Thursday, September 19, 2019

Bottle of Lies


I can calculate the motions of heavenly bodies, but not the madness of people--Newton


Mom is exhausted.
I have made some progress on my hospital applications, which are unreasonably difficult.
The Pirates look destroyed.

Cole struck out 10 batters, including his 300th of the season, in eight strong innings, Yuli Gurriel and Jose Altuve homered and the Astros beat the Texas Rangers 3-2 Wednesday night to lock up a postseason berth.

This question popped up on a philosophy blog. The author is advancing it as bad thinking. So, what do you think?
"People in the legal system should not attempt to pursue justice, because they don’t know what is really just or unjust. For example, juries don’t know what is objectively just; therefore, they should just apply the law as explained to them by the judge. Judges don’t know what is really just, so they should just interpret and apply the law as written by the legislature. And lawyers don’t know whether their clients are guilty, or in general what justice requires in a given case, so they should just pursue the interests of their clients."

William Stanley Jevons (1835-1882), one of the leading British economists of the second half of the 19th century, and one of the developers of marginal utility theory, called for the end to private charity and its replacement with a full government system because of what he considered its excessive generosity. Private charity was creating a class of permanent poor, he said, which resulted in “the casual paupers [having] their London season and their country season, following the movements of those on whom they feed.”


In The Road to Serfdom Hayek explained how socialism naturally leads to totalitarianism over time and how there is, in fact, no third way of peaceful socialism:
Few recognize that the rise of fascism and Marxism was not a reaction against the socialist trends of the preceding period but a necessary outcome of those tendencies.
 
On September 19, 1957, the United States detonated a 1.7 kiloton nuclear weapon in an underground tunnel at the Nevada Test Site (NTS), a 1,375 square mile research center located 65 miles north of Las Vegas. The test, known as Rainier, was the first fully contained underground detonation and produced no radioactive fallout.


                             Bottle of Lies

This is from Bate's article reviewing Katherine Eban's disturbing new book about Indian generics called Bottle of Lies.

"Most damning of all is Eban’s assessment of the fallout from the Ranbaxy case: “Many of Ranbaxy executives had become experts at data fraud. They had spent years immersed in the intricacies of altering test data, from the research and development phase through to commercial manufacturing, all while managing questions from skeptical regulators. They had learned a system that aimed to get drug applications approved at record speed, even before the company mastered how to make the drug in question. Now these executives were leaving Ranbaxy in droves…getting jobs throughout the industry, taking their colleagues and their skillsets with them.“
Data infractions may sound trivial but they lead to lethal outcomes. For example, Ranbaxy sold numerous substandard products that probably compromised HIV and TB patients in Africa and with unknown effects in US and Wockhardt, another Indian firm, sold insulin it knew was potentially lethal to patients, including in US.
While the most acute problem is the short run danger to patients, the longer run risk is that substandard products will drive antimicrobial resistance.  Dr. Muhammed Zaman of Boston University coauthored the first study to link substandard drugs to antimicrobial resistance.
The drug in question was rifampicin, a drug my team tested and found substandard from India.  If manufactured poorly, The product  when manufactured poorly  contains a quinone impurity that leads to a mutation which allows bacteria to resist rifampicin. Those mutated bacteria are also resistant to high-quality, similar drugs too — a very concerning phenomenon. In the researcher’s tests on tuberculosis, the substandard drugs drove resistance 100-fold over non-substandard products.
While Bottle of Lies is primarily the story of Ranbaxy, it also provides a critique of the FDA. It shows several damaging traits: how inspectors can be lazy or co-opted, and those that want to push for safety are threatened or even made sick (being provided dirty water by host companies to induce sickness); how others are forced out; how FDA demands safety except when the substandard producer is the only maker of a product, then prioritizes availability; how its senior leaders and lower-level inspectors leave for lucrative jobs in the same industry they just regulated; how it approves products so that a company has enough revenue to pay fines to FDA, even when said company is known by FDA to be lying repeatedly about quality; and how FDA knowingly misleads Americans about the bioequivalence of products it allows into US to make us feel safe when it knows full well the products are not the same as the originator."

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