Larry Hosken. Technical writer. Puzzlehunt enthusiast.
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FTC and NY Attorney General Charge Vyera Pharmaceuticals, Martin Shkreli, and Other Defendants with Anticompetitive Scheme to Protect a List-Price Increase of More Than 4,000 Percent for Life-Saving Drug Daraprim

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The Federal Trade Commission has filed a complaint in federal court against Vyera Pharmaceuticals, LLC, alleging an elaborate anticompetitive scheme to preserve a monopoly for the life-saving drug, Daraprim.

Daraprim is the gold standard treatment for a rare, potentially fatal parasitic infection known as toxoplasmosis. In most people, toxoplasmosis is easily contained by the immune system and causes no symptoms, according to the complaint. But for those with compromised immune systems—such as individuals with HIV/AIDS, cancer patients, or recipients of organ transplants—toxoplasmosis can lead to deadly infections of the brain and lungs.

“Daraprim is a lifesaving drug for vulnerable patients,” said Gail Levine, Deputy Director of the Bureau of Competition at the Federal Trade Commission. “Vyera kept the price of Daraprim astronomically high by illegally boxing out the competition.”

The complaint, which the FTC filed jointly with the New York State Office of the Attorney General, alleges that when Vyera acquired Daraprim, the drug had been an affordable, life-saving treatment for more than 60 years. Vyera immediately raised the list price from $17.50 to $750 per tablet, which significantly impacted access to care. Because the defendants knew the increase would attract generic competition, they maneuvered to preserve the Daraprim revenue stream, according to the complaint. They illegally restrained trade through restrictive distribution agreements that ensured that would-be generic entrants could not buy samples of Daraprim, the complaint alleges. Without samples, generics were unable to conduct the FDA-mandated bioequivalence tests necessary for obtaining approval. The defendants also prevented competitors from accessing a critical ingredient used to manufacture Daraprim.

In addition, the defendants signed “data blocking” agreements preventing several distributors from selling Daraprim sales data to third-party data reporting companies, the complaint alleges. Generic companies rely on this data to assess whether a given development project is worth pursuing. With these agreements, the defendants sought to keep potential generic competitors from accurately assessing the market.

The complaint alleges that consumers and other purchasers of Daraprim likely would have saved tens of millions of dollars by purchasing generic versions of Daraprim. Instead, as a result of the defendants’ anticompetitive conduct, there is no generic version on the market today.

The FTC’s complaint also names as defendants Martin Shkreli and Kevin Mulleady, who allegedly were directly responsible for orchestrating the anticompetitive scheme, as well as Phoenixus AG, Vyera’s parent company.

The complaint seeks equitable monetary relief to provide redress to purchasers who have overpaid for the drug. The complaint also seeks remedial injunctive relief to restore competitive conditions to the market, halt any ongoing anticompetitive conduct, and prevent the defendants from engaging in similar conduct in the future.

The Commission vote authorizing the staff to file the complaint was 5-0. Commissioners Rohit Chopra and Rebecca Kelly Slaughter issued concurring statements. The complaint was filed on Jan. 27, 2020, in the U.S. District Court for the Southern District of New York.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about how competition benefits consumers or file an antitrust complaint. Like the FTC on Facebook, follow us on Twitter, read our blogs, and subscribe to press releases for the latest FTC news and resources.

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lahosken
13 hours ago
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San Francisco, USA
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Poor Craft

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Ghosting

“It’s a poor craftsman that blames his tools” is an old line, and it took me a long time to understand it.

[ https://www.youtube.com/embed/ShEez0JkOF ]

A friend of mine sent me this talk. And while I want to like it a lot, it reminded me uncomfortably of Dabblers and Blowhards, the canon rebuttal to “Hackers And Painters”, an early entry in Paul Graham’s long-running oeuvre elaborating how special and magical it is to be just like Paul Graham.

It’s surprisingly hard to pin Paul Graham down on the nature of the special bond he thinks hobbyist programmers and painters share. In his essays he tends to flit from metaphor to metaphor like a butterfly, never pausing long enough to for a suspicious reader to catch up with his chloroform jar. […] You can safely replace “painters” in this response with “poets”, “composers”, “pastry chefs” or “auto mechanics” with no loss of meaning or insight. There’s nothing whatsoever distinctive about the analogy to painters, except that Paul Graham likes to paint, and would like to feel that his programming allows him a similar level of self-expression.

There’s an old story about Soundcloud (possibly Spotify? DDG tends to the literal these days and Google is just all chaff) that’s possibly apocryphal but too good not to turn into a metaphor, about how for a long time their offices were pindrop-quiet. About how during that rapid-growth phase they hired people in part for their love of and passion for music, and how that looked absolutely reasonable until they realized their people didn’t love music: they loved their music. Your music, obviously, sucks. So everyone there wears fantastic headphones, nobody actually talks to each other, and all you can hear is in their office is keyboard noise and the HVAC.

I frequently wonder if the people who love Lisp or Smalltalk fall into that same broad category: that they don’t “love Lisp” so much as they love their Lisp, the Howl’s Moving Memory Palaces they’ve built for themselves, tailored to the precise cut of their own idiosyncracies. That if you really dig in and ask them you’ll find that other people’s Lisp, obviously, sucks.

It seems like an easy trap to fall in to, but I suspect it means we collectively spend a lot of time genuflecting this magical yesteryear and its imagined perfect crystal tools when the fact of it is that we spend almost all of our time in other people’s code, not our own.

I feel similarly about Joel Spolsky’s notion of “leaky abstractions”; maybe those abstractions aren’t “leaking” or “failing”. Instead it’s that you’ve found the point where your goals, priorities or assumptions have diverged from those of the abstraction’s author, and that’s ultimately not a problem with the abstraction.

The more time I spend in front of a keyboard, the more I think my core skills here aren’t any more complicated than humility, empathy and patience; that if you understand its authors the code will reveal itself. I’ve mentioned before that programming is, a lot more than most people realize, inherently political. You’re making decisions about how to allocate scarce resources in ways that affect other people; there’s no other word for it. So when you’re building on other people’s code, you’re inevitably building on their assumptions and values as well, and if that’s true – that you spend most of your time as a programmer trying to work with other people’s values and decisions – then it’s guaranteed that it’s a lot more important to think about how to best spend that time, or optimize those tools and interactions, rather than championing tools that amount to applied reminiscence, a nostalgia with a grammar. In any other context we’d have a term for that, we’d recognize it for what it is, and it’s unflattering.

What does a programming language optimized for ease-of-collaboration or even ease-of-empathy look like, I wonder? What does that development environment do, and how many of our assumptions about best collaborative practices are just accidental emergent properties of the shortcomings of our tools? Maybe compiler pragmas up front as expressions of preferred optimizations, and therefore priorities? Culture-of-origin tags, demarking the shared assumptions of developers? “Reds and yellows are celebratory colors here, recompile with western sensibilities to swap your alert and default palettes with muted blues/greens.” Read, Eval, Print looping feels for all its usefulness like a huge missed opportunity, an evolutionary dead end that was just the best model we could come up with forty years ago, and maybe we’ve accidentally spent a lot of time looking backwards without realizing it.

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lahosken
38 days ago
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San Francisco, USA
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How Racial Bias May Have Saved 14,000 Black Lives

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The following originally appeared on The Upshot (copyright 2019, The New York Times Company). It is jointly authored by Austin Frakt and Toni Monkovic.

When the opioid crisis began to escalate some 20 years ago, many African-Americans had a layer of protection against it.

But that protection didn’t come from the effectiveness of the American medical system. Instead, researchers believe, it came from racial stereotypes embedded within that system.

As unlikely as it may seem, these negative stereotypes appear to have shielded many African-Americans from fatal prescription opioid overdoses. This is not a new finding. But for the first time an analysis has put a number behind it, projecting that around 14,000 black Americans would have died had their mortality rates related to prescription opioids been equivalent to that of white Americans.

Source: National Center for Health Statistics, Centers for Disease Control and Prevention.

Starting in the 1990s, new prescription opioids were marketed more aggressively in white rural areas, where pain drug prescriptions were already high. African-Americans received fewer opioid prescriptions, some researchers think, because doctors believed, contrary to fact, that black people 1) were more likely to become addicted to the drugs 2) would be more likely to sell the drugs and 3) had a higher pain threshold than white people because they were biologically different.

A fourth possibility is that some white doctors were more empathetic to the pain of people who were like them, and less empathetic to those who weren’t. Some of this bias “can be unconscious,” said Dr. Andrew Kolodny, a director of opioid policy research at Brandeis University.

This accidental benefit for African-Americans is far outweighed by the long history of harm they have endured from inferior health care, including infamous episodes like the Tuskegee study. And it doesn’t remedy the way damaging stereotypes continue to influence aspects of medical practice today. “The reason to study this further is twofold,” Dr. Kolodny said. “It’s easy to imagine the harm that could come to blacks in the future, and we need to know what went wrong with whites, and how they were left exposed” to overprescribing.

The prescription-opioid-related mortality rates of black and white Americans were relatively similar two decades ago, but researchers found that by 2010, the rate was two times higher for whites than for African-Americans.

Because African-Americans were less likely to receive those prescriptions, they were less likely to become addicted (though they were more likely to endure unnecessary and excruciating pain for illnesses like cancer).

The researchers, Monica Alexander, a statistician with the University of Toronto; Mathew Kiang, an epidemiologist at Stanford; and Magali Barbieri, a demographer at the University of California, Berkeley; published their study in the journal Epidemiology.

With additional analysis at The Upshot’s request, Mr. Kiang calculated that had the African-American population’s mortality rates caused by prescription opioids been equivalent to those of whites, black Americans would have experienced 14,124 additional deaths from 1999 to 2017.

It’s a counterfactual analysis that relies on some large assumptions. Among other things, the projection assumes that the public health and medical response to the epidemic would have remained the same even if the African-American mortality rate had been higher. And it doesn’t take into consideration any potential changes in overdoses from heroin and fentanyl had African-Americans had greater access to prescription opioids. Still, Mr. Kiang found the results “fairly remarkable in at least two ways.”

“First, it’s a good example of how more medical care is not necessarily a good thing,” he said. “Second, it’s an extremely rare case where racial biases actually protected the population being discriminated against.”

A crackdown in recent years has reduced opioid prescribing over all, “and the racial/ethnic gap in opioid prescribing has narrowed,” said Mr. Kiang, but he said it was unclear whether the gap had closed entirely.

In recent years, drug overdoses have risen sharply among black Americans, particularly among older heroin users in places where fentanyl has become widespread. One reason that the death rates from heroin and fentanyl have converged between black and white people may be simple: Heroin and fentanyl are readily available outside the health system, so they’re less affected by bias within it.

The public response to drug epidemics also tends to diverge along racial lines. During the crack epidemic, there was a greater emphasis on punishment and incarceration. With the opioid crisis primarily affecting white people, there has been more emphasis on empathy and rehabilitation. (This same disparity was seen in crack versus powder cocaine.) Race played an obvious role in the policy response, Dr. Kolodny said: “From ‘Arrest our way out of it’ to, ‘It’s a disease.’”

The response to drug epidemics also cuts along class lines, said Dr. M. Norman Oliver, Virginia’s health commissioner. “At the beginning, the opioid epidemic was centered in rural Appalachia, and as long as it involved poor rural whites, it did not get much attention,” he said. “When those prescription opioids hit the more affluent white suburbs around big cities, that’s when people started paying attention.”

Race-based physiological myths have long influenced medical practice, he said. Even today, some doctors believe that African-Americans are more tolerant of pain. One study found that relative to other racial groups, physicians are twice as likely to underestimate black patients’ pain.

Several years ago, researchers at the University of Virginia, including Dr. Oliver, probed the beliefs of 222 white medical students and residents and published results in the Proceedings of the National Academy of Science. Half held false physiological beliefs about African-Americans. Nearly 60 percent thought their skins were thicker, and 12 percent thought their nerve endings were less sensitive than those of white people.

The medical students and residents who endorsed false beliefs like these were more likely to rate the pain of a black patient as less severe than that of an otherwise identical white patient and less likely to recommend treating black patients’ pain.

Other studies show that physicians, white ones in particular, implicitly prefer white patients, falsely viewing them as more intelligent and more likely to follow professional advice.

In 2013, the American Medical Association — the largest medical association in the United States — published a review of the relationship between pain and ethnicity in its Journal of Ethics. It concluded that variations in treatment stem in part from racial misconceptions about heightened pain tolerance among African-Americans and from the (false) notion that blacks and Hispanics are more likely than whites to abuse drugs.

In turn, nonwhite patients receive less pain treatment, just as there are discrepancies in how they are treated for heart diseasecancerdiabeteskidney disease, among many other illnesses.

Dr. Oliver said the bias problem in medicine was “not intractable — I’m actually hopeful that we can change the way people think.”

He is African-American and said he was old enough to remember when racism was commonly overt and direct. “It’s primarily unconscious biases today,” he said, but he didn’t want to minimize those biases either. “They can lead to death.”

It’s a bias that is overwhelmingly harmful to minority patients, even as it may have spared some from the worst outcomes of the early opioid epidemic.

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lahosken
61 days ago
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USA racism only 99.9% bad, it turns out
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California’s methane super-emitters

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Seagulls attack a garbage heap.

Enlarge (credit: Oregon Metro)

Methane is a much more potent greenhouse gas than carbon dioxide, trapping much more heat. Point-source methane emitters are typically small—usually less than 10 meters in diameter—but they emit plumes of highly concentrated methane. So if we want to reduce the amount of methane we’re spouting into the air (which we obviously should, although we’re not), they’d be great potential targets. If only we could identify them.

To map such point emissions, scientists in California flew over the state with an airborne imaging spectrometer, using it to measure methane emissions. They focused on a long list of potential sources: oil and gas production, processing, transmission, storage, and distribution equipment; refineries; dairy-manure management sites; landfills and composting facilities; wastewater-treatment plants; gas-fired power plants; and liquified and compressed natural gas facilities.

Most facilities, especially the dairies and the oil fields, were in the San Joaquin Valley. The researchers ended up measuring emissions from 564 distinct sources at 250 different facilities. These point emitters had not really been examined before, because they often only belch out their methane intermittently or in a somewhat sporadic manner. To catch them in the act, the researchers repeated the flyovers five times between August 2016 and October 2018.

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lahosken
70 days ago
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Cow farts are bad but maybe landfills are worse?
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Maersk to Trial Containerized Battery on Containership

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containerized marine batteryA.P.Moller- Maersk is getting ready to test a containerized battery on board one of its containerships as the world’s largest container shipping company continues to develop low carbon solutions in order to meet its environmental goals. The 600 kWh battery, which is housed inside a shipping container, will be installed on board the 249-meter MV Maersk […]
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lahosken
82 days ago
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I dare you to lick this intermodal freight container.
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Hero dog declines White House invitation

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Hero dog declines White House invitation
FORT BRAGG, N.C. — The Trump administration announced this week Conan, the hero canine of the US raid that killed ISIS leader and austere religious scholar Abu Bakr al-Baghdadi, would receive a VIP visit to the White House next week. Sources close to the canine report Conan may have other plans. Conan, a female Belgian […]
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lahosken
85 days ago
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San Francisco, USA
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