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From Wash Post 1/10/2020 — not online yet
Note Sen. Mike Lee’s comment to the effect that facts aren’t facts if we don’t make them up.
I often fall into the trap of believing that the class and political differences between Democrats and Republicans are driven primarily by economic self-interest, but these data from the Pew Research Center show the stark differences apparent on the relatively non-economic issue of same-sex marriage. The tribes really are different.
An early journalistic hero — obit on page C9 of the Sunday, 12/22/19, Washington Post, or at < https://www.washingtonpost.com/local/obituaries/ward-just-washington-post-reporter-and-acclaimed-political-novelist-dies-at-84/2019/12/20/803137a4-21b5-11ea-a153-dce4b94e4249_story.html >
“… unsigned editorial on Maryland Gov. Spiro Agnew’s selection as Richard M. Nixon’s running mate in 1968. It was, he said, “perhaps the most eccentric political appointment since the Roman emperor Caligula named his horse a consul.”
Ward Just, Washington Post reporter and
acclaimed political novelist, dies at 84
Ward Just, seen in 1988, was the “quintessential Washington reporter,” a former colleague once said, “except he’s doing it through fiction.”
By Harrison Smith Dec. 20, 2019 at 1:36 a.m. EST
Ward Just, a former journalist who helped rejuvenate an uninspiring Washington newspaper with his visceral dispatches from the Vietnam War, then gave up reporting to chronicle power, patriotism and moral corruption in a slew of celebrated short stories and novels, died Dec. 19 at a hospital in Plymouth, Mass. He was 84.
He had Lewy body dementia, said his wife, Sarah Catchpole.
A distinguished reporter for Newsweek and then The Washington Post, Mr. Just turned to fiction in 1970 and wrote 19 novels, including the National Book Award finalist “Echo House” (1997), about three generations of a Washington family, and the Pulitzer Prize finalist “An Unfinished Season” (2004), about an aspiring journalist in 1950s Chicago.
Heavily influenced by Ernest Hemingway, another onetime journalist who shared Mr. Just’s affection for Scotch, cigarettes and the ambiguities of war, Mr. Just acquired a reputation for crafting elegant, understated prose and psychologically complex characters. He often wrote of the fraught dynamics between fathers and sons and of the machinations of political insiders — “people,” he said, “who speak in low voices without using verbs.”
A distinguished reporter for Newsweek and then The Washington Post, Mr. Just turned to fiction in 1970 and wrote 19 novels. (Larry Morris/The Washington Post)
“He is not only the most literary chronicler of the daily lives and moral dilemmas of contemporary politicians, bureaucrats, intelligence agents, military officers, diplomats, lawyers and journalists, but one of the few novelists even interested in depicting such people realistically,” wrote syndicated columnist and author Judith Martin, reviewing Mr. Just’s novel “Jack Gance” (1989) for the New York Times.
Mr. Just seemed to have a long career in journalism ahead of him when he gave it up to write novels. The son and grandson of Midwestern newspaper publishers, he joined The Post in 1965 as one of the first hires made by Ben Bradlee, his former boss at Newsweek’s Washington bureau. At the time, the paper was generally regarded as a home for dull, stodgy writing and reporting that rarely commanded a national audience.
Its coverage of Vietnam in particular was far outpaced by competitors such as the New York Times and Associated Press. Mr. Just, seeking a change of pace after separating from his first wife, helped close that gap soon after arriving in Saigon in December 1965. He remained for 18 months, aside from a brief return home to recuperate from a grenade blast that left shrapnel lodged in his back.
“Perhaps no reporter working for a major daily paper wrote as well from Vietnam or with as much subtlety and grace as he did,” fellow Vietnam correspondent David Halberstam wrote in his book “The Powers That Be.” “His were stories of men at war, and they were wonderful, in the best sense timeless.”
Mr. Just, he added, “took exceptional risks in combat” and initially focused on the bravery of ordinary soldiers above broader issues of politics and strategy.
He “found drama everywhere he looked — the drama that turned details into truth and isolated events into history,” Bradlee wrote in his memoir, “A Good Life.” “Sometimes Just would get a single quote that would tell an entire story. We spread one of those quotes, from a frightened GI surrounded by his enemies, eight columns over the top of the front page: ‘Ain’t Nobody Here but Charlie Cong,’ as in Viet Cong.”
Mr. Just grew increasingly critical of the war after June 1966, when he was wounded while accompanying a reconnaissance unit that was ambushed near Dak To. He had been handed a .45-caliber pistol that he didn’t know how to use when a grenade landed a few feet away, knocking him off his feet. When U.S. helicopters arrived two hours later, Mr. Just and 18 other wounded soldiers were lifted into the air by cable, amid continued gunfire from the North Vietnamese.
“You heard the bullets as you were rising and your body went stiff and you pulled out all the plugs,” he wrote in his book “To What End: Report From Vietnam” (1968). “You gripped the T-bar and made a number of very difficult promises if God got you safely into the helicopter. But when you got there, you said instinctively, I made it. And over and over again, Jesus Christ.”
After his tour ended in May 1967, Mr. Just wrote a scathing Post essay about the conflict, challenging the Johnson administration’s rosy assessments of its progress. “This war is not being won, and by any reasonable estimate, it is not going to be won in the foreseeable future,” he began. “It may be unwinnable.”
Mr. Just covered the 1968 presidential election and became an editorial writer, but he found that life in a newsroom paled in comparison to his work overseas. He took a leave of absence to write his first novel, “A Soldier of the Revolution” (1970), involving guerrillas in South America, and was said to have stunned Bradlee when he chose fiction over reporting.
In its strict reliance on the facts, Mr. Just said, journalism was limited in what it could reveal about the world or human nature. He chronicled the Vietnam era in novels such as “Stringer” (1974) and “In the City of Fear” (1982), and by the time he published “Jack Gance” — about the rise of a senator from Illinois — he was generally regarded as the finest “Washington novelist” since Allen Drury, who won the Pulitzer for his 1959 book “Advise and Consent.”
“He’s the quintessential Washington reporter,” author and former Post colleague Stanley Karnow told the Times in 1997, “except he’s doing it through fiction.”
Ward Swift Just was born in Michigan City, Ind., on Sept. 5, 1935, and grew up in the Chicago suburbs of Waukegan and Lake Forest, Ill. He said he struggled to make friends as a boy, throwing himself into books and eventually journalism. An early stint at his family’s newspaper, the Waukegan News-Sun, ended when he was fired for wearing shorts in the office.
Mr. Just graduated from the Cranbrook boarding school in Bloomfield Hills, Mich., and studied at Trinity College in Hartford, Conn., before leaving in 1957 without a degree. He spent two years at the News-Sun before landing a job at Newsweek, where he covered conflicts in Cyprus and the Dominican Republic and worked in Washington under Bradlee.
Mr. Just also worked for the Reporter news magazine before moving to The Post with Bradlee, who was hired in July 1965, as deputy managing editor, and soon rose to oversee the newsroom. He said he hired Mr. Just as part of a plan to recruit “the best horseflesh around” — an ace reporting team that included Karnow, David S. Broder, Richard Harwood, Nicholas von Hoffman and George C. Wilson.
As an editorial writer, Mr. Just was credited with penning one of The Post’s most biting pieces of political commentary, an unsigned editorial on Maryland Gov. Spiro Agnew’s selection as Richard M. Nixon’s running mate in 1968. It was, he said, “perhaps the most eccentric political appointment since the Roman emperor Caligula named his horse a consul.”
Mr. Just won National Magazine Awards for his 1970 Atlantic article “Soldiers” (adapted from his Vietnam book “Military Men,” also published that year) and for his 1980 short story “A Guide to the Geography of Vermont.”
His novels included “A Family Trust” (1978), which drew on his newspaper-family upbringing; “Forgetfulness” (2006), set after the 9/11 terrorist attacks; “Rodin’s Debutante” (2011), about a Midwesterner’s coming of age; and the Vietnam diplomacy tale “American Romantic” (2014), which Post book critic Jonathan Yardley called perhaps “the best of them all . . . opening our eyes to things we don’t know about worlds we think we know well and transporting us to worlds totally alien to us.”
Mr. Just also featured German characters and settings in much of his work — he was the descendant of 19th-century immigrants from Darmstadt — notably in “The American Ambassador” (1987), about a U.S. diplomat whose son joins a West German terrorist group, and “The Translator” (1991), about a German expatriate living in Paris.
His marriages to Jean Ramsay and Anne Burling ended in divorce. In 1983, he married Catchpole, with whom he lived for many years on Martha’s Vineyard and in Paris. In addition to his wife, survivors include two daughters from his first marriage, Jennifer Just of Woodbridge, Conn., and Julia Just of Brooklyn; a son from his second marriage, Ian Just of Arlington, Mass.; and six grandchildren.
Mr. Just dismissed suggestions that he might someday return to journalism, telling the Times in 1999, “Many of the things that make you a good journalist have to be discarded to make you a good writer. . . . In a novel, every fact is a rock thrown in the hull, and the boat sinks a bit.”
Nevertheless, as a reporter, Mr. Just repeatedly found ways to assemble facts into stories and scenes that resembled works of literature. In his 1967 Vietnam War essay, he analyzed the dismal state of the conflict before relating, in the essay’s final paragraphs, the death of a single soldier, 19-year-old Truman Schockley.
“Smoking a Lucky Strike and staring off into the mountains, Schockley died with a sniper’s bullet through the heart and stopped breathing before the cigarette stopped burning,” Mr. Just concluded. “The company commander sent a platoon into the underbrush to look for the sniper, but the sniper had left. Schockley was put in a green body bag and sent to Bongson for transport to Saigon and then home.”
The Washington Post: Former White House officials think Trump’s false Ukraine theory came from Putin
This story from The Washington Post 20 December, is such a great example of the insane world that Trump and those sycophants around have created.
Former White House officials think Trump’s false Ukraine theory came from Putin
One former senior White House official said Trump even stated so explicitly at one point, saying he knew Ukraine was the real culprit because “Putin told me.”
This article, from the Sunday, 17 November 2019, Washington Post, puts the lie to Big Pharma’s claim that we have to pay exhorbitant prices for our drugs in order to assure the perfect purity of “American” drugs:
A tiny pharmacy is identifying big problems with common drugs, including Zantac
Nicola Zenzola, senior research associate, prepares a sample for impurity analysis at Valisure, a small pharmacy that checks the composition of drugs and that prompted a worldwide recall of the heartburn drug Zantac.
(Stan Godlewski for The Washington Post)
By Carolyn Y. Johnson November 8, 2019 at 9:00 a.m. EST
NEW HAVEN, Conn. — The escalating global recall of Zantac, the heartburn pill that once ranked as the world’s best-selling drug , has its roots not in government oversight or a high-profile lawsuit but in a tiny online pharmacy here whose founders feared that U.S. drugs might not be as safe as people think.
The pharmacy, Valisure, is a start-up with only 14 full-time employees. But since its scientists alerted American regulators that Zantac and its generic form, ranitidine, contained a chemical thought to cause cancer, more than 40 countries from Australia to Vietnam have either stopped sales, launched investigations or otherwise stepped in to protect consumers from possible health risks.
In the United States, the Food and Drug Administration this month confirmed unacceptable levels of the chemical, N-nitrosodimethylamine (NDMA), in some ranitidine products — including in some syrups taken by babies. FDA officials have urged people not to panic, because the levels of NDMA are similar to the amount found in grilled and smoked meats. The agency is still investigating and asking companies to recall ranitidine and a similar drug, nizatidine, if they discover unacceptable amounts of NDMA. The agency’s testing suggests Pepcid, Tagamet, Nexium, Prevacid and Prilosec do not contain the chemical.
In the meantime, major pharmacy chains have jumped ahead and yanked both brand-name and generic versions of Zantac off their shelves. Some hospitals have switched to alternatives, and major drug manufacturers have recalled products — including Sanofi, the maker of over-the-counter Zantac in the United States. The company announced a recall last month “as a precautionary measure.”
“We know impurities in medicines are of great concern to patients and consumers who rely on safe and effective medicines approved by the FDA, and we are working with manufacturers and global regulators to provide clear and actionable information,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “These investigations take time and do not provide instantaneous answers.”
For Valisure’s scientists, finding NDMA in ranitidine was a particularly dramatic example of the kind of discovery they make routinely. Valisure checks the chemical makeup of drugs before it ships them to consumers, and it rejects more than 10 percent of the batches because its tests detect contaminants, medicine that didn’t dissolve properly or pills that contain the wrong dose, among other issues. Since late 2018, Valisure has reported more than 50 problems directly to drug companies. Occasionally — as in the case of Zantac — their scientists find a problem so urgent they play the role of watchdog.
“I had a fairly dim view of drug quality in the United States going into this, but we’ve discovered tons of problems I never even thought of — and they’re all over the place,” said Adam Clark-Joseph, one of Valisure’s founders.
The FDA firmly rejects the idea that the drug supply is unsafe and said that one of Valisure’s conclusions — that ranitidine turns into NDMA in the stomach — is not supported by the agency’s testing. The agency reviews reams of data before approving a drug, inspects factories that make them, runs its own tests on selected drugs and collects reports of safety problems.
“Americans can be confident in the quality of the products the FDA approves,” spokesman Jeremy Kahn said.
Valisure makes money the same way other pharmacies do — buying drugs from wholesalers and taking a cut of the price when it sells them. To set itself apart, it chemically tests the medicines it dispenses — marketing its services on the premise that people can’t be confident about what’s inside the pill bottles that fill their bathroom cabinets.
Clark-Joseph, an economist with some chemistry training, was drawn to the idea because he kept getting sick. In graduate school, he refilled a prescription only to find that the new, supposedly identical drug didn’t work. When his doctor told him to try another pharmacy because he probably got a bad batch, he was appalled. After similar incidents occurred, he started searching for a lab that would verify the chemical contents of his medication. When he didn’t find an obvious solution, he called his college friend David Light, who had worked in biotech, and suggested that they partner on a business that would verify the chemical contents of drugs.
“He thought I was being kind of paranoid at first,” Clark-Joseph said.
Light researched the issue and became convinced that it was a real problem — and a potential opportunity. But it wasn’t easy to sell investors on the concept, so the two friends provided much of the initial funding for the company from their own bank accounts.
In a modest two-room laboratory in a former gun factory, Valisure’s half-dozen scientists churn pills in a solution formulated to mimic stomach acid and warmed to body temperature, a test to determine whether medicines dissolve properly. They use lasers to probe pills for inactive ingredients. A specialized instrument used in forensic investigations is used to detect carcinogens. Each time the company has expanded its panel of tests, new problems with medications have emerged.
One of the first drugs it tested was lamotrigine, an anticonvulsant medication made by several generic drug companies. (Valisure typically doesn’t disclose the makers of a specific batch that failed its quality standards.) Valisure’s scientists put different batches of the extended-release version of the pill into a fancy blender that emulated the stomach and were dismayed at the results. Multiple batches took longer than 24 hours to dissolve, and one took more than 48 hours — despite the fact that the label said it was supposed to dissolve in 12 to 15 hours. Ultimately, they found a version that met their standard to dispense to patients. Decals depicting the chemical structure of lamotrigine now decorate a wall of the pharmacy.
Late last year, the company published a scientific paper showing that rapid-release Tylenol dissolved more slowly than less expensive tablets of the same dose. This wasn’t a public health problem, but it made the marketing of one of the most familiar drugs seem misleading.
Ernie Knewitz, a spokesman for Johnson & Johnson, the maker of brand-name Tylenol, said at the time the gelcaps were “rapid release” in comparison with conventional gelcaps, not uncoated tablets. The company did not respond to a request for an update.
After Valisure added a carcinogen test in March, it threw a form of ranitidine, the active ingredient in Zantac, into the queue — because Clark-Joseph’s infant daughter was taking the drug for acid reflux. Kaury Kucera, the chief scientific officer, recalled seeing with disbelief a spiking peak on a graph that indicated the presence of a large amount of NDMA. She ran the test again. Then she ran into Light’s office. He called Clark-Joseph and warned him to hold off on giving his daughter the drug until they could sort out what this meant. Scientists worked feverishly to confirm and understand the result. They sent samples to an independent lab to verify their finding. In June, they alerted the FDA to their initial results.
Much of the concern over the quality and safety of the drug supply has been propelled by a massive movement of drug production to foreign factories in recent years, “driven by the pharmaceutical industry’s desire for cost savings and less stringent environmental regulations,” Woodcock said in testimony submitted to Congress in October.
The FDA rigorously evaluates drugs for effectiveness and safety before approval, including visits by inspectors, who review records to ensure compliance with requirements — including that companies test batches of medicine before distributing them, Kahn said.
A 2016 Government Accountability Office report found that almost a third of 3,000 foreign drug establishments licensed by the FDA may not have been inspected, although the FDA said it has now caught up on the backlog.
Sen. Charles E. Grassley (R-Iowa), has sent letters to the FDA questioning the adequacy of its foreign drug inspection program.
David Gortler, a former FDA official who now works as chief medical officer of Valisure, says that inspections simply aren’t sufficient in foreign factories. He thinks the agency needs to test each batch of drug that enters the country.
Companies have been cited by the FDA not just for technical mishaps and errors but occasionally also for systematic failures to properly investigate quality problems.
“It’s really becoming a national health crisis,” Gortler said, “and eventually it’s going to become a national security crisis.”
Kahn, the FDA spokesman, said the agency “regularly samples and tests selected drug products.” A survey of 323 products in 2015 found that all drugs met the agency’s standard for potency and purity, he said.
But the FDA’s own data shows that testing is selective. At the end of 2013, there were 12,100 approved drugs. Over the previous decade, the agency had tested fewer than 4,000 of them.
Valisure sees that gap as an opportunity. The company first alerted U.S. regulators in June that Zantac and ranitidine products contained a probable carcinogen. In September, Valisure filed a citizens petition to have the products pulled from the market entirely, and the FDA issued an alert to the public that the agency had learned some products contained NDMA. Follow-up testing had led Valisure’s scientists to suspect that the drug wasn’t contaminated but that the drug itself is unstable and could form NDMA, particularly in the conditions found in the stomach.
Woodcock testified before Congress that FDA scientists do think the drug might be reacting with itself to form NDMA. But the FDA said the levels of NDMA it has found are lower than Valisure flagged and that it is not formed in the stomach. “We still must test the drugs in the human body to fully understand if ranitidine forms NDMA,” Woodcock said in a statement.
GlaxoSmithKline, the company that first brought Zantac to market in the 1980s, said in a statement that its scientists had carefully examined whether the drug could form NDMA in the stomach when Zantac was being approved.
“The reason for the current precautionary recall of ranitidine is due to an emerging finding that some sources of drug substance and therefore drug product may contain very small amounts of nitrosamine,” the statement said.
Sanofi critiqued Valisure’s testing, saying the high levels of the chemical formed “only after exposing ranitidine to extreme artificial conditions.”
Sanofi said on Oct. 18 that it would recall its over-the-counter Zantac in the United States and Canada, noting “inconsistencies” in its preliminary test results of the active ingredient in drugs sold in both countries, which were sourced from different suppliers. Several other major ranitidine manufacturers have also pulled their U.S. products, including Novartis’s Sandoz division, Dr. Reddy’s Laboratories and Apotex.
Sandoz and Dr. Reddy’s both cited “confirmed contamination” above the FDA’s limits in a statement. Apotex said its recall was on a “precautionary basis.”
Meanwhile, GSK has recalled its products overseas and is investigating the possible source of the NDMA. (GSK no longer sells ranitidine products in the United States.)
Exposure to low levels of NDMA, which occurs naturally in food and the environment, is not acutely dangerous. But if consumers wonder what to make of the growing recalls, they are not alone.
Erin Fox, senior director of Drug Information and Support Services for University of Utah Health, purchases medicines for a hospital system with 5,000 drugs on the formulary. Not a day goes by without a recall notice of some kind, she said — adding that as soon as Valisure’s petition became public, her hospital swapped ranitidine products for an alternative.
Fox is a drug safety nerd. She geeks out on reading the warning letters and inspection documents the FDA posts about drug factories. Fox then tries to sleuth out more information, calling up company contacts.
“I’m almost always completely frustrated and thwarted,” Fox said. “We have a pass-fail system in the U.S., where it’s on the market or not on the market, and FDA does not provide us with any kind of quality metrics. In many cases, we don’t even know the company that is making the product.”
That can make it difficult to understand whether, when a problem is detected, it is a single bad batch or an example of a much broader problem. Over the past year and a half, an expanding recall of blood pressure medicines have been traced back to a problem in the manufacturing process in factories in China and India, according to the FDA.
Consumers may not care where their drugs are made, as long as they are safe and effective, and that’s what the FDA monitors through programs that tally adverse effects. But that system is imperfect. Many side effects — or people’s perception that a pill doesn’t work very well — may never be reported.
And for chemicals such as NDMA, which may be harmful over the long term, there may be no immediate health impact to report.
William Mitch, an environmental engineering professor at Stanford University, generated support for the idea ranitidine could turn into NDMA in the stomach several years ago, while investigating the presence of NDMA in wastewater. As a side study, he asked 10 volunteers to collect urine samples before and after ingesting a Zantac.
Mitch found high levels of NDMA in their urine after they ingested the pill, in some cases more than 45,000 nanograms. The FDA has set the acceptable daily intake of NDMA at 96 nanograms.
“That was concerning, but we don’t know that field,” Mitch said. “We sort of did it to spur further interest.”
GSK cited studies from the late 1980s and early 1990s that did not find a substantial increase in NDMA levels in people taking Zantac.
“Extensive pharmacovigilance monitoring, regular safety reviews and substantive epidemiological studies have not linked ranitidine to raised cancer risks,” GSK said in a statement.
The disagreement over the source of NDMA adds urgency to the investigation by regulators and companies. For Valisure, identifying problems can be a form of marketing, and the global attention over Zantac has helped boost business. But increasingly, its employees see themselves as patient advocates.
“We always thought of consumer protection . . . as an important part of what we would do, but I never appreciated how big of a problem we’re watching over,” Light said. “We find more problems than we have resources to fully investigate.”
FDA identifies contamination source in blood pressure medicines used by millions
‘Rapid release’ Tylenol gelcaps are slower to dissolve than cheaper tablets, study finds
The generic drug industry has brought huge cost savings. That may be changing.
of Carolyn Y. Johnson
Carolyn Y. Johnson
Carolyn Johnson is a science reporter. She previously covered the business of health and the affordability of health care to consumers. Follow