<ul style="list-style-type:circle;"><li>How do researchers assess psychiatric medication with nothing tangible to observe?</li><li>Are clinical trials for new psychiatric drugs really placebo-controlled?</li><li>Can researchers be relied upon to present their data in an accurate manner?</li><li>Are accepted standards of efficacy adhered to when approving new (and very expensive) drugs?</li><li>Can the FDA be relied upon as a guarantor of efficacy of the drugs it approves?</li></ul>As medicine moved into a new age beyond treating the obvious – visible injuries, nasty diseases with obvious symptoms and so forth – new ways of assessing treatment efficacy developed, chief among them the clinical trial. To cut a very long story short, the basic idea today is that when you pick up a drug from the pharmacy, you can feel confident that a bunch of scientists tested it rigorously for efficacy and safety and that the results of their trials were then passed to the FDA or its foreign equivalent. The FDA reviewed trials for accuracy and bias, approved the drug – and there you go, a solution to whatever was ailing you.That was potentially simple when dealing with a nasty germ that was exterminated on a petri dish by the latest antibiotic. But what happens when the “disease” is entirely intangible – nothing to be seen on a monitor or in a test tube? In such cases, clinical trials have to rely on the reporting of the trial participants themselves. Modern psychiatry has developed a variety of scales to rate the severity of mental illness and gauge how well a drug alleviates its features.For schizophrenia, the main scale in use is called PANSS, the Positive and Negative Syndrome Scale. It assesses things like delusions, hallucinations, apathy, lack of spontaneity, disorientation, poor impulse control, and social avoidance, assigning a score between 1 and 7 for each of the 30 items on the list for a total that can range between 30 and 210. The question then arose: When gauging the efficacy of a new drug to treat schizophrenia, how much improvement should one look for in a PANSS score? Many studies have been made to develop what is called the MCID – Minimum Clinically Important Difference. The basic consensus is that an improvement of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3786588/" target="_blank" rel="noopener noreferrer">at least 15 points</a> is necessary to declare a drug effective.On a scale of 30 to 210, 15 really isn’t very much, although of course depending on where the added points stack up, it could actually translate into significant improvement. But at least now that there are numbers to rely on, and the FDA to check that they actually exist, we can feel confident that any drug prescribed by a GP or psychiatrist is actually going to help.Right? Let’s see.The example we will be looking at here is a drug called Rexulti (brexpiprazole), used to treat schizophrenia, although many more examples are available. Rexulti went through the usual stages of clinical trials. &nbsp;You can see the summary of its Phase 3 study <a href="https://ajp.psychiatryonline.org/doi/epub/10.1176/appi.ajp.2015.14101275" target="_blank" rel="noopener noreferrer">here</a>. Around 700 people participated in the study, randomized into four groups: placebo, 0.25 mg/day, 2mg/day, and 4mg/day. The study ran for six weeks, and the authors made it easier to assess the results (a long series of tables with lots and lots of figures) by printing them nicely in a graph.Here it is:<figure class="image"><img src="/uploads/brexpip_6933413322.png"></figure>It’s quite clear from here that placebo did worst of all and that any amount of the drug did significantly better. Or is it?Take a look at this graphic instead:<figure class="image"><img src="/uploads/brexpip_a_b95f378fd8.png"></figure>This graph doesn’t appear in the article describing the Phase 3 study. It was produced by Robert Whitaker of Mad in America (see <a href="https://www.madinamerica.com/2021/11/visual-illusion-efficacy-psychiatric-drug-trials/" target="_blank" rel="noopener noreferrer">here</a>).To produce the more dramatic graph, the study’s authors took a small section of the total graph and magnified the y-axis by a factor of 7.2 (180 divided by 25). The question is: Why?After all, the study results went to the FDA; the graph wasn’t produced for advertising to the general public. But they approved Rexulti in 2015 and over the next four years, Otsuka and Lundbeck made $1.4 billion from Medicare and Medicaid sales alone.&nbsp;Placebo effectsLooking back at the graphic, we see that a placebo improved PANSS scores by around 12, the lowest dose of Rexulti by 15, and the 2mg and 4mg doses by around 21. In other words, just 9 points of improvement can be attributed to the drug, significantly less than the 15 noted above. Yet the FDA still approved Rexulti.Will your psychiatrist tell you this as he writes out a prescription for this latest wonder drug? Will your GP tell you?&nbsp;But there’s more. What does “placebo” actually mean in a trial like this one?One might have expected that a study such as this would examine the effects of Rexulti on people experiencing schizophrenia symptoms and free of all drugs (or, at least, pharma drugs) prior to the study’s onset. That is not what happened (and this is typical of psychiatric drug trials):<blockquote>Almost all patients were taking antipsychotics before the study (579 of 636, 91.0%).</blockquote>The placebo cohort comprised people who had been on powerful drugs for an undisclosed (and possibly unknown) length of time. To participate in the study they were abruptly weaned and given no substitute. While it is common (although not advisable) to transfer psychiatric patients from one drug to another without a long weaning period, what is less common (although unfortunately also found) is to transition people off psychiatric medication abruptly (aka going “cold turkey”). The results of abrupt discontinuation of psychiatric medication (and this includes commonly prescribed drugs in the benzodiazepine class) can be dramatic, even life-threatening. &nbsp;They are physiological, not just psychological.The study makes no effort to describe this possible effect on the trial results, nor to control for it. Instead, it dismisses this effect as being “related to the underlying condition”. (This too is common in psychiatric practice, when withdrawal effects from a drug are interpreted as “signs that the disease is returning” and used as justification for restarting the drug, even in cases where the person had ceased using the drug due to intolerable side effects.)What is noted is that the “overall incidence of treatment-emergent adverse events was lower in the three brexipiprazole groups than in the placebo group.” This is an interesting way of terming side effects. &nbsp;The problem, of course, is that the trial has conflated side effects with withdrawal effects from those discontinuing their previous medication in the placebo cohort.There is also no information on how long trial participants had been on antipsychotics, but what is noted is that many were on a cocktail of other drugs as well and continued to use drugs such as lorazepam (an anti-anxiety drug) throughout the trial, regardless of whether they were in a trial or a placebo cohort. How this may affect the trial results is similarly neither described nor controlled for.“Overall, 410 patients completed the study.” The reasons for which the others dropped out are not detailed; they are not even listed. Many trial participants will have dropped out after realizing that they were on a placebo and experiencing the significant discomfort that accompanies withdrawal. Others will have dropped out because of intolerable side effects. Given the divergent experiences of those in the trial, can one truly call it blinded?&nbsp;ConclusionsThe trial’s authors concluded that<blockquote>… brexpiprazole at a dosage of either 2mg or 4mg/day resulted in statistically significantly greater improvement than placebo as indicated by the primary outcome measure, change in PANSS total score…</blockquote>and that this was<blockquote>… not only statistically significant but also clinically relevant, indicated by a significantly greater change in CGI severity score…</blockquote>An increase of 9 points on a 180-point axis would not seem significant or clinically relevant to many people, but the FDA evidently though it was. &nbsp;This may be because they are not expecting much better, since<blockquote>… the numbers needed to treat for response (&gt;30% improvement in PANSS total score…) were 6 for 2mg and 7 for 4mg. Both the effect sizes and numbers needed to treat are within the midrange across examined antipsychotics…</blockquote>In other words, most drugs don’t do any better.&nbsp;The study’s authors also noted that<blockquote>… the results of this study need to be interpreted within its limitations. These include the lack of an active comparator, short study duration, and inclusion of patients with schizophrenia without other psychiatric comorbidities. However, this study was designed as an acute, short-term regulatory approval study…. Longer-term studies that include a comparator, as well as patients with common comorbid conditions, will be needed to further evaluate the efficacy, safety, and effectiveness of brexpiprazole…</blockquote>A trial with an active comparator is one in which the trial cohort is matched with a cohort on another, similar drug, rather than those not on medication. While also not ideal, this at least eliminates much of the concern regarding withdrawal symptoms muddying the trial results. From the perspective of the FDA, the consideration might also be whether there is any justification for approving a new (and very expensive) drug with a long list of side effects when pre-existing drugs are just as effective at treating the same disorder.Several further studies have been conducted to test Rexulti; none has shown a 15-point improvement in PANSS scores. The FDA has not reconsidered its approval of Rexulti; it remains a much-prescribed, and highly lucrative drug.

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Medical

Scientific, or rather, pharmacologic deception predates COVID era

Can FDA be relied upon as guarantor of drugs it approves?

A British vigilante group known as the “Blade Runners” is receiving widespread support from British taxpayers as it continues to destroy climate surveillance cameras across London.<h2>The ULEZ mandate</h2>By order of London Mayor Sadiq Khan, the city is peppered with ultra-low emission zones (ULEZs), areas accessible only to low-emission vehicles. Cars that do not meet the city’s environmental standards are charged £12.50 ($16) for entering the ULEZ. Automatic Number Plate Recognition (ANPR) cameras positioned around the zones read license plates and check them against the vehicles’ make and model in real time. If a vehicle does not meet the environmental threshold, a fine is levied against the car owner.&nbsp;The ULEZ climate mandate has drawn heavy&nbsp;<a href="https://frontline.news/post/london-hundreds-protest-against-climate-mandates">protests</a> from residents, including&nbsp;<a href="https://frontline.news/post/british-veteran-launches-hunger-strike-as-unrest-grows-over-climate-mandates">hunger strikes</a> and refusals to pay fines. Taxpayers have also taken to disabling the ANPR surveillance cameras which Transport for London (TfL), the city’s transportation department, said will be used both for climate and law enforcement.<h2>Taxpayers cheer the ‘Blade Runners’</h2>Since the climate restrictions were expanded last year, the Blade Runners have taken to disabling and destroying hundreds of cameras. Between April and September 2023, Metropolitan Police recorded 200 reports of cameras being stolen and 595 reports of cameras being vandalized.TfL began placing black boxes around ULEZ camera wirings to protect them from being cut, but taxpayers found other ways to disable the cameras — like removing them completely.<div class="raw-html-embed"><blockquote class="twitter-tweet" data-media-max-width="560"> MUST SEE: Blade Runners topple THREE ULEZ cameras in a coordinated strike… The people are fighting back! <a href="https://t.co/Yvr2Xr7Lun">pic.twitter.com/Yvr2Xr7Lun</a>— David Morgan #StayFree (@david_r_morgan) <a href="https://twitter.com/david_r_morgan/status/1802726912050995623?ref_src=twsrc%5Etfw">June 17, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>In response, the city&nbsp;<a href="https://frontline.news/post/london-taxpayers-attack-surveillance-vans-in-continued-revolt">deployed</a> mobile surveillance vans mounted with ANPR cameras across London in the hopes of evading attacks, but Blade Runners soon began targeting those as well. Some surveillance vans have been spotted covered in graffiti with their tires slashed, while others have been completely covered in tarp.Last month, 21 cameras were destroyed in the hours after Sadiq Khan was re-elected mayor of London, the&nbsp;Daily Mail&nbsp;<a href="https://www.dailymail.co.uk/news/article-13538797/Moment-Blade-Runner-uses-power-tool-cut-ULEZ-camera-traffic-light-latest-attack-Sadiq-Khans-hated-scheme.html">reported</a>. Last weekend, Blade Runners used power tools to topple a ULEZ camera and traffic lights to the delight of some fellow taxpayers. In a video that was posted to social media, passing cars can be heard honking in support.The video received over 37,000 likes. Comments on the post were largely supportive, with users writing that, “When tyranny becomes law, rebellion becomes duty,” and “Fair play to them, it's a complete scam that does nothing.”Blade Runner Matt Hardy told the&nbsp;Daily Mail&nbsp;that the Blade Runners are “people pissed off about the tyranny reigning over us and getting out and doing things about it – real votes, real boys here.”<h2>‘These cameras are not about the climate. They are about control’</h2>British actor and influencer Laurence Fox said this week he was just given back his electronic devices by police after being arrested earlier this year for cheering on the Blade Runners:<blockquote>These cameras are not about the climate. They are about control. They are the primary infrastructure for all sorts of things that ideologues like the midget dictator [Sadiq Khan] would like to impose upon us.I can now finally say the word ‘Bladerunners’ again. One of the ridiculous restrictions on free speech imposed by the police.It’s a dreadful shame to see so many of these cameras dying suddenly. I’m not at all thrilled about it. Just because I am smiling like a Cheshire Cat, it doesn’t mean that I am over the moon that these scameras continue to topple in high winds.&nbsp;Vive la résistance!</blockquote><div class="raw-html-embed"><blockquote class="twitter-tweet">POLICE UPDATE Following 6 coppers bursting into my house earlier this year to arrest me for saying how pleased I was that the <a href="https://twitter.com/hashtag/ULEZ?src=hash&amp;ref_src=twsrc%5Etfw">#ULEZ</a> scam was meeting such robust resistance, this morning the <a href="https://twitter.com/metpoliceuk?ref_src=twsrc%5Etfw">@metpoliceuk</a> were ordered by the magistrate to hand back all my devices, including my…— Laurence Fox (@LozzaFox) <a href="https://twitter.com/LozzaFox/status/1803030521095622912?ref_src=twsrc%5Etfw">June 18, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div> &nbsp;

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Pushback_Resistance

Climate Change

‘Pissed off about the tyranny reigning over us’

British taxpayers cheer vigilante group destroying climate cams

Fisker is filing for Chapter 11 bankruptcy, the electric vehicle (EV) company announced Tuesday.<h2>‘Like other companies in the electric vehicle industry’</h2>“Fisker has made incredible progress since our founding, bringing the Ocean SUV to market twice as fast as expected in the auto industry and making good on our promises to deliver the most sustainable vehicle in the world,” a spokesperson <a href="https://assets.ctfassets.net/cghen8gr8e1n/6W19OiEBJDVIFVEmo4feHA/df902c5cb2b067251a300efb0b35f611/Fisker-Filing-FINAL.pdf" target="_blank" rel="noopener noreferrer">said</a>.The California-based company added it is not the only EV maker that has been struggling to stay in business.“We are proud of our achievements, and we have put thousands of Fisker Ocean SUVs in customers’ hands in both North American [sic] and Europe. But like other companies in the electric vehicle industry, we have faced various market and macroeconomic headwinds that have impacted our ability to operate efficiently. After evaluating all options for our business, we determined that proceeding with a sale of our assets under Chapter 11 is the most viable path forward for the company.”Fisker’s collapse is the latest indication that the EV industry is folding due to sinking demand. Other EV industry players are also cutting their losses as they jump ship.<h2>Hertz</h2>In March, Hertz CEO Stephen Scherr&nbsp;<a href="https://www.motorfinanceonline.com/news/hertz-ceo-resigns-amid-ev-investment-setback/#:~:text=Scherr's%20departure%20coincides%20with%20Hertz's,electric%20vehicle%20(EV)%20rentals">resigned</a> after his bet on EVs cost the car rental giant its biggest quarterly loss since 2020. Hertz had been praised by the Biden administration for its ambition to convert 25% of its fleet to EVs by the end of this year. In January, however, the company announced it would instead be selling its 20,000 EVs — including Teslas — at heavily discounted prices and replacing them with gas-powered cars.<h2>Mercedes-Benz</h2>Mercedes-Benz also recently had to give up its ambition to only sell electric cars by 2030. Instead, EVs are expected to make up only 50% of the German carmaker’s sales over the next decade.<h2>Apple</h2>In February, Apple abandoned its multi-billion dollar effort to create an electric car. Despite being a decade in the works and employing 2,000 people, Project Titan was axed due to falling consumer demand.<h2>Aston Martin</h2>A lack of consumer demand is also partly to blame for Aston Martin&nbsp;<a href="https://www.dailymail.co.uk/news/article-13138123/Aston-Martin-puts-brakes-new-electric-supercar-2026-bosses-say-drivers-want-engines-throaty-roar.html">placing</a> its battery-operated “supercar” on hold until 2026.“Demand, certainly at an Aston Martin price point, is not what we thought it was going to be two years ago,” said Aston Martin Executive Chairman Lawrence Stroll.&nbsp;<h2>Ford</h2>In December, Ford slashed production of its flagship EV at its assembly plant in Dearborn, Michigan by half. The automaker cut the monthly production quote for the all-electric F-150 Lightning pickup truck from 3,200 units to 1,600 units per month.<h2>Biden administration continues to force EV production</h2>Nevertheless, the Biden administration in March issued new climate mandates aimed at forcing more EV production. The new rules from the Environmental Protection Agency (EPA) contain tight emissions standards that will&nbsp;<a href="https://apnews.com/article/epa-electric-vehicles-emissions-limits-climate-biden-e6d581324af51294048df24269b5d20a">require</a> 56% of new vehicle sales to be fully electric by 2032, with an additional 13% required to be hybrids.

car market decline.jpg

US News

Biden administration continues to force EV production

Electric car company files bankruptcy as EV market folds

For the last two years, British authorities have been testing AI-powered emotion recognition cameras on travelers in train stations, according to recently disclosed documents.<h2>What can the cameras see?</h2>In each of eight train stations around the UK, five to seven cameras or sensors scan the passing crowds. Using AI software from Amazon, the cameras use object recognition algorithms to spot criminal activity, trespassing, weapons, wet floors, overcrowding, and overstuffed trash cans.&nbsp;They can also alert authorities when passengers engage in “unusual behavior,” such as shouting, running, smoking, or skateboarding.&nbsp;A combination of existing cameras and newly installed smart cameras are being used for the surveillance project. All are equipped with Amazon’s Rekognition surveillance system.<h2>Emotional recognition</h2>Through a combination of facial and behavioral analyses, the Rekognition software allows officials to also <a href="https://www.wired.com/story/amazon-ai-cameras-emotions-uk-train-passengers/" target="_blank" rel="noopener noreferrer">analyze visitors’ emotions</a>. Internal documents note that the cameras can detect whether a passenger is “happy, sad [or] angry.” They can also recognize passenger satisfaction, which “could be utilized to maximum advertising and retail revenue.”<h2>Anti-social behavior</h2>Authorities can also detect passengers who exhibit “anti-social behaviour,” which&nbsp;<a href="https://www.met.police.uk/advice/advice-and-information/asb/asb/antisocial-behaviour/what-is-antisocial-behaviour/">according</a> to London’s Metropolitan Police Service means “behaviour by a person which causes, or is likely to cause, harassment, alarm or distress to persons not of the same household as the person.”<h2>Social distancing, face masks, and demographics</h2>Other&nbsp;<a href="https://www.documentcloud.org/documents/24757655-usecases_dpas_review_managed_stations?responsive=1&amp;title=1">use cases</a> for the surveillance cameras include detecting whether passengers are keeping to social distancing rules and wearing face masks. The cameras can also scan for demographics by identifying people’s age profiles and “socio-economic classification,” which the documents note can create “revenue opportunities for better targeted advertising and product placement.”<h2>‘Quite a concerning step’</h2>The documents were obtained by Big Brother Watch, a civil rights and government watchdog group, in response to a Freedom of Information (FOI) request. Network Rail, a body within the Department of Transportation which manages most of the country’s train network, has been overseeing the surveillance project.&nbsp;“The rollout and normalization of AI surveillance in these public spaces, without much consultation and conversation, is quite a concerning step,” Jake Hurfurt, head of research and investigations at Big Brother Watch,&nbsp;<a href="https://www.wired.com/story/amazon-ai-cameras-emotions-uk-train-passengers/">told</a> Wired.As of now, the surveillance systems do not use facial recognition technology, which analyzes faces and matches them against facial images stored in certain databases.

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surveillance

World News

Cameras can also detect 'anti-social behavior,' social distancing

UK tests emotion recognition cameras in train stations

The European Union (EU) is considering subjecting foreign travelers to lie detector tests administered by AI technology.&nbsp;<h2>How would it work?</h2>Authorities at airports and ferry ports would use cameras equipped with machine-learning software to detect whether a person is being untruthful. As travelers fill out their entry applications, their eye, facial, and behavioral movements would be analyzed. If the camera indicates the traveler is lying, the software will send an alert to an immigration officer who will investigate.The technology has already been successfully tested in trials conducted by EU countries in the last few years. iBorderCtrl and TRESPASS, two such trials, explored how to create an automated border control system. Several features were tested, including the lie detector tests described above. They also piloted a feature in which AI software scans the social media accounts of travelers before granting them entry.Critics of the lie-detection scheme include Patrick Breyer, a German MEP. Breyer&nbsp;<a href="https://www.dailymail.co.uk/news/article-13534215/Outrage-British-tourists-going-away-EU-countries-face-lie-detector-test-carried-artificial-intelligence-granted-entry.html">told</a> The Mail on Sunday that the technology is “pseudoscience” that threatens to profile the wrong people.&nbsp;“It will discriminate against anyone who is disabled or who has an anxious personality. It will not work,” said Breyer.<h2>Part of the Entry-Exit System</h2>If the EU decides to implement AI-powered lie detection, it will likely be introduced as part of the new Entry-Exit System (EES) due to take effect on October 6th. EES will replace the passport-stamping process by having foreign travelers apply for entry through self-service kiosks. These kiosks will collect the travelers’ biometric data, including their fingerprints and facial images.These data will eventually be stored in the Common Identity Repository (CIR), a massive database being built by the EU. The CIR will be capable of storing biometric files on 300 million individuals.&nbsp;<h2>EES for outsiders, digital ID for insiders</h2>While the EU prepares to roll out the EES for foreigners, including British citizens, it is also rolling out a digital ID program for EU citizens .Regulations that took effect last month&nbsp;<a href="https://frontline.news/post/europe-launches-digital-id-scheme/">require</a> EU&nbsp;Member States in the European Union to provide a digital ID wallet to their citizens by 2026 which must conform to the European Union Digital Identity (EUDI) wallet specifications. These specifications include the ability to store a taxpayer’s identity papers, such as driver’s licenses, health insurance cards, diplomas and other official documents.&nbsp;&nbsp;<h2>How will the wallet be used?</h2>The digital wallet will allow access to both public and private services. Uses include making payments, opening a bank account, getting prescriptions, signing contracts, traveling, accessing government services, receiving social security benefits, logging into social media accounts, and more.&nbsp;“It can also be used to facilitate the freedom of movement by storing documents such as the European Health Insurance Card,” explains the European Commission (EC) on its&nbsp;<a href="https://digital-strategy.ec.europa.eu/en/policies/eudi-wallet-implementation">website</a>.Under the current rules, the EUDI wallet will be optional for taxpayers.&nbsp;<h2>Critics raise concerns about the wallet</h2>The EUDI wallet’s main selling point is that users will be able to share only the details necessary to authenticate themselves for a given service. All other personal information will remain hidden. The EC expects this feature to satisfy widespread privacy concerns.But concerns about the wallet remain. The main worry is that while users only share those details that are necessary, the government can decide at any point which information is “necessary” to share. During the COVID-19 pandemic, for example, the European Commission made proof of vaccination necessary to access services and establishments. Prior to that, each taxpayer’s health information was considered confidential.

face scanning.jpg

Technology could be introduced with new biometric entry system

Europe may subject travelers to lie detector tests

Can FDA be relied upon as guarantor of drugs it approves?

Scientific, or rather, pharmacologic deception predates COVID era

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British taxpayers cheer vigilante group destroying climate cams

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UK tests emotion recognition cameras in train stations

Europe may subject travelers to lie detector tests