Supporters of the 21st Century Cures Act, which passed the House in July and is now with the Senate, say it will help get new and better treatments to patients faster. A contrary view—voiced by experts such as cardiologists Rita Redberg and Sanket Dhruva in a July 17 New York Times op-ed—is that the act would “subject millions of Americans to unsafe or untested medical devices” and loosely vetted drug therapies.
An underlying premise of the bill is the need to accelerate approval for new products, but the U.S. Food and Drug Administration (FDA) already approves new medications about as quickly as any regulatory agency in the world, evaluating nearly all new drug applications within 6 to 10 months. Currently, a third of new drugs are approved on the basis of a single trial lasting six months or less—“a potential problem for medications designed to be taken for a lifetime,” write Dr. Jerry Avorn and Dr. Aaron S. Kesselheim in the New England Journal of Medicine.
As introduced, the 21st Century Cures Act would allow the FDA to consider nontraditional study designs and methods of data analysis to further speed approvals. Adaptive trial designs hold promise in some areas, particularly in cancer treatment, but critics argue that more problematic elements of the Act encourage the use of “shorter or smaller clinical trials” for medical devices, and call for the FDA to rely on “evidence from clinical experience” instead of randomized, controlled trials for approving new uses for existing drugs. “There is considerable evidence that these approaches are not as rigorous or valid as randomized trials in assessing efficacy,” doctors Avorn and Kesselheim asserted in the June 25 New England Journal article.
In MemoriamJulian Bond, Civil Rights Champion
Julian Bond died on August 15, at the age of 75. Bond’s story is that of a young, charismatic civil rights activist who grew to become one of the nation’s most beloved statesmen. President Barack Obama remembered him as a “hero” who “helped change this country for the better.”
Bond’s life of service began in 1960, when he co-founded the Student Nonviolent Coordinating Committee (SNCC) at Morehouse College in Atlanta and led student protests against segregated public facilities. In 1965, he was elected to the Georgia House of Representatives, but white legislators refused to seat him because he opposed the Vietnam War. He fought the block all the way to the Supreme Court, which ruled unanimously in his favor. In 1967, he was sworn in and held his seat until 1975.
Bond was the first president of the Southern Poverty Law Center (SPLC), which in his tenure challenged numerous discriminatory policies, such as the forced sterilization of thousands of black teenage girls and the placement of homeless black children in detention facilities.
In 1975, Bond began serving the first of six terms in the Georgia Senate. He also served as president of the Atlanta chapter of the NAACP from 1974 to 1989, and national chair of the NAACP from 1998 to 2010. He was also a popular history professor at the University of Virginia, making civil rights accessible to his students.
“With Julian’s passing, the country has lost one of its most passionate and eloquent voices for the cause of justice,” said SPLC founder Morris Dees. “He advocated not just for African Americans, but for every group, indeed every person subject to oppression and discrimination, because he recognized the common humanity in us all.”
Dr. Frances Kelsey, FDA Reformer
Dr. Frances Kelsey had only been in her job at the Food and Drug Administration for a month when she was asked to sign off on a drug—already in use in Canada and more than 20 European and African countries—for treating morning sickness in pregnant women. The year was 1960, and the drug was thalidomide.
After uncovering an English study that documented a nervous system side effect, Kelsey refused, insisting that more data be gathered and that the drug be fully tested prior to approval. Thalidomide’s manufacturer, William S. Merrell Co. (later Marion Merrell Dow), applied strong pressure, complaining to Kelsey’s superiors and calling her a pesky bureaucrat.
But Kelsey stood her ground and proved a heroine when a year later, in 1961, researchers linked severe birth defects in thousands of babies in Europe—many born with deformed or missing arms and legs—to thalidomide ingestion by their mothers during pregnancy. She was credited with averting a similar tragedy in the U.S.
For her role in blocking American approval of thalidomide, Kelsey received the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy in 1962.
Kelsey went on to play a key role in shaping and enforcing the 1962 Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act, which strengthened regulations by forcing drug companies to disclose side effects and prove efficacy. She remained at the FDA until 2005, when at age 90 she retired after 45 years of service.
Kelsey died in London, Ontario, on August 7. She was 101.
Improving the Health of the System
“Under our constitutional tradition, the power to arrest and forcibly hold a person against his or her will is generally reserved for officers of the law acting in the name of the people of Texas. By bestowing that grave authority on private parties who lack the training of peace officers and are not bound by the same oath to protect and serve the public, [Senate Bill] 359 raises serious constitutional concerns and would lay the groundwork for further erosion of constitutional liberties.”
With those words, Texas Governor Greg Abbott vetoed a measure passed by the Texas legislature that would have given hospitals, emergency rooms and mental health clinics in the state authority to detain people if they refused medical treatment.
“By making refusal of treatment and attempts to leave the trigger for assessing and then holding patients, instead of observed danger to self or others, the bill is contrary to individual and parental rights,” wrote Johana Scot on behalf of a coalition of groups that opposed the bill. “Clearly, competent adults have the right to make informed decisions about their medical care, including the right to seek help elsewhere and the right to forgo treatment altogether.”
Scot, who is executive director of the Parent Guidance Center, a Texas nonprofit organization that helps parents involved in the child welfare system, asserted that the bill would have undermined the right of parents to direct the upbringing of their children by leaving the door open for “a doctor to force his preference on parents who may disagree with a proposed treatment or who want a second opinion.”
The bill was opposed by Texans for Accountable Government, the Texas Home School Coalition, the Texas State League of United Latin American Citizens, the Libertarian Party of Texas, and the Texas chapter of the Citizens Commission on Human Rights (CCHR).
Lee Spiller, executive director of CCHR Texas, told Freedom that the Hogg Foundation for Mental Health and the Meadows Foundation were major drivers of the now-defunct bill, each providing $10 million grants to forward substantial revisions of the Texas mental health code, including changes that would make it easier to detain patients.
The veto by Gov. Abbott, who has served as Texas attorney general and as a Texas Supreme Court justice, “was in line with his record on similar matters,” wrote Peggy Fikac in the San Antonio Express‑News.
No Fly List fails can bring a chuckle—like when Senator Ted Kennedy was repeatedly blocked from boarding an aircraft in the spring of 2004. Or when an 18-month-old baby was removed from a JetBlue flight in 2012, at which Forbes quipped, “They didn’t stop and think about whether a one-and-a-half-year-old posed a security threat, or whether it could possibly be a case of mistaken identity. […] No sir, the TSA agents … pulled that terror-baby off the plane.”
But it’s not so funny when it happens to you, according to 13 Americans—two military veterans among them—who found themselves blacklisted without notice, reason, or a meaningful way to address it. The American Civil Liberties Union (ACLU) filed a lawsuit in June 2010 on their behalf, and the longstanding case is still underway. In a filing in the case, the government was forced to admit the No Fly List relies upon “predictive assessments about potential threats” rather than demonstrated ones—a process the ACLU likens to the sci-fi notion of “pre-crime.”
U.S. District Judge Anna J. Brown is currently considering what ACLU attorney Hina Shamsi told The Guardian is “the first case in which a court is being asked to review the basis for the government’s predictive model for blacklisting people who have never even been charged, let alone convicted, of a violent crime.”
A former CIA counterterrorism analyst submitted a brief for the ACLU arguing that “the government’s predictive judgments cannot be considered reliable” and amount to guesses that don’t meet the criteria for putting someone on the No Fly List.
In March, as a result of the lawsuit, the Department of Homeland Security began informing people when they are blacklisted and permitting them to file a “redress inquiry” to trigger a process of “careful” (but secret) evaluation of the reasons why.
The Obama administration opposes both the release of further information about how the predictive assessments are made and providing people more information that could help them challenge their no-fly status, citing national security concerns.
On August 22, more than 100 kids ages 6-14 signed a pledge to remain drug free at a back-to-school event in the Tampa Bay area community of Lealman, Florida. The pledges are part of the Foundation for a Drug-Free World (FDFW) The Truth About Drugs program. “The most effective weapon in the fight against drug abuse is education and that is why we work so hard to educate as many youth as we can,” says Julieta Santagostino, executive director of the FDFW Florida chapter.
Foundation for a Drug-Free World is supported by the Church of Scientology and The Truth About Drugs is the world’s largest nongovernmental drug education and awareness campaign, used by more than 1,200 community, governmental and law enforcement agencies around the world. The program encourages kids to commit to remain drug free, and provides them with no-nonsense information about commonly used and abused drugs, trusting that—armed with information—they will make the right choices. More than 400 Truth About Drugs booklets were passed out along with backpacks and school supplies provided by the Pinellas County Police Athletic League (PAL).