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Mick Mulvaney’s Master Class in Destroying a Bureaucracy From Within

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Nicholas Confessore reports in the NY Times:

One rainy afternoon early in February 2018, a procession of consumer experts and activists made their way to the headquarters of the Consumer Financial Protection Bureau in Washington to meet Mick Mulvaney, then the bureau’s acting director. The building — an aging Brutalist layer cake, selected by the bureau’s founders for the aspirational symbolism of its proximity to the White House, one block away — was under renovation, and so each visitor in turn trudged around to a side entrance. Inside the building, Mulvaney had begun another kind of reconstruction, one that would shift the balance of power between the politically influential industries that lend money and the hundreds of millions of Americans who borrow it.

Three months earlier, President Trump installed Mulvaney, a former congressman from South Carolina, as the C.F.P.B.’s acting director. Elizabeth Warren, who helped create the agency in the wake of the 2008 financial crisis, envisioned it as a kind of economic equalizer for American consumers, a counter to the country’s rising structural inequality. Republicans had come to view her creation as a “rogue agency” with “dictatorial powers unique in the American republic,” as the party’s 2016 platform put it. In Congress, Mulvaney had established himself as an outspoken enemy of the bureau, describing it, memorably, as a “joke” in “a sick, sad kind of way” and sponsoring legislation to abolish it.

Some of those invited to the meeting in February had picketed outside the bureau’s headquarters on Mulvaney’s first day at work. Their unease had only grown as Mulvaney ordered a hiring freeze, put new enforcement cases on hold and sent the Federal Reserve, which funds the C.F.P.B., a budget request for zero dollars, saying the bureau could make do with the money it had on hand. Within weeks, Mulvaney announced that he would reconsider one of the bureau’s major long-term initiatives: rules to restrict payday loans, products that are marketed to the working poor as an emergency lifeline but frequently leave them buried in debt. “Anybody who thinks that a Trump-administration C.F.P.B. would be the same as an Obama-administration C.F.P.B. is simply being naïve,” Mulvaney told reporters. “Elections have consequences at every agency.”

Mulvaney was also aware that appearances have consequences. For agency heads, it is important to appear open to all points of view about their regulatory decisions, especially if they end up having to defend them in court. In February, he agreed to meet with his critics in person. Thirty or so people gathered around a conference table as rain lashed the windows. Mulvaney, who is 51, has close-cropped hair and a bulldog countenance that befits his manner. A founder of the House’s hard-line Freedom Caucus, he can be sarcastic, even withering, in hearings and speeches. But Mulvaney struck a placating tone with his guests. He kept his opening remarks brief, according to six people who attended the meeting. Important things at the bureau would not change, he reassured them. “I’m not here to burn the place down,” he insisted. Mulvaney said he did not intend to discuss his plans for the payday-loan rule with them but encouraged everyone to share their views.

Many of Mulvaney’s guests came from advocacy groups, like Americans for Financial Reform and the Center for Responsible Lending, that often did battle with Washington’s powerful financial-industry lobby. But the meeting also included a dozen religious leaders, among them officials from national evangelical and Baptist organizations, whose members tend to be among Trump’s most loyal supporters. These leaders viewed payday lending as not only unfair but also sinful, and they had fought against it across Trump country — in deep-red South Dakota, on the same day Trump won the presidency, voters overwhelmingly approved a ballot measure effectively banning payday loans. The ministers had planned carefully for their moment with Mulvaney, and for 20 minutes they took turns detailing the harm that payday lending had inflicted on their neighborhoods and congregations. Eventually they gave the floor to the Rev. Amiri B. Hooker, who led an African-American church near Mulvaney’s old congressional district.

“I told him I was from Kershaw County,” Hooker told me recently, recalling his exchange with Mulvaney. “He smiled and asked how were the good folks from Kershaw.” When Hooker pastored in Lake City, an hour away from Kershaw, a quarter of his congregation either had taken out payday loans themselves or knew someone who had. He told Mulvaney about an 84-year-old congregant in Lake City whom, during a week that she was so sick that she missed services, he saw hobbling toward him down the street. “She said, ‘I had to go pay my bill,’ ” Hooker recalled. The woman had taken out a $250 loan almost three years earlier to cover her granddaughter’s heating bill. She was still paying it off, Hooker told Mulvaney, at a cost of $75 a month, rolling over the loan into a new one each time.

Despite his earlier reticence, Mulvaney seemed eager to offer his own view of how the bureau ought to operate. It wasn’t up to the federal government to stop people from taking the kind of credit that suited them, he suggested: “There’s no reason people should be taking these loans — but they do.” He pointed out that there wasn’t anyone in the room from North Carolina, where payday lending was illegal. They should plead their case to state officials. “You have a place to go to address payday loans, and it’s not me,” he said, according to multiple attendees. As the C.F.P.B.’s acting director, he wouldn’t stop enforcing the law as written. He only wanted a more efficient bureau, he explained, one steeped in evidence-based decision-making, one that educated consumers to make good decisions on their own. Mulvaney provided few details about how it would all look, but he promised the pastors he would follow up to let them know which way he decided to go on payday-loan regulation. “I’ve never heard from him,” Hooker says.

In the months that followed, Mulvaney’s vision for the Consumer Financial Protection Bureau would become clearer. This account of Mulvaney’s tenure is based on interviews with more than 60 current or former bureau employees, current and former Mulvaney aides, consumer advocates and financial-industry executives and lobbyists, as well as hundreds of pages of internal bureau documents obtained by The New York Times and others. When Mulvaney took over, the fledgling C.F.P.B. was perhaps Washington’s most feared financial regulator: It announced dozens of cases annually against abusive debt collectors, sloppy credit agencies and predatory lenders, and it was poised to force sweeping changes on the $30 billion payday-loan industry, one of the few corners of the financial world that operates free of federal regulation. What he left behind is an agency whose very mission is now a matter of bitter dispute. “The bureau was constructed really deliberately to protect ordinary people,” says Lisa Donner, the head of Americans for Financial Reform. “He’s taken it apart — dismantled it, piece by piece, brick by brick.”

Mulvaney’s careful campaign of deconstruction offers a case study in the Trump administration’s approach to transforming Washington, one in which strategic neglect and bureaucratic self-sabotage create versions of agencies that seem to run contrary to their basic premises. According to one person who speaks with Mulvaney often, his smooth subdual of the C.F.P.B. was part of his pitch to Trump for his promotion to White House chief of staff — long one of the most powerful jobs in Washington. Mulvaney’s slow-rolling attack on the bureau’s enforcement and regulatory powers wasn’t just one of the Trump era’s most emblematic assaults on the so-called administrative state. It was also, in part, an audition.

The Consumer Financial Protection Bureau emerged from a liberal concern that the American political economy was increasingly defined by inequality and consumer debt. As a young academic in the 1980s, Warren began studying how and why some Americans ended up taking on more debt than they could handle. The act of borrowing money, she learned, was growing increasingly risky and complex. As the consumer-credit industry grew, credit-card companies and mortgage lenders began to design their products to appear cheaper than they actually were. Unlike most things people buy, financial products became defined by their ever-lengthening terms and conditions: mandatory arbitration, reverse amortization, interest-rate calculations that can change at a whim, cross-default clauses and two-cycle billing, mysterious credit scores that emanate from Equifax and Experian as if from the temples of an obscurantist cult. “The real money was in the fine print,” Warren told me recently.

Warren, who is now a senator from Massachusetts and a Democratic candidate for president, spoke to me by phone as she was making her way to New Hampshire for a campaign swing. On the trail and off, Warren depicts the rise of the consumer financial industry as part of an elemental structural shift in American life. Wealthy people and big corporations were not just eating up a growing share of the pie; they had rigged the marketplace to help them do it. All that fine print didn’t just shift billions upon billions of dollars into the hands of lenders, Warren argued. It shifted power. Lenders could more safely harvest a few dollars in fees from the checking account of each customer, even when doing so broke the law, when mandatory arbitration clauses in the fine print prohibit customers from joining together in a class action to get their money back. Brokers could more easily push a family to a higher-cost mortgage, even when they qualified for a cheaper one, if the family believed they were getting the best possible deal. The increase in debt-financed consumption helped paper over the stagnating wages of the middle class and the growing gap between the rich and everyone else. But it was also driving an epidemic of social misery: bankruptcy and lost homes, anxiety and shame.

In her research, Warren found that people got in over their heads not because they were greedy or lacked self-discipline, but because they were being outmatched by a sophisticated and often predatory industry of lenders. Warren recalled being struck by “the number of people who said, in our interviews, ‘I never understood my payment would go up on that’ or ‘I didn’t understand I owed more on my house than I paid for it,’ ” she told me. “Even after they had seen a lawyer and declared bankruptcy, they still didn’t understand what had happened.” In a 2007 article titled “Unsafe at Any Rate,” Warren proposed the creation of a new regulatory agency to oversee consumer-credit products. When she lobbied lawmakers on Capitol Hill after the financial crisis, Warren would take them a selection of credit-card agreements. “I’d lay three of them down on the table, and I’d say, ‘Tell me which one is the cheapest credit card.’ ” None could.

Warren and other consumer advocates argued that . . .

Continue reading. There’s much more.

Written by LeisureGuy

16 April 2019 at 11:04 am

How PG&E Ignored California Fire Risks in Favor of Profits

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The opening graphic of this report is stunning, and the report itself shows the Achilles’ heel of capitalism: that the structure of the capitalistic endeavor works to focus a company’s attention and efforts totally on increasing profits, and any measures that take away from profits must be curtailed—including, for example, spending any money at all to make the workplace safer (cf. coal mines). That’s why the government and its agencies must closely monitor and regulate private corporations—for example, by having Congress pass the Occupational Safety and Health Act, and then by having the Executive branch see that companies act in accordance with the Act. And that effort must be stead and vigorous because companies are driven to increase profits and are willing to do anything to achieve that goal, including (as we have repeatedly see, in example after example) things that are immoral, unethical, and illegal. It helps that such crimes rarely lead to any company personnel being imprisoned. The typical punishment is a fine, and surprisingly often the fine is small compared to the profits realized. And the pressure to increase profits is always there. Naturally, then, companies start to view fines as a cost of doing business, and if the net effect is that profits increased, so what?

The tragedy of the wildfires caused by PG&E’s deliberate decisions not to do maintenance is a good example. Maintenance is expensive, and if the company discontinues it, profits will increase.

Ivan Penn, Peter Eavis, and James Glanz report for the NY Times:

Tower 27/222 looms almost 100 feet tall in the Sierra Nevada foothills, a hunk of steel that has endured through 18 United States presidents. The transmission lines that it supports keep electricity flowing to much of California.

On the morning of Nov. 8, a live wire broke free of its grip. A power failure occurred on the line, affecting a single customer. But 15 minutes later, a fire was observed nearby. Within hours, flames engulfed the region, ultimately killing 85 and destroying the town of Paradise.

The equipment belonged to the state’s biggest utility, Pacific Gas and Electric. To the company’s critics, the tower and its vulnerability reflect a broken safety culture.

Five of the 10 most destructive fires in California since 2015 have been linked to PG&E’s electrical network. Regulators have found that in many fires, PG&E violated state law or could have done more to make its equipment safer.

Long before the failure suspected in the Paradise fire, a company email had noted that some of PG&E’s structures in the area, known for fierce winds, were at risk of collapse. It reported corrosion of one tower so severe that it endangered crews trying to repair the tower. The company’s own guidelines put Tower 27/222 a quarter-century beyond its useful life — but the tower remained.

In January, the company sought bankruptcy protection, saying it might face more than $30 billion in wildfire liabilities. Its financial straits could hamper its preparations for the next wildfire season, and those beyond, even as weather patterns increase the fire risk.

“There is a climate change component to this,” said Michael W. Wara, director of the climate and energy policy program at Stanford University and a member of a state commission examining the cost of wildfires. “But there’s also a failure of management and a failure of vision.”

Another major utility in the state, San Diego Gas & Electric, has added hundreds of weather stations, cameras and satellite technology in recent years to reduce fire risk. PG&E is now trying to catch up.

Beyond wildfires, PG&E has a broader history of safety problems. A 2010 explosion of a PG&E gas pipeline killed eight people and destroyed a suburban neighborhood, prompting state and federal officials to investigate PG&E’s safety practices. Regulators ultimately fined the utility $1.6 billion, and a federal jury convicted it of violating a pipeline safety law and obstructing an investigation. The company is still under court-supervised probation.

PG&E executives acknowledge that the company has made mistakes. “We have heard the calls for change and are committed to taking action by focusing our resources on reducing risk and improving safety throughout our system,” John Simon, PG&E’s interim chief executive, said in a recent statement.

But Gov. Gavin Newsom said the company’s record made it hard to take its promises seriously.

“They have simply been caught red-handed over and over again, lying, manipulating or misleading the public,” Mr. Newsom said in an interview. “They cannot be trusted.” . . .

Continue reading. There is much more.

Speaking of companies that absolutely cannot be trusted, I offer Facebook as a prime example. How many times more will Mark Zuckerberg apologize and promise to do better? Answer: As many times as needed. He’s not going to change, and Facebook is not going to change. Government intervention is required.

I do understand that government can also go bad, with regulatory agencies in effect taken over by the industries that they are supposed to regulate—just look at the Trump administration, or how the Obama administration refused to take any serious action to regulate Wall Street. (The Obama administration did create the Consumer Finance Protection Bureau—actually, Elizabeth Warren created it—but now that agency is defunct: Trump allowed the payroll lending industry to destroy it.)

Obviously, the government itself must be watched carefully, and that is the job of the free press and investigative journalism—like this report.

Later in the article:

. . . “Some people believe that you run equipment to failure,” Catherine Sandoval, a former California regulator who has been pushing for improved maintenance of electrical poles and towers. “They believe ‘run to failure’ to save money. This is the danger of run to failure.”

In December 2012, five other aging towers on the same stretch, the Caribou-Palermo line, collapsed in a storm. In July 2013, Brian Cherry, PG&E’s vice president for regulatory affairs at the time, notified state regulators that the company would replace the five fallen towers and one more, but not 27/222.

A 2014 company email that has come to light in the bankruptcy proceedings said that “the likelihood of failed structures happening is high.” But PG&E determined that if the structures failed, the cause would probably be heavy rain, precluding a wildfire risk. PG&E said this week that the structures in question were temporary wooden poles that had since been replaced.

In April 2016, PG&E made another request to regulators: to install fresh wires on the Caribou-Palermo line. But the company said it would not replace any of the line’s remaining nearly century-old towers.

That October, during painting work on a lattice tower on the line, a piece of hardware called a J hook broke when a contract worker grabbed it while repositioning himself. A PG&E report said workers had determined that corrosion — the reason for the painting — was enough of a problem that “crews working on these towers need to use caution.”

The company said that tower had a different design from Tower 27/222’s. But it would not comment on why it didn’t replace 27/222 given its age. It said it considered many factors when making decisions on maintenance and repairs. . .

It makes my blood boil. The executives who made these cost-cutting decisions should face very long prison terms. Here’s why:

. . . The deadly 2010 gas pipeline explosion in San Bruno, a San Francisco suburb, was PG&E’s second in a two-year period. The ensuing investigations and litigation produced an alarming picture of the company’s practices and priorities.

In court depositions, employees said supervisors routinely ignored their concerns about the company’s use of faulty analysis and outdated equipment. The state’s Public Utilities Commission, which regulates PG&E, concluded that the company was more concerned with profit than with safety.

The commission’s safety and enforcement division found in 2012 that PG&E’s gas and transmission revenues exceeded what it was authorized to collect by $224 million in the decade leading up to the explosion. But capital spending fell $93 million short of its authorized budget between 1997 and 2000. PG&E also spent millions less on operations and maintenance than it was supposed to.

“There was very much a focus on the bottom line over everything: ‘What are the earnings we can report this quarter?’” said Mike Florio, a utilities commissioner from 2011 through 2016. “And things really got squeezed on the maintenance side.”

Five years after the explosion, a PG&E line started the Butte Fire, which scorched more than 70,000 acres, killing two people and destroying nearly a thousand homes and other buildings.

State investigators said workers should have known that when they had cleared a stand of trees for PG&E, they had exposed a gray pine weak enough to be blown into a power line. On Sept. 9, 2015, strong winds knocked that tree into the line, igniting the fire.

State officials also blamed PG&E equipment for starting 17 of 21 major fires in 2017 that ripped through Northern California, including wine-growing Napa and Sonoma Counties.

2017 report commissioned by state regulators determined that PG&E often made improvements only after a disaster. The report, which was produced by NorthStar Consulting, also found that the transmission and distribution side of the company had less robust safety policies than its gas and power generation divisions. . .

As soon as safety reduces profit, safety is sacrificed. Companies can do good—from later in the article:

. . . State officials say there is a good template elsewhere in California for what PG&E should be aiming for: the practices of San Diego Gas & Electric.

The San Diego utility keeps data on every utility pole and transmission tower in its service territory, which is smaller than PG&E’s but has a higher proportion of overhead lines in areas at high fire risk. It uses nearly 177 stations to monitor temperature, humidity and wind speeds in an area roughly the size of Connecticut and records video from 100 high-definition cameras. It uses satellites to track how green or dry the grass is and employs the state’s largest water-dropping helicopter to douse fires quickly. When data indicates a high wildfire threat, the utility cuts off power to some areas.

San Diego Gas & Electric upgraded its fire-prevention efforts after residents sued it for causing a devastating wildfire in 2007. In recent years, it has been responsible for far fewer fires than PG&E. “We want to make sure that we’re doing everything we can to mitigate ignition,” said Scott Drury, the utility’s president. . .

They can, but the systemic pressures to increase profit means that more often they will do anything to grow profit.

Written by LeisureGuy

19 March 2019 at 3:59 pm

Did the FDA ignite the opioid epidemic?

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Bill Whittaker writes for 60 Minutes:

We have reported on the causes and effects of the opioid epidemic for several years — interviewing government whistleblowers, doctors, and Americans who’ve grown dependent on the powerful pain pills. We have not had a high-ranking executive from the pharmaceutical industry sit before our cameras, until now. Tonight, Ed Thompson, a drug manufacturer who spent decades managing and producing opioids for Big Pharma, breaks ranks to denounce his industry and its federal regulator, the Food and Drug Administration, which he says opened the floodgates on the crisis with a few little changes to a label.

Ed Thompson: The root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain.

Bill Whitaker: The FDA ignited this opioid crisis?

Ed Thompson: Without question, they start the fire.

Ed Thompson told us when the top selling opioid, Oxycontin, was first approved in 1995, it was based on science that only showed it safe and effective when used “short-term.” But in 2001, pressured by Big Pharma and pain sufferers, the FDA made a fateful decision and, with no new science to back it up, expanded the use of Oxycontin to just about anyone with chronic ailments like arthritis and back pain.  

Ed Thompson: So this is what a package insert looks like.

Bill Whitaker: Wow

The FDA did it by simply changing a few words on the label, that lengthy insert no one ever reads. Today the label says the powerful pain pills are effective for “daily, around-the-clock, long-term… treatment.” And that small label change made a big change in the way drug companies would market all opioids, allowing them to sell more and more pills at higher and higher doses.

Ed Thompson: A drug’s label is the single most important document for that product. It determines whether somebody can make $10 million or a billion dollars.

Bill Whitaker: How so?

Ed Thompson: Because it allows you to then promote the drug based on the labeling.

Ed Thompson owns PMRS, a successful Pennsylvania pharmaceutical company that manufactures drugs for Big Pharma. It’s made him a rich man. But now he’s putting his livelihood at risk. He’s doing what no other drug maker has ever done, he’s suing the FDA in federal court to force it to follow the science and limit the opioid label to short term use.

“There are no studies on the safety or efficacy of opioids for long-term use.”

Thompson is challenging the FDA to start with his newest opioid. It’s Thompson’s creative way to sabotage the system. He may lose money rolling out his new drug, but if he is successful, it would set a precedent. Other manufacturers would be forced to change their labels and limit their marketing.

Bill Whitaker: A decision going in your direction could pull down a multi-billion-dollar industry.

Ed Thompson: Correct. Probably somewhere between $7 and $10 billion a year would come off the market. We made a decision to stop selling snake oil to U.S. citizens in 1962.

Bill Whitaker: Snake oil?

Ed Thompson: Yes, sir. You’re using high-dose, long-duration opioids when they’ve never been designed to do that. There’s no evidence that they’re effective. There’s extreme evidence of harms and deaths when you use them.

Brandeis professor Dr. Andrew Kolodny is one of the country’s most-recognized addiction specialists and has been an expert witness in litigation against Big Pharma, including Purdue, the maker of Oxycontin. He has been trying to get the FDA label changed since 2011 to make clear opioids are not for everyone.

Dr. Andrew Kolodny: These are essential medicines for easing suffering at the end of life and when used for a couple of days after major surgery or a serious accident. If you’re taking them around the clock every day, quickly, you become tolerant to the pain-relieving effect. In order to continue getting pain relief, you’ll need higher and higher doses. As the doses get higher, the treatment becomes more dangerous and the risk of death goes up.

Bill Whitaker: That sounds exactly like heroin addiction.

Dr. Andrew Kolodny: It’s essentially the same drug.

To understand how this began we traveled to this small courthouse in Welch, West Virginia, where we uncovered the minutes of secret meetings in 2001 between Purdue Pharma and the FDA. The files were part of the state’s lawsuit against Purdue for deceitful marketing.

60 Minutes got a court order to obtain these documents. They reveal it was at those secret meetings the FDA bowed to Purdue Pharma’s demands to ignore the lack of scientific data, and changed the label to, “around the clock…for an extended period of time.”

Ed Thompson: I can’t think of anything more harmful taking place that took place then. It opened the floodgates. It was the decision of no return for the FDA.

Purdue told us Oxycontin always was approved for long-term use. But an internal document shows the company was jubilant about the labeling change.  Quote: “The action by the FDA…has created enormous opportunities” to expand the market. The drug company’s ads soon extolled the virtues of Oxycontin’s effectiveness and sales tripled.

Dr. David Kessler: It was a marketing tsunami.  And the agency didn’t catch it.

60 Minutes has called on former FDA commissioner David Kessler many times for his expertise on drug safety issues. He ran the FDA in the 1990s when Oxycontin was first approved, but he left before the labeling change. Today, he’s been retained by cities and counties suing Big Pharma for the opioid crisis. After reviewing the documents we obtained, and checking on his own, he says changing the label to long-term use was a mistake.

Dr. David Kessler: There are no studies on the safety or efficacy of opioids for long-term use.

Bill Whitaker: But there’s a law that says that a drug cannot be promoted as safe and effective unless it’s proven to be safe and effective. But yet, with FDA sanction, these opioids are being used in that way that you say have not been proven.

Dr. David Kessler: That’s correct. The rigorous kind of scientific evidence that the agency should be relying on is not there.

The label change was a blank check – one the drug industry cashed in for billions and billions of dollars. Now, Big Pharma had a green light to push opioids to tens of millions of new pain patients nationwide.

Bill Whitaker: Let me remind you of some of the words that you have used to describe the pharmaceutical industry, your industry.

Ed Thompson: Yeah?

Bill Whitaker: Corrupt.

Ed Thompson: Yeah.

Bill Whitaker: Immoral?

Ed Thompson: Yes.

Bill Whitaker: Depraved?

Ed Thompson: Yes. They’re appropriate for the behavior that’s taken place.

Bill Whitaker: You are a drug executive. You manufacture drugs.

Ed Thompson: Many drugs.

Bill Whitaker: Are you at fault in this epidemic in any way?

Ed Thompson: I wish I was smart enough to have seen this epidemic before– before I got three or four years into it. Absolutely. But once you find out that it’s not correct, you have to do the right thing. Is there anything more important?

Emily Walden: My son wanted to fight for his country. His country failed him. . .

Continue reading.

There’s much more, and it is damning. The US government should start doing things to protect its citizens and stop protecting the corporations that destroy their lives. It’s not right.

Written by LeisureGuy

25 February 2019 at 12:19 pm

When our guardians fail: FDA, drug companies, doctors mishandled use of powerful fentanyl painkiller

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Lenny Bernstein reports in the Washington Post:

The Food and Drug Administration, drug companies and doctors mishandled distribution of a powerful fentanyl painkiller, allowing widespread prescribing to ineligible patients despite special measures designed to safeguard its use, according to a report released Tuesday.

The unusual paper in the medical journal JAMA relies on nearly 5,000 pages of documents that researchers obtained from the government via the Freedom of Information Act, rather than a more typical controlled scientific study.

After reviewing the data, the researchers concluded that prescribers, pharmacists, drug companies and the FDA — all of whom had agreed to special rules and monitoring for use of the powerful opioid — had allowed it to fall into the hands of thousands of inappropriate patients. Over time, the FDA and drug companies became aware this was happening but took no action, the researchers found.

Using five years of insurance claims data, the researchers found that between 34.6 percent and 55.4 percent of patients shouldn’t have received the drugs.

“The whole purpose of this distribution system was to prevent exactly what we found,” said Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins University Bloomberg School of Public Health, and one of the leaders of the study. “It should never happen. It’s a never event. And yet we found it was happening in 50 percent” of the cases.

The researchers looked at the distribution of pharmaceutical fentanyl for cancer patients experiencing “breakthrough pain” despite receiving opioids round the clock. The fentanyl, administered via lollipops, lozenges or nasal spray, marketed under several names by different companies, is about 100 times as powerful as morphine. According to the FDA, about 5,000 people in the United States receive such prescriptions at any one time.

In a statement, a spokesperson for the FDA said the agency “shares the concerns” about how the drug is being prescribed and whether its safeguards are working.

“These products are medically important for a small group of patients who are opioid-tolerant but also pose serious risks. That’s why the agency has sought to ensure that the. . . program is achieving its public health goal of assuring safe use and mitigating the risks of misuse, abuse, addiction, overdose and complications due to medication errors.”

The JAMA paper comes during the trial in Boston of Insys Therapeutics founder John Kapoor, who is accused of racketeering. Prosecutors say that the company paid doctors kickbacks to increase the use of its product Subsys, a form of fentanyl that is sprayed under the tongue for pain relief, and encouraged them to offer higher doses.

The strength of pharmaceutical fentanyl products and their quick absorption through the mucosal linings of the mouth and nose pose a serious risk of overdose, abuse and addiction for anyone who hasn’t already built up a tolerance to opioids. To guard against prescribing to such patients, the FDA created a “risk evaluation and mitigation strategy” for the products.

Under the plan, drug companies, doctors, pharmacists and patients themselves received special instruction on the use of the drugs and signed up to be part of the small, closed group allowed to prescribe, dispense and take them. Drug companies and the FDA monitored prescribing.

But the report contends that those safeguards didn’t work. In an assessment of claims data after four years, the drug industry told the FDA that 12,916 of 25,322 patients who took the drugs, or about 51 percent, had not built up tolerance to opioids, according to FDA standards.

A report after 60 months determined that 34.6 percent to 55.4 percent of patients were ineligible, depending on the product, the Hopkins researchers reported. The FDA concluded that its primary goal of keeping the drug out of the hands of ineligible patients was not being met.

The FDA responded to a few complaints that the rules tied the hands of clinical decision-makers by making the definition of opioid tolerance more specific, the report shows. Doctors have authority to prescribe medications “off-label” — for problems other than those spelled out on the drug packaging. But in this case, the drugs were specifically prohibited for patients who weren’t already tolerant of other opioids.

Drug companies were supposed to boot doctors and others who wrongly prescribed the drugs. But after two years, and in subsequent analyses, the researchers found “no reports” of the medications “being prescribed to an opioid non-tolerant individual.” No prescriber was cut from the program despite the results available in the claims data, they said. . .

Continue reading.

Outsourcing regulation to companies whose profits increase if they ignore regulatory responsibilities is the acme of stupidity. It’s equivalent to paying manufacturing quality control inspectors based on how many items pass inspection: stupid, stupid, stupid.

Written by LeisureGuy

20 February 2019 at 9:56 am

Republicans Keep Admitting Everything They Said About Obama Was a Lie

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Jonathan Chait writes in New York:

White House chief of staff Mick Mulvaney, appearing on Fox News Sunday, repeated the official administration line that Democrats had to choose between legislation and investigation. Chris Wallace reminded Mulvaney that he had supported a Republican Congress that had engaged in continuous investigations of the White House, reopening probes to chase conspiracy theories even after they had been conclusively debunked.

This prompted Mulvaney to make an interesting confession. The Republican Congress never wanted to pass laws in the first place:

WALLACE: You were there, of what the Republicans did to Barack Obama and Hillary Clinton on Benghazi, on Fast and Furious. And they got some things done despite the fact that these were aggressive partisan investigations.

MULVANEY: Well, we didn’t get very much done. Listen, I’ll be the first to admit that when the tea party wave, of which I was one, got here in 2011, the last thing we were interested in was giving President Obama legislative successes.

When somebody says “I’ll be the first to admit,” it’s usually an idiom, suggesting they are not trying to hide a fact that is widely known and frequently confessed. But in this case the sentence construction makes more sense if read literally. Mulvaney may actually be the first person to admit that congressional Republicans did not want to give Obama any legislative successes at all.

Mitch McConnell boasted that he pressured Republicans to refuse to compromise with any of the Obama administration’s priorities in his first two years (“We worked very hard to keep our fingerprints off of these proposals. Because we thought — correctly, I think — that the only way the American people would know that a great debate was going on was if the measures were not bipartisan.”).

Yet after Republicans won control of Congress on the shoulders of a tea party wave of debt hysteria in 2010, a conventional wisdom took hold that President Obama needed to get Republicans to make a deal. Most outside observers conceded that the congressional GOP might not be the easiest negotiating counterparty. Still, Obama was widely held to bear a share of the blame for his inability to get Republicans to make a deal. He didn’t play enough golf with them, or drink enough with them, or “lead.” The idea that Obama could and should force Republicans to make deals with him was pure conventional wisdom for years on end.

As a high-profile link between the Obama-era Republican Congress and the Trump administration, Mulvaney has retrospectively clarified a lot of points people refused to understand at the time. Mulvaney casually confessed last week that nobody cares about the deficit. Mulvaney of course spent the Obama era claiming to care about the deficit a lot — so much, indeed, that he was willing to shut down the government or even default on the national debt in order to reduce it. The debt hysteria was manufactured to cover a different agenda. Republicans wanted to force Obama to reduce popular domestic spending programs so they could cut taxes for the affluent. But since neither cutting retirement programs nor reducing taxes for the rich are popular goals, Republicans framed their policy as “deficit reduction,” and the debt-scold community and most of the mainstream news media took this framing at face value.

That’s one reason why Obama couldn’t make a deficit deal with Republicans: They didn’t care about the deficit. Also, as Mulvaney now casually concedes, they didn’t want to give him any accomplishments at all, so even if Obama offered a deal they could live with, they would have opposed it rather than allow him to claim legislative success. . .

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Written by LeisureGuy

11 February 2019 at 3:00 pm

Three entertaining charts: How to Lie With Statistics, Manufacturing Edition

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Written by LeisureGuy

5 February 2019 at 11:23 am

Did CIA Director Gina Haspel run a black site at Guantánamo?

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I certainly would not be surprised. She seems totally comfortable with torturing suspects (aka extreme interrogation techniques). Carol Rosenberg reports for McClatchy:

An attorney for the accused architect of the Sept. 11 attacks told a judge in a secret session last year that CIA Director Gina Haspel ran a secret agency outpost at Guantánamo, an apparent reference to a post-9/11 black site, according to a recently declassified transcript.

The claim by Rita Radostitz, a lawyer for Khalid Sheik Mohammed, appears in one paragraph of a partially redacted transcript of a secret hearing held at Guantánamo on Nov. 16. Defense lawyers were arguing, in a motion that ultimately failed, that Haspel’s role at the prison precludes the possibility of a fair trial for the men accused of orchestrating the 9/11 attacks who were also held for years in covert CIA prisons.

Neither the public nor the accused was allowed to attend the hearing but, following an intelligence review, the Pentagon released portions of its transcript on a war court website.

Haspel reportedly ran a CIA black site in Thailand where two terror suspects were waterboarded, probably before her arrival there. The unverified statement that she had a similar assignment at the terror-detention center at the U.S. Navy base at Guantánamo Bay, Cuba, would reveal a never-before disclosed chapter of the spy chief’s clandestine career.

The CIA declined to comment on the claim.

But in the transcript of a discussion about CIA torture and restrictions on the lawyers for the alleged plotters of the Sept. 11, 2001 attacks, Radostitz notes that prosecutors claim they are “not trying to cover up the torture … But the one thing that they’re not willing to talk about is the names of the people involved in the torture.” Then, after a large censored section, she says, “it makes it impossible for people at Guantánamo, who may have seen her when she was here as chief of base, to identify her and talk about it.”

Chief of base is a CIA term for the officer in charge of a secret foreign outpost. A 2014 Senate study of the CIA’s network of secret overseas prisons, called black sites, said the CIA had two such secret prisons at Guantánamo in 2003 and 2004 — apart from the Pentagon’s Guantánamo prison known as Camp Delta. While the military prison commanders’ names were disclosed, those who served as CIA chief of base were not.

The CIA sent the alleged 9/11 conspirators and other “high-value detainees” to military detention at Guantánamo in September 2006 after the captives spent three or four years in secret spy agency custody. But at least one 9/11 defendant, Ramzi bin al Shibh, was earlier held at Guantánamo, according to the public portion of the 6,200-page Senate Intelligence Committee study of the CIA’s overseas prison program, known as the torture report.

It says the agency operated two black sites there — code named Maroon and Indigo — from September 2003 to April 2004 then spirited them away for fear their captives might be entitled to attorneys.

Former CIA counterterrorism officer John Kiriakou told McClatchy that he was offered theGuantánamo chief of base position in late 2002 or early 2003 — and declined. “Nobody wanted the job,” he said. So they resorted to sending people on temporary duty assignments ranging from six weeks to nine months, he said.

“If it was during one of those periods when they couldn’t find somebody to fill the billet it would’ve made sense that she would’ve been there a short period of time,” Kiriakou said, describing a Gitmo stint as essentially a ticket punch for some agents associated with the black site program. “So when I read it, although I was surprised by it, I kind of believed it.”

Former CIA analyst Gail Helt, now a professor of Security and Intelligence Studies at King University in Tennessee, said there’s been “a lot of shadiness” with the way the spy agency has spoken about Haspel’s agency career.

An official CIA timeline of Haspel’s 33-year career notes that the agency won’t disclose 30 short-term, temporary duty assignments she held over the course of her career, suggesting they were covert. “Was one of those at Guantánamo for a couple of months?,” said Helt. “I don’t have personal knowledge of that, and couldn’t discuss it if I did. But it doesn’t surprise me.” . . .

Continue reading. There’s more.

Written by LeisureGuy

8 January 2019 at 6:54 pm

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