Viewpoints: Thoughts On Nominee To Lead The FDA; What Makes A Drug Policy ‘Bad’?

The New England Journal Of Medicine: An FDA Commissioner For The 21st Century
President Donald Trump has named Scott Gottlieb as his nominee to be the next commissioner of the Food and Drug Administration (FDA). As compared with some of the other people whose names were floated publicly for the position, Gottlieb is a traditional choice, a physician who served in a deputy commissioner role under President George W. Bush. Observers who opposed Commissioner Robert Califf because of his relationships with drug companies will surely express concern about Gottlieb’s consulting in this area. But he would have been on the short list for any Republican administration. If confirmed, Gottlieb would take the helm of the FDA at a time when it faces a number of key challenges. We highlight these challenges, to emphasize the talents required of the next commissioner. (Amitabh Chandra and Rachel E. Sachs, 3/29)

The New England Journal Of Medicine: Scott Gottlieb And The Credibility Of U.S. Therapeutics
President Donald Trump has nominated Scott Gottlieb as U.S. Commissioner of Food and Drugs. The Trump administration’s approach to the Food and Drug Administration (FDA) is guided by a libertarian belief in markets over science, and Gottlieb apparently shares this view. He has argued that the agency displays an “unreasonable hunger for statistical certainty” and a “profound lack of confidence in the ability of doctors to make careful judgments.” He seems poised to weaken phase 3 testing requirements.1 The administration considered nominees with even more extreme views, including the belief that the FDA should not be in the business of regulating drug efficacy. (Daniel Carpenter, 3/29)

RealClear Health: Why It’s Important To Just Say No To Bad Drug Policy
In all the discussions about the proposed health care law, it was easy to overlook a statement made by Attorney General Jeff Sessions on March 15: “I think we have too much of a tolerance for drug use – psychologically, politically, morally… We need to say, as Nancy Reagan said, ‘Just say no.’” ... Sessions’ statement aligns with his stated commitment to increase the number of private prisons, as in February 2017, he revoked the directive by President Obama to reduce the number of for-profit prisons. ... Between Sessions’ statements about our country being too tolerant of drugs and his plans to expand private prisons, we appear to be heading back toward criminalizing addiction, rather than treating it. (Margie Skeer, 3/30)

The Washington Post: To Solve An Opioid ‘State Of Emergency,’ Maryland Starts Very Small
Maryland faces a horrific opioid epidemic, which claimed nearly 1,100 lives in 2015, the last full year for which data exist. Though a growing share of the toll is attributable to heroin and illicit fentanyl, prescription opioids still account for a large portion: more than 32 percent of the deaths in 2015, to be exact. Legal drugs, often obtained initially with a physician’s authorization, drove the upsurge of opioid addiction in the 21st century and continue to create havoc. (3/30)

The Kansas City Star: Claire McCaskill Right To Plunge Ahead With Opioid Probe
Claire McCaskill is no shrinking violet. So the Missouri senator’s much-publicized incursion this week into the opioid epidemic that is rocking this country should surprise no one. That includes Sen. Ron Johnson, the Republican chairman of the Senate Committee on Homeland Security and Governmental Affairs on which McCaskill sits. Johnson said he was disappointed in the Democrat’s go-it-alone decision to demand marketing information, sales records and studies from opioid manufacturers. (3/30)

The New England Journal Of Medicine: Scientific Drought, Golden Eggs, And Global Leadership — Why Trump’s NIH Funding Cuts Would Be A Disaster
On March 16, 2017, President Donald Trump submitted his budget titled “America First,” with a proposal to cut the 2018 National Institutes of Health (NIH) budget by 18.3%, or approximately $5.8 billion. It is the first time a president has proposed a cut of this magnitude since the NIH received its first appropriation in 1938, with an initial investment of $400,000 in the National Cancer Institute. Since that time, the NIH budget has grown to $32 billion, with nearly 80% being awarded through competitive grants to more than 300,000 investigators at 2500 universities, medical schools, and other research institutions in every state and around the world. (Ingrid T. Katz and Alexi A. Wright, 3/29)

Boston Globe: Time For Action On Mental Health In Massachusetts
The Boston Globe Spotlight series paints a disturbing picture of the current state of mental health care in the Commonwealth. Vulnerable people and their families are left to fend for themselves. Individuals who suffer from severe and debilitating mental illness are often criminalized or lack access to appropriate treatment. Our criminal justice system has become the de-facto provider of behavioral health services. The response of the legislature to tragic stories from our first responders, our courts, and our family members has been anemic at best. Our system does not adequately serve those with severe mental illness, and it is well beyond the time to take bold action. (Kenneth Donnelly, 3/31)

The New England Journal Of Medicine: Medical Liability — Prospects For Federal Reform
Medical malpractice reform appears to be back on the federal policy agenda. The appointment of Tom Price, a long-time proponent of tort reform, as secretary of health and human services, in conjunction with Republican control of both houses of Congress, has created fertile conditions for several Republican proposals that have languished for years without the requisite support. Although it has been debated many times, a major federal foray into medical liability, a state-based area of law, would be unprecedented. The prospect raises several questions: Which reforms are on the table? Would they be effective? And is the time right? (Michelle M. Mello, Allen Kachalia and David M. Studdert, 3/29)

Lexington Herald Leader: Bevin Can’t Outlaw Abortion But He’s Trying
Gov. Matt Bevin continues to waste public resources — including the federal courts’ time — by attacking the rights of Kentuckians to make private decisions about their lives and their families’ futures. Bevin’s latest assault would effectively outlaw abortion in Kentucky by shutting down the state’s last abortion provider. Fortunately, a history of U.S. Supreme Court decisions stands as a bulwark against this attack on reproductive rights. (3/30)

The Des Moines Register: Myths Like 'Life Begins At Conception' Don't Belong In The Law
As suddenly as they announced it, Iowa House Republicans withdrew a piece of legislation that would have banned abortions as early as six weeks of pregnancy, or once a fetal heartbeat could be detected, which would have effectively banned all abortions. But not before Democrats on the House Human Resources Committee spent a frantic 30 hours trying to figure out what they could do to protect Iowa women’s constitutional right to choose. The answer is, not much. (Rekha Basu, 3/30)

Lexington Herald Leader: Don’t Like Abortion? Make Sure No Kentuckian Lacks Access To Family Planning
Research shows that in states where abortion access has been severely limited, some women terminate their pregnancies on their own, sometimes using extreme methods such as inserting sticks or toxic liquids into their wombs. The potential shutdown of Kentucky’s only remaining licensed abortion facility, EMW Women’s Surgical Center in Louisville, puts Kentuckians in danger. (Marcie Crim, 3/30)

Stat: Robert F. Kennedy Jr.: Your Anti-Vaccine Crusade Is A Disgrace To Science
Not that long ago, Americans lived in fear of infectious diseases such as polio. In the early 1950s, polio caused more than 15,000 cases of paralysis each year. Following the introduction of vaccines in 1955 and 1963, the number of polio cases fell rapidly to less than 100 in the 1960s and fewer than 10 in the 1970s. Since 1979, no cases of polio have originated in the United States. Your uncle, President John F. Kennedy, joined with then-Surgeon General Dr. Luther Terry, in “urging that every person who has not been vaccinated immediately do so with the vaccine now available.” You could build on your family’s legacy of science-based, public health prevention. Instead, you are sowing fear and doubt at the highest levels of government by doubling down on your conspiracy theory that the use of thimerosal in vaccines causes brain disorders, including autism. (Susan Peschin, 3/30)

Stat: Taking Stock Of Medicine On National Doctors Day
To better understand the profession from the perspective of those who are new or relatively new to it, my organization, the American Medical Association, recently surveyed a total of 1,200 medical students, residents, and physicians with 10 or fewer years on the job. The survey asked, among other things, why they became physicians, what challenges they face professionally, and whether they are satisfied with their career choice. One answer that was loud and clear: medical students, residents, and young physicians overwhelmingly view the profession as a calling, one driven by an innate desire to help others. Nearly three-quarters of those surveyed said they heard this calling while still in their teens. (Patrice A. Harris, 3/30)

Cleveland Plain Dealer: Cuyahoga County Must Live Up To Commitment To MetroHealth Transformation
By providing care of last resort for all Cuyahgoa County residents no matter their income or level of health insurance; by adding clinics in the Cleveland schools; by expanding its primary care network throughout the county and by taking over responsibility for the medical care of Cuyahoga County jail inmates, the MetroHealth System continues to be an irreplaceable asset for the county and its residents. ... And what has Cuyahoga County done in return? Cut its subsidy by double-digits. Cut MetroHealth's share of the county health and human services levies down to 14 percent from 18 percent just four years ago. Refused to put even this funding on a sustainable basis. (3/31)

The Wall Street Journal: A Right-Left Cure For Disabilities Torts
California is supposed to be the heartland of resistance to all things Donald Trump, but then what to make of the effort by Golden State Democrats and Republicans in Washington to stop runaway disabilities torts? Congress passed the Americans with Disabilities Act (ADA) in 1990 to ensure that handicapped people aren’t discriminated against or denied access to services. But due to regulatory overgrowth, the 275-page ADA building code now specifies everything from the height of bathroom mirrors to the size of toilet-paper dispensers. (3/30)