Physician Selling a Supplement for Mood Symptoms in Early Postpartum That Doesn’t Work

Despite media hype, a new supplement drink that doesn’t block depressive signals in the brain is not the key to beating the baby blues, according to a new study. The product, which costs $79.95 for a full dose, will be available to buy on April 11th and has been shown in trials to not reduce symptoms of post partum depression for up to six months after use. It doesn’t blunt the effects of a protein called MAO-A which interferes with mood-boosting hormones in the brain, as was hoped.

The new supplement is based on findings recently published in the journal eClinicalMedicine by researchers at Centre for Addiction and Mental Health in Canada, affiliated with the University of Toronto. Jeffrey Meyer, M.D, is the guy foisting this sugary drink on mothers. He is funded by Exeltis USA Inc, a pharmaceutical company in New Jersey.

So what did Mr. Meyer discover in his studies of his sugary blueberry juice drink for new mothers. Taken form the study is the following:

Findings

Between January 2019 and December 2022, participants took supplement (n = 51) or placebo (n = 52). There was no significant effect on primary outcome MIP on visual analogue scale for depressed mood (mean difference = −0.39 mm, 95% CI: −6.42 to 5.65 mm). Stein Maternity Blues scores, exploratory PPB measure, was lower in the active group (effect size 0.62; median, interquartile range (IQR): active 2.00 (IQR 1, 4); placebo 4.00 (IQR 1.5, 6); regression with general linear model, supplement effect, β coefficient = −1.50 (95%: CI −2.60, −0.40), p = 0.008; effect of CES-D crying category before supplement, p = 0.03–0.00000023). Twenty-six and 40 different adverse events occurred within 25% and 42% of supplement and placebo cases respectively (Chi-Square, p = 0.06).

Interpretation

The primary outcome was negative for effect on depressed mood induction, however the supplement moderately reduced PPB.

In other words, the sugary concoction failed to meet its primary objective, to prevent the induction of depressed mood in postpartum women. Despite the failure, the media is abuzz about this sugary drink. Better to eat some whole, fresh blueberries along with some nuts and seeds – it’ll provide what the supplement does (antioxidants, tryptophan, tyrosine), and more, and without the high dose of sugar.

Another Physician Foisting A Bogus Genetic Test Into the Market

Genetics have little to do with disease. But that doesn’t stop some people from pretending they do, and the hype continues. First it was the physician, Francis Collins at the NIH. So determined was Francis that he and his lab faked 5 studies to prove his point. He was promising that knowing a person’s genetic code would predict the person’s disease status, and that people would carry a genomics card in their wallet to present to physicians for treatment purposes. Apparently god told him these were the facts. That was bogus, just like his data. Now another physician, Keri Donaldson, MD, is the CEO of a company that’s had a genetic test approved by the FDA to predict opioid addiction. That too is bogus.

The FDA approved AvertD in December 2023. The prescription-only genetic test from SOLVD Health is expected to be on the market soon. AvertD detects the presence of 15 single nucleotide polymorphisms (SNPs) to help identify people who may have an increased risk of opioid addiction. It’s intended to be used in combination with clinical evaluations and patient assessments when prescription opioids are being considered to treat acute pain.

The major risks associated with AvertD are false-negative and false-positive results. Before the FDA approved it, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.

Apparently the FDA thought that the test wasn’t a very good test, but that it’s better than nothing. However, the problem isn’t that the test has weak specificity and sensitivity, the problem is that it doesn’t work.

The AvertD test will only cause harm. Patients who test negative, and their clinicians, will be left with a false sense of security, which can result in overuse of opioids and addiction. Patients who test positive will be falsely branded as prone to a highly stigmatized condition. These patients may become fearful of taking opioids, even in situations where use is beneficial.

ALS Drug Pulled From Market; It Should Never Have Gone to Market – And A New Methodology to Better Treat Neurodegeneration

Although a public corporation used poor study design and manipulated data in a small study (Phase II) that found no benefit of the drug, and that truncated needed efficacy studies (Phase III), Relyvrio was approved in 2022 by physicians at the FDA to treat ALS. Now that efficacy studies (Phase III) have been performed in 2024, the company has pulled the drug because no benefit was measured. Much money has been wasted following approval of this drug, money that could have been used for things that provide benefit and for finding therapeutics that really work.

The Continued Failure of Drug Development for Neurodegenerative Disorders

Amylyx Pharmaceuticals announced today that it has begun the process of voluntarily withdrawing its ALS drug, Relyvrio, from the market after it failed to prove efficacy in a large Phase III clinical trial. On the positive side, Relyvrio is a form of a short chain fatty acid called butyrate and was found to cause, as would be expected, few negative side effects. The bad news is it didn’t work, but was approved anyway, leading to years of wasted money and false promises to those who are suffering from a deadly disease.

So why was this lousy drug approved by physicians at the FDA?

Physicians, not scientists, run the FDA. Physicians make many decisions that are not scientifically sound. As scientists have published, “There is ample evidence that many clinical decisions made by physicians are inconsistent with current and generally accepted evidence.”  Doing things that don’t work is rampant in medicine, but those things they do make the physicians big bucks. Further, many of the physicians have conflicts of interest. They make most of their money working for the very pharma corporations that they have been tasked to regulate. And the physicians and phamra companies use tricks to avoid conflict of interest regulations. What could go wrong?

Here’s what happened at the FDA as physicians decided to approve this drug that didn’t work. As the FDA viewed it, there were a number of problems with the small trial used to approve Relyvrio. Patients recruited into the trial had been told that they might experience gastrointestinal side effects if they had been assigned the drug, so they could have guessed if they were getting the real thing or a placebo. In a trial that relied on self-reported measures, instead of more objective measures, blinding the patients is critical. Patients used the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), a self-reported data scale that measures motor impairment and functional deterioration in people with amyotrophic lateral sclerosis (ALS)

Confounding the study design were potential “baseline imbalances,” especially during the trial’s extension because those who switched from the placebo to the drug were, on average, healthier than those who had dropped out along the way, which might have exaggerated the ostensible effects. Also, some of the study’s outcomes were compared with “external” control, which were data from patients in previous decades, when the general standard of care was lower. Importantly, the FDA had proposed one method of statistical analysis, but Amylyx had elected to use an alternative method. When the FDA subjected Amylyx’s data to its own test, the results were no longer statistically significant.

The FDA was reluctant to accept the apparent five-month survival benefit, which it regarded as the result of a statistical fishing expedition. So in a small study that was designed to test safety, not efficacy, the drug was approved. This unscientific nonsense is occurring at high rate in the US, and you’re paying for it.

A New Methodology for Treating Neurodegenerative Disorders

I developed a therapeutic strategy and technology, called a systems therapeutic, where a multitude of molecules are used together, to renormalize physiology. I’ve published how to use this strategy to successfully treat ALS, and in vitro data provide evidence that this methodology may work. My strategy is even likely to benefit the development of vaccines. It’s a new paradigm in therapeutic development, very safe, and hopefully one day I can help to diminish the unscientific nonsense in drug development and move forward with an FDA approval for this new paradigm. My paradigm can also use one molecule as the therapeutic, a molecules that activates multiple targets. All diseases involve multiple pathways and therefore therapeutics need to target those multiple pathways. Most current drugs don’t this – unfortunately. We found this strategy worked to rescue degenerating retinal ganglion cells (neurons) in a model of glaucoma. We activated a number of normal physiological pathways using one drug candidate to rescue the neurons. Paradigm shifts aren’t easy and they require much time. I persist.

Oops, Another Physician Has His Medical Journal Articles Retracted – This Time It’s Columbia University

Sam Yoon, M.D. has had four medical journal articles retracted thus far, including a recent 2024 paper that featured faked data where images were used multiple times in one paper to represent different phenomenon.

Physicians in a prominent cancer lab at Columbia University, including the Chief of Cancer Surgery at Columbia, have now had four studies retracted and a stern note added to a fifth accusing it of “severe abuse of the scientific publishing system,” the latest in a long history of research misconduct by physicians. These retracted papers often live on given the publicity of the retraction often doesn’t rival the publicity of their publication. Physicians will continue to cite retracted papers by other physicians, perhaps because the papers by physicians are often ghostwritten by others – often times it is companies that ghostwrite for physicians, and both the physician and the company are morally bankrupt if they are doing this. So who cares if you cite a retracted paper.

Unfortunately, misconduct and fakery plagues the clinical trials run by physicians too. Your tax dollars, your insurance fees, and the money you pay for healthcare is supporting this physician fakery. It’s part of the Medicalization of America. Your wallet goes thin in the process, and your health suffers. If ever there were a time to reform our treatment system (some call it healthcare), the time is now.

Novel Brain Implant in 2023 From Berkeley/UCSF, Not Neuralink, Helps Paralyzed Woman Speak Using a Digital Avatar

Berkeley engineers develop an AI technology that can help restore natural communication

Published by Nature in August 2023, scientists and engineers from UC Berkeley developed a neural prosthetic to enable speech in those unable to speak because of various afflictions, such as brainstem strokes. Led by Dr. Gopala Anumanchipalli, Ph.D., Assistant Professor in Electrical Engineering and Computer Sciences at Berkeley, and implanted by Dr. Edward Chang, M.D. a neurosurgeon at UCSF, the implanted device allowed a patient to speak for the first time in 18 years since her injury. Unlike Neuralink, and the technology not developed by Elon Musk, the Berkeley/UCSF technology made little mention in mainstream media.

 The Berkeley/UCSF team implanted a paper-thin rectangle of 253 electrodes onto the surface of her brain over areas they previously discovered were critical for speech. The electrodes record the brain signals that, if not for the stroke, would have gone to muscles in Ann’s lips, tongue, jaw and larynx, as well as her face. A cable, plugged into a port fixed to Ann’s head, connected the electrodes to a bank of computers.

For weeks, the patient (Ann) worked with the team to train the system’s artificial intelligence (AI) algorithms to recognize her unique brain signals for speech. This involved repeating different phrases from a 1,024-word conversational vocabulary over and over again until the computer recognized the brain activity patterns associated with all the basic sounds of speech.

The work at Berkeley/UCSF continues without the hype of a ketamine addicted, attention seeking misanthrope who seems to dominate the corporatized mainstream media, the purveyors of stuff that reflects their “do anything for money” mentality.

A Tech Festival Where They Boo Tech – SXSW in Texas

South by Southwest 2024, a combined tech conference and entertainment industry festival held in Austin, Texas, a regressive city inhabited by conservatives like Greg Abbott, Elon Musk, and Alex Jones, ran a minute-long promotional video featuring brief clips from panels earlier in the conference. In each clip, the speakers were either explicitly pro-AI or emphasizing the nascent tech’s importance. The crowd watching the clip burst into a chorus of boos, according to footage shared on social media by film critic Marcelo Pico and by Variety.

True to Texas, the clip opens with a twangy, “Welcome to Day 4, Y’all” before the AI clips begin. 

Footage began of Josh Constine, a partner at the San Francisco-based venture capital firm SignalFire. The crowd started booing when he said, “If you look out into this room, you can tell that AI is a culture.” The video cut Constine there, but during the session featured in the clip, he continued, “There were the beats, the hippies, the punks and now the developers.” Loud boos continued through a clip of Future Today Institute CEO Amy Webb proclaiming AI’s present-day importance and another of journalist Kara Swisher saying every company will be using AI. Indeed, most are at this point, but people are so dumb they don’t realize how their lives depend on AI in the present.

If any of the booing morons had bothered to read articles about AI, including this one from the Brookings Institute that dates back to 2018, they’d know that AI is all around them and serving many useful purposes. AI is a tool, and a powerful tool. Like all tools, it can be put to good use, or as used by others, it can be not-so-good.

Beyond AI in robotics or accident prevention in our current automobiles or as used in various search engines, a recent article by BerkeleyExecEd has a nice article on how to use AI successfully in business. As written in Forbes, Pieter den Hamer, Vice President of Research at Gartner, notes, “Every job will be impacted by AI… Most of that will be more augmentation rather than replacing workers.”

So, instead of booing, learn about AI, embrace it’s positive aspects and work hard to not allow AI to be used for evil intent. It’s up to us, the people, because all change, all revolutions are created from the bottom up – from the people.

AI Models in Healthcare Are Not Generalizable When Predicting Disease

Artificial intelligence (AI) in healthcare has made claims that large datasets can be mined to predict and identify diseases and the best course of care for future patients. Unfortunately, we do not know how these models would perform in terms of predicting disease and treatment on new patients because they are rarely tested prospectively on truly independent patient samples. AI models of schizophrenia have proven themselves no better than chance prediction.

Chekroud et al. (2024) have found that machine learning models routinely achieve perfect performance in one dataset even when that dataset is a large international multisite clinical trial. However, when that exact model was tested in truly independent clinical trials, performance fell to chance levels. Even when building what should be a more robust model by aggregating across a group of similar multisite trials, subsequent predictive performance remained poor. 

Reports that statistical models can improve decision-making related to medical treatments pervade the media. However, partly because of the cost and scarcity of medical outcomes data, these models are typically based on investigators observing a model’s success in one or two datasets or clinical contexts. When Checkroud et al (2024) scrutinized how well a machine learning model performed across several independent clinical trials of antipsychotic medication for schizophrenia, the models predicted patient outcomes with high accuracy within the trial in which the model was developed but performed no better than chance when applied out-of-sample. In an attempt to improve performance of the model, data were pooled across trials to predict outcomes but did not improve predictions. Their results suggest that models predicting treatment outcomes in schizophrenia are highly context-dependent and may have limited generalizability.

In other words, AI models can be good at “predicting” what’s already known (and that is progress), but if you want to predict something new in healthcare in terms of diagnosing and treating a condition, go out and buy yourself a coin to flip, it’s much cheaper than buying an AI program.

Medical Procedure That Caused Alzheimer’s Disease

New study from the UK’s MRC finds that Alzheimer’s Disease was caused by physicians injecting growth hormone from cadavers into children. This is one more way in which the modern exposome of humans, including those exposed to modern medicine, is causing diseases such as dementia, including Alzheimer’s Disease.

Whether it’s C-sections, coronary stenting, colonoscopies, cancer screening, overprescribing antibiotics and drugs in general, physicians are making us sick.

Considering the brain, we have a generation of young people addicted to and being harmed and often dying from depression drugs, that are worse than a placebo in efficacy and with a horrible safety profile.

Your exposome, not genetics, is the cause of most disease, at least 90%, so take care of yourself by eating a plant-forward diet, exercising, staying mentally and socially engaged, and have purpose in life. Like people in the Blue Zones, if you do this, you won’t need a physician.

DeSantis Decides to Take Off His High-Heel Boots, Stop Injecting Ozempic in His Fat Ass, and Not Force a Hyena’s Smile on His Face

Meanwhile, his wife heads back to working with her Mafia family instead of campaigning with a dunce. Time to return focus on keeping Florida the crime capital of the USA.

The whiny weirdo spent $150 million for nothing, other than to put cringe on the face of a generation that had to see and listen to him.

How much was spent on his high-heel boots?

Florida, he’s all yours. Enjoy.

Four Physicians, Not Scientists, at Harvard’s Dana-Farber Cancer Institute Accused of Falsifying Research Papers

Four physicians, not scientists, working at a private university, not a public university, run by a corporation, are found to have committed fraud on numerous medical publications.

In the continued waste of taxpayer’s dollars by funding physicians to do research, DFCI President and CEO Laurie H. Glimcher, M.D., Executive Vice President and COO William C. Hahn, M.D., Senior Vice President for Experimental Medicine Irene M. Ghobrial, M.D., and Harvard Medical School professor Kenneth C. Anderson, M.D., allegedly committed research misconduct across dozens of papers. Already these physicians have have sent the journals where the papers in question were published, new figures to replace the falsified data. So far, 6 of their papers have been retracted, and 31 need modifications.

First, physicians are not trained to be scientists or to analyze science. They are taught to memorize facts, mostly outdated and not current with what scientists know, and how to administer drugs to patients as the pharma companies have told them to do. When physicians do research, it’s often fraudulent, flawed, and ghostwritten, and used to sell harmful drugs that don’t work, through what Peter Gotzsche, M.D. describes as an organized crime syndicate – otherwise known using a more genteel descriptor, The Medical Industrial Complex. With the worst health care system and the most expensive, a massive amount of government money is spent in the US on biological and medical research, almost all of which is controlled by these non-scientist physicians.  The NIH invests nearly $30.1 billion annually in medical research. The NIH controls most biological research in the US, and it is always led by physicians, not scientists. The National Science Foundation, led by scientists, the people trained to do research and analyze it, funds little biological research. When NSF does fund biological related research, such as the chemistry performed by Jennifer Doudna, Ph.D. at Berkeley, and the physics performed by Don Glaser, Ph.D. at Berkeley, consequential discoveries and outcomes result. Dr. Doudna was awarded the Nobel Prize in chemistry for her co-creation of CRISPR, and Nobel Laureate, Dr Glaser started the biotech industry in 1971 with his co-creation of Cetus Corp, leading to doctor of chemistry (Ph.D. Chemistry, Berkeley), Kary Mullis’ Nobel Prize for the creation of PCR. Notice what happens with public funding of public universities directed by and to Ph.D. scientists. Of course, some of the funding by the NIH results in good work. Case in point, and continuing with public funding at a public university, Berkeley, the NIH funded Prof. Dr. Jim Allsison, Ph.D, for his work at Berkeley on checkpoint inhibition of T-cells in cancer. His Nobel Prize winning research eventually led to the development of checkpoint inhibitors for cancer treatment, a revolutionary new paradigm of immunotherapy for cancer..

As Marcia Angell, M.D., former editor in chief of NEJM wrote in 2009, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor” A private school, led by a corporation, which is led by Penny Pritzker, a corrupt billionaire-heiress of the notorious Pritzker fortune, Harvard is an epicenter of medical corruption. Whether it was the fraud of John Darsee, M.D., Piero Anversa, M.D. , Ellis Reinherz, M.D., Robert B. Fogel, M.D., or Elizabeth Homes (Stanford dropout and a Houston-born daughter of an Enron executive), of the fraudulent company, Theranos, who became a member of the Harvard Medical School’s Board of Fellows, the place is a den of fraudsters. And get this, some of these Harvard Medical School physicians are replicating themselves without the surrogate mother’s awareness. Once again, truth is stranger than fiction.

These physicians join the international list of fraudsters in medicine, including Japanese physicians Yoshihiro Sato, M.D. and Jun Iwamoto, M.D., who have almost 300 papers “that bore signs of fabrication and other ethical lapses. Nearly half have been retracted.” However, in the current rankings, Joachim Boldt, M.D. of Germany is in the lead with 184 papers retracted. Yoshitaka Fujii, M.D., also of Japan, is in second place with 171 retracted medical papers.

And the editors at the medical journals, they’re as corrupt as the physicians who submit the fraudulent articles. State medical boards are corrupt and/or inept and do little to protect patients from corrupt and inept physicians. So too are the physicians at the NIH, where one-third of HHS (Human Health Services, of which NIH is a part) appointees between 2004 and 2020 exited to industry. Compared with other sectors (for example, government, nonprofit, and academia), industry accounted for the greatest share of exits. This HHS industry exit rate is somewhat higher than that reported for appointees at the Department of Defense, which was the only other agency for which we could find revolving-door estimates (32 percent versus 28 percent). Physicians are the salespeople for drug companies, being the only people that can legally sell prescription drugs, and their money-making sales schemes are often fraudulent. Sometimes their fraudulent sales schemes are as reviewers for the FDA, as they are paid-off by the drug companies. These are the guys deciding what drugs will be approved for sale by physicians, after having reviewed the fraudulent, ghostwritten clinical trial studies presented by physicians on behalf of their money-suppliers, the pharma companies.

Little wonder why most prescription drugs don’t work, and most medical procedures may only cause harm. Medicine is all about the money, and little else matters. Solution – put the biological research in the hands of scientists at the NSF, and stop the privatization of clinical trials that were foisted on us by Ronald Reagan’s privatization and deregulation of almost everything..