified Theory' Of Childhood Leukemia Raises Possibility Of Preventing The Disease
Kids who develop acute lymphoblastic leukemia may be the victims of a triple-whammy stroke of bad luck, according to a provocative new theory from a respected British cancer researcher. If the explanation turns out to be correct, it would be good news for the most common type of childhood cancer: Doctors could prevent cases of acute lymphoblastic leukemia with the strategic introduction of something the world has plenty of: filth and pestilence. (Healy, 5/23)

The New York Times: Air Pollution Near Power Plants Tied To Premature Births
Closing coal- and oil-fired power plants is associated with a reduction in preterm births in the surrounding region, researchers report. Scientists counted the number of preterm babies born in regions surrounding eight power plants before and after their closings from 2001 to 2011. The study is in the American Journal of Epidemiology. Based on the mother’s home address, the researchers looked at preterm birthrates within three, six and 12 miles of each plant in the year before and the year after closing. (Bakalar, 5/22)

The Washington Post: New Ebola Vaccine Faces Major Test In Congo Outbreak
Authorities in Congo began an ambitious campaign this week to use a pioneering Ebola vaccine to help stem a growing outbreak of the deadly virus. It’s the first widespread use of the therapeutic since a devastating 2014 epidemic in West Africa and represents a major strategic shift for public health. World Health Organization officials, criticized for their slow response four years ago, began vaccinating health workers in affected areas Monday and plan to vaccinate about 1,000 people in the next week. More than 7,500 doses have been sent to the Democratic Republic of Congo, and an additional 8,000 doses will be available in the coming days, according to WHO. (Sun, 5/22)

Stat: Excitement Over Use Of Ebola Vaccine Tempered By Real-World Challenges
The start of a vaccination program this week in the Democratic Republic of the Congo, a first in an Ebola outbreak, was a cause for a mini celebration in research and outbreak response circles. But there are challenges ahead in the real-world use of the vaccine, warned the head of the global health organization that is funding the vaccination effort. Successful use of the vaccine requires response planners and vaccination teams to hit the right notes on several challenging communications messages, said Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, a public-private partnership that assists developing countries with immunization programs. (Branswell, 5/23)

The Associated Press: WHO Says 9 Nations Mobilize To Prevent Possible Ebola Spread
The World Health Organization’s regional director for Africa says the agency is accelerating efforts with nine countries neighboring Congo to try to prevent the spread of the current Ebola outbreak beyond its borders. Matshidiso Moeti says teams are being deployed to assess preparedness and “immediate next steps” include boosting capacity-building, training and resource mobilization. The top two priority countries are Central African Republic and the Republic of Congo, near the epicenter of the outbreak. In the Republic of Congo, for example, WHO is working with government officials “to stop functioning” an active market on its side of the Congo River. (Keaten, 5/23)

The Hill: US To Contribute Up To $7 Million To Fight Ebola Outbreak
The U.S. will contribute up to $7 million to fight an Ebola outbreak in the Democratic Republic of Congo (DRC), Health and Human Services Secretary Alex Azar announced Tuesday. Azar made the announcement in Switzerland at the World Health Assembly, the decisionmaking body of the World Health Organization (WHO), while urging other member states to contribute to "ensure we defeat this outbreak."  (Hellmann, 5/22)

Los Angeles Times: Tax Bill And Obamacare Repeal Are Potent Issues In California Congressional Races, Poll Shows
With Democrats angling to win back control of the U.S. House, the new tax law and the failed attempt to repeal Obamacare may prove to be important campaign flashpoints against California Republicans, according to a new USC Dornsife/Los Angeles Times poll. Sixty percent of registered voters statewide approved of the Affordable Care Act, also known as Obamacare. The support was highest among Democrats and people who disapprove of President Trump, and concentrated in urban and coastal areas — which happen to be regions where there are several competitive congressional races. (Mai-Duc, 5/23)

The Associated Press: Maryland Candidates To Endorse ACA Down Payment Plan
Democratic candidates for governor of Maryland are scheduled to endorse a plan to help protect the Affordable Care Act in Maryland. The Maryland Health Care for All Coalition is announcing the candidates who support the plan on Wednesday at a news conference in Baltimore. The plan would create an individual health care mandate at the state level. The proposal differs from the federal mandate that is set to expire, because the Maryland plan would give people the option of putting a down payment on health insurance, instead of paying a penalty if they don’t have it. (5/23)

NPR: Unnecessary C-Sections Targeted By Covered California
Covered California, the state's health insurance marketplace under the Affordable Care Act, has devised what could be a powerful new way to hold hospitals accountable for the quality of their care. Starting in less than two years, if the hospitals haven't met certain designated targets for safety and quality, they'll risk being excluded from the "in-network" designation of health plans sold on the state's insurance exchange. "We're saying 'time's up,'" says Dr. Lance Lang, the chief medical officer for Covered California. "We've told health plans that by the end of 2019, we want networks to only include hospitals that have achieved that target." (Dembosky, 5/23)

The Associated Press: Texas Governor's School Safety Talks To Tackle Gun Control
Texas Gov. Greg Abbott's meetings on school violence and safety promised to wade into the thorny issue of gun control with the next round, even though the Republican has been a staunch supporter of gun rights and worked to expand them in the state in recent years. Abbott called for a series of high-level policy meetings after a high school near Houston became the latest to have a mass shooting. Eight students and two teachers were killed last week at Santa Fe High School and more than a dozen wounded. (5/23)

The Associated Press: Woman Who Shot Kansas Abortion Doctor Moved To Halfway House
An anti-abortion activist who shot and wounded a Kansas abortion doctor and firebombed clinics in Oregon and other states in the 1990s was released Tuesday from federal prison to a halfway house to finish her sentence, sparking fears for the safety of abortion clinic workers. The Federal Correctional Institution in Waseca, Minnesota confirmed Rachelle "Shelley" Shannon has been released, and sent to a halfway house where she will finish a 20-year sentence related to two Oregon cases of arson and other crimes targeting abortion clinics. Her final release date is Nov. 7. (5/22)

The Associated Press: Mother: 15-Year-Old Son Killed Himself After Being Bullied
A Minnesota woman says her 15-year-old son killed himself after months of being bullied and assaulted, and that school staff didn't do enough to support the boy, who had mental health issues and learning disabilities. Faith Elsharkawy says she can't be certain that her son Jacob LeTourneau-Elsharkawy, who was a freshman at Chisago Lakes High School, was bullied because her family is Muslim. But she says the bullying began when he was in 8th grade, after she started wearing a hijab. (5/22)

The Washington Post: Court Sides With Transgender Va. Student In His Fight To Use The Boys’ Bathroom
A federal judge in Virginia sided Tuesday with a transgender teenager who spent most of his high school years fighting to use the boys’ bathroom, ruling that school officials violated his constitutional rights. Gavin Grimm sued the Gloucester County School Board after it barred him from the boys’ bathroom. The case made Grimm, now a 19-year-old activist in Berkeley, Calif., the face of a national fight for transgender student rights and ascended to the Supreme Court. (Balingit, 5/22)